Adherence and retention in clinical trials: a community-based approach.

PubMed

Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine; Person, Sharina D; Partridge, Edward E

2014-04-01

The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials. © 2014 American Cancer Society.

Limb length inequality: clinical implications for assessment and intervention.

PubMed

Brady, Rebecca J; Dean, John B; Skinner, T Marc; Gross, Michael T

2003-05-01

The purpose of this paper is to review relevant literature concerning limb length inequalities in adults and to make recommendations for assessment and intervention based on the literature and our own clinical experience. Literature searches were conducted in the MEDLINE, PubMed, and CINAHL databases. Limb length inequality and common classification criteria are defined and etiological factors are presented. Common methods of detecting limb length inequality include direct (tape measure methods), indirect (pelvic leveling), and radiological techniques. Interventions include shoe inserts or external shoe lift therapy for mild cases. Surgery may be appropriate in severe cases. Little agreement exists regarding the prevalence of limb length inequality, the degree of limb length inequality that is considered clinically significant, and the reliability and validity of assessment methods. Based on correlational studies, the relationship between limb length inequality and orthopaedic pathologies is questionable. Stronger support for the link between low back pain (LBP) and limb length inequality is provided by intervention studies. Methods involving palpation of pelvic landmarks with block correction have the most support for clinical assessment of limb length inequality. Standing radiographs are suggested when clinical assessment methods are unsatisfactory. Clinicians should exercise caution when undertaking intervention strategies for limb length inequality of less than 5 mm when limb length inequality has been identified with clinical techniques. Recommendations are provided regarding intervention strategies.

An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers.

PubMed

Hagedorn, Hildi J; Stetler, Cheryl B; Bangerter, Ann; Noorbaloochi, Siamak; Stitzer, Maxine L; Kivlahan, Daniel

2014-07-09

One of the pressing concerns in health care today is the slow rate at which promising interventions, supported by research evidence, move into clinical practice. One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data. This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration (VHA) medical centers. Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial, were assigned to the intervention arm, and completed a post intervention survey (n = 147). All staff and leadership from the participating clinics were eligible to participate. A descriptive process evaluation was used, focused on participant perceptions and contextual/feasibility issues. Data collection was guided by the RE-AIM and PARIHS implementation frameworks. Data collection methods included chart review, intervention cost tracking, patient and staff surveys, and qualitative interviews with staff and administrators. Results indicated that patients, staff and administrators held generally positive attitudes toward the incentive intervention. However, staff and administrators identified substantial barriers to routine implementation. Despite the documented low cost and modest staff time required for implementation of the intervention, securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers. Recommendations to facilitate implementation are presented. Recommendations include: 1) solicit explicit support from the highest levels of the organization through, for example, performance measures or clinical practice guideline recommendations; 2) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread; and 3) educate staff about the process, goals, and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention.

The Virtual Maternity Clinic: a teaching and learning innovation for midwifery education.

PubMed

Phillips, Diane; Duke, Maxine; Nagle, Cate; Macfarlane, Susie; Karantzas, Gery; Patterson, Denise

2013-10-01

There are challenges for midwifery students in developing skill and competency due to limited placements in antenatal clinics. The Virtual Maternity Clinic, an online resource, was developed to support student learning in professional midwifery practice. Identifying students' perceptions of the Virtual Maternity Clinic; learning about the impact of the Virtual Maternity Clinic on the students' experience of its use and access; and learning about the level of student satisfaction of the Virtual Maternity Clinic. Two interventions were used including pre and post evaluations of the online learning resource with data obtained from questionnaires using open ended and dichotomous responses and rating scales. The pre-Virtual Maternity Clinic intervention used a qualitative design and the post-Virtual Maternity Clinic intervention applied both qualitative and quantitative approaches. Three campuses of Deakin University, located in Victoria, Australia. Midwifery students enrolled in the Bachelor of Nursing/Bachelor of Midwifery and Graduate Diploma of Midwifery were recruited across three campuses of Deakin University (n=140). Thematic analysis of the pre-Virtual Maternity Clinic intervention (return rate n=119) related to students' expectations of this resource. The data for the post-Virtual Maternity Clinic intervention (return rate n=42) including open-ended responses were thematically analysed; dichotomous data examined in the form of frequencies and percentages of agreement and disagreement; and 5-rating scales were analysed using Pearson's correlations (α=.05, two-tailed). Results showed from the pre-Virtual Maternity Clinic intervention that students previously had placements in antenatal clinics were optimistic about the online learning resource. The post-Virtual Maternity Clinic intervention results indicated that students were satisfied with the Virtual Maternity Clinic as a learning resource despite some technological issues. The Virtual Maternity Clinic provides benefits for students in repeated observation of the practice of the midwife to support their professional learning and practice development. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effective Mental Health Interventions and Treatments for Young Children with Diverse Needs

ERIC Educational Resources Information Center

Osofsky, Joy; Wieder, Serena; Noroña, Carmen Rosa; Lowell, Darcy; Worthy, D'Lisa Ramsey

2018-01-01

Infant and early childhood mental health interventions and treatment take place in many different settings including clinics serving adults and children, primary care centers, pediatric clinics, private practice offices, homes, early intervention offices, and child care centers. In addition, the types of evaluations and services offered in these…

Early intervention and recovery among children with failure to thrive: follow-up at age 8.

PubMed

Black, Maureen M; Dubowitz, Howard; Krishnakumar, Ambika; Starr, Raymond H

2007-07-01

We sought to examine the impact of a randomized, controlled trial of home visiting among infants with failure to thrive on growth, academic/cognitive performance, and home/classroom behavior at age 8. Infants with failure to thrive (N = 130) or adequate growth (N = 119) were recruited from pediatric primary care clinics serving low-income, urban communities. Eligibility criteria included age <25 months, gestational age >36 weeks, birth weight >2500 g, and no significant medical conditions. Evaluation included anthropometries, Bayley scales, maternal anthropometries, demographics, negative affect, IQ, and the Home Observation for Measurement of the Environment scale. Infants with failure to thrive were treated in an interdisciplinary growth and nutrition clinic and randomized into clinical-intervention-plus-home-intervention or clinical-care-only groups. The home-visiting curriculum promoted maternal sensitivity, parent-infant relationships, and child development. Follow-up visits were conducted by evaluators who were unaware of the children's growth or intervention history. At age 8, the evaluation included anthropometries, the Wechsler Intelligence Scale for Children III, and the Wide Range Achievement Test, Revised. Mothers completed the Child Behavior Checklist and teachers completed the Teacher Report Form. Multivariate analyses of variance were used to examine differences in growth, cognitive/academic performance, and home/school behavior, adjusted by maternal education, public assistance, and, when appropriate, infant Bayley score, maternal BMI, height, negative affect, IQ, and Home Observation for Measurement of the Environment scores. Retention was 74% to 78%. Children in the adequate-growth group were significantly taller, heavier, and had better arithmetic scores than the clinical-intervention-only group, with the clinical-intervention-plus-home-intervention group intermediate. There were no group differences in IQ, reading, or mother-reported behavior problems. Children in the clinical-intervention-plus-home-intervention group had fewer teacher-reported internalizing problems and better work habits than the clinical-intervention-only group. Early failure to thrive increased children's vulnerability to short stature, poor arithmetic performance, and poor work habits. Home visiting attenuated some of the negative effects of early failure to thrive, possibly by promoting maternal sensitivity and helping children build strong work habits that enabled them to benefit from school. Findings provide evidence for early intervention programs for vulnerable infants.

Selecting a Clinical Intervention Documentation System for an Academic Setting

PubMed Central

Andrus, Miranda; Hester, E. Kelly; Byrd, Debbie C.

2011-01-01

Pharmacists' clinical interventions have been the subject of a substantial body of literature that focuses on the process and outcomes of establishing an intervention documentation program within the acute care setting. Few reports describe intervention documentation as a component of doctor of pharmacy (PharmD) programs; none describe the process of selecting an intervention documentation application to support the complete array of pharmacy practice and experiential sites. The process that a school of pharmacy followed to select and implement a school-wide intervention system to document the clinical and financial impact of an experiential program is described. Goals included finding a tool that allowed documentation from all experiential sites and the ability to assign dollar savings (hard and soft) to all documented interventions. The paper provides guidance for other colleges and schools of pharmacy in selecting a clinical intervention documentation system for program-wide use. PMID:21519426

Selecting a clinical intervention documentation system for an academic setting.

PubMed

Fox, Brent I; Andrus, Miranda; Hester, E Kelly; Byrd, Debbie C

2011-03-10

Pharmacists' clinical interventions have been the subject of a substantial body of literature that focuses on the process and outcomes of establishing an intervention documentation program within the acute care setting. Few reports describe intervention documentation as a component of doctor of pharmacy (PharmD) programs; none describe the process of selecting an intervention documentation application to support the complete array of pharmacy practice and experiential sites. The process that a school of pharmacy followed to select and implement a school-wide intervention system to document the clinical and financial impact of an experiential program is described. Goals included finding a tool that allowed documentation from all experiential sites and the ability to assign dollar savings (hard and soft) to all documented interventions. The paper provides guidance for other colleges and schools of pharmacy in selecting a clinical intervention documentation system for program-wide use.

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Interventions to Improve Sexually Transmitted Disease Screening in Clinic-Based Settings.

PubMed

Taylor, Melanie M; Frasure-Williams, Jessica; Burnett, Phyllis; Park, Ina U

2016-02-01

The asymptomatic nature and suboptimal screening rates of sexually transmitted diseases (STD) call for implementation of successful interventions to improve screening in community-based clinic settings with attention to cost and resources. We used MEDLINE to systematically review comparative analyses of interventions to improve STD (chlamydia, gonorrhea, or syphilis) screening or rescreening in clinic-based settings that were published between January 2000 and January 2014. Absolute differences in the percent of the target population screened between comparison groups or relative percent increase in the number of tests or patients tested were used to score the interventions as highly effective (>20% increase) or moderately effective (5%-19% increase) in improving screening. Published cost of the interventions was described where available and, when not available, was estimated. Of the 4566 citations reviewed, 38 articles describing 42 interventions met the inclusion criteria. Of the 42 interventions, 16 (38.1%) were categorized as highly effective and 14 (33.3%) as moderately effective. Effective low-cost interventions (<$1000) included the strategic placement of specimen collection materials or automatic collection of STD specimens as part of a routine visit (7 highly effective and 1 moderately effective) and the use of electronic health records (EHRs; 3 highly effective and 4 moderately effective). Patient reminders for screening or rescreening (via text, telephone, and postcards) were highly effective (3) or moderately effective (2) and low or moderate cost (<$1001-10,000). Interventions with dedicated clinic staff to improve STD screening were highly effective (2) or moderately effective in improving STD screening (1) but high-cost ($10,001-$100,000). Successful interventions include changing clinic flow to routinely collect specimens for testing, using EHR screening reminders, and reminding patients to get screened or rescreened. These strategies can be tailored to different clinic settings to improve screening at a low cost.

Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes

PubMed Central

Oles, Sylwia K.; Mundell, James; London, Susan; Khan, Babar

2016-01-01

Objective The purpose of this scoping review was to identify evidence describing benefits of interventions provided in ICU-survivor follow-up clinics. Background Advances in intensive care unit (ICU) treatments have increased the number of survivors who require specialized care for ICU-related sequelae. ICU survivor follow-up clinics exist yet little is known about the nature and impact of interventions provided in such clinics. A scoping review of publications about in-person post-ICU follow-up care was undertaken. Method Ten databases were searched yielding one-hundred eleven relevant unique publication titles and abstracts. Sample heterogeneity supported using a scoping review method. After excluding non-related publications, 33 reports were fully reviewed. Twenty international publications were included that described ICU follow-up clinic interventions and/or outcomes. Results Authors discussed very diverse interventions in 15 publications, and 9 reported some level of intervention effectiveness. Evidence was strongest that supported the use of prospective diaries as an intervention to prevent or improve psychological symptoms whereas evidence to support implementation of other interventions was weak. Conclusions Although ICU follow-up clinics exist, evidence for interventions and effectiveness of treatments in these clinics remains under-explored. Implications ICU survivor follow-up clinics provide a venue for further interdisciplinary intervention research that could lead to better health outcomes for ICU survivors. PMID:27309787

Implementation Process of a Canadian Community-based Nurse Mentorship Intervention in HIV Care

PubMed Central

Caine, Vera; Mill, Judy; O’Brien, Kelly; Solomon, Patricia; Worthington, Catherine; Dykeman, Margaret; Gahagan, Jacqueline; Maina, Geoffrey; De Padua, Anthony; Arneson, Cheryl; Rogers, Tim; Chaw-Kant, Jean

2016-01-01

We describe salient individual and organizational factors that influenced engagement of registered nurses in a 12-month clinical mentorship intervention on HIV care in Canada. The intervention included 48 nurses and 8 people living with HIV (PLWH) who were involved in group-based and one-on-one informal mentorship informed by transformative learning theory. We evaluated the process of implementing the mentorship intervention using qualitative content analysis. The inclusion of PLWH as mentors, the opportunities for reciprocal learning, and the long-term commitment of individual nurses and partner organizations in HIV care were major strengths. Challenges included the need for multiple ethical approvals, the lack of organizational support at some clinical sites, and the time commitment required by participants. We recommend that clinical mentorship interventions in HIV care consider organizational support, adhere to the Greater Involvement of People Living with HIV/AIDS principles, and explore questions of professional obligations. PMID:26644019

Information Technology-Based Interventions to Improve Drug-Drug Interaction Outcomes: A Systematic Review on Features and Effects.

PubMed

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Medlock, Stephanie; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

The purpose of this systematic review was to identify features and effects of information technology (IT)-based interventions on outcomes related to drug-drug interactions (DDI outcomes). A literature search was conducted in Medline, EMBASE, and the Cochrane Library for published English-language studies. Studies were included if a main outcome was related to DDIs, the intervention involved an IT-based system, and the study design was experimental or observational with controls. Study characteristics, including features and effects of IT-based interventions, were extracted. Nineteen studies comprising five randomized controlled trials (RCT), five non-randomized controlled trials (NRCT) and nine observational studies with controls (OWC) were included. Sixty-four percent of prescriber-directed interventions, and all non-prescriber interventions, were effective. Each of the following characteristics corresponded to groups of studies of which a majority were effective: automatic provision of recommendations within the providers' workflow, intervention at the time of decision-making, integration into other systems, and requiring the reason for not following the recommendations. Only two studies measured clinical outcomes: an RCT that showed no significant improvement and an OWC that showed improvement, but did not statistically assess the effect. Most studies that measured surrogate outcomes (e.g. potential DDIs) and other outcomes (e.g. adherence to alerts) showed improvements. IT-based interventions improve surrogate clinical outcomes and adherence to DDI alerts. However, there is lack of robust evidence about their effectiveness on clinical outcomes. It is recommended that researchers consider the identified features of effective interventions in the design of interventions and evaluate the effectiveness on DDI outcomes, particularly clinical outcomes.

Evidence-Based Parenting Interventions to Promote Secure Attachment

PubMed Central

Wright, Barry; Edginton, Elizabeth

2016-01-01

Various interventions are used in clinical practice to address insecure or disorganized attachment patterns and attachment disorders. The most common of these are parenting interventions, but not all have a robust empirical evidence base. We undertook a systematic review of randomized trials comparing a parenting intervention with a control, where these used a validated attachment instrument, in order to evaluate the clinical and cost-effectiveness of interventions aiming to improve attachment in children with severe attachment problems (mean age <13 years). This article aims to inform clinicians about the parenting interventions included in our systematic review that were clinically effective in promoting secure attachment. For completeness, we also briefly discuss other interventions without randomized controlled trial evidence, identified in Patient Public Involvement workshops and expert groups at the point our review was completed as being used or recommended. We outline the key implications of our findings for clinical practice and future research. PMID:27583298

Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

PubMed

McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

2017-10-01

The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

Barriers to participation in clinical trials: a physician survey.

PubMed

Mahmud, A; Zalay, O; Springer, A; Arts, K; Eisenhauer, E

2018-04-01

Clinical trials are vital for evidence-based cancer care. Oncologist engagement in clinical trials has an effect on patient recruitment, which in turn can affect trial success. Identifying barriers to clinical trial participation might enable interventions that could help to increase physician participation. To assess factors affecting physician engagement in oncology trials, a national survey was conducted using the online SurveyMonkey tool (SurveyMonkey, San Mateo, CA, U.S.A.; http://www.surveymonkey.com). Physicians associated with the Canadian Cancer Clinical Trials Network and the Canadian Cancer Trials Group were asked about their specialty, years of experience, barriers to participation, and motivating interventions, which included an open-ended question inviting survey takers to suggest interventions. The survey collected 207 anonymous responses. Respondents were predominantly medical oncologists (46.4%), followed by radiation oncologists (24.6%). Almost 70% of the respondents had more than 10 years of experience. Significant time constraints included extra paperwork (77%), patient education (54%), and extended follow-up or clinic visits (53%). Timing of events within trials was also a barrier to participation (55%). Most respondents favoured clinical work credits (72%), academic credits (67%), a clinical trial alert system (75%), a regular meeting to review trial protocols (65%), and a screening log to aid in patient accrual (67%) as motivational strategies. Suggested interventions included increased support staff, streamlined regulatory burden, and provision of greater funding for trials and easier access to ancillary services. The present study confirms that Canadian oncologists are willing to participate in clinical research, but face multiple barriers to trial participation. Those barriers could be mitigated by the implementation of several interventions identified in the study.

A systematic review of evidence relating to clinical supervision for nurses, midwives and allied health professionals.

PubMed

Pollock, Alex; Campbell, Pauline; Deery, Ruth; Fleming, Mick; Rankin, Jean; Sloan, Graham; Cheyne, Helen

2017-08-01

The aim of this study was to systematically review evidence relating to clinical supervision for nurses, midwives and allied health professionals. Since 1902 statutory supervision has been a requirement for UK midwives, but this is due to change. Evidence relating to clinical supervision for nurses and allied health professions could inform a new model of clinical supervision for midwives. A systematic review with a contingent design, comprising a broad map of research relating to clinical supervision and two focussed syntheses answering specific review questions. Electronic databases were searched from 2005 - September 2015, limited to English-language peer-reviewed publications. Systematic reviews evaluating the effectiveness of clinical supervision were included in Synthesis 1. Primary research studies including a description of a clinical supervision intervention were included in Synthesis 2. Quality of reviews were judged using a risk of bias tool and review results summarized in tables. Data describing the key components of clinical supervision interventions were extracted from studies included in Synthesis 2, categorized using a reporting framework and a narrative account provided. Ten reviews were included in Synthesis 1; these demonstrated an absence of convincing empirical evidence and lack of agreement over the nature of clinical supervision. Nineteen primary studies were included in Synthesis 2; these highlighted a lack of consistency and large variations between delivered interventions. Despite insufficient evidence to directly inform the selection and implementation of a framework, the limited available evidence can inform the design of a new model of clinical supervision for UK-based midwives. © 2017 John Wiley & Sons Ltd.

How can primary care providers manage pediatric obesity in the real world?

PubMed

Hopkins, Kristy F; Decristofaro, Claire; Elliott, Lydia

2011-06-01

To provide information regarding evidence-based interventions and clinical practice guidelines as a basis for a clinical toolkit utilizing a step management approach for the primary care provider in managing childhood obesity. Evidence-based literature including original clinical trials, literature reviews, and clinical practice guidelines. Interventions can be stratified based on initial screening of children and adolescents so that selection of treatment options is optimized. For all treatments, lifestyle modifications include attention to diet and activity level. Levels of initial success, as well as maintenance of target body mass index, may be related to the intensity and duration of interventions; involvement of family may increase success rates. For failed lifestyle interventions, or for patients with extreme obesity and/or certain comorbidities, pharmacologic or surgical options should be considered. Many intensive programs have shown success, but the resources required for these approaches may be unavailable to the typical community provider and family. However, using current guidelines, the primary care provider can initiate and manage ongoing interventions in pediatric obesity. A toolkit for primary care implementation and maintenance interventions is provided. ©2011 The Author(s) Journal compilation ©2011 American Academy of Nurse Practitioners.

Endoscopic vs. Surgical Interventions for Painful Chronic Pancreatitis: What is Needed for Future Clinical Trials

PubMed Central

Windsor, John A; Reddy, Nageshwar D

2017-01-01

The treatment of painful chronic pancreatitis remains controversial. The available evidence from two randomized controlled trials favor surgical intervention, whereas an endotherapy-first approach is widely practiced. Chronic pancreatitis is complex disease with different genetic and environmental factors, different pain mechanisms and different treatment modalities including medical, endoscopic, and surgical. The widely practiced step-up approach remains unproven. In designing future clinical trials there are some important pre-requisites including a more comprehensive pain assessment tool, the optimization of conservative medical treatment and interventional techniques. Consideration should be given to the need of a control arm and the optimal timing of intervention. Pending better designed studies, the practical way forward is to identify subgroups of patients who clearly warrant endotherapy or surgery first, and to design the future clinical trials for the remainder. PMID:28079861

Economic Analysis of Nutrition Interventions for Chronic Disease Prevention: Methods, Research, and Policy

PubMed Central

Wong, John B.; Coates, Paul M.; Russell, Robert M.; Dwyer, Johanna T.; Schuttinga, James A.; Bowman, Barbara A.; Peterson, Sarah A.

2011-01-01

Increased interest in the potential societal benefit of incorporating health economics as a part of clinical translational science, particularly nutrition interventions, led the Office of Dietary Supplements at the National Institutes of Health to sponsor a conference to address key questions about economic analysis of nutrition interventions to enhance communication among health economic methodologists, researchers, reimbursement policy makers, and regulators. Issues discussed included the state of the science, such as what health economic methods are currently used to judge the burden of illness, interventions, or health care policies, and what new research methodologies are available or needed to address knowledge and methodological gaps or barriers. Research applications included existing evidence-based health economic research activities in nutrition that are ongoing or planned at federal agencies. International and U.S. regulatory, policy and clinical practice perspectives included a discussion of how research results can help regulators and policy makers within government make nutrition policy decisions, and how economics affects clinical guideline development. PMID:21884133

[Clinical use of interventional MR imaging].

PubMed

Kahn, Thomas; Schulz, Thomas; Moche, Michael; Prothmann, Sascha; Schneider, Jens-Peter

2003-01-01

The integration of diagnostic and therapeutic procedures by MRI is based on the combination of excellent morphologic and functional imaging. The spectrum of MR-guided interventions includes biopsies, thermal ablation procedures, vascular applications, and intraoperative MRI. In all these applications, different scientific groups have obtained convincing results in basic developments as well as in clinical use. Interventional MRI (iMRI) is expected to attain an important role in interventional radiology, minimal invasive therapy, and monitoring of surgical procedures.

Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program.

PubMed

Drieling, Rebecca L; Ma, Jun; Stafford, Randall S

2011-02-14

Obesity exerts an enormous health impact through its effect on coronary heart disease and its risk factors. Primary care-based and community-based intensive lifestyle counseling may effectively promote weight loss. There has been limited implementation and evaluation of these strategies, particularly the added benefit of community-based intervention, in low-income Latino populations. The Vivamos Activos Fair Oaks project is a randomized clinical trial designed to evaluate the clinical and cost-effectiveness of two obesity reduction lifestyle interventions: clinic-based intensive lifestyle counseling, either alone (n = 80) or combined with community health worker support (n = 80), in comparison to usual primary care (n = 40). Clinic-based counseling consists of 15 group and four individual lifestyle counseling sessions provided by health educators targeting behavior change in physical activity and dietary practices. Community health worker support includes seven home visits aimed at practical implementation of weight loss strategies within the person's home and neighborhood. The interventions use a framework based on Social Cognitive Theory, the Transtheoretical Model of behavior change, and techniques from previously tested lifestyle interventions. Application of the framework was culturally tailored based on past interventions in the same community and elsewhere, as well as a community needs and assets assessment. The interventions include a 12-month intensive phase followed by a 12-month maintenance phase. Participants are obese Spanish-speaking adults with at least one cardiovascular risk factor recruited from a community health center in a low-income neighborhood of San Mateo County, California. Follow-up assessments occur at 6, 12, and 24 months for the primary outcome of percent change in body mass index at 24 months. Secondary outcomes include specific cardiovascular risk factors, particularly blood pressure and fasting glucose levels. If successful, this study will provide evidence for broad implementation of obesity interventions in minority populations and guidance about the selection of strategies involving clinic-based case management and community-based community health worker support. ClinicalTrials.gov: NCT01242683.

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Early awareness and uptake of an effective waiting room video intervention by STD clinics.

PubMed

DeShazo, Jonathan P; Richardson, Douglas B; Malotte, C Kevin; Rietmeijer, Cornelis A

2011-12-01

Successful diffusion and adoption is critical for the effectiveness and impact of a new intervention. The objective of this research was to evaluate the uptake and implementation of a newly released educational waiting room video in US sexually transmitted diseases (STD) Clinics. A telephone survey was administered to a random sample of 73 clinic directors representing 76 US STD clinics 3 to 5 months following the availability of the intervention. A qualitative analysis was used to categorize survey responses and detect associations among them. Of the 76 clinics, 22% were aware of the intervention and 17% had ordered the intervention kit. The most frequently reported sources for hearing about the video were interpersonal communication/word of mouth, national conferences, and the STDPreventionOnline.org Website. The majority (74%) of clinic directors reported using state or local entities as primary sources of new information; however, reporting these channels was associated with unawareness of the new intervention. Facilitators to adoption included having adequate video/DVD equipment (55%) and a separate, nonshared waiting room for STD services in which to show the video (47%). The data from this sample suggest that making greater use of prominent thought leaders and interpersonal communication, including social networking, and professional groups may improve awareness of new interventions. Some barriers to adoption, such as lack of equipment, have relatively inexpensive solutions yet bureaucratic or technical support issues may still play a role. However, some structural barriers, such as shared waiting areas, will require innovative alternatives to conventional practice.

Enhancing system-wide implementation of opioid prescribing guidelines in primary care: protocol for a stepped-wedge quality improvement project.

PubMed

Zgierska, Aleksandra E; Vidaver, Regina M; Smith, Paul; Ales, Mary W; Nisbet, Kate; Boss, Deanne; Tuan, Wen-Jan; Hahn, David L

2018-06-05

Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

A Two-Week Psychosocial Intervention Reduces Future Aggression and Incarceration in Clinically Aggressive Juvenile Offenders.

PubMed

Kendall, Ashley D; Emerson, Erin M; Hartmann, William E; Zinbarg, Richard E; Donenberg, Geri R

2017-12-01

There is a largely unmet need for evidence-based interventions that reduce future aggression and incarceration in clinically aggressive juvenile offenders serving probation. We addressed this gap using a group randomized controlled trial. Offenders both with and without clinical aggression were included, enabling comparison of intervention effects. Juveniles 13 to 17 years old (N = 310, mean = 16 years, 90% African-American, 66% male) on probation were assigned to a 2-week intervention targeting psychosocial factors implicated in risky behavior (e.g., learning strategies to manage "hot" emotions that prompt risk taking) or to an equally intensive health promotion control. Participants completed aggression measures at baseline, 6-, and 12-month follow-up and reported on incarceration at 12 months. Spline regression tested symptom change. Among clinically aggressive offenders (n = 71), the intervention arm showed significantly greater reductions in aggression over the first 6 months compared with controls. Juveniles from the intervention no longer met clinical criteria, on average, but clinically significant symptoms persisted in the control group. By 12 months, participants from the intervention appeared to maintain treatment gains, but their symptom levels no longer differed significantly from those in the control. However, the intervention group was nearly 4 times less likely than controls to report incarceration. Intervention effects were significantly stronger for offenders with clinical than with nonclinical (n = 239) baseline aggression. A 2-week intervention expedited improvements in aggression and reduced incarceration in clinically aggressive juvenile offenders. The findings underscore the importance of directing intervention resources to the most aggressive youth. Clinical trial registration information-PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice (PHAT Life); http://clinicaltrials.gov/; NCT02647710. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Do educational interventions improve nurses' clinical decision making and judgement? A systematic review.

PubMed

Thompson, Carl; Stapley, Sally

2011-07-01

Despite the growing popularity of decision making in nursing curricula, the effectiveness of educational interventions to improve nursing judgement and decision making is unknown. We sought to synthesise and summarise the comparative evidence for educational interventions to improve nursing judgements and clinical decisions. A systematic review. Electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL and PsycINFO, Social Sciences Citation Index, OpenSIGLE conference proceedings and hand searching nursing journals. Studies published since 1960, reporting any educational intervention that aimed to improve nurses' clinical judgements or decision making were included. Studies were assessed for relevance and quality. Data extracted included study design; educational setting; the nature of participants; whether the study was concerned with the clinical application of skills or the application of theory; the type of decision targeted by the intervention (e.g. diagnostic reasoning) and whether the evaluation of the intervention focused on efficacy or effectiveness. A narrative approach to study synthesis was used due to heterogeneity in interventions, study samples, outcomes and settings and incomplete reporting of effect sizes. From 5262 initial citations 24 studies were included in the review. A variety of educational approaches were reported. Study quality and content reporting was generally poor. Pedagogical theories were widely used but use of decision theory (with the exception of subjective expected utility theory implicit in decision analysis) was rare. The effectiveness and efficacy of interventions was mixed. Educational interventions to improve nurses' judgements and decisions are complex and the evidence from comparative studies does little to reduce the uncertainty about 'what works'. Nurse educators need to pay attention to decision, as well as pedagogical, theory in the design of interventions. Study design and reporting requires improvement to maximise the information contained in reports of educational interventions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Implementation Process of a Canadian Community-based Nurse Mentorship Intervention in HIV Care.

PubMed

Caine, Vera; Mill, Judy; O'Brien, Kelly; Solomon, Patricia; Worthington, Catherine; Dykeman, Margaret; Gahagan, Jacqueline; Maina, Geoffrey; De Padua, Anthony; Arneson, Cheryl; Rogers, Tim; Chaw-Kant, Jean

2016-01-01

We describe salient individual and organizational factors that influenced engagement of registered nurses in a 12-month clinical mentorship intervention on HIV care in Canada. The intervention included 48 nurses and 8 people living with HIV (PLWH) who were involved in group-based and one-on-one informal mentorship informed by transformative learning theory. We evaluated the process of implementing the mentorship intervention using qualitative content analysis. The inclusion of PLWH as mentors, the opportunities for reciprocal learning, and the long-term commitment of individual nurses and partner organizations in HIV care were major strengths. Challenges included the need for multiple ethical approvals, the lack of organizational support at some clinical sites, and the time commitment required by participants. We recommend that clinical mentorship interventions in HIV care consider organizational support, adhere to the Greater Involvement of People Living with HIV/AIDS principles, and explore questions of professional obligations. Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

A Systematic Review of CPAP Adherence Across Age Groups: Clinical and Empiric Insights for Developing CPAP Adherence Interventions

PubMed Central

Sawyer, A.M.; Gooneratne, N.; Marcus, C.L.; Ofer, D.; Richards, K.C.; Weaver, T.E.

2011-01-01

Continuous positive airway pressure (CPAP) is a highly efficacious treatment for obstructive sleep apnea (OSA) but adherence to the treatment limits its overall effectiveness across all age groups of patients. Factors that influence adherence to CPAP include disease and patient characteristics, treatment titration procedures, technological device factors and side effects, and psychological and social factors. These influential factors have guided the development of interventions to promote CPAP adherence. Various intervention strategies have been described and include educational, technological, psychosocial, pharmacological, and multi-dimensional approaches. Though evidence to date has led to innovative strategies that address adherence in CPAP-treated children, adults, and older adults, significant opportunities exist to develop and test interventions that are clinically applicable, specific to subgroups of patients likely to demonstrate poor adherence, and address the multifactorial nature of CPAP adherence. The translation of CPAP adherence promotion interventions to clinical practice is imperative to improve health and functional outcomes in all persons with CPAP-treated OSA. PMID:21652236

A family planning clinic partner violence intervention to reduce risk associated with reproductive coercion

PubMed Central

Miller, Elizabeth; Decker, Michele R.; McCauley, Heather L.; Tancredi, Daniel J.; Levenson, Rebecca R.; Waldman, Jeffrey; Schoenwald, Phyllis; Silverman, Jay G.

2010-01-01

Background This study examined the efficacy of a family planning clinic-based intervention to address intimate partner violence (IPV) and reproductive coercion. Study Design Four free-standing urban family planning clinics in Northern California were randomized to intervention (trained family planning counselors) or standard-of-care. English-and Spanish-speaking females ages 16-29 years (N=906) completed audio computer-assisted surveys prior to a clinic visit and 12 to 24 weeks later (75% retention rate). Analyses included assessment of intervention effects on recent IPV, awareness of IPV services, and reproductive coercion. Results Among women reporting past 3-month IPV at baseline, there was a 71% reduction in the odds of pregnancy coercion among participants in intervention clinics compared to participants from the control clinics that provided standard of care. Women in the intervention arm were more likely to report ending a relationship because the relationship was unhealthy or unsafe regardless of IPV status (AOR 1.63, 95% CI 1.01 – 2.63). Conclusions Results of this pilot study suggest that this intervention may reduce risk for reproductive coercion from abusive male partners among family planning clients and support such women to leave unsafe relationships. PMID:21310291

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

PubMed

Fisher, Jeffrey D; Amico, K Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Trayling, Cynthia; Redding, Caroline; Barta, William; Lemieux, Anthony F; Altice, Frederick L; Dieckhaus, Kevin; Friedland, Gerald

2011-11-01

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

Role of interventional radiologists in the management of lower extremity venous insufficiency.

PubMed

Hardman, Rulon L; Rochon, Paul J

2013-12-01

Lower extremity venous insufficiency affects over half of all women. Interventional radiologists should be aware of the clinical evaluation of women with venous insufficiency and classification of disease. Endovascular therapies available for treatment of lower extremity venous insufficiency include: endovenous laser ablation, radiofrequency endovascular ablation, and sclerotherapy. The interventional radiologist should be versed on which therapy to select in each clinical presentation and the procedural techniques. The authors review the role of the interventional radiologist in managing this lower extremity venous disorder.

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms

PubMed Central

Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-01-01

Objective This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. Design This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. Setting The study takes place in five diagnostic centres in Germany. Participants A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. Interventions This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). Main outcome measures The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). Results The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Conclusion Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. Trial registration number ClinicalTrials.gov NCT01636752. PMID:28710212

Nutritional psychiatry: the present state of the evidence.

PubMed

Marx, Wolfgang; Moseley, Genevieve; Berk, Michael; Jacka, Felice

2017-11-01

Mental illness, including depression, anxiety and bipolar disorder, accounts for a significant proportion of global disability and poses a substantial social, economic and heath burden. Treatment is presently dominated by pharmacotherapy, such as antidepressants, and psychotherapy, such as cognitive behavioural therapy; however, such treatments avert less than half of the disease burden, suggesting that additional strategies are needed to prevent and treat mental disorders. There are now consistent mechanistic, observational and interventional data to suggest diet quality may be a modifiable risk factor for mental illness. This review provides an overview of the nutritional psychiatry field. It includes a discussion of the neurobiological mechanisms likely modulated by diet, the use of dietary and nutraceutical interventions in mental disorders, and recommendations for further research. Potential biological pathways related to mental disorders include inflammation, oxidative stress, the gut microbiome, epigenetic modifications and neuroplasticity. Consistent epidemiological evidence, particularly for depression, suggests an association between measures of diet quality and mental health, across multiple populations and age groups; these do not appear to be explained by other demographic, lifestyle factors or reverse causality. Our recently published intervention trial provides preliminary clinical evidence that dietary interventions in clinically diagnosed populations are feasible and can provide significant clinical benefit. Furthermore, nutraceuticals including n-3 fatty acids, folate, S-adenosylmethionine, N-acetyl cysteine and probiotics, among others, are promising avenues for future research. Continued research is now required to investigate the efficacy of intervention studies in large cohorts and within clinically relevant populations, particularly in patients with schizophrenia, bipolar and anxiety disorders.

Attenuating the Systemic Inflammatory Response to Adult Cardiopulmonary Bypass: A Critical Review of the Evidence Base

PubMed Central

Landis, R. Clive; Brown, Jeremiah R.; Fitzgerald, David; Likosky, Donald S.; Shore-Lesserson, Linda; Baker, Robert A.; Hammon, John W.

2014-01-01

Abstract: A wide range of pharmacological, surgical, and mechanical pump approaches have been studied to attenuate the systemic inflammatory response to cardiopulmonary bypass, yet no systematically based review exists to cover the scope of anti-inflammatory interventions deployed. We therefore conducted an evidence-based review to capture “self-identified” anti-inflammatory interventions among adult cardiopulmonary bypass procedures. To be included, trials had to measure at least one inflammatory mediator and one clinical outcome, specified in the “Outcomes 2010” consensus statement. Ninety-eight papers satisfied inclusion criteria and formed the basis of the review. The review identified 33 different interventions and approaches to attenuate the systemic inflammatory response. However, only a minority of papers (35 of 98 [35.7%]) demonstrated any clinical improvement to one or more of the predefined outcome measures (most frequently myocardial protection or length of intensive care unit stay). No single intervention was supported by strong level A evidence (multiple randomized controlled trials [RCTs] or meta-analysis) for clinical benefit. Interventions at level A evidence included off-pump surgery, minimized circuits, biocompatible circuit coatings, leukocyte filtration, complement C5 inhibition, preoperative aspirin, and corticosteroid prophylaxis. Interventions at level B evidence (single RCT) for minimizing inflammation included nitric oxide donors, C1 esterase inhibition, neutrophil elastase inhibition, propofol, propionyl-L-carnitine, and intensive insulin therapy. A secondary analysis revealed that suppression of at least one inflammatory marker was necessary but not sufficient to confer clinical benefit. The most effective interventions were those that targeted multiple inflammatory pathways. These observations are consistent with a “multiple hit” hypothesis, whereby clinically effective suppression of the systemic inflammatory response requires hitting multiple inflammatory targets simultaneously. Further research is warranted to evaluate if combinations of interventions that target multiple inflammatory pathways are capable of synergistically reducing inflammation and improving outcomes after cardiopulmonary bypass. PMID:26357785

An Intervention to Promote the Female Condom to Sexually Transmitted Disease Clinic Patients

ERIC Educational Resources Information Center

Artz, Lynn; Macaluso, Maurizio; Kelaghan, Joseph; Austin, Harland; Fleenor, Michael; Robey, Lawrence; Hook, III, Edward W.; Brill, Ilene

2005-01-01

This article describes a 1-hour behavioral intervention designed to promote female condoms and safer sex to women at a high risk for sexually transmitted diseases (STDs). The intervention includes a promotional videotape; a skills-oriented counseling session with a nurse clinician; assorted take-home items, including a videotape for men; and free…

Family intervention to control type 2 diabetes: a controlled clinical trial.

PubMed

García-Huidobro, Diego; Bittner, Marcela; Brahm, Paulina; Puschel, Klaus

2011-02-01

Chilean patients with type 2 diabetes mellitus (T2DM) have a low rate of blood sugar control. We studied the effectiveness of a culturally sensitive family oriented intervention designed to improve metabolic control in primary care patients with uncontrolled T2DM. Patients with T2DM from three primary care clinics in Santiago, Chile were randomly selected for inclusion if they had a recent HbA1c ≥7%, were between 18 and 70 years old and lived with a family member. Patients from one clinic received the family oriented intervention; patients from the other two (control) clinics received standard care. The intervention involved family members in care and included family counselling during clinic visits, family meetings and home visits. The primary outcome was HbA1c, measured at 6 and 12 months. A total of 243 patients were enrolled and 209 (86%) completed the study. The intervention was fully administered to only 34% of patients in the intervention clinic. The reduction in the HbA1c from baseline to 12 months was not significantly different between clinics. During the second 6-month period, when the intervention was more intensive, the patients in the intervention clinic significantly improved their HbA1c (P < 0.001) compared to the control patients. A family intervention for the control of T2DM was associated with a significant reduction in HbA1c when the intervention was provided. Incomplete implementation, low statistical power and potential confounding variables between groups could be some of the main factors that explain the lack of difference between clinics in the 12-month period.

Does Improving Patient-Practitioner Communication Improve Clinical Outcomes in Patients with Cardiovascular Diseases? A Systematic Review of the Evidence

PubMed Central

Schoenthaler, Antoinette; Kalet, Adina; Nicholson, Joseph; Lipkin, Mack

2014-01-01

Objective To conduct a systematic literature review appraising the effects of interventions to improve patient-practitioner communication on cardiovascular-related clinical outcomes. Methods Databases were searched up to March 27, 2013 to identify eligible studies that included interventions to improve patient and/or practitioner communication skills and assessment of a cardiovascular-related clinical outcome in adults ≥ 18 years of age. Results Fifteen papers were reviewed: The primary focus in seven studies was the patient; seven included a practitioner-focused intervention and one targeted both. Two patient-focused and two practitioner-focused studies demonstrated a beneficial effect of the intervention compared to a control group. Patient-focused studies were designed to improve patients’ information-seeking and question-asking skills with their practitioner. Practitioner-focused studies were designed to either improve practitioner’s general patient-centered communication or risk communication skills. Conclusions Few interventions targeting patient-practitioner communication have assessed the impact on cardiovascular-related clinical outcomes, limiting the ability to determine effectiveness. Additional rigorous research supported by theoretical frameworks and validated measurement is needed to understand the potential of patient-practitioner communication to improve cardiovascular-related clinical outcomes. Practice Implications Investments in communication skills trainings in medical education and practice are needed in order to attain the full potential of patient-centered care on cardiovascular-related clinical outcomes. Systematic Review Protocol Registration CRD42013006302 PMID:24795073

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

2018-01-25

This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.

PubMed

Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E

2018-06-13

In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.

The Program Cost of a Brief Video Intervention Shown in Sexually Transmitted Disease Clinic Waiting Rooms.

PubMed

Gift, Thomas L; OʼDonnell, Lydia N; Rietmeijer, Cornelis A; Malotte, Kevin C; Klausner, Jeffrey D; Margolis, Andrew D; Borkowf, Craig B; Kent, Charlotte K; Warner, Lee

2016-01-01

Patients in sexually transmitted disease (STD) clinic waiting rooms represent a potential audience for delivering health messages via video-based interventions. A controlled trial at 3 sites found that patients exposed to one intervention, Safe in the City, had a significantly lower incidence of STDs compared with patients in the control condition. An evaluation of the intervention's cost could help determine whether such interventions are programmatically viable. The cost of producing the Safe in the City intervention was estimated using study records, including logs, calendars, and contract invoices. Production costs were divided by the 1650 digital video kits initially fabricated to get an estimated cost per digital video. Clinic costs for showing the video in waiting rooms included staff time costs for equipment operation and hardware depreciation and were estimated for the 21-month study observation period retrospectively. The intervention cost an estimated $416,966 to develop, equaling $253 per digital video disk produced. Per-site costs to show the video intervention were estimated to be $2699 during the randomized trial. The cost of producing and implementing Safe in the City intervention suggests that similar interventions could potentially be produced and made available to end users at a price that would both cover production costs and be low enough that the end users could afford them.

Antimicrobial stewardship programs: interventions and associated outcomes.

PubMed

Patel, Dimple; Lawson, Wendy; Guglielmo, B Joseph

2008-04-01

Guidelines regarding antimicrobial stewardship programs recommend an infectious diseases-trained physician and an infectious diseases-trained pharmacist as core members. Inclusion of clinical microbiologists, infection-control practitioners, information systems experts and hospital epidemiologists is considered optimal. Recommended stewardship interventions include prospective audit and intervention, formulary restriction, education, guideline development, clinical pathway development, antimicrobial order forms and the de-escalation of therapy. The primary outcome associated with these interventions has been the associated cost savings; however, few published investigations have taken into account the overall cost of the intervention. Over the past 5 years, there has been an increased focus upon interventions intended to decrease bacterial resistance or reduce superinfection, including infections associated with Clostridium difficile colitis. Few programs have been associated with a reduction in antimicrobial drug adverse events. Antimicrobial stewardship programs are becoming increasingly associated with clear benefits and will be integral in the in-patient healthcare setting.

Clinical utilization of musculoskeletal sonography involving non-physician rehabilitation providers: A scoping review

PubMed Central

Roll, Shawn C.; Asai, Christina; Tsai, Julieann

2015-01-01

Background Musculoskeletal sonography use in point-of-care physical medicine and rehabilitation is rapidly expanding, not only by physiatrists, but also by non-physician rehabilitation providers. Aim To evaluate the current range, extent and nature of literature and to identify emerging areas of evidence for the use of musculoskeletal sonography involving non-physician rehabilitation providers to guide research and clinical practice. Design Scoping Review Setting Inpatient, Outpatient, Other Population Musculoskeletal conditions Methods Five databases were searched and 578 unique abstracts were identified and screened for eligibility. Three raters independently read 68 full texts and 36 articles that reported on applied uses of sonography by non-physician rehabilitation providers were included. Results Eighteen studies described direct clinical use, primarily for outcomes measurement (n=12) or as a biofeedback intervention (n=10). Twelve laboratory studies were included that related morphology to patient reports or validated clinical interventions. Six additional studies, although not involving non-physician providers, were included as they presented potential valuable uses that were not noted in the other included studies, such as monitoring bone healing, tendon repair, and evaluation of idiopathic symptom reports or non-specific primary diagnoses. Conclusion This review indicates that non-physician rehabilitation providers use sonography for outcomes measurement and biofeedback interventions. Research is needed to evaluate effects of these uses on patient outcomes and to explore additional potential uses for clinical reasoning, treatment planning, and monitoring of tissue healing related to intervention. Clinical Rehabilitation Impact Implementation of musculoskeletal sonography by non-physician rehabilitation providers has the potential to be a critically advantageous addition to improve care. PMID:26201705

Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol

PubMed Central

Nash, Danielle M.; Ivers, Noah M.; Young, Jacqueline; Jaakkimainen, R. Liisa; Garg, Amit X.; Tu, Karen

2017-01-01

Background: Many patients with or at risk for chronic kidney disease (CKD) in the primary care setting are not receiving recommended care. Objective: The objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting. Design: A pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted. Setting: The study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group. Intervention: The intervention group will receive resources from the “CKD toolkit” to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support. Measurements: Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of physicians in the intervention group to understand why the intervention achieved the observed effects. Conclusions: If our intervention improves care, then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records. Trial Registration: ClinicalTrials.gov Identifier: NCT02274298 PMID:28607686

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.

PubMed

Messier, S P; Callahan, L F; Golightly, Y M; Keefe, F J

2015-05-01

The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Assessment and intervention for dysphagia in infants and children: beyond the neonatal intensive care unit.

PubMed

Bell, Hannah R; Alper, Beth Sheckman

2007-08-01

Over the last 10 years, the assessment and intervention for feeding and swallowing problems in infants and children have attracted increased attention on a national and international level. Increases in the population of children with dysphagia are due, in large part, to advances in medical and surgical management of at-risk term infants, improved medical support for viability of younger and smaller preterm infants, and increases in the number of children on the autism spectrum. Because of legislative initiatives, settings in which children are seen for assessment and intervention have shifted, with services provided more often in the natural environments of homes, daycares, preschools, and schools, as well as in hospitals and outpatient clinics in the United States. Assessment of infants and children with dysphagia continues to include clinical and instrumental evaluations with clinical assessment including a specific focus on the feeding environment. Speech-language pathologists are increasingly assuming consultative roles to support the needs of children in all settings. Areas for further research in the era of evidence-based practice include efficacy of oral exercises and other intervention strategies.

Effects of a Problem-Solving Intervention (COPE) on Quality of Life for Patients with Advanced Cancer on Clinical Trials and their Caregivers: Simultaneous Care Educational Intervention (SCEI): Linking Palliation and Clinical Trials

PubMed Central

Carducci, Michael; Loscalzo, Matthew J.; Linder, John; Greasby, Tamara; Beckett, Laurel A.

2011-01-01

Abstract Context Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. Objective To examine the effect of a standardized cognitive–behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Design Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Participants Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Outcome Measures Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. Results The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms (p = 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm (p = 0.02). Conclusions The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time. PMID:21413846

Effectiveness of interventions designed to reduce the use of imaging for low-back pain: a systematic review

PubMed Central

Jenkins, Hazel J.; Hancock, Mark J.; French, Simon D.; Maher, Chris G.; Engel, Roger M.; Magnussen, John S.

2015-01-01

Background: Rates of imaging for low-back pain are high and are associated with increased health care costs and radiation exposure as well as potentially poorer patient outcomes. We conducted a systematic review to investigate the effectiveness of interventions aimed at reducing the use of imaging for low-back pain. Methods: We searched MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials from the earliest records to June 23, 2014. We included randomized controlled trials, controlled clinical trials and interrupted time series studies that assessed interventions designed to reduce the use of imaging in any clinical setting, including primary, emergency and specialist care. Two independent reviewers extracted data and assessed risk of bias. We used raw data on imaging rates to calculate summary statistics. Study heterogeneity prevented meta-analysis. Results: A total of 8500 records were identified through the literature search. Of the 54 potentially eligible studies reviewed in full, 7 were included in our review. Clinical decision support involving a modified referral form in a hospital setting reduced imaging by 36.8% (95% confidence interval [CI] 33.2% to 40.5%). Targeted reminders to primary care physicians of appropriate indications for imaging reduced referrals for imaging by 22.5% (95% CI 8.4% to 36.8%). Interventions that used practitioner audits and feedback, practitioner education or guideline dissemination did not significantly reduce imaging rates. Lack of power within some of the included studies resulted in lack of statistical significance despite potentially clinically important effects. Interpretation: Clinical decision support in a hospital setting and targeted reminders to primary care doctors were effective interventions in reducing the use of imaging for low-back pain. These are potentially low-cost interventions that would substantially decrease medical expenditures associated with the management of low-back pain. PMID:25733741

Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions.

PubMed

Lamb, Sarah E; Becker, Clemens; Gillespie, Lesley D; Smith, Jessica L; Finnegan, Susanne; Potter, Rachel; Pfeiffer, Klaus

2011-05-17

Interventions for preventing falls in older people often involve several components, multidisciplinary teams, and implementation in a variety of settings. We have developed a classification system (taxonomy) to describe interventions used to prevent falls in older people, with the aim of improving the design and reporting of clinical trials of fall-prevention interventions, and synthesis of evidence from these trials. Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus. Robust techniques were used including literature reviews, expert presentations, and structured consensus workshops moderated by experienced facilitators. The taxonomy was refined using an international test panel of five health care practitioners. We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 randomly selected published papers describing a variety of fall-prevention interventions. The taxonomy consists of four domains, summarized as the "Approach", "Base", "Components" and "Descriptors" of an intervention. Sub-domains include; where participants are identified; the theoretical approach of the intervention; clinical targeting criteria; details on assessments; descriptions of the nature and intensity of interventions. Chance corrected agreement of the final version of the taxonomy was good to excellent for all items. Further independent evaluation of the taxonomy is required. The taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention. Investigators are encouraged to use the taxonomy to report their interventions.

Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions

PubMed Central

2011-01-01

Background Interventions for preventing falls in older people often involve several components, multidisciplinary teams, and implementation in a variety of settings. We have developed a classification system (taxonomy) to describe interventions used to prevent falls in older people, with the aim of improving the design and reporting of clinical trials of fall-prevention interventions, and synthesis of evidence from these trials. Methods Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus. Robust techniques were used including literature reviews, expert presentations, and structured consensus workshops moderated by experienced facilitators. The taxonomy was refined using an international test panel of five health care practitioners. We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 randomly selected published papers describing a variety of fall-prevention interventions. Results The taxonomy consists of four domains, summarized as the "Approach", "Base", "Components" and "Descriptors" of an intervention. Sub-domains include; where participants are identified; the theoretical approach of the intervention; clinical targeting criteria; details on assessments; descriptions of the nature and intensity of interventions. Chance corrected agreement of the final version of the taxonomy was good to excellent for all items. Further independent evaluation of the taxonomy is required. Conclusions The taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention. Investigators are encouraged to use the taxonomy to report their interventions. PMID:21586143

Image fusion and navigation platforms for percutaneous image-guided interventions.

PubMed

Rajagopal, Manoj; Venkatesan, Aradhana M

2016-04-01

Image-guided interventional procedures, particularly image guided biopsy and ablation, serve an important role in the care of the oncology patient. The need for tumor genomic and proteomic profiling, early tumor response assessment and confirmation of early recurrence are common scenarios that may necessitate successful biopsies of targets, including those that are small, anatomically unfavorable or inconspicuous. As image-guided ablation is increasingly incorporated into interventional oncology practice, similar obstacles are posed for the ablation of technically challenging tumor targets. Navigation tools, including image fusion and device tracking, can enable abdominal interventionalists to more accurately target challenging biopsy and ablation targets. Image fusion technologies enable multimodality fusion and real-time co-displays of US, CT, MRI, and PET/CT data, with navigational technologies including electromagnetic tracking, robotic, cone beam CT, optical, and laser guidance of interventional devices. Image fusion and navigational platform technology is reviewed in this article, including the results of studies implementing their use for interventional procedures. Pre-clinical and clinical experiences to date suggest these technologies have the potential to reduce procedure risk, time, and radiation dose to both the patient and the operator, with a valuable role to play for complex image-guided interventions.

Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

PubMed

Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

2014-04-01

In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

Systematic Review of Integrated Medical and Psychiatric Self-Management Interventions for Adults with Serious Mental Illness

PubMed Central

Whiteman, Karen L.; Naslund, John A.; DiNapoli, Elizabeth A.; Bruce, Martha L.; Bartels, Stephen J.

2016-01-01

Objective Adults with serious mental illness are disproportionately affected by medical comorbidity, earlier onset of disease, and premature mortality. Integrated self-management interventions have been developed to address both medical and psychiatric illnesses. This systematic review aimed to: review the evidence of the effect of self-management interventions targeting both medical and psychiatric illnesses and evaluate the potential for implementation. Methods Databases including CINAHL, Cochrane Central, Ovid Medline, PsycINFO, and Web of Science were searched for articles published between 1946 and July 2015. Studies evaluating integrated medical and psychiatric self-management interventions for adults with schizophrenia spectrum or mood disorders and medical comorbidity were included. Results Fifteen studies reported on nine interventions (i.e., nine randomized control trials, six pre/post designs). Most studies demonstrated feasibility, acceptability, and preliminary effectiveness; however, clinical effectiveness could not be established in most of the studies due to methodological limitations. Factors identified that may deter implementation included operating costs, impractical length of the intervention, and the workforce needs of these interventions. Conclusions Integrated medical and psychiatric illness self-management interventions appear feasible and acceptable, with high potential for clinical effectiveness. However, implementation considerations were rarely considered in intervention development, contributing to limited uptake and reach in real-world settings. PMID:27301767

[Clinical interventions in overweight and obesity: a systematic literature review 2009-2014].

PubMed

Rajmil, Luis; Bel, Joan; Clofent, Rosa; Cabezas, Carmen; Castell, Conxa; Espallargues, Mireia

2017-04-01

To update the literature review on the effectiveness of clinical interventions on childhood obesity, proposed in Clinical Practice Guidelines, excluding prevention and pharmacological and surgical treatments. A systematic review was carried out in electronic databases of the Cochrane Database of Systematic Reviews (The Cochrane Library), MEDLINE, and SCOPUS, replicating the search for the Clinical Practice Guidelines, from 2009 to 2014. The Clinical Practice Guidelines of National Institute for Health and Care Excellence were taken as a reference. Systematic reviews were given priority, and the quality of the studies was assessed. Out of a total of 3,703 documents initially identified, 48 were finally included. Studies showed great heterogeneity in the type and duration of interventions, and in outcome measures. Adherence to treatment was, in general, low. Multi-component interventions including diet, physical activity, sedentary lifestyle, and behaviour changes, involving the family, and starting at early ages, were the most effective for reducing body mass index. There is no consensus on criteria for referral to specialised care. It is recommended to implement multi-component programs conducted by professionals with previous training, involving the family, and addressing behavioural, individual and socio-demographic aspects. Lack of adherence is one of the reasons for failure of interventions. Diagnostic and referral criteria, the outcome measures, and the type and duration of interventions need to be improved and standardised. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

The use of behavior change theory in Internet-based asthma self-management interventions: a systematic review.

PubMed

Al-Durra, Mustafa; Torio, Monika-Bianca; Cafazzo, Joseph A

2015-04-02

The high prevalence rate of asthma represents a major societal burden. Advancements in information technology continue to affect the delivery of patient care in all areas of medicine. Internet-based solutions, social media, and mobile technology could address some of the problems associated with increasing asthma prevalence. This review evaluates Internet-based asthma interventions that were published between 2004 and October 2014 with respect to the use of behavioral change theoretical frameworks, applied clinical guidelines, and assessment tools. The search term (Asthma AND [Online or Internet or Mobile or Application or eHealth or App]) was applied to six bibliographic databases (Ovid MEDLINE, PubMed, BioMed Central, ProQuest Computing, Web of Knowledge, and ACM Digital Library) including only English-language articles published between 2004 and October 2014. In total, 3932 articles matched the priori search terms and were reviewed by the primary reviewer based on their titles, index terms, and abstracts. The matching articles were then screened by the primary reviewer for inclusion or exclusion based on their abstract, study type, and intervention objectives with respect to the full set of priori inclusion and exclusion criteria; 331 duplicates were identified and removed. A total of 85 articles were included for in-depth review and the remaining 3516 articles were excluded. The primary and secondary reviewer independently reviewed the complete content of the 85 included articles to identify the applied behavioral change theories, clinical guidelines, and assessment tools. Findings and any disagreement between reviewers were resolved by in-depth discussion and through a consolidation process for each of the included articles. The reviewers identified 17 out of 85 interventions (20%) where at least one model, framework, and/or construct of a behavioral change theory were applied. The review identified six clinical guidelines that were applied across 30 of the 85 interventions (35%) as well as a total of 21 assessment tools that were applied across 32 of the 85 interventions (38%). The findings of this literature review indicate that the majority of published Internet-based interventions do not use any documented behavioral change theory, clinical guidelines, and/or assessment tools to inform their design. Further, it was found that the application of clinical guidelines and assessment tools were more salient across the reviewed interventions. A consequence, as such, is that many Internet-based asthma interventions are designed in an ad hoc manner, without the use of any notable evidence-based theoretical frameworks, clinical guidelines, and/or assessment tools.

Cancer concepts and principles: primer for the interventional oncologist-part I.

PubMed

Hickey, Ryan; Vouche, Michael; Sze, Daniel Y; Hohlastos, Elias; Collins, Jeremy; Schirmang, Todd; Memon, Khairuddin; Ryu, Robert K; Sato, Kent; Chen, Richard; Gupta, Ramona; Resnick, Scott; Carr, James; Chrisman, Howard B; Nemcek, Albert A; Vogelzang, Robert L; Lewandowski, Robert J; Salem, Riad

2013-08-01

A sophisticated understanding of the rapidly changing field of oncology, including a broad knowledge of oncologic disease and the therapies available to treat them, is fundamental to the interventional radiologist providing oncologic therapies, and is necessary to affirm interventional oncology as one of the four pillars of cancer care alongside medical, surgical, and radiation oncology. The first part of this review intends to provide a concise overview of the fundamentals of oncologic clinical trials, including trial design, methods to assess therapeutic response, common statistical analyses, and the levels of evidence provided by clinical trials. Copyright © 2013 SIR. Published by Elsevier Inc. All rights reserved.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Ryan, R E; Prictor, M J; McLaughlin, K J; Hill, S J

2008-01-23

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented for example on the Internet, DVD, or video cassette) are one such method. To assess the effects of providing audio-visual information alone, or in conjunction with standard forms of information provision, to potential clinical trial participants in the informed consent process, in terms of their satisfaction, understanding and recall of information about the study, level of anxiety and their decision whether or not to participate. We searched: the Cochrane Consumers and Communication Review Group Specialised Register (searched 20 June 2006); the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 2, 2006; MEDLINE (Ovid) (1966 to June week 1 2006); EMBASE (Ovid) (1988 to 2006 week 24); and other databases. We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. Randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or oral information as usually employed in the particular service setting), with standard forms of information provision alone, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to participate in a real (not hypothetical) clinical study. Two authors independently assessed studies for inclusion and extracted data. Due to heterogeneity no meta-analysis was possible; we present the findings in a narrative review. We included 4 trials involving data from 511 people. Studies were set in the USA and Canada. Three were randomised controlled trials (RCTs) and the fourth a quasi-randomised trial. Their quality was mixed and results should be interpreted with caution. Considerable uncertainty remains about the effects of audio-visual interventions, compared with standard forms of information provision (such as written or oral information normally used in the particular setting), for use in the process of obtaining informed consent for clinical trials. Audio-visual interventions did not consistently increase participants' levels of knowledge/understanding (assessed in four studies), although one study showed better retention of knowledge amongst intervention recipients. An audio-visual intervention may transiently increase people's willingness to participate in trials (one study), but this was not sustained at two to four weeks post-intervention. Perceived worth of the trial did not appear to be influenced by an audio-visual intervention (one study), but another study suggested that the quality of information disclosed may be enhanced by an audio-visual intervention. Many relevant outcomes including harms were not measured. The heterogeneity in results may reflect the differences in intervention design, content and delivery, the populations studied and the diverse methods of outcome assessment in included studies. The value of audio-visual interventions for people considering participating in clinical trials remains unclear. Evidence is mixed as to whether audio-visual interventions enhance people's knowledge of the trial they are considering entering, and/or the health condition the trial is designed to address; one study showed improved retention of knowledge amongst intervention recipients. The intervention may also have small positive effects on the quality of information disclosed, and may increase willingness to participate in the short-term; however the evidence is weak. There were no data for several primary outcomes, including harms. In the absence of clear results, triallists should continue to explore innovative methods of providing information to potential trial participants. Further research should take the form of high-quality randomised controlled trials, with clear reporting of methods. Studies should conduct content assessment of audio-visual and other innovative interventions for people of differing levels of understanding and education; also for different age and cultural groups. Researchers should assess systematically the effects of different intervention components and delivery characteristics, and should involve consumers in intervention development. Studies should assess additional outcomes relevant to individuals' decisional capacity, using validated tools, including satisfaction; anxiety; and adherence to the subsequent trial protocol.

Post-procedural Care in Interventional Radiology: What Every Interventional Radiologist Should Know-Part II: Catheter Care and Management of Common Systemic Post-procedural Complications.

PubMed

Taslakian, Bedros; Sridhar, Divya

2017-09-01

Interventional radiology (IR) has evolved into a full-fledged clinical specialty with attendant comprehensive patient care responsibilities. Providing excellent and thorough clinical care is as essential to the practice of IR as achieving technical success in procedures. Basic clinical skills that every interventional radiologist should learn include routine management of percutaneously inserted drainage and vascular catheters and rapid effective management of common systemic post-procedural complications. A structured approach to post-procedural care, including routine follow-up and early identification and management of complications, facilitates efficient and thorough management with an emphasis on quality and patient safety. The aim of this second part, in conjunction with part 1, is to complete the comprehensive review of post-procedural care in patients undergoing interventional radiology procedures. We discuss common problems encountered after insertion of drainage and vascular catheters and describe effective methods of troubleshooting these problems. Commonly encountered systemic complications in IR are described, and ways for immediate identification and management of these complications are provided.

Thromboembolic Risk of Endovascular Intervention for Lower Extremity Deep Venous Thrombosis.

PubMed

Lindsey, Philip; Echeverria, Angela; Poi, Mun J; Matos, Jesus; Bechara, Carlos F; Cheung, Mathew; Lin, Peter H

2018-05-01

This study evaluated the risk of thromboembolism during endovascular interventions in patients with symptomatic lower extremity deep vein thrombosis (DVT) METHODS: Clinical records of all patients who underwent endovascular interventions for symptomatic lower extremity DVT from 2001 to 2017 were retrospectively analyzed using a prospectively maintained database. Only patients who received an inferior vena cava (IVC) filter were included in the analysis. Trapped intrafilter thrombus was assessed for procedure-related thromboembolism. Clinical outcomes of thrombus management and thromboembolism risk were analyzed. A total 172 patients (mean age 57.4 years, 98 females) who underwent 174 endovascular DVT interventions were included in the analysis. Treatment strategies included thrombolytic therapy (64%), mechanical thrombectomy (n = 86%), pharmacomechanical thrombolysis (51%), balloon angioplasty (98%), and stent placement (28%). Thrombectomy device used included AngioJet (56%), Trellis (19%), and Aspire (11%). Trapped IVC filter thrombus was identified in 58 patients (38%) based on the IVC venogram. No patient developed clinically evident pulmonary embolism (PE). IVC filter retrieval was performed in 98 patients (56%, mean 11.8 months after implantation). Multivariate analysis showed that iliac vein occlusion (P = 0.04) was predictive for procedure-related thromboembolism. Iliac vein thrombotic occlusion is associated with an increased thromboembolic risk in DVT intervention. Retrievable IVC filter should be considered when performing percutaneous thrombectomy in patients with iliac venous occlusion to prevent PE. Copyright © 2017 Elsevier Inc. All rights reserved.

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

PubMed Central

Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

2017-01-01

Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. Results During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. Conclusions The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost‐effectiveness of the ILI and will contain additional follow‐up data. PMID:28392928

Promoting oral cancer examinations to medical primary care providers: a cluster randomized trial.

PubMed

Wee, Alvin G; Zimmerman, Lani M; Anderson, James R; Nunn, Martha E; Loberiza, Fausto R; Sitorius, Michael A; Pullen, Carol H

2016-09-01

To compare the percentage of patients who had an oral cancer examination (OCE) by their primary care provider (PCP) in medical clinics participating in a web-based education with poster reminder intervention to that of patients in control clinics. To also determine the effects for PCPs in medical clinics participating in the web-based education with poster reminder intervention as compared with those in control clinics regarding: a) index of knowledge of oral cancer risk factors (RiskOC) and b) index of knowledge of oral cancer diagnostic procedures (DiagOC). Six medical clinics were recruited to participate in this study and randomly assigned to an intervention group or a control group. PCPs (physicians, physician assistants, and advanced practice registered nurses) took a pretest; 2 weeks later, they participated in the web-based educational program, including a posttest (intervention group) or took a posttest only (control group). In each clinic, 1 week following completion of the PCPs' posttests, 94 patients were recruited to complete a one-page survey. The intervention clinics were found to be a significant factor for the PCPs to perform patient OCEs, after controlling for significant covariates, that is, age, main reason for clinic visit, OCE for patient in the past year, clinic's mean DiagOC score, and clinic's mean RiskOC score. The intervention also resulted in the PCPs increasing their pretest to posttest RiskOC scores. The use of intervention has the potential to increase PCPs' short-term knowledge and to increase the frequency of PCPs' routine, nonsymptomatic opportunistic OCE on patients. © 2016 American Association of Public Health Dentistry.

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors.

PubMed

Kirkham, Amy A; Bland, Kelcey A; Sayyari, Sarah; Campbell, Kristin L; Davis, Margot K

2016-02-01

Evidence is currently limited for the effect of exercise on breast cancer clinical outcomes. However, several of the reported physical benefits of exercise, including peak oxygen consumption, functional capacity, muscle strength and lean mass, cardiovascular risk factors, and bone health, have established associations with disability, cardiovascular disease risk, morbidity, and mortality. This review will summarize the clinically relevant physical benefits of exercise interventions in breast cancer survivors and discuss recommendations for achieving these benefits. It will also describe potential differences in intervention delivery that may impact outcomes and, lastly, describe current physical activity guidelines for cancer survivors.

Care and Feeding of the Endocannabinoid System: A Systematic Review of Potential Clinical Interventions that Upregulate the Endocannabinoid System

PubMed Central

McPartland, John M.; Guy, Geoffrey W.; Di Marzo, Vincenzo

2014-01-01

Background The “classic” endocannabinoid (eCB) system includes the cannabinoid receptors CB1 and CB2, the eCB ligands anandamide (AEA) and 2-arachidonoylglycerol (2-AG), and their metabolic enzymes. An emerging literature documents the “eCB deficiency syndrome” as an etiology in migraine, fibromyalgia, irritable bowel syndrome, psychological disorders, and other conditions. We performed a systematic review of clinical interventions that enhance the eCB system—ways to upregulate cannabinoid receptors, increase ligand synthesis, or inhibit ligand degradation. Methodology/Principal Findings We searched PubMed for clinical trials, observational studies, and preclinical research. Data synthesis was qualitative. Exclusion criteria limited the results to 184 in vitro studies, 102 in vivo animal studies, and 36 human studies. Evidence indicates that several classes of pharmaceuticals upregulate the eCB system, including analgesics (acetaminophen, non-steroidal anti-inflammatory drugs, opioids, glucocorticoids), antidepressants, antipsychotics, anxiolytics, and anticonvulsants. Clinical interventions characterized as “complementary and alternative medicine” also upregulate the eCB system: massage and manipulation, acupuncture, dietary supplements, and herbal medicines. Lifestyle modification (diet, weight control, exercise, and the use of psychoactive substances—alcohol, tobacco, coffee, cannabis) also modulate the eCB system. Conclusions/Significance Few clinical trials have assessed interventions that upregulate the eCB system. Many preclinical studies point to other potential approaches; human trials are needed to explore these promising interventions. PMID:24622769

Care and feeding of the endocannabinoid system: a systematic review of potential clinical interventions that upregulate the endocannabinoid system.

PubMed

McPartland, John M; Guy, Geoffrey W; Di Marzo, Vincenzo

2014-01-01

The "classic" endocannabinoid (eCB) system includes the cannabinoid receptors CB1 and CB2, the eCB ligands anandamide (AEA) and 2-arachidonoylglycerol (2-AG), and their metabolic enzymes. An emerging literature documents the "eCB deficiency syndrome" as an etiology in migraine, fibromyalgia, irritable bowel syndrome, psychological disorders, and other conditions. We performed a systematic review of clinical interventions that enhance the eCB system--ways to upregulate cannabinoid receptors, increase ligand synthesis, or inhibit ligand degradation. We searched PubMed for clinical trials, observational studies, and preclinical research. Data synthesis was qualitative. Exclusion criteria limited the results to 184 in vitro studies, 102 in vivo animal studies, and 36 human studies. Evidence indicates that several classes of pharmaceuticals upregulate the eCB system, including analgesics (acetaminophen, non-steroidal anti-inflammatory drugs, opioids, glucocorticoids), antidepressants, antipsychotics, anxiolytics, and anticonvulsants. Clinical interventions characterized as "complementary and alternative medicine" also upregulate the eCB system: massage and manipulation, acupuncture, dietary supplements, and herbal medicines. Lifestyle modification (diet, weight control, exercise, and the use of psychoactive substances--alcohol, tobacco, coffee, cannabis) also modulate the eCB system. Few clinical trials have assessed interventions that upregulate the eCB system. Many preclinical studies point to other potential approaches; human trials are needed to explore these promising interventions.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l=515) and the intervention group received lecture plus a simulation exercise (n l+s=1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

Background The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. Purpose To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. Methods This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l =515) and the intervention group received lecture plus a simulation exercise (n l+s =1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Results Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Discussion Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

Interventional management of neuropathic pain: NeuPSIG recommendations

PubMed Central

Dworkin, Robert H.; O’Connor, Alec B.; Kent, Joel; Mackey, Sean C.; Raja, Srinivasa N.; Stacey, Brett R.; Levy, Robert M.; Backonja, Miroslav; Baron, Ralf; Harke, Henning; Loeser, John D.; Treede, Rolf-Detlef; Turk, Dennis C.; Wells, Christopher D.

2015-01-01

Neuropathic pain (NP) is often refractory to pharmacologic and non-interventional treatment. On behalf of the International Association for the Study of Pain Neuropathic Pain Special Interest Group (NeuPSIG), the authors evaluated systematic reviews, clinical trials, and existing guidelines for the interventional management of NP. Evidence is summarized and presented for neural blockade, spinal cord stimulation (SCS), intrathecal medication, and neurosurgical interventions in patients with the following peripheral and central NP conditions: herpes zoster and postherpetic neuralgia (PHN); painful diabetic and other peripheral neuropathies; spinal cord injury NP; central post-stroke pain; radiculopathy and failed back surgery syndrome (FBSS); complex regional pain syndrome (CRPS); and trigeminal neuralgia and neuropathy. Due to the paucity of high-quality clinical trials, no strong recommendations can be made. Four weak recommendations based on the amount and consistency of evidence, including degree of efficacy and safety, are: (1) epidural injections for herpes zoster; (2) steroid injections for radiculopathy; (3) SCS for FBSS; and (4) SCS for CRPS type 1. Based on the available data, we recommend not to use sympathetic blocks for PHN nor RF lesions for radiculopathy. No other conclusive recommendations can be made due to the poor quality of available of data. Whenever possible, these interventions should either be part of randomized clinical trials or documented in pain registries. Priorities for future research include randomized clinical trials; long-term studies; and head-to-head comparisons among different interventional and non-interventional treatments. PMID:23748119

Evaluation of a Clinical Pharmacist Intervention on Clinical and Drug-Related Problems Among Coronary Heart Disease Inpatients: A pre-experimental prospective study at a general hospital in Indonesia.

PubMed

Sagita, Vina A; Bahtiar, Anton; Andrajati, Retnosari

2018-02-01

This study aimed to evaluate the role of a clinical pharmacist intervention in decreasing subsequent clinical and drug-related problems (DRPs) among coronary heart disease (CHD) inpatients with at least one previous DRP. This pre-experimental study with a pre-post design was carried out from January to April 2017 among inpatients with at least one previous DRP at a general hospital in Tangerang District, Banten, Indonesia. Clinical and DRPs were documented prospectively by a clinical pharmacist, with DRPs classified using Version 6.2 of the DRP classification scheme of the Pharmaceutical Care Network Europe Foundation. The intervention consisted of a discussion of identified DRPs with physicians, patients, pharmaceutical logistics clerks, nurses and nutritionists. Following this, any subsequent clinical and DRPs were re-identified and further interventions were conducted as necessary. A total of 75 inpatients were included in the study. Pre-intervention, there were 443 DRPs and 202 clinical problems. The most frequent DRPs were adverse drug reactions (52.6%), followed by drug effects (41.8%). Most DRPs were of moderate severity and would have resulted in moderate consequences had the pharmacist not intervened. The interventions resulted in a significant reduction in the number of DRPs, type of DRPs and number of clinical problems ( P <0.05 each). Patients with complications were 26.047 times more likely to have no reduction or an increased number of clinical problems compared to patients without complications ( P <0.05). Clinical pharmacist interventions were found to reduce subsequent DRPs and clinical problems among CHD patients with at least one previous DRP.

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

PubMed

Klein, Jan Philipp; Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-07-13

This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. The study takes place in five diagnostic centres in Germany. A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. ClinicalTrials.gov NCT01636752. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Integrative techniques related to positive processes in psychotherapy.

PubMed

Cromer, Thomas D

2013-09-01

This review compiles and evaluates a number of therapist interventions that have been found to significantly contribute to positive psychotherapy processes (i.e., increased alliance, patient engagement/satisfaction, and symptomatic improvement). Four forms of intervention are presented: Affect-focused, Supportive, Exploratory, and Patient-Therapist Interaction. The intention of this review is to link specific interventions to applied practice so that integrative clinicians can potentially use these techniques to improve their clinical work. To this end, there is the inclusion of theory and empirical studies from a range of orientations including Emotionally Focused, Psychodynamic, Client-Centered, Cognitive-Behavioral, Interpersonal, Eclectic, and Motivational Interviewing. Each of the four sections will include the theoretical basis and proposed mechanism of change for the intervention, research that supports its positive impact on psychotherapy processes, and conclude with examples demonstrating its use in actual practice. Clinical implications and considerations regarding the use of these interventions will also be presented. 2013 APA, all rights reserved

Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

PubMed

Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

2016-01-01

Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline release without active dissemination. We hypothesize that the clinics randomized to the intervention group will have a lower proportion of early dialysis starts. Limitations include passive dissemination of the guideline through publication, and lead-time and survivor bias, which favors delayed dialysis initiation. If successful, this active knowledge translation intervention will reduce early dialysis starts, lead to health and economic benefits, and provide a successful framework for evaluating and disseminating future guidelines. ClinicalTrials.gov, NCT02183987.

Changing physician behavior: what works?

PubMed

Mostofian, Fargoi; Ruban, Cynthiya; Simunovic, Nicole; Bhandari, Mohit

2015-01-01

There are various interventions for guideline implementation in clinical practice, but the effects of these interventions are generally unclear. We conducted a systematic review to identify effective methods of implementing clinical research findings and clinical guidelines to change physician practice patterns, in surgical and general practice. Systematic review of reviews. We searched electronic databases (MEDLINE, EMBASE, and PubMed) for systematic reviews published in English that evaluated the effectiveness of different implementation methods. Two reviewers independently assessed eligibility for inclusion and methodological quality, and extracted relevant data. Fourteen reviews covering a wide range of interventions were identified. The intervention methods used include: audit and feedback, computerized decision support systems, continuing medical education, financial incentives, local opinion leaders, marketing, passive dissemination of information, patient-mediated interventions, reminders, and multifaceted interventions. Active approaches, such as academic detailing, led to greater effects than traditional passive approaches. According to the findings of 3 reviews, 71% of studies included in these reviews showed positive change in physician behavior when exposed to active educational methods and multifaceted interventions. Active forms of continuing medical education and multifaceted interventions were found to be the most effective methods for implementing guidelines into general practice. Additionally, active approaches to changing physician performance were shown to improve practice to a greater extent than traditional passive methods. Further primary research is necessary to evaluate the effectiveness of these methods in a surgical setting.

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

The Efficacy of Endoscopic Palliation of Obstructive Jaundice in Hepatocellular Carcinoma

PubMed Central

Park, Semi; Park, Jeong Youp; Chung, Moon Jae; Chung, Jae Bock; Park, Seung Woo; Han, Kwang-Hyub; Song, Si Young

2014-01-01

Purpose Obstructive jaundice in patients with hepatocellular carcinoma (HCC) is uncommon (0.5-13%). Unlike other causes of obstructive jaundice, the role of endoscopic intervention in obstructive jaundice complicated by HCC has not been clearly defined. The aim of this study was to evaluate the clinical characteristics of obstructive jaundice caused by HCC and predictive factors for successful endoscopic intervention. Materials and Methods From 1999 to 2009, 54 patients with HCC who underwent endoscopic intervention to relieve obstructive jaundice were included. We defined endoscopic intervention as a clinical success when the obstructive jaundice was relieved within 4 weeks. Results Clinical success was achieved in 23 patients (42.6%). Patients in the clinical success group showed better Child-Pugh liver function (C-P grade A or B/C; 17/6 vs. 8/20), lower total bilirubin levels (8.1±5.3 mg/dL vs. 23.1±10.4 mg/dL) prior to the treatment, and no history of alcohol consumption. The only factor predictive of clinical success by multivariate analysis was low total bilirubin level at the time of endoscopic intervention, regardless of history of alcohol consumption [odds ratio 1.223 (95% confidence interval, 1.071-1.396), p=0.003]. The cut-off value of pre-endoscopic treatment total bilirubin level was 12.8 mg/dL for predicting the clinical prognosis. Median survival after endoscopic intervention in the clinical success group was notably longer than that in the clinical failure group (5.6 months vs. 1.5 months, p≤0.001). Conclusion Before endoscopic intervention, liver function, especially total bilirubin level, should be checked to achieve the best clinical outcome. Endoscopic intervention can be helpful to relieve jaundice in well selected patients with HCC. PMID:25048484

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

PubMed

Pyatak, Elizabeth A; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A; Wood, Jamie R; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L

2017-03-01

This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. Copyright © 2017 Elsevier Inc. All rights reserved.

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Study: Methodology and Baseline Characteristics of a Randomized Controlled Trial Evaluating an Occupation-Based Diabetes Management Intervention for Young Adults

PubMed Central

Pyatak, Elizabeth A.; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A.; Wood, Jamie R.; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L.

2017-01-01

Overview This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. Methods In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study’s primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. Results At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6 years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrate clinically significant diabetes distress and 27.2% report symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Discussion Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. PMID:28064028

The Clinical Value, Principle, and Basic Practical Technique of Mindfulness Intervention.

PubMed

Zou, Tao; Wu, Chenghan; Fan, Xiaoduo

2016-06-25

Mindfulness intervention is a psychotherapy based on the Buddhist practice of meditation, combining the theories and methodology of contemporary psychology. The empirical research in recent years has indicated that mindfulness intervention yields favorable results including reduction of depression relapse, alleviation of the symptoms of depression and anxiety, reduction of substance abuse, relief of pain, blood pressure management, enhancement of immunity, and improvement of sleep. Currently, mindfulness therapy has become the mainstream of psychotherapy in the realm of European and American psychotherapy. The fields of psychology and psychotherapy in China have also begun to introduce mindfulness intervention in recent years. However, there is a lack of relevant practice and research in the field of clinical mental health. This article will briefly introduce the concept of mindfulness, the basic mechanism of the intervention, and the basic skills and guidelines in clinical practice.

Ethical clinical translation of stem cell interventions for neurologic disease.

PubMed

Cote, David J; Bredenoord, Annelien L; Smith, Timothy R; Ammirati, Mario; Brennum, Jannick; Mendez, Ivar; Ammar, Ahmed S; Balak, Naci; Bolles, Gene; Esene, Ignatius Ngene; Mathiesen, Tiit; Broekman, Marike L

2017-01-17

The application of stem cell transplants in clinical practice has increased in frequency in recent years. Many of the stem cell transplants in neurologic diseases, including stroke, Parkinson disease, spinal cord injury, and demyelinating diseases, are unproven-they have not been tested in prospective, controlled clinical trials and have not become accepted therapies. Stem cell transplant procedures currently being carried out have therapeutic aims, but are frequently experimental and unregulated, and could potentially put patients at risk. In some cases, patients undergoing such operations are not included in a clinical trial, and do not provide genuinely informed consent. For these reasons and others, some current stem cell interventions for neurologic diseases are ethically dubious and could jeopardize progress in the field. We provide discussion points for the evaluation of new stem cell interventions for neurologic disease, based primarily on the new Guidelines for Stem Cell Research and Clinical Translation released by the International Society for Stem Cell Research in May 2016. Important considerations in the ethical translation of stem cells to clinical practice include regulatory oversight, conflicts of interest, data sharing, the nature of investigation (e.g., within vs outside of a clinical trial), informed consent, risk-benefit ratios, the therapeutic misconception, and patient vulnerability. To help guide the translation of stem cells from the laboratory into the neurosurgical clinic in an ethically sound manner, we present an ethical discussion of these major issues at stake in the field of stem cell clinical research for neurologic disease. © 2016 American Academy of Neurology.

Interventions for the treatment of uveitic macular edema: a systematic review and meta-analysis

PubMed Central

Karim, Rushmia; Sykakis, Evripidis; Lightman, Susan; Fraser-Bell, Samantha

2013-01-01

Background Uveitic macular edema is the major cause of reduced vision in eyes with uveitis. Objectives To assess the effectiveness of interventions in the treatment of uveitic macular edema. Search strategy Cochrane Central Register of Controlled Trials, Medline, and Embase. There were no language or data restrictions in the search for trials. The databases were last searched on December 1, 2011. Reference lists of included trials were searched. Archives of Ophthalmology, Ophthalmology, Retina, the British Journal of Ophthalmology, and the New England Journal of Medicine were searched for clinical trials and reviews. Selection criteria Participants of any age and sex with any type of uveitic macular edema were included. Early, chronic, refractory, or secondary uveitic macular edema were included. We included trials that compared any interventions of any dose and duration, including comparison with another treatment, sham treatment, or no treatment. Data collection and analysis Best-corrected visual acuity and central macular thickness were the primary outcome measures. Secondary outcome data including adverse effects were collected. Conclusion More results from randomized controlled trials with long follow-up periods are needed for interventions for uveitic macular edema to assist in determining the overall long-term benefit of different treatments. The only intervention with sufficiently robust randomized controlled trials for a meta-analysis was acetazolamide, which was shown to be ineffective in improving vision in eyes with uveitic macular edema, and is clinically now rarely used. Interventions showing promise in this disease include dexamethasone implants, immunomodulatory drugs and anti-vascular endothelial growth-factor agents. When macular edema has become refractory after multiple interventions, pars plana vitrectomy could be considered. The disease pathophysiology is uncertain and the course of disease unpredictable. As there are no clear guidelines from the literature, interventions should be tailored to the individual patient. PMID:23807831

[Management of acute and subacute clinical situations by interventional radiology: non-vascular interventions and treatment for hemoptysis].

PubMed

Nemes, Balázs; Doros, Attila

2015-04-26

Interventional radiology provides fast, straightforward and tolerable solutions for many medical problems including acute and subacute situations. Aspiration and drainage of fluid collections, biliary and endourologic interventions and gastrointestinal interventions are parts of non-vascular interventions. In addition, the authors discuss in detail interventional radiological treatment options in patients with hemoptysis. In acute cases interventions must be performed within 12-24 hours. For background, an everyday 24 hours service should be provided with well-trained personnel, high quality equipment and devices, and a reasonable financial reimbursement should be included, too. Multidisciplinary teamwork, consultations, consensus in indications and structured education should make these centers function most effectively.

Development of a Multilevel Intervention to Increase HIV Clinical Trial Participation among Rural Minorities

PubMed Central

Corbie-Smith, Giselle; Odeneye, Ebun; Banks, Bahby; Miles, Margaret Shandor; Isler, Malika Roman

2013-01-01

Minorities are disproportionately affected by HIV/AIDS in the rural Southeast; therefore, it is important to develop targeted, culturally appropriate interventions to support rural minority participation in HIV/AIDS research. Using Intervention Mapping, we developed a comprehensive multilevel intervention for service providers (SPs) and people living with HIV/AIDS (PLWHA). We collected data from both groups through 11 focus groups and 35 individual interviews. Resultant data were used to develop matrices of behavioral outcomes, performance objectives and learning objectives. Each performance objective was mapped with changeable, theory-based determinants to inform components of the intervention. Behavioral outcomes for the intervention included: (a) Eligible PLWHA will enroll in clinical trials; and (b) SPs will refer eligible PLWHA to clinical trials. The ensuing intervention consists of four SPs and six PLWHA educational sessions. Its contents, methods and strategies were grounded in the theory of reasoned action, social cognitive theory, and the concept of social support. All materials were pretested and refined for content appropriateness and effectiveness. PMID:22991051

DianaHealth.com, an On-Line Database Containing Appraisals of the Clinical Value and Appropriateness of Healthcare Interventions: Database Development and Retrospective Analysis.

PubMed

Bonfill, Xavier; Osorio, Dimelza; Solà, Ivan; Pijoan, Jose Ignacio; Balasso, Valentina; Quintana, Maria Jesús; Puig, Teresa; Bolibar, Ignasi; Urrútia, Gerard; Zamora, Javier; Emparanza, José Ignacio; Gómez de la Cámara, Agustín; Ferreira-González, Ignacio

2016-01-01

To describe the development of a novel on-line database aimed to serve as a source of information concerning healthcare interventions appraised for their clinical value and appropriateness by several initiatives worldwide, and to present a retrospective analysis of the appraisals already included in the database. Database development and a retrospective analysis. The database DianaHealth.com is already on-line and it is regularly updated, independent, open access and available in English and Spanish. Initiatives are identified in medical news, in article references, and by contacting experts in the field. We include appraisals in the form of clinical recommendations, expert analyses, conclusions from systematic reviews, and original research that label any health care intervention as low-value or inappropriate. We obtain the information necessary to classify the appraisals according to type of intervention, specialties involved, publication year, authoring initiative, and key words. The database is accessible through a search engine which retrieves a list of appraisals and a link to the website where they were published. DianaHealth.com also provides a brief description of the initiatives and a section where users can report new appraisals or suggest new initiatives. From January 2014 to July 2015, the on-line database included 2940 appraisals from 22 initiatives: eleven campaigns gathering clinical recommendations from scientific societies, five sets of conclusions from literature review, three sets of recommendations from guidelines, two collections of articles on low clinical value in medical journals, and an initiative of our own. We have developed an open access on-line database of appraisals about healthcare interventions considered of low clinical value or inappropriate. DianaHealth.com could help physicians and other stakeholders make better decisions concerning patient care and healthcare systems sustainability. Future efforts should be focused on assessing the impact of these appraisals in the clinical practice.

DianaHealth.com, an On-Line Database Containing Appraisals of the Clinical Value and Appropriateness of Healthcare Interventions: Database Development and Retrospective Analysis

PubMed Central

Bonfill, Xavier; Osorio, Dimelza; Solà, Ivan; Pijoan, Jose Ignacio; Balasso, Valentina; Quintana, Maria Jesús; Puig, Teresa; Bolibar, Ignasi; Urrútia, Gerard; Zamora, Javier; Emparanza, José Ignacio; Gómez de la Cámara, Agustín; Ferreira-González, Ignacio

2016-01-01

Objective To describe the development of a novel on-line database aimed to serve as a source of information concerning healthcare interventions appraised for their clinical value and appropriateness by several initiatives worldwide, and to present a retrospective analysis of the appraisals already included in the database. Methods and Findings Database development and a retrospective analysis. The database DianaHealth.com is already on-line and it is regularly updated, independent, open access and available in English and Spanish. Initiatives are identified in medical news, in article references, and by contacting experts in the field. We include appraisals in the form of clinical recommendations, expert analyses, conclusions from systematic reviews, and original research that label any health care intervention as low-value or inappropriate. We obtain the information necessary to classify the appraisals according to type of intervention, specialties involved, publication year, authoring initiative, and key words. The database is accessible through a search engine which retrieves a list of appraisals and a link to the website where they were published. DianaHealth.com also provides a brief description of the initiatives and a section where users can report new appraisals or suggest new initiatives. From January 2014 to July 2015, the on-line database included 2940 appraisals from 22 initiatives: eleven campaigns gathering clinical recommendations from scientific societies, five sets of conclusions from literature review, three sets of recommendations from guidelines, two collections of articles on low clinical value in medical journals, and an initiative of our own. Conclusions We have developed an open access on-line database of appraisals about healthcare interventions considered of low clinical value or inappropriate. DianaHealth.com could help physicians and other stakeholders make better decisions concerning patient care and healthcare systems sustainability. Future efforts should be focused on assessing the impact of these appraisals in the clinical practice. PMID:26840451

Smoking Cessation Interventions in Cancer Care: Opportunities for Oncology Nurses and Nurse Scientists

PubMed Central

Cooley, Mary E.; Lundin, Rebecca; Murray, Lyndsay

2016-01-01

Smoking cessation is essential after the diagnosis of cancer to improve clinical outcomes. The purpose of this chapter is to provide a systematic review of research on smoking cessation in the context of cancer care with an emphasis on nursing contributions to the field. Data sources included research reports of smoking cessation interventions conducted in people with cancer. Nineteen primary studies were reviewed. High intensity interventions, targeting multiple behaviors, and/or using a multicomponent intervention that included pharmacotherapy, behavioral counseling, and social support were characteristics of the most successful treatments for tobacco dependence. The majority of interventions were conducted in adults with smoking-related malignancies during acute phases of illness. The most striking finding was that more than one half of the studies tested the efficacy of nurse-delivered interventions. Conceptual and methodological issues that can be improved in future studies include: using theoretical frameworks to specify how the intervention will affect outcomes, ensuring adequate sample sizes, using biochemical verification to monitor smoking outcomes, and using standardized outcome measures of abstinence. Although effective interventions are available for healthy populations, further research is needed to determine if tailored cessation interventions are needed for patients with cancer. To provide optimal quality care it is imperative that delivery of evidence-based smoking cessation interventions be integrated into the cancer treatment trajectory. Multiple barriers, including patient and nurse attitudes toward smoking and lack of knowledge related to tobacco treatment, prevent translating evidence-based tobacco dependence treatment into clinical practice. Further nursing research is needed to address these barriers. PMID:20192107

Outcomes associated with virtual reality in psychological interventions: where are we now?

PubMed

Turner, Wesley A; Casey, Leanne M

2014-12-01

The impending commercial release of affordable VR systems is likely to accelerate both the opportunity and demand for VR applications that specifically target psychological conditions. The aim of this study was to conduct a meta-analysis of outcomes associated with VR psychological interventions and to examine the methodological rigour used in these interventions. Literature search was conducted via Ovid, ProQuest Psychology Journals and ScienceDirect (Psychology) databases. Interventions were required to: be published between 1980 to 2014; use a randomised controlled trial design; be published in a scholarly journal; focused primarily on psychological/behavioural intervention; include validated measures; include reported means and standard deviations of outcome measures; and include one group with clinical/subclinical disorders, syndromes or distressing behaviours. Thirty eligible studies were identified. Random effects meta-analysis found an overall moderate effect size for VR interventions. Individual meta-analyses found an overall large effect size against non-intervention wait-lists and an overall moderate effect size against active interventions. No correlation was found between treatment outcomes and methodological rigour. Limitations may include limited study numbers, the use of a single coder, a need for more in-depth analyses of variation in form VR intervention, and omission of presence as a moderating factor. The current review supports VR interventions as efficacious, promising forms of psychological treatment. Use of reporting guidelines such as the CONSORT and CONSORT-EHEALTH statements should promote greater emphasis on methodological rigour, providing a firm foundation for the further development of clinical VR applications. Copyright © 2014 Elsevier Ltd. All rights reserved.

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara

2014-05-09

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation. To assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress. We searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies). Two authors independently assessed studies for inclusion and extracted data. We synthesised the findings using meta-analysis, where possible, and narrative synthesis of results. We assessed the risk of bias of individual studies and considered the impact of the quality of the overall evidence on the strength of the results. We included 16 studies involving data from 1884 participants. Nine studies included participants considering real clinical trials, and eight included participants considering hypothetical clinical trials, with one including both. All studies were conducted in high-income countries.There is still much uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. However, when considered across comparisons, we found low to very low quality evidence that such interventions may slightly improve knowledge or understanding of the parent trial, but may make little or no difference to rate of participation or willingness to participate. Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent. We found conflicting, very low quality evidence about whether audio-visual interventions took more or less time to administer. No study measured researcher satisfaction with the informed consent process, nor ease of use.The evidence from real clinical trials was rated as low quality for most outcomes, and for hypothetical studies, very low. We note, however, that this was in large part due to poor study reporting, the hypothetical nature of some studies and low participant numbers, rather than inconsistent results between studies or confirmed poor trial quality. We do not believe that any studies were funded by organisations with a vested interest in the results. The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction. Many relevant outcomes have not been evaluated in randomised trials. Triallists should continue to explore innovative methods of providing information to potential trial participants during the informed consent process, mindful of the range of outcomes that the intervention should be designed to achieve, and balancing the resource implications of intervention development and delivery against the purported benefits of any intervention.More trials, adhering to CONSORT standards, and conducted in settings and populations underserved in this review, i.e. low- and middle-income countries and people with low literacy, would strengthen the results of this review and broaden its applicability. Assessing process measures, such as time taken to administer the intervention and researcher satisfaction, would inform the implementation of audio-visual consent materials.

A systematic review on US-based community health navigator (CHN) interventions for cancer screening promotion--comparing community- versus clinic-based navigator models.

PubMed

Hou, Su-I; Roberson, Kiersten

2015-03-01

This study synthesized lessons learned from US-based community and clinic health navigator (CHN) interventions on cancer screening promotion to identify characteristics of models and approaches for addressing cancer disparities. The combination terms "cancer screening" and "community health workers or navigators" or "patient navigators" were used in searching Medline, CINAHL, and PsycInfo. A total of 27 articles published during January 2005∼April 2014 were included. Two CHN models were identified: community-based (15 studies) and clinic/hospital-based (12 studies). While both models used the term "navigators," most community-based programs referred them as community health workers/navigators/advisors, whereas clinic-based programs often called them patient navigators. Most community-based CHN interventions targeted specific racial/ethnic minority or rural groups, while clinic-based programs mostly targeted urban low income or mixed ethnic groups. Most community-based CHN programs outreached members from community networks, while clinic-based programs commonly worked with pre-identified in-service clients. Overall, regardless model type, CHNs had similar roles and responsibilities, and interventions demonstrated effective outcomes. Our review identified characteristics of CHN interventions with attention to different settings. Lessons learned have implication on the dissemination and implementation of CHN interventions for cancer screening promotion across setting and target groups.

An intervention for reducing secondary traumatization and improving professional self-efficacy in well baby clinic nurses following war and terror: a random control group trial.

PubMed

Berger, Rony; Gelkopf, Marc

2011-05-01

Due to the terror and war-related situation in Israel, well baby clinic nurses dealing with a large number of traumatized and highly distressed infants, toddlers and their parents have become overwhelmed. (1) Assess the level of secondary traumatization, including lack of compassion satisfaction, burnout and compassion fatigue of well baby clinic nurses living under chronic threat of war and terror. (2) Assess the efficacy of an intervention aimed at providing well baby clinic nurses with psycho-educational knowledge pertaining to stress and trauma in infants, young children and parents. This intervention provides the nurses with screening tools for identifying children and parents at risk of developing stress-related problems and equips them with stress management techniques. Quasi-random control trial. The intervention took place in Israel, in war (North) and terror (South) affected areas. Ninety well baby clinic nurses from the most war and terror affected areas in Israel were approached, 42 were randomly assigned the experimental intervention and 38 served as a waiting list group. The intervention was comprised of 12 weekly 6-h sessions. Each session included theoretical knowledge, experiential exercises based on the nurses' work or personal life experience, and the learning of skills accompanied by homework assignments. Participants were assessed on self-report measures of secondary traumatization, professional self-efficacy, hope, sense of mastery and self-esteem before and after the intervention. (1) Well baby clinic nurses were found to have elevated secondary traumatization levels. (2) Compared to the waiting list group, the intervention group improved significantly on the professional self-efficacy measure as well as reducing the level of secondary traumatization. Furthermore, improvement on all secondary traumatization measures covaried with the improvement on the professional self-efficacy assessments. Based on additional informal reports, the improvement was observed to be clinically significant. Training of medical personnel who work with traumatized children and their families and who may also be under the threat of war and terror is essential to both improving their professional functioning, as well as reducing the vulnerability to secondary traumatization. Copyright © 2010 Elsevier Ltd. All rights reserved.

Conference Report: 6th Annual International Symposium on Regenerative Rehabilitation.

PubMed

Loghmani, M Terry; Roche, Joseph A

2018-04-03

The 6th International Symposium on Regenerative Rehabilitation, hosted by the Alliance for Regenerative Rehabilitation Research and Training (AR 3 T), included a preconference meeting of institutional representatives of the International Consortium of Regenerative Rehabilitation, keynote talks from distinguished scientists, platform and poster presentations from experts and trainees, panel discussions and postconference workshops. The following priorities were identified: increasing rigor in basic, preclinical and clinical studies, especially the use of better controls; developing better outcome measures for preclinical and clinical trials; focusing on developing more tissue-based interventions versus cell-based interventions; including regenerative rehabilitation in curricula of professional programs like occupational and physical therapy; and developing better instruments to quantify rehabilitative interventions.

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients With Cancer

PubMed Central

Hamel, Lauren M.; Penner, Louis A.; Albrecht, Terrance L.; Heath, Elisabeth; Gwede, Clement K.; Eggly, Susan

2016-01-01

Background Clinical trials that study cancer are essential for testing the safety and effectiveness of promising treatments, but most people with cancer never enroll in a clinical trial — a challenge exemplified in racial and ethnic minorities. Underenrollment of racial and ethnic minorities reduces the generalizability of research findings and represents a disparity in access to high-quality health care. Methods Using a multilevel model as a framework, potential barriers to trial enrollment of racial and ethnic minorities were identified at system, individual, and interpersonal levels. Exactly how each level directly or indirectly contributes to doctor–patient communication was also reviewed. Selected examples of implemented interventions are included to help address these barriers. We then propose our own evidence-based intervention addressing barriers at the individual and interpersonal levels. Results Barriers to enrolling a diverse population of patients in clinical trials are complex and multilevel. Interventions focused at each level have been relatively successful, but multilevel interventions have the greatest potential for success. Conclusion To increase the enrollment of racial and ethnic minorities in clinical trials, future interventions should address barriers at multiple levels. PMID:27842322

Interventions for improving research productivity in clinical radiology.

PubMed

Akhtar, Waseem; Arain, Mubashir Aslam; Ali, Arif; Sajjad, Zafar

2012-07-01

The purpose of this study was to evaluate the effects of research promotion activities on overall quality and quantity of research output in a clinical department of a teaching tertiary care hospital. Simple research enhancing strategies including regular journal club, research hour, basic research skills training, hiring of research faculty, research awards, and annual research retreat and research board to increase research production were implemented in the Department of Radiology of a teaching hospital in Pakistan. A total of 77 papers were produced by the Department of Radiology before the intervention, which increased to 92 after the introduction of research initiatives. There was a significant increase in the overall proportion of publications in the international journals after the intervention (p < 0.001) with an increasing trend towards indexed journals (p < 0.001). The research enhancing interventions had a positive effect on increasing clinical research output by the Department of Radiology. Such interventions can also be replicated in other clinical departments to increase their research productivity.

Implementation of a Telephone Postoperative Clinic in an Integrated Health System.

PubMed

Kummerow Broman, Kristy; Roumie, Christianne L; Stewart, Melissa K; Castellanos, Jason A; Tarpley, John L; Dittus, Robert S; Pierce, Richard A

2016-10-01

Earlier work suggested that telephone follow-up could be used in lieu of in-person follow-up after surgery, saving patients time and travel and maximizing use of scarce surgeon and facility resources. We report our experience implementing and evaluating telephone postoperative follow-up within an integrated health system. We conducted a pre-post evaluation of a general surgery telephone postoperative clinic at a tertiary care Veterans Affairs facility from April 2015 to February 2016. Patients were offered a telephone postoperative visit from a surgical provider in lieu of an in-person clinic visit. Telephone clinic operating procedures were refined through iterative cycles of change using the Plan-Do-Study-Act method. The study period included 2 months pre-intervention and 9 months post-intervention. The primary end point was mean number of clinic visits per eligible patient before and after telephone clinic implementation. Secondary outcomes were rates of emergency department visits and readmissions before vs after telephone clinic implementation and complication rates in patients scheduled for telephone vs in-person postoperative care. During the study period, 200 patients underwent eligible operations, 29 pre-intervention and 171 post-intervention. In-person clinic use decreased from 0.83 visits per eligible patient pre-intervention to 0.40 after implementation of the telephone clinic (p < 0.01). There was no difference in rates of emergency department presentation or readmission in eligible patients (0.17 visits/patient pre-intervention vs 0.12 post-intervention; p = 0.36). Complication rates were comparable for eligible patients who were and were not scheduled for telephone care (6% vs 8%; p = 0.31). Telephone postoperative care can be used in select populations as a triage tool to identify patients who require in-person care and decrease overall in-person clinic use. Published by Elsevier Inc.

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

PubMed

Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

2016-08-02

Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

Rehabilitation technologies and interventions for individuals with spinal cord injury: translational potential of current trends.

PubMed

Musselman, Kristin E; Shah, Meeral; Zariffa, José

2018-05-16

In the past, neurorehabilitation for individuals with neurological damage, such as spinal cord injury (SCI), was focused on learning compensatory movements to regain function. Presently, the focus of neurorehabilitation has shifted to functional neurorecovery, or the restoration of function through repetitive movement training of the affected limbs. Technologies, such as robotic devices and electrical stimulation, are being developed to facilitate repetitive motor training; however, their implementation into mainstream clinical practice has not been realized. In this commentary, we examined how current SCI rehabilitation research aligns with the potential for clinical implementation. We completed an environmental scan of studies in progress that investigate a physical intervention promoting functional neurorecovery. We identified emerging interventions among the SCI population, and evaluated the strengths and gaps of the current direction of SCI rehabilitation research. Seventy-three study postings were retrieved through website and database searching. Study objectives, outcome measures, participant characteristics and the mode(s) of intervention being studied were extracted from the postings. The FAME (Feasibility, Appropriateness, Meaningfulness, Effectiveness, Economic Evidence) Framework was used to evaluate the strengths and gaps of the research with respect to likelihood of clinical implementation. Strengths included aspects of Feasibility, as the research was practical, aspects of Appropriateness as the research aligned with current scientific literature on motor learning, and Effectiveness, as all trials aimed to evaluate the effect of an intervention on a clinical outcome. Aspects of Feasibility were also identified as a gap; with two thirds of the studies examining emerging technologies, the likelihood of successful clinical implementation was questionable. As the interventions being studied may not align with the preferences of clinicians and priorities of patients, the Appropriateness of these interventions for the current health care environment was questioned. Meaningfulness and Economic Evidence were also identified as gaps since few studies included measures reflecting the perceptions of the participants or economic factors, respectively. The identified gaps will likely impede the clinical uptake of many of the interventions currently being studied. Future research may lessen these gaps through a staged approach to the consideration of the FAME elements as novel interventions and technologies are developed, evaluated and implemented.

Theory based interventions for caries related sugar intake in adults: systematic review.

PubMed

Al Rawahi, Said Hartih; Asimakopoulou, Koula; Newton, Jonathon Timothy

2017-07-25

Theories of behavior change are essential in the design of effective behaviour change strategies. No studies have assessed the effectiveness of interventions based on psychological theories to reduce sugar intake related to dental caries. The study assessed the effect of interventions based on Social Congition Models (SCMs) on sugar intake in adults, when compared with educational interventions or no intervention. A range of papers were considered: Systematic review Systematic Reviews with or without Meta Analyses; Randomised Controlled Trials; Controlled Clinical Trials and Before and after studies, of interventions based on Social Cognition Models aimed at dietary intake of sugar in adults. The Cochrane database including: Oral Health Group's Trials Register (2015), MEDLINE (from 1966 to September 2015), EMBASE (from 1980 to September 2015), PsycINFO (from 1966 to September 2015) were searched. No article met the full eligibility criteria for the current systematic review so no articles were included. There is a need for more clinical trials to assess the effectiveness of interventions based on psychological theory in reducing dietary sugar intake among adults. PROSPERO: CRD42015026357 .

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention.

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-05-19

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines. Copyright © 2015 The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, The Heart Failure Society of America, and The Society for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie D'intervention).

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-06-01

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella®; left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines. © 2015 by The Society for Cardiovascular Angiography and Interventions, The American College of Cardiology Foundation, The Heart Failure Society of America, and The Society for Thoracic Surgery.

Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial.

PubMed

Ben-Zeev, Dror; Brian, Rachel M; Jonathan, Geneva; Razzano, Lisa; Pashka, Nicole; Carpenter-Song, Elizabeth; Drake, Robert E; Scherer, Emily A

2018-05-25

mHealth approaches that use mobile phones to deliver interventions can help improve access to care for people with serious mental illness. The goal was to evaluate how mHealth performs against more traditional treatment. A three-month randomized controlled trial was conducted of a smartphone-delivered intervention (FOCUS) versus a clinic-based group intervention (Wellness Recovery Action Plan [WRAP]). Participants were 163 clients, mostly from racial minority groups and with long-term, serious mental illness (schizophrenia or schizoaffective disorder, 49%; bipolar disorder, 28%; and major depressive disorder, 23%). Outcomes were engagement throughout the intervention; satisfaction posttreatment (three months); and improvement in clinical symptoms, recovery, and quality of life (assessed at baseline, posttreatment, and six months). Participants assigned to FOCUS were more likely than those assigned to WRAP to commence treatment (90% versus 58%) and remain fully engaged in eight weeks of care (56% versus 40%). Satisfaction ratings were comparably high for both interventions. Participants in both groups improved significantly and did not differ in clinical outcomes, including general psychopathology and depression. Significant improvements in recovery were seen for the WRAP group posttreatment, and significant improvements in recovery and quality of life were seen for the FOCUS group at six months. Both interventions produced significant gains among clients with serious and persistent mental illnesses who were mostly from racial minority groups. The mHealth intervention showed superior patient engagement and produced patient satisfaction and clinical and recovery outcomes that were comparable to those from a widely used clinic-based group intervention for illness management.

Building capacity for education research among clinical educators in the health professions: A BEME (Best Evidence Medical Education) Systematic Review of the outcomes of interventions: BEME Guide No. 34.

PubMed

Ahmed, Rabia; Farooq, Ameer; Storie, Dale; Hartling, Lisa; Oswald, Anna

2016-01-01

There is a growing desire for health professions educators to generate high-quality education research; yet, few of them encounter the training to do so. In response, health professions faculties have increasingly been devoting resources to provide members with the skills necessary for education research. The form and impact of these efforts have not been reviewed, though such a synthesis could be useful for practice. The objectives of this systematic review were to (1) identify interventions aimed at building capacity for education research among health professions clinical educators and (2) review the outcomes of these interventions. We developed a systematic review protocol based on our pilot scoping search. This protocol underwent peer review and was prospectively registered with the Best Evidence Medical Education Collaboration. Based on this protocol, we conducted a comprehensive search of health professions' databases and related grey literature. Systematic methods were applied: two independent reviewers completed title screening and full text review for inclusion, data extraction, and methodological quality assessment. Studies were included if they reported outcomes for interventions designed to increase capacity for health professions clinical educators to conduct education research. We conducted a qualitative synthesis of the evidence which included detailed reporting of intervention characteristics and outcomes. Our search returned 14, 149 results, 241 of which were retained after title and abstract screening, and 30 of which met inclusion criteria after full text review. Seven groups of interventions were identified, the most frequent being teaching scholars programs (n = 10), health professions education fellowships (n = 3) or master's programs (n = 4). The most commonly measured outcome was change related to enhanced scholarly outputs (grants, papers, abstracts, and presentations) post-intervention. Unfortunately, most of the included studies lacked detailed description of the intervention and were of low to moderate quality with post-test only design. This review demonstrates that various interventions can have a positive impact on the ability of health professions clinical educators to conduct education research. We note several key elements of the interventions including: (1) protected time, (2) mentorship and/or collaboration, (3) departmental and institutional commitment and leadership, and (4) financial support. Through our analysis we describe the complexities around evaluating clinical educators' health professions research activities and the interventions used to promote education research. While improved study quality would allow more detailed understanding and evaluation of these key features, we are able to provide recommendations for potential strategies for improving participation in and quality of health professions education research based on this analysis.

HPV vaccination: Population approaches for improving rates.

PubMed

Oliver, Kristin; Frawley, Alean; Garland, Elizabeth

2016-06-02

To review the literature on interventions to increase HPV vaccinations and assess whether The Community Preventive Services Task Force recommendations are supported by current evidence. We used a PubMed search to identify studies that assessed interventions that looked at provider assessment and feedback, provider reminders, client reminder and recall, and clinic based education programs. Of the 13 studies identified, 8 included client reminder and recall interventions, 4 included provider assessment and feedback and/or provider reminders and 2 included clinic based education. 11 of the 13 studies demonstrated a positive effect on HPV vaccine initiation or completion. Provider assessment and feedback studies were more likely to report a positive effect on HPV vaccine initiation than on series completion, while client reminder recall interventions more frequently produced an effect on series completion than on initiation. There is evidence to support the application of the Community Preventive Services Task Force recommendations specifically to HPV vaccination both for client reminder and recall programs and for provider assessment and feedback interventions. Multiple targeted approaches will be needed to substantially impact HPV vaccine rates.

Enhancing self-directed learning among Italian nursing students: A pre- and post-intervention study.

PubMed

Cadorin, L; Rei, A; Dante, A; Bulfone, T; Viera, G; Palese, A

2015-06-01

In accordance with Knowles's theory, self-directed learning (SDL) may be improved with tutorial strategies focused on guided reflection and critical analysis of the learning process. No evidence on effects on SDL abilities of different tutorial strategies offered to nursing students during the 1st clinical experience is available. To evaluate the effect of different tutorial strategies offered to nursing students on their SDL abilities. A pre-post intervention non-equivalent control group design was adopted in 2013. For the treatment group, structured and intensive tutorial interventions including different strategies such as briefing, debriefing, peer support, Socratic questioning, performed by university tutors were offered during the 1st clinical experience; for the control group, unstructured and non-intensive tutorial strategies were instead offered. Two Bachelor of Nursing Degree. Students awaiting their clinical experience (n=238) were the target sample. Those students who have completed the pre- and the post-intervention evaluation (201; 84.4%) were included in the analysis. SDL abilities were measured with the SRSSDL_ITA (Self Rating Scale of Self Directed Learning-Italian Version). A multiple linear regression analysis was developed to explore the predictive effect of individual, contextual and intervention variables. Three main factors explained the 36.8% of the adjusted variance in SDL scores have emerged: a) having received a lower clinical nurse-to-student supervision (B 9.086, β 2.874), b) having received higher level and structured tutorial intervention by university tutors (B 8.011, β 2.741), and c) having reported higher SDL scores at the baseline (B .550, β .556). A lower clinical nurse-to-student ratio (1:4), accompanied by unstructured and non-intensive tutorial intervention adopted by university tutors, seemed to be equivalent to an intensive clinical supervision (1:1) accompanied by higher level and structured tutorial strategies activated by the university tutors. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effect of spiritual interventions addressing existential themes using a narrative approach on quality of life of cancer patients: a systematic review and meta-analysis.

PubMed

Kruizinga, Renske; Hartog, Iris D; Jacobs, Marc; Daams, Joost G; Scherer-Rath, Michael; Schilderman, Johannes B A M; Sprangers, Mirjam A G; Van Laarhoven, Hanneke W M

2016-03-01

The aim of this study was to examine the effect of spiritual interventions on quality of life of cancer patients. We conducted our search on June 6, 2014 in Medline, PsycINFO, Embase, and PubMed. All clinical trials were included that compared standard care with a spiritual intervention that addressed existential themes using a narrative approach. Study quality was evaluated by the Cochrane Risk of Bias Tool. A total of 4972 studies were identified, of which 14 clinical trials (2050 patients) met the inclusion criteria, and 12 trials (1878 patients) were included in the meta-analysis. The overall risk of bias was high. When combined, all studies showed a moderate effect (d) 0.50 (95% CI = 0.20-0.79) 0-2 weeks after the intervention on overall quality of life in favor of the spiritual interventions. Meta-analysis at 3-6 months after the intervention showed a small insignificant effect (0.14, 95% CI = -0.08 to 0.35). Subgroup analysis including only the western studies showed a small effect of 0.17 (95% CI = 0.05-0.29). Including only studies that met the allocation concealment criteria showed an insignificant effect of 0.14 (95% CI = -0.05 to 0.33). Directly after the intervention, spiritual interventions had a moderate beneficial effect in terms of improving quality of life of cancer patients compared with that of a control group. No evidence was found that the interventions maintained this effect up to 3-6 months after the intervention. Further research is needed to understand how spiritual interventions could contribute to a long-term effect of increasing or maintaining quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

Intervention for medical students: effective infection control.

PubMed

Calabro, K; Weltge, A; Parnell, S; Kouzekanani, K; Ramirez, E

1998-08-01

Needlestick injuries, which lead to the transmission of hepatitis B, hepatitis C, and the AIDS virus, are a potentially serious threat to students during their clinical experiences. Exposure to infectious diseases, blood, and hazardous body fluids is one of the most frequently reported injury events by medical students at a health science center in the southwestern region of the United States. This study was conducted to determine the effectiveness of a customized intervention about infection control for second-year medical students (N = 200). Preparation for the intervention included a needs assessment, which included both qualitative and quantitative research methods that incorporated input from fourth-year medical students, medical staff members, and local hospital infection control specialists. The intervention included a pretest, a lecture, a demonstration of standard precautions and infection control procedure with 2 clinical scenarios, an exercise on proper handwashing, and a posttest. The evaluation of the intervention demonstrated a significant increase in posttest knowledge scores about infection control (from 12.6 +/- 2.1 pretest to 16.5 +/- 1.8 posttest, P < .001). Medical students showed a significant knowledge increase about infection control after participating in the intervention . Thus we recommend that all medical colleges and universities develop and evaluate a similar customized intervention for their medical students.

Implementation of the CALM intervention for anxiety disorders: a qualitative study

PubMed Central

2012-01-01

Background Investigators recently tested the effectiveness of a collaborative-care intervention for anxiety disorders: Coordinated Anxiety Learning and Management(CALM) []) in 17 primary care clinics around the United States. Investigators also conducted a qualitative process evaluation. Key research questions were as follows: (1) What were the facilitators/barriers to implementing CALM? (2) What were the facilitators/barriers to sustaining CALM after the study was completed? Methods Key informant interviews were conducted with 47 clinic staff members (18 primary care providers, 13 nurses, 8 clinic administrators, and 8 clinic staff) and 14 study-trained anxiety clinical specialists (ACSs) who coordinated the collaborative care and provided cognitive behavioral therapy. The interviews were semistructured and conducted by phone. Data were content analyzed with line-by-line analyses leading to the development and refinement of themes. Results Similar themes emerged across stakeholders. Important facilitators to implementation included the perception of "low burden" to implement, provider satisfaction with the intervention, and frequent provider interaction with ACSs. Barriers to implementation included variable provider interest in mental health, high rates of part-time providers in clinics, and high social stressors of lower socioeconomic-status patients interfering with adherence. Key sustainability facilitators were if a clinic had already incorporated collaborative care for another disorder and presence of onsite mental health staff. The main barrier to sustainability was funding for the ACS. Conclusions The CALM intervention was relatively easy to incorporate during the effectiveness trial, and satisfaction was generally high. Numerous implementation and sustainability barriers could limit the reach and impact of widespread adoption. Findings should be interpreted with the knowledge that the ACSs in this study were provided and trained by the study. Future research should explore uptake of CALM and similar interventions without the aid of an effectiveness trial. PMID:22404963

Counselors, Students of Color, and College: Student-Centered and Systemic Multicultural Interventions.

ERIC Educational Resources Information Center

Gary, Juneau Mahan

Student demographics on campuses increasingly reflect diversity. A counselor's ability to help this emerging campus population requires the use of multicultural interventions that affect the student and the system. Counselors must redefine the process of clinical assessment and intervention to include ethnocultural factors and they must intervene…

An evolving perspective on physical activity counselling by medical professionals.

PubMed

McPhail, Steven; Schippers, Mandy

2012-04-23

Physical inactivity is a modifiable risk factor for many chronic conditions and a leading cause of premature mortality. An increasing proportion of adults worldwide are not engaging in a level of physical activity sufficient to prevent or alleviate these adverse effects. Medical professionals have been identified as potentially powerful sources of influence for those who do not meet minimum physical activity guidelines. Health professionals are respected and expected sources of advice and they reach a large and relevant proportion of the population. Despite this potential, health professionals are not routinely practicing physical activity promotion. Medical professionals experience several known barriers to physical activity promotion including lack of time and lack of perceived efficacy in changing physical activity behaviour in patients. Furthermore, evidence for effective physical activity promotion by medical professionals is inconclusive. To address these problems, new approaches to physical activity promotion are being proposed. These include collaborating with community based physical activity behaviour change interventions, preparing patients for effective brief counselling during a consultation with the medical professional, and use of interactive behaviour change technology. It is important that we recognise the latent risk of physical inactivity among patients presenting in clinical settings. Preparation for improving patient physical activity behaviours should commence before the consultation and may include physical activity screening. Medical professionals should also identify suitable community interventions to which they can refer physically inactive patients. Outsourcing the majority of a comprehensive physical activity intervention to community based interventions will reduce the required clinical consultation time for addressing the issue with each patient. Priorities for future research include investigating ways to promote successful referrals and subsequent engagement in comprehensive community support programs to increase physical activity levels of inactive patients. Additionally, future clinical trials of physical activity interventions should be evaluated in the context of a broader framework of outcomes to inform a systematic consideration of broad strengths and weaknesses regarding not only efficacy but cost-effectiveness and likelihood of successful translation of interventions to clinical contexts.

Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice.

PubMed

Légaré, France; Turcotte, Stéphane; Stacey, Dawn; Ratté, Stéphane; Kryworuchko, Jennifer; Graham, Ian D

2012-01-01

Shared decision making is the process in which a healthcare choice is made jointly by the health professional and the patient. Little is known about what patients view as effective or ineffective strategies to implement shared decision making in routine clinical practice. This systematic review evaluates the effectiveness of interventions to improve health professionals' adoption of shared decision making in routine clinical practice, as seen by patients. We searched electronic databases (PubMed, the Cochrane Library, EMBASE, CINAHL, and PsycINFO) from their inception to mid-March 2009. We found additional material by reviewing the reference lists of the studies found in the databases; systematic reviews of studies on shared decision making; the proceedings of various editions of the International Shared Decision Making Conference; and the transcripts of the Society for Medical Decision Making's meetings. In our study selection, we included randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series analyses in which patients evaluated interventions to improve health professionals' adoption of shared decision making. The interventions in question consisted of the distribution of printed educational material; educational meetings; audit and feedback; reminders; and patient-mediated initiatives (e.g. patient decision aids). Two reviewers independently screened the studies and extracted data. Statistical analyses considered categorical and continuous process measures. We computed the standardized effect size for each outcome at the 95% confidence interval. The primary outcome of interest was health professionals' adoption of shared decision making as reported by patients in a self-administered questionnaire. Of the 6764 search results, 21 studies reported 35 relevant comparisons. Overall, the quality of the studies ranged from 0% to 83%. Only three of the 21 studies reported a clinically significant effect for the primary outcome that favored the intervention. The first study compared an educational meeting and a patient-mediated intervention with another patient-mediated intervention (median improvement of 74%). The second compared an educational meeting, a patient-mediated intervention, and audit and feedback with an educational meeting on an alternative topic (improvement of 227%). The third compared an educational meeting and a patient-mediated intervention with usual care (p = 0.003). All three studies were limited to the patient-physician dyad. To reduce bias, future studies should improve methods and reporting, and should analyze costs and benefits, including those associated with training of health professionals. Multifaceted interventions that include educating health professionals about sharing decisions with patients and patient-mediated interventions, such as patient decision aids, appear promising for improving health professionals' adoption of shared decision making in routine clinical practice as seen by patients.

Group intervention for burnout in parents of chronically ill children - a small-scale study.

PubMed

Lindström, Caisa; Åman, Jan; Anderzén-Carlsson, Agneta; Lindahl Norberg, Annika

2016-12-01

Long-term stress leading to burnout symptoms is prevalent in parents of chronically ill children. The aim of the study was to evaluate the effect of a group intervention by measuring changes in self-rated clinical burnout and performance-based self-esteem. In addition, the parental perceptions of the acceptability of the intervention were explored. Previously, we have explored the prevalence of clinical burnout in parents of patients 1-18 years with type 1 diabetes mellitus (T1DM) and inflammatory bowel disease (IBD) in the county of Örebro. All parents who exhibited clinical burnout symptoms in accordance with the Shirom-Melamed Burnout Questionnaire (SMBQ) were then invited to participate in a group intervention, which was evaluated in the present small-scale study. The group intervention consisted of eight sessions over a 12-week period, including education about behaviour, cognition and symptoms associated with burnout, intending to help the parents to develop adequate strategies for coping with and reducing stress. We evaluated the effect of the intervention in terms of self-rated clinical burnout and performance-based self-esteem (PBSE). In addition, the acceptability of the intervention was evaluated by analyses of recruitment and retention and self-reports from parents. Sixteen parents (13 of children with TIDM and three of children with IBD) out of 104 reporting clinical burnout participated in the intervention. All participants completed the intervention, and the mean attendance rate at all sessions was 90%. Parents' subjective evaluations were mainly positive, and SMBQ (p = 0.01) and PBSE scale (p = 0.04) measurements were significantly reduced, which effects remained 6 months after completion of the intervention. Despite the small-scale study, we consider that this intervention for parents with clinical burnout was appreciated and well accepted. The significant reduction in clinical burnout symptoms requires further evaluation in randomised controlled studies based on larger groups of parents. © 2015 Nordic College of Caring Science.

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

PubMed Central

van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.

2017-01-01

Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

PubMed

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention).

PubMed

Rihal, Charanjit S; Naidu, Srihari S; Givertz, Michael M; Szeto, Wilson Y; Burke, James A; Kapur, Navin K; Kern, Morton; Garratt, Kirk N; Goldstein, James A; Dimas, Vivian; Tu, Thomas

2015-06-01

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines. Copyright © 2015. Published by Elsevier Inc.

An Electronic Adherence Measurement Intervention to Reduce Clinical Inertia in the Treatment of Uncontrolled Hypertension: The MATCH Cluster Randomized Clinical Trial.

PubMed

Kronish, Ian M; Moise, Nathalie; McGinn, Thomas; Quan, Yan; Chaplin, William; Gallagher, Benjamin D; Davidson, Karina W

2016-11-01

To appropriately manage uncontrolled hypertension, clinicians must decide whether blood pressure (BP) is above goal due to a need for additional medication or to medication nonadherence. Yet, clinicians are poor judges of adherence, and uncertainty about adherence may promote inertia with respect to medication modification. We aimed to determine the effect of sharing electronically-measured adherence data with clinicians on the management of uncontrolled hypertension. This was a cluster randomized trial. Twenty-four primary care providers (12 intervention, 12 usual care; cluster units) and 100 patients with uncontrolled hypertension (65 intervention, 35 usual care) were included in the study. At one visit per patient, clinicians in the intervention group received a report summarizing electronically measured adherence to the BP regimen and recommended clinical actions. Clinicians in the control group did not receive a report. The primary outcome was the proportion of visits with appropriate clinical management (i.e., treatment intensification among adherent patients and adherence counseling among nonadherent patients). Secondary outcomes included patient-rated quality of care and communication during the visit. The proportion of visits with appropriate clinical management was higher in the intervention group than the control group (45 out of 65; 69 %) versus (12 out of 35; 34 %; p = 0.001). A higher proportion of adherent patients in the intervention group had their regimen intensified (p = 0.01), and a higher proportion of nonadherent patients in the intervention group received adherence counseling (p = 0.005). Patients in the intervention group were more likely to give their clinician high ratings on quality of care (p = 0.05), and on measures of patient-centered (p = 0.001) and collaborative communication (p = 0.02). Providing clinicians with electronically-measured antihypertensive adherence reports reduces inertia in the management of uncontrolled hypertension. NCT01257347 ; http://clinicaltrials.gov/show/ NCT01257347.

Brief educational interventions to improve performance on novel quality metrics in ambulatory settings in Kenya: A multi-site pre-post effectiveness trial.

PubMed

Korom, Robert Ryan; Onguka, Stephanie; Halestrap, Peter; McAlhaney, Maureen; Adam, Mary

2017-01-01

The quality of primary care delivered in resource-limited settings is low. While some progress has been made using educational interventions, it is not yet clear how to sustainably improve care for common acute illnesses in the outpatient setting. Management of urinary tract infection is particularly important in resource-limited settings, where it is commonly diagnosed and associated with high levels of antimicrobial resistance. We describe an educational programme targeting non-physician health care providers and its effects on various clinical quality metrics for urinary tract infection. We used a series of educational interventions including 1) formal introduction of a clinical practice guideline, 2) peer-to-peer chart review, and 3) peer-reviewed literature describing local antimicrobial resistance patterns. Interventions were conducted for clinical officers (N = 24) at two outpatient centers near Nairobi, Kenya over a one-year period. The medical records of 474 patients with urinary tract infections were scored on five clinical quality metrics, with the primary outcome being the proportion of cases in which the guideline-recommended antibiotic was prescribed. The results at baseline and following each intervention were compared using chi-squared tests and unpaired two-tailed T-tests for significance. Logistic regression analysis was used to assess for possible confounders. Clinician adherence to the guideline-recommended antibiotic improved significantly during the study period, from 19% at baseline to 68% following all interventions (Χ2 = 150.7, p < 0.001). The secondary outcome of composite quality score also improved significantly from an average of 2.16 to 3.00 on a five-point scale (t = 6.58, p < 0.001). Interventions had different effects at different clinical sites; the primary outcome of appropriate antibiotic prescription was met 83% of the time at Penda Health, and 50% of the time at AICKH, possibly reflecting differences in onboarding and management of clinical officers. Logistic regression analysis showed that intervention stage and clinical site were independent predictors of the primary outcome (p < 0.0001), while all other features, including provider and patient age, were not significant at a conservative threshold of p < 0.05. This study shows that brief educational interventions can dramatically improve the quality of care for routine acute illnesses in the outpatient setting. Measurement of quality metrics allows for further targeting of educational interventions depending on the needs of the providers and the community. Further study is needed to expand routine measurement of quality metrics and to identify the interventions that are most effective in improving quality of care.

A narrative review on cervical interventions in adults with chronic whiplash-associated disorder

PubMed Central

Yeung, Euson; Tong, Tiffany; Reed, Nick

2018-01-01

Introduction Whiplash injuries are common in society, but clinical interventions are inconclusive on the most effective treatment. Research and reviews have been completed with the goal of determining clinical interventions that are effective for whiplash injuries and disorders, but literature has not recently been summarised on best practices for cervical spine interventions for adults with chronic whiplash. Purpose The objective of this narrative review is to update and expand on previous works, to provide recommendations for clinical interventions and future research in the area of cervical spine rehabilitation for adults with chronic whiplash-associated disorder. Method The Arskey and O’Malley methodology was used for this narrative review. CINHAL, EMBASE, Medline, PsychInfo, Scopus, Web of Science, as well as grey literature, were searched from 2003 to April 2017. Two reviewers screened titles and abstracts for relevance to the review, and content analysis summarised the study findings. A total of 14 citations were included in the final review. Findings Exercise-based interventions targeted at the cervical spine appear most beneficial for adults with chronic whiplash-associated disorder (WAD). Invasive interventions still require more rigorous studies to deem their effectiveness for this population. Conclusion Further research is required to investigate and determine clinically relevant results for cervical spine intervention in patients with chronic WAD. PMID:29719724

A Business Case Framework for Planning Clinical Nurse Specialist-Led Interventions.

PubMed

Bartlett Ellis, Rebecca J; Embree, Jennifer L; Ellis, Kurt G

2015-01-01

The purpose of this article is to describe a business case framework that can guide clinical nurse specialists (CNS) in clinical intervention development. Increased emphasis on cost-effective interventions in healthcare requires skills in analyzing the need to make the business case, especially for resource-intensive interventions. This framework assists the CNS to anticipate resource use and then consider if the intervention makes good business sense. We describe a business case framework that can assist the CNS to fully explore the problem and determine if developing an intervention is a good investment. We describe several analyses that facilitate making the business case to include the following: problem identification and alignment with strategic priorities, needs assessment, stakeholder analysis, market analysis, intervention implementation planning, financial analysis, and outcome evaluation. The findings from these analyses can be used to develop a formal proposal to present to hospital leaders in a position to make decisions. By aligning intervention planning with organizational priorities and engaging patients in the process, interventions will be more likely to be implemented in practice and produce robust outcomes. The business case framework can be used to justify to organization decision makers the need to invest resources in new interventions that will make a difference for quality outcomes as well as the financial bottom line. This framework can be used to plan interventions that align with organizational strategic priorities, plan for associated costs and benefits, and outcome evaluation. Clinical nurse specialists are well positioned to lead clinical intervention projects that will improve the quality of patient care and be cost-effective. To do so requires skill development in making the business case.

Interventions for reducing fear of childbirth: A systematic review and meta-analysis of clinical trials.

PubMed

MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh

2017-11-07

Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I 2 index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Involving clinical librarians at the point of care: results of a controlled intervention.

PubMed

Aitken, Elizabeth M; Powelson, Susan E; Reaume, Renée D; Ghali, William A

2011-12-01

To measure the effect of including a clinical librarian in the health care team on medical residents and clinical clerks. In 2009, medical residents and clinical clerks were preassigned to one of two patient care teams (intervention and control). Each team had a month-long rotation on the general medicine teaching unit. The clinical librarian joined the intervention team for morning intake, clinical rounding, or an afternoon patient list review, providing immediate literature searches, formal group instruction, informal bedside teaching, and/or individual mentoring for use of preappraised resources and evidence-based medicine search techniques. Both intervention and control teams completed pre and post surveys comparing their confidence levels and awareness of resources as well as their self-reported use of evidence for making patient care decisions. The nonintervention team was surveyed as the control group. The clinical librarian intervention had a significant positive effect on medical trainees' self-reported ability to independently locate and evaluate evidence resources to support patient care decisions. Notably, 30 of 34 (88%) reported having changed a treatment plan based on skills taught by the clinical librarian, and 27 of 34 (79%) changed a treatment plan based on the librarian's mediated search support. Clinical librarians on the care team led to positive effects on self-reported provider attitudes, provider information retrieval tendencies, and, notably, clinical decision making. Future research should evaluate economic effects of widespread implementation of on-site clinical librarians.

Evaluation of a pilot parent-delivered play-based intervention for children with attention deficit hyperactivity disorder.

PubMed

Wilkes-Gillan, Sarah; Bundy, Anita; Cordier, Reinie; Lincoln, Michelle

2014-01-01

OBJECTIVE. This study evaluated a parent-delivered intervention aiming to address the social difficulties of children with attention deficit hyperactivity disorder (ADHD). The intervention was evaluated from three perspectives: effectiveness, feasibility, and appropriateness. METHOD. This one-group pretest-posttest study included 5 children with ADHD and their parents, who had previously participated in a therapist-delivered play-based intervention. The 7-wk parent-delivered intervention involved home modules (including a DVD, manual, and play dates with a typically developing playmate) and three therapist-led clinic-based play sessions. The Test of Playfulness was used as a pre- and postintervention and follow-up measure. Parents were interviewed 1 mo following the intervention, and data were analyzed for recurring themes. RESULTS. Children's social play outcomes improved significantly from pretest to 1-mo follow-up (Z = 2.02, p = .04, d = 1.0). Three themes emerged: the clinic play environment as a sanctuary, parental barriers to intervention delivery, and tools for repeating learned lessons. CONCLUSION. The parent-delivered intervention demonstrated preliminary evidence for feasibility and effectiveness. Further research is warranted regarding appropriateness. Copyright © 2014 by the American Occupational Therapy Association, Inc.

Individual-level outcomes from a national clinical leadership development programme.

PubMed

Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina

2013-08-01

A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context.

Effective implementation of research into practice: an overview of systematic reviews of the health literature.

PubMed

Boaz, Annette; Baeza, Juan; Fraser, Alec

2011-06-22

The gap between research findings and clinical practice is well documented and a range of interventions has been developed to increase the implementation of research into clinical practice. A review of systematic reviews of the effectiveness of interventions designed to increase the use of research in clinical practice. A search for relevant systematic reviews was conducted of Medline and the Cochrane Database of Reviews 1998-2009. 13 systematic reviews containing 313 primary studies were included. Four strategy types are identified: audit and feedback; computerised decision support; opinion leaders; and multifaceted interventions. Nine of the reviews reported on multifaceted interventions. This review highlights the small effects of single interventions such as audit and feedback, computerised decision support and opinion leaders. Systematic reviews of multifaceted interventions claim an improvement in effectiveness over single interventions, with effect sizes ranging from small to moderate. This review found that a number of published systematic reviews fail to state whether the recommended practice change is based on the best available research evidence. This overview of systematic reviews updates the body of knowledge relating to the effectiveness of key mechanisms for improving clinical practice and service development. Multifaceted interventions are more likely to improve practice than single interventions such as audit and feedback. This review identified a small literature focusing explicitly on getting research evidence into clinical practice. It emphasizes the importance of ensuring that primary studies and systematic reviews are precise about the extent to which the reported interventions focus on changing practice based on research evidence (as opposed to other information codified in guidelines and education materials).

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

PubMed

Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

2013-05-22

The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. ClinicalTrials.gov: NCT01815710.

Clinical service organisation for heart failure

PubMed Central

Taylor, Stephanie JC; Bestall, Janine C; Cotter, Sarah; Falshaw, Margaret; Hood, Sonja G; Parsons, Suzanne; Wood, Lesley; Underwood, Martin

2014-01-01

Background Chronic heart failure (CHF) is a serious, common condition associated with frequent hospitalisation. Several different disease management interventions (clinical service organisation interventions) for patients with CHF have been proposed. Objectives To assess the effectiveness of disease management interventions for patients with CHF. Search methods We searched: Cochrane CENTRAL Register of Controlled Trials (to June 2003); MEDLINE (January 1966 to July 2003); EMBASE (January 1980 to July 2003); CINAHL (January 1982 to July 2003); AMED (January 1985 to July 2003); Science Citation Index Expanded (searched January 1981 to March 2001); SIGLE (January 1980 to July 2003); DARE (July 2003); National Research Register (July 2003); NHS Economic Evaluations Database (March 2001); reference lists of articles and asked experts in the field. Selection criteria Randomised controlled trials comparing disease management interventions specifically directed at patients with CHF to usual care. Data collection and analysis At least two reviewers independently extracted data information and assessed study quality. Study authors were contacted for further information where necessary. Main results Sixteen trials involving 1,627 people were included. We classified the interventions into three models: multidisciplinary interventions (a holistic approach bridging the gap between hospital admission and discharge home delivered by a team); case management interventions (intense monitoring of patients following discharge often involving telephone follow up and home visits); and clinic interventions (follow up in a CHF clinic). There was considerable overlap within these categories, however the components, intensity and duration of the interventions varied. Case management interventions tended to be associated with reduced all cause mortality but these findings were not statistically significant (odds ratio 0.86, 95% confidence interval 0.67 to 1.10, P = 0.23), although the evidence was stronger when analysis was limited to the better quality studies (odds ratio 0.68, 95% confidence interval 0.46 to 0.98, P = 0.04). There was weak evidence that case management interventions may be associated with a reduction in admissions for heart failure. It is unclear what the effective components of the case management interventions are. The single RCT of a multidisciplinary intervention showed reduced heart-failure related re-admissions in the short term. At present there is little available evidence to support clinic based interventions. Authors’ conclusions The data from this review are insufficient for forming recommendations. Further research should include adequately powered, multicentre studies. Future studies should also investigate the effect of interventions on patients’ and carers’ quality of life, their satisfaction with the interventions and cost effectiveness. PMID:15846638

Pursuing cost-effectiveness in mental health service delivery for youth with complex needs.

PubMed

Grimes, Katherine E; Schulz, Margaret F; Cohen, Steven A; Mullin, Brian O; Lehar, Sophie E; Tien, Shelly

2011-06-01

Mental health advocates seek to expand children's services, noting widespread failure to meet the needs of public sector youth suffering from serious emotional disturbance (SED). However, state and national budgets face deepening cuts, with rising health care costs taking the blame. As the gap between needs and finances widens, identification of cost-effective treatments that will benefit children with SED and their families is of increasing importance. Community-based interventions for this population, such as the wraparound approach and systems-of-care, are being disseminated but literature is scant regarding effects on expense. The Mental Health Services Program for Youth (MHSPY) model is aligned philosophically with wraparound and systems-of-care but unique in blending public agency dollars to deliver integrated medical, mental health and social services. MHSPY's linked clinical and expense data is useful to study community-based treatment cost-effectiveness. To examine the cost-effectiveness of an intensively integrated, family and community-based clinical intervention for youth with mental health needs in comparison to "usual care.'' Study and reference populations were matched on age, gender, community, psychiatric diagnosis, morbidity and insurance type. Claims analyses included patterns of service utilization and medical expense for both groups. Using propensity score matching, results for study youth are compared with results for the population receiving "usual care.'' Clinical functioning was measured for the intervention group at baseline and 12 months. The intervention group used lower intensity services and had substantially lower claims expense (e.g. 32% lower for emergency room, 74% lower for inpatient psychiatry) than their matched counterparts in the "usual care'' group. Intervention youth were consistently maintained in least restrictive settings, with over 88% of days spent at home and showed improved clinical functioning on standard measures. The intensive MHSPY model of service delivery offers potential as a cost-effective intervention for complex youth. Its integrated approach, recognizing needs across multiple life domains, appears to enhance engagement and the effectiveness of mental health treatment, resulting in statistically significant clinical improvements. Functional measures are not collected in "usual care,'' limiting comparisons. However, claims expense for intervention youth was substantially lower than claims expense for Medicaid comparison youth, suggesting clinical needs for intervention youth post-enrollment were lower than for those receiving "usual care.'' The MHSPY model, which intentionally engages families in "clustered'' traditional and non-traditional services, represents a replicable strategy for enhancing the impact of clinical interventions, thereby reducing medical expense. Blending categorical state agency dollars and insurance funds creates flexibility to support community-based care, including individualized services for high-risk youth. Resulting expenses total no more, and are often less, than "treatment as usual'' but yield greater clinical benefits. Further research is needed regarding which intervention elements contribute the most towards improved clinical functioning, as well as which patients are most likely to benefit. A randomized trial of MHSPY vs. "usual care,'' including examination of the sustainability of effects post-disenrollment, would provide a chance to further test this innovative model.

Babies Living Safe & Smokefree: randomized controlled trial of a multilevel multimodal behavioral intervention to reduce low-income children's tobacco smoke exposure.

PubMed

Collins, Bradley N; Lepore, Stephen J

2017-03-14

Addressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations. This trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the "Ask, Advise, Refer (AAR)" best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1) The multimodal behavioral intervention (MBI) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling, mobile app, and multimedia text messages about improving nutrition. The control condition also receives a referral to the state smoking cessation quitline. This study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. Clinicaltrials.gov NCT02602288 . Registered 9 November 2015.

Clinic Versus Online Social Network–Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial

PubMed Central

Wang, Monica L; Waring, Molly E; Jake-Schoffman, Danielle E; Oleski, Jessica L; Michaels, Zachary; Goetz, Jared M; Lemon, Stephenie C; Ma, Yunsheng

2017-01-01

Background Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. Objective This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. Methods Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Results The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. Conclusions Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. Trial Registration ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW) PMID:29229591

Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials.

PubMed

Gray, Alastair; McQuillan, Conor; Menown, Ian B A

2017-07-01

The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter defibrillator in non-ischemic cardiomyopathy), and electrophysiology (cryoballoon vs radiofrequency ablation). This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers.

Educational interventions to improve quality of life in people with chronic inflammatory skin diseases: systematic reviews of clinical effectiveness and cost-effectiveness.

PubMed

Pickett, Karen; Loveman, Emma; Kalita, Neelam; Frampton, Geoff K; Jones, Jeremy

2015-10-01

Inflammatory skin diseases include a broad range of disorders. For some people, these conditions lead to psychological comorbidities and reduced quality of life (QoL). Patient education is recommended in the management of these conditions and may improve QoL. To assess the clinical effectiveness and cost-effectiveness of educational interventions to improve health-related quality of life (HRQoL) in people with chronic inflammatory skin diseases. Twelve electronic bibliographic databases, including The Cochrane Library, MEDLINE and EMBASE, were searched to July 2014. Bibliographies of retrieved papers were searched and an Advisory Group contacted. Systematic reviews were conducted following standard methodologies. Clinical effectiveness studies were included if they were undertaken in people with a chronic inflammatory skin condition. Educational interventions that aimed to, or could, improve HRQoL were eligible. Studies were required to measure HRQoL, and other outcomes such as disease severity were also included. Randomised controlled trials (RCTs) or controlled clinical trials were eligible. For the review of cost-effectiveness, studies were eligible if they were full economic evaluations, cost-consequence or cost analyses. Seven RCTs were included in the review of clinical effectiveness. Two RCTs focused on children with eczema and their carers. Five RCTs were in adults. Of these, two were of people with psoriasis, one was of people with acne and two were of people with a range of conditions. There were few similarities in the interventions (e.g. the delivery mode, the topics covered, the duration of the education), which precluded any quantitative synthesis. Follow-up ranged from 4 weeks to 12 months, samples sizes were generally small and, overall, the study quality was poor. There appeared to be positive effects on HRQoL in participants with psoriasis in one trial, but no difference between groups in another trial in which participants had less severe psoriasis. Carers of children in one RCT of eczema showed improvement in HRQoL; however, in a RCT evaluating a website intervention there were no demonstrable effects on HRQoL. Neither the RCT in those adults with acne nor the RCT in those adults with mixed skin conditions demonstrated an effect on HRQoL. One RCT reported subgroups with atopic dermatitis or psoriasis and education was effective for psoriasis only. Other outcomes also showed mixed results. It is unclear how clinically meaningful any of the observed improvements are. Three studies of cost-effectiveness were included. The interventions, comparators and populations varied across the studies and, overall, the studies provided limited information on cost-effectiveness. The studies did provide detailed information on resources and costs that could be useful to inform a future cost-effectiveness evaluation in this area. The application of the inclusion criterion around whether the interventions were aimed at improving HRQoL or the inference that they could improve HRQoL was difficult as information was rarely reported. There is uncertainty regarding whether educational interventions addressing issues that could improve HRQoL in people with chronic skin conditions are effective. Tentative conclusions about the best approach to delivering these kinds of interventions are that face-to-face, group, sessions may be beneficial; however, text messages may also be effective. Delivery over a period of time and by a multidisciplinary team may also be associated with positive outcomes. There is uncertainty over whether or not educational interventions are cost-effective. This study is registered as PROSPERO CRD42014007426. The National Institute for Health Research Health Technology Assessment programme.

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy.

PubMed

Nayak, Madhabika B; Korcha, Rachael A; Kaskutas, Lee A; Kaskustas, Lee A; Avalos, Lyndsay A

2014-11-25

Recommended screening and brief intervention (SBI) for alcohol use during pregnancy is impeded by high patient loads and limited resources in public health settings. We evaluated the feasibility, acceptability and validity of a new self-administered, single-session, bilingual, computerized Screening and Brief Intervention (SBI) program for alcohol and sugar sweetened beverage (SSB) use in pregnancy. We developed and tested the computerized SBI program at a public health clinic with 290 pregnant women. Feasibility, acceptability, and validity measures were included in the program which had several modules, including those on demographics, health and beverage use. Time to complete the program and user experience items were used to determine program feasibility and acceptability. Validity analyses compared proportions of prenatal alcohol use identified by the program versus in-person screening by clinic staff. Most program users (87%, n = 251) completed the entire program; 91% (n = 263) completed the key screening and brief intervention modules. Most users also completed the program in ten to fifteen minutes. Program users reported that the program was easy to use (97%), they learned something new (88%), and that they would share what they learned with others (83%) and with their doctors or clinic staff (76%). Program acceptability did not differ by age, education, or type of beverage intervention received. The program identified alcohol use in pregnancy among 21% of users, a higher rate than the 13% (p < .01) found via screening by clinic staff. Computerized Screening and Brief Intervention for alcohol and SSB use in public health clinics is feasible and acceptable to English and Spanish speaking pregnant women and can efficiently identify prenatal alcohol use.

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices.

PubMed

Pollak, Kathryn I; Nagy, Paul; Bigger, John; Bilheimer, Alicia; Lyna, Pauline; Gao, Xiaomei; Lancaster, Michael; Watkins, R Chip; Johnson, Fred; Batish, Sanjay; Skelton, Joseph A; Armstrong, Sarah

2016-02-01

Studies indicate needed improvement in clinician communication and patient satisfaction. Motivational interviewing (MI) helps promote patient behavior change and improves satisfaction. In this pilot study, we tested a coaching intervention to teach MI to all clinic staff to improve clinician and patient satisfaction. We included four clinics (n=29 staff members). In the intervention clinics (one primary care and one pediatric obesity-focused), we trained all clinic staff in MI through meetings as a group seven times, directly observing clinicians in practice 4-10 times, and providing real-time feedback on MI techniques. In all clinics, we assessed patient satisfaction via anonymous surveys and also assessed clinician burnout and self-rated MI skills. Clinicians in the intervention clinics reported improvements in burnout scores, self-rated MI skills, and perceived cohesion whereas clinicians in the control clinic reported worse scores. Patient satisfaction improved in the intervention clinics more than in the control clinics. This is the first study to find some benefit of training an entire clinic staff in MI via a coaching model. It might help to train staff in MI to improve clinician satisfaction, team cohesion, perceived skills, and patient satisfaction. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach.

PubMed

Amorrortu, Rossybelle P; Arevalo, Mariana; Vernon, Sally W; Mainous, Arch G; Diaz, Vanessa; McKee, M Diane; Ford, Marvella E; Tilley, Barbara C

2018-02-17

Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan. The intervention included five educational modules, one in-person and four web-based, plus technical assistance calls to coordinators. Modules addressed the intervention rationale, development of clinic-specific plans to obtain minority-serving physician referrals, physician-centered and patient-centered communication, and patient navigation. The evaluation, a randomized trial, was recently completed in 50 specialty clinics and is under analysis. Using IM we developed a recruitment intervention that focused on building relationships with minority-serving physicians to encourage minority patient referrals. IM enhanced our understanding of factors that may influence minority recruitment and helped us integrate strategies from multiple disciplines that were relevant for our audience.

The impact of a multifaceted intervention including sepsis electronic alert system and sepsis response team on the outcomes of patients with sepsis and septic shock.

PubMed

Arabi, Yaseen M; Al-Dorzi, Hasan M; Alamry, Ahmed; Hijazi, Ra'ed; Alsolamy, Sami; Al Salamah, Majid; Tamim, Hani M; Al-Qahtani, Saad; Al-Dawood, Abdulaziz; Marini, Abdellatif M; Al Ehnidi, Fatimah H; Mundekkadan, Shihab; Matroud, Amal; Mohamed, Mohamed S; Taher, Saadi

2017-12-01

Compliance with the clinical practice guidelines of sepsis management has been low. The objective of our study was to describe the results of implementing a multifaceted intervention including an electronic alert (e-alert) with a sepsis response team (SRT) on the outcome of patients with sepsis and septic shock presenting to the emergency department. This was a pre-post two-phased implementation study that consisted of a pre-intervention phase (January 01, 2011-September 24, 2012), intervention phase I (multifaceted intervention including e-alert, from September 25, 2012-March 03, 2013) and intervention phase II when SRT was added (March 04, 2013-October 30, 2013) in a 900-bed tertiary-care academic hospital. We recorded baseline characteristics and processes of care in adult patients presenting with sepsis or septic shock. The primary outcome measures were hospital mortality. Secondary outcomes were the need for mechanical ventilation and length of stay in the intensive unit and in the hospital. After implementing the multifaceted intervention including e-alert and SRT, cases were identified with less severe clinical and laboratory abnormalities and the processes of care improved. When adjusted to propensity score, the interventions were associated with reduction in hospital mortality [for intervention phase II compared to pre-intervention: adjusted odds ratio (aOR) 0.71, 95% CI 0.58-0.85, p = 0.003], reduction in the need for mechanical ventilation (aOR 0.45, 95% CI 0.37-0.55, p < 0.0001) and reduction in ICU LOS and hospital LOS for all patients as well as ICU LOS for survivors. Implementing a multifaceted intervention including sepsis e-alert with SRT was associated with earlier identification of sepsis, increase in compliance with sepsis resuscitation bundle and reduction in the need for mechanical ventilation and reduction in hospital mortality and LOS.

When It Comes to Lifestyle Recommendations, More is Sometimes Less: A Meta-Analysis of Theoretical Assumptions Underlying the Effectiveness of Interventions Promoting Multiple Behavior Domain Change

PubMed Central

Wilson, Kristina; Senay, Ibrahim; Durantini, Marta; Sánchez, Flor; Hennessy, Michael; Spring, Bonnie; Albarracín, Dolores

2016-01-01

A meta-analysis of 150 research reports summarizing the results of multiple behavior domain interventions examined theoretical predictions about the effects of the included number of recommendations on behavioral and clinical change in the domains of smoking, diet, and physical activity. The meta-analysis yielded three main conclusions. First, there is a curvilinear relation between the number of behavioral recommendations and improvements in behavioral and clinical measures, with a moderate number of recommendations producing the highest level of change. A moderate number of recommendations is likely to be associated with stronger effects because the intervention ensures the necessary level of motivation to implement the recommended changes, thereby increasing compliance with the goals set by the intervention, without making the intervention excessively demanding. Second, this curve was more pronounced when samples were likely to have low motivation to change, such as when interventions were delivered to non-patient (vs. patient) populations, were implemented in non-clinic (vs. clinic) settings, used lay community (vs. expert) facilitators, and involved group (vs. individual) delivery formats. Finally, change in behavioral outcomes mediated the effects of number of recommended behaviors on clinical change. These findings provide important insights that can help guide the design of effective multiple behavior domain interventions. PMID:25528345

A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

PubMed

Hollen, Patricia J; Gralla, Richard J; Jones, Randy A; Thomas, Christopher Y; Brenin, David R; Weiss, Geoffrey R; Schroen, Anneke T; Petroni, Gina R

2013-03-01

Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants. This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals. The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably. This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.

The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC): a randomised cluster controlled trial.

PubMed

Li, Yanping; Hu, Xiaoqi; Zhang, Qian; Liu, Ailing; Fang, Hongyun; Hao, Linan; Duan, Yifan; Xu, Haiquan; Shang, Xianwen; Ma, Jun; Xu, Guifa; Du, Lin; Li, Ying; Guo, Hongwei; Li, Tingyu; Ma, Guansheng

2010-05-02

Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook) and physical activity intervention (Happy 10 program) will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years) will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device), physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the intervention strategies would justify a national school-based program to prevent childhood obesity in China.

The Sun Sense Study: An Intervention to Improve Sun Protection in Children

ERIC Educational Resources Information Center

Glasser, Alice; Shaheen, Magda; Glenn, Beth A.; Bastani, Roshan

2010-01-01

Objectives: To assess the effect of a multicomponent intervention on parental knowledge, sun avoidance behaviors, and sun protection practices in children 3-10 years. Methods: A randomized trial at a pediatric clinic recruited 197 caregiver-child pairs (90% parents). Intervention included a brief presentation and brochure for the parent and…

Knowledge Translation and Barriers to Imaging Optimization in the Emergency Department: A Research Agenda.

PubMed

Probst, Marc A; Dayan, Peter S; Raja, Ali S; Slovis, Benjamin H; Yadav, Kabir; Lam, Samuel H; Shapiro, Jason S; Farris, Coreen; Babcock, Charlene I; Griffey, Richard T; Robey, Thomas E; Fortin, Emily M; Johnson, Jamlik O; Chong, Suzanne T; Davenport, Moira; Grigat, Daniel W; Lang, Eddy L

2015-12-01

Researchers have attempted to optimize imaging utilization by describing which clinical variables are more predictive of acute disease and, conversely, what combination of variables can obviate the need for imaging. These results are then used to develop evidence-based clinical pathways, clinical decision instruments, and clinical practice guidelines. Despite the validation of these results in subsequent studies, with some demonstrating improved outcomes, their actual use is often limited. This article outlines a research agenda to promote the dissemination and implementation (also known as knowledge translation) of evidence-based interventions for emergency department (ED) imaging, i.e., clinical pathways, clinical decision instruments, and clinical practice guidelines. We convened a multidisciplinary group of stakeholders and held online and telephone discussions over a 6-month period culminating in an in-person meeting at the 2015 Academic Emergency Medicine consensus conference. We identified the following four overarching research questions: 1) what determinants (barriers and facilitators) influence emergency physicians' use of evidence-based interventions when ordering imaging in the ED; 2) what implementation strategies at the institutional level can improve the use of evidence-based interventions for ED imaging; 3) what interventions at the health care policy level can facilitate the adoption of evidence-based interventions for ED imaging; and 4) how can health information technology, including electronic health records, clinical decision support, and health information exchanges, be used to increase awareness, use, and adherence to evidence-based interventions for ED imaging? Advancing research that addresses these questions will provide valuable information as to how we can use evidence-based interventions to optimize imaging utilization and ultimately improve patient care. © 2015 by the Society for Academic Emergency Medicine.

Consensus Report of the Coalition for Clinical Research—Self-Monitoring of Blood Glucose

PubMed Central

Klonoff, David C.; Bergenstal, Richard; Blonde, Lawrence; Boren, Suzanne Austin; Church, Timothy S.; Gaffaney, Jenifer; Jovanovič, Lois; Kendall, David M.; Kollman, Craig; Kovatchev, Boris P.; Leippert, Claudia; DDG, Diabetesberaterin; Owens, David R.; Polonsky, William H.; Reach, Gérard; Renard, Eric; Riddell, Michael C.; Rubin, Richard R.; Schnell, Oliver; Siminiero, Linda M.; Vigersky, Robert A.; Wilson, Darrell M.; Wollitzer, Alison Okada

2008-01-01

The Coalition for Clinical Research—Self-Monitoring of Blood Glucose Scientific Board, a group of nine academic clinicians and scientists from the United States and Europe, convened in San Francisco, California, on June 11–12, 2008, to discuss the appropriate uses of self-monitoring of blood glucose (SMBG) and the measures necessary to accurately assess the potential benefit of this practice in noninsulin-treated type 2 diabetes mellitus (T2DM). Thirteen consultants from the United States, Europe, and Canada from academia, practice, and government also participated and contributed based on their fields of expertise. These experts represent a range of disciplines that include adult endocrinology, pediatric endocrinology, health education, mathematics, statistics, psychology, nutrition, exercise physiology, and nursing. This coalition was organized by Diabetes Technology Management, Inc. Among the participants, there was consensus that: protocols assessing the performance of SMBG in noninsulin treated T2DM must provide the SMBG intervention subjects with blood glucose (BG) goals and instructions on how to respond to BG data in randomized controlled trials (RCTs);intervention subjects in clinical trials of SMBG-driven interventions must aggressively titrate their therapeutic responses or lifestyle changes in response to hyperglycemia;control subjects in clinical trials of SMBG must be isolated from SMBG-driven interventions and not be contaminated by physician experience with study subjects receiving a SMBG intervention;the best endpoints to measure in a clinical trial of SMBG in T2DM include delta Hemoglobin A1c levels, hyperglycemic events, hypoglycemic events, time to titrate noninsulin therapy to a maximum necessary dosage, and quality of life indices;either individual randomization or cluster randomization may be appropriate methods for separating control subjects from SMBG intervention subjects, provided that precautions are taken to avoid bias and that the sample size is adequate;treatment algorithms for assessing SMBG in T2DM may include a dietary, exercise, and/or medication intervention, which are all titratable according to the SMBG values;the medical literature contains very little information about the performance of SMBG in T2DM from RCTs in which treatment algorithms were used for dysglycemic values; andresearch on the performance of SMBG in T2DM based on sound scientific principles and clinical practices is needed at this time. PMID:19885292

A mapping review of international guidance on the management and care of amyotrophic lateral sclerosis (ALS).

PubMed

Janssens, Astrid I W A; Ruytings, Marijke; Al-Chalabi, Ammar; Chio, Adriano; Hardiman, Orla; Mcdermott, Christopher J; Meyer, Thomas; Mora, Gabriele; Van Damme, Philip; Van Den Berg, Leonard H; Vanhaecht, Kris; Winkler, Andrea S; Sermeus, Walter

2016-01-01

Management of ALS is suboptimal. Consequently, quality improvement interventions are needed to improve ALS care. An evidence-based insight into how patients should be managed is essential when developing quality improvement interventions. Therefore, this study aimed to map, categorize and summarize international guidance on the management and care of ALS and to identify gaps in this guidance by means of a mapping review. Literature was searched for clinical practice guidelines, quality indicators and evidence-based clinical summaries. A content analysis and meta-synthesis of the included literature was performed. Interventions and outcomes used in the management and care of ALS were identified and categorized. Furthermore, the amount of guidance underpinning these interventions and outcomes was analysed. Six clinical practice guidelines, one set of quality indicators and three evidence-based clinical summaries were identified. The results demonstrated that certain domains in ALS care, mainly disease-specific domains such as breathing and swallowing, are extensively addressed in the literature whereas other subjects, such as care coordination, receive little attention. In conclusion, this mapping review provides a scientific basis for targeting and developing the clinical content of a quality improvement intervention for the management of ALS.

Greater involvement of HIV-infected peer-mothers in provision of reproductive health services as "family planning champions" increases referrals and uptake of family planning among HIV-infected mothers.

PubMed

Mudiope, Peter; Musingye, Ezra; Makumbi, Carolyne Onyango; Bagenda, Danstan; Homsy, Jaco; Nakitende, Mai; Mubiru, Mike; Mosha, Linda Barlow; Kagawa, Mike; Namukwaya, Zikulah; Fowler, Mary Glenn

2017-06-27

In 2012, Makerere University Johns - Hopkins University, and Mulago National Referral Hospital, with support from the National Institute of Health (under Grant number: NOT AI-01-023) undertook operational research at Mulago National Hospital PMTCT/PNC clinics. The study employed Peer Family Planning Champions to offer health education, counselling, and triage aimed at increasing the identification, referral and family planning (FP) uptake among HIV positive mothers attending the clinic. The Peer Champion Intervention to improve FP uptake was introduced into Mulago Hospital PMTCT/PNC clinic, Kampala Uganda. During the intervention period, peers provided additional FP counselling and education; assisted in identification and referral of HIV Positive mothers in need of FP services; and accompanied referred mothers to FP clinics. We compiled and compared the average proportions of mothers in need that were referred and took up FP in the pre-intervention (3 months), intervention (6 months), and post-intervention(3 months) periods using interrupted time series with segmented regression models with an autoregressive term of one. Overall, during the intervention, the proportion of referred mothers in need of FP increased by 30.4 percentage points (P < 0.001), from 52.7 to 83.2 percentage points. FP uptake among mothers in need increased by over 31 percentage points (P < 0.001) from 47.2 to 78.5 percentage points during the intervention. There was a positive non-significant change in the weekly trend of referral β 3  = 2.9 percentage points (P = 0.077) and uptake β 3  = 1.9 percentage points (P = 0.176) during the intervention as compared to the pre-intervention but this was reversed during the post intervention. Over 57% (2494) mothers took up Depo-Provera injectable-FP method during the study. To support overstrained health care work force in post-natal clinics, peers in trained effective family planning can be a valuable addition to clinic staff in limited-resource settings. The study provides additional evidence on the utilization of peer mothers in HIV care, improves health services uptake including family planning which is a common practice in many donor supported programs. It also provides evidence that may be used to advocate for policy revisions in low-income countries to include peers as support staff especially in busy clinic settings with poor services uptake.

Interventions for paracetamol (acetaminophen) overdose.

PubMed

Chiew, Angela L; Gluud, Christian; Brok, Jesper; Buckley, Nick A

2018-02-23

Paracetamol (acetaminophen) is the most widely used non-prescription analgesic in the world. Paracetamol is commonly taken in overdose either deliberately or unintentionally. In high-income countries, paracetamol toxicity is a common cause of acute liver injury. There are various interventions to treat paracetamol poisoning, depending on the clinical status of the person. These interventions include inhibiting the absorption of paracetamol from the gastrointestinal tract (decontamination), removal of paracetamol from the vascular system, and antidotes to prevent the formation of, or to detoxify, metabolites. To assess the benefits and harms of interventions for paracetamol overdosage irrespective of the cause of the overdose. We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (January 2017), CENTRAL (2016, Issue 11), MEDLINE (1946 to January 2017), Embase (1974 to January 2017), and Science Citation Index Expanded (1900 to January 2017). We also searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov database (US National Institute of Health) for any ongoing or completed trials (January 2017). We examined the reference lists of relevant papers identified by the search and other published reviews. Randomised clinical trials assessing benefits and harms of interventions in people who have ingested a paracetamol overdose. The interventions could have been gastric lavage, ipecacuanha, or activated charcoal, or various extracorporeal treatments, or antidotes. The interventions could have been compared with placebo, no intervention, or to each other in differing regimens. Two review authors independently extracted data from the included trials. We used fixed-effect and random-effects Peto odds ratios (OR) with 95% confidence intervals (CI) for analysis of the review outcomes. We used the Cochrane 'Risk of bias' tool to assess the risks of bias (i.e. systematic errors leading to overestimation of benefits and underestimation of harms). We used Trial Sequential Analysis to control risks of random errors (i.e. play of chance) and GRADE to assess the quality of the evidence and constructed 'Summary of findings' tables using GRADE software. We identified 11 randomised clinical trials (of which one acetylcysteine trial was abandoned due to low numbers recruited), assessing several different interventions in 700 participants. The variety of interventions studied included decontamination, extracorporeal measures, and antidotes to detoxify paracetamol's toxic metabolite; which included methionine, cysteamine, dimercaprol, or acetylcysteine. There were no randomised clinical trials of agents that inhibit cytochrome P-450 to decrease the activation of the toxic metabolite N-acetyl-p-benzoquinone imine.Of the 11 trials, only two had two common outcomes, and hence, we could only meta-analyse two comparisons. Each of the remaining comparisons included outcome data from one trial only and hence their results are presented as described in the trials. All trial analyses lack power to access efficacy. Furthermore, all the trials were at high risk of bias. Accordingly, the quality of evidence was low or very low for all comparisons. Interventions that prevent absorption, such as gastric lavage, ipecacuanha, or activated charcoal were compared with placebo or no intervention and with each other in one four-armed randomised clinical trial involving 60 participants with an uncertain randomisation procedure and hence very low quality. The trial presented results on lowering plasma paracetamol levels. Activated charcoal seemed to reduce the absorption of paracetamol, but the clinical benefits were unclear. Activated charcoal seemed to have the best risk:benefit ratio among gastric lavage, ipecacuanha, or supportive treatment if given within four hours of ingestion. There seemed to be no difference between gastric lavage and ipecacuanha, but gastric lavage and ipecacuanha seemed more effective than no treatment (very low quality of evidence). Extracorporeal interventions included charcoal haemoperfusion compared with conventional treatment (supportive care including gastric lavage, intravenous fluids, and fresh frozen plasma) in one trial with 16 participants. The mean cumulative amount of paracetamol removed was 1.4 g. One participant from the haemoperfusion group who had ingested 135 g of paracetamol, died. There were no deaths in the conventional treatment group. Accordingly, we found no benefit of charcoal haemoperfusion (very low quality of evidence). Acetylcysteine appeared superior to placebo and had fewer adverse effects when compared with dimercaprol or cysteamine. Acetylcysteine superiority to methionine was unproven. One small trial (low quality evidence) found that acetylcysteine may reduce mortality in people with fulminant hepatic failure (Peto OR 0.29, 95% CI 0.09 to 0.94). The most recent randomised clinical trials studied different acetylcysteine regimens, with the primary outcome being adverse events. It was unclear which acetylcysteine treatment protocol offered the best efficacy, as most trials were underpowered to look at this outcome. One trial showed that a modified 12-hour acetylcysteine regimen with a two-hour acetylcysteine 100 mg/kg bodyweight loading dose was associated with significantly fewer adverse reactions compared with the traditional three-bag 20.25-hour regimen (low quality of evidence). All Trial Sequential Analyses showed lack of sufficient power. Children were not included in the majority of trials. Hence, the evidence pertains only to adults. These results highlight the paucity of randomised clinical trials comparing different interventions for paracetamol overdose and their routes of administration and the low or very low level quality of the evidence that is available. Evidence from a single trial found activated charcoal seemed the best choice to reduce absorption of paracetamol. Acetylcysteine should be given to people at risk of toxicity including people presenting with liver failure. Further randomised clinical trials with low risk of bias and adequate number of participants are required to determine which regimen results in the fewest adverse effects with the best efficacy. Current management of paracetamol poisoning worldwide involves the administration of intravenous or oral acetylcysteine which is based mainly on observational studies. Results from these observational studies indicate that treatment with acetylcysteine seems to result in a decrease in morbidity and mortality, However, further evidence from randomised clinical trials comparing different treatments are needed.

Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial

PubMed Central

Cabezas, Carmen; Martin, Carlos; Granollers, Silvia; Morera, Concepció; Ballve, Josep Lluis; Zarza, Elvira; Blade, Jordi; Borras, Margarida; Serra, Antoni; Puente, Diana

2009-01-01

Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC). Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis. Study population: Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. Control group: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The application of a stepped intervention based on the stages of a change model is possible under real and diverse clinical practice conditions, and improves the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline. Trial Registration Clinical Trials.gov Identifier: NCT00125905 PMID:19193233

Cognition before curriculum: rethinking the integration of basic science and clinical learning.

PubMed

Kulasegaram, Kulamakan Mahan; Martimianakis, Maria Athina; Mylopoulos, Maria; Whitehead, Cynthia R; Woods, Nicole N

2013-10-01

Integrating basic science and clinical concepts in the undergraduate medical curriculum is an important challenge for medical education. The health professions education literature includes a variety of educational strategies for integrating basic science and clinical concepts at multiple levels of the curriculum. To date, assessment of this literature has been limited. In this critical narrative review, the authors analyzed literature published in the last 30 years (1982-2012) using a previously published integration framework. They included studies that documented approaches to integration at the level of programs, courses, or teaching sessions and that aimed to improve learning outcomes. The authors evaluated these studies for evidence of successful integration and to identify factors that contribute to integration. Several strategies at the program and course level are well described but poorly evaluated. Multiple factors contribute to successful learning, so identifying how interventions at these levels result in successful integration is difficult. Evidence from session-level interventions and experimental studies suggests that integration can be achieved if learning interventions attempt to link basic and clinical science in a causal relationship. These interventions attend to how learners connect different domains of knowledge and suggest that successful integration requires learners to build cognitive associations between basic and clinical science. One way of understanding the integration of basic and clinical science is as a cognitive activity occurring within learners. This perspective suggests that learner-centered, content-focused, and session-level-oriented strategies can achieve cognitive integration.

Methodology Series Module 4: Clinical Trials.

PubMed

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Methodology Series Module 4: Clinical Trials

PubMed Central

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an “open trial.” However, many of the trials are not open – they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India. PMID:27512184

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up.

PubMed

Dillingham, Rebecca; Ingersoll, Karen; Flickinger, Tabor E; Waldman, Ava Lena; Grabowski, Marika; Laurence, Colleen; Wispelwey, Erin; Reynolds, George; Conaway, Mark; Cohn, Wendy F

2018-06-01

Mobile health interventions may help People Living with HIV (PLWH) improve engagement in care. We designed and piloted PositiveLinks, a clinic-affiliated mobile intervention for PLWH, and assessed longitudinal impact on retention in care and viral suppression. The program was based at an academic Ryan White Clinic serving a nonurban population in Central Virginia. The PL intervention included a smartphone app that connected participants to clinic staff and provided educational resources, daily queries of stress, mood and medication adherence, weekly quizzes, appointment reminders, and a virtual support group. Outcomes were analyzed using McNemar's tests for HRSA-1, visit constancy, and viral suppression and nonparametric Wilcoxon signed-rank tests for CD4 counts and viral loads. Of 77 participants, 63% were male, 49% black non-Hispanic, and 72% below the federal poverty level. Participants' achievement of a retention in care benchmark (HRSA-1) increased from 51% at baseline to 88% at 6 months (p < 0.0001) and 81% at 12 months (p = 0.0003). Visit constancy improved from baseline to 6 months (p = 0.016) and 12 months (p = 0.0004). Participants' mean CD4 counts increased from baseline to 6 months (p = 0.0007) and 12 months (p = 0.0005). The percentage of participants with suppressed viral loads increased from 47% at baseline to 87% at 6 months (p < 0.0001) and 79% at 12 months (p = 0.0007). This study is one of the first to demonstrate that a mobile health intervention can have a positive impact on retention in care and clinical outcomes for vulnerable PLWH. Next steps include integration with clinical practice and dissemination.

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up

PubMed Central

Ingersoll, Karen; Flickinger, Tabor E.; Waldman, Ava Lena; Grabowski, Marika; Laurence, Colleen; Wispelwey, Erin; Reynolds, George; Conaway, Mark; Cohn, Wendy F.

2018-01-01

Abstract Mobile health interventions may help People Living with HIV (PLWH) improve engagement in care. We designed and piloted PositiveLinks, a clinic-affiliated mobile intervention for PLWH, and assessed longitudinal impact on retention in care and viral suppression. The program was based at an academic Ryan White Clinic serving a nonurban population in Central Virginia. The PL intervention included a smartphone app that connected participants to clinic staff and provided educational resources, daily queries of stress, mood and medication adherence, weekly quizzes, appointment reminders, and a virtual support group. Outcomes were analyzed using McNemar's tests for HRSA-1, visit constancy, and viral suppression and nonparametric Wilcoxon signed-rank tests for CD4 counts and viral loads. Of 77 participants, 63% were male, 49% black non-Hispanic, and 72% below the federal poverty level. Participants' achievement of a retention in care benchmark (HRSA-1) increased from 51% at baseline to 88% at 6 months (p < 0.0001) and 81% at 12 months (p = 0.0003). Visit constancy improved from baseline to 6 months (p = 0.016) and 12 months (p = 0.0004). Participants' mean CD4 counts increased from baseline to 6 months (p = 0.0007) and 12 months (p = 0.0005). The percentage of participants with suppressed viral loads increased from 47% at baseline to 87% at 6 months (p < 0.0001) and 79% at 12 months (p = 0.0007). This study is one of the first to demonstrate that a mobile health intervention can have a positive impact on retention in care and clinical outcomes for vulnerable PLWH. Next steps include integration with clinical practice and dissemination. PMID:29851504

Strategies and Challenges in Clinical Trials Targeting Human Aging

PubMed Central

Newman, John C.; Milman, Sofiya; Hashmi, Shahrukh K.; Austad, Steve N.; Kirkland, James L.; Halter, Jeffrey B.

2016-01-01

Interventions that target fundamental aging processes have the potential to transform human health and health care. A variety of candidate drugs have emerged from basic and translational research that may target aging processes. Some of these drugs are already in clinical use for other purposes, such as metformin and rapamycin. However, designing clinical trials to test interventions that target the aging process poses a unique set of challenges. This paper summarizes the outcomes of an international meeting co-ordinated by the NIH-funded Geroscience Network to further the goal of developing a translational pipeline to move candidate compounds through clinical trials and ultimately into use. We review the evidence that some drugs already in clinical use may target fundamental aging processes. We discuss the design principles of clinical trials to test such interventions in humans, including study populations, interventions, and outcomes. As examples, we offer several scenarios for potential clinical trials centered on the concepts of health span (delayed multimorbidity and functional decline) and resilience (response to or recovery from an acute health stress). Finally, we describe how this discussion helped inform the design of the proposed Targeting Aging with Metformin study. PMID:27535968

Language Development, Delay and Intervention--The Views of Parents from Communities That Speech and Language Therapy Managers in England Consider to Be Under-Served

ERIC Educational Resources Information Center

Marshall, Julie; Harding, Sam; Roulstone, Sue

2017-01-01

Background: Evidence-based practice includes research evidence, clinical expertise and stakeholder perspectives. Stakeholder perspectives are important and include parental ethno-theories, which embrace views about many aspects of speech, language and communication, language development, and interventions. The Developmental Niche Framework…

Implementation and evaluation of Parkinson disease management in an outpatient clinical pharmacist-run neurology telephone clinic.

PubMed

Stefan, Teodora Cristina; Elharar, Nicole; Garcia, Guadalupe

2018-05-01

Parkinson disease (PD) is a progressive, debilitating neurodegenerative disease that often requires complex pharmacologic treatment regimens. Prior to this clinic, there was no involvement of a clinical pharmacy specialist (CPS) in the outpatient neurology clinic at the West Palm Beach Veterans Affairs Medical Center. This was a prospective, quality-improvement project to develop a clinical pharmacist-run neurology telephone clinic and evaluate pharmacologic and nonpharmacologic interventions in an effort to improve the quality of care for patients with PD. Additionally, the CPS conducted medication education groups to 24 patients with PD and their caregivers, if applicable, at this medical center with the purpose of promoting patient knowledge and medication awareness. Medication management was performed via telephone rather than face to face. Only patients with a concomitant mental health diagnosis for which they were receiving at least one psychotropic medication were included for individual visits due to the established scope of practice of the CPS being limited to mental health and primary care medications. Data collection included patient and clinic demographics as well as pharmacologic and nonpharmacologic interventions made for patients enrolled from January 6, 2017, through March 31, 2017. A total of 49 pharmacologic and nonpharmacologic interventions were made for 10 patients. We successfully implemented and evaluated a clinical pharmacist-run neurology telephone clinic for patients with PD. Expansion of this clinic to patients with various neurological disorders may improve access to care using an innovative method of medication management expertise by a CPS.

Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement.

PubMed

Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn; Ballard, Rachel M; Bruinooge, Suanna S; Courneya, Kerry S; Daniels, Elvan C; Demark-Wahnefried, Wendy; Frank, Elizabeth S; Goodwin, Pamela J; Irwin, Melinda L; Levit, Laura A; McCaskill-Stevens, Worta; Minasian, Lori M; O'Rourke, Mark A; Pierce, John P; Stein, Kevin D; Thomson, Cynthia A; Hudis, Clifford A

2015-11-20

Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a routine part of cancer care. The ASCO Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice. Recommendations highlight the need for large-scale trials evaluating the impact of energy balance interventions on cancer outcomes, as well as the concurrent conduct of studies focused on dissemination and implementation of interventions in diverse populations of cancer survivors, including answering critical questions about the degree of benefit in key subgroups of survivors. Other considerations include the importance of incorporating economic metrics into energy balance intervention trials, the need to establish intermediate biomarkers, and the importance of integrating traditional and nontraditional funding sources. Establishing lifestyle change after cancer diagnosis as a routine part of cancer care will require a multipronged effort to overcome barriers related to study development, funding, and stakeholder engagement. Given the prevalence of obesity and inactivity in cancer survivors in the United States and elsewhere, energy balance interventions hold the potential to reduce cancer morbidity and mortality in millions of patients, and it is essential that we move forward in determining their role in cancer care with the same care and precision used to test pharmacologic and other interventions.

Multifamily Psychoeducation for First-Episode Psychosis: A Cost-Effectiveness Analysis

PubMed Central

Breitborde, Nicholas J. K.; Woods, Scott W.; Srihari, Vinod H.

2017-01-01

Objective Family psychoeducation is considered part of optimal treatment for first-episode psychosis, but concerns about the cost of this intervention have limited its availability. Although evidence suggests that family psychoeducation is cost-effective, many cost-effectiveness analyses have suffered from limitations that reduce their utility in guiding decisions to incorporate this intervention within existing clinical services. These include not presenting results in present-day dollars and not examining whether the intervention would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. Thus the goal of this study was to investigate the cost of providing a specific psychoeducation program—multifamily group psychoeducation—to individuals with first-episode psychosis and their families. Methods Statistical simulation was used to estimate the cost and burden of illness associated with usual treatment versus usual treatment plus multifamily group psychoeducation. In addition, the simulation model was rerun to test whether multifamily psychoeducation would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. Results When provided for two years, multifamily group psychoeducation ranged from a cost-effective to a cost-saving intervention, depending on the clinical benefits achieved by staff delivering the intervention. When provided for longer durations (five, ten, or 20 years), multifamily psychoeducation was a cost-saving intervention even in scenarios where the clinical benefits of the intervention were reduced by 90%. Conclusions The results suggest that multifamily group psychoeducation may not only be a cost-effective intervention for first-episode psychosis but may often be a cost-saving intervention. PMID:19880465

Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis.

PubMed

Breitborde, Nicholas J K; Woods, Scott W; Srihari, Vinod H

2009-11-01

Family psychoeducation is considered part of optimal treatment for first-episode psychosis, but concerns about the cost of this intervention have limited its availability. Although evidence suggests that family psychoeducation is cost-effective, many cost-effectiveness analyses have suffered from limitations that reduce their utility in guiding decisions to incorporate this intervention within existing clinical services. These include not presenting results in present-day dollars and not examining whether the intervention would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. Thus the goal of this study was to investigate the cost of providing a specific psychoeducation program-multifamily group psychoeducation-to individuals with first-episode psychosis and their families. Statistical simulation was used to estimate the cost and burden of illness associated with usual treatment versus usual treatment plus multifamily group psychoeducation. In addition, the simulation model was rerun to test whether multifamily psychoeducation would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. When provided for two years, multifamily group psychoeducation ranged from a cost-effective to a cost-saving intervention, depending on the clinical benefits achieved by staff delivering the intervention. When provided for longer durations (five, ten, or 20 years), multifamily psychoeducation was a cost-saving intervention even in scenarios where the clinical benefits of the intervention were reduced by 90%. The results suggest that multifamily group psychoeducation may not only be a cost-effective intervention for first-episode psychosis but may often be a cost-saving intervention.

Community-Clinical Linkages With Community Health Workers in the United States: A Scoping Review.

PubMed

Lohr, Abby M; Ingram, Maia; Nuñez, Annabelle V; Reinschmidt, Kerstin M; Carvajal, Scott C

2018-05-01

Despite the proliferation of community-clinical linkage (CCL) interventions with community health workers (CHWs), little is known about the components of these programs or how linkages are realized. In this scoping review, we synthesize evidence concerning the role of CHWs in creating and sustaining CCLs aimed at improving individual health outcomes. Our inclusion criteria included peer-reviewed articles that described a CHW intervention in the United States that used a CCL model. A total of 2,776 titles and/or abstracts were screened and 47 articles underwent full text review. Two independent reviewers rated the screened articles based on additional criteria including the CHW connection to community and evidence of linkage follow up rather than simple referral. For the 11 peer-reviewed articles included in the final review, we describe the CHW's relationship to the community, training, and role within the intervention, linkage, and outcomes. We used a standardized framework to determine commonalities in CHW roles across the interventions. CCLs with CHWs positively affect the delivery of both clinical care and community resources across a range of disease areas in a variety of contexts. To identify effective CCL models, additional information on CHW training, CCL follow-up methods, and the CHW role in CCLs is recommended.

Effective interventions on service quality improvement in a physiotherapy clinic.

PubMed

Gharibi, Farid; Tabrizi, JafarSadegh; Eteraf Oskouei, MirAli; AsghariJafarabadi, Mohammad

2014-01-01

Service quality is considered as a main domain of quality associ-ated with non-clinical aspect of healthcare. This study aimed to survey and im-proves service quality of delivered care in the Physiotherapy Clinic affiliated with the Tabriz University of Medical Sciences, Tabriz, Iran. A quasi experimental interventional study was conducted in the Physiotherapy Clinic, 2010-2011. Data were collected using a validated and reli-able researcher made questionnaire with participation of 324 patients and their coadjutors. The study questionnaire consisted of 7 questions about demographic factors and 38 questions for eleven aspects of service quality. Data were then analyzed using paired samples t-test by SPSS16. In the pre intervention phase, six aspects of service quality including choice of provider, safety, prevention and early detection, dignity, autonomy and availability achieved non-acceptable scores. Following interventions, all aspects of the service quality improved and also total service quality score improved from 8.58 to 9.83 (P<0.001). Service quality can be improved by problem implementation of appropriate interventions. The acquired results can be used in health system fields to create respectful environments for healthcare customers.

What's new in perioperative nutritional support?

PubMed

Awad, Sherif; Lobo, Dileep N

2011-06-01

To highlight recent developments in the field of perioperative nutritional support by reviewing clinically pertinent English language articles from October 2008 to December 2010, that examined the effects of malnutrition on surgical outcomes, optimizing metabolic function and nutritional status preoperatively and postoperatively. Recognition of patients with or at risk of malnutrition remains poor despite the availability of numerous clinical aids and clear evidence of the adverse effects of poor nutritional status on postoperative clinical outcomes. Unfortunately, poor design and significant heterogeneity remain amongst many studies of nutritional interventions in surgical patients. Patients undergoing elective surgery should be managed within a multimodal pathway that includes evidence-based interventions to optimize nutritional status perioperatively. The aforementioned should include screening patients to identify those at high nutritional risk, perioperative immuno-nutrition, minimizing 'metabolic stress' and insulin resistance by preoperative conditioning with carbohydrate-based drinks, glutamine supplementation, minimal access surgery and enhanced recovery protocols. Finally gut-specific nutrients and prokinetics should be utilized to improve enteral feed tolerance thereby permitting early enteral feeding. An evidence-based multimodal pathway that includes interventions to optimize nutritional status may improve outcomes following elective surgery.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis.

PubMed

Bukhsh, Allah; Khan, Tahir M; Lee, Shaun W H; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [-0.86, 95% CI -0.983, -0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [-4.94; 95%CI -8.65, -1.23] and triglycerides levels [-0.26, 95%CI -0.51, -0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [-0.57; 95%CI -1.25, -0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes.

Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

PubMed

Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

2017-12-01

Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Expanding mental health services through novel models of intervention delivery.

PubMed

Kazdin, Alan E

2018-06-13

Currently, in the United States and worldwide, the vast majority of children and adolescents in need of mental health services receive no treatment. Although there are many barriers, a key barrier is the dominant model of delivering psychosocial interventions. That model includes one-to-one, in-person treatment, with a trained mental health professional, provided in clinical setting (e.g., clinic, private practice office, health-care facility). That model greatly limits the scale and reach of psychosocial interventions. The article discusses many novel models of delivering interventions that permit scaling treatment to encompass children and adolescents who are not likely to receive services. Special attention is accorded the use of social media, socially assistive robots, and social networks that not only convey the ability to scale interventions but also encompass interventions that depart from the usual forms of intervention that currently dominate psychosocial treatment research. © 2018 Association for Child and Adolescent Mental Health.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

A systematic review of clinical pharmacist interventions in paediatric hospital patients.

PubMed

Drovandi, Aaron; Robertson, Kelvin; Tucker, Matthew; Robinson, Niechole; Perks, Stephen; Kairuz, Therése

2018-06-19

Clinical pharmacists provide beneficial services to adult patients, though their benefits for paediatric hospital patients are less defined. Five databases were searched using the MeSH terms 'clinical pharmacist', 'paediatric/paediatric', 'hospital', and 'intervention' for studies with paediatric patients conducted in hospital settings, and described pharmacist-initiated interventions, published between January 2000 and October 2017. The search strategy after full-text review identified 12 articles matching the eligibility criteria. Quality appraisal checklists from the Joanna Briggs Institute were used to appraise the eligible articles. Clinical pharmacist services had a positive impact on paediatric patient care. Medication errors intercepted by pharmacists included over- and under-dosing, missed doses, medication history gaps, allergies, and near-misses. Interventions to address these errors were positively received, and implemented by physicians, with an average acceptance rate of over 95%. Clinical pharmacist-initiated education resulted in improved medication understanding and adherence, improved patient satisfaction, and control of chronic medical conditions. This review found that clinical pharmacists in paediatric wards may reduce drug-related problems and improve patient outcomes. The benefits of pharmacist involvement appear greatest when directly involved in ward rounds, due to being able to more rapidly identify medication errors during the prescribing phase, and provide real-time advice and recommendations to prescribers. What is Known: • Complex paediatric conditions can require multiple pharmaceutical treatments, utilised in a safe manner to ensure good patient outcomes • The benefits of pharmacist interventions when using these treatments are well-documented in adult patients, though less so in paediatric patients What is New: • Pharmacists are adept at identifying and managing medication errors for paediatric patients, including incorrect doses, missed doses, and gaps in medication history • Interventions recommended by pharmacists are generally well-accepted by prescribing physicians, especially when recommendations can be made during the prescribing phase of treatment.

Clinical inertia in the pharmacological management of hypertension: A systematic review and meta-analysis.

PubMed

Milman, Tal; Joundi, Raed A; Alotaibi, Naif M; Saposnik, Gustavo

2018-06-01

Clinical Inertia is defined as "failure of health care providers to initiate or intensify therapy according to current guidelines". This phenomenon is gaining increasing attention as a major cause of clinicians' failure to adequately manage hypertension, thus leading to an increased incidence of cardiovascular events. We performed a systematic review and meta-analysis of randomized controlled trials to determine whether interventions aimed at reducing clinical inertia in the pharmacological treatment of hypertension improve blood pressure (BP) control. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched from the start of their database until October 3, 2017 for the MESH terms "Hypertension" or "Blood Pressure", their subheadings, and the keywords "Therapeutic Inertia" or "Clinical Inertia". Studies were included if they addressed pharmacologic hypertension management, clinical inertia, were randomized controlled trials, reported an outcome describing prescriber behavior, and were available in English. Data for the included studies was extracted by two independent observers. Quality of studies was analyzed using the Cochrane Risk of Bias Assessment. Data was pooled for statistical analysis using both fixed- and random-effects models. The primary study outcome was the percentage of patients achieving blood pressure control as defined by the Joint National Committee guidelines or study authors. Of 474 citations identified, ten met inclusion criteria comprising a total of 26,871 patients, and eight were selected for meta-analysis. Interventions included Physician Education, Physician Reminders, Patient Education, Patient Reminders, Ambulatory BP Monitoring, Digital Medication Offerings, Physician Peer Visits, and Pharmacist-led Counselling. Pooled event rates revealed more patients with controlled BP in the intervention group versus control (55%, 95% CI 46-63% versus 45%, 95% CI 37-53%) and interventions significantly improved the odds of BP control (OR = 1.19, 95% CI = 1.12-1.27, P < .001). Heterogeneity in the quantitative analysis was moderate. Addressing clinical inertia through physician reminders, ambulatory BP monitoring, and educational interventions for primary care providers was associated with an improvement in blood pressure control. Our findings encourage further research to investigate strategies at reducing clinical inertia in the management of hypertension.

A process evaluation exploring the lay counsellor experience of delivering a task shared psycho-social intervention for perinatal depression in Khayelitsha, South Africa.

PubMed

Munodawafa, Memory; Lund, Crick; Schneider, Marguerite

2017-07-01

Task sharing of psycho-social interventions for perinatal depression has been shown to be feasible, acceptable and effective in low and middle-income countries. This study conducted a process evaluation exploring the perceptions of counsellors who delivered a task shared psycho-social counselling intervention for perinatal depression in Khayelitsha, Cape Town together with independent fidelity ratings. Post intervention qualitative semi-structured interviews were conducted with six counsellors from the AFrica Focus on Intervention Research for Mental health (AFFIRM-SA) randomised controlled trial on their perceptions of delivering a task shared psycho-social intervention for perinatal depression. Themes were identified using the framework approach and were coded and analysed using Nvivo v11. These interviews were supplemented with fidelity ratings for each counsellor and supervision notes. Facilitating factors in the delivery of the intervention included intervention related factors such as: the content of the intervention, ongoing training and supervision, using a counselling manual, conducting counselling sessions in the local language (isiXhosa) and fidelity to the manual; counsellor factors included counsellors' confidence and motivation to conduct the sessions; participant factors included older age, commitment and a desire to be helped. Barriers included contextual factors such as poverty, crime and lack of space to conduct counselling sessions and participant factors such as the nature of the participant's problem, young age, and avoidance of contact with counsellors. Fidelity ratings and dropout rates varied substantially between counsellors. These findings show that a variety of intervention, counsellor, participant and contextual factors need to be considered in the delivery of task sharing counselling interventions. Careful attention needs to be paid to ongoing supervision and quality of care if lay counsellors are to deliver good quality task shared counselling interventions in under-resourced communities. Clinical Trials: NCT01977326 , registered on 24/10/2013; Pan African Clinical Trials Registry: PACTR201403000676264 , registered on 11/10/2013.

Maintenance of a smoking cessation program in public health clinics beyond the experimental evaluation period.

PubMed Central

Manfredi, C.; Crittenden, K.; Cho, Y. I.; Engler, J.; Warnecke, R.

2001-01-01

OBJECTIVES: As phase 3 of a study to evaluate a smoking cessation program in public health practice, the authors assess the maintenance and impact of the It's Time smoking cessation program in seven public maternal and child health clinics in Chicago. METHODS: The authors interviewed 404 clinic patients in the study's baseline phase (prior to introduction of the It's Time intervention program), and 610 in the program maintenance phase (in the year after experimental evaluation had ended) to assess exposure to smoking cessation interventions offered at the clinic, and smoking cessation outcomes (quit, actions toward quitting, scores on action, motivation, readiness, and confidence scales). The authors controlled for clustering of smokers within clinics, smokers' characteristics prior to clinic visit, and type of clinic service. They compared outcomes by study group (control or intervention) to which each clinic had been assigned in the earlier experimental phase. RESULTS: Compared to baseline, smokers in the maintenance phase had greater exposure to posters, provider advice and booklet, and better outcomes on seven of eight smoking cessation measures, including quitting. These improvements were larger for clinics with prior experience implementing It's Time. CONCLUSION: Participation in the experimental evaluation of the It's Time program prepared and possibly motivated the clinics to continue the program. Continuing the program resulted in greater delivery of interventions and improved smoking cessation outcomes for smokers in the clinics. PMID:11889280

The design and methodology of premature ejaculation interventional studies

PubMed Central

2016-01-01

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

Multimodal interventions including nutrition in the prevention and management of disease-related malnutrition in adults: a systematic review of randomised control trials.

PubMed

Thorne, Frances; Baldwin, Christine

2014-06-01

There has been a move to improve nutritional status in malnourished patients through the use of multimodal interventions (MI). There are currently no systematic reviews that have examined their effectiveness. This analysis aimed to examine the effects on nutritional, clinical, functional and patient-centred outcomes. A systematic review and meta-analysis using Cochrane methodology. 15 studies were included in the analysis, 13 comparing MI with usual care and 2 comparing MI with a nutrition intervention alone. Quality of studies varied and studies reported few relevant outcomes. Only 3 outcomes were compatible with meta-analysis; weight, mortality and length of stay (LOS). No statistically significant differences between groups were found. Narrative review was inconclusive. There was no evidence of benefit in the intervention groups in relation to body composition, functional status or quality of life (QoL). Intervention groups appeared to show a trend towards increased energy and protein intake however data was provided by only 2 studies (301 participants). No conclusive evidence of benefit for MI on any of the reviewed outcomes was found. Well designed, high quality trials addressing the impact of MI on relevant nutritional, functional and clinical outcomes are required. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Advances in Diagnosis and Treatment of Fetal Alcohol Spectrum Disorders

PubMed Central

Murawski, Nathen J.; Moore, Eileen M.; Thomas, Jennifer D.; Riley, Edward P.

2015-01-01

Prenatal alcohol exposure can cause a number of physical, behavioral, cognitive, and neural impairments, collectively known as fetal alcohol spectrum disorders (FASD). This article examines basic research that has been or could be translated into practical applications for the diagnosis or treatment of FASD. Diagnosing FASD continues to be a challenge, but advances are being made at both basic science and clinical levels. These include identification of biomarkers, recognition of subtle facial characteristics of exposure, and examination of the relation between face, brain, and behavior. Basic research also is pointing toward potential new interventions for FASD involving pharmacotherapies, nutritional therapies, and exercise interventions. Although researchers have assessed the majority of these treatments in animal models of FASD, a limited number of recent clinical studies exist. An assessment of this literature suggests that targeted interventions can improve some impairments resulting from developmental alcohol exposure. However, combining interventions may prove more efficacious. Ultimately, advances in basic and clinical sciences may translate to clinical care, improving both diagnosis and treatment. PMID:26259091

Cost-benefit of a clinical services integrated with a decentralized unit dose system.

PubMed

Warrian, K; Irvine-Meek, J

1988-06-01

Clinical pharmacy services are believed to be beneficial to patient care and to have the potential to reduce drug costs. This study was designed to apply cost-benefit analysis techniques to selected clinical pharmacy services provided by staff pharmacists assigned to a mobile decentralized unit-dose drug distribution system. Pharmacists' interventions were identified and recorded by the pharmacists and the investigator over an eight-week period. Interventions, to which a monetary value could be assigned, included non-formulary drug use, drug regimen adjustments, and the duration of drug therapy. A total of 543 interventions were recorded or observed. Of these, 174 (32 percent) fit the criteria for inclusion in the study. Those interventions accepted by physicians (87 percent) were assigned a dollar value and tabulated. Costs to provide the service were the pharmacists' salaries. Benefit to cost ratios of 1.08 and 1.59 demonstrated that the benefits accrued from selected clinical pharmacy services exceeded the costs to the hospital.

Impact of a mHealth intervention for peer health workers on AIDS care in rural Uganda: a mixed methods evaluation of a cluster-randomized trial.

PubMed

Chang, Larry W; Kagaayi, Joseph; Arem, Hannah; Nakigozi, Gertrude; Ssempijja, Victor; Serwadda, David; Quinn, Thomas C; Gray, Ronald H; Bollinger, Robert C; Reynolds, Steven J

2011-11-01

Mobile phone access in low and middle-income countries is rapidly expanding and offers an opportunity to leverage limited human resources for health. We conducted a mixed methods evaluation of a cluster-randomized trial exploratory substudy on the impact of a mHealth (mobile phone) support intervention used by community-based peer health workers (PHW) on AIDS care in rural Uganda. 29 PHWs at 10 clinics were randomized by clinic to receive the intervention or not. PHWs used phones to call and text higher level providers with patient-specific clinical information. 970 patients cared for by the PHWs were followed over a 26 month period. No significant differences were found in patients' risk of virologic failure. Qualitative analyses found improvements in patient care and logistics and broad support for the mHealth intervention among patients, clinic staff, and PHWs. Key challenges identified included variable patient phone access, privacy concerns, and phone maintenance.

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children.

PubMed

Lepore, Stephen J; Winickoff, Jonathan P; Moughan, Beth; Bryant-Stephens, Tyra C; Taylor, Daniel R; Fleece, David; Davey, Adam; Nair, Uma S; Godfrey, Melissa; Collins, Bradley N

2013-08-30

Secondhand smoke exposure (SHSe) harms children's health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers' advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to "ask, advise, and refer" guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. NCT01745393 (clinicaltrials.gov).

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children

PubMed Central

2013-01-01

Background Secondhand smoke exposure (SHSe) harms children’s health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers’ advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. Methods/design This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. Discussion This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to “ask, advise, and refer” guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. Trial registration NCT01745393 (clinicaltrials.gov). PMID:23987302

Paper Bag Books: A Creative Intervention with Elementary School Children Experiencing High-Conflict Parental Divorce

ERIC Educational Resources Information Center

Somody, Catherine; Hobbs, Marsha

2007-01-01

Research has found that school-based interventions for children of divorce help counter the adverse effects. Studies of school-based interventions have identified effective means for helping children of divorce cope with their situation and produce a significant reduction in clinical symptoms. Those components include activities that: (a) help…

Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial.

PubMed

Deales, A; Fratini, M; Romano, S; Rappelli, A; Penco, M; Perna, G Piero; Beccaceci, G; Borgia, R; Palumbo, W; Magi, M; Vespasiani, G; Bronzini, M; Musilli, A; Nocciolini, M; Mezzetti, A; Manzoli, L

2014-05-01

This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Eligible subjects had ≥ 1 among: blood pressure ≥ 140/90 mmHg; glycated hemoglobin ≥ 7%; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL (primary or secondary prevention, respectively); BMI ≥ 30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p < 0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity. The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice. ACTRN12611000813987. Copyright © 2013 Elsevier B.V. All rights reserved.

The effectiveness of nurse education and training for clinical alarm response and management: a systematic review.

PubMed

Yue, Liqing; Plummer, Virginia; Cross, Wendy

2017-09-01

To identify the effectiveness of education interventions provided for nurses for clinical alarm response and management. Some education has been undertaken to improve clinical alarm response, but the evidence for evaluating effectiveness for nurse education interventions is limited. Systematic review. A systematic review of experimental studies published in English from 2005-2015 was conducted in four computerised databases (MEDLINE, EMBASE, CINAHL and Scopus). After identification, screening and appraisal using Joanna Briggs Institute instruments, quality research papers were selected, data extraction and analysis followed. Five studies met the inclusion criteria for alarm response and no articles were concerned with clinical alarm education for management. All had different types and methods of interventions and statistical pooling was not possible. Response accuracy, response time and perceptions were consistent when different interventions were adopted. A positive effect was identified when learning about general alarms, single alarms, sequential alarms and medium-level alarms for learning as the primary task. Nurses who were musically trained had a faster and more accurate alarm response. Simulation interventions had a positive effect, but the effect of education provided in the care unit was greater. Overall, clinical alarm awareness was improved through education activities. Nurses are the main users of healthcare alarms and work in complex environments with high numbers of alarms, including nuisance alarms and other factors. Alarm-related adverse events are common. The findings of a small number of experimental studies with diverse evidence included consideration of various factors when formulating education strategies. The factors which influence effectiveness of nurse education are nurse demographics, nurse participants with musical training, workload and characteristics of alarms. Education interventions based in clinical practice settings increase education effectiveness, although simulation can be effective. No study shows any type of intervention results in sustained improvement. There are workload implications in education and the matching of load, number and type of alarms with nurse demographics which should be evaluated. There also needs to be a connection between education and the clinical setting to contribute to clinical alarm awareness for undergraduate nurses and practicing nurses. Education solely supported by employers is insufficient. Patient safety and long-term effects must be further explored. © 2016 John Wiley & Sons Ltd.

The 5As team intervention: bridging the knowledge gap in obesity management among primary care practitioners.

PubMed

Ogunleye, Ayodele; Osunlana, Adedayo; Asselin, Jodie; Cave, Andrew; Sharma, Arya Mitra; Campbell-Scherer, Denise Lynn

2015-12-22

Despite opportunities for didactic education on obesity management, we still observe low rates of weight management visits in our primary care setting. This paper describes the co-creation by front-line interdisciplinary health care providers and researchers of the 5As Team intervention to improve obesity prevention and management in primary care. We describe the theoretical foundations, design, and core elements of the 5AsT intervention, and the process of eliciting practitioners' self-identified knowledge gaps to inform the curricula for the 5AsT intervention. Themes and topics were identified through facilitated group discussion and a curriculum relevant to this group of practitioners was developed and delivered in a series of 12 workshops. The research question and approach were co-created with the clinical leadership of the PCN; the PCN committed internal resources and a practice facilitator to the effort. Practice facilitation and learning collaboratives were used in the intervention For the content, front-line providers identified 43 topics, related to 13 themes around obesity assessment and management for which they felt the need for further education and training. These needs included: cultural identity and body image, emotional and mental health, motivation, setting goals, managing expectations, weight-bias, caregiver fatigue, clinic dynamics and team-based care, greater understanding of physiology and the use of a systematic framework for obesity assessment (the "4Ms" of obesity). The content of the 12 intervention sessions were designed based on these themes. There was a strong innovation values fit with the 5AsT intervention, and providers were more comfortable with obesity management following the intervention. The 5AsT intervention, including videos, resources and tools, has been compiled for use by clinical teams and is available online at http://www.obesitynetwork.ca/5As_Team . Primary care interdisciplinary practitioners perceive important knowledge gaps across a wide range of topics relevant to obesity assessment and management. This description of the intervention provides important information for trial replication. The 5AsT intervention may be a useful aid for primary care teams interested to improve their knowledge of obesity prevention and management. Clinical Trials.gov (NCT01967797).

Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial.

PubMed

Epstein, Ronald M; Duberstein, Paul R; Fenton, Joshua J; Fiscella, Kevin; Hoerger, Michael; Tancredi, Daniel J; Xing, Guibo; Gramling, Robert; Mohile, Supriya; Franks, Peter; Kaesberg, Paul; Plumb, Sandy; Cipri, Camille S; Street, Richard L; Shields, Cleveland G; Back, Anthony L; Butow, Phyllis; Walczak, Adam; Tattersall, Martin; Venuti, Alison; Sullivan, Peter; Robinson, Mark; Hoh, Beth; Lewis, Linda; Kravitz, Richard L

2017-01-01

Observational studies demonstrate links between patient-centered communication, quality of life (QOL), and aggressive treatments in advanced cancer, yet few randomized clinical trials (RCTs) of communication interventions have been reported. To determine whether a combined intervention involving oncologists, patients with advanced cancer, and caregivers would promote patient-centered communication, and to estimate intervention effects on shared understanding, patient-physician relationships, QOL, and aggressive treatments in the last 30 days of life. Cluster RCT at community- and hospital-based cancer clinics in Western New York and Northern California; 38 medical oncologists (mean age 44.6 years; 11 (29%) female) and 265 community-dwelling adult patients with advanced nonhematologic cancer participated (mean age, 64.4 years, 146 [55.0%] female, 235 [89%] white; enrolled August 2012 to June 2014; followed for 3 years); 194 patients had participating caregivers. Oncologists received individualized communication training using standardized patient instructors while patients received question prompt lists and individualized communication coaching to identify issues to address during an upcoming oncologist visit. Both interventions focused on engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information. Control participants received no training. The prespecified primary outcome was a composite measure of patient-centered communication coded from audio recordings of the first oncologist visit following patient coaching (intervention group) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QOL, and aggressive treatments and hospice use in the last 30 days of life. Data from 38 oncologists (19 randomized to intervention) and 265 patients (130 intervention) were analyzed. In fully adjusted models, the intervention resulted in clinically and statistically significant improvements in the primary physician-patient communication end point (adjusted intervention effect, 0.34; 95% CI, 0.06-0.62; P = .02). Differences in secondary outcomes were not statistically significant. A combined intervention that included oncologist communication training and coaching for patients with advanced cancer was effective in improving patient-centered communication but did not affect secondary outcomes. clinicaltrials.gov Identifier: NCT01485627.

Process evaluation of Internet-based cognitive behavioural therapy for adults with tinnitus in the context of a randomised control trial.

PubMed

Beukes, Eldré W; Manchaiah, Vinaya; Baguley, David M; Allen, Peter M; Andersson, Gerhard

2018-02-01

The research objective was to identify processes that could either facilitate or hinder clinical implementation of an Internet-based cognitive behavioural therapy intervention for tinnitus in the UK. This was done by exploring the research context, the intervention components and the factors that contributed to the outcomes obtained. This study investigated eight processes including the recruitment strategies, reach, research context, treatment dose delivered and received, implementation fidelity, barriers to implementation and effectiveness of the intervention. Of the 169 registered participants, 146 were randomly assigned to the experimental or control groups (23 were excluded). The mean age was 55.57 years with an average tinnitus duration of 11.63 years. The intended sample of people with distressing tinnitus who were underserved with evidence-based tinnitus interventions was reached. The full guided intervention was delivered. The recommended modules were read more than the optional modules. Intervention components such as the easily readable format and the benefits of the applied relaxation programme facilitated significant positive post-intervention outcomes. Barriers hampering the intervention application included time pressures and low self-motivation. Results of this process evaluation together with the outcome data can be used to facilitate translating this research into clinical practice.

[Impact of a multidimensional intervention in elderly patients with community-acquired pneumonia: IMIEPCAP clinical trial].

PubMed

Torres, Olga Herminia; Gil, Eva; Comas, Maria Teresa; Saez, Maria Encarnación; Clotet, Sandra; Ramirez, Hector David; Mateo, Miriam; Ruiz, Domingo

2016-01-01

The main objective of this study is to determine whether a multidimensional intervention applied to elderly patients admitted to hospital due to pneumonia reduces re-admissions and emergency department visits in the year after the intervention. This is a single-centre non-pharmacological randomised clinical trial with a parallel design. Three hundred and fourteen patients will be included (157 in each arm). Eligible patients will be ≥65 years old and with a Barthel index ≥60 that are admitted to hospital due to pneumonia. Participants will be randomised to multidimensional intervention or to control group. Two months after hospital discharge the intervention group will receive a geriatric intervention, carried out by a nurse and a physician. It will include assessment of co-morbidities, nutritional, functional and cognitive status, and immunisation. The control group will receive conventional follow-up. The number of re-admissions, visits to the emergency department, functional status, survival, and institutionalisation will be evaluated one year after intervention. If the intervention shows an improvement in the studied outcomes, it would allow us to improve individual outcomes, and indirectly reduce healthcare costs using a relatively simple, standardised tool. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.

Education strategies to foster health professional students' clinical reasoning skills.

PubMed

Rochmawati, Erna; Wiechula, Rick

2010-06-01

Clinical reasoning is an important skill for health professionals that should be developed to achieve high levels of expertise. Several education strategies have been suggested for implementation by health professional educators to foster their students' clinical reasoning skills. The strategies have included the following: problem-based learning, the integrative curriculum, reflection, and concept mapping. This review assesses which is the most effective education strategy for developing the clinical reasoning skills of health professional students. Four publications, from a total of 692 identified records, were included. Overall, this review was not able to make a final conclusion to answer the question. Therefore, there is a need to conduct more studies with larger samples and to undertake research that evaluates the following aspects: more alternate education interventions, variations in the delivery of education interventions, and the cost-effectiveness of implementing education strategies.

Impact of a pharmacist-delivered discharge and follow-up intervention for patients with acute coronary syndromes in Qatar: a study protocol for a randomised controlled trial.

PubMed

Zidan, Amani; Awaisu, Ahmed; Kheir, Nadir; Mahfoud, Ziyad; Kaddoura, Rasha; AlYafei, Sumaya; El Hajj, Maguy Saffouh

2016-11-18

Acute coronary syndrome (ACS) is one of the leading causes of morbidity and mortality worldwide. Secondary cardiovascular risk reduction therapy (consisting of an aspirin, a β-blocker, an ACE inhibitor or an angiotensin II receptor blocker and a statin) is needed for all patients with ACS. Less than 80% of patients with ACS in Qatar use this combination after discharge. This study is aimed to evaluate the effectiveness of clinical pharmacist-delivered intervention at discharge and tailored follow-up postdischarge on decreasing hospital readmissions, emergency department (ED) visits and mortality among patients with ACS. A prospective, randomised controlled trial will be conducted at the Heart Hospital in Qatar. Patients are eligible for enrolment if they are at least 18 years of age and are discharged from any non-surgical cardiology service with ACS. Participants will be randomised into 1 of 3 arms: (1) 'control' arm which includes patients discharged during weekends or after hours; (2) 'clinical pharmacist delivered usual care at discharge' arm which includes patients receiving the usual care at discharge by clinical pharmacists; and (3) 'clinical pharmacist-delivered structured intervention at discharge and tailored follow-up postdischarge' arm which includes patients receiving intensive structured discharge interventions in addition to 2 follow-up sessions by intervention clinical pharmacists. Outcomes will be measured by blinded research assistants at 3, 6 and 12 months after discharge and will include: all-cause hospitalisations and cardiac-related hospital readmissions (primary outcome), all-cause mortality including cardiac-related mortality, ED visits including cardiac-related ED visits, adherence to medications and treatment burden. Percentage of readmissions between the 3 arms will be compared on intent-to-treat basis using χ 2 test with Bonferroni's adjusted pairwise comparisons if needed. The study was ethically approved by the Qatar University and the Hamad Medical Corporation Institutional Review Boards. The results shall be disseminated in international conferences and peer-reviewed publications. NCT02648243; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

Community-based comprehensive intervention for people with schizophrenia in Guangzhou, China: Effects on clinical symptoms, social functioning, internalized stigma and discrimination.

PubMed

Li, Jie; Huang, Yuan-Guang; Ran, Mao-Sheng; Fan, Yu; Chen, Wen; Evans-Lacko, Sara; Thornicroft, Graham

2018-04-01

Comprehensive interventions including components of stigma and discrimination reduction in schizophrenia in low- and middle-income countries (LMICs) are lacking. We developed a community-based comprehensive intervention to evaluate its effects on clinical symptoms, social functioning, internalized stigma and discrimination among patients with schizophrenia. A randomized controlled trial including an intervention group (n = 169) and a control group (n = 158) was performed. The intervention group received comprehensive intervention (strategies against stigma and discrimination, psycho-education, social skills training and cognitive behavioral therapy) and the control group received face to face interview. Both lasted for nine months. Participants were measured at baseline, 6 months and 9 months using the Internalized Stigma of Mental Illness scale (ISMI), Discrimination and Stigma Scale (DISC-12), Global Assessment of Functioning (GAF), Schizophrenia Quality of Life Scale (SQLS), Self-Esteem Scale (SES), Brief Psychiatric Rating Scale (BPRS) and PANSS negative scale (PANSS-N). Insight and medication compliance were evaluated by senior psychiatrists. Data were analyzed by descriptive statistics, t-test, chi-square test or Fisher's exact test. Linear Mixed Models were used to show intervention effectiveness on scales. General Linear Mixed Models with multinomial logistic link function were used to assess the effectiveness on medication compliance and insight. We found a significant reduction on anticipated discrimination, BPRS and PANSS-N total scores, and an elevation on overcoming stigma and GAF in the intervention group after 9 months. These suggested the intervention may be effective in reducing anticipated discrimination, increasing skills overcoming stigma as well as improving clinical symptoms and social functioning in Chinese patients with schizophrenia. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Development and Delivery of a Physical Activity Intervention for People With Huntington Disease: Facilitating Translation to Clinical Practice

PubMed Central

Quinn, Lori; Trubey, Rob; Gobat, Nina; Dawes, Helen; Edwards, Rhiannon Tudor; Jones, Carys; Townson, Julia; Drew, Cheney; Kelson, Mark; Poile, Vincent; Rosser, Anne; Hood, Kerenza

2016-01-01

Background and Purpose: We studied the development and delivery of a 14-week complex physical activity intervention for people with Huntington disease, where detailed information about the intervention was fully embedded in the trial design process. Methods: Intervention Development: The intervention was developed through a series of focus groups. The findings from the focus groups informed the development of a logic model for the physical activity intervention that was broadly consistent with the framework of self-determination theory. Intervention Delivery: Key components underpinning the delivery of the intervention were implemented including a defined coach training program and intervention fidelity assessment methods. Training of coaches (physical therapists, occupational therapists, research nurses, and exercise trainers) was delivered via group and 1:1 training sessions using a detailed coach's manual, and with ongoing support via video calls, and e-mail communication as needed. Detailed documentation was provided to determine costs of intervention development and coach training. Results: Intervention delivery coaches at 8 sites across the United Kingdom participated in the face-to-face training. Self-report checklists completed by each of the coaches indicated that all components of the intervention were delivered in accordance with the protocol. Mean (standard deviation) intervention fidelity scores (n = 15), as measured using a purpose-developed rating scale, was 11 (2.4) (out of 16 possible points). Coaches' perceptions of intervention fidelity were similarly high. The total cost of developing the intervention and providing training was £30,773 ($47,042 USD). Discussion and Conclusions: An important consideration in promoting translation of clinical research into practice is the ability to convey the detailed components of how the intervention was delivered to facilitate replication if the results are favorable. This report presents an illustrative example of a physical activity intervention, including the development and the training required to deliver it. This approach has the potential to facilitate reproducibility, evidence synthesis, and implementation in clinical practice. Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A122). PMID:26863152

ANMCO/GICR-IACPR/SICI-GISE Consensus Document: the clinical management of chronic ischaemic cardiomyopathy

PubMed Central

Gulizia, Michele Massimo; Colivicchi, Furio; Di Lenarda, Andrea; Musumeci, Giuseppe; Faggiano, Pompilio Massimo; Abrignani, Maurizio Giuseppe; Rossini, Roberta; Fattirolli, Francesco; Valente, Serafina; Mureddu, Gian Francesco; Temporelli, Pier Luigi; Olivari, Zoran; Amico, Antonio Francesco; Casolo, Giancarlo; Fresco, Claudio; Menozzi, Alberto; Nardi, Federico

2017-01-01

Stable coronary artery disease (CAD) is a clinical entity of great epidemiological importance. It is becoming increasingly common due to the longer life expectancy, being strictly related to age and to advances in diagnostic techniques and pharmacological and non-pharmacological interventions. Stable CAD encompasses a variety of clinical and anatomic presentations, making the identification of its clinical and anatomical features challenging. Therapeutic interventions should be defined on an individual basis according to the patient’s risk profile. To this aim, management flow charts have been reviewed based on sustainability and appropriateness derived from recent evidence. Special emphasis has been placed on non-pharmacological interventions, stressing the importance of lifestyle changes, including smoking cessation, regular physical activity, and diet. Adherence to therapy as an emerging risk factor is also discussed. PMID:28533729

New Medicine for the U.S. Health Care System: Training Physicians for Structural Interventions.

PubMed

Hansen, Helena; Metzl, Jonathan M

2017-03-01

Structural competency provides a language and theoretical framework to promote institutional-level interventions by clinical practitioners working with community organizations, non-health-sector institutions, and policy makers. The special collection of articles on structural competency in this issue of Academic Medicine addresses the need to move from theory to an appraisal of core educational interventions that operationalize the goals of and foster structural competency. In this Commentary, the authors review the role of clinical practitioners in enhancing population-level health outcomes through collaborations with professionals in fields outside medicine, including the social sciences and law. They describe the core elements of structural competency in preclinical and clinical education, as illustrated by the articles of this special collection: perceiving the structural causes of patients' disease, envisioning structural interventions, and cultivating alliances with non-health-sector agencies that can implement structural interventions. Finally, the authors argue that preparing trainees to form partnerships will empower them to influence the social determinants of their patients' health and reduce health inequalities.

A cluster-randomized controlled study to evaluate a team coaching concept for improving teamwork and patient-centeredness in rehabilitation teams.

PubMed

Körner, Mirjam; Luzay, Leonie; Plewnia, Anne; Becker, Sonja; Rundel, Manfred; Zimmermann, Linda; Müller, Christian

2017-01-01

Although the relevance of interprofessional teamwork in the delivery of patient-centered care is well known, there is a lack of interventions for improving team interaction in the context of rehabilitation in Germany. The aim of the present study is to evaluate whether a specially developed team coaching concept (TCC) could improve both teamwork and patient-centeredness. A multicenter, cluster-randomized controlled intervention study was conducted with both staff and patient questionnaires. Data was collected at ten German rehabilitation clinics (five clusters) of different indication fields before (t1) and after (t2) the intervention. Intervention clinics received the TCC, while control clinics did not receive any treatment. Staff questionnaires were used to measure internal participation and other aspects of teamwork, such as team organization, while patient questionnaires assessed patient-centeredness. A multivariate analysis of variance was applied for data analysis. In order to analyze the effect of TCC on internal participation and teamwork, 305 questionnaires were included for t1 and 213 for t2 in the staff survey. In the patient survey, 523 questionnaires were included for t1 and 545 for t2. The TCC improved team organization, willingness to accept responsibility and knowledge integration according to staff, with small effect sizes (univariate: η2=.010-.017), whereas other parameters including internal participation, team leadership and cohesion did not improve due to the intervention. The patient survey did not show any improvements on the assessed dimensions. The TCC improved dimensions that were addressed directly by the approach and were linked to the clinics' needs, such as restructured team meetings and better exchange of information. The TCC can be used to improve team organization, willingness to accept responsibility, and knowledge integration in rehabilitation practice, but some further evaluation is needed to understand contextual factors and processes regarding the implementation of the intervention.

A systematic review of assessment and intervention strategies for effective clinical communication in culturally and linguistically diverse students.

PubMed

Chan, Annie; Purcell, Alison; Power, Emma

2016-09-01

Culturally and linguistically diverse (CALD) students often experience difficulties with the clinical communication skills that are essential for successful interactions in the workplace. However, there is little evidence on the effectiveness of assessment and intervention strategies for this population. The two aims of this study were: to evaluate the effectiveness of assessment tools in identifying and describing the clinical communication difficulties of CALD health care students; and to determine whether communication programmes improved their clinical communication skills. Systematic review based on the Cochrane protocol. Articles were identified through a search of established databases using MeSH and key search terms. Studies published in English from 1990 to March 2015 were included if they described assessment strategies or a training programme for communication skills of CALD students. Studies were excluded if they did not describe implementation of a specific assessment or intervention programme. Data were extracted independently by the first author and verified by the second author. Quality was measured by the Best Evidence Medical Education guide and the Educational Interventions Critical Appraisal Tool. The Kirkpatrick hierarchy was used to measure impact. Meta-analysis was not conducted because of the heterogeneity of programme design and outcome measures. One hundred and twenty-nine articles met the criteria for full text review. Eighty-six articles were excluded. Thirteen articles addressing assessment and 30 articles reporting on communication training programmes were included in this review. Assessment tools used rubrics and rating scales effectively. Intervention studies focused on speech and language skills (n = 20), interpersonal skills (n = 7) and faculty-level support (n = 5). Although 17 studies reported positive findings on student satisfaction, only eight reported improved skills post-training. The development of effective assessment and intervention programmes should have an integrated design and include specific outcome measures to increase educational impact. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

A systematic review of educational interventions to change behaviour of prescribers in hospital settings, with a particular emphasis on new prescribers

PubMed Central

Brennan, Nicola; Mattick, Karen

2013-01-01

Aims Prescribing is a complex task and a high risk area of clinical practice. Poor prescribing occurs across staff grades and settings but new prescribers are attributed much of the blame. New prescribers may not be confident or even competent to prescribe and probably have different support and development needs than their more experienced colleagues. Unfortunately, little is known about what interventions are effective in this group. Previous systematic reviews have not distinguished between different grades of staff, have been narrow in scope and are now out of date. Therefore, to inform the design of educational interventions to change prescribing behaviour, particularly that of new prescibers, we conducted a systematic review of existing hospital-based interventions. Methods Embase, Medline, SIGLE, Cinahl and PsychINFO were searched for relevant studies published 1994–2010. Studies describing interventions to change the behaviour of prescribers in hospital settings were included, with an emphasis on new prescibers. The bibliographies of included papers were also searched for relevant studies. Interventions and effectiveness were classified using existing frameworks and the quality of studies was assessed using a validated instrument. Results Sixty-four studies were included in the review. Only 13% of interventions specifically targeted new prescribers. Most interventions (72%) were deemed effective in changing behaviour but no particular type stood out as most effective. Conclusion Very few studies have tailored educational interventions to meet needs of new prescribers, or distinguished between new and experienced prescribers. Educational development and research will be required to improve this important aspect of early clinical practice. PMID:22831632

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

PubMed

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

Defining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document.

PubMed

Spitzer, Ernest; McFadden, Eugène; Vranckx, Pascal; de Vries, Ton; Ren, Ben; Collet, Carlos; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Lopes, Renato D; Stone, Gregg W; Cutlip, Donald E; Serruys, Patrick W

2018-05-14

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A randomized control trial of interventions in school-aged children with auditory processing disorders.

PubMed

Sharma, Mridula; Purdy, Suzanne C; Kelly, Andrea S

2012-07-01

The primary purpose of the study was to compare intervention approaches for children with auditory processing disorder (APD): bottom-up training including activities focused on auditory perception, discrimination, and phonological awareness, and top-down training including a range of language activities. Another purpose was to determine the benefits of personal FM systems. The study is a randomized control trial where participants were allocated to groups receiving one of the two interventions, with and without personal FM, or to the no intervention group. The six-week intervention included weekly one-hour sessions with a therapist in the clinic, plus 1-2 hours per week of parent-directed homework. 55 children (7 to 13 years) with APD participated in the study. Intervention outcomes included reading, language, and auditory processing. Positive outcomes were observed for both training approaches and personal FM systems on several measures. Pre-intervention nonverbal IQ, age, and severity of APD did not influence outcomes. Performance of control group participants did not change when retested after the intervention period. Both intervention approaches were beneficial and there were additional benefits with the use of personal FM. Positive results were not limited to the areas specifically targeted by the interventions.

Interprofessional collaboration to improve professional practice and healthcare outcomes.

PubMed

Reeves, Scott; Pelone, Ferruccio; Harrison, Reema; Goldman, Joanne; Zwarenstein, Merrick

2017-06-22

Poor interprofessional collaboration (IPC) can adversely affect the delivery of health services and patient care. Interventions that address IPC problems have the potential to improve professional practice and healthcare outcomes. To assess the impact of practice-based interventions designed to improve interprofessional collaboration (IPC) amongst health and social care professionals, compared to usual care or to an alternative intervention, on at least one of the following primary outcomes: patient health outcomes, clinical process or efficiency outcomes or secondary outcomes (collaborative behaviour). We searched CENTRAL (2015, issue 11), MEDLINE, CINAHL, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to November 2015. We handsearched relevant interprofessional journals to November 2015, and reviewed the reference lists of the included studies. We included randomised trials of practice-based IPC interventions involving health and social care professionals compared to usual care or to an alternative intervention. Two review authors independently assessed the eligibility of each potentially relevant study. We extracted data from the included studies and assessed the risk of bias of each study. We were unable to perform a meta-analysis of study outcomes, given the small number of included studies and their heterogeneity in clinical settings, interventions and outcomes. Consequently, we summarised the study data and presented the results in a narrative format to report study methods, outcomes, impact and certainty of the evidence. We included nine studies in total (6540 participants); six cluster-randomised trials and three individual randomised trials (1 study randomised clinicians, 1 randomised patients, and 1 randomised clinicians and patients). All studies were conducted in high-income countries (Australia, Belgium, Sweden, UK and USA) across primary, secondary, tertiary and community care settings and had a follow-up of up to 12 months. Eight studies compared an IPC intervention with usual care and evaluated the effects of different practice-based IPC interventions: externally facilitated interprofessional activities (e.g. team action planning; 4 studies), interprofessional rounds (2 studies), interprofessional meetings (1 study), and interprofessional checklists (1 study). One study compared one type of interprofessional meeting with another type of interprofessional meeting. We assessed four studies to be at high risk of attrition bias and an equal number of studies to be at high risk of detection bias.For studies comparing an IPC intervention with usual care, functional status in stroke patients may be slightly improved by externally facilitated interprofessional activities (1 study, 464 participants, low-certainty evidence). We are uncertain whether patient-assessed quality of care (1 study, 1185 participants), continuity of care (1 study, 464 participants) or collaborative working (4 studies, 1936 participants) are improved by externally facilitated interprofessional activities, as we graded the evidence as very low-certainty for these outcomes. Healthcare professionals' adherence to recommended practices may be slightly improved with externally facilitated interprofessional activities or interprofessional meetings (3 studies, 2576 participants, low certainty evidence). The use of healthcare resources may be slightly improved by externally facilitated interprofessional activities, interprofessional checklists and rounds (4 studies, 1679 participants, low-certainty evidence). None of the included studies reported on patient mortality, morbidity or complication rates.Compared to multidisciplinary audio conferencing, multidisciplinary video conferencing may reduce the average length of treatment and may reduce the number of multidisciplinary conferences needed per patient and the patient length of stay. There was little or no difference between these interventions in the number of communications between health professionals (1 study, 100 participants; low-certainty evidence). Given that the certainty of evidence from the included studies was judged to be low to very low, there is not sufficient evidence to draw clear conclusions on the effects of IPC interventions. Neverthess, due to the difficulties health professionals encounter when collaborating in clinical practice, it is encouraging that research on the number of interventions to improve IPC has increased since this review was last updated. While this field is developing, further rigorous, mixed-method studies are required. Future studies should focus on longer acclimatisation periods before evaluating newly implemented IPC interventions, and use longer follow-up to generate a more informed understanding of the effects of IPC on clinical practice.

Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

PubMed Central

2014-01-01

Background Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. Methods/design The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012). PMID:25012235

Treatment of Depression in Nursing Home Residents without Significant Cognitive Impairment: a Systematic Review

PubMed Central

Simning, Adam; Simons, Kelsey V.

2017-01-01

Background Depression in nursing facilities is widespread and has been historically under-recognized and inadequately treated. Many interventions have targeted depression among residents with dementia in these settings. Less is known about depression treatment in residents without dementia who may be more likely to return to community living. Our study aimed to systematically evaluate randomized control trials (RCTs) in nursing facilities that targeted depression within samples largely comprised of residents without dementia. Methods The following databases were evaluated with searches covering January 1991 through December 2015 (PubMed, PsycINFO) and March 2016 (CINAHL). We also examined national and international clinical trial registries including ClinicalTrials.gov. RCTs were included if they were published in English, evaluated depression or depressive symptoms as primary or secondary outcomes, and included a sample with a mean age of 65 and older for which most had no or only mild cognitive impairment. Results A total of 32 RCTs met our criteria including those testing psychotherapeutic interventions (n=13), psychosocial and recreation interventions (n=9), and pharmacologic or other biologic interventions (n=10). Seven psychotherapeutic, six psychosocial and recreation, and four pharmacologic or other biologic interventions demonstrated a treatment benefit. Conclusions Many studies had small samples, were of poor methodological quality, and did not select for depressed residents. There is limited evidence suggesting that cognitive behavioral therapies, reminiscence, interventions to reduce social isolation, and exercise-based interventions have some promise for decreasing depression in cognitively intact nursing home residents; little can be concluded from the pharmacologic or other biologic RCTs. PMID:27758728

A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study.

PubMed

Mackie, Andrew S; Rempel, Gwen R; Kovacs, Adrienne H; Kaufman, Miriam; Rankin, Kathryn N; Jelen, Ahlexxi; Manlhiot, Cedric; Anthony, Samantha J; Magill-Evans, Joyce; Nicholas, David; Sananes, Renee; Oechslin, Erwin; Dragieva, Dimi; Mustafa, Sonila; Williams, Elina; Schuh, Michelle; McCrindle, Brian W

2016-06-06

The population of adolescents and young adults with congenital heart disease (CHD) is growing exponentially. These survivors are at risk of late cardiac complications and require lifelong cardiology care. However, there is a paucity of data on how to prepare adolescents to assume responsibility for their health and function within the adult health care system. Evidence-based transition strategies are required. The Congenital Heart Adolescents Participating in Transition Evaluation Research (CHAPTER 2) Study is a two-site cluster randomized clinical trial designed to evaluate the efficacy of a nurse-led transition intervention for 16-17 year olds with moderate or complex CHD. The primary endpoint is excess time to adult CHD care, defined as the time interval between the final pediatric cardiology appointment and the first adult CHD appointment, minus the recommended time interval between these appointments. Secondary endpoints include the MyHeart score (CHD knowledge), Transition Readiness Assessment Questionnaire score, and need for catheter or surgical re-intervention. Participants are enrolled in clusters based on week of attendance in the pediatric cardiology clinic. The intervention consists of two one-hour individualized sessions between a cardiology nurse and study participant. Session One focuses on knowledge of the participant's CHD, review of their cardiac anatomy and prior interventions, and potential late cardiac complications. Session Two focuses on self-management and communication skills through review and discussion of videos and role-play. The study will recruit 120 participants. Many adolescents and young adults experience a gap in care predisposing them to late cardiac complications. The CHAPTER 2 Study will investigate the impact of a nurse-led transition intervention among adolescents with CHD. Fidelity of the intervention is a major focus and priority. This study will build on our experience by (i) enrolling at two tertiary care programs, (ii) including a self-management intervention component, and (iii) evaluating the impact of the intervention on time to ACHD care, a clinically relevant outcome. The results of this study will inform pediatric cardiology programs, patients and policy makers in judging whether a structured intervention program provides clinically meaningful outcomes for adolescents and young adults living with CHD. ClinicalTrials.gov ID NCT01723332.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

PubMed

Carmona-Terés, Victoria; Lumillo-Gutiérrez, Iris; Jodar-Fernández, Lina; Rodriguez-Blanco, Teresa; Moix-Queraltó, Joanna; Pujol-Ribera, Enriqueta; Mas, Xavier; Batlle-Gualda, Enrique; Gobbo-Montoya, Milena; Berenguera, Anna

2015-02-25

The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. will receive standard care. quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. ISRCTN57405925. Registred 20 June 2014.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study

PubMed Central

2011-01-01

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596. PMID:22078490

Exposure-based Interventions for the management of individuals with high levels of needle fear across the lifespan: a clinical practice guideline and call for further research

PubMed Central

McMurtry, C. Meghan; Taddio, Anna; Noel, Melanie; Antony, Martin M.; Chambers, Christine T.; Asmundson, Gordon J. G.; Pillai Riddell, Rebecca; Shah, Vibhuti; MacDonald, Noni E.; Rogers, Jess; Bucci, Lucie M.; Mousmanis, Patricia; Lang, Eddy; Halperin, Scott; Bowles, Susan; Halpert, Christine; Ipp, Moshe; Rieder, Michael J.; Robson, Kate; Uleryk, Elizabeth; Votta Bleeker, Elizabeth; Dubey, Vinita; Hanrahan, Anita; Lockett, Donna; Scott, Jeffrey

2016-01-01

Abstract Needle fear typically begins in childhood and represents an important health-related issue across the lifespan. Individuals who are highly fearful of needles frequently avoid health care. Although guidance exists for managing needle pain and fear during procedures, the most highly fearful may refuse or abstain from such procedures. The purpose of a clinical practice guideline (CPG) is to provide actionable instruction on the management of a particular health concern; this guidance emerges from a systematic process. Using evidence from a rigorous systematic review interpreted by an expert panel, this CPG provides recommendations on exposure-based interventions for high levels of needle fear in children and adults. The AGREE-II, GRADE, and Cochrane methodologies were used. Exposure-based interventions were included. The included evidence was very low quality on average. Strong recommendations include the following. In vivo (live/in person) exposure-based therapy is recommended (vs. no treatment) for children seven years and older and adults with high levels of needle fear. Non-in vivo (imaginal, computer-based) exposure (vs. no treatment) is recommended for individuals (over seven years of age) who are unwilling to undergo in vivo exposure. Although there were no included trials which examined children < 7 years, exposure-based interventions are discussed as good clinical practice. Implementation considerations are discussed and clinical tools are provided. Utilization of these recommended practices may lead to improved health outcomes due to better health care compliance. Research on the understanding and treatment of high levels of needle fear is urgently needed; specific recommendations are provided. PMID:27007463

Exposure-based Interventions for the management of individuals with high levels of needle fear across the lifespan: a clinical practice guideline and call for further research.

PubMed

McMurtry, C Meghan; Taddio, Anna; Noel, Melanie; Antony, Martin M; Chambers, Christine T; Asmundson, Gordon J G; Pillai Riddell, Rebecca; Shah, Vibhuti; MacDonald, Noni E; Rogers, Jess; Bucci, Lucie M; Mousmanis, Patricia; Lang, Eddy; Halperin, Scott; Bowles, Susan; Halpert, Christine; Ipp, Moshe; Rieder, Michael J; Robson, Kate; Uleryk, Elizabeth; Votta Bleeker, Elizabeth; Dubey, Vinita; Hanrahan, Anita; Lockett, Donna; Scott, Jeffrey

2016-04-01

Needle fear typically begins in childhood and represents an important health-related issue across the lifespan. Individuals who are highly fearful of needles frequently avoid health care. Although guidance exists for managing needle pain and fear during procedures, the most highly fearful may refuse or abstain from such procedures. The purpose of a clinical practice guideline (CPG) is to provide actionable instruction on the management of a particular health concern; this guidance emerges from a systematic process. Using evidence from a rigorous systematic review interpreted by an expert panel, this CPG provides recommendations on exposure-based interventions for high levels of needle fear in children and adults. The AGREE-II, GRADE, and Cochrane methodologies were used. Exposure-based interventions were included. The included evidence was very low quality on average. Strong recommendations include the following. In vivo (live/in person) exposure-based therapy is recommended (vs. no treatment) for children seven years and older and adults with high levels of needle fear. Non-in vivo (imaginal, computer-based) exposure (vs. no treatment) is recommended for individuals (over seven years of age) who are unwilling to undergo in vivo exposure. Although there were no included trials which examined children < 7 years, exposure-based interventions are discussed as good clinical practice. Implementation considerations are discussed and clinical tools are provided. Utilization of these recommended practices may lead to improved health outcomes due to better health care compliance. Research on the understanding and treatment of high levels of needle fear is urgently needed; specific recommendations are provided.

Developing a tool to measure pharmacoeconomic outcomes of post-surgical pain management interventions.

PubMed

Keller, Deborah S; Smalarz, Amy; Haas, Eric M

2016-01-01

Financial pressures have limited the ability of providers to use medication that may improve clinical outcomes and patient satisfaction. New interventions are often fraught with resistance from individual cost centers. A value realization tool (VRT) is essential for separate cost centers to communicate and comprehend the overall financial and clinical implications of post-surgical pain management medication interventions (PSMI). The goal was to describe development of a VRT. An evaluation of common in-patient PSMI approaches, impacts, and costs was performed. A multidisciplinary task force guided development of the VRT to ensure appropriate representation and relevance to clinical practice. The main outcome was an Excel-based tool that communicates the overall cost/benefit of PSMI for the post-operative patient encounter. The VRT aggregated input data on costs, clinical impact, and nursing burden of PSMI assessment and monitoring into two high-level outcome reports: Overall Cost Impact and Nurse & Patient Impact. Costs included PSMI specific medication, equipment, professional placement, labor, overall/opioid-related adverse events, re-admissions, and length of stay. Nursing impact included level of practice interference, job satisfaction, and patient care metrics. Patient impact included pain scores, opioid use, PACU time, and satisfaction. Reference data was provided for individual institutions that may not collect all variables included in the VRT. The VRT is a valuable way for administrators to assess PSMI cost/benefits and for individual cost centers to see the overall value of individual interventions. The user-friendly, decision-support tool allows the end-user to use built-in referenced or personalized outcome data, increasing relevance to their institutions. This broad picture could facilitate communication across cost centers and evidence-based decisions for appropriate use and impacts of PSMI.

An evolving perspective on physical activity counselling by medical professionals

PubMed Central

2012-01-01

Background Physical inactivity is a modifiable risk factor for many chronic conditions and a leading cause of premature mortality. An increasing proportion of adults worldwide are not engaging in a level of physical activity sufficient to prevent or alleviate these adverse effects. Medical professionals have been identified as potentially powerful sources of influence for those who do not meet minimum physical activity guidelines. Health professionals are respected and expected sources of advice and they reach a large and relevant proportion of the population. Despite this potential, health professionals are not routinely practicing physical activity promotion. Discussion Medical professionals experience several known barriers to physical activity promotion including lack of time and lack of perceived efficacy in changing physical activity behaviour in patients. Furthermore, evidence for effective physical activity promotion by medical professionals is inconclusive. To address these problems, new approaches to physical activity promotion are being proposed. These include collaborating with community based physical activity behaviour change interventions, preparing patients for effective brief counselling during a consultation with the medical professional, and use of interactive behaviour change technology. Summary It is important that we recognise the latent risk of physical inactivity among patients presenting in clinical settings. Preparation for improving patient physical activity behaviours should commence before the consultation and may include physical activity screening. Medical professionals should also identify suitable community interventions to which they can refer physically inactive patients. Outsourcing the majority of a comprehensive physical activity intervention to community based interventions will reduce the required clinical consultation time for addressing the issue with each patient. Priorities for future research include investigating ways to promote successful referrals and subsequent engagement in comprehensive community support programs to increase physical activity levels of inactive patients. Additionally, future clinical trials of physical activity interventions should be evaluated in the context of a broader framework of outcomes to inform a systematic consideration of broad strengths and weaknesses regarding not only efficacy but cost-effectiveness and likelihood of successful translation of interventions to clinical contexts. PMID:22524484

Integrating Language, Pragmatics, and Social Intervention in a Single-Subject Case Study of a Child With a Developmental Social Communication Disorder.

PubMed

Adams, Catherine; Gaile, Jacqueline; Lockton, Elaine; Freed, Jenny

2015-10-01

This clinical focus article presents an illustration of a complex communication intervention, the Social Communication Intervention Programme (SCIP), as delivered to a child who has a social communication disorder (SCD). The SCIP intervention combined language processing and pragmatic and social understanding therapies in a program of individualized therapy activities and in close liaison with families. The study used an enhanced AB single-subject design in which an 8-year-old child with an SCD participated in 20 therapy sessions with a specialist speech-language pathologist. A procedure of matching assessment findings to intervention choices was followed to construct an individualized treatment program. Examples of intervention content and the embedded structure of SCIP are illustrated. Observational and formal measurements of receptive and expressive language, conversation, and parent-teacher ratings of social communication were completed before therapy, after therapy, and at a 6-month follow-up session. Outcomes revealed change in total and receptive language scores but not in expressive language. Conversation showed marked improvement in responsiveness, appreciation of listener knowledge, turn taking, and adaptation of discourse style. Teacher-reported outcomes included improved classroom behavior and enhanced literacy skills. Parent-reported outcomes included improved verbal interactions with family members and personal narratives. This clinical focus article demonstrates the complexity of needs in a child with an SCD and how these can be addressed in individualized intervention. Findings are discussed in relation to the essential nature of language support including pragmatic therapy for children with SCDs. Discussion of the role of formal and functional outcome measurement as well as the proximity of chosen outcomes to the intervention is included.

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study.

PubMed

Grossert, Astrid; Urech, Corinne; Alder, Judith; Gaab, Jens; Berger, Thomas; Hess, Viviane

2016-11-03

Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients. In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program. New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support. ClinicalTrials.gov NCT02289014 .

Pharmacological interventions for self-injurious behaviour in adults with intellectual disabilities: Abridged republication of a Cochrane systematic review.

PubMed

Gormez, A; Rana, F; Varghese, S

2014-07-01

We aimed to determine clinical effectiveness of pharmacological interventions for self-injurious behaviour in adults with intellectual disability. We searched the following databases: CENTRAL; MEDLINE; EMBASE; PsycINFO; CINAHL; SCI; SSCI; Conference Proceedings Citation Index - Science; Conference Proceedings Citation Index - Social Science and Humanities; ZETOC; World Cat .We also searched ClinicalTrials.gov,ICTRP and the reference lists of included trials. We included randomised controlled trials that examined drug interventions versus placebo for self-injurious behaviour. We found five double-blind, placebo-controlled trials, which included a total of 50 people. Four trials compared the effects of naltrexone versus placebo and one trial clomipramine versus placebo. We did not identify any relevant placebo-controlled trials for other drugs. We presented a narrative summary, as meta-analysis was not appropriate due to differences in study designs, differences between interventions and heterogeneous outcome measures. There was weak evidence in included trials that any active drug was more effective than placebo for people with intellectual disability demonstrating self-injurious behaviour. Due to sparse data, an absence of power and statistical significance, and high risk of bias for four of the included trials, we are unable to reach any definite conclusions about the relative benefits of naltrexone or clomipramine compared to placebo. © The Author(s) 2014.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. Design/methods We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. Discussion This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. Trial registration ClinicalTrials.gov: NCT01815710 PMID:23692634

Improving Primary Care Provider Practices in Youth Concussion Management.

PubMed

Arbogast, Kristy B; Curry, Allison E; Metzger, Kristina B; Kessler, Ronni S; Bell, Jeneita M; Haarbauer-Krupa, Juliet; Zonfrillo, Mark R; Breiding, Matthew J; Master, Christina L

2017-08-01

Primary care providers are increasingly providing youth concussion care but report insufficient time and training, limiting adoption of best practices. We implemented a primary care-based intervention including an electronic health record-based clinical decision support tool ("SmartSet") and in-person training. We evaluated consequent improvement in 2 key concussion management practices: (1) performance of a vestibular oculomotor examination and (2) discussion of return-to-learn/return-to-play (RTL/RTP) guidelines. Data were included from 7284 primary care patients aged 0 to 17 years with initial concussion visits between July 2010 and June 2014. We compared proportions of visits pre- and post-intervention in which the examination was performed or RTL/RTP guidelines provided. Examinations and RTL/RTP were documented for 1.8% and 19.0% of visits pre-intervention, respectively, compared with 71.1% and 72.9% post-intervention. A total of 95% of post-intervention examinations were documented within the SmartSet. An electronic clinical decision support tool, plus in-person training, may be key to changing primary care provider behavior around concussion care.

A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care.

PubMed

Cadogan, Cathal A; Ryan, Cristín; Gormley, Gerard J; Francis, Jill J; Passmore, Peter; Kerse, Ngaire; Hughes, Carmel M

2018-01-01

A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council's complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection). GPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients' medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants' feedback and clinical assessment findings. Four GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients' clinical data. The findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention's effectiveness. ISRCTN18176245.

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients.

PubMed

Griva, Konstadina; Mooppil, Nandakumar; Seet, Penny; Krishnan, Deby Sarojiuy Pala; James, Hayley; Newman, Stanton P

2011-01-28

Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.

Quality appraisal of clinical practice guidelines on the use of physiotherapy in rheumatoid arthritis: a systematic review.

PubMed

Hurkmans, Emalie J; Jones, Anamaria; Li, Linda C; Vliet Vlieland, Theodora P M

2011-10-01

To assess the quality of guidelines published in peer-reviewed literature concerning the role of physiotherapy in the management of patients with RA. A systematic literature search for clinical practice guidelines that included physiotherapy interventions was performed in four electronic databases. We assessed the quality of the selected guidelines using the appraisal of guidelines for research and evaluation (AGREE) instrument. In addition, the recommendations of guidelines with the highest quality scores were summarized. Eight clinical practice guidelines fulfilled the inclusion criteria. Scope/purpose was the most often adequately addressed AGREE domain (in seven of the eight guidelines) and applicability the least (in two of the eight guidelines). Based on the AGREE domain scores, six guidelines could be recommended or strongly recommended for clinical use. Five out of these six (strongly) recommended guidelines included a recommendation on exercise therapy and/or patient education, with these interventions being recommended in every case. Transcutaneous electrical nerve stimulation and thermotherapy were recommended in four of these six guidelines. US, thermotherapy, low-level laser therapy, massage, passive mobilization and balneotherapy were addressed in one or two of these six guidelines. Six of eight clinical practice guidelines addressing physiotherapy interventions were recommended or strongly recommended according to the AGREE instrument. In general, guideline recommendations on physiotherapy intervention, from both the recommended guidelines as well as from the not recommended guidelines, lacked detail concerning mode of delivery, intensity, frequency and duration.

Video-based sexually transmitted disease patient education: its impact on condom acquisition.

PubMed Central

O'Donnell, L N; Doval, A S; Duran, R; O'Donnell, C

1995-01-01

OBJECTIVES. This study assessed the impact of video-based educational interventions on condom acquisition among men and women seeking services at a large sexually transmitted disease clinic in the South Bronx, New York. METHODS. During 1992, 3348 African American and Hispanic patients were enrolled in a clinical trial of video-based interventions designed to promote safer sex behaviors, including increased condom use. Patients were assigned to one of three groups: control, video, or video plus interactive group discussion. Subjects were given a coupon to redeem for free condoms at a pharmacy several blocks from the clinic. Rates of condom acquisition were assessed by level of intervention. RESULTS. In comparison with a control group, subjects who viewed videos were significantly more likely to redeem coupons for condoms (21.2% redemption rate vs 27.6%). However, participation in interactive sessions after video viewing augmented the positive effects of video viewing alone (27.6% redemption rate vs 36.9%). Gender and ethnicity were significantly associated with outcomes. CONCLUSIONS. The condom acquisition are almost doubled with the use of culturally appropriate, video-based interventions. Designed to present minimal disruption to clinical services, these interventions can be implemented in clinics servicing at-risk men and women. Images FIGURE 1 PMID:7762716

Neurodevelopmental delay among children under the age of three years at immunization clinics in Lagos State, Nigeria - Preliminary report.

PubMed

Bakare, Muideen O; Bello-Mojeed, Mashudat A; Munir, Kerim M; Ogun, Oluwayemi C; Eaton, Julian

2016-04-29

Late diagnosis and interventions characterize childhood neurodevelopmental disorders in Sub-Saharan Africa. This has negatively impacted on the prognosis of the children with neurodevelopmental disorders. This study examined the prevalence and pattern of neurodevelopmental delays among children under the age of 3 years attending immunization clinics in Lagos State, Nigeria and also affords opportunity of early follow-up and interventions, which had been documented to improve prognosis. The study involved two stage assessments; which consisted of first phase screening of the children for neurodevelopmental delays in immunization clinics at primary healthcare centers Lagos State, Nigeria and second phase which consists of definitive clinical evaluation and follow-up interventions for children screened positive for neurodevelopmental delays. Twenty seven (0.9%) of a total of 3,011 children under the age of 3 years were screened positive for neurodevelopmental delays and subsequently undergoing clinical evaluation and follow-up interventions. Preliminary working diagnoses among these children include cerebral palsy, autism spectrum disorder trait, nutritional deficiency, Down syndrome and Non-specific neurodevelopmental delay with co-morbid seizure disorder accounting for 33.3%, 14.8%, 18.5%, 7.4% and 25.9% respectively. This is a preliminary report that would be followed up with information on medium and long term intervention phase.

Non-retrieval of inferior vena cava filters as a patient safety concern: evaluation of a new process improvement project to increase retrieval rates in a vascular and interventional radiology clinic.

PubMed

Brown, Joshua; Talbert, Jeffery; Pennington, Ryan; Han, Qiong; Raissi, Driss

2018-01-01

Retrieval of inferior vena cava filters (IVCFs) is important to decrease the long-term risk of complications associated with indwelling devices. Our hospital experienced low retrieval rates and implemented a low-cost intervention and evaluation for quality improvement. The working hypothesis was that a simple, mailed letter intervention could increase retrieval rates by increasing patient and primary care provider knowledge of the need for retrieval. For all prospective patients who received a retrievable IVCF during the intervention period from January 1, 2014 to February 29, 2016, patients and their primary care providers were mailed letters encouraging contact with the clinic for evaluation of eligibility for retrieval. The main outcome was retrieval of the IVCF if clinically indicated with a secondary outcome of time-to-retrieval. A pre-intervention control group from October 1, 2011 to December 31, 2013 was used to evaluate the impact of the intervention. Competing risks, time-to-event analysis was used to compare the pre- and post-intervention period retrieval rates correcting for patients who died during follow-up. Between the pre- and post-intervention periods, crude retrieval rates increased from 4.4% to 8.1% with a 12-fold change at comparable time points. The time-to-retrieval in the pre-intervention period was a mean (SD) of 503 (207) days with a median (IQR) of 505 (301-742). In the post-intervention period, time-to-retrieval was a mean (SD) of 119 (83) days and with median (IQR) of 128 (38-164) days. This low-cost intervention significantly increased retrieval rates in a single clinic. However, retrieval rates remain low and can be further improved. Ongoing interventions, including improved patient follow-up and physician education, are being implemented to further improve retrieval and use of inferior vena cava filters. Implanting clinics should implement quality improvement initiatives to improve patient care and follow-up with IVCFs to ensure retrievals occur once clinically relevant in order to minimize long-term complications.

Pharmacotherapies for fatigue in chronic liver disease (CLD): a systematic review and meta-analysis (protocol).

PubMed

Effiong, Andem; Kumari, Prerna

2018-02-14

This is the protocol for a systematic review (and meta-analysis) of an intervention. The primary objective of this systematic review will be to assess the benefits and harms of pharmacological therapies (pharmacotherapies) for the management of fatigue in adults with CLD of any etiology. The effects of pharmacological therapies on fatigue in CLD will be compared against those of placebo, no intervention, or non-pharmacological interventions. Specifically, this review will examine whether pharmacological therapies improve CLD-associated fatigue, and if they do, what key elements are associated with their effectiveness. The results of this systematic review will assist clinicians, policy-makers, researchers, and people with CLD in decision-making on how best to manage fatigue and its associated symptoms. MEDLINE, SCOPUS, EMBASE, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform, CENTRAL (The Cochrane Library), ClinicalTrials.gov, reference lists of articles and conference proceedings will be searched for relevant studies. No language or date restrictions will be applied. Eligible studies will include adults with CLD of any etiology. Included studies will be randomized controlled trials. From included studies, data on participant characteristics, study design, setting, research ethics compliance, and intervention outcomes will be extracted. Risk of bias in included studies will be assessed using the Cochrane Risk of Bias Tool. A random-effects meta-analysis will be conducted. If substantial or considerable levels of heterogeneity are detected, analysis will be limited to a narrative synthesis. This systematic review will examine the effectiveness of pharmacological therapies on fatigue reduction in people with CLD. Such therapies may be more effective than non-pharmacological interventions in treating fatigue symptoms in CLD. Evidence derived from the findings of this study will guide future practice, policy, and research. PROSPERO, CRD42017076957.

The Impact of a Community-Based Intervention Including a Monthly Food Ration on Food Insecurity Among HIV-Positive Adults During the First Year of Antiretroviral Therapy.

PubMed

Rothman, Jessica; Kayigamba, Felix; Hills, Victoria; Gupta, Neil; Machara, Faustin; Niyigena, Peter; Franke, Molly F

2018-01-01

The objective of this study was to examine how food insecurity changed among HIV-positive adults during the first 12 months of combination antiretroviral therapy (cART) and whether any change differed according to the receipt of food support, which was provided in the context of a comprehensive community-based intervention. We conducted secondary data analyses of data from a prospective cohort study of the effectiveness of a community-based cART delivery model when added to clinic-based cART delivery in Rwanda. We included patients from four health centers that implemented a clinic-based cART delivery model alone and five health centers that additionally implemented the intervention, which included 10 months of food support. We compared food insecurity at 3, 6, and 12 months, relative to baseline, and stratified by receipt of the intervention. Relative to baseline, median food insecurity score decreased after 3, 6, and 12 months (p value <0.0001 for all) for patients receiving a food ration through the community-based model for cART delivery. Among patients receiving care under the clinic-based cART model, food insecurity scores remained unchanged at 3 and 12 months and were significantly higher after 6 months. In adjusted analyses, participants enrolled in the community-based intervention with a food ration had a lower risk of severe food insecurity and a lower risk of moderate or severe food insecurity after 12 months. A comprehensive community-based HIV program including a food ration likely contributes to an alleviation of food insecurity among adults newly initiating cART.

Improving Clinical Practices for Children with Language and Learning Disorders

ERIC Educational Resources Information Center

Kamhi, Alan G.

2014-01-01

Purpose: This lead article of the Clinical Forum addresses some of the gaps that exist between clinical practice and current knowledge about instructional factors that influence learning and language development. Method: Topics reviewed and discussed include principles of learning, generalization, treatment intensity, processing interventions,…

When it comes to lifestyle recommendations, more is sometimes less: a meta-analysis of theoretical assumptions underlying the effectiveness of interventions promoting multiple behavior domain change.

PubMed

Wilson, Kristina; Senay, Ibrahim; Durantini, Marta; Sánchez, Flor; Hennessy, Michael; Spring, Bonnie; Albarracín, Dolores

2015-03-01

A meta-analysis of 150 research reports summarizing the results of multiple behavior domain interventions examined theoretical predictions about the effects of the included number of recommendations on behavioral and clinical change in the domains of smoking, diet, and physical activity. The meta-analysis yielded 3 main conclusions. First, there is a curvilinear relation between the number of behavioral recommendations and improvements in behavioral and clinical measures, with a moderate number of recommendations producing the highest level of change. A moderate number of recommendations is likely to be associated with stronger effects because the intervention ensures the necessary level of motivation to implement the recommended changes, thereby increasing compliance with the goals set by the intervention, without making the intervention excessively demanding. Second, this curve was more pronounced when samples were likely to have low motivation to change, such as when interventions were delivered to nonpatient (vs. patient) populations, were implemented in nonclinic (vs. clinic) settings, used lay community (vs. expert) facilitators, and involved group (vs. individual) delivery formats. Finally, change in behavioral outcomes mediated the effects of number of recommended behaviors on clinical change. These findings provide important insights that can help guide the design of effective multiple behavior domain interventions. PsycINFO Database Record (c) 2015 APA, all rights reserved.

The effect of an educational intervention, based on clinical simulation, on the diagnosis of rheumatoid arthritis and osteoarthritis.

PubMed

Fernández-Ávila, Daniel G; Ruiz, Álvaro J; Gil, Fabián; Mora, Sergio A; Tobar, Carlos; Gutiérrez, Juan M; Rosselli, Diego

2018-03-01

The aim of the present study was to evaluate the effectiveness of an educational tool for general physicians, based on rheumatological clinical simulation, for the diagnosis of rheumatoid arthritis and osteoarthritis. A randomized clinical study was carried out, in which the physician research subjects were assigned to one of two groups: the experimental group (educational intervention for rheumatoid arthritis with clinical simulation) or the control group (educational intervention for the basic aspects of the diagnosis and treatment of osteoporosis). Four weeks after the educational intervention, the members of both groups completed an examination that included four clinical cases with real patients, two clinical cases with two clinical simulation models and six virtual clinical cases. In this examination, the participants noted clinical findings, established a diagnosis and defined the complementary tests they would request, if necessary, to corroborate their diagnosis. A total of 160 doctors participated (80 in the active educational intervention for rheumatoid arthritis and 80 in the control group), of whom 89 were women (56%). The mean age was 35 (standard deviation 7.7) years. Success was defined as a physician correctly diagnosing at least 10 of the 12 cases presented. A significant difference of 81.3% (95% confidence interval 72-90%; p < 0.001) in success was found in favour of the active group (88.8% versus 7.5%). A greater number of correct answers was found in the active group compared with the control group in the detection of clinical findings and in the number of complementary tests requested (p < 0.001). The study showed the effectiveness of an educational intervention based on clinical simulation to improve the diagnostic approach to rheumatoid arthritis and osteoarthritis. The results open a new horizon in the teaching of rheumatology. Copyright © 2017 John Wiley & Sons, Ltd.

Retesting for genital Chlamydia trachomatis among visitors of a sexually transmitted infections clinic: randomized intervention trial of home- versus clinic-based recall.

PubMed

Götz, Hannelore M; Wolfers, Mireille E G; Luijendijk, Ad; van den Broek, Ingrid V F

2013-05-24

Reinfections of Chlamydia trachomatis (Ct) are common. In a two-armed intervention study at an urban STI clinic in the Netherlands, heterosexual Ct-positive visitors received an invitation for retesting after 4-5 months. Interventions were either home-based sampling by mailed test-kit, or clinic-based testing without appointment. Data collection included socio-demographic and sexual behavioural variables at first (T0) and repeat test (T1). Participation in retesting, prevalence and determinants of repeat infection among study participants are described and compared with findings from non-participants. Of the 216 visitors enrolled in the study, 75 accepted retesting (35%). The retest participation was 46% (50/109) in the home group versus 23% (25/107) in the clinic group (p = 0.001). Men were less often retested than women (15% versus 43%, p < 0.001). The overall chlamydia positivity rate at retest was 17.3% (13/75) compared to 12.4% seen at all visits at the STI clinic in 2011. Repeated infections were more frequent among non-Dutch than Dutch participants (27.0% versus 7.9%; p = 0.04) and in persons reporting symptoms (31.0% versus 7.0%; p = 0.01). Both untreated infections of current partners as well as unprotected sex with new partners contribute to repeated infections. The high rate of repeated infections indicates the need for interventions to increase retesting; improvement of partner-management and risk reduction counselling remain necessary. Home- based testing was more effective than clinic-based testing. However other strategies, including self-triage of patients, may also increase repeat testing rates and personal preferences should be taken into account.

Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial.

PubMed

Cabezas, Carmen; Martin, Carlos; Granollers, Silvia; Morera, Concepció; Ballve, Josep Lluis; Zarza, Elvira; Blade, Jordi; Borras, Margarida; Serra, Antoni; Puente, Diana

2009-02-04

There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC). Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis. Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation - contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. usual care. Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of

Audit of HIV testing frequency and behavioural interventions for men who have sex with men: policy and practice in sexual health clinics in England.

PubMed

Desai, Monica; Desai, Sarika; Sullivan, Ann Kathleen; Mohabeer, Malika; Mercey, Danielle; Kingston, Margaret A; Thng, Caroline; McCormack, Sheena; Gill, O Noel; Nardone, Anthony

2013-08-01

National guidance recommends targeted behavioural interventions and frequent HIV testing for men who have sex with men (MSM). We reviewed current policy and practice for HIV testing and behavioural interventions (BI) in England to determine adherence to guidance. 25 sexual health clinics were surveyed using a semistructured audit asking about risk ascertainment for MSM, HIV testing and behavioural intervention policies. Practice was assessed by reviewing the notes of the first 40 HIV-negative MSM aged over 16 who attended from 1 June 2010, in a subset of 15 clinics. 24 clinics completed the survey: 18 (75%) defined risk for MSM and 17 used unprotected anal intercourse (UAI) as an indication of high risk. 21 (88%) offered one or more structured BI. Of 598 notes reviewed, 199 (33%) MSM reported any UAI. BI, including safer sex advice, was offered to and accepted by 251/598 (42%) men. A low proportion of all MSM (52/251: 21%) accepted a structured one-to-one BI as recommended by national guidance and uptake was still low among higher risk MSM (29/107: 27%). 92% (552/598) of men had one or more HIV test over a 1-year period. In 2010, the number of HIV tests performed met the national minimum standard but structured behavioural interventions were being offered to and accepted by only a small proportion of MSM, including those at a higher risk of infection. Reasons for not offering behavioural interventions to higher risk MSM, whether due to patient choice, a lack of staff training or resource shortage, need to be investigated and addressed.

Expectations and requests regarding team training interventions to promote interdisciplinary collaboration in medical rehabilitation--A qualitative study.

PubMed

Müller, C; Plewnia, A; Becker, S; Rundel, M; Zimmermann, L; Körner, M

2015-08-19

Interdisciplinary teamwork and team interventions are highly valued in the rehabilitation sector because they can improve outcomes of care for persons with complex health problems. However, little is known about expectations and requests regarding team interventions, especially in medical rehabilitation. This study aimed to explore how clinical managers and health professionals within multidisciplinary rehabilitation teams describe their expectations and requests regarding team-training interventions in the field of medical rehabilitation. Considering the methodology of qualitative research, data were collected using semi-structured interviews and focus groups at five rehabilitation clinics in Germany. We conducted face-to-face interviews with 5 clinical managers and 13 department heads of health care teams as well as five focus groups with a total of 35 members of interdisciplinary rehabilitation teams. Afterwards, the data were analyzed through qualitative content analysis encompassing data coding and using inductive thematic analysis. The exploration of team members' and clinical managers' descriptions showed that, to them, interdisciplinary team training programs should include a wide array of training contents. Seven common core themes emerged from the interviews, including participation of employees, leadership, communication, team meetings, team composition, coordination, and equal esteem. Additionally, 13 themes were identified by either managers or team members. The body of expectations regarding team training content in healthcare spans the continuum of changes on the team and organizational levels. On the organizational level, a number of structural factors were mentioned (e.g. improving the general conditions for team meetings, organized workshops to exchange interdisciplinary experiences, and leadership training), and on the team level, changes in procedural factors were listed (e.g. optimizing the consecutive planning and coordination of patient treatments, clarity with regard to roles and responsibilities of team members, and mutual esteem and appreciation between different professions). The synthesis underscores that there is meaningful heterogeneity in team training needs; training interventions should be locally adapted for each clinic in terms of training content and training strategies. Tailored team interventions are important for rehabilitation clinics. Future work should evaluate employed team training concepts over time as well as training contents, implementation strategies, and learning outcomes. This includes using robust study designs and evaluating team-training effects.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

PubMed

Pai, Menaka; Lloyd, Nancy S; Cheng, Ji; Thabane, Lehana; Spencer, Frederick A; Cook, Deborah J; Haynes, R Brian; Schünemann, Holger J; Douketis, James D

2013-01-02

Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

Emergency department provider preferences related to clinical practice guidelines for tobacco cessation: a multicenter survey.

PubMed

Walters, Elizabeth L; Reibling, Ellen T; Wilber, Scott T; Sullivan, Ashley F; Gaeta, Theodore J; Camargo, Carlos A; Boudreaux, Edwin D

2014-07-01

The objective was to assess current emergency department (ED) provider practices and preferences for tobacco cessation interventions. The ED is an opportune place to initiate smoking cessation interventions. However, little is known about ED provider current practices and preferences for cessation counseling in the ED. This was a survey of ED providers conducted in 2008-2009 (including physicians, nurse practitioners, physician assistants, and nurses), working at least half-time at 10 U.S. academic EDs, regarding adherence to clinical practice guidelines ("5 As") and preferences for cessation interventions/styles. Data analysis occurred in 2012-2013. The response rate was 64% (800 out of 1,246 completed surveys). Providers reported strongest adherence to asking about patient smoking status, followed by advising, with significant variance by clinical role. Assessing, assisting, and arranging support for patients was low overall. Most frequently used interventions were to provide patients with a list of telephone numbers for stop-smoking counseling (87%), pamphlets on smoking health risks and the benefits of stopping (85%), and referrals to the National Toll-Free Smoker's Quitline (84%). Most providers (80%) were supportive of personally conducting brief (less than 3 minutes) smoking cessation counseling sessions during the ED visit, emphasizing education and encouragement. The least appealing intervention was writing a prescription for nicotine replacement therapies or medications to stop smoking (35%). Interventions most likely to be used were brief and delivered with a positive tone and included referral to external resources. The logical next step is to design and test interventions that ED providers find acceptable. © 2014 by the Society for Academic Emergency Medicine.

Skin cancer interventions across the cancer control continuum: A review of experimental evidence (1/1/2000-6/30/2015) and future research directions.

PubMed

Geller, Alan C; Dickerman, Barbra A; Taber, Jennifer M; Dwyer, Laura A; Hartman, Anne M; Perna, Frank M

2018-06-01

While the general efficacy of skin cancer interventions have been reviewed, employing the cancer control continuum would be useful to identify research gaps at specific cancer control points. We characterized the intervention evidence base for specific behavioral targets (e.g., tanning, sun protection, screening) and clinically related targets (e.g., sunburn, skin exams, cancers) at each point in the cancer control continuum. The review included articles published from 1/1/2000-6/30/15 that had an experimental design and targeted behavioral intervention in skin cancer (e.g., specific behaviors or clinically related targets). The search yielded 86 articles, including seven dissemination studies. Of the 79 non-dissemination studies, 57 exclusively targeted primary prevention behaviors, five exclusively targeted screening, 10 targeted both detection and prevention, and eight addressed cancer survivorship. Among prevention studies (n=67), 29 (43%) targeted children and 38 (57%) targeted adults. Of the 15 screening studies, nine targeted high-risk groups (e.g., men aged ≥50 years) and six targeted the general population. Although research has focused on skin cancer prevention, empirically validated interventions are still needed for youth engaged in indoor tanning and for behavioral interventions to pursue change in clinically relevant targets. Research must also address detection among those at highest risk for skin cancer, amelioration of emotional distress attendant to diagnosis and treatment, and survivorship concerns. We discuss essential qualities and opportunities for intervention development and translational research to inform the field. Copyright © 2018 Elsevier Inc. All rights reserved.

Knowledge translation and implementation in spinal cord injury: a systematic review.

PubMed

Noonan, V K; Wolfe, D L; Thorogood, N P; Park, S E; Hsieh, J T; Eng, J J

2014-08-01

To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions.

Integrating intervention for substance use disorder in a healthcare setting: practice and outcomes in New York City STD clinics.

PubMed

Yu, Jiang; Appel, Phil; Rogers, Meighan; Blank, Susan; Davis, Carrie; Warren, Barbara; Freeman, Anthony; Harris, Brett; Hussain, Shazia

2016-01-01

This article reports the integration and outcomes of implementing intervention services for substance use disorder (SUD) in three New York City public sexually transmitted disease (STD) clinics. The screening, brief intervention, and referral to treatment (SBIRT) service model was implemented in the STD clinics in 2008. A relational database was developed, which included screening results, service dispositions, face-to-face interviews with 6-month follow-ups, and treatment information. From February 2008 to the end of September 2012, 146,657 STD clinic patients 18 years or older were screened for current or past substance use disorders; 15,687 received a brief intervention; 954 received referrals to formal substance abuse treatment; 2082 were referred to substance abuse support services such as Alcoholics Anonymous (AA), and 690 were referred to mental health, social or HIV awareness services. Intervention services delivered through SBIRT resulted in improvements in multiple outcomes at 6 month follow-up. Patients who received interventions had reduced SUD risks, fewer mental health problems, and fewer unprotected sexual contacts. Delivery of SUD services in a public health setting represents a significant policy and practice change and benefits many individuals whose SUDs might otherwise be overlooked. Intervention services for substance use disorder were integrated and highly utilized in the STD setting. Further research needs to focus on the long-term impact of SUD interventions in the STD setting, their cost effectiveness, and the extent they are financially sustainable under the new healthcare law.

Cost-effectiveness of food, supplement and environmental interventions to address malnutrition in residential aged care: a systematic review.

PubMed

Hugo, Cherie; Isenring, Elisabeth; Miller, Michelle; Marshall, Skye

2018-05-01

observational studies have shown that nutritional strategies to manage malnutrition may be cost-effective in aged care; but more robust economic data is needed to support and encourage translation to practice. Therefore, the aim of this systematic review is to compare the cost-effectiveness of implementing nutrition interventions targeting malnutrition in aged care homes versus usual care. residential aged care homes. systematic literature review of studies published between January 2000 and August 2017 across 10 electronic databases. Cochrane Risk of Bias tool and GRADE were used to evaluate the quality of the studies. eight included studies (3,098 studies initially screened) reported on 11 intervention groups, evaluating the effect of modifications to dining environment (n = 1), supplements (n = 5) and food-based interventions (n = 5). Interventions had a low cost of implementation (<£2.30/resident/day) and provided clinical improvement for a range of outcomes including weight, nutritional status and dietary intake. Supplements and food-based interventions further demonstrated a low cost per quality adjusted life year or unit of physical function improvement. GRADE assessment revealed the quality of the body of evidence that introducing malnutrition interventions, whether they be environmental, supplements or food-based, are cost-effective in aged care homes was low. this review suggests supplements and food-based nutrition interventions in the aged care setting are clinically effective, have a low cost of implementation and may be cost-effective at improving clinical outcomes associated with malnutrition. More studies using well-defined frameworks for economic analysis, stronger study designs with improved quality, along with validated malnutrition measures are needed to confirm and increase confidence with these findings.

A multifaceted intervention to improve sepsis management in general hospital wards with evaluation using segmented regression of interrupted time series.

PubMed

Marwick, Charis A; Guthrie, Bruce; Pringle, Jan E C; Evans, Josie M M; Nathwani, Dilip; Donnan, Peter T; Davey, Peter G

2014-12-01

Antibiotic administration to inpatients developing sepsis in general hospital wards was frequently delayed. We aimed to reproduce improvements in sepsis management reported in other settings. Ninewells Hospital, an 860-bed teaching hospital with quality improvement (QI) experience, in Scotland, UK. The intervention wards were 22 medical, surgical and orthopaedic inpatient wards. A multifaceted intervention, informed by baseline process data and questionnaires and interviews with junior doctors, evaluated using segmented regression analysis of interrupted time series (ITS) data. MEASURES FOR IMPROVEMENT: Primary outcome measure: antibiotic administration within 4 hours of sepsis onset. Secondary measures: antibiotics within 8 hours; mean and median time to antibiotics; medical review within 30 min for patients with a standardised early warning system score .4; blood cultures taken before antibiotic administration; blood lactate level measured. The intervention included printed and electronic clinical guidance, educational clinical team meetings including baseline performance data, audit and monthly feedback on performance. Performance against all study outcome measures improved postintervention but differences were small and ITS analysis did not attribute the observed changes to the intervention. Rigorous analysis of this carefully designed improvement intervention could not confirm significant effects. Statistical analysis of many such studies is inadequate, and there is insufficient reporting of negative studies. In light of recent evidence, involving senior clinical team members in verbal feedback and action planning may have made the intervention more effective. Our focus on rigorous intervention design and evaluation was at the expense of iterative refinement, which likely reduced the effect. This highlights the necessary, but challenging, requirement to invest in all three components for effective QI.

A Pilot Study of a Peer-Group Lifestyle Intervention Enhanced With mHealth Technology and Social Media for Adults With Serious Mental Illness.

PubMed

Aschbrenner, Kelly A; Naslund, John A; Shevenell, Megan; Kinney, Elizabeth; Bartels, Stephen J

2016-06-01

This pilot study examined the preliminary effectiveness of a peer-group lifestyle intervention enhanced with mobile health technology and social media for obese individuals with serious mental illness. Thirty-two participants with a body mass index of 30 or higher received a 24-week intervention designed to facilitate peer support for lifestyle change through experiential learning and use of wearable activity tracking devices, smartphone applications, and Facebook to reinforce physical activity, healthy eating, and group participation between sessions. The primary outcome was weight loss. Secondary measures included fitness and participants' perceptions of peer-group support. Most participants (72%) lost weight, including 28% achieving clinically significant weight loss, and 17% of participants showed clinically significant improvements in cardiovascular fitness. Weight loss was associated with perceived peer-group support. This evaluation demonstrated the preliminary effectiveness of a potentially scalable peer-group lifestyle intervention delivered in community mental health settings for obese individuals with serious mental illness.

Impact of a primary care intervention on physician practice and patient and family behavior: keep ME Healthy---the Maine Youth Overweight Collaborative.

PubMed

Polacsek, Michele; Orr, Joan; Letourneau, Lisa; Rogers, Victoria; Holmberg, Robert; O'Rourke, Karen; Hannon, Cindy; Lombard, Kenneth A; Gortmaker, Steven L

2009-06-01

To evaluate the effect of a pediatric primary care-based intervention, on improved clinical decision support and family management of risk behaviors for childhood overweight. An experimental field trial was conducted with 12 intervention sites in urban and rural areas of Maine and nonrandomized control sites. Change was assessed by using clinical and parent measures from 9 intervention and 10 control sites before and during the Maine Youth Overweight Collaborative intervention. Longitudinal information was collected from chart audits of patients aged 5-18 years (n = 600), systematic samples of parents collected before (n = 346) and during (n = 386) the intervention in 12 sites, and systematic samples of parents in 9 intervention (n = 235) and 10 control (n = 304) sites collected during the intervention. Surveys of health care providers (n = 14 and 17) before and during the intervention were also collected. Teams worked over 18 months to implement improvements in clinical decision support, including tracking BMI percentiles, identification of overweight patients, appropriate laboratory tests, counseling of families and patients use of a behavioral screening tool, and other improvements following the chronic-care model targeting patients aged 5 to 18 and their families. Large changes occurred in clinical practice from before to during the Maine Youth Overweight Collaborative: increases in assessment of BMI (38%-94%), BMI percentile for age and gender (25%-89%), use of the 5-2-1-0 behavioral screening tool (0%-82%), and weight classification (19%-75%). Parent surveys indicated improvements in providers' behavior and rates of counseling. Intervention providers reported improvements in knowledge, attitudes, self-efficacy, and practice. The Maine Youth Overweight Collaborative intervention improved clinical decision support and family management of risk behaviors, indicating a promising primary care-based approach to address overweight risk among children and youth.

Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature.

PubMed

Kennelty, Korey A; Polgreen, Linnea A; Carter, Barry L

2018-01-18

We review studies published since 2014 that examined team-based care strategies and involved pharmacists to improve blood pressure (BP). We then discuss opportunities and challenges to sustainment of team-based care models in primary care clinics. Multiple studies presented in this review have demonstrated that team-based care including pharmacists can improve BP management. Studies highlighted the cost-effectiveness of a team-based pharmacy intervention for BP control in primary care clinics. Little information was found on factors influencing sustainability of team-based care interventions to improve BP control. Future work is needed to determine the best populations to target with team-based BP programs and how to implement team-based approaches utilizing pharmacists in diverse clinical settings. Future studies need to not only identify unmet clinical needs but also address reimbursement issues and stakeholder engagement that may impact sustainment of team-based care interventions.

Advice for acute low back pain: a comparison of what research supports and what guidelines recommend.

PubMed

Stevens, Matthew L; Lin, Chung-Wei C; de Carvalho, Flavia A; Phan, Kevin; Koes, Bart; Maher, Chris G

2017-10-01

Advice is widely considered an effective treatment for acute low back pain (LBP); however, details on what and how to deliver this intervention is less clear. We assessed and compared clinical trials that test advice for acute LBP with practice guidelines for their completeness of reporting and concordance on the content, method of delivery, and treatment regimen of advice interventions. Systematic review. Advice randomized controlled trials were identified through a systematic search. Guidelines were taken from recent overviews of guidelines for LBP. Completeness of reporting was assessed using the Template for Intervention Description and Replication checklist. Thematic analysis was used to characterize advice interventions into topics across the aspects of content, method of delivery, and regimen. Concordance between clinical trials and guidelines was assessed by comparing the number of trials that found a statistically significant treatment effect for an intervention that included a specific advice topic with the number of guidelines recommending that topic. The median (interquartile range) completeness of reporting for clinical trials and guidelines was 8 (7-9) and 3 (2-4) out of nine items on the Template for Intervention Description and Replication checklist, respectively. Guideline recommendations were discordant with clinical trials for 50% of the advice topics identified. Completeness of reporting was less than ideal for randomized controlled trials and extremely poor for guidelines. The recommendations made in guidelines of advice for acute LBP were often not concordant with the results of clinical trials. Taken together, these findings mean that the potential clinical value of advice interventions for patients with acute LBP is probably not being realized. Copyright © 2017 Elsevier Inc. All rights reserved.

Cost-effectiveness of medical, endovascular and surgical management of peripheral vascular disease☆

PubMed Central

Fanari, Zaher; Weintraub, William S.

2015-01-01

Peripheral arterial disease (PAD) is responsible for 20% of all US hospital admissions. Management of PAD has evolved over time to include many medical and transcatheter interventions in addition to the traditional surgical approach. Non-invasive interventions including supervised exercise programs and antiplatelets use are economically attractive therapies that should be considered in all patients at risk. While surgery offers so far a clinically and economically appropriate option, the improvement of percutaneous transluminal angioplasty (PTA) technique with the addition of drug-coated balloons offers a reasonably clinically and economically attractive alternative that will continue to evolve in the future. PMID:26238266

Exploring the therapeutic family intervention of commendations: insights from research.

PubMed

Limacher, Lori Houger; Wright, Lorraine M

2006-08-01

Offered in this article are interpretations that emerged in a qualitative, interpretive study focused on the family intervention called a "commendation." The tradition of philosophical hermeneutics informs and shapes the analysis of the data. Research participants include a heterosexual couple and a nurse who engaged in therapeutic conversations focused on difficulties with Internet pornography. Data sources include videotapes of clinical sessions, documentation, and research interviews. Isolated segments of clinical videotape are shared with the couple to prompt their memory of commending practices that emerged in clinical sessions. Commendations are not experienced by this couple as gentle and warm but instead as extremely provocative, albeit constructive. This study illuminates the complex, contextual nature of commending practice and suggests that the noticing of strengths and resources contains much more than the spoken word.

Ethical considerations in preventive interventions for bipolar disorder.

PubMed

Ratheesh, Aswin; Cotton, Susan M; Davey, Christopher G; Adams, Sophie; Bechdolf, Andreas; Macneil, Craig; Berk, Michael; McGorry, Patrick D

2017-04-01

Early intervention and prevention of serious mental disorders such as bipolar disorder has the promise of decreasing the burden associated with these disorders. With increasing early and preventive intervention efforts among cohorts such as those with a familial risk for bipolar disorder, there is a need to examine the associated ethical concerns. The aim of this review was to examine the ethical issues underpinning the clinical research on pre-onset identification and preventive interventions for bipolar disorder. We undertook a PubMed search updated to November 2014 incorporating search terms such as bipolar, mania, hypomania, ethic*(truncated), early intervention, prevention, genetic and family. Fifty-six articles that were identified by this method as well as other relevant articles were examined within a framework of ethical principles including beneficence, non-maleficence, respect for autonomy and justice. The primary risks associated with research and clinical interventions include stigma and labelling, especially among familial high-risk youth. Side effects from interventions are another concern. The benefits of preventive or early interventions were in the amelioration of symptoms as well as the possibility of minimizing disability, cognitive impairment and progression of the illness. Supporting the autonomy of individuals and improving access to stigma-free care may help moderate the potential challenges associated with the risks of interventions. Concerns about the risks of early identification and pre-onset interventions should be balanced against the potential benefits, the individuals' right to choice and by improving availability of services that balance such dilemmas. © 2016 John Wiley & Sons Australia, Ltd.

Adapting and Testing Telephone Based Depression Care Management Intervention for Adolescent Mothers

PubMed Central

Logsdon, M. Cynthia; Pinto-Foltz, Melissa D.; Stein, Bradley; Usui, Wayne; Josephson, Allan

2011-01-01

Purpose and Methods This Phase 1 clinical trial combined qualitative and quantitative methods to modify a collaborative care, telephone based, depression care management intervention for adolescent mothers, and to determine the acceptability, feasibility, and initial efficacy of the intervention in a sample of adolescent mothers (n=97) who were recruited from a Teen Parent Program. Outcomes included measures of depressive symptoms, functioning, and use of mental health services. Results Acceptability of the intervention was demonstrated, but feasibility issues related to the complex life challenges confronting the adolescent mother. Although only four adolescent mothers received mental health treatment, there was a trend for improved depressive symptoms over time. Conclusion Results of the study provide data for the need of further refinement of the intervention before a large clinical trial is conducted for adolescent mothers with symptoms of depression. PMID:20020164

Guideline-based intervention to reduce telemetry rates in a large tertiary centre.

PubMed

Ramkumar, Satish; Tsoi, Edward H; Raghunath, Ajay; Dias, Floyd F; Li Wai Suen, Christopher; Tsoi, Andrew H; Mansfield, Darren R

2017-07-01

Inappropriate cardiac telemetry use is associated with reduced patient flow and increased healthcare costs. To evaluate the outcomes of guideline-based application of cardiac telemetry. Phase I involved a prospective audit (March to August 2011) of telemetry use at a tertiary hospital. Data were collected on indication for telemetry and clinical outcomes. Phase II prospectively included patients more than 18 years under general medicine requiring ward-based telemetry. As phase II occurred at a time remotely from phase I, an audit similar to phase I (phase II - baseline) was completed prior to a 3-month intervention (May to August 2015). The intervention consisted of a daily telemetry ward round and an admission form based on the American Heart Association guidelines (class I, telemetry indicated; class II, telemetry maybe indicated; class III, telemetry not indicated). Patient demographics, telemetry data, and clinical outcomes were studied. Primary endpoint was the percentage reduction of class III indications, while secondary endpoint included telemetry duration. In phase I (n = 200), 38% were admitted with a class III indication resulting in no change in clinical management. A total of 74 patients was included in phase II baseline (mean ± standard deviation (SD) age 73 years ± 14.9, 57% male), whilst 65 patients were included in the intervention (mean ± SD age 71 years ± 18.4, 35% male). Both groups had similar baseline characteristics. There was a reduction in class III admissions post-intervention from 38% to 11%, P < 0.001. Intervention was associated with a reduction in median telemetry duration (1.8 ± 1.8 vs 2.4 ± 2.5 days, P = 0.047); however, length of stay was similar in both groups (P > 0.05). Guideline-based telemetry admissions and a regular telemetry ward round are associated with a reduction in inappropriate telemetry use. © 2017 Royal Australasian College of Physicians.

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

PubMed

Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

2016-08-22

Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period. This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).

Impact of the Provider and Healthcare team Adherence to Treatment Guidelines (PHAT-G) intervention on adherence to national obesity clinical practice guidelines in a primary care centre.

PubMed

Barnes, Emily R; Theeke, Laurie A; Mallow, Jennifer

2015-04-01

Obesity is significantly underdiagnosed and undertreated in primary care settings. The purpose of this clinical practice change project was to increase provider adherence to national clinical practice guidelines for the diagnosis and treatment of obesity in adults. Based upon the National Institutes of Health guidelines for the diagnosis and treatment of obesity, a clinical change project was implemented. Guided by the theory of planned behaviour, the Provider and Healthcare team Adherence to Treatment Guidelines (PHAT-G) intervention includes education sessions, additional provider resources for patient education, a provider reminder system and provider feedback. Primary care providers did not significantly increase on documentation of diagnosis and planned management of obesity for patients with body mass index (BMI) greater than or equal to 30. Medical assistants increased recording of height, weight and BMI in the patient record by 13%, which was significant. Documentation of accurate BMI should lead to diagnosis of appropriate weight category and subsequent care planning. Future studies will examine barriers to adherence to clinical practice guidelines for obesity. Interventions are needed that include inter-professional team members and may be more successful if delivered separately from routine primary care visits. © 2015 John Wiley & Sons, Ltd.

A Review of Multidisciplinary Interventions in Atopic Dermatitis

PubMed Central

Spielman, Sara C.; LeBovidge, Jennifer S.; Timmons, Karol G.; Schneider, Lynda C.

2015-01-01

Multidisciplinary interventions have been developed for patients with atopic dermatitis (AD) and their families, with the aim of improving outcomes such as disease control, adherence, and quality of life. We reviewed the content of different multidisciplinary approaches to intervention for AD and evidence for their impact on key outcome measures. We also provided data from our multidisciplinary outpatient program for pediatric AD. Studies included in the review suggest benefits of multidisciplinary interventions as models of treatment or adjuncts to standard medical care, with a positive impact on outcomes including disease severity and itching/scratching. There were limitations to existing studies, including heterogeneous methods used to assess quality of life outcomes across studies and lack of controlled studies assessing the outcome of clinical care programs. Further research will be useful in assessing the impact of multidisciplinary interventions on important outcomes such as treatment adherence and sleep, identifying the elements of multidisciplinary interventions that are most critical for improved outcomes, and identifying the best candidates for multidisciplinary intervention approaches. PMID:26239470

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Controlling childhood obesity: A systematic review on strategies and challenges

PubMed Central

Kelishadi, Roya; Azizi-Soleiman, Fatemeh

2014-01-01

Background: Childhood obesity is a global health problem with short- and long-term health consequences. This systematic review presents a summary of the experiences on different family-, school-, and clinic-based interventions. Materials and Methods: Electronic search was conducted in MEDLINE, PubMed, ISI Web of Science, and Scopus scientific databases. We included those studies conducted among obese individuals aged up to 18 years. Our search yielded 105 relevant papers, 70 of them were conducted as high quality clinical trials. Results: Our findings propose that school-based programs can have long-term effects in a large target group. This can be related to this fact that children spend a considerable part of their time in school, and adopt some parts of lifestyle there. They have remarkable consequences on health behaviors, but as there are some common limitations, their effects on anthropometric measures are not clear. Due to the crucial role of parents in development of children's behaviors, family-based interventions are reported to have successful effects in some aspects; but selection bias and high dropout rate can confound their results. Clinic-based interventions revealed favorable effects. They include dietary or other lifestyle changes like increasing physical activity or behavior therapy. It seems that a comprehensive intervention including diet and exercise are more practical. When they have different designs, results are controversial. Conclusion: We suggest that among different types of interventional programs, a multidisciplinary approach in schools in which children's family are involved, can be the best and most sustainable approach for management of childhood obesity. PMID:25538786

Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease.

PubMed

Lo, Bernard; Parham, Lindsay

2010-01-01

Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial to yield generalizable knowledge, negative findings and serious adverse events must be reported.

The role of fantasies, countertransference, and psychological defenses in patient violence.

PubMed

Dubin, W R

1989-12-01

Over the past decade the management of aggression on psychiatric units has generally focused on pharmacologic and physical interventions rather than on psychodynamic concerns. The author reviews the dynamics of violence and discusses how clinical staff's fantasies, countertransferences, and psychological defenses may interact to trigger patient aggression. Interventions that address these issues with staff include developing a cohesive treatment team in which clinical staff can express their feelings without the need to explore the psychodynamic underpinnings, having clinical leaders maintain a strong presence on the unit to serve as role models, and providing regular inservice training.

Weight management interventions in adults with intellectual disabilities and obesity: a systematic review of the evidence.

PubMed

Spanos, Dimitrios; Melville, Craig Andrew; Hankey, Catherine Ruth

2013-09-23

To evaluate the clinical effectiveness of weight management interventions in adults with intellectual disabilities (ID) and obesity using recommendations from current clinical guidelines for the first line management of obesity in adults. Full papers on lifestyle modification interventions published between 1982 to 2011 were sought by searching the Medline, Embase, PsycINFO and CINAHL databases. Studies were evaluated based on (1) intervention components, (2) methodology, (3) attrition rate (4) reported weight loss and (5) duration of follow up. Twenty two studies met the inclusion criteria. The interventions were classified according to inclusion of the following components: behaviour change alone, behaviour change plus physical activity, dietary advice or physical activity alone, dietary plus physical activity advice and multi-component (all three components). The majority of the studies had the same methodological limitations: no sample size justification, small heterogeneous samples, no information on randomisation methodologies. Eight studies were classified as multi-component interventions, of which one study used a 600 kilocalorie (2510 kilojoule) daily energy deficit diet. Study durations were mostly below the duration recommended in clinical guidelines and varied widely. No study included an exercise program promoting 225-300 minutes or more of moderate intensity physical activity per week but the majority of the studies used the same behaviour change techniques. Three studies reported clinically significant weight loss (≥ 5%) at six months post intervention. Current data indicate weight management interventions in those with ID differ from recommended practice and further studies to examine the effectiveness of multi-component weight management interventions for adults with ID and obesity are justified.

Weight management interventions in adults with intellectual disabilities and obesity: a systematic review of the evidence

PubMed Central

2013-01-01

To evaluate the clinical effectiveness of weight management interventions in adults with intellectual disabilities (ID) and obesity using recommendations from current clinical guidelines for the first line management of obesity in adults. Full papers on lifestyle modification interventions published between 1982 to 2011 were sought by searching the Medline, Embase, PsycINFO and CINAHL databases. Studies were evaluated based on 1) intervention components, 2) methodology, 3) attrition rate 4) reported weight loss and 5) duration of follow up. Twenty two studies met the inclusion criteria. The interventions were classified according to inclusion of the following components: behaviour change alone, behaviour change plus physical activity, dietary advice or physical activity alone, dietary plus physical activity advice and multi-component (all three components). The majority of the studies had the same methodological limitations: no sample size justification, small heterogeneous samples, no information on randomisation methodologies. Eight studies were classified as multi-component interventions, of which one study used a 600 kilocalorie (2510 kilojoule) daily energy deficit diet. Study durations were mostly below the duration recommended in clinical guidelines and varied widely. No study included an exercise program promoting 225–300 minutes or more of moderate intensity physical activity per week but the majority of the studies used the same behaviour change techniques. Three studies reported clinically significant weight loss (≥ 5%) at six months post intervention. Current data indicate weight management interventions in those with ID differ from recommended practice and further studies to examine the effectiveness of multi-component weight management interventions for adults with ID and obesity are justified. PMID:24060348

[Development of studies on bioeffects of ultrasound-acupuncture therapy and its underlying mechanism].

PubMed

Yang, Yu-Hua; Zhang, Di; Sa, Zhe-Yan; Huang, Meng; Ding, Guang-Hong

2012-08-01

The so-called ultrasound acupuncture is a therapeutic approach for clinical problems and health care by applying the ultrasound energy to the acupoints of the human body directly or indirectly. It has been applied in clinic for about 30 years since 1980s. In the present paper, the authors review the development of both experimental and clinical researches in the past 30 years. Its clinical application includes allergic rhinitis, local pain, mastitis, angina pectoris of coronary heart disease, stroke, etc. Regarding the researches on the underlying mechanism of ultrasound and ultrasound acupuncture, the authors make a summary from 1) bioeffects (thermal and nonthermal effects) of ultrasound intervention; 2) cell lysis and nonlysis effects of ultrasound intervention; and 3) effects of ultrasound acupuncture on the degranulation of mast cells. Based on the idea that "inflammatory reaction caused by mast cell degranulation is one of the initial factors of acupuncture for inducing therapeutic effects", bioeffects including cellular changes, especially mast cell degranulation caused by ultrasound stimulation, are thought to be the main possible mechanisms underlying the favorable efficacy of ultrasound acupuncture intervention. However, the ultrasound metrology and the specific superiority of ultrasound acupuncture remain unknown up to now.

An education and motivation intervention to change clinical management of the third stage of labor - the GIRMMAHP Initiative.

PubMed

Figueras, Albert; Narváez, Edgar; Valsecia, Mabel; Vásquez, Susana; Rojas, Germán; Camilo, Angiolina; del Valle, José-María; Aguilera, Cristina

2008-12-01

Hemorrhage and hypertensive disorders are major contributors to death after delivery in developing countries. The GIRMMAHP Initiative was designed to describe the actual delivery care in five Latin American countries and to educate and motivate clinical staff at 17 hospitals with the purpose of implementing their own clinical practice guidelines to prevent postpartum hemorrhage. A multicountry education intervention was developed in four consecutive stages, using two analyses: (a) an observational study of the clinical records in eight teaching and nine nonteaching hospitals and (b) a study of the long-term changes measured 12 months after completion of an education intervention and writing a local clinical guideline. Data from 2,247 pregnant women showed that only 23.3 percent had an active management of the third stage of labor and that 22.7 percent received no prenatal care visit. These data were used to prepare local clinical practice guidelines in each participant hospital. The proportion of active management increased to 72.6 percent of deliveries at 3 months and 58.7 percent 1 year later. Use of oxytocin during the third stage of labor increased to 85.9 percent of included deliveries. The proportion of women who had postpartum hemorrhage decreased from 12.7 percent at baseline to 5 percent at 1 year after the intervention. An education intervention and discussion of actual clinical practice problems with health professionals and their involvement in drafting clinical guidelines helped improve health care quality and practitioners' adherence to these guidelines.

Tobacco dependence counseling in a randomized multisite clinical trial

PubMed Central

Croghan, Ivana T.; Trautman, Judith A.; Winhusen, Theresa; Ebbert, Jon O.; Kropp, Frankie; Schroeder, Darrell R.; Hurt, Richard D.

2012-01-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a “train-the-trainer” model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 ± 2.8 sessions (mean ± SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and “meeting expectations” on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. PMID:22406192

Effectiveness of Collaborative Care for Depression in Public-Sector Primary Care Clinics Serving Latinos.

PubMed

Lagomasino, Isabel T; Dwight-Johnson, Megan; Green, Jennifer M; Tang, Lingqi; Zhang, Lily; Duan, Naihua; Miranda, Jeanne

2017-04-01

Quality improvement interventions for depression care have been shown to be effective for improving quality of care and depression outcomes in settings with primarily insured patients. The aim of this study was to determine the impact of a collaborative care intervention for depression that was tailored for low-income Latino patients seen in public-sector clinics. A total of 400 depressed patients from three public-sector primary care clinics were enrolled in a randomized controlled trial of a tailored collaborative care intervention versus enhanced usual care. Social workers without previous mental health experience served as depression care specialists for the intervention patients (N=196). Depending on patient preference, they delivered a cognitive-behavioral therapy (CBT) intervention or facilitated antidepressant medication given by primary care providers or both. In enhanced usual care, patients (N=204) received a pamphlet about depression, a letter for their primary care provider stating that they had a positive depression screen, and a list of local mental health resources. Intent-to-treat analyses examined clinical and process-of-care outcomes at 16 weeks. Compared with patients in the enhanced usual care group, patients in the intervention group had significantly improved depression, quality of life, and satisfaction outcomes (p<.001 for all). Intervention patients also had significantly improved quality-of-care indicators, including the proportion of patients receiving either psychotherapy or antidepressant medication (77% versus 21%, p<.001). Collaborative care for depression can greatly improve care and outcomes in public-sector clinics. Social workers without prior mental health experience can effectively provide CBT and manage depression care.

Tobacco dependence counseling in a randomized multisite clinical trial.

PubMed

Croghan, Ivana T; Trautman, Judith A; Winhusen, Theresa; Ebbert, Jon O; Kropp, Frankie B; Schroeder, Darrell R; Hurt, Richard D

2012-07-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. Copyright © 2012 Elsevier Inc. All rights reserved.

Impact of an educational intervention and clinical performance dashboard on neonatal bloodstream infections.

PubMed

Raban, Moegammad Shukri; Bamford, Colleen; Joolay, Yaseen; Harrison, Michael C

2015-09-21

Blood cultures are the most direct method of detecting bacteraemia. Reducing contamination rates improves the specificity and positive predictive value of the blood culture. Clinical performance dashboards have been shown to be powerful tools in improving patient care and outcomes. To determine whether prospective surveillance of bloodstream infections (BSIs), introduction of an educational intervention and the use of a clinical performance dashboard could reduce BSIs and blood culture contamination rates in a neonatal nursery. We compared two time periods, before and after an intervention. Blood culture data were extracted from the local microbiology laboratory database. The educational intervention included the establishment of hand-washing protocols, blood culture techniques and video tools. A clinical performance dashboard was developed to demonstrate the monthly positive blood culture and contamination rates, and this was highlighted and referred to weekly at the unit staff meeting. Before the intervention, 1 460 blood cultures were taken; 206 (14.1%) were positive, of which 104 (7.1% of the total) were contaminants. In the period following the intervention, 1 282 blood cultures were taken; 131 (10.2%) were positive, of which 42 (3.3% of the total) were contaminants. The number of positive blood cultures and contamination rates after the intervention were both statistically significantly reduced (p=0.002 and p<0.001, respectively). This study demonstrates that adopting a relatively simple educational tool, making use of a clinical performance dashboard indicator and benchmarking practice can significantly reduce the level of neonatal sepsis while also reducing contaminated blood cultures.

Weight management by phone conference call: A comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial

PubMed Central

Lambourne, Kate; Washburn, Richard A.; Gibson, Cheryl; Sullivan, Debra K.; Goetz, Jeannine; Lee, Robert; Smith, Bryan K.; Mayo, Matthew S.; Donnelly, Joseph E.

2012-01-01

State-of-the-art treatment for weight management consists of a behavioral intervention to facilitate decreased energy intake and increased physical activity. These interventions are typically delivered face-to-face (FTF) by a health educator to a small group of participants. There are numerous barriers to participation in FTF clinics including availability, scheduling, the expense and time required to travel to the clinic site, and possible need for dependent care. Weight management clinics delivered by conference call have the potential to diminish or eliminate these barriers. The conference call approach may also reduce burden on providers, who could conduct clinic groups from almost any location without the expenses associated with maintaining FTF clinic space. A randomized trial will be conducted in 395 overweight/obese adults (BMI 25–39.9 kg/m2) to determine if weight loss (6 months) and weight maintenance (12 months) are equivalent between weight management interventions utilizing behavioral strategies and pre-packaged meals delivered by either a conference call or the traditional FTF approach. The primary outcome, body weight, will be assessed at baseline, 6, 12 and 18 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity and will be assessed on the same schedule. In addition, a cost analysis and extensive process evaluation will be completed. PMID:22664647

Weight management by phone conference call: a comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial.

PubMed

Lambourne, Kate; Washburn, Richard A; Gibson, Cheryl; Sullivan, Debra K; Goetz, Jeannine; Lee, Robert; Smith, Bryan K; Mayo, Matthew S; Donnelly, Joseph E

2012-09-01

State-of-the-art treatment for weight management consists of a behavioral intervention to facilitate decreased energy intake and increased physical activity. These interventions are typically delivered face-to-face (FTF) by a health educator to a small group of participants. There are numerous barriers to participation in FTF clinics including availability, scheduling, the expense and time required to travel to the clinic site, and possible need for dependent care. Weight management clinics delivered by conference call have the potential to diminish or eliminate these barriers. The conference call approach may also reduce burden on providers, who could conduct clinic groups from almost any location without the expenses associated with maintaining FTF clinic space. A randomized trial will be conducted in 395 overweight/obese adults (BMI 25-39.9 kg/m(2)) to determine if weight loss (6 months) and weight maintenance (12 months) are equivalent between weight management interventions utilizing behavioral strategies and pre-packaged meals delivered by either a conference call or the traditional FTF approach. The primary outcome, body weight, will be assessed at baseline, 6, 12 and 18 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity and will be assessed on the same schedule. In addition, a cost analysis and extensive process evaluation will be completed. Copyright © 2012 Elsevier Inc. All rights reserved.

Rubber stamp templates for improving clinical documentation: A paper-based, m-Health approach for quality improvement in low-resource settings.

PubMed

Kleczka, Bernadette; Musiega, Anita; Rabut, Grace; Wekesa, Phoebe; Mwaniki, Paul; Marx, Michael; Kumar, Pratap

2018-06-01

The United Nations' Sustainable Development Goal #3.8 targets 'access to quality essential healthcare services'. Clinical practice guidelines are an important tool for ensuring quality of clinical care, but many challenges prevent their use in low-resource settings. Monitoring the use of guidelines relies on cumbersome clinical audits of paper records, and electronic systems face financial and other limitations. Here we describe a unique approach to generating digital data from paper using guideline-based templates, rubber stamps and mobile phones. The Guidelines Adherence in Slums Project targeted ten private sector primary healthcare clinics serving informal settlements in Nairobi, Kenya. Each clinic was provided with rubber stamp templates to support documentation and management of commonly encountered outpatient conditions. Participatory design methods were used to customize templates to the workflows and infrastructure of each clinic. Rubber stamps were used to print templates into paper charts, providing clinicians with checklists for use during consultations. Templates used bubble format data entry, which could be digitized from images taken on mobile phones. Besides rubber stamp templates, the intervention included booklets of guideline compilations, one Android phone for digitizing images of templates, and one data feedback/continuing medical education session per clinic each month. In this paper we focus on the effect of the intervention on documentation of three non-communicable diseases in one clinic. Seventy charts of patients enrolled in the chronic disease program (hypertension/diabetes, n=867; chronic respiratory diseases, n=223) at one of the ten intervention clinics were sampled. Documentation of each individual patient encounter in the pre-intervention (January-March 2016) and post-intervention period (May-July) was scored for information in four dimensions - general data, patient assessment, testing, and management. Control criteria included information with no counterparts in templates (e.g. notes on presenting complaints, vital signs). Documentation scores for each patient were compared between both pre- and post-intervention periods and between encounters documented with and without templates (post-intervention only). The total number of patient encounters in the pre-intervention (282) and post-intervention periods (264) did not differ. Mean documentation scores increased significantly in the post-intervention period on average by 21%, 24% and 17% for hypertension, diabetes and chronic respiratory diseases, respectively. Differences were greater (47%, 43% and 27%, respectively) when documentation with and without templates was compared. Changes between pre- vs.post-intervention, and with vs.without template, varied between individual dimensions of documentation. Overall, documentation improved more for general data and patient assessment than in testing or management. The use of templates improves paper-based documentation of patient care, a first step towards improving the quality of care. Rubber stamps provide a simple and low-cost method to print templates on demand. In combination with ubiquitously available mobile phones, information entered on paper can be easily and rapidly digitized. This 'frugal innovation' in m-Health can empower small, private sector facilities, where large numbers of urban patients seek healthcare, to generate digital data on routine outpatient care. These data can form the basis for evidence-based quality improvement efforts at large scale, and help deliver on the SDG promise of quality essential healthcare services for all. Copyright © 2017 Elsevier B.V. All rights reserved.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

Effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: Results from the SHAIP cluster-randomized controlled trial in Kenya

PubMed Central

Turan, Janet M.; Onono, Maricianah; Steinfeld, Rachel L.; Shade, Starley B.; Owuor, Kevin; Washington, Sierra; Bukusi, Elizabeth A.; Ackers, Marta L.; Kioko, Jackson; Interis, Evelyn C.; Cohen, Craig R.

2015-01-01

Background Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14–13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62–3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81–5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions. PMID:25967269

Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): protocol for a cluster-randomised clinical trial of a complex intervention

PubMed Central

Richards-Belle, Alvin; Mouncey, Paul R; Wade, Dorothy; Brewin, Chris R; Emerson, Lydia M; Grieve, Richard; Harrison, David A; Harvey, Sheila; Howell, David; Mythen, Monty; Sadique, Zia; Smyth, Deborah; Weinman, John; Welch, John; Rowan, Kathryn M

2018-01-01

Introduction Acute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial. Methods and analysis This is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team. Ethics and dissemination This protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals. Trial registration number ISRCTN53448131; Pre-results. PMID:29439083

[Interventions to prevent the development of overweight and obesity in children younger than five years].

PubMed

Bonilla, Catherine; Híjar, Gisely; Márquez, Delia; Aramburú, Adolfo; Aparco, Juan Pablo; Gutiérrez, Ericson L

2017-01-01

Childhood obesity is one of the most severe public health problems worldwide. The present study describes the interventions used to prevent overweight and obesity in children younger than 5 years. The objective of the interventions was to stimulate breastfeeding, monitor the child's growth, and promote adequate complementary feeding by means of nutritional counseling using a responsive feeding approach in different settings, including health centers and residences. The interventions included physical activity and nutritional counseling, with the active participation of the parents. The quality of evidence from most studies was high because the evidence was derived from controlled clinical trials, systematic reviews, and meta-analyses. All interventions were conducted or could be replicated in Peru by adequate contextualization.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis

PubMed Central

Bukhsh, Allah; Khan, Tahir M.; Lee, Shaun W. H.; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [−0.86, 95% CI −0.983, −0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [−4.94; 95%CI −8.65, −1.23] and triglycerides levels [−0.26, 95%CI −0.51, −0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [−0.57; 95%CI −1.25, −0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes. PMID:29692730

Designing for Clinical Change: Creating an Intervention to Implement New Statin Guidelines in a Primary Care Clinic.

PubMed

DeJonckheere, Melissa; Robinson, Claire H; Evans, Lindsey; Lowery, Julie; Youles, Bradley; Tremblay, Adam; Kelley, Caitlin; Sussman, Jeremy B

2018-04-24

Recent clinical practice guidelines from major national organizations, including a joint United States Department of Veterans Affairs (VA) and Department of Defense (DoD) committee, have substantially changed recommendations for the use of the cholesterol-lowering statin medications after years of relative stability. Because statin medications are among the most commonly prescribed treatments in the United States, any change in their use may have significant implications for patients and providers alike. Prior research has shown that effective implementation interventions should be both user centered and specifically chosen to address identified barriers. The objectives of this study were to identify potential determinants of provider uptake of the new statin guidelines and to use that information to tailor a coordinated and streamlined local quality improvement intervention focused on prescribing appropriate statins. We employed user-centered design principles to guide the development and testing of a multicomponent guideline implementation intervention to improve statin prescribing. This paper describes the intervention development process whereby semistructured qualitative interviews with providers were conducted to (1) illuminate the knowledge, attitudes, and behaviors of providers and (2) elicit feedback on intervention prototypes developed to align with and support the use of the VA/DoD guidelines. Our aim was to use this information to design a local quality improvement intervention focused on statin prescribing that was tailored to the needs of primary care providers at our facility. Cabana's Clinical Practice Guidelines Framework for Improvement and Nielsen's Usability Heuristics were used to guide the analysis of data obtained in the intervention development process. Semistructured qualitative interviews were conducted with 15 primary care Patient Aligned Care Team professionals (13 physicians and 2 clinical pharmacists) at a single VA medical center. Findings highlight that providers were generally comfortable with the paradigm shift to risk-based guidelines but less clear on the need for the VA/DoD guidelines in specific. Providers preferred a clinical decision support tool that helped them calculate patient risk and guide their care without limiting autonomy. They were less comfortable with risk communication and performance measurement systems that do not account for shared decision making. When possible, we incorporated their recommendations into the intervention. By combining qualitative methods and user-centered design principles, we could inform the design of a multicomponent guideline implementation intervention to better address the needs and preferences of providers, including clear and direct language, logical decision prompts with an option to dismiss a clinical decision support tool, and logical ordering of feedback information. Additionally, this process allowed us to identify future design considerations for quality improvement interventions. ©Melissa DeJonckheere, Claire H Robinson, Lindsey Evans, Julie Lowery, Bradley Youles, Adam Tremblay, Caitlin Kelley, Jeremy B Sussman. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 24.04.2018.

Evaluation of a Smartphone Decision-Support Tool for Diarrheal Disease Management in a Resource-Limited Setting

PubMed Central

Khatun, Selina; Ahmed, Mujaddeed; Kache, Saraswati; Chisti, Mohammod Jobayer; Sarker, Shafiqul Alam; Maples, Stace D.; Pieri, Dane; Vardhan Korrapati, Teja; Sarnquist, Clea; Federspiel, Nancy; Rahman, Muhammad Waliur; Andrews, Jason R.; Rahman, Mahmudur; Nelson, Eric Jorge

2017-01-01

The emergence of mobile technology offers new opportunities to improve clinical guideline adherence in resource-limited settings. We conducted a clinical pilot study in rural Bangladesh to evaluate the impact of a smartphone adaptation of the World Health Organization (WHO) diarrheal disease management guidelines, including a modality for age-based weight estimation. Software development was guided by end-user input and evaluated in a resource-limited district and sub-district hospital during the fall 2015 cholera season; both hospitals lacked scales which necessitated weight estimation. The study consisted of a 6 week pre-intervention and 6 week intervention period with a 10-day post-discharge follow-up. Standard of care was maintained throughout the study with the exception that admitting clinicians used the tool during the intervention. Inclusion criteria were patients two months of age and older with uncomplicated diarrheal disease. The primary outcome was adherence to guidelines for prescriptions of intravenous (IV) fluids, antibiotics and zinc. A total of 841 patients were enrolled (325 pre-intervention; 516 intervention). During the intervention, the proportion of prescriptions for IV fluids decreased at the district and sub-district hospitals (both p < 0.001) with risk ratios (RRs) of 0.5 and 0.2, respectively. However, when IV fluids were prescribed, the volume better adhered to recommendations. The proportion of prescriptions for the recommended antibiotic azithromycin increased (p < 0.001 district; p = 0.035 sub-district) with RRs of 6.9 (district) and 1.6 (sub-district) while prescriptions for other antibiotics decreased; zinc adherence increased. Limitations included an absence of a concurrent control group and no independent dehydration assessment during the pre-intervention. Despite limitations, opportunities were identified to improve clinical care, including better assessment, weight estimation, and fluid/ antibiotic selection. These findings demonstrate that a smartphone-based tool can improve guideline adherence. This study should serve as a catalyst for a randomized controlled trial to expand on the findings and address limitations. PMID:28103233

The effect of systematic clinical interventions with cigarette smokers on quit status and the rates of smoking-related primary care office visits.

PubMed

Land, Thomas G; Rigotti, Nancy A; Levy, Douglas E; Schilling, Thad; Warner, Donna; Li, Wenjun

2012-01-01

The United States Public Health Service (USPHS) Guideline for Treating Tobacco Use and Dependence includes ten key recommendations regarding the identification and the treatment of tobacco users seen in all health care settings. To our knowledge, the impact of system-wide brief interventions with cigarette smokers on smoking prevalence and health care utilization has not been examined using patient population-based data. Data on clinical interventions with cigarette smokers were examined for primary care office visits of 104,639 patients at 17 Harvard Vanguard Medical Associates (HVMA) sites. An operational definition of "systems change" was developed. It included thresholds for intervention frequency and sustainability. Twelve sites met the criteria. Five did not. Decreases in self-reported smoking prevalence were 40% greater at sites that achieved systems change (13.6% vs. 9.7%, p<.01). On average, the likelihood of quitting increased by 2.6% (p<0.05, 95% CI: 0.1%-4.6%) per occurrence of brief intervention. For patients with a recent history of current smoking whose home site experienced systems change, the likelihood of an office visit for smoking-related diagnoses decreased by 4.3% on an annualized basis after systems change occurred (p<0.05, 95% CI: 0.5%-8.1%). There was no change in the likelihood of an office visit for smoking-related diagnoses following systems change among non-smokers. The clinical practice data from HVMA suggest that a systems approach can lead to significant reductions in smoking prevalence and the rate of office visits for smoking-related diseases. Most comprehensive tobacco intervention strategies focus on the provider or the tobacco user, but these results argue that health systems should be included as an integral component of a comprehensive tobacco intervention strategy. The HVMA results also give us an indication of the potential health impacts when meaningful use core tobacco measures are widely adopted.

The Effect of Systematic Clinical Interventions with Cigarette Smokers on Quit Status and the Rates of Smoking-Related Primary Care Office Visits

PubMed Central

Land, Thomas G.; Rigotti, Nancy A.; Levy, Douglas E.; Schilling, Thad; Warner, Donna; Li, Wenjun

2012-01-01

Background The United States Public Health Service (USPHS) Guideline for Treating Tobacco Use and Dependence includes ten key recommendations regarding the identification and the treatment of tobacco users seen in all health care settings. To our knowledge, the impact of system-wide brief interventions with cigarette smokers on smoking prevalence and health care utilization has not been examined using patient population-based data. Methods and Findings Data on clinical interventions with cigarette smokers were examined for primary care office visits of 104,639 patients at 17 Harvard Vanguard Medical Associates (HVMA) sites. An operational definition of “systems change” was developed. It included thresholds for intervention frequency and sustainability. Twelve sites met the criteria. Five did not. Decreases in self-reported smoking prevalence were 40% greater at sites that achieved systems change (13.6% vs. 9.7%, p<.01). On average, the likelihood of quitting increased by 2.6% (p<0.05, 95% CI: 0.1%–4.6%) per occurrence of brief intervention. For patients with a recent history of current smoking whose home site experienced systems change, the likelihood of an office visit for smoking-related diagnoses decreased by 4.3% on an annualized basis after systems change occurred (p<0.05, 95% CI: 0.5%–8.1%). There was no change in the likelihood of an office visit for smoking-related diagnoses following systems change among non-smokers. Conclusions The clinical practice data from HVMA suggest that a systems approach can lead to significant reductions in smoking prevalence and the rate of office visits for smoking-related diseases. Most comprehensive tobacco intervention strategies focus on the provider or the tobacco user, but these results argue that health systems should be included as an integral component of a comprehensive tobacco intervention strategy. The HVMA results also give us an indication of the potential health impacts when meaningful use core tobacco measures are widely adopted. PMID:22911834

Evaluation of a Smartphone Decision-Support Tool for Diarrheal Disease Management in a Resource-Limited Setting.

PubMed

Haque, Farhana; Ball, Robyn L; Khatun, Selina; Ahmed, Mujaddeed; Kache, Saraswati; Chisti, Mohammod Jobayer; Sarker, Shafiqul Alam; Maples, Stace D; Pieri, Dane; Vardhan Korrapati, Teja; Sarnquist, Clea; Federspiel, Nancy; Rahman, Muhammad Waliur; Andrews, Jason R; Rahman, Mahmudur; Nelson, Eric Jorge

2017-01-01

The emergence of mobile technology offers new opportunities to improve clinical guideline adherence in resource-limited settings. We conducted a clinical pilot study in rural Bangladesh to evaluate the impact of a smartphone adaptation of the World Health Organization (WHO) diarrheal disease management guidelines, including a modality for age-based weight estimation. Software development was guided by end-user input and evaluated in a resource-limited district and sub-district hospital during the fall 2015 cholera season; both hospitals lacked scales which necessitated weight estimation. The study consisted of a 6 week pre-intervention and 6 week intervention period with a 10-day post-discharge follow-up. Standard of care was maintained throughout the study with the exception that admitting clinicians used the tool during the intervention. Inclusion criteria were patients two months of age and older with uncomplicated diarrheal disease. The primary outcome was adherence to guidelines for prescriptions of intravenous (IV) fluids, antibiotics and zinc. A total of 841 patients were enrolled (325 pre-intervention; 516 intervention). During the intervention, the proportion of prescriptions for IV fluids decreased at the district and sub-district hospitals (both p < 0.001) with risk ratios (RRs) of 0.5 and 0.2, respectively. However, when IV fluids were prescribed, the volume better adhered to recommendations. The proportion of prescriptions for the recommended antibiotic azithromycin increased (p < 0.001 district; p = 0.035 sub-district) with RRs of 6.9 (district) and 1.6 (sub-district) while prescriptions for other antibiotics decreased; zinc adherence increased. Limitations included an absence of a concurrent control group and no independent dehydration assessment during the pre-intervention. Despite limitations, opportunities were identified to improve clinical care, including better assessment, weight estimation, and fluid/ antibiotic selection. These findings demonstrate that a smartphone-based tool can improve guideline adherence. This study should serve as a catalyst for a randomized controlled trial to expand on the findings and address limitations.

Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews.

PubMed

Ryan, Rebecca; Santesso, Nancy; Lowe, Dianne; Hill, Sophie; Grimshaw, Jeremy; Prictor, Megan; Kaufman, Caroline; Cowie, Genevieve; Taylor, Michael

2014-04-29

Many systematic reviews exist on interventions to improve safe and effective medicines use by consumers, but research is distributed across diseases, populations and settings. The scope and focus of such reviews also vary widely, creating challenges for decision-makers seeking to inform decisions by using the evidence on consumers' medicines use.This is an update of a 2011 overview of systematic reviews, which synthesises the evidence, irrespective of disease, medicine type, population or setting, on the effectiveness of interventions to improve consumers' medicines use. To assess the effects of interventions which target healthcare consumers to promote safe and effective medicines use, by synthesising review-level evidence. We included systematic reviews published on the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. We identified relevant reviews by handsearching databases from their start dates to March 2012. We screened and ranked reviews based on relevance to consumers' medicines use, using criteria developed for this overview. We used standardised forms to extract data, and assessed reviews for methodological quality using the AMSTAR tool. We used standardised language to summarise results within and across reviews; and gave bottom-line statements about intervention effectiveness. Two review authors screened and selected reviews, and extracted and analysed data. We used a taxonomy of interventions to categorise reviews and guide syntheses. We included 75 systematic reviews of varied methodological quality. Reviews assessed interventions with diverse aims including support for behaviour change, risk minimisation and skills acquisition. No reviews aimed to promote systems-level consumer participation in medicines-related activities. Medicines adherence was the most frequently-reported outcome, but others such as knowledge, clinical and service-use outcomes were also reported. Adverse events were less commonly identified, while those associated with the interventions themselves, or costs, were rarely reported.Looking across reviews, for most outcomes, medicines self-monitoring and self-management programmes appear generally effective to improve medicines use, adherence, adverse events and clinical outcomes; and to reduce mortality in people self-managing antithrombotic therapy. However, some participants were unable to complete these interventions, suggesting they may not be suitable for everyone.Other promising interventions to improve adherence and other key medicines-use outcomes, which require further investigation to be more certain of their effects, include:· simplified dosing regimens: with positive effects on adherence;· interventions involving pharmacists in medicines management, such as medicines reviews (with positive effects on adherence and use, medicines problems and clinical outcomes) and pharmaceutical care services (consultation between pharmacist and patient to resolve medicines problems, develop a care plan and provide follow-up; with positive effects on adherence and knowledge).Several other strategies showed some positive effects, particularly relating to adherence, and other outcomes, but their effects were less consistent overall and so need further study. These included:· delayed antibiotic prescriptions: effective to decrease antibiotic use but with mixed effects on clinical outcomes, adverse effects and satisfaction;· practical strategies like reminders, cues and/or organisers, reminder packaging and material incentives: with positive, although somewhat mixed effects on adherence;· education delivered with self-management skills training, counselling, support, training or enhanced follow-up; information and counselling delivered together; or education/information as part of pharmacist-delivered packages of care: with positive effects on adherence, medicines use, clinical outcomes and knowledge, but with mixed effects in some studies;· financial incentives: with positive, but mixed, effects on adherence.Several strategies also showed promise in promoting immunisation uptake, but require further study to be more certain of their effects. These included organisational interventions; reminders and recall; financial incentives; home visits; free vaccination; lay health worker interventions; and facilitators working with physicians to promote immunisation uptake. Education and/or information strategies also showed some positive but even less consistent effects on immunisation uptake, and need further assessment of effectiveness and investigation of heterogeneity.There are many different potential pathways through which consumers' use of medicines could be targeted to improve outcomes, and simple interventions may be as effective as complex strategies. However, no single intervention assessed was effective to improve all medicines-use outcomes across all diseases, medicines, populations or settings.Even where interventions showed promise, the assembled evidence often only provided part of the picture: for example, simplified dosing regimens seem effective for improving adherence, but there is not yet sufficient information to identify an optimal regimen.In some instances interventions appear ineffective: for example, the evidence suggests that directly observed therapy may be generally ineffective for improving treatment completion, adherence or clinical outcomes.In other cases, interventions may have variable effects across outcomes. As an example, strategies providing information or education as single interventions appear ineffective to improve medicines adherence or clinical outcomes, but may be effective to improve knowledge; an important outcome for promoting consumers' informed medicines choices.Despite a doubling in the number of reviews included in this updated overview, uncertainty still exists about the effectiveness of many interventions, and the evidence on what works remains sparse for several populations, including children and young people, carers, and people with multimorbidity. This overview presents evidence from 75 reviews that have synthesised trials and other studies evaluating the effects of interventions to improve consumers' medicines use.Systematically assembling the evidence across reviews allows identification of effective or promising interventions to improve consumers' medicines use, as well as those for which the evidence indicates ineffectiveness or uncertainty.Decision makers faced with implementing interventions to improve consumers' medicines use can use this overview to inform decisions about which interventions may be most promising to improve particular outcomes. The intervention taxonomy may also assist people to consider the strategies available in relation to specific purposes, for example, gaining skills or being involved in decision making. Researchers and funders can use this overview to identify where more research is needed and assess its priority. The limitations of the available literature due to the lack of evidence for important outcomes and important populations, such as people with multimorbidity, should also be considered in practice and policy decisions.

Early clinical outcomes of primary percutaneous coronary intervention in bharatpur, Nepal.

PubMed

Dubey, Laxman; Bhattacharya, Rabindra; Guruprasad, Sogunuu; Subramanyam, Gangapatnam

2013-06-01

Primary percutaneous coronary intervention represents one of the cornerstone management modalities for patients with acute ST-elevation myocardial infarction and has undergone tremendous growth over the past two decades. This study was aimed to determine the early clinical outcomes of primary percutaneous coronary interventions in a tertiary-level teaching hospital without onsite cardiac surgery backup. This was a prospective descriptive study which included all consecutive patients who were admitted for primary percutaneous coronary interventions between March 2011 and January 2013 at the College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal. Total 68 patients underwent primary percutaneous coronary interventions as a mode of revascularization. The primary end point of the study was to identify in-hospital as well as 30-day clinical outcomes of primary percutaneous coronary interventions. The mean age was 56.31 ± 11.47 years, with age range of 32 years to 91 years. Of the 68 primary percutaneous coronary interventions performed, 15 (22.05%) were carried out in women and 10 (14.70%) in patients over 75 years of age. Primary percutaneous coronary intervention for anterior wall myocardial infarction was more common than for non-anterior wall myocardial infarction (55.88% vs. 44.12%). Proximal artery stenting was performed in 38.50% and the non proximal artery stenting in 61.50%. The outcomes were mortality (5.88%), cardiogenic shock (5.88%), contrast-induced nephropathy requiring dialysis (2.94%), arrhythmias requiring treatment (4.41%), early stent thrombosis (2.94%) and minor complications (14.70%). Primary percutaneous coronary intervention improves the early clinical outcomes in patient with acute ST-elevation myocardial infarction. Despite having no onsite cardiac surgery backup, primary percutaneous coronary intervention was feasible with acceptable complications in a tertiary-care teaching hospital.

Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy

PubMed Central

Wu, Yuan; Yao, Xun; Vespasiani, Giacomo; Nicolucci, Antonio; Dong, Yajie; Kwong, Joey; Li, Ling; Sun, Xin

2017-01-01

Background Mobile health apps for diabetes self-management have different functions. However, the efficacy and safety of each function are not well studied, and no classification is available for these functions. Objective The aims of this study were to (1) develop and validate a taxonomy of apps for diabetes self-management, (2) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of randomized controlled trials (RCTs), and (3) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy. Methods We developed a 3-axis taxonomy with columns of clinical modules, rows of functional modules and cells of functions with risk assessments. This taxonomy was validated by reviewing and classifying commercially available diabetes apps. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Chinese Biomedical Literature Database, and ClinicalTrials.gov from January 2007 to May 2016. We included RCTs of adult outpatients with diabetes that compared using mobile app-based interventions with usual care alone. The mean differences (MDs) in hemoglobin A1c (HbA1c) concentrations and risk ratios of adverse events were pooled using a random-effects meta-analysis. After taxonomic classification, we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions. Results Across 12 included trials involving 974 participants, using app-based interventions was associated with a clinically significant reduction of HbA1c (MD 0.48%, 95% CI 0.19%-0.78%) without excess adverse events. Larger HbA1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes (MD 0.67%, 95% CI 0.30%-1.03% vs MD 0.37%, 95% CI –0.12%-0.86%). Having a complication prevention module in app-based interventions was associated with a greater HbA1c reduction (with complication prevention: MD 1.31%, 95% CI 0.66%-1.96% vs without: MD 0.38%, 95% CI 0.09%-0.67%; intersubgroup P=.01), as was having a structured display (with structured display: MD 0.69%, 95% CI 0.32%-1.06% vs without: MD 0.69%, 95% CI –0.18%-0.53%; intersubgroup P=.03). However, having a clinical decision-making function was not associated with a larger HbA1c reduction (with clinical decision making: MD 0.19%, 95% CI –0.24%-0.63% vs without: MD 0.61%, 95% CI 0.27%-0.95%; intersubgroup P=.14). Conclusions The use of mobile app-based interventions yields a clinically significant HbA1c reduction among adult outpatients with diabetes, especially among those with type 2 diabetes. Our study suggests that the clinical decision-making function needs further improvement and evaluation before being added to apps. PMID:28292740

Closing the quality gap: revisiting the state of the science (vol. 4: medication adherence interventions: comparative effectiveness).

PubMed

Viswanathan, Meera; Golin, Carol E; Jones, Christine D; Ashok, Mahima; Blalock, Susan; Wines, Roberta C M; Coker-Schwimmer, Emmanuel J L; Grodensky, Catherine A; Rosen, David L; Yuen, Andrea; Sista, Priyanka; Lohr, Kathleen N

2012-09-01

To assess the effectiveness of patient, provider, and systems interventions (Key Question [KQ] 1) or policy interventions (KQ 2) in improving medication adherence for an array of chronic health conditions. For interventions that are effective in improving adherence, we then assessed their effectiveness in improving health, health care utilization, and adverse events. MEDLINE®, the Cochrane Library. Additional studies were identified from reference lists and technical experts. Two people independently selected, extracted data from, and rated the risk of bias of relevant trials and systematic reviews. We synthesized the evidence for effectiveness separately for each clinical condition, and within each condition, by type of intervention. We also evaluated the prevalence of intervention components across clinical conditions and the effectiveness of interventions for a range of vulnerable populations. Two reviewers graded the strength of evidence using established criteria. We found a total of 62 eligible studies (58 trials and 4 observational studies) from our review of 3,979 abstracts. These studies included patients with diabetes, hyperlipidemia, hypertension, heart failure, myocardial infarction, asthma, depression, glaucoma, multiple sclerosis, musculoskeletal diseases, and multiple chronic conditions. Fifty-seven trials of patient, provider, or systems interventions (KQ 1) evaluated 20 different types of interventions; 4 observational studies and one trial of policy interventions (KQ 2) evaluated the effect of reduced out-of-pocket expenses or improved prescription drug coverage. We found the most consistent evidence of improvement in medication adherence for interventions to reduce out-of-pocket expenses or improve prescription drug coverage, case management, and educational interventions across clinical conditions. Within clinical conditions, we found the strongest support for self-management of medications for short-term improvement in adherence for asthma patients; collaborative care or case management programs for short-term improvement of adherence and to improve symptoms for patients taking depression medications; and pharmacist-led approaches for hypertensive patients to improve systolic blood pressure. Diverse interventions offer promising approaches to improving medication adherence for chronic conditions, particularly for the short term. Evidence on whether these approaches have broad applicability for clinical conditions and populations is limited, as is evidence regarding long-term medication adherence or health outcomes.

Diabetes and cardiovascular disease interventions by community pharmacists: a systematic review.

PubMed

Evans, Charity D; Watson, Erin; Eurich, Dean T; Taylor, Jeff G; Yakiwchuk, Erin M; Shevchuk, Yvonne M; Remillard, Alfred; Blackburn, David

2011-05-01

To systematically review and assess the quality of studies evaluating community pharmacist interventions for preventing or managing diabetes or cardiovascular disease (CVD) and/or their major risk factors. A comprehensive literature search was performed using MEDLINE (1950-February 2011), EMBASE (1980-February 2011), International Pharmaceutical Abstracts (1970-February 2011), Cumulative Index to Nursing and Allied Health Literature (1982-June 2007), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included: community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases. Articles published in English or French with all study designs were considered for the review. Studies were included if they contained interventions designed to reduce the incidence, risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, or hemoglobin A(1c)); and/or improve adherence to treatment strategies. Only studies involving interventions carried out primarily by pharmacists in community pharmacy settings were included. Study quality was assessed using a checklist validated for both randomized and nonrandomized studies. A total of 4142 studies were initially identified, with 40 meeting our inclusion criteria. Eleven studies were randomized controlled trials, 4 were cluster randomized trials, and 2 studies had randomized before-after designs. The remaining studies were controlled before-after (n = 2), cohort (n = 4), and uncontrolled before-after (n = 17) designs. Interventions focused on diabetes (n = 12), hypertension (n = 9), medication adherence (n = 9), lipids (n = 5), evidence-based medication initiation or optimization (n = 3), risk factor prediction scores (n = 1), and body mass index (n = 1). All studies contained interventions focused at the patient level and the majority of studies (34/40) involved interventions directed at both the physician and patient. No specific intervention emerged as superior, and study quality was generally poor, making it difficult to determine the true effect of the interventions. Poor study quality, time-intensive interventions, and unproven clinical significance warrant the need for further high-quality studies of community pharmacist interventions for preventing or managing diabetes or CVD and/or their major risk factors.

[Adaptation of critical time intervention for use in Brazil and its implementation among users of psychosocial service centers (CAPS) in the municipality of Rio de Janeiro].

PubMed

Cavalcanti, Maria Tavares; Carvalho, Maria Cecília de Araújo; Valência, Elie; Dahl, Catarina Magalhães; Souza, Flávia Mitkiewicz de

2011-12-01

Brazilian Psychiatric Reform proposes a mental healthcare model based on the implementation of a community-based service network, in which Psychosocial Service Centers (CAPS) play a fundamental role. The report presents the results of a pilot study which aimed to adapt Critical Time Intervention to the Brazilian context, and to test its feasibility to provide it to persons with schizophrenic spectrum disorders who are enrolled in CAPS of Rio de Janeiro. The research design included three inter-related phases. Phase one consisted in carrying out qualitative and quantitative field work. This phase included mapping out the socio-demographic, clinical and service utilization data of CAPS users, as well as assessing the mental health needs of participants in the study. The second phase consisted in translation of the CTI clinical manual to include the adaptations made for use in Brazil, which were based on data collected in the first phase, as well as training individuals with moderate education as CTI intervention workers. The third phase consisted of pilot implementation of the adapted intervention among a group of individuals with schizophrenia spectrum disorders enrolled in CAPS, but with difficulties in being included in treatment.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

PubMed

Martin-Lujan, Francisco; Piñol-Moreso, Josep L I; Martin-Vergara, Nuria; Basora-Gallisa, Josep; Pascual-Palacios, Irene; Sagarra-Alamo, Ramon; Llopis, Estefania Aparicio; Basora-Gallisa, Maria T; Pedret-Llaberia, Roser

2011-11-11

There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Multicentre randomized clinical trial with an intervention and a control group. 12 primary care centres in the province of Tarragona (Spain). 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Smoking cessation at 12 months. Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. ClinicalTrial.gov, number NCT01194596.

CDC Kerala 15: Developmental Evaluation Clinic (2-10 y)--developmental diagnosis and use of home intervention package.

PubMed

Nair, M K C; Lakshmi, M A; Latha, S; Lakshmi, Geetha; Harikumaran Nair, G S; Bhaskaran, Deepa; George, Babu; Leena, M L; Russell, Paul Swamidhas Sudhakar

2014-12-01

To describe the last 5 years' experience of Child Development Centre (CDC), Kerala Developmental Evaluation Clinic II for children between 2 and 10 y, referred for suspicion of developmental lag in the preschool years and scholastic difficulty in the primary classes with specific focus on developmental profile and the experience of the home based intervention package taught to the mothers. A team of evaluators including developmental therapist, preschool teacher with special training in clinical child development, speech therapist, special educator, clinical psychologist and developmental pediatrician assessed all the children referred to CDC Kerala. Denver Developmental Screening Test (DDST-II), Vineland Social Maturity Scale (VSMS) and Intelligent Quotient (IQ) tests were administered to all children below 6 y and those above 6 with apparent developmental delay. Speech/delay (35.9%), behavior problem (15.4%), global delay/ intellectual disability (15.4%), learning problem (10.9%), pervasive developmental disorders (7.7%), seizure disorder (1.7%), hearing impairment (0.7%), and visual impairment (0.7%) were the clinical diagnosis by a developmental pediatrician. Each child with developmental problem was offered a home based intervention package consisting of developmental therapy and special education items, appropriate to the clinical diagnosis of the individual child and the same was taught to the mother. The experience of conducting the developmental evaluation clinic for children between 2 and 10 y has shown that a team consisting of developmental therapist, speech therapist, preschool teacher, special educator, clinical child psychologist and developmental pediatrician, using appropriate test results of the child could make a clinical diagnosis good enough for providing early intervention therapy using a home based intervention package.

Deviant adolescent subcultures: assessment strategies and clinical interventions.

PubMed

Clark, C M

1992-01-01

Alienation is a contributing factor in adolescents' participation in Satanism, the neo-Nazi skinhead movement, and violent street gangs. Many of their needs are met by gang and/or cult affiliation, including a sense of belonging, self-worth, companionship, and excitement. Emphasizing prevention may minimize deviant subculture involvement, but some adolescents require clinical intervention, ranging from a few outpatient sessions to lengthy inpatient hospitalization. Therapists must be knowledgeable about adolescents' involvement, empathic to their circumstances, and sophisticated in the approach to treatment.

California's digital divide: clinical information systems for the haves and have-nots.

PubMed

Miller, Robert H; D'Amato, Katherine; Oliva, Nancy; West, Christopher E; Adelson, Joel W

2009-01-01

Strong barriers prevent the financing of clinical information systems (CIS) in health care delivery system organizations in market segments serving disadvantaged patients. These segments include community health centers, public hospitals, unaffiliated rural hospitals, and some Medicaid-oriented solo and small-group medical practices. Policy interventions such as loans, grants, pay-for-performance and other reimbursement changes, and support services assistance will help lower these barriers. Without intervention, progress will be slow and worsen health care disparities between the advantaged and disadvantaged populations.

Local Implementation of Alcohol Screening and Brief Intervention at Five Veterans Health Administration Primary Care Clinics: Perspectives of Clinical and Administrative Staff.

PubMed

Williams, Emily C; Achtmeyer, Carol E; Young, Jessica P; Rittmueller, Stacey E; Ludman, Evette J; Lapham, Gwen T; Lee, Amy K; Chavez, Laura J; Berger, Douglas; Bradley, Katharine A

2016-01-01

Population-based alcohol screening, followed by brief intervention for patients who screen positive for unhealthy alcohol use, is widely recommended for primary care settings and considered a top prevention priority, but is challenging to implement. However, new policy initiatives in the U.S., including the Affordable Care Act, may help launch widespread implementation. While the nationwide Veterans Health Administration (VA) has achieved high rates of documented alcohol screening and brief intervention, research has identified quality problems with both. We conducted a qualitative key informant study to describe local implementation of alcohol screening and brief intervention from the perspectives of frontline adopters in VA primary care in order to understand the process of implementation and factors underlying quality problems. A purposive snowball sampling method was used to identify and recruit key informants from 5 VA primary care clinics in the northwestern U.S. Key informants completed 20-30 minute semi-structured interviews, which were recorded, transcribed, and qualitatively analyzed using template analysis. Key informants (N=32) included: clinical staff (n=14), providers (n=14), and administrative informants (n=4) with varying participation in implementation of and responsibility for alcohol screening and brief intervention at the medical center. Ten inter-related themes (5 a priori and 5 emergent) were identified and grouped into 3 applicable domains of Greenhalgh's conceptual framework for dissemination of innovations, including values of adopters (theme 1), processes of implementation (themes 2 and 3), and post-implementation consequences in care processes (themes 4-10). While key informants believed alcohol use was relevant to health and important to address, the process of implementation (in which no training was provided and electronic clinical reminders "just showed up") did not address critical training and infrastructure needs. Key informants lacked understanding of the goals of screening and brief intervention, believed referral to specialty addictions treatment (as opposed to offering brief intervention) was the only option for following up on a positive screen, reported concern regarding limited availability of treatment resources, and lacked optimism regarding patients' interest in seeking help. Findings suggest that the local process of implementing alcohol screening and brief intervention may have inadequately addressed important adopter needs and thus may have ultimately undermined, instead of capitalized on, staff and providers' belief in the importance of addressing alcohol use as part of primary care. Additional implementation strategies, such as training or academic detailing, may address some unmet needs and help improve the quality of both screening and brief intervention. However, these strategies may be resource-intensive and insufficient for comprehensively addressing implementation barriers. Published by Elsevier Inc.

Challenges in defining 'palliative care' for the purposes of clinical trials.

PubMed

Bausewein, Claudia; Higginson, Irene J

2012-12-01

Palliative care has become part of mainstream medicine with increasing evidence about the effectiveness of specialist palliative care (SPC) on patient and family outcomes. Comparison of studies testing SPC interventions is challenging as types of interventions and reporting of components of the intervention vary. In consequence, study results are difficult to interpret. There is a continuous lack of clarity in palliative care definitions. For clinical trials, multidisciplinary care, supportive care documentation, symptom assessment and symptom management are suggested as key domains. In recent studies testing palliative care as an intervention SPC physicians and palliative care nurses were core members of multiprofessional teams, but integration of other team members varied. Management of symptoms and psychosocial issues were central to SPC with various other areas described. Services were delivered by hospital and community support teams, in palliative care units, outpatient clinics and hospital. Cost information was only provided by a few studies. Due to the lack of an agreed definition of palliative care and heterogeneity in reporting of components of an SPC intervention comparison of studies remains challenging. Key aspects of palliative care interventions are incurable disease, multidisciplinary approach, focus on symptom management including standardized assessment, psychosocial and family support, and (advance) care planning. Detailed information about all aspects of the intervention should be provided.

The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study.

PubMed

Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus; Rasmussen, Maria Birkvad; Mogensen, Simon Skibsted; Jensen, Michael Kammer; Frost, Torben; Ringsted, Charlotte

2009-02-01

The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome and retention of learning. This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS-competence assessed using a validated composite test including assessment of skills and knowledge. The intervention was half a year of clinical work before an ALS course. The intervention group received the course after a half-year of clinical experience. The control group participated in an ALS course immediately following graduation. Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the immediate learning outcome. The intervention group had significantly higher retention of learning compared to the control group, intervention group mean 82% (CI 80-83), control group mean 78% (CI 76-80), P=0.002. The magnitude of this difference was medium (effect size=0.57). Half a year of clinical experience, before participation in an ALS course had a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome.

Excess of non-verbal cases of autism spectrum disorders presenting to orthodox clinical practice in Africa – a trend possibly resulting from late diagnosis and intervention

PubMed Central

Bakare, Muideen O; Munir, Kerim M

2012-01-01

Objectives Characteristics of children with autism spectrum disorders (ASDs) in Africa are not known because of unavailability of large-scale epidemiological studies in this region. This review explored the age at first presentation to orthodox clinical practice of African children with ASDs and their expressive language ability at presentation. Methods A literature search of case series and case reports of ASDs from Africa was done through PubMed/MEDLINE, Google Scholar, African Journals Online (AJOL), and archives of the Nigerian Journal of Psychiatry. Six articles included content relating to age of the child at first presentation to orthodox clinical practice and symptoms at presentation related to expressive language ability and therefore fulfilled the inclusion criteria. Suggestions are made to explain the observations emanating from the review. Results An excess of non-verbal over verbal cases of ASDs have been presenting to orthodox clinical practice and there is a common denominator of late presentation/diagnosis and in turn late intervention, with most cases presenting for the first time well above 8 years of age. Attempts to explain these observations included low levels of knowledge and awareness about ASDs in Africa; problems with help-seeking behaviour; and lack of mental healthcare facilities and trained personnel. Conclusions Enhancement of processes directed at ensuring early diagnosis and interventions, especially interventions aimed at improving speech and language development well and sufficiently early, may bring about a shift in the trend of excess non-verbal cases of ASDs over verbal cases presenting to orthodox clinical practice. PMID:22229024

Differing approaches to falls and fracture prevention between Australia and Colombia

PubMed Central

Gomez, Fernando; Curcio, Carmen Lucia; Suriyaarachchi, Pushpa; Demontiero, Oddom; Duque, Gustavo

2013-01-01

Falls and fractures are major causes of morbidity and mortality in older people. More importantly, previous falls and/or fractures are the most important predictors of further events. Therefore, secondary prevention programs for falls and fractures are highly needed. However, the question is whether a secondary prevention model should focus on falls prevention alone or should be implemented in combination with fracture prevention. By comparing a falls prevention clinic in Manizales (Colombia) versus a falls and fracture prevention clinic in Sydney (Australia), the objective was to identify similarities and differences between these two programs and to propose an integrated model of care for secondary prevention of fall and fractures. A comparative study of services was performed using an internationally agreed taxonomy. Service provision was compared against benchmarks set by the National Institute for Health and Clinical Excellence (NICE) and previous reports in the literature. Comparison included organization, administration, client characteristics, and interventions. Several similarities and a number of differences that could be easily unified into a single model are reported here. Similarities included population, a multidisciplinary team, and a multifactorial assessment and intervention. Differences were eligibility criteria, a bone health assessment component, and the therapeutic interventions most commonly used at each site. In Australia, bone health assessment is reinforced whereas in Colombia dizziness assessment and management is pivotal. The authors propose that falls clinic services should be operationally linked to osteoporosis services such as a “falls and fracture prevention clinic,” which would facilitate a comprehensive intervention to prevent falls and fractures in older persons. PMID:23378748

WIC providers' perspectives on offering smoking cessation interventions.

PubMed

Aquilino, Mary Lober; Goody, Cynthia M; Lowe, John B

2003-01-01

To examine the perspectives of WIC clinic providers on offering smoking cessation interventions for pregnant women. Four focus groups consisting of WIC nurses, dietitians, and social workers (N = 25) were conducted at WIC clinics in eastern Iowa. Researchers developed discussion guidelines to determine how WIC providers currently approached pregnant women who smoke cigarettes and what they considered barriers to providing effective smoking cessation interventions. Code mapping was used to analyze focus group discussions. Factors influencing the ability of WIC staff to provide a smoking cessation intervention for pregnant women included available time, clinic priorities, staff approaches to clients, and staff training. In addition, providers expressed concerns about educational materials for clients as well as additional client issues that prevented smoking cessation. The absence of mechanisms to track clinic outcomes related to smoking cessation was also noted. WIC providers have time limitations that may necessitate minimal or low-intensity interventions for smoking cessation, but did not know that such approaches are actually effective. WIC providers require more education about the entire issue of smoking cessation in order to become more proactive in their attempts to help pregnant women quit. Training that enhances self-efficacy and understanding of the impact of smoking on mothers, infants, and children should be initiated to motivate staff to intervene. Another strategy to motivate WIC staff in this regard could be tracking clinic outcomes in helping women to quit smoking or prevent relapse.

An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: a cluster randomized trial.

PubMed

Dryden-Peterson, Scott; Bennett, Kara; Hughes, Michael D; Veres, Adrian; John, Oaitse; Pradhananga, Rosina; Boyer, Matthew; Brown, Carolyn; Sakyi, Bright; van Widenfelt, Erik; Keapoletswe, Koona; Mine, Madisa; Moyo, Sikhulile; Asmelash, Aida; Siedner, Mark; Mmalane, Mompati; Shapiro, Roger L; Lockman, Shahin

2015-01-01

Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy (ART) globally initiate treatment prior to delivery, with lack of access to timely CD4 results being a principal barrier. We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART. We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone, Botswana. From July 2011-April 2012, 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing. CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed. Three-hundred-sixty-six ART-naïve women were included, 189 registering for antenatal care under Intervention and 177 under Usual Care periods. Of CD4-eligible women, 100 (59.2%) women under Intervention and 79 (50.6%) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation, adjusted odds ratio (aOR, adjusted for time that a clinic initiated Intervention) 0.87 (95% confidence interval [CI]0.47-1.63, P = 0.67). The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days (P<0.001), was appreciated by clinic staff, and was associated with reduced operational cost. However, rates of ART initiation remained low, with 56 (36.4%) women registering under Intervention versus 37 (24.2%) women under Usual Care initiating ART prior to 30 weeks gestation, aOR 1.06 (95%CI 0.53-2.13, P = 0.87). The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently, and this type of SMS-based results delivery platform may be useful for a variety of tests and settings. However, the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation, as obstacles other than CD4 impeded ART initiation during pregnancy.

Retrospective chart review for obesity and associated interventions among rural Mexican-American adolescents accessing healthcare services.

PubMed

Champion, Jane Dimmitt; Collins, Jennifer L

2013-11-01

To report a retrospective analysis of data routinely collected in the course of healthcare services at a rural health clinic and to assess obesity incidence and associated interventions among rural Mexican-American adolescents. Two hundred and twelve charts reviewed; 98 (46.2%) males and 114 (53.8%) females. Data extracted included Medicaid exams conducted at the clinic within 5 years. Equal overweight or obese (n = 105, 49.5%), versus normal BMI categorizations (n = 107, 50.5%) documented overall and by gender. Female obesity higher (25.4%) than national norms (17.4%); male rates (25.5%) were within national norm. Interventions provided by nurse practitioners (94%) for 34.8%-80% of overweight/obese had limited follow-up (4%). Obesity incidence markedly increased between 13 and 18 years of age without associated interventions; 51.4%-75.6% without interventions. Obesity is a healthcare problem among rural Mexican-American adolescents accessing care at the rural health clinic. Obesity intervention and follow-up was suboptimal within this setting. Rural and ethnic minority adolescents experience health disparities concerning obesity prevalence and remote healthcare access. Obesity prevention and treatment during adolescence is a national health priority given physiologic and psychological tolls on health and potential for obesity into adulthood. Obesity assessment and translation of evidence-based interventions for rural Mexican-American adolescents at rural health clinics is implicated. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

A patient-mount navigated intervention system for spinal diseases and its clinical trial on percutaneous pulsed radiofrequency stimulation of dorsal root ganglion.

PubMed

Yang, Chi-Lin; Yang, Been-Der; Lin, Mu-Lien; Wang, Yao-Hung; Wang, Jaw-Lin

2010-10-01

Development of a patient-mount navigated intervention (PaMNI) system for spinal diseases. An in vivo clinical human trial was conducted to validate this system. To verify the feasibility of the PaMNI system with the clinical trial on percutaneous pulsed radiofrequency stimulation of dorsal root ganglion (PRF-DRG). Two major image guiding techniques, i.e., computed tomography (CT)-guided and fluoro-guided, were used for spinal intervention. The CT-guided technique provides high spatial resolution, and is claimed to be more accurate than the fluoro-guided technique. Nevertheless, the CT-guided intervention usually reaches higher radiograph exposure than the fluoro-guided counterpart. Some navigated intervention systems were developed to reduce the radiation of CT-guided intervention. Nevertheless, these systems were not popularly used due to the longer operation time, a new protocol for surgeons, and the availability of such a system. The PaMNI system includes 3 components, i.e., a patient-mount miniature tracking unit, an auto-registered reference frame unit, and a user-friendly image processing unit. The PRF-DRG treatment was conducted to find the clinical feasibility of this system. The in vivo clinical trial showed that the accuracy, visual analog scale evaluation after surgery, and radiograph exposure of the PaMNI-guided technique are comparable to the one of conventional fluoro-guided technique, while the operation time is increased by 5 minutes. Combining the virtues of fluoroscopy and CT-guided techniques, our navigation system is operated like a virtual fluoroscopy with augmented CT images. This system elevates the performance of CT-guided intervention and reduces surgeons' radiation exposure risk to a minimum, while keeping low radiation dose to patients like its fluoro-guided counterpart. The clinical trial of PRF-DRG treatment showed the clinical feasibility and efficacy of this system.

Multisociety consensus quality improvement guidelines for intraarterial catheter-directed treatment of acute ischemic stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology.

PubMed

Sacks, David; Black, Carl M; Cognard, Christophe; Connors, John J; Frei, Donald; Gupta, Rishi; Jovin, Tudor G; Kluck, Bryan; Meyers, Philip M; Murphy, Kieran J; Ramee, Stephen; Rüfenacht, Daniel A; Bernadette Stallmeyer, M J; Vorwerk, Dierk

2013-02-01

In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization. Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years. In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days. Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures. Copyright © 2013 SIR. Published by Elsevier Inc. All rights reserved.

Treating reading comprehension deficits in sub-acute brain injury rehabilitation: Identifying clinical practice and management.

PubMed

Watter, Kerrin; Copley, Anna; Finch, Emma

There is limited evidence for cognitive-communication reading comprehension (CCRC) interventions for adults following acquired brain injury (ABI), particularly during sub-acute rehabilitation. The purpose of this study was to investigate the clinical practice of speech-language pathologists (SLPs) with CCRC deficits during sub-acute ABI rehabilitation and compare it to the best available evidence. An electronic survey was used to gather information from clinicians across Australia regarding clinical practice in the areas of assessment, intervention, treatment hierarchies and service delivery; survey questions were developed from an extensive review of the literature and expert clinician opinion. Survey findings were then compared with the literature in the form of a systematic review. Surveyed clinicians provided multiple interventions for CCRC rehabilitation, including impairment based (94.7%), activity based (94.7%) and reading strategy interventions (100.0%). Five strategies were used by >94% of SLPs (highlighting, identifying main points/wh- questioning, re-reading, summarising, reducing visual load). When compared with the literature, strong similarities were found for strategy-based interventions and individual service delivery, with broad similarities for functional and impairment-based interventions, and impairment based treatment hierarchies. Strong differences in assessment were identified. Strategy use reported in clinical practice (100.0% SLPs) was higher than in the literature. Further investigation into the effectiveness of specific reading strategies for people with ABI is warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

A Clinical Trial on Weight Loss among Truck Drivers.

PubMed

Thiese, M S; Effiong, A C; Ott, U; Passey, D G; Arnold, Z C; Ronna, B B; Muthe, P A; Wood, E M; Murtaugh, M A

2015-04-01

The high prevalence of obesity among commercial truck drivers may be related to sedentary nature of the job, lack of healthy eating choices, and lack of exercise. There may be a link between obesity and crash risk, therefore an intervention to reduce obesity in this population is needed. To assess feasibility of a 12-week weight loss intervention for truck drivers with a weight loss goal of 10% of initial body weight. Drivers were selected based on age (≥21 years) and body mass index (≥30 kg/m^2). The drivers participated in a before-after clinical trial. The intervention included a 12-week program that provided information on healthy diet and increasing exercise, and telephone-based coaching using SMART goals. Outcomes included change from baseline in reported energy intake, measured weight, waist, hip, and neck circumference, blood pressure, and point of care capillary blood lipids and hemoglobin A1c. Exit interviews were conducted to gain insight into driver opinions on the program features and usefulness. This study was registered with the NIH Clinical Trials Registry, number NCT02348983. 12 of 13 drivers completed the study. Weight loss was statistically significant (p=0.03). Reported energy (p=0.005), total fat consumption (p=0.04), and saturated fat consumption (p=0.02) intake were also lower after the 12-week intervention. Drivers attributed their weight loss to health coaching and suggested a longer intervention so that they could reach their goal and become accustomed to the changes. This weight loss intervention is feasible for this difficult population. Additional research is needed to compare this intervention with a control group.

Implementation of a Family Planning Clinic-Based Partner Violence and Reproductive Coercion Intervention: Provider and Patient Perspectives.

PubMed

Miller, Elizabeth; McCauley, Heather L; Decker, Michele R; Levenson, Rebecca; Zelazny, Sarah; Jones, Kelley A; Anderson, Heather; Silverman, Jay G

2017-06-01

Despite multiple calls for clinic-based services to identify and support women victimized by partner violence, screening remains uncommon in family planning clinics. Furthermore, traditional screening, based on disclosure of violence, may miss women who fear reporting their experiences. Strategies that are sensitive to the signs, symptoms and impact of trauma require exploration. In 2011, as part of a cluster randomized controlled trial, staff at 11 Pennsylvania family planning clinics were trained to offer a trauma-informed intervention addressing intimate partner violence and reproductive coercion to all women seeking care, regardless of exposure to violence. The intervention sought to educate women about available resources and harm reduction strategies. In 2013, at the conclusion of the trial, 18 providers, five administrators and 49 patients completed semistructured interviews exploring acceptability of the intervention and barriers to implementation. Consensus and open coding strategies were used to analyze the data. Providers reported that the intervention increased their confidence in discussing intimate partner violence and reproductive coercion. They noted that asking patients to share the educational information with other women facilitated the conversation. Barriers to implementation included lack of time and not having routine reminders to offer the intervention. Patients described how receiving the intervention gave them important information, made them feel supported and less isolated, and empowered them to help others. A universal intervention may be acceptable to providers and patients. However, successful implementation in family planning settings may require attention to system-level factors that providers view as barriers. Copyright © 2017 by the Guttmacher Institute.

Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions.

PubMed

Elwyn, Glyn; Frosch, Dominick; Volandes, Angelo E; Edwards, Adrian; Montori, Victor M

2010-01-01

This article provides an analysis of 'decision aids', interventions to support patients facing tough decisions. Interest has increased since the concept of shared decision making has become widely considered to be a means of achieving desirable clinical outcomes. We consider the aims of these interventions and examine assumptions about their use. We propose three categories, interventions that are used in face-to-face encounters, those designed for use outside clinical encounters and those which are mediated, using telephone or other communication media. We propose the following definition: decision support interventions help people think about choices they face; they describe where and why choice exists; they provide information about options, including, where reasonable, the option of taking no action. These interventions help people to deliberate, independently or in collaboration with others, about options, by considering relevantattributes; they support people to forecast how they might feel about short, intermediate and long-term outcomes which have relevant consequences, in ways which help the process of constructing preferences and eventual decision making, appropriate to their individual situation. Although quality standards have been published for these interventions, we are also cautious about premature closure and consider that the need for short versions for use inside clinical encounters and long versions for external use requires further research. More work is also needed on the use of narrative formats and the translation of theory into practical designs. The interest in decision support interventions for patients heralds a transformation in clinical practice although many important areas remain unresolved.

Promotion of tobacco use cessation for lesbian, gay, bisexual, and transgender people: a systematic review.

PubMed

Lee, Joseph G L; Matthews, Alicia K; McCullen, Cramer A; Melvin, Cathy L

2014-12-01

Lesbian, gay, bisexual, and transgender (LGBT) people are at increased risk for the adverse effects of tobacco use, given their high prevalence of use, especially smoking. Evidence regarding cessation is limited. To determine if efficacious interventions are available and to aid the development of interventions, a systematic review was conducted of grey and peer-reviewed literature describing clinical, community, and policy interventions, as well as knowledge, attitudes, and behaviors regarding tobacco use cessation among LGBT people. Eight databases for articles from 1987 to April 23, 2014, were searched. In February-November 2013, authors and researchers were contacted to identify grey literature. The search identified 57 records, of which 51 were included and 22 were from the grey literature; these were abstracted into evidence tables, and a narrative synthesis was conducted in October 2013-May 2014. Group cessation curricula tailored for LGBT populations were found feasible to implement and show evidence of effectiveness. Community interventions have been implemented by and for LGBT communities, although these interventions showed feasibility, no rigorous outcome evaluations exist. Clinical interventions show little difference between LGBT and heterosexual people. Focus groups suggest that care is needed in selecting the messaging used in media campaigns. LGBT-serving organizations should implement existing evidence-based tobacco-dependence treatment and clinical systems to support treatment of tobacco use. A clear commitment from government and funders is needed to investigate whether sexual orientation and gender identity moderate the impacts of policy interventions, media campaigns, and clinical interventions. Copyright © 2014 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Unproven stem cell-based interventions and achieving a compromise policy among the multiple stakeholders.

PubMed

Matthews, Kirstin R W; Iltis, Ana S

2015-11-04

In 2004, patient advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policy makers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. Many advocates did this because they were told stem cell research would lead to cures. After waiting more than 10 years, many of these same patients are now approaching clinics around the world offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials. How did the same groups who were once (and often still are) the strongest supporters of stem cell research become stem cell tourists? And how can scientists, clinicians, and regulators work to bring stem cell patients back home to the US and into the clinical trial process? In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation. The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell-based interventions with respect to the design, initiation, and conduct of US clinical trials. Stakeholders, including scientists, clinicians, regulators and patient advocates, need to work together to find a compromise to keep patients in the US and within the clinical trial process. Using HIV/AIDS and breast cancer advocate cases as examples, we identify key priorities and goals for this policy effort.

Feasibility of a Manualized Occupation-Based Diabetes Management Intervention.

PubMed

Carandang, Kristine M; Pyatak, Elizabeth A

We investigated the feasibility and acceptability of an occupational therapy intervention targeting diabetes management for underserved young adults. Eight participants completed the intervention and a battery of assessments at baseline and after the intervention. At completion, the participants and occupational therapist were interviewed about their experiences with the study. Four categories of assessment questions were used to guide the study: process, resource, management, and scientific. Successes included recruitment; fulfillment of tasks by staff and partnering clinics; adequate space, financial support, and equipment; and meaningfulness of the intervention for participants. Challenges included scheduling participants for the intervention and follow-up focus groups and providing client centeredness and flexibility while reducing burden on the intervener. This feasibility study allowed us to make necessary revisions to our study protocol before implementing a larger pilot study. Copyright © 2018 by the American Occupational Therapy Association, Inc.

Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

PubMed Central

2011-01-01

Background Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC) intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial. Methods After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered. Results We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures used to capture impact across a range of components was also collected, though some process orientated uncertainties including eligibility and recruitment rates remain to be further explored within a Phase II exploratory trial. Conclusions Complex interventions can be captured and described in a manner which facilitates evaluation in the form of exploratory and subsequently definitive clinical trials. If effective, the evidence captured relating to the intervention context will facilitate translation into clinical practice. PMID:21729277

Antiplatelet and anticoagulation therapy during percutaneous coronary interventions: A review for the interventionalist.

PubMed

Basman, Craig; Tariq, Afnan; Parmar, Yuvrajsinh J; Asti, Deepak; Coplan, Neil L; Singh, Varinder P; Reimers, Carl D

2018-06-19

Pharmacotherapy for percutaneous coronary interventions is essential to optimize the balance between thrombosis and bleeding. Currently, choices abound for the selection of antiplatelet and anticoagulation therapies during percutaneous intervention (PCI). This review article discusses the mechanisms, pharmacokinetics/dynamics, and clinical data behind the various pharmacotherapies including; aspirin, thienopyridines, glycoprotein IIb/IIIa inhibitors, vorapaxar, heparin, direct thrombin inhibitors, and factor Xa inhibitors. © 2018, Wiley Periodicals, Inc.

Efficacy of falls prevention interventions: protocol for a systematic review and network meta-analysis

PubMed Central

2013-01-01

Background Falls are a leading cause of morbidity and mortality in older adults. Although numerous trials of falls prevention interventions have been completed, there is extensive variation in their intervention components and clinical context, such that the key elements of an effective falls prevention program remain unclear to patients, clinicians, and policy-makers. Our objective is to identify the most effective interventions and combinations of interventions that prevent falls though a systematic review and meta-analysis, including a network meta-analysis. Methods/Design We will search for published (e.g., MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Ageline) and unpublished (e.g., trial registries, dissertations) randomised clinical trials (RCTs) in all languages examining interventions to prevent falls compared to usual care or other falls prevention interventions among adults aged ≥65 years from all settings (e.g., community, acute care, long-term care, and rehabilitation). The primary outcomes are number of injurious falls and number of hospitalizations due to falls. Secondary outcomes include falls rate, number of fallers, number of emergency room visits due to falls, number of physician visits due to falls, number of fractures, costs, and number of intervention-related harms (e.g., muscle soreness related to exercise). We will calibrate our eligibility criteria amongst the team and two independent team members will screen the literature search results in duplicate. Conflicts will be resolved through team discussion. A similar process will be used for data abstraction and quality appraisal with the Cochrane risk of bias tool. Our results will be synthesized descriptively and a random effects meta-analysis will be conducted if the studies are deemed methodologically, clinically, and statistically (e.g., I2<60%) similar. If appropriate, a network meta-analysis will be conducted, which will allow the comparison of interventions that have not been compared in head-to-head RCTs, as well as the effectiveness of interventions. Discussion We will identify the most effective interventions and combinations of interventions that prevent falls in older people. Our results will be used to optimize falls prevention strategies, and our goal is to ultimately improve the health of seniors internationally. Trial registration PROSPERO registry number: CRD42013004151 PMID:23738619

REACH VA: Moving from Translation to System Implementation.

PubMed

Nichols, Linda O; Martindale-Adams, Jennifer; Burns, Robert; Zuber, Jeffrey; Graney, Marshall J

2016-02-01

Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA) has been implemented in the VA system as a national program for caregivers. We describe the trajectory of REACH VA from national randomized clinical trial through translation to national implementation. The implementation is examined through the six stages of the Fixsen and Blasé implementation process model: exploration and adoption, program installation, initial implementation, full operation, innovation, and sustainability. Different drivers that move the implementation process forward are important at each stage, including staff selection, staff training, consultation and coaching, staff evaluation, administrative support, program evaluation/fidelity, and systems interventions. Caregivers in the REACH VA 4 session intervention currently implemented in the VA had similar outcomes to longer REACH interventions, including Resources for Enhancing Alzheimer's Caregivers Health (REACH II). Caregivers experienced significant decreases in burden, depression, anxiety, number of troubling patient behaviors reported, caregiving frustrations, stress symptoms (feeling overwhelmed, feeling like crying, being frustrated as a result of caregiving, being lonely), and general stress. Effect sizes (Cohen's d) for these significant variables were between small and medium ranging from .24 to .46. The implementation of REACH VA provides a road map for implementation of other behavioral interventions in health care delivery settings. Lessons learned include the importance of implementing a proven, needed intervention, support from both leadership and clinical staff, willingness to respond to staff and organization needs and modify the intervention while preserving its integrity, and fitting the intervention into ongoing routines and practices. Published by Oxford University Press on behalf of the Gerontological Society of America 2014.

Knowledge translation and implementation in spinal cord injury: a systematic review

PubMed Central

Noonan, VK; Wolfe, DL; Thorogood, NP; Park, SE; Hsieh, JT; Eng, JJ

2015-01-01

Objective To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. Methods MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. Results A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. Conclusion The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions. PMID:24796445

Features and Effects of Information Technology-Based Interventions to Improve Self-Management in Chronic Kidney Disease Patients: a Systematic Review of the Literature.

PubMed

Jeddi, Fateme Rangraz; Nabovati, Ehsan; Amirazodi, Shahrzad

2017-09-18

Slowing down the progression of chronic kidney disease (CKD) and its adverse health outcomes requires the patient's self-management and attention to treatment recommendations. Information technology (IT)-based interventions are increasingly being used to support self-management in patients with chronic diseases such as CKD. We conducted a systematic review of randomized controlled trials (RCTs) to assess the features and effects of IT-based interventions on self-management outcomes of CKD patients. A comprehensive search was conducted in Medline, Scopus, and the Cochrane Library to identify relevant papers that were published until May 2016. RCT Studies that assessed at least one automated IT tool in patients with CKD stages 1 to 5, and reported at least one self-management outcome were included. Studies were appraised for quality using the Cochrane Risk of Bias assessment tool. Out of 12,215 papers retrieved, eight study met the inclusion criteria. Interventions were delivered via smartphones/personal digital assistants (PDAs) (three studies), wearable devices (three studies), computerized systems (one study), and multiple component (one study). The studies assessed 15 outcomes, including eight clinical outcomes and seven process of care outcomes. In 12 (80%) of the 15 outcomes, the studies had revealed the effects of the interventions as statistically significant positive. These positive effects were observed in 75% of the clinical outcomes and 86% of the process of care outcomes. The evidence indicates the potential of IT-based interventions (i.e. smartphones/PDAs, wearable devices, and computerized systems) in self-management outcomes (clinical and process of care outcomes) of CKD patients.

Improving Participants' Retention in a Smoking Cessation Intervention Using a Community-based Participatory Research Approach.

PubMed

Estreet, Anthony; Apata, Jummai; Kamangar, Farin; Schutzman, Christine; Buccheri, Jane; O'Keefe, Anne-Marie; Wagner, Fernando; Sheikhattari, Payam

2017-01-01

This study compares participant' sretention in three phases of smoking cessation interventions, one provided in a health clinic and the subsequent two in community-based settings. Smoking cessation interventions were conducted in three phases from 2008 to 2015 in two underserved urban communities with low socioeconomic profiles and high rates of smoking ( n = 951). Phase I was conducted in a clinic; Phases II and III were conducted in community venues. In Phases II and III, incremental changes were made based on lessons learned from the previous phases. Retention (attending six or more sessions) was the primary predictor of cessation and was analyzed while controlling for associated factors including age, gender, race, employment, education, and nicotine dependence. Retention increased substantially over the three phases, with rates for attending six or more sessions of 13.8%, 51.9%, and 67.9% in Phases I, II, and III, respectively. Retention was significantly higher in community settings than in the clinic setting (adjusted odds ratio [OR] = 6.7; 95% confidence intervals [CI] = 4.6, 9.8). In addition to the intervention in community venues, predictors of retention included age and unemployment. Higher retention was significantly associated with higher quit rates (adjusted OR = 2.4; 95% CI = 1.5, 3.8). Conducting the intervention in community settings using trained peer motivators rather than health-care providers resulted in significantly higher retention and smoking cessation rates. This was due in part to the ability to tailor cessation classes in the community for specific populations and improving the quality of the intervention based on feedback from participants and community partners.

Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review.

PubMed

Warner, Molly M; Kelly, Jaimon T; Reidlinger, Dianne P; Hoffmann, Tammy C; Campbell, Katrina L

2017-12-11

Telehealth-delivered dietary interventions are effective for chronic disease management and are an emerging area of clinical practice. However, to apply interventions from the research setting in clinical practice, health professionals need details of each intervention component. The aim of this study was to evaluate the completeness of intervention reporting in published dietary chronic disease management trials that used telehealth delivery methods. Eligible randomized controlled trial publications were identified through a systematic review. The completeness of reporting of experimental and comparison interventions was assessed by two independent assessors using the Template for Intervention Description and Replication (TIDieR) checklist that consists of 12 items including intervention rationale, materials used, procedures, providers, delivery mode, location, when and how much intervention delivered, intervention tailoring, intervention modifications, and fidelity. Where reporting was incomplete, further information was sought from additional published material and through email correspondence with trial authors. Within the 37 eligible trials, there were 49 experimental interventions and 37 comparison interventions. One trial reported every TIDieR item for their experimental intervention. No publications reported every item for the comparison intervention. For the experimental interventions, the most commonly reported items were location (96%), mode of delivery (98%), and rationale for the essential intervention elements (96%). Least reported items for experimental interventions were modifications (2%) and intervention material descriptions (39%) and where to access them (20%). Of the 37 authors, 14 responded with further information, and 8 could not be contacted. Many details of the experimental and comparison interventions in telehealth-delivered dietary chronic disease management trials are incompletely reported. This prevents accurate interpretation of trial results and implementation of effective interventions in clinical practice. ©Molly M Warner, Jaimon T Kelly, Dianne P Reidlinger, Tammy C Hoffmann, Katrina L Campbell. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 11.12.2017.

Brief Behavioral Intervention to Improve Adolescent Sexual Health: A Feasibility Study in the Emergency Department.

PubMed

Miller, Melissa K; Champassak, Sofie; Goggin, Kathy; Kelly, Patricia; Dowd, M Denise; Mollen, Cynthia J; Humiston, Sharon G; Linebarger, Jennifer; Apodaca, Timothy

2016-01-01

Although emergency department (ED) visits offer an opportunity to deliver brief behavioral interventions to improve health, provision of ED-based interventions targeting adolescent sexual health is uncommon. The objectives for this study were to evaluate the feasibility and preliminary effects of a novel sexual health service intervention for adolescents. In this cross-sectional feasibility study, sexually active patients aged 14 to 19 years presenting to a Midwestern pediatric ED were recruited to receive an intervention to improve sexual health. The intervention, based on motivational interviewing (MI), included agenda setting, exploration of behaviors, a decisional balance exercise, tailored feedback, and provision of personalized health services (including condoms, prescription for emergency contraception, urine testing for Chlamydia trachomatis and Neisseria gonorrheae, and referral to the hospital-affiliated adolescent clinic). Data were collected before and after intervention administration and at a 3-month follow-up telephone interview. Surveys assessed sexual risk behaviors, satisfaction with the intervention, health care use, and demographics. Feasibility criteria were (1) subject-rated interventionist fidelity to MI principles (Likert scale 1 [strongly agree] to 4 [strongly disagree]), (2) subject satisfaction (Likert scale 1 [not at all] to 5 [very]), and (3) session duration (minutes, recorded by the interventionist). A secondary outcome was the proportion of subjects who completed at least 1 health service. Services provided at the adolescent clinic were determined by an electronic medical record review. Comparisons of responses between sex subgroups were analyzed using Χ test. From August to November 2012, 69 adolescents were approached, 66 (96%) completed the screening survey, and 24 (37%) reported previous sexual activity. Of those, 20 (83%) agreed to participate. The mean (SD) age was 16.2 (1.4) years; 60% were female. Most (78%) reported that the interventionist maintained high fidelity to MI principles and most (80%) were very satisfied with the intervention. Mean (SD) intervention length was 15.7 (2.2) minutes. Most subjects (65%) accepted 1 or more health services, including 42% who completed clinic follow-up. In the ED or the referral clinic, the following services were provided to the subjects: condoms (n = 11), emergency contraception prescription (n = 5), C. trachomatis/N. gonorrheae testing (n = 4), hormonal birth control provision (n = 2), and human immunodeficiency virus testing (n = 3). Fifteen subjects (75%) were reached for the 3-month follow-up, and condom use was maintained by 67% of those reporting sexual activity. This study demonstrated the feasibility and potential utility of an MI-based service navigation intervention to connect youth with point-of-care services as well as resources for ongoing sexual health needs.

Cancer therapies in HIV cure research.

PubMed

Rasmussen, Thomas A; Anderson, Jenny L; Wightman, Fiona; Lewin, Sharon R

2017-01-01

This article provides an overview of anticancer therapies in various stages of clinical development as potential interventions to target HIV persistence. Epigenetic drugs developed for cancer have been investigated in vitro, ex vivo and in clinical trials as interventions aimed at reversing HIV latency and depleting the amount of virus that persists on antiretroviral therapy. Treatment with histone deacetylase inhibitors induced HIV expression in patients on antiretroviral therapy but did not reduce the frequency of infected cells. Other interventions that may accelerate the decay of latently infected cells, in the presence or absence of latency-reversing therapy, are now being explored. These include apoptosis-promoting agents, nonhistone deacetylase inhibitor compounds to reverse HIV latency and immunotherapy interventions to enhance antiviral immunity such as immune checkpoint inhibitors and Toll-like receptor agonists. A curative strategy in HIV will likely need to both reduce the amount of virus that persists on antiretroviral therapy and improve anti-HIV immune surveillance. Although we continue to explore advances in the field of oncology including cancer immunotherapy, there are major differences in the risk-benefit assessment between HIV-infected individuals and patients with malignancies. Drug development specifically targeting HIV persistence will be the key to developing effective interventions with an appropriate safety profile.

Helping Her Heal: a pilot study of an educational counseling intervention for spouses of women with breast cancer.

PubMed

Lewis, Frances Marcus; Cochrane, Barbara B; Fletcher, Kristin A; Zahlis, Ellen H; Shands, Mary Ellen; Gralow, Julie R; Wu, Salene M; Schmitz, KrisAnn

2008-02-01

Breast cancer is known to cause substantial anxiety, depressed mood, and diminished marital functioning in the diagnosed woman's spouse. Despite the scope and magnitude of these issues, few intervention studies have included spouses or addressed the causes of their lower functioning. The purpose of this pilot study was to evaluate the short-term impact of a 5-session, clinic-based, educational counseling intervention for spouses whose wife was recently diagnosed with early stage breast cancer. The goals of the intervention were to enhance spouses' skills and confidence to communicate and interpersonally support his wife about the breast cancer as well as improve spouses' self-care, depressed mood, anxiety, and marital adjustment. Pre-post-test results obtained from 20 spouses from valid and reliable standardized questionnaires showed significant improvements in spouses' depressed mood, anxiety, skills, self-confidence, and self-care. Confidential post-intervention interviews with spouses and wives included detailed examples of positive changes in the spouse's communication and support to his wife about the breast cancer, diminished tension in the spouse, and improved quality in the couple's relationship. Further evaluation of the Helping Her Heal Program is warranted within a clinical trial.

A critical appraisal of nutritional intervention studies in malnourished, community dwelling older persons.

PubMed

de van der Schueren, M A E; Wijnhoven, H A H; Kruizenga, H M; Visser, M

2016-10-01

With the rapidly increasing number of malnourished older persons in the community, this review aims to summarize the effects of nutritional intervention studies for this target group. Based on 2 previous reviews (2009, 2011) an update of the literature was performed. Selected were higher quality studies which included malnourished community dwelling older adults who received dietetic counselling and/or oral nutritional supplements. Ten studies were included. Six studies showed (trends towards) weight gain. Meta-analysis showed a modest effect of the intervention on weight gain, standardized mean difference 0.210 kg (95% CI 0.03-0.40). Effects on other relevant functional and clinical outcomes were inconsistent. Studies were hampered by low sample sizes, low adherence to the interventions, and participants not meeting nutritional requirements. Currently, nutritional intervention studies for malnourished community dwelling older adults show limited effects, which may be caused by methodological shortcomings and participants not meeting treatment goals. High quality studies are eagerly awaited to be able to identify (sub)groups of older persons who are most likely to benefit from nutritional support. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

What Are the Effects of Teaching Evidence-Based Health Care (EBHC)? Overview of Systematic Reviews

PubMed Central

Young, Taryn; Rohwer, Anke; Volmink, Jimmy; Clarke, Mike

2014-01-01

Background An evidence-based approach to health care is recognized internationally as a key competency for healthcare practitioners. This overview systematically evaluated and organized evidence from systematic reviews on teaching evidence-based health care (EBHC). Methods/Findings We searched for systematic reviews evaluating interventions for teaching EBHC to health professionals compared to no intervention or different strategies. Outcomes covered EBHC knowledge, skills, attitudes, practices and health outcomes. Comprehensive searches were conducted in April 2013. Two reviewers independently selected eligible reviews, extracted data and evaluated methodological quality. We included 16 systematic reviews, published between 1993 and 2013. There was considerable overlap across reviews. We found that 171 source studies included in the reviews related to 81 separate studies, of which 37 are in more than one review. Studies used various methodologies to evaluate educational interventions of varying content, format and duration in undergraduates, interns, residents and practicing health professionals. The evidence in the reviews showed that multifaceted, clinically integrated interventions, with assessment, led to improvements in knowledge, skills and attitudes. Interventions improved critical appraisal skills and integration of results into decisions, and improved knowledge, skills, attitudes and behaviour amongst practicing health professionals. Considering single interventions, EBHC knowledge and attitude were similar for lecture-based versus online teaching. Journal clubs appeared to increase clinical epidemiology and biostatistics knowledge and reading behavior, but not appraisal skills. EBHC courses improved appraisal skills and knowledge. Amongst practicing health professionals, interactive online courses with guided critical appraisal showed significant increase in knowledge and appraisal skills. A short workshop using problem-based approaches, compared to no intervention, increased knowledge but not appraisal skills. Conclusions EBHC teaching and learning strategies should focus on implementing multifaceted, clinically integrated approaches with assessment. Future rigorous research should evaluate minimum components for multifaceted interventions, assessment of medium to long-term outcomes, and implementation of these interventions. PMID:24489771

Suicide Risk Assessment and Prevention: A Systematic Review Focusing on Veterans.

PubMed

Nelson, Heidi D; Denneson, Lauren M; Low, Allison R; Bauer, Brian W; O'Neil, Maya; Kansagara, Devan; Teo, Alan R

2017-10-01

Suicide rates in veteran and military populations in the United States are high. This article reviews studies of the accuracy of methods to identify individuals at increased risk of suicide and the effectiveness and adverse effects of health care interventions relevant to U.S. veteran and military populations in reducing suicide and suicide attempts. Trials, observational studies, and systematic reviews relevant to U.S. veterans and military personnel were identified in searches of MEDLINE, PsycINFO, SocINDEX, and Cochrane databases (January 1, 2008, to September 11, 2015), on Web sites, and in reference lists. Investigators extracted and confirmed data and dual-rated risk of bias for included studies. Nineteen studies evaluated accuracy of risk assessment methods, including models using retrospective electronic records data and clinician- or patient-rated instruments. Most methods demonstrated sensitivity ≥80% or area-under-the-curve values ≥.70 in single studies, including two studies based on electronic records of veterans and military personnel, but specificity varied. Suicide rates were reduced in six of eight observational studies of population-level interventions. Only two of ten trials of individual-level psychotherapy reported statistically significant differences between treatment and usual care. Risk assessment methods have been shown to be sensitive predictors of suicide and suicide attempts, but the frequency of false positives limits their clinical utility. Research to refine these methods and examine clinical applications is needed. Studies of suicide prevention interventions are inconclusive; trials of population-level interventions and promising therapies are required to support their clinical use.

Clinical process in an integrative psychotherapy for self-wounds.

PubMed

Wolfe, Barry E

2013-09-01

In this article, I will briefly describe the clinical process of an integrative psychotherapy for the healing of self-wounds, including its intended interventions and the variability of their application and outcome. Four specific strategies will be considered, including (a) the role of empathy throughout the course of therapy; (b) exposure therapy as a paradigmatic treatment for the treatment of feared thoughts, behavior, and emotions; (c) focusing and other experiential interventions for eliciting self-wounds; and (d) modification and healing of self-wounds with an individualized array of psychodynamic, experiential, and cognitive-behavioral strategies. In addition, we will briefly consider the impact of transference and countertransference on the trajectory of therapy. 2013 APA, all rights reserved

Evaluating the Types of Pharmacy Student Interventions Made During an Interprofessional 6-Week Adult Internal Medicine Rotation.

PubMed

Vinluan, Celeste M; Jabalie, Melanie M; Navarrete, Jacquelyn P; Padilla, Margie E

2018-06-01

The new standards for pharmacy education require that pharmacy students are involved in direct and interprofessional team-based care in multiple practice settings, which include "real-time" interactions with physician prescribers and medical students. From April 2014 to December 2015, fourth-year Doctor of Pharmacy (PharmD) students at University Medical Center of El Paso, Texas were assigned to an interprofessional team that was comprised of physician prescribers, medical students, and a pharmacist faculty. They recorded their interventions that were analyzed for type, number, physician acceptance, clinical importance, and time requirements for intervention recommendation. Interventions were divided into 5 main types and further divided into specific categories. Twelve PharmD students contributed 531 interventions, resulting in an average of 44 interventions per student with a physician acceptance rate of 87%. The most common types of interventions performed by PharmD students were under the categories of Therapy Needed (29.8%), Too Low Dose/Frequency (21.1%), Too High Dose/Frequency (8.3%), Therapeutic Level Monitoring (6.8%), and IV to PO Conversion (4.9%). A majority of interventions were of moderate clinical importance (56.1%) and took approximately 15 minutes to complete (92.5%). PharmD students under the supervision of clinical faculty on an interprofessional internal medicine team are valuable collaborators and contributors in decreasing the number of drug-related problems that can negatively impact patient care.

Training peers to treat Ebola centre workers with anxiety and depression in Sierra Leone.

PubMed

Waterman, Samantha; Hunter, Elaine Catherine Margaret; Cole, Charles L; Evans, Lauren Jayne; Greenberg, Neil; Rubin, G James; Beck, Alison

2018-03-01

Following the 2014 Ebola virus disease (EVD) outbreak in West Africa, the UK Department for International Development funded South London and Maudsley National Health Service (NHS) to develop a psychological intervention that ex-Ebola Treatment Centre (ETC) staff could be trained to deliver to their peers to improve mental health in Sierra Leone. The two key aims were to assess the feasibility of training a national team to deliver a cognitive behavioural therapy (CBT)-based group intervention, and to evaluate the effectiveness of the overall intervention within this population. UK clinicians travelled to Sierra Leone to train a small team of ex-ETC staff in a three-phased CBT-based intervention. Standardised clinical measures, as well as bespoke measures, were applied with participants through the intervention to assess changes in mental health symptomology, and the effectiveness of the intervention. The results found improvements across all factors of mental health in the bespoke measure from phase 1 to phase 3. Additionally, the majority of standardised clinical measures showed improvements between phase 2 and the start of phase 3, and pre- and post-phase 3. Overall, the findings suggest that it is possible to train staff from ETCs to deliver effective CBT interventions to peers. The implications of these results are discussed, including suggestions for future research and clinical intervention implementation within this population. The limitations of this research are also addressed.

Nursing Intervention on the Compliance of Hemodialysis Patients with End-Stage Renal Disease: A Meta-Analysis.

PubMed

Wang, Jing; Yue, Peng; Huang, Jing; Xie, Xiaodong; Ling, Yunhua; Jia, Li; Xiong, Yunjin; Sun, Fang

2018-01-01

Dialysis is imperative for patients with end-stage renal disease (ESRD); however, compliance ensures its efficacy. Nursing intervention has been considered to improve compliance. This meta-analysis is aimed at exploring the effects of nursing intervention on dialysis compliance. A search was performed in the PubMed, Cochrane, and Embase databases for relevant original research articles. Studies were included or excluded based on the simultaneous consideration of quality as ranked by Jadad score and the compliance with predefined selection criteria. A total of 817 participants were included. The results showed that nursing intervention led to significantly higher compliance with dialysis than in standard care. A pilot analysis evidenced that different intervention strategies, including educational, cognitive, and behavioral approaches, had limited effects on dialysis compliance. Nursing intervention is beneficial for raising dialysis compliance, providing evidence of the need to strengthen nursing care for ESRD patients administered with dialysis in daily clinical practice. © 2017 S. Karger AG, Basel.

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

PubMed

Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe

2018-06-01

Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

Working together: Using a unique approach to evaluate an interactive and clinic-based longitudinal interprofessional education experience with 13 professions.

PubMed

Thompson, Britta M; Bratzler, Dale W; Fisher, Mark J; Torres, Amie; Faculty, Epic; Sparks, Rhonda A

2016-11-01

Interprofessional education (IPE) involving an interactive and longitudinal clinic experience at an inner-city charitable clinic from September to May 2013/2014 was evaluated. Pre-, mid-, and post-intervention data were collected from students in 13 different professions including medicine (medical and physician assistant), dentistry (dental and dental hygiene), nursing (undergraduate and clinical nurse specialist), public health, pharmacy, physical therapy, occupational therapy, nutritional sciences, speech and language pathology, and social work. To evaluate their interprofessional attitudes, students completed the TeamSTEPPS Teamwork Attitudes Questionnaire (T-TAQ) and Readiness for Interprofessional Learning Scale (RIPLS). They also completed a unique measure, healthcare professionals circles diagrams (HPCDs), that indicated student conceptualisation of a healthcare team caring for a complex patient, along with perception of their team's progress towards meeting patient goals. Results from the T-TAQ and RIPLS scores indicated small but significant increases from pre- to post-intervention (p = 0.005 and 0.012, respectively). Analysis of the HPCDs revealed significant increases in students' perceptions of the types of interprofessional team members, relationships, and communication between professions to provide medical care to patients (p < 0.01). Most HPCDs included pharmacists, nurses, and physicians as part of the care team at all time points. Students significantly increased their inclusion of dentistry, public health, social work, and physician assistants as members of the healthcare team from pre- to post-intervention. Implications of our data indicated the importance of IPE interventions that include not only classroom-based sessions, but actual patient care experiences within interprofessional teams. It also reinforced the importance of new and unique methods to assess IPE.

[A new joint approach to drug management: clinical pharmacy services and risk management unit].

PubMed

Schwartz, Vardit; Kravitz, Martine Szyper

2015-04-01

According to the "To Err is Human" report, medication-related errors are common in medicine and may have several and different effects. Clinical Pharmacy is a leading worldwide established pharmacy service which has been improving the quality of care for the last 30 years. The accumulated experience shows improved quality of care, improved patient safety and economic benefit. These understandings led to the definition and expansion of the Clinical Pharmacist Intervention Program and a joint project with the Risk Management Unit was created. A characterization process was conducted, parameters were defined for monitoring and surveillance and interventions were devised. The relevant data requiring pharmacist intervention was defined (e.g., dose adjustments, contraindications, side-effects); a report was devised, based on the patient's electronic medical record; daily follow-up included analysis, stratification, quantification and understanding of the different types of pharmacist interventions. The pharmacist interventions were summed up and assessed for performance and quality control. Between March 2013 and February 2014 the medical records of 14,499 patients were examined in our hospital Only in 16% of the records an active pharmacist intervention was performed, according to the parameters defined. Interventions for potentially high risk events such as therapeutic duplication, drug administration in spite of contraindication and in spite of documented allergy were very rare, less than 2% of all the pharmacist interventions. This joint venture, which is based on an existing platform, reflects an up-to-date view of an important facet of the clinical work performed at the hospital, helps identify trends, potential failures and vulnerabilities with regard to medication treatment and allows the formulation of intervention programs to improve the quality and safety of drug therapy.

RCT of a care manager intervention for major depression in primary care: 2-year costs for patients with physical vs psychological complaints.

PubMed

Dickinson, L Miriam; Rost, Kathryn; Nutting, Paul A; Elliott, Carl E; Keeley, Robert D; Pincus, Harold

2005-01-01

Depression care management for primary care patients results in sustained improvement in clinical outcomes with diminishing costs over time. Clinical benefits, however, are concentrated primarily in patients who report to their primary care clinicians psychological rather than exclusively physical symptoms. This study proposes to determine whether the intervention affects outpatient costs differentially when comparing patients who have psychological with patients who have physical complaints. We undertook a group-randomized controlled trial (RCT) of depression comparing intervention with usual care in 12 primary care practices. Intervention practices encouraged depressed patients to engage in active treatment, using nurses to provide regularly scheduled care management for 24 months. The study sample included 200 adults beginning a new depression treatment episode where patient presentation style could be identified. Outpatient costs were defined as intervention plus outpatient treatment costs for the 2 years. Cost-offset analysis used general linear mixed models, 2-part models, and bootstrapping to test hypotheses regarding a differential intervention effect by patients' style, and to obtain 95% confidence intervals for costs. Intervention effects on outpatient costs over time differed by patient style (P <.05), resulting in a $980 cost decrease for depressed patients who complain of psychological symptoms and a 1,378 dollars cost increase for depressed patients who complain of physical symptoms only. Depression intervention for a 2-year period produced observable clinical benefit with decreased outpatient costs for depressed patients who complain of psychological symptoms. It produced limited clinical benefit with increased costs, however, for depressed patients who complain exclusively of physical symptoms, suggesting the need for developing new intervention approaches for this group.

Increasing referral of at-risk travelers to travel health clinics: evaluation of a health promotion intervention targeted to travel agents.

PubMed

MacDougall, L A; Gyorkos, T W; Leffondré, K; Abrahamowicz, M; Tessier, D; Ward, B J; MacLean, J D

2001-01-01

Increases in travel-related illness require new partnerships to ensure travelers are prepared for health risks abroad. The travel agent is one such partner and efforts to encourage travel agents to refer at-risk travelers to travel health clinics may help in reducing travel-attributable morbidity. A health promotion intervention encouraging travel agents to refer at-risk travelers to travel health clinics was evaluated. Information on the knowledge, attitudes, and behaviors of travel agents before and after the intervention was compared using two self-administered questionnaires. The Wilcoxon signed rank test was used to compare the mean difference in overall scores to evaluate the overall impact of the intervention and also subscores for each of the behavioral construct groupings (attitudes, barriers, intent, and subjective norms). Multiple regression techniques were used to evaluate which travel agent characteristics were independently associated with a stronger effect of the intervention. A small improvement in travel agents overall attitudes and beliefs (p =.03) was found, in particular their intention to refer (p =.01). Sixty-five percent of travel agents self-reported an increase in referral behavior; owners or managers of the agency were significantly more likely to do so than other travel agents (OR = 7.25; 95% CI: 1.64 32.06). Older travel agents, those that worked longer hours and those with some past referral experience, had significantly higher post-intervention scores. Travel agents can be willing partners in referral, and agencies should be encouraged to develop specific referral policies. Future research may be directed toward investigating the role of health education in certification curricula, the effectiveness of different types of health promotion interventions, including Internet-facilitated interventions, and the direct impact that such interventions would have on travelers attending travel health clinics.

Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology.

PubMed

Räber, Lorenz; Mintz, Gary S; Koskinas, Konstantinos C; Johnson, Thomas W; Holm, Niels R; Onuma, Yoshinubo; Radu, Maria D; Joner, Michael; Yu, Bo; Jia, Haibo; Menevau, Nicolas; de la Torre Hernandez, Jose M; Escaned, Javier; Hill, Jonathan; Prati, Francesco; Colombo, Antonio; di Mario, Carlo; Regar, Evelyn; Capodanno, Davide; Wijns, William; Byrne, Robert A; Guagliumi, Giulio

2018-05-22

This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.

Effectiveness of Workplace Weight Management Interventions: a Systematic Review.

PubMed

Weerasekara, Yasoma Kumari; Roberts, Susan B; Kahn, Mira A; LaVertu, Amy E; Hoffman, Ben; Das, Sai Krupa

2016-06-01

A systematic review was conducted of randomized trials of workplace weight management interventions, including trials with dietary, physical activity, environmental, behavioral, and incentive-based components. Main outcomes were defined as change in weight-related measures. Keywords related to weight management and workplace interventions were used to search relevant databases, and 23 eligible studies were reviewed in detail using a data extraction form and quality assessment checklist. The trials were conducted mainly in the USA and Europe, with four additional countries represented. Interventions were mostly multicomponent and were implemented in both sexes and in a range of employment categories. Intervention effectiveness appeared unrelated to region of the world and was highest in 6-12-month trials. The results ranged widely from clinically significant 8.8-kg weight loss in one trial to less effective than the control treatment in others. Some workplace interventions achieve clinically significant benefits, and further studies are needed to replicate those results in wider sociocultural and geographical contexts.

Excess mortality in persons with severe mental disorders: a multilevel intervention framework and priorities for clinical practice, policy and research agendas

PubMed Central

Liu, Nancy H.; Daumit, Gail L.; Dua, Tarun; Aquila, Ralph; Charlson, Fiona; Cuijpers, Pim; Druss, Benjamin; Dudek, Kenn; Freeman, Melvyn; Fujii, Chiyo; Gaebel, Wolfgang; Hegerl, Ulrich; Levav, Itzhak; Munk Laursen, Thomas; Ma, Hong; Maj, Mario; Elena Medina‐Mora, Maria; Nordentoft, Merete; Prabhakaran, Dorairaj; Pratt, Karen; Prince, Martin; Rangaswamy, Thara; Shiers, David; Susser, Ezra; Thornicroft, Graham; Wahlbeck, Kristian; Fekadu Wassie, Abe; Whiteford, Harvey; Saxena, Shekhar

2017-01-01

Excess mortality in persons with severe mental disorders (SMD) is a major public health challenge that warrants action. The number and scope of truly tested interventions in this area remain limited, and strategies for implementation and scaling up of programmes with a strong evidence base are scarce. Furthermore, the majority of available interventions focus on a single or an otherwise limited number of risk factors. Here we present a multilevel model highlighting risk factors for excess mortality in persons with SMD at the individual, health system and socio‐environmental levels. Informed by that model, we describe a comprehensive framework that may be useful for designing, implementing and evaluating interventions and programmes to reduce excess mortality in persons with SMD. This framework includes individual‐focused, health system‐focused, and community level and policy‐focused interventions. Incorporating lessons learned from the multilevel model of risk and the comprehensive intervention framework, we identify priorities for clinical practice, policy and research agendas. PMID:28127922

The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles.

PubMed

Ijichi, Shinji; Ijichi, Naomi

2003-11-01

Although the randomized controlled trial (RCT) is a major methodological breakthrough extending the limits of objectivity in clinical medical science, clinical trials of surgery have seldom included placebo surgery as a control, for ethical reasons. Especially in clinical studies intended eventually to establish a new intervention for developmental conditions, it has been recognized that there is huge examiner bias. In addition, the many miraculous cases that have been reported in nonsurgical open trials for developmental conditions and have eventually been evaluated as nonspecific positive outcomes in RCTs suggest that empirically promising interventions must be subjected to scientific scrutiny as soon as possible in the field of developmental conditions. Therefore, in childhood neurosurgery, clinical studies to establish a new therapeutic measure for developmental conditions should be designed as rigorously as possible using optimized scientific methods. The worldwide ethical guideline, the Declaration of Helsinki issued by the World Medical Association, can provide principles for the establishment of a new intervention in the treatment of a patient when proven therapeutic methods do not exist or methods used thus far have been ineffective. Physicians' discretion to use unproven or new therapeutic measures for such patients is approved in the presence of efforts of an ethical and scientific approach. Even if the measure is a very promising intervention, the research aspects must completely be demonstrated for informed consent and review by the ethical committee and the trial must be regarded as a clinical research. Especially when an RCT is not possible for ethical reasons, appropriate epidemiological data or animal experiments should suggest that the new measure is effective before a clinical trial. In a clinical setting, where neither epidemiological studies nor animal experimentation can be introduced, if necessary the researcher should collaborate with experts to obtain multidisciplinary justification for clinical testing.

The natural history of subjective tinnitus in adults: A systematic review and meta-analysis of no-intervention periods in controlled trials.

PubMed

Phillips, John S; McFerran, Don J; Hall, Deborah A; Hoare, Derek J

2018-01-01

Tinnitus is a prevalent condition, but little has been published regarding the natural history of the condition. One technique for evaluating the long-term progression of the disease is to examine what happens to participants in the no-intervention control arm of a clinical trial. The aim of this study was to examine no-intervention or waiting-list data reported in trials, in which participants on the active arm received any form of tinnitus intervention. CINAHL, PsychINFO, EMBASE, ASSIA, PubMed, Web of Science, Science Direct, EBSCO Host, and Cochrane. Inclusion criteria followed the PICOS principles: Participants, adults with tinnitus; Intervention, none; Control, any intervention for alleviating tinnitus; Outcomes, a measure assessing tinnitus symptoms using a multi-item patient-reported tinnitus questionnaire. Secondary outcome measures included multi-item patient-reported questionnaires of mood and health-related quality of life and measures that quantified change in tinnitus loudness; Study design, randomized controlled trials or observational studies utilizing a no-intervention or waiting-list control group. Data were extracted and standardized mean difference was calculated for each study to enable meta-analysis. The evidence strongly favored a statistically significant decrease in the impact of tinnitus over time, though there was significant heterogeneity and clinical significance cannot be interpreted. Outcome data regarding secondary measures did not demonstrate any clinically significant change. Participants allocated to the no-intervention or waiting-list control arm of clinical trials for a tinnitus intervention show a small but significant improvement in self-reported measures of tinnitus with time; the clinical significance of this finding is unknown. There is, however, considerable variation across individuals. These findings support previous work and can cautiously be used when counseling patients. Laryngoscope, 128:217-227, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Impact of a Routine, Opt-Out HIV Testing Program on HIV Testing and Case Detection in North Carolina Sexually-Transmitted Disease Clinics

PubMed Central

Klein, Pamela W.; Messer, Lynne C.; Myers, Evan R.; Weber, David J.; Leone, Peter A.; Miller, William C.

2016-01-01

The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection. Adults aged 18–64 who received an HIV test in a North Carolina STD clinic July 1, 2005 through June 30, 2011 were included in this analysis, dichotomized at the date of implementation on November 1, 2007. HIV testing and case detection counts and rates were analyzed using interrupted time series analysis, and Poisson and multilevel logistic regression. Pre-intervention, 426 new HIV-infected cases were identified from 128,029 tests (0.33%), whereas 816 new HIV-infected cases were found from 274,745 tests post-intervention (0.30%). Pre-intervention, HIV testing increased by 55 tests per month (95% confidence interval [CI]: 41, 72), but only 34 tests per month (95% CI: 26, 42) post-intervention. Increases in HIV testing rates were most pronounced in females and non-Hispanic whites. A slight pre-intervention decline in case detection was mitigated by the intervention (mean difference [MD]=0.01; 95% CI: −0.02, 0.05). Increases in case detection rates were observed among females and non-Hispanic blacks. The impact of a routine HIV screening in North Carolina STD clinics was marginal, with the greatest benefit among persons not traditionally targeted for HIV testing. The use of a pre-intervention comparison period identified important temporal trends that otherwise would have been ignored. PMID:24825338

Structured patient handoff on an internal medicine ward: A cluster randomized control trial.

PubMed

Tam, Penny; Nijjar, Aman P; Fok, Mark; Little, Chris; Shingina, Alexandra; Bittman, Jesse; Raghavan, Rashmi; Khan, Nadia A

2018-01-01

The effect of a multi-faceted handoff strategy in a high volume internal medicine inpatient setting on process and patient outcomes has not been clearly established. We set out to determine if a multi-faceted handoff intervention consisting of education, standardized handoff procedures, including fixed time and location for face-to-face handoff would result in improved rates of handoff compared with usual practice. We also evaluated resident satisfaction, health resource utilization and clinical outcomes. This was a cluster randomized controlled trial in a large academic tertiary care center with 18 inpatient internal medicine ward teams from January-April 2013. We randomized nine inpatient teams to an intervention where they received an education session standardizing who and how to handoff patients, with practice and feedback from facilitators. The control group of 9 teams continued usual non-standardized handoffs. The primary process outcome was the rate of patients handed over per 1000 patient nights. Other process outcomes included perceptions of inadequate handoff by overnight physicians, resource utilization overnight and hospital length of stay. Clinical outcomes included medical errors, frequency of patients requiring higher level of care overnight, and in-hospital mortality. The intervention group demonstrated a significant increase in the rate of patients handed over to the overnight physician (62.90/1000 person-nights vs. 46.86/1000 person-nights, p = 0.002). There was no significant difference in other process outcomes except resource utilization was increased in the intervention group (26.35/1000 person-days vs. 17.57/1000 person-days, p-value = 0.01). There was no significant difference between groups in medical errors (4.8% vs. 4.1%), need for higher level of care or in hospital mortality. Limitations include a dependence of accurate record keeping by the overnight physician, the possibility of cross-contamination in the handoff process, analysis at the cluster level and an overall low number of clinical events. Implementation of a multi-faceted resident handoff intervention did not result in a significant improvement in patient safety although did improve number of patients handed off. Novel methods to improve handoff need to be explored. Registered at ClinicalTrials.gov: NCT01796756.

Statin-Induced Cardioprotection Against Ischemia-Reperfusion Injury: Potential Drug-Drug Interactions. Lesson to be Learnt by Translating Results from Animal Models to the Clinical Settings.

PubMed

Birnbaum, Gilad D; Birnbaum, Itamar; Ye, Yumei; Birnbaum, Yochai

2015-01-01

Numerous interventions have been shown to limit myocardial infarct size in animal models; however, most of these interventions have failed to have a significant effect in clinical trials. One potential explanation for the lack of efficacy in the clinical setting is that in bench models, a single intervention is studied without the background of other interventions or modalities. This is in contrast to the clinical setting in which new medications are added to the "standard of care" treatment that by now includes a growing number of medications. Drug-drug interaction may lead to alteration, dampening, augmenting or masking the effects of the intended intervention. We use the well described model of statin-induced myocardial protection to demonstrate potential interactions with agents which are commonly concomitantly used in patients with stable coronary artery disease and/or acute coronary syndromes. These interactions could potentially explain the reduced efficacy of statins in the clinical trials compared to the animal models. In particular, caffeine and aspirin could attenuate the infarct size limiting effects of statins; morphine could delay the onset of protection or mask the protective effect in patients with ST elevation myocardial infarction, whereas other anti-platelet agents (dipyridamole, cilostazol and ticagrelor) may augment (or mask) the effect due to their favorable effects on adenosine cell reuptake and intracellular cAMP levels. We recommend that after characterizing the effects of new modalities in single intervention bench research, studies should be repeated in the background of standard-of-care medications to assure that the magnitude of the effect is not altered before proceeding with clinical trials.

A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

PubMed

Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

2018-03-01

To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

An Interrupted Time Series Analysis to Determine the Effect of an Electronic Health Record-Based Intervention on Appropriate Screening for Type 2 Diabetes in Urban Primary Care Clinics in New York City.

PubMed

Albu, Jeanine B; Sohler, Nancy; Li, Rui; Li, Xuan; Young, Edwin; Gregg, Edward W; Ross-Degnan, Dennis

2017-08-01

To determine the impact of a health system-wide primary care diabetes management system, which included targeted guidelines for type 2 diabetes (T2DM) and prediabetes (dysglycemia) screening, on detection of previously undiagnosed dysglycemia cases. Intervention included electronic health record (EHR)-based decision support and standardized providers and staff training for using the American Diabetes Association guidelines for dysglycemia screening. Using EHR data, we identified 40,456 adults without T2DM or recent screening with a face-to-face visit (March 2011-December 2013) in five urban clinics. Interrupted time series analyses examined the impact of the intervention on trends in three outcomes: 1 ) monthly proportion of eligible patients receiving dysglycemia testing, 2 ) two negative comparison conditions (dysglycemia testing among ineligible patients and cholesterol screening), and 3 ) yield of undiagnosed dysglycemia among those tested. Baseline monthly proportion of eligible patients receiving testing was 7.4-10.4%. After the intervention, screening doubled (mean increase + 11.0% [95% CI 9.0, 13.0], proportion range 18.6-25.3%). The proportion of ineligible patients tested also increased (+5.0% [95% CI 3.0, 8.0]) with no concurrent change in cholesterol testing (+0% [95% CI -0.02, 0.05]). About 59% of test results in eligible patients showed dysglycemia both before and after the intervention. Implementation of a policy for systematic dysglycemia screening including formal training and EHR templates in urban academic primary care clinics resulted in a doubling of appropriate testing and the number of patients who could be targeted for treatment to prevent or delay T2DM. © 2017 by the American Diabetes Association.

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

PubMed Central

2011-01-01

Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. Methods/Design This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients. Trial registration Current Controlled Trials ISRTN31434033 PMID:21272382

Non-pharmacological approaches to alleviate distress in dementia care.

PubMed

Mitchell, Gary; Agnelli, Joanne

2015-11-25

Distress is one of the most common clinical manifestations associated with dementia. Pharmacological intervention may be appropriate in managing distress in some people. However, best practice guidelines advocate non-pharmacological interventions as the preferred first-line treatment. The use of non-pharmacological interventions encourages healthcare professionals to be more person-centred in their approach, while considering the causes of distress. This article provides healthcare professionals with an overview of some of the non-pharmacological approaches that can assist in alleviating distress for people living with dementia including: reminiscence therapy, reality orientation, validation therapy, music therapy, horticultural therapy, doll therapy and pet therapy. It provides a summary of their use in clinical practice and links to the relevant literature.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

The future of interventional and neurointerventional radiology: learning lessons from the past.

PubMed

Maingard, Julian; Kok, Hong Kuan; Ranatunga, Dinesh; Brooks, Duncan Mark; Chandra, Ronil V; Lee, Michael J; Asadi, Hamed

2017-12-01

The rapid progression of medical imaging technology and the ability to leverage knowledge from non-invasive imaging means that Interventional Radiologists (IRs) and Interventional Neuroradiologists are optimally placed to incorporate minimally invasive interventional paradigms into clinical management to advance patient care. There is ample opportunity to radically change the management options for patients with a variety of diseases through the use of minimally invasive interventional procedures. However, this will need to be accompanied by an increased clinical role of IRs to become active partners in the clinical management of patients. Unfortunately, the development of IR clinical presence has lagged behind and is reflected by declining rates of IR involvement in certain areas of practice such as vascular interventions. Current and future IRs must be willing to take on clinical responsibilities; reviewing patients in clinic to determine suitability for a procedure and potential contraindications, rounding on hospital inpatients and be willing to manage procedure related complications, which are all important parts of a successful IR practice. Increasing our clinical presence has several advantages over the procedure-driven model including enhanced patient knowledge and informed consent for IR procedures, improved rapport with patients and other clinical colleagues through active participation and engagement in patient care, visibility as a means to facilitate referrals and consistency of follow-up with opportunities for further learning. Many of the solutions to these problems are already in progress and the use of IR as a "hired gun" or "technician" is a concept that should be relegated to the past, and replaced with recognition of IRs as clinicians and partners in delivering modern high quality multidisciplinary team-based patient care. The following article will review the history of IR, the challenges facing this rapidly evolving profession and discuss recent developments occurring globally that are essential in maintaining expertise, securing future growth and improving patient outcomes in the modern multidisciplinary practice of medicine.

A Place-Based Community Health Worker Program: Feasibility and Early Outcomes, New York City, 2015

PubMed Central

Lopez, Priscilla M.; Islam, Nadia; Feinberg, Alexis; Myers, Christa; Seidl, Lois; Drackett, Elizabeth; Riley, Lindsey; Mata, Andrea; Pinzon, Juan; Benjamin, Elisabeth; Wyka, Katarzyna; Dannefer, Rachel; Lopez, Javier; Trinh-Shevrin, Chau; Maybank, Karen Aletha; Thorpe, Lorna E.

2017-01-01

Introduction This study examined feasibility of a place-based community health worker (CHW) and health advocate (HA) initiative in five public housing developments selected for high chronic disease burden and described early outcomes. Methods This intervention was informed by a mixed-method needs assessment performed December 2014–January 2015 (representative telephone survey, n=1,663; six focus groups, n=55). Evaluation design was a non-randomized, controlled quasi-experiment. Intake and 3-month follow-up data were collected February–December 2015 (follow-up response rate, 93%) on 224 intervention and 176 comparison participants, and analyzed in 2016. All participants self-reported diagnoses of hypertension, diabetes, or asthma. The intervention consisted of chronic disease self-management and goal setting through six individual CHW-led health coaching sessions, instrumental support, and facilitated access to insurance/clinical care navigation from community-based HAs. Feasibility measures included CHW service satisfaction and successful goal setting. Preliminary outcomes included clinical measures (blood pressure, BMI); disease management behaviors and self-efficacy; and preventive behaviors (physical activity). Results At the 3-month follow-up, nearly all intervention participants reported high satisfaction with their CHW (90%) and HA (76%). Intervention participants showed significant improvements in self-reported physical activity (p=0.005) and, among hypertensive participants, self-reported routine blood pressure self-monitoring (p=0.013) compared with comparison participants. No improvements were observed in self-efficacy or clinical measures at the 3-month follow-up. Conclusions Housing-based initiatives involving CHW and HA teams are acceptable to public housing residents and can be effectively implemented to achieve rapid improvements in physical activity and chronic disease self-management. At 3-month assessment, additional time and efforts are required to improve clinical outcomes. PMID:28215382

Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

PubMed

Tonet, Elisabetta; Maietti, Elisa; Chiaranda, Giorgio; Vitali, Francesco; Serenelli, Matteo; Bugani, Giulia; Mazzoni, Gianni; Ruggiero, Rossella; Myers, Jonathan; Villani, Giovanni Quinto; Corvi, Ursula; Pasanisi, Giovanni; Biscaglia, Simone; Pavasini, Rita; Lucchi, Giulia Ricci; Sella, Gianluigi; Ferrari, Roberto; Volpato, Stefano; Campo, Gianluca; Grazzi, Giovanni

2018-05-21

Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance. HULK is an investigator-initiated, prospective multicenter randomized controlled trial (NCT03021044). After successful management of the ACS acute phase and uneventful first 1 month, elderly (≥70 years) patients showing reduced physical performance are randomized (1:1 ratio) to either standard of care or physical activity intervention. Reduced physical performance is defined as a short physical performance battery (SPPB) score of 4-9. The early, tailored, low-cost physical intervention includes 4 sessions of physical activity with a supervisor and an home-based program of physical exercise. The chosen primary endpoint is the 6-month SPPB value. Secondary endpoints briefly include quality of life, on-treatment platelet reactivity, some laboratory data and clinical adverse events. To demonstrate an increase of at least one SPPB point in the experimental arm, a sample size of 226 patients is needed. The HULK study will test the hypothesis that an early, tailored low-cost physical activity intervention improves physical performance, quality of life, frailty status and outcome in elderly ACS patients with reduced physical performance. Clinicaltrials.gov, identifier NCT03021044 , first posted January, 13th 2017.

Cost and sustainability of a successful package of interventions to improve vaccination coverage for children in urban slums of Bangladesh.

PubMed

Hayford, K; Uddin, M J; Koehlmoos, T P; Bishai, D M

2014-04-25

To estimate the incremental economic costs and explore satisfaction with a highly effective intervention for improving immunization coverage among slum populations in Dhaka, Bangladesh. A package of interventions based on extended clinic hours, vaccinator training, active surveillance, and community participation was piloted in two slum areas of Dhaka, and resulted in an increase in valid fully immunized children (FIC) from 43% pre-intervention to 99% post-intervention. Cost data and stakeholder perspectives were collected January-February 2010 via document review and 10 key stakeholders interviews to estimate the financial and opportunity costs of the intervention, including uncompensated time, training and supervision costs. The total economic cost of the 1-year intervention was $18,300, comprised of external management and supervision (73%), training (11%), coordination costs (1%), uncompensated staff time and clinic costs (2%), and communications, supplies and other costs (13%). An estimated 874 additional children were correctly and fully immunized due to the intervention, at an average cost of $20.95 per valid FIC. Key stakeholders ranked extended clinic hours and vaccinator training as the most important components of the intervention. External supervision was viewed as the most important factor for the intervention's success but also the costliest. All stakeholders would like to reinstate the intervention because it was effective, but additional funding would be needed to make the intervention sustainable. Targeting slum populations with an intensive immunization intervention was highly effective but would nearly triple the amount spent on immunization per FIC in slum areas. Those committed to increasing vaccination coverage for hard-to-reach children need to be prepared for substantially higher costs to achieve results. Copyright © 2014. Published by Elsevier Ltd.

Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial.

PubMed

Ring, Howard; Gilbert, Nakita; Hook, Roxanne; Platt, Adam; Smith, Christopher; Irvine, Fiona; Donaldson, Cam; Jones, Elizabeth; Kelly, Joanna; Mander, Adrian; Murphy, Caroline; Pennington, Mark; Pullen, Angela; Redley, Marcus; Rowe, Simon; Wason, James

2016-06-24

In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money. The EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a 'treatment as usual' control or a 'defined epilepsy nurse role' active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants' carers are also undertaken. The EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed. International Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.

[Does the prescribing of antibiotics in paediatrics improve after a multidisciplinary intervention?].

PubMed

Lalana-Josa, Pilar; Laclaustra-Mendizábal, Blanca; Aza-Pascual-Salcedo, M Mercedes; Carcas-de-Benavides, Cristina; Lallana-Álvarez, M Jesús; Pina-Gadea, M Belén

2015-02-01

Antibiotics overuse is linked to elevated antimicrobial resistance. In Aragon, Spain, the highest antibiotic prescription rates occur among children from 1 to 4 years old. The rate of use in this age group is over 60%. To evaluate the effect of multi-faceted intervention on Primary Care paediatricians to reduce antibiotic use and to improve antibiotic prescribing for paediatric outpatients. Outpatient antimicrobial prescribing was analysed before and after an intervention in paediatricians. The intervention included a clinical education session about diagnosis and treatment in the most prevalent paediatric infectious diseases, a clinical interview and communication skills, a workshop on rapid Streptococcus antigen detection test and patient information leaflets and useful internet websites for parents. The control group included paediatricians without this educational intervention on antibiotics. Antibiotic prescribing decreased from 19.17 defined daily doses per 1000 inhabitants/day (DID) to 14.36 DID among intervention paediatricians vs 19.84 DID to 16.02 DID in controls. The decreasing was higher in the intervention group, but the effect was not statistically significant. Macrolides and broad-spectrum penicillins prescribing decreased in both groups. Antibiotic prescribing decreased, but there were no statistically significant differences between the two groups. The high satisfaction of paediatricians in the intervention group makes it necessary to continue with these kinds of strategies to improve antibiotic use in outpatients. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Interventions in randomised controlled trials in surgery: issues to consider during trial design.

PubMed

Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M

2015-09-04

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

Joint BAP NAPICU evidence-based consensus guidelines for the clinical management of acute disturbance: De-escalation and rapid tranquillisation.

PubMed

Patel, Maxine X; Sethi, Faisil N; Barnes, Thomas Re; Dix, Roland; Dratcu, Luiz; Fox, Bernard; Garriga, Marina; Haste, Julie C; Kahl, Kai G; Lingford-Hughes, Anne; McAllister-Williams, Hamish; O'Brien, Aileen; Parker, Caroline; Paterson, Brodie; Paton, Carol; Posporelis, Sotiris; Taylor, David M; Vieta, Eduard; Völlm, Birgit; Wilson-Jones, Charlotte; Woods, Laura

2018-06-01

The British Association for Psychopharmacology and the National Association of Psychiatric Intensive Care and Low Secure Units developed this joint evidence-based consensus guideline for the clinical management of acute disturbance. It includes recommendations for clinical practice and an algorithm to guide treatment by healthcare professionals with various options outlined according to their route of administration and category of evidence. Fundamental overarching principles are included and highlight the importance of treating the underlying disorder. There is a focus on three key interventions: de-escalation, pharmacological interventions pre-rapid tranquillisation and rapid tranquillisation (intramuscular and intravenous). Most of the evidence reviewed relates to emergency psychiatric care or acute psychiatric adult inpatient care, although we also sought evidence relevant to other common clinical settings including the general acute hospital and forensic psychiatry. We conclude that the variety of options available for the management of acute disturbance goes beyond the standard choices of lorazepam, haloperidol and promethazine and includes oral-inhaled loxapine, buccal midazolam, as well as a number of oral antipsychotics in addition to parenteral options of intramuscular aripiprazole, intramuscular droperidol and intramuscular olanzapine. Intravenous options, for settings where resuscitation equipment and trained staff are available to manage medical emergencies, are also included.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

PubMed

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials

PubMed Central

Zabetian, Azadeh; Ferket, Bart S.; Zhou, Jing; Testani, Jeffrey M.; Garg, Amit X.; Parikh, Chirag R.

2016-01-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short–term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between–group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo–controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. PMID:26712525

Interventions to Modify Health Care Provider Adherence to Asthma Guidelines: A Systematic Review

PubMed Central

Okelo, Sande O.; Butz, Arlene M.; Sharma, Ritu; Diette, Gregory B.; Pitts, Samantha I.; King, Tracy M.; Linn, Shauna T.; Reuben, Manisha; Chelladurai, Yohalakshmi

2013-01-01

BACKGROUND AND OBJECTIVE: Health care provider adherence to asthma guidelines is poor. The objective of this study was to assess the effect of interventions to improve health care providers’ adherence to asthma guidelines on health care process and clinical outcomes. METHODS: Data sources included Medline, Embase, Cochrane CENTRAL Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, PsycINFO, and Research and Development Resource Base in Continuing Medical Education up to July 2012. Paired investigators independently assessed study eligibility. Investigators abstracted data sequentially and independently graded the evidence. RESULTS: Sixty-eight eligible studies were classified by intervention: decision support, organizational change, feedback and audit, clinical pharmacy support, education only, quality improvement/pay-for-performance, multicomponent, and information only. Half were randomized trials (n = 35). There was moderate evidence for increased prescriptions of controller medications for decision support, feedback and audit, and clinical pharmacy support and low-grade evidence for organizational change and multicomponent interventions. Moderate evidence supports the use of decision support and clinical pharmacy interventions to increase provision of patient self-education/asthma action plans. Moderate evidence supports use of decision support tools to reduce emergency department visits, and low-grade evidence suggests there is no benefit for this outcome with organizational change, education only, and quality improvement/pay-for-performance. CONCLUSIONS: Decision support tools, feedback and audit, and clinical pharmacy support were most likely to improve provider adherence to asthma guidelines, as measured through health care process outcomes. There is a need to evaluate health care provider-targeted interventions with standardized outcomes. PMID:23979092

Outcomes of psychotherapeutic and psychoeducative group interventions for children exposed to intimate partner violence.

PubMed

Pernebo, Karin; Fridell, Mats; Almqvist, Kjerstin

2018-05-01

Witnessing violence toward a caregiver during childhood is associated with negative impact on children's health and development, and there is a need for effective interventions for children exposed to intimate partner violence in clinical as well as in community settings. The current effectiveness study investigated symptom reduction after participation in two established group interventions (one community-based psychoeducative intervention; one psychotherapeutic treatment intervention) for children exposed to intimate partner violence and for their non-offending parent. The study included 50 children-24 girls and 26 boys-aged 4-13 years and their mothers. Child and maternal mental health problems and trauma symptoms were assessed pre- and post-treatment. The results indicate that although children showed benefits from both interventions, symptom reduction was larger in the psychotherapeutic intervention, and children with initially high levels of trauma symptoms benefited the most. Despite these improvements, a majority of the children's mothers still reported child trauma symptoms at clinical levels post-treatment. Both interventions substantially reduced maternal post-traumatic stress. The results indicate a need for routine follow-up of children's symptoms after interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 2: Liver and Other Applications in Oncology.

PubMed

Barkhausen, Jörg; Kahn, Thomas; Krombach, Gabriele A; Kuhl, Christiane K; Lotz, Joachim; Maintz, David; Ricke, Jens; Schönberg, Stefan O; Vogl, Thomas J; Wacker, Frank K

2017-11-01

Background  MRI is attractive for guiding and monitoring interventional procedures due to its high intrinsic soft tissue contrast and the possibility to measure flow and cardiac function. Methods  Technical solutions have been developed for all procedural steps including imaging guidance, MR-safe catheters and instruments and patient monitoring. This has led to widening of the clinical applications. Interventional MRI is becoming increasingly important for the treatment of patients suffering from malignant diseases. The detectability of masses and consequently their accessibility for biopsy is higher, compared to other modalities, due to the high intrinsic soft tissue contrast of MRI. Temperature-dependent sequences allow for minimally invasive and tissue-sparing ablation (A-0 ablation). Conclusion  Interventional MRI has become established in the clinical routine for a variety of indications, including biopsies and tumor ablation. Since the economic requirement of covering costs by reimbursement is met and interventional MRI decreases the mortality and morbidity of interventional procedures, broader application of interventional MRI can be expected in the clinical routine in the future. Key points   · Particularly for the treatment of oncological patients, interventional MRI is superior to other methods with respect to minimal invasiveness and tissue protection due to the ability to exactly determine tumor borders and to visualize and control the size of the ablation area on the basis of MR temperature measurement.. · Due to the better visualization of targets and the effects of ablation in tissue, interventional MRI can lower the mortality and morbidity associated with these interventions for many indications.. · The complex comparison of costs and reimbursement shows that this application can be performed in a cost-covering manner and broader application can be expected in the future.. Citation Format · Barkhausen J, Kahn T, Krombach GA et al. White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 2: Liver and Other Applications in Oncology. Fortschr Röntgenstr 2017; 189: 1047 - 1054. © Georg Thieme Verlag KG Stuttgart · New York.

Comparison of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial.

PubMed

Champion, Jane Dimmitt; Collins, Jennifer L

2012-02-01

Ethnic minority adolescent women with a history of sexual or physical abuse and sexually transmitted infections represent a vulnerable population at risk for HIV. Community-based interventions for behavior modification and subsequent risk reduction have not been effective among these women. To evaluate the effects of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention model versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection at 6 and 12 months follow-up. Controlled randomized trial with longitudinal follow-up. Southwestern United States, Metropolitan community-based clinic. Mexican-and-African American adolescent women aged 14-18 years with a history of abuse or sexually transmitted infection seeking sexual health care. Extensive preliminary study for intervention development was conducted including individual interviews, focus groups, secondary data analysis, pre-testing and feasibility testing for modification of an evidence-based intervention prior to testing in the randomized controlled trial. Following informed consents for participation in the trial, detailed interviews concerning demographics, abuse history, sexual risk behavior, sexual health and physical exams were obtained. Randomization into either control or intervention groups was conducted. Intervention participants received workshop, support group and individual counseling sessions. Control participants received abuse and enhanced clinical counseling. Follow-up including detailed interview and physical exam was conducted at 6 and 12 months following study entry to assess for infection. Intention to treat analysis was conducted to assess intervention effects using chi-square and multiple regression models. 409 Mexican-(n=342) and African-(n=67) American adolescent women with abuse and sexually transmitted infection histories were enrolled; 90% intervention group attendance; longitudinal follow-up at 6 (93%) and 12 (94%) months. Intervention (n=199) versus control (n=210) group participants experienced fewer infections at 0-6 (0% versus 6.6%, p=.001), 6-12 (3.6% versus 7.8%, p=.005, CI 95% lower-upper .001-.386) and 0-12 (4.8% versus 13.2%, p=.002, CI 95% lower-upper, .002-.531) month intervals. A cognitive behavioral intervention specifically designed for ethnic minority adolescent women with a history of abuse and sexually transmitted infection was effective for prevention of infection. These results provide evidence for development of evidence-based interventions for sexually transmitted infection/HIV. Implications include translation to community-clinic-based settings for prevention of adverse outcomes regarding sexual health of adolescent women. Copyright © 2011 Elsevier Ltd. All rights reserved.

Capability for change at community health centers serving Asian Pacific Islanders: an exploratory study of a cancer screening evidence-based intervention.

PubMed

Sohng, Hee Yon; Kuniyuki, Alan; Edelson, Jane; Weir, Rosy Chang; Song, Hui; Tu, Shin-Ping

2013-01-01

Understanding and enhancing change capabilities, including Practice Adaptive Reserve (PAR), of Community Health Centers (CHCs) may mitigate cancer-related health disparities. Using stratified random sampling, we recruited 232 staff from seven CHCs serving Asian Pacific Islander communities to complete a self-administered survey. We performed multilevel regression analyses to examine PAR composite scores by CHC, position type, and number of years worked at their clinic. The mean PAR score was 0.7 (s.d. 0.14). Higher scores were associated with a greater perceived likelihood that clinic staff would participate in an evidence-based intervention (EBI). Constructs such as communication, clinic flow, sensemaking, change valence, and resource availability were positively associated with EBI implementation or trended toward significance. PAR scores are positively associated with perceived likelihood of clinic staff participation in cancer screening EBI. Future research is needed to determine PAR levels most conducive to implementing change and to developing interventions that enhance Adaptive Reserve.

Comparative Approaches to Understanding the Relation Between Aging and Physical Function

PubMed Central

Cesari, Matteo; Seals, Douglas R.; Shively, Carol A.; Carter, Christy S.

2016-01-01

Despite dedicated efforts to identify interventions to delay aging, most promising interventions yielding dramatic life-span extension in animal models of aging are often ineffective when translated to clinical trials. This may be due to differences in primary outcomes between species and difficulties in determining the optimal clinical trial paradigms for translation. Measures of physical function, including brief standardized testing batteries, are currently being proposed as biomarkers of aging in humans, are predictive of adverse health events, disability, and mortality, and are commonly used as functional outcomes for clinical trials. Motor outcomes are now being incorporated into preclinical testing, a positive step toward enhancing our ability to translate aging interventions to clinical trials. To further these efforts, we begin a discussion of physical function and disability assessment across species, with special emphasis on mice, rats, monkeys, and man. By understanding how physical function is assessed in humans, we can tailor measurements in animals to better model those outcomes to establish effective, standardized translational functional assessments with aging. PMID:25910845

Consensus and clinical recommendations for nutritional intervention for head and neck cancer patients undergoing chemoradiotherapy in Taiwan.

PubMed

Lin, Mei-Chun; Shueng, Pei-Wei; Chang, Wei-Kuo; Mu-Hsin Chang, Peter; Feng, Hsin-Chun; Yang, Muh-Hwa; Lou, Pei-Jen

2018-06-01

Because of the anatomical location, patients with head and neck cancer (HNC) frequently experience dysphagia and malnutrition at the time of diagnosis and these conditions are often exacerbated after chemoradiotherapy. There is an emerging medical need to establish a consensus on nutritional intervention for these patients. A panel of 30 senior physicians and experts from multidisciplinary teams drafted clinical recommendations to improve the management of nutritional interventions in Taiwan and to provide updated treatment strategy recommendations in hope of improving the nutritional status of patients with HNC. This clinical review describes the resulting consensus document, including the impact of malnutrition on clinical outcomes, the role of prophylactic tube feeding, the choice of tube feeding, and the benefit of oral nutritional supplements in patients with HNC undergoing chemoradiotherapy. The outcomes of this review will support clinicians in their efforts to improve the nutritional status of patients with HNC. Copyright © 2018 Elsevier Ltd. All rights reserved.

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

PubMed

Joseph, Christine Lm; Ownby, Dennis R; Zoratti, Edward; Johnson, Dayna; Considine, Shannon; Bourgeois, Renee; Melkonian, Christina; Miree, Cheryl; Johnson, Christine Cole; Lu, Mei

2016-01-01

Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings. We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention. 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing. Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more "explanatory" framework. .

Middle Managers' Experiences and Role in Implementing an Interactive Tailored Patient Assessment eHealth Intervention in Clinical Practice.

PubMed

Varsi, Cecilie; Ekstedt, Mirjam; Gammon, Deede; Børøsund, Elin; Ruland, Cornelia M

2015-06-01

The role of nurse and physician managers is considered crucial for implementing eHealth interventions in clinical practice, but few studies have explored this. The aim of the current study was to examine the perceptions of nurse and physician managers regarding facilitators, barriers, management role, responsibility, and action taken in the implementation of an eHealth intervention called Choice into clinical practice. Individual qualitative interviews were conducted with six nurses and three physicians in management positions at five hospital units. The findings revealed that nurse managers reported conscientiously supporting the implementation, but workloads prevented them from participating in the process as closely as they wanted. Physician managers reported less contribution. The implementation process was influenced by facilitating factors such as perceptions of benefits from Choice and use of implementation strategies, along with barriers such as physician resistance, contextual factors and difficulties for front-line providers in learning a new way of communicating with the patients. The findings suggest that role descriptions for both nurse and physician managers should include implementation knowledge and implementation skills. Managers could benefit from an implementation toolkit. Implementation management should be included in management education for healthcare managers to prepare them for the constant need for implementation and improvement in clinical practice.

Patent Ductus Arteriosus in Preterm Infants: Do We Have the Right Answers?

PubMed Central

Nasef, Nehad; Nour, Islam

2013-01-01

Patent ductus arteriosus (PDA) is a common clinical condition in preterm infants. Preterm newborns with PDA are at greater risk for several morbidities, including higher rates of bronchopulmonary dysplasia (BPD), decreased perfusion of vital organs, and mortality. Therefore, cyclooxygenase (COX) inhibitors and surgical interventions for ligation of PDA are widely used. However, these interventions were reported to be associated with side effects. In the absence of clear restricted rules for application of these interventions, different strategies are adopted by neonatologists. Three different approaches have been investigated including prophylactic treatment shortly after birth irrespective of the state of PDA, presymptomatic treatment using echocardiography at variable postnatal ages to select infants for treatment prior to the duct becoming clinically significant, and symptomatic treatment once PDA becomes clinically apparent or hemodynamically significant. Future appropriately designed randomized controlled trials (RCTs) to refine selection of patients for medical and surgical treatments should be conducted. Waiting for new evidence, it seems wise to employ available clinical and echocardiographic parameters of a hemodynamically significant (HS) PDA to select patients who are candidates for medical treatment. Surgical ligation of PDA could be used as a back-up tool for those patients who failed medical treatment and continued to have hemodynamic compromise. PMID:24455715

COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.

PubMed

Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

2015-09-15

Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff's knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular. ClinicalTrials.gov NCT02238652.

Diagnostic and interventional musculoskeletal ultrasound: part 2. Clinical applications.

PubMed

Smith, Jay; Finnoff, Jonathan T

2009-02-01

Musculoskeletal ultrasound involves the use of high-frequency sound waves to image soft tissues and bony structures in the body for the purposes of diagnosing pathology or guiding real-time interventional procedures. Recently, an increasing number of physicians have integrated musculoskeletal ultrasound into their practices to facilitate patient care. Technological advancements, improved portability, and reduced costs continue to drive the proliferation of ultrasound in clinical medicine. This increased interest creates a need for education pertaining to all aspects of musculoskeletal ultrasound. The primary purpose of this article is to review diagnostic ultrasound technology and its potential clinical applications in the evaluation and treatment of patients with neurological and musculoskeletal disorders. After reviewing this article, physicians should be able to (1) list the advantages and disadvantages of ultrasound compared to other available imaging modalities; (2) describe how ultrasound machines produce images using sound waves; (3) discuss the steps necessary to acquire and optimize an ultrasound image; (4) understand the difference ultrasound appearances of tendons, nerves, muscles, ligaments, blood vessels, and bones; and (5) identify multiple applications for diagnostic and interventional musculoskeletal ultrasound. Part 2 of this 2-part article will focus on the clinical applications of musculoskeletal ultrasound in clinical practice, including the ultrasonographic appearance of normal and abnormal tissues as well as specific diagnostic and interventional applications in major body regions.

Self-care interventions for the school-aged child with encopresis.

PubMed

Vitito, L M

2000-01-01

Encopresis, an elimination disorder in children, presents as a challenging problem for gastroenterology nurses working with patients and families confronted with this disorder. This article offers a summary of the literature on encopresis, including pathogenesis, causative factors, early treatment, and clinical interventions focused on self-care. The antecedent factors that facilitate the child's participation in self-care are summarized, along with the intended outcomes of the self-care intervention plan.

Improved Clinical Performance and Teamwork of Pediatric Interprofessional Resuscitation Teams With a Simulation-Based Educational Intervention.

PubMed

Gilfoyle, Elaine; Koot, Deanna A; Annear, John C; Bhanji, Farhan; Cheng, Adam; Duff, Jonathan P; Grant, Vincent J; St George-Hyslop, Cecilia E; Delaloye, Nicole J; Kotsakis, Afrothite; McCoy, Carolyn D; Ramsay, Christa E; Weiss, Matthew J; Gottesman, Ronald D

2017-02-01

To measure the effect of a 1-day team training course for pediatric interprofessional resuscitation team members on adherence to Pediatric Advanced Life Support guidelines, team efficiency, and teamwork in a simulated clinical environment. Multicenter prospective interventional study. Four tertiary-care children's hospitals in Canada from June 2011 to January 2015. Interprofessional pediatric resuscitation teams including resident physicians, ICU nurse practitioners, registered nurses, and registered respiratory therapists (n = 300; 51 teams). A 1-day simulation-based team training course was delivered, involving an interactive lecture, group discussions, and four simulated resuscitation scenarios, each followed by a debriefing. The first scenario of the day (PRE) was conducted prior to any team training. The final scenario of the day (POST) was the same scenario, with a slightly modified patient history. All scenarios included standardized distractors designed to elicit and challenge specific teamwork behaviors. Primary outcome measure was change (before and after training) in adherence to Pediatric Advanced Life Support guidelines, as measured by the Clinical Performance Tool. Secondary outcome measures were as follows: 1) change in times to initiation of chest compressions and defibrillation and 2) teamwork performance, as measured by the Clinical Teamwork Scale. Correlation between Clinical Performance Tool and Clinical Teamwork Scale scores was also analyzed. Teams significantly improved Clinical Performance Tool scores (67.3-79.6%; p < 0.0001), time to initiation of chest compressions (60.8-27.1 s; p < 0.0001), time to defibrillation (164.8-122.0 s; p < 0.0001), and Clinical Teamwork Scale scores (56.0-71.8%; p < 0.0001). A positive correlation was found between Clinical Performance Tool and Clinical Teamwork Scale (R = 0.281; p < 0.0001). Participation in a simulation-based team training educational intervention significantly improved surrogate measures of clinical performance, time to initiation of key clinical tasks, and teamwork during simulated pediatric resuscitation. A positive correlation between clinical and teamwork performance suggests that effective teamwork improves clinical performance of resuscitation teams.

Hypnosis for procedure-related pain and distress in pediatric cancer patients: a systematic review of effectiveness and methodology related to hypnosis interventions.

PubMed

Richardson, Janet; Smith, Joanna E; McCall, Gillian; Pilkington, Karen

2006-01-01

The aim of this study was to systematically review and critically appraise the evidence on the effectiveness of hypnosis for procedure-related pain and distress in pediatric cancer patients. A comprehensive search of major biomedical and specialist complementary and alternative medicine databases was conducted. Citations were included from the databases' inception to March 2005. Efforts were made to identify unpublished and ongoing research. Controlled trials were appraised using predefined criteria. Clinical commentaries were obtained for each study. Seven randomized controlled clinical trials and one controlled clinical trial were found. Studies report positive results, including statistically significant reductions in pain and anxiety/distress, but a number of methodological limitations were identified. Systematic searching and appraisal has demonstrated that hypnosis has potential as a clinically valuable intervention for procedure-related pain and distress in pediatric cancer patients. Further research into the effectiveness and acceptability of hypnosis for pediatric cancer patients is recommended.

A clinical treatment intervention for dysphoria: externalizing metaphors therapy.

PubMed

McGuinty, Everett; Armstrong, David; Carrière, Anne-Marie

2014-01-01

The purpose of this article is to explore a novel, short-term treatment intervention for internalizing behaviours. This intervention is primarily based upon an externalizing process, transforming of metaphoric imagery, and shifting of underlying maladaptive emotional schemas. This article addresses the clinical population of children and youth, specifically through outlining the protocol, externalizing metaphors therapy. A selective review of significant works regarding the efficacy of short-term therapy was conducted, including the process of change within narrative therapy. It is proposed that two specific processes account for the mental health change experienced by clients who receive this new treatment intervention: (1) externalization of problems and (2) purposeful client-generated metaphor manipulation, impacting upon underlying schemas. From these theoretical constructs, the present article outlines a three-session treatment protocol that manualizes these key clinical processes. A case study is presented to illustrate this intervention for anxiety and depression. Further clinical research is underway to address the testable hypotheses resulting from the current theoretical model. Clinical trials in brief psychotherapy are suggested to empirically evaluate the efficacy of this new treatment intervention for dysphoria. This article outlines a short-term treatment intervention for anxiety and depression (dysphoira) through a novel 3-session model, where the clinician-practitioner can obtain competency through a one-day workshop.Its relevance for the clinical researcher and the mental health community is in its versatility in addressing internalizing behavior for four clinical populations: (1) children and adolescents; (2) children and adolescents on the autism spectrum; (3) adults in general; and, (4) adults with a dual-diagnosis. The treatment protocol described within is based upon the externalizing and deconstructive properties of Narrative Therapy, and the transformation of metaphoric imagery of Metaphor Therapy; both of which have little empirical support with narrative practices gaining international attention and widespread usage - through brief therapy, long-term therapy, and walk-in clinics in North America. For the first time, the theoretical constructs of the 3-session model are described and a case example illustrates the interlinking concepts. Copyright © 2013 John Wiley & Sons, Ltd.

Prolonged impact of home versus clinic-based management of chronic heart failure: extended follow-up of a pragmatic, multicentre randomized trial cohort.

PubMed

Stewart, Simon; Carrington, Melinda J; Horowitz, John D; Marwick, Thomas H; Newton, Phillip J; Davidson, Patricia M; Macdonald, Peter; Thompson, David R; Chan, Yih-Kai; Krum, Henry; Reid, Christopher; Scuffham, Paul A

2014-07-01

We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure (CHF). We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 ± 216 days. Blinded endpoints included event-free survival from all-cause emergency hospitalization or death, all-cause mortality and rate of all-cause hospitalization and stay. 280 patients (73% male, aged 71 ± 14 years and 73% left ventricular systolic dysfunction) were initially randomized to home-based (n=143) or clinic-based (n=137) intervention. During extended follow-up (complete for 274 patients), 1139 all-cause hospitalizations (7477 days of hospital stay) and 121 (43.2%) deaths occurred. There was no difference in the primary endpoint; 20 (14.0%) home-based versus 13 (7.4%) clinic-based patients remained event-free (adjusted HR 0.89, 95% CI 0.70 to 1.15; p=0.378). Significantly fewer home-based (51/143, 35.7%) than clinic-based intervention (71/137, 51.8%) patients died (adjusted HR 0.62, 95% CI 0.42 to 0.90: p=0.012). Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations (p=0.087) associated with 3067 (median 4.0, IQR 2.0 to 6.8) versus 4410 (6.0, IQR 3.0 to 12.0) days of hospital stay (p<0.01 for rate and duration of hospital stay). Relative to clinic-based intervention, home-based intervention was not associated with prolonged event-free survival. Home-based intervention was, however, associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term. Australian New Zealand Clinical Trials Registry number 12607000069459 (http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81803). Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Hypnotherapy for the Management of Chronic Pain

PubMed Central

Elkins, Gary; Jensen, Mark P.; Patterson, David R.

2009-01-01

This article reviews controlled prospective trials of hypnosis for the treatment of chronic pain. Thirteen studies, excluding studies of headaches, were identified that compared outcomes from hypnosis for the treatment of chronic pain to either baseline data or a control condition. The findings indicate that hypnosis interventions consistently produce significant decreases in pain associated with a variety of chronic-pain problems. Also, hypnosis was generally found to be more effective than nonhypnotic interventions such as attention, physical therapy, and education. Most of the hypnosis interventions for chronic pain include instructions in self-hypnosis. However, there is a lack of standardization of the hypnotic interventions examined in clinical trials, and the number of patients enrolled in the studies has tended to be low and lacking long-term follow-up. Implications of the findings for future clinical research and applications are discussed. PMID:17558718

Changes and Clinical Consequences of Smoking Cessation in Patients With COPD: A Prospective Analysis From the CHAIN Cohort.

PubMed

Martínez-González, Cristina; Casanova, Ciro; de-Torres, Juan P; Marín, José M; de Lucas, Pilar; Fuster, Antonia; Cosío, Borja G; Calle, Myriam; Peces-Barba, Germán; Solanes, Ingrid; Agüero, Ramón; Feu-Collado, Nuria; Alfageme, Inmaculada; Romero Plaza, Amparo; Balcells, Eva; de Diego, Alfredo; Marín Royo, Margarita; Moreno, Amalia; Llunell Casanovas, Antonia; Galdiz, Juan B; Golpe, Rafael; Lacárcel Bautista, Celia; Cabrera, Carlos; Marin, Alicia; Soriano, Joan B; Lopez-Campos, Jose Luis

2018-02-22

Despite the existing evidence-based smoking cessation interventions, chances of achieving that goal in real life are still low among patients with COPD. We sought to evaluate the clinical consequences of changes in smoking habits in a large cohort of patients with COPD. CHAIN (COPD History Assessment in Spain) is a Spanish multicenter study carried out at pulmonary clinics including active and former smokers with COPD. Smoking status was certified by clinical history and co-oximetry. Clinical presentation and disease impact were recorded via validated questionnaires, including the London Chest Activity of Daily Living (LCADL) and the Hospital Anxiety and Depression Scale (HADS). No specific smoking cessation intervention was carried out. Factors associated with and clinical consequences of smoking cessation were analyzed by multivariate regression and decision tree analyses. One thousand and eighty-one patients with COPD were included (male, 80.8%; age, 65.2 [SD 8.9] years; FEV 1 , 60.2 [20.5]%). During the 2-year follow-up time (visit 2, 906 patients; visit 3, 791 patients), the majority of patients maintained the same smoking habit. Decision tree analysis detected chronic expectoration as the most relevant variable to identify persistent quitters in the future, followed by an LCADL questionnaire (cutoff 9 points). Total anxiety HADS score was the most relevant clinical impact associated with giving up tobacco, followed by the LCADL questionnaire with a cutoff value of 10 points. In this real-life prospective COPD cohort with no specific antismoking intervention, the majority of patients did not change their smoking status. Our study also identifies baseline expectoration, anxiety, and dyspnea with daily activities as the major determinants of smoking status in COPD. ClinicalTrials.gov; No. NCT01122758; URL: www.clinicaltrials.gov. Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

A cluster-randomized controlled study to evaluate a team coaching concept for improving teamwork and patient-centeredness in rehabilitation teams

PubMed Central

Körner, Mirjam; Luzay, Leonie; Plewnia, Anne; Becker, Sonja; Rundel, Manfred; Zimmermann, Linda; Müller, Christian

2017-01-01

Purpose Although the relevance of interprofessional teamwork in the delivery of patient-centered care is well known, there is a lack of interventions for improving team interaction in the context of rehabilitation in Germany. The aim of the present study is to evaluate whether a specially developed team coaching concept (TCC) could improve both teamwork and patient-centeredness. Method A multicenter, cluster-randomized controlled intervention study was conducted with both staff and patient questionnaires. Data was collected at ten German rehabilitation clinics (five clusters) of different indication fields before (t1) and after (t2) the intervention. Intervention clinics received the TCC, while control clinics did not receive any treatment. Staff questionnaires were used to measure internal participation and other aspects of teamwork, such as team organization, while patient questionnaires assessed patient-centeredness. A multivariate analysis of variance was applied for data analysis. Results In order to analyze the effect of TCC on internal participation and teamwork, 305 questionnaires were included for t1 and 213 for t2 in the staff survey. In the patient survey, 523 questionnaires were included for t1 and 545 for t2. The TCC improved team organization, willingness to accept responsibility and knowledge integration according to staff, with small effect sizes (univariate: η2=.010–.017), whereas other parameters including internal participation, team leadership and cohesion did not improve due to the intervention. The patient survey did not show any improvements on the assessed dimensions. Conclusion The TCC improved dimensions that were addressed directly by the approach and were linked to the clinics’ needs, such as restructured team meetings and better exchange of information. The TCC can be used to improve team organization, willingness to accept responsibility, and knowledge integration in rehabilitation practice, but some further evaluation is needed to understand contextual factors and processes regarding the implementation of the intervention. PMID:28704377

The Technology Acceptance Model for Resource-Limited Settings (TAM-RLS): A Novel Framework for Mobile Health Interventions Targeted to Low-Literacy End-Users in Resource-Limited Settings.

PubMed

Campbell, Jeffrey I; Aturinda, Isaac; Mwesigwa, Evans; Burns, Bridget; Santorino, Data; Haberer, Jessica E; Bangsberg, David R; Holden, Richard J; Ware, Norma C; Siedner, Mark J

2017-11-01

Although mobile health (mHealth) technologies have shown promise in improving clinical care in resource-limited settings (RLS), they are infrequently brought to scale. One limitation to the success of many mHealth interventions is inattention to end-user acceptability, which is an important predictor of technology adoption. We conducted in-depth interviews with 43 people living with HIV in rural Uganda who had participated in a clinical trial of a short messaging system (SMS)-based intervention designed to prompt return to clinic after an abnormal laboratory test. Interviews focused on established features of technology acceptance models, including perceived ease of use and perceived usefulness, and included open-ended questions to gain insight into unexplored issues related to the intervention's acceptability. We used conventional (inductive) and direct content analysis to derive categories describing use behaviors and acceptability. Interviews guided development of a proposed conceptual framework, the technology acceptance model for resource-limited settings (TAM-RLS). This framework incorporates both classic technology acceptance model categories as well as novel factors affecting use in this setting. Participants described how SMS message language, phone characteristics, and experience with similar technologies contributed to the system's ease of use. Perceived usefulness was shaped by the perception that the system led to augmented HIV care services and improved access to social support from family and colleagues. Emergent themes specifically related to mHealth acceptance among PLWH in Uganda included (1) the importance of confidentiality, disclosure, and stigma, and (2) the barriers and facilitators downstream from the intervention that impacted achievement of the system's target outcome. The TAM-RLS is a proposed model of mHealth technology acceptance based upon end-user experiences in rural Uganda. Although the proposed model requires validation, the TAM-RLS may serve as a useful tool to guide design and implementation of mHealth interventions.

Comparative-effectiveness research to aid population decision making by relating clinical outcomes and quality-adjusted life years.

PubMed

Campbell, Jonathan D; Zerzan, Judy; Garrison, Louis P; Libby, Anne M

2013-04-01

Comparative-effectiveness research (CER) at the population level is missing standardized approaches to quantify and weigh interventions in terms of their clinical risks, benefits, and uncertainty. We proposed an adapted CER framework for population decision making, provided example displays of the outputs, and discussed the implications for population decision makers. Building on decision-analytical modeling but excluding cost, we proposed a 2-step approach to CER that explicitly compared interventions in terms of clinical risks and benefits and linked this evidence to the quality-adjusted life year (QALY). The first step was a traditional intervention-specific evidence synthesis of risks and benefits. The second step was a decision-analytical model to simulate intervention-specific progression of disease over an appropriate time. The output was the ability to compare and quantitatively link clinical outcomes with QALYs. The outputs from these CER models include clinical risks, benefits, and QALYs over flexible and relevant time horizons. This approach yields an explicit, structured, and consistent quantitative framework to weigh all relevant clinical measures. Population decision makers can use this modeling framework and QALYs to aid in their judgment of the individual and collective risks and benefits of the alternatives over time. Future research should study effective communication of these domains for stakeholders. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

A combination SMS and transportation reimbursement intervention to improve HIV care following abnormal CD4 test results in rural Uganda: a prospective observational cohort study.

PubMed

Siedner, Mark J; Santorino, Data; Lankowski, Alexander J; Kanyesigye, Michael; Bwana, Mwebesa B; Haberer, Jessica E; Bangsberg, David R

2015-07-06

Up to 50 % of HIV-infected persons in sub-Saharan Africa are lost from care between HIV diagnosis and antiretroviral therapy (ART) initiation. Structural barriers, including cost of transportation to clinic and poor communication systems, are major contributors. We conducted a prospective, pragmatic, before-and-after clinical trial to evaluate a combination mobile health and transportation reimbursement intervention to improve care at a publicly operated HIV clinic in Uganda. Patients undergoing CD4 count testing were enrolled, and clinicians selected a result threshold that would prompt early return for ART initiation or further care. Participants enrolled in the pre-intervention period (January - August 2012) served as a control group. Participants in the intervention period (September 2012 - November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. Participants returning within seven days of their first message received transportation reimbursements (about $6USD). Our primary outcomes of interest were time to return to clinic and time to ART initiation. There were 45 participants in the pre-intervention period and 138 participants in the intervention period (46, 49, and 43 in the direct, PIN, and coded groups, respectively) with low CD4 count results. Median time to clinic return was 33 days (IQR 11-49) in the pre-intervention period and 6 days (IQR 3-16) in the intervention period (P < 0.001); and median time to ART initiation was 47 days (IQR 11-75) versus 12 days (IQR 5-19), (P < 0.001). In multivariable models, participants in the intervention period had earlier return to clinic (AHR 2.32, 95 %CI 1.53 to 3.51) and earlier time to ART initiation (AHR 2.27, 95 %CI 1.38 to 3.72). All three randomized message formats improved time to return to clinic and time to ART initiation (P < 0.01 for all comparisons versus the pre-intervention period). A combination of an SMS laboratory result communication system and transportation reimbursements significantly decreased time to clinic return and time to ART initiation after abnormal CD4 test results. Clinicaltrials.gov NCT01579214 , approved 13 April 2012.

The health Oriented pedagogical project (HOPP) - a controlled longitudinal school-based physical activity intervention program.

PubMed

Fredriksen, Per Morten; Hjelle, Ole Petter; Mamen, Asgeir; Meza, Trine J; Westerberg, Ane C

2017-04-28

The prevalence of non-communicable diseases (NCDs) is increasing worldwide, also among children. Information about primary prevention of NCD's is increasing; however, convincing strategies among children is needed. The present paper describes the design and methods in the Health Oriented Pedagogical Project (HOPP) study. The main objective is to evaluate the effects of a school-based physical activity intervention program on cardio-metabolic risk factors. Secondary objectives include assessment of physical, psychological and academic performance variables. The HOPP study is a 7 years longitudinal large-scale controlled intervention in seven elementary schools (n = 1545) with two control schools (n = 752); all aged 6-11 years at baseline. The school-based physical activity intervention program includes an increase in physical activity (PA) of 225 min/week as an integrated part of theoretical learning, in addition to the curriculum based 90 min/week of ordinary PA. Primary outcomes include cardio-metabolic risk factors measured as PA level, BMI status, waist circumference, muscle mass, percent fat, endurance test performance, total serum cholesterol, high-density lipoprotein (HDL), non-HDL, micro C-reactive protein (mCRP) and long-term blood sugar (HbA1c). In addition, secondary outcomes include anthropometric growth measures, physical fitness, quality of life (QoL), mental health, executive functions, diet and academic performance. HOPP will provide evidence of effects on cardio-metabolic risk factors after a long-term PA intervention program in elementary schoolchildren. School-based PA intervention programs may be an effective arena for health promotion and disease prevention. The study is registered in Clinical trials (ClinicalTrials.gov Identifier: NCT02495714 ) as of June 20 th - 2015, retrospectively registered. The collection of baseline values was initiated in mid-January 2015.

Team-training in healthcare: a narrative synthesis of the literature.

PubMed

Weaver, Sallie J; Dy, Sydney M; Rosen, Michael A

2014-05-01

Patients are safer and receive higher quality care when providers work as a highly effective team. Investment in optimising healthcare teamwork has swelled in the last 10 years. Consequently, evidence regarding the effectiveness for these interventions has also grown rapidly. We provide an updated review concerning the current state of team-training science and practice in acute care settings. A PubMed search for review articles examining team-training interventions in acute care settings published between 2000 and 2012 was conducted. Following identification of relevant reviews with searches terminating in 2008 and 2010, PubMed and PSNet were searched for additional primary studies published in 2011 and 2012. Primary outcomes included patient outcomes and quality indices. Secondary outcomes included teamwork behaviours, knowledge and attitudes. Both simulation and classroom-based team-training interventions can improve teamwork processes (eg, communication, coordination and cooperation), and implementation has been associated with improvements in patient safety outcomes. Thirteen studies published between 2011 and 2012 reported statistically significant changes in teamwork behaviours, processes or emergent states and 10 reported significant improvement in clinical care processes or patient outcomes, including mortality and morbidity. Effects were reported across a range of clinical contexts. Larger effect sizes were reported for bundled team-training interventions that included tools and organisational changes to support sustainment and transfer of teamwork competencies into daily practice. Overall, moderate-to-high-quality evidence suggests team-training can positively impact healthcare team processes and patient outcomes. Additionally, toolkits are available to support intervention development and implementation. Evidence suggests bundled team-training interventions and implementation strategies that embed effective teamwork as a foundation for other improvement efforts may offer greatest impact on patient outcomes.

Team-training in healthcare: a narrative synthesis of the literature

PubMed Central

Weaver, Sallie J; Dy, Sydney M; Rosen, Michael A

2014-01-01

Background Patients are safer and receive higher quality care when providers work as a highly effective team. Investment in optimising healthcare teamwork has swelled in the last 10 years. Consequently, evidence regarding the effectiveness for these interventions has also grown rapidly. We provide an updated review concerning the current state of team-training science and practice in acute care settings. Methods A PubMed search for review articles examining team-training interventions in acute care settings published between 2000 and 2012 was conducted. Following identification of relevant reviews with searches terminating in 2008 and 2010, PubMed and PSNet were searched for additional primary studies published in 2011 and 2012. Primary outcomes included patient outcomes and quality indices. Secondary outcomes included teamwork behaviours, knowledge and attitudes. Results Both simulation and classroom-based team-training interventions can improve teamwork processes (eg, communication, coordination and cooperation), and implementation has been associated with improvements in patient safety outcomes. Thirteen studies published between 2011 and 2012 reported statistically significant changes in teamwork behaviours, processes or emergent states and 10 reported significant improvement in clinical care processes or patient outcomes, including mortality and morbidity. Effects were reported across a range of clinical contexts. Larger effect sizes were reported for bundled team-training interventions that included tools and organisational changes to support sustainment and transfer of teamwork competencies into daily practice. Conclusions Overall, moderate-to-high-quality evidence suggests team-training can positively impact healthcare team processes and patient outcomes. Additionally, toolkits are available to support intervention development and implementation. Evidence suggests bundled team-training interventions and implementation strategies that embed effective teamwork as a foundation for other improvement efforts may offer greatest impact on patient outcomes. PMID:24501181

Perceptions of work stress causes and effective interventions in employees working in public, private and non-governmental organisations: a qualitative study

PubMed Central

Bhui, Kamaldeep; Dinos, Sokratis; Galant-Miecznikowska, Magdalena; de Jongh, Bertine; Stansfeld, Stephen

2016-01-01

Aims and method To identify causes of stress at work as well as individual, organisational and personal interventions used by employees to manage stress in public, private and non-governmental organizations (NGOs). Qualitative interviews were conducted with 51 employees from a range of organisations. Results Participants reported adverse working conditions and management practices as common causes of work stress. Stress-inducing management practices included unrealistic demands, lack of support, unfair treatment, low decision latitude, lack of appreciation, effort–reward imbalance, conflicting roles, lack of transparency and poor communication. Organisational interventions were perceived as effective if they improved management styles, and included physical exercise, taking breaks and ensuring adequate time for planning work tasks. Personal interventions used outside of work were important to prevent and remedy stress. Clinical implications Interventions should improve management practices as well as promoting personal interventions outside of the work setting. PMID:28377811

Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial.

PubMed

Phelan, Suzanne; Hagobian, Todd; Brannen, Anna; Hatley, Karen E; Schaffner, Andrew; Muñoz-Christian, Karen; Tate, Deborah F

2017-06-20

Postpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women. To test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months. A 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016. Clinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics. The primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet. Participants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P < .001; difference, 2.3 kg (95% CI, 1.1 to 3.5). More participants in the intervention group than the standard care group returned to preconception weight by 12 months (32.8% in the intervention group vs 18.6% in the standard care group, P < .001; difference, 14.2 percentage points [95% CI, 4.7 to 23.5]). The intervention group and standard care group did not significantly differ in 12-month changes in physical activity (mean [95% CI]: -7.8 min/d [-16.1 to 0.4] in the intervention group vs -7.2 min/d [-14.6 to 0.3] in the standard care group; difference, -0.7 min/d [95% CI, -42.0 to 10.6], P = .76), calorie intake (mean [95% CI]: -298 kcal/d [-423 to -174] in the intervention group vs -144 kcal/d [-257 to -32] in the standard care group; difference, -154 kcal/d [-325 to 17], P = .06), or incidences of injury (16 in the intervention group vs 16 in the standard care group) or low breastmilk supply from baseline to month 6 (21 of 61 participants in the intervention group vs 23 of 72 participants in the standard care group) and from month 6 to 12 (13 of 32 participants in the intervention group vs 14 of 37 participants in the standard care group). Among low-income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to determine program and cost-effectiveness as part of the WIC program. clinicaltrials.gov Identifier: NCT01408147.

Barriers and facilitators to implementing an evidence-based woman-focused intervention in South African health services.

PubMed

Howard, Brittni N; Van Dorn, Richard; Myers, Bronwyn J; Zule, William A; Browne, Felicia A; Carney, Tara; Wechsberg, Wendee M

2017-11-21

Since the beginning of the HIV epidemic, numerous behavior change, risk-reduction, and biomedical interventions have been developed and tested. While some of these interventions have shown to be efficacious in randomized trials, it often takes almost two decades for an intervention to be translated into practice. Meanwhile, South Africa continues to have among the highest prevalence of HIV globally, with women of childbearing age bearing the burden of the epidemic. Given the urgency of the HIV epidemic among vulnerable women in South Africa, it is imperative that evidence-based interventions be implemented rapidly into practice. This study presents a first step toward examining the acceptability and feasibility of implementing the Women's Health CoOp (WHC) in clinics and substance abuse rehab settings in Cape Town, South Africa. We conducted focus group discussions with women who use substances and with service providers, we also conducted in-depth interviews with health service planners. Our goal was to examine implementation and clinical outcomes associated with delivery of the WHC across clinics and substance abuse rehab programs. All participants agreed on the need for the WHC. Perceived facilitators to implementing the WHC included the recognizable need for programs to empower women and to build the capacity of staff to address issues of substance use, sexual risk, and intimate partner violence. Participants also identified potential barriers to women engaging with this program, including the stigma women experience when seeking services and the lack of person-centered care at healthcare facilities. In a country with the largest number of women of childbearing age living with HIV, an evidence-based woman-focused intervention that comprehensively addresses women's risk for suboptimal antiretroviral adherence may be essential for reducing HIV incidence. However, potential barriers to implementing the WHC successfully must be addressed before the program can be fully integrated into the services delivered by healthcare facilities. Clinical trials NCT02733003 . Date of Registration: January 21, 2016, registered retroactively after participant enrollment.

Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

PubMed

Mousavi, Maryam; Hayatshahi, Alireza; Sarayani, Amir; Hadjibabaie, Molouk; Javadi, Mohammadreza; Torkamandi, Hassan; Gholami, Kheirollah; Ghavamzadeh, Ardeshir

2013-12-01

Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P < 0.01). Patients in the intervention group received fewer days of PN (10.7 ± 4.2 vs. 18.4 ± 5.5 days, P < 0.01). All nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values < 0.01). Length of hospital stay was significantly shorter in the intervention group (P < 0.01). Regarding PN complications, hyperglycemia was observed more frequently in the intervention group (34.5 %, P = 0.01). Two patients in the control group expired due to graft versus host disease at the 3-month follow-up. A clinical pharmacist-based nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

The clinical effectiveness and cost-effectiveness of low-intensity psychological interventions for the secondary prevention of relapse after depression: a systematic review.

PubMed

Rodgers, M; Asaria, M; Walker, S; McMillan, D; Lucock, M; Harden, M; Palmer, S; Eastwood, A

2012-05-01

Depression is the most common mental disorder in community settings and a major cause of disability across the world. The objective of treatment is to achieve remission or at least adequate control of depressive symptoms; however, even after successful treatment, the risk of relapse after remission is significant. Although the effectiveness of low-intensity interventions has been extensively evaluated to treat primary symptoms of psychological difficulties, there has been substantially less research examining the use of these interventions as a relapse prevention strategy. To systematically review the clinical effectiveness and cost-effectiveness of low-intensity psychological or psychosocial interventions to prevent relapse or recurrence in patients with depression. As the broader definition of 'low-intensity' psychological intervention is somewhat contested, the review was conducted in two parts: A, a systematic review of all evaluations of 'low-intensity' interventions that were delivered by para-professionals, peer supporters or psychological well-being practitioners as defined by the Improving Access to Psychological Therapies programme; and B, a scoping review of relevant evaluations of interventions involving qualified mental health professionals (e.g. psychiatrists, clinical psychologists, cognitive behavioural therapists) involving < 6 hours of contact per patient. Comprehensive literature searches were developed; electronic databases were searched from inception until September 2010 (including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, EMBASE, The Cochrane Library), internet resources were used to identify guidelines on the treatment of depression, and the bibliographies of relevant reviews, guidelines and included studies were scrutinised. Two reviewers independently screened titles and abstracts; data were extracted independently by one reviewer using a standardised data extraction form and checked by another. Discrepancies were resolved by consensus, with involvement of a third reviewer when necessary. The inclusion criteria were population - adults or adolescents who had received treatment for depression; intervention - part A, low-intensity interventions, specifically any unsupported psychological/psychosocial interventions or any supported interventions that did not involve highly qualified mental health professionals, and, part B, interventions carried out by qualified mental health professionals that involved < 6 hours of contact per patient; comparator - any, including no treatment, placebo, psychological or pharmacological interventions; outcomes - relapse or recurrence, other outcomes (e.g. social function, quality of life) were recorded where reported; and study design - for clinical effectiveness, randomised, quasi-randomised and non-randomised studies with concurrent control patients. For cost-effectiveness, full economic evaluations that compared two or more treatment options and considered both costs and consequences. No studies met the main part A inclusion criteria. For the clinical effectiveness review, 17 studies (14 completed, three ongoing), reported in 27 publications, met the part B inclusion criteria. These studies were clinically and methodologically diverse, and reported differing degrees of efficacy for the evaluated interventions. One randomised controlled trial (RCT), which evaluated a collaborative care-type programme, was potentially relevant to part A; this study reported no difference between patients receiving the intervention and those receiving usual care in terms of relapse of depression over 12 months. For the cost-effectiveness review, two studies met the criteria for part B. One of these was an economic evaluation of the RCT above, which was potentially relevant to part A. This evaluation found that the intervention may be a cost-effective use of resources when compared with usual care; however, it was unclear how valid these estimates were for the NHS. Although any definition of 'brief' is likely to be somewhat arbitrary, an inclusion threshold of 6 hours contact per patient was used to select brief high-intensity intervention studies. Most excluded studies evaluated clearly resource-intensive interventions, though occasionally, studies were excluded on the basis of having only slightly more than 6 hours contact per patient. There is inadequate evidence to determine the clinical effectiveness or cost-effectiveness of low-intensity interventions for the prevention of relapse or recurrence of depression. A scoping review of brief high-intensity therapies indicates that some approaches have shown promise in some studies, but findings have not been consistent. Many uncertainties remain and further primary research is required. Careful consideration should be given to the scope of such research; it is important to evaluate the broader patient pathway accounting for the heterogeneous patient groups of interest. Future RCTs conducted in a UK primary care setting should include adult participants in remission or recovery from depression, and evaluate the quality of the intervention and consistency of delivery across practitioners where appropriate. The occurrence of relapse or recurrence should be measured using established methods, and functional outcomes as well as symptoms should be measured; data on quality of life using a generic instrument, such as the European Quality of Life-5 Dimensions (EQ-5D), should be collected. The National Institute for Health Research Health Technology Assessment programme.

Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy.

PubMed

Wu, Yuan; Yao, Xun; Vespasiani, Giacomo; Nicolucci, Antonio; Dong, Yajie; Kwong, Joey; Li, Ling; Sun, Xin; Tian, Haoming; Li, Sheyu

2017-03-14

Mobile health apps for diabetes self-management have different functions. However, the efficacy and safety of each function are not well studied, and no classification is available for these functions. The aims of this study were to (1) develop and validate a taxonomy of apps for diabetes self-management, (2) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of randomized controlled trials (RCTs), and (3) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy. We developed a 3-axis taxonomy with columns of clinical modules, rows of functional modules and cells of functions with risk assessments. This taxonomy was validated by reviewing and classifying commercially available diabetes apps. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Chinese Biomedical Literature Database, and ClinicalTrials.gov from January 2007 to May 2016. We included RCTs of adult outpatients with diabetes that compared using mobile app-based interventions with usual care alone. The mean differences (MDs) in hemoglobin A 1c (HbA 1c ) concentrations and risk ratios of adverse events were pooled using a random-effects meta-analysis. After taxonomic classification, we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions. Across 12 included trials involving 974 participants, using app-based interventions was associated with a clinically significant reduction of HbA 1c (MD 0.48%, 95% CI 0.19%-0.77%) without excess adverse events. Larger HbA 1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes (MD 0.67%, 95% CI 0.30%-1.03% vs MD 0.36%, 95% CI 0.08%-0.81%). Having a complication prevention module in app-based interventions was associated with a greater HbA 1c reduction (with complication prevention: MD 1.31%, 95% CI 0.66%-1.96% vs without: MD 0.38%, 95% CI 0.09%-0.67%; intersubgroup P=.01), as was having a structured display (with structured display: MD 0.69%, 95% CI 0.32%-1.06% vs without: MD 0.16%, 95% CI 0.16%-0.48%; intersubgroup P=.03). However, having a clinical decision-making function was not associated with a larger HbA 1c reduction (with clinical decision making: MD 0.18%, 95% CI 0.21%-0.56% vs without: MD 0.61%, 95% CI 0.27%-0.95%; intersubgroup P=.10). The use of mobile app-based interventions yields a clinically significant HbA 1c reduction among adult outpatients with diabetes, especially among those with type 2 diabetes. Our study suggests that the clinical decision-making function needs further improvement and evaluation before being added to apps. ©Yuan Wu, Xun Yao, Giacomo Vespasiani, Antonio Nicolucci, Yajie Dong, Joey Kwong, Ling Li, Xin Sun, Haoming Tian, Sheyu Li. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 14.03.2017.

Theoretical rationale for music selection in oncology intervention research: an integrative review.

PubMed

Burns, Debra S

2012-01-01

Music-based interventions have helped patients with cancer improve their quality of life, decrease treatment related distress, and manage pain. However, quantitative findings from music intervention studies are inconsistent. The purpose of this review was to explore the theoretical underpinnings for the selection of the music stimuli used to influence targeted outcomes. It was hypothesized that disparate findings were due in part to the atheoretical nature of music selection and the resulting diversity in music stimuli between and within studies. A systematic research synthesis including a comprehensive database and reference list search resulted in 22 studies. Included studies were compiled into two tables cataloging intervention theory, intervention content, and outcomes. A majority of studies did not provide a rationale or intervention theory for the delivery of music or choice of outcomes. Recorded music was the most common delivery method, but the specific music was rarely included within the report. Only two studies that included a theoretical framework reported null results on at least some of the outcomes. Null results are partially explained by an incomplete or mismatch in intervention theory and music selection and delivery. While the inclusion of an intervention theory does not guarantee positive results, including a theoretical rationale for the use of music, particular therapeutic processes or mechanisms, and the specifics of how music is selected and delivered increases scientific rigor and the probability of clinical translation.

Chiropractic treatment including instrument-assisted manipulation for non-specific dizziness and neck pain in community-dwelling older people: a feasibility randomised sham-controlled trial.

PubMed

Kendall, Julie C; French, Simon D; Hartvigsen, Jan; Azari, Michael F

2018-01-01

Dizziness in older people is a risk factor for falls. Neck pain is associated with dizziness and responds favourably to neck manipulation. However, it is unknown if chiropractic intervention including instrument-assisted manipulation of the neck in older people with neck pain can also improve dizziness. This parallel two-arm pilot trial was conducted in Melbourne, Australia over nine months (October 2015 to June 2016). Participants aged 65-85 years, with self-reported chronic neck pain and dizziness, were recruited from the general public through advertisements in local community newspapers and via Facebook. Participants were randomised using a permuted block method to one of two groups: 1) Activator II™-instrument-assisted cervical and thoracic spine manipulation plus a combination of: light massage; mobilisation; range of motion exercises; and home advice about the application of heat, or 2) Sham-Activator II™-instrument-assisted manipulation (set to zero impulse) plus gentle touch of cervical and thoracic spinal regions. Participants were blinded to group allocation. The interventions were delivered weekly for four weeks. Assessments were conducted one week pre- and post-intervention. Clinical outcomes were assessed blindly and included: dizziness (dizziness handicap inventory [DHI]); neck pain (neck disability index [NDI]); self-reported concerns of falling; mood; physical function; and treatment satisfaction. Feasibility outcomes included recruitment rates, compliance with intervention and outcome assessment, study location, success of blinding, costs and harms. Out of 162 enquiries, 24 participants were screened as eligible and randomised to either the chiropractic ( n  = 13) or sham ( n  = 11) intervention group. Compliance was satisfactory with only two participants lost to follow up; thus, post-intervention data for 12 chiropractic intervention and 10 sham intervention participants were analysed. Blinding was similar between groups. Mild harms of increased spinal pain or headaches were reported by 6 participants. Costs amounted to AUD$2635 per participant. The data showed a trend favouring the chiropractic group in terms of clinically-significant improvements in both NDI and DHI scores. Sample sizes of n  = 150 or n  = 222 for dizziness or neck pain disability as the primary outcome measure, respectively, would be needed for a fully powered trial. Recruitment of participants in this setting was difficult and expensive. However, a larger trial may be feasible at a specialised dizziness clinic within a rehabilitation setting. Compliance was acceptable and the outcome measures used were well accepted and responsive. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000653763. Registered 13 June 2013.Trial funding: Foundation for Chiropractic Research and Postgraduate Education (Denmark).

Association Between the Safe Delivery App and Quality of Care and Perinatal Survival in Ethiopia: A Randomized Clinical Trial.

PubMed

Lund, Stine; Boas, Ida Marie; Bedesa, Tariku; Fekede, Wondewossen; Nielsen, Henriette Svarre; Sørensen, Bjarke Lund

2016-08-01

Health apps in low-income countries are emerging tools with the potential to improve quality of health care services, but few apps undergo rigorous scientific evaluation. To determine the effects of the safe delivery app (SDA) on perinatal survival and on health care workers' knowledge and skills in neonatal resuscitation. In a cluster-randomized clinical trial in 5 rural districts of Ethiopia, 73 health care facilities were randomized to the mobile phone intervention or to standard care (control). From September 1, 2013, to February 1, 2015, 3601 women in active labor were included at admission and followed up until 7 days after delivery to record perinatal mortality. Knowledge and skills in neonatal resuscitation were assessed at baseline and at 6 and 12 months after the intervention among 176 health care workers at the included facilities. Analyses were performed based on the intention-to-treat principle. Health care workers in intervention facilities received a smartphone with the SDA. The SDA is a training tool in emergency obstetric and neonatal care that uses visual guidance in animated videos with clinical instructions for management. The primary outcome was perinatal death. Secondary outcomes included the knowledge and clinical management of neonatal resuscitation (skills) of health care workers before the intervention and after 6 and 12 months. The analysis included 3601 women and 176 health care workers. Use of the SDA was associated with a nonsignificant lower perinatal mortality of 14 per 1000 births in intervention clusters compared with 23 per 1000 births in control clusters (odds ratio, 0.76; 95% CI, 0.32-1.81). The skill scores of intervention health care workers increased significantly compared with those of controls at 6 months (mean difference, 6.04; 95% CI, 4.26-7.82) and 12 months (mean difference, 8.79; 95% CI, 7.14-10.45) from baseline, corresponding to 80% and 107%, respectively, above the control level. Knowledge scores also significantly improved in the intervention compared with the control group at 6 months (mean difference, 1.67; 95% CI, 1.02-2.32) and at 12 months (mean difference, 1.54; 95% CI, 0.98-2.09), corresponding to 39% and 38%, respectively, above the control level. The SDA was an effective method to improve and sustain the health care workers' knowledge and skills in neonatal resuscitation as long as 12 months after introduction. Perinatal mortality was nonsignificantly reduced after the intervention. The results are highly relevant in low-income countries, where quality of care is challenged by a lack of continuing education. clinicaltrials.gov Identifier: NCT01945931.

Education and training to enhance end-of-life care for nursing home staff: a systematic literature review.

PubMed

Anstey, Sally; Powell, Tom; Coles, Bernadette; Hale, Rachel; Gould, Dinah

2016-09-01

The delivery of end-of-life care in nursing homes is challenging. This situation is of concern as 20% of the population die in this setting. Commonly reported reasons include limited access to medical care, inadequate clinical leadership and poor communication between nursing home and medical staff. Education for nursing home staff is suggested as the most important way of overcoming these obstacles. To identify educational interventions to enhance end-of-life care for nursing home staff and to identify types of study designs and outcomes to indicate success and benchmark interventions against recent international guidelines for education for palliative and end-of-life care. Thirteen databases and reference lists of key journals were searched from the inception of each up to September 2014. Included studies were appraised for quality and data were synthesised thematically. Twenty-one studies were reviewed. Methodological quality was poor. Education was not of a standard that could be expected to alter clinical behaviour and was evaluated mainly from the perspectives of staff: self-reported increase in knowledge, skills and confidence delivering care rather than direct evidence of impact on clinical practice and patient outcomes. Follow-up was often short term, and despite sound economic arguments for delivering effective end-of-life care to reduce burden on the health service, no economic analyses were reported. There is a clear and urgent need to design educational interventions that have the potential to improve end-of-life care in nursing homes. Robust evaluation of these interventions should include impact on residents, families and staff and include economic analysis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Warfarin therapy: in need of improvement after all these years

PubMed Central

Kimmel, Stephen E

2010-01-01

Background Warfarin therapy has been used clinically for over 60 years, yet continues to be problematic because of its narrow therapeutic index and large inter-individual variability in patient response. As a result, warfarin is a leading cause of serious medication-related adverse events, and its efficacy is also suboptimal. Objective To review factors that are responsible for variable response to warfarin, including clinical, environmental, and genetic factors, and to explore some possible approaches to improving warfarin therapy. Results Recent efforts have focused on developing dosing algorithms that included genetic information to try to improve warfarin dosing. These dosing algorithms hold promise, but have not been fully validated or tested in rigorous clinical trials. Perhaps equally importantly, adherence to warfarin is a major problem that should be addressed with innovative and cost-effective interventions. Conclusion Additional research is needed to further test whether interventions can be used to improve warfarin dosing and outcomes. PMID:18345947

Nonadherence in dialysis patients: prevalence, measurement, outcome, and psychological determinants.

PubMed

Clark, Sarah; Farrington, Ken; Chilcot, Joseph

2014-01-01

Nonadherence to aspects of the management of End-Stage Kidney Disease (ESKD) is common. Estimates of nonadherence vary with assessment method. Whilst readily available and free from report bias, physiological proxies-frequently used as measures of adherence-are often confounded by clinical factors including residual kidney function and dialysis adequacy. Despite variation in estimates of its prevalence, it is clear that suboptimal adherence to dialysis prescriptions, medication and diet can lead to adverse clinical outcomes. Several factors can help explain nonadherence in ESKD including mood, self-efficacy, social support, illness, and treatment perceptions. Psychological interventions have been shown to improve ESKD adherence, yet achieving long-term behavior change remains challenging. Identifying individuals who struggle to adhere to aspects of the dialysis regime, and tailoring theory-led interventions to improve and support adherence is a clear clinical need requiring further empirical enquiry. © 2013 Wiley Periodicals, Inc.

Motorized mobility scooters – The use of training/intervention and technology for improving driving skills in aging adults - A Mini-Review

PubMed Central

Toosizadeh, Nima; Bunting, Matthew; Howe, Carol; Mohler, Jane; Sprinkle, Jonathan; Najafi, Bijan

2014-01-01

Background Motorized mobility scooters (MMS) have become the most acceptable powered assistive device for those with impaired mobility, who have sufficient upper body strength and dexterity, and postural stability. Although several benefits have been attributed to MMS usage, there are likewise risks of use, including injuries and even deaths. Objective The aim of the current review was to summarize results from clinical studies regarding the enhancement of MMS driver safety with a primary focus on improving driving skills/performance using clinical approaches. We addressed three main objectives: 1) to identify and summarize any available evidence (strong, moderate, or weak evidence based on the quality of studies) regarding improved driving skills/performance following training/intervention; 2) to identify types of driving skills/performance that might be improved by training/intervention; and 3) to identify the use of technology in improving MMS performance or training procedure. Methods Articles were searched for in the following medical and engineering electronic databases: PubMed, Cochrane Library, Web of Science, ClinicalTrials.gov, PsycINFO, CINAHL, ERIC, EI Compendix, IEEE Explore, and REHABDATA. Inclusion criteria included: aging adults or those with ambulatory problems; intervention or targeted training; and clinical trial. Outcomes included: MMS skills/performance. Results Six articles met the inclusion criteria and are analyzed in this review. Four of the six articles contained training approaches for MMS drivers including skill trainings using real MMS inside and outside (i.e., in community) and in a 3D virtual environment. The other two studies contain infrastructural assessments (i.e., the minimum space required for safe maneuverability of MMS users) and additional mobility assistance tools to improve maneuverability and to enhance driving performance. Conclusions Results from the current review showed improved driving skills/performance by training, infrastructural assessments, and incorporating mobility assistance tools. MMS driving skills that can be improved through driver training include: weaving, negotiating with and avoiding pedestrian interference, simultaneous reading of signs and obstacle avoidance in path, level driving, forward and reverse driving, figure 8s, turning in place, crossing left slope, maneuvering down a 2-inch curb, and driving up and down inclines. However, several limitations exist in the available literature regarding evidence of improved driving skills/performance following training/intervention, such as small sample sizes, lack of control groups and statistical analysis. PMID:24481257

Impact of a low-technology simulation-based obstetric and newborn care training scheme on non-emergency delivery practices in Guatemala.

PubMed

Walton, Anna; Kestler, Edgar; Dettinger, Julia C; Zelek, Sarah; Holme, Francesca; Walker, Dilys

2016-03-01

To assess the effect of a low-technology simulation-based training scheme for obstetric and perinatal emergency management (PRONTO; Programa de Rescate Obstétrico y Neonatal: Tratamiento Óptimo y Oportuno) on non-emergency delivery practices at primary level clinics in Guatemala. A paired cross-sectional birth observation study was conducted with a convenience sample of 18 clinics (nine pairs of intervention and control clinics) from June 28 to August 7, 2013. Outcomes included implementation of practices known to decrease maternal and/or neonatal mortality and improve patient care. Overall, 25 and 17 births occurred in intervention and control clinics, respectively. Active management of the third stage of labor was appropriately performed by 20 (83%) of 24 intervention teams versus 7 (50%) of 14 control teams (P=0.015). Intervention teams implemented more practices to decrease neonatal mortality than did control teams (P<0.001). Intervention teams ensured patient privacy in 23 (92%) of 25 births versus 11 (65%) of 17 births for control teams (P=0.014). All 15 applicable intervention teams kept patients informed versus 6 (55%) of 11 control teams (P=0.001). Differences were also noted in teamwork; in particular, skill-based tools were used more often at intervention sites than control sites (P=0.012). Use of PRONTO enhanced non-emergency delivery care by increasing evidence-based practice, patient-centered care, and teamwork. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Managing ankle ligament sprains and tears: current opinion

PubMed Central

McGovern, Ryan P; Martin, RobRoy L

2016-01-01

The purpose of this paper is to present a current review of pathoanatomical features, differential diagnosis, objective assessment, intervention, and clinical course associated with managing lateral ankle ligament sprains. Proper diagnosis and identification of affected structures should be obtained through history and objective assessment. From this information, an individualized evidence-based intervention plan can be developed to enable recovery while decreasing the risk of reinjury. An appropriate evaluation is needed not only to determine the correct diagnosis but also to allow for grading and determining the prognosis of the injury in those with an acute lateral ankle sprain. Examination should include an assessment of impairments as well as a measure of activity and participation. Evidence-based interventions for those with an acute lateral ankle sprain should include weight bearing with bracing, manual therapy, progressive therapeutic exercises, and cryotherapy. For those with chronic ankle instability (CAI), interventions should include manual therapy and a comprehensive rehabilitation program. It is essential to understand the normal clinical course for athletes who sustain a lateral ankle sprain as well as risk factors for an acute injury and CAI. Risk factors for both an acute lateral ankle sprain and CAI include not using an external support and not participating in an appropriate exercise program. Incorporating the latest evidence-based rehabilitation techniques provides the best course of treatment for athletes with an acute ankle sprain or CAI. PMID:27042147

Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy.

PubMed

Al-Aqeel, Sinaa; Gershuni, Olga; Al-Sabhan, Jawza; Hiligsmann, Mickael

2017-02-03

Poor adherence to antiepileptic medication is associated with increased mortality, morbidity and healthcare costs. In this review, we focus on interventions designed and tested in randomised controlled trials and quasi-randomised controlled trials to assist people with adherence to antiepileptic medication. This is an updated version of the original Cochrane review published in the Cochrane Library, Issue 1, 2010. To determine the effectiveness of interventions aimed at improving adherence to antiepileptic medication in adults and children with epilepsy. For the latest update, on 4 February 2016 we searched the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO), MEDLINE (Ovid 1946 to 4 February 2016), CINAHL Plus (EBSCOhost 1937 to 4 February 2016), PsycINFO (EBSCOhost 1887 to 4 February 2016), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. We also searched the reference lists of relevant articles. Randomised and quasi-randomised controlled trials of adherence-enhancing interventions aimed at people with a clinical diagnosis of epilepsy (as defined in individual studies), of any age and treated with antiepileptic drugs in a primary care, outpatient or other community setting. All review authors independently assessed lists of potentially relevant citations and abstracts. At least two review authors independently extracted data and performed quality assessment of each study according to the Cochrane tool for assessing risk of bias. We graded the level of evidence for each outcome according to the GRADE working group scale.The studies differed widely according to the type of intervention and measures of adherence; therefore combining data was not appropriate. We included 12 studies reporting data on 1642 participants (intervention = 833, control = 809). Eight studies targeted adults with epilepsy, one study included participants of all ages, one study included participants older than two years, one study targeted caregivers of children with epilepsy, and one study targeted families of children with epilepsy. We identified six ongoing trials. Follow-up time was generally short in most trials, ranging from one to 12 months. The trials examined three main types of interventions: educational interventions, behavioural interventions and mixed interventions. All studies compared treatment versus usual care or 'no intervention', except for two studies. Due to heterogeneity between studies in terms of interventions, methods used to measure adherence and the way the studies were reported, we did not pool the results and these findings were inappropriate to be included in a meta-analysis. Education and counselling of participants with epilepsy resulted in mixed success (moderate-quality evidence). Behavioural interventions such as use of intensive reminders provided more favourable effects on adherence (moderate-quality evidence). The effect on adherence to antiepileptic drugs described by studies of mixed interventions showed improved adherence in the intervention groups compared to the control groups (high-quality evidence). Behavioural interventions such as intensive reminders and the use of mixed interventions demonstrate some positive results; however, we need more reliable evidence on their efficacy, derived from carefully-designed randomised controlled trials before we can draw a firm conclusion. Since the last version of this review, none of the new relevant studies have provided additional information that would lead to significant changes in our conclusions. This current update includes 12 studies, of which six came from the latest searches.

The efficacy of the direct clinical intervention for infectious diseases by a pediatric infectious disease specialist in the pediatric ward of a tertiary medical facility without a pediatric antimicrobial stewardship program.

PubMed

Hoshina, T; Yamamoto, N; Ogawa, M; Nakamoto, T; Kusuhara, K

2017-08-01

Antimicrobial stewardship programs (ASPs) have been introduced in most hospital complexes; however, they are not always useful for pediatric patients. The aim of this study is to investigate the efficacy of direct clinical intervention for infectious diseases by a pediatric infectious disease specialist in a tertiary medical facility without pediatric ASP. This retrospective study included 1,821 patients who were hospitalized in the pediatric ward of a large metropolitan hospital from 2010 to 2015. The clinical course, the use of intravenous antimicrobial agents and the results of a microbiological analysis were compared between the period after the beginning of direct intervention by the specialist (post-intervention period) and the previous period (pre-intervention period). In the post-intervention period, the proportion of the patients who received intravenous antimicrobial agents, the number of antimicrobial agents used for each episode, and the proportion of episodes in which an antimicrobial agent was re-administrated were significantly lower (P = 0.006, P = 0.004, P = 0.036, respectively), and the duration of antimicrobial treatment was significantly shorter (P < 0.001). In addition, narrower spectrum antimicrobial agents were used, and the incidence of meropenem-sensitive Pseudomonas aeruginosa significantly increased (P = 0.037) in the post-intervention period. There was no change of mortality between the two periods. Direct clinical intervention by a pediatric infectious diseases specialist is useful for the treatment of infectious diseases in the pediatric ward of a tertiary medical facility without a pediatric ASP. The creation of a pediatric ASP is recommended in hospital complexes.

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

PubMed

Martínez-Andrade, Gloria Oliva; Cespedes, Elizabeth M; Rifas-Shiman, Sheryl L; Romero-Quechol, Guillermina; González-Unzaga, Marco Aurelio; Benítez-Trejo, María Amalia; Flores-Huerta, Samuel; Horan, Chrissy; Haines, Jess; Taveras, Elsie M; Pérez-Cuevas, Ricardo; Gillman, Matthew W

2014-03-20

Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics. We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2-5 years old with WHO body mass index (BMI) z-score 0-3. We measured children's height and weight and parents reported children's diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values. 93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention v. usual care children increased vegetables by 6.3 servings/week (95% CI, 1.8, 10.8). In stratified analyses, intervention participants with high program adherence (5-6 sessions) decreased snacks and screen time and increased vegetables v. usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program. Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI. ClinicalTrials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS: 2009-785-120.

Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER).

PubMed

Richmond, Helen; Lait, Clare; Srikesavan, Cynthia; Williamson, Esther; Moser, Jane; Newman, Meredith; Betteley, Lauren; Fordham, Beth; Rees, Sophie; Lamb, Sarah E; Bruce, Julie

2018-06-18

Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER). A pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres. The PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions. International Standard Randomised Controlled Trial Number: ISRCTN 35358984 .

Bioresorbable scaffolds: talking about a new interventional revolution [corrected].

PubMed

Hassell, M E C J; Grundeken, M J D; Delewi, R; Wykrzykowska, J J; Piek, J J

2013-04-01

After the introduction of coronary balloon angioplasty, bare-metal, and drug-eluting stents, fully bioresorbable scaffolds (BRS) could be the fourth revolution in interventional cardiology. The BRS technology shares the advantages of metallic stents regarding acute gain and prevention of acute vessel occlusion by providing transient scaffolding, while potentially overcoming many of the safety concerns of drug-eluting stents. Furthermore, without a permanent metallic cage, the vessel could remodel favourably and atherosclerotic plaques could regress in the long-term. This attracted increased interest and several BRS have been developed. In this review we will describe all BRS which are thus far clinically evaluated and provide an overview of ongoing clinical studies. Although the technology seems to be very promising, more studies including patients with more complex lesions are needed to evaluate whether the BRS can be used in daily clinical practice and if it is indeed becoming a new interventional revolution.

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS

PubMed Central

Chambers, James D.; Saret, Cayla J.; Anderson, Jordan E.; Deverka, Patricia A.; Douglas, Michael P.; Phillips, Kathryn A.

2017-01-01

Objectives The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. Methods We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Results Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73–100 percent), clinical studies in 69 percent (50–87 percent), technology assessments 47 percent (33–86 percent), systematic reviews or meta-analyses 31 percent (7–71 percent), and CEAs 5 percent (0–7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Conclusions Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions. PMID:29065945

The Dutch Hospital Standardised Mortality Ratio (HSMR) method and cardiac surgery: benchmarking in a national cohort using hospital administration data versus a clinical database

PubMed Central

Siregar, S; Pouw, M E; Moons, K G M; Versteegh, M I M; Bots, M L; van der Graaf, Y; Kalkman, C J; van Herwerden, L A; Groenwold, R H H

2014-01-01

Objective To compare the accuracy of data from hospital administration databases and a national clinical cardiac surgery database and to compare the performance of the Dutch hospital standardised mortality ratio (HSMR) method and the logistic European System for Cardiac Operative Risk Evaluation, for the purpose of benchmarking of mortality across hospitals. Methods Information on all patients undergoing cardiac surgery between 1 January 2007 and 31 December 2010 in 10 centres was extracted from The Netherlands Association for Cardio-Thoracic Surgery database and the Hospital Discharge Registry. The number of cardiac surgery interventions was compared between both databases. The European System for Cardiac Operative Risk Evaluation and hospital standardised mortality ratio models were updated in the study population and compared using the C-statistic, calibration plots and the Brier-score. Results The number of cardiac surgery interventions performed could not be assessed using the administrative database as the intervention code was incorrect in 1.4–26.3%, depending on the type of intervention. In 7.3% no intervention code was registered. The updated administrative model was inferior to the updated clinical model with respect to discrimination (c-statistic of 0.77 vs 0.85, p<0.001) and calibration (Brier Score of 2.8% vs 2.6%, p<0.001, maximum score 3.0%). Two average performing hospitals according to the clinical model became outliers when benchmarking was performed using the administrative model. Conclusions In cardiac surgery, administrative data are less suitable than clinical data for the purpose of benchmarking. The use of either administrative or clinical risk-adjustment models can affect the outlier status of hospitals. Risk-adjustment models including procedure-specific clinical risk factors are recommended. PMID:24334377

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS.

PubMed

Chambers, James D; Saret, Cayla J; Anderson, Jordan E; Deverka, Patricia A; Douglas, Michael P; Phillips, Kathryn A

2017-01-01

The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73-100 percent), clinical studies in 69 percent (50-87 percent), technology assessments 47 percent (33-86 percent), systematic reviews or meta-analyses 31 percent (7-71 percent), and CEAs 5 percent (0-7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

Behavioral Interventions Associated with Smoking Cessation in the Treatment of Tobacco Use

PubMed Central

Roberts, Nicola J.; Kerr, Susan M.; Smith, Sheree M.S.

2013-01-01

Tobacco smoke is the leading cause of preventable premature death worldwide. While the majority of smokers would like to stop, the habitual and addictive nature of smoking makes cessation difficult. Clinical guidelines suggest that smoking cessation interventions should include both behavioural support and pharmacotherapy (e.g. nicotine replacement therapy). This commentary paper focuses on the important role of behavioural interventions in encouraging and supporting smoking cessation attempts. Recent developments in the field are discussed, including ‘cut-down to quit’, the behaviour change techniques taxonomy (BCTT) and very brief advice (VBA) on smoking. The paper concludes with a discussion of the important role that health professionals can and should play in the delivery of smoking cessation interventions. PMID:25114563

A Randomised Controlled Trial of a Brief Online Mindfulness-Based Intervention on Paranoia in a Non-Clinical Sample.

PubMed

Shore, Robert; Strauss, Clara; Cavanagh, Kate; Hayward, Mark; Ellett, Lyn

2018-01-01

Paranoia is common and distressing in the general population and can impact on health, emotional well-being and social functioning, such that effective interventions are needed. Brief online mindfulness-based interventions (MBIs) have been shown to reduce symptoms of anxiety and depression in non-clinical samples; however, at present, there is no research investigating whether they can reduce paranoia. The current study explored whether a brief online MBI increased levels of mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect of mindfulness on any changes in paranoia was also investigated. One hundred and ten participants were randomly allocated to either a 2-week online MBI including 10 min of daily guided mindfulness practice or to a waitlist control condition. Measures of mindfulness and paranoia were administered at baseline, post-intervention and 1-week follow-up. Participants in the MBI group displayed significantly greater reductions in paranoia compared to the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills (specifically the observe, describe and non-react facets of the FFMQ) mediated the relationship between intervention type and change in levels of paranoia. This study provides evidence that a brief online MBI can significantly reduce levels of paranoia in a non-clinical population. Furthermore, increases in mindfulness skills from this brief online MBI can mediate reductions in non-clinical paranoia. The limitations of the study are discussed.

Educational interventions by pharmacists to patients with chronic pain: systematic review and meta-analysis.

PubMed

Bennett, Michael I; Bagnall, Anne-Marie; Raine, Gary; Closs, S José; Blenkinsopp, Alison; Dickman, Andrew; Ellershaw, John

2011-09-01

We hypothesized that educational interventions delivered by pharmacists to patients with chronic pain might improve pain-related outcomes and sought to establish "proof of concept" for this hypothesis. We searched electronic databases and published literature for randomized studies that examined an educational intervention in relation to the management of chronic pain that was delivered by a pharmacist to an adult patient. Four studies were included that randomized 400 patients with chronic pain and which followed up patients between 1 and 16 weeks. Patients receiving these interventions experienced statistically significant benefits in the following outcomes compared with controls: a reduction in average pain intensity of 0.5 on a 0 to 10 rating scale, a reduction in adverse effects by more than 50%, and an improvement in satisfaction with treatment equivalent to approximately 1 point on a 0 to 10 rating scale. The interventions neither had effect on reducing interference from pain on daily life, nor on improving self-efficacy. Pharmacist-delivered educational interventions seem to reduce adverse events and improve satisfaction, but their clinical benefit on pain intensity is debatable. Our analysis suggests that the role of pharmacists may be important but a deeper understanding and evaluation of the active components of these interventions is needed within clinical trials before wider implementation into clinical practice can be recommended.

A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

PubMed

Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

2012-03-01

Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

Evaluation of an online partner notification program.

PubMed

Rietmeijer, Cornelis A; Westergaard, Benton; Mickiewicz, Theresa A; Richardson, Doug; Ling, Sarah; Sapp, Terri; Jordan, Rebecca; Wilmoth, Ralph; Kachur, Rachel; McFarlane, Mary

2011-05-01

Internet-based programs for sexually transmitted infections (STI)/HIV partner notification have generated considerable interest as public health interventions; yet data are lacking to support widespread dissemination. We report on a clinic-based and web-based evaluation of the Colorado inSPOT online partner notification program. Clinic-based surveys were conducted at a large urban STI clinic before and after the implementation of feasible clinic interventions as well as nonclinic campaigns to promote the use of inSPOT Colorado. Questions assessed recognition and use of the site. Website statistics were provided by the inSPOT service, including the number of site hits, e-cards sent, and specific STI exposures identified on the card. Recognition and use of the service among STI clinic patients remained low (<6%) despite the interventions. Site statistics demonstrated an immediate but quickly diminishing response after placement of a banner ad on a popular gay website. Newspaper advertisements and radio public service announcements showed small increases in website use. Analysis of STIs specified on the e-cards, showed scabies and pediculosis as the most-identified STIs, accounting for nearly 30% of all e-cards sent. Clinic survey data indicated that when respondents were faced with the hypothetical situation of being diagnosed with an STI, more than 90% would notify partners in person; only 5% would use e-mail or the Internet. Our data did not support the effectiveness of the inSPOT intervention among a predominantly heterosexual population in a large urban STI clinic.

Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models.

PubMed

Symon, Andrew; Pringle, Jan; Downe, Soo; Hundley, Vanora; Lee, Elaine; Lynn, Fiona; McFadden, Alison; McNeill, Jenny; Renfrew, Mary J; Ross-Davie, Mary; van Teijlingen, Edwin; Whitford, Heather; Alderdice, Fiona

2017-01-06

Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models. A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions. Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or complications); Restricted 'lower-risk'-based provision model (midwifery-led or reduced/flexible visit approach for healthy women); Augmented provision model (antenatal care as in Universal provision above but augmented by clinical, educational or behavioural intervention); Targeted 'higher-risk'-based provision model (for woman with defined clinical or socio-demographic risk factors). The first category was most commonly tested in low-income countries (i.e. resource-poor settings), particularly in Asia. The other categories were tested around the world. The trials included a range of care providers, including midwives, nurses, doctors, and lay workers. Interventions can be defined and described in many ways. The intended antenatal care population group proved the simplest and most clinically relevant way of distinguishing trials which might otherwise be categorised together. Since our review excluded non-trial interventions, the taxonomy does not represent antenatal care provision worldwide. It offers a stable and reproducible approach to describing the purpose and content of models of antenatal care which have been tested in a trial. It highlights a lack of reported detail of trial interventions and usual care processes. It provides a baseline for future work to examine and test the salient characteristics of the most effective models, and could also help decision-makers and service planners in planning implementation.

Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.

PubMed

Willis, Thomas A; Hartley, Suzanne; Glidewell, Liz; Farrin, Amanda J; Lawton, Rebecca; McEachan, Rosemary R C; Ingleson, Emma; Heudtlass, Peter; Collinson, Michelle; Clamp, Susan; Hunter, Cheryl; Ward, Vicky; Hulme, Claire; Meads, David; Bregantini, Daniele; Carder, Paul; Foy, Robbie

2016-02-29

There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive a set of 'high impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice. The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an 'opt-out' recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data extracted 1 year after randomisation. Economic modelling will estimate intervention cost-effectiveness. A process evaluation involving eight non-trial practices will examine intervention delivery, mechanisms of action and unintended consequences. ASPIRE will provide 'real-world' evidence about the effects, cost-effectiveness and delivery of adapted intervention packages targeting high impact recommendations. By implementing our adaptable intervention package across four distinct clinical topics, and using 'opt-out' recruitment, our findings will provide evidence of wider generalisability. ISRCTN91989345.

Improving Participants’ Retention in a Smoking Cessation Intervention Using a Community-based Participatory Research Approach

PubMed Central

Estreet, Anthony; Apata, Jummai; Kamangar, Farin; Schutzman, Christine; Buccheri, Jane; O’Keefe, Anne-Marie; Wagner, Fernando; Sheikhattari, Payam

2017-01-01

Background: This study compares participant’ sretention in three phases of smoking cessation interventions, one provided in a health clinic and the subsequent two in community-based settings. Methods: Smoking cessation interventions were conducted in three phases from 2008 to 2015 in two underserved urban communities with low socioeconomic profiles and high rates of smoking (n = 951). Phase I was conducted in a clinic; Phases II and III were conducted in community venues. In Phases II and III, incremental changes were made based on lessons learned from the previous phases. Retention (attending six or more sessions) was the primary predictor of cessation and was analyzed while controlling for associated factors including age, gender, race, employment, education, and nicotine dependence. Results: Retention increased substantially over the three phases, with rates for attending six or more sessions of 13.8%, 51.9%, and 67.9% in Phases I, II, and III, respectively. Retention was significantly higher in community settings than in the clinic setting (adjusted odds ratio [OR] = 6.7; 95% confidence intervals [CI] = 4.6, 9.8). In addition to the intervention in community venues, predictors of retention included age and unemployment. Higher retention was significantly associated with higher quit rates (adjusted OR = 2.4; 95% CI = 1.5, 3.8). Conclusions: Conducting the intervention in community settings using trained peer motivators rather than health-care providers resulted in significantly higher retention and smoking cessation rates. This was due in part to the ability to tailor cessation classes in the community for specific populations and improving the quality of the intervention based on feedback from participants and community partners. PMID:29416835

Improvement of Physical Therapist Assessment of Risk of Falls in the Hospital and Discharge Handover Through an Intervention to Modify Clinical Behavior.

PubMed

Thomas, Susie; Mackintosh, Shylie

2016-06-01

Discharge from the hospital is a high risk transition period for older adults at risk of falls. Guidelines relevant to physical therapists for managing this risk are well documented, but commonly not implemented. This project implemented an intervention to improve physical therapists' adherence to key guideline recommendations for managing risk of falls on discharge from one hospital. A pretest-posttest study design was undertaken and was underpinned by the Theoretical Domains Framework (TDF) to aid in the design of interventions to increase physical therapists' adherence to guideline recommendations and to identify barriers to these interventions. A multifaceted intervention was implemented, including the establishment of a governance committee, education sessions, development of a "pathway" to guide practice, modification of an existing standardized assessment proforma, development of standardized processes and indicators for handover, increasing availability of educational handouts, audit and feedback processes, and allocation of dedicated staffing to oversee falls prevention within the physical therapy department. There were significant improvements in physical therapist behavior leading to key guideline recommendations being met, including: the proportion of patients who were identified to be at risk of falls (6.3% preintervention versus 94.8% postintervention) prior to discharge, an increase in documentation of clinical handover at discharge (68.6% preintervention versus 90.9% postintervention), and improvement in the quality of this documented clinical handover (34.9% of case notes met 5 criteria preintervention versus 92.9% postintervention). The approach was resource intensive and consequently may be difficult to replicate at other sites. A multifaceted intervention underpinned by the TDF, designed to modify physical therapists' behavior to improve adherence to guideline recommendations for managing risk of falls on discharge from one hospital, was successful. © 2016 American Physical Therapy Association.

Perspectives of health care professionals on the facilitators and barriers to the implementation of a stroke rehabilitation guidelines cluster randomized controlled trial.

PubMed

Munce, Sarah E P; Graham, Ian D; Salbach, Nancy M; Jaglal, Susan B; Richards, Carol L; Eng, Janice J; Desrosiers, Johanne; MacKay-Lyons, Marilyn; Wood-Dauphinee, Sharon; Korner-Bitensky, Nicol; Mayo, Nancy E; Teasell, Robert W; Zwarenstein, Merrick; Mokry, Jennifer; Black, Sandra; Bayley, Mark T

2017-06-26

The Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE-IT) was a cluster randomized controlled trial that evaluated two knowledge translation (KT) interventions for the promotion of the uptake of best practice recommendations for interventions targeting upper and lower extremity function, postural control, and mobility. Twenty rehabilitation centers across Canada were randomly assigned to either the facilitated or passive KT intervention. The objective of the current study was to understand the factors influencing the implementation of the recommended treatments and KT interventions from the perspective of nurses, occupational therapists and physical therapists, and clinical managers following completion of the trial. A qualitative descriptive approach involving focus groups was used. Thematic analysis was used to understand the factors influencing the implementation of the recommended treatments and KT interventions. The Clinical Practice Guidelines Framework for Improvement guided the analysis. Thirty-three participants were interviewed from 11 of the 20 study sites (6 sites from the facilitated KT arm and 5 sites from the passive KT arm). The following factors influencing the implementation of the recommended treatments and KT interventions emerged: facilitation, agreement with the intervention - practical, familiarity with the recommended treatments, and environmental factors, including time and resources. Each of these themes includes the sub-themes of facilitator and/or barrier. Improved team communication and interdisciplinary collaboration emerged as an unintended outcome of the trial across both arms in addition to a facilitator to the implementation of the treatment recommendations. Facilitation was identified as a facilitator to implementation of the KT interventions in the passive KT intervention arm despite the lack of formally instituted facilitators in this arm of the trial. This is one of the first studies to examine the factors influencing the implementation of stroke recommendations and associated KT interventions within the context of a trial. Findings highlight the important role of self-selected facilitators to implementation efforts. Future research should seek to better understand the specific characteristics of facilitators that are associated with successful implementation and clinical outcomes, especially within the context of stroke rehabilitation.

Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill.

PubMed

Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

2017-01-01

Physicians encounter various symptom-based complaints each day. While physicians strive to support patients with chronic illnesses, evidence indicates that patients who are actively involved in their health care have better health outcomes and sometimes lowers costs. This article is to analyze how patient engagement is described when complex interventions such as Tai Chi were delivered in Randomized Controlled clinical Trials (RCTs). It reviews the dynamic patient- physician relationship in chronic illness management and to illustrate the patient engagement process, using Tai Chi as an example intervention. RCTs are considered the gold standard in clinical research. This study is a qualitative analysis of RCTs using Tai Chi as an intervention. A systematic literature search was performed to identify quality randomized controlled clinical trials that investigated the effects of Tai Chi. Selected clinical trials were classified according to research design, intervention style, patient engagement, and outcomes. Patient engagement was classified based on levels of patient participation, compliance, and selfmanagement. The chronic health conditions included in this paper are Parkinson's disease, polyneuropathy, hypertension, stroke, chronic insomnia, chronic heart failure, fibromyalgia, osteoarthritis, central obesity, depression, deconditioning in the elderly, or being pre-clinically disabled. We found that patient engagement, as a concept, was not well defined in literature. It covers a wide range of related terms, such as patient involvement, participation, shared decision- making, patient activation, adherence, compliance, and self-management. Tai Chi, as a very complex practice system, is to balance all aspects of a patient's life; however, the level of patient engagement is difficult to describe using conventional clinical trial design. To accurately illustrate the effect of a complex intervention, novel research design must explore ways to measure patient engagement in the intervention in order to clarify its specific role on health. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Cost-outcome description of clinical pharmacist interventions in a university teaching hospital.

PubMed

Gallagher, James; Byrne, Stephen; Woods, Noel; Lynch, Deirdre; McCarthy, Suzanne

2014-04-17

Pharmacist interventions are one of the pivotal parts of a clinical pharmacy service within a hospital. This study estimates the cost avoidance generated by pharmacist interventions due to the prevention of adverse drug events (ADE). The types of interventions identified are also analysed. Interventions recorded by a team of hospital pharmacists over a one year time period were included in the study. Interventions were assigned a rating score, determined by the probability that an ADE would have occurred in the absence of an intervention. These scores were then used to calculate cost avoidance. Net cost benefit and cost benefit ratio were the primary outcomes. Categories of interventions were also analysed. A total cost avoidance of €708,221 was generated. Input costs were calculated at €81,942. This resulted in a net cost benefit of €626,279 and a cost benefit ratio of 8.64: 1. The most common type of intervention was the identification of medication omissions, followed by dosage adjustments and requests to review therapies. This study provides further evidence that pharmacist interventions provide substantial cost avoidance to the healthcare payer. There is a serious issue of patient's regular medication being omitted on transfer to an inpatient setting in Irish hospitals.

The IR Evolution in Oncology: Tools, Treatments, and Guidelines.

PubMed

de Baere, Thierry

2017-01-01

Early focus of interventional oncologists was developing tools and imaging guidance, performing "procedures" acting as a skillful technician without knowledge of clinical patient outcomes, beyond post-treatment image findings. Interventional oncologists must deliver "treatments" and not "procedures", and focus on clinically relevant outcomes, provide clinical continuity of care, which means stand at multidisciplinary tumor boards, see patients in consultation before treatment and for follow-up. Interventional oncologists have fought for the same "market" with surgery in a head to head, bloody competition called red ocean strategy in marketing terms, resulting in many aborted trials. Wide adoption of interventional oncology is facing the challenge to build evidence with overall survival as endpoint in randomized trials while the benefits of a treatment on overall survival are diluted by the effects of possible/inevitable subsequent therapies. Because interventional oncology is a disruptive force in medicine achieving same results as others (surgery) using different, less invasive approaches, patients where surgery is irrelevant can be target with a blue ocean strategy (to propose treatment where there is no competition). Recently interventional oncology has been included in the ESMO guidelines for colorectal cancer with oligometastatic disease with both surgical resection, and thermal ablation classified in the same category called "local ablative treatments". Interventional oncologists have to shape the future by publications in oncologic journal, by being active members of oncology scientific societies, and use modern public megaphone (blog, video sharing, …) to disseminate information and let society know that interventional is not a me-too product but a disruptive treatment.

Can Clinical Skills Be Taught Online? Comparing Skill Development between Online and F2F Students Using a Blinded Review

ERIC Educational Resources Information Center

Wilke, Dina J.; King, Erin; Ashmore, Margaret; Stanley, Craig

2016-01-01

This study compared the development of clinical assessment and intervention skills between students enrolled in a face-to-face (F2F) or an asynchronous online clinical social work class. All students from three semesters of F2F (n = 74) and online (n = 78) sections of an MSW clinical class taught by the same instructor were included. Two…

Effects of Functional Communication Training (FCT) on the Communicative, Self-Initiated Toileting Behavior for Students with Developmental Disabilities in a School Setting

ERIC Educational Resources Information Center

Kim, Jinnie

2012-01-01

Far less is known about the effects of functional communication-based toileting interventions for students with developmental disabilities in a school setting. Furthermore, the currently available toileting interventions for students with disabilities include some undesirable procedures such as the use of punishment, unnatural clinic/university…

Improving participant comprehension in the informed consent process.

PubMed

Cohn, Elizabeth; Larson, Elaine

2007-01-01

To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention

PubMed Central

Murchie, Peter; Allan, Julia L; Brant, William; Dennis, Matthew; Hall, Susan; Masthoff, Judith; Walter, Fiona M; Johnston, Marie

2015-01-01

Objectives To develop a digital intervention to prompt, support, and respond to the outcomes of total skin self-examinations (TSSEs) at home by people treated for cutaneous melanoma. Design A complex intervention development study. Setting Northeast Scotland. Participants Semistructured scoping interviews; people previously treated for cutaneous melanoma (n=21). Pilot testing: people treated for melanoma stages 0–2C (n=20); general practitioners (n=6); and a nurse specialist in dermatology (n=1). Intervention A tablet-based digital intervention designed to prompt and support TSSEs comprising instructional videos and electronic reporting (including photographs) to a clinical nurse specialist in dermatology, with subsequent clinical triage. Primary and secondary outcome measures Qualitative assessment of intervention feasibility and acceptability, and quantitative assessment of intentions and confidence to perform TSSEs in pilot participants. Results The majority of pilot participants were strongly positive and adhered well to the intervention (n=15), with 7 of these reporting symptoms of concern at some point during the 6-month pilot. 4 patients complied intermittently, 3 reporting skin problems at least once during the pilot, and 1 withdrew. 2 patients underwent skin surgery as a result of participating in the pilot, with 1 diagnosed as having a recurrent melanoma and the other, a benign lesion. A number of practical issues to improve the usability of the intervention were identified. The proportion of participants reporting intention to check their skin at least monthly increased during the intervention as did confidence to conduct a skin check. Conclusions People previously treated for cutaneous melanoma are prepared to use digital technology to support them in conducting TSSE. An intervention has been developed which is practical, effective and safe, and after addressing minor practical issues, could now be evaluated for clinical outcomes in a randomised clinical trial. PMID:26251412

Enhancing Placebo Effects: Insights From Social Psychology

PubMed Central

SLIWINSKI, JIM; ELKINS, GARY R.

2012-01-01

Placebo effects are widely recognized as having a potent impact upon treatment outcomes in both medical and psychological interventions, including hypnosis. In research utilizing randomized clinical trials, there is usually an effort to minimize or control placebo effects. However, in clinical practice there may be significant benefits in enhancing placebo effects. Prior research from the field of social psychology has identified three factors that may enhance placebo effects, namely: priming, client perceptions, and the theory of planned behavior. These factors are reviewed and illustrated via a case example. The consideration of social-psychological factors to enhance positive expectancies and beliefs has implications for clinical practice as well as future research into hypnotic interventions. PMID:23488251

Tolerability and suitability of brief group mindfulness-oriented interventions in psychiatric inpatients: a pilot study.

PubMed

Nikolitch, Katerina; Laliberté, Vincent; Yu, Ching; Strychowsky, Natalie; Segal, Marilyn; Looper, Karl J; Rej, Soham

2016-09-01

Mindfulness-oriented therapies have a positive impact on patients' overall well-being and alleviate many psychiatric conditions. However, little is known about their use in people with severe mental illness. We aimed to identify which clinical and sociodemographic factors are associated with suitability/tolerability of a brief group mindfulness-oriented therapy. This retrospective study examines pre-/post-data from 40 psychiatric inpatients who underwent one session of a 10-min mindfulness-oriented group intervention between January and March 2014. The main outcome was 'suitability for and tolerating the brief mindfulness-oriented group intervention'. We assessed potential correlates of the main outcome, including female gender, shorter hospitalisation, the absence of psychosis and good pre-morbid functioning. The intervention was well tolerated (92.5%) and 50% of patients met both of our relatively stringent suitability and tolerability criteria. Sociodemographic and clinical variables were not associated with suitability/tolerability. Tai chi was the most suitable/tolerable compared to body scan and mindful eating (76.5% vs. 35.7% vs. 22.2%, Fisher's exact p = 0.01, Bonferroni p < 0.05). Brief group mindfulness therapy interventions are very well tolerated and often suitable for acutely hospitalised psychiatric inpatients, including those with acute psychosis. Mindfulness-oriented intervention with an active component (e.g., tai chi, mindful walking) may potentially be best suited for this population.

Interventions to Reduce the Incidence of Hospital-Onset Clostridium difficile Infection: An Agent-Based Modeling Approach to Evaluate Clinical Effectiveness in Adult Acute Care Hospitals.

PubMed

Barker, Anna K; Alagoz, Oguzhan; Safdar, Nasia

2018-04-03

Despite intensified efforts to reduce hospital-onset Clostridium difficile infection (HO-CDI), its clinical and economic impacts continue to worsen. Many institutions have adopted bundled interventions that vary considerably in composition, strength of evidence, and effectiveness. Considerable gaps remain in our knowledge of intervention effectiveness and disease transmission, which hinders HO-CDI prevention. We developed an agent-based model of C. difficile transmission in a 200-bed adult hospital using studies from the literature, supplemented with primary data collection. The model includes an environmental component and 4 distinct agent types: patients, visitors, nurses, and physicians. We used the model to evaluate the comparative clinical effectiveness of 9 single interventions and 8 multiple-intervention bundles at reducing HO-CDI and asymptomatic C. difficile colonization. Daily cleaning with sporicidal disinfectant and C. difficile screening at admission were the most effective single-intervention strategies, reducing HO-CDI by 68.9% and 35.7%, respectively (both P < .001). Combining these interventions into a 2-intervention bundle reduced HO-CDI by 82.3% and asymptomatic hospital-onset colonization by 90.6% (both, P < .001). Adding patient hand hygiene to healthcare worker hand hygiene reduced HO-CDI rates an additional 7.9%. Visitor hand hygiene and contact precaution interventions did not reduce HO-CDI, compared with baseline. Excluding those strategies, healthcare worker contact precautions were the least effective intervention at reducing hospital-onset colonization and infection. Identifying and managing the vast hospital reservoir of asymptomatic C. difficile by screening and daily cleaning with sporicidal disinfectant are high-yield strategies. These findings provide much-needed data regarding which interventions to prioritize for optimal C. difficile control.

The Effectiveness of Early Educational Interventions in the Emergency Department to Reduce Incidence or Severity of Postconcussion Syndrome Following a Concussion: A Systematic Review.

PubMed

Eliyahu, Leeor; Kirkland, Scott; Campbell, Sandy; Rowe, Brian H

2016-05-01

Concussions or mild traumatic brain injury are a major public health concern accounting for 85% of all brain injuries. Postconcussion syndrome (PCS) has been found to affect between 15 and 25% of patients with concussion 1 year after the initial injury. The goal of this review is to assess the effectiveness of early educational information or interventions provided in the emergency department on the onset and/or severity of PCS. A comprehensive literature search strategy involving seven electronic databases was developed. A grey literature search of Google Scholar, recent conference proceedings in emergency medicine, bibliographies of included studies, and clinical trial registries was also performed. The citation list was reviewed independently by two reviewers; no restrictions on publication status or language of publication were applied. The Cochrane risk-of-bias tool and the Newcastle-Ottawa scale were used to assess quality. From 1,325 citations retrieved, four RCTs and one controlled clinical trial met inclusion criteria. Interventions identified in these studies included: educational information sheets, with or without telephone or in-person follow-up, and one study on bed rest. While rarely requested, one study offered referrals and additional treatment, if needed. None of the studies were deemed to be high quality. Heterogeneity among outcome reporting, follow-up dates and interventions used precluded a pooled analysis. Overall, only two of the five included studies involving adult patients receiving early educational interventions reported a significant improvement in PCS symptoms. No reduction in PCS symptoms was found in the study on bed rest interventions. Limited evidence exists regarding the effectiveness of early educational interventions following concussion. Standardization of the interventions, outcome measures, and follow-up periods would make quantitative comparisons more valid. Moreover, higher-quality research in the field of early interventions for patients in the acute care setting is urgently required. © 2016 by the Society for Academic Emergency Medicine.

Can We Increase Psychological Well-Being? The Effects of Interventions on Psychological Well-Being: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Westerhof, Gerben J.; Bohlmeijer, Ernst T.

2016-01-01

Background There is a rapidly growing interest in psychological well-being (PWB) as outcome of interventions. Ryff developed theory-based indicators of PWB that are consistent with a eudaimonic perspective of happiness. Numerous interventions have been developed with the aim to increase PWB. However, the effects on PWB measured as coherent outcome have not been examined across studies yet. This meta-analysis of randomized controlled trials of behavioral interventions aims to answer the question whether it is possible to enhance PWB. Methods A systematic literature search was performed in PsycINFO, Cochrane and Web of Science. To be included, studies had to be randomized controlled trials of behavioral interventions with psychological well-being as primary or secondary outcome measure, measured with either Ryff’s Psychological Well-Being Scales or the Mental Health Continuum—Short Form. The meta-analysis was performed using a random effects model. From the 2,298 articles found, 27 met the inclusion criteria. The included studies involved 3,579 participants. Results We found a moderate effect (Cohen’s d = 0.44; z = 5.62; p < .001). Heterogeneity between the studies was large (Q (26) = 134.12; p < .001; I2 = 80.62). At follow-up after two to ten months, a small but still significant effect size of 0.22 was found. There was no clear indication of publication bias. Interventions were more effective in clinical groups and when they were delivered individually. Effects were larger in studies of lower quality. Conclusions It appears to be possible to improve PWB with behavioral interventions. The results are promising for the further development and implementation of interventions to promote PWB. Delivering interventions face-to-face seems to be the most promising option. We recommend to keep including clinical groups in the research of psychological well-being. Heterogeneity is a limitation of the study and there is need for more high-quality studies. PMID:27328124

Interventions to reduce medication errors in neonatal care: a systematic review

PubMed Central

Nguyen, Minh-Nha Rhylie; Mosel, Cassandra

2017-01-01

Background: Medication errors represent a significant but often preventable cause of morbidity and mortality in neonates. The objective of this systematic review was to determine the effectiveness of interventions to reduce neonatal medication errors. Methods: A systematic review was undertaken of all comparative and noncomparative studies published in any language, identified from searches of PubMed and EMBASE and reference-list checking. Eligible studies were those investigating the impact of any medication safety interventions aimed at reducing medication errors in neonates in the hospital setting. Results: A total of 102 studies were identified that met the inclusion criteria, including 86 comparative and 16 noncomparative studies. Medication safety interventions were classified into six themes: technology (n = 38; e.g. electronic prescribing), organizational (n = 16; e.g. guidelines, policies, and procedures), personnel (n = 13; e.g. staff education), pharmacy (n = 9; e.g. clinical pharmacy service), hazard and risk analysis (n = 8; e.g. error detection tools), and multifactorial (n = 18; e.g. any combination of previous interventions). Significant variability was evident across all included studies, with differences in intervention strategies, trial methods, types of medication errors evaluated, and how medication errors were identified and evaluated. Most studies demonstrated an appreciable risk of bias. The vast majority of studies (>90%) demonstrated a reduction in medication errors. A similar median reduction of 50–70% in medication errors was evident across studies included within each of the identified themes, but findings varied considerably from a 16% increase in medication errors to a 100% reduction in medication errors. Conclusion: While neonatal medication errors can be reduced through multiple interventions aimed at improving the medication use process, no single intervention appeared clearly superior. Further research is required to evaluate the relative cost-effectiveness of the various medication safety interventions to facilitate decisions regarding uptake and implementation into clinical practice. PMID:29387337

Adherence to Treatment in Hypertension.

PubMed

Villalva, Carlos Menéndez; Alvarez-Muiño, Xosé Luís López; Mondelo, Trinidad Gamarra; Fachado, Alfonso Alonso; Fernández, Joaquín Cubiella

2017-01-01

The lack of adherence to treatment in hypertension affects approximately 30 % of patients. The elderly, those with several co-morbidities, social isolation, low incomes or depressive symptoms are the most vulnerable to this problem. There is no ideal method to quantify the adherence to the treatment. Indirect methods are recommended in clinical practice. Any intervention strategy should not blame the patient and try a collaborative approach. It is recommended to involve the patient in decision-making. The clinical interview style must be patient-centered including motivational techniques. The improvement strategies that showed greater effectiveness in the compliance of hypertension treatment were: treatment simplification, appointment reminders systems, blood pressure self-monitoring, organizational improvements and nurse and pharmacists care. The combination of different interventions are recommended against isolated interventions.

Behavioural and Developmental Interventions for Autism Spectrum Disorder: A Clinical Systematic Review

PubMed Central

Ospina, Maria B.; Krebs Seida, Jennifer; Clark, Brenda; Karkhaneh, Mohammad; Hartling, Lisa; Tjosvold, Lisa; Vandermeer, Ben; Smith, Veronica

2008-01-01

Background Much controversy exists regarding the clinical efficacy of behavioural and developmental interventions for improving the core symptoms of autism spectrum disorders (ASD). We conducted a systematic review to summarize the evidence on the effectiveness of behavioural and developmental interventions for ASD. Methods and Findings Comprehensive searches were conducted in 22 electronic databases through May 2007. Further information was obtained through hand searching journals, searching reference lists, databases of theses and dissertations, and contacting experts in the field. Experimental and observational analytic studies were included if they were written in English and reported the efficacy of any behavioural or developmental intervention for individuals with ASD. Two independent reviewers made the final study selection, extracted data, and reached consensus on study quality. Results were summarized descriptively and, where possible, meta-analyses of the study results were conducted. One-hundred-and-one studies at predominantly high risk of bias that reported inconsistent results across various interventions were included in the review. Meta-analyses of three controlled clinical trials showed that Lovaas treatment was superior to special education on measures of adaptive behaviour, communication and interaction, comprehensive language, daily living skills, expressive language, overall intellectual functioning and socialization. High-intensity Lovaas was superior to low-intensity Lovaas on measures of intellectual functioning in two retrospective cohort studies. Pooling the results of two randomized controlled trials favoured developmental approaches based on initiative interaction compared to contingency interaction in the amount of time spent in stereotyped behaviours and distal social behaviour, but the effect sizes were not clinically significant. No statistically significant differences were found for: Lovaas versus special education for non-verbal intellectual functioning; Lovaas versus Developmental Individual-difference relationship-based intervention for communication skills; computer assisted instruction versus no treatment for facial expression recognition; and TEACCH versus standard care for imitation skills and eye-hand integration. Conclusions While this review suggests that Lovaas may improve some core symptoms of ASD compared to special education, these findings are based on pooling of a few, methodologically weak studies with few participants and relatively short-term follow-up. As no definitive behavioural or developmental intervention improves all symptoms for all individuals with ASD, it is recommended that clinical management be guided by individual needs and availability of resources. PMID:19015734

Dissonance-based interventions for health behaviour change: a systematic review.

PubMed

Freijy, Tanya; Kothe, Emily J

2013-05-01

Increasing evidence suggests that various health behaviours are amenable to change following the induction of cognitive dissonance. This systematic review sought to evaluate the effectiveness and methodological quality of dissonance-based health behaviour interventions and to explore identified sources of heterogeneity in intervention effects. Bibliographic databases were searched for relevant articles from inception to March 2012. Only studies targeting non-clinical health behaviour in non-clinical populations were included in the review. One author extracted data and assessed quality of evidence and a second author verified all content. Reports of 20 studies were included. A variety of health behaviours and outcome measures were addressed across studies. Most studies produced one or more significant effects on measures of behaviour, attitude or intention. Across studies, methodological risk for bias was frequently high, particularly for selection bias. Gender and self-esteem were identified as potential moderator variables. The evidence for the effectiveness of dissonance-based interventions was generally positive. The hypocrisy paradigm was found to be the most commonly applied research paradigm and was most effective at inciting change across a range of health behaviours. There was no observable link between type of target behaviour and positive outcomes. Researchers are encouraged to minimize potential for bias in future studies and explore moderators of the dissonance effect. What is already known on this subject? A recent meta-analysis indicates that dissonance-based interventions primarily based on the induced compliance paradigm are effective for eating disorder prevention (Stice, Shaw, Becker, & Rohde, 2008, Prev. Sci., 9, 114). However, it is currently unclear whether such outcomes are generalizable to interventions targeting non-clinical health behaviours such as smoking, sun protection and sexual risk taking. Other research indicates that studies based on the hypocrisy paradigm may lead to changes in non-clinical health behaviours (Stone & Fernandez, 2008, Soc. Personal. Psychol. Compass, 2, 1024; Stone & Focella, 2011, Self Identity, 10, 295) although this literature lacks systematic evaluation of interventions across a range of experimental paradigms. What does this study add? The hypocrisy paradigm appears most effective in inciting change across a range of non-clinical health behaviours. The dissonance effect may be moderated by variables such as self-esteem and gender. Risk of bias needs to be minimised to increase the validity of studies within this topic area. © 2013 The British Psychological Society.

An Augmented SMS Intervention to Improve Access to Antenatal CD4 Testing and ART Initiation in HIV-Infected Pregnant Women: A Cluster Randomized Trial

PubMed Central

Dryden-Peterson, Scott; Bennett, Kara; Hughes, Michael D.; Veres, Adrian; John, Oaitse; Pradhananga, Rosina; Boyer, Matthew; Brown, Carolyn; Sakyi, Bright; van Widenfelt, Erik; Keapoletswe, Koona; Mine, Madisa; Moyo, Sikhulile; Asmelash, Aida; Siedner, Mark; Mmalane, Mompati; Shapiro, Roger L.; Lockman, Shahin

2015-01-01

Background Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy (ART) globally initiate treatment prior to delivery, with lack of access to timely CD4 results being a principal barrier. We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART. Methods We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone, Botswana. From July 2011-April 2012, 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing. CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed. Results Three-hundred-sixty-six ART-naïve women were included, 189 registering for antenatal care under Intervention and 177 under Usual Care periods. Of CD4-eligible women, 100 (59.2%) women under Intervention and 79 (50.6%) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation, adjusted odds ratio (aOR, adjusted for time that a clinic initiated Intervention) 0.87 (95% confidence interval [CI]0.47–1.63, P = 0.67). The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days (P<0.001), was appreciated by clinic staff, and was associated with reduced operational cost. However, rates of ART initiation remained low, with 56 (36.4%) women registering under Intervention versus 37 (24.2%) women under Usual Care initiating ART prior to 30 weeks gestation, aOR 1.06 (95%CI 0.53–2.13, P = 0.87). Conclusions The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently, and this type of SMS-based results delivery platform may be useful for a variety of tests and settings. However, the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation, as obstacles other than CD4 impeded ART initiation during pregnancy. PMID:25693050

Do psychosocial interventions improve rehabilitation outcomes after anterior cruciate ligament reconstruction? A systematic review.

PubMed

Coronado, Rogelio A; Bird, Mackenzie L; Van Hoy, Erin E; Huston, Laura J; Spindler, Kurt P; Archer, Kristin R

2018-03-01

To examine the role of psychosocial interventions in improving patient-reported clinical outcomes, including return to sport/activity, and intermediary psychosocial factors after anterior cruciate ligament reconstruction. MEDLINE/PubMed, CINAHL, PsycINFO, and Web of Science were searched from each database's inception to March 2017 for published studies in patients after anterior cruciate ligament reconstruction. Studies were included if they reported on the effects of a postoperative psychosocial intervention on a patient-reported clinical measure of disability, function, pain, quality of life, return to sport/activity, or intermediary psychosocial factor. Data were extracted using a standardized form and summary effects from each article were compiled. The methodological quality of randomized trials was assessed using the Physiotherapy Evidence Database Scale and scores greater than 5/10 were considered high quality. A total of 893 articles were identified from the literature search. Of these, four randomized trials ( N = 210) met inclusion criteria. The four articles examined guided imagery and relaxation, coping modeling, and visual imagery as postoperative psychosocial interventions. Methodological quality scores of the studies ranged from 5 to 9. There were inconsistent findings for the additive benefit of psychosocial interventions for improving postoperative function, pain, or self-efficacy and limited evidence for improving postoperative quality of life, anxiety, or fear of reinjury. No study examined the effects of psychosocial interventions on return to sport/activity. Overall, there is limited evidence on the efficacy of postoperative psychosocial interventions for improving functional recovery after anterior cruciate ligament reconstruction.

Clinical assessments and care interventions to promote oral hydration amongst older patients: a narrative systematic review.

PubMed

Oates, Lloyd L; Price, Christopher I

2017-01-01

Older patients in hospital may be unable to maintain hydration by drinking, leading to intravenous fluid replacement, complications and a longer length of stay. We undertook a systematic review to describe clinical assessment tools which identify patients at risk of insufficient oral fluid intake and the impact of simple interventions to promote drinking, in hospital and care home settings. MEDLINE, CINAHL, and EMBASE databases and two internet search engines (Google and Google Scholar) were examined. Articles were included when the main focus was use of a hydration/dehydration risk assessment in an adult population with/without a care intervention to promote oral hydration in hospitals or care homes. Reviews which used findings to develop new assessments were also included. Single case reports, laboratory results only, single technology assessments or non-oral fluid replacement in patients who were already dehydrated were excluded. Interventions where nutritional intake was the primary focus with a hydration component were also excluded. Identified articles were screened for relevance and quality before a narrative synthesis. No statistical analysis was planned. From 3973 citations, 23 articles were included. Rather than prevention of poor oral intake, most focused upon identification of patients already in negative fluid balance using information from the history, patient inspection and urinalysis. Nine formal hydration assessments were identified, five of which had an accompanying intervention/ care protocol, and there were no RCT or large observational studies. Interventions to provide extra opportunities to drink such as prompts, preference elicitation and routine beverage carts appeared to support hydration maintenance, further research is required. Despite a lack of knowledge of fluid requirements and dehydration risk factors amongst staff, there was no strong evidence that increasing awareness alone would be beneficial for patients. Despite descriptions of features associated with dehydration, there is insufficient evidence to recommend a specific clinical assessment which could identify older persons at risk of poor oral fluid intake; however there is evidence to support simple care interventions which promote drinking particularly for individuals with cognitive impairment. PROSPERO 2014:CRD42014015178.

Implementing a knowledge translation intervention in long-term care: feasibility results from the Vitamin D and Osteoporosis Study (ViDOS).

PubMed

Kennedy, Courtney C; Thabane, Lehana; Ioannidis, George; Adachi, Jonathan D; Papaioannou, Alexandra

2014-12-01

To evaluate the feasibility of implementing an interdisciplinary, multifaceted knowledge translation intervention within long-term care (LTC) and to identify any challenges that should be considered in designing future studies. Cluster randomized controlled trial. Forty LTC homes across the province of Ontario, Canada. LTC teams composed of physicians, nurses, pharmacists, and other staff. Cluster-level feasibility measures, including recruitment, retention, data completion, and participation in the intervention. A process evaluation was completed by directors of care indicating which process/policy changes had been implemented. Recruitment and retention rates were 22% and 63%, respectively. Good fidelity with the intervention was achieved, including attendance at educational meetings. After ViDOS, 7 process indicators were being newly implemented by more than 50% of active intervention homes. Despite recruitment and retention challenges, the multifaceted intervention produced a number of policy/process changes and had good intervention fidelity. This study is registered at ClinicalTrials.gov NCT01398527. Copyright © 2014. Published by Elsevier Inc.

Effectiveness of interventions to improve occupational performance of people with cognitive impairments after stroke: an evidence-based review.

PubMed

Gillen, Glen; Nilsen, Dawn M; Attridge, Jessica; Banakos, Erasmia; Morgan, Marie; Winterbottom, Lauren; York, Wesley

2015-01-01

This evidence-based review was conducted to determine which interventions are effective in improving occupational performance after stroke. Forty-six articles met the inclusion criteria and were examined. Interventions for the following impairments were reviewed: general cognitive deficits, executive dysfunction, apraxia, memory loss, attention deficits, visual field deficits (included because of their close relationship with neglect), and unilateral neglect. Evidence is available from a variety of clinical trials to guide interventions regarding general cognition, apraxia, and neglect. The evidence regarding interventions for executive dysfunction and memory loss is limited. There is insufficient evidence regarding impairments of attention and mixed evidence regarding interventions for visual field deficits. The effective interventions have some commonalities, including being performance focused, involving strategy training, and using a compensatory as opposed to a remediation approach. The implications of the findings for practice, research, and education are discussed. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Symptom Dimensions as Outcomes in Interventions for Patients With Cancer: A Systematic Review

PubMed

Henoch, Ingela; Olsson, Cecilia; Larsson, Maria; Ahlberg, Karin

2018-03-01

Symptom experience in patients with cancer consists of several dimensions, often measured descriptively within various populations but seldom used as intervention outcomes. This review aims at describing symptom dimensions as outcomes of interventions designed to alleviate symptoms in patients with cancer and to describe these interventions' effects on at least two symptom dimensions. 
. The PRISMA statement for reporting systematic reviews was used. Searches were undertaken in various indexing sites.
. Extracted data included design, participants, intervention and control group treatment, targeted symptom dimension, and summary of results.
. 2,041 articles were identified and 15 were included. The symptom dimensions were intensity, distress, prevalence, frequency, consequences, and quality. Eleven interventions had significant effect on symptom dimensions, mostly on intensity and distress.
. Oncology nurses need clinical skills to be able to understand patients' experiences through their narratives. Various interventions are targeted at symptoms, and these need to be implemented to provide evidence-based symptom management.

Improving patient access to an interventional US clinic.

PubMed

Steele, Joseph R; Clarke, Ryan K; Terrell, John A; Brightmon, Tonya R

2014-01-01

A continuous quality improvement project was conducted to increase patient access to a neurointerventional ultrasonography (US) clinic. The clinic was experiencing major scheduling delays because of an increasing patient volume. A multidisciplinary team was formed that included schedulers, medical assistants, nurses, technologists, and physicians. The team created an Ishikawa diagram of the possible causes of the long wait time to the next available appointment and developed a flowchart of the steps involved in scheduling and completing a diagnostic US examination and biopsy. The team then implemented a staged intervention that included adjustments to staffing and room use (stage 1); new procedures for scheduling same-day add-on appointments (stage 2); and a lead technician rotation to optimize patient flow, staffing, and workflow (stage 3). Six months after initiation of the intervention, the mean time to the next available appointment had decreased from 25 days at baseline to 1 day, and the number of available daily appointments had increased from 38 to 55. These improvements resulted from a coordinated provider effort and had a net present value of more than $275,000. This project demonstrates that structural changes in staffing, workflow, and room use can substantially reduce scheduling delays for critical imaging procedures. © RSNA, 2014.

Mindfulness Interventions in Physical Rehabilitation: A Scoping Review

PubMed Central

Hardison, Mark E.

2016-01-01

A scoping review was conducted to describe how mindfulness is used in physical rehabilitation, identify implications for occupational therapy practice, and guide future research on clinical mindfulness interventions. A systematic search of four literature databases produced 1,524 original abstracts, of which 16 articles were included. Although only 3 Level I or II studies were identified, the literature included suggests that mindfulness interventions are helpful for patients with musculoskeletal and chronic pain disorders and demonstrate trends toward outcome improvements for patients with neurocognitive and neuromotor disorders. Only 2 studies included an occupational therapist as the primary mindfulness provider, but all mindfulness interventions in the selected studies fit within the occupational therapy scope of practice according to the American Occupational Therapy Association’s Occupational Therapy Practice Framework: Domain and Process. Higher-level research is needed to evaluate the effects of mindfulness interventions in physical rehabilitation and to determine best practices for the use of mindfulness by occupational therapy practitioners. PMID:27089297

Mindfulness Interventions in Physical Rehabilitation: A Scoping Review.

PubMed

Hardison, Mark E; Roll, Shawn C

2016-01-01

A scoping review was conducted to describe how mindfulness is used in physical rehabilitation, identify implications for occupational therapy practice, and guide future research on clinical mindfulness interventions. A systematic search of four literature databases produced 1,524 original abstracts, of which 16 articles were included. Although only 3 Level I or II studies were identified, the literature included suggests that mindfulness interventions are helpful for patients with musculoskeletal and chronic pain disorders and demonstrate trends toward outcome improvements for patients with neurocognitive and neuromotor disorders. Only 2 studies included an occupational therapist as the primary mindfulness provider, but all mindfulness interventions in the selected studies fit within the occupational therapy scope of practice according to the American Occupational Therapy Association's Occupational Therapy Practice Framework: Domain and Process. Higher-level research is needed to evaluate the effects of mindfulness interventions in physical rehabilitation and to determine best practices for the use of mindfulness by occupational therapy practitioners. Copyright © 2016 by the American Occupational Therapy Association, Inc.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS)

PubMed Central

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-01

Introduction International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. Methods/analysis This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. Ethics/dissemination This feasibility trial protocol was approved by the UCD Human Research Ethics—Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. Trial registration number ISRCTN 49875385; Pre-results. PMID:26801470

Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial.

PubMed

Adachi, Misa; Yamaoka, Kazue; Watanabe, Mariko; Nishikawa, Masako; Hida, Eisuke; Kobayashi, Itsuro; Tango, Toshiro

2010-11-30

The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents.Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. UMIN000004049.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

PubMed

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-21

International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. ISRCTN 49875385; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Integrating an internet-mediated walking program into family medicine clinical practice: a pilot feasibility study.

PubMed

Goodrich, David E; Buis, Lorraine R; Janney, Adrienne W; Ditty, Megan D; Krause, Christine W; Zheng, Kai; Sen, Ananda; Strecher, Victor J; Hess, Michael L; Piette, John D; Richardson, Caroline R

2011-06-24

Regular participation in physical activity can prevent many chronic health conditions. Computerized self-management programs are effective clinical tools to support patient participation in physical activity. This pilot study sought to develop and evaluate an online interface for primary care providers to refer patients to an Internet-mediated walking program called Stepping Up to Health (SUH) and to monitor participant progress in the program. In Phase I of the study, we recruited six pairs of physicians and medical assistants from two family practice clinics to assist with the design of a clinical interface. During Phase II, providers used the developed interface to refer patients to a six-week pilot intervention. Provider perspectives were assessed regarding the feasibility of integrating the program into routine care. Assessment tools included quantitative and qualitative data gathered from semi-structured interviews, surveys, and online usage logs. In Phase I, 13 providers used SUH and participated in two interviews. Providers emphasized the need for alerts flagging patients who were not doing well and the ability to review participant progress. Additionally, providers asked for summary views of data across all enrolled clinic patients as well as advertising materials for intervention recruitment. In response to this input, an interface was developed containing three pages: 1) a recruitment page, 2) a summary page, and 3) a detailed patient page. In Phase II, providers used the interface to refer 139 patients to SUH and 37 (27%) enrolled in the intervention. Providers rarely used the interface to monitor enrolled patients. Barriers to regular use of the intervention included lack of integration with the medical record system, competing priorities, patient disinterest, and physician unease with exercise referrals. Intention-to-treat analyses showed that patients increased walking by an average of 1493 steps/day from pre- to post-intervention (t = (36) = 4.13, p < 0.01). Providers successfully referred patients using the SUH provider interface, but were less willing to monitor patient compliance in the program. Patients who completed the program significantly increased their step counts. Future research is needed to test the effectiveness of integrating SUH with clinical information systems over a longer evaluation period.

The effectiveness of toolkits as knowledge translation strategies for integrating evidence into clinical care: a systematic review

PubMed Central

Yamada, Janet; Shorkey, Allyson; Barwick, Melanie; Widger, Kimberley; Stevens, Bonnie J

2015-01-01

Objectives The aim of this systematic review was to evaluate the effectiveness of toolkits as a knowledge translation (KT) strategy for facilitating the implementation of evidence into clinical care. Toolkits include multiple resources for educating and/or facilitating behaviour change. Design Systematic review of the literature on toolkits. Methods A search was conducted on MEDLINE, EMBASE, PsycINFO and CINAHL. Studies were included if they evaluated the effectiveness of a toolkit to support the integration of evidence into clinical care, and if the KT goal(s) of the study were to inform, share knowledge, build awareness, change practice, change behaviour, and/or clinical outcomes in healthcare settings, inform policy, or to commercialise an innovation. Screening of studies, assessment of methodological quality and data extraction for the included studies were conducted by at least two reviewers. Results 39 relevant studies were included for full review; 8 were rated as moderate to strong methodologically with clinical outcomes that could be somewhat attributed to the toolkit. Three of the eight studies evaluated the toolkit as a single KT intervention, while five embedded the toolkit into a multistrategy intervention. Six of the eight toolkits were partially or mostly effective in changing clinical outcomes and six studies reported on implementation outcomes. The types of resources embedded within toolkits varied but included predominantly educational materials. Conclusions Future toolkits should be informed by high-quality evidence and theory, and should be evaluated using rigorous study designs to explain the factors underlying their effectiveness and successful implementation. PMID:25869686

Exercise and well-being: a review of mental and physical health benefits associated with physical activity.

PubMed

Penedo, Frank J; Dahn, Jason R

2005-03-01

This review highlights recent work evaluating the relationship between exercise, physical activity and physical and mental health. Both cross-sectional and longitudinal studies, as well as randomized clinical trials, are included. Special attention is given to physical conditions, including obesity, cancer, cardiovascular disease and sexual dysfunction. Furthermore, studies relating physical activity to depression and other mood states are reviewed. The studies include diverse ethnic populations, including men and women, as well as several age groups (e.g. adolescents, middle-aged and older adults). Results of the studies continue to support a growing literature suggesting that exercise, physical activity and physical-activity interventions have beneficial effects across several physical and mental-health outcomes. Generally, participants engaging in regular physical activity display more desirable health outcomes across a variety of physical conditions. Similarly, participants in randomized clinical trials of physical-activity interventions show better health outcomes, including better general and health-related quality of life, better functional capacity and better mood states. The studies have several implications for clinical practice and research. Most work suggests that exercise and physical activity are associated with better quality of life and health outcomes. Therefore, assessment and promotion of exercise and physical activity may be beneficial in achieving desired benefits across several populations. Several limitations were noted, particularly in research involving randomized clinical trials. These trials tend to involve limited sample sizes with short follow-up periods, thus limiting the clinical implications of the benefits associated with physical activity.

Methodological considerations in the design and implementation of clinical trials.

PubMed

Cirrincione, Constance T; Lavoie Smith, Ellen M; Pang, Herbert

2014-02-01

To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted. The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on. Copyright © 2014 Elsevier Inc. All rights reserved.

Handbook of Cross-Cultural and Multicultural Personality Assessment. Personality and Clinical Psychology Series.

ERIC Educational Resources Information Center

Dana, Richard H., Ed.

This collection of papers includes: (1) "An Assessment-Intervention Model for Research and Practice with Multicultural Populations" (Richard H. Dana); (2) "An Africentric Perspective for Clinical Research and Practice" (Edward F. Morris); (3) "Myths about the Null Hypothesis and the Path to Reform" (Robert G.…

Teacher-Child Interaction Training with an Urban Clinical Preschool Population

ERIC Educational Resources Information Center

Schaffner, Kristen F.; McGoey, Kara E.; Venesky, Lindsey

2016-01-01

The current study examined the impact of the relationship-enhancement phase of the Teacher-Child Interaction Training (TCIT) intervention on child behavior and teacher skill use within an urban therapeutic classroom milieu. Participants included four preschool children (mean age 4 years, 8 months) with clinical diagnoses attending a therapeutic…

Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer.

PubMed

Birnie, Kathryn A; Kulandaivelu, Yalinie; Jibb, Lindsay; Hroch, Petra; Positano, Karyn; Robertson, Simon; Campbell, Fiona; Abla, Oussama; Stinson, Jennifer

2018-06-01

Needle procedures are among the most distressing aspects of pediatric cancer-related treatment. Virtual reality (VR) distraction offers promise for needle-related pain and distress given its highly immersive and interactive virtual environment. This study assessed the usability (ease of use and understanding, acceptability) of a custom VR intervention for children with cancer undergoing implantable venous access device (IVAD) needle insertion. Three iterative cycles of mixed-method usability testing with semistructured interviews were undertaken to refine the VR. Participants included 17 children and adolescents (8-18 years old) with cancer who used the VR intervention prior to or during IVAD access. Most participants reported the VR as easy to use (82%) and understand (94%), and would like to use it during subsequent needle procedures (94%). Based on usability testing, refinements were made to VR hardware, software, and clinical implementation. Refinements focused on increasing responsiveness, interaction, and immersion of the VR program, reducing head movement for VR interaction, and enabling participant alerts to steps of the procedure by clinical staff. No adverse events of nausea or dizziness were reported. The VR intervention was deemed acceptable and safe. Next steps include assessing feasibility and effectiveness of the VR intervention for pain and distress.

Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention.

PubMed

DiCarlo, Abby; Fayorsey, Ruby; Syengo, Masila; Chege, Duncan; Sirengo, Martin; Reidy, William; Otieno, Juliana; Omoto, Jackton; Hawken, Mark P; Abrams, Elaine J

2018-01-10

The recent scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services has rapidly accelerated antiretroviral therapy (ART) uptake among pregnant and postpartum women in sub-Saharan Africa. The Mother and Infant Retention for Health (MIR4Health) study evaluates the impact of a combination intervention administered by trained lay health workers to decrease attrition among HIV-positive women initiating PMTCT services and their infants through 6 months postpartum. This was a qualitative study nested within the MIR4Health trial. MIR4Health was conducted at 10 health facilities in Nyanza, Kenya from September 2013 to September 2015. The trial intervention addressed behavioral, social, and structural barriers to PMTCT retention and included: appointment reminders via text and phone calls, follow-up and tracking for missed clinic visits, PMTCT health education at home visits and during clinic visits, and retention and adherence support and counseling. All interventions were administered by lay health workers. We describe results of a nested small qualitative inquiry which conducted two focus groups to assess the experiences and perceptions of lay health workers administering the interventions. Discussions were recorded and simultaneously transcribed and translated into English. Data were analyzed using framework analysis approach. Study findings show lay health workers played a critical role supporting mothers in PMTCT services across a range of behavioral, social, and structural domains, including improved communication and contact, health education, peer support, and patient advocacy and assistance. Findings also identified barriers to the uptake and implementation of the interventions, such as concerns about privacy and stigma, and the limitations of the healthcare system including healthcare worker attitudes. Overall, study findings indicate that lay health workers found the interventions to be feasible, acceptable, and well received by clients. Lay health workers played a fundamental role in supporting mothers engaged in PMTCT services and provided valuable feedback on the implementation of PMTCT interventions. Future interventions must include strategies to ensure client privacy, decrease stigma within communities, and address the practical limitations of health systems. This study adds important insight to the growing body of research on lay health worker experiences in HIV and PMTCT care. Clinicaltrials.gov NCT01962220 .

Integrating a Nurse-Midwife-Led Oral Health Intervention Into CenteringPregnancy Prenatal Care: Results of a Pilot Study.

PubMed

Adams, Sally H; Gregorich, Steven E; Rising, Sharon S; Hutchison, Margaret; Chung, Lisa H

2017-07-01

National and professional organizations recommend oral health promotion in prenatal care to improve women's oral health. However, few prenatal programs include education about oral health promotion. The objective of this study was to determine if women receiving a brief, low-cost, and sustainable educational intervention entitled CenteringPregnancy Oral Health Promotion had clinically improved oral health compared to women receiving standard CenteringPregnancy care. Women attending CenteringPregnancy, a group prenatal care model, at 4 health centers in the San Francisco Bay Area, participated in this nonrandomized controlled pilot study in 2010 to 2011. The intervention arm received the CenteringPregnancy Oral Health Promotion intervention consisting of two 15-minute skills-based educational modules addressing maternal and infant oral health, each module presented in a separate CenteringPregnancy prenatal care session. The present analysis focused on the maternal module that included facilitated discussions and skills-building activities including proper tooth brushing. The control arm received standard CenteringPregnancy prenatal care. Dental examinations and questionnaires were administered prior to and approximately 9 weeks postintervention. Primary outcomes included the Plaque Index, percent bleeding on probing, and percent of gingival pocket depths 4 mm or greater. Secondary outcomes were self-reported oral health knowledge, attitudes (importance and self-efficacy), and behaviors (tooth brushing and flossing). Regression models tested whether pre to post changes in outcomes differed between the intervention versus the control arms. One hundred and one women participated in the study; 49 were in the intervention arm, and 52 were in the control arm. The control and intervention arms did not vary significantly at baseline. Significant pre to post differences were noted between the arms with significant improvements in the intervention arm for the Plaque Index, bleeding on probing, and pocket depths 4 mm or greater. Providing brief oral health education and skills-building activities within prenatal care may be effective in improving women's oral health during pregnancy. These findings provide support for developing a full-scale randomized clinical trial of the CenteringPregnancy Oral Health Promotion intervention. © 2017 by the American College of Nurse-Midwives.

Predictors of effects of lifestyle intervention on diabetes mellitus type 2 patients.

PubMed

Jacobsen, Ramune; Vadstrup, Eva; Røder, Michael; Frølich, Anne

2012-01-01

The main aim of the study was to identify predictors of the effects of lifestyle intervention on diabetes mellitus type 2 patients by means of multivariate analysis. Data from a previously published randomised clinical trial, which compared the effects of a rehabilitation programme including standardised education and physical training sessions in the municipality's health care centre with the same duration of individual counseling in the diabetes outpatient clinic, were used. Data from 143 diabetes patients were analysed. The merged lifestyle intervention resulted in statistically significant improvements in patients' systolic blood pressure, waist circumference, exercise capacity, glycaemic control, and some aspects of general health-related quality of life. The linear multivariate regression models explained 45% to 80% of the variance in these improvements. The baseline outcomes in accordance to the logic of the regression to the mean phenomenon were the only statistically significant and robust predictors in all regression models. These results are important from a clinical point of view as they highlight the more urgent need for and better outcomes following lifestyle intervention for those patients who have worse general and disease-specific health.

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

PubMed

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (<72% correct), 6 were about intervention strength, 3 about categorizing error, 1 about workplace culture, and 1 about prioritization of interventions. Of the 13 questions about intervention strength, 6 (46%) were in the lowest quartile, suggesting that this may be a difficult topic for laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

Interventions for improving upper limb function after stroke.

PubMed

Pollock, Alex; Farmer, Sybil E; Brady, Marian C; Langhorne, Peter; Mead, Gillian E; Mehrholz, Jan; van Wijck, Frederike

2014-11-12

Improving upper limb function is a core element of stroke rehabilitation needed to maximise patient outcomes and reduce disability. Evidence about effects of individual treatment techniques and modalities is synthesised within many reviews. For selection of effective rehabilitation treatment, the relative effectiveness of interventions must be known. However, a comprehensive overview of systematic reviews in this area is currently lacking. To carry out a Cochrane overview by synthesising systematic reviews of interventions provided to improve upper limb function after stroke. We comprehensively searched the Cochrane Database of Systematic Reviews; the Database of Reviews of Effects; and PROSPERO (an international prospective register of systematic reviews) (June 2013). We also contacted review authors in an effort to identify further relevant reviews. We included Cochrane and non-Cochrane reviews of randomised controlled trials (RCTs) of patients with stroke comparing upper limb interventions with no treatment, usual care or alternative treatments. Our primary outcome of interest was upper limb function; secondary outcomes included motor impairment and performance of activities of daily living. When we identified overlapping reviews, we systematically identified the most up-to-date and comprehensive review and excluded reviews that overlapped with this. Two overview authors independently applied the selection criteria, excluding reviews that were superseded by more up-to-date reviews including the same (or similar) studies. Two overview authors independently assessed the methodological quality of reviews (using a modified version of the AMSTAR tool) and extracted data. Quality of evidence within each comparison in each review was determined using objective criteria (based on numbers of participants, risk of bias, heterogeneity and review quality) to apply GRADE (Grades of Recommendation, Assessment, Development and Evaluation) levels of evidence. We resolved disagreements through discussion. We systematically tabulated the effects of interventions and used quality of evidence to determine implications for clinical practice and to make recommendations for future research. Our searches identified 1840 records, from which we included 40 completed reviews (19 Cochrane; 21 non-Cochrane), covering 18 individual interventions and dose and setting of interventions. The 40 reviews contain 503 studies (18,078 participants). We extracted pooled data from 31 reviews related to 127 comparisons. We judged the quality of evidence to be high for 1/127 comparisons (transcranial direct current stimulation (tDCS) demonstrating no benefit for outcomes of activities of daily living (ADLs)); moderate for 49/127 comparisons (covering seven individual interventions) and low or very low for 77/127 comparisons.Moderate-quality evidence showed a beneficial effect of constraint-induced movement therapy (CIMT), mental practice, mirror therapy, interventions for sensory impairment, virtual reality and a relatively high dose of repetitive task practice, suggesting that these may be effective interventions; moderate-quality evidence also indicated that unilateral arm training may be more effective than bilateral arm training. Information was insufficient to reveal the relative effectiveness of different interventions.Moderate-quality evidence from subgroup analyses comparing greater and lesser doses of mental practice, repetitive task training and virtual reality demonstrates a beneficial effect for the group given the greater dose, although not for the group given the smaller dose; however tests for subgroup differences do not suggest a statistically significant difference between these groups. Future research related to dose is essential.Specific recommendations for future research are derived from current evidence. These recommendations include but are not limited to adequately powered, high-quality RCTs to confirm the benefit of CIMT, mental practice, mirror therapy, virtual reality and a relatively high dose of repetitive task practice; high-quality RCTs to explore the effects of repetitive transcranial magnetic stimulation (rTMS), tDCS, hands-on therapy, music therapy, pharmacological interventions and interventions for sensory impairment; and up-to-date reviews related to biofeedback, Bobath therapy, electrical stimulation, reach-to-grasp exercise, repetitive task training, strength training and stretching and positioning. Large numbers of overlapping reviews related to interventions to improve upper limb function following stroke have been identified, and this overview serves to signpost clinicians and policy makers toward relevant systematic reviews to support clinical decisions, providing one accessible, comprehensive document, which should support clinicians and policy makers in clinical decision making for stroke rehabilitation.Currently, no high-quality evidence can be found for any interventions that are currently used as part of routine practice, and evidence is insufficient to enable comparison of the relative effectiveness of interventions. Effective collaboration is urgently needed to support large, robust RCTs of interventions currently used routinely within clinical practice. Evidence related to dose of interventions is particularly needed, as this information has widespread clinical and research implications.

Chemical Interventions for Pain.

ERIC Educational Resources Information Center

Aronoff, Gerald M.; And Others

1986-01-01

Reviews properties and pharmacological effects of medications for pain, including peripherally acting analgesics, centrally acting narcotics, and adjuvant analgesics including antidepressants. Discusses the role of the endogenous opioid system in pain and depression. Explores clinical management issues in both inpatient and outpatient settings,…

Failure to Thrive: A Prospective Study in a Pediatric Gastroenterology Clinic.

PubMed

Larson-Nath, Catherine M; Goday, Praveen S

2016-06-01

We aimed to describe the clinical characteristics, diagnostic work-up, interventions, and outcomes of children referred to a pediatric gastroenterology clinic with the diagnosis of failure to thrive (FTT). We prospectively enrolled 110 children seen for the first time in our pediatric gastroenterology clinic for FTT. Standard demographic information, history, and anthropometric data were collected at initial and follow-up visits. We also obtained data about diagnostic workup, therapeutic interventions, and growth outcomes. Seventy patients (63.6%) were boys with a median age of 0.79 years (interquartile range 0.36-1.98). Of the 91 children with follow-up data, 81 (89%) were found to have nonorganic etiologies of their FTT. The majority of children (56.4%) underwent laboratory evaluation. Imaging and endoscopic evaluations were performed in fewer patients (29.6 and 10.2%, respectively). Endoscopic intervention yielded a diagnosis in 16.7% of patients while the positive result rates for laboratory testing and imaging were 3.2% and 3.1%, respectively. The most common therapeutic interventions included increasing calories (71.8%), avoiding grazing (71.8%), and structuring meals and snacks (67.3%). Compared with nonadherent children, children who were adherent with standard behavioral and nutritional interventions showed a higher positive change in z scores for weight (0.36 vs -0.01, P = 0.001) and body mass index (0.58 vs -0.18, P = 0.031). The majority of children in a pediatric gastroenterology clinic with FTT have nonorganic etiologies of their failure to thrive. Laboratory, imaging, and endoscopic evaluation are rarely positive and should be judiciously performed. Adherence to standardized interventions leads to improved growth.

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

PubMed

Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

2016-08-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review.

PubMed

Chou, Roger; Dana, Tracy; Bougatsos, Christina; Blazina, Ian; Starmer, Amy J; Reitel, Katie; Buckley, David I

2013-07-02

Pressure ulcers are associated with substantial health burdens but may be preventable. To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk. MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists. Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes. Multiple investigators abstracted and checked study details and quality using predefined criteria. One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions. Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings. More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.

Offering Annual Fecal Occult Blood Tests at Annual Flu Shot Clinics Increases Colorectal Cancer Screening Rates

PubMed Central

Potter, Michael B.; Phengrasamy, La; Hudes, Esther S.; McPhee, Stephen J.; Walsh, Judith M.E.

2009-01-01

PURPOSE We wanted to determine whether providing home fecal occult blood test (FOBT) kits to eligible patients during influenza inoculation (flu shot) clinics can contribute to higher colorectal cancer screening (CRCS) rates. METHODS The study was time randomized. On 8 dates of an annual flu shot clinic at the San Francisco General Hospital, patients were offered flu shots as usual (control group) and on 9 other dates, patients were offered both flu shots and FOBT kits (intervention group). RESULTS The study included 514 patients aged 50 to 79 years, with 246 in the control group and 268 in the intervention group. At the conclusion of flu season, FOBT screening rates increased by 4.4 percentage points from 52.9% at baseline to 57.3% (P = .07) in the control group, and increased by 29.8 percentage points from 54.5% to 84.3% (P <.001) in the intervention group, with the change among intervention participants 25.4 percentage points greater than among control participants (P value for change difference <.001). Among patients initially due for CRCS, 20.7% in the control group and 68.0% in the intervention group were up-to-date at the conclusion of the study (P <.001). In multivariate analyses, the odds ratio for becoming up-to-date with screening in the intervention group (vs the control group) was 11.3 (95% CI, 5.8–22.0). CONCLUSIONS Offering FOBT kits during flu shot clinics dramatically increased the CRCS rate for flu shot clinic attendees. Pairing home FOBT kits with annual flu shots may be a useful strategy to improve CRCS rates in other primary care or public health settings. PMID:19139445

Impact of financial and educational interventions on maternity care: results of cluster randomized trials in rural China, CHIMACA.

PubMed

Hemminki, Elina; Long, Qian; Zhang, Wei-Hong; Wu, Zhuochun; Raven, Joanna; Tao, Fangbiao; Yan, Hong; Wang, Yang; Klemetti, Reija; Zhang, Tuohong; Regushevskaya, Elena; Tang, Shenglan

2013-02-01

To report on the design and basic outcomes of three interventions aimed at improving the use and quality of maternity care in rural China: financial interventions, training in clinical skills, and training in health education. Community-based cluster randomized trials were carried out in one central and two western provinces between 2007 and 2009: (1) financial interventions covered part of women's costs for prenatal and postnatal care, (2) training of midwives in clinical skills was given by local maternity care experts in two- or three-group training courses, (3) health education training for midwives and village doctors were given by local experts in health education in two- or three-group training courses. A survey was conducted in a stratified random sample of women who had been pregnant in the study period. 73% of women (n = 3,673) were interviewed within 1-10 months of giving birth. Outcomes were compared by the different intervention and control groups. Adjusted odds ratios were calculated by logistic regression to adjust for varying maternal characteristics. Most of the differences found between the groups were small and some varied between provinces. The financial intervention did not influence the number of visits, but was associated with increased caesarean sections and a decrease in many ultrasound tests. The clinical intervention influenced some indicators of care content. There was no consistent finding for the health education intervention. Financial and training interventions have the potential to improve maternity care, but better implementation is required. Unintended consequences, including overuse of technology, are possible.

Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention.

PubMed

Weiser, Sheri D; Hatcher, Abigail M; Hufstedler, Lee L; Weke, Elly; Dworkin, Shari L; Bukusi, Elizabeth A; Burger, Rachel L; Kodish, Stephen; Grede, Nils; Butler, Lisa M; Cohen, Craig R

2017-02-01

This longitudinal qualitative study sought to understand how and why a livelihood intervention affected the health and health behaviors of HIV-infected Kenyan adults. The intervention included a microfinance loan, agricultural and financial training, and a human-powered water pump. In-depth interviews were conducted at two time points with intervention and control participants and program staff. We double coded interviews (n = 117) and used thematic content analysis of transcripts following an integrative inductive-deductive approach. Intervention participants described improvements in HIV health, including increased CD4 counts and energy, improved viral suppression, and fewer HIV-related symptoms. Better health was linked to improved clinic attendance and ART adherence through several mechanisms: (1) reductions in food insecurity and abject hunger; (2) improved financial stability; (3) improved productivity which enhanced social support; (4) better control over work situations; and, (5) renewed desire to prioritize their own health. Livelihood interventions may improve health by influencing upstream determinants of health behavior including food security and poverty.

Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention

PubMed Central

Hatcher, Abigail M.; Hufstedler, Lee L.; Weke, Elly; Dworkin, Shari L.; Bukusi, Elizabeth A.; Burger, Rachel L.; Kodish, Stephen; Grede, Nils; Butler, Lisa M.; Cohen, Craig R.

2018-01-01

This longitudinal qualitative study sought to understand how and why a livelihood intervention affected the health and health behaviors of HIV-infected Kenyan adults. The intervention included a microfinance loan, agricultural and financial training, and a human-powered water pump. In-depth interviews were conducted at two time points with intervention and control participants and program staff. We double coded interviews (n = 117) and used thematic content analysis of transcripts following an integrative inductive–deductive approach. Intervention participants described improvements in HIV health, including increased CD4 counts and energy, improved viral suppression, and fewer HIV-related symptoms. Better health was linked to improved clinic attendance and ART adherence through several mechanisms: (1) reductions in food insecurity and abject hunger; (2) improved financial stability; (3) improved productivity which enhanced social support; (4) better control over work situations; and, (5) renewed desire to prioritize their own health. Livelihood interventions may improve health by influencing upstream determinants of health behavior including food security and poverty. PMID:27637497

Effectiveness of online and mobile telephone applications ('apps') for the self-management of suicidal ideation and self-harm: a systematic review and meta-analysis.

PubMed

Witt, Katrina; Spittal, Matthew J; Carter, Gregory; Pirkis, Jane; Hetrick, Sarah; Currier, Dianne; Robinson, Jo; Milner, Allison

2017-08-15

Online and mobile telephone applications ('apps') have the potential to improve the scalability of effective interventions for suicidal ideation and self-harm. The aim of this review was therefore to investigate the effectiveness of digital interventions for the self-management of suicidal ideation or self-harm. Seven databases (Applied Science & Technology; CENTRAL; CRESP; Embase; Global Health; PsycARTICLES; PsycINFO; Medline) were searched to 31 March, 2017. Studies that examined the effectiveness of digital interventions for suicidal ideation and/or self-harm, or which reported outcome data for suicidal ideation and/or self-harm, within a randomised controlled trial (RCT), pseudo-RCT, or observational pre-test/post-test design were included in the review. Fourteen non-overlapping studies were included, reporting data from a total of 3,356 participants. Overall, digital interventions were associated with reductions for suicidal ideation scores at post-intervention. There was no evidence of a treatment effect for self-harm or attempted suicide. Most studies were biased in relation to at least one aspect of study design, and particularly the domains of participant, clinical personnel, and outcome assessor blinding. Performance and detection bias therefore cannot be ruled out. Digital interventions for suicidal ideation and self-harm may be more effective than waitlist control. It is unclear whether these reductions would be clinically meaningful at present. Further evidence, particularly with regards to the potential mechanisms of action of these interventions, as well as safety, is required before these interventions could recommended.

Primary care interventions and current service innovations in modifying long-term outcomes after stroke: a protocol for a scoping review

PubMed Central

Pindus, Dominika M; Lim, Lisa; Rundell, A Viona; Hobbs, Victoria; Aziz, Noorazah Abd; Mullis, Ricky; Mant, Jonathan

2016-01-01

Introduction Interventions delivered by primary and/or community care have the potential to reach the majority of stroke survivors and carers and offer ongoing support. However, an integrative account emerging from the reviews of interventions addressing specific long-term outcomes after stroke is lacking. The aims of the proposed scoping review are to provide an overview of: (1) primary care and community healthcare interventions by generalist healthcare professionals to stroke survivors and/or their informal carers to address long-term outcomes after stroke, (2) the scope and characteristics of interventions which were successful in addressing long-term outcomes, and (3) developments in current clinical practice. Methods and analysis Studies that focused on adult community dwelling stroke survivors and informal carers were included. Academic electronic databases will be searched to identify reviews of randomised controlled trials (RCTs) and controlled trials, trials from the past 5 years; reviews of observational studies. Practice exemplars from grey literature will be identified through advanced Google search. Reports, guidelines and other documents of major health organisations, clinical professional bodies, and stroke charities in the UK and internationally will be included. Two reviewers will independently screen titles, abstracts and full texts for inclusion of published literature. One reviewer will screen search results from the grey literature and identify relevant documents for inclusion. Data synthesis will include analysis of the number, type of studies, year and country of publication, a summary of intervention components/service or practice, outcomes addressed, main results (an indicator of effectiveness) and a description of included interventions. Ethics and dissemination The review will help identify components of care and care pathways for primary care services for stroke. By comparing the results with stroke survivors' and carers' needs identified in the literature, the review will highlight potential gaps in research and practice relevant to long-term care after stroke. PMID:27798023

A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression.

PubMed

Morrell, C Jane; Sutcliffe, Paul; Booth, Andrew; Stevens, John; Scope, Alison; Stevenson, Matt; Harvey, Rebecca; Bessey, Alice; Cantrell, Anna; Dennis, Cindy-Lee; Ren, Shijie; Ragonesi, Margherita; Barkham, Michael; Churchill, Dick; Henshaw, Carol; Newstead, Jo; Slade, Pauline; Spiby, Helen; Stewart-Brown, Sarah

2016-05-01

Postnatal depression (PND) is a major depressive disorder in the year following childbirth, which impacts on women, their infants and their families. A range of interventions has been developed to prevent PND. To (1) evaluate the clinical effectiveness, cost-effectiveness, acceptability and safety of antenatal and postnatal interventions for pregnant and postnatal women to prevent PND; (2) apply rigorous methods of systematic reviewing of quantitative and qualitative studies, evidence synthesis and decision-analytic modelling to evaluate the preventive impact on women, their infants and their families; and (3) estimate cost-effectiveness. We searched MEDLINE, EMBASE, Science Citation Index and other databases (from inception to July 2013) in December 2012, and we were updated by electronic alerts until July 2013. Two reviewers independently screened titles and abstracts with consensus agreement. We undertook quality assessment. All universal, selective and indicated preventive interventions for pregnant women and women in the first 6 postnatal weeks were included. All outcomes were included, focusing on the Edinburgh Postnatal Depression Scale (EPDS), diagnostic instruments and infant outcomes. The quantitative evidence was synthesised using network meta-analyses (NMAs). A mathematical model was constructed to explore the cost-effectiveness of interventions contained within the NMA for EPDS values. From 3072 records identified, 122 papers (86 trials) were included in the quantitative review. From 2152 records, 56 papers (44 studies) were included in the qualitative review. The results were inconclusive. The most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by the mean 12-month EPDS score difference of -1.43 (95% credible interval -4.00 to 1.36)], person-centred approach (PCA)-based and cognitive-behavioural therapy (CBT)-based intervention (universal), interpersonal psychotherapy (IPT)-based intervention and education on preparing for parenting (selective), promoting parent-infant interaction, peer support, IPT-based intervention and PCA-based and CBT-based intervention (indicated). Women valued seeing the same health worker, the involvement of partners and access to several visits from a midwife or health visitor trained in person-centred or cognitive-behavioural approaches. The most cost-effective interventions were estimated to be midwifery redesigned postnatal care (universal), PCA-based intervention (indicated) and IPT-based intervention in the sensitivity analysis (indicated), although there was considerable uncertainty. Expected value of partial perfect information (EVPPI) for efficacy data was in excess of £150M for each population. Given the EVPPI values, future trials assessing the relative efficacies of promising interventions appears to represent value for money. In the NMAs, some trials were omitted because they could not be connected to the main network of evidence or did not provide EPDS scores. This may have introduced reporting or selection bias. No adjustment was made for the lack of quality of some trials. Although we appraised a very large number of studies, much of the evidence was inconclusive. Interventions warrant replication within randomised controlled trials (RCTs). Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. Future research conducting RCTs to establish which interventions are most clinically effective and cost-effective should be considered. This study is registered as PROSPERO CRD42012003273. The National Institute for Health Research Health Technology Assessment programme.

A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol.

PubMed

Kestler, Edgar; Walker, Dilys; Bonvecchio, Anabelle; de Tejada, Sandra Sáenz; Donner, Allan

2013-03-21

Maternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries. A matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. ClinicalTrial.gov,http://NCT01653626.

A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol

PubMed Central

2013-01-01

Background Maternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries. Methods/Design A matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. Discussion A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. Trial registration ClinicalTrial.gov,http://NCT01653626. PMID:23517050

Conceptual and methodological issues in research on mindfulness and meditation.

PubMed

Davidson, Richard J; Kaszniak, Alfred W

2015-10-01

Both basic science and clinical research on mindfulness, meditation, and related constructs have dramatically increased in recent years. However, interpretation of these research results has been challenging. The present article addresses unique conceptual and methodological problems posed by research in this area. Included among the key topics is the role of first-person experience and how it can be best studied, the challenges posed by intervention research designs in which true double-blinding is not possible, the nature of control and comparison conditions for research that includes mindfulness or other meditation-based interventions, issues in the adequate description of mindfulness and related trainings and interventions, the question of how mindfulness can be measured, questions regarding what can and cannot be inferred from self-report measures, and considerations regarding the structure of study design and data analyses. Most of these topics are germane to both basic and clinical research studies and have important bearing on the future scientific understanding of mindfulness and meditation. (c) 2015 APA, all rights reserved).

Conceptual and Methodological Issues in Research on Mindfulness and Meditation

PubMed Central

Davidson, Richard J.; Kaszniak, Alfred W.

2015-01-01

Both basic science and clinical research on mindfulness, meditation, and related constructs has dramatically increased in recent years. However, interpretation of these research results has been challenging. The present article addresses unique conceptual and methodological problems posed by research in this area. Included among the key topics is the role of first person experience and how it can be best studied; the challenges posed by intervention research designs in which true double-blinding is not possible; the nature of control and comparison conditions for research that includes mindfulness or other meditation-based interventions; issues in the adequate description of mindfulness and related trainings and interventions; the question of how mindfulness can be measured; questions regarding what can and cannot be inferred from self-report measures; and considerations regarding the structure of study design and data analyses. Most of these topics are germane to both basic and clinical research studies and have important bearing on the future scientific understanding of mindfulness and meditation. PMID:26436310

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

PubMed

Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Can the theoretical domains framework account for the implementation of clinical quality interventions?

PubMed

Lipworth, Wendy; Taylor, Natalie; Braithwaite, Jeffrey

2013-12-21

The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. We conducted a thematic synthesis of the qualitative literature exploring clinicians' perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a "drilling down" to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF.

Can the theoretical domains framework account for the implementation of clinical quality interventions?

PubMed Central

2013-01-01

Background The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. Methods We conducted a thematic synthesis of the qualitative literature exploring clinicians’ perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Results Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. Conclusions The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a “drilling down” to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF. PMID:24359085

Evaluation of the implementation of a clinical pharmacy service on an acute internal medicine ward in Italy.

PubMed

Lombardi, Nicola; Wei, Li; Ghaleb, Maisoon; Pasut, Enrico; Leschiutta, Silvia; Rossi, Paolo; Troncon, Maria Grazia

2018-04-10

Successful implementation of clinical pharmacy services is associated with improvement of appropriateness of prescribing. Both high clinical significance of pharmacist interventions and their high acceptance rate mean that potential harm to patients could be avoided. Evidence shows that low acceptance rate of pharmacist interventions can be associated with lack of communication between pharmacists and the rest of the healthcare team. The objective of this study was to evaluate the effect of a structured communication strategy on acceptance rate of interventions made by a clinical pharmacist implementing a ward-based clinical pharmacy service targeting elderly patients at high risk of drug-related problems. Characteristics of interventions made to improve appropriateness of prescribing, their clinical significance and intervention acceptance rate by doctors were recorded. A clinical pharmacy intervention study was conducted between September 2013 and December 2013 in an internal medicine ward of a teaching hospital. A trained clinical pharmacist provided pharmaceutical care to 94 patients aged over 70 years. The clinical pharmacist used the following communication and marketing tools to implement the service described: Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis; Specific, Measurable, Achievable, Realistic and Timely (SMART) goals; Awareness, Interest, Desire, Action (AIDA) model. A total of 740 interventions were made by the clinical pharmacist. The most common drug classes involved in interventions were: antibacterials for systemic use (11.1%) and anti-parkinson drugs (10.8%). The main drug-related problem categories triggering interventions were: no specific problem (15.9%) and prescription writing error (12.0%). A total of 93.2% of interventions were fully accepted by physicians. After assessment by an external panel 63.2% of interventions (96 interventions/ per month) were considered of moderate clinical significance and 23.4% (36 interventions/ per month) of major clinical significance. The most frequent interventions were to educate a healthcare professional (20.4%) and change dose (16.1%). To our knowledge this is the first study evaluating the effect of a structured communication strategy on acceptance rate of pharmacist interventions. Pharmaceutical care delivered by the clinical pharmacist is likely to have had beneficial outcomes. Clinical pharmacy services like the one described should be implemented widely to increase patient safety.

Exercise and nutrition interventions in advanced lung cancer: a systematic review

PubMed Central

Payne, C.; Larkin, P.J.; McIlfatrick, S.; Dunwoody, L.; Gracey, J.H.

2013-01-01

In this systematic review, we sought to evaluate the effect of physical activity or nutrition interventions (or both) in adults with advanced non-small-cell lung cancer (nsclc). Methods A systematic search for relevant clinical trials was conducted in 6 electronic databases, by hand searching, and by contacting key investigators. No limits were placed on study language. Information about recruitment rates, protocol adherence, patient-reported and clinical outcome measures, and study conclusions was extracted. Methodologic quality and risk of bias in each study was assessed using validated tools. Main Results Six papers detailing five studies involving 203 participants met the inclusion criteria. Two of the studies were single-cohort physical activity studies (54 participants), and three were controlled nutrition studies (149 participants). All were conducted in an outpatient setting. None of the included studies combined physical activity with nutrition interventions. Conclusions Our systematic review suggests that exercise and nutrition interventions are not harmful and may have beneficial effects on unintentional weight loss, physical strength, and functional performance in patients with advanced nsclc. However, the observed improvements must be interpreted with caution, because findings were not consistent across the included studies. Moreover, the included studies were small and at significant risk of bias. More research is required to ascertain the optimal physical activity and nutrition interventions in advanced inoperable nsclc. Specifically, the potential benefits of combining physical activity with nutrition counselling have yet to be adequately explored in this population. PMID:23904771

Exo-organoplasty interventions: A brief review of past, present and future directions for advance heart failure management.

PubMed

Nawaz, Waqas; Khan, Farhan Ullah; Khan, Muhammad Zahid; Gang, Wang; Yang, Mengqi; Liao, Xiaoqian; Zhang, Li; Ihsan, Awais Ullah; Khan, Amjad; Han, Lei; Zhou, Xiaohui

2017-04-01

Heart failure (HF) is a debilitating disease in which abnormal function of the heart leads to imbalance of blood demand to tissues and organs. The pathogenesis of HF is very complex and various factors can contribute including myocardial infarction, ischemia, hypertension and genetic cardiomyopathies. HF is the leading cause of death and its prevalence is expected to increase in parallel with the population age. Different kind of therapeutic approaches including lifestyle modification, medication and pacemakers are used for HF patients in NYHA I-III functional class. However, for advance stage HF patient's (NYHA IV), ventricle assist devices are clinically use and stem cells are under active investigation. Most of these therapies leads to modest symptoms relief and have no significant role in long-term survival rate. Currently there is no effective treatment for advance HF except heart transplantation, which is still remain clinically insignificant because of donor pool limitation. As HF is a result of multiple etiologies therefore multi-functional therapeutic platform is needed. Exo-organoplasty interventions are studied from almost one century. The major goals of these interventions are to treat various kind of heart disease from outside the heart muscle without having direct contact with blood. Various kind of interventions (devices and techniques) are developed in this arena with the passage of time. The purpose of this review is to describe the theory behind intervention devices, the devices themselves, their clinical results, advantages and limitations. Furthermore, to present a future multi-functional therapeutic platform (ASD) for advance stage HF management. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer

PubMed Central

Epstein, Ronald M.; Duberstein, Paul R.; Fenton, Joshua J.; Fiscella, Kevin; Hoerger, Michael; Tancredi, Daniel J.; Xing, Guibo; Gramling, Robert; Mohile, Supriya; Franks, Peter; Kaesberg, Paul; Plumb, Sandy; Cipri, Camille S.; Street, Richard L.; Shields, Cleveland G.; Back, Anthony L.; Butow, Phyllis; Walczak, Adam; Tattersall, Martin; Venuti, Alison; Sullivan, Peter; Robinson, Mark; Hoh, Beth; Lewis, Linda; Kravitz, Richard L.

2018-01-01

IMPORTANCE Observational studies demonstrate links between patient-centered communication, quality of life (QOL), and aggressive treatments in advanced cancer, yet few randomized clinical trials (RCTs) of communication interventions have been reported. OBJECTIVE To determine whether a combined intervention involving oncologists, patients with advanced cancer, and caregivers would promote patient-centered communication, and to estimate intervention effects on shared understanding, patient-physician relationships, QOL, and aggressive treatments in the last 30 days of life. DESIGN, SETTING, AND PARTICIPANTS Cluster RCT at community- and hospital-based cancer clinics in Western New York and Northern California; 38 medical oncologists (mean age 44.6 years; 11 (29%) female) and 265 community-dwelling adult patients with advanced nonhematologic cancer participated (mean age, 64.4 years, 146 [55.0%] female, 235 [89%] white; enrolled August 2012 to June 2014; followed for 3 years); 194 patients had participating caregivers. INTERVENTIONS Oncologists received individualized communication training using standardized patient instructors while patients received question prompt lists and individualized communication coaching to identify issues to address during an upcoming oncologist visit. Both interventions focused on engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information. Control participants received no training. MAIN OUTCOMES AND MEASURES The prespecified primary outcome was a composite measure of patient-centered communication coded from audio recordings of the first oncologist visit following patient coaching (intervention group) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QOL, and aggressive treatments and hospice use in the last 30 days of life. RESULTS Data from 38 oncologists (19 randomized to intervention) and 265 patients (130 intervention) were analyzed. In fully adjusted models, the intervention resulted in clinically and statistically significant improvements in the primary physician-patient communication end point (adjusted intervention effect, 0.34; 95% CI, 0.06–0.62; P = .02). Differences in secondary outcomes were not statistically significant. CONCLUSIONS AND RELEVANCE A combined intervention that included oncologist communication training and coaching for patients with advanced cancer was effective in improving patient-centered communication but did not affect secondary outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01485627 PMID:27612178

Comparison of the efficacy of three PubMed search filters in finding randomized controlled trials to answer clinical questions.

PubMed

Yousefi-Nooraie, Reza; Irani, Shirin; Mortaz-Hedjri, Soroush; Shakiba, Behnam

2013-10-01

The aim of this study was to compare the performance of three search methods in the retrieval of relevant clinical trials from PubMed to answer specific clinical questions. Included studies of a sample of 100 Cochrane reviews which recorded in PubMed were considered as the reference standard. The search queries were formulated based on the systematic review titles. Precision, recall and number of retrieved records for limiting the results to clinical trial publication type, and using sensitive and specific clinical queries filters were compared. The number of keywords, presence of specific names of intervention and syndrome in the search keywords were used in a model to predict the recalls and precisions. The Clinical queries-sensitive search strategy retrieved the largest number of records (33) and had the highest recall (41.6%) and lowest precision (4.8%). The presence of specific intervention name was the only significant predictor of all recalls and precisions (P = 0.016). The recall and precision of combination of simple clinical search queries and methodological search filters to find clinical trials in various subjects were considerably low. The limit field strategy yielded in higher precision and fewer retrieved records and approximately similar recall, compared with the clinical queries-sensitive strategy. Presence of specific intervention name in the search keywords increased both recall and precision. © 2010 John Wiley & Sons Ltd.

Psychosocial interventions in attention-deficit/hyperactivity disorder: update.

PubMed

Antshel, Kevin M

2015-01-01

Attention-deficit/hyperactivity disorder (ADHD) is the most common reason for referral to child and adolescent psychiatry clinics. Although stimulant medications represent an evidence-based approach to managing ADHD, psychosocial interventions for child/adolescent ADHD target functional impairments as the intervention goal, and rely heavily on behavioral therapy techniques and operant conditioning principles. Evidence-based psychosocial interventions for managing pediatric ADHD include behavioral parent training, school-based interventions relying on behavioral modification, teaching skills, and operant conditioning principles, and intensive summer treatment programs. The use of conjoint psychosocial treatments with ADHD medications may enable lower doses of each form of treatment. Copyright © 2015 Elsevier Inc. All rights reserved.

Linkages Between Clinical Practices and Community Organizations for Prevention: A Literature Review and Environmental Scan

PubMed Central

Hinnant, Laurie W.; Kane, Heather; Horne, Joseph; McAleer, Kelly; Roussel, Amy

2012-01-01

Objectives. We conducted a literature review and environmental scan to develop a framework for interventions that utilize linkages between clinical practices and community organizations for the delivery of preventive services, and to identify and characterize these efforts. Methods. We searched 4 major health services and social science electronic databases and conducted an Internet search to identify examples of linkage interventions in the areas of tobacco cessation, obesity, nutrition, and physical activity. Results. We identified 49 interventions, of which 18 examples described their evaluation methods or reported any intervention outcomes. Few conducted evaluations that were rigorous enough to capture changes in intermediate or long-term health outcomes. Outcomes in these evaluations were primarily patient-focused and did not include organizational or linkage characteristics. Conclusions. An attractive option to increase the delivery of preventive services is to link primary care practices to community organizations; evidence is not yet conclusive, however, that such linkage interventions are effective. Findings provide recommendations to researchers and organizations that fund research, and call for a framework and metrics to study linkage interventions. PMID:22690974

Can medical therapy mimic the clinical efficacy or physiological effects of bariatric surgery?

PubMed Central

Miras, A D; le Roux, C W

2014-01-01

The number of bariatric surgical procedures performed has increased dramatically. This review discusses the clinical and physiological changes, and in particular, the mechanisms behind weight loss and glycaemic improvements, observed following the gastric bypass, sleeve gastrectomy and gastric banding bariatric procedures. The review then examines how close we are to mimicking the clinical or physiological effects of surgery through less invasive and safer modern interventions that are currently available for clinical use. These include dietary interventions, orlistat, lorcaserin, phentermine/topiramate, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, pramlintide, dapagliflozin, the duodenal–jejunal bypass liner, gastric pacemakers and gastric balloons. We conclude that, based on the most recent trials, we cannot fully mimic the clinical or physiological effects of surgery; however, we are getting closer. A ‘medical bypass' may not be as far in the future as we previously thought, as the physician's armamentarium against obesity and type 2 diabetes has recently got stronger through the use of specific dietary modifications, novel medical devices and pharmacotherapy. Novel therapeutic targets include not only appetite but also taste/food preferences, energy expenditure, gut microbiota, bile acid signalling, inflammation, preservation of β-cell function and hepatic glucose output, among others. Although there are no magic bullets, an integrated multimodal approach may yield success. Non-surgical interventions that mimic the metabolic benefits of bariatric surgery, with a reduced morbidity and mortality burden, remain tenable alternatives for patients and health-care professionals. PMID:24213310

Barriers and Promoters of an Evidenced-Based Smoking Cessation Counseling During Prenatal Care in Argentina and Uruguay

PubMed Central

Tong, Van T.; Morello, Paola; Farr, Sherry L.; Lawsin, Catalina; Dietz, Patricia M.; Aleman, Alicia; Berrueta, Mabel; Mazzoni, Agustina; Becu, Ana; Buekens, Pierre; Belizán, José; Althabe, Fernando

2015-01-01

In Argentina and Uruguay, 10.3 and 18.3 %, respectively, of pregnant women smoked in 2005. Brief cessation counseling, based on the 5A’s model, has been effective in different settings. This qualitative study aims to improve the understanding of factors influencing the provision of smoking cessation counseling during pregnancy in Argentina and Uruguay. In 2010, we obtained prenatal care providers’, clinic directors’, and pregnant smokers’ opinions regarding barriers and promoters to brief smoking cessation counseling in publicly-funded prenatal care clinics in Buenos Aires, Argentina and Montevideo, Uruguay. We interviewed six prenatal clinic directors, conducted focus groups with 46 health professionals and 24 pregnant smokers. Themes emerged from three issue areas: health professionals, health system, and patients. Health professional barriers to cessation counseling included inadequate knowledge and motivation, perceived low self-efficacy, and concerns about inadequate time and large workload. They expressed interest in obtaining a counseling script. Health system barriers included low prioritization of smoking cessation and a lack of clinic protocols to implement interventions. Pregnant smokers lacked information on the risks of prenatal smoking and underestimated the difficulty of smoking cessation. Having access to written materials and receiving cessation services during clinic waiting times were mentioned as promoters for the intervention. Women also were receptive to non-physician office staff delivering intervention components. Implementing smoking cessation counseling in publicly-funded prenatal care clinics in Argentina and Uruguay may require integrating counseling into routine prenatal care and educating and training providers on best-practices approaches. PMID:25500989

Measuring the quality of life of the elderly in health promotion intervention clinical trials.

PubMed Central

Kutner, N G; Ory, M G; Baker, D I; Schechtman, K B; Hornbrook, M C; Mulrow, C D

1992-01-01

The Multicenter Trials of Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT) is a series of clinical trials of biomedical, behavioral, and environmental interventions to reduce the risks of frailty and injury among the elderly. Reliable assessment of the quality of life reported by the subjects is a central issue in evaluating the interventions. An intervention may have a significant impact on an elderly person's sense of well-being, even though significant improvement is not observed in selected physical outcome measures. Elderly persons' compliance with particular intervention regimens may be influenced by the quality of life effects that they perceive in relation to the intervention. The researchers review the definition and measurement of quality of life in the trials, with particular attention to issues in determining common measures used at all study locations. Practical considerations in the selection and use of quality of life measures in both community and institutional populations are addressed. Topics discussed include the interrelation of aging, functional capacities, and quality of life; the multi-dimensionality of quality of life in relation to differential intervention effects; and age-related issues in the collection of quality of life data. Preliminary observations are reviewed, and potential contributions of FICSIT to intervention-sensitive quality of life assessments among the elderly are noted. PMID:1410233

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

PubMed

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Self-management interventions for adults with chronic kidney disease: a scoping review

PubMed Central

Donald, Maoliosa; Kahlon, Bhavneet Kaur; Beanlands, Heather; Straus, Sharon; Ronksley, Paul; Herrington, Gwen; Tong, Allison; Grill, Allan; Waldvogel, Blair; Large, Chantel A; Large, Claire L; Harwood, Lori; Novak, Marta; James, Matthew T; Elliott, Meghan; Fernandez, Nicolas; Brimble, Scott; Samuel, Susan; Hemmelgarn, Brenda R

2018-01-01

Objective To systematically identify and describe self-management interventions for adult patients with chronic kidney disease (CKD). Setting Community-based. Participants Adults with CKD stages 1–5 (not requiring kidney replacement therapy). Interventions Self-management strategies for adults with CKD. Primary and secondary outcome measures Using a scoping review, electronic databases and grey literature were searched in October 2016 to identify self-management interventions for adults with CKD stages 1–5 (not requiring kidney replacement therapy). Randomised controlled trials (RCTs), non-RCTs, qualitative and mixed method studies were included and study selection and data extraction were independently performed by two reviewers. Outcomes included behaviours, cognitions, physiological measures, symptoms, health status and healthcare. Results Fifty studies (19 RCTs, 7 quasi-experimental, 5 observational, 13 pre-post intervention, 1 mixed method and 5 qualitative) reporting 45 interventions were included. The most common intervention topic was diet/nutrition and interventions were regularly delivered face to face. Interventions were administered by a variety of providers, with nursing professionals the most common health professional group. Cognitions (ie, changes in general CKD knowledge, perceived self-management and motivation) were the most frequently reported outcome domain that showed improvement. Less than 1% of the interventions were co-developed with patients and 20% were based on a theory or framework. Conclusions There was a wide range of self-management interventions with considerable variability in outcomes for adults with CKD. Major gaps in the literature include lack of patient engagement in the design of the interventions, with the majority of interventions not applying a behavioural change theory to inform their development. This work highlights the need to involve patients to co-developed and evaluate a self-management intervention based on sound theories and clinical evidence. PMID:29567848

Impact of pharmacist interventions in older patients: a prospective study in a tertiary hospital in Germany

PubMed Central

Cortejoso, L; Dietz, RA; Hofmann, G; Gosch, M; Sattler, A

2016-01-01

Background Inappropriate pharmacotherapy among older adults remains a critical issue in our health care systems. Besides polypharmacy and multiple comorbidities, the age-related pharmacokinetic and pharmacodynamic changes may increase the risk of adverse drug reactions and medication errors. Objective The main target of this study was to describe the characteristics of pharmaceutical interventions in two geriatric wards (orthogeriatric ward and geriatric day unit) of a general teaching hospital and to evaluate the clinical significance of the detected medication errors. Materials and methods The study was conducted between August 2014 and October 2015 and was based on a triple approach that included validation of medical orders, medication reconciliation at patients’ admission, and a predischarge planning appointment with the patient. The validation of medical orders was based on analyzing the suitability of the drugs prescribed, the drug dose depending on the patient’s characteristics, the presence of contraindications and interactions between drugs, and the proposal of alternative drugs included in the hospital formulary. Results A total of 2,307 interventions associated to a medication error in 15,282 medical orders for 1,859 older patients were recorded. The greater part of the interventions carried out on the orthogeriatric ward at admission and at discharge were due to omission of a drug in the medical order (20.0%) and clinically significant interactions requiring monitoring (30.4%), respectively. The main factor triggering pharmacist’s recommendations on the geriatric day unit was clinically significant interactions (21.1%). With regard to the clinical severity of the detected errors, 68.1% were considered significant, 24.8% were of minor significance, and 7.2% were clinically serious. Conclusion Our findings show the importance of clinical pharmacist involvement in the optimization of pharmacotherapy in older adults, ensuring that they receive effective, safe, and efficient drug therapy. PMID:27713625

Effects of reflection on clinical decision-making of intensive care unit nurses.

PubMed

Razieh, Shahrokhi; Somayeh, Ghafari; Fariba, Haghani

2018-07-01

Nurses are one of the most influential factors in overcoming the main challenges faced by health systems throughout the world. Every health system should, hence, empower nurses in clinical judgment and decision-making skills. This study evaluated the effects of implementing Tanner's reflection method on clinical decision-making of nurses working in an intensive care unit (ICU). This study used an experimental, pretest, posttest design. The setting was the intensive care unit of Amin Hospital Isfahan, Iran. The convenience sample included 60 nurses working in the ICU of Amin Hospital (Isfahan, Iran). This clinical trial was performed on 60 nurses working in the ICU of Amin Hospital (Isfahan, Iran). The nurses were selected by census sampling and randomly allocated to either the case or the control group. Data were collected using a questionnaire containing demographic characteristics and the clinical decision-making scale developed by Laurie and Salantera (NDMI-14). The questionnaire was completed before and one week after the intervention. The data were analyzed using SPSS 21.0. The two groups were not significantly different in terms of the level and mean scores of clinical decision-making before the intervention (P = 0.786). Based on the results of independent t-test, the mean score of clinical decision-making one week after the intervention was significantly higher in the case group than in the control group (P = 0.009; t = -2.69). The results of Mann Whitney test showed that one week after the intervention, the nurses' level of clinical decision-making in the case group rose to the next level (P = 0.001). Reflection could improve the clinical decision-making of ICU nurses. It is, thus, recommended to incorporate this method into the nursing curriculum and care practices. Copyright © 2018. Published by Elsevier Ltd.

Effectiveness of Interventions for Breast Cancer Screening in African American Women: A Meta-Analysis.

PubMed

Copeland, Valire Carr; Kim, Yoo Jung; Eack, Shaun M

2017-11-21

The purpose of this study was to report the results of a meta-analysis conducted on the effects of clinical trials in breast cancer screening for African American women between 1997 and 2017. Articles published in English and in the United States, between January 1997 and March 2017, were eligible for inclusion if they (1) conducted psychosocial, behavioral, or educational interventions designed to increase screening mammography rates in predominantly African American women of all ages; (2) utilized a randomized, controlled trial (RCT) design; and (3) reported quantitative screening rates following the intervention. Randomized clinical trials on breast cancer screening in African American women, published between January 1997 and March 2017, were selected from database searches. Data collected included effect size of screening versus comparison interventions, intervention characteristics, and a number of study characteristics to explore potential moderators. Search results yielded 327 articles, of which 14 met inclusion criteria and were included in analyses. Findings indicated that screening interventions for African American women were significantly more likely to result in mammography than control (OR = 1.56 [95 percent CI = 1.27-1.93], p < .0001). Although no patient or study characteristics significantly moderated screening efficacy, the most effective interventions were those specifically tailored to meet the perceived risk of African American women. Screening interventions are at least minimally effective for promoting mammography among African American women, but research in this area is limited to a small number of studies. More research is needed to enhance the efficacy of existing interventions and reduce the high morbidity and mortality rate of this underserved population. © Health Research and Educational Trust.

Pediatric interventional radiology workforce survey: 10-year follow-up.

PubMed

Kaufman, Claire S; James, Charles A; Harned, Roger K; Connolly, Bairbre L; Roebuck, Derek J; Cahill, Anne M; Dubois, Josee; Morello, Frank P; Morgan, Robin K; Sidhu, Manrita K

2017-05-01

Pediatric interventional radiology is a distinct subspecialty differing from both pediatric diagnostic radiology and adult interventional radiology. We conducted a workforce survey in 2005 to evaluate the state of pediatric interventional radiology at that time. Since then there have been many advancements to the subspecialty, including the founding of the Society for Pediatric Interventional Radiology (SPIR). To evaluate the current state of the pediatric interventional radiology workforce and compare findings with those of the initial 2005 workforce survey. We sent a two-part survey electronically to members of SPIR, the Society for Pediatric Radiology (SPR), the Society of Chairmen of Radiology in Children's Hospitals (SCORCH) and the Society of Interventional Radiology (SIR). Part 1 focused on individual practitioners (n=177), while part 2 focused on group practices and was answered by a leader from each group (n=88). We examined descriptive statistics and, when possible, compared the results to the study from 2005. A total of 177 individuals replied (a 331% increase over the first study) and 88 pediatric interventional radiology (IR) service sites responded (a 131.6% increase). Pediatric IR has become a more clinically oriented specialty, with a statistically significant increase in services with admitting privileges, clinics and performance of daily rounds. Pediatric IR remains diverse in training and practice. Many challenges still exist, including anesthesia/hospital support, and the unknown impact of the new IR residency on pediatric IR training, although the workforce shortage has been somewhat alleviated, as demonstrated by the decreased mean call from 165 days/year to 67.2 days/year. Pediatric interventional radiology practitioners and services have grown significantly since 2005, although the profile of this small subspecialty has changed and some challenges remain.

A systematic review of interventions to improve diabetes care in socially disadvantaged populations.

PubMed

Glazier, Richard H; Bajcar, Jana; Kennie, Natalie R; Willson, Kristie

2006-07-01

To identify and synthesize evidence about the effectiveness of patient, provider, and health system interventions to improve diabetes care among socially disadvantaged populations. Studies that were included targeted interventions toward socially disadvantaged adults with type 1 or type 2 diabetes; were conducted in industrialized countries; were measured outcomes of self-management, provider management, or clinical outcomes; and were randomized controlled trials, controlled trials, or before-and-after studies with a contemporaneous control group. Seven databases were searched for articles published in any language between January 1986 and December 2004. Twenty-six intervention features were identified and analyzed in terms of their association with successful or unsuccessful interventions. Eleven of 17 studies that met inclusion criteria had positive results. Features that appeared to have the most consistent positive effects included cultural tailoring of the intervention, community educators or lay people leading the intervention, one-on-one interventions with individualized assessment and reassessment, incorporating treatment algorithms, focusing on behavior-related tasks, providing feedback, and high-intensity interventions (>10 contact times) delivered over a long duration (>or=6 months). Interventions that were consistently associated with the largest negative outcomes included those that used mainly didactic teaching or that focused only on diabetes knowledge. This systematic review provides evidence for the effectiveness of interventions to improve diabetes care among socially disadvantaged populations and identifies key intervention features that may predict success. These types of interventions would require additional resources for needs assessment, leader training, community and family outreach, and follow-up.

A pilot study to assess the pharmacy impact of implementing a chemotherapy-induced nausea or vomiting collaborative disease therapy management in the outpatient oncology clinics.

PubMed

Jackson, Kasey; Letton, Cathy; Maldonado, Andy; Bodiford, Andrew; Sion, Amy; Hartwell, Rebekah; Graham, Anastasia; Bondarenka, Carolyn; Uber, Lynn

2018-01-01

Background Collaborative drug therapy management is a formal partnership between a pharmacist and physician to allow the pharmacist to manage a patient's drug therapy. Literature supports collaborative disease therapy management can improve patient outcomes, improve medication adherence, enhance medication safety, and positively influence healthcare expenditures. Chemotherapy induced nausea or vomiting is considered one of the most distressing and feared adverse events among patients receiving chemotherapy. Chemotherapy induced nausea or vomiting can impact a patient's quality of life and may affect compliance with the treatment plan. Purpose The objective of this pilot study was to determine the pharmacy impact of implementing a chemotherapy induced nausea or vomiting collaborative disease therapy management protocol in the outpatient oncology clinics at a National Cancer Institute (NCI)-designated cancer center associated with an academic medical center. The primary endpoint was to determine the number and type of chemotherapy induced nausea or vomiting clinical interventions made by the oncology pharmacists. Secondary endpoints included comparing patient's Multinational Association for Supportive Care in Cancer scores and revenue of pharmacists' services. Methods The credentialed oncology pharmacists were consulted by an oncologist to manage chemotherapy induced nausea or vomiting. Patients were included in the chemotherapy induced nausea or vomiting collaborative disease therapy management if they were seen in an outpatient oncology clinic from October 2016 to January 2017 and had a referral from a qualified provider to help manage chemotherapy induced nausea or vomiting. Patients admitted to the hospital at the time of consult were excluded from the study. The pharmacists interviewed patients and provided recommendations. The pharmacists followed up with the patient via a telephone call or during the next scheduled clinic visit to assess their symptoms. Results The chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study was implemented in October 2016. From October 2016 to January 2017, there were 45 consults for the management of chemotherapy induced nausea or vomiting. The pharmacists made 188 clinical interventions, which included addition of new medications (37%), patient education (34%), deletion of medications (10%), changing a dose/duration/frequency (8%), and other interventions (11%). Multinational Association for Supportive Care in Cancer symptom scores were available for 5 patients, in which all showed improvements from baseline with the pharmacists' clinical interventions. Conclusions The implementation of our chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study has shown favorable results after a 4-month evaluation period. The pharmacists have made a substantial number of clinical interventions and provided patient education to patients undergoing chemotherapy.

Type 2 diabetes–related foot care knowledge and foot self-care practice interventions in the United States: a systematic review of the literature

PubMed Central

Bonner, Timethia; Foster, Margaret; Spears-Lanoix, Erica

2016-01-01

Introduction The purpose of this systematic literature review is to review published studies on foot care knowledge and foot care practice interventions as part of diabetic foot care self-management interventions. Methods Medline, CINAHL, CENTRAL, and Cochrane Central Register of Controlled Trials databases were searched. References from the included studies were reviewed to identify any missing studies that could be included. Only foot care knowledge and foot care practice intervention studies that focused on the person living with type 2 diabetes were included in this review. Author, study design, sample, intervention, and results were extracted. Results Thirty studies met the inclusion criteria and were classified according to randomized controlled trial (n=9), survey design (n=13), cohort studies (n=4), cross-sectional studies (n=2), qualitative studies (n=2), and case series (n=1). Improving lower extremity complications associated with type 2 diabetes can be done through effective foot care interventions that include foot care knowledge and foot care practices. Conclusion Preventing these complications, understanding the risk factors, and having the ability to manage complications outside of the clinical encounter is an important part of a diabetes foot self-care management program. Interventions and research studies that aim to reduce lower extremity complications are still lacking. Further research is needed to test foot care interventions across multiple populations and geographic locations. PMID:26899439

Type 2 diabetes-related foot care knowledge and foot self-care practice interventions in the United States: a systematic review of the literature.

PubMed

Bonner, Timethia; Foster, Margaret; Spears-Lanoix, Erica

2016-01-01

The purpose of this systematic literature review is to review published studies on foot care knowledge and foot care practice interventions as part of diabetic foot care self-management interventions. Medline, CINAHL, CENTRAL, and Cochrane Central Register of Controlled Trials databases were searched. References from the included studies were reviewed to identify any missing studies that could be included. Only foot care knowledge and foot care practice intervention studies that focused on the person living with type 2 diabetes were included in this review. Author, study design, sample, intervention, and results were extracted. Thirty studies met the inclusion criteria and were classified according to randomized controlled trial (n=9), survey design (n=13), cohort studies (n=4), cross-sectional studies (n=2), qualitative studies (n=2), and case series (n=1). Improving lower extremity complications associated with type 2 diabetes can be done through effective foot care interventions that include foot care knowledge and foot care practices. Preventing these complications, understanding the risk factors, and having the ability to manage complications outside of the clinical encounter is an important part of a diabetes foot self-care management program. Interventions and research studies that aim to reduce lower extremity complications are still lacking. Further research is needed to test foot care interventions across multiple populations and geographic locations.

An educational approach to improve outcomes in acute kidney injury (AKI): report of a quality improvement project.

PubMed

Xu, Gang; Baines, Richard; Westacott, Rachel; Selby, Nick; Carr, Susan

2014-03-20

To assess the impact of a quality improvement project that used a multifaceted educational intervention on how to improve clinician's knowledge, confidence and awareness of acute kidney injury (AKI). 2 large acute teaching hospitals in England, serving a combined population of over 1.5 million people. All secondary care clinicians working in the clinical areas were targeted, with a specific focus on clinicians working in acute admission areas. A multifaceted educational intervention consisting of traditional didactic lectures, case-based teaching in small groups and an interactive web-based learning resource. We assessed clinicians' knowledge of AKI and their self-reported clinical behaviour using an interactive questionnaire before and after the educational intervention. Secondary outcome measures included clinical audit of patient notes before and after the intervention. 26% of clinicians reported that they were aware of local AKI guidelines in the preintervention questionnaire compared to 64% in the follow-up questionnaire (χ²=60.2, p<0.001). There was an improvement in the number of clinicians reporting satisfactory practice when diagnosing AKI, 50% vs 68% (χ²=12.1, p<0.001) and investigating patients with AKI, 48% vs 64% (χ²=9.5, p=0.002). Clinical audit makers showed a trend towards better clinical practice. This quality improvement project utilising a multifaceted educational intervention improved awareness of AKI as demonstrated by changes in the clinician's self-reported management of patients with AKI. Elements of the project have been sustained beyond the project period, and demonstrate the power of quality improvement projects to help initiate changes in practice. Our findings are limited by confounding factors and highlight the need to carry out formal randomised studies to determine the impact of educational initiatives in the clinical setting.

Recent Internet Use and Associations with Clinical Outcomes among Patients Entering Addiction Treatment Involved in a Web-Delivered Psychosocial Intervention Study.

PubMed

Tofighi, B; Campbell, A N C; Pavlicova, M; Hu, M C; Lee, J D; Nunes, E V

2016-10-01

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (NIDA Clinical Trials Network-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU). Demographic and clinical characteristics, and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N = 374) and without internet access (N = 133). Primary outcome variables included (1) acceptability of TES (i.e., module completion; acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests; retention measured as time to dropout). Internet use was common (74 %) and was more likely among younger (18-49 years old) participants and those who completed high school (p < .001). Participants randomized to TES (n = 255) without baseline internet access rated the acceptability of TES modules significantly higher than those with internet access (t = 2.49, df = 218, p = .01). There was a near significant interaction between treatment, baseline abstinence, and internet access on time to dropout (χ 2 (1) = 3.8089, p = .051). TES was associated with better retention among participants not abstinent at baseline who had internet access (X 2 (1) = 6.69, p = .01). These findings demonstrate high acceptability of this web-based intervention among participants that lacked recent internet access.

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

PubMed

Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary

2017-12-04

Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.