The influence of applying insurance medicine guidelines for depression on disability assessments

PubMed Central

2013-01-01

Background In the current study we report on the effects of an implementation strategy in the form of a training programme on the assessed work limitations of a client with depression by insurance physicians (IPs) participating in a RCT. These assessed work limitations of a client were in the form of scores on the List of Functional Abilities (LFA). Method We conducted a randomised controlled trial (RCT) for IPs in which we compared the intervention of a specially developed training programme with the usual methods of implementation and training currently used. The outcome was the mean sum score and the inter-rater reliability (Intraclass Correlation Coefficient, ICC) of the LFA scores. These LFA scores were scored by the IPs participating in the RCT for the work limitations of the cases presented in different videos, two videos before the training and two after the training of the intervention group. Results At baseline, the intervention group (IG) consisted of 21 IPs and the control group (CG) of 19. For one participant of the IG and for one of the CG the LFAs of the two case reports after training were not available. Before training the sum scores for the first case report did not differ significantly between the groups, while the mean sum score was higher in the IG than in the CG for the second case report. For both case reports after training a higher score was found in the IG than in the CG. The inter-rater reliability measured for the two case reports before training was about the same in the IG and the CG: 0.64 and 0.65, respectively. For the two case reports after training, the ICC was higher in the IG than in the CG: 0.69 and 0.54, respectively. This difference was not significant however. Conclusion It would appear that the implementation of a specially designed training programme on guidelines for depression may lead to greater inter-rater reliability in the assessments by insurance physicians of the work limitations of clients with depression. It is, however, important to note that insurance physicians who receive training may find more work limitations than those who do not. Trial registration Netherlands’ Trial Register NTR1863 PMID:23758690

Impact of a clinical trial initiative on clinical trial enrollment in a multidisciplinary prostate cancer clinic.

PubMed

Madsen, Lydia T; Kuban, Deborah A; Choi, Seungtaek; Davis, John W; Kim, Jeri; Lee, Andrew K; Domain, Delora; Levy, Larry; Pisters, Louis L; Pettaway, Curtis A; Ward, John F; Logothetis, Christopher; Hoffman, Karen E

2014-07-01

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (P<.001) and men seen after implementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative. Copyright © 2014 by the National Comprehensive Cancer Network.

Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

PubMed

Bordet, Régis; Lang, Marie; Dieu, Christelle; Billon, Nathalie; Duffet, Jean-Pierre

2015-08-19

A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials. We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of <15 % of trials sites without patients enrolled. In 2013, the median delay to contract signature was: 55 days, compared with 76 days in 2008 (27.6 % reduction), 50.5 % of all sites and 58 % of sites with a dedicated CRA included ≥80 % of the planned number of patients compared with 44.8 % in 2008 (12.7 % increase) and 21.3 % of all sites and 9 % of sites with a dedicated CRA closed with no patients included, compared with 26.4 % in 2008 (19.3 and 65.9 %, respectively). These results provide evidence that it is possible to improve a country's attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe's attractiveness to industry-funded trials.

Selecting Patients for Intra-Arterial Therapy in the Context of a Clinical Trial for Neuroprotection.

PubMed

Lyden, Patrick; Weymer, Sara; Coffey, Chris; Cudkowicz, Merit; Berg, Samantha; O'Brien, Sarah; Fisher, Marc; Haley, E Clarke; Khatri, Pooja; Saver, Jeff; Levine, Steven; Levy, Howard; Rymer, Marilyn; Wechsler, Lawrence; Jadhav, Ashutosh; McNeil, Elizabeth; Waddy, Salina; Pryor, Kent

2016-12-01

The advent of intra-arterial neurothrombectomy (IAT) for acute ischemic stroke opens a potentially transformative opportunity to improve neuroprotection studies. Combining a putative neuroprotectant with recanalization could produce more powerful trials but could introduce heterogeneity and adverse event possibilities. We sought to demonstrate feasibility of IAT in neuroprotectant trials by defining IAT selection criteria for an ongoing neuroprotectant clinical trial. The study drug, 3K3A-APC, is a pleiotropic cytoprotectant and may reduce thrombolysis-associated hemorrhage. The NeuroNEXT trial NN104 (RHAPSODY) is designed to establish a maximally tolerated dose of 3K3A-APC. Each trial site provided their IAT selection criteria. An expert panel reviewed site criteria and published evidence. Finally, the trial leadership designed IAT selection criteria. Derived selection criteria reflected consistency among the sites and comparability to published IAT trials. A protocol amendment allowing IAT (and relaxed age, National Institutes of Health Stroke Scale, and time limits) in the RHAPSODY trial was implemented on June 15, 2015. Recruitment before and after the amendment improved from 8 enrolled patients (601 screened, 1.3%) to 51 patients (821 screened, 6.2%; odds ratio [95% confidence limit] of 4.9 [2.3-10.4]; P<0.001). Gross recruitment was 0.11 patients per site month versus 0.43 patients per site per month, respectively, before and after the amendment. It is feasible to include IAT in a neuroprotectant trial for acute ischemic stroke. Criteria are presented for including such patients in a manner that is consistent with published evidence for IAT while still preserving the ability to test the role of the putative neuroprotectant. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02222714. © 2016 American Heart Association, Inc.

Successful increase in contraceptive uptake among Kenyan HIV-1-serodiscordant couples enrolled in an HIV-1 prevention trial.

PubMed

Ngure, Kenneth; Heffron, Renee; Mugo, Nelly; Irungu, Elizabeth; Celum, Connie; Baeten, Jared M

2009-11-01

To evaluate a multipronged approach to promote dual contraceptive use by women within heterosexual HIV-1-serodiscordant partnerships. For 213 HIV-1-serodiscordant couples in Thika, Kenya, participating in an HIV-1 prevention clinical trial, contraceptive promotion was initiated through a multipronged intervention that included staff training, couples family planning sessions, and free provision of hormonal contraception on-site. Contraceptive use and pregnancy incidence were compared between two time periods (before versus after June 2007, when the intervention was initiated) and between Thika and other Kenyan trial sites (Eldoret, Kisumu, and Nairobi). Generalized estimating equations and Andersen-Gill proportional hazards modeling were used. Nonbarrier contraceptive use increased after implementation of the intervention: from 31.5 to 64.7% of visits among HIV-1-seropositive women [odds ratio 4.0, 95% confidence interval (CI) 3.0-5.3] and from 28.6 to 46.7% of visits among HIV-1-seronegative women (odds ratio 2.2, 95% CI 1.4-3.5). In comparison, at the other Kenyan sites, where the intervention was not implemented, contraceptive use changed minimally, from 15.6 to 22.3% of visits for HIV-1-seropositive women and from 13.6 to 12.7% among HIV-1-seronegative women. Self-reported condom use remained high during follow-up. Pregnancy incidence at the Thika was significantly lower after compared with before June 2007 (hazard ratio 0.2, 95% CI 0.1-0.6) and was approximately half that at other Kenyan sites during the intervention period (hazard ratio 0.5, 95% CI 0.3-0.8). A multipronged family planning intervention can lead to high nonbarrier contraceptive uptake and reduced pregnancy incidence among women in HIV-1-serodiscordant partnerships.

Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany.

PubMed

Isbary, Georg; Staab, Thomas R; Amelung, Volker E; Dintsios, Charalabos-Markos; Iking-Konert, Christof; Nesurini, Sonja Mariotti; Walter, Miriam; Ruof, Jörg

2018-06-01

In oncology clinical trials, crossover is used frequently but may lead to uncertainties regarding treatment effects. To investigate the handling of evidence from crossover trials by the European Medicines Agency (EMA) and the German Federal Joint Committee (G-BA). For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analyzed from manufacturers' dossiers, G-BA appraisals, European Public Assessment Reports, and original publications. Eleven of 21 benefit assessments included crossover trials. Significant intergroup differences (P < 0.05) in overall survival (OS) were noted in 7 of 11 trials with and 7 of 10 without crossover. For 6 of 11 medicines with crossover, these were demonstrated before crossover. Treatment effects generally worsened with increasing proportions of crossover. The EMA requested additional data more frequently if crossover was performed, particularly if no OS data were available before crossover. The G-BA granted a considerable benefit to 73% of medicines with crossover and 40% of those without. Evidence levels were intermediate for 50% and 75%, respectively. None of the medicines received the highest evidence level. In G-BA appraisals, oncology medicines with crossover received better additional benefit ratings, but were assigned lower evidence levels, than those without. The five medicines with crossover after progression were assigned lower evidence levels than the six medicines with crossover after demonstration of superior OS, indicating that the way in which crossover is implemented may be one factor influencing the assignment of evidence levels by the G-BA. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

GPs' role security and therapeutic commitment in managing alcohol problems: a randomised controlled trial of a tailored improvement programme.

PubMed

Keurhorst, Myrna; van Beurden, Ivonne; Anderson, Peter; Heinen, Maud; Akkermans, Reinier; Wensing, Michel; Laurant, Miranda

2014-04-17

General practitioners with more positive role security and therapeutic commitment towards patients with hazardous or harmful alcohol consumption are more involved and manage more alcohol-related problems than others. In this study we evaluated the effects of our tailored multi-faceted improvement implementation programme on GPs' role security and therapeutic commitment and, in addition, which professional related factors influenced the impact of the implementation programme. In a cluster randomised controlled trial, 124 GPs from 82 Dutch general practices were randomised to either the intervention or control group. The tailored, multi-faceted programme included combined physician, organisation, and patient directed alcohol-specific implementation strategies to increase role security and therapeutic commitment in GPs. The control group was mailed the national guideline and patients received feedback letters. Questionnaires were completed before and 12 months after start of the programme. We performed linear multilevel regression analysis to evaluate effects of the implementation programme. Participating GPs were predominantly male (63%) and had received very low levels of alcohol related education before start of the study (0.4 h). The programme increased therapeutic commitment (p = 0.005; 95%-CI 0.13 - 0.73) but not role security (p = 0.58; 95%-CI -0.31 - 0.54). How important GPs thought it was to improve their care for problematic alcohol consumption, and the GPs' reported proportion of patients asked about alcohol consumption at baseline, contributed to the effect of the programme on therapeutic commitment. A tailored, multi-faceted programme aimed at improving GP management of patients with hazardous and harmful alcohol consumption improved GPs' therapeutic commitment towards patients with alcohol-related problems, but failed to improve GPs' role security. How important GPs thought it was to improve their care for problematic alcohol consumption, and the GPs' reported proportion of patients asked about alcohol consumption at baseline, both increased the impact of the programme on therapeutic commitment. It might be worthwhile to monitor proceeding of role security and therapeutic commitment throughout the year after the implementation programme, to see whether the programme is effective on short term but faded out on the longer term. ClinicalTrials.gov Identifier: NCT00298220.

Effects of physical exercise programme on happiness among older people.

PubMed

Khazaee-Pool, M; Sadeghi, R; Majlessi, F; Rahimi Foroushani, A

2015-02-01

This randomized-controlled trial investigated the effect of physical exercise programme (PEP) on happiness among older adults in Nowshahr, Iran. Results of this study on 120 male and female volunteers showed that an 8-week group physical exercise programme was significantly effective in older adults' happiness. Findings showed that physical exercise programme is so beneficial for increasing older adults' happiness. Physical activity is associated with well-being and happiness. The purpose of this study was to determine the effects of an 8-week long physical exercise programme (PEP) on happiness among older adults in Nowshahr, Iran. This was a randomized control trial study. The participants consisted of a group of 120 male and female volunteers (mean ± SD age: 71 ± 5.86 years) in a convenience sampling among older adults in public parks in Nowshahr, Iran. We randomly allocated them into experimental (n = 60) and control (n = 60) groups. A validated instrument was used to measure well-being and happiness [Oxford Happiness Inventory (OHI)]. Respondents were asked to complete the OHI before and 2 months after implementing PEP. The 8-week PEP was implemented with the intervention group. The statistical analysis of the data was conducted using paired t-test, Fisher's exact test and χ(2). Before the intervention, there was no significant difference in the happiness mean score between the case and control groups; however, after implementing PEP, happiness significantly improved among the experimental group (P = 0.001) and did not improve within the control group (P = 0.79). It can be concluded that PEP had positive effects on happiness among older adults. Planning and implementing of physical activity is so important for older happiness. © 2014 John Wiley & Sons Ltd.

Effects of preemptive analgesia with parecoxib sodium on haemodynamics and plasma stress hormones in surgical patients with thyroid carcinoma.

PubMed

Wang, Lian-Dong; Gao, Xia; Li, Jun-Ying; Yu, Hong-Yan; Su, Hai-Wen; Liu, Lian-Zhong; Qi, Jun

2015-01-01

To investigate the effects of preemptive analgesia with parecoxib sodium on haemodynamics and plasma stress hormones in surgical patients with thyroid carcinoma. Fifty-seven patients with thyroid carcinoma who underwent thyroidectomy selectively in Laiwu Hospital Affiliated to Taishan Medical University and Binzhou People's Hospital were selected and randomly divided into three groups, 19 cases in each group. The control group was intravenously injected 0.9% sodium chloride injection before anesthesia induction; trial group I was intravenously injected with parecoxib sodium 20 min before anesthesia induction; based on trial group I, trial group II was injected with parecoxib sodium again 12 h after surgery. The levels of plasma norepinephrine (NE), cortisol (Cor) and blood glucose before, 12 and 24 h after surgery and changes of haemodynamics before surgery, at the end of surgery and 12, 24 and 48 h after surgery were compared in the three groups. Besides, visual analogue scale (VAS) scores were recorded 4, 8, 12 and 24 h after surgery. 12 and 24 h after surgery, the levels of plasma NE and Cor in three groups rose dramatically (P<0.05 or (P<0.01); The levels of plasma NE and Cor in trial groups I and II were evidently lower than in control group (P<0.05 or P<0.01), and those in trial group II slightly lower than in trial group I. 12 h after surgery, the heart rates (HR) and systolic pressures (SBP) in trial groups I and II increased obviously by comparison to surgery before (P<0.05 or P<0.01), but gradually returned to the preoperative level. HR, SBP and diastolic pressures (DBP) in trial groups I and II at the end of surgery and 12 h after surgery were all lower than in the control group, and significant differences were present (P<0.05 or (P<0.01). At 4, 8, 12 and 24 h after surgery, VAS scores in trial groups I and II were markedly lower than in the control group ((P<0.05 or (P<0.01), the scores in trial group II being the lowest. Combined application of parecoxib sodium for preemptive analgesia before anesthesia and after surgery can effectively reduce the levels of plasma stress hormones and improve analgesic effects in surgical patients with thyroid carcinoma, and without conspicuous impact on haemodynamics.

A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project.

PubMed

Herrman, Helen; Humphreys, Cathy; Halperin, Stephen; Monson, Katherine; Harvey, Carol; Mihalopoulos, Cathrine; Cotton, Susan; Mitchell, Penelope; Glynn, Tony; Magnus, Anne; Murray, Lenice; Szwarc, Josef; Davis, Elise; Havighurst, Sophie; McGorry, Patrick; Tyano, Sam; Kaplan, Ida; Rice, Simon; Moeller-Saxone, Kristen

2016-12-07

Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required. This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC. The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts: 1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention. Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers. Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system. Australian New Zealand Clinical Trials Registry ACTRN12615000501549 . Retrospectively registered 19 May 2015.

An implementation strategy to improve the guideline adherence of insurance physicians: an experiment in a controlled setting

PubMed Central

2011-01-01

Background The aim of this study was to investigate the efficacy of a newly developed implementation strategy for the insurance medicine guidelines for depression in the Netherlands. We hypothesized that an educational intervention would increase the insurance physicians' (IPs) guideline adherence in a controlled setting. Methods Forty IPs were allocated in a randomised controlled trial (RCT) to an intervention group (IG) (n = 21) and a control group (CG) (n = 19). The IG received tailored training in applying the guidelines for depression, while the CG received an alternative programme. Baseline (T0) and follow-up (T1) measurements were conducted before and after the intervention within a period of two weeks. The intervention consisted of a workshop in which the evidence-based theory of the guidelines was translated for use in practice, with the help of various tools. The IPs had to write a case-report on the basis of video cases, two before and two after the training. Specially trained and blinded test IPs judged the case reports independently on the basis of six performance indicators. Primary outcome measure in the controlled setting of the trial was guideline adherence measured by six performance indicators on a scale of one to seven. Secondary outcome measure was knowledge of the guidelines for depression. Analyses were performed using Linear Mixed Models, and ANCOVA. Results We found significantly higher scores in the IG than in the CG at T1 for both outcomes. The interaction effect (standard error; p-value) of group crossed with time was 0.97 (0.19; p < 0.0005) for guideline adherence in the controlled setting. The group effect at T1 for the knowledge test was 0.86 (0.40; p = 0.038). Conclusions The newly developed implementation strategy for the insurance medicine guidelines for depression improved the guideline adherence of the trained IPs in disability assessments of clients with depression when performed in a controlled setting. Furthermore, the trained IPs showed gains in knowledge of the guidelines for depression. Trial registration Netherlands' Trial Register NTR1863. PMID:22188876

A controlled trial on the effect of hypnosis on dental anxiety in tooth removal patients.

PubMed

Glaesmer, Heide; Geupel, Hendrik; Haak, Rainer

2015-09-01

Empirical evidence concerning the efficacy of hypnosis to reduce anxiety in dental patients is limited. Hence we conducted a controlled trial in patients undergoing tooth removal. The study aims at assessing patient's attitude toward hypnosis and comparing the course of dental anxiety before, during and subsequent to tooth removal in patients with treatment as usual (TAU) and patients with treatment as usual and hypnosis (TAU+HYP). 102 patients in a dental practice were assigned to TAU or TAU+HYP. Dental anxiety was assessed before, during and after treatment. All patients were asked about their experiences and attitudes toward hypnosis. More than 90% of patients had positive attitudes toward hypnosis. Dental anxiety was highest before treatment, and was decreasing across the three assessment points in both groups. The TAU+HYP group reported significantly lower levels of anxiety during treatment, but not after treatment compared with TAU group. Our findings confirm that hypnosis is beneficial as an adjunct intervention to reduce anxiety in patients undergoing tooth removal, particularly with regard to its no-invasive nature. The findings underline that hypnosis is not only beneficial, but also highly accepted by the patients. Implementation of hypnosis in routine dental care should be forwarded. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Molekulare Diagnostik der HPV Infektion

PubMed Central

Wentzensen, PD Dr. med. Nicolas

2014-01-01

Carcinogenic human papillomaviruses (HPV) cause the majority of cervical cancers and other anogentical cancers. Large randomized trials have shown that HPV testing can be efficiently used for primary cervical cancer screening. Other applications include the triage of abnormal cytology results and the follow-up of women after treatment. Many assays have been developed to measure DNA, RNA, and proteins of HPV. The various tests can have very different applications. It is important to validate HPV assays before they are implemented in screening or clinical care. PMID:21845360

Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial

PubMed Central

Al-Itejawi, Hoda H M; van Uden-Kraan, Cornelia F; van de Ven, Peter M; Coupé, Veerle M H; Vis, André N; Nieuwenhuijzen, Jakko A; van Moorselaar, Jeroen A; Verdonck-de Leeuw, Irma M

2017-01-01

Introduction Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. Methods/analysis A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA. The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient’s quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner’s treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA. Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation. Ethics and dissemination This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center, Amsterdam, The Netherlands. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer-reviewed journals. Trial registration Nederlands Trial Register NTR TC5177, registration date: May 28th 2015. Pre-results. PMID:28918408

Enrollment into a time sensitive clinical study in the critical care setting: results from computerized septic shock sniffer implementation.

PubMed

Herasevich, Vitaly; Pieper, Matthew S; Pulido, Juan; Gajic, Ognjen

2011-01-01

Recruitment of patients into time sensitive clinical trials in intensive care units (ICU) poses a significant challenge. Enrollment is limited by delayed recognition and late notification of research personnel. The objective of the present study was to evaluate the effectiveness of the implementation of electronic screening (septic shock sniffer) regarding enrollment into a time sensitive (24 h after onset) clinical study of echocardiography in severe sepsis and septic shock. We developed and tested a near-real time computerized alert system, the septic shock sniffer, based on established severe sepsis/septic shock diagnostic criteria. A sniffer scanned patients' data in the electronic medical records and notified the research coordinator on call through an institutional paging system of potentially eligible patients. The performance of the septic shock sniffer was assessed. The septic shock sniffer performed well with a positive predictive value of 34%. Electronic screening doubled enrollment, with 68 of 4460 ICU admissions enrolled during the 9 months after implementation versus 37 of 4149 ICU admissions before sniffer implementation (p<0.05). Efficiency was limited by study coordinator availability (not available at nights or weekends). Automated electronic medical records screening improves the efficiency of enrollment and should be a routine tool for the recruitment of patients into time sensitive clinical trials in the ICU setting.

Enrollment into a time sensitive clinical study in the critical care setting: results from computerized septic shock sniffer implementation

PubMed Central

Pieper, Matthew S; Pulido, Juan; Gajic, Ognjen

2011-01-01

Objective Recruitment of patients into time sensitive clinical trials in intensive care units (ICU) poses a significant challenge. Enrollment is limited by delayed recognition and late notification of research personnel. The objective of the present study was to evaluate the effectiveness of the implementation of electronic screening (septic shock sniffer) regarding enrollment into a time sensitive (24 h after onset) clinical study of echocardiography in severe sepsis and septic shock. Design We developed and tested a near-real time computerized alert system, the septic shock sniffer, based on established severe sepsis/septic shock diagnostic criteria. A sniffer scanned patients' data in the electronic medical records and notified the research coordinator on call through an institutional paging system of potentially eligible patients. Measurement The performance of the septic shock sniffer was assessed. Results The septic shock sniffer performed well with a positive predictive value of 34%. Electronic screening doubled enrollment, with 68 of 4460 ICU admissions enrolled during the 9 months after implementation versus 37 of 4149 ICU admissions before sniffer implementation (p<0.05). Efficiency was limited by study coordinator availability (not available at nights or weekends). Conclusions Automated electronic medical records screening improves the efficiency of enrollment and should be a routine tool for the recruitment of patients into time sensitive clinical trials in the ICU setting. PMID:21508415

Implementing guidelines in nursing homes: a systematic review.

PubMed

Diehl, Heinz; Graverholt, Birgitte; Espehaug, Birgitte; Lund, Hans

2016-07-25

Research on guideline implementation strategies has mostly been conducted in settings which differ significantly from a nursing home setting and its transferability to the nursing home setting is therefore limited. The objective of this study was to systematically review the effects of interventions to improve the implementation of guidelines in nursing homes. A systematic literature search was conducted in the Cochrane Library, CINAHL, Embase, MEDLINE, DARE, HTA, CENTRAL, SveMed + and ISI Web of Science from their inception until August 2015. Reference screening and a citation search were performed. Studies were eligible if they evaluated any type of guideline implementation strategy in a nursing home setting. Eligible study designs were systematic reviews, randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted-time-series studies. The EPOC risk of bias tool was used to evaluate the risk of bias in the included studies. The overall quality of the evidence was rated using GRADE. Five cluster-randomised controlled trials met the inclusion criteria, evaluating a total of six different multifaceted implementation strategies. One study reported a small statistically significant effect on professional practice, and two studies demonstrated small to moderate statistically significant effects on patient outcome. The overall quality of the evidence for all comparisons was low or very low using GRADE. Little is known about how to improve the implementation of guidelines in nursing homes, and the evidence to support or discourage particular interventions is inconclusive. More implementation research is needed to ensure high quality of care in nursing homes. PROSPERO 2014: CRD42014007664.

Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India.

PubMed

Hirschhorn, Lisa Ruth; Semrau, Katherine; Kodkany, Bhala; Churchill, Robyn; Kapoor, Atul; Spector, Jonathan; Ringer, Steve; Firestone, Rebecca; Kumar, Vishwajeet; Gawande, Atul

2015-08-14

Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India. Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4-6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed. In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch. The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality. NCT02148952 .

Antibiotic Rotation for Febrile Neutropenic Patients with Hematological Malignancies: Clinical Significance of Antibiotic Heterogeneity

PubMed Central

Chong, Yong; Shimoda, Shinji; Yakushiji, Hiroko; Ito, Yoshikiyo; Miyamoto, Toshihiro; Kamimura, Tomohiko; Shimono, Nobuyuki; Akashi, Koichi

2013-01-01

Background Our unit adopted the single administration of cefepime as the initial treatment for febrile episodes in neutropenic patients with hematological malignancies. However, recently, cefepime-resistant gram-negative bacteremia, including those with extended-spectrum β-lactamase (ESBL)-producers, was frequently observed in these patients. Therefore, we instituted a rotation of primary antibiotics for febrile neutropenic patients in an attempt to control antibiotic resistance. Methods This prospective trial was performed from August 2008 through March 2011 at our unit. After a pre-intervention period, in which cefepime was used as the initial agent for febrile neutropenia, 4 primary antibiotics, namely, piperacillin-tazobactam, ciprofloxacin, meropenem, and cefepime, were rotated at 1-month intervals over 20 months. Blood and surveillance cultures were conducted for febrile episodes, in order to assess the etiology, the resistance pattern (particularly to cefepime), and the prognosis. Results In this trial, 219 patients were registered. A 65.9% reduction in the use of cefepime occurred after the antibiotic rotation. In the surveillance stool cultures, the detection rate of cefepime-resistant gram-negative isolates, of which ESBL-producers were predominant, declined significantly after the intervention (8.5 vs 0.9 episodes per 1000 patient days before and after intervention respectively, P<0.01). Interestingly, ESBL-related bacteremia was not detected after the initiation of the trial (1.7 vs 0.0 episodes per 1000 patient days before and after intervention respectively, P<0.01). Infection-related mortality was comparable between the 2 periods. Conclusions We implemented a monthly rotation of primary antibiotics for febrile neutropenic patients. An antibiotic heterogeneity strategy, mainly performed as a cycling regimen, would be useful for controlling antimicrobial resistance among patients treated for febrile neutropenia. PMID:23372683

Balance training and center-of-pressure location in participants with chronic ankle instability.

PubMed

Mettler, Abby; Chinn, Lisa; Saliba, Susan A; McKeon, Patrick O; Hertel, Jay

2015-04-01

Chronic ankle instability (CAI) occurs in some people after a lateral ankle sprain and often results in residual feelings of instability and episodes of the ankle's giving way. Compared with healthy people, patients with CAI demonstrated poor postural control and used a more anteriorly and laterally positioned center of pressure (COP) during a single-limb static-balance task on a force plate. Balance training is an effective means of altering traditional COP measures; however, whether the overall location of the COP distribution under the foot also changes is unknown. To determine if the spatial locations of COP data points in participants with CAI change after a 4-week balance-training program. Randomized controlled trial. Laboratory. Thirty-one persons with self-reported CAI. Participants were randomly assigned to a 4-week balance-training program or no balance training. We collected a total of 500 COP data points while participants balanced using a single limb on a force plate during a 10-second trial. The location of each COP data point relative to the geometric center of the foot was determined, and the frequency count in 4 sections (anteromedial, anterolateral, posteromedial, posterolateral) was analyzed for differences between groups. Overall, COP position in the balance-training group shifted from being more anterior to less anterior in both eyes-open trials (before trial = 319.1 ± 165.4, after trial = 160.5 ± 149.5; P = .006) and eyes-closed trials (before trial = 387.9 ± 123.8, after trial = 189.4 ± 102.9; P < .001). The COP for the group that did not perform balance training remained the same in the eyes-open trials (before trial = 214.1 ± 193.3, after trial = 230.0 ± 176.3; P = .54) and eyes-closed trials (before trial = 326.9 ± 134.3, after trial = 338.2 ± 126.1; P = .69). In participants with CAI, the balance-training program shifted the COP location from anterolateral to posterolateral. The program may have repaired some of the damaged sensorimotor system pathways, resulting in a more optimally functioning and less constrained system.

Perceptual analyses of spasmodic dysphonia before and after treatment.

PubMed

Cannito, Michael P; Woodson, Gayle E; Murry, Thomas; Bender, Brenda

2004-12-01

To evaluate expert listeners' perceptions of voice and fluency in persons with adductor spasmodic dysphonia (ADSD) before and after treatment with botulinum toxin type A (Botox), as a function of initial severity of the disorder (while controlling for patients' age at injection). Simple before-and-after trial with blinded randomized listener judgments. Ambulatory care clinic at a single medical center. Forty-two consecutive patients with ADSD who underwent examination, with a 3- to 6-week follow-up, after initial botulinum toxin type A injection. There were also 42 age- and sex-matched healthy control subjects. Injections of botulinum toxin type A into the thyroarytenoid muscle(s). Computer-implemented visual analog scaling judgments of voice quality and speech fluency made by expert listeners under psychoacoustically controlled conditions. Response to botulinum toxin type A varied markedly as a function of pretreatment severity of ADSD. More severe initial symptoms exhibited greater magnitudes of improvement. Patients with mild dysphonia did not exhibit pretreatment to posttreatment change. Following treatment, voice and fluency remained significantly (P<.05) poorer in ADSD than in healthy speakers. Older patients exhibited less improvement than younger patients when the effect of initial severity was statistically controlled. Voice quality and fluency improved for most patients following treatment, but older patients and those with milder dysphonia exhibited the least optimal responses to the procedure. Patients who were profoundly impaired demonstrated the greatest amount of improvement. Computer-implemented visual analog scaling provided a reliable clinical tool for determining treatment-related changes in those with ADSD.

In-situ medical simulation for pre-implementation testing of clinical service in a regional hospital in Hong Kong.

PubMed

Chen, P P; Tsui, N Tk; Fung, A Sw; Chiu, A Hf; Wong, W Cw; Leong, H T; Lee, P Sf; Lau, J Yw

2017-08-01

The implementation of a new clinical service is associated with anxiety and challenges that may prevent smooth and safe execution of the service. Unexpected issues may not be apparent until the actual clinical service commences. We present a novel approach to test the new clinical setting before actual implementation of our endovascular aortic repair service. In-situ simulation at the new clinical location would enable identification of potential process and system issues prior to implementation of the service. After preliminary planning, a simulation test utilising a case scenario with actual simulation of the entire care process was carried out to identify any logistic, equipment, settings or clinical workflow issues, and to trial a contingency plan for a surgical complication. All patient care including anaesthetic, surgical, and nursing procedures and processes were simulated and tested. Overall, 17 vital process and system issues were identified during the simulation as potential clinical concerns. They included difficult patient positioning, draping pattern, unsatisfactory equipment setup, inadequate critical surgical instruments, blood products logistics, and inadequate nursing support during crisis. In-situ simulation provides an innovative method to identify critical deficiencies and unexpected issues before implementation of a new clinical service. Life-threatening and serious practical issues can be identified and corrected before formal service commences. This article describes our experience with the use of simulation in pre-implementation testing of a clinical process or service. We found the method useful and would recommend it to others.

Successful increase in contraceptive uptake among Kenyan HIV-1 serodiscordant couples enrolled in an HIV-1 prevention trial

PubMed Central

Ngure, Kenneth; Heffron, Renee; Mugo, Nelly; Irungu, Elizabeth; Celum, Connie; Baeten, Jared

2016-01-01

Objective To evaluate a multi-pronged approach to promote dual contraceptive use by women within heterosexual HIV-1 serodiscordant partnerships. Methods For 213 HIV-1 serodiscordant couples in Thika, Kenya participating in an HIV-1 prevention clinical trial, contraceptive promotion was initiated through a multi-pronged intervention that included staff training, couples family planning sessions, and free provision of hormonal contraception on-site. Contraceptive use and pregnancy incidence were compared between two time periods (before versus after June 2007, when the intervention was initiated) and between Thika and other Kenyan trial sites (Eldoret, Kisumu, and Nairobi). Generalized estimating equations and Andersen-Gill proportional hazards modeling were used. Results Non-barrier contraceptive use increased after implementation of the intervention: from 31.5% to 64.7% of visits among HIV-1 seropositive women (odds ratio [OR] 4.0, 95% confidence interval [CI] 3.0–5.3) and from 28.6% to 46.7% of visits among HIV-1 seronegative women (OR 2.2, 95% CI 1.4–3.5). In comparison, at the other Kenyan sites, where the intervention was not implemented, contraceptive use changed minimally, from 15.6% to 22.3% of visits for HIV-1 seropositive women and from 13.6% to 12.7% among HIV-1 seronegative women. Self-reported condom use remained high during follow-up. Pregnancy incidence at the Thika was significantly lower after compared with before June 2007 (hazard ratio [HR] 0.2, 95% CI 0.1–0.6), and was approximately half that at other Kenyan sites during the intervention period (HR 0.5, 95% CI 0.3–0.8). Conclusions A multi-pronged family planning intervention can lead to high non-barrier contraceptive uptake and reduced pregnancy incidence among women in HIV-1 serodiscordant partnerships. PMID:20081393

Effect of probiotics on vaginal health in pregnancy. EFFPRO, a randomized controlled trial.

PubMed

Gille, Christian; Böer, Bettina; Marschal, Matthias; Urschitz, Michael S; Heinecke, Volker; Hund, Verena; Speidel, Sarah; Tarnow, Inge; Mylonas, Ioannis; Franz, Axel; Engel, Corinna; Poets, Christian F

2016-11-01

Preterm delivery is a leading cause of neonatal morbidity and death. It often results from chorioamnionitis, which is a complication of bacterial vaginosis. Probiotics are effective in the treatment of bacterial vaginosis in women who were not pregnant; studies in pregnant woman are missing. The purpose of this study was to evaluate whether an oral probiotic food supplement supports the maintenance or restoration of a normal vaginal microbiota during pregnancy. We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (10 9 colony-forming units) or placebo were administered for 8 weeks to women with <12 completed weeks of pregnancy. Participants were enrolled at Tuebingen University Hospital and 10 recruiting gynecologic practices. Vaginal swabs were taken before and after intervention and analyzed according to the Nugent scoring system. Telephone interviews were performed before and after intervention and after delivery. Primary outcome was the proportion of swabs with normal Nugent score (<4) after intervention, compared by Fisher's exact test in an intention-to-treat analysis. Three hundred twenty pregnant women were enrolled. Vaginal swabs were analyzed from 290 women before and 271 women after intervention. The proportion of normal vaginal microbiota decreased from 82.6 to 77.8% in the treatment group and from 79.1 to 74.3% in the placebo group, with no significant difference across groups after intervention (P=.297). Oral probiotics may be suitable for implementation in antenatal care but, as administered here, had no effect on vaginal health during mid gestation. Other application routes or probiotic preparations may be more effective in supporting vaginal microbiota during pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis

PubMed Central

2013-01-01

Background The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins. Methods We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians’ prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients’ overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes). Results There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect. Conclusion Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician’s prescribing behaviour is affected by an established health care system, which is not easy to change. Trial registration ISRCTN71348772 PMID:23819600

An ounce of prevention: A pre-randomization protocol to improve retention in substance use disorder clinical trials.

PubMed

Northrup, Thomas F; Greer, Tracy L; Walker, Robrina; Rethorst, Chad D; Warden, Diane; Stotts, Angela L; Trivedi, Madhukar H

2017-01-01

Missing data in substance use disorder (SUD) research pose a significant threat to internal validity. Participants terminate involvement or become less likely to attend intervention and research visits for many reasons, which should be addressed prior to becoming problematic. During a 9-month study targeting stimulant abuse, early dropouts and participant reported attendance barriers led to implementing a structured, pre-randomization protocol with participants about retention and solution-focused strategies (the "Fireside Chat"). Our aim is to outline this approach and present data on intervention participation and research visit attendance after implementation. STimulant Reduction using Dosed Exercise (STRIDE) was a two-arm, multisite randomized clinical trial testing treatment-as-usual for stimulant abuse/dependence augmented by Exercise or Health Education. For both groups, study intervention visits at the site were scheduled 3/week for 12weeks followed by 1/week for 24weeks. During The Chat, research staff thoroughly reviewed participants' expectations, and barriers and solutions to retention. Fifteen participants were randomized (to Exercise or Health Education) prior to and fourteen were randomized after Chat implementation. Intervention and monthly follow-up attendance (before and after implementation) were compared at the site (N=29) that developed and rigorously implemented The Chat. Individuals who participated in The Chat (n=14) attended significantly more intervention visits during weeks 1-12 (p<0.001) and weeks 13-36 (p<0.05) and attended more research visits (p<0.001). Proactive discussion of expectations and barriers prior to randomization was associated with greater study attendance. SUD researchers should consider tailoring this approach to suit their needs. Further investigation is warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

A stepped-wedge evaluation of an initiative to spread the collaborative care model for depression in primary care.

PubMed

Solberg, Leif I; Crain, A Lauren; Maciosek, Michael V; Unützer, Jürgen; Ohnsorg, Kris A; Beck, Arne; Rubenstein, Lisa; Whitebird, Robin R; Rossom, Rebecca C; Pietruszewski, Pamela B; Crabtree, Benjamin F; Joslyn, Kenneth; Van de Ven, Andrew; Glasgow, Russell E

2015-09-01

Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials. Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes. There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P <.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94). Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome improvement. © 2015 Annals of Family Medicine, Inc.

Introduction of a closed-system cell processor for red blood cell washing: postimplementation monitoring of safety and efficacy.

PubMed

Acker, Jason P; Hansen, Adele L; Yi, Qi-Long; Sondi, Nayana; Cserti-Gazdewich, Christine; Pendergrast, Jacob; Hannach, Barbara

2016-01-01

After introduction of a closed-system cell processor, the effect of this product change on safety, efficacy, and utilization of washed red blood cells (RBCs) was assessed. This study was a pre-/postimplementation observational study. Efficacy data were collected from sequentially transfused washed RBCs received as prophylactic therapy by β-thalassemia patients during a 3-month period before and after implementation of the Haemonetics ACP 215 closed-system processor. Before implementation, an open system (TerumoBCT COBE 2991) was used to wash RBCs. The primary endpoint for efficacy was a change in hemoglobin (Hb) concentration corrected for the duration between transfusions. The primary endpoint for safety was the frequency of adverse transfusion reactions (ATRs) in all washed RBCs provided by Canadian Blood Services to the transfusion service for 12 months before and after implementation. Data were analyzed from more than 300 RBCs transfused to 31 recipients before implementation and 29 recipients after implementation. The number of units transfused per episode reduced significantly after implementation, from a mean of 3.5 units to a mean of 3.1 units (p < 0.005). The corrected change in Hb concentration was not significantly different before and after implementation. ATRs occurred in 0.15% of transfusions both before and after implementation. Safety and efficacy of washed RBCs were not affected after introduction of a closed-system cell processor. The ACP 215 allowed for an extended expiry time, improving inventory management and overall utilization of washed RBCs. Transfusion of fewer RBCs per episode reduced exposure of recipients to allogeneic blood products while maintaining efficacy. © 2015 AABB.

Hospital staff views of prescribing and discharge communication before and after electronic prescribing system implementation.

PubMed

Mills, Pamela Ruth; Weidmann, Anita Elaine; Stewart, Derek

2017-12-01

Background Electronic prescribing system implementation is recommended to improve patient safety and general practitioner's discharge information communication. There is a paucity of information about hospital staff perspectives before and after system implementation. Objective To explore hospital staff views regarding prescribing and discharge communication systems before and after hospital electronic prescribing and medicines administration (HEPMA) system implementation. Setting A 560 bed United Kingdom district general hospital. Methods Semi-structured face-to-face qualitative interviews with a purposive sample of hospital staff involved in the prescribing and discharge communication process. Interviews transcribed verbatim and coded using the Framework Approach. Behavioural aspects mapped to Theoretical Domains Framework (TDF) to highlight associated behavioural change determinants. Main outcome measure Staff perceptions before and after implementation. Results Nineteen hospital staff (consultant doctors, junior doctors, pharmacists and advanced nurse practitioners) participated before and after implementation. Pre-implementation main themes were inpatient chart and discharge letter design and discharge communication process with issues of illegible and inaccurate information. Improved safety was anticipated after implementation. Post-implementation themes were improved inpatient chart clarity and discharge letter quality. TDF domains relevant to staff behavioural determinants preimplementation were knowledge (task or environment); skills (competence); social/professional roles and identity; beliefs about capabilities; environmental context and resources (including incidents). An additional two were relevant post-implementation: social influences and behavioural regulation (including self-monitoring). Participants described challenges and patient safety concerns pre-implementation which were mostly resolved post-implementation. Conclusion HEPMA implementation produced perceptions of patient safety improvement. TDF use enabled behaviour change analysis due to implementation, for example, staff adoption of behaviours to ensure general practitioners receive good quality discharge information.

Development, Evaluation and Implementation of Chief Complaint Groupings to Activate Data Collection: A Multi-Center Study of Clinical Decision Support for Children with Head Trauma.

PubMed

Deakyne, S J; Bajaj, L; Hoffman, J; Alessandrini, E; Ballard, D W; Norris, R; Tzimenatos, L; Swietlik, M; Tham, E; Grundmeier, R W; Kuppermann, N; Dayan, P S

2015-01-01

Overuse of cranial computed tomography scans in children with blunt head trauma unnecessarily exposes them to radiation. The Pediatric Emergency Care Applied Research Network (PECARN) blunt head trauma prediction rules identify children who do not require a computed tomography scan. Electronic health record (EHR) based clinical decision support (CDS) may effectively implement these rules but must only be provided for appropriate patients in order to minimize excessive alerts. To develop, implement and evaluate site-specific groupings of chief complaints (CC) that accurately identify children with head trauma, in order to activate data collection in an EHR. As part of a 13 site clinical trial comparing cranial computed tomography use before and after implementation of CDS, four PECARN sites centrally developed and locally implemented CC groupings to trigger a clinical trial alert (CTA) to facilitate the completion of an emergency department head trauma data collection template. We tested and chose CC groupings to attain high sensitivity while maintaining at least moderate specificity. Due to variability in CCs available, identical groupings across sites were not possible. We noted substantial variability in the sensitivity and specificity of seemingly similar CC groupings between sites. The implemented CC groupings had sensitivities greater than 90% with specificities between 75-89%. During the trial, formal testing and provider feedback led to tailoring of the CC groupings at some sites. CC groupings can be successfully developed and implemented across multiple sites to accurately identify patients who should have a CTA triggered to facilitate EHR data collection. However, CC groupings will necessarily vary in order to attain high sensitivity and moderate-to-high specificity. In future trials, the balance between sensitivity and specificity should be considered based on the nature of the clinical condition, including prevalence and morbidity, in addition to the goals of the intervention being considered.

Building system capacity for the integration of mental health at the level of primary care in Tunisia: a study protocol in global mental health.

PubMed

Spagnolo, Jessica; Champagne, François; Leduc, Nicole; Piat, Myra; Melki, Wahid; Charfi, Fatma; Laporta, Marc

2017-01-17

In low- and middle-income countries (LMICs), addressing the high prevalence of mental disorders is a challenge given the limited number and unequal distribution of specialists, as well as scarce resources allocated to mental health. The Mental Health Gap Action Programme (mhGAP) and its accompanying Intervention Guide (IG), developed by the World Health Organization (WHO), aim to address this challenge by training non-specialists such as general practitioners (GPs) in mental health care. This trial aims to implement and evaluate an adapted version of the mhGAP-IG (version 1.0) offered to GPs in 2 governorates of Tunisia (i.e., Tunis and Sousse), in order to uncover important information regarding implementation process and study design before country-wide implementation and evaluation. First, a systematic review will be conducted to explore types and effectiveness of mental health training programs offered to GPs around the world, with a specific focus on programs implemented and evaluated in LMICs. Second, a cluster randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the implemented training based on the mhGAP-IG (version 1.0). Third, multiple case study design will be used to explore how contextual factors impact the successful implementation of the training and desired outcomes. In Tunisia, an important need exists to further develop proximity health services and to address the growing mental health treatment gap. One solution is to train GPs in the detection, treatment, and management of mental health problems, given their strategic role in the healthcare system. This trial thus aims to implement and evaluate an adapted version of a training based on the mhGAP-IG (version 1.0) in Tunis and Sousse before country-wide implementation and evaluation. Several contributions are envisioned: adding to the growing evidence on the mhGAP and its accompanying guide, especially in French-speaking nations; building research capacity in Tunisia and more generally in LMICs by employing rigorous designs; evaluating an adapted version of the mhGAP-IG (version 1.0) on a sample of GPs; generating important information regarding implementation process and study design before country-wide implementation; and complimenting the trial results with implementation analysis, a priority in global mental health.

Effect of Fordyce Happiness Model on depression, stress, anxiety, and fatigue in patients with multiple sclerosis.

PubMed

Khayeri, Fereydoon; Rabiei, Leili; Shamsalinia, Abbas; Masoudi, Reza

2016-11-01

This study was conducted to investigate the effect of Fordyce Happiness Model (FHM) on depression, stress, anxiety, and fatigue in MS patients. In this clinical trial, 140 MS patients assigned to experimental and control groups. Depression, anxiety, stress, and fatigue were measured by Depression Anxiety Stress Scale-21 and Piper Standard Scale before and immediately and three months after the implementation of FHM. The data were analyzed by SPSS 18. Independent t-test indicated that total scores of stress, depression, and fatigue of the two groups were not significantly different before the intervention but were significantly different after the intervention (P˂0.05). Moreover, anxiety scores of the two were not significantly different after the intervention (P˃0.05). FHM can assist MS patients to manage their disease and associated problems in life. Besides that, since FHM is efficient and costless, it can be incorporated into the health interventions for MS patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Skin hydration in nursing home residents using disposable bed baths.

PubMed

Gillis, Katrin; Tency, Inge; Roelant, Ella; Laureys, Sarina; Devriendt, Hendrik; Lips, Dirk

2016-01-01

The objective of this study was to evaluate a new way for applying bed baths and reducing the risk for dry skin by comparing the effect of two washing methods on skin hydration. A cluster randomized trial was conducted. Skin hydration was measured before and after implementation of disposable wash gloves, using a MoistureMeter SC at three skin sites. Total skin hydration did not differ between residents at the start of the study in both groups. After implementation, the post minus pre hydration scores were higher for the intervention group than the control group at all skin sites. However, the difference was only significant at cheek site. The use of disposable wash gloves does not increase the risk for dry skin in comparison with traditional washing methods. These results may encourage the introduction of disposable wash gloves as an innovation in daily skin care practice. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial.

PubMed

Al-Itejawi, Hoda H M; van Uden-Kraan, Cornelia F; van de Ven, Peter M; Coupé, Veerle M H; Vis, André N; Nieuwenhuijzen, Jakko A; van Moorselaar, Jeroen A; Verdonck-de Leeuw, Irma M

2017-09-15

Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA.The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient's quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner's treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA.Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation. This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center, Amsterdam, The Netherlands. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer-reviewed journals. Nederlands Trial Register NTR TC5177, registration date: May 28 th 2015.Pre-results. © 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.

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections.

PubMed

Haas, David M; Morgan, Sarah; Contreras, Karenrose

2014-09-09

Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (21 July 2014). We included randomized and quasi-randomized trials assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. We independently assessed eligibility and quality of the studies. Five trials randomizing 1946 women (1766 analyzed) evaluated the effects of vaginal cleansing (all with povidone-iodine) on post-cesarean infectious morbidity. The risk of bias was generally low, with the quality of most of the studies being high. Vaginal preparation immediately before cesarean delivery significantly reduced the incidence of post-cesarean endometritis from 7.2% in control groups to 3.6% in vaginal cleansing groups (average risk ratio (RR) 0.39, 95% confidence interval (CI) 0.16 to 0.97, five trials, 1766 women). The risk reduction was particularly strong for women with ruptured membranes (1.4% in the vaginal cleansing group versus 15.4% in the control group; RR 0.13, 95% CI 0.02 to 0.66, two trials, 148 women). No other outcomes realized statistically significant differences between the vaginal cleansing and control groups. No adverse effects were reported with the povidone-iodine vaginal cleansing.The quality of the evidence using GRADE was low for post-cesarean endometritis, moderate for postoperative fever, and low for wound infection. Vaginal preparation with povidone-iodine solution immediately before cesarean delivery reduces the risk of postoperative endometritis. This benefit is particularly realized for women undergoing cesarean delivery with ruptured membranes. As a simple, generally inexpensive intervention, providers should consider implementing preoperative vaginal cleansing with povidone-iodine before performing cesarean deliveries.

[Effects of group psychological counseling on self-confidence and social adaptation of burn patients].

PubMed

Dang, Rui; Wang, Yishen; Li, Na; He, Ting; Shi, Mengna; Liang, Yanyan; Zhu, Chan; Zhou, Yongbo; Qi, Zongshi; Hu, Dahai

2014-12-01

To explore the effects of group psychological counseling on the self-confidence and social adaptation of burn patients during the course of rehabilitation. Sixty-four burn patients conforming to the inclusion criteria and hospitalized from January 2012 to January 2014 in Xijing Hospital were divided into trial group and control group according to the method of rehabilitation, with 32 cases in each group. Patients in the two groups were given ordinary rehabilitation training for 8 weeks, and the patients in trial group were given a course of group psychological counseling in addition. The Rosenberg's Self-Esteem Scale was used to evaluate the changes in self-confidence levels, and the number of patients with inferiority complex, normal feeling, self-confidence, and over self-confidence were counted before and after treatment. The Abbreviated Burn-Specific Health Scale was used to evaluate physical function, psychological function, social relationship, health condition, and general condition before and after treatment to evaluate the social adaptation of patients. Data were processed with t test, chi-square test, Mann-Whitney U test, and Wilcoxon test. (1) After treatment, the self-confidence levels of patients in trial group were significantly higher than those in control group (Z = -2.573, P < 0.05). Among trial group, the number of patients with inferiority complex was 17 (53.1%) before treatment, which was decreased to 6 (18.8%) after treatment; the number of patients with normal feeling and that of self-confidence were 8 (25.0%) and 4 (12.5%) before treatment, which were respectively increased to 13 (40.6%) and 10 (31.3%) after treatment. The overall difference in trial group was obvious between before and after treatment (Z = -4.123, P < 0.01) . There was no obvious difference in self-confidence level of patients in control group between before and after treatment (Z = -1.000, P > 0.05). (2) After treatment, the scores of psychological function, social relationship, health condition, and general condition were (87 ± 3), (47.8 ± 3.6), (49 ± 3), and (239 ± 10) points in trial group, which were significantly higher than those in control group [(79 ± 4), (38.3 ± 5.6), (46 ± 4), and (231 ± 9) points, with t values respectively -8.635, -8.125, -3.352, -3.609, P values below 0.01]. After treatment, the scores of physical function, psychological function, social relationship, health condition, and general condition in trial group were significantly higher than those before treatment (with t values from -33.282 to -19.515, P values below 0.05). The scores of physical function, psychological function, health condition, and general condition in control group after treatment were significantly higher than those before treatment (with t values from -27.137 to -17.790, P values below 0.05). Group psychological counseling combined with ordinary rehabilitation training give rise to significant effects on self-confidence level and social adaptation for burn patients.

Factors associated with willingness to participate in a vaccine clinical trial among elderly Hispanic patients.

PubMed

Rikin, Sharon; Shea, Steven; LaRussa, Philip; Stockwell, Melissa

2017-09-01

A population specific understanding of barriers and facilitators to participation in clinical trials could improve recruitment of elderly and minority populations. We investigated how prior exposure to clinical trials and incentives were associated with likelihood of participation in a vaccine clinical trial through a questionnaire administered to 200 elderly patients in an academic general internal medicine clinic. Wilcoxon signed rank sum test compared likelihood of participation with and without monetary incentives. Logistic regression evaluated characteristics associated with intent to participate in an influenza vaccine trial, adjusted for age, gender, language, and education history. When asked about likelihood of participation if there was monetary compensation, there was a 12.2% absolute increase in those reporting that they would not participate, with a significant difference in the distribution of likelihood before and after mentioning a monetary incentive (Wilcoxon signed rank test, p = 0.001). Those with previous knowledge of clinical trials (54.4%) were more likely to report they would participate vs. those without prior knowledge (OR 2.5, 95% CI [1.2, 5.2]). The study highlights the importance of pre-testing recruitment materials and incentives in key group populations prior to implementing clinical trials.

Use of interrupted time series analysis in evaluating health care quality improvements.

PubMed

Penfold, Robert B; Zhang, Fang

2013-01-01

Interrupted time series (ITS) analysis is arguably the strongest quasi-experimental research design. ITS is particularly useful when a randomized trial is infeasible or unethical. The approach usually involves constructing a time series of population-level rates for a particular quality improvement focus (eg, rates of attention-deficit/hyperactivity disorder [ADHD] medication initiation) and testing statistically for a change in the outcome rate in the time periods before and time periods after implementation of a policy/program designed to change the outcome. In parallel, investigators often analyze rates of negative outcomes that might be (unintentionally) affected by the policy/program. We discuss why ITS is a useful tool for quality improvement. Strengths of ITS include the ability to control for secular trends in the data (unlike a 2-period before-and-after t test), ability to evaluate outcomes using population-level data, clear graphical presentation of results, ease of conducting stratified analyses, and ability to evaluate both intended and unintended consequences of interventions. Limitations of ITS include the need for a minimum of 8 time periods before and 8 after an intervention to evaluate changes statistically, difficulty in analyzing the independent impact of separate components of a program that are implemented close together in time, and existence of a suitable control population. Investigators must also be careful not to make individual-level inferences when population-level rates are used to evaluate interventions (though ITS can be used with individual-level data). A brief description of ITS is provided, including a fully implemented (but hypothetical) study of the impact of a program to reduce ADHD medication initiation in children younger than 5 years old and insured by Medicaid in Washington State. An example of the database needed to conduct an ITS is provided, as well as SAS code to implement a difference-in-differences model using preschool-age children in California as a comparison group. Copyright © 2013 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Effectiveness of guideline dissemination and implementation strategies on health care professionals' behaviour and patient outcomes in the cancer care context: a systematic review protocol.

PubMed

Tomasone, Jennifer R; Chaudhary, Rushil; Brouwers, Melissa C

2015-08-25

Health care professionals (HCPs) are able to make effective decisions regarding patient care through the use of systematically developed clinical practice guidelines (CPGs). These recommendations are especially important in a cancer health care context as patients are exposed to a multitude of interdisciplinary HCPs offering high-quality care throughout diagnosis, treatment, survivorship and palliative care. Although a large number of CPGs targeted towards cancer are widely disseminated, it is unknown whether implementation strategies targeting the use of these guidelines are effective in effecting HCP behaviour and patient outcomes in the cancer care context. The purpose of this systematic review will be to determine the effectiveness of different CPG dissemination and implementation interventions on HCPs' behaviour and patient outcomes in the cancer health care context. Five electronic databases (CINAHL, the Cochrane Controlled Trials Register, MEDLINE via Ovid, EMBASE via Ovid and PsycINFO via Ovid) will be searched to include all studies examining the dissemination and/or implementation of CPGs in a cancer care setting targeting all HCPs. CPG implementation strategies will be included if the CPGs were systematically developed (e.g. literature review/evidence-informed, expert panel, evidence appraisal). The studies will be limited to randomized controlled trials, controlled clinical trials and quasi-experimental (interrupted time series, controlled before-and-after designs) studies. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. The aim of this review is to inform cancer care health care professionals and policymakers about evidence-based implementation strategies that will allow for effective use of CPGs. PROSPERO CRD42015019331.

Contribution of creatine to protein homeostasis in athletes after endurance and sprint running.

PubMed

Tang, Fu-Chun; Chan, Chun-Chen; Kuo, Po-Ling

2014-02-01

Few studies have focused on the metabolic changes induced by creatine supplementation. This study investigated the effects of creatine supplementation on plasma and urinary metabolite changes of athletes after endurance and sprint running. Twelve male athletes (20.3 ± 1.4 y) performed two identical (65-70 % maximum heart rate reserved) 60 min running exercises (endurance trial) before and after creatine supplementation (12 g creatine monohydrate/day for 15 days), followed by a 5-day washout period. Subsequently, they performed two identical 100 m sprint running exercises (power trial) before and after 15 days of creatine supplementation in accordance with the supplementary protocol of the endurance trial. Body composition measurements were performed during the entire study. Plasma samples were examined for the concentrations of glucose, lactate, branched-chain amino acids (BCAAs), free-tryptophan (f-TRP), glutamine, alanine, hypoxanthine, and uric acid. Urinary samples were examined for the concentrations of hydroxyproline, 3-methylhistidine, urea nitrogen, and creatinine. Creatine supplementation significantly increased body weights of the athletes of endurance trial. Plasma lactate concentration and ratio of f-TRP/BCAAs after recovery from endurance running were significantly decreased with creatine supplementation. Plasma purine metabolites (the sum of hypoxanthine and uric acid), glutamine, urinary 3-methylhistidine, and urea nitrogen concentrations tended to decrease before running in trials with creatine supplements. After running, urinary hydroxyproline concentration significantly increased in the power trial with creatine supplements. The findings suggest that creatine supplementation tended to decrease muscle glycogen and protein degradation, especially after endurance exercise. However, creatine supplementation might induce collagen proteolysis in athletes after sprint running.

Implementation of multifamily group treatment for veterans with traumatic brain injury.

PubMed

Perlick, Deborah A; Straits-Troster, Kristy; Strauss, Jennifer L; Norell, Diane; Tupler, Larry A; Levine, Bruce; Luo, Xiaodong; Holman, Caroline; Marcus, Tara; Dixon, Lisa B; Dyck, Dennis G

2013-06-01

This study evaluated the initial efficacy and feasibility of implementing multifamily group treatment for veterans with traumatic brain injury (TBI). Veterans at two Veterans Affairs medical centers were prescreened by their providers for participation in an open trial of multifamily group treatment for TBI. Enrollment was limited to consenting veterans with a clinical diagnosis of TBI sustained during the Operation Enduring Freedom-Operation Iraqi Freedom era, a family member or partner consenting to participate, and a score ≥20 on the Mini-Mental State Examination. The nine-month (April 2010-March 2011) trial consisted of individual family sessions, an educational workshop, and bimonthly multifamily problem-solving sessions. Interpersonal functioning and symptomatic distress among veterans and family burden, empowerment, and symptomatic distress among families were assessed before and after treatment. Providers referred 34 (58%) of 59 veterans screened for the study; of those, 14 (41%) met criteria and consented to participate, and 11 (32%) completed the study. Severity of TBI, insufficient knowledge about the benefits of family involvement, and access problems influenced decisions to exclude veterans or refuse to participate. Treatment was associated with decreased veteran anger expression (p≤.01) and increased social support and occupational activity (p≤.05), with effect sizes ranging from .6 to 1.0. Caregivers reported decreased burden (p≤.05) and increased empowerment (p≤.01). The results supported implementation of a randomized controlled trial, building in education at the provider and family level.

Acute effects of repeated bouts of aerobic exercise on arterial stiffness after glucose ingestion.

PubMed

Kobayashi, Ryota; Hashimoto, Yuto; Hatakeyama, Hiroyuki; Okamoto, Takanobu

2018-03-22

The aim of this study was to investigate the acute repeated bouts of aerobic exercise decrease leg arterial stiffness. However, the influence of repeated bouts of aerobic exercise on arterial stiffness after glucose ingestion is unknown. The present study investigates the acute effects of repeated bouts of aerobic exercise on arterial stiffness after the 75-g oral glucose tolerance test (OGTT). Ten healthy young men (age, 23.2 ± 0.9 years) performed repeated bouts of aerobic exercise trial (RE, 65% peak oxygen uptake; two 15 min bouts of cycling performed 20 min apart) and control trial (CON, seated and resting in a quiet room) at 80 min before the 75-g OGTT on separate days in a randomized, controlled crossover fashion. Carotid-femoral (aortic) and femoral-ankle (leg) pulse wave velocity, carotid augmentation index, brachial and ankle blood pressure, heart rate and blood glucose and insulin levels were measured before (baseline) and 30, 60 and 120 min after the 75-g OGTT. Leg pulse wave velocity, ankle systolic blood pressure and blood glucose levels increased from baseline after the 75-g OGTT in the CON trial, but not in the RE trial. The present findings indicate that acute repeated bouts of aerobic exercise before glucose ingestion suppress increases in leg arterial stiffness following glucose ingestion. RE trial repeated bouts of aerobic exercise trial; CON trial control trial; BG blood glucose; VO 2peak peak oxygen uptake; PWV Pulse wave velocity; AIx carotid augmentation index; BP blood pressure; HR heart rate; CVs coefficients of variation; RPE Ratings of perceived exertion; SE standard error.

A quasi-experimental, before-after trial examining the impact of an emergency department mechanical ventilator protocol on clinical outcomes and lung-protective ventilation in acute respiratory distress syndrome

PubMed Central

Fuller, Brian M.; Ferguson, Ian T.; Mohr, Nicholas M.; Drewry, Anne M.; Palmer, Christopher; Wessman, Brian T.; Ablordeppey, Enyo; Keeperman, Jacob; Stephens, Robert J.; Briscoe, Cristopher C.; Kolomiets, Angelina A.; Hotchkiss, Richard S.; Kollef, Marin H.

2017-01-01

Objective To evaluate the impact of an emergency department (ED) mechanical ventilation protocol on clinical outcomes and adherence to lung-protective ventilation in patients with acute respiratory distress syndrome (ARDS). Design Quasi-experimental, before-after trial. Setting ED and intensive care units (ICU) of an academic center. Patients Mechanically ventilated ED patients experiencing ARDS while in the ED or after admission to the ICU. Interventions An ED ventilator protocol which targeted parameters in need of quality improvement, as identified by prior work: 1) lung-protective tidal volume; 2) appropriate setting of positive end-expiratory pressure (PEEP); 3) oxygen weaning; and 4) head-of-bed elevation. Measurements and Main Results A total of 229 patients (186 pre-intervention group, 43 intervention group) were studied. In the ED, the intervention was associated with significant changes (P < 0.01 for all) in tidal volume, PEEP, respiratory rate, oxygen administration, and head-of-bed elevation. There was a reduction in ED tidal volume from 8.1 mL/kg PBW (7.0 – 9.1) to 6.4 mL/kg PBW (6.1 – 6.7), and an increase in lung-protective ventilation from 11.1% to 61.5%, P < 0.01. The intervention was associated with a reduction in mortality from 54.8% to 39.5% (OR 0.38, 95% CI 0.17 – 0.83, P = 0.02), and a 3.9 day increase in ventilator-free days, P = 0.01. Conclusions This before-after study of mechanically ventilated patients with ARDS demonstrates that implementing a mechanical ventilator protocol in the ED is feasible, and associated with improved clinical outcomes. PMID:28157140

A Quasi-Experimental, Before-After Trial Examining the Impact of an Emergency Department Mechanical Ventilator Protocol on Clinical Outcomes and Lung-Protective Ventilation in Acute Respiratory Distress Syndrome.

PubMed

Fuller, Brian M; Ferguson, Ian T; Mohr, Nicholas M; Drewry, Anne M; Palmer, Christopher; Wessman, Brian T; Ablordeppey, Enyo; Keeperman, Jacob; Stephens, Robert J; Briscoe, Cristopher C; Kolomiets, Angelina A; Hotchkiss, Richard S; Kollef, Marin H

2017-04-01

To evaluate the impact of an emergency department mechanical ventilation protocol on clinical outcomes and adherence to lung-protective ventilation in patients with acute respiratory distress syndrome. Quasi-experimental, before-after trial. Emergency department and ICUs of an academic center. Mechanically ventilated emergency department patients experiencing acute respiratory distress syndrome while in the emergency department or after admission to the ICU. An emergency department ventilator protocol which targeted variables in need of quality improvement, as identified by prior work: 1) lung-protective tidal volume, 2) appropriate setting of positive end-expiratory pressure, 3) oxygen weaning, and 4) head-of-bed elevation. A total of 229 patients (186 preintervention group, 43 intervention group) were studied. In the emergency department, the intervention was associated with significant changes (p < 0.01 for all) in tidal volume, positive end-expiratory pressure, respiratory rate, oxygen administration, and head-of-bed elevation. There was a reduction in emergency department tidal volume from 8.1 mL/kg predicted body weight (7.0-9.1) to 6.4 mL/kg predicted body weight (6.1-6.7) and an increase in lung-protective ventilation from 11.1% to 61.5%, p value of less than 0.01. The intervention was associated with a reduction in mortality from 54.8% to 39.5% (odds ratio, 0.38; 95% CI, 0.17-0.83; p = 0.02) and a 3.9 day increase in ventilator-free days, p value equals to 0.01. This before-after study of mechanically ventilated patients with acute respiratory distress syndrome demonstrates that implementing a mechanical ventilator protocol in the emergency department is feasible and associated with improved clinical outcomes.

Checklists change communication about key elements of patient care.

PubMed

Newkirk, Michelle; Pamplin, Jeremy C; Kuwamoto, Roderick; Allen, David A; Chung, Kevin K

2012-08-01

Combat casualty care is distributed across professions and echelons of care. Communication within it is fragmented, inconsistent, and prone to failure. Daily checklists used during intensive care unit (ICU) rounds have been shown to improve compliance with evidence-based practices, enhance communication, promote consistency of care, and improve outcomes. Checklists are criticized because it is difficult to establish a causal link between them and their effect on outcomes. We investigated how checklists used during ICU rounds affect communication. We conducted this project in two military ICUs (burn and surgical/trauma). Checklists contained up to 21 questions grouped according to patient population. We recorded which checklist items were discussed during rounds before and after implementation of a "must address" checklist and compared the frequency of discussing items before checklist prompting. Patient discussions addressed more checklist items before prompting at the end of the 2-week evaluation compared with the 2-week preimplementation period (surgical trauma ICU, 36% vs. 77%, p < 0.0001; burn ICU, 47% vs. 72 %, p < 0.001). Most items were addressed more frequently in both ICUs after implementation. Key items such as central line removal, reduction of laboratory testing, medication reconciliation, medication interactions, bowel movements, sedation holidays, breathing trials, and lung protective ventilation showed significant improvements. Checklists modify communication patterns. Improved communication facilitated by checklists may be one mechanism behind their effectiveness. Checklists are powerful tools that can rapidly alter patient care delivery. Implementing checklists could facilitate the rapid dissemination of clinical practice changes, improve communication between echelons of care and between individuals involved in patient care, and reduce missed information.

The Project Towards No Drug Abuse (TND) Dissemination Trial: Implementation Fidelity and Immediate Outcomes

PubMed Central

Gunning, Melissa; Sun, Ping; Sussman, Steve

2009-01-01

One of the important research issues in the emerging area of research on dissemination of prevention programs relates to the type and extent of training needed by program providers to prepare them to implement effective programs with fidelity. The present paper describes the immediate outcomes of a dissemination and implementation trial of Project Toward No Drug Abuse, an evidence-based prevention program for high school students. A total of 65 high schools in 14 school districts across the USA were recruited and randomly assigned to one of three experimental conditions: comprehensive implementation support for teachers, regular workshop training only, or standard care control. The comprehensive intervention was comprised of on-site coaching, web-based support, and technical assistance, in addition to the regular workshop. Students (n=2,983) completed self-report surveys before and immediately after program implementation. Fidelity of implementation was assessed with a classroom observation procedure that focused on program process. Results indicated that relative to the controls, both intervention conditions produced effects on hypothesized program mediators, including greater gains in program-related knowledge; greater reductions in cigarette, marijuana and hard drug use intentions; and more positive changes in drug-related beliefs. There were stronger effects on implementation fidelity in the comprehensive, relative to the regular, training condition. However, seven of the ten immediate student outcome measures showed no significant differences between the two training conditions. The implications of these findings for dissemination research and practice are discussed. PMID:19757052

The Project Towards No Drug Abuse (TND) dissemination trial: implementation fidelity and immediate outcomes.

PubMed

Rohrbach, Louise Ann; Gunning, Melissa; Sun, Ping; Sussman, Steve

2010-03-01

One of the important research issues in the emerging area of research on dissemination of prevention programs relates to the type and extent of training needed by program providers to prepare them to implement effective programs with fidelity. The present paper describes the immediate outcomes of a dissemination and implementation trial of Project Toward No Drug Abuse, an evidence-based prevention program for high school students. A total of 65 high schools in 14 school districts across the USA were recruited and randomly assigned to one of three experimental conditions: comprehensive implementation support for teachers, regular workshop training only, or standard care control. The comprehensive intervention was comprised of on-site coaching, web-based support, and technical assistance, in addition to the regular workshop. Students (n = 2,983) completed self-report surveys before and immediately after program implementation. Fidelity of implementation was assessed with a classroom observation procedure that focused on program process. Results indicated that relative to the controls, both intervention conditions produced effects on hypothesized program mediators, including greater gains in program-related knowledge; greater reductions in cigarette, marijuana and hard drug use intentions; and more positive changes in drug-related beliefs. There were stronger effects on implementation fidelity in the comprehensive, relative to the regular, training condition. However, seven of the ten immediate student outcome measures showed no significant differences between the two training conditions. The implications of these findings for dissemination research and practice are discussed.

Requests for euthanasia in general practice before and after implementation of the Dutch Euthanasia Act.

PubMed

van Alphen, Jojanneke E; Donker, Gé A; Marquet, Richard L

2010-04-01

The Netherlands was the first country in the world to implement a Euthanasia Act in 2002. It is unknown whether legalizing euthanasia under strict conditions influences the number and nature of euthanasia requests. To investigate changes in the number of, and reasons for, requests for euthanasia in Dutch general practice after implementation of the Euthanasia Act. Retrospective dynamic cohort study comparing 5 years before (1998-2002) and 5 years after (2003-2007) implementation of the Act. Standardised registration forms were used to collect data on requests for euthanasia via the Dutch Sentinel Practice Network. This network of 45 general practices is nationally representative by age, sex, geographic distribution, and population density. The mean annual incidence of requests before implementation amounted to 3.1/10,000 and thereafter to 2.8/10,000 patients. However, trends differed by sex. The number of requests by males decreased significantly from 3.7/10,000 to 2.6/10,000 (P = 0.008); the requests by females increased non-significantly from 2.6/10,000 to 3.1/10,000. Before and after implementation, cancer remained the major underlying disease for requesting euthanasia: 82% versus 77% for men; 73% versus 75% for females. Pain was a major reason for a request, increasing in the period before implementation (mean 27%), but declining in the period thereafter (mean 22%). Loss of dignity became a less important reason after implementation (from 18% to 10%, P = 0.04), predominantly due to a marked decrease in the number of females citing it as a reason (from 17% to 6%, P = 0.02). There was no increase in demand for euthanasia after implementation of the Euthanasia Act. Pain as a reason for requesting euthanasia showed an increasing trend before implementation, but declined thereafter. Loss of dignity as a reason declined, especially in females.

Requests for euthanasia in general practice before and after implementation of the Dutch Euthanasia Act

PubMed Central

van Alphen, Jojanneke E; Donker, Gé A; Marquet, Richard L

2010-01-01

Background The Netherlands was the first country in the world to implement a Euthanasia Act in 2002. It is unknown whether legalising euthanasia under strict conditions influences the number and nature of euthanasia requests. Aim To investigate changes in the number of, and reasons for, requests for euthanasia in Dutch general practice after implementation of the Euthanasia Act. Design of study Retrospective dynamic cohort study comparing 5 years before (1998–2002) and 5 years after (2003–2007) implementation of the Act. Method Standardised registration forms were used to collect data on requests for euthanasia via the Dutch Sentinel Practice Network. This network of 45 general practices is nationally representative by age, sex, geographic distribution, and population density. Results The mean annual incidence of requests before implementation amounted to 3.1/10 000 and thereafter to 2.8/10 000 patients. However, trends differed by sex. The number of requests by males decreased significantly from 3.7/10 000 to 2.6/10 000 (P = 0.008); the requests by females increased non-significantly from 2.6/10 000 to 3.1/10 000. Before and after implementation, cancer remained the major underlying disease for requesting euthanasia: 82% versus 77% for men; 73% versus 75% for females. Pain was a major reason for a request, increasing in the period before implementation (mean 27%), but declining in the period thereafter (mean 22%). Loss of dignity became a less important reason after implementation (from 18% to 10%, P = 0.04), predominantly due to a marked decrease in the number of females citing it as a reason (from 17% to 6%, P = 0.02). Conclusion There was no increase in demand for euthanasia after implementation of the Euthanasia Act. Pain as a reason for requesting euthanasia showed an increasing trend before implementation, but declined thereafter. Loss of dignity as a reason declined, especially in females. PMID:20353671

77 FR 7080 - Changes To Implement Transitional Program for Covered Business Method Patents

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... 0651-AC73 Changes To Implement Transitional Program for Covered Business Method Patents AGENCY: United... covered business method patents to be conducted before the Patent Trial and Appeal Board (Board). These..., Covered Business Method Patent Review Proposed Rules.'' Comments may also be sent by electronic mail...

77 FR 7060 - Changes To Implement Post-Grant Review Proceedings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... 0651-AC72 Changes To Implement Post-Grant Review Proceedings AGENCY: United States Patent and Trademark... Invents Act that create a new post-grant review proceeding to be conducted before the Patent Trial and... mail message over the Internet addressed to: post[email protected] . Comments may also be...

Using artificial neural networks to model aluminium based sheet forming processes and tools details

NASA Astrophysics Data System (ADS)

Mekras, N.

2017-09-01

In this paper, a methodology and a software system will be presented concerning the use of Artificial Neural Networks (ANNs) for modeling aluminium based sheet forming processes. ANNs models’ creation is based on the training of the ANNs using experimental, trial and historical data records of processes’ inputs and outputs. ANNs models are useful in cases that processes’ mathematical models are not accurate enough, are not well defined or are missing e.g. in cases of complex product shapes, new material alloys, new process requirements, micro-scale products, etc. Usually, after the design and modeling of the forming tools (die, punch, etc.) and before mass production, a set of trials takes place at the shop floor for finalizing processes and tools details concerning e.g. tools’ minimum radii, die/punch clearance, press speed, process temperature, etc. and in relation with the material type, the sheet thickness and the quality achieved from the trials. Using data from the shop floor trials and forming theory data, ANNs models can be trained and created, and can be used to estimate processes and tools final details, hence supporting efficient set-up of processes and tools before mass production starts. The proposed ANNs methodology and the respective software system are implemented within the EU H2020 project LoCoMaTech for the aluminium-based sheet forming process HFQ (solution Heat treatment, cold die Forming and Quenching).

Enhanced Recovery After Surgery (ERAS®) in Individuals with Diabetes: A Systematic Review.

PubMed

Albalawi, Zaina; Laffin, Michael; Gramlich, Leah; Senior, Peter; McAlister, Finlay A

2017-08-01

Prevalence of diabetes in surgical patients is 10-40%. It is well recognized that they have higher rates of complications, and longer stays in hospital compared to patients without diabetes. Enhanced recovery after surgery (ERAS) is an evidence-based multimodal surgical care pathway that improves postoperative complications and length of stay in patients without diabetes. This review evaluates the evidence on whether individuals with diabetes would benefit from ERAS implementation. MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE searched with no language restrictions applied. Conference proceedings and bibliographies were reviewed. Experts in the field were contacted, and www.clinicaltrials.gov searched for ongoing trials. Randomized controlled trials (RCT) looking at individuals with diabetes undergoing surgery randomized to ERAS ® or conventional care. Non-randomized controlled trials, controlled before-after studies, interrupted time series, and cohort studies with concurrent controls were also considered. Two authors independently screened studies. The electronic search yielded 437 references. After removing duplicates, 376 were screened for eligibility. Conference proceedings and bibliographies identified additional references. Searching www.clinicaltrials.gov yielded 59 references. Contacting experts in the field identified no further studies. Fourteen full articles were assessed and subsequently excluded for the following reasons: used an intervention other than ERAS ® , did not include patients with diabetes, or used an uncontrolled observational design. To date, the effects of ERAS ® on patients with diabetes have not been rigorously evaluated. This review highlights the lack of evidence in this area and provides guidance on design for future studies.

Subjective assessments of floor slipperiness before and after walk under two lighting conditions.

PubMed

Li, Kai Way; Zhao, Caijun; Peng, Lu; Liu, Ai-Qun

2018-06-01

A gait experiment was performed. The participants were tested under shoes, floors, surface and lighting conditions. They gave floor slipperiness ratings before and after a gait trial. The perceived sense of slip (PSOS) was collected. It was found that the perceived floor slipperiness (PFS) before walking was affected significantly by the lighting, floor and surface conditions. Relative low PFS values were recorded under wet and detergent-contaminated conditions in the normal daylight condition as compared with those in the dimmed condition. The PFS after the gait was significantly affected by the floor and surface conditions. The PSOS was highly correlated with the PFS after trial. The regression analyses results indicated that both the coefficient of friction (COF) of the floor and lighting were primary predictors of the PFS before a gait. The COF and walking speed were the primary predictors of the PFS after a gait.

Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial.

PubMed

Calvo-Marín, Javier; Torrealba-Acosta, Gabriel; Campbell, Matthew; Gaboury, Jesse; Ali, Ajmol; Chen-Ku, Chih Hao

2017-07-20

Despite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for its effectiveness with intermittent forms of exercise, such as soccer, is still lacking. We designed a study protocol for a randomized, crossover, double-blinded, controlled trial, for the evaluation of the effect that a strategy of dietary and therapeutic modifications may have on safety and performance of persons with T1D in soccer training sessions and cognitive testing. Inclusion criteria comprise: age older than 18 years, more than 2 years since T1D diagnosis, low C-peptide level, a stable insulin regimen, HbA1c less than 9.0% and regular participation in soccer activities. Our primary outcome evaluates safety regarding hypoglycemia events in patients using dietary and therapeutic adjustments, compared with the performance under the implementation of current American Diabetes Association (ADA) usual recommendations for nutritional and pharmacological adjustments for exercise. Additionally, we will evaluate as secondary outcomes: soccer performance, indexed by performance in well-established soccer skill tests, cognitive functions (indexed by Stroop, digital vigilance test (DVT), Corsi block-tapping task (CBP), and rapid visual information processing (RVIP) tests), and glycemic control measured with a continuous glucose monitor (CGM). Dietary and insulin adjustments standardized under a 4-step method strategy have never been tested in a clinical trial setting with intermittent forms of exercise, such as soccer. We hypothesize that through this strategy we will observe better performance by persons with T1D in soccer and cognitive evaluations, and more stable control of glycemic parameters before, during and after exercise execution, indexed by CGM measurements. ISRCTN, ISRCTN17447843. Registered on 5 January 2017.

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

PubMed

Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David

2014-09-01

To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.

Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach.

PubMed

Pathak, Swati; George, Nerissa; Monti, Denise; Robinson, Kathy; Politi, Mary C

2018-06-03

Rural-residing cancer patients often do not participate in clinical trials. Many patients misunderstand cancer clinical trials and their rights as participant. The purpose of this study is to modify a previously developed cancer clinical trials decision aid (DA), incorporating the unique needs of rural populations, and test its impact on knowledge and decision outcomes. The study was conducted in two phases. Phase I recruited 15 rural-residing cancer survivors in a qualitative usability study. Participants navigated the original DA and provided feedback regarding usability and implementation in rural settings. Phase II recruited 31 newly diagnosed rural-residing cancer patients. Patients completed a survey before and after using the revised DA, R-CHOICES. Primary outcomes included decisional conflict, decision self-efficacy, knowledge, communication self-efficacy, and attitudes towards and willingness to consider joining a trial. In phase I, the DA was viewed positively by rural-residing cancer survivors. Participants provided important feedback about factors rural-residing patients consider when thinking about trial participation. In phase II, after using R-CHOICES, participants had higher certainty about their choice (mean post-test = 3.10 vs. pre-test = 2.67; P = 0.025) and higher trial knowledge (mean percentage correct at post-test = 73.58 vs. pre-test = 57.77; P < 0.001). There was no significant change in decision self-efficacy, communication self-efficacy, and attitudes towards or willingness to join trials. The R-CHOICES improved rural-residing patients' knowledge of cancer clinical trials and reduced conflict about making a trial decision. More research is needed on ways to further support decisions about trial participation among this population.

[Managing concerns about falls in older people: evaluation of the implementation of an evidence-based program].

PubMed

Zijlstra, G A R; Du Moulin, M F M T; van Haastregt, J C M; de Jonge, M; Kempen, G I J M; van der Poel, A

2013-12-01

A cognitive behavioral program reduced concerns about falling and related avoidance behavior among older community-dwelling adults in a randomized controlled trial. In the current study we examined the effects and acceptability of the program after nation-wide implementation into home care organizations in The Netherlands. In a one-group pretest-posttest study with data collection before the start of the program and at 2 and 4 months, the effects and acceptability of the program were assessed in 125 community-dwelling older people. The outcomes of the effect evaluation included concerns about falls, related avoidance behavior, falls, fall-related medical attention, feelings of anxiety, symptoms of depression, and loneliness. Pretest-posttest analyses with the Wilcoxon signed-rank test and the paired t-test showed significant improvements at 4 months for concerns about falls, activity avoidance, number of falls in the past 2 months, feelings of anxiety, and symptoms of depression. No significant differences were shown for the other outcomes. After implementation in home care organizations, the outcomes indicate positive program effects on concerns about falls, avoidance behavior, and falls in community-dwelling older people. Given the similarity in results, i.e. between those of the previously performed randomized controlled trial and those of the current pretest-posttest study, we conclude that the program can be successfully implemented in practice. This article is an adjusted, Dutch version of Zijlstra GA, van Haastregt JC, Du Moulin MF, de Jonge MC, van der Poel A, Kempen GI. Effects of the implementation of an evidenc-based program to manage concerns about falls in older adults. The Gerontologist 2013;53(5):839-849; doi: 10.1093/geront/gns142.

Effectiveness of applying flipped learning to clinical nursing practicums for nursing students in Korea: A randomized controlled trial.

PubMed

Kim, Hyun Sook; Kim, Mi Young; Cho, Mi-Kyoung; Jang, Sun Joo

2017-10-01

The purpose of this study was to develop flipped learning models for clinical practicums and compare their effectiveness regarding learner motivation toward learning, satisfaction, and confidence in performing core nursing skills among undergraduate nursing students in Korea. This study was a randomized clinical trial designed to compare the effectiveness of 2 flipped learning models. Data were collected for 3 days from October 21 to 23, 2015 before the clinical practicum was implemented and for 2 weeks from October 26 to December 18, 2015 during the practicum period. The confidence of the students in performing core nursing skills was likely to increase after they engaged in the clinical practicum in both study groups. However, while learner confidence and motivation were not affected by the type of flipped learning, learner satisfaction did differ between the 2 groups. The findings indicate that applying flipped learning allows students to conduct individualized learning with a diversity of clinical cases at their own level of understanding and at their own pace before they participate in real-world practicums. © 2017 John Wiley & Sons Australia, Ltd.

A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments

PubMed Central

Stiell, Ian G.; Clement, Catherine M.; Grimshaw, Jeremy M.; Brison, Robert J.; Rowe, Brian H.; Lee, Jacques S.; Shah, Amit; Brehaut, Jamie; Holroyd, Brian R.; Schull, Michael J.; McKnight, R. Douglas; Eisenhauer, Mary A.; Dreyer, Jonathan; Letovsky, Eric; Rutledge, Tim; MacPhail, Iain; Ross, Scott; Perry, Jeffrey J.; Ip, Urbain; Lesiuk, Howard; Bennett, Carol; Wells, George A.

2010-01-01

Background The Canadian CT Head Rule was developed to allow physicians to be more selective when ordering computed tomography (CT) imaging for patients with minor head injury. We sought to evaluate the effectiveness of implementing this validated decision rule at multiple emergency departments. Methods We conducted a matched-pair cluster-randomized trial that compared the outcomes of 4531 patients with minor head injury during two 12-month periods (before and after) at hospital emergency departments in Canada, six of which were randomly allocated as intervention sites and six as control sites. At the intervention sites, active strategies, including education, changes to policy and real-time reminders on radiologic requisitions were used to implement the Canadian CT Head Rule. The main outcome measure was referral for CT scan of the head. Results Baseline characteristics of patients were similar when comparing control to intervention sites. At the intervention sites, the proportion of patients referred for CT imaging increased from the “before” period (62.8%) to the “after” period (76.2%) (difference +13.3%, 95% CI 9.7%–17.0%). At the control sites, the proportion of CT imaging usage also increased, from 67.5% to 74.1% (difference +6.7%, 95% CI 2.6%–10.8%). The change in mean imaging rates from the “before” period to the “after” period for intervention versus control hospitals was not significant (p = 0.16). There were no missed brain injuries or adverse outcomes. Interpretation Our knowledge–translation-based trial of the Canadian CT Head Rule did not reduce rates of CT imaging in Canadian emergency departments. Future studies should identify strategies to deal with barriers to implementation of this decision rule and explore more effective approaches to knowledge translation. (ClinicalTrials.gov trial register no. NCT00993252) PMID:20732978

Quality of antenatal and delivery care before and after the implementation of a prevention of mother-to-child HIV transmission programme in Côte d'Ivoire.

PubMed

Delvaux, Thérèse; Konan, Jean-Paul Diby; Aké-Tano, Odile; Gohou-Kouassi, Valérie; Bosso, Patrice Emery; Buvé, Anne; Ronsmans, Carine

2008-08-01

To assess whether implementation of a prevention of mother-to-child HIV transmission (PMTCT) programme in Côte d'Ivoire improved the quality of antenatal and delivery care services. Quality of antenatal and delivery care services was assessed in five urban health facilities before (2002-2003) and after (2005) the implementation of a PMTCT programme through review of facility data; observation of antenatal consultations (n = 606 before; n = 591 after) and deliveries (n = 229 before; n = 231 after) and exit interviews of women; and interviews of health facility staff. HIV testing was never proposed at baseline and was proposed to 63% of women at the first ANC visit after PMTCT implementation. The overall testing rate was 42% and 83% of tested HIV-infected pregnant women received nevirapine. In addition, inter-personal communication and confidentiality significantly improved in all health facilities. In the maternity ward, quality of obstetrical care at admission, delivery and post-partum care globally improved in all facilities after the implementation of the programme although some indicators remained poor, such as filling in the partograph directly during labour. Episiotomy rates among primiparous women dropped from 64% to 25% (P < 0.001) after PMTCT implementation. Global scores for quality of antenatal and delivery care significantly improved in all facilities after the implementation of the programme. Introducing comprehensive PMTCT services can improve the quality of antenatal and delivery care in general.

Reframing implementation as an organisational behaviour problem.

PubMed

Clay-Williams, Robyn; Braithwaite, Jeffrey

2015-01-01

The purpose of this paper is to report on a process evaluation of a randomised controlled trial (RCT) intervention study that tested the effectiveness of classroom- and simulation-based crew resource management courses, alone and in combination, and identifies organisational barriers and facilitators to implementation of team training programmes in healthcare. The RCT design consisted of a before and after study with a team training intervention. Quantitative data were gathered on utility and affective reactions to training, and on teamwork knowledge, attitudes, and behaviours of the learners. A sample of participants was interviewed at the conclusion of the study. Interview responses were analysed, alongside qualitative elements of the classroom course critique, to search for evidence, context, and facilitation clues to the implementation process. The RCT method provided scientifically robust data that supported the benefits of classroom training. Qualitative data identified a number of facilitators to implementation of team training, and shed light on some of the ways that learning was diffused throughout the organisation. Barriers to successful implementation were also identified, including hospital time and resource constraints and poor organisational communication. Quantitative randomised methods have intermittently been used to evaluate team training interventions in healthcare. Despite two decades of team training trials, however, the authors do not know as well as the authors would like what goes on inside the "black box" of such RCTs. While results are usually centred on outcomes, this study also provides insight into the context and mechanisms associated with those outcomes and identifies barriers and facilitators to successful intervention implementation.

Process and Outcomes of Patient-Centered Medical Care With Alaska Native People at Southcentral Foundation

PubMed Central

Driscoll, David L.; Hiratsuka, Vanessa; Johnston, Janet M.; Norman, Sara; Reilly, Katie M.; Shaw, Jennifer; Smith, Julia; Szafran, Quenna N.; Dillard, Denise

2013-01-01

PURPOSE This study describes key elements of the transition to a patient-centered medical home (PCMH) model at Southcentral Foundation (SCF), a tribally owned and managed primary care system, and evaluates changes in emergency care use for any reason, for asthma, and for unintentional injuries, during and after the transition. METHODS We conducted a time series analyses of emergency care use from medical record data. We also conducted 45 individual, in-depth interviews with PCMH patients (customer-owners), primary care clinicians, health system employees, and tribal leaders. RESULTS Emergency care use for all causes was increasing before the PCMH implementation, dropped during and immediately after the implementation, and subsequently leveled off. Emergency care use for adult asthma dropped before, during, and immediately after implementation, subsequently leveling off approximately 5 years after implementation. Emergency care use for unintentional injuries, a comparison variable, showed an increasing trend before and during implementation and decreasing trends after implementation. Interview participants observed improved access to primary care services after the transition to the PCMH tempered by increased staff fatigue. Additional themes of PCMH transformation included the building of relationships for coordinated, team-based care, and the important role of leadership in PCMH implementation. CONCLUSIONS All reported measures of emergency care use show a decreasing trend after the PCMH implementation. Before the implementation, overall use and use for unintentional injuries had been increasing. The combined quantitative and qualitative results are consistent with decreased emergency care use resulting from a decreased need for emergency care services due to increased availability of primary care services and same-day appointments. PMID:23690385

Cluster randomized trial to evaluate the impact of team training on surgical outcomes.

PubMed

Duclos, A; Peix, J L; Piriou, V; Occelli, P; Denis, A; Bourdy, S; Carty, M J; Gawande, A A; Debouck, F; Vacca, C; Lifante, J C; Colin, C

2016-12-01

The application of safety principles from the aviation industry to the operating room has offered hope in reducing surgical complications. This study aimed to assess the impact on major surgical complications of adding an aviation-based team training programme after checklist implementation. A prospective parallel-group cluster trial was undertaken between September 2011 and March 2013. Operating room teams from 31 hospitals were assigned randomly to participate in a team training programme focused on major concepts of crew resource management and checklist utilization. The primary outcome measure was the occurrence of any major adverse event, including death, during the hospital stay within the first 30 days after surgery. Using a difference-in-difference approach, the ratio of the odds ratios (ROR) was estimated to compare changes in surgical outcomes between intervention and control hospitals. Some 22 779 patients were enrolled, including 5934 before and 16 845 after team training implementation. The risk of major adverse events fell from 8·8 to 5·5 per cent in 16 intervention hospitals (adjusted odds ratio 0·57, 95 per cent c.i. 0·48 to 0·68; P < 0·001) and from 7·9 to 5·4 per cent in 15 control hospitals (odds ratio 0·64, 0·50 to 0·81; P < 0·001), resulting in the absence of difference between arms (ROR 0·90, 95 per cent c.i. 0·67 to 1·21; P = 0·474). Outcome trends revealed significant improvements among ten institutions, equally distributed across intervention and control hospitals. Surgical outcomes improved substantially, with no difference between trial arms. Successful implementation of an aviation-based team training programme appears to require modification and adaptation of its principles in the context of the the surgical milieu. Registration number: NCT01384474 (http://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

Effect of intravenous infusion of a beta-adrenergic blocking agent on the haemodynamic changes in human masseter muscle induced by cold-pressor stimulation.

PubMed

Maekawa, K; Kuboki, T; Miyawaki, T; Shimada, M; Yamashita, A; Clark, G T

1999-06-01

Eight healthy non-smoking males (mean age: 24.1 +/- 1.1 years) without any history of chronic muscle pain and migraine participated in this study. Haemoglobin (Hb) and oxygen (O2) saturation in the right masseter muscle were continuously recorded with a non-invasive near-infrared spectroscopic device. Heart rate and blood pressure were also recorded. The experiment had three phases: a placebo drug (physiological saline) with cold-pressor trial, a 30-sec maximal voluntary clenching (MVC) trial, and a propranolol with cold-pressor trial. The saline and drug trials each involved continuous recording for 1 min before, 2 min during and 5 min after the cold-pressor stimulation (4 degrees C). Physiological saline (20 ml) or propranolol hydrochloride (20 ml) were infused at the rate of 2 ml/min. This infusion was begun 20 min before the baseline recording and participants did not know which solution (saline or propranolol) was being infused. For the MVC trial, each participant was asked to perform a 30-sec clench of their jaw-closing muscles. There was a rest period of 15 min between each trial. The individual Hb and O2 data were normalized so that the baseline at the beginning of the experiment was equal to zero, and the Hb and O2 data were normalized as a percentage of the individual's own highest absolute Hb and O2 after and during the MVC, respectively. The results showed that the mean baseline Hb 1 min before cold-pressor stimulation was significantly lower in the beta-blocker trial than in the placebo trial (p = 0.035). The mean change in Hb from baseline during cold-pressor stimulation in the beta-blocker trial was also significantly less than in the placebo trial (p = 0.035). The mean Hb rebound change after the cold-pressor stimulation in the beta-blocker trial was significantly higher than in the placebo trial, and no significant heart-rate differences were observed in the period after cold-pressor stimulation. Overall, the mean heart rate before and during that stimulation was significantly lower in the beta-blocker trial than the placebo trial (p < 0.001). There was no significant mean blood-pressure difference between placebo and beta-blocker trials at any time. These results suggest that beta-adrenoceptor blocking decreases the blood volume in the resting masseter, suppresses the incremental blood-volume change during cold-pressor stimulation, and discloses a hidden vasoconstrictive effect after that stimulation.

Effect of a provincial system of stroke care delivery on stroke care and outcomes

PubMed Central

Kapral, Moira K.; Fang, Jiming; Silver, Frank L.; Hall, Ruth; Stamplecoski, Melissa; O’Callaghan, Christina; Tu, Jack V.

2013-01-01

Background: Systems of stroke care delivery have been promoted as a means of improving the quality of stroke care, but little is known about their effectiveness. We assessed the effect of the Ontario Stroke System, a province-wide strategy of regionalized stroke care delivery, on stroke care and outcomes in Ontario, Canada. Methods: We used population-based provincial administrative databases to identify all emergency department visits and hospital admissions for acute stroke and transient ischemic attack from Jan. 1, 2001, to Dec. 31, 2010. Using piecewise regression analyses, we assessed the effect of the full implementation of the Ontario Stroke System in 2005 on the proportion of patients who received care at stroke centres, and on rates of discharge to long-term care facilities and 30-day mortality after stroke. Results: We included 243 287 visits by patients with acute stroke or transient ischemic attack. The full implementation of the Ontario Stroke System in 2005 was associated with an increase in rates of care at stroke centres (before implementation: 40.0%; after implementation: 46.5%), decreased rates of discharge to long-term care facilities (before implementation: 16.9%; after implementation: 14.8%) and decreased 30-day mortality for hemorrhagic (before implementation: 38.3%; after implementation: 34.4%) and ischemic stroke (before implementation: 16.3%; after implementation: 15.7%). The system’s implementation was also associated with marked increases in the proportion of patients who received neuroimaging, thrombolytic therapy, care in a stroke unit and antithrombotic therapy. Interpretation: The implementation of an organized system of stroke care delivery was associated with improved processes of care and outcomes after stroke. PMID:23713072

Variability in Postarrest Targeted Temperature Management Practice: Implications of the 2015 Guidelines.

PubMed

Leary, Marion; Blewer, Audrey L; Delfin, Gail; Abella, Benjamin S

2015-12-01

In 2002 postarrest care was significantly altered when multiple randomized controlled trials found that therapeutic hypothermia at a goal temperature of 32-34°C significantly improved survival and neurologic outcomes. In 2013, targeted temperature management (TTM) was reexamined via a randomized controlled trial between 33°C and 36°C in post-cardiac arrest patients and found similar outcomes in both cohorts. Before the release of the 2015 American Heart Association (AHA) Guidelines, our group found that across hospitals in the United States, and even within the same institution, TTM protocol variability existed. After the 2013 TTM trial, it was anticipated that the 2015 Guidelines would clarify which target temperature should be used during postarrest care. The AHA released their updates for post-cardiac arrest TTM recently and, based on the literature available, have recommended the use of TTM at a goal temperature between 32°C and 36°C. Whether this variability has an effect on TTM implementation or patient outcomes is unknown.

Comparison of Two Different Educational Methods for Teachers' Mammography Based on the Health Belief Model.

PubMed

Heydari, Esmat; Noroozi, Azita

2015-01-01

Breast cancer is the most common cancer in women. One way to decrease the burden of this cancer is early detection through mammography. This study compared the effectiveness of two different educational methods for teachers' uptake of mammography based on the Health Belief Model. The current study was a randomised trial of 120 teachers over 40 years old in two groups receiving multimedia or group education, both based on the Health Belief Model. Participants completed questionnaires before, immediately and three months after educational intervention. Mammography was evaluated before and after educational intervention. The participants in the two groups were demographically similar. Comparison showed no difference noted in the scores of knowledge, perceived barriers, susceptibility, and severity constructs between two groups (p > 0.05). Health motivation and benefit were perceived to be higher in the group education compared to the multimedia group. There was a significant difference in mammography between two groups after the intervention (p= 0.003). Planning and implementation of educational program based on the Health Belief Model can raise knowledge and increase participation in mammography especially with group education.

Effects of implementing electronic medical records on primary care billings and payments: a before-after study.

PubMed

Jaakkimainen, R Liisa; Shultz, Susan E; Tu, Karen

2013-09-01

Several barriers to the adoption of electronic medical records (EMRs) by family physicians have been discussed, including the costs of implementation, impact on work flow and loss of productivity. We examined billings and payments received before and after implementation of EMRs among primary care physicians in the province of Ontario. We also examined billings and payments before and after switching from a fee-for-service to a capitation payment model, because EMR implementation coincided with primary care reform in the province. We used information from the Electronic Medical Record Administrative Data Linked Database (EMRALD) to conduct a retrospective before-after study. The EMRALD database includes EMR data extracted from 183 community-based family physicians in Ontario. We included EMRALD physicians who were eligible to bill the Ontario Health Insurance Plan at least 18 months before and after the date they started using EMRs and had completed a full 18-month period before Mar. 31, 2011, when the study stopped. The main outcome measures were physicians' monthly billings and payments for office visits and total annual payments received from all government sources. Two index dates were examined: the date physicians started using EMRs and were in a stable payment model (n = 64) and the date physicians switched from a fee-for-service to a capitation payment model (n = 42). Monthly billings and payments for office visits did not decrease after the implementation of EMRs. The overall weighted mean annual payment from all government sources increased by 27.7% after the start of EMRs among EMRALD physicians; an increase was also observed among all other primary care physicians in Ontario, but it was not as great (14.4%). There was a decline in monthly billings and payments for office visits after physicians changed payment models, but an increase in their overall annual government payments. Implementation of EMRs by primary care physicians did not result in decreased billings or government payments for office visits. Further economic analyses are needed to measure the effects of EMR implementation on productivity and the costs of implementing an EMR system, including the costs of nonclinical work by physicians and their staff.

Uterine massage for preventing postpartum haemorrhage.

PubMed

Hofmeyr, G Justus; Abdel-Aleem, Hany; Abdel-Aleem, Mahmoud A

2013-07-01

Postpartum haemorrhage (PPH) (bleeding from the genital tract after childbirth) is a major cause of maternal mortality and disability, particularly in under-resourced areas. In these settings, uterotonics are often not accessible. There is a need for simple, inexpensive techniques which can be applied in low-resourced settings to prevent and treat PPH. Uterine massage is recommended as part of the routine active management of the third stage of labour. However, it is not known whether it is effective. If shown to be effective, uterine massage would represent a simple intervention with the potential to have a major effect on PPH and maternal mortality in under-resourced settings. To determine the effectiveness of uterine massage after birth and before or after delivery of the placenta, or both, to reduce postpartum blood loss and associated morbidity and mortality. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). All published, unpublished and ongoing randomised controlled trials comparing uterine massage alone or in addition to uterotonics before or after delivery of the placenta, or both, with non-massage. Two researchers independently considered trials for eligibility, assessed risk of bias and extracted the data using the agreed form. Data were checked for accuracy. The effect of uterine massage commenced before or after placental delivery were first assessed separately, and then the combined for an overall result. This review included two randomised controlled trials. The first trial included 200 women who were randomised to receive uterine massage or no massage following delivery of the placenta, after active management of the third stage of labour including use of oxytocin. The numbers of women with blood loss more than 500 mL was small, with no statistically significant difference (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.16 to 1.67). There were no cases of retained placenta in either group. The mean blood loss was significantly less in the uterine massage group at 30 minutes (mean difference (MD) -41.60 mL, 95% CI -75.16 to -8.04) and 60 minutes after trial entry (MD -77.40 mL, 95% CI -118.71 to -36.09). The need for additional uterotonics was significantly reduced in the uterine massage group (RR 0.20, 95% CI 0.08 to 0.50).For use of uterine massage before and after delivery of the placenta, one trial recruited 1964 women in Egypt and South Africa. Women were assigned to receive oxytocin, uterine massage or both after delivery of the baby but before delivery of the placenta. There was no added benefit for uterine massage plus oxytocin over oxytocin alone as regards blood loss greater than or equal to 500 mL (average RR 1.56, 95% CI 0.44, 5.49; random-effects) or need for additional use of uterotonics (RR 1.02, 95% CI 0.56 to 1.85).The two trials were combined to examine the effect of uterine massage commenced either before or after delivery of the placenta. There was substantial heterogeneity with respect to the blood loss 500 mL or more after trial entry. The average effect using a random-effects model found no statistically significant differences between groups (average RR 1.14, 95% CI 0.39 to 3.32; random-effects). The results of this review are inconclusive, and should not be interpreted as a reason to change current practice. Due to the limitations of the included trials, more trials with sufficient numbers of women are needed in order to estimate the effects of sustained uterine massage. All the women compared in this review received oxytocin as part of the active management of labour. Recent research suggests that once an oxytocic has been given, there is limited scope for further reduction in postpartum blood loss. Trials of uterine massage in settings where uterotonics are not available, and which measure women's experience of the procedure, are needed.

Following an HIV Regimen: Steps to Take Before and After Starting HIV Medicines

MedlinePlus

... AIDS Drugs Clinical Trials Apps skip to content HIV Treatment Home Understanding HIV/AIDS Fact Sheets Following ... m. ET) Send us an email Following an HIV Regimen: Steps to Take Before and After Starting ...

Policy support, norms, and secondhand smoke exposure before and after implementation of a comprehensive smoke-free law in Mexico city.

PubMed

Thrasher, James F; Pérez-Hernández, Rosaura; Swayampakala, Kamala; Arillo-Santillán, Edna; Bottai, Matteo

2010-09-01

We assessed attitudes and beliefs about smoke-free laws, compliance, and secondhand smoke exposure before and after implementation of a comprehensive smoke-free law in Mexico City. Trends and odds of change in attitudes and beliefs were analyzed across 3 representative surveys of Mexico City inhabitants: before implementation of the policy (n=800), 4 months after implementation (n=961), and 8 months after implementation (n=761). Results indicated high and increasing support for 100% smoke-free policies, although support did not increase for smoke-free bars. Agreement that such policies improved health and reinforced rights was high before policy implementation and increased thereafter. Social unacceptability of smoking increased substantially, although 25% of nonsmokers and 50% of smokers agreed with smokers' rights to smoke in public places at the final survey wave. Secondhand smoke exposure declined generally as well as in venues covered by the law, although compliance was incomplete, especially in bars. Comprehensive smoke-free legislation in Mexico City has been relatively successful, with changes in perceptions and behavior consistent with those revealed by studies conducted in high-income countries. Normative changes may prime populations for additional tobacco control interventions.

Meal frequency of pre-exercise carbohydrate feedings.

PubMed

Chryssanthopoulos, C; Petridou, A; Maridaki, M; Mougios, V

2008-04-01

This study compared the effect of single and multiple carbohydrate feedings before exercise on biochemical and physiological responses during exercise. Eight males performed 3 runs for 1 h at 70 % VO(2max) after consuming a meal containing 2.5 g carbohydrate per kg body mass in a single dose 3 h before exercise (SF), the same meal in 5 equal doses at 3, 2.5, 2, 1.5, and 1 h before exercise (MF), or a liquid placebo 3 h before exercise (P). RER and carbohydrate oxidation rates were higher in SF and MF compared to P trials, but there was no difference between SF and MF trials. Pre-exercise insulin was 2.0- and 3.4- fold higher in SF and MF, respectively, compared to P, and 1.7-fold higher in MF compared to SF. Glycerol and NEFA were higher in P compared to SF and MF trials before and at the end of exercise. In conclusion, a carbohydrate meal containing 2.5 g . kg(-1) ingested in doses over 3 h before running produced higher hyperinsulinemia pre-exercise than that produced when the meal was consumed in a single dose. Nevertheless, estimated carbohydrate utilization and adipose tissue lipolysis during exercise after multiple feedings seemed to be as high as after a single feeding.

Evaluation of parenteral nutrition-associated liver disease in infants with necrotizing enterocolitis before and after the implementation of feeding guidelines.

PubMed

Tillman, Emma M; Norman, Johanna L; Huang, Eunice Y; Lazar, Linda F; Crill, Catherine M

2014-04-01

In 2009, an intestinal rehabilitation team implemented feeding guidelines for infants following gastrointestinal surgery at our institution. The purpose of this study was to determine the effect of enteral feeding guidelines on the incidence of parenteral nutrition (PN)-associated liver disease (PNALD) in infants with surgically managed necrotizing enterocolitis (NEC). This retrospective study included infants treated during 18-month time periods before and after the implementation of feeding guidelines. PNALD diagnosis was based on serum direct bilirubin >2 mg/dL after ≥14 days of PN exposure. Of the 140 infants identified, 64 were surgically managed and included in the analysis. The duration of PN and the time nil per os (NPO) were significantly reduced after guideline implementation from a median of 106 days to 65 days (P = .03) and from 29 days to 16 days (P = .02), respectively. The incidence of PNALD decreased from 73% before guideline implementation to 42% after guideline implementation (P = .01). Implementation of feeding guidelines resulted in decreased time NPO and duration of PN support. Significantly fewer infants developed PNALD after guideline implementation. These data suggest that feeding guidelines may expedite the transition from PN to enteral nutrition and may improve outcomes.

Trial of labor after myomectomy and uterine rupture: a systematic review.

PubMed

Gambacorti-Passerini, Zita; Gimovsky, Alexis C; Locatelli, Anna; Berghella, Vincenzo

2016-07-01

There is concern about the risk of uterine rupture in the subsequent pregnancy after myomectomy. This risk is reported in literature to be around 0.7-1%. The aim of this study was to evaluate the incidence of uterine rupture and associated risk factors in women who had a trial of labor after prior myomectomy. A systematic review of the literature was performed including all cohort studies with at least five cases reporting outcomes of pregnancies after prior myomectomy. The terms "myomectomy", "pregnancy", "trial of labor" and "uterine rupture" were used in PubMed and EMBASE searches for identification purposes. Every reference was reviewed for possible inclusion and all eligible cases of uterine rupture were considered. Twenty-three studies with at least five cases of pregnancy after myomectomy were identified, with an overall incidence of uterine rupture of 0.6% (0.3-1.1%) (n = 11/1825). Of these 23 studies, 11 studies reported detailed data about trial of labor after myomectomy and related pregnancy outcomes, including 1034 pregnancies and 756 viable (≥24 weeks) deliveries. The overall incidence of uterine rupture after myomectomy in the included studies was 0.93% (0.45-1.92%) (n = 7/756); specifically, it was 0.47% (0.13-1.70%) (n = 2/426) in women undergoing trial of labor after myomectomy, and 1.52% (0.65-3.51%) (n = 5/330) in women before the onset of labor. Of the seven uterine ruptures, five (71%) occurred within 36 weeks (range 24-40 weeks). Trial of labor after myomectomy is associated with a 0.47% risk of uterine rupture. There were no identified risk factors among the variables studied. The present systematic review of the literature revealed that uterine rupture after prior myomectomy occurred mainly before 36 weeks and before labor. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

[Comparative analysis of the donor cornea quality and of the interval between death and preservation before and after new sanitary and technique rules in a University Eye Bank].

PubMed

Zantut, Fabio; Holzchuh, Ricardo; Boni, Reginaldo Carlos; Mackus, Eva Cristina; Zantut, Paulo Roberto; Nakano, Claudio; Netto, Adamo Lui; Hida, Richard Yudi

2012-01-01

To compare the interval between death and enucleation (ΔT-O-E), between enucleation and preservation (ΔT-E-P) and the quality of the cornea before and after the implantation of new technique and sanitary rules. A retrospective study that evaluated the records of cornea donors in Sao Paulo's Santa Casa Eye Tissue Bank 2 years before and 2 years after the implementation new sanitary rules. An increase was observed in the absolute number of 205 to 374 donors following the adopted changes. There was no statistically significant difference in Δt-O-E and ΔT-E-P before and after the implemented changes. Of the total of 1,105 donor corneas, 388 donor corneas were observed before the changes and 717 donor corneas after the implemented changes. We observed a statistically significant increase in grading of donor cornea quality from 1.76 ± 0.90 to 1.94 ± 0.88 after the implementation of new standards of resolution. After the changes required by Resolution 347, there was a large increase in the number of donated, taken and preserved corneas. The BTO has not diminished the ΔT O-E and ΔT E-P. Cornea quality presented itself lower after the new rules.

The unbearable lightness of technocratic efforts at dengue control.

PubMed

Toledo, Maria E; Baly, Alberto; Vanlerberghe, Veerle; Rodríguez, Maritza; Benitez, Juan R; Duvergel, Jacinto; Van der Stuyft, Patrick

2008-05-01

To identify key elements that should provide an added value and assure sustainable effects of the deployment of technical tools for Aedes aegypti control. An observational study was conducted between April 2001 and March 2002 in 30 blocks (1574 houses) in the central zone of Guantanamo city. A trial that combined two complementary technical interventions, the distribution of new ground level water tanks and the intensive use of insecticide, was nested in May 2001. Another 30 blocks (1535 houses) were selected as control area. We assessed community perceptions and household risk behaviour at baseline and after 9 months, and measured the trial's impact through entomological indices. Perceived self efficacy to solve A. aegypti infestation and prevent dengue was not modified. We found no changes in behaviour. In the study area the container indices decreased significantly from 0.7% before to 0.1% 1 month after the intervention. Six months later, they had increased to 2.7% and uncovered new water tanks constituted 75.9% of all breeding sites. Over the 9 months after the trial the average monthly house indices were similar in the study and control areas. A technical approach and lack of community involvement in the trial's implementation were the main causes of these short-lived results. Top-down deployment of technical tools without active involvement of the community has a temporary effect and does not lead to the behavioural changes necessary for sustainable A. aegypti control.

Prevention of venous thromboembolism in hospitalized patients: analysis of reduced cost and improved clinical outcomes.

PubMed

Duff, Jed; Walker, Kim; Omari, Abdullah; Stratton, Charlie

2013-03-01

The impact of implementing a guideline on venous thromboembolism (VTE) prophylaxis was evaluated in a metropolitan private hospital with a before- and after-intervention study. This subsequent study aimed to identify if improved prophylaxis rates translated into cost savings and improved clinical outcomes. A conceptual decision-tree analytical model incorporating local treatment algorithms and clinical trial data was used to compare prophylaxis costs and clinical outcomes before and after the guideline implementation. The study analyzed data from 21,942 medical and surgical patients admitted to a 250-bed acute-care private hospital in Sydney, Australia. The modeled simulation estimated the incidence of symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as adverse events such as heparin-induced thrombocytopenia (HIT), post-thrombotic syndrome (PTS), major bleeding, and mortality. The costs of prophylaxis therapy and treating adverse events were also calculated. The improvement in prophylaxis rates following the implementation of the guideline was estimated to result in 13 fewer deaths, 84 fewer symptomatic DVTs, 19 fewer symptomatic PEs, and 512 fewer hospital-bed days. Improved adherence to evidence-based prophylaxis regimens was associated with overall cost savings of $245,439 over 12 months. We conclude that improved adherence to evidence-based guidelines for VTE prophylaxis is achievable and is likely to result in fewer deaths, fewer VTE events, and a significant overall cost saving. Copyright © 2013 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.

Autoshaping as a function of prior food presentations1

PubMed Central

Downing, Kevin; Neuringer, Allen

1976-01-01

Young chickens were given 1, 10, 100, or 1000 presentations of grain in a hopper. Subsequently, the key was illuminated before each presentation of grain to study autoshaping of the key-peck response. The number of keylight-grain pairings before a bird first pecked the lighted key was found to be a U-shaped function of the number of prior food-only presentations, with pecks occurring significantly sooner after 100 food-only trials than after any of the other values. Two of five chicks at the 100-trial value pecked on the first illumination of the key. Experiment II showed further that when a series of food-only trials (no keylight) preceded keylight-only trials (no food) 30% of the chicks pecked the illuminated key. Experiment III extended the generality of first-trial pecking to pigeons. After preliminary training with food-only, two of five pigeons pecked on the first illumination of a key. The results suggest a close relationship between autoshaping and pseudo-conditioning. PMID:16811961

Autoshaping as a function of prior food presentations.

PubMed

Downing, K; Neuringer, A

1976-11-01

Young chickens were given 1, 10, 100, or 1000 presentations of grain in a hopper. Subsequently, the key was illuminated before each presentation of grain to study autoshaping of the key-peck response. The number of keylight-grain pairings before a bird first pecked the lighted key was found to be a U-shaped function of the number of prior food-only presentations, with pecks occurring significantly sooner after 100 food-only trials than after any of the other values. Two of five chicks at the 100-trial value pecked on the first illumination of the key. Experiment II showed further that when a series of food-only trials (no keylight) preceded keylight-only trials (no food) 30% of the chicks pecked the illuminated key. Experiment III extended the generality of first-trial pecking to pigeons. After preliminary training with food-only, two of five pigeons pecked on the first illumination of a key. The results suggest a close relationship between autoshaping and pseudo-conditioning.

Making innovations accessible to the poor through implementation research.

PubMed

Squire, S B; Ramsay, A R C; van den Hof, S; Millington, K A; Langley, I; Bello, G; Kritski, A; Detjen, A; Thomson, R; Cobelens, F; Mann, G H

2011-07-01

Within countries, poorer populations have greater health needs and less access to good medical care than better-off populations. This is particularly true for tuberculosis (TB), the archetypal disease of poverty. Innovations also tend to become available to better-off populations well before they become available to those who need them the most. In a new era of innovations for TB diagnosis and treatment, it is increasingly important not only to be sure that these innovations can work in terms of accuracy and efficacy, but also that they will work, especially for the poor. We argue that after an innovation or a group of innovations has been endorsed, based on demonstrated accuracy and/or efficacy, introduction into routine practice should proceed through implementation by research. Cluster-randomised pragmatic trials are suited to this approach, and permit the prospective collection of evidence needed for full impact assessment according to a previously published framework. The novel approach of linking transmission modelling with operational modelling provides a methodology for expanding and enhancing the range of evidence, and can be used alongside evidence from pragmatic implementation trials. This evidence from routine practice should then be used to ensure that innovations in TB control are used for positive action for all, and particularly the poor.

Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections.

PubMed

Haas, David M; Morgan, Sarah; Contreras, Karenrose

2014-12-21

Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (10 December 2014). We included randomized and quasi-randomized trials assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. We independently assessed eligibility and quality of the studies. Seven trials randomizing 2816 women (2635 analyzed) evaluated the effects of vaginal cleansing (all with povidone-iodine) on post-cesarean infectious morbidity. The risk of bias was generally low, with the quality of most of the studies being high. Vaginal preparation immediately before cesarean delivery significantly reduced the incidence of post-cesarean endometritis from 8.3% in control groups to 4.3% in vaginal cleansing groups (average risk ratio (RR) 0.45, 95% confidence interval (CI) 0.25 to 0.81, seven trials, 2635 women). The risk reduction was particularly strong for women who were already in labor at the time of the cesarean delivery (7.4% in the vaginal cleansing group versus 13.0% in the control group; RR 0.56, 95% CI 0.34 to 0.95, three trials, 523 women) and for women with ruptured membranes (4.3% in the vaginal cleansing group versus 17.9% in the control group; RR 0.24, 95% CI 0.10 to 0.55, three trials, 272 women). No other outcomes realized statistically significant differences between the vaginal cleansing and control groups. No adverse effects were reported with the povidone-iodine vaginal cleansing.The quality of the evidence using GRADE was low for post-cesarean endometritis, moderate for postoperative fever, and low for wound infection. Vaginal preparation with povidone-iodine solution immediately before cesarean delivery reduces the risk of postoperative endometritis. This benefit is particularly realized for women undergoing cesarean delivery, who are already in labor or who have ruptured membranes. As a simple, generally inexpensive intervention, providers should consider implementing preoperative vaginal cleansing with povidone-iodine before performing cesarean deliveries.

Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.

PubMed

Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja; Gold, Christian

2016-01-01

To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature. Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures. Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization. Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility. By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Impact of preoperative oral liquid carbohydrate on postoperative insulin resistance in gastric cancer patients and its associated study].

PubMed

Chen, Junyong; Cheng, Liyang; Xie, Zhengyong; Li, Zehang

2015-12-01

To investigate the impact of preoperative oral liquid carbohydrate on postoperative insulin resistance (IR) in gastric cancer patients undergoing elective resection, and to examine the association of IR index (homeostasis model assessment, HOMA-IR) with tumor necrosis factor-α (TNF-α). Between January 2013 and September 2013, 35 patients undergoing elective resection for gastric cancer were prospectively enrolled and randomized into two groups. Patients in trial group (n=18) received oral 500 ml of 10% glucose solution two hours before surgery. Patients in control group (n=17) were asked to fast for 8-12 hours before operation. About 300 mg of rectus abdominis and subcutaneous fatty tissues was removed before the closure of abdominal wall. Blood samples were collected to measure the serum concentration of TNF-α with double antibody sandwich ELISA in perioperative period (3-hour before operation, end of operation, 1-day and 3-day after operation). HOMA-IR was calculated on preoperative 3-hour and postoperative 1-day. Western blotting was used to detect protein expression of TNF-α. Correlation of HOMA-IR with TNF-α was examined. HOMA-IR on the first day after surgery was not different from that at 3-hour before surgery in trial group (P=0.090), which was significantly lower than that in control group (P=0.000). In trial group, serum TNF-α at the end of operation was higher than that at 3-hour before surgery, which declined rapidly on the first day after surgery and had no significant difference compared with that on the third day after surgery. In control group, serum TNF-α at the end of operation was also higher than that before surgery, which rose to the peak on the first day after surgery and was still higher than that at 3-hour before surgery. The TNF-α protein expression in muscle tissues of trial group was higher than that of control group (P=0.001), while no significant difference was observed between two groups in adipose tissues (P=0.987). Correlation analysis showed that HOMA-IR was positively correlated with TNF-α on the first day after surgery (r=0.832, P=0.000). Oral intake of liquid carbohydrate 2 hours before surgery can reduce the level of TNF-α, which is likely to improve the postoperative insulin resistance.

Series: Pragmatic trials and real world evidence: Paper 7. Safety, quality and monitoring.

PubMed

Irving, Elaine; van den Bor, Rutger; Welsing, Paco; Walsh, Veronica; Alfonso-Cristancho, Rafael; Harvey, Catherine; Garman, Nadia; Grobbee, Diederick E

2017-11-01

Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorization. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials. This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that all serious adverse events and all drug-related events must be reported in an interventional trial. In line with current guidance, we propose a risk-based approach to the collection of non-drug-related non-serious adverse events and even serious events not related to treatment based on the risk profile of the medicine/class in the patient population of interest. Different options available to support the collection and reporting of safety data while minimizing study-related follow-up visits are discussed. A risk-based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials and the careful consideration that must be given to the mitigation and management of these risks to maintain routine care. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

PubMed

Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

2015-10-01

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

Changes in perceptions and motivators that influence the implementation of on-farm Salmonella control measures by pig farmers in England.

PubMed

Marier, Elizabeth; Piers Smith, Richard; Ellis-Iversen, Johanne; Watson, Eamon; Armstrong, Derek; Hogeveen, Henk; Cook, Alasdair J C

2016-10-01

This study presents British farmers' perception of, and barriers to, implementing Salmonella control on pig farms. Four farms that had implemented interventions and their 33 close contacts (known to the intervention farmers) took part in interviews before (phase 1) and after (phase 2) intervention trials to assess the difference in perception over time. Their results were compared against those from nine randomly selected control farms. The hypothesis was that farms implementing interventions whether or not successful, would influence their close contacts' opinion over time. Based on a 'pathway to disease control' model, three intrinsic factors known to influence motivation - attitudes, social norms and self-efficacy - were evaluated. Farmers mentioned that successful interventions on a farm would attract their attention. The use of an appropriate communication strategy is therefore recommended to stimulate farmers' intent to implement control measures. Both before and after the intervention trials, all farmers had a positive attitude towards Salmonella control and felt that their peers and authorities were supportive of controlling Salmonella on farms. In phase 2, however, farmers were more likely to want to share the burden of control with other stakeholders along the food chain and their belief in self-efficacy had weakened. Whilst social norms were not associated with an intention to take action on control, a positive attitude towards Salmonella control and a belief in self-efficacy were more likely to result in an intent to control. In phase 2, farmers with an intent to implement an intervention appeared to have a greater, but not significant positive belief in self-efficacy (p=0.108). This study confirmed that farmers recognised their responsibility for controlling Salmonella in pork - even though their confidence in their ability to control Salmonella decreased over time - and believed that responsibility should be shared with the rest of the production chain. It showed that farmers trusted their veterinarian as a source of advice to guide them during the process of implementing change, though an increase in farms' Salmonella seroprevalence score (Zoonosis National Control Programme (ZNCP) score) especially for those with a low ZNCP score was also likely to influence their behaviour. Getting concrete feedback from customers or a tangible benefit from their action was a strong incentive especially for farms with a ZNCP score higher than 50%. The study also revealed a need to validate which measures are effective as farmers did not perceive that the current advised interventions were worth the additional effort. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

The optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs.

PubMed

Thompson, Jennifer A; Fielding, Katherine; Hargreaves, James; Copas, Andrew

2017-12-01

Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences. We compared the design effect of this optimised stepped wedge trial to the design effects of a parallel cluster-randomised trial, a cluster-randomised trial with baseline observations, and a hybrid trial design (a mixture of cluster-randomised trial and stepped wedge trial) with the same total cluster size for all designs. Results We found that a stepped wedge trial with an equal allocation to sequences is optimised by obtaining all observations after the first sequence switches and before the final sequence switches to the intervention; this means that the first sequence remains in the control condition and the last sequence remains in the intervention condition for the duration of the trial. With this design, the optimal number of sequences is [Formula: see text], where [Formula: see text] is the cluster-mean correlation, [Formula: see text] is the intracluster correlation coefficient, and m is the total cluster size. The optimal number of sequences is small when the intracluster correlation coefficient and cluster size are small and large when the intracluster correlation coefficient or cluster size is large. A cluster-randomised trial remains more efficient than the optimised stepped wedge trial when the intracluster correlation coefficient or cluster size is small. A cluster-randomised trial with baseline observations always requires a larger sample size than the optimised stepped wedge trial. The hybrid design can always give an equally or more efficient design, but will be at most 5% more efficient. We provide a strategy for selecting a design if the optimal number of sequences is unfeasible. For a non-optimal number of sequences, the sample size may be reduced by allowing a proportion of observations before the first or after the final sequence has switched. Conclusion The standard stepped wedge trial is inefficient. To reduce sample sizes when a hybrid design is unfeasible, stepped wedge trial designs should have no observations before the first sequence switches or after the final sequence switches.

The effect of lithium chloride on one-trial passive avoidance learning in rats.

PubMed Central

Johnson, F N

1976-01-01

1 Expression of a one-trial passive avoidance learning response in rats was examined following injections of lithium chloride or sodium chloride before and after initial training and before the first day of testing. Five tests were given at daily intervals, 24 h after training being the time of the first test. 2. Lithium given before the first day of testing impaired response expression on the first and all subsequent days of testing; the rate of extinction was unaffected. 3. Given both before and immediately after initial training, lithium impaired response expression on the first day of testing but slowed down the subsequent rate of extinction, leading eventually to improved performance on the fifth day, as compared with placebo-treated control subjects. 4. The results are interpreted in the light of the hypothesis that lithium impaired the central processing of sensory information. PMID:1252666

Effects of antithyroid drugs on radioiodine treatment: systematic review and meta-analysis of randomised controlled trials.

PubMed

Walter, Martin A; Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat

2007-03-10

To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Meta-analysis. Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively.

[Is it ethically acceptable to invite a pregnant woman to enroll in a clinical trial with Tdap if it could entail not being vaccinated with Tdap before delivery?

PubMed

Dal-Ré, Rafael

2017-02-01

Pertussis incidence has increased in recent years, especially among infants aged <2months. A number of Spanish regions have started a vaccination program with Tdap vaccine to all pregnant women in the third trimester of pregnancy. An observational study has shown that this strategy reduces the number of cases of pertussis by 90% in infants aged <2months. Mathematical models showed that a cocooning strategy (i.e. vaccination of the mother at immediate postpartum, and other adults and adolescents who have close contact with the newborn and caregivers) will reduce the incidence of pertussis by 70% in infants aged <2months. It is intended to conduct a clinical trial in which 340 pregnant women will receive Tdap vaccine, whereas another 340 pregnant woman will be vaccinated soon after delivery. Vaccination with Tdap will be offered to all partners and caregivers of the newborn. After assessing both the ethical and scientific reasons supporting the trial, it is concluded that it is ethically and legally acceptable to invite pregnant women living in communities where Tdap vaccination has been implemented to participate in the trial. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Policy Support, Norms, and Secondhand Smoke Exposure Before and After Implementation of a Comprehensive Smoke-Free Law in Mexico City

PubMed Central

Thrasher, James F.; Pérez-Hernández, Rosaura; Swayampakala, Kamala; Arillo-Santillán, Edna; Bottai, Matteo

2010-01-01

Objectives. We assessed attitudes and beliefs about smoke-free laws, compliance, and secondhand smoke exposure before and after implementation of a comprehensive smoke-free law in Mexico City. Methods. Trends and odds of change in attitudes and beliefs were analyzed across 3 representative surveys of Mexico City inhabitants: before implementation of the policy (n = 800), 4 months after implementation (n = 961), and 8 months after implementation (n = 761). Results. Results indicated high and increasing support for 100% smoke-free policies, although support did not increase for smoke-free bars. Agreement that such policies improved health and reinforced rights was high before policy implementation and increased thereafter. Social unacceptability of smoking increased substantially, although 25% of nonsmokers and 50% of smokers agreed with smokers' rights to smoke in public places at the final survey wave. Secondhand smoke exposure declined generally as well as in venues covered by the law, although compliance was incomplete, especially in bars. Conclusions. Comprehensive smoke-free legislation in Mexico City has been relatively successful, with changes in perceptions and behavior consistent with those revealed by studies conducted in high-income countries. Normative changes may prime populations for additional tobacco control interventions. PMID:20466952

A Hybrid Effectiveness-Implementation Trial of an Evidence-Based Exercise Intervention for Breast Cancer Survivors

PubMed Central

Beidas, Rinad S.; Paciotti, Breah; Barg, Fran; Branas, Andrea R.; Brown, Justin C.; Glanz, Karen; DeMichele, Angela; DiGiovanni, Laura; Salvatore, Domenick

2014-01-01

Background The primary aims of this hybrid Type 1 effectiveness-implementation trial were to quantitatively assess whether an evidence-based exercise intervention for breast cancer survivors, Strength After Breast Cancer, was safe and effective in a new setting and to qualitatively assess barriers to implementation. Methods A cohort of 84 survivors completed measurements related to limb volume, muscle strength, and body image at baseline, 67 survivors completed measurements 12 months later. Qualitative methods were used to understand barriers to implementation experienced by referring oncology clinicians and physical therapists who delivered the program. Results Similar to the efficacy trial, the revised intervention demonstrated safety with regard to lymphedema, and led to improvements in lymphedema symptoms, muscular strength, and body image. Comparison of effects in the effectiveness trial to effects in the efficacy trial revealed larger strength increases in the efficacy trial than in the effectiveness trial (P < .04), but few other differences were found. Qualitative implementation data suggested significant barriers around intervention characteristics, payment, eligibility criteria, the referral process, the need for champions (ie, advocates), and the need to adapt during implementation of the intervention, which should be considered in future dissemination and implementation efforts. Conclusions This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting while retaining the effectiveness and safety of the clinical trial. However, during the translation process, strategies to reduce barriers to implementation are required. This new program can inform larger scale dissemination and implementation efforts. PMID:25749601

Effect of implementation of the mass breast cancer screening programme in older women in the Netherlands: population based study.

PubMed

de Glas, Nienke A; de Craen, Anton J M; Bastiaannet, Esther; Op 't Land, Ester G; Kiderlen, Mandy; van de Water, Willemien; Siesling, Sabine; Portielje, Johanneke E A; Schuttevaer, Herman M; de Bock, Geertruida Truuske H; van de Velde, Cornelis J H; Liefers, Gerrit-Jan

2014-09-14

To assess the incidence of early stage and advanced stage breast cancer before and after the implementation of mass screening in women aged 70-75 years in the Netherlands in 1998. Prospective nationwide population based study. National cancer registry, the Netherlands. Patients aged 70-75 years with a diagnosis of invasive or ductal carcinoma in situ breast cancer between 1995 and 2011 (n=25,414). Incidence rates were calculated using population data from Statistics Netherlands. Incidence rates of early stage (I, II, or ductal carcinoma in situ) and advanced stage (III and IV) breast cancer before and after implementation of screening. Hypotheses were formulated before data collection. The incidence of early stage tumours significantly increased after the extension for implementation of screening (248.7 cases per 100,000 women before screening up to 362.9 cases per 100,000 women after implementation of screening, incidence rate ratio 1.46, 95% confidence interval 1.40 to 1.52, P<0.001). However, the incidence of advanced stage breast cancers decreased to a far lesser extent (58.6 cases per 100,000 women before screening to 51.8 cases per 100,000 women after implementation of screening, incidence rate ratio 0.88, 0.81 to 0.97, P<0.001). The extension of the upper age limit to 75 years has only led to a small decrease in incidence of advanced stage breast cancer, while that of early stage tumours has strongly increased. © de Glas et al 2014.

Assessment of the Efficiency of Hospitals Before and After the Implementation of Health Sector Evolution Plan in Iran Based on Pabon Lasso Model

PubMed Central

MORADI, Ghobad; PIROOZI, Bakhtiar; SAFARI, Hossein; ESMAIL NASAB, Nader; MOHAMADI BOLBANABAD, Amjad; YARI, Arezoo

2017-01-01

Background: Pabon Lasso model was applied to assess the relative performance of hospitals affiliated to Kurdistan University of Medical Sciences (KUMS) before and after the implementation of Health Sector Evolution Plan (HSEP) in Iran. Methods: This cross-sectional study was carried out in 11 public hospitals affiliated to KUMS in 2015. Twelve months before and after the implementation of the first phase of HSEP, a checklist was used to collect data from computerized databases within the hospitals’ admission and discharge units. Pabon Lasso model includes three indices: bed turnover, bed occupancy ratio, and average length of stay. Results: Analysis of hospital performance showed an increase in mean of bed occupancy and turnover ratio, which changed from 65.40% and 86.22 times/year during 12 months before to 69.97% and 90.98 times/year during 12 months after HSEP, respectively. In line with Pabon Lasso model, before the implementation of HSEP, 27.27% and 36.36% of the hospitals were entirely efficient and inefficient, respectively, whilst after the implementation of HSEP, their condition changed to 18.18% and 27.27%, in order. Conclusion: Indicators of bed occupancy and turnover ratio had a 4% increase in the studied hospitals after the implementation of HSEP. Number of the hospitals in the efficient zone reduced because of the relative measurement of efficiency by Pabon Lasso model. Since more than 50% of the hospitals in the studied province have not yet reached their optimal bed occupancy ratio (more than 70%), short-term and suitable strategy for improving the efficiency is to stop further expansion of hospitals as well as developing the number of hospital beds. PMID:28435825

AATA AOS evaluation : transfer and on-time performance study : before and after AOS implementation, October 1996 - May 1999

DOT National Transportation Integrated Search

1999-01-01

This study develops, using data before AOS in 1996 and 1997 and after AOS in 1998 and 1999, implementation data on AATAs on-time performance and vehicle-to-vehicle timing of transfers at four major transfer location. Systematic evaluation of on-ti...

Effect of a checklist on advanced trauma life support workflow deviations during trauma resuscitations without pre-arrival notification.

PubMed

Kelleher, Deirdre C; Jagadeesh Chandra Bose, R P; Waterhouse, Lauren J; Carter, Elizabeth A; Burd, Randall S

2014-03-01

Trauma resuscitations without pre-arrival notification are often initially chaotic, which can potentially compromise patient care. We hypothesized that trauma resuscitations without pre-arrival notification are performed with more variable adherence to ATLS protocol and that implementation of a checklist would improve performance. We analyzed event logs of trauma resuscitations from two 4-month periods before (n = 222) and after (n = 215) checklist implementation. Using process mining techniques, individual resuscitations were compared with an ideal workflow model of 6 ATLS primary survey tasks performed by the bedside evaluator and given model fitness scores (range 0 to 1). Mean fitness scores and frequency of conformance (fitness = 1) were compared (using Student's t-test or chi-square test, as appropriate) for activations with and without notification both before and after checklist implementation. Multivariable linear regression, controlling for patient and resuscitation characteristics, was also performed to assess the association between pre-arrival notification and model fitness before and after checklist implementation. Fifty-five (12.6%) resuscitations lacked pre-arrival notification (23 pre-implementation and 32 post-implementation; p = 0.15). Before checklist implementation, resuscitations without notification had lower fitness (0.80 vs 0.90; p < 0.001) and conformance (26.1% vs 50.8%; p = 0.03) than those with notification. After checklist implementation, the fitness (0.80 vs 0.91; p = 0.007) and conformance (26.1% vs 59.4%; p = 0.01) improved for resuscitations without notification, but still remained lower than activations with notification. In multivariable analysis, activations without notification had lower fitness both before (b = -0.11, p < 0.001) and after checklist implementation (b = -0.04, p = 0.02). Trauma resuscitations without pre-arrival notification are associated with a decreased adherence to key components of the ATLS primary survey protocol. The addition of a checklist improves protocol adherence and reduces the effect of notification on task performance. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Life After Transplant

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A Markov chain model for reliability growth and decay

NASA Technical Reports Server (NTRS)

Siegrist, K.

1982-01-01

A mathematical model is developed to describe a complex system undergoing a sequence of trials in which there is interaction between the internal states of the system and the outcomes of the trials. For example, the model might describe a system undergoing testing that is redesigned after each failure. The basic assumptions for the model are that the state of the system after a trial depends probabilistically only on the state before the trial and on the outcome of the trial and that the outcome of a trial depends probabilistically only on the state of the system before the trial. It is shown that under these basic assumptions, the successive states form a Markov chain and the successive states and outcomes jointly form a Markov chain. General results are obtained for the transition probabilities, steady-state distributions, etc. A special case studied in detail describes a system that has two possible state ('repaired' and 'unrepaired') undergoing trials that have three possible outcomes ('inherent failure', 'assignable-cause' 'failure' and 'success'). For this model, the reliability function is computed explicitly and an optimal repair policy is obtained.

[Defining an ethics for preventive trials].

PubMed

Chippaux, J-P

2008-04-01

Preventive trials (to prevent from infection) or prophylaxis trials (to avoid consequences of the disease) differ from other clinical trials as they apply to healthy subjects or subjects considering themselves as such: the latter do not ask for intervention even less for trial. Moreover, it is generally an experiment which aims at validating a public health intervention, the individual character of which could appear as secondary regarding the collective interest. It concerns many tools or methods: preventive or prophylactic vaccines and drugs, condoms, impregnated bed nets, etc. The field of implementation of preventive trials is large and covers routine immunization (EPI), large-scale control or eradication of endemic diseases or epidemics, for which the concept of individual risk is generally better understood. Preventive trials imply ethical obligations (high individual or collective benefits and absence of risks as there is no immediate therapeutic compensation), methodological adaptations (because the number of subjects is considerably larger than for therapeutic trials) and a sensitive valorization towards a large population who is not asking for the recommended intervention. As regard the benefits, it is also necessary to consider the costs in comparison with the expected efficacy The methodological constraints are important because the demonstration of both safety and efficacy requires a very large number of subjects to validate the product. It is often necessary to use indirect or substitutive markers and indicators (title of protective antibodies rather than definite clinical protection) which need a preliminary validation. Before carrying out a preventive or prophylactic trial, it is advisable to specify the objectives in order to assess the real profits and absence of risks during the trial and after the implementation of the tested product. Preventive trials require a phase of technological transfer to guarantee the application of the validated tools for the benefit of the population at stake. In this respect, if trials for prevention are now well codified both on ethical and methodological aspects, trials for prophylaxis (filariasis with ivermectin, schistosomiasis with praziquantel, malaria with intermittent "preventive" treatment or HIV with antiretroviral treatment, for example) still remain a difficult issue at both ethical and methodological levels.

Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

PubMed

Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective in increasing uptake of Health Checks and whether an incentive alters questionnaire return rates as well as uptake of Health Checks. The trial interventions can be readily translated into routine service delivery if they are shown to be cost-effective. Current Controlled Trials ISRCTN42856343. Date registered: 21.03.2013.

Development of a Mobile Tool That Semiautomatically Screens Patients for Stroke Clinical Trials.

PubMed

Spokoyny, Ilana; Lansberg, Maarten; Thiessen, Rosita; Kemp, Stephanie M; Aksoy, Didem; Lee, YongJae; Mlynash, Michael; Hirsch, Karen G

2016-10-01

Despite several national coordinated research networks, enrollment in many cerebrovascular trials remains challenging. An electronic tool was needed that would improve the efficiency and efficacy of screening for multiple simultaneous acute clinical stroke trials by automating the evaluation of inclusion and exclusion criteria, improving screening procedures and streamlining the communication process between the stroke research coordinators and the stroke clinicians. A multidisciplinary group consisting of physicians, study coordinators, and biostatisticians designed and developed an electronic clinical trial screening tool on a HIPAA (Health Insurance Portability and Accountability Act)-compliant platform. A web-based tool was developed that uses branch logic to determine eligibility for simultaneously enrolling clinical trials and automatically notifies the study coordinator teams about eligible patients. After 12 weeks of use, 225 surveys were completed, and 51 patients were enrolled in acute stroke clinical trials. Compared with the 12 weeks before implementation of the tool, there was an increase in enrollment from 16.5% of patients screened to 23.4% of patients screened (P<0.05). Clinicians and coordinators reported increased satisfaction with the process and improved ease of screening. We created a semiautomated electronic screening tool that uses branch logic to screen patients for stroke clinical trials. The tool has improved efficiency and efficacy of screening, and it could be adapted for use at other sites and in other medical fields. © 2016 American Heart Association, Inc.

Negative transfer of heart rate control following biofeedback training: a partial replication.

PubMed

Steptoe, A; Macready, D

1985-09-01

Ability to raise and lower heart rate (HR) on instruction was tested before and after unidirectional biofeedback training in two groups of 10 male volunteers. Instructional control was assessed in 2-min trials before training, and after 5 and 10 biofeedback trials of increasing (Group I) and decreasing (Group D) HR. The magnitude of HR elevations produced by Group D diminished following training, while modifications in Group I were unchanged. This negative transfer effect is discussed in relation to whether voluntary speeding and slowing HR reflect distinct capacities.

Evaluating the Training of Chinese-Speaking Community Health Workers to Implement a Small-Group Intervention Promoting Mammography.

PubMed

Gu, Jiayan; Maxwell, Annette E; Ma, Grace X; Qian, Xiaokun; Tan, Yin; Hsieh, Hsing-Chuan; Tu, Shin-Ping; Wang, Judy Huei-Yu

2018-04-14

This study evaluated the training of Chinese American Community Health Workers (CHWs) to implement a small-group mammography video and discussion program as part of a randomized controlled trial that had the goal to increase adherence to mammography screening guidelines among Chinese American women. A total of 26 Chinese American CHWs in the metropolitan Washington DC area, Southern California, and New York City participated in a 4-h training workshop and completed surveys before and after the workshop to assess their knowledge regarding mammography screening guidelines and human subjects protection rules. The results showed significantly increased knowledge of mammography screening guidelines and human subjects protection rules (both p < 0.01) after the training. CHWs were also trained to lead a discussion of the video, including screening benefits and misconceptions. Forty-three audio recordings of discussions led by 13 active CHWs were transcribed and qualitatively analyzed to assess implementation fidelity. Ten out of 13 active CHWs fully addressed about 3 of the 5 benefit items, and 11 out of 13 CHWs fully addressed more than 5 of the 9 misconception items. Chinese CHWs can be trained to implement research-based intervention programs. However, a one-time training resulted in moderate adherence to the discussion protocol. Ongoing or repeat trainings throughout the intervention period may be needed to enhance implementation fidelity.

Bovine colostrum supplementation's lack of effect on immune variables during short-term intense exercise in well-trained athletes.

PubMed

Carol, Arnoud; Witkamp, Renger F; Wichers, Harry J; Mensink, Marco

2011-04-01

The purpose of this study was to investigate the potential of bovine colostrum to attenuate postexercise decline in immune function. The authors evaluated the time course of a number of immune variables after short-term intense exercise in 9 male athletes after 10 d of supplementation with either colostrum or skim-milk powder. To increase the stress on the immune system subjects performed a glycogen-depletion trial the evening before the endurance trial (90 min at 50% Wmax). Blood samples were taken before the glycogen-depletion trial, before and after the endurance trial, and the next morning, ~22 hr after cessation of the exercise. Plasma cortisol levels increased over time, reaching the highest level directly after exercise, and were still elevated ~22 hr after exercise compared with baseline values (p < .001). Neutrophil cell count was increased after exercise and dropped below starting values 22 hr after exercise (time effect p < .001). Circulating immunoglobulins did not change over time. A significant time effect was seen for interleukin (IL)-6, IL-10, IL-1-receptor agonist, and C-reactive protein, with levels being higher directly after exercise (p < .05). Other cytokines (interferon-γ, IL-1a, IL-8, tumor necrosis factor-a) did not show a time effect. No differences were seen between colostrum and skim-milk powder in any of the investigated variables. Our results are consistent with the hypothesis that intense exercise affects several variables of the immune system. Colostrum did not alter any of the postexercise immune variables compared with skim-milk powder, suggesting no role for bovine colostrum supplementation in preventing postexercise immune suppression after short-term intense exercise.

Effectiveness of training in evidence-based medicine skills for healthcare professionals: a systematic review.

PubMed

Hecht, Lars; Buhse, Susanne; Meyer, Gabriele

2016-04-04

Basic skills in evidence-based medicine (EbM) are indispensable for healthcare professionals to promote consumer-centred, evidence-based treatment. EbM training courses are complex interventions - a fact that has not been methodologically reflected by previous systematic reviews. This review evaluates the effects of EbM training for healthcare professionals as well as the quality of reporting of such training interventions. We searched PubMed, EMBASE, CINAHL, Cochrane Library, ERIC, Campbell Library and PsycINFO up to 9/2014. Randomised controlled trials, controlled clinical trials as well as before-after trials were included. Authors were contacted in order to obtain missing data. Two independent reviewers extracted data and assessed risk of bias. We reviewed 14.507 articles; n = 61 appeared potentially eligible; n = 13 involving 1,120 participants were included. EbM training shows some impact on knowledge and skills, whereas the impact on practical EbM application remains unclear. Risk of bias of included trials raises uncertainty about the effects. Description of complex interventions was poor. EbM training has some positive effects on knowledge and skills of healthcare professionals. Appropriate methods for development, piloting, evaluation, reporting and implementation of the training should be applied.

The effect of a complementary e-learning course on implementation of a quality improvement project regarding care for elderly patients: a stepped wedge trial.

PubMed

Van de Steeg, Lotte; Langelaan, Maaike; Ijkema, Roelie; Wagner, Cordula

2012-03-02

Delirium occurs frequently in elderly hospitalised patients and is associated with higher mortality, increased length of hospital stay, functional decline, and admission to long-term care. Healthcare professionals frequently do not recognise delirium, indicating that education can play an important role in improving delirium care for hospitalised elderly. Previous studies have indicated that e-learning can provide an effective way of educating healthcare professionals and improving quality of care, though results are inconsistent. This stepped wedge cluster randomised trial will assess the effects of a complementary delirium e-learning course on the implementation of quality improvement initiative, which aims to enhance the recognition and management of delirium in elderly patients. The trial will be conducted in 18 Dutch hospitals and last 11 months. Measurements will be taken in all participating wards using monthly record reviews, in order to monitor delivered care. These measurements will include the percentage of elderly patients who were screened for the risk of developing delirium, use of the Delirium Observation Screening scale, use of nursing or medical interventions, and the percentage of elderly patients who were diagnosed with delirium. Data regarding the e-learning course will be gathered as well. These data will include user characteristics, information regarding use of the course, delirium knowledge before and after using the course, and the attitude and intentions of nurses concerning delirium care. The study will be conducted in internal medicine and surgical wards of eighteen hospitals that are at the beginning stages of implementing the Frail Elderly Project in the Netherlands. Better recognition of elderly patients at risk for delirium and subsequent care is expected from the introduction of an e-learning course for nurses that is complementary to an existing quality improvement project. This trial has the potential to demonstrate that e-learning can be a vital part of the implementation process, especially for quality improvement projects aimed at complex health issues such as delirium. The study will contribute to a growing body of knowledge concerning e-learning and the effects it can have on knowledge as well as delivered care. Netherlands Trial Register (NTR): NTR2885.

Australian smokers' support for plain or standardised packs before and after implementation: findings from the ITC Four Country Survey.

PubMed

Swift, Elena; Borland, Ron; Cummings, K Michael; Fong, Geoffrey T; McNeill, Ann; Hammond, David; Thrasher, James F; Partos, Timea R; Yong, Hua-Hie

2015-11-01

Plain packaging (PP) for tobacco products was fully implemented in Australia on 1 December 2012 along with larger graphic health warnings. Using longitudinal data from the Australian arm of the ITC Four Country Survey, we examined attitudes to the new packs before and after implementation, predictors of attitudinal change, and the relationship between support and quitting activity. A population-based cohort study design, with some cross-sectional analyses. Surveys of Australian smokers assessed attitudes to PP at four time points prior to implementation (from 2007 to 2012) and one post-implementation wave collected (early/mid-2013). Trend analysis showed a slight rise in opposition to PP among smokers in the waves leading up to their implementation, but no change in support. Support for PP increased significantly after implementation (28.2% pre vs 49% post), such that post-PP more smokers were supportive than opposed (49% vs 34.7%). Multivariate analysis showed support either before or after implementation was predicted by belief in greater adverse health impacts of smoking, desire to quit and lower addiction. Among those not supportive before implementation, having no clear opinion about PP (versus being opposed) prior to the changes also predicted support post-implementation. Support for PP was prospectively associated with higher levels of quitting activity. Since implementation of PP along with larger warnings, support among Australian smokers has increased. Support is related to lower addiction, stronger beliefs in the negative health impacts of smoking, and higher levels of quitting activity. 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/

Implementing a 6-day physiotherapy service in rehabilitation: exploring staff perceptions.

PubMed

Caruana, Erin L; Kuys, Suzanne S; Clarke, Jane; Brauer, Sandra G

2017-11-20

Objective Australian weekend rehabilitation therapy provision is increasing. Staff engagement optimises service delivery. The present mixed-methods process evaluation explored staff perceptions regarding implementation of a 6-day physiotherapy service in a private rehabilitation unit. Methods All multidisciplinary staff working in the rehabilitation unit were surveyed regarding barriers, facilitators and perceptions of the effect of a 6-day physiotherapy service on length of stay (LOS) and patient goal attainment at three time points: before and after implementation, as well as after modification of a 6-day physiotherapy service. Descriptive statistics and thematic analysis was used to analyse the data. Results Fifty-one staff (50%) responded. Before implementation, all staff identified barriers, the most common being staffing (62%) and patient selection (29%). After implementation, only 30% of staff identified barriers, which differed to those identified before implementation, and included staff rostering and experience (20%), timing of therapy (10%) and increasing the allocation of patients (5%). Over time, staff perceptions changed from being unsure to being positive about the effect of the 6-day service on LOS and patient goal attainment. Conclusion Staff perceived a large number of barriers before implementation of a 6-day rehabilitation service, but these did not eventuate following implementation. Staff perceived improved LOS and patient goal attainment after implementation of a 6-day rehabilitation service incorporating staff feedback. What is known about this topic? Rehabilitation weekend services improve patient quality of life and functional independence while reducing LOS. What does this study add? Staff feedback during implementation and modification of new services is important to address potential barriers and ensure staff satisfaction and support. What are the implications for practitioners? Staff engagement and open communication are important to successfully implement a new service in rehabilitation.

37 CFR 42.409 - Settlement agreements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Derivation After Institution of Derivation Proceeding § 42.409 Settlement agreements. An agreement or understanding under 35 U.S.C. 135(e) is...

Trial Registration at ClinicalTrials.gov between May and October 2005

PubMed Central

Zarin, Deborah A.; Tse, Tony; Ide, Nicholas C.

2006-01-01

BACKGROUND Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication. METHODS We reviewed ClinicalTrials.gov records to determine patterns of completion of the “Intervention Name” and “Primary Outcome Measure” data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively. RESULTS During the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank. CONCLUSIONS During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement. PMID:16382064

Variability of inter-observer agreement on feasibility of partial nephrectomy before and after neoadjuvant axitinib for locally advanced renal cell carcinoma (RCC): independent analysis from a phase II trial.

PubMed

Karam, Jose A; Devine, Catherine E; Fellman, Bryan M; Urbauer, Diana L; Abel, E Jason; Allaf, Mohamad E; Bex, Axel; Lane, Brian R; Thompson, R Houston; Wood, Christopher G

2016-04-01

To evaluate how many patients could have undergone partial nephrectomy (PN) rather than radical nephrectomy (RN) before and after neoadjuvant axitinib therapy, as assessed by five independent urological oncologists, and to study the variability of inter-observer agreement. Pre- and post-systemic treatment computed tomography scans from 22 patients with clear cell renal cell carcinoma in a phase II neoadjuvant axitinib trial were reviewed by five independent urological oncologists. R.E.N.A.L. nephrometry score and κ statistics were calculated. The median R.E.N.A.L. nephrometry score changed from 11 before treatment to 10 after treatment (P = 0.002). Five tumours with moderate complexity before axitinib treatment remained moderate complexity after treatment. Of 17 tumours with high complexity before axitinib treatment, three became moderate complexity after treatment. The overall κ statistic was 0.611. Moderate-complexity κ was 0.611 vs a high-complexity κ of 0.428. Before axitinib treatment the κ was 0.550 vs 0.609 after treatment. After treatment with axitinib, all five reviewers agreed that only five patients required RN (instead of eight before treatment) and that 10 patients could now undergo PN (instead of three before treatment). The odds of PN feasibility were 22.8-times higher after treatment with axitinib. There is considerable variability in inter-observer agreement on the feasibility of PN in patients treated with neoadjuvant targeted therapy. Although more patients were candidates for PN after neoadjuvant axitinib therapy, it remains difficult to identify these patients a priori. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic.

PubMed

Annane, Djillali; Antona, Marion; Lehmann, Blandine; Kedzia, Cecile; Chevret, Sylvie

2012-01-01

To analyze the hurdles in implementing a randomized trial of corticosteroids for severe 2009 H1N1 influenza infections. This was an investigator-led, multicenter, randomized, placebo-controlled, double-blind trial of corticosteroids in ICU patients with 2009 H1N1 influenza pneumonia requiring mechanical ventilation. The feasibility of and hurdles in designing and initiating a phase III trial in a short-lived pandemic crisis were analyzed. The regulatory agency and ethics committee approved the study's scientific, financial, and ethical aspects within 4 weeks. Hydrocortisone and placebo were prepared centrally and shipped to participating hospitals within 6 weeks. The inclusion period started on November 9, 2009. From August 1, 2009 to March 8, 2010, only 205/224 ICU patients with H1N1 infections required mechanical ventilation. The peak of the wave was missed by 2-3 weeks and only 26 patients were randomized. The two main reasons for non-inclusion were patients' admission before the beginning of the trial and ICU personnel overwhelmed by clinical duties. Parallel rather than sequential regulatory and ethics approval, and preparation and masking of study drugs by local pharmacists would have allowed the study to start 1 month earlier and before the peak of the "flu" wave. A dedicated research team in each participating center would have increased the ratio of screened to randomized patients. This report highlights the main hurdles in implementing a randomized trial for a pandemic critical illness and proposes solutions for future trials.

School Lunch before and after Implementation of the Healthy Hunger-Free Kids Act

ERIC Educational Resources Information Center

Bergman, Ethan A.; Englund, Tim; Taylor, Katie Weigt; Watkins, Tracee; Schepman, Stephen; Rushing, Keith

2014-01-01

Purpose/Objectives: This study compares the mean nutrients selected and consumed in National School Lunch Program (NSLP) meals before and after implementation of the new nutrition standards mandated by the Healthy Hunger-Free Kids Act of 2010 (HHFKA) in July 2012. Four elementary schools achieving Healthier US Schools Challenge awards serving…

Predictive Factors of Plasma HIV Suppression during Pregnancy: A Prospective Cohort Study in Benin

PubMed Central

Ogouyemi-Hounto, Aurore; Azon-Kouanou, Angèle; d'Almeida, Marcelline; Azondékon, Alain; Alao, Marouf J.; Dossou-Gbété, Véronique; Afangnihoun, Aldric; Girard, Pierre-Marie; Cot, Michel; Zannou, Djimon-Marcel

2013-01-01

Objective To investigate the factors associated with HIV1 RNA plasma viral load (pVL) below 40 copies/mL at the third trimester of pregnancy, as part of prevention of mother-to-child transmission (PMTCT) in Benin. Design Sub study of the PACOME clinical trial of malaria prophylaxis in HIV-infected pregnant women, conducted before and after the implementation of the WHO 2009 revised guidelines for PMTCT. Methods HIV-infected women were enrolled in the second trimester of pregnancy. Socio-economic characteristics, HIV history, clinical and biological characteristics were recorded. Malaria prevention and PMTCT involving antiretroviral therapy (ART) for mothers and infants were provided. Logistic regression helped identifying factors associated with virologic suppression at the end of pregnancy. Results Overall 217 third trimester pVLs were available, and 71% showed undetectability. Virologic suppression was more frequent in women enrolled after the change in PMTCT recommendations, advising to start ART at 14 weeks instead of 28 weeks of pregnancy. In multivariate analysis, Fon ethnic group (the predominant ethnic group in the study area), regular job, first and second pregnancy, higher baseline pVL and impaired adherence to ART were negative factors whereas higher weight, higher antenatal care attendance and longer ART duration were favorable factors to achieve virologic suppression. Conclusions This study provides more evidence that ART has to be initiated before the last trimester of pregnancy to achieve an undetectable pVL before delivery. In Benin, new recommendations supporting early initiation were well implemented and, together with a high antenatal care attendance, led to high rate of virologic control. PMID:23555035

Predictive factors of plasma HIV suppression during pregnancy: a prospective cohort study in Benin.

PubMed

Denoeud-Ndam, Lise; Fourcade, Camille; Ogouyemi-Hounto, Aurore; Azon-Kouanou, Angèle; d'Almeida, Marcelline; Azondékon, Alain; Alao, Marouf J; Dossou-Gbété, Véronique; Afangnihoun, Aldric; Girard, Pierre-Marie; Cot, Michel; Zannou, Djimon-Marcel

2013-01-01

To investigate the factors associated with HIV1 RNA plasma viral load (pVL) below 40 copies/mL at the third trimester of pregnancy, as part of prevention of mother-to-child transmission (PMTCT) in Benin. Sub study of the PACOME clinical trial of malaria prophylaxis in HIV-infected pregnant women, conducted before and after the implementation of the WHO 2009 revised guidelines for PMTCT. HIV-infected women were enrolled in the second trimester of pregnancy. Socio-economic characteristics, HIV history, clinical and biological characteristics were recorded. Malaria prevention and PMTCT involving antiretroviral therapy (ART) for mothers and infants were provided. Logistic regression helped identifying factors associated with virologic suppression at the end of pregnancy. Overall 217 third trimester pVLs were available, and 71% showed undetectability. Virologic suppression was more frequent in women enrolled after the change in PMTCT recommendations, advising to start ART at 14 weeks instead of 28 weeks of pregnancy. In multivariate analysis, Fon ethnic group (the predominant ethnic group in the study area), regular job, first and second pregnancy, higher baseline pVL and impaired adherence to ART were negative factors whereas higher weight, higher antenatal care attendance and longer ART duration were favorable factors to achieve virologic suppression. This study provides more evidence that ART has to be initiated before the last trimester of pregnancy to achieve an undetectable pVL before delivery. In Benin, new recommendations supporting early initiation were well implemented and, together with a high antenatal care attendance, led to high rate of virologic control.

A tailored implementation strategy to reduce the duration of intravenous antibiotic treatment in community-acquired pneumonia: a controlled before-and-after study.

PubMed

Engel, M F; Bruns, A H W; Hulscher, M E J L; Gaillard, C A J M; Sankatsing, S U C; Teding van Berkhout, F; Emmelot-Vonk, M H; Kuck, E M; Steeghs, M H M; den Breeijen, J H; Stellato, R K; Hoepelman, A I M; Oosterheert, J J

2014-11-01

We previously showed that 40 % of clinically stable patients hospitalised for community-acquired pneumonia (CAP) are not switched to oral therapy in a timely fashion because of physicians' barriers. We aimed to decrease this proportion by implementing a novel protocol. In a multi-centre controlled before-and-after study, we evaluated the effect of an implementation strategy tailored to previously identified barriers to an early switch. In three Dutch hospitals, a protocol dictating a timely switch strategy was implemented using educational sessions, pocket reminders and active involvement of nursing staff. Primary outcomes were the proportion of patients switched timely and the duration of intravenous antibiotic therapy. Length of hospital stay (LOS), patient outcome, education effects 6 months after implementation and implementation costs were secondary outcomes. Statistical analysis was performed using mixed-effects models. Prior to implementation, 146 patients were included and, after implementation, 213 patients were included. The case mix was comparable. The implementation did not change the proportion of patients switched on time (66 %). The median duration of intravenous antibiotic administration decreased from 4 days [interquartile range (IQR) 2-5] to 3 days (IQR 2-4), a decrease of 21 % [95 % confidence interval (CI) 11 %; 30 %) in the multi-variable analysis. LOS and patient outcome were comparable before and after implementation. Forty-three percent (56/129) of physicians attended the educational sessions. After 6 months, 24 % (10/42) of the interviewed attendees remembered the protocol's main message. Cumulative implementation costs were 5,798 (20/reduced intravenous treatment day). An implementation strategy tailored to previously identified barriers reduced the duration of intravenous antibiotic administration in hospitalised CAP patients by 1 day, at minimal cost.

A pressure ulcer prevention programme specially designed for nursing homes: does it work?

PubMed

Kwong, Enid W-Y; Lau, Ada T-Y; Lee, Rainbow L-P; Kwan, Rick Y-C

2011-10-01

The aim of this study was to evaluate a pressure ulcer prevention programme for nursing homes to ascertain the feasibility of its implementation, impact on care staff and outcomes for pressure ulcer knowledge and skills and pressure ulcer reduction. No pressure ulcer prevention protocol for long-term care settings has been established to date. The first author of this study thus developed a pressure ulcer prevention programme for nursing homes. A quasi-experimental pretest and post-test design was adopted. Forty-one non-licensed care providers and eleven nurses from a government-subsidised nursing home voluntarily participated in the study. Knowledge and skills of the non-licensed care providers were assessed before, immediately after and six weeks after the training course, and pressure ulcer prevalence and incidence were recorded before and during the protocol implementation. At the end of the programme implementation, focus group interviews with the subjects were conducted to explore their views on the programme. A statistically significant improvement in knowledge and skills scores amongst non-licensed care providers was noted. Pressure ulcer prevalence and incidence rates dropped from 9-2·5% and 2·5-0·8%, respectively, after programme implementation. The focus group findings indicated that the programme enhanced the motivation of non-licensed care providers to improve their performance of pressure ulcer prevention care and increased communication and cooperation amongst care staff, but use of the modified Braden scale was considered by nurses to increase their workload. A pressure ulcer prevention programme for nursing homes, which was feasible and acceptable, with positive impact and outcome in a nursing home was empirically developed. The study findings can be employed to modify the programme and its outcomes for an evaluation of effectiveness of the programme through a randomised controlled trial. © 2011 Blackwell Publishing Ltd.

The effect of the combination of acids and tannin in diet on the performance and selected biochemical, haematological and antioxidant enzyme parameters in grower pigs.

PubMed

Stukelj, Marina; Valencak, Zdravko; Krsnik, Mladen; Svete, Alenka Nemec

2010-03-06

The abolition of in-feed antibiotics or chemotherapeutics as growth promoters have stimulated the swine industry to look for alternatives such as organic acids, botanicals, probiotics and tannin. The objective of the present study was to compare the effects of a combination of acids and tannin with diet with organic acids and diet without growth promoters on the growth performance and selected biochemical, haematological and antioxidant enzyme parameters in grower pigs. Tannin is more natural and cheaper but possibly with the same effectiveness as organic acids with regard to growth performance. Thirty-six 7 week old grower pigs, divided into three equal groups, were used in a three week feeding trial. Group I was fed basal diet, group II basal diet with added organic acids and group III basal diet with added organic and inorganic acids and tannin. Pigs were weighed before and after feeding and observed daily. Blood was collected before and after the feeding trial for the determination of selected biochemical, haematological and antioxidant enzyme parameters. One-way ANOVA was used to assess any diet related changes of all the parameters. Paired t-test was used to evaluate changes of blood parameters individually in each group of growers before and after feeding. No clinical health problems related to diet were noted during the three week feeding trial. The average daily gain (ADG) and selected blood parameters were not affected by the addition to basal diet of either acids and tannin or of organic acids alone. Selected blood parameters remained within the reference range before and after the feeding trial, with the exception of total serum proteins that were below the lower value of reference range at both times. The significant changes (paired t-test) observed in individual groups before and after the feeding trial are related to the growth of pigs. Diet with acids and tannin did not improve the growth performance of grower pigs but had no deleterious effects on selected blood parameters. The possibility of beneficial effects of adding acids and tannin in diets on growth performance over a longer period, however, could not be excluded.

Dispensing error rate after implementation of an automated pharmacy carousel system.

PubMed

Oswald, Scott; Caldwell, Richard

2007-07-01

A study was conducted to determine filling and dispensing error rates before and after the implementation of an automated pharmacy carousel system (APCS). The study was conducted in a 613-bed acute and tertiary care university hospital. Before the implementation of the APCS, filling and dispensing rates were recorded during October through November 2004 and January 2005. Postimplementation data were collected during May through June 2006. Errors were recorded in three areas of pharmacy operations: first-dose or missing medication fill, automated dispensing cabinet fill, and interdepartmental request fill. A filling error was defined as an error caught by a pharmacist during the verification step. A dispensing error was defined as an error caught by a pharmacist observer after verification by the pharmacist. Before implementation of the APCS, 422 first-dose or missing medication orders were observed between October 2004 and January 2005. Independent data collected in December 2005, approximately six weeks after the introduction of the APCS, found that filling and error rates had increased. The filling rate for automated dispensing cabinets was associated with the largest decrease in errors. Filling and dispensing error rates had decreased by December 2005. In terms of interdepartmental request fill, no dispensing errors were noted in 123 clinic orders dispensed before the implementation of the APCS. One dispensing error out of 85 clinic orders was identified after implementation of the APCS. The implementation of an APCS at a university hospital decreased medication filling errors related to automated cabinets only and did not affect other filling and dispensing errors.

Process evaluation of a multifaceted health program aiming to improve physical activity levels and dietary patterns among construction workers.

PubMed

Viester, Laura; Verhagen, Evert A L M; Bongers, Paulien M; van der Beek, Allard J

2014-11-01

To evaluate the process of a health promotion program, aiming to improve physical activity levels and diet among construction workers. The process evaluation was conducted after the RE-AIM framework for the evaluation of the public health impact of health promotion interventions. Effectiveness was assessed on motivational stage-of-change, self-efficacy, and decisional balance for physical activity and dietary behavior. The external validity of the trial was satisfactory with representative reach of workers and adoption of workplace units in the participating construction company. The extent to which the program was implemented as intended was modest. The intervention was effective on participants' progress through stages of behavior change. Based on the RE-AIM dimensions, it is concluded that for construction workers, the program is feasible and potentially effective, but adjustments are required before widespread implementation.

Depression Care Management: Can Employers Purchase Improved Outcomes?

PubMed Central

Rost, Kathryn; Marshall, Donna; Shearer, Benjamin; Dietrich, Allen J.

2011-01-01

Fourteen vendors are currently selling depression care management products to US employers after randomized trials demonstrate improved work outcomes. The research team interviewed 10 (71.4%) of these vendors to compare their products to four key components of interventions demonstrated to improve work outcomes. Five of 10 depression products incorporate all four key components, three of which are sold by health maintenance organizations (HMOs); however, HMOs did not deliver these components at the recommended intensity and/or duration. Only one product delivered by a disease management company delivered all four components of care at the recommended intensity and duration. This “voltage drop,” which we anticipate will increase with product implementation, suggests that every delivery system should carefully evaluate the design of its depression product before implementation for its capacity to deliver evidence-based care, repeating these evaluations as new evidence emerges. PMID:21738872

Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

PubMed

Stoller, Oliver; de Bruin, Eling D; Schuster-Amft, Corina; Schindelholz, Matthias; de Bie, Rob A; Hunt, Kenneth J

2013-09-22

After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events. This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

Implementing a bedside assessment of respiratory mechanics in patients with acute respiratory distress syndrome.

PubMed

Chen, Lu; Chen, Guang-Qiang; Shore, Kevin; Shklar, Orest; Martins, Concetta; Devenyi, Brian; Lindsay, Paul; McPhail, Heather; Lanys, Ashley; Soliman, Ibrahim; Tuma, Mazin; Kim, Michael; Porretta, Kerri; Greco, Pamela; Every, Hilary; Hayes, Chris; Baker, Andrew; Friedrich, Jan O; Brochard, Laurent

2017-04-04

Despite their potential interest for clinical management, measurements of respiratory mechanics in patients with acute respiratory distress syndrome (ARDS) are seldom performed in routine practice. We introduced a systematic assessment of respiratory mechanics in our clinical practice. After the first year of clinical use, we retrospectively assessed whether these measurements had any influence on clinical management and physiological parameters associated with clinical outcomes by comparing their value before and after performing the test. The respiratory mechanics assessment constituted a set of bedside measurements to determine passive lung and chest wall mechanics, response to positive end-expiratory pressure, and alveolar derecruitment. It was obtained early after ARDS diagnosis. The results were provided to the clinical team to be used at their own discretion. We compared ventilator settings and physiological variables before and after the test. The physiological endpoints were oxygenation index, dead space, and plateau and driving pressures. Sixty-one consecutive patients with ARDS were enrolled. Esophageal pressure was measured in 53 patients (86.9%). In 41 patients (67.2%), ventilator settings were changed after the measurements, often by reducing positive end-expiratory pressure or by switching pressure-targeted mode to volume-targeted mode. Following changes, the oxygenation index, airway plateau, and driving pressures were significantly improved, whereas the dead-space fraction remained unchanged. The oxygenation index continued to improve in the next 48 h. Implementing a systematic respiratory mechanics test leads to frequent individual adaptations of ventilator settings and allows improvement in oxygenation indexes and reduction of the risk of overdistention at the same time. The present study involves data from our ongoing registry for respiratory mechanics (ClinicalTrials.gov identifier: NCT02623192 . Registered 30 July 2015).

The impact of group therapy training on social communications of Afghan immigrants

PubMed Central

Mehrabi, Tayebeh; Musavi, Tayebeh; Ghazavi, Zahra; Zandieh, Zahra; Zamani, Ahmadreza

2011-01-01

BACKGROUND: Mental training considers sharing of mental health care information as the primary objective. The secondary objectives include facilitating dialogue about feelings such as isolation, sadness, labeling, loneliness and possible strategies for confronting with these feelings. Group therapy trainings have supportive functioning in accepting the environment so that the members are able to be part of the indigenous groups. However, no study has been ever done on the impact of this educational method on the communication problems of this group. This study aimed to determine the impact of group therapy training on the communication problems of Afghan immigrants. METHODS: This was a clinical trial study. Eighty-eight Afghan men were investigated. Sampling method was simple sampling method. Thereafter, the study subjects were divided randomly into two groups of test and control based on the inclusion criteria. Data collection tool was a self-made questionnaire about the social problems. For analyzing the data, software SPSS, independent t-test and paired t-test were used. RESULTS: Reviewing the data indicated lower mean score of the social problems after implementing the group therapy training in social communication compared with before implementing the group therapy training. Paired t-test showed a significant difference between mean scores of the social communication problems before and after the implementation of group therapy training. CONCLUSIONS: Given the effectiveness of the intervention, group therapy training on social problems in social communication of Afghan immigrants is recommended. This program should be part of continuous education and training of the Afghan immigrants. PMID:22224098

Reduction in specimen labeling errors after implementation of a positive patient identification system in phlebotomy.

PubMed

Morrison, Aileen P; Tanasijevic, Milenko J; Goonan, Ellen M; Lobo, Margaret M; Bates, Michael M; Lipsitz, Stuart R; Bates, David W; Melanson, Stacy E F

2010-06-01

Ensuring accurate patient identification is central to preventing medical errors, but it can be challenging. We implemented a bar code-based positive patient identification system for use in inpatient phlebotomy. A before-after design was used to evaluate the impact of the identification system on the frequency of mislabeled and unlabeled samples reported in our laboratory. Labeling errors fell from 5.45 in 10,000 before implementation to 3.2 in 10,000 afterward (P = .0013). An estimated 108 mislabeling events were prevented by the identification system in 1 year. Furthermore, a workflow step requiring manual preprinting of labels, which was accompanied by potential labeling errors in about one quarter of blood "draws," was removed as a result of the new system. After implementation, a higher percentage of patients reported having their wristband checked before phlebotomy. Bar code technology significantly reduced the rate of specimen identification errors.

Physicians' satisfaction with a collaborative disease management program for late-life depression in primary care.

PubMed

Levine, Stuart; Unützer, Jürgen; Yip, Judy Y; Hoffing, Marc; Leung, Moon; Fan, Ming-Yu; Lin, Elizabeth H B; Grypma, Lydia; Katon, Wayne; Harpole, Linda H; Langston, Christopher A

2005-01-01

This study describes physicians' satisfaction with care for patients with depression before and after the implementation of a primary care-based collaborative care program. Project Improving Mood, Promoting Access to Collaborative Treatment for late-life depression (IMPACT) is a multisite, randomized controlled trial comparing a primary care-based collaborative disease management program for late-life depression with care as usual. A total of 450 primary care physicians at 18 participating clinics participated in a satisfaction survey before and 12 months after IMPACT initiation. The preintervention survey focused on physicians' satisfaction with current mental health resources and ability to provide depression care. The postintervention survey repeated these and added questions about physician's experience with the IMPACT collaborative care model. Before intervention, about half (54%) of the participating physicians were satisfied with resources to treat patients with depression. After intervention, more than 90% reported the intervention as helpful in treating patients with depression and 82% felt that the intervention improved patients' clinical outcomes. Participating physicians identified proactive patient follow-up and patient education as the most helpful components of the IMPACT model. Physicians perceived a substantial need for improving depression treatment in primary care. They were very satisfied with the IMPACT collaborative care model for treating depressed older adults and felt that similar care management models would also be helpful for treating other chronic medical illnesses.

Impact of an Educational Program to Reduce Healthcare Resources in Community-Acquired Pneumonia: The EDUCAP Randomized Controlled Trial

PubMed Central

Simonetti, Antonella; Jiménez-Martínez, Emilio; Molero, Lorena; González-Samartino, Maribel; Castillo, Elena; Juvé-Udina, María-Eulalia; Alcocer, María-Jesús; Hernández, Carme; Buera, María-Pilar; Roel, Asunción; Abad, Emilia; Zabalegui, Adelaida; Ricart, Pilar; Gonzalez, Anna; Isla, Pilar; Dorca, Jordi; Garcia-Vidal, Carolina

2015-01-01

Background Additional healthcare visits and rehospitalizations after discharge are frequent among patients with community-acquired pneumonia (CAP) and have a major impact on healthcare costs. We aimed to determine whether the implementation of an individualized educational program for hospitalized patients with CAP would decrease subsequent healthcare visits and readmissions within 30 days of hospital discharge. Methods A multicenter, randomized trial was conducted from January 1, 2011 to October 31, 2014 at three hospitals in Spain. We randomly allocated immunocompetent adults patients hospitalized for CAP to receive either an individualized educational program or conventional information before discharge. The educational program included recommendations regarding fluid intake, adherence to drug therapy and preventive vaccines, knowledge and management of the disease, progressive adaptive physical activity, and counseling for alcohol and smoking cessation. The primary trial endpoint was a composite of the frequency of additional healthcare visits and rehospitalizations within 30 days of hospital discharge. Intention-to-treat analysis was performed. Results We assigned 102 patients to receive the individualized educational program and 105 to receive conventional information. The frequency of the composite primary end point was 23.5% following the individualized program and 42.9% following the conventional information (difference, -19.4%; 95% confidence interval, -6.5% to -31.2%; P = 0.003). Conclusions The implementation of an individualized educational program for hospitalized patients with CAP was effective in reducing subsequent healthcare visits and rehospitalizations within 30 days of discharge. Such a strategy may help optimize available healthcare resources and identify post-acute care needs in patients with CAP. Trial Registration Controlled-Trials.com ISRCTN39531840 PMID:26460907

Effects of antithyroid drugs on radioiodine treatment: systematic review and meta-analysis of randomised controlled trials

PubMed Central

Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat

2007-01-01

Objective To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Design Meta-analysis. Data sources Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. Results We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Conclusions Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively. PMID:17309884

Formulary management of recombinant factor VIIa at an academic medical center.

PubMed

Owen, Phillip S; Golightly, Larry K; MacLaren, Robert; Ferretti, Kenneth A; Badesch, David B

2008-06-01

Recombinant human coagulation factor VIIa (rVIIa) is a procoagulant indicated for treatment of bleeding in patients with hemophilia. A large proportion of rVIIa utilization is for off-label administration in nonhemophiliac patients with acute hemorrhage. Concerns of potentially inappropriate use, safety, and cost of rVIIa led to efforts to standardize use of this agent. To comparatively describe the utilization of rVIIa upon implementation of an evidence-based guideline at a university hospital. With advisory direction from a multidisciplinary task force, an evidence-based guideline for use of rVIIa was developed, approved, and fully implemented. Assessment of appropriateness of use and retrospective review were required for all cases. Effects of these actions were evaluated by auditing and comparing rVIIa use in patients treated in two 6-month observation periods before and after guideline implementation. Outcomes assessed were proportions of patients deemed appropriate to receive rVIIa, compliance with dosing recommendations, and acquisition costs. Twenty-two and 29 patients were treated in the periods before and after guideline implementation, respectively. Patient characteristics were similar, except more cardiothoracic surgeries were performed in patients treated before implementation of the guideline. Indications for rVIIa use were judged appropriate in 21 (95.5%) before-cases and in all (100%) after-cases. The dose was compliant in 1 (4.6%) before-case and 27 (93.1%) after-cases (p < 0.001). Mean dosages of rVIIa administered were 81.8 microg/kg and 45.3 microg/kg in before- and after-cases, respectively (p < 0.001). During the respective periods of observation, amounts of rVIIa purchased monthly averaged 42.6 mg and 21.8 mg, a 49% difference. Semiannual expenditures for rVIIa decreased approximately $110,000 following guideline implementation. Patient outcomes were similar. A guideline based on currently available evidence can serve to sustain the clinical appropriateness of rVIIa therapy and substantially decrease costs.

Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

PubMed Central

2012-01-01

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results. PMID:23270486

Protecting intellectual property associated with Canadian academic clinical trials--approaches and impact.

PubMed

Ross, Sue; Magee, Laura; Walker, Mark; Wood, Stephen

2012-12-27

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.

A continuous quality improvement project to improve the quality of cervical Papanicolaou smears.

PubMed

Burkman, R T; Ward, R; Balchandani, K; Kini, S

1994-09-01

To improve the quality of cervical Papanicolaou smears by continuous quality improvement techniques. The study used a Papanicolaou smear data base of over 200,000 specimens collected between June 1988 and December 1992. A team approach employing techniques such as process flow-charting, cause and effect diagrams, run charts, and a randomized trial of collection methods was used to evaluate potential causes of Papanicolaou smear reports with the notation "inadequate" or "less than optimal" due to too few or absent endocervical cells. Once a key process variable (method of collection) was identified, the proportion of Papanicolaou smears with inadequate or absent endocervical cells was determined before and after employment of a collection technique using a spatula and Cytobrush. We measured the rate of less than optimal Papanicolaou smears due to too few or absent endocervical cells. Before implementing the new collection technique fully by June 1990, the overall rate of less than optimal cervical Papanicolaou smears ranged from 20-25%; by December 1993, it had stabilized at about 10%. Continuous quality improvement can be used successfully to study a clinical process and implement change that will lead to improvement.

The Effects of Video Modeling with Voiceover Instruction on Accurate Implementation of Discrete-Trial Instruction

ERIC Educational Resources Information Center

Vladescu, Jason C.; Carroll, Regina; Paden, Amber; Kodak, Tiffany M.

2012-01-01

The present study replicates and extends previous research on the use of video modeling (VM) with voiceover instruction to train staff to implement discrete-trial instruction (DTI). After staff trainees reached the mastery criterion when teaching an adult confederate with VM, they taught a child with a developmental disability using DTI. The…

Trends in Community Pharmacy Counts and Closures before and after the Implementation of Medicare Part D

ERIC Educational Resources Information Center

Klepser, Donald G.; Xu, Liyan; Ullrich, Fred; Mueller, Keith J.

2011-01-01

Purpose: Medicare Part D provided 3.4 million American seniors with prescription drug insurance. It may also have had an unintended effect on pharmacy viability. This study compares trends in the number of pharmacies and rate of pharmacy closures before and after the implementation of Medicare Part D. Methods: This retrospective observational…

Using Minitel Network and New Software Engineering Techniques for Randomized Clinical Trials Management

PubMed Central

Lepage, E.; Tavernier, H.; Bouhaddou, O.; Jais, JP.; Gisselbrecht, C.; Aurengo, A.; Boiron, M.

1989-01-01

The usual Randomized Clinical Trials (RCT) management using an anachronic procedure involving a flowsheet exchange between the remote centers and the coordinating center presents a number of inadequacies. Eligibility criteria are not always verified by the coordinating center before inclusion in the trial and randomization. Laboratory tests and therapeutic adjustments are frequently decided from memory by the clinician which often leads to data oversight and variability of therapeutic decisions. This results in protocol deviations and alteration of the efficiency of the RCT. HICREN is a medical consultation system designed to take into account the different difficulties encountered during RCT driving. The system integrates a clinical database with artificial intelligence technics to manage clinical trial data on non-expensive and widely available Minitel® terminals. Randomization is then possible, after eligibility criteria are satisfied, anytime and anywhere in France through the national telematic network. HICREN also includes an intuitive graphic interface to increase physician's compliance: a user friendly dialogue manager supports on line data entry with multi-windowing facilities and pull down menus. Interactive data validation is achieved through an interface to dedicated C programs. Patient follow up is achieved by an expert system that proposes appropriate dose of treatment according to the rules defined in the trial. At present, HICREN is implemented on the CISARC system for conducting three randomized clinical trials and one epidemiologic study.

Improving Transfer of Learning: An Innovative Comentoring Program to Enhance Workplace Implementation After an Occupational Therapy Course on Autism Spectrum Disorders.

PubMed

Ashburner, Jill; Ziviani, Jenny; Rodger, Sylvia; Hinder, Elizabeth A; Cartmill, Linda; White, Jessica; Vickerstaff, Sandy

2015-01-01

Research suggests that learning gained through training is infrequently implemented in the workplace. A short-term postcourse comentoring program was developed with the aim of facilitating workplace implementation of learning after a 3-day course for occupational therapists. The program was evaluated for usefulness, successes, challenges, recommended improvements, and associations with changes in self-rated knowledge and confidence. Two months after the course, 42 participants completed an evaluation of the comentoring program with closed- and open-ended questions addressing usefulness, successes, challenges, pairing preferences, and recommendations. They also completed a record on whether or not they had worked on goals nominated in their comentoring contract. Before and 2 months after the course, they completed a self-rated questionnaire on knowledge and confidence. The comentoring program was recommended by 80% of participants. Benefits included opportunities for information and resource sharing, debriefing, problem solving, reassurance, and implementation of ideas. Ninety-five percent of participants worked on some or all their comentoring goals. Although there were significant improvements in knowledge (P < 0.001) and confidence (P < 0.001), the total comentoring evaluation score was not significantly associated with these changes. It is therefore possible that these improvements related to the course itself rather than the comentoring program. Challenges related to time, scheduling, distance, and pairing of comentors. Reported benefits of the program included enhanced psychosocial support and prompting to trial newly learned strategies. Effectiveness may be improved by setting aside time for comentoring in the workplace and better matching of comentors.

Implementation of a multi-professional standardized care plan in electronic health records for the care of stroke patients.

PubMed

Pöder, Ulrika; Fogelberg-Dahm, Marie; Wadensten, Barbro

2011-09-01

To compare staff opinions about standardized care plans and self-reported habits with regard to documentation, and their perceived knowledge about the evidence-based guidelines in stroke care before and after implementation of an evidence-based-standardized care plan (EB-SCP) and quality standard for stroke care. The aim was also to describe staff opinions about, and their use of, the implemented EB-SCP. To facilitate evidence-based practice (EBP), a multi-professional EB-SCP and quality standard for stroke care was implemented in the electronic health record (EHR). Quantitative, descriptive and comparative, based on questionnaires completed before and after implementation. Perceived knowledge about evidence-based guidelines in stroke care increased after implementation of the EB-SCP. The majority agreed that the EB-SCP is useful and facilitates their work. There was no change between before and after implementation with regard to opinions about standardized care plans, self-reported documentation habits or time spent on documentation. An evidence-based SCP seems to be useful in patient care and improves perceived knowledge about evidence-based guidelines in stroke care. For nursing managers, introduction of evidence-based SCP in the EHR may improve the prerequisites for promoting high-quality EBP in multi-professional care. 2011 Blackwell Publishing Ltd.

Accuracy of Cardiac Output by Nine Different Pulse Contour Algorithms in Cardiac Surgery Patients: A Comparison with Transpulmonary Thermodilution.

PubMed

Broch, Ole; Bein, Berthold; Gruenewald, Matthias; Masing, Sarah; Huenges, Katharina; Haneya, Assad; Steinfath, Markus; Renner, Jochen

2016-01-01

Objective. Today, there exist several different pulse contour algorithms for calculation of cardiac output (CO). The aim of the present study was to compare the accuracy of nine different pulse contour algorithms with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB). Methods. Thirty patients scheduled for elective coronary surgery were studied before and after CPB. A passive leg raising maneuver was also performed. Measurements included CO obtained by transpulmonary thermodilution (CO TPTD ) and by nine pulse contour algorithms (CO X1-9 ). Calibration of pulse contour algorithms was performed by esophageal Doppler ultrasound after induction of anesthesia and 15 min after CPB. Correlations, Bland-Altman analysis, four-quadrant, and polar analysis were also calculated. Results. There was only a poor correlation between CO TPTD and CO X1-9 during passive leg raising and in the period before and after CPB. Percentage error exceeded the required 30% limit. Four-quadrant and polar analysis revealed poor trending ability for most algorithms before and after CPB. The Liljestrand-Zander algorithm revealed the best reliability. Conclusions. Estimation of CO by nine different pulse contour algorithms revealed poor accuracy compared with transpulmonary thermodilution. Furthermore, the less-invasive algorithms showed an insufficient capability for trending hemodynamic changes before and after CPB. The Liljestrand-Zander algorithm demonstrated the highest reliability. This trial is registered with NCT02438228 (ClinicalTrials.gov).

Sustaining the Control of Schistosoma mansoni in Western Côte d'Ivoire: Baseline Findings before the Implementation of a Randomized Trial

PubMed Central

Assaré, Rufin K.; Hürlimann, Eveline; Ouattara, Mamadou; N'Guessan, Nicaise A.; Tian-Bi, Yves-Nathan T.; Yapi, Ahoua; Yao, Patrick K.; Coulibaly, Jean T.; Knopp, Stefanie; N'Goran, Eliézer K.; Utzinger, Jürg

2016-01-01

We report baseline findings before the implementation of a 4-year intervention trial designed to assess the impact of three different school-based treatment schedules with praziquantel to sustain the control of intestinal schistosomiasis. The baseline survey was conducted in 75 schools of western Côte d'Ivoire previously identified with moderate Schistosoma mansoni endemicity (prevalence: 10–24% in children aged 13–14 years). Three stool samples collected over consecutive days were subjected to duplicate Kato-Katz thick smears each. A questionnaire was administered to collect village-specific information that is relevant for schistosomiasis transmission. Overall, 4,953 first graders (aged 5–8 years) and 7,011 school children (aged 9–12 years) had complete parasitologic data. The overall prevalence of S. mansoni was 5.4% among first graders and 22.1% in 9- to 12-year-old children. Open defecation was practiced in all villages. The current baseline findings will be important to better understand the dynamics of S. mansoni prevalence and intensity over the course of this trial that might be governed by village characteristics and specific treatment interventions. PMID:26598571

Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial

PubMed Central

2013-01-01

Background After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. Methods/Design This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject’s inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Discussion Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events. Trial registration This trial is registered with the Clinical Trials.gov Registry (NCT01679600). PMID:24053609

Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information.

PubMed

Saillour-Glénisson, Florence; Duhamel, Sylvie; Fourneyron, Emmanuelle; Huiart, Laetitia; Joseph, Jean Philippe; Langlois, Emmanuel; Pincemail, Stephane; Ramel, Viviane; Renaud, Thomas; Roberts, Tamara; Sibé, Matthieu; Thiessard, Frantz; Wittwer, Jerome; Salmi, Louis Rachid

2017-04-21

Improvement of coordination of all health and social care actors in the patient pathways is an important issue in many countries. Health Information (HI) technology has been considered as a potentially effective answer to this issue. The French Health Ministry first funded the development of five TSN ("Territoire de Soins Numérique"/Digital health territories) projects, aiming at improving healthcare coordination and access to information for healthcare providers, patients and the population, and at improving healthcare professionals work organization. The French Health Ministry then launched a call for grant to fund one research project consisting in evaluating the TSN projects implementation and impact and in developing a model for HI technology evaluation. EvaTSN is mainly based on a controlled before-after study design. Data collection covers three periods: before TSN program implementation, during early TSN program implementation and at late TSN program implementation, in the five TSN projects' territories and in five comparison territories. Three populations will be considered: "TSN-targeted people" (healthcare system users and people having characteristics targeted by the TSN projects), "TSN patient users" (people included in TSN experimentations or using particular services) and "TSN professional users" (healthcare professionals involved in TSN projects). Several samples will be made in each population depending on the objective, axis and stage of the study. Four types of data sources are considered: 1) extractions from the French National Heath Insurance Database (SNIIRAM) and the French Autonomy Personalized Allowance database, 2) Ad hoc surveys collecting information on knowledge of TSN projects, TSN program use, ease of use, satisfaction and understanding, TSN pathway experience and appropriateness of hospital admissions, 3) qualitative analyses using semi-directive interviews and focus groups and document analyses and 4) extractions of TSN implementation indicators from TSN program database. EvaTSN is a challenging French national project for the production of evidenced-based information on HI technologies impact and on the context and conditions of their effectiveness and efficiency. We will be able to support health care management in order to implement HI technologies. We will also be able to produce an evaluation toolkit for HI technology evaluation. ClinicalTrials.gov ID: NCT02837406 , 08/18/2016.

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial

PubMed Central

2013-01-01

Background In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of ‘Smoke Free Homes’, an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. Methods/Design This is a pilot cluster randomised controlled trial of ‘Smoke Free Homes’, with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. Discussion The results of this pilot study will inform the protocol for a definitive trial. Trial registration Current Controlled Trials ISRCTN03035510 PMID:24034853

Sustaining High Quality Teaching and Evidence-based Curricula: Follow-up Assessment of Teachers in the REDI Project

PubMed Central

Bierman, Karen L; DeRousie, Rebecca M. Sanford; Heinrichs, Brenda; Domitrovich, Celene E.; Greenberg, Mark T.; Gill, Sukhdeep

2013-01-01

Recent research has validated the power of evidence-based preschool interventions to improve teaching quality and promote child school readiness when implemented in the context of research trials. However, very rarely are follow-up assessments conducted with teachers in order to evaluate the maintenance of improved teaching quality or sustained use of evidence-based curriculum components after the intervention trial. In the current study, we collected follow-up assessments of teachers one year after their involvement in the REDI research trial to evaluate the extent to which intervention teachers continued to implement the REDI curriculum components with high-quality, and to explore possible pre-intervention predictors of sustained implementation. In addition, we conducted classroom observations to determine whether general improvements in the teaching quality of intervention teachers (relative to control group teachers) were sustained. Results indicated sustained high-quality implementation of some curriculum components (the PATHS curriculum), but decreased implementation of other components (the language-literacy components). Sustained intervention effects were evident on most aspects of general teaching quality targeted by the intervention. Implications for practice and policy are discussed. PMID:24204101

Immediate pre-meal water ingestion decreases voluntary food intake in lean young males.

PubMed

Corney, Robert A; Sunderland, Caroline; James, Lewis J

2016-03-01

Consuming 375-500 ml of water 30 min before a meal has been shown to reduce energy intake in older, but not younger adults. This study investigated the effects of ingesting a water preload immediately pre-meal (<1 min before eating) on within-meal ad libitum energy intake in non-obese young males. Fourteen healthy males [mean (SD) age 27 (3) years, height 1.83 (0.05) m, body weight 80.47 (9.89) kg, body fat 17.5 (4.0) %, body mass index 24.0 (2.5) kg/m(2)] completed a familiarisation trial and two experimental trials in randomised counterbalanced order. Subjects arrived at the laboratory overnight fasted and consumed an ad libitum porridge breakfast. Immediately prior to the meal, subjects consumed either a 568 ml (1 pint) water preload (preload trial) or no preload (control trial). Visual analogue scale questionnaires to assess hunger, fullness and satisfaction were completed before and after the meal in both trials, as well as after the water preload. Ad libitum energy intake was greater (P < 0.001) during control [2551 (562) kJ] than preload [1967 (454) kJ]. Ad libitum water intake was also greater (P < 0.001) during control [318 (226-975) ml] than preload [116 (0-581) ml]. The water preload increased fullness and satisfaction and decreased hunger compared to pre-trial (P < 0.001) and the control trial (P < 0.001). This study demonstrates that consumption of a 568 ml water preload immediately before a meal reduces energy intake in non-obese young males. This might therefore be an effective strategy to suppress energy intake in this population and possibly assist with weight management.

The Use of Electronic Sensor Device to Augment Ligament Balancing Leads to a Lower Rate of Arthrofibrosis After Total Knee Arthroplasty.

PubMed

Geller, Jeffrey A; Lakra, Akshay; Murtaugh, Taylor

2017-05-01

Total knee arthroplasty (TKA) is a highly successful surgery shown to improve quality of life. One of the more common known complications of TKA is early arthrofibrosis requiring manipulation under anesthesia (MUA). This investigation evaluates the incidence of arthrofibrosis before and after the implementation of an electronic sensor device used to assist with ligament balancing. Six hundred ninety TKAs performed without sensor use were compared to a cohort of 252 TKAs performed with sensor usage. Prior to usage, there was a 5% rate of MUA after TKA, while after implementation, the MUA rate went down to 1.6% (P = .004). Ligament balancing using sensor assistance led to a statistically significant decrease in MUA in this cohort of patients. An odds ratio analysis also demonstrated that non-sensor patients had a 3.2× higher likelihood of requiring MUA than the sensor patients. The use of an electronic sensor device during trialing of TKA with resultant improved ligamentous balancing led to a statistically significant reduction in the rate of MUA in this cohort of patients. This type of approach to ligamentous balancing may continue to show evidence of improved clinical outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

[The effectiveness of therapeutic touch on pain, depression and sleep in patients with chronic pain: clinical trial].

PubMed

Marta, Ilda Estefani Ribeiro; Baldan, Sueli Santiago; Berton, Ani Fabiana; Pavam, Michele; da Silva, Maria Júlia Paes

2010-12-01

This research aimed to check the effectiveness of Therapeutic Touch on decreased pain intensity, depression self-assessment scores and improved sleep quality. A clinical before-after trial is presented. The study was carried out at a Basic Health Unit in Fernandópolis, SP-Brazil, involving 30 elderly patients with chronic non-oncologic pain who received 8 sessions of Therapeutic Touch in accordance with the Krieger-Kunz method. The Visual Analogue Scale for pain was applied before and after each session, and Beck Depression Inventory and the Pittsburgh Sleep Quality Index before the first and after the last session. Data analysis showed a significant decrease (p < 0.05) in pain intensity, depression self-assessment scores and the sleep quality index. It is concluded that the Therapeutic Touch was effective to decrease pain intensity and depressive attitudes and symptoms, as well as to improve sleep quality.

Transabdominal amnioinfusion for improving fetal outcomes after oligohydramnios secondary to preterm prelabour rupture of membranes before 26 weeks.

PubMed

Van Teeffelen, Stijn; Pajkrt, Eva; Willekes, Christine; Van Kuijk, Sander M J; Mol, Ben Willem J

2013-08-03

Preterm prelabour rupture of membranes (PPROM) before 26 weeks can delay lung development and can cause pulmonary hypoplasia, as a result of oligohydramnios. Restoring the amniotic fluid volume by transabdominal amnioinfusion might prevent abnormal lung development and might have a protective effect for neurological complications, fetal deformities and neonatal sepsis. To assess the effectiveness of transabdominal amnioinfusion in improving perinatal outcome in women with oligohydramnios secondary to rupture of fetal membranes before 26 weeks. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). All randomised controlled trials comparing transabdominal amnioinfusion with no transabdominal amnioinfusion. Cluster- or quasi-randomised trials were not eligible for inclusion. In cases where only an abstract was available, we attempted to find the full articles. Two review authors assessed trials for inclusion. No eligible trials were identified. There are no included studies. There is currently no evidence to evaluate the use of transabdominal amnioinfusion in women with oligohydramnios secondary to rupture of fetal membranes before 26 weeks for improving perinatal outcome. Further research examining the effects of this intervention is needed. Two randomised controlled trials are ongoing but final data have not yet been published.

Quality of life following trauma before and after implementation of a physician-staffed helicopter.

PubMed

Funder, K S; Rasmussen, L S; Hesselfeldt, R; Siersma, V; Lohse, N; Sonne, A; Wulffeld, S; Steinmetz, J

2017-01-01

Implementation of a physician-staffed helicopter emergency medical service (PS-HEMS) in Denmark was associated with lower 30-day mortality in severely injured trauma patients and less time on social subsidy. However, the reduced 30-day mortality in severely injured patients might be at the expense of a worse functional outcome and quality of life (QoL) in those who survive. The aim of this study was to investigate the effect of a physician-staffed helicopter on long-term QoL in trauma patients. Prospective, observational study including trauma patients who survived at least 3 years after injury. A 5-month period prior to PS-HEMS implementation was compared with the first 12 months after PS-HEMS implementation. QoL was assessed 4.5 years after trauma by the SF-36 questionnaire. Primary endpoint was the Physical Component Summary score. Of the 1994 patients assessed by a trauma team, 1521 were eligible for inclusion in the study. Of these, 566 (37%) gave consent to participate and received a questionnaire by mail, and 402 (71%) of them returned the questionnaire (n = 114 before PS-HEMS; n = 288 after PS-HEMS implementation). Older patients, women and patients with trauma in the after PS-HEMS period were more likely to return the questionnaire. No significant association between QoL and period (before vs. after PS-HEMS) was found; the Physical Component Summary scores were 50.0 and 50.9 in the before and after PS-HEMS periods, respectively (P = 0.47). We also found no difference on multivariable analysis with adjustment for sex, age and injury severity score. No significant difference in QoL among trauma patients was found after implementation of a PS-HEMS. © 2016 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

The Impact of a Management Protocol on the Outcomes of Child Abuse in Hospitalized Children in Hong Kong

ERIC Educational Resources Information Center

Lee, Anselm C. W.; Li, C. H.; So, K. T.

2006-01-01

Objective: To study the outcomes of children hospitalized for suspected child abuse before and after the implementation of a management protocol in a hospital in Hong Kong. Study period: Two 2-year periods before (1994-1995) and after (2002-2003) the implementation of the protocol in 1998. Methods: This is a retrospective hospital chart review in…

A randomized controlled trial of a brief online intervention to reduce alcohol consumption in new university students: Combining self-affirmation, theory of planned behaviour messages, and implementation intentions.

PubMed

Norman, Paul; Cameron, David; Epton, Tracy; Webb, Thomas L; Harris, Peter R; Millings, Abigail; Sheeran, Paschal

2018-02-01

Excessive alcohol consumption increases when students enter university. This study tests whether combining (1) messages that target key beliefs from the theory of planned behaviour (TPB) that underlie binge drinking, (2) a self-affirmation manipulation to reduce defensive processing, and (3) implementation intentions (if-then plans to avoid binge drinking) reduces alcohol consumption in the first 6 months at university. A 2 (self-affirmation) × 2 (TPB messages) × 2 (implementation intention) between-participants randomized controlled trial with 6-month follow-up. Before starting university, students (N = 2,951) completed measures of alcohol consumption and were randomly assigned to condition in a full-factorial design. TPB cognitions about binge drinking were assessed immediately post-intervention (n = 2,682). Alcohol consumption was assessed after 1 week (n = 1,885), 1 month (n = 1,389), and 6 months (n = 892) at university. TPB cognitions were assessed again at 1 and 6 months. Participants who received the TPB messages had significantly less favourable cognitions about binge drinking (except perceived control), consumed fewer units of alcohol, engaged in binge drinking less frequently, and had less harmful patterns of alcohol consumption during their first 6 months at university. The other main effects were non-significant. The findings support the use of TPB-based interventions to reduce students' alcohol consumption, but question the use of self-affirmation and implementation intentions before starting university when the messages may not represent a threat to self-identity and when students may have limited knowledge and experience of the pressures to drink alcohol at university. Statement of contribution What is already known on this subject? Alcohol consumption increases when young people enter university. Significant life transitions represent potential teachable moments to change behaviour. Interventions with a strong theoretical basis have been found to be more effective. What does this study add? A brief online intervention delivered to students before they start university can reduce alcohol consumption. The theory of planned behaviour can be used to inform the design of interventions to change health behaviour. © 2017 The British Psychological Society.

Home-exercise Childhood Obesity Intervention: A Randomized Clinical Trial Comparing Print Versus Web-based (Move It) Platforms.

PubMed

Bruñó, Alejandro; Escobar, Patricia; Cebolla, Ausias; Álvarez-Pitti, Julio; Guixeres, Jaime; Lurbe, Empar; Baños, Rosa; Lisón, Juan F

2018-05-07

To compare the impact of adhering to a Mediterranean diet plus mixed physical exercise program (Move-It) implemented by means of printed instructions or via a web-platform (with or without e-mail support) on body composition, physical fitness, and blood pressure. Randomized clinical trial. Fifty-two overweight or obese Spanish children and adolescents were randomly assigned to the print-based (n = 18), Move-It (n = 18), or Move-It plus support (n = 16) intervention groups. Two-way mixed ANOVA tests were used to compare any changes between the groups in terms of percentage body fat, physical fitness (VO 2 peak), handgrip strength, and systolic and diastolic blood pressure. The measurements were taken before and after a three-month mixed-exercise (aerobic and resistance) and Mediterranean-diet program which was either implemented by means of printed instructions or via a web-platform (with or without e-mail support). No statistical differences were found between groups. However, the results highlighted significant improvements in body fat percentage metrics over time for all three groups (print-based: -1.8%, 95%CI -3.3% to -0.3%; Move-It: -1.8%, 95%CI -3.3% to -0.3%; Move-It plus support: -2.0%, 95%CI -3.7% to -0.4%, P < 0.05). We also observed a tendency towards improvement in the VO 2 peak, handgrip strength, and blood pressure variable values 10 min after the exercise-stress test in these three groups. The program improved the body composition, regardless of the way it is implemented. A mixed physical exercise program lasting for three months, combined with a Mediterranean diet, improves the body composition of children and adolescents with overweight/obesity. Copyright © 2018 Elsevier Inc. All rights reserved.

Recovery of gait after quadriceps muscle fatigue.

PubMed

Barbieri, Fabio Augusto; Beretta, Stephannie Spiandor; Pereira, Vinicius A I; Simieli, Lucas; Orcioli-Silva, Diego; dos Santos, Paulo Cezar Rocha; van Dieën, Jaap H; Gobbi, Lilian Teresa Bucken

2016-01-01

The aim of this study was to investigate the effect of recovery time after quadriceps muscle fatigue on gait in young adults. Forty young adults (20-40 years old) performed three 8-m gait trials at preferred velocity before and after muscle fatigue, and after 5, 10 and 20min of passive rest. In addition, at each time point, two maximal isometric voluntary contractions were preformed. Muscle fatigue was induced by repeated sit-to-stand transfers until task failure. Spatio-temporal, kinetic and muscle activity parameters, measured in the central stride of each trial, were analyzed. Data were compared between before and after the muscle fatigue protocol and after the recovery periods by one-way repeated measures ANOVA. The voluntary force was decreased after the fatigue protocol (p<0.001) and after 5, 10 and 20min of recovery compared to before the fatigue protocol. Step width (p<0.001) and RMS of biceps femoris (p<0.05) were increased immediately after the fatigue protocol and remained increased after the recovery periods. In addition, stride duration was decreased immediately after the fatigue protocol compared to before and to after 10 and 20min of rest (p<0.001). The anterior-posterior propulsive impulse was also decreased after the fatigue protocol (p<0.001) and remained low after 5, 10 and 20min of rest. We conclude that 20min is not enough to see full recovery of gait after exhaustive quadriceps muscle fatigue. Copyright © 2015 Elsevier B.V. All rights reserved.

Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN60695184 (date of registration: 13 May 2009), ISRCTN80061723 (date of registration: 8 March 2010), ISRCTN69423238 (date of registration: 18 November 2010).

Implementing an Ebola Vaccine Study - Sierra Leone.

PubMed

Widdowson, Marc-Alain; Schrag, Stephanie J; Carter, Rosalind J; Carr, Wendy; Legardy-Williams, Jennifer; Gibson, Laura; Lisk, Durodami R; Jalloh, Mohamed I; Bash-Taqi, Donald A; Kargbo, Samuel A Sheku; Idriss, Ayesha; Deen, Gibrilla F; Russell, James B W; McDonald, Wendi; Albert, Alison P; Basket, Michelle; Callis, Amy; Carter, Victoria M; Ogunsanya, Kelli R Clifton; Gee, Julianne; Pinner, Robert; Mahon, Barbara E; Goldstein, Susan T; Seward, Jane F; Samai, Mohamed; Schuchat, Anne

2016-07-08

In October 2014, the College of Medicine and Allied Health Sciences of the University of Sierra Leone, the Sierra Leone Ministry of Health and Sanitation, and CDC joined the global effort to accelerate assessment and availability of candidate Ebola vaccines and began planning for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). STRIVE was an individually randomized controlled phase II/III trial to evaluate efficacy, immunogenicity, and safety of the recombinant vesicular stomatitis virus Ebola vaccine (rVSV-ZEBOV). The study population was health care and frontline workers in select chiefdoms of the five most affected districts in Sierra Leone. Participants were randomized to receive a single intramuscular dose of rVSV-ZEBOV at enrollment or to receive a single intramuscular dose 18-24 weeks after enrollment. All participants were followed up monthly until 6 months after vaccination. Two substudies separately assessed detailed reactogenicity over 1 month and immunogenicity over 12 months. During the 5 months before the trial, STRIVE and partners built a research platform in Sierra Leone comprising participant follow-up sites, cold chain, reliable power supply, and vaccination clinics and hired and trained at least 350 national staff. Wide-ranging community outreach, informational sessions, and messaging were conducted before and during the trial to ensure full communication to the population of the study area regarding procedures and current knowledge about the trial vaccine. During April 9-August 15, 2015, STRIVE enrolled 8,673 participants, of whom 453 and 539 were also enrolled in the safety and immunogenicity substudies, respectively. As of April 28, 2016, no Ebola cases and no vaccine-related serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability, were reported in the study population. Although STRIVE will not produce an estimate of vaccine efficacy because of low case frequency as the epidemic was controlled, data on safety and immunogenicity will support decisions on licensure of rVSV-ZEBOV.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).

Memory Retrieval before or after Extinction Reduces Recovery of Fear in Adolescent Rats

ERIC Educational Resources Information Center

Baker, Kathryn D.; McNally, Gavan P.; Richardson, Rick

2013-01-01

Adolescent rats exhibit impaired extinction retention compared to pre-adolescent and adult rats. A single nonreinforced exposure to the conditioned stimulus (CS; a retrieval trial) given shortly before extinction has been shown in some circumstances to reduce the recovery of fear after extinction in adult animals. This study investigated whether a…

Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

PubMed Central

Daud Albasini, Omar A.; Oboe, Roberto; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain. PMID:24319496

Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

PubMed

Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial.

PubMed

Ainsworth, Hannah; Shah, Sarwat; Ahmed, Faraz; Amos, Amanda; Cameron, Ian; Fairhurst, Caroline; King, Rebecca; Mir, Ghazala; Parrott, Steve; Sheikh, Aziz; Torgerson, David; Thomson, Heather; Siddiqi, Kamran

2013-09-13

In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of 'Smoke Free Homes', an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. This is a pilot cluster randomised controlled trial of 'Smoke Free Homes', with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. The results of this pilot study will inform the protocol for a definitive trial. Current Controlled Trials ISRCTN03035510.

Influence of Lumbar Muscle Fatigue on Trunk Adaptations during Sudden External Perturbations

PubMed Central

Abboud, Jacques; Nougarou, François; Lardon, Arnaud; Dugas, Claude; Descarreaux, Martin

2016-01-01

Introduction: When the spine is subjected to perturbations, neuromuscular responses such as reflex muscle contractions contribute to the overall balance control and spinal stabilization mechanisms. These responses are influenced by muscle fatigue, which has been shown to trigger changes in muscle recruitment patterns. Neuromuscular adaptations, e.g., attenuation of reflex activation and/or postural oscillations following repeated unexpected external perturbations, have also been described. However, the characterization of these adaptations still remains unclear. Using high-density electromyography (EMG) may help understand how the nervous system chooses to deal with an unknown perturbation in different physiological and/or mechanical perturbation environments. Aim: To characterize trunk neuromuscular adaptations following repeated sudden external perturbations after a back muscle fatigue task using high-density EMG. Methods: Twenty-five healthy participants experienced a series of 15 sudden external perturbations before and after back muscle fatigue. Erector spinae muscle activity was recorded using high-density EMG. Trunk kinematics during perturbation trials were collected using a 3-D motion analysis system. A two-way repeated measure ANOVA was conducted to assess: (1) the adaptation effect across trials; (2) the fatigue effect; and (3) the interaction effect (fatigue × adaptation) for the baseline activity, the reflex latency, the reflex peak and trunk kinematic variables (flexion angle, velocity and time to peak velocity). Muscle activity spatial distribution before and following the fatigue task was also compared using t-tests for dependent samples. Results: An attenuation of muscle reflex peak was observed across perturbation trials before the fatigue task, but not after. The spatial distribution of muscle activity was significantly higher before the fatigue task compared to post-fatigue trials. Baseline activity showed a trend to higher values after muscle fatigue, as well as reduction through perturbation trials. Main effects of fatigue and adaptation were found for time to peak velocity. No adaptation nor fatigue effect were identified for reflex latency, flexion angle or trunk velocity. Conclusion: The results show that muscle fatigue leads to reduced spatial distribution of back muscle activity and suggest a limited ability to use across-trial redundancy to adapt EMG reflex peak and optimize spinal stabilization using retroactive control. PMID:27895569

Knowledge translation strategies for enhancing nurses' evidence-informed decision making: a scoping review.

PubMed

Yost, Jennifer; Thompson, David; Ganann, Rebecca; Aloweni, Fazila; Newman, Kristine; McKibbon, Ann; Dobbins, Maureen; Ciliska, Donna

2014-06-01

Nurses are increasingly expected to engage in evidence-informed decision making (EIDM); the use of research evidence with information about patient preferences, clinical context and resources, and their clinical expertise in decision making. Strategies for enhancing EIDM have been synthesized in high-quality systematic reviews, yet most relate to physicians or mixed disciplines. Existing reviews, specific to nursing, have not captured a broad range of strategies for promoting the knowledge and skills for EIDM, patient outcomes as a result of EIDM, or contextual information for why these strategies "work." To conduct a scoping review to identify and map the literature related to strategies implemented among nurses in tertiary care for promoting EIDM knowledge, skills, and behaviours, as well as patient outcomes and contextual implementation details. A search strategy was developed and executed to identify relevant research evidence. Participants included registered nurses, clinical nurse specialists, nurse practitioners, and advanced practice nurses. Strategies were those enhancing nurses' EIDM knowledge, skills, or behaviours, as well as patient outcomes. Relevant studies included systematic reviews, randomized controlled trials, cluster randomized controlled trials, non-randomized trials (including controlled before and after studies), cluster non-randomized trials, interrupted time series designs, prospective cohort studies, mixed-method studies, and qualitative studies. Two reviewers performed study selection and data extraction using standardized forms. Disagreements were resolved through discussion or third party adjudication. Using a narrative synthesis, the body of research was mapped by design, clinical areas, strategies, and provider and patient outcomes to determine areas appropriate for a systematic review. There are a sufficiently high number of studies to conduct a more focused systematic review by care settings, study design, implementation strategies, or outcomes. A focused review could assist in determining which strategies can be recommended for enhancing EIDM knowledge, skills, and behaviours among nurses in tertiary care. © 2014 The Authors. Worldviews on Evidence-Based Nursing published by Wiley Periodicals, Inc. on behalf of Sigma Theta Tau International.

[Human papillomavirus vaccine. Efficacy and safety].

PubMed

Bruni, Laia; Serrano, Beatriz; Bosch, Xavier; Castellsagué, Xavier

2015-05-01

Human papillomavirus (HPV) related disease remains a major cause of morbidity and mortality worldwide. Prophylactic vaccines have been recognized as the most effective intervention to control for HPV-related diseases. This article reviews the major phaseii/iii trials of the bivalent (HPVs16/18), quadrivalent (HPVs6/11/16/18), and the recently approved 9-valent vaccine (HPVs6/11/16/18/31/33/45/52/58). Large trials have been conducted showing the safety, immunogenicity and high efficacy of the bivalent and quadrivalent vaccines in the prevention of pre-invasive lesions and infection, especially when administered at young ages before exposure to HPV. Trials of the 9-valent vaccine have also demonstrated the safety, immunogenicity and efficacy of the vaccine in the prevention of infection and disease associated with the vaccine types, and its potential to substantially increase the overall prevention of HPV-related diseases. Post-licensure country reports have shown the recent and early impact of these vaccines at population level after the implementation of established HPV vaccination programs, including decreases in the prevalence of vaccine HPV types, the incidence of genital warts, and the incidence of high-grade cervical abnormalities. If widely implemented, current HPV vaccines may drastically reduce the incidence of cervical cancer and other HPV-related cancers and diseases. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

The effect of the combination of acids and tannin in diet on the performance and selected biochemical, haematological and antioxidant enzyme parameters in grower pigs

PubMed Central

2010-01-01

Background The abolition of in-feed antibiotics or chemotherapeutics as growth promoters have stimulated the swine industry to look for alternatives such as organic acids, botanicals, probiotics and tannin. The objective of the present study was to compare the effects of a combination of acids and tannin with diet with organic acids and diet without growth promoters on the growth performance and selected biochemical, haematological and antioxidant enzyme parameters in grower pigs. Tannin is more natural and cheaper but possibly with the same effectiveness as organic acids with regard to growth performance. Methods Thirty-six 7 week old grower pigs, divided into three equal groups, were used in a three week feeding trial. Group I was fed basal diet, group II basal diet with added organic acids and group III basal diet with added organic and inorganic acids and tannin. Pigs were weighed before and after feeding and observed daily. Blood was collected before and after the feeding trial for the determination of selected biochemical, haematological and antioxidant enzyme parameters. One-way ANOVA was used to assess any diet related changes of all the parameters. Paired t-test was used to evaluate changes of blood parameters individually in each group of growers before and after feeding. Results No clinical health problems related to diet were noted during the three week feeding trial. The average daily gain (ADG) and selected blood parameters were not affected by the addition to basal diet of either acids and tannin or of organic acids alone. Selected blood parameters remained within the reference range before and after the feeding trial, with the exception of total serum proteins that were below the lower value of reference range at both times. The significant changes (paired t-test) observed in individual groups before and after the feeding trial are related to the growth of pigs. Conclusion Diet with acids and tannin did not improve the growth performance of grower pigs but had no deleterious effects on selected blood parameters. The possibility of beneficial effects of adding acids and tannin in diets on growth performance over a longer period, however, could not be excluded. PMID:20205921

Sample size calculations for stepped wedge and cluster randomised trials: a unified approach

PubMed Central

Hemming, Karla; Taljaard, Monica

2016-01-01

Objectives To clarify and illustrate sample size calculations for the cross-sectional stepped wedge cluster randomized trial (SW-CRT) and to present a simple approach for comparing the efficiencies of competing designs within a unified framework. Study Design and Setting We summarize design effects for the SW-CRT, the parallel cluster randomized trial (CRT), and the parallel cluster randomized trial with before and after observations (CRT-BA), assuming cross-sectional samples are selected over time. We present new formulas that enable trialists to determine the required cluster size for a given number of clusters. We illustrate by example how to implement the presented design effects and give practical guidance on the design of stepped wedge studies. Results For a fixed total cluster size, the choice of study design that provides the greatest power depends on the intracluster correlation coefficient (ICC) and the cluster size. When the ICC is small, the CRT tends to be more efficient; when the ICC is large, the SW-CRT tends to be more efficient and can serve as an alternative design when the CRT is an infeasible design. Conclusion Our unified approach allows trialists to easily compare the efficiencies of three competing designs to inform the decision about the most efficient design in a given scenario. PMID:26344808

Results of implementation of a hospital-based strategy to reduce cesarean delivery among low-risk women in Canada.

PubMed

Shoemaker, Esther S; Bourgeault, Ivy L; Cameron, Carol; Graham, Ian D; Hutton, Eileen K

2017-11-01

To assess the cesarean delivery (CD) rate among low-risk pregnancies before and after implementation of a hospital-based program in Canada. A prospective before-and-after study was conducted to assess the effects of the CARE (CAesarean REduction) strategy, which was developed and implemented at Markham Stouffville Hospital, Toronto, ON, Canada, in 2010 to reduce CD among low-risk women. Hospital records were reviewed to identify changes in the proportions of CD performed during 12 months (April 2009-March 2010) before implementation of the CARE strategy versus 12 months after implementation (April 2012-March 2013) at Markham Stouffville Hospital and 36 hospitals of the same level in the same province. At the intervention hospital, 30.3% (964/3181) of women underwent CD in 2009-2010, compared with 26.4% (803/3045) in 2012-2013 (difference -3.9%, P<0.001). By contrast, no significant difference was recorded in control hospitals (28.1% [23 694/84 361] vs 28.2% [23 683/83 895]; difference 0.1%, P=0.5157). Implementation of the CARE strategy reduced rates of CD among the target population. © 2017 International Federation of Gynecology and Obstetrics.

PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial.

PubMed

Hammond, Simon P; Cross, Jane L; Shepstone, Lee; Backhouse, Tamara; Henderson, Catherine; Poland, Fiona; Sims, Erika; MacLullich, Alasdair; Penhale, Bridget; Howard, Robert; Lambert, Nigel; Varley, Anna; Smith, Toby O; Sahota, Opinder; Donell, Simon; Patel, Martyn; Ballard, Clive; Young, John; Knapp, Martin; Jackson, Stephen; Waring, Justin; Leavey, Nick; Howard, Gregory; Fox, Chris

2017-12-04

Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including but not exclusively, dementia and/or delirium and/or cognitive impairment(s)) before, during or after acute admissions. Older people experiencing hip fracture and confusion risk serious complications, linked to delayed recovery and higher mortality post-operatively. Specific care pathways acknowledging the differences in patient presentation and care needs are proposed to improve clinical and process outcomes. This protocol describes a multi-centre, feasibility, cluster-randomised, controlled trial (CRCT) to be undertaken across ten National Health Service hospital trusts in the UK. The trial will explore the feasibility of undertaking a CRCT comparing the multicomponent PERFECTED enhanced recovery intervention (PERFECT-ER), which acknowledges the differences in care needs of confused older patients experiencing hip fracture, with standard care. The trial will also have an integrated process evaluation to explore how PERFECT-ER is implemented and interacts with the local context. The study will recruit 400 hip fracture patients identified as experiencing confusion and will also recruit "suitable informants" (individuals in regular contact with participants who will complete proxy measures). We will also recruit NHS professionals for the process evaluation. This mixed methods design will produce data to inform a definitive evaluation of the intervention via a large-scale pragmatic randomised controlled trial (RCT). The trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt. ISRCTN, 99336264 . Registered on 5 September 2016.

Implementation of Evidence-Based Employment Services in Specialty Mental Health

PubMed Central

Hamilton, Alison B; Cohen, Amy N; Glover, Dawn L; Whelan, Fiona; Chemerinski, Eran; McNagny, Kirk P; Mullins, Deborah; Reist, Christopher; Schubert, Max; Young, Alexander S

2013-01-01

Objective. Study a quality improvement approach for implementing evidence-based employment services at specialty mental health clinics. Data Sources/Study Setting. Semistructured interviews with clinicians and administrators before, during, and after implementation. Qualitative field notes, structured baseline and follow-up interviews with patients, semistructured interviews with patients after implementation, and administrative data. Study Design. Site-level controlled trial at four implementation and four control sites. Hybrid implementation–effectiveness study with mixed methods intervention evaluation design. Data Collection/Extraction Methods. Site visits, in-person and telephone interviews, patient surveys, patient self-assessment. A total of 801 patients completed baseline surveys and 53 clinicians and other clinical key stakeholders completed longitudinal qualitative interviews. Principal Findings. At baseline, sites varied in the availability, utilization, and quality of supported employment. Each site needed quality improvement for this service, though for differing reasons, with some needing development of the service itself and others needing increased service capacity. Improvements in knowledge, attitudes, beliefs, and referral behaviors were evident in mid- and postimplementation interviews, though some barriers persisted. Half of patients expressed an interest in working at baseline. Patients at implementation sites were 2.3 times more likely to receive employment services during the study year. Those who had a service visit were more likely to be employed at follow-up than those who did not. Conclusions. Studies of implementation and effectiveness require mixed methods to both enhance implementation in real time and provide context for interpretation of complex results. In this study, a quality improvement approach resulted in superior patient-level outcomes and improved clinician knowledge, attitudes, and behaviors, in the context of substantial variation among sites. PMID:24138608

Comparative efficacy of interventions to promote hand hygiene in hospital: systematic review and network meta-analysis

PubMed Central

Hongsuwan, Maliwan; Limmathurotsakul, Direk; Lubell, Yoel; Lee, Andie S; Harbarth, Stephan; Day, Nicholas P J; Graves, Nicholas; Cooper, Ben S

2015-01-01

Objective To evaluate the relative efficacy of the World Health Organization 2005 campaign (WHO-5) and other interventions to promote hand hygiene among healthcare workers in hospital settings and to summarize associated information on use of resources. Design Systematic review and network meta-analysis. Data sources Medline, Embase, CINAHL, NHS Economic Evaluation Database, NHS Centre for Reviews and Dissemination, Cochrane Library, and the EPOC register (December 2009 to February 2014); studies selected by the same search terms in previous systematic reviews (1980-2009). Review methods Included studies were randomised controlled trials, non-randomised trials, controlled before-after trials, and interrupted time series studies implementing an intervention to improve compliance with hand hygiene among healthcare workers in hospital settings and measuring compliance or appropriate proxies that met predefined quality inclusion criteria. When studies had not used appropriate analytical methods, primary data were re-analysed. Random effects and network meta-analyses were performed on studies reporting directly observed compliance with hand hygiene when they were considered sufficiently homogeneous with regard to interventions and participants. Information on resources required for interventions was extracted and graded into three levels. Results Of 3639 studies retrieved, 41 met the inclusion criteria (six randomised controlled trials, 32 interrupted time series, one non-randomised trial, and two controlled before-after studies). Meta-analysis of two randomised controlled trials showed the addition of goal setting to WHO-5 was associated with improved compliance (pooled odds ratio 1.35, 95% confidence interval 1.04 to 1.76; I2=81%). Of 22 pairwise comparisons from interrupted time series, 18 showed stepwise increases in compliance with hand hygiene, and all but four showed a trend for increasing compliance after the intervention. Network meta-analysis indicated considerable uncertainty in the relative effectiveness of interventions, but nonetheless provided evidence that WHO-5 is effective and that compliance can be further improved by adding interventions including goal setting, reward incentives, and accountability. Nineteen studies reported clinical outcomes; data from these were consistent with clinically important reductions in rates of infection resulting from improved hand hygiene for some but not all important hospital pathogens. Reported costs of interventions ranged from $225 to $4669 (£146-£3035; €204-€4229) per 1000 bed days. Conclusion Promotion of hand hygiene with WHO-5 is effective at increasing compliance in healthcare workers. Addition of goal setting, reward incentives, and accountability strategies can lead to further improvements. Reporting of resources required for such interventions remains inadequate. PMID:26220070

[Analysis of palliative sedation in hospitalised elderly patients: Effectiveness of a protocol].

PubMed

Mateos-Nozal, Jesús; García-Cabrera, Lorena; Montero Errasquín, Beatriz; Cruz-Jentoft, Alfonso José; Rexach Cano, Lourdes

2016-01-01

To measure changes in the practice of palliative sedation during agony in hospitalised elderly patients before and after the implementation of a palliative sedation protocol. A retrospective before-after study was performed in hospitalised patients over 65 years old who received midazolam during hospital admission and died in the hospital in two 3-month periods, before and after the implementation of the protocol. Non-sedative uses of midazolam and patients in intensive care were excluded. Patient and admission characteristics, the consent process, withdrawal of life-sustaining treatments, and the sedation process (refractory symptom treated, drug doses, assessment and use of other drugs) were recorded. Association was analysed using the Chi(2) and Student t tests. A total of 143 patients were included, with no significant differences between groups in demographic characteristics or symptoms. Do not resuscitate (DNR) orders were recorded in approximately 70% of the subjects of each group, and informed consent for sedation was recorded in 91% before vs. 84% after the protocol. Induction and maintenance doses of midazolam followed protocol recommendations in 1.3% before vs 10.4% after the protocol was implemented (P=.02) and adequate rescue doses were used in 1.3% vs 11.9% respectively (P=.01). Midazolam doses were significantly lower (9.86mg vs 18.67mg, P<.001) when the protocol was used than when it was not used. Ramsay sedation score was used in 8% vs. 12% and the Palliative Care Team was involved in 35.5% and 16.4% of the cases (P=.008) before and after the protocol, respectively. Use of midazolam slightly improved after the implementation of a hospital protocol on palliative sedation. The percentage of adequate sedations and the general process of sedation were mostly unchanged by the protocol. More education and further assessment is needed to gauge the effect of these measures in the future. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.

When global rule reversal meets local task switching: The neural mechanisms of coordinated behavioral adaptation to instructed multi-level demand changes.

PubMed

Shi, Yiquan; Wolfensteller, Uta; Schubert, Torsten; Ruge, Hannes

2018-02-01

Cognitive flexibility is essential to cope with changing task demands and often it is necessary to adapt to combined changes in a coordinated manner. The present fMRI study examined how the brain implements such multi-level adaptation processes. Specifically, on a "local," hierarchically lower level, switching between two tasks was required across trials while the rules of each task remained unchanged for blocks of trials. On a "global" level regarding blocks of twelve trials, the task rules could reverse or remain the same. The current task was cued at the start of each trial while the current task rules were instructed before the start of a new block. We found that partly overlapping and partly segregated neural networks play different roles when coping with the combination of global rule reversal and local task switching. The fronto-parietal control network (FPN) supported the encoding of reversed rules at the time of explicit rule instruction. The same regions subsequently supported local task switching processes during actual implementation trials, irrespective of rule reversal condition. By contrast, a cortico-striatal network (CSN) including supplementary motor area and putamen was increasingly engaged across implementation trials and more so for rule reversal than for nonreversal blocks, irrespective of task switching condition. Together, these findings suggest that the brain accomplishes the coordinated adaptation to multi-level demand changes by distributing processing resources either across time (FPN for reversed rule encoding and later for task switching) or across regions (CSN for reversed rule implementation and FPN for concurrent task switching). © 2017 Wiley Periodicals, Inc.

Effects of computerized prescriber order entry on pharmacy order-processing time.

PubMed

Wietholter, Jon; Sitterson, Susan; Allison, Steven

2009-08-01

The effect of computerized prescriber order entry (CPOE) on the efficiency of medication-order-processing time was evaluated. This study was conducted at a 761-bed, tertiary care hospital. A total of 2988 medication orders were collected and analyzed before (n = 1488) and after CPOE implementation (n = 1500). Data analyzed included the time the prescriber ordered the medication, the time the pharmacy received the order, and the time the order was completed by a pharmacist. The mean order-processing time before CPOE implementation was 115 minutes from prescriber composition to pharmacist verification. After CPOE implementation, the mean order-processing time was reduced to 3 minutes (p < 0.0001). The time that an order was received by the pharmacy to the time it was verified by a pharmacist was reduced from 31 minutes before CPOE implementation to 3 minutes after CPOE implementation (p < 0.0001). The implementation of CPOE reduced the order-processing time (from order composition to verification) by 97%. Additionally, pharmacy-specific order-processing time (from order receipt in the pharmacy to pharmacist verification) was reduced by 90%. This reduction in order-processing time improves patient care by shortening the interval between physician prescribing and medication availability and may allow pharmacists to explore opportunities for enhanced clinical activities that will further positively impact patient care. CPOE implementation reduced the mean pharmacy order-processing time from composition to verification by 97%. After CPOE implementation, a new medication order was verified as appropriate by a pharmacist in three minutes, on average.

Quality of Life Outcomes From a Phase 2 Trial of Short-Course Radiation Therapy Followed by FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Khwaja, Shariq S.; Roy, Amit; Markovina, Stephanie

Purpose: A prospective phase 2 trial of short-course (SC) radiation therapy (RT) with 25 Gy over 5 fractions, followed by 4 cycles of 5-fluorouracil, oxaliplatin, and leucovorin (mFOLFOX6) before surgery was recently completed at our institution. We present here the patient-reported quality of life (QOL) outcomes from this trial. Methods and Materials: Eighty patients with cT3/T4, any N, any M rectal adenocarcinoma planned for resection were enrolled between 2009 and 2012. The QOL data were obtained prospectively using the Functional Assessment of Cancer Therapy-Colon (FACT-C) questionnaire before RT, before surgery, and 1 year after surgery. The previously validated minimally importance difference (MID)more » method was used to measure clinically significant QOL changes in FACT-C scores for each patient across time points. We examined the role of ostomy on QOL. We also compared QOL with disease outcomes and physician-reported toxicity. Results: The FACT-C questionnaire was completed by 97% of patients before RT, 85% immediately before surgery, and 62% 1 year after surgery. There was no statistically significant change in mean FACT-C scores from before treatment to after treatment. The majority of patients had either no change or an increase in QOL 1 year after treatment using the MID method. There were significant changes in QOL between patients with ostomy versus no ostomy 1 year after treatment for functional well-being (FWB) (14.81 vs 20.52, P=.018) and the colorectal cancer subscale (CCS) using the MID method (P=.004). Patients without ostomy reported stable changes in bowel control 1 year after surgery. There was no statistically significant correlation between QOL and disease recurrence, pathologic complete response, pathologic T stage downstaging, or acute/late toxicity. Conclusions: SC-RT and sequential mFOLFOX6 as preoperative therapy for rectal cancer results in stable patient-reported QOL outcomes 1 year after treatment. These findings in conjunction with previously reported oncologic outcomes support further evaluation of this regimen in a phase 3 setting.« less

Reshaping of large aeronautical structural parts: A simplified simulation approach

NASA Astrophysics Data System (ADS)

Mena, Ramiro; Aguado, José V.; Guinard, Stéphane; Huerta, Antonio

2018-05-01

Large aeronautical structural parts present important distortions after machining. This problem is caused by the presence of residual stresses, which are developed during previous manufacturing steps (quenching). Before being put into service, the nominal geometry is restored by means of mechanical methods. This operation is called reshaping and exclusively depends on the skills of a well-trained and experienced operator. Moreover, this procedure is time consuming and nowadays, it is only based on a trial and error approach. Therefore, there is a need at industrial level to solve this problem with the support of numerical simulation tools. By using a simplification hypothesis, it was found that the springback phenomenon behaves linearly and it allows developing a strategy to implement reshaping at an industrial level.

Effects of resistance exercise on the HPA axis response to psychological stress during short-term smoking abstinence in men.

PubMed

Ho, Jen-Yu; Kraemer, William J; Volek, Jeff S; Vingren, Jakob L; Fragala, Maren S; Flanagan, Shawn D; Maladouangdock, Jesse; Szivak, Tunde K; Hatfield, Disa L; Comstock, Brett A; Dunn-Lewis, Courtenay; Ciccolo, Joseph T; Maresh, Carl M

2014-03-01

The purpose of this study was to examine the effects of resistance exercise on the hypothalamic-pituitary-adrenal axis (HPA) response to mental challenge, withdrawal symptoms, urge to smoke, and cognitive stress during 24-hour smoking abstinence. 8 sedentary smokers (mean±SD age: 20.1±1.7y; height: 171.6±10.8cm; body mass: 70.4±12.0kg; smoking history: 2.9±0.8y) completed a 24-hour ad libitum smoking trial (SMO) followed by two 24-hour smoking abstinence trials. During abstinence trials, participants performed six whole body resistance exercises (EX) or a control condition (CON) in the morning, followed by mental challenge tasks in the afternoon. Plasma adrenocorticotropin hormone (ACTH), and salivary and serum cortisol were measured during each visit at rest (REST), and then before (PRE-EX), immediately after (IP-EX), and 30min after exercise (30-EX); and before (PRE-MC), immediately after (IP-MC), and 30min after mental challenge (30-MC). Resistance exercise significantly (p≤0.05) elevated plasma ACTH and serum cortisol at IP-EX during EX compared with SMO and CON trials. Resting ACTH, salivary and serum cortisol concentrations at Pre-MC did not differ between EX and CON trials. The HPA axis response to mental challenge was similar after EX and CON trials. Finally, resistance exercise did not reduce withdrawal symptoms, urge to smoke, or stress. Resistance exercise did not substantially alter resting HPA hormones or the HPA response to mental challenge tasks during 24h of smoking abstinence. © 2013.

Changes in transverse relaxation time of quadriceps femoris muscles after active recovery exercises with different intensities.

PubMed

Mukaimoto, Takahiro; Semba, Syun; Inoue, Yosuke; Ohno, Makoto

2014-01-01

The purpose of this study was to examine the changes in the metabolic state of quadriceps femoris muscles using transverse relaxation time (T2), measured by muscle functional magnetic resonance (MR) imaging, after inactive or active recovery exercises with different intensities following high-intensity knee-extension exercise. Eight healthy men performed recovery sessions with four different conditions for 20 min after high-intensity knee-extension exercise on separate days. During the recovery session, the participants conducted a light cycle exercise for 20 min using a cycle (50%, 70% and 100% of the lactate threshold (LT), respectively: active recovery), and inactive recovery. The MR images of quadriceps femoris muscles were taken before the trial and after the recovery session every 30 min for 120 min. The percentage changes in T2 for the rectus femoris and vastus medialis muscles after the recovery session in 50% LT and 70% LT were significantly lower than those in either inactive recovery or 100% LT. There were no significant differences in those for vastus lateralis and vastus intermedius muscles among the four trials. The percentage changes in T2 of rectus femoris and vastus medialis muscles after the recovery session in 50% LT and 70% LT decreased to the values before the trial faster than those in either inactive recovery or 100% LT. Those of vastus lateralis and vastus intermedius muscles after the recovery session in 50% LT and 70% LT decreased to the values before the trial faster than those in 100% LT. Although the changes in T2 after active recovery exercises were not uniform in exercised muscles, the results of this study suggest that active recovery exercise with the intensities below LT are more effective to recover the metabolic state of quadriceps femoris muscles after intense exercise than with either intensity at LT or inactive recovery.

A program for thai rubber tappers to improve the cost of occupational health and safety.

PubMed

Arphorn, Sara; Chaonasuan, Porntip; Pruktharathikul, Vichai; Singhakajen, Vajira; Chaikittiporn, Chalermchai

2010-01-01

The purposes of this research were to determine the cost of occupational health and safety and work-related health problems, accidents, injuries and illnesses in rubber tappers by implementing a program in which rubber tappers were provided training on self-care in order to reduce and prevent work-related accidents, injuries and illnesses. Data on costs for healthcare, the prevention and the treatment of work-related accidents, injuries and illnesses were collected by interview using a questionnaire. The findings revealed that there was no relationship between what was spent on healthcare and the prevention of work-related accidents, injuries and illnesses and that spent on the treatment of work-related accidents, injuries and illnesses. The proportion of the injured subjects after the program implementation was significantly less than that before the program implementation (p<0.001). The level of pain after the program implementation was significantly less than that before the program implementation (p<0.05). The treatment costs incurred after the program implementation were significantly less than those incurred before the program implementation (p<0.001). It was demonstrated that this program raised the health awareness of rubber tappers. It strongly empowered the leadership in health promotion for the community.

Quality of life in China rural-to-urban female migrant factory workers: a before-and-after study.

PubMed

Zhu, Chunyan; Geng, Qingshan; Yang, Hongling; Chen, Li; Fu, Xianhua; Jiang, Wei

2013-07-23

Rural-to-urban female migrant workers have a lower quality of life compared to the general population. Improving these conditions remains highly challenging. This paper reports the health-related quality of life (HRQoL) of the female migrant workers in an educational project. In this before-and-after study, a community-based health education intervention was developed to improve female migrant workers' HRQoL and job satisfaction. A factory was selected as the location to implement the trial, using a before-and-after design. The education intervention included distribution and free access to study materials, monthly lectures, and counseling. The primary endpoint was HRQoL, and gynecological disease and job satisfaction were secondary endpoints. We assessed HRQoL at baseline and at 6-month follow-up using the Health Survey Short Form (SF-36). Compared to the baseline assessment, the participants at the 6-month survey reported higher General Health scores (standardized-β coefficients (Betas) of β = 0.056; P <0.001), Vitality scores (β = 0.066; P <0.001), Mental Health scores (β = 0.062; P <0.001), mental component summary scores (β = 0.040; P <0.001), and job satisfaction (Odds Ratio [OR] 2.104, 95% confidence interval [CI] 1.837-2.408; P <0.01). A community-based educational intervention, targeted at female migrant workers, appears effective in improving HRQoL and job satisfaction.

Implementation of an innovative hands-on training to improve adherence to hygiene rules: A feasibility Study.

PubMed

Stock, Stephanie; Tebest, Ralf; Westermann, Kristina; Samel, Christina; Strohbücker, Barbara; Stosch, Christoph; Wenchel, Hans-Martin; Redaèlli, Marcus

2016-01-01

Hospital-acquired infections (HAI) still pose a major problem in inpatient care. The single most important measure for preventing HAIs is to improve adherence to hand hygiene among health care professionals. To assess the feasibility of an innovative hands-on training to improve adherence to hygiene rules under standardized and under real life conditions. Before-after controlled cohort trial to assess the feasibility of implementing an innovative hands-on training to improve hand hygiene adherence. Large university hospital in Germany. Fifty trained nurses from three wards with an average age of 32years (±10.22years) and an average vocational experience of 6.85years (±7.54years). The intervention consisted of a hands-on training in the skills lab of the University of Cologne complemented by a 12-week observation period before and after the training on participating wards. The training comprised important skills with respect to hand hygiene, venipuncture, dressing changes of central venous catheters, preparation of IV infusions, and donning of gloves using sterile technique. A communication training was included to enable nurses to enforce hygiene rules in their collaboration with peers and physicians. The intervention was taught in small groups with a wide array of interactive teaching methods. It was evaluated using the objective structured clinical examination (OSCE) format. Observations were conducted by a trained infection control nurse. Before (after) the intervention 622 (612) occasions of hand hygiene were documented. A highly significant improvement in hygiene compliance was observed pre- and post-intervention (64.3% vs. 79.2%; p≤0.0001). The OSCE evaluation showed significant improvements in all subscales. The developed and conducted hands-on training seems feasible and is successful in significantly improving adherence to hygiene rules under standardized and real life conditions. Whether the effect is stable over time is subject to further investigation. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Checklist to Improve Patient Safety in Interventional Radiology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Koetser, Inge C. J.; Vries, Eefje N. de; Delden, Otto M. van

2013-04-15

To develop a specific RADiological Patient Safety System (RADPASS) checklist for interventional radiology and to assess the effect of this checklist on health care processes of radiological interventions. On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice in a tertiary referral centre and evaluation by users. To assess the effect of RADPASS, in a series of radiological interventions, all deviations from optimal care were registered before and after implementation of the checklist. In addition, the checklist and its use were evaluated by interviewingmore » all users. The RADPASS checklist has two parts: A (Planning and Preparation) and B (Procedure). The latter part comprises checks just before starting a procedure (B1) and checks concerning the postprocedural care immediately after completion of the procedure (B2). Two cohorts of, respectively, 94 and 101 radiological interventions were observed; the mean percentage of deviations of the optimal process per intervention decreased from 24 % before implementation to 5 % after implementation (p < 0.001). Postponements and cancellations of interventions decreased from 10 % before implementation to 0 % after implementation. Most users agreed that the checklist was user-friendly and increased patient safety awareness and efficiency. The first validated patient safety checklist for interventional radiology was developed. The use of the RADPASS checklist reduced deviations from the optimal process by three quarters and was associated with less procedure postponements.« less

Using Single-trial EEG to Predict and Analyze Subsequent Memory

PubMed Central

Noh, Eunho; Herzmann, Grit; Curran, Tim; de Sa, Virginia R.

2013-01-01

We show that it is possible to successfully predict subsequent memory performance based on single-trial EEG activity before and during item presentation in the study phase. Two-class classification was conducted to predict subsequently remembered vs. forgotten trials based on subjects’ responses in the recognition phase. The overall accuracy across 18 subjects was 59.6 % by combining pre- and during-stimulus information. The single-trial classification analysis provides a dimensionality reduction method to project the high-dimensional EEG data onto a discriminative space. These projections revealed novel findings in the pre- and during-stimulus period related to levels of encoding. It was observed that the pre-stimulus information (specifically oscillatory activity between 25–35Hz) −300 to 0 ms before stimulus presentation and during-stimulus alpha (7–12 Hz) information between 1000–1400 ms after stimulus onset distinguished between recollection and familiarity while the during-stimulus alpha information and temporal information between 400–800 ms after stimulus onset mapped these two states to similar values. PMID:24064073

Methodological issues in a before-after study design to evaluate the Liverpool Care Pathway for the Dying Patient in hospital.

PubMed

Costantini, Massimo; Di Leo, Silvia; Beccaro, Monica

2011-12-01

In 2006, as the first step of a 3-year research programme to assess the Liverpool Care Pathway for the Dying Patient (LCP) in hospital, the original LCP documentation was translated and piloted in four Italian hospital wards in Genoa. The primary aim was to evaluate the feasibility of LCP implementation in the Italian context. The secondary aim of the study was to evaluate the effectiveness of the LCP with an uncontrolled before-after design. The aim of the study was to discuss and critically evaluate the methodological issues in designing and interpreting the results of the before-after study design. All cancer deaths which occurred in four hospital wards (three general medicine and one respiratory disease) 4 months before and 4 months after LCP implementation (2 months for the respiratory disease ward) were registered. Caregivers were interviewed after the patient's death using the Toolkit After-Death Bereaved Family Member Interview. A total of 111 cancer deaths were identified (63 before and 48 after) and 79 caregivers (71.2%) were interviewed (46 before and 33 after). The analyses on number and characteristics of the patients, interviewed caregivers, compliance and modality of assessment showed significant differences before and after. A remarkable internal correlation coefficient for all of the Toolkit scales within the four hospital wards was observed. This analysis confirms the high risk of selection and information bias inherent the uncontrolled before- after study design. The high internal correlation strongly suggests that clustering should be taken into account in this kind of study.

Cost effectiveness of total knee arthroplasty from a health care providers' perspective before and after introduction of an interdisciplinary clinical pathway--is investment always improvement?

PubMed

Krummenauer, Frank; Guenther, Klaus-Peter; Kirschner, Stephan

2011-12-14

Total knee arthroplasty (TKA) is an effective, but also cost-intensive health care intervention for end stage osteoarthritis. This investigation was designed to evaluate the cost-effectiveness of TKA before versus after introduction of an interdisciplinary clinical pathway from a University Orthopedic Surgery Department's cost perspective as an interdisciplinary full service health care provider. A prospective trial recruited two sequential cohorts of 132 and 128 consecutive patients, who were interviewed by means of the WOMAC questionnaire. Direct process costs from the health care providers' perspective were estimated according to the German DRG calculation framework. The health economic evaluation was based on margiual cost-effectveness ratios (MCERs); an individual marginal cost effectiveness relation≤100 € per % WOMAC index increase was considered as primary endpoint of the confirmatory cohort comparison. The interdisciplinary clinical pathway under consideration primarily consisted of a voluntary preoperative personal briefing of patients concerning postoperatively expectable progess in health status and optimum use of walking aids after surgery. All patients were supplied with written information on these topics, attendance of the personal briefing also included preoperative training for postoperative mobilisation by the Department's physiotherapeutic staff. An individual marginal cost effectiveness relation≤100 €/% WOMAC index increase was found in 38% of the patients in the pre pathway implementation cohort versus in 30% of the post pathway implementation cohort (Fisher p=0.278). Both cohorts showed substantial improvement in WOMAC scores (39 versus 35% in median), whereas the cohort did not differ significantly in the median WOMAC score before surgery (41% for the pre pathway cohort versus 44% for the post pathway cohort). Despite a locally significant decrease in costs (4303 versus 4194 € in median), the individual cost/benefit relation became worse after introduction of the pathway: for the first cohort the MCER was estimated 108 € per gained % WOMAC index increase (86-150 €/%) versus 118 €/% WOMAC gain (93-173 €/%) in the second cohort after pathway implementation. In summary, the proposed critical pathway for TKA could be shown to be significantly cost efficient, but not cost effective concerning functional outcome, when the above individual marginal cost effectiveness criterion was concentrated on. The introduction of an interdisciplinary clinical pathway does not necessarily improve patient related outcomes. On the contrary, cost effectiveness from the health care providers' perspective may even turn out remarkably reduced in the setting considered here (functional outcome assessment after treatment by a full service health care provider).

Cost effectiveness of total knee arthroplasty from a health care providers' perspective before and after introduction of an interdisciplinary clinical pathway - is investment always improvement?

PubMed Central

2011-01-01

Background Total knee arthroplasty (TKA) is an effective, but also cost-intensive health care intervention for end stage osteoarthritis. This investigation was designed to evaluate the cost-effectiveness of TKA before versus after introduction of an interdisciplinary clinical pathway from a University Orthopedic Surgery Department's cost perspective as an interdisciplinary full service health care provider. Methods A prospective trial recruited two sequential cohorts of 132 and 128 consecutive patients, who were interviewed by means of the WOMAC questionnaire. Direct process costs from the health care providers' perspective were estimated according to the German DRG calculation framework. The health economic evaluation was based on margiual cost-effectveness ratios (MCERs); an individual marginal cost effectiveness relation ≤ 100 € per % WOMAC index increase was considered as primary endpoint of the confirmatory cohort comparison. The interdisciplinary clinical pathway under consideration primarily consisted of a voluntary preoperative personal briefing of patients concerning postoperatively expectable progess in health status and optimum use of walking aids after surgery. All patients were supplied with written information on these topics, attendance of the personal briefing also included preoperative training for postoperative mobilisation by the Department's physiotherapeutic staff. Results An individual marginal cost effectiveness relation ≤ 100 €/% WOMAC index increase was found in 38% of the patients in the pre pathway implementation cohort versus in 30% of the post pathway implementation cohort (Fisher p = 0.278). Both cohorts showed substantial improvement in WOMAC scores (39 versus 35% in median), whereas the cohort did not differ significantly in the median WOMAC score before surgery (41% for the pre pathway cohort versus 44% for the post pathway cohort). Despite a locally significant decrease in costs (4303 versus 4194 € in median), the individual cost/benefit relation became worse after introduction of the pathway: for the first cohort the MCER was estimated 108 € per gained % WOMAC index increase (86 - 150 €/%) versus 118 €/% WOMAC gain (93 - 173 €/%) in the second cohort after pathway implementation. In summary, the proposed critical pathway for TKA could be shown to be significantly cost efficient, but not cost effective concerning functional outcome, when the above individual marginal cost effectiveness criterion was concentrated on. Conclusions The introduction of an interdisciplinary clinical pathway does not necessarily improve patient related outcomes. On the contrary, cost effectiveness from the health care providers' perspective may even turn out remarkably reduced in the setting considered here (functional outcome assessment after treatment by a full service health care provider). PMID:22168149

The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: A protocol for a double-blind randomised controlled trial

PubMed Central

2011-01-01

Background For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthethic wound infiltration additional to a standard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA. Methods 300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals. Discussion Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particulary in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain management after lower limb joint replacement. If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention, implementation into clinical practice could improve long-term pain outcomes for patients undergoing lower limb joint replacement. Trial registration Current Controlled Trials ISRCTN96095682 PMID:21352559

Use of plasma exchange or double filtration plasmapheresis to reduce body burden of polychlorinated biphenyls: A pilot trial.

PubMed

Gube, Monika; Schettgen, Thomas; Kraus, Thomas; Schikowsky, Christian; Heibges, Andreas; Klingel, Reinhard; Hoffmann, Christian; Wiemeyer, Andreas; Jacobson, Jewgeni; Esser, André

2017-07-01

The aim of the study was to examine whether plasma exchange (PE) or selective double filtration plasmapheresis (DFPP) is able to reduce the internal Polychlorinated biphenyl (PCB) burden of highly exposed participants of the health effects in high-level exposure to PCB (HELPcB) cohort. HELPcB is a surveillance program for former PCB-exposed workers of a German capacitor recycling company. After comparative evaluation of PE and DFPP in a phase I, DFPP was chosen as method for further treatment. In phase II, five participants underwent DFPP at weekly intervals for the duration of 12 weeks. Six PCB species were selected as indicators and were analyzed in the plasma before and after each treatment and 4 weeks after the last treatment. The PCB levels before and after each DFPP treatment showed a significant reduction in PCB blood levels; however, there was no significant change in PCB levels within the samples collected before each treatment as compared with the samples collected in the following week before treatment. Even the difference between PCB levels at the onset of the study and 4 weeks after the last treatment was not significant. The results of this pilot trial do not encourage further investigations in using therapeutic apheresis to reduce the PCB body burden.

The effect of nebulized salbutamol or isotonic saline on exercise-induced bronchoconstriction in elite skaters following a 1,500-meter race: study protocol for a randomized controlled trial.

PubMed

Driessen, Jean M M; Gerritsma, Margryt; Westbroek, Jaap; ten Hacken, Nick H T; de Jongh, Frans H C

2013-07-09

Prevalence of exercise-induced bronchoconstriction (EIB) is high in elite athletes, especially after many years training in cold and dry air conditions. The primary treatment of EIB is inhaling a short-acting beta-2-agonist such as salbutamol. However, professional speed skaters also inhale nebulized isotonic saline or tap water before and after a race or intense training. The use of nebulized isotonic saline or tap water to prevent EIB has not been studied before, raising questions about safety and efficacy. The aim of this study is to analyze the acute effect of nebulized isotonic saline or salbutamol on EIB in elite speed skaters following a 1,500-meter race. This randomized controlled trial compares single dose treatment of 1 mg nebulized salbutamol in 4 mL of isotonic saline, or with 5 mL of isotonic saline. A minimum of 13 participants will be allocated in each treatment group. Participants should be between 18 and 35 years of age and able to skate 1,500 m in less than 2 min 10 s (women) or 2 min 05 s (men). Repeated measurements of spirometry, forced oscillation technique, and electromyography will be performed before and after an official 1,500-m race. Primary outcome of the study is the difference in fall in FEV1 after exercise in the different treatment groups. The trial is currently enrolling participants. Elite athletes run the risk of pulmonary inflammation and remodeling as a consequence of their frequent exercise, and thus increased ventilation in cold and dry environments. Although inhalation of nebulized isotonic saline is commonplace, no study has ever investigated the safety or efficacy of this treatment. This trial protocol was registered with the Dutch trial registration for clinical trials under number NTR3550.

Implementing structured functional assessments in general practice for persons with long-term sick leave: a cluster randomised controlled trial.

PubMed

Østerås, Nina; Gulbrandsen, Pål; Benth, Jūrate Saltyte; Hofoss, Dag; Brage, Søren

2009-05-06

The increasing attention on functional assessments in medical and vocational rehabilitation requires a focus change for the general practitioners (GP) into paying attention to patient resources, possibilities and coping instead of symptoms, problems and limitations. The GPs report difficulties in performing the requested explicit functional assessments. The purpose of this study was to implement a structured method in general practice for assessing functional ability in persons with long-term sick leave. The study aim was to evaluate intervention effects on important GP parameters; knowledge, attitudes, self-efficacy towards functional assessments and knowledge about patient work factors. Fifty-seven GPs were randomly assigned to an intervention or a control group. The intervention group GPs attended an introductory one-day work-shop and implemented structured functional assessments during an eight months intervention period. GP knowledge, GP attitudes, and GP self-efficacy towards functional assessments, as well as GP knowledge of patient work factors, were collected before, after and six months after the intervention period started. Evaluation score-sheets were filled in by both the intervention GPs and their patients immediately after the consultation to evaluate the GPs' knowledge of patient work factors. The intervention GPs reported increased knowledge (B: 0.56, 95% CI (0.19, 0.91)) and self-efficacy (B: 0.90, 95% CI (0.53, 1.26)) towards functional assessments, and increased knowledge about their patients' workplace (B: 0.75, 95% CI (0.35, 1.15)) and perceived stressors (B: 0.55, 95% CI (0.23, 0.88)) with lasting effects at the second follow-up. No intervention effect was seen in relation to GP attitudes. Both before and after the intervention, the GPs were most informed about physical stressors, and less about mental and work organisational stressors (Guttman's reproducibility coefficient: 0.95 and 1.00). After the consultation, both the intervention GPs and their patients reported that the GPs' knowledge about patient work factors had increased (GP B: 0.60 (95% CI: 0.42, 0.78); patient B: 0.50 (95% CI: 0.34, 0.66)). Introducing and implementing structured functional assessments in general practice made the GPs capable to assess functional ability of their patients in a structured manner. Intervention effects of increased GP knowledge and GP self-efficacy sustained at the second follow-up.

Do large-scale hospital- and system-wide interventions improve patient outcomes: a systematic review.

PubMed

Clay-Williams, Robyn; Nosrati, Hadis; Cunningham, Frances C; Hillman, Kenneth; Braithwaite, Jeffrey

2014-09-03

While health care services are beginning to implement system-wide patient safety interventions, evidence on the efficacy of these interventions is sparse. We know that uptake can be variable, but we do not know the factors that affect uptake or how the interventions establish change and, in particular, whether they influence patient outcomes. We conducted a systematic review to identify how organisational and cultural factors mediate or are mediated by hospital-wide interventions, and to assess the effects of those factors on patient outcomes. A systematic review was conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Database searches were conducted using MEDLINE from 1946, CINAHL from 1991, EMBASE from 1947, Web of Science from 1934, PsycINFO from 1967, and Global Health from 1910 to September 2012. The Lancet, JAMA, BMJ, BMJ Quality and Safety, The New England Journal of Medicine and Implementation Science were also hand searched for relevant studies published over the last 5 years. Eligible studies were required to focus on organisational determinants of hospital- and system-wide interventions, and to provide patient outcome data before and after implementation of the intervention. Empirical, peer-reviewed studies reporting randomised and non-randomised controlled trials, observational, and controlled before and after studies were included in the review. Six studies met the inclusion criteria. Improved outcomes were observed for studies where outcomes were measured at least two years after the intervention. Associations between organisational factors, intervention success and patient outcomes were undetermined: organisational culture and patient outcomes were rarely measured together, and measures for culture and outcome were not standardised. Common findings show the difficulty of introducing large-scale interventions, and that effective leadership and clinical champions, adequate financial and educational resources, and dedicated promotional activities appear to be common factors in successful system-wide change.The protocol has been registered in the international prospective register of systematic reviews, PROSPERO (Registration No. CRD42103003050).

An echo to Choosing Wisely® in Switzerland

PubMed Central

Chok, Lionel; Debrunner, Johann; Jaeggli, Sandra; Kusic, Karmen; Bachli, Esther B

2018-01-01

Background Inspired by the US Choosing Wisely®, in 2016 the Swiss Society of General Internal Medicine released a list of five treatments or diagnostic tests used in the hospital and considered unnecessary based on not improving patient care and adding to health care costs. These “Smarter Medicine” recommendations were implemented in the Department of Internal Medicine, Uster Hospital, in August 2016. They were supported by lectures and weekly email communications. We analyzed the number of blood draws before and after implementation of the recommendation aimed at reducing blood tests. Methods This retrospective analysis was conducted in the Department of Internal Medicine, Uster Hospital, Canton of Zurich, Switzerland. Patients hospitalized in the 3 months before and after implementation were analyzed. Results A total of 2023 hospitalizations were analyzed. There was a significant decrease in the number of blood draws after introduction of the recommendation: before implementation, the median number of blood draws per patient was 4 (interquartile range [IQR], 2–7); after implementation, the median was 4 (IQR, 2–6; P = 0.002). Indeed, since 46% of the patients in the first group had more than four blood tests, this ratio decreased to 39% after implementation. Discussion Inappropriate blood draws may lead to anemia, patient discomfort and false-positive results. The simple and low-cost interventions used to implement “Smarter Medicine” have changed physician behavior by reducing the number of blood orders. These results are promising. Whether such recommendations will impact patient and clinical outcomes remains unknown; hence, further studies are needed to clarify this issue. PMID:29765244

Changing practice in the assessment and treatment of somatosensory loss in stroke survivors: protocol for a knowledge translation study.

PubMed

Cahill, Liana S; Lannin, Natasha A; Mak-Yuen, Yvonne Y K; Turville, Megan L; Carey, Leeanne M

2018-01-23

The treatment of somatosensory loss in the upper limb after stroke has been historically overshadowed by therapy focused on motor recovery. A double-blind randomized controlled trial has demonstrated the effectiveness of SENSe (Study of the Effectiveness of Neurorehabilitation on Sensation) therapy to retrain somatosensory discrimination after stroke. Given the acknowledged prevalence of upper limb sensory loss after stroke and the evidence-practice gap that exists in this area, effort is required to translate the published research to clinical practice. The aim of this study is to determine whether evidence-based knowledge translation strategies change the practice of occupational therapists and physiotherapists in the assessment and treatment of sensory loss of the upper limb after stroke to improve patient outcomes. A pragmatic, before-after study design involving eight (n = 8) Australian health organizations, specifically sub-acute and community rehabilitation facilities. Stroke survivors (n = 144) and occupational therapists and physiotherapists (~10 per site, ~n = 80) will be involved in the study. Stroke survivors will be provided with SENSe therapy or usual care. Occupational therapists and physiotherapists will be provided with a multi-component approach to knowledge translation including i) tailoring of the implementation intervention to site-specific barriers and enablers, ii) interactive group training workshops, iii) establishing and fostering champion therapists and iv) provision of written educational materials and online resources. Outcome measures for occupational therapists and physiotherapists will be pre- and post-implementation questionnaires and audits of medical records. The primary outcome for stroke survivors will be change in upper limb somatosensory function, measured using a standardized composite measure. This study will provide evidence and a template for knowledge translation in clinical, organizational and policy contexts in stroke rehabilitation. Australian New Zealand Clinical Trials Registry (ANZCTR) retrospective registration ACTRN12615000933550 .

37 CFR 42.120 - Patent owner response.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Patent owner response. 42.120 Section 42.120 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Inter Partes Review After...

37 CFR 42.220 - Patent owner response.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Patent owner response. 42.220 Section 42.220 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Post-Grant Review After...

37 CFR 42.220 - Patent owner response.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Patent owner response. 42.220 Section 42.220 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Post-Grant Review After...

37 CFR 42.120 - Patent owner response.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Patent owner response. 42.120 Section 42.120 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Inter Partes Review After...

Autism Treatment in the First Year of Life: A Pilot Study of Infant Start, a Parent-Implemented Intervention for Symptomatic Infants

PubMed Central

Vismara, L.; Wagner, A. L.; McCormick, C.; Young, G.; Ozonoff, S.

2016-01-01

The goal of early autism screening is earlier treatment. We pilot-tested a 12-week, low-intensity treatment with seven symptomatic infants ages 7–15 months. Parents mastered the intervention and maintained skills after treatment ended. Four comparison groups were matched from a study of infant siblings. The treated group of infants was significantly more symptomatic than most of the comparison groups at 9 months of age but was significantly less symptomatic than the two most affected groups between 18 and 36 months. At 36 months, the treated group had much lower rates of both ASD and DQs under 70 than a similarly symptomatic group who did not enroll in the treatment study. It appears feasible to identify and enroll symptomatic infants in parent-implemented intervention before 12 months, and the pilot study outcomes are promising, but testing the treatment’s efficacy awaits a randomized trial. PMID:25212413

Effects of implementing electronic medical records on primary care billings and payments: a before–after study

PubMed Central

Shultz, Susan E.; Tu, Karen

2013-01-01

Background Several barriers to the adoption of electronic medical records (EMRs) by family physicians have been discussed, including the costs of implementation, impact on work flow and loss of productivity. We examined billings and payments received before and after implementation of EMRs among primary care physicians in the province of Ontario. We also examined billings and payments before and after switching from a fee-for-service to a capitation payment model, because EMR implementation coincided with primary care reform in the province. Methods We used information from the Electronic Medical Record Administrative Data Linked Database (EMRALD) to conduct a retrospective before–after study. The EMRALD database includes EMR data extracted from 183 community-based family physicians in Ontario. We included EMRALD physicians who were eligible to bill the Ontario Health Insurance Plan at least 18 months before and after the date they started using EMRs and had completed a full 18-month period before Mar. 31, 2011, when the study stopped. The main outcome measures were physicians’ monthly billings and payments for office visits and total annual payments received from all government sources. Two index dates were examined: the date physicians started using EMRs and were in a stable payment model (n = 64) and the date physicians switched from a fee-for-service to a capitation payment model (n = 42). Results Monthly billings and payments for office visits did not decrease after the implementation of EMRs. The overall weighted mean annual payment from all government sources increased by 27.7% after the start of EMRs among EMRALD physicians; an increase was also observed among all other primary care physicians in Ontario, but it was not as great (14.4%). There was a decline in monthly billings and payments for office visits after physicians changed payment models, but an increase in their overall annual government payments. Interpretation Implementation of EMRs by primary care physicians did not result in decreased billings or government payments for office visits. Further economic analyses are needed to measure the effects of EMR implementation on productivity and the costs of implementing an EMR system, including the costs of nonclinical work by physicians and their staff. PMID:25077111

A performance improvement prescribing guideline reduces opioid prescriptions for emergency department dental pain patients.

PubMed

Fox, Timothy R; Li, James; Stevens, Sandra; Tippie, Tracy

2013-09-01

In an effort to reduce prescription opioid abuse originating from our institution, we implement and measure the effect of a prescribing guideline on the rate of emergency department (ED) opioid prescriptions written for patients presenting with dental pain, a complaint previously associated with drug-seeking behavior. After implementing a departmental guideline on controlled substance prescriptions, we performed a structured before-and-after chart review of dental pain patients aged 16 and older. Before the guideline, the rate of opioid prescription was 59% (302/515). After implementation, the rate was 42% (65/153). The absolute decrease in rates was 17% (95% confidence interval 7% to 25%). Additionally, in comparing the 12-month period before and after implementation, the dental pain visit rate decreased from 26 to 21 per 1,000 ED visits (95% confidence interval of decrease 2 to 9 visits/1,000). A performance improvement program involving a departmental prescribing guideline was associated with a reduction in the rate of opioid prescriptions and visits for ED patients presenting with dental pain. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Development and evaluation of a training workshop for lay health promoters to implement a community-based intervention program in a public low rent housing estate: The Learning Families Project in Hong Kong

PubMed Central

Lai, Agnes Y.; Stewart, Sunita M.; Wan, Alice; Fok, Helen; Lai, Hebe Y. W.; Lam, Tai-hing; Chan, Sophia S.

2017-01-01

This paper presents the development and evaluation of the train-the-trainer (TTT) workshop for lay resident leaders to be lay health promoters. The TTT workshop aimed to prepare the trainees to implement and/or assist in conducting a series of community-based family well-being activities for the residents in a public low rent housing estate, entitled “Learning Families Project”, under the FAMILY project. The four-hour TTT workshop was conducted for 32 trainees (72% women, 43% aged ≥ 60, 41% ≤ elementary school education). The workshop aimed to promote trainees’ knowledge, self-efficacy, attitude and practice of incorporating the positive psychology themes into their community activities and engaging the residents to join these activities and learn with their family members. Post-training support was provided. The effectiveness of the TTT was examined by self-administered questionnaires about trainees’ reactions to training content, changes in learning and practice at three time points (baseline, and immediately and one year after training), and the difference in residents’ survey results before and after participating in the community activities delivered by the trainees. The trainees’ learning about the general concepts of family well-being, learning family, leadership skills and planning skills increased significantly with medium to large effect sizes (Cohen’s d: 0.5–1.4) immediately after the training. The effects of perceived knowledge and attitude towards practice were sustained to one year (Cohen’s d: 0.4–0.6). The application of planning skills to implement community activities was higher at one year (Cohen’s d: 0.4), compared with baseline. At one year, the residents’ survey results showed significant increases in the practice of positive communication behaviours and better neighbour cohesions after joining the family well-being activities of LFP. Qualitative feedback supported the quantitative results. Our TTT workshop could serve as a practical example of development and evaluation of training programs for lay personnel to be lay health promoters. Trial registration: ClinicalTrials.gov NCT02844244 PMID:28841677

Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial

PubMed Central

2014-01-01

Background Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. Methods/Design In a double–blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. Discussion Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms. Trial registration ANZCTR.org.au Identifier: ACTRN12613000120774. PMID:24712653

Timing of dornase alfa inhalation for cystic fibrosis.

PubMed

Dentice, Ruth; Elkins, Mark

2016-07-26

Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane review. To determine the effect of timing of dornase alfa inhalation on measures of clinical efficacy in people with cystic fibrosis (in relation to airway clearance techniques or time of day). Relevant randomised and quasi-randomised controlled trials were identified from the Cochrane Cystic Fibrosis Trials Register, Physiotherapy Evidence Database (PEDro), and international cystic fibrosis conference proceedings.Date of the most recent search: 25 April 2016. Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the study with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation. Both authors independently selected trials, assessed risk of bias and extracted data with disagreements resolved by discussion. Relevant data were extracted and, where possible, meta-analysed. We identified 115 trial reports representing 55 studies, of which five studies (providing data on 122 participants) met our inclusion criteria. All five studies used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second. Similarly, forced vital capacity and quality of life were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small studies in children (seven to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant.In one trial, morning versus evening inhalation had no impact on lung function or symptoms. The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and studies with variable follow up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alpha inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.

Hospital discharge rates before and after implementation of a city-wide smoking ban in a Texas city, 2004-2008.

PubMed

Head, Phil; Jackson, Bradford E; Bae, Sejong; Cherry, Debra

2012-01-01

The objective of this study was to examine hospital discharge data on 5 tobacco-related diagnoses before and after implementation of a smoking ban in a small Texas city. We compared hospital discharge rates for 2 years before and 2 years after implementation of the ban in the intervention city with discharge rates during the same time in a similar city with no ban. The discharge rates for blacks and whites combined declined significantly after the ban in the intervention city for acute myocardial infarction (MI) (rate ratio [RR], 0.74; 95% confidence interval [CI], 0.65-0.85) and for stroke or cerebrovascular accident (RR, 0.71; 95% CI, 0.62-0.82); discharge rates in the intervention city also declined significantly for chronic obstructive pulmonary disease (RR, 0.64; 95% CI, 0.54-0.75) and asthma (RR, 0.69; 95% CI, 0.52-0.91) for whites only. Discharge rates for 4 of 5 diagnoses in the control city did not change. Although postban reduction in acute MI is well documented, this is one of the first studies to show a racial disparity in health benefits and a decline in tobacco-related diagnoses other than acute MI after implementation of a city-wide smoking ban.

A Trial of the Objective Structured Practical Examination in Physiology at Melaka Manipal Medical College, India

ERIC Educational Resources Information Center

Abraham, Reem Rachel; Raghavendra, Rao; Surekha, Kamath; Asha, Kamath

2009-01-01

A single examination does not fulfill all the functions of assessment. The present study was undertaken to determine the reliability and student satisfaction regarding the objective structured practical examination (OSPE) as a method of assessment of laboratory exercises in physiology before implementing it in the forthcoming university…

Study of neurontin: titrate to effect, profile of safety (STEPS) trial: a narrative account of a gabapentin seeding trial.

PubMed

Krumholz, Samuel D; Egilman, David S; Ross, Joseph S

2011-06-27

Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail. We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation. Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in 2 published articles. The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

37 CFR 42.221 - Amendment of the patent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Amendment of the patent. 42.221 Section 42.221 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Post-Grant Review After...

37 CFR 42.221 - Amendment of the patent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Amendment of the patent. 42.221 Section 42.221 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Post-Grant Review After...

37 CFR 42.121 - Amendment of the patent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Amendment of the patent. 42.121 Section 42.121 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Inter Partes Review After...

37 CFR 42.121 - Amendment of the patent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Amendment of the patent. 42.121 Section 42.121 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Inter Partes Review After...

The role of organisational and cultural factors in the implementation of system-wide interventions in acute hospitals to improve patient outcomes: protocol for a systematic literature review.

PubMed

Nosrati, Hadis; Clay-Williams, Robyn; Cunningham, Frances; Hillman, Ken; Braithwaite, Jeffrey

2013-03-09

Little is known about the role of the organisational culture in the success and sustainability of the hospital-wide interventions, and how local culture affects patient outcomes in acute hospitals. A systematic literature review will be conducted to identify organisational factors influencing hospital-wide interventions and patient outcomes. A search of English language articles will be performed in MEDLINE, CINAHL, EMBASE, Web of Science, PsychInfo and Global Health databases using Medical Subject Headings and keywords. Randomised controlled trials, quasi-randomised trials, controlled before and after design studies and interrupted time-series analysis studies will be included. 'Grey literature' will be excluded, however peer-reviewed journals that are likely to publish relevant studies (JAMA, BMJ, BMJ Quality and Safety, Lancet and New England Journal of Medicine and Implementation Science) will be hand searched for the last 5 years. Two reviewers will independently undertake a title and abstract review using inclusion and exclusion criteria. Studies will be excluded only after discussion between at least two reviewers, who will assess and agree on the inclusion, risk of bias and quality rating of the studies. One author will extract summary descriptive data from these studies; the other author will review this documentation for accuracy and completeness. It is likely that the studies will be heterogeneous in nature, therefore a narrative synthesis of the findings will be conducted. We will discuss characteristics of the studies and stratify the results according to the type of hospital-wide interventions, organisational factors associated with them and outcomes measured.

Cars, CONSORT 2010, and clinical practice.

PubMed

Williams, Hywel C

2010-03-24

Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the updated CONSORT 2010 statement enables the reader to see exactly what was done in a trial, to whom and when. A fully "CONSORTed" trial report does not necessarily mean the trial is a good one, but at least the reader can make a judgement. Clear reporting is a pre-requisite for judgement of study quality. The CONSORT statement evolves as empirical research moves on. CONSORT 2010 is even clearer than before and includes some new items with a particular emphasis on selective reporting of outcomes. The challenge is for everyone to use it.

Biotechnology stock prices before public announcements: evidence of insider trading?

PubMed

Overgaard, C B; van den Broek, R A; Kim, J H; Detsky, A S

2000-03-01

Unique financial challenges faced by biotechnology companies developing therapeutics have contributed to the creation of a highly sensitive market, where stock prices are capable of great fluctuation. The potential for significant financial reward and the nature of the scientific review process make this industry susceptible to illegal share trading on nonpublic information. We examined stock prices of biotechnology products before and after announcement of Phase III clinical trial and Food and Drug Administration (FDA) Advisory Panel results for indirect evidence of insider trading. Biotechnology stock prices were recorded for 98 products undergoing Phase III clinical trials and 49 products undergoing FDA Advisory Panel review between 1990 and 1998. Prices were recorded for 120 consecutive trading days before and after public announcement of these two events. We compared the average change in stock price of successful products ('winners') with unsuccessful products ('losers') before the public announcement of results for both critical events. The difference between average stock price change from 120 to 3 days before public announcement of results of Phase III clinical trial winners (+27%) and losers (-4%) was highly significant (P = 0.0007). A similar but non-significant difference was observed between the average stock price of winning (+27%) and losing products (+13%) before FDA Advisory Panel review announcements (P = 0.25). Our results provide indirect evidence that insider trading may be common in the biotechnology industry. Clinical investigators may wish to consider this issue before participating in any equity position in the biotechnology industry, especially if they are going to perform research for those companies.

External cephalic version for breech presentation before term.

PubMed

Hutton, E K; Hofmeyr, G J

2006-01-25

External cephalic version (ECV) of the breech fetus at term (after 37 weeks) has been shown to be effective in reducing the number of breech presentations and caesarean sections, but the rates of success are relatively low. This review examines studies initiating ECV prior to term (before 37 weeks' gestation). To assess the effectiveness of a policy of beginning ECV before term (before 37 weeks' gestation) for breech presentation on fetal presentation at birth, method of delivery, and the rate of preterm birth, perinatal morbidity, stillbirth or neonatal mortality. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), MEDLINE (1965 to April 2005), EMBASE (1988 to April 2005), and Controlled Clinical Trials randomised controlled trials registry (April 2005). Randomised trials of ECV beginning before term (before 37 weeks' gestation) compared with a control group in women with breech presentation before term. Two review authors independently assessed eligibility and trial quality and extracted data. Three studies are included. One study reported on ECV that was undertaken and completed before 37 weeks' gestation compared to no ECV. No difference was found in the rate of non-cephalic presentation at birth. One study reported on a policy of ECV that was initiated before term (33 weeks) and up until 40 weeks' gestation and which could be repeated up until delivery compared to no ECV. This study showed a decrease in the rate of non-cephalic presentation at birth (relative risk 0.59, 95% confidence interval 0.45 to 0.77). One study reported on ECV started at between 34 to 35 weeks' gestation compared to beginning at 37 to 38 weeks' gestation. Although findings were not statistically significant, a 9.5% decrease in the rate of non-cephalic presentation at birth and a 7% decrease in the caesarean section rate were reported when ECV was started early. Compared with no ECV attempt, ECV commenced before term reduces non-cephalic births. Compared with ECV at term, beginning ECV at between 34 to 35 weeks may have some benefit in terms of decreasing the rate of non-cephalic presentation, and caesarean section. Further trials are needed to confirm this finding and to rule out increased rates of preterm birth, or other adverse perinatal outcomes. A large pragmatic trial is ongoing (www.utoronto.ca/miru/eecv2).

Computerized Dose Range Checking Using Hard and Soft Stop Alerts Reduces Prescribing Errors in a Pediatric Intensive Care Unit.

PubMed

Balasuriya, Lilanthi; Vyles, David; Bakerman, Paul; Holton, Vanessa; Vaidya, Vinay; Garcia-Filion, Pamela; Westdorp, Joan; Sanchez, Christine; Kurz, Rhonda

2017-09-01

An enhanced dose range checking (DRC) system was developed to evaluate prescription error rates in the pediatric intensive care unit and the pediatric cardiovascular intensive care unit. An enhanced DRC system incorporating "soft" and "hard" alerts was designed and implemented. Practitioner responses to alerts for patients admitted to the pediatric intensive care unit and the pediatric cardiovascular intensive care unit were retrospectively reviewed. Alert rates increased from 0.3% to 3.4% after "go-live" (P < 0.001). Before go-live, all alerts were soft alerts. In the period after go-live, 68% of alerts were soft alerts and 32% were hard alerts. Before go-live, providers reduced doses only 1 time for every 10 dose alerts. After implementation of the enhanced computerized physician order entry system, the practitioners responded to soft alerts by reducing doses to more appropriate levels in 24.7% of orders (70/283), compared with 10% (3/30) before go-live (P = 0.0701). The practitioners deleted orders in 9.5% of cases (27/283) after implementation of the enhanced DRC system, as compared with no cancelled orders before go-live (P = 0.0774). Medication orders that triggered a soft alert were submitted unmodified in 65.7% (186/283) as compared with 90% (27/30) of orders before go-live (P = 0.0067). After go-live, 28.7% of hard alerts resulted in a reduced dose, 64% resulted in a cancelled order, and 7.4% were submitted as written. Before go-live, alerts were often clinically irrelevant. After go-live, there was a statistically significant decrease in orders that were submitted unmodified and an increase in the number of orders that were reduced or cancelled.

Computers in the examination room and the electronic health record: physicians' perceived impact on clinical encounters before and after full installation and implementation.

PubMed

Doyle, Richard J; Wang, Nina; Anthony, David; Borkan, Jeffrey; Shield, Renee R; Goldman, Roberta E

2012-10-01

We compared physicians' self-reported attitudes and behaviours regarding electronic health record (EHR) use before and after installation of computers in patient examination rooms and transition to full implementation of an EHR in a family medicine training practice to identify anticipated and observed effects these changes would have on physicians' practices and clinical encounters. We conducted two individual qualitative interviews with family physicians. The first interview was before and second interview was 8 months later after full implementation of an EHR and computer installation in the examination rooms. Data were analysed through project team discussions and subsequent coding with qualitative analysis software. At the first interviews, physicians frequently expressed concerns about the potential negative effect of the EHR on quality of care and physician-patient interaction, adequacy of their skills in EHR use and privacy and confidentiality concerns. Nevertheless, most physicians also anticipated multiple benefits, including improved accessibility of patient data and online health information. In the second interviews, physicians reported that their concerns did not persist. Many anticipated benefits were realized, appearing to facilitate collaborative physician-patient relationships. Physicians reported a greater teaching role with patients and sharing online medical information and treatment plan decisions. Before computer installation and full EHR implementation, physicians expressed concerns about the impact of computer use on patient care. After installation and implementation, however, many concerns were mitigated. Using computers in the examination rooms to document and access patients' records along with online medical information and decision-making tools appears to contribute to improved physician-patient communication and collaboration.

Embracing model-based designs for dose-finding trials

PubMed Central

Love, Sharon B; Brown, Sarah; Weir, Christopher J; Harbron, Chris; Yap, Christina; Gaschler-Markefski, Birgit; Matcham, James; Caffrey, Louise; McKevitt, Christopher; Clive, Sally; Craddock, Charlie; Spicer, James; Cornelius, Victoria

2017-01-01

Background: Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM). Methods: We carried out a literature review of dose-finding designs and conducted a survey to identify perceived barriers to their implementation. Results: We describe the benefits of model-based designs (flexibility, superior operating characteristics, extended scope), their current uptake, and existing resources. The most prominent barriers to implementation of a model-based design were lack of suitable training, chief investigators’ preference for algorithm-based designs (e.g., 3+3), and limited resources for study design before funding. We use a real-world example to illustrate how these barriers can be overcome. Conclusions: There is overwhelming evidence for the benefits of CRM. Many leading pharmaceutical companies routinely implement model-based designs. Our analysis identified barriers for academic statisticians and clinical academics in mirroring the progress industry has made in trial design. Unified support from funders, regulators, and journal editors could result in more accurate doses for later-phase testing, and increase the efficiency and success of clinical drug development. We give recommendations for increasing the uptake of model-based designs for dose-finding trials in academia. PMID:28664918

Comparison of Burnout among Medical Residents before and after the Implementation of Work Hours Limits

ERIC Educational Resources Information Center

Martini, Shahm; Arfken, Cynthia L.; Balon, Richard

2006-01-01

Objective: The authors assess whether implementation of work hour limits is associated with a lower prevalence of medical resident burnout. Method: A survey was mailed to medical residents in different medical specialties at one university. Results: Somewhat lower burnout prevalence was reported among residents after implementation of work hour…

The Effects of 52 Weeks of Soccer or Resistance Training on Body Composition and Muscle Function in +65-Year-Old Healthy Males – A Randomized Controlled Trial

PubMed Central

Andersen, Thomas Rostgaard; Schmidt, Jakob Friis; Pedersen, Mogens Theisen; Krustrup, Peter; Bangsbo, Jens

2016-01-01

The effects of 52 weeks of soccer or resistance training were investigated in untrained elderly men. The subjects aged 68.1±2.1 yrs were randomised into a soccer (SG; n = 9), a resistance (RG; n = 9) and a control group (CG; n = 8). The subjects in SG and RG, respectively, trained 1.7±0.3 and 1.8±0.3 times weekly on average during the intervention period. Muscle function and body composition were determined before and after 16 and 52 weeks of the intervention period. In SG, BMI was reduced by 1.5% and 3.0% (p<0.05) after 16 and 52 weeks, respectively, unchanged in RG and 2% higher (p<0.05) in CG after 52 weeks of the intervention period. In SG, the response to a glucose tolerance test was 16% lower (p<0.05) after 16 wks, but not after 52 wks, compared to before the intervention period, and unchanged in RG and CG. In SG, superoxide dismutase-2 expression was 59% higher (p<0.05) after 52 wks compared to before the intervention period, and unchanged in RG and CG. In RG, upper body lean mass was 3 and 2% higher (p<0.05) after 16 and 52 wks, respectively, compared to before the intervention period, and unchanged in SG and CG. In RG, Akt-2 expression increased by 28% (p<0.01) and follistatin expression decreased by 38% (p<0.05) during the 52-wk intervention period, and was unchanged in SG and CG. Thus, long-term soccer training reduces BMI and improves anti-oxidative capacity, while long-term resistance training impacts muscle protein enzyme expression and increases lean body mass in elderly men. Trial Registration ClinicalTrials.gov: NCT01530035 PMID:26886262

The Effects of 52 Weeks of Soccer or Resistance Training on Body Composition and Muscle Function in +65-Year-Old Healthy Males--A Randomized Controlled Trial.

PubMed

Andersen, Thomas Rostgaard; Schmidt, Jakob Friis; Pedersen, Mogens Theisen; Krustrup, Peter; Bangsbo, Jens

2016-01-01

The effects of 52 weeks of soccer or resistance training were investigated in untrained elderly men. The subjects aged 68.1±2.1 yrs were randomised into a soccer (SG; n = 9), a resistance (RG; n = 9) and a control group (CG; n = 8). The subjects in SG and RG, respectively, trained 1.7±0.3 and 1.8±0.3 times weekly on average during the intervention period. Muscle function and body composition were determined before and after 16 and 52 weeks of the intervention period. In SG, BMI was reduced by 1.5% and 3.0% (p<0.05) after 16 and 52 weeks, respectively, unchanged in RG and 2% higher (p<0.05) in CG after 52 weeks of the intervention period. In SG, the response to a glucose tolerance test was 16% lower (p<0.05) after 16 wks, but not after 52 wks, compared to before the intervention period, and unchanged in RG and CG. In SG, superoxide dismutase-2 expression was 59% higher (p<0.05) after 52 wks compared to before the intervention period, and unchanged in RG and CG. In RG, upper body lean mass was 3 and 2% higher (p<0.05) after 16 and 52 wks, respectively, compared to before the intervention period, and unchanged in SG and CG. In RG, Akt-2 expression increased by 28% (p<0.01) and follistatin expression decreased by 38% (p<0.05) during the 52-wk intervention period, and was unchanged in SG and CG. Thus, long-term soccer training reduces BMI and improves anti-oxidative capacity, while long-term resistance training impacts muscle protein enzyme expression and increases lean body mass in elderly men. Trial Registration: ClinicalTrials.gov: NCT01530035.

The role of economics in the QUERI program: QUERI Series

PubMed Central

Smith, Mark W; Barnett, Paul G

2008-01-01

Background The United States (U.S.) Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) has implemented economic analyses in single-site and multi-site clinical trials. To date, no one has reviewed whether the QUERI Centers are taking an optimal approach to doing so. Consistent with the continuous learning culture of the QUERI Program, this paper provides such a reflection. Methods We present a case study of QUERI as an example of how economic considerations can and should be integrated into implementation research within both single and multi-site studies. We review theoretical and applied cost research in implementation studies outside and within VA. We also present a critique of the use of economic research within the QUERI program. Results Economic evaluation is a key element of implementation research. QUERI has contributed many developments in the field of implementation but has only recently begun multi-site implementation trials across multiple regions within the national VA healthcare system. These trials are unusual in their emphasis on developing detailed costs of implementation, as well as in the use of business case analyses (budget impact analyses). Conclusion Economics appears to play an important role in QUERI implementation studies, only after implementation has reached the stage of multi-site trials. Economic analysis could better inform the choice of which clinical best practices to implement and the choice of implementation interventions to employ. QUERI economics also would benefit from research on costing methods and development of widely accepted international standards for implementation economics. PMID:18430199

The role of economics in the QUERI program: QUERI Series.

PubMed

Smith, Mark W; Barnett, Paul G

2008-04-22

The United States (U.S.) Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) has implemented economic analyses in single-site and multi-site clinical trials. To date, no one has reviewed whether the QUERI Centers are taking an optimal approach to doing so. Consistent with the continuous learning culture of the QUERI Program, this paper provides such a reflection. We present a case study of QUERI as an example of how economic considerations can and should be integrated into implementation research within both single and multi-site studies. We review theoretical and applied cost research in implementation studies outside and within VA. We also present a critique of the use of economic research within the QUERI program. Economic evaluation is a key element of implementation research. QUERI has contributed many developments in the field of implementation but has only recently begun multi-site implementation trials across multiple regions within the national VA healthcare system. These trials are unusual in their emphasis on developing detailed costs of implementation, as well as in the use of business case analyses (budget impact analyses). Economics appears to play an important role in QUERI implementation studies, only after implementation has reached the stage of multi-site trials. Economic analysis could better inform the choice of which clinical best practices to implement and the choice of implementation interventions to employ. QUERI economics also would benefit from research on costing methods and development of widely accepted international standards for implementation economics.

Use of Noninvasive Ventilation During Feeding Tube Placement.

PubMed

Banfi, Paolo; Volpato, Eleonora; Valota, Chiara; D'Ascenzo, Salvatore; Alunno, Chiara Bani; Lax, Agata; Nicolini, Antonello; Ticozzi, Nicola; Silani, Vincenzo; Bach, John R

2017-11-01

Parenteral nutrition is indicated in amyotrophic lateral sclerosis (ALS) when dysphagia, loss of appetite, and difficulty protecting the airways cause malnutrition, severe weight loss, dehydration, and increased risk of aspiration pneumonia. The aim of this review is to compare percutaneous endoscopic gastrostomy (PEG), radiologically inserted G-tube (RIG), and percutaneous radiologic gastrostomy (PRG) in patients with ALS, performed with or without noninvasive ventilation (NIV). We searched PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the EBSCO Online Research Database, and Scopus up to December 2015. A priori selection included all randomized controlled trials (RCTs), quasi-randomized trials, and prospective and retrospective studies. The primary outcome was 30-d survival. We found no RCTs or quasi-RCTs. Seven studies about the implementation of the PEG/RIG procedure during the use of NIV and 5 studies without NIV were included. In another study of 59 subjects undergoing open gastrostomy, all with vital capacity < 30% of normal, 18 of whom were dependent on continuous NIV at full ventilatory support settings, there were no respiratory complications. Thus, the use of NIV during the implementation of these procedures, especially when used at full ventilatory support settings of pressure preset 18-25 cm H 2 O, can support alveolar ventilation before, during, and after the procedures and prevent respiratory complications. The procedures investigated appear equivalent, but the methodological quality of the studies could be improved. Possible benefits with regard to nutrition parameters, quality of life, and psychological features need to be further investigated. Copyright © 2017 by Daedalus Enterprises.

Substantial reduction in hospital stay of children and adolescents with diabetic ketoacidosis after implementation of Clinical Practice Guidelines in a university hospital in Saudi Arabia.

PubMed

Al Nemri, Abdulrahman; Amer, Yasser Sami; Gasim, Hala; Osman, Mohamed Elfaki; Aleyadhy, Ayman; Al Otaibi, Hessah; Iqbal, Shaikh Mohammed; Aljurayyan, Nasir Abdullah; Assiri, Asaad M; Babiker, Amir; Mohamed, Sarar

2017-02-01

We aimed to determine the effect of Clinical Practice Guideline (CPG) implementation on length of hospital stay of children and adolescents with diabetic ketoacidosis (DKA). This was a 6-year (2008-2014) case-control retrospective study conducted at King Khalid University Hospital, Riyadh, that compared patients with DKA managed using CPG with those treated before CPG implementation. There were 63 episodes of DKA in 41 patients managed using CPG compared with 40 episodes in 33 patients treated before implementation of CPG. Baseline characteristics of the 2 groups were similar (age, sex, newly diagnosed patients, recurrent DKA, DKA severity, and mean glycosylated hemoglobin). The mean length of hospital stay (±SD) was 68.6 ± 53.1 hours after implementation of CPG compared with 107.4 ± 65.6 hours before implementation (P < .001). The reduction in length of hospital stay equals to 1700 bed days saved per year per 1000 patients. Implementation of CPG for DKA decreased the length of hospital stay. © 2016 John Wiley & Sons, Ltd.

Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.

PubMed

Kalkman, Shona; van Thiel, Ghislaine J M W; Grobbee, Diederick E; Meinecke, Anna-Katharina; Zuidgeest, Mira G P; van Delden, Johannes J M

2016-08-22

We explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders' attitudes towards the implementation of pragmatic trials in the drug development process. We conducted semistructured, in-depth interviews among individuals from different key stakeholder groups (academia and independent research institutions, the pharmaceutical industry, regulators, Health Technology Assessment (HTA) agencies and patients' organizations) through telephone or face-to-face sessions. Interviews were structured around the question "what challenges were experienced or perceived during the design, conduct and/or review of pragmatic trials." Respondents were additionally asked about their views on implementation of pragmatic trials in the drug development process. Thematic analysis was used to identify the ethically relevant features across data sets. We interviewed 34 stakeholders in 25 individual sessions and four group sessions. The four perceived challenges of ethical relevance were: (1) less controlled conditions creating safety concerns, (2) comparison with usual care potentially compromising clinical equipoise, (3) tailored or waivers of informed consent affecting patient autonomy, and (4) minimal interference with "real-world" practice reducing the knowledge value of trial results. We identified stakeholder concerns regarding risk assessment, use of suboptimal usual care as a comparator, tailoring of informed consent procedures and ensuring the social value of pragmatic trials. These concerns increased when respondents were asked about pragmatic trials conducted before market authorization.

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.

Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial.

PubMed

McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-06-01

Exercise using virtual reality (VR) has improved balance in adults with traumatic brain injury and community-dwelling older adults. Rigorous randomized studies regarding its efficacy, safety, and applicability with individuals after stroke are lacking. The purpose of this study was to determine whether an adjunct VR therapy improves balance, mobility, and gait in stroke rehabilitation inpatients. A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed. The treatment group (n=30) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance (eg, soccer goaltending, snowboarding) performed while standing. The control group (n=29) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance (performed in sitting). VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period. Objective outcome measures of balance and mobility were assessed before, immediately after, and 1 month after training. Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test, with both groups meeting minimal clinical important differences after training. More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain (P=0.04) immediately after training. This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes. Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR. http://www.ANZCTR.org.au/. Unique identifier: ACTRN12613000710729. © 2014 American Heart Association, Inc.

A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

PubMed

de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

2015-07-30

Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary outcome is length of postoperative hospital stay. Additional outcome measures are length of recovery, guideline adherence, and mean implementation costs per patient. This study takes up the challenge to evaluate an efficient strategy for large-scale implementation. Comparing effectiveness and costs of two different approaches, this study will help to define a preferred strategy for nationwide dissemination of best practices. Dutch Trial Register NTR4058.

Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting.

PubMed

Dal-Ré, Rafael; Ross, Joseph S; Marušić, Ana

2016-07-01

To examine compliance with International Committee of Medical Journal Editors' (ICMJE) policy on prospective trial registration along with predictors of compliance. Cross-sectional analysis of all articles reporting trial results published in the six highest-impact general medicine journals in January-June 2014 that were registered in a public trial registry. The main outcome measure was compliance with ICMJE policy. The time frame for trial primary end point ascertainment was used to assess whether retrospective registration could have allowed changing of primary end points following an interim analysis. Forty of 144 (28%) articles did not comply with the ICMJE policy. Trials of non-FDA-regulated interventions were less compliant than trials of FDA-regulated interventions (i.e., medicines, medical devices) (42% vs. 21%; P = 0.016). Twenty-nine of these 40 (72%; 20% overall) were registered before any interim analysis of primary end points could have been conducted; 11 (28%; 8% overall) were registered after primary end point ascertainment, such that investigators could have had the opportunity to conduct an interim analysis before trial registration. Twenty-eight percent of trials published in high-impact journals were retrospectively registered including nearly 10% that were registered after primary end point ascertainment could have had taken place. Prospective registration should be prompted and enforced to ensure transparency and accountability in clinical research. Copyright © 2016 Elsevier Inc. All rights reserved.

THE EFFECTS OF VIDEO MODELING WITH VOICEOVER INSTRUCTION ON ACCURATE IMPLEMENTATION OF DISCRETE-TRIAL INSTRUCTION

PubMed Central

Vladescu, Jason C; Carroll, Regina; Paden, Amber; Kodak, Tiffany M

2012-01-01

The present study replicates and extends previous research on the use of video modeling (VM) with voiceover instruction to train staff to implement discrete-trial instruction (DTI). After staff trainees reached the mastery criterion when teaching an adult confederate with VM, they taught a child with a developmental disability using DTI. The results showed that the staff trainees' accurate implementation of DTI remained high, and both child participants acquired new skills. These findings provide additional support that VM may be an effective method to train staff members to conduct DTI. PMID:22844149

The effects of video modeling with voiceover instruction on accurate implementation of discrete-trial instruction.

PubMed

Vladescu, Jason C; Carroll, Regina; Paden, Amber; Kodak, Tiffany M

2012-01-01

The present study replicates and extends previous research on the use of video modeling (VM) with voiceover instruction to train staff to implement discrete-trial instruction (DTI). After staff trainees reached the mastery criterion when teaching an adult confederate with VM, they taught a child with a developmental disability using DTI. The results showed that the staff trainees' accurate implementation of DTI remained high, and both child participants acquired new skills. These findings provide additional support that VM may be an effective method to train staff members to conduct DTI.

Integrating health-related quality of life into cross-national clinical trials.

PubMed

Cella, D F; Wiklund, I; Shumaker, S A; Aaronson, N K

1993-12-01

When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)

Fat oxidation after acipimox-induced reduction in plasma nonesterified fatty acids during exercise at 0 degrees C and 20 degrees C.

PubMed

Layden, Joseph D; Malkova, Dalia; Nimmo, Myra A

2004-09-01

The main aim of this study was to investigate if whole body fat oxidation, after acipimox administration, during submaximal exercise in the cold, is different from that at temperate environments. Seven healthy recreationally active male subjects cycled at 70% Vo(2peak) for 60 minutes; once at 0 degrees C and once at 20 degrees C. To exclude availability, and therefore oxidation of plasma-derived nonesterified fatty acids (NEFA), 90 minutes before each cycling bout, subjects ingested 250 mg of the antilipolytic drug, acipimox. Blood and expired gas measurements were obtained at rest, immediately before exercise, and at 15, 30, 45, and 60 minutes of exercise. In both trials, after the ingestion of acipimox, plasma NEFA concentrations fell dramatically and immediately before and during exercise were lower than 0.05 mmol. L(-1) in both trials. Pre-exercise and exercise values of glycerol, glucose, triacylglycerol (TG), and rectal temperature (T(re)) were not different between the 0 degrees C and 20 degrees C trials. During exercise at 0 degrees C, skin temperature (T(sk)) was significantly reduced from pre-exercise values (P <.05) and at all time points was significantly lower than during exercise at 20 degrees C. Muscle temperature did not differ between trials but in both trials was lower (P <.05) at 1 cm depth than at 3 cm and 2 cm. Gross energy expenditure of cycling (0 degrees C trial, 3.6 +/- 0.1 MJ; 20 degrees C trial, 3.6 +/- 0.1 MJ), the oxidation rates of carbohydrate (0 degrees C, 32.4 +/- 0.5 KJ. min(-1); 20 degrees C, 32.6 +/- 0.7 KJ. min(-1)) and fat (0 degrees C, 24.6 +/- 1.2 KJ. min(-1); 20 degrees C, 23.0 +/- 1.8 KJ. min(-1)), and the proportion of energy derived from fat (0 degrees C, 45 +/- 1 %; 20 degrees C, 40 +/- 4%) and carbohydrate (0 degrees C, 55 +/- 1%; 20 degrees C, 58 +/- 3%) were not different between the 2 trials. In conclusion, after acipimox administration, whole body fat oxidation during exercise, designed to avoid adjustment of core temperature or thermogenesis, is not different at 0 degrees C compared with 20 degrees C. This allows the inference that during submaximal exercise, cold has no effect on the utilization of intramuscular TG (IMTG).

The cost-savings of implementing kangaroo mother care in Nicaragua.

PubMed

Broughton, Edward I; Gomez, Ivonne; Sanchez, Nieves; Vindell, Concepción

2013-09-01

To examine the costs of implementing kangaroo mother care (KMC) in a referral hospital in Nicaragua, including training, implementation, and ongoing operating costs, and to estimate the economic impact on the Nicaraguan health system if KMC were implemented in other maternity hospitals in the country. After receiving clinical training in KMC, the implementation team trained their colleagues, wrote guidelines for clinicians and education material for parents, and ensured adherence to the new guidelines. The intervention began September 2010 The study compared data on infant weight, medication use, formula consumption, incubator use, and hospitalization for six months before and after implementation. Cost data were collected from accounting records of the implementers and health ministry formularies. A total of 46 randomly selected infants before implementation were compared to 52 after implementation. Controlling for confounders, neonates after implementation had lower lengths of hospitalization by 4.64 days (P = 0.017) and 71% were exclusively breastfed (P < 0.001). The intervention cost US$ 23 113 but the money saved with shorter hospitalization, elimination of incubator use, and lower antibiotic and infant formula costs made up for this expense in 1 - 2 months. Extending KMC to 12 other facilities in Nicaragua is projected to save approximately US$ 166 000 (based on the referral hospital incubator use estimate) or US$ 233 000 after one year (based on the more conservative incubator use estimate). Treating premature and low-birth-weight infants in Nicaragua with KMC implemented as a quality improvement program saves money within a short period even without considering the beneficial health effects of KMC. Implementation in more facilities is strongly recommended.

Effects of Iranian Economic Reforms on Equity in Social and Healthcare Financing: A Segmented Regression Analysis.

PubMed

Zandian, Hamed; Takian, Amirhossein; Rashidian, Arash; Bayati, Mohsen; Zahirian Moghadam, Telma; Rezaei, Satar; Olyaeemanesh, Alireza

2018-03-01

One of the main objectives of the Targeted Subsidies Law (TSL) in Iran was to improve equity in healthcare financing. This study aimed at measuring the effects of the TSL, which was implemented in Iran in 2010, on equity in healthcare financing. Segmented regression analysis was applied to assess the effects of TSL implementation on the Gini and Kakwani indices of outcome variables in Iranian households. Data for the years 1977-2014 were retrieved from formal databases. Changes in the levels and trends of the outcome variables before and after TSL implementation were assessed using Stata version 13. In the 33 years before the implementation of the TSL, the Gini index decreased from 0.401 to 0.381. The Gini index and its intercept significantly decreased to 0.362 (p<0.001) 5 years after the implementation of the TSL. There was no statistically significant change in the gross domestic product or inflation rate after TSL implementation. The Kakwani index significantly increased from -0.020 to 0.007 (p<0.001) before the implementation of the TSL, while we observed no statistically significant change (p=0.81) in the Kakwani index after TSL implementation. The TSL reform, which was introduced as part of an economic development plan in Iran in 2010, led to a significant reduction in households' income inequality. However, the TSL did not significantly affect equity in healthcare financing. Hence, while measuring the long-term impact of TSL is paramount, healthcare decision-makers need to consider the efficacy of the TSL in order to develop plans for achieving the desired equity in healthcare financing.

Effects of Iranian Economic Reforms on Equity in Social and Healthcare Financing: A Segmented Regression Analysis

PubMed Central

Bayati, Mohsen

2018-01-01

Objectives One of the main objectives of the Targeted Subsidies Law (TSL) in Iran was to improve equity in healthcare financing. This study aimed at measuring the effects of the TSL, which was implemented in Iran in 2010, on equity in healthcare financing. Methods Segmented regression analysis was applied to assess the effects of TSL implementation on the Gini and Kakwani indices of outcome variables in Iranian households. Data for the years 1977-2014 were retrieved from formal databases. Changes in the levels and trends of the outcome variables before and after TSL implementation were assessed using Stata version 13. Results In the 33 years before the implementation of the TSL, the Gini index decreased from 0.401 to 0.381. The Gini index and its intercept significantly decreased to 0.362 (p<0.001) 5 years after the implementation of the TSL. There was no statistically significant change in the gross domestic product or inflation rate after TSL implementation. The Kakwani index significantly increased from -0.020 to 0.007 (p<0.001) before the implementation of the TSL, while we observed no statistically significant change (p=0.81) in the Kakwani index after TSL implementation. Conclusions The TSL reform, which was introduced as part of an economic development plan in Iran in 2010, led to a significant reduction in households’ income inequality. However, the TSL did not significantly affect equity in healthcare financing. Hence, while measuring the long-term impact of TSL is paramount, healthcare decision-makers need to consider the efficacy of the TSL in order to develop plans for achieving the desired equity in healthcare financing. PMID:29631352

Decreasing Medication Turnaround Time with Digital Scanning Technology in a Canadian Health Region

PubMed Central

Neville, Heather; Nodwell, Lisa; Alsharif, Sahar

2014-01-01

Background: Reducing medication turnaround time can improve efficiency, patient safety, and quality of care in the hospital setting. Digital scanning technology (DST) can be used to electronically transmit scanned prescriber orders to a pharmacy computer queue for verification and processing, which may help to improve medication turnaround time. Objectives: To evaluate medication turnaround time before and after implementation of DST for all medications and for antibiotics only. Methods: Medication turnaround times were evaluated retrospectively for periods before (June 6–10, 2011) and after (September 26–30, 2011) implementation of DST at 2 hospital sites in 1 health region. Medication turnaround time was defined as the time from composition of a medication order by the prescriber to its verification by the pharmacy (phase 1) and the time from prescriber composition to administration to the patient by a nurse (total). Median turnaround times were analyzed with SPSS software using the Mann–Whitney U test. Results: In total, 304 and 244 medication orders were audited before and after DST implementation, respectively. Median phase 1 turnaround time for all medications declined significantly, from 2 h 23 min before DST implementation to 1 h 33 min after DST implementation (p < 0.001). Antibiotics were also processed significantly faster (1 h 51 min versus 1 h 9 min, p = 0.015). However, total turnaround time for all medications did not differ significantly (5 h 15 min versus 5 h 0 min, p = 0.42). Conclusions: Implementation of DST was associated with a 50-min decrease in medication turnaround time for the period from when an order was prescribed to the time it was processed by the pharmacy. Regular evaluation of medication turnaround times is recommended to compare with benchmarks, to ensure that hospital standards are being met, and to measure the effects of policy changes and implementation of new technology on medication-use processes. PMID:25548397

Decreasing medication turnaround time with digital scanning technology in a canadian health region.

PubMed

Neville, Heather; Nodwell, Lisa; Alsharif, Sahar

2014-11-01

Reducing medication turnaround time can improve efficiency, patient safety, and quality of care in the hospital setting. Digital scanning technology (DST) can be used to electronically transmit scanned prescriber orders to a pharmacy computer queue for verification and processing, which may help to improve medication turnaround time. To evaluate medication turnaround time before and after implementation of DST for all medications and for antibiotics only. Medication turnaround times were evaluated retrospectively for periods before (June 6-10, 2011) and after (September 26-30, 2011) implementation of DST at 2 hospital sites in 1 health region. Medication turnaround time was defined as the time from composition of a medication order by the prescriber to its verification by the pharmacy (phase 1) and the time from prescriber composition to administration to the patient by a nurse (total). Median turnaround times were analyzed with SPSS software using the Mann-Whitney U test. In total, 304 and 244 medication orders were audited before and after DST implementation, respectively. Median phase 1 turnaround time for all medications declined significantly, from 2 h 23 min before DST implementation to 1 h 33 min after DST implementation (p < 0.001). Antibiotics were also processed significantly faster (1 h 51 min versus 1 h 9 min, p = 0.015). However, total turnaround time for all medications did not differ significantly (5 h 15 min versus 5 h 0 min, p = 0.42). Implementation of DST was associated with a 50-min decrease in medication turnaround time for the period from when an order was prescribed to the time it was processed by the pharmacy. Regular evaluation of medication turnaround times is recommended to compare with benchmarks, to ensure that hospital standards are being met, and to measure the effects of policy changes and implementation of new technology on medication-use processes.

Using the bedside wellness system during chemotherapy decreases fatigue and emesis in cancer patients.

PubMed

Oyama, H; Kaneda, M; Katsumata, N; Akechi, T; Ohsuga, M

2000-06-01

The bedside wellness system (BSW) is effective for decreasing stress and improving mental well-being and should help relieve the side effects and mental disorders of patients during cancer chemotherapy. The study was a randomized clinical trial. After giving informed consent, patients were randomly assigned to the BSW intervention or control groups. The patients were given the Hospital Anxiety and Depression Scale (HADS) test before the trial to evaluate their emotional baseline. The Cancer Fatigue Scale, which was developed at our institute, and face visual analog scale were used to measure the emotional state and subjective feelings before and after the trial. The degree of emesis was measured using a visual analogue scale after the experience. We set up the system in a room in the outpatient clinic of the National Cancer Center New Hospital Building. The decreases in the fatigue score and emesis score 3-5 days after chemotherapy were statistically significant (both p < 0.05) and carry-over effects were detected. BSW intervention therapy is an effective way to treat fatigue and emesis. This virtual reality system is a new therapeutic method that can be used in palliative medicine.

Perceptual structure of adductor spasmodic dysphonia and its acoustic correlates.

PubMed

Cannito, Michael P; Doiuchi, Maki; Murry, Thomas; Woodson, Gayle E

2012-11-01

To examine the perceptual structure of voice attributes in adductor spasmodic dysphonia (ADSD) before and after botulinum toxin treatment and identify acoustic correlates of underlying perceptual factors. Reliability of perceptual judgments is considered in detail. Pre- and posttreatment trial with comparison to healthy controls, using single-blind randomized listener judgments of voice qualities, as well as retrospective comparison with acoustic measurements. Oral readings were recorded from 42 ADSD speakers before and after treatment as well as from their age- and sex-matched controls. Experienced judges listened to speech samples and rated attributes of overall voice quality, breathiness, roughness, and brokenness, using computer-implemented visual analog scaling. Data were adjusted for regression to the mean and submitted to principal components factor analysis. Acoustic waveforms, extracted from the reading samples, were analyzed and measurements correlated with perceptual factor scores. Four reliable perceptual variables of ADSD voice were effectively reduced to two underlying factors that corresponded to hyperadduction, most strongly associated with roughness, and hypoadduction, most strongly associated with breathiness. After treatment, the hyperadduction factor improved, whereas the hypoadduction factor worsened. Statistically significant (P<0.01) correlations were observed between perceived roughness and four acoustic measures, whereas breathiness correlated with aperiodicity and cepstral peak prominence (CPPs). This study supported a two-factor model of ADSD, suggesting perceptual characterization by both hyperadduction and hypoadduction before and after treatment. Responses of the factors to treatment were consistent with previous research. Correlations among perceptual and acoustic variables suggested that multiple acoustic features contributed to the overall impression of roughness. Although CPPs appears to be a partial correlate of perceived breathiness, a physical basis of this percept remained less clear. Copyright © 2012 The Voice Foundation. Published by Mosby, Inc. All rights reserved.

Design of the Quality of Life in Motion (QLIM) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer.

PubMed

Braam, Katja I; van Dijk, Elisabeth M; Veening, Margreet A; Bierings, Marc B; Merks, Johannes H M; Grootenhuis, Martha A; Chinapaw, Mai J M; Sinnema, Gerben; Takken, Tim; Huisman, Jaap; Kaspers, Gertjan J L; van Dulmen-den Broeder, Eline

2010-11-11

Childhood cancer and its treatment have considerable impact on a child's physical and mental wellbeing. Especially long-term administration of chemotherapy and/or radiotherapy impairs physical fitness both during and after therapy, when children often present with muscle weakness and/or low cardiorespiratory fitness. Physical exercise can improve these two elements of physical fitness, but the positive effects of physical exercise might be further increased when a child's wellbeing is simultaneously enhanced by psychosocial training. Feeling better may increase the willingness and motivation to engage in sports activities. Therefore, this multi-centre study evaluates the short and long-term changes in physical fitness of a child with a childhood malignancy, using a combined physical exercise and psychosocial intervention program, implemented during or shortly after treatment. Also examined is whether positive effects on physical fitness reduce inactivity-related adverse health problems, improve quality of life, and are cost-effective. This multi-centre randomized controlled trial compares a combined physical and psychosocial intervention program for children with cancer, with care as usual (controls). Children with cancer (aged 8-18 years) treated with chemotherapy and/or radiotherapy, and who are no longer than 1 year post-treatment, are eligible for participation. A total of 100 children are being recruited from the paediatric oncology/haematology departments of three Dutch university medical centres. Patients are stratified according to pubertal stage (girls: age ≤10 or >10 years; boys: ≤11 or >11 years), type of malignancy (haematological or solid tumour), and moment of inclusion into the study (during or after treatment), and are randomly assigned to the intervention or control group. Childhood cancer patients undergoing long-term cancer therapy may benefit from a combined physical exercise and psychosocial intervention program since it may maintain or enhance their physical fitness and increase their quality of life. However, the feasibility, patient need, and effectiveness of such a program should be established before the program can be implemented as part of standard care. NTR1531 (The Netherlands National Trial Register).

Changes in the number of resident publications after inception of the 80-hour work week.

PubMed

Namdari, Surena; Baldwin, Keith D; Weinraub, Barbara; Mehta, Samir

2010-08-01

Since the inception of resident work-hour regulations, there has been considerable concern regarding the influence of decreased work hours on graduate medical education. In particular, it is unclear whether implementation of work-hour restrictions has influenced resident academic performance as defined by quantity of peer-reviewed publications while participating in graduate medical education. We determined the impact of work-hour changes on resident involvement in the number of published clinical studies, laboratory research, case reports, and review articles. We conducted a PubMed literature search of 139 consecutive orthopaedic surgery residents (789 total resident-years) at one institution from academic years 1995-1996 to 2008-2009. This represented a continuous timeline before and after implementation of work-hour restrictions. The number of resident publications before and after implementation of work-hour changes was compared. There was a greater probability of peer review authorship in any given resident-year after work-hour changes than before. Average publications per resident-year increased for total articles, clinical articles, case reports, and reviews. There was an increased rate of publications in which the resident was the first author. Since implementation of work-hour changes, total resident publications and publications per resident-year have increased.

Effect of intravenous infusion of an alpha-adrenergic blocking agent on the haemodynamic changes in human masseter muscle induced by cold pressor stimulation.

PubMed

Maekawa, K; Kuboki, T; Miyawaki, T; Shimada, M; Yamashita, A; Clark, G T

1999-04-01

This study evaluated the effect of intravenous infusion of a non-selective alpha-adrenergic blocking agent on masseter muscle haemodynamics induced by 4 degrees C cold pressor stimulation (CPS) of the right foot and ankle, which reportedly evokes a rapidly increasing sympathetic nerve activity in human skeletal muscle. Nine healthy non-smoking males (mean age 23.7+/-2.1 year) with no history of chronic muscle pain or migraine participated. The haemoglobin (Hb) concentration in the right masseter was continuously recorded by non-invasive, near-infrared spectroscopy. Heart rate and blood pressure were also recorded. The experiment involved the following sequence: (1) a placebo (physiological saline) with a CPS trial; (2) a 30-sec maximal voluntary clenching (MVC)-only trial; and (3) an alpha-adrenergic blocking agent with a CPS trial. The saline and drug trials each involved continuous recording for 1 min before, 2 min during and 5 min after the CPS. Physiological saline (20 ml) or phentolamine mesylate (20 ml) were infused at the rate of 2 ml/min. This infusion was begun 15 min before baseline recording and participants were not aware which solution (saline or phentolamine) was being infused. For the MVC trial, each participant performed a 30-sec MVC of his jaw-closing muscles followed by a 15-min rest between each trial. The individual Hb data were adjusted so that the baseline at the beginning of the experiment was equal to zero and all data were normalized as a percentage of the individual's highest absolute Hb change seen after the MVC. The mean baseline Hb concentrations 1 min before CPS were significantly higher in the alpha-blocker trial (83.6%) than in the placebo saline trial (P < 0.001). The change in mean Hb concentration from baseline during CPS in the alpha-blocker trial was significantly less than in the placebo trial (P = 0.006). Mean heart rate before CPS was also significantly higher in the alpha-blocker trial (85.2 beats/min) than in the placebo trial (69.6 beats/min) (P < 0.001). There were no significant differences in the mean systolic and diastolic blood pressures between the placebo and alpha-blocker trials in any time period. The results suggest that non-selective alpha-adrenoceptor blockade increases the blood volume in the masseter muscle. This change might be due to a combination of peripheral vasodilation and an increase in cardiac output.

A study on the effect of self bedside exercise program on resilience and activities of daily living for patients with hemiplegia

PubMed Central

Lee, Yang-Chool; Yi, Eun-Surk; Choi, Won-Ho; Lee, Byung-Mun; Cho, Sung-Bo; Kim, Ji-Youn

2015-01-01

The purpose of this study was to design a repeatable universal rehabilitation program in which patients with hemiplegia can participate voluntarily, complementing physical and occupational therapies to increase voluntary exercise practice rate. Also, this study attempted to identify the relationship between psychological resilience due to the implementation of self-bedside exercise and functional recovery of activity of daily living (ADL). 12 patients with hemiplegia voluntarily participated in 8 weeks of self-bedside exercise 5 times a day and more than 5 days a week. Their program implementation, resilience, activities of daily living (MBI), upper limb motor functions (MFT), and balance ability (BBS) were analyzed and compared before and after the program. Compared to before implementing the program, significant increases were found in resilience, MBI, BBS, and MFT in the affected side after the implementation, and the resilience scores showed statistically positive correlation in MBI and MFT. Also, the change in resilience before and after the program implementation showed a statistically positive correlation. Therefore, it can be concluded that the self-bedside exercise developed in this study had a positive effect on voluntary participation in exercise as well as resilience and ADL. However, many studies which complement the psychological aspects of hemiparetic patients with stroke are still needed. PMID:25830141

Plasma carotenoid concentrations before and after supplementation with astaxanthin in middle-aged and senior subjects.

PubMed

Miyazawa, Taiki; Nakagawa, Kiyotaka; Kimura, Fumiko; Satoh, Akira; Miyazawa, Teruo

2011-01-01

A randomized, double-blind human trial was conducted to assess the effect on the plasma carotenoid concentration of 4- or 12-week astaxanthin supplementation (1 or 3 mg/d) of 20 Japanese middle-aged and senior subjects. The plasma carotenoid concentration was significantly higher after the astaxanthin supplementation than that before in both the 1 mg/d (10 subjects) and 3 mg/d (10 subjects) groups.

STEPS: A NARRATIVE ACCOUNT OF A GABAPENTIN SEEDING TRIAL

PubMed Central

Krumholz, Samuel D.; Egilman, David S.; Ross, Joseph S.

2012-01-01

Background Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail. Methods We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing v. Pfizer and Franklin v. Warner-Lambert, the majority of which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial, in order to identify key themes related to the trial’s conduct and determine the extent of marketing involvement in its planning and implementation. Results Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company’s marketing plans. Documents demonstrated that several external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in two published papers. Conclusions The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation. PMID:21709111

Is the introduction of anonymous delivery associated with a reduction of high neonaticide rates in Austria? A retrospective study.

PubMed

Klier, C M; Grylli, C; Amon, S; Fiala, C; Weizmann-Henelius, G; Pruitt, S L; Putkonen, H

2013-03-01

To assess rates of neonaticide after the implementation of a preventative 'anonymous delivery' law in mid-2001 in Austria. Women are allowed to access antenatal care and give birth in a hospital anonymously, without showing any ID and free of charge. Retrospective study. A complete census of police-reported neonaticides was obtained from the police statistics of Austria, Sweden and Finland. All neonaticides reported to the police, 1991-2009. Neonaticide rates before (1991-2001) and after (2002-2009) the introduction of anonymous delivery legislation per 100 000 births. The Mann-Whitney U-test for two independent samples was used to compare neonaticide rates in the period before the new law was introduced with the rates observed after the implementation of the new law for each country. On average the rate of police-reported neonaticides was 7.2 per 100 000 births (SD 3.5, median 7.1) in Austria prior to the new law being passed, and 3.1 per 100 000 births (SD 2.1, median 2.6) after the law was passed. A significant decrease in neonaticide was observed in Austria after the implementation of anonymous delivery (Mann-Whitney U-test P = 0.017). Whereas the Finnish and Swedish rates were lower than the Austrian rates before and after the implementation of the Austrian law, they remained unchanged over the study period. Our data demonstrate a significant decrease in the number of police-reported neonaticides in Austria after the implementation of anonymous delivery. Even though underlying factors associated with neonaticide are complex, the findings could indicate an effect of anonymous delivery in the prevention of this crime. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

Comparison of a Web-Based Teaching Tool and Traditional Didactic Learning for In Vitro Fertilization Patients: A Preliminary Randomized Controlled Trial.

PubMed

Vause, Tannys Dawn Reiko; Allison, David J; Vause, Tricia; Tekok-Kilic, Ayda; Ditor, David S; Min, Jason K

2018-05-01

The objective of this prospective RCT was to compare the efficacy of a web-based teaching tool to traditional didactic teaching in IVF patients. Forty women undergoing their first IVF cycle were randomly allocated to an interactive web-based teaching session or a nurse-led didactic teaching session. The primary outcome measure was participant knowledge regarding the IVF process, risks, and logistics assessed before and after the respective teaching session. Secondary outcomes included patient stress, assessed before and after the respective teaching session, and patient satisfaction, assessed following the respective teaching session and on the day of embryo transfer (following implementation of the teaching protocol). Both groups demonstrated similar and significant improvements in knowledge and stress after exposure to their respective teaching sessions. The web-based group was significantly more satisfied than the didactic teaching group. Web-based teaching was also shown to be equally effective for participants of high versus low income and education status for knowledge, stress, and satisfaction. This study provides preliminary support for the use of web-based teaching as an equally effective tool for increasing knowledge and reducing stress compared to traditional didactic teaching in IVF patients, with the added benefit of increased patient satisfaction. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Transcatheter closure of patent ductus arteriosus with severe pulmonary arterial hypertension in adults.

PubMed

Yan, C; Zhao, S; Jiang, S; Xu, Z; Huang, L; Zheng, H; Ling, J; Wang, C; Wu, W; Hu, H; Zhang, G; Ye, Z; Wang, H

2007-04-01

Surgical closure of patent ductus arteriosus (PDA) with severe pulmonary arterial hypertension in adults carries higher risk than in children. To investigate the application of self-expandable occluders for transcatheter closure of PDA associated with severe pulmonary arterial hypertension in adults, and the assessment of immediate and short-term results. 29 adult patients (6 men, 23 women) underwent attempted transcatheter closure of PDA at a mean (standard deviation (SD)) age of 31.1 (11.4) years (range 18-58 years) and a mean (SD) weight of 54.1 (7.1) kg (range 42-71 kg). On the basis of haemodynamic and clinical data obtained before and after trial occlusion, the final duct occlusion was determined and carried out. Radiographs of the chest, electrocardiograms and echocardiograms were used for follow-up evaluation of the treatment within 1 day, 1 month and 3-6 months after successful closure. 20 of the 29 patients had successful occlusion (group 1), and 9 patients failed (named group 2). In group 1, in which occlusion was successful, mean (SD) pulmonary arterial pressures decreased markedly after trial occlusion: 78 (19.3) mm Hg (range 50-125 mm Hg) before occlusion and 41 (13.8) mm Hg (range 23-77 mm Hg) after occlusion. Systemic arterial oxygen saturation was found to be >90% in 19 patients and <90% in the remaining patient before inhalation of oxygen, and >95% during inhalation of oxygen or after occlusion in all 20 patients. In group 2, the occlusion was not successful, because in two patients the device was not available; another two patients showed worsening of symptoms. The other five patients showed increased pulmonary arterial pressures after trial closure; their mean (SD) pulmonary arterial pressures increased by 10.3 (6) mm Hg (4-16 mm Hg) after trial occlusion, and systemic arterial oxygen saturation was 85.5% (2.6%) (range 82.6-88%) before inhalation of oxygen and 94.7% (1.7%) (range 90.7-99.1%) during inhalation of oxygen. In group 1, the dimensions of the left atrium, left ventricle and pulmonary artery increased considerably in 3-6-months of follow-up compared with those of preocclusion. Transcatheter closure is an effective treatment for adults with PDA associated with reversible severe pulmonary arterial hypertension. Further research is needed for the evaluation of long-term results.

Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial.

PubMed

Marx, Wolfgang; McCarthy, Alexandra L; Ried, Karin; Vitetta, Luis; McKavanagh, Daniel; Thomson, Damien; Sali, Avni; Isenring, Liz

2014-04-09

Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. In a double-blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms. ANZCTR.org.au Identifier: ACTRN12613000120774.

The Effect of Psychomotor Performance, Cerebral and Arterial Blood Saturation between African-American and Caucasian Males Before, During and After Normobaric Hypoxic Exercise

PubMed Central

FEEBACK, MATTHEW R.; SEO, YONGSUK; DANCY, MATTHEW; GLICKMAN, ELLEN L.

2017-01-01

To further elucidate physiological and cognitive performance differences between African-American (AA) and Caucasian individuals (CAU) before, during or after hypoxic and normoxic exercise. Twelve college aged (18–25) apparently healthy African-American (six volunteers) and Caucasian (six subjects) males took part in two trials consisting of normobaric normoxia and normobaric hypoxia (12% oxygen). Each subject cycled at 50% of their altitude adjusted VO2max (−26% of normoxia VO2max) for one hour after a two-hour baseline. Subjects were monitored for cerebral and arterial O2 saturation, as well as the Trail Making Test A and B (TMT) psychomotor performance. Arterial saturation proved to be significantly higher in AA (86.0±4.7) compared to CAU (79.5±4.8) during the first 60 minutes of exposure to hypoxia at rest (p=0.039), but not during exercise. However, cerebral oxygenation to the left frontal lobe was decreased near the conclusion and in 30 minutes after normoxic exercise. TMT B data revealed that CAU (79±12.7) had faster scores than the AA subjects (98±25.1) at all time points and was significantly different at the 115-minute time point of the hypoxic trial (p=0.024). The data suggests that before, during and after normobaric normoxia and hypoxia trial there is a differential response between AA and CAU in regards to arterial and cerebral oxygenation, as well as psychomotor tests. PMID:28966706

Systemic inflammatory responses to maximal versus submaximal lengthening contractions of the elbow flexors.

PubMed

Peake, Jonathan M; Nosaka, Kazunori; Muthalib, Makii; Suzuki, Katsuhiko

2006-01-01

We compared changes in markers of muscle damage and systemic inflammation after submaximal and maximal lengthening muscle contractions of the elbow flexors. Using a cross-over design, 10 healthy young men not involved in resistance training completed a submaximal trial (10 sets of 60 lengthening contractions at 10% maximum isometric strength, 1 min rest between sets), followed by a maximal trial (10 sets of three lengthening contractions at 100% maximum isometric strength, 3 min rest between sets). Lengthening contractions were performed on an isokinetic dynamometer. Opposite arms were used for the submaximal and maximal trials, and the trials were separated by a minimum of two weeks. Blood was sampled before, immediately after, 1 h, 3 h, and 1-4 d after each trial. Total leukocyte and neutrophil numbers, and the serum concentration of soluble tumor necrosis factor-alpha receptor 1 were elevated after both trials (P < 0.01), but there were no differences between the trials. Serum IL-6 concentration was elevated 3 h after the submaximal contractions (P < 0.01). The concentrations of serum tumor necrosis factor-alpha, IL-1 receptor antagonist, IL-10, granulocyte-colony stimulating factor and plasma C-reactive protein remained unchanged following both trials. Maximum isometric strength and range of motion decreased significantly (P < 0.001) after both trials, and were lower from 1-4 days after the maximal contractions compared to the submaximal contractions. Plasma myoglobin concentration and creatine kinase activity, muscle soreness and upper arm circumference all increased after both trials (P < 0.01), but were not significantly different between the trials. Therefore, there were no differences in markers of systemic inflammation, despite evidence of greater muscle damage following maximal versus submaximal lengthening contractions of the elbow flexors.

ICare-ACS (Improving Care Processes for Patients With Suspected Acute Coronary Syndrome): A Study of Cross-System Implementation of a National Clinical Pathway.

PubMed

Than, Martin P; Pickering, John W; Dryden, Jeremy M; Lord, Sally J; Aitken, S Andrew; Aldous, Sally J; Allan, Kate E; Ardagh, Michael W; Bonning, John W N; Callender, Rosie; Chapman, Laura R E; Christiansen, Jonathan P; Cromhout, Andre P J; Cullen, Louise; Deely, Joanne M; Devlin, Gerard P; Ferrier, Katherine A; Florkowski, Christopher M; Frampton, Christopher M A; George, Peter M; Hamilton, Gregory J; Jaffe, Allan S; Kerr, Andrew J; Larkin, G Luke; Makower, Richard M; Matthews, Timothy J E; Parsonage, William A; Peacock, W Frank; Peckler, Bradley F; van Pelt, Niels C; Poynton, Louise; Richards, A Mark; Scott, Anthony G; Simmonds, Mark B; Smyth, David; Thomas, Oliver P; To, Andrew C Y; Du Toit, Stephen A; Troughton, Richard W; Yates, Kim M

2018-01-23

Efforts to safely reduce length of stay for emergency department patients with symptoms suggestive of acute coronary syndrome (ACS) have had mixed success. Few system-wide efforts affecting multiple hospital emergency departments have ever been evaluated. We evaluated the effectiveness of a nationwide implementation of clinical pathways for potential ACS in disparate hospitals. This was a multicenter pragmatic stepped-wedge before-and-after trial in 7 New Zealand acute care hospitals with 31 332 patients investigated for suspected ACS with serial troponin measurements. The implementation was a clinical pathway for the assessment of patients with suspected ACS that included a clinical pathway document in paper or electronic format, structured risk stratification, specified time points for electrocardiographic and serial troponin testing within 3 hours of arrival, and directions for combining risk stratification and electrocardiographic and troponin testing in an accelerated diagnostic protocol. Implementation was monitored for >4 months and compared with usual care over the preceding 6 months. The main outcome measure was the odds of discharge within 6 hours of presentation RESULTS: There were 11 529 participants in the preimplementation phase (range, 284-3465) and 19 803 in the postimplementation phase (range, 395-5039). Overall, the mean 6-hour discharge rate increased from 8.3% (range, 2.7%-37.7%) to 18.4% (6.8%-43.8%). The odds of being discharged within 6 hours increased after clinical pathway implementation. The odds ratio was 2.4 (95% confidence interval, 2.3-2.6). In patients without ACS, the median length of hospital stays decreased by 2.9 hours (95% confidence interval, 2.4-3.4). For patients discharged within 6 hours, there was no change in 30-day major adverse cardiac event rates (0.52% versus 0.44%; P =0.96). In these patients, no adverse event occurred when clinical pathways were correctly followed. Implementation of clinical pathways for suspected ACS reduced the length of stay and increased the proportions of patients safely discharged within 6 hours. URL: https://www.anzctr.org.au/ (Australian and New Zealand Clinical Trials Registry). Unique identifier: ACTRN12617000381381. © 2017 American Heart Association, Inc.

Transient cutaneous vasodilatation and hypotension after drinking in dehydrated and exercising men

PubMed Central

Kamijo, Yoshi-Ichiro; Okumoto, Tadashi; Takeno, Yoshiaki; Okazaki, Kazunobu; Inaki, Mitsuharu; Masuki, Shizue; Nose, Hiroshi

2005-01-01

We examined whether oropharyngeal stimulation by drinking released the dehydration-induced suppression of cutaneous vasodilatation and decreased mean arterial pressure (MAP) in exercising subjects, and assessed the effects of hypovolaemia or hyperosmolality alone on these responses. Seven young males underwent four hydration conditions. These were two normal plasma volume (PV) trials: normal plasma osmolality (Posmol, control trial) and hyperosmolality (ΔPosmol = +11 mosmol (kg H2O)−1); and two low PV trials: isosmolality (ΔPV = −310 ml) and hyperosmolality (ΔPV = −345 ml; ΔPosmol = +9 mosmol (kg H2O)−1), attained by combined treatment with furosemide (frusemide), hypertonic saline and/or 24 h water restriction. In each trial, the subjects exercised at 60% peak aerobic power for ∼50 min at 30°C atmospheric temperature and 50% relative humidity. When oesophageal temperature (Toes) reached a plateau after ∼30 min of exercise, the subjects drank 200 ml water at 37.5°C within a minute. Before drinking, forearm vascular conductance (FVC), calculated as forearm blood flow divided by MAP, was lowered by 20–40% in hypovolaemia, hyperosmolality, or both, compared with that in the control trial, despite increased Toes. After drinking, FVC increased by ∼20% compared with that before drinking (P < 0.05) in both hyperosmotic trials, but it was greater in normovolaemia than in hypovolaemia (P < 0.05). However, no increases occurred in either isosmotic trial. MAP fell by 4–8 mmHg in both hyperosmotic trials (P < 0.05) after drinking, but more rapidly in normovolaemia than in hypovolaemia. PV and Posmol did not change during this period. Thus, oropharyngeal stimulation by drinking released the dehydration-induced suppression of cutaneous vasodilatation and reduced MAP during exercise, and this was accelerated when PV was restored. PMID:16123108

Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial.

PubMed

Vousden, Nicola; Lawley, Elodie; Nathan, Hannah L; Seed, Paul T; Brown, Adrian; Muchengwa, Tafadzwa; Charantimath, Umesh; Bellad, Mrutyunjaya; Gidiri, Muchabayiwa Francis; Goudar, Shivaprasad; Chappell, Lucy C; Sandall, Jane; Shennan, Andrew H

2018-04-27

The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4-10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. ISRCTN41244132 ; Registered 24/11/2015.

Implementation Intentions as a Strategy to Increase the Notification Rate of Potential Ocular Tissue Donors by Nurses: A Clustered Randomized Trial in Hospital Settings

PubMed Central

2014-01-01

Aim. The purpose of this study is to evaluate the impact, among nurses in hospital settings, of a questionnaire-based implementation intentions intervention on notification of potential ocular tissue donors to donation stakeholders. Methods. This randomized intervention was clustered at the level of hospital departments with two study arms: questionnaire-based implementation intentions intervention and control. In the intervention group, nurses were asked to plan specific actions if faced with a number of barriers when reporting potential ocular donors. The primary outcome was the potential ocular tissue donors' notification rate before and after the intervention. Analysis was based on a generalized linear model with an identity link and a binomial distribution. Results. We compared outcomes in 26 departments from 5 hospitals, 13 departments per condition. The implementation intentions intervention did not significantly increase the notification rate of ocular tissue donors (intervention: 23.1% versus control: 21.1%; χ 2 = 1.14, 2; P = 0.56). Conclusion. A single and brief implementation intentions intervention among nurses did not modify the notification rate of potential ocular tissue donors to donation stakeholders. Low exposure to the intervention was a major challenge in this study. Further studies should carefully consider a multicomponent intervention to increase exposure to this type of intervention. PMID:25132990

Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy.

PubMed

Hartzler, Bryan; Peavy, K Michelle; Jackson, T Ron; Carney, Molly

2016-01-22

Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM. Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation. Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures. It is hoped this discussion offers ideas for how to impact local clinical and policy decisions via effective behavior therapy dissemination.

Paid maternity leave and breastfeeding practice before and after California's implementation of the nation's first paid family leave program.

PubMed

Huang, Rui; Yang, Muzhe

2015-01-01

California was the first state in the United States to implement a paid family leave (PFL) program in 2004. We use data from the Infant Feeding Practices Study to examine the changes in breastfeeding practices in California relative to other states before and after the implementation of PFL. We find an increase of 3-5 percentage points for exclusive breastfeeding and an increase of 10-20 percentage points for breastfeeding at several important markers of early infancy. Our study supports the recommendation of the Surgeon General to establish paid leave policies as a strategy for promoting breastfeeding. Copyright © 2014 Elsevier B.V. All rights reserved.

Comparison between oral antibiotics and probiotics as bowel preparation for elective colon cancer surgery to prevent infection: prospective randomized trial.

PubMed

Sadahiro, Sotaro; Suzuki, Toshiyuki; Tanaka, Akira; Okada, Kazutake; Kamata, Hiroko; Ozaki, Toru; Koga, Yasuhiro

2014-03-01

We have already reported that, for patients undergoing elective colon cancer operations, perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented. Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations. The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial. Three hundred ten patients with colon cancer randomly were assigned to one of three groups. All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation. Probiotics were administered in Group A; oral antibiotics were administered in Group B; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure. Clostridium difficile toxin and the number of bacteria in the intestine were determined. The rates of incisional surgical-site infection were 18.0%, 6.1%, and 17.9% in Groups A, B, and C, and the rates of leakage were 12.0%, 1.0%, and 7.4% in Groups A, B, and C, respectively, indicating that both rates were lesser in Group B than in Groups A and C (P = .014 and P = .004, respectively). The detection rates of C. difficile toxin were not changed among the three groups. We recommend oral antibiotics, rather than probiotics, as bowel preparation for elective colon cancer procedures to prevent surgical-site infections. Copyright © 2014 Mosby, Inc. All rights reserved.

Medical Advice for Sick-reported Students (MASS) in intermediate vocational education schools: design of a controlled before-and-after study.

PubMed

Van der Vlis, Madelon K; Lugtenberg, Marjolein; Vanneste, Yvonne T M; Berends, Wenda; Mulder, Wico; Bannink, Rienke; Van Grieken, Amy; Raat, Hein; de Kroon, Marlou L A

2017-06-29

School absenteeism, including medical absenteeism, is associated with early school dropout and may result in physical, mental, social and work-related problems in later life. Especially at intermediate vocational education schools, high rates of medical absenteeism are found. In 2012 the Dutch intervention 'Medical Advice for Sick-reported Students' (MASS), previously developed for pre-vocational secondary education, was adjusted for intermediate vocational education schools. The aim of the study outlined in this paper is to evaluate the effectiveness of the MASS intervention at intermediate vocational education schools in terms of reducing students' medical absenteeism and early dropping out of school. Additionally, the extent to which biopsychosocial and other factors moderate the effectiveness of the intervention will be assessed. A controlled before-and-after study will be conducted within Intermediate Vocational Education schools. Schools are allocated to be an intervention or control school based on whether the schools have implemented the MASS intervention (intervention schools) or not (control schools). Intervention schools apply the MASS intervention consisting of active support for students with medical absenteeism provided by the school including a consultation with the Youth Health Care (YHC) professional if needed. Control schools provide care as usual. Data will be collected by questionnaires among students in both groups meeting the criteria for extensive medical absenteeism (i.e. 'reported sick four times in 12 school weeks or for more than six consecutive school days' at baseline and at 6 months follow-up). Additionally, in the intervention group a questionnaire is completed after each consultation with a YHC professional, by both the student and the YHC professional. Primary outcome measures are duration and cumulative incidence of absenteeism and academic performances. Secondary outcome measures are biopsychosocial outcomes of the students. It is hypothesized that implementing the MASS intervention including a referral to a YHC professional on indication, will result in a lower level of medical absenteeism and a lower level of school drop outs among intermediate vocational education students compared to students receiving usual care. The study will provide insight in the effectiveness of the intervention as well as in factors moderating the intervention's effectiveness. Nederlands Trial Register NTR5556. Date of clinical trial registration: 29-Oct-2015.

Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

PubMed

Yan, Lijing L; Fang, Weigang; Delong, Elizabeth; Neal, Bruce; Peterson, Eric D; Huang, Yining; Sun, Ningling; Yao, Chen; Li, Xian; MacMahon, Stephen; Wu, Yangfeng

2014-04-11

The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China. The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged≥50 years and 20 women aged≥60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted. This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries. The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

Evaluation and refinement of a handheld health information technology tool to support the timely update of bedside visual cues to prevent falls in hospitals.

PubMed

Teh, Ruth C-A; Visvanathan, Renuka; Ranasinghe, Damith; Wilson, Anne

2018-06-01

To evaluate clinicians' perspectives, before and after clinical implementation (i.e. trial) of a handheld health information technology (HIT) tool, incorporating an iPad device and automatically generated visual cues for bedside display, for falls risk assessment and prevention in hospital. This pilot study utilized mixed-methods research with focus group discussions and Likert-scale surveys to elicit clinicians' attitudes. The study was conducted across three phases within two medical wards of the Queen Elizabeth Hospital. Phase 1 (pretrial) involved focus group discussion (five staff) and surveys (48 staff) to elicit preliminary perspectives on tool use, benefits and barriers to use and recommendations for improvement. Phase 2 (tool trial) involved HIT tool implementation on two hospital wards over consecutive 12-week periods. Phase 3 (post-trial) involved focus group discussion (five staff) and surveys (29 staff) following tool implementation, with similar themes as in Phase 1. Qualitative data were evaluated using content analysis, and quantitative data using descriptive statistics and logistic regression analysis, with subgroup analyses on user status (P ≤ 0.05). Four findings emerged on clinicians' experience, positive perceptions, negative perceptions and recommendations for improvement of the tool. Pretrial, clinicians were familiar with using visual cues in hospital falls prevention. They identified potential benefits of the HIT tool in obtaining timely, useful falls risk assessment to improve patient care. During the trial, the wards differed in methods of tool implementation, resulting in lower uptake by clinicians on the subacute ward. Post-trial, clinicians remained supportive for incorporating the tool into clinical practice; however, there were issues with usability and lack of time for tool use. Staff who had not used the tool had less appreciation for it improving their understanding of patients' falls risk factors (odds ratio 0.12), or effectively preventing hospital falls (odds ratio 0.12). Clinicians' recommendations resulted in subsequent technological refinement of the tool, and provision of an additional iPad device for more efficient use. This study adds to the limited pool of knowledge about clinicians' attitudes toward health technology use in falls avoidance. Clinicians were willing to use the HIT tool, and their concerns about its usability were addressed in ongoing tool improvement. Including end-users in the development and refinement processes, as well as having high staff uptake of new technologies, is important in improving their acceptance and usage, and in maximizing beneficial feedback to further inform tool development.

Survival following ruptured abdominal aortic aneurysm before and during the IMPROVE Trial: a single-centre series.

PubMed

Ambler, G K; Twine, C P; Shak, J; Rollins, K E; Varty, K; Coughlin, P A; Hayes, P D; Boyle, J R

2014-04-01

The first large-scale randomised trial (Immediate Management of the Patient with Rupture: Open Versus Endovascular repair [IMPROVE]) for endovascular repair of ruptured abdominal aortic aneurysm (rEVAR) has recently finished recruiting patients. The aim of this study was to examine the impact on survival after rEVAR when the IMPROVE protocol was initiated in a high volume abdominal aortic aneurysm (AAA) centre previously performing rEVAR. One hundred and sixty-nine patients requiring emergency infrarenal AAA repair from January 2006 to April 2013 were included. Eighty-four patients were treated before (38 rEVAR, 46 open) and 85 (31 rEVAR, 54 open) were treated during the trial period. A retrospective analysis was performed. Before the trial, there was a significant survival benefit for rEVAR over open repair (90-day mortality 13% vs. 30%, p = .04, difference remained significant up to 2 years postoperatively). This survival benefit was lost after starting randomisation (90-day mortality 35% vs. 33%, p = .93). There was an increase in overall 30-day mortality from 15% to 31% (p = .02), while there was no change for open repair (p = .438). There was a significant decrease in general anaesthetic use (p = .002) for patients treated during the trial. Randomised patients had shorter hospital and intensive treatment unit stays (p = .006 and p = .03 respectively). The change in survival seen during the IMROVE trial highlights the need for randomised rather than cohort data to eliminate selection bias. These results from a single centre reinforce those recently reported in IMPROVE. Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Implementation of a Goal-Directed Mechanical Ventilation Order Set Driven by Respiratory Therapists Improves Compliance With Best Practices for Mechanical Ventilation.

PubMed

Radosevich, Misty A; Wanta, Brendan T; Meyer, Todd J; Weber, Verlin W; Brown, Daniel R; Smischney, Nathan J; Diedrich, Daniel A

2017-01-01

Data regarding best practices for ventilator management strategies that improve outcomes in acute respiratory distress syndrome (ARDS) are readily available. However, little is known regarding processes to ensure compliance with these strategies. We developed a goal-directed mechanical ventilation order set that included physician-specified lung-protective ventilation and oxygenation goals to be implemented by respiratory therapists (RTs). We sought as a primary outcome to determine whether an RT-driven order set with predefined oxygenation and ventilation goals could be implemented and associated with improved adherence with best practice. We evaluated 1302 patients undergoing invasive mechanical ventilation (1693 separate episodes of invasive mechanical ventilation) prior to and after institution of a standardized, goal-directed mechanical ventilation order set using a controlled before-and-after study design. Patient-specific goals for oxygenation partial pressure of oxygen in arterial blood (Pao 2 ), ARDS Network [Net] positive end-expiratory pressure [PEEP]/fraction of inspired oxygen [Fio 2 ] table use) and ventilation (pH, partial pressure of carbon dioxide) were selected by prescribers and implemented by RTs. Compliance with the new mechanical ventilation order set was high: 88.2% compliance versus 3.8% before implementation of the order set ( P < .001). Adherence to the PEEP/Fio 2 table after implementation of the order set was significantly greater (86.0% after vs 82.9% before, P = .02). There was no difference in duration of mechanical ventilation, intensive care unit (ICU) length of stay, and in-hospital or ICU mortality. A standardized best practice mechanical ventilation order set can be implemented by a multidisciplinary team and is associated with improved compliance to written orders and adherence to the ARDSNet PEEP/Fio 2 table.

Time Series Analysis on the Impact of Generic Substitution and Reference Pricing on Antipsychotic Costs in Finland.

PubMed

Koskinen, Hanna; Mikkola, Hennamari; Saastamoinen, Leena K; Ahola, Elina; Martikainen, Jaana E

2015-12-01

To analyze the medium- to long-term impact of generic substitution and the reference price system on the daily cost of antipsychotics in Finland. The additional impact of reference pricing over and above previously implemented generic substitution was also assessed. An interrupted time series design with a control group and segmented regression analysis was used to estimate the effect of the implementation of generic substitution and the reference price system on the daily cost of antipsychotics. The data have 69 monthly values of the average daily cost for each of the studied antipsychotics: 39 months before and 30 months after the introduction of reference pricing. For one of the studied antipsychotic, the time before the introduction of reference pricing could be further divided into time before and after the introduction of generic substitution. According to the model, 2.5 years after the implementation of reference pricing, the daily cost of the studied antipsychotics was 24.6% to 50.6% lower than it would have been if reference pricing had not been implemented. Two and a half years after the implementation of the reference price system, however, the additional impact of reference pricing over and above previously implemented generic substitution was modest, less than 1 percentage point. Although the price competition induced by reference pricing decreased the prices of antipsychotics in Finland in the short-term, the prices had a tendency to stagnate or even to turn in an upward direction in the medium- to long-term. Furthermore, the additional impact of reference pricing over and above previously implemented generic substitution remained quite modest. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design

PubMed Central

Verdijk, Noortje A; Kasteleyn, Marise J; Harmans, Lara M; Talboom, Irvin JSH; Looijmans-van den Akker, Ingrid; van Geloven, Nan; Numans, Mattijs E; Chavannes, Niels H

2017-01-01

Background Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes. Objectives The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ). Methods The parallel cohort design includes 3 levels of integration in IDM (groups 1, 2, 3) and randomization of 2 levels of personal assistance for patients (group A, high assistance, group B, low assistance). Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data. Results Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (–0.47% per month) and after the intervention (–0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945). Conclusions The e-Vita eHealth-supported COPD programs had no beneficial impact on the health status of COPD patients. Also, no differences were found between the patient groups receiving different levels of personal assistance. Trial Registration Netherlands Trial Registry NTR4098; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4098 (Archived by WebCite at http://www.webcitation.org/6sbM5PayG) PMID:28814380

Cross shift changes in lung function among bar and restaurant workers before and after implementation of a smoking ban

PubMed Central

Skogstad, M; Kjærheim, K; Fladseth, G; Gjølstad, M; Daae, H L; Olsen, R; Molander, P; Ellingsen, D G

2006-01-01

Objective To study possible cross shift effects of environmental tobacco smoke (ETS) on pulmonary function among bar and restaurant employees before and after the implementation of a smoking ban in Norway. Methods The study included 93 subjects employed in 13 different establishments in Oslo. They were examined at the beginning and end of a workshift both while ETS exposure was present and when smoking was banned. The mean exposure level of nicotine and total dust before the ban was 28 μg/m3 (range 3–65) and 275 μg/m3 (range 81–506), respectively. Following the smoking ban, the mean level of nicotine and total dust was 0.6 μg/m3 and 77 μg/m3, respectively. Assessment of lung function included dynamic lung volumes and flows. Results The cross shift reduction in forced vital capacity (FVC) among 69 subjects participating in both examinations changed from 81 ml (SD 136) during exposure to ETS to 52 ml (SD 156) (p = 0.24) following the smoking ban. The reduction in forced expired volume in one second (FEV1) during a workshift, was borderline significantly reduced when comparing the situation before and after the intervention, by 89 ml (SD = 132) compared to 46 ml (SD = 152) (p = 0.09), respectively. The reduction in forced mid‐expiratory flow rate (FEF25–75%) changed significantly from 199 ml/s (SD = 372) to 64 ml/s (SD = 307) (p = 0.01). Among 26 non‐smokers and 11 asthmatics, the reduction in FEV1 and FEF25–75% was significantly larger during ETS exposure compared to after the smoking ban. There was an association between the dust concentration and decrease in FEF25–75% before the ban among non‐smokers (p = 0.048). Conclusions This first study of cross shift changes before and after the implementation of a smoking ban in restaurants and bars shows a larger cross shift decrease in lung function before compared with after the implementation of the ban. PMID:16551754

Active sleep is associated with the face preference in the newborns who familiarized with a responsive face.

PubMed

Cecchini, Marco; Iannoni, Maria Elena; Aceto, Paola; Baroni, Eleonora; Di Vito, Cinzia; Lai, Carlo

2017-11-01

Aim of this study was to investigate the preferential looking behaviour, subsequent to a familiarization task (8-min) with a previously responsive or motionless face, before and after a sleep cycle. Moreover, the role of the active sleep in memory consolidation of the responsive or motionless faces was explored. Hypotheses were that the newborns undergoing a motionless familiarization will exhibit a novelty effect (preference for the novel face) whereas the newborns undergoing a responsive familiarization will show a familiarity effect (preference for the known face) before and after the sleep cycle; moreover, the amount of active sleep will be associated with the looking time at the known face after a sleep cycle. Forty-five healthy full-term newborns were randomly assigned to two groups (group 1: motionless-familiarization and group 2: responsive-familiarization); in both groups newborns were video-recorded during four post-familiarization face-preference tasks, two of them performed before and two after a sleep cycle. During the pre-sleep-trials, there was not a significant preference for one face in both groups. During the post-sleep trials, the newborns showed a clear preference for the novel face. This effect was more evident in group 1. Only in group 2 there was a significant positive correlation between the active sleep duration and the looking duration at the known-face during the post-sleep trials (r=0.41; p=0.040). Multiple regression confirmed that only in the group 2 the total duration of the active sleep was associated with the looking duration at the known-face during the post-sleep trials (Adjusted R 2 =0.13; β=0.41; t=2.2; p=0.040). Findings showed that in newborns the face representation can be recalled after a sleep cycle. Moreover, the amount of the active sleep predicted the post-sleep looking toward the known-face only in the newborns who interactively familiarized with the face. Copyright © 2017 Elsevier Inc. All rights reserved.

Safety culture in the gynecology robotics operating room.

PubMed

Zullo, Melissa D; McCarroll, Michele L; Mendise, Thomas M; Ferris, Edward F; Roulette, G D; Zolton, Jessica; Andrews, Stephen J; von Gruenigen, Vivian E

2014-01-01

To measure the safety culture in the robotics surgery operating room before and after implementation of the Robotic Operating Room Computerized Checklist (RORCC). Prospective study. Gynecology surgical staff (n = 32). An urban community hospital. The Safety Attitudes Questionnaire domains examined were teamwork, safety, job satisfaction, stress recognition, perceptions of management, and working conditions. Questions and domains were described using percent agreement and the Cronbach alpha. Paired t-tests were used to describe differences before and after implementation of the checklist. Mean (SD) staff age was 46.7 (9.5) years, and most were women (78%) and worked full-time (97%). Twenty respondents (83% of nurses, 80% of surgeons, 66% of surgical technicians, and 33% of certified registered nurse anesthetists) completed the Safety Attitudes Questionnaire; 6 were excluded because of non-matching identifiers. Before RORCC implementation, the highest quality of communication and collaboration was reported by surgeons and surgical technicians (100%). Certified registered nurse anesthetists reported only adequate levels of communication and collaboration with other positions. Most staff reported positive responses for teamwork (48%; α = 0.81), safety (47%; α = 0.75), working conditions (37%; α = 0.55), stress recognition (26%; α = 0.71), and perceptions of management (32%; α = 0.52). No differences were observed after RORCC implementation. Quality of communication and collaboration in the gynecology robotics operating room is high between most positions; however, safety attitude responses are low overall. No differences after RORCC implementation and low response rates may highlight lack of staff support. Copyright © 2014. Published by Elsevier Inc.

Caffeine and carbohydrate supplementation during exercise when in negative energy balance: effects on performance, metabolism, and salivary cortisol.

PubMed

Slivka, Dustin; Hailes, Walter; Cuddy, John; Ruby, Brent

2008-12-01

The ingestion of carbohydrate (+CHO) and caffeine (+CAF) during exercise is a commonly used ergogenic practice. Investigations are typically conducted with subjects who are in a rested state after an overnight fast. However, this state of positive energy balance is not achieved during many work and exercise circumstances. The aim of this study was to evaluate the substrate use and performance effects of caffeine and carbohydrate consumed alone and in combination while participants were in negative energy balance. Male participants (n = 9; 23 +/- 3 years; 74.1 +/- 10.6 kg) completed 4 trials in random order: -CAF/-CHO, -CAF/+CHO, +CAF/-CHO, and +CAF/+CHO. Diet and exercise were prescribed for 2 days before each trial to ensure negative energy balance. For each trial, before and after 2 h of cycling at 50% of maximal watts, a saliva sample and a muscle biopsy (vastus lateralis) were obtained. A simulated 20 km time trial was then performed. The respiratory exchange ratio was higher (p < 0.05) in +CHO trials and lower (p < 0.05) in the +CAF/+CHO trial than in the -CAF/+CHO trial. Salivary cortisol response was higher (p < 0.05) in the +CAF/-CHO trial than in any of the other trials. Muscle glycogen and heart rates were similar in all trials. Performance in the 20 km time trial was better in the -CAF/+CHO trial than in the -CAF/-CHO trial (p < 0.05), but the +CAF/+CHO trial was no better than the +CAF/-CHO trial (p > 0.05), or any of the other trials. When co-ingested with carbohydrate, caffeine increased fat use and decreased nonmuscle glycogen carbohydrate use over carbohydrate alone when participants are in negative energy balance; however, caffeine had no effect on the 20 km cycling time trial performance.

Composite outcomes in randomized clinical trials: arguments for and against.

PubMed

Ross, Sue

2007-02-01

Composite outcomes that combine a number of individual outcomes (such as types of morbidity) are frequently used as primary outcomes in obstetrical trials. The main argument for their use is to ensure that trials can answer important clinical questions in a timely fashion, without needing huge sample sizes. Arguments against their use are that composite outcomes may be difficult to use and interpret, leading to errors in sample size estimation, possible contradictory trial results, and difficulty in interpreting findings. Such problems may reduce the credibility of the research, and may impact on the implementation of findings. Composite outcomes are an attractive solution to help to overcome the problem of limited available resources for clinical trials. However, future studies should carefully consider both the advantages and disadvantages before using composite outcomes. Rigorous development and reporting of composite outcomes is essential if the research is to be useful.

Effects on cervical cytology screening productivity associated with implementation of the BD FocalPoint™ Guided Screener Imaging System.

PubMed

Sweeney, Brenda J; Wilbur, David C

2013-01-01

Automated screening will become important due to an aging workforce, declining numbers of new cytotechnologists, and the need for increased screening sensitivity in the vaccine era, where high-grade abnormalities will decline. This study documents workload in gynecologic cytology throughput before and after the implementation of the BD FocalPoint™ Guided Screener (GS) System. We collected daily screening data from 3 time periods: the 12 months prior to GS implementation, the 6 months immediately after implementation, and the ensuing 7-18 months after implementation. Data was tabulated at the individual and total laboratory levels. In the 6-month period immediately following implementation, productivity increased in 3 of 5 cytotechnologists, as compared to the figures 12 months before implementation. The laboratory increased productivity slightly (+2.4%), with individual changes ranging from -6.9 to +14.7%. In the 7- to 18-month 'mature' period after implementation, productivity increased in all 5 cytotechnologists with an average of +15.4%. Individual increases ranged from +6.1 to +26.9%. Overall productivity increased in the period beyond 6 months, and this increase was eventually noted in all personnel. Increased productivity was associated with a short period of learning in which the magnitude of the effect was less than in the mature period. Copyright © 2013 S. Karger AG, Basel.

Electronic health record in the internal medicine clinic of a Brazilian university hospital: Expectations and satisfaction of physicians and patients.

PubMed

Duarte, Jurandir Godoy; Azevedo, Raymundo Soares

2017-06-01

To evaluate the satisfaction and expectations of patients and physicians before and after the implementation of an electronic health record (EHR) in the outpatient clinic of a university hospital. We conducted 389 interviews with patients and 151 with physicians before and after the implementation of a commercial EHR at the internal medicine clinic of Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (HC-FMUSP), Brazil. The physicians were identified by their connection to the outpatient clinic and categorized by their years since graduation: residents and preceptors (with 10 years or less of graduation) or assistants (with more than 10 years of graduation). The answers to the questionnaire given by the physicians were classified as favorable or against the use of EHR, before and after the implementation of this system in this clinic, receiving 1 or 0 points, respectively. The sum of these points generated a multiple regression score to determine which factors contribute to the acceptance of EHR by physicians. We also did a third survey, after the EHR was routinely established in the outpatient clinic. The degree of patient satisfaction was the same before and after implementation, with more than 90% positive evaluations. They noted the use of the computer during the consultation and valued such use. Resident (younger) physicians had more positive expectations than assistants (older physicians) before EHR implementation. This optimism was reduced after implementation. In the third evaluation the use of EHR was higher among resident physicians. Resident physicians perceived and valued the EHR more and used it more. In 28 of the 57 questions on performance of clinical tasks, resident physicians found it easier to use EHR than assistant physicians with significant differences (p<0.05). When questioned specifically about EHR satisfaction, resident physicians responded "good" and "excellent" to a greater extent than assistant physicians (p=0.002). Our results reinforce the idea that the EHR introduction in a clinical setting should be preceded by careful planning to improve physician's adherence to the use of EHR. Patients do not seem to notice much difference to the quality of the consultation done using paper or EHR. It became clear after the third evaluation with the physicians that the younger (residents and some preceptors) perceived the advantages of the EHR more than the older physicians. Resident physicians use the EHR more and are more satisfied with it. Copyright © 2017 Elsevier B.V. All rights reserved.

Implementing situation-background-assessment-recommendation in an anaesthetic clinic and subsequent information retention among receivers: A prospective interventional study of postoperative handovers.

PubMed

Randmaa, Maria; Swenne, Christine L; Mårtensson, Gunilla; Högberg, Hans; Engström, Maria

2016-03-01

Communication errors cause clinical incidents and adverse events in relation to surgery. To ensure proper postoperative patient care, it is essential that personnel remember and recall information given during the handover from the operating theatre to the postanaesthesia care unit. Formalizing the handover may improve communication and aid memory, but research in this area is lacking. The objective of this study was to evaluate whether implementing the communication tool Situation-Background-Assessment-Recommendation (SBAR) affects receivers' information retention after postoperative handover. A prospective intervention study with an intervention group and comparison nonintervention group, with assessments before and after the intervention. The postanaesthesia care units of two hospitals in Sweden during 2011 and 2012. Staff involved in the handover between the operating theatre and the postanaesthesia care units within each hospital. Implementation of the communication tool SBAR in one hospital. The main outcome was the percentage of recalled information sequences among receivers after the handover. Data were collected using both audio-recordings and observations recorded on a study-specific protocol form. Preintervention, 73 handovers were observed (intervention group, n = 40; comparison group, n = 33) involving 72 personnel (intervention group, n = 40; comparison group, n = 32). Postintervention, 91 handovers were observed (intervention group, n = 44; comparison group, n = 47) involving 57 personnel (intervention group, n = 31; comparison group, n = 26). In the intervention group, the percentage of recalled information sequences by the receivers increased from 43.4% preintervention to 52.6% postintervention (P = 0.004) and the SBAR structure improved significantly (P = 0.028). In the comparison group, the corresponding figures were 51.3 and 52.6% (P = 0.725) with no difference in SBAR structure. When a linear regression generalised estimating equation model was used to account for confounding influences, we were unable to show a significant difference in the information recalled between the intervention group and the nonintervention group over time. Compared with the comparison group with no intervention, when SBAR was implemented in an anaesthetic clinic, we were unable to show any improvement in recalled information among receivers following postoperative handover. Current controlled trials http://www.controlled-trials.com Identifier: ISRCTN37251313.

25 CFR 1000.165 - Are provisions in compacts negotiated before January 16, 2001, effective after implementation?

Code of Federal Regulations, 2012 CFR

2012-04-01

... SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ANNUAL FUNDING AGREEMENTS UNDER THE TRIBAL SELF... Funding Agreements Negotiating A Self-Governance Compact § 1000.165 Are provisions in compacts negotiated... negotiated with BIA before January 16, 2001, shall remain in effect for BIA programs only after January 16...

25 CFR 1000.165 - Are provisions in compacts negotiated before January 16, 2001, effective after implementation?

Code of Federal Regulations, 2014 CFR

2014-04-01

... SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ANNUAL FUNDING AGREEMENTS UNDER THE TRIBAL SELF... Funding Agreements Negotiating A Self-Governance Compact § 1000.165 Are provisions in compacts negotiated... negotiated with BIA before January 16, 2001, shall remain in effect for BIA programs only after January 16...

25 CFR 1000.165 - Are provisions in compacts negotiated before January 16, 2001, effective after implementation?

Code of Federal Regulations, 2010 CFR

2010-04-01

... SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ANNUAL FUNDING AGREEMENTS UNDER THE TRIBAL SELF... Funding Agreements Negotiating A Self-Governance Compact § 1000.165 Are provisions in compacts negotiated... negotiated with BIA before January 16, 2001, shall remain in effect for BIA programs only after January 16...

25 CFR 1000.165 - Are provisions in compacts negotiated before January 16, 2001, effective after implementation?

Code of Federal Regulations, 2011 CFR

2011-04-01

... SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ANNUAL FUNDING AGREEMENTS UNDER THE TRIBAL SELF... Funding Agreements Negotiating A Self-Governance Compact § 1000.165 Are provisions in compacts negotiated... negotiated with BIA before January 16, 2001, shall remain in effect for BIA programs only after January 16...

Immediate and Distal Effects of the Good Behavior Game

ERIC Educational Resources Information Center

Donaldson, Jeanne M.; Wiskow, Katie M.; Soto, Paul L.

2015-01-01

The Good Behavior Game (GBG) has been demonstrated to reduce disruptive student behavior during implementation. The effects of playing the GBG on disruption immediately before and after the GBG are unknown. The current study evaluated the effects of the GBG on disruption in 5 kindergarten classes immediately before, during, and after GBG…

'Opt-out' referrals after identifying pregnant smokers using exhaled air carbon monoxide: impact on engagement with smoking cessation support.

PubMed

Campbell, Katarzyna A; Cooper, Sue; Fahy, Samantha J; Bowker, Katharine; Leonardi-Bee, Jo; McEwen, Andy; Whitemore, Rachel; Coleman, Tim

2017-05-01

In the UK, free smoking cessation support is available to pregnant women; only a minority accesses this. 'Opt-out' referrals to stop smoking services (SSS) are recommended by UK guidelines. These involve identifying pregnant smokers using exhaled carbon monoxide (CO) and referring them for support unless they object. To assess the impact of 'opt-out' referrals for pregnant smokers on SSS uptake and effectiveness, we conducted a 'before-after' service development evaluation. In the 6-month 'before' period, there was a routine 'opt-in' referral system for self-reported smokers at antenatal 'booking' appointments. In the 6-month 'after' period, additional 'opt-out' referrals were introduced at the 12-week ultrasound appointments; women with CO≥4 ppm were referred to, and outcome data were collected from, local SSS. Approximately 2300 women attended antenatal care in each period. Before the implementation, 536 (23.4%) women reported smoking at 'booking' and 290 (12.7%) were referred to SSS. After the implementation, 524 (22.9%) women reported smoking at 'booking', an additional 156 smokers (6.8%) were identified via the 'opt-out' referrals and, in total, 421 (18.4%) were referred to SSS. Over twice as many women set a quit date with the SSS after 'opt-out' referrals were implemented (121 (5.3%, 95% CI 4.4% to 6.3%) compared to 57 (2.5%, 95% CI 1.9% to 3.2%) before implementation) and reported being abstinent 4 weeks later (93 (4.1%, 95% CI 3.3% to 4.9%) compared to 46 (2.0%, 1.5% to 2.7%) before implementation). In a hospital with an 'opt-in' referral system, adding CO screening with 'opt-out' referrals as women attended ultrasound examinations doubled the numbers of pregnant smokers setting quit dates and reporting smoking cessation. 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/.

Effects of age and weaning conditions on blood indicators of oxidative status in pigs

PubMed Central

Belloc, Catherine; Leblanc-Maridor, Mily; Merlot, Elodie

2017-01-01

Weaning is a source of social, nutritional and environmental disorders that challenge piglet health. This study assesses the relevance of using plasma indicators of oxidative status as biomarkers of health around weaning in pigs. Blood antioxidant potential (BAP), hydroperoxides (HPO), oxidative stress index (OSI, e.g. HPO/BAP), vitamin A and E concentrations were investigated in two different trials. Trial A was carried out in an experimental unit to investigate the effects of age (from 12 to 147 days of age), weaning (at 21 or 28 days of age) and management at weaning (in optimal (OC) or deteriorated (DC) conditions) on those parameters. Trial B was performed in 16 commercial pig farms to describe the variability of these indicators on field between 26 and 75 days of age. In trial A, between 12 and 147 days of age, HPO globally increased (P < 0.001), vitamin E concentration decreased (P < 0.001) whereas BAP and vitamin A concentration remained relatively stable (P > 0.1). Vitamins E and A concentrations dropped 5 days after weaning independently of weaning age, weaning conditions and expression of diarrhea (P < 0.001). Twelve days after weaning, whatever the weaning age, HPO and OSI increased in DC compared to OC piglets (P = 0.05 and P < 0.01) and in piglets exhibiting diarrhea compared to those without diarrhea (P < 0.01 and P < 0.001). In DC pigs, BAP was also decreased (P < 0.05) 12 days after weaning. On trial B, plasma concentrations of vitamins A and E decreased and HPO increased 5 and 19 days respectively after weaning (P < 0,001). Contrarily to trial A, BAP values did not drop after weaning. Piglets which had the lowest ADG (Average Daily Gain) after weaning had greater HPO and OSI and lower vitamin A and E concentrations after weaning but also lower vitamin E concentration before weaning (P < 0.05). In conclusion, HPO or OSI seem to be good indicators of health disorders around weaning and plasma concentration of vitamin E before weaning is associated to growth after weaning. PMID:28542567

Current education versus peer-education on walking in type 2 diabetic patients based on Health Belief Model: a randomized control trial study.

PubMed

Baghianimoghadam, M H; Hadavandkhani, M; Mohammadi, M; Fallahzade, H; Baghianimoghadam, B

2012-01-01

Diabetes is a disease with several metabolic and organic symptoms. Physical activity plays a key role in controlling type 2 diabetes. Several researches confirm that educational strategies can lead to healthy behaviors and its continuation is effective and can indicate what type of relationship with the client is better. The purpose of this study is comparing the Effect of Current Education and Peer-Education on Walking in Type 2 Diabetic Patients based on Health Belief Model (HBM). This was a clinical trial (RCT) study done on 80 people with type 2 diabetes. Patients were divided into two groups, Current education and Peer education groups. Data were collected using a questionnaire based on the health belief model, a checklist related to patients' practice and recording patients' HbA1c, 2HPP and FBS levels. Results were documented before and three months after intervention. The patients participated in 2 educational classes during three months of intervention, as the follow-up of the intervention. Mean scores for HBM Model variables, i.e. perceived susceptibility, perceived severity, perceived benefit and self-efficacy, were significantly increased in the peer education group compared to current education group after intervention. Also, behavioral walking, rates of HbA1c and FBS and 2HPP levels were improved significantly among the peer education group. Applying walking training program developed for diabetic patients and its implementation by the peers in order to control blood sugar using the health belief model is very useful and effective. During implementation of these control programs, monitoring and follow-up training is recommended.

Introducing an enhanced recovery programme to an established totally intracorporeal robot-assisted radical cystectomy service.

PubMed

Collins, Justin W; Adding, Christofer; Hosseini, Abolfazl; Nyberg, Tommy; Pini, Giovannalberto; Dey, Linda; Wiklund, Peter N

2016-01-01

The aim of this study was to assess the effect of introducing an enhanced recovery programme (ERP) to an established robot-assisted radical cystectomy (RARC) service. Data were prospectively collected on 221 consecutive patients undergoing totally intracorporeal RARC between December 2003 and May 2014. The ERP was specifically designed to support an evolving RARC service, where increasing proportions of patients requiring radical cystectomy underwent RARC. Patient demographics and outcomes before and after implementation of the ERP were compared. The primary endpoint was length of stay (LOS). Secondary outcomes included age, American Society of Anesthesiologists (ASA) score, preoperative staging, operative time, complications and readmissions. Differences in outcomes between patients before and after implementation of ERP were tested with the Jonckheere-Terpstra trend test and quantile regression with backward selection. Following implementation of the ERP, the demographics of the patients (n = 135) changed, with median age increasing from 66 to 70 years (p < 0.01), higher ASA grade (p < 0.001), higher preoperative stage cancer (pT ≥ 2, p < 0.05) and increased likelihood of undergoing an ileal conduit diversion (p < 0.001). Median LOS before ERP was 9 days [interquartile range (IQR) 8-13 days] and after ERP was 8 days (IQR 6-10 days) (p < 0.001). ASA grade and neoadjuvant chemotherapy also affected LOS (p < 0.05 and p < 0.01, respectively). There was no significant difference in 30 day complication rates, readmission rates or 90 day mortality, with 59% experiencing complications before ERP implementation and 57% after implementation. The majority of complications were low grade. Patient demographics changed as the RARC service evolved from selected patients to a general service. Despite worsening demographics, LOS decreased following ERP implementation. This evidence-based ERP safely standardized perioperative care, resulting in decreased LOS and decreased variability in LOS.

Human Papillomavirus Vaccination Uptake before and after the Affordable Care Act: Variation According to Insurance Status, Race, and Education (NHANES 2006-2014).

PubMed

Corriero, Rosemary; Gay, Jennifer L; Robb, Sara Wagner; Stowe, Ellen W

2018-02-01

The purpose of the study was to compare human papillomavirus (HPV) vaccination rates before and after Affordable Care Act (ACA) implementation among women, and examine differences according to insurance status and other sociodemographic variables. This was a cross-sectional analysis of the National Health and Nutrition Examination Survey questionnaire data. Participants (n = 4599) were from a random sample of the United States population. HPV vaccination status and number of doses received according to age, income, education, race, and insurance coverage. Over time, the proportion of women reporting HPV vaccination increased from 16.4% to 27.6%, and reporting vaccination completion (3 doses) increased from 56.8% to 67.2%. After ACA implementation, respondents were 3.3 times more likely to be vaccinated compared with before ACA implementation (95% confidence interval [CI], 2.0-5.5) adjusting for age, race, and insurance coverage. Similarly, respondents were more likely to have received 2 (odds ratio, 2.8; 95% CI, 1.5-5.3) or 3 doses (odds ratio, 5.8; 95% CI, 2.5-13.6). Vaccination uptake increased in a comparison of waves of data from before and after ACA implementation. This increase in vaccination coverage could be related to the increased preventative service coverage, which includes vaccines, required by the ACA. Future studies might focus on the role insurance has on vaccination uptake, and meeting Healthy People 2020 objectives for vaccination coverage. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Sex differences in memory estimates for pictures and words with multiple recall trials.

PubMed

Ionescu, Marcos D

2004-04-01

Undergraduate students (23 men and 23 women) provided memory performance estimates before and after each of three recall trials involving 80 stimuli (40 pictures and 40 words). No sex differences were found across trials for the total recall of items or for the recall of pictures and words separately. A significant increase in recall for pictures (not words) was found for both sexes across trials. The previous results of Ionescu were replicated on the first and second recall trials: men underestimated their performance on the pictures and women underestimated their performance on the word items. These differences in postrecall estimates were not found after the third recall trial: men and women alike underestimated their performance on both the picture and word items. The disappearance of item-specific sex differences in postrecall estimates for the third recall trial does not imply that men and women become more accurate at estimating their actual performance with multiple recall trials.

Early access programs: Benefits, challenges, and key considerations for successful implementation

PubMed Central

Patil, Sanjaykumar

2016-01-01

Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies. This white paper outlines various circumstances to be considered for the implementation of EAPs named patient programs, the regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation. PMID:26955570

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

Reduction of Broad-Spectrum Antimicrobial Use in a Tertiary Children's Hospital Post Antimicrobial Stewardship Program Guideline Implementation.

PubMed

Lee, Kelley R; Bagga, Bindiya; Arnold, Sandra R

2016-03-01

The core strategies recommended for antimicrobial stewardship programs, formulary restriction with preauthorization and prospective audit and feedback, can be difficult to implement with limited resources; therefore, we took an approach of guideline development and education with the goal of reducing overall antibiotic use and unwarranted use of broad-spectrum antimicrobials. Retrospective chart review before and after intervention. Le Bonheur Children's Hospital pediatric, neonatal, and cardiac ICUs. All patients in our pediatric, neonatal, and cardiac ICUs within the time frame of the study. Baseline review in our ICUs revealed excessive use of broad-spectrum antibiotics and inconsistency in managing common pediatric infections. Guidelines were developed and implemented using cycles of education, retrospective review, and feedback. Purchasing and antibiotic use data were obtained to assess changes before and after guideline implementation. Unit-specific days of therapy were measured using periodic chart audit. Segmented regression analysis was used to assess changes in purchasing and broad-spectrum antibiotic days of therapy. The change in median monthly purchases was assessed using 2-tail Student t test. Hospital-wide targeted broad-spectrum antibiotic days of therapy/1,000 patient-days during the preimplementation year averaged 105 per month and decreased 33% to 70 per month during the postimplementation year. The overall antibiotic days of therapy decreased 41%, 21%, and 18%, and targeted broad-spectrum antibiotic days of therapy decreased by 99%, 75%, and 61% in the cardiac, pediatric, and neonatal ICUs, respectively, after guideline implementation. Yearly purchases of our most common broad-spectrum antibiotics decreased 62% from $230,059 to $86,887 after guideline implementation. Median monthly purchases of these drugs before implementation were $19,389 and $11,043 after implementation (p < 0.001). Guideline implementation was successful in reducing targeted broad-spectrum antibiotic use and acquisition cost. Programs with very limited resources may find similar implementation of guidelines effective to provide initial success, so that putting into practice one of the more resource intensive core strategies, such as prospective audit and feedback, may be feasible.

Impact of a bladder scan protocol on discharge efficiency within a care pathway for ambulatory inguinal herniorraphy.

PubMed

Antonescu, I; Baldini, G; Watson, D; Kaneva, P; Fried, G M; Khwaja, K; Vassiliou, M C; Carli, F; Feldman, L S

2013-12-01

Postoperative urinary retention (POUR) is a common complication of ambulatory inguinal herniorraphy, with an incidence reaching 38%, and many surgeons require patients to void before discharge. This study aimed to assess whether the implementation of a bladder scan-based voiding protocol reduces the time until discharge after ambulatory inguinal herniorraphy without increasing the rate of POUR. As part of a perioperative care pathway, a protocol was implemented to standardize decision making after elective inguinal hernia repair (February 2012). Patients were assessed with a bladder scan, and those with <600 mL of urine were discharged home, whereas those with more than 600 mL of urine had an in-and-out catheterization before discharge. The patients received written information about urinary symptoms and instructions to present to the emergency department if they were unable to void at home. An audit of scheduled outpatient inguinal hernia repairs between October 2011 and July 2012 was performed. Comparisons were made using the t test, Fisher's exact test, and Wilcoxon rank sum test where appropriate. Statistical significance was defined a priori as a p value lower than 0.05. During the study period, 124 patients underwent hernia repair: 60 before and 64 after implementation of the protocol. The findings showed no significant differences in patient characteristics, laparoscopic approach (35 vs. 33%; p = 0.80), proportion receiving general anesthesia (70 vs. 73%; p = 0.67), or amount of intravenous fluids given (793 vs. 663 mL; p = 0.07). The proportion of patients voiding before discharge was higher after protocol implementation (73 vs. 89%; p = 0.02). The protocol had no impact on median time to discharge (190 vs. 205 min; p = 0.60). Only one patient in each group presented to the emergency department with POUR (2%). After ambulatory inguinal herniorraphy, implementation of a bladder scan-based voiding protocol did not result in earlier discharge. The incidence of POUR was lower than reported in the literature.

Changes in canopy fuels and fire behavior after ponderosa pine restoration treatments: A landscape perspective

Treesearch

J. P. Roccaforte; P. Z. Fule

2008-01-01

(Please note, this is an abstract only) We modeled crown fire behavior and assessed changes in canopy fuels before and after the implementation of restoration treatments in a ponderosa pine landscape at Mt. Trumbull, Arizona. We measured 117 permanent plots before (1996/1997) and after (2003) thinning and burning treatments. The plots are evenly distributed across the...

Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial.

PubMed

Ott, O J; Hertel, S; Gaipl, U S; Frey, B; Schmidt, M; Fietkau, R

2012-10-01

The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 ± 20.2 and 55.7 ± 18.0 (p = 0.463), 32.1 ± 24.5 and 34.4 ± 22.5 (p = 0.256), and 27.0 ± 27.7 and 23.5 ± 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 ± 2.9 and 8.1 ± 3.1 (p = 0.207), 4.5 ± 3.2 and 5.0 ± 3.4 (p = 0.507), 3.9 ± 3.6 and 2.8 ± 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy.

Dexamethasone does not diminish sugammadex reversal of neuromuscular block - clinical study in surgical patients undergoing general anesthesia.

PubMed

Rezonja, Katja; Mars, Tomaz; Jerin, Ales; Kozelj, Gordana; Pozar-Lukanovic, Neva; Sostaric, Maja

2016-10-21

Sugammadex reverses neuromuscular block (NMB) through binding aminosteroid neuromuscular blocking agents. Although sugammadex appears to be highly selective, it can interact with other drugs, like corticosteroids. A prospective single-blinded randomized clinical trial was designed to explore the significance of interactions between dexamethasone and sugammadex. Sixty-five patients who were anesthetized for elective abdominal or urological surgery were included. NMB was assessed using train-of-four stimulation (TOF), with rocuronium used to maintain the desired NMB depth. NMB reversal at the end of anaesthesia was achieved using sugammadex. According to their received antiemetics, the patients were randomized to either the granisetron or dexamethasone group. Blood samples were taken before and after NMB reversal, for plasma dexamethasone and rocuronium determination. Primary endpoint was time from sugammadex administration to NMB reversal. Secondary endpoints included the ratios of the dexamethasone and rocuronium concentrations after NMB reversal versus before sugammadex administration. There were no differences for time to NMB reversal between the control (mean 121 ± 61 s) and the dexamethasone group (mean 125 ± 57 s; P = 0.760). Time to NMB reversal to a TOF ratio ≥0.9 was significantly longer in patients with lower TOF prior to sugammadex administration (Beta = -0.268; P = 0.038). The ratio between the rocuronium concentrations after NMB reversal versus before sugammadex administration was significantly affected by sugammadex dose (Beta = -0.375; P = 0.004), as was rocuronium dose per hour of operation (Beta = -0.366; p = 0.007), while it was not affected by NMB depth before administration of sugammadex (Beta = -0.089; p = 0.483) and dexamethasone (Beta = -0.186; p = 0.131). There was significant drop in plasma dexamethasone after sugammadex administration and NMB reversal (p < 0.001). Administration of dexamethasone to anesthetized patients did not delay NMB reversal by sugammadex. The trial was retrospectively registered with The Australian New Zealand Clinical Trials Registry (ANZCTR) on February 28th 2012 (enrollment of the first patient on February 2nd 2012) and was given a trial ID number ACTRN12612000245897 and universal trial number U1111-1128-5104.

[Evaluation of a program to promote network building between disciplinary agencies and informal community organizations: trial in a community comprehensive support center].

PubMed

Murayama, Hiroshi; Kojima, Tomoko; Tomaru, Meiko; Narabu, Harumi; Tachibana, Reiko; Yamaguchi, Takuhiro; Murashima, Sachiyo

2010-10-01

To examine the effectiveness of a program promoting network building between disciplinary agencies and informal community organizations (IGOs) comprising community residents, by implemention with staff of a community comprehensive support center (CJCSG). The program was implemented for nine staff of a GGSG in Setagaya Ward, Tokyo for a year. For process evaluation, items were assessed concerning the contents of the program such as satisfaction and understandability, participants' goal attainment level at each period of the program, and program satisfaction as a whole. Outcome evaluation included measurement of participants' self-efficacy regarding network building with ICOs before and after the program, using interviews of the members who completed the program. Eight out of the nine participants completed the program. All positively evaluated the contents of the program and their own goal attainment at each period of the program. After its completion, they felt highly satisfied. Moreover, there was an improvement in the cognition of the participants, including self-efficacy on network building with IGOs and the atmosphere in the GGSG with regard to network building. The efficacy of this program could be confirmed as demonstrated by the staff of the CCSC, although a more detailed assessment of validity and effectiveness will be necessary in the future.

GPs' prescription routines and cooperation with other healthcare personnel before and after implementation of multidose drug dispensing.

PubMed

Wekre, Liv Johanne; Bakken, Kjersti; Garåsen, Helge; Grimsmo, Anders

2012-08-01

This study addresses GPs' attitudes towards multidose drug dispensing before and after implementation and their perceived experience of how multidose drug dispensing affects prescription and communication routines for patients in the home care services. This study contributes to a method triangulation with two other studies on the introduction of multidose drug dispensing in Trondheim. A controlled before-and-after study carried out in Trondheim (intervention) and Tromsø (control). A questionnaire was distributed to all GPs in the two towns in 2005 with a follow-up questionnaire in 2008. The GPs in Trondheim showed a positive attitude to multidose drug dispensing both before and after the implementation. Increased workload was reported, but still the GPs wanted the system to be continued. Most of the GPs reported a better overview of the patients' medication and a supposed reduction in medication errors. The GPs' prescription- and communication routines were changed only for the multidose drug users and not for the other patients in the home care services. The study supports the results presented in two previous publications according to GPs' positive attitude towards multidose drug dispensing, their better overview of the patients' medications, and improved cooperation with the pharmacy. This study adds to our understanding of prescription routines among GPs and the use of the medication module in the electronic health record.

Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial

PubMed Central

2011-01-01

Background Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC) counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Methods Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. Discussion To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster randomised controlled design, we aim to provide further evidence on intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers. Trial registration Current Controlled Trials ISRCTN15427433 PMID:21320312

Attitudes of Registered and Licensed Practical Nurses About the Importance of Families in Surgical Hospital Units: Findings From the Landspitali University Hospital Family Nursing Implementation Project.

PubMed

Blöndal, Katrin; Zoëga, Sigridur; Hafsteinsdottir, Jorunn E; Olafsdottir, Olof Asdis; Thorvardardottir, Audur B; Hafsteinsdottir, Sigrun A; Sveinsdóttir, Herdis

2014-08-01

The purpose of this study was to examine attitudes of registered nurses and licensed practical nurses about the importance of the family in surgical hospital units before (T1) and after (T2) implementation of a Family Systems Nursing educational intervention based on the Calgary Family Assessment and Intervention Models. This study was part of the Landspitali University Hospital Family Nursing Implementation Project and used a nonrandomized, quasi-experimental design with nonequivalent group before and after and without a control group. There were 181 participants at T1 and 130 at T2. No difference was found in nurses' attitudes as measured by the Families Importance in Nursing Care-Nurses' Attitudes (FINC-NA) questionnaire, before and after the educational intervention. Attitudes toward families were favorable at both times. Analysis of demographic variables showed that age, work experience, and workplace (inpatient vs. outpatient units) had an effect on the nurses' attitudes toward families. The influence of work experience on attitudes toward family care warrants further exploration. © The Author(s) 2014.

Tobacco marketing awareness on youth smoking susceptibility and perceived prevalence before and after an advertising ban.

PubMed

Moodie, Crawford; MacKintosh, Anne Marie; Brown, Abraham; Hastings, Gerard B

2008-10-01

The Tobacco Advertising and Promotion Act (TAPA) was implemented in the United Kingdom in 2003. This study is the first to assess its impact on young people, examining smoking susceptibility (intention to smoke among never smokers) and perceived prevalence across three British cross-sectional samples (aged 11-16) before and after the introduction of the ban. Three in-home surveys (n = 1078, 1121 and 1121) were conducted before (1999 and 2002) and after (2004) the implementation of the TAPA. Significant declines in awareness of tobacco marketing and perceived prevalence occurred across the three waves. Higher levels of awareness and perceived prevalence were associated with increased susceptibility, but direct measures of susceptibility remained stable. The TAPA is protecting young people in United Kingdom from tobacco marketing and reducing perceived prevalence, both of which are linked to susceptibility. The stability of susceptibility across the three waves is probably best explained by both the partial implementation of TAPA at the final survey point and the time such effects take to emerge. The evidence from this and previous studies is, however, that, ultimately, they will appear.

Implementation of guidelines for management of possible multidrug-resistant pneumonia in intensive care: an observational, multicentre cohort study.

PubMed

Kett, Daniel H; Cano, Ennie; Quartin, Andrew A; Mangino, Julie E; Zervos, Marcus J; Peyrani, Paula; Cely, Cynthia M; Ford, Kimbal D; Scerpella, Ernesto G; Ramirez, Julio A

2011-03-01

The American Thoracic Society and Infectious Diseases Society of America provide guidelines for management of hospital-acquired, ventilator-associated, and health-care-associated pneumonias, consisting of empirical antibiotic regimens for patients at risk for multidrug-resistant pathogens. We aimed to improve compliance with these guidelines and assess outcomes. We implemented a performance-improvement initiative in four academic medical centres in the USA with protocol-based education and prospective observation of outcomes. Patients were assessed for severity of illness and followed up until death, hospital discharge, or day 28. We included patients in intensive-care units who were at risk for multidrug-resistant pneumonia and were treated empirically. 303 patients at risk for multidrug-resistant pneumonia were treated empirically, and prescribed treatment was guideline compliant in 129 patients and non-compliant in 174 patients. 44 (34%) patients died before 28 days in the compliance group and 35 (20%) died in the non-compliance group. Five patients in the compliance group and seven in the non-compliance group were lost to follow-up after day 14. Kaplan-Meier estimated survival to 28 days was 65% in the compliance group and 79% in the non-compliance group (p=0·0042). This difference persisted after adjustment for severity of illness. Median length of stay and duration of mechanical ventilation did not differ between groups. Compliance failures included non-use of dual treatment for Gram-negative pathogens in 154 patients and absence of meticillin-resistant Staphylococcus aureus coverage in 24 patients. For patients in whom pathogens were subsequently identified, empirical treatment was active in 79 (81%) of 97 of patients receiving compliant therapy compared with 109 (85%) of 128 of patients receiving non-compliant therapy. Because adherence with empirical treatment was associated with increased mortality, we recommend a randomised trial be done before further implementation of these guidelines. Pfizer, US Medical. Copyright © 2011 Elsevier Ltd. All rights reserved.

A before-after study of multidisciplinary Out-of-Hours handover: combining management and frontline efforts to create sustainable improvement.

PubMed

Pennell, Christopher; Flynn, Lorna; Boulton, Belinda; Hughes, Tracey; Walker, Graham; McCulloch, Peter

2017-04-01

The importance of implementation strategy in systems improvement is increasingly recognized and both 'bottom-up' and 'top-down' approaches have significant barriers. A trial of a combined approach involving frontline and managerial staff therefore seems merited. We attempted to improve handover using a Human Factors-based approach integrated with a combined 'top and bottom' implementation strategy. A before-after study was conducted across 9 months. The study was set in a 236 bed district general hospital. Participants included any member of staff involved in Out of Hours handover. Existing processes were analysed using Human Factors methods. Changes made were based on this analysis and developed via facilitation between management and frontline staff. These included creating a single multidisciplinary handover, changing the venue, standardizing the meeting structure, developing an standard operating procedure for identifying unwell patients for handover and creating a clinical coordinator role. Meeting attendance, duration, start time efficiency, the type of patients handed over and the transfer of important information were measured pre- and post-intervention. We found improvement in handover start time (P = 0.002, r = 0) and multidisciplinary participation (P = 0.002, r = -0.534). Handover of unwell patients improved, but not significantly. Communication of plan (P < 0.001, r = 0.14) and pending tasks (P < 0.001, r = 0.30) improved, but diagnosis (P = 0.233, r = -0.05), history (P = 0.482, r = -0.03) and comorbidities (P = 0.19, r = -0.05) did not. The changes produced greater multidisciplinary participation, a broader focus and improved communication of plans and tasks outstanding. The 'top and bottom' implementation approach appeared valuable. Management involvement was essential for significant changes, while frontline staff involvement facilitated the design of context-specific practical solutions with staff buy-in. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Effects of a programme of interventions on regional comprehensive palliative care for patients with cancer: a mixed-methods study.

PubMed

Morita, Tatsuya; Miyashita, Mitsunori; Yamagishi, Akemi; Akiyama, Miki; Akizuki, Nobuya; Hirai, Kei; Imura, Chizuru; Kato, Masashi; Kizawa, Yoshiyuki; Shirahige, Yutaka; Yamaguchi, Takuhiro; Eguchi, Kenji

2013-06-01

Improvement of palliative care is an important public health issue, but knowledge about how to deliver palliative care throughout a region remains inadequate. We used surveys and in-depth interviews to assess changes in the quality of palliative care after regional interventions and to gain insights for improvement of palliative care at a regional level. In this mixed-methods study, a comprehensive programme of interventions for regional palliative care for patients with cancer was implemented from April 1, 2008, to March 31, 2011 in Tsuruoka, Kashiwa, Hamamatsu, and Nagasaki in Japan. Interventions included education, specialist support, and networking. We surveyed patients, bereaved family members, physicians, and nurses before and after the interventions were introduced. We also did qualitative interviews with health-care professionals after the interventions were introduced. Primary endpoints were numbers of home deaths, coverage of specialist services, and patient-reported and family-reported qualities of care. This trial is registered with UMIN Clinical Trial Registry, Japan (UMIN000001274). 859 patients, 1110 bereaved family members, 911 physicians, and 2378 nurses provided analysable preintervention surveys; 857 patients, 1137 bereaved family members, 706 physicians, and 2236 nurses provided analysable postintervention surveys. Proportions of home deaths increased significantly, from 348 of 5147 (6.76%) before the intervention programme to 581 of 5546 (10.48%) after the intervention programme (p<0.0001). Furthermore, 194 of 221 (87.78%) family members of patients who died at home answered that these patients had wanted to die at home. The ratio of patients who received palliative care services to all patients who died of cancer increased significantly (from 0.31 to 0.50; p<0.0001). The patient-reported (effect size 0.14; adjusted p=0.0027) and family-reported (0.23; p<0.0001) qualities of care were significantly better after interventions than before interventions. Physician-reported and nurse-reported difficulties decreased significantly after the introduction of the interventions. Qualitative interviews showed improved communication and cooperation between health-care professionals because of greater opportunities for interactions at various levels. A regional programme of interventions could improve the quality of palliative care. Improvement of communication between health-care professionals is key to improvement of services. Third Term Comprehensive Control Research for Cancer Health and Labor Sciences Research Grants of the Ministry of Health, Labour and Welfare of Japan. Copyright © 2013 Elsevier Ltd. All rights reserved.

Non-invasive high-frequency ventilation versus bi-phasic continuous positive airway pressure (BP-CPAP) following CPAP failure in infants <1250 g: a pilot randomized controlled trial.

PubMed

Mukerji, A; Sarmiento, K; Lee, B; Hassall, K; Shah, V

2017-01-01

Non-invasive high-frequency ventilation (NIHFV), a relatively new modality, is gaining popularity despite limited data. We sought to evaluate the effectiveness of NIHFV versus bi-phasic continuous positive airway pressure (BP-CPAP) in preterm infants failing CPAP. Infants with BW<1250 g on CPAP were randomly assigned to NIHFV or BP-CPAP if they met pre-determined criteria for CPAP failure. Infants were eligible for randomization after 72 h age and until 2000 g. Guidelines for adjustment of settings and criteria for failure of assigned mode were implemented. The primary aim was to assess feasibility of a larger trial. In addition, failure of assigned non-invasive respiratory support (NRS) mode, invasive mechanical ventilation (MV) 72 h and 7 days post-randomization, and bronchopulmonary dysplasia (BPD) were assessed. Thirty-nine infants were randomized to NIHFV (N=16) or BP-CPAP (N=23). There were no significant differences in mean (s.d.) postmenstrual age (28.6 (1.5) versus 29.0 (2.3) weeks, P=0.47), mean (s.d.) weight at randomization (965.0 (227.0) versus 958.1 (310.4) g, P=0.94) or other baseline demographics between the groups. Failure of assigned NRS mode was lower with NIHFV (37.5 versus 65.2%, P=0.09), although not statistically significant. There were no differences in rates of invasive MV 72 h and 7 days post-randomization or BPD. NIHFV was not superior to BP-CPAP in this pilot study. Effectiveness of NIHFV needs to be proven in larger multi-center, appropriately powered trials before widespread implementation.

Controlling the Ecotourist in a Wild Dolphin Feeding Program: Is Education the Answer?

ERIC Educational Resources Information Center

Orams, Mark B.; Hill, Greg J. E.

1998-01-01

The effectiveness of an education program for tourists who hand-feed wild dolphins at Tangalooma, Moreton Island in eastern Australia was evaluated. Data were gathered on tourist behavior during feeding sessions before and after the education policy was implemented. After implementation of the education program, inappropriate behaviors such as…

Interprofessional Team's Perception of Care Delivery After Implementation of a Pediatric Pain and Sedation Protocol.

PubMed

Staveski, Sandra L; Wu, May; Tesoro, Tiffany M; Roth, Stephen J; Cisco, Michael J

2017-06-01

Pain and agitation are common experiences of patients in pediatric cardiac intensive care units. Variability in assessments by health care providers, communication, and treatment of pain and agitation creates challenges in management of pain and sedation. To develop guidelines for assessment and treatment of pain, agitation, and delirium in the pediatric cardiac intensive unit in an academic children's hospital and to document the effects of implementation of the guidelines on the interprofessional team's perception of care delivery and team function. Before and after implementation of the guidelines, interprofessional team members were surveyed about the members' perception of analgesia, sedation, and delirium management RESULTS: Members of the interprofessional team felt more comfortable with pain and sedation management after implementation of the guidelines. Team members reported improvements in team communication on patients' comfort. Members thought that important information was less likely to be lost during transfer of care. They also noted that the team carried out comfort management plans and used pharmacological and nonpharmacological therapies better after implementation of the guidelines than they did before implementation. Guidelines for pain and sedation management were associated with perceived improvements in team function and patient care by members of the interprofessional team. ©2017 American Association of Critical-Care Nurses.

Sustainability of professionals’ adherence to clinical practice guidelines in medical care: a systematic review

PubMed Central

Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

2015-01-01

Objectives To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals’ adherence to guideline recommendations in medical practice. Design Systematic review. Data sources Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Eligibility criteria Studies needed to be focused on sustainability and on professionals’ adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). Results The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5–maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals’ adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals’ adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. Conclusions (2) Professionals’ adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the sustainability of professionals’ adherence to guidelines in medical practice can be drawn. PMID:26715477

Sustainability of professionals' adherence to clinical practice guidelines in medical care: a systematic review.

PubMed

Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

2015-12-29

To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals' adherence to guideline recommendations in medical practice. Systematic review. Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Studies needed to be focused on sustainability and on professionals' adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5-maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals' adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals' adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. (2) Professionals' adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the sustainability of professionals' adherence to guidelines in medical practice can be drawn. 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/

Effect of Intravenous Acetaminophen on Postoperative Pain in Vitrectomy: A Randomized, Double-Blind, Clinical Trial.

PubMed

Sadrolsadat, Seyed Hossein; Yousefshahi, Fardin; Ostadalipour, Abbas; Mohammadi, Fatemeh Zahra; Makarem, Jalil

2017-06-01

Nowadays, pain, nausea, and vomiting are regarded as important complications of anesthesia and surgery. The current study aimed at assessing the effect of preemptive intravenous acetaminophen on control of pain, nausea, vomiting, shivering, and drowsiness following the general anesthesia for retina and/or vitrectomy surgeries. In a randomized, double-blind, clinical trial, 83 candidates for retina or vitrectomy eye surgery under general anesthesia were distributed into 3 groups: A) 41 patients in the control group who received 100 mL of normal saline just before the surgery and 100 mL of normal saline 20 minutes before the end of surgery; B) 21 patients in the preemptive group who received acetaminophen 15 mg/kg in 100 mL normal saline just before the surgery and 100 mL normal saline 20 minutes before the end of surgery; C) 21 patients in the preventive group who received 100 mL normal saline just before the surgery and acetaminophen 15 mg/kg in 100 mL normal saline 20 minutes before the end of surgery. Pain, nausea, vomiting, and shivering were assessed at the recovery and 2, 4, and 24 hours after the operation. Anesthesia emergence situation was assessed after arrival in the recovery room by the Richmond agitation-sedation scale (RASS) questionnaire. Blood pressure and heart rate were recorded before anesthesia induction, just after intubation, before extubation, and on discharge from the recovery room. Total intraoperative fentanyl, duration of operation, and duration of anesthesia were not different among the studied groups. Vital signs were not statistically different among the groups at before anesthesia induction, just after intubation, before extubation, and on discharge from the recovery room. Thirty-three patients in the control group (87.8%), 11 in preemptive (52.4%), and 14 in preventive groups (66.7%) needed acetaminophen in the first 24 hours after the surgery (P value = 0.008). Pain scores measured by visual rating scale (VRS) was lower in the preemptive and preventive groups, compared with those of the control group, in the recovery (P value = 0.006), 2 hours after the surgery (P value = 0.008), and 4 hours after the surgery (P value = 0.012), but not in 24 hours after the operation (P value = 0.1). Intravenous acetaminophen administered as preemptive or preventive medication was effective and safe to control acute postoperative pain and analgesic request after the vitrectomy eye surgery.

Effect of Intravenous Acetaminophen on Postoperative Pain in Vitrectomy: A Randomized, Double-Blind, Clinical Trial

PubMed Central

Sadrolsadat, Seyed Hossein; Yousefshahi, Fardin; Ostadalipour, Abbas; Mohammadi, Fatemeh Zahra; Makarem, Jalil

2017-01-01

Background Nowadays, pain, nausea, and vomiting are regarded as important complications of anesthesia and surgery. The current study aimed at assessing the effect of preemptive intravenous acetaminophen on control of pain, nausea, vomiting, shivering, and drowsiness following the general anesthesia for retina and/or vitrectomy surgeries. Methods In a randomized, double-blind, clinical trial, 83 candidates for retina or vitrectomy eye surgery under general anesthesia were distributed into 3 groups: A) 41 patients in the control group who received 100 mL of normal saline just before the surgery and 100 mL of normal saline 20 minutes before the end of surgery; B) 21 patients in the preemptive group who received acetaminophen 15 mg/kg in 100 mL normal saline just before the surgery and 100 mL normal saline 20 minutes before the end of surgery; C) 21 patients in the preventive group who received 100 mL normal saline just before the surgery and acetaminophen 15 mg/kg in 100 mL normal saline 20 minutes before the end of surgery. Pain, nausea, vomiting, and shivering were assessed at the recovery and 2, 4, and 24 hours after the operation. Anesthesia emergence situation was assessed after arrival in the recovery room by the Richmond agitation-sedation scale (RASS) questionnaire. Blood pressure and heart rate were recorded before anesthesia induction, just after intubation, before extubation, and on discharge from the recovery room. Results Total intraoperative fentanyl, duration of operation, and duration of anesthesia were not different among the studied groups. Vital signs were not statistically different among the groups at before anesthesia induction, just after intubation, before extubation, and on discharge from the recovery room. Thirty-three patients in the control group (87.8%), 11 in preemptive (52.4%), and 14 in preventive groups (66.7%) needed acetaminophen in the first 24 hours after the surgery (P value = 0.008). Pain scores measured by visual rating scale (VRS) was lower in the preemptive and preventive groups, compared with those of the control group, in the recovery (P value = 0.006), 2 hours after the surgery (P value = 0.008), and 4 hours after the surgery (P value = 0.012), but not in 24 hours after the operation (P value = 0.1). Conclusions Intravenous acetaminophen administered as preemptive or preventive medication was effective and safe to control acute postoperative pain and analgesic request after the vitrectomy eye surgery. PMID:29181331

Impact of 2003 State Regulation on Raw Oyster–associated Vibrio vulnificus Illnesses and Deaths, California, USA

PubMed Central

Tabnak, Farzaneh; Newton, Anna E.; Hernandez, Michael; Griffin, Patricia M.

2013-01-01

US vibriosis rates have increased since 1996, and many Vibrio vulnificus infections are fatal. In April 2003, California implemented a regulation restricting the sale of raw oysters harvested from the Gulf of Mexico during April 1–October 31, unless they were processed to reduce V. vulnificus to nondetectable levels. We analyzed California cases of V. vulnificus infection before and after the regulation’s implementation and compared case data with data from other states. The annual number of reported V. vulnificus infections and deaths in California with patient’s sole exposure to raw oysters dropped from 0 to 6 cases and 0 to 5 deaths per year during 1991–2002, before implementation, to 0 during 2003–2010, after implementation (p = 0.0005 for both). In other states, median annual numbers of similar cases and deaths increased slightly after 2002. The data strongly suggest that the 2003 regulation led to a significant reduction in reported raw oyster–associated V. vulnificus illnesses and deaths. PMID:23876744

Impact of 2003 state regulation on raw oyster-associated Vibrio vulnificus illnesses and deaths, California, USA.

PubMed

Vugia, Duc J; Tabnak, Farzaneh; Newton, Anna E; Hernandez, Michael; Griffin, Patricia M

2013-08-01

US vibriosis rates have increased since 1996, and many Vibrio vulnificus infections are fatal. In April 2003, California implemented a regulation restricting the sale of raw oysters harvested from the Gulf of Mexico during April 1-October 31, unless they were processed to reduce V. vulnificus to nondetectable levels. We analyzed California cases of V. vulnificus infection before and after the regulation's implementation and compared case data with data from other states. The annual number of reported V. vulnificus infections and deaths in California with patient's sole exposure to raw oysters dropped from 0 to 6 cases and 0 to 5 deaths per year during 1991-2002, before implementation, to 0 during 2003-2010, after implementation (p = 0.0005 for both). In other states, median annual numbers of similar cases and deaths increased slightly after 2002. The data strongly suggest that the 2003 regulation led to a significant reduction in reported raw oyster-associated V. vulnificus illnesses and deaths.

The US Air Force suicide prevention program: implications for public health policy.

PubMed

Knox, Kerry L; Pflanz, Steven; Talcott, Gerald W; Campise, Rick L; Lavigne, Jill E; Bajorska, Alina; Tu, Xin; Caine, Eric D

2010-12-01

We evaluated the effectiveness of the US Air Force Suicide Prevention Program (AFSPP) in reducing suicide, and we measured the extent to which air force installations implemented the program. We determined the AFSPP's impact on suicide rates in the air force by applying an intervention regression model to data from 1981 through 2008, providing 16 years of data before the program's 1997 launch and 11 years of data after launch. Also, we measured implementation of program components at 2 points in time: during a 2004 increase in suicide rates, and 2 years afterward. Suicide rates in the air force were significantly lower after the AFSPP was launched than before, except during 2004. We also determined that the program was being implemented less rigorously in 2004. The AFSPP effectively prevented suicides in the US Air Force. The long-term effectiveness of this program depends upon extensive implementation and effective monitoring of implementation. Suicides can be reduced through a multilayered, overlapping approach that encompasses key prevention domains and tracks implementation of program activities.

Integrating evidence-based treatments for common mental disorders in routine primary care: feasibility and acceptability of the MANAS intervention in Goa, India

PubMed Central

CHATTERJEE, SUDIPTO; CHOWDHARY, NEERJA; PEDNEKAR, SULOCHANA; COHEN, ALEX; ANDREW, GRACY; ANDREW, GRACY; ARAYA, RICARDO; SIMON, GREGORY; KING, MICHAEL; TELLES, SHIRLEY; VERDELI, HELENA; CLOUGHERTY, KATHLEEN; KIRKWOOD, BETTY; PATEL, VIKRAM

2008-01-01

Common mental disorders, such as depression and anxiety, pose a major public health burden in developing countries. Although these disorders are thought to be best managed in primary care settings, there is a dearth of evidence about how this can be achieved in low resource settings. The MANAS project is an attempt to integrate an evidence based package of treatments into routine public and private primary care settings in Goa, India. Before initiating the trial, we carried out extensive preparatory work, over a period of 15 months, to examine the feasibility and acceptability of the planned intervention. This paper describes the systematic development and evaluation of the intervention through this preparatory phase. The preparatory stage, which was implemented in three phases, utilized quantitative and qualitative methods to inform our understanding of the potential problems and possible solutions in implementing the trial and led to critical modifications of the original intervention plan. Investing in systematic formative work prior to conducting expensive trials of the effectiveness of complex interventions is a useful exercise which potentially improves the likelihood of a positive result of such trials. PMID:18458786

Randomized clinical trial of the effect of preoperative oral carbohydrate treatment on postoperative whole-body protein and glucose kinetics.

PubMed

Svanfeldt, M; Thorell, A; Hausel, J; Soop, M; Rooyackers, O; Nygren, J; Ljungqvist, O

2007-11-01

Preoperative oral carbohydrate (CHO) reduces postoperative insulin resistance. In this randomized trial, the effect of CHO on postoperative whole-body protein turnover was studied. Glucose and protein kinetics ([6,6(2)H(2)]D-glucose, [(2)H(5)]phenylalanine, [(2)H(2)]tyrosine and [(2)H(4)]tyrosine) and substrate oxidation (indirect calorimetry) were studied at baseline and during hyperinsulinaemic normoglycaemic clamping before and on the first day after colorectal resection. Fifteen patients were randomized to receive a preoperative beverage with high (125 mg/ml) or low (25 mg/ml) CHO content. Three patients were excluded after the intervention, leaving six patients in each group. After surgery whole-body protein balance did not change in the high oral CHO group, whereas it was more negative in the low oral CHO group after surgery at baseline (P = 0.003) and during insulin stimulation (P = 0.005). Insulin-stimulated endogenous glucose release was similar before and after surgery in the high oral CHO group, but was higher after surgery in the low oral CHO group (P = 0.013) and compared with the high oral CHO group (P = 0.044). Whole-body protein balance and the suppressive effect of insulin on endogenous glucose release are better maintained when patients receive a CHO-rich beverage before surgery. Copyright (c) 2007 British Journal of Surgery Society Ltd.

A theory-based online health behaviour intervention for new university students (U@Uni:LifeGuide): results from a repeat randomized controlled trial.

PubMed

Cameron, David; Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L; Julious, Steven A; Brennan, Alan; Thomas, Chloe; Petroczi, Andrea; Naughton, Declan; Shah, Iltaf

2015-12-07

This paper reports the results of a repeat trial assessing the effectiveness of an online theory-based intervention to promote healthy lifestyle behaviours in new university students. The original trial found that the intervention reduced the number of smokers at 6-month follow-up compared with the control condition, but had non-significant effects on the other targeted health behaviours. However, the original trial suffered from low levels of engagement, which the repeat trial sought to rectify. Three weeks before staring university, all incoming undergraduate students at a large university in the UK were sent an email inviting them to participate in the study. After completing a baseline questionnaire, participants were randomly allocated to intervention or control conditions. The intervention consisted of a self-affirmation manipulation, health messages based on the theory of planned behaviour and implementation intention tasks. Participants were followed-up 1 and 6 months after starting university. The primary outcome measures were portions of fruit and vegetables consumed, physical activity levels, units of alcohol consumed and smoking status at 6-month follow-up. The study recruited 2,621 students (intervention n=1346, control n=1275), of whom 1495 completed at least one follow-up (intervention n=696, control n=799). Intention-to-treat analyses indicated that the intervention had a non-significant effect on the primary outcomes, although the effect of the intervention on fruit and vegetable intake was significant in the per-protocol analyses. Secondary analyses revealed that the intervention had significant effects on having smoked at university (self-report) and on a biochemical marker of alcohol use. Despite successfully increasing levels of engagement, the intervention did not have a significant effect on the primary outcome measures. The relatively weak effects of the intervention, found in both the original and repeat trials, may be due to the focus on multiple versus single health behaviours. Future interventions targeting the health behaviour of new university students should therefore focus on single health behaviours. Current Controlled Trials ISRCTN07407344 .

Comparison of burnout among medical residents before and after the implementation of work hours limits.

PubMed

Martini, Shahm; Arfken, Cynthia L; Balon, Richard

2006-01-01

The authors assess whether implementation of work hour limits is associated with a lower prevalence of medical resident burnout. A survey was mailed to medical residents in different medical specialties at one university. Somewhat lower burnout prevalence was reported among residents after implementation of work hour limits compared with the rates prior to the implementation period. The decrease in burnout prevalence occurred primarily among PGY-1 residents. Prevalence of burnout increased with hours worked. Implementing work hour limits appeared to reduce burnout prevalence.

Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article.

PubMed

Hsieh, Ling-Yu; Chen, Yi-Rong; Lu, Mei-Chun

2017-11-01

Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain. A prospective, randomized, single-blind, sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600-g ice packs 15 minutes before CTR, whereas subjects in the sham group (n = 30) received tap water packs. Numerical rating scale was used to measure pain intensity before, immediately after, and 10 minutes after CTR. The generalized linear estimating equation (GEE) model, adjusted for other factors, both the groups demonstrated a trend toward decreased pain during CTR over time (P < .001), but no significant differences between the 2 groups (P = .65), even stratifying by gender. If we fixed experimental group, women significant reduced pain score of 2.7 on immediately after CTR compared with before CTR (P < .0001) and reduced pain score of 2.05 on 10 minutes after CTR compared with before CTR (P < .0001). The sham group had no similar performance as the experimental group. In the male subgroup, both experimental and sham groups, men significantly reduced pain score on immediately after CTR and 10 minutes after CTR compared with before CTR (P < .0001). The results indicate that cold application is not more effective than sham treatment in decreasing pain during CTR, even among gender. Although statistically non-significant, clinically important differences of decreased pain score were observed with cold application among women (Clinical Trial Registration: clinicaltrials.gov identifier NCT03307239).

Oak restoration trials: Santa Catalina Island

Treesearch

Lisa Stratton

2002-01-01

Two restoration trials involving four oak species have been implemented as part of a larger restoration program for Catalina Island. In 1997 the Catalina Island Conservancy began an active program of restoration after 50 years of ranching and farming activities on the island. The restoration program includes removing feral goats and pigs island-wide and converting 80...

Institutional Trial Quality Audit of the University of South Africa (UNISA)

ERIC Educational Resources Information Center

Commonwealth of Learning, 2007

2007-01-01

This report presents the findings of the Trial Audit Panel (TAP) after studying a range of documentation before and during the audit and discussing issues with a wide range of University of South Africa (Unisa) staff during their visit to the University in June 2007. The original intention was to produce two reports, one in the format and…

The Impact of Preoperative Enteral Nutrition Enriched with Eicosapentaenoic Acid on Postoperative Hypercytokinemia after Pancreatoduodenectomy: The Results of a Double-Blinded Randomized Controlled Trial.

PubMed

Ashida, Ryo; Okamura, Yukiyasu; Wakabayashi-Nakao, Kanako; Mizuno, Takashi; Aoki, Shuichi; Uesaka, Katsuhiko

2018-06-08

To investigate whether preoperative enteral diets -enriched in eicosapentaenoic acid (EPA) supplements could reduce the incidence of hypercytokinemia after pancreatoduodenectomy (PD) in a double-blinded randomized -controlled trial. Patients with resectable periampullary cancer were randomized into either the control group or the treatment group. Patients in the treatment group received oral supplementation (600 kcal/day) containing EPA for 7 days before surgery. Patients in the control group received isocaloric isonitrogenous standard nutrition (600 kcal/day) without EPA for 7 days before surgery. The primary endpoint was postoperative serum concentrations of interleukin-6 (IL-6). The secondary endpoints were the postoperative nutritional status and the incidence of postoperative infectious complications. Twenty-four patients were enrolled in the present study. After exclusion, 20 patients (control group, n = 9; treatment group, n = 11) were analyzed. There were no significant differences in the curves for the serum concentration of IL-6 (p = 0.68) or the incidence of infectious complications between the 2 groups (control group: 78%, treatment group: 55%, p = 0.37). The results of a double-blinded randomized controlled trial indicated that preoperative immunonutrition had no marked impact on the rates of postoperative hypercytokinemia or infectious complications after PD. © 2018 S. Karger AG, Basel.

Wearing lower-body compression garment with medium pressure impaired exercise-induced performance decrement during prolonged running

PubMed Central

Mizuno, Sahiro

2017-01-01

Objective To investigate the effect of wearing a lower body compression garment (CG) exerting different pressure levels during prolonged running on exercise-induced muscle damage and the inflammatory response. Methods Eight male participants completed three exercise trials in a random order. The exercise consisted of 120 min of uphill running at 60% of VO2max. The exercise trials included 1) wearing a lower-body CG with 30 mmHg pressure [HIGH]; 2) wearing a lower-body CG with 15 mmHg pressure [MED]; and 3) wearing a lower-body garment with < 5 mmHg pressure [CON]. Heart rate (HR), and rate of perceived exertion for respiration and legs were monitored continuously during exercise. Time-course change in jump height was evaluated before and immediately after exercise. Blood samples were collected to determine blood glucose, lactate, serum creatine kinase, myoglobin, free fatty acids, glycerol, cortisol, and plasma interleukin-6 (IL-6) concentrations before exercise, 60 min of the 120 min exercise period, immediately after exercise, and 60 min after exercise. Results Jump height was significantly higher immediately after the exercise in the MED trial compared with that in the HIGH trial (P = 0.04). Mean HR during the 120 min exercise was significantly lower in the MED trial (162 ± 4 bpm) than that in the CON trial (170 ± 4 bpm, P = 0.01). Plasma IL-6 concentrations increased significantly with exercise in all trials, but the area under the curve during exercise was significantly lower in the MED trial (397 ± 58 pg/ml·120 min) compared with that in the CON trial (670 ± 86 pg/ml·120 min, P = 0.04). Conclusion Wearing a lower body CG exerting medium pressure (approximately 15 mmHg) significantly attenuated decrease in jump performance than that with wearing a lower body CG exerting high pressure (approximately 30 mmHg). Furthermore, exercise-induced increases in HR and the inflammatory response were significantly smaller with CG exerted 15mmHg than that with garment exerted < 5 mmHg. PMID:28562650

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence.

PubMed

Komesu, Yuko M; Rogers, Rebecca G; Sapien, Robert E; Schrader, Ronald M; Simmerman-Sierra, Timothy; Mayer, Andrew R; Ketai, Loren H

2017-06-01

We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. We describe the development and design challenges of a study comparing the efficacy of hypnotherapy and conventional pharmacotherapy in the treatment of UUI. The study randomizes women to either of these treatments, and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a noninferiority test (alpha = 0.025, beta = 0.20), after considering dropout subjects and subjects lost to follow-up, indicated that approximately 150 woman would be required to test the hypothesis that hypnotherapy is not inferior to pharmacotherapy within a 5 % noninferiority margin. The study will also evaluate fMRI changes in a subset of participants before and after therapy. Challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, and confronting the reality that trials are time-consuming for participants who have to make appropriate accommodations in their schedule. Study enrollment began in March 2013 and is ongoing. We describe the design of a randomized controlled trial comparing mind-body therapy and pharmacotherapy in the treatment of UUI and the challenges encountered in its implementation.

Effects of managerial intervention on drug utilization pattern at King Chulalongkorn Memorial Hospital.

PubMed

Limpanasithikul, Wacharee; Wangsaturaka, Danai; Nantawan, Patra; Itthipanichapong, Chandhanee; Thamaree, Sopit; Wittayalertpanya, Supeecha; Ketcharoen, Aurawan; Taworn, Nongnuch; Kemsri, Wandee; Kusolsomboon, Thammarat; Tangphao, Oranee

2002-06-01

The economic crisis in Thailand since 1997 has a major impact on all sections of the country including health care. There were several suggestions for reducing the drug expenditure budget including restriction of hospital formulary, generic prescribing and generic dispensing. At King Chulalongkorn Memorial hospital, the new hospital formulary was established and implemented in March 1998. The generic dispensing policy was also in place at the same time. This study aimed to evaluate the impact of the new implementation by comparing the prescription patterns in out patient departments (OPDs) of the hospital before and after the new hospital formulary implementation. The prescriptions from several OPDs were systematically stratified samplings 5 weeks before and 5 weeks after March 1st, 1998. The information from the prescriptions including drug category, drug name, amount of dispensed drug, drug cost, etc. was collected and analyzed. The total number of prescriptions and the average number of drug items/prescription before and after the implementation were similar (2,049 vs 2,052, and 2.52 +/- 0.048 vs 2.45 +/- 0.03 respectively). The total cost of the prescription, the cost/prescription and the cost/item seemed to be different (1,690,484 baht vs 1,282,343 baht, 844 +/- 54.04 vs 633 +/- 41.11 and 332.58 +/- 29.59 vs 255.29 +/- 19.98 respectively). After the implementation, physicians in the hospital increasingly prescribed drugs by generic name (37.1% vs 44.85%). Locally made drugs were also prescribed by physicians and received by patients more than before (9.56% vs 84.27% and 28.15% vs 60.72%, respectively). Anti-infective agents were studied in depth as they contribute to significant amount of drug expenditure. The total cost of prescribed anti-infective agents and the cost/prescription were increased after the implementation (223,529 vs 274,435 Baht and 585.38 +/- 102.84 vs 772.71 +/- 147.59). The increased cost mainly came from the cost of anti-HIV drugs. Our data indicate that the new hospital formulary may have played a part on the impact of drug expenditure reduction and may have changed the prescribing attitude of physicians in King Chulalongkorn Memorial Hospital.

Deregulation of sale of over-the-counter drugs outside of pharmacies in the Republic of Korea: interrupted-time-series analysis of outpatient visits before and after the policy.

PubMed

Chun, Sung-Youn; Park, Hye-Ki; Han, Kyu-Tae; Kim, Woorim; Lee, Hyo-Jung; Park, Eun-Cheol

2017-07-12

We evaluated the effectiveness of a policy allowing for the sale of over-the-counter drugs outside of pharmacies by examining its effect on number of monthly outpatient visits for acute upper respiratory infections, dyspepsia, and migraine. We used medical claims data extracted from the Korean National Health Insurance Cohort Database from 2009 to 2013. The Korean National Health Insurance Cohort Database comprises a nationally representative sample of claims - about 2% of the entire population - obtained from the medical record data held by the Korean National Health Insurance Corporation (which has data on the entire nation). The analysis included26,284,706 person-months of 1,042,728 individuals. An interrupted-time series analysis was performed. Outcome measures were monthly outpatient visits for acute upper respiratory infections, dyspepsia, and migraine. To investigate the effect of the policy, we compared the number of monthly visits before and after the policy's implementation in 2012. For acute upper respiratory infections, monthly outpatient visits showed a decreasing trend before the policy (ß = -0.0003);after it, a prompt change and increasing trend in monthly outpatient visits were observed, but these were non-significant. For dyspepsia, the trend was increasing before implementation (ß = -0.0101), but this reversed after implementation(ß = -0.007). For migraine, an increasing trend was observed before the policy (ß = 0.0057). After it, we observed a significant prompt change (ß = -0.0314) but no significant trend. Deregulation of selling over-the-counter medication outside of pharmacies reduced monthly outpatient visits for dyspepsia and migraine symptoms, but not acute upper respiratory infections.

A study of the use and impacts of LifeStraw in a settlement camp in southern Gezira, Sudan.

PubMed

Elsanousi, Salwa; Abdelrahman, Samira; Elshiekh, Ibtisam; Elhadi, Magda; Mohamadani, Ahmed; Habour, Ali; ElAmin, Somaia E; ElNoury, Ahmed; Ahmed, Elhadi A; Hunter, Paul R

2009-09-01

This paper reports a study of the LifeStraw in El-Masraf camp within Gezira State, Sudan. A total of 647 eligible subjects participated in the study. Two week incidence of diarrhoeal rates were estimated by a community survey some four months before and again four months after provision of the LifeStraw. In addition counts were kept of people attending at the community clinic with diarrhoea. Compliance rates were good with 86.5% of people saying they always used it and only 3.7% saying they had never used it. In a before implementation survey 16.8% of participants reported diarrhoea in the previous 2 weeks compared with only 15.3% in a survey after implementation. Similarly 58 people presented to the clinic as a new case of diarrhoea in the four months before compared with only six in the four months after implementation. When compared with diarrhoeal attendances at the regional hospital, this was a statistically significant decline in attendances (p<0.0001). The LifeStraw is likely to find a role as an adjunct to water quality interventions aimed at the home. However, more research is needed to assess the long-term impact and uptake of these devices before their definitive value can be assessed.

Effect of whey protein hydrolysate on performance and recovery of top-class orienteering runners.

PubMed

Hansen, Mette; Bangsbo, Jens; Jensen, Jørgen; Bibby, Bo Martin; Madsen, Klavs

2015-04-01

This trial aimed to examine the effect of whey protein hydrolysate intake before and after exercise sessions on endurance performance and recovery in elite orienteers during a training camp. Eighteen elite orienteers participated in a randomized controlled intervention trial during a 1-week training camp (13 exercise sessions). Half of the runners (PRO-CHO) ingested a protein drink before (0.3 g kg(-1)) and a protein-carbohydrate drink after (0.3 g protein kg(-1) and 1 g carbohydrate kg(-1)) each exercise session. The others ingested energy and time-matched carbohydrate drinks (CHO). A 4-km run-test with 20 control points was performed before and on the last day of the intervention. Blood and saliva were obtained in the mornings, before and after run-tests, and after the last training session. During the intervention, questionnaires were fulfilled regarding psychological sense of performance capacity and motivation. PRO-CHO and not CHO improved performance in the 4-km run-test (interaction p < .05). An increase in serum creatine kinase was observed during the week, which was greater in CHO than PRO-CHO (interaction p < .01). Lactate dehydrogenase (p < .001) and cortisol (p = .057) increased during the week, but the change did not differ between groups. Reduction in sense of performance capacity during the intervention was greater in CHO (p < .05) than PRO-CHO. In conclusion, ingestion of whey protein hydrolysate before and after each exercise session improves performance and reduces markers of muscle damage during a strenuous 1-week training camp. The results indicate that protein supplementation in conjunction with each exercise session facilitates the recovery from strenuous training in elite orienteers.

Effects of low-level laser therapy applied before or after plyometric exercise on muscle damage markers: randomized, double-blind, placebo-controlled trial.

PubMed

Fritsch, Carolina Gassen; Dornelles, Maurício Pinto; Severo-Silveira, Lucas; Marques, Vanessa Bernardes; Rosso, Isabele de Albuquerque; Baroni, Bruno Manfredini

2016-12-01

Promising effects of phototherapy on markers of exercise-induced muscle damage has been already demonstrated in constant load or isokinetic protocols. However, its effects on more functional situations, such as plyometric exercises, and when is the best moment to apply this treatment (pre- or post-exercise) remain unclear. Therefore, the purpose of this study was to investigate the effect of low-level laser therapy (LLLT) before or after plyometric exercise on quadriceps muscle damage markers. A randomized, double-blinded, placebo-controlled trial was conducted with 24 healthy men, 12 at pre-exercise treatment group and 12 at post-exercise treatment group. Placebo and LLLT (810 nm, 200 mW per diode, 6 J per diode, 240 J per leg) were randomly applied on right/left knee extensor muscles of each volunteer before/after a plyometric exercise protocol. Muscular echo intensity (ultrasonography images), soreness (visual analogue scale - VAS), and strength impairment (maximal voluntary contraction - MVC) were assessed at baseline, 24, 48, and 72 h post-exercise. Legs treated with LLLT before or after exercise presented significantly smaller increments of echo intensity (values up to 1 %) compared to placebo treatments (increased up to ∼7 %). No significant treatment effect was found for VAS and MVC, although a trend toward better results on LLLT legs have been found for VAS (mean values up to 30 % lesser than placebo leg). In conclusion, LLLT applied before or after plyometric exercise reduces the muscle echo intensity response and possibly attenuates the muscle soreness. However, these positive results were not observed on strength impairment.

The use of wireless laptop computers for computer-assisted learning in pharmacokinetics.

PubMed

Munar, Myrna Y; Singh, Harleen; Belle, Donna; Brackett, Carolyn C; Earle, Sandra B

2006-02-15

To implement computer-assisted learning workshops into pharmacokinetics courses in a doctor of pharmacy (PharmD) program. Workshops were designed for students to utilize computer software programs on laptop computers to build pharmacokinetic models to predict drug concentrations resulting from various dosage regimens. In addition, students were able to visualize through graphing programs how altering different parameters changed drug concentration-time curves. Surveys were conducted to measure students' attitudes toward computer technology before and after implementation. Finally, traditional examinations were used to evaluate student learning. Doctor of pharmacy students responded favorably to the use of wireless laptop computers in problem-based pharmacokinetic workshops. Eighty-eight percent (n = 61/69) and 82% (n = 55/67) of PharmD students completed surveys before and after computer implementation, respectively. Prior to implementation, 95% of students agreed that computers would enhance learning in pharmacokinetics. After implementation, 98% of students strongly agreed (p < 0.05) that computers enhanced learning. Examination results were significantly higher after computer implementation (89% with computers vs. 84% without computers; p = 0.01). Implementation of wireless laptop computers in a pharmacokinetic course enabled students to construct their own pharmacokinetic models that could respond to changing parameters. Students had greater comprehension and were better able to interpret results and provide appropriate recommendations. Computer-assisted pharmacokinetic techniques can be powerful tools when making decisions about drug therapy.

The Use of Wireless Laptop Computers for Computer-Assisted Learning in Pharmacokinetics

PubMed Central

Munar, Myrna Y.; Singh, Harleen; Belle, Donna; Brackett, Carolyn C.; Earle, Sandra B.

2006-01-01

Objective To implement computer-assisted learning workshops into pharmacokinetics courses in a doctor of pharmacy (PharmD) program. Design Workshops were designed for students to utilize computer software programs on laptop computers to build pharmacokinetic models to predict drug concentrations resulting from various dosage regimens. In addition, students were able to visualize through graphing programs how altering different parameters changed drug concentration-time curves. Surveys were conducted to measure students’ attitudes toward computer technology before and after implementation. Finally, traditional examinations were used to evaluate student learning. Assessment Doctor of pharmacy students responded favorably to the use of wireless laptop computers in problem-based pharmacokinetic workshops. Eighty-eight percent (n = 61/69) and 82% (n = 55/67) of PharmD students completed surveys before and after computer implementation, respectively. Prior to implementation, 95% of students agreed that computers would enhance learning in pharmacokinetics. After implementation, 98% of students strongly agreed (p < 0.05) that computers enhanced learning. Examination results were significantly higher after computer implementation (89% with computers vs. 84% without computers; p = 0.01). Conclusion Implementation of wireless laptop computers in a pharmacokinetic course enabled students to construct their own pharmacokinetic models that could respond to changing parameters. Students had greater comprehension and were better able to interpret results and provide appropriate recommendations. Computer-assisted pharmacokinetic techniques can be powerful tools when making decisions about drug therapy. PMID:17136147

Postural control after a prolonged treadmill run at individual ventilatory and anaerobic threshold.

PubMed

Guidetti, Laura; Franciosi, Emanuele; Gallotta, Maria Chiara; Emerenziani, Gian Pietro; Baldari, Carlo

2011-01-01

The objective of the study was to verify whether young males' balance was affected by 30min prolonged treadmill running (TR) at individual ventilatory (IVT) and anaerobic (IAT) thresholds in recovery time. The VO2max, IAT and IVT during an incremental TR were determined. Mean displacement amplitude (Acp) and velocity (Vcp) of center of pressure were recorded before (pre) and after (0min post; 5min post; and 10min post) prolonged TR at IAT and IVT, through posturographic trials performed with eyes open (EO) and closed (EC). Significant differences between IVT and IAT for Vcp, between EO and EC for Acp and Vcp, were observed. The IAT induced higher destabilizing effect when postural trials were performed with EC. The IVT intensity produced also a destabilizing effect on postural control immediately after exercise. An impairment of postural control after prolonged treadmill running exercise at IVT and IAT intensity was showed. However, destabilizing effect on postural control disappeared within 10min after IAT intensity and within 5min after IVT intensity. Key pointsTo verify whether young males' balance was affected by 30min prolonged treadmill running at individual ventilatory and anaerobic thresholds in recovery time.Mean displacement amplitude and velocity of foot pressure center were recorded before and after prolonged treadmill running at individual ventilatory and anaerobic thresholds, through posturographic trials performed with eyes open and closed.Destabilizing effect on postural control disappeared within 10min post individual anaerobic threshold, and within 5min post individual ventilatory threshold.

Reconciling the effects of screening on prostate cancer mortality in the ERSPC and PLCO trials

PubMed Central

Tsodikov, Alex; Gulati, Roman; Heijnsdijk, Eveline AM; Pinsky, Paul F; Moss, Sue M; Qiu, Sheng; de Carvalho, Tiago M; Hugosson, Jonas; Berg, Christine D; Auvinen, Anssi; Andriole, Gerald L; Roobol, Monique J; Crawford, E David; Nelen, Vera; Kwiatkowski, Maciej; Zappa, Marco; Luján, Marcos; Villers, Arnauld; Feuer, Eric J; de Koning, Harry J; Mariotto, Angela B; Etzioni, Ruth

2017-01-01

Background The European Randomized Study of Screening for Prostate Cancer (ERSPC) found screening reduced prostate cancer (PC) mortality, but the Prostate, Lung, Colorectal, and Ovarian trial (PLCO) found no reduction. Objective To evaluate whether effects of screening on PC mortality relative to no screening differed between the ERSPC and PLCO. Design Cox regression of PC death in each trial arm adjusted for age and trial, and extended analyses that accounted for increased incidence due to screening and diagnostic workup on each arm via mean lead times (MLTs). MLTs were estimated empirically and using analytic or microsimulation models. Setting Randomized controlled trials in Europe and the US. Participants Men aged 55–69 (ERSPC) or 55–74 (PLCO) at randomization. Intervention Prostate cancer screening. Measurements PC incidence and survival from randomization; PC incidence in the US before screening began. Results Estimated MLTs were similar in the ERSPC and PLCO intervention arms but were longer in the PLCO control arm than the ERSPC control arm. Extended analyses found no evidence that effects of screening differed between trials (P=0.37–0.47, range across MLT estimation approaches) but strong evidence that benefit increased with MLT (P=0.0027–0.0032). Screening was estimated to confer a 7–9% reduction in PC death per year of MLT. This translated into an estimated 25–31% and 27–32% lower risk of PC death under screening as performed in the ERSPC and PLCO intervention arms, respectively, relative to no screening. Limitations MLT is a simple metric of screening and diagnostic workup. Conclusion After accounting for differences in implementation and settings, the ERSPC and PLCO provide compatible evidence that screening reduces PC mortality. PMID:28869989

Registered Nurse Staffing in Pennsylvania Nursing Homes: Comparison before and after Implementation of Medicare's Prospective Payment System.

ERIC Educational Resources Information Center

Kanda, Katsuya; Mezey, Mathy

1991-01-01

Examined changes in resident acuity and registered nurse staffing in all nursing homes in Pennsylvania before and after introduction of Medicare Prospective Payment System (PPS) in 1983. Found that acuity of nursing home residents increased significantly since introduction of PPS, full-time registered nurse staffing remained unchanged, and…

Using a Before-During-After (BDA) Model to Plan Effective Secondary Mathematics Lessons

ERIC Educational Resources Information Center

Wilburne, Jane Murphy; Peterson, Winnie

2007-01-01

Creating effective mathematics lessons can be a challenge for any teacher. One approach to design an effective lesson is using a before-during-after (BDA) format. This article describes what a BDA format is and provides two examples of how it is implemented in high school mathematics classes. (Contains 2 tables and 5 figures.)

Thyroid fine-needle aspiration reporting rates and outcomes before and after Bethesda implementation within a combined academic and community hospital system.

PubMed

Harvey, Aaron M; Mody, Dina R; Amrikachi, Mojgan

2013-11-01

The current study compares data from our hospital system before and after the 2008 implementation of the Bethesda System for Reporting Thyroid Cytology (BSRTC). To show the effects the BSRTC has had on the reporting rates and outcomes for thyroid lesions. A search for thyroid fine-needle aspiration biopsies (FNABs) was performed for 2002-2005 (before BSRTC) and 2009-2011 (after BSRTC). Diagnostic outcomes were reviewed for cases with available follow-up. For 2002-2005, cytology reports for 3302 thyroid FNABs were reviewed, and 309 (9.4%) were classified as suspicious. For 2009-2011, cytology reports for 3432 thyroid FNABs were reviewed; 72 (2.1%) were classified as "atypia of undetermined significance or follicular lesion of undetermined significance" (AUS/FLUS), and 142 (4.1%) were classified as suspicious. Follow-up material was available for 31 AUS/FLUS cases (43.0%), and 6 of these cases (19%) were malignant. Follow-up material was available for 60 cases (42.3%) classified as suspicious, and 23 of these cases (38%) were malignant. The AUS/FLUS rate of 2.1% at our institution is at the lower range of the <7% recommended by the BSRTC, and our rate of 19% for risk of malignancy for AUS/FLUS is slightly above the BSRTC recommendation of 5% to 15%. Implementation of the BSRTC did not significantly affect our institution's reporting rates, most likely because an essentially similar classification system was employed before implementation of the BSRTC.

Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients

PubMed Central

Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

2016-01-01

Background Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. Method A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0–10) numerical rating scale at three months post-mastectomy. Results Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. Conclusions This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Trial Registration Clinicaltrials.gov NCT01536314 PMID:27050431

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

PubMed

Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Changes in insurance physicians' attitudes, self-efficacy, intention, and knowledge and skills regarding the guidelines for depression, following an implementation strategy.

PubMed

Zwerver, Feico; Schellart, Antonius J M; Anema, Johannes R; van der Beek, Allard J

2013-03-01

To improve guideline adherence by insurance physicians (IPs), an implementation strategy was developed and investigated in a randomized controlled trial. This implementation strategy involved a multifaceted training programme for a group of IPs in applying the guidelines for depression. In this study we report the impact of the implementation strategy on the physicians' attitude, intention, self-efficacy, and knowledge and skills as behavioural determinants of guideline adherence. Any links between these self-reported behavioural determinants and levels of guideline adherence were also determined. Just before and 3 months after the implementation of the multifaceted training, a questionnaire designed to measure behavioural determinants on the basis of the ASE (attitude, social norm, self-efficacy) model was completed by the intervention (n = 21) and the control group (n = 19). Items of the questionnaire were grouped to form scales of ASE determinants. Internal consistency of the scales was calculated using Cronbach's alphas. Differences between groups concerning changes in ASE determinants, and the association of these changes with improvements in guideline adherence, were analyzed using analysis of covariance. The internal consistency of the scales of ASE determinants proved to be sufficiently reliable, with Cronbach's alphas of at least 0.70. At follow-up after 3 months, the IPs given the implementation strategy showed significant improvement over the IPs in the control group for all ASE determinants investigated. Changes in knowledge and skills were only weakly associated with improvements in guideline adherence. The implementation strategy developed for insurance physicians can increase their attitude, intention, self-efficacy, and knowledge and skills when applying the guidelines for depression. These changes in behavioural determinants might indicate positive changes in IPs' behaviour towards the use of the guidelines for depression. However, only changes in knowledge and skills related to the use of the guidelines were associated with improvements in IPs' actual performance when applying the guidelines.

Conducting research in individual patients: lessons learnt from two series of N-of-1 trials

PubMed Central

Wegman, Anke CM; van der Windt, Daniëlle AWM; Stalman, Wim AB; de Vries, Theo PGM

2006-01-01

Background Double-blind randomised N-of-1 trials (N-of-1 trials) may help with decisions concerning treatment when there is doubt regarding the effectiveness and suitability of medication for individual patients. The patient is his or her own control, and receives the experimental and the control treatment during several periods of time in random order. Reports of N-of-1 trials are still relatively scarce, and the research methodology is not as firmly established as that of RCTs. Recently, we have conducted two series of N-of-1 trials in general practice. Before, during, and after data-collection, difficulties regarding outcome assessment, analysis of the results, the withdrawal of patients, and the follow-up had to be dealt with. These difficulties are described and our solutions are discussed. Discussion To prevent or anticipate difficulties in N-of-1 trials, we argue that that it is important to individualise the outcome measures, and to carefully consider the objective, type of randomisation and the analysis. It is recommended to use the same dosages and dosage forms that the patient used before the trial, to start the trial with a run-in period, to formulate both general and individualised decision rules regarding the efficacy of treatment, to adjust treatment policies immediately after the trial, and to provide adequate instructions and support if treatment is adjusted. Summary Because of the specific characteristics of N-of-1 trials it is difficult to formulate general 'how to do it' guidelines for designing N-of-1 trials. However, when the design of each N-of-1 trial is tailored to the specific characteristics of each individual patient and the underlying medical problem, most difficulties in N-of-1 trials can be prevented or overcome. In this way, N-of-1 trials may be of help when deciding on drug treatment for individual patients. PMID:16984636

Population Support Before and After the Implementation of Smoke-Free Laws in the United States: Trends From 1992–2007

PubMed Central

Nagelhout, Gera E.; Wolfson, Tanya; Zhuang, Yue-Lin; Gamst, Anthony; Willemsen, Marc C.

2015-01-01

Introduction: Several states implemented comprehensive smoke-free laws in workplaces (14 states), restaurants (17 states), and bars (13 states) between 2002 and 2007. We tested the hypothesis that public support for smoke-free laws increases at a higher rate in states that implemented smoke-free laws between 2002 and 2007 (group A) than in states that implemented smoke-free laws after that time or not at all (group B). The period before the implementation (1992–2001) was also considered. Methods: Data was used from the Current Population Survey (CPS) Tobacco Use Supplements (TUS), which is representative for the U.S. adult population. Respondents were asked whether they thought smoking should not be allowed in indoor work areas, restaurants, and bars and cocktail lounges. Differences in trends were analyzed with binomial mixed effects models. Results: Population support for smoke-free restaurants and bars was higher among group A than among group B before 2002. After 2002, support for smoke-free restaurants and bars increased at a higher rate among group A than among group B. Population support for smoke-free workplaces did not differ between group A and B, and the increase in support for smoke-free workplaces also did not differ between these groups. Conclusions: The positive association between the implementation of smoke-free restaurant and bar laws and the rate of increase in support for these laws partly supported the hypothesis. The implementation of the laws may have caused support to increase, but also states that have higher support may have been more likely to implement smoke-free laws. PMID:25143293

Implementation of a guideline for physical therapy in the postoperative period of upper abdominal surgery reduces the incidence of atelectasis and length of hospital stay.

PubMed

Souza Possa, S; Braga Amador, C; Meira Costa, A; Takahama Sakamoto, E; Seiko Kondo, C; Maida Vasconcellos, A L; Moran de Brito, C M; Pereira Yamaguti, W

2014-01-01

The aim of this study was to evaluate the effectiveness of implementing a physical therapy guideline for patients undergoing upper abdominal surgery (UAS) in reducing the incidence of atelectasis and length of hospital stay in the postoperative period. A "before and after" study design with historical control was used. The "before" period included consecutive patients who underwent UAS before guideline implementation (intervention). The "after" period included consecutive patients after guideline implementation. Patients in the pre-intervention period were submitted to a program of physical therapy in which the treatment planning was based on the individual experience of each professional. On the other hand, patients who were included in the post-intervention period underwent a standardized program of physical therapy with a focus on the use of additional strategies (EPAP, incentive spirometry and early mobilization). There was a significant increase in the use of incentive spirometry and positive expiratory airway pressure after guideline implementation. Moreover, it was observed that early ambulation occurred in all patients in the post-intervention period. No patient who adhered totally to the guideline in the post-intervention period developed atelectasis. Individuals in the post-intervention period presented a shorter length of hospital stay (9.2±4.1 days) compared to patients in the pre-intervention period (12.1±8.3 days) (p<0.05). The implementation of a physical therapy guideline for patients undergoing UAS resulted in reduced incidence of atelectasis and reduction in length of hospital stay in the postoperative period. Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

Unintended adverse consequences of electronic health record introduction to a mature universal HIV screening program.

PubMed

Medford-Davis, Laura N; Yang, Katharine; Pasalar, Siavash; Pillow, M Tyson; Miertschin, Nancy P; Peacock, William F; Giordano, Thomas P; Hoxhaj, Shkelzen

2016-01-01

Early HIV detection and treatment decreases morbidity and mortality and reduces high-risk behaviors. Many Emergency Departments (EDs) have HIV screening programs as recommended by the Centers for Disease Control and Prevention. Recent federal legislation includes incentives for electronic health record (EHR) adoption. Our objective was to analyze the impact of conversion to EHR on a mature ED-based HIV screening program. A retrospective pre- and post-EHR implementation cohort study was conducted in a large urban, academic ED. Medical records were reviewed for HIV screening rates from August 2008 through October 2013. On 1 November 2010, a comprehensive EHR system was implemented throughout the hospital. Before EHR implementation, labs were requested by providers by paper orders with HIV-1/2 automatically pre-selected on every form. This universal ordering protocol was not duplicated in the new EHR; rather it required a provider to manually enter the order. Using a chi-squared test, we compared HIV testing in the 6 months before and after EHR implementation; 55,054 patients presented before, and 50,576 after EHR implementation. Age, sex, race, acuity of presenting condition, and HIV seropositivity rates were similar pre- and post-EHR, and there were no major patient or provider changes during this period. Average HIV testing rate was 37.7% of all ED patients pre-, and 22.3% post-EHR, a 41% decline (p < 0.0001), leading to 167 missed new diagnoses after EHR. The rate of HIV screening in the ED decreased after EHR implementation, and could have been improved with more thoughtful inclusion of existing human processes in its design.

Poor hospital infection control practice in hand hygiene, glove utilization, and usage of tourniquets.

PubMed

Sacar, Suzan; Turgut, Huseyin; Kaleli, Ilknur; Cevahir, Nural; Asan, Ali; Sacar, Mustafa; Tekin, Koray

2006-11-01

Hospital-acquired infection often occurs because of lapses in accepted standards of practice on the part of health care personnel. The aim of this study is to attract attention on poor hospital infection control practice in venepuncture and use of tourniquets and emphasize the importance of hand hygiene. Overall compliance with hygiene during usage of tourniquets and routine patient care before and after implementation of a hospital infection control measures was evaluated. According to the questionnaire, only 26.9% of respondents always washed their hands both before and after venepuncture. In the second step of the study, based on direct observation, hands were washed both before and after venepuncture on only 41 (45.1%) occasions. Failure to remove gloves after patient contact was observed on 23.1% occasions. Our survey reveals poor infection control practice in hand hygiene, glove utilization, and usage of tourniquets and the implementation of infection control measures produced a moderate improvement in compliance with them.

INTEGRATED WEED CONTROL IN MAIZE.

PubMed

Latré, J; Dewitte, K; Derycke, V; De Roo, B; Haesaert, G

2015-01-01

Integrated pest management has been implemented as a general practice by EU legislation. As weed control actually is the most important crop protection measure in maize for Western Europe, the new legislation will have its impact. The question is of course which systems can be successfully implemented in practice with respect to labour efficiency and economical parameters. During 3 successive growing seasons (2007, 2008, 2009) weed control in maize was evaluated, the main focus was put on different techniques of integrated weed control and was compared with chemical weed control. Additionally, during 4 successive growing seasons (2011, 2012, 2013 and 2014) two objects based on integrated weed control and two objects based on mechanical weed control were compared to about twenty different objects of conventional chemical weed control. One of the objects based on mechanical weed control consisted of treatment with the flex-tine harrow before and after emergence in combination with chemical weed control at a reduced rate in 3-4 leave stage. The second one consisted of broadcast mechanical treatments before and after emergence followed by a final in-row application of herbicides and an inter-row cultivation at 6-7(8) leave stage. All trials were conducted on the Experimental farm of Bottelare HoGent-UGent on a sandy loam soil. Maize was growing in 1/3 crop rotation. The effect on weed growth as well as the economic impact of the different applications was evaluated. Combining chemical and mechanical weed control is a possible option in conventional farming but the disadvantages must be taken into account. A better planned weed control based on the real present weed-population in combination with a carefully thought-out choice of herbicides should also be considered as an IPM--approach.

Nystagmus responses of the cat to rotation and to directionally equivalent and non-equivalent stimuli after unitaleral caloric habituation.

DOT National Transportation Integrated Search

1963-08-01

Six cats were exposed to mild angular acceleration before and after an intervening serried of 15 caloric irrigations. All trials were in total darkness. Slowphase displacement of the eyes, beat frequency, and duration of nystagmus were scored. All...

Implementation of an educational intervention to improve hand washing in primary schools: process evaluation within a randomised controlled trial.

PubMed

Chittleborough, Catherine R; Nicholson, Alexandra L; Young, Elaine; Bell, Sarah; Campbell, Rona

2013-08-15

Process evaluations are useful for understanding how interventions are implemented in trial settings. This is important for interpreting main trial results and indicating how the intervention might function beyond the trial. The purpose of this study was to examine the reach, dose, fidelity, acceptability, and sustainability of the implementation of an educational hand washing intervention in primary schools, and to explore views regarding acceptability and sustainability of the intervention. Process evaluation within a cluster randomised controlled trial, including focus groups with pupils aged 6 to 11, semi-structured interviews with teachers and external staff who coordinated the intervention delivery, and school reports and direct observations of the intervention delivery. The educational package was delivered in 61.4% of schools (85.2% of intervention schools, 37.8% of control schools following completion of the trial). Teachers and pupils reacted positively to the intervention, although concerns were raised about the age-appropriateness of the resources. Teachers adapted the resources to suit their school setting and pupils. Staff coordinating the intervention delivery had limited capacity to follow up and respond to schools. The hand washing intervention was acceptable to schools, but its reach outside of a randomised trial, evidenced in the low proportion of schools in the control arm who received it after the trial had ended, suggests that the model of delivery may not be sustainable. ISRCTN: ISRCTN93576146.

The effects of carbohydrate ingestion on the badminton serve after fatiguing exercise.

PubMed

Bottoms, Lindsay; Sinclair, Jonathan; Taylor, Katrina; Polman, Remco; Fewtrell, David

2012-01-01

The badminton serve requires great skill and may be affected by fatigue. The aim of the present study was to determine whether carbohydrate ingestion affects badminton performance. Nine male badminton players (age 25 ± 7 years, mass 80.6 ± 8.0 kg) attended the laboratory on three occasions. The first visit involved an incremental exercise test to exhaustion to determine peak heart rate. Participants were given 1 L of a carbohydrate-electrolyte drink or a matched placebo during the experimental trials. The accuracy of 10 long and 10 short serves was determined before and after exercise. The fatiguing exercise was 33 min in duration (83 ± 10% and 84 ± 8% peak heart rate for the placebo and carbohydrate trial respectively). Capillary blood samples (20 μL) were taken before and after exercise for determination of blood glucose and lactate. There was deterioration in long serve accuracy with fatigue (P = 0.002), which carbohydrate ingestion had a tendency to prevent (P = 0.077). There was no effect of fatigue (P = 0.402) or carbohydrate ingestion (P = 0.109) on short serve accuracy. There was no difference in blood glucose concentration between trials (P = 0.851). Blood lactate concentration was higher during the placebo trial (P = 0.016). These results suggest that only the long serve is influenced by fatigue and carbohydrate had a tendency to prevent the deterioration in performance.

Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States.

PubMed

Pinheiro, Simone P; Kang, Elizabeth M; Kim, Clara Y; Governale, Laura A; Zhou, Esther H; Hammad, Tarek A

2013-12-01

The major concern associated with isotretinoin treatment is its high teratogenic potential. Therefore, ensuring use of contraception while on therapy is an important strategy for at-risk patients and has been emphasized in all risk management programs. iPledge, the latest and most rigorous isotretinoin program, requires, among other stipulations, monthly assessments of contraceptive use for patients undergoing isotretinoin treatment. The purpose of this study is to evaluate isotretinoin usage patterns and assess concomitant use of isotretinoin and contraceptives before and after iPledge. Female patients aged 13-45 years with a new prescription for isotretinoin products during 2004-2008 were identified in the IMS Health longitudinal prescription claims database. Monthly concomitant use of isotretinoin and contraceptives was estimated. Segmented regression analysis of interrupted time series data was used to assess changes in monthly proportion of concomitant use in the 24 months preceding versus following iPledge implementation. The number of isotretinoin prescriptions decreased after iPledge implementation. A small but significant increase in monthly proportion of patients concomitantly using isotretinoin and contraceptive therapies was observed immediately after iPledge implementation (1.3%, p-value = 0.02), particularly among younger patients (2.5%, p-value < 0.01). No changes in the proportion of concomitancy over time (i.e. slope) between the periods before and after iPledge implementation were observed. The findings of this pharmacy prescription claims-based study suggest a small increase in concomitant use of isotretinoin and contraceptives coincident with the time of implementation of iPledge, particularly among younger women. Published 2013. This article is a U. S. Government work and is in the public domain in the USA. Published 2013. This article is a U. S. Government work and is in the public domain in the USA.

Absorbed radiation doses to staff after implementation of a radiopharmacy clean room.

PubMed

Ponto, James A

2014-12-01

In response to U.S. Pharmacopeia general chapter <797> standards, a clean room was constructed for our in-house radiopharmacy. Previously, most patient doses were prepared as needed just before injection. Currently, to minimize repeated entries into the clean room, most patient doses are prepared in batches; that is, early morning and noontime preparation of doses to be injected at various times throughout the morning and the afternoon, respectively. Because these patient doses may be prepared well before injection time, radioactive decay necessitates higher amounts of radioactivity to be handled for patient dose preparation. Hence, absorbed radiation doses to staff, all of whom rotate into the radiopharmacy clean room in addition to their regular patient-related activities, were retrospectively evaluated. Monthly dosimetry reports for body (chest badge) and extremities (finger ring) were retrospectively reviewed for each staff member for 12 mo before and 12 mo after implementation of the radiopharmacy clean room. Monthly data were evaluated for average and SD, and 12-mo groups were evaluated using a paired t test. Data for the second 12-mo period were also normalized to the same number of patient doses to account for an increase in procedure volume and were reevaluated. Before the radiopharmacy clean room had been implemented, average monthly absorbed radiation doses to body and extremities were 23 ± 15 mrem (0.23 ± 0.15 mSv) and 93 ± 59 mrem (0.93 ± 0.59 mSv), respectively. After the clean room had been implemented, average monthly absorbed radiation doses increased to 32 ± 16 mrem (0.32 ± 0.16 mSv) (P < 0.001) and 121 ± 89 mrem (1.21 ± 0.89 mSv) (P = 0.0015), respectively. When normalized for procedure volume, average monthly absorbed radiation doses after implementation of the clean room were still higher, at 29 ± 15 mrem (0.29 ± 0.15 mSv) (P = 0.001) and 110 ± 80 mrem (1.10 ± 0.80 mSv) (P = 0.039), respectively. After implementation of a radiopharmacy clean room, absorbed radiation doses to body and extremities increased by 26% and 18%, respectively, even after normalizing for procedure volume. Because absorbed radiation doses from other activities, such as patient dose administration and patient imaging, are assumed to remain relatively constant, these increases in absorbed radiation doses to staff are attributed to changes in work flow after implementation of the radiopharmacy clean room. © 2014 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Impact of a rapid respiratory panel test on patient outcomes.

PubMed

Rogers, Beverly B; Shankar, Prabhu; Jerris, Robert C; Kotzbauer, David; Anderson, Evan J; Watson, J Renee; O'Brien, Lauren A; Uwindatwa, Francine; McNamara, Kelly; Bost, James E

2015-05-01

Evolution of polymerase chain reaction testing for infectious pathogens has occurred concurrent with a focus on value-based medicine. To determine if implementation of the FilmArray rapid respiratory panel (BioFire Diagnostics, Salt Lake City, Utah) (hereafter RRP), with a shorter time to the test result and expanded panel, results in different outcomes for children admitted to the hospital with an acute respiratory tract illness. Patient outcomes were compared before implementation of the RRP (November 1, 2011, to January 31, 2012) versus after implementation of the RRP (November 1, 2012, to January 31, 2013). The study included inpatients 3 months or older with an acute respiratory tract illness, most admitted through the emergency department. Testing before RRP implementation used batched polymerase chain reaction analysis for respiratory syncytial virus and influenza A and B, with additional testing for parainfluenza 1 through 3 in approximately 11% of patients and for human metapneumovirus in less than 1% of patients. The RRP tested for respiratory syncytial virus, influenza A and B, parainfluenza 1 through 4, human metapneumovirus, adenovirus, rhinovirus/enterovirus, and coronavirus NL62. The pre-RRP group had 365 patients, and the post-RRP group had 771 patients. After RRP implementation, the mean time to the test result was shorter (383 minutes versus 1119 minutes, P < .001), and the percentage of patients with a result in the emergency department was greater (51.6% versus 13.4%, P < .001). There was no difference in whether antibiotics were prescribed, but the duration of antibiotic use was shorter after RRP implementation (P = .003) and was dependent on receiving test results within 4 hours. If the test result was positive, the inpatient length of stay (P = .03) and the time in isolation (P = .03) were decreased after RRP implementation compared with before RRP implementation. The RRP decreases the duration of antibiotic use, the length of inpatient stay, and the time in isolation.

Immediate Effects of Smoking on Cardiorespiratory Responses During Dynamic Exercise: Arm Vs. Leg Ergometry.

PubMed

Chen, Chien-Liang; Tang, Jing-Shia; Li, Ping-Chia; Chou, Pi-Ling

2015-01-01

This study compared the immediate effects of smoking on cardiorespiratory responses to dynamic arm and leg exercises. This randomized crossover study recruited 14 college students. Each participant underwent two sets of arm-cranking (AC) and leg-cycling (LC) exercise tests. The testing sequences of the control trial (participants refrained from smoking for 8 h before testing) and the experimental trial (participants smoked two cigarettes immediately before testing) were randomly chosen. We observed immediate changes in pulmonary function and heart rate variability after smoking and before the exercise test. The participants then underwent graded exercise tests of their arms and legs until reaching exhaustion. We compared the peak work achieved and time to exhaustion during the exercise tests with various cardiorespiratory indices [i.e., heart rate, oxygen consumption (VO2), minute ventilation (VE)]. The differences between the smoking and control trials were calculated using paired t-tests. For the exercise test periods, VO2, heart rate, and VE values were calculated at every 10% increment of the maximal effort time. The main effects of the time and trial, as well as their trial-by-time (4 × 10) interaction effects on the outcome measures, were investigated using repeated measure ANOVA with trend analysis. 5 min after smoking, the participants exhibited reduced forced vital capacities and forced expiratory volumes in the first second (P < 0.05), in addition to elevated resting heart rates (P < 0.001). The high-frequency, low-frequency, and the total power of the heart rate variability were also reduced (P < 0.05) at rest. For the exercise test periods, smoking reduced the time to exhaustion (P = 0.005) and the ventilatory threshold (P < 0.05) in the LC tests, whereas no significant effects were observed in the AC tests. A trend analysis revealed a significant trial-by-time interaction effect for heart rate, VO2, and VE during the graded exercise test (all P < 0.001). Lower VO2 and VE levels were exhibited in the exercise response of the smoking trial than in those of the control LC trials, whereas no discernable inter-trial difference was observed in the AC trials. Moreover, the differences in heart rate and VE response between the LC and AC exercises were significantly smaller after the participants smoked. This study verified that smoking significantly decreased performance and cardiorespiratory responses to leg exercises. However, the negative effects of smoking on arm exercise performance were not as pronounced.

Cutaneous fungal microbiome: Malassezia yeasts in seborrheic dermatitis scalp in a randomized, comparative and therapeutic trial.

PubMed

Kamamoto, C S L; Nishikaku, A S; Gompertz, O F; Melo, A S; Hassun, K M; Bagatin, E

2017-01-01

Malassezia spp in skin microbiome scalp has been implicated in seborrheic dermatitis pathogenesis. Thus, treatment based in antifungal combined to topical keratolitic agents have been indicated as well as oral isotretinoin as it reduces the sebum production, glandular's size and possesses anti-inflammatory properties. This randomized, comparative and therapeutic trial aimed toper form the genotypic identification of Malassezia species before and after low-dose oral isotretinoin or topical antifungal treatments for moderate to severe seborrhea and/or seborrheic dermatitis on scalp. Scales and sebum of the scalp were seeded in the middle of modified Dixon and incubated at 32°C. For genotypic identification polymerase chain reaction primers for the ITS and D1/D2 ribossomal DNA were used and followed by samples sequencing. The procedure was conducted before and after therapeutic and randomized intervention for moderate to severe seborrhea/seborrheic dermatitis on the scalp, including oral isotretinoin, 10 mg, every other day and anti-seborrheic shampoo (piroctone olamine), over six months. The M. globosa and M. restricta were the most frequent species isolated on the scalp before and after both treatments. Other non- Malassezia species were also identified. The Malassezia spp. were maintained in the scalp after both treatments that were equally effective for the control of seborrhea/seborrheic dermatitis clinical signs.

Pre-Visit Prioritization for Complex Patients with Diabetes: Randomized Trial Design and Implementation within an Integrated Health Care System

PubMed Central

Grant, Richard W; Uratsu, Connie S; Hansen, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-01-01

Background/Aims Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. Methods We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. Results This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015 – 6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) Navigating research vs. quality improvement requirements; (2) Addressing informed consent considerations; and (3) Introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for “self-learning health system” research. Conclusions By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. PMID:26820612

Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.

PubMed

Grant, Richard W; Uratsu, Connie S; Estacio, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-03-01

Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research. By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. Copyright © 2016 Elsevier Inc. All rights reserved.

[The effect of Deanol on amnesic disorders. A preliminary trial (author's transl)].

PubMed

Caffarra, P; Cattelani, R; Mazzucchi, A; Moretti, G; Parma, M

1980-01-01

Twenty-one patients showing memory deficits were submitted to neuropsychological battery, before and after treatment with Deanol. No significant effect has been found. Arguments suggesting further investigation are discussed.

A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial.

PubMed

Chaillet, N; Bujold, E; Masse, B; Grobman, W A; Rozenberg, P; Pasquier, J C; Shorten, A; Johri, M; Beaudoin, F; Abenhaim, H; Demers, S; Fraser, W; Dugas, M; Blouin, S; Dubé, E; Gauthier, R

2017-09-20

Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans. Women who have undergone a first cesarean are facing a difficult choice for their next pregnancy, i.e.: (1) to plan for a second cesarean delivery, associated with higher risk of maternal complications than vaginal delivery; or (b) to have a trial of labor (TOL) with the aim to achieve a vaginal birth after cesarean (VBAC) and to accept a significant, but rare, risk of uterine rupture and its related maternal and neonatal complications. The objective of this trial is to assess whether a multifaceted intervention would reduce the rate of major perinatal morbidity among women with one prior cesarean. The study is a stratified, non-blinded, cluster-randomized, parallel-group trial of a multifaceted intervention. Hospitals in Quebec are the units of randomization and women are the units of analysis. As depicted in Figure 1, the study includes a 1-year pre-intervention period (baseline), a 5-month implementation period, and a 2-year intervention period. At the end of the baseline period, 20 hospitals will be allocated to the intervention group and 20 to the control group, using a randomization stratified by level of care. Medical records will be used to collect data before and during the intervention period. Primary outcome is the rate of a composite of major perinatal morbidities measured during the intervention period. Secondary outcomes include major and minor maternal morbidity; minor perinatal morbidity; and TOL and VBAC rate. The effect of the intervention will be assessed using the multivariable generalized-estimating-equations extension of logistic regression. The evaluation will include subgroup analyses for preterm and term birth, and a cost-effectiveness analysis. The intervention is designed to facilitate: (1) women's decision-making process, using a decision analysis tool (DAT), (2) an estimate of uterine rupture risk during TOL using ultrasound evaluation of low-uterine segment thickness, (3) an estimate of chance of TOL success, using a validated prediction tool, and (4) the implementation of best practices for intrapartum management. Current Controlled Trials, ID: ISRCTN15346559 . Registered on 20 August 2015.

The impact of using an intravenous workflow management system (IVWMS) on cost and patient safety.

PubMed

Lin, Alex C; Deng, Yihong; Thaibah, Hilal; Hingl, John; Penm, Jonathan; Ivey, Marianne F; Thomas, Mark

2018-07-01

The aim of this study was to determine the financial costs associated with wasted and missing doses before and after the implementation of an intravenous workflow management system (IVWMS) and to quantify the number and the rate of detected intravenous (IV) preparation errors. A retrospective analysis of the sample hospital information system database was conducted using three months of data before and after the implementation of an IVWMS System (DoseEdge ® ) which uses barcode scanning and photographic technologies to track and verify each step of the preparation process. The financial impact associated with wasted and missing >IV doses was determined by combining drug acquisition, labor, accessory, and disposal costs. The intercepted error reports and pharmacist detected error reports were drawn from the IVWMS to quantify the number of errors by defined error categories. The total number of IV doses prepared before and after the implementation of the IVWMS system were 110,963 and 101,765 doses, respectively. The adoption of the IVWMS significantly reduced the amount of wasted and missing IV doses by 14,176 and 2268 doses, respectively (p < 0.001). The overall cost savings of using the system was $144,019 over 3 months. The total number of errors detected was 1160 (1.14%) after using the IVWMS. The implementation of the IVWMS facilitated workflow changes that led to a positive impact on cost and patient safety. The implementation of the IVWMS increased patient safety by enforcing standard operating procedures and bar code verifications. Published by Elsevier B.V.

[Western area surge for controlling Ebola hemorrhagic fever outbreak in Sierra Leone and evaluation of its effect].

PubMed

Chen, Yong; Wu, Dan; Zhang, Wenyi; Chen, Zeliang; Chang, Guohui; Tian, Shuguang; Yang, Ruifu; Liu, Chao

2015-10-01

To investigate the Western Area Surge (WAS) program in the Ebola outbreak of Sierra Leone, and to analyze its implementing effect. The subject of this study was 3,813 laboratory confirmed Ebola hemorrhagic fever (EHF) cases reported in Sierra Leone from November 19, 2014 through January 27, 2015, a period before and after the implementation of the WAS program. To analyze and make conclusions according to the working experience of China Mobile Laboratory Reponses Team in the fight of Ebola outbreak, using WHO published EHF case definition to make diagnosis and compare the number of bed numbers, confirmed EHF cases, samples tested, and positive rates before and after implementation of WAS program. From the implementation of WAS program on 17th December 2014 to half a month later, the total numbers of Ebola holding and treatment centers increased from 640 to 960, six additional laboratories were established. On January, 2015, another two laboratories from America and The Netherlands were established. The numbers of samples tested one month before and after WAS program were 7,891 and 9,783, respectively, with an increase of 24.0 percent, while the positive rate of Ebola virus decreased from 22.2% (1,752/7,891) to 11.0% (1,077/9,783). The positive rate of blood samples decreased from 39.6% (248/626) in the month before WAS program to 27.4% (131/478) (χ2=17.93, P<0.001) in the mother after WAS program, the positive rate of blood samples 22.7% (103/454) to 10% (62/609) (χ2=31.03, P<0.001), accordingly. After 3 weeks of WAS program, in addition to Western Area, another four hotspots in Sierra Leone had also reported a significant decrease of the numbers of confirmed EVD cases. Forty-two days after implementation of WAS program, the daily number of laboratory confirmed EHF cases decreased from 63 to 10. WAS program played a vital role in controlling the EHF outbreak rapidly in Sierra Leone. It could also provide guidance for the control similar large infectious diseases outbreak in the future.

Implementing a bar-code assisted medication administration system: effects on the dispensing process and user perceptions.

PubMed

Samaranayake, N R; Cheung, S T D; Cheng, K; Lai, K; Chui, W C M; Cheung, B M Y

2014-06-01

We assessed the effects of a bar-code assisted medication administration system used without the support of computerised prescribing (stand-alone BCMA), on the dispensing process and its users. The stand-alone BCMA system was implemented in one ward of a teaching hospital. The number of dispensing steps, dispensing time and potential dispensing errors (PDEs) were directly observed one month before and eight months after the intervention. Attitudes of pharmacy and nursing staff were assessed using a questionnaire (Likert scale) and interviews. Among 1291 and 471 drug items observed before and after the introduction of the technology respectively, the number of dispensing steps increased from five to eight and time (standard deviation) to dispense one drug item by one staff personnel increased from 0.8 (0.09) to 1.5 (0.12) min. Among 2828 and 471 drug items observed before and after the intervention respectively, the number of PDEs increased significantly (P<0.001). 'Procedural errors' and 'missing drug items' were the frequently observed PDEs in the after study. 'Perceived usefulness' and 'job relevance' of the technology decreased significantly (P=0.003 and P=0.004 respectively) among users who participated in the before (N=16) and after (N=16) questionnaires surveys. Among the interviewees, pharmacy staff felt that the system offered less benefit to the dispensing process (9/16). Nursing staff perceived the system as useful in improving the accuracy of drug administration (7/10). Implementing a stand-alone BCMA system may slow down and complicate the dispensing process. Nursing staff believe the stand-alone BCMA system could improve the drug administration process but pharmacy staff believes the technology would be more helpful if supported by computerised prescribing. However, periodical assessments are needed to identify weaknesses in the process after implementation, and all users should be educated on the benefits of using this technology. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Lasting impact of an implemented self-management programme for people with type 2 diabetes referred from primary care: a one-group, before-after design.

PubMed

Fløde, Mari; Iversen, Marjolein M; Aarflot, Morten; Haltbakk, Johannes

2017-12-01

Research interventions in uniform clinical settings and in patients fulfilling well-defined inclusion criteria might show a more pronounced effect than implementing the same intervention in existing practice. Diabetes Self-Management Education (DSME) is complex, and should be assessed in existing practice as it is an intervention widely implemented. To examine the impact of an established group-based DSME in unselected people with type 2 diabetes referred from primary care. A one-group, before-after design was used for assessments before, immediately after, and 3 months after participation in a group-based DSME programme conducted at two Learning and Mastering Centres in Norway between November 2013 and June 2014. Participants completed a questionnaire before (n = 115), immediately after (n = 95) and 3 months after (n = 42) the DSME programme. Primary outcome measure was diabetes knowledge (Michigan Diabetes Knowledge Test). Also patient activation (Patient Activation Measure [PAM]) and self-efficacy (General Self-Efficacy scale [GSE]) were measured. Changes in outcome measures were analysed using paired t-tests for normally distributed data and Wilcoxon signed-rank test for skewed data. Mean knowledge improved significantly from baseline (p < 0.001). Changes persisted at the 3-month assessment. Mean PAM scores improved significantly from baseline (p < 0.001), and changes persisted for 3 months. Mean GSE scores improved from baseline (p = 0.022) and persisted for 3 months. However, when results were stratified for participants who responded at all three time points, GSE showed no change during the study period. The complexity self-management in the individual is challenging to reflect in DSME. This implemented DSME programme for people with type 2 diabetes improved levels of diabetes knowledge and patient activation, persisting for at least 3 months. Hence, the DSME programme appears to be robust beyond standardised research settings, in educating unselected diabetes patients referred from primary care. © 2017 Nordic College of Caring Science.

An Empirical Bayes before-after evaluation of road safety effects of a new motorway in Norway.

PubMed

Elvik, Rune; Ulstein, Heidi; Wifstad, Kristina; Syrstad, Ragnhild S; Seeberg, Aase R; Gulbrandsen, Magnus U; Welde, Morten

2017-11-01

This paper presents an Empirical Bayes before-after evaluation of the road safety effects of a new motorway (freeway) in Østfold county, Norway. The before-period was 1996-2002. The after-period was 2009-2015. The road was rebuilt from an undivided two-lane road into a divided four-lane road. The number of killed or seriously injured road users was reduced by 75 percent, controlling for (downward) long-term trends and regression-to-the-mean (statistically significant at the 5 percent level; recorded numbers 71 before, 11 after). There were small changes in the number of injury accidents (185 before, 123 after; net effect -3%) and the number of slightly injured road users (403 before 279 after; net effect +5%). Motorways appear to mainly reduce injury severity, not the number of accidents. The paper discusses challenges in implementing the Empirical Bayes design when less than ideal data are available. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Systematic Review of Antimicrobial Stewardship Interventions in the Emergency Department.

PubMed

Losier, Mia; Ramsey, Tasha D; Wilby, Kyle John; Black, Emily K

2017-09-01

To improve antimicrobial utilization, development and implementation of antimicrobial stewardship programs in the emergency department (ED) has been recommended. The primary objective of this review was to characterize antimicrobial stewardship (AMS) in the ED and to identify interventions that improve patient outcomes or process of care and/or reduce consequences of antimicrobial use. This study was completed as a systematic review. The following databases were searched from inception through November, 2016: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Scopus, and Web of Science. Randomized controlled trials, nonrandomized controlled trials, controlled and uncontrolled before-and-after studies, interrupted time series studies, and repeated-measures studies evaluating AMS interventions in the ED were included in the review. Studies published in languages other than English were excluded. A total of 43 studies meeting inclusion criteria were identified from our search. Patient or provider education and guideline or clinical pathway implementation were the most commonly reported interventions. Few studies reported on audit and feedback, and no study evaluated preauthorization. Impact of interventions showed variable results. Where identified, benefits of AMS interventions primarily included improvement in delivery of care or a decrease in antimicrobial utilization; however, most studies were rated as having unclear or high risk of bias. AMS interventions in the ED may improve patient care. However, the optimal combination of interventions is unclear. Additional studies with more rigorous design evaluating core components of AMS programs, including prospective audit and feedback are needed.

Implementation of a Bayesian design in a dose-escalation study of an experimental agent in healthy volunteers.

PubMed

Zhou, Yinghui; Whitehead, John; Korhonen, Pasi; Mustonen, Mika

2008-03-01

Bayesian decision procedures have recently been developed for dose escalation in phase I clinical trials concerning pharmacokinetic responses observed in healthy volunteers. This article describes how that general methodology was extended and evaluated for implementation in a specific phase I trial of a novel compound. At the time of writing, the study is ongoing, and it will be some time before the sponsor will wish to put the results into the public domain. This article is an account of how the study was designed in a way that should prove to be safe, accurate, and efficient whatever the true nature of the compound. The study involves the observation of two pharmacokinetic endpoints relating to the plasma concentration of the compound itself and of a metabolite as well as a safety endpoint relating to the occurrence of adverse events. Construction of the design and its evaluation via simulation are presented.

An Evaluation of the Implementation of Hand Held Health Records with Adults with Learning Disabilities: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Turk, Vicky; Burchell, Sarah; Burrha, Sukhjinder; Corney, Roslyn; Elliott, Sandra; Kerry, Sally; Molloy, Catherine; Painter, Kerry

2010-01-01

Background: Personal health records were implemented with adults with learning disabilities (AWLD) to try to improve their health-care. Materials and Method: Forty GP practices were randomized to the Personal Health Profile (PHP) implementation or control group. Two hundred and one AWLD were interviewed at baseline and 163 followed up after 12…

Bias reduction in repeated-measures observational studies by the use of propensity score: the case of enteral sedation for critically ill patients.

PubMed

Umbrello, Michele; Mistraletti, Giovanni; Corbella, Davide; Cigada, Marco; Salini, Silvia; Morabito, Alberto; Iapichino, Gaetano

2012-12-01

Within the evidence-based medicine paradigm, randomized controlled trials represent the "gold standard" to produce reliable evidence. Indeed, planning and implementing randomized controlled trials in critical care medicine presents limitations because of intrinsic and structural problems. As a consequence, observational studies still occur frequently. In these cases, propensity score (PS) (probability of receiving a treatment conditional on observed covariates) is an increasingly used technique to adjust the results. Few studies addressed the specific issue of a PS correction of repeated-measures designs. Three techniques for correcting the analysis of nonrandomized designs (matching, stratification, regression adjustment) are presented in a tutorial form and applied to a real case study: the comparison between intravenous and enteral sedative therapy in the intensive care unit setting. After showing the results before and after the use of PS, we suggest that such a tool allows to partially overcoming the bias associated with the observational nature of the study. It permits to correct the estimates for any observed covariate, while unobserved confounders cannot be controlled for. Propensity score represents a useful additional tool to estimate the effects of treatments in nonrandomized studies. In the case study, an enteral sedation approach was equally effective to an intravenous regime, allowing for a lower level of sedation and spare of resources. Copyright © 2012 Elsevier Inc. All rights reserved.

A randomised controlled trial of an intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol.

PubMed

Wolfenden, Luke; Nathan, Nicole; Williams, Christopher M; Delaney, Tessa; Reilly, Kathryn L; Freund, Megan; Gillham, Karen; Sutherland, Rachel; Bell, Andrew C; Campbell, Libby; Yoong, Serene; Wyse, Rebecca; Janssen, Lisa M; Preece, Sarah; Asmar, Melanie; Wiggers, John

2014-10-11

The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain. Internationally, research suggests that schools often fail to implement practices consistent with healthy school canteen policies. Without a population wide implementation, the potential benefits of these policies will not be realised. The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales (NSW), Australia, government known as the 'Fresh Tastes @ School NSW Healthy School Canteen Strategy'. The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales, Australia. Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy. Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel. Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff, staff training, resources, recognition and incentives, consensus and leadership strategies, follow-up support and implementation feedback. The 35 schools allocated to the control group will not receive any intervention support as part of the research trial. The primary outcome measures will be i) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ('red' and 'banned' items) and ii) the proportion of schools where healthy canteen items ('green' items) represent the majority (>50%) of products listed on the menu. Outcome data will be collected via a comprehensive menu audit, conducted by dietitians blind to group allocation. Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values. The proposed trial will represent a novel contribution to the literature, being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy. Australian New Zealand Clinical Trials Registry ACTRN12613000311752.

Race/Ethnicity and Adoption of a Population Health Management Approach to Colorectal Cancer Screening in a Community-Based Healthcare System.

PubMed

Mehta, Shivan J; Jensen, Christopher D; Quinn, Virginia P; Schottinger, Joanne E; Zauber, Ann G; Meester, Reinier; Laiyemo, Adeyinka O; Fedewa, Stacey; Goodman, Michael; Fletcher, Robert H; Levin, Theodore R; Corley, Douglas A; Doubeni, Chyke A

2016-11-01

Screening outreach programs using population health management principles offer services uniformly to all eligible persons, but racial/ethnic colorectal cancer (CRC) screening patterns in such programs are not well known. To examine the association between race/ethnicity and the receipt of CRC screening and timely follow-up of positive results before and after implementation of a screening program. Retrospective cohort study of screen-eligible individuals at the Kaiser Permanente Northern California community-based integrated healthcare delivery system (2004-2013). A total of 868,934 screen-eligible individuals 51-74 years of age at cohort entry, which included 662,872 persons in the period before program implementation (2004-2006), 654,633 during the first 3 years after implementation (2007-2009), and 665,268 in the period from 4 to 7 years (2010-2013) after program implementation. A comprehensive system-wide long-term effort to increase CRC that included leadership alignment, goal-setting, and quality assurance through a PHM approach, using mailed fecal immunochemical testing (FIT) along with offering screening at office visits. Differences over time and by race/ethnicity in up-to-date CRC screening (overall and by test type) and timely follow-up of a positive screen. Race/ethnicity categories included non-Hispanic white, non-Hispanic black, Hispanic/Latino, Asian/Pacific Islander, Native American, and multiple races. From 2004 to 2013, age/sex-adjusted CRC screening rates increased in all groups, including 35.2 to 81.1 % among whites and 35.6 to 78.0 % among blacks. Screening rates among Hispanics (33.1 to 78.3 %) and Native Americans (29.4 to 74.5 %) remained lower than those for whites both before and after program implementation. Blacks, who had slightly higher rates before program implementation (adjusted rate ratio [RR] = 1.04, 99 % CI: 1.02-1.05), had lower rates after program implementation (RR for period from 4 to 7 years = 0.97, 99 % CI: 0.96-0.97). There were also substantial improvements in timely follow-up of positive screening results. In this screening program using core PHM principles, CRC screening increased markedly in all racial/ethnic groups, but disparities persisted for some groups and developed in others, which correlated with levels of adoption of mailed FIT.

The Effect of Swimming Experience on Acquisition and Retention of Swimming-Based Taste Aversion Learning in Rats

ERIC Educational Resources Information Center

Masaki, Takahisa; Nakajima, Sadahiko

2010-01-01

Swimming endows rats with an aversion to a taste solution consumed before swimming. The present study explored whether the experience of swimming before or after the taste-swimming trials interferes with swimming-based taste aversion learning. Experiment 1 demonstrated that a single preexposure to 20 min of swimming was as effective as four or…

Two-year intervention trial to control of fish-borne zoonotic trematodes in giant gourami (Osphronemus goramy) and striped catfish (Pangasianodon hypophthalmus) in nursery ponds in the Mekong Delta, Vietnam.

PubMed

Madsen, H; Thien, P C; Nga, H T N; Clausen, J H; Dalsgaard, A; Murrell, K D

2015-12-01

Fish-borne zoonotic trematode parasites (FZT) pose a food safety and public health problem in Vietnam. The transmission cycle is complex as domestic animals, especially dogs, cats, fish-eating birds and pigs together with humans serve as reservoir hosts and contribute to FZT egg contamination of aquaculture ponds and the environment. This intervention trial was conducted to determine the effectiveness of various on-farm interventions, including reduction in FZT egg contamination through treatment of infected people and domestic animals, reduction in snail density through mud removal from aquaculture ponds prior to fish stocking, and various other measures in reducing FZT infection in juvenile striped catfish (Pangasianodon hypophthalmus) and giant gourami (Osphronemus goramy). Interventions were implemented on 5 farms for each fish species during production cycles in 2009 and 2010 while 5 similar farms for each species served as control. For both fish species, both prevalence and intensity of infection did not differ significantly between intervention and non-intervention farms prior to the interventions. The interventions significantly reduced both prevalence and intensity of FZT infection in the juvenile fish compared to control ponds. For giant gourami, odds of infection in intervention ponds was 0.13 (95% CL: 0.09-0.20; p<0.001) of that in non-intervention ponds after the 2009 trial and 0.07 (0.03-0.14; p<0.001) after the 2010 trial. For striped catfish, these figures were 0.17 (0.08-0.35; p<0.001) after the 2009 trial while after the 2010 trial all ponds with interventions were free from infection. Metacercariae intensity (no. of metacercariae/fish) in giant gourami from intervention ponds was 0.16 (0.11-0.23; p<0.001) of that in fish from non-intervention ponds after the 2009 trial and 0.07 (0.04-0.15; p<0.001) after the 2010 trial; for striped catfish these figures were 0.18 (0.09-0.36; p<0.001) and 0.00 (confidence limits not estimated), respectively. The aquaculture farm pond intervention approaches taken in this trial have the potential to reduce or eliminate FZT infections in fish and may be implemented across the entire region if adjusted to local conditions and fish species. Copyright © 2015 Elsevier B.V. All rights reserved.

The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

PubMed

Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

2016-01-01

This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

A person-centred and thriving-promoting intervention in nursing homes - study protocol for the U-Age nursing home multi-centre, non-equivalent controlled group before-after trial.

PubMed

Edvardsson, David; Sjögren, Karin; Lood, Qarin; Bergland, Ådel; Kirkevold, Marit; Sandman, Per-Olof

2017-01-17

The literature suggests that person-centred care can contribute to quality of life and wellbeing of nursing home residents, relatives and staff. However, there is sparse research evidence on how person-centred care can be operationalised and implemented in practice, and the extent to which it may promote wellbeing and satisfaction. Therefore, the U-Age nursing home study was initiated to deepen the understanding of how to integrate person-centred care into daily practice and to explore the effects and meanings of this. The study aims to evaluate effects and meanings of a person-centred and thriving-promoting intervention in nursing homes through a multi-centre, non-equivalent controlled group before-after trial design. Three nursing homes across three international sites have been allocated to a person-centred and thriving-promoting intervention group, and three nursing homes have been allocated to an inert control group. Staff at intervention sites will participate in a 12-month interactive educational programme that operationalises thriving-promoting and person-centred care three dimensions: 1) Doing a little extra, 2) Developing a caring environment, and 3) Assessing and meeting highly prioritised psychosocial needs. A pedagogical framework will guide the intervention. The primary study endpoints are; residents' thriving, relatives' satisfaction with care and staff job satisfaction. Secondary endpoints are; resident, relative and staff experiences of the caring environment, relatives' experience of visiting their relative and the nursing home, as well as staff stress of conscience and perceived person-centredness of care. Data on study endpoints will be collected pre-intervention, post-intervention, and at a six-month follow up. Interviews will be conducted with relatives and staff to explore experiences and meanings of the intervention. The study is expected to provide evidence that can inform further research, policy and practice development on if and how person-centred care may improve wellbeing, thriving and satisfaction for people who reside in, visit or work in nursing homes. The combination of quantitative and qualitative data will illuminate the operationalisation, effects and meaning of person-centred and thriving-promoting care. The trial was registered at ClinicalTrials.gov March 19, 2016, identifier NCT02714452 .

Effect of Sleep Hygiene Education on Sleep Quality in Hemodialysis Patients

PubMed Central

Soleimani, Farzaneh; Hasanpour-Dehkordi, Ali

2016-01-01

Introduction Sleep is referred a regular, recurring and easily revocable state of organism which is characterized by relative immobility and significant increase in response threshold to environmental stimuli. Sleep disorders are common among haemodialysis patients. Aim The aim of this study was to investigate the effect of sleep hygiene education on sleep quality in haemodialysis patients. Materials and Methods This study is a randomized controlled clinical trial. The participants of this study were 60 haemodialysis patients admitted to the Dialysis Center of Shahid Ayatollah Madani Hospital of Khoy, affiliated with the Urmia University of Medical Sciences. Sampling was done randomly and the partcipants were randomly divided into intervention group (30 patients) and control group (30 patients). Sleep quality of participants was measured before and after the intervention by Pittsburgh Sleep Quality Index (PSQI). Training process for sleep hygiene behaviours was presented to the participants face-to-face. The data were analysed using SPSS 16. Results A significant difference in the mean (standard deviation) score for PSQI (p<0.001) was observed before and after intervention in the intervention group, while in the control group, the difference was not significant (p=0.704), In addition, a significant difference was observed in the mean (standard deviation) score for PSQI between the two, intervention and control groups after the educational intervention (p=0.034). Conclusion Sleep hygiene education, alongside other appro-aches, is a low-cost, accessible and practical method which can be implemented within a short period of time. PMID:28208884

Implementation of an educational intervention to improve hand washing in primary schools: process evaluation within a randomised controlled trial

PubMed Central

2013-01-01

Background Process evaluations are useful for understanding how interventions are implemented in trial settings. This is important for interpreting main trial results and indicating how the intervention might function beyond the trial. The purpose of this study was to examine the reach, dose, fidelity, acceptability, and sustainability of the implementation of an educational hand washing intervention in primary schools, and to explore views regarding acceptability and sustainability of the intervention. Methods Process evaluation within a cluster randomised controlled trial, including focus groups with pupils aged 6 to 11, semi-structured interviews with teachers and external staff who coordinated the intervention delivery, and school reports and direct observations of the intervention delivery. Results The educational package was delivered in 61.4% of schools (85.2% of intervention schools, 37.8% of control schools following completion of the trial). Teachers and pupils reacted positively to the intervention, although concerns were raised about the age-appropriateness of the resources. Teachers adapted the resources to suit their school setting and pupils. Staff coordinating the intervention delivery had limited capacity to follow up and respond to schools. Conclusions The hand washing intervention was acceptable to schools, but its reach outside of a randomised trial, evidenced in the low proportion of schools in the control arm who received it after the trial had ended, suggests that the model of delivery may not be sustainable. Trial registration ISRCTN: ISRCTN93576146 PMID:23947388

A Randomized Controlled Trial of the Morningside Math Facts Curriculum on Fluency, Stability, Endurance and Application Outcomes

ERIC Educational Resources Information Center

McTiernan, Aoife; Holloway, Jennifer; Healy, Olive; Hogan, Michael

2016-01-01

A randomized controlled trial was used to evaluate the impact of a frequency-building curriculum to increase the fluency of component mathematics skills in a sample of 28 males aged 9-11 years. Assessments of mathematical ability were conducted before and after the training period to evaluate the impact of learning component skills fluently on…

Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex.

PubMed

Keller, Marla J; Buckley, Niall; Katzen, Lauren L; Walsh, Jennifer; Friedland, Barbara; Littlefield, Sarah; Lin, Juan; Xue, Xiaonan; Cornelison, Terri; Herold, Betsy C; Einstein, Mark H

2013-12-01

Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. Healthy monogamous couples received Microlax-type applicators (Tectubes, Åstorp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches. Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97%) compared with DSA (90%), and the specificity was similar (≥96%). For presex applicators, the sensitivity and specificity were higher for DSA (100%) compared with UV testing (87% sensitivity, 96% specificity). Among returned postsex applicators, 95% tested positive by UV compared with 87% by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant. Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex.

Strength of smoke-free air laws and indoor air quality.

PubMed

Lee, Kiyoung; Hahn, Ellen J; Robertson, Heather E; Lee, Seongjik; Vogel, Suzann L; Travers, Mark J

2009-04-01

Smoke-free air laws have been implemented in many Kentucky communities to protect the public from the harmful effects of secondhand smoke exposure. The impact of different strengths of smoke-free air laws on indoor air quality was assessed. Indoor air quality in hospitality venues was assessed in seven communities before and after comprehensive smoke-free air laws and in two communities only after partial smoke-free air laws. One community was measured three times: before any smoke-free air law, after the initial partial law, and after the law was strengthened to cover all workplaces and public places with few exemptions. Real-time measurements of particulate matters with 2.5 mum aerodynamic diameter or smaller (PM(2.5)) were obtained. When comprehensive smoke-free air laws were implemented, indoor PM(2.5) concentrations decreased significantly from 161 to 20 microg/m3. In one community that implemented a comprehensive smoke-free law after initially passing a partial law, indoor PM(2.5) concentrations were 304 microg/m3 before the law, 338 microg/m3 after the partial law, and 9 microg/m3 after the comprehensive law. The study clearly demonstrated that partial smoke-free air laws do not improve indoor air quality. A significant linear trend indicated that PM(2.5) levels in the establishments decreased with fewer numbers of burning cigarettes. Only comprehensive smoke-free air laws are effective in reducing indoor air pollution from secondhand tobacco smoke.

Strength of smoke-free air laws and indoor air quality

PubMed Central

Hahn, Ellen J.; Robertson, Heather E.; Vogel, Suzann L.; Travers, Mark J.

2009-01-01

Introduction: Smoke-free air laws have been implemented in many Kentucky communities to protect the public from the harmful effects of secondhand smoke exposure. The impact of different strengths of smoke-free air laws on indoor air quality was assessed. Methods: Indoor air quality in hospitality venues was assessed in seven communities before and after comprehensive smoke-free air laws and in two communities only after partial smoke-free air laws. One community was measured three times: before any smoke-free air law, after the initial partial law, and after the law was strengthened to cover all workplaces and public places with few exemptions. Real-time measurements of particulate matters with 2.5 μm aerodynamic diameter or smaller (PM2.5) were obtained. Results: When comprehensive smoke-free air laws were implemented, indoor PM2.5 concentrations decreased significantly from 161 to 20 μg/m3. In one community that implemented a comprehensive smoke-free law after initially passing a partial law, indoor PM2.5 concentrations were 304 μg/m3 before the law, 338 μg/m3 after the partial law, and 9 μg/m3 after the comprehensive law. Discussion: The study clearly demonstrated that partial smoke-free air laws do not improve indoor air quality. A significant linear trend indicated that PM2.5 levels in the establishments decreased with fewer numbers of burning cigarettes. Only comprehensive smoke-free air laws are effective in reducing indoor air pollution from secondhand tobacco smoke. PMID:19346510

Quality of HIV Testing Data Before and After the Implementation of a National Data Quality Assessment and Feedback System.

PubMed

Beltrami, John; Wang, Guoshen; Usman, Hussain R; Lin, Lillian S

In 2010, the Centers for Disease Control and Prevention (CDC) implemented a national data quality assessment and feedback system for CDC-funded HIV testing program data. Our objective was to analyze data quality before and after feedback. Coinciding with required quarterly data submissions to CDC, each health department received data quality feedback reports and a call with CDC to discuss the reports. Data from 2008 to 2011 were analyzed. Fifty-nine state and local health departments that were funded for comprehensive HIV prevention services. Data collected by a service provider in conjunction with a client receiving HIV testing. National data quality assessment and feedback system. Before and after intervention implementation, quality was assessed through the number of new test records reported and the percentage of data values that were neither missing nor invalid. Generalized estimating equations were used to assess the effect of feedback in improving the completeness of variables. Data were included from 44 health departments. The average number of new records per submission period increased from 197 907 before feedback implementation to 497 753 afterward. Completeness was high before and after feedback for race/ethnicity (99.3% vs 99.3%), current test results (99.1% vs 99.7%), prior testing and results (97.4% vs 97.7%), and receipt of results (91.4% vs 91.2%). Completeness improved for HIV risk (83.6% vs 89.5%), linkage to HIV care (56.0% vs 64.0%), referral to HIV partner services (58.9% vs 62.8%), and referral to HIV prevention services (55.3% vs 63.9%). Calls as part of feedback were associated with improved completeness for HIV risk (adjusted odds ratio [AOR] = 2.28; 95% confidence interval [CI], 1.75-2.96), linkage to HIV care (AOR = 1.60; 95% CI, 1.31-1.96), referral to HIV partner services (AOR = 1.73; 95% CI, 1.43-2.09), and referral to HIV prevention services (AOR = 1.74; 95% CI, 1.43-2.10). Feedback contributed to increased data quality. CDC and health departments should continue monitoring the data and implement measures to improve variables of low completeness.

Effects of (-)-S-2,8-dimethyl-3-methylene-1-oxa-8-azaspiro[4,5]decane L-tartrate monohydrate (YM796), a novel muscarinic agonist, on disturbance of passive avoidance learning behavior in drug-treated and senescence-accelerated mice.

PubMed

Suzuki, M; Yamaguchi, T; Ozawa, Y; Ohyama, M; Yamamoto, M

1995-11-01

Effects of YM796 (-)-S-2,8-dimethyl-3-methylene-1-oxa-8-azaspiro[4,5]decane L-tartrate monohydrate; a novel muscarinic agonist, were observed on disturbance of passive avoidance learning behavior in drug- (protein synthesis inhibitor and anticholinergic drugs) treated and senescence-accelerated mice in comparison with those of a muscarinic agonist (AF102B) and acetylcholinesterase inhibitors (E2020 (1-benzyl-4-[(5,6-dimethoxy-1-indanone-2-yl) methyl] piperidene hydrochloride), NIK247 [9-amino-2,3,5,6,7,8-hexahydro-1H-cyclopenta(b)-quinoline monohydrate hydrochloride], THA (9-amino-1,2,3,4-tetrahydroacridine) and physostigmine). All tested drugs administered before training significantly prolonged the shortened latency of step-through induced by the protein synthesis inhibitor cycloheximide (150 mg/kg s.c.). This shortened latency was also significantly prolonged when YM796 was administered immediately after training, but not when administered before the test trial. The ameliorating effect of YM796 on the impairment in learning behavior by cycloheximide was significantly suppressed by pirenzepine (0.1 micrograms/mouse i.c.v.). When administered before training, all test drugs prolonged the shortened latency of step-through induced by treatment with the anticholinergic drugs [scopolamine (1 mg/kg s.c.) and hemicholinium-3 (0.3 microgram/mouse i.c.v.)], suggesting that they ameliorated the impairment of learning behavior. This shortened latency in scopolamine-treated mice was also significantly prolonged by YM796, AF102B, E2020, NIK247 and physostigmine when administered immediately after training, but not when administered before the test trial. The pharmacological actions of YM796 administered immediately after training and before the test trial in hemicholinium-3-treated mice were similar to those in scopolamine-treated mice.(ABSTRACT TRUNCATED AT 250 WORDS)

Lessons learnt from the Bristol Girls Dance Project cluster RCT: implications for designing and implementing after-school physical activity interventions

PubMed Central

Edwards, Mark J; May, Thomas; Kesten, Joanna M; Banfield, Kate; Bird, Emma L; Powell, Jane E; Sebire, Simon J; Jago, Russell

2016-01-01

Objective To consider implementation issues associated with the delivery of Bristol Girls Dance Project (BGDP) and to identify improvements that may aid the design of after-school physical activity (PA) interventions. Design Two-armed cluster randomised control trial. The BGDP was a 20-week school-based intervention, consisting of two 75 min after-school dance sessions per week, which aimed to support Year 7 girls to be more physically active. Setting 18 secondary schools (nine intervention, nine control) in the Greater Bristol area (as an indication of deprivation, children eligible for the pupil premium in participant schools ranged from 6.9 to 53.3%). Participants 571 Year 7 girls. This article reports on qualitative data collected from 59 girls in the intervention arm of the trial, 10 dance instructors and 9 school contacts involved in the delivering of the BGDP. Methods Data were obtained from nine focus groups with girls (one per intervention school), and interviews with dance instructors and school contacts. Focus groups sought views of girls’ motivation to participate, teaching styles and experiences of the intervention. Interviews explored views on implementation and dissemination. Framework analysis was used to analyse data. Results Qualitative data elicited three themes associated with the delivery of BGDP that affected implementation: project design, session content and project organisation. ‘Project design’ found issues associated with recruitment, timetabling and session quantity to influence the effectiveness of BGDP. ‘Session content’ found that dance instructors delivered a range of content and that girls enjoyed a variety of dance. Themes within ‘project organisation’ suggested an ‘open enrolment’ policy and greater parental involvement may facilitate better attendance. Conclusions After-school PA interventions have potential for increasing PA levels among adolescent girls. There is a need to consider the context in which interventions are delivered and implement them in ways that are appropriate to the needs of participants. Trial registration number ISRCTN52882523. PMID:26747038

[The efficacy of the systems training for emotional predictability and problem solving (STEPPS) in the treatment of borderline personality disorder. A randomized controlled trial].

PubMed

van Wel, E B; Bos, E H; Appelo, M T; Berendsen, E M; Willgeroth, F C; Verbraak, M J P M

2009-01-01

The types of treatment for borderline personality disorder devised over the last few decades are often difficult to implement in therapy centres. stepps is a group treatment for this disorder which is easy to implement. To compare the efficacy of stepps supported by limited individual treatment with 'treatment as usual' (tau). 79 patients with bpd were randomly assigned to stepps or to tau. Measurements were taken before and after the intervention and at one-year follow-up. Outcome measures were: borderline and general psychiatric symptomatology, suicide attempts, quality of life and use of care services. results stepps led to a larger reduction in symptoms than did tau, the difference being still significant at follow-up. 70% of patients treated with stepps showed improvement compared to 47% of patients treated with tau. In both treatment groups the percentage of patients who recovered was small. There was no difference in the number of suicide attempts in each group. stepps led to a greater improvement in quality of life than did tau, particularly at follow-up. Care service use seemed about equal. The efficacy of treatment for bpd can be improved by the introduction of stepps, which is relatively simple to implement.

Hospital admissions for acute myocardial infarction before and after implementation of a comprehensive smoke-free policy in Uruguay

PubMed Central

Sebrié, Ernesto Marcelo; Sandoya, Edgardo; Hyland, Andrew; Bianco, Eduardo; Glantz, Stanton A; Cummings, K Michael

2012-01-01

Background Stimulated by the WHO Framework Convention on Tobacco Control, many countries in Latin America adopted comprehensive smoke-free policies. In March 2006, Uruguay became the first Latin American country to adopt 100% smoke-free national legislation, which ended smoking in all indoor public places and workplaces, including restaurants and bars. The objective of this study was to evaluate trends in hospital admissions for cardiovascular disease 2 years before and 2 years after the policy was implemented in Uruguay. Methods Reports of hospital admissions for acute myocardial infarction (AMI) (International Classification of Disease-10 I21) from 37 hospitals (79% of all hospital admissions in the country), representing the period 2 years before and 2 years after the adoption of a nationwide smoke-free policy in Uruguay (between 1 March 2004 and 29 February 2008), were reviewed. A time series analysis was undertaken to compare the average monthly number of events of hospital admission for AMI before and after the smoke-free law. Results A total of 7949 hospital admissions for AMI were identified during the 4-year study period. Two years after the smoke-free policy was enacted, hospital admissions for AMI fell by 22%. The same pattern and roughly the same magnitude of reduction in AMI admissions were observed for patients seen in public and private hospitals, men, women and people aged 40–65 years and older than 65 years. Conclusions The national smoke-free policy implemented in Uruguay in 2006 was associated with a significant reduction in hospital admissions for AMI. PMID:22337557

Urinary cotinine and breath carbon monoxide levels among bar and restaurant employees in ankara.

PubMed

Caman, Ozge Karadag; Erguder, Berrin I; Ozcebe, Hilal; Bilir, Nazmi

2013-08-01

Hospitality sector employees constitute one of the key groups with respect to their secondhand tobacco smoke exposure at work. This study aimed to detect urinary cotinine and breath carbon monoxide (CO) levels among bar and restaurant employees in Ankara, as well as the employees' opinions on the new antitobacco law, changes in smoking behavior, and subjective health status before and after the law entered into force. This before-after study was conducted in 19 premises, with the participation of 65 employees before implementation and 81 employees 3 months after implementation of the new antitobacco law in the hospitality sector. Data in both phases were collected through face-to-face surveys, breath CO measurements, and urinary cotinine analysis. Descriptive statistics were used to summarize data, whereas chi-square test, paired and unpaired t tests, and analysis of variance were used to compare groups. Most of the restaurant and bar employees were male and below 35 years old. Before-after comparison showed that health complaints of the hospitality sector employees such as watering and itching in the eyes, difficulty in breathing, and cough (p < .001), as well as breath CO (p < .001) and urinary cotinine levels (p < .001) decreased significantly 3 months after implementation of the law. Among the smoking employees, mean number of cigarettes smoked was also found to decrease (p = .012). Majority of the employees (83.8%) were found to support the smoking ban in enclosed public places. Results of this study provide solid evidence on the positive health effects of smoke-free laws and employees' support for smoke-free workplaces.

Patient-experienced effect of an active implementation of a disease management programme for COPD – a randomised trial

PubMed Central

2013-01-01

Background People living with chronic disease currently account for the majority of the total healthcare costs. The Central Denmark Region implemented a disease management programme (DMP) for chronic obstructive pulmonary disease (COPD) in 2008. This presented an opportunity to examine the effect of an evidence-based, planned and proactive implementation of a DMP compared to the usual implementation strategy. Methods We performed a block- and cluster-randomised controlled trial with two groups and an extra external control group. The primary outcome was patients’ assessment of their care after using an active implementation model for a DMP for COPD measured with the Patient-Assessment-of-Chronic-Illness-Care (PACIC) instrument. At baseline, questionnaires were sent to 2,895 patients identified by an algorithm based on health registry data on lung-related contacts to the healthcare system. Patients were asked to confirm or refute their diagnosis of COPD. Of those who responded, 1,445 (72.8%) confirmed their diagnosis. PACIC data were collected at baseline and at a 12-month follow-up for 744 (51.1%) patients. Results Comparing the three groups after the implementation of the DMP, we found a statistically significantly higher change in the PACIC score in the intervention group than in the control groups. No statistically significant differences were found between the control and the external control groups in any of the dimensions. Conclusions Reinforcing the role of general practice as coordinator for care-and self-management-support with an active implementation of a DMP for COPD made patients score higher on the PACIC instrument, which indicates a better experience of the received healthcare. Trial registration NCT01228708. PMID:24088417

The effect of inhalation aromatherapy with damask rose (Rosa damascena) essence on the pain intensity after dressing in patients with burns: A clinical randomized trial.

PubMed

Bikmoradi, Ali; Harorani, Mehdi; Roshanaei, Ghodratollah; Moradkhani, Shirin; Falahinia, Golam Hossein

2016-01-01

Pain is one of the common problems encountered by patients with burns, which increases after each dressing. This study aimed to investigate the effect of inhalation aromatherapy with damask rose essence on the pain of patients with burns that is caused after dressing. A randomized clinical trial was conducted on 50 patients with second- and third-degree burn wounds. The baseline pain of the patients was assessed 30 min before they entered into the dressing room on the first and second days of intervention. The patients in the experimental group inhaled five drops of damask rose essence 40% in distilled water, while those in the control group inhaled five drops of distilled water as placebo. The pain intensity was assessed using Visual Analogue Scale at 15 and 30 min after the patients exited from the dressing room. Data were analyzed by SPSS (version 18) using descriptive and inferential statistics. There was significant difference between the mean of pain intensity before and after intervention at 15 and 30 min after dressing (P < 0.001). Moreover, there was significant difference in reduction of pain intensity before and after aromatherapy in the experimental group (P < 0.05). Also, there was a significant reduction in severity of pain after dressing in the experimental group compared with the control group (P < 0.05). Inhalation aromatherapy with damask rose could be effective for relieving the pain caused after dressing in patients with burns. Therefore, it could be suggested as a complementary therapy in burn patients for pain relief.

Optical fiber reliability results from the Biarritz field trial

NASA Astrophysics Data System (ADS)

Gouronnec, Alain; Goarin, Rolland; Le Moigne, G.; Baptiste, M.

1994-09-01

The first experimental optical fiber network (fiber to the home CATV and video-phone) was installed in BIARRITZ, France) at the beginning or 1980. Some parts of the first optical links have now been removed. FRANCE TELECOM decided to stop field trial services, it appeared interesting to evaluate and expertise fiber reliability after more than 10 years of aging in a real adverse field environment. In this paper we give a short description of the layed down links, and indicate how we have carefully removed the individual fibers from the cables. After a first measurement of the mechanical parameters using normalized dynamic and static tests, we compared the results obtained with those of the equivalent tests used to evaluate these fibers before their installation on the field. The tests used are the same than those used in the 80 th. In conclusion, the paper gives the ageing results measured on the BIARRITZ optical fibers after more than 10 years of service in real environment and evaluate it by comparison with the results before installation.

Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial.

PubMed

Amemori, Masamitsu; Korhonen, Tellervo; Kinnunen, Taru; Michie, Susan; Murtomaa, Heikki

2011-02-14

Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC) counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster randomised controlled design, we aim to provide further evidence on intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers. Current Controlled Trials ISRCTN15427433.

Assessing prescribing practices of clozapine before and after the implementation of an updated risk evaluation and mitigation strategy

PubMed Central

2018-01-01

Introduction: Clozapine is an atypical antipsychotic medication approved for treatment-resistant schizophrenia and suicidal behavior in schizophrenia or schizoaffective disorders. Despite its therapeutic efficacy, clozapine is associated with several adverse effects, including agranulocytosis. In late 2015, the Food and Drug Administration updated the risk evaluation and mitigation strategy (REMS) for clozapine with new requirements for monitoring, prescribing, and dispensing. The purpose of this study was to evaluate clozapine prescribing practices at a Kentucky state psychiatric hospital before and after the implementation of the updated REMS program. Methods: The primary outcome of this study was to evaluate clozapine prescribing practices by identifying the number of patients on clozapine therapy in the 6 months pre and post updated REMS implementation. Included in the study were patients at a Kentucky state psychiatric hospital on clozapine therapy for the 24 months before the updated REMS implementation and in the 6-month study period after the implementation. The secondary objective of this study examined psychiatrist comfort level of prescribing clozapine. Results: Since the implementation of the updated REMS program, there has been an increased percentage of patients that were prescribed clozapine at a Kentucky state psychiatric hospital. This increase was not statistically significant (P = .2610). Discussion: The prescribing practices of clozapine within this facility did not differ significantly comparing pre- and post-REMS change in terms of number of patients prescribed clozapine, patient's dose, and therapy duration. Data from this study contributes to the body of knowledge evaluating this new standard of practice under the updated REMS.

Mortality Trends After a Voluntary Checklist-based Surgical Safety Collaborative.

PubMed

Haynes, Alex B; Edmondson, Lizabeth; Lipsitz, Stuart R; Molina, George; Neville, Bridget A; Singer, Sara J; Moonan, Aunyika T; Childers, Ashley Kay; Foster, Richard; Gibbons, Lorri R; Gawande, Atul A; Berry, William R

2017-12-01

To determine whether completion of a voluntary, checklist-based surgical quality improvement program is associated with reduced 30-day postoperative mortality. Despite evidence of efficacy of team-based surgical safety checklists in improving perioperative outcomes in research trials, effective methods of population-based implementation have been lacking. The Safe Surgery 2015 South Carolina program was designed to foster state-wide engagement of hospitals in a voluntary, collaborative implementation of a checklist program. We compared postoperative mortality rates after inpatient surgery in South Carolina utilizing state-wide all-payer discharge claims from 2008 to 2013, linked with state vital statistics, stratifying hospitals on the basis of completion of the checklist program. Changes in risk-adjusted 30-day mortality were compared between hospitals, using propensity score-adjusted difference-in-differences analysis. Fourteen hospitals completed the program by December 2013. Before program launch, there was no difference in mortality trends between the completion cohort and all others (P = 0.33), but postoperative mortality diverged thereafter (P = 0.021). Risk-adjusted 30-day mortality among completers was 3.38% in 2010 and 2.84% in 2013 (P < 0.00001), whereas mortality among other hospitals (n = 44) was 3.50% in 2010 and 3.71% in 2013 (P = 0.3281), reflecting a 22% difference between the groups on difference-in-differences analysis (P = 0.0021). Despite similar pre-existing rates and trends of postoperative mortality, hospitals in South Carolina completing a voluntary checklist-based surgical quality improvement program had a reduction in deaths after inpatient surgery over the first 3 years of the collaborative compared with other hospitals in the state. This may indicate that effective large-scale implementation of a team-based surgical safety checklist is feasible.

Assessment of air quality after the implementation of compressed natural gas (CNG) as fuel in public transport in Delhi, India.

PubMed

Ravindra, Khaiwal; Wauters, Eric; Tyagi, Sushil K; Mor, Suman; Van Grieken, René

2006-04-01

Public transport in Delhi was amended by the Supreme Court of India to use Compressed Natural Gas (CNG) instead of diesel or petrol. After the implementation of CNG since April 2001, Delhi has the highest fraction of CNG-run public vehicles in the world and most of them were introduced within 20 months. In the present study, the concentrations of various criteria air pollutants (SPM, PM(10), CO, SO(2) and NO(x)) and organic pollutants such as benzene, toluene, xylene (BTX) and polycyclic aromatic hydrocarbons (PAHs) were assessed before and after the implementation of CNG. A decreasing trend was found for PAHs, SO(2) and CO concentrations, while the NO(x) level was increased in comparison to those before the implementation of CNG. Further, SPM, PM(10), and BTX concentrations showed no significant change after the implementation of CNG. However, the BTX concentration demonstrated a clear relation with the benzene content of gasoline. In addition to the impact of the introduction of CNG the daily variation in PAHs levels was also studied and the PAHs concentrations were observed to be relatively high between 10 pm to 6 am, which gives a proof of a relation with the limited day entry and movement of heavy vehicles in Delhi.

Effects of analgesia of the digital flexor tendon sheath on pain originating in the sole, distal interphalangeal joint or navicular bursa of horses.

PubMed

Harper, J; Schumacher, John; Degraves, F; Schramme, M; Schumacher, Jim

2007-11-01

Specific analgesic techniques are required in diagnosis of lameness to isolate the exact origin of pain to the many structures of the foot that may be involved. To determine if analgesia of the digital flexor tendon sheath (DFTS) results in anaesthesia of other portions of the foot, such as the sole, distal interphalangeal joint (DIPJ), or navicular bursa (NB). Lameness caused by pain in the dorsal margin or heel region of the sole of the foot was induced in 18 horses by: using set-screws to create solar pressure (Trial 1: n = 5); or administering endotoxin intrasynovially into the DIPJ (Trial 2: n = 6) and NB (Trial 3: n = 7). The gait of each horse was evaluated by examining videotape recorded before and after creation of lameness and after administration of mepivacaine hydrochloride into the DFTS. Median lameness scores in Trial 1 at 10 min post injection of the DFTS were not significantly different from those before administration of local anaesthetic solution into the DFTS (P> or =0.05), but median lameness scores were reduced significantly at 20 min (P< or =0.05). In Trials 2 and 3, median lameness scores were not significantly different at observations made at 10 and 20 min post injection of the DFTS. Analgesia of the DFTS has little effect on lameness caused by pain originating in the sole, DIPJ or NB. Improvement of lameness in horses after intrasynovial analgesia of the DFTS is probably caused by attenuation of pain within the structures contained in the DFTS.

Cyanide poisoning in Thailand before and after establishment of the National Antidote Project.

PubMed

Srisuma, Sahaphume; Pradoo, Aimon; Rittilert, Panee; Wongvisavakorn, Sunun; Tongpoo, Achara; Sriapha, Charuwan; Krairojananan, Wannapa; Suchonwanich, Netnapis; Khomvilai, Sumana; Wananukul, Winai

2018-04-01

Antidote shortage is a global problem. In Thailand, the National Antidote Project (NAP) has operated since November 2010 to manage the national antidote stockpile, educate the healthcare providers on appropriate antidote use, and evaluate antidote usage. To evaluate the effect of NAP implementation on mortality rate and antidote use in cyanide poisoning cases arising from ingestion of cyanide or cyanogenic glycoside. This is a retrospective cohort of poisoning cases involving cyanide or cyanogenic glycoside ingestion reported to Ramathibodi Poison Center from 1 January 2007 to 31 December 2015. Mortality rate, antidote use, and appropriateness of antidote use (defined as correct indication, proper dosing regimen, and administration within 90 min) before and after NAP implementation were compared. Association between parameters and fatal outcomes was analyzed. A total of 343 cases involving cyanide or cyanogenic glycoside ingestion were reported to Ramathibodi Poison Center. There were 213 cases (62.1%) during NAP (Project group) and 130 cases (37.9%) pre-NAP implementation (Before group). Implementation of NAP led to increased antidote use (39.9% in Project group versus 24.6% in Before group) and a higher rate of appropriate antidote use (74.1% in Project group versus 50.0% in Before group). All 30 deaths were presented with initial severe symptoms. Cyanide chemical source and self-harm intent were associated with death (OR: 12.919, 95% CI: 4.863-39.761 and OR: 10.747, 95% CI: 3.884-28.514, respectively). No difference in overall mortality rate (13 [10.0%] deaths before versus 17 [8.0%] deaths after NAP) was found. In subgroup analysis of 80 cases with initial severe symptoms, NAP and appropriate antidote use reduced mortality (OR: 0.327, 95% CI: 0.106-0.997 and OR: 0.024, 95% CI: 0.004-0.122, respectively). In the multivariate analysis of the cases with initial severe symptoms, presence of the NAP and appropriate antidote use independently reduced the risk of death (OR: 0.122, 95% CI: 0.023-0.633 and OR: 0.034, 95% CI: 0.007-0.167, respectively), adjusted for intent of exposure, cyanide source, age, and sex. After NAP implementation, both antidote use and appropriate antidote use increased. In cases presenting with severe symptoms, presence of the NAP and appropriate antidote use independently reduced the risk of mortality.

Reproductive Health of Women in Rural Areas of East Azerbaijan - Iran, before and after Implementation of rural Family Physician Program: an Ecologic Study.

PubMed

Alizadeh, Mahasti; Jabbari Birami, Hossein; Moradi, Siavash

2015-12-01

Implementation of rural family physician program in Iran in 2005 has been evaluated and shown that this program has been led to some improvements in health indicators. In this study, some reproductive health (RH) indicators were compared before and after implementation of this program in rural areas of East Azerbaijan, Iran. In this ecologic- time trend study, the data of 191075 births of rural women of East Azerbaijan from 2001 to 2010 was extracted from vital horoscope (ZIJ) and used for calculation of 20 important RH indicators. The paired t-test and correlation analysis wear used for data analysis. Some indicators such as adolescent marriage rate, adolescent birth and over 35 year olds birth rate were increased after rural family physician program implementation in 2005. Also stillbirth rate and unsafe delivery were decreased during this period. There was a significant correlation between increasing adolescent birth rate and increasing low birth weight deliveries (r= 0.911, P= 0.031) and also between increasing over 35 year olds birth rate and increasing neonatal mortality rate in term of prematurity and congenital malformations (r= 0.912, P= 0.031) after program implementation. Perinatal care and safe delivery even for pregnancies outside the typical child-bearing ages are promoting after implementation of rural family physician program in East Azerbaijan. Also decreasing unsafe delivery and stillbirth rate can be considered as achievements of running this program in this province.

Food caregivers influence on nutritional intake among admitted haematological cancer patients - a prospective study.

PubMed

Lindman, Astrid; Rasmussen, Helle Brygger; Andersen, Niels Frost

2013-12-01

Haematological cancer patients have an increased risk of undernourishment due to their malignancy, treatment toxicity and severe infections. This study examines whether kitchen assistants working as food caregivers increase nutritional intake and knowledge among haematological cancer patients. Comparison of two cross-sectional studies with dietary assessment of patients with haematological malignancies before (N = 42) and after (N = 45) implementation of food caregivers. Secondly, a questionnaire concerning dietary counselling performed before (N = 74) and after (N = 78) the implementation. The energy requirements were fulfilled with 76.2% (CI 95% 64.6-87.9) and 93.3% (CI 95% 82.3-104.3) of the calculated need in the before-group and the after-group, respectively (p = 0.03). The improvement was mainly due to increased energy intake through between meal snacks served by the food caregivers. There was no difference in protein intake between the two groups. The study showed that more than two-thirds of the patients in both groups had side effects like fatigue, loss of appetite, vomiting, xerostomia or taste disorder to a degree that affected nutritional intake. When adjusted for side effects, patients in the after-group increased energy intake by 22% (CI 95% 6.1-38.0) (p = 0.007). After implementation of food caregivers significantly more patients stated that they were informed about their nutritional needs, 41% in the before-group and 67% in the after-group (p = 0.001). Educated and trained food caregivers working at the wards increase nutritional intake and knowledge among haematological cancer patients and play an important role in the multi professional nutritional management. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effects of a Tobacco-Free Work Site Policy on Employee Tobacco Attitudes and Behaviors, Travis County, Texas, 2010-2012.

PubMed

Seidel, Sarah E; Metzger, Kristi; Guerra, Andrea; Patton-Levine, Jessie; Singh, Sandeepkumar; Wilson, William T; Huang, Philip

2017-12-14

The adoption of tobacco-free policies in behavioral health settings is an important step in reducing staff tobacco use as well as the high rates of tobacco use among people with mental illness and behavioral disorders. Studies have demonstrated the importance of staff support when implementing tobacco-free workplace policies, but there is limited research examining tobacco use prevalence among staff and staff attitude before and after policy adoption. Integral Care, a local authority for behavioral health and developmental disabilities in Austin, Texas, and Austin Public Health embarked on a comprehensive planning process before implementing a 100% tobacco-free campus policy. The objectives were 1) assess staff tobacco use and attitudes toward a tobacco-free policy, 2) communicate policy to staff, 3) provide staff education and training, and 4) provide cessation resources. Integral Care and Austin Public Health conducted a web-based employee survey 6 months before and 6 and 12 months after implementation of the policy to measure tobacco use prevalence and attitudes among employees. Employees had significant improvements in tobacco use prevalence and attitudes toward the tobacco-free policy from pre-implementation to post-implementation. Tobacco use prevalence among staff decreased from 27.6% to 13.8%, and support for the policy increased from 60.6% to 80.3% at 12 months post-implementation. Adoption of 100% tobacco-free campus policies in behavioral health settings can result in significant reductions in staff tobacco use. Leadership should provide staff with education, training, and cessation support before adoption of tobacco-free work site policies to ensure success.

[Assessment of a supervision grid being used in the laboratories of cutaneous leishmaniasis in Morocco].

PubMed

El Mansouri, Bouchra; Amarir, Fatima; Hajli, Yamina; Fellah, Hajiba; Sebti, Faiza; Delouane, Bouchra; Sadak, Abderrahim; Adlaoui, El Bachir; Rhajaoui, Mohammed

2017-01-01

The aim of our study was to assess a standardized supervisory grid as a new supervision tool being used in the laboratories of leishmaniasis. We conducted a pilot trial to evaluate the ongoing performances of seven provincial laboratories, in four provinces in Morocco, over a period of two years, between 2006 and 2014. This study detailed the situation in provincial laboratories before and after the implementation of the supervisory grid. A total of twenty-one grids were analyzed. In 2006, the results clearly showed a poor performance of laboratories: need for training (41.6%), staff performing skin biopsy (25%), shortage of materials and reagents (65%), non-compliant document and local management (85%). Several corrective actions were conducted by the National Reference Laboratory (LNRL) of Leishmaniasis during the study period. In 2014, the LNRL recorded a net improvement of the performances of the laboratories. The need for training, the quality of the biopsy, the supply of tools and reagents were met and an effective coordination activity was established between the LNRL and the provincial laboratories. This trial shows the effectiveness of the grid as a high quality supervisory tool and as a cornerstone of making progress on fight programs against leishmaniases.

A comprehensive study on pavement edge line implementation.

DOT National Transportation Integrated Search

2014-04-01

The previous 2011 study Safety Improvement from Edge Lines on Rural Two-Lane Highways analyzed the crash data of : three years before and one year after edge line implementation by using the latest safety analysis statistical method. It : concl...

Bright light treatment as add-on therapy for depression in 28 adolescents: a randomized trial.

PubMed

Niederhofer, Helmut; von Klitzing, Kai

2011-01-01

In the last decade, a significant incidence of depression in the younger population has been observed. Bright light therapy, an effective therapeutic option for depressed adults, could also provide safe, economical, and effective rapid recovery in adolescents. The randomized trial included 28 inpatients (18 females and 10 males) between 14 and 17 years old with depressive complaints. The study was conducted between February and December of 2010 in Rodewisch, Germany. Half of the patients (n = 14) first received placebo (50 lux) 1 hour a day in the morning from 9:00 am to 10:00 am for 1 week and then received bright light therapy (2,500 lux) for 1 week in the morning from 9:00 am to 10:00 am. The other half (n = 14) first received bright light therapy and then received placebo. Patients were encouraged to continue ongoing treatment (fluoxetine 20 mg/day and 2 sessions of psychotherapy/week) because there were no changes in medication/dosage and psychotherapy since 1 month before the 4-week study period. For assessment of depressive symptoms, the Beck Depression Inventory (BDI) was administered 1 week before and 1 day before placebo treatment, on the day between placebo and bright light treatment, and on the day after and 1 week after bright light treatment. Saliva samples of melatonin and cortisol were collected at 8:00 am and 8:00 pm 1 week before and 1 day before placebo treatment, on the day between placebo and bright light treatment, on the day after bright light treatment, and 1 week after bright light treatment and were assayed for melatonin and cortisol to observe any change in circadian timing. The BDI scores improved significantly (P = .015). The assays of saliva showed significant differences between treatment and placebo for evening melatonin (P = .040). No significant adverse reactions were observed. Antidepressant response to bright light treatment in this age group was statistically superior to placebo. World Health Organization International Clinical Trials Registry Platform identifier: DRKS00003309.

Sustainability of knowledge implementation in a low- and middle- income context: Experiences from a facilitation project in Vietnam targeting maternal and neonatal health

PubMed Central

Bergström, Anna; Hoa, Dinh Thi Phuong; Nga, Nguyen Thu; Eldh, Ann Catrine

2017-01-01

Background In a previous trial in Vietnam, a facilitation strategy to secure evidence-based practice in primary care resulted in reduced neonatal mortality over a period of three years. While little is known as to what ensures sustainability in the implementation of community-based strategies, the aim of this study was to investigate factors promoting or hindering implementation, and sustainability of knowledge implementation strategies, by means of the former Neonatal Knowledge Into Practice (NeoKIP) trial. Methods In 2014 we targeted all levels in the Vietnamese healthcare system: six individual interviews with representatives at national, provincial and district levels, and six focus group discussions with representatives at the commune level. The interviews were transcribed verbatim, translated to English, and analysed using inductive and deductive thematic analysis. Results To achieve successful implementation and sustained effect of community-based knowledge implementation strategies, engagement of leaders and key stakeholders at all levels of the healthcare system is vital–prior to, during and after a project. Implementation and sustainability require thorough needs assessment, tailoring of the intervention, and consideration of how to attain and manage funds. The NeoKIP trial was characterised by a high degree of engagement at the primary healthcare system level. Further, three years post trial, maternal and neonatal care was still high on the agenda for healthcare workers and leaders, even though primary aspects such as stakeholder engagement at all levels, and funding had been incomplete or lacking. Conclusions The current study illustrates factors to support successful implementation and sustain effects of community-based strategies in projects in low- and middle-income settings; some but not all factors were represented during the post-NeoKIP era. Most importantly, trials in this and similar contexts require deliberate management throughout and beyond the project lifetime, and engagement of key stakeholders, in order to promote and sustain knowledge implementation. PMID:28806744

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Trial registration Current Controlled Trials ISRCTN19506752 PMID:21672213

37 CFR 41.33 - Amendments and affidavits or other Evidence after appeal.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Amendments and affidavits or other Evidence after appeal. 41.33 Section 41.33 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex...

Residues after fumigation with methyl bromide: bromide ion and methyl bromide in middlings and final cereal foodstuffs.

PubMed

Cova, D; Molinari, G P; Rossini, L

1986-01-01

Methyl bromide and bromide ion concentrations were estimated in pasta manufactured before and after fumigation with methyl bromide. The first trial estimated the bromide ion concentrations in fumigated and unfumigated flours and in pastas obtained from these. The concentration of bromide ions in fumigated flours was not significantly different from unfumigated flours. Only some pastas, manufactured from fumigated flours, showed a higher bromide ion concentration than those manufactured from unfumigated flours. The second trial evaluated the bromide ion concentrations of rices, white flours, flours, pastas made only from flours, pastas with eggs and pastas with eggs and spinach, before and after exposure to methyl bromide in their retail packagings. The bromide ion concentrations in fumigated pastas with eggs, pastas with eggs and spinach and rice were higher than in those unfumigated. In the pastas with eggs the bromide ion concentration after fumigation increased ten times (from about 4 to 40 mg/kg). Results showed that the bromide ion and methyl bromide levels estimated in all the foodstuffs examined were lower than the maximum limits fixed by several different national regulations.

Effects of an electronic reminder system on guideline-concordant treatment of psychotic disorders : Results from a pilot feasibility trial.

PubMed

Franke, Irina; Thier, Sarah; Riecher-Rössler, Anita

2016-12-01

Adherence to evidence-based guidelines is essential for the treatment outcome of psychotic disorders. Previous studies showed that IT-supported pathways are able to increase guideline adherence in psychiatric care. This paper describes a pilot study on the development of an electronic recall-reminder-system (RRS) for supporting guideline-adherent treatment in outpatient care of patients with chronic psychotic disorders and analyses its feasibility. Guidelines were integrated in the RRS software M.E.M.O.R.E.S. Software training for the staff was provided. We compared the number of conducted vs. guideline-recommended interventions 6 months before and after implementation. Subsequently both the caregivers' and the patients' satisfaction with the RRS was evaluated. Guideline adherence in general was low and the RRS was barely used. After its implementation a significant increase was observed in chemogram-check-ups and diagnostics regarding cardiovascular risks (esp. ECG). Both patients and professionals described problems with integrating the RRS in their daily routine and questioned the usefulness of the guidelines for chronically ill, although they basically approved its importance and usefulness. Participants appreciated the idea of supporting guideline adherence with an IT-system, but there seemed to be major obstacles to implementation: caregivers appear to be concerned of being exposed or questioned, technical difficulties might lead to avoidance, and there seems to be a lack of knowledge and awareness about the health risks for individuals with psychotic disorders. Possibly guidelines adapted for the chronically ill would find more acceptance. Technical simplifications and better information should be considered prior to further attempts to implement IT-supported guidelines in order to increase acceptance.

De-implementation strategy to Reduce the Inappropriate use of urinary and intravenous CATheters: study protocol for the RICAT-study.

PubMed

Laan, Bart J; Spijkerman, Ingrid J B; Godfried, Mieke H; Pasmooij, Berend C; Maaskant, Jolanda M; Borgert, Marjon J; Opmeer, Brent C; Vos, Margreet C; Geerlings, Suzanne E

2017-01-10

Urinary and (peripheral and central) intravenous catheters are widely used in hospitalized patients. However, up to 56% of the catheters do not have an appropriate indication and some serious complications with the use of these catheters can occur. The main objective of our quality improvement project is to reduce the use of catheters without an appropriate indication by 25-50%, and to evaluate the affecting factors of our de-implementation strategy. In a multicenter, prospective interrupted time series analysis, several interventions to avoid inappropriate use of catheters will be conducted in seven hospitals in the Netherlands. Firstly, we will define a list of appropriate indications for urinary and (peripheral and central) intravenous catheters, which will restrict the use of catheters and urge catheter removal when the indication is no longer appropriate. Secondly, after the baseline measurements, the intervention will take place, which consists of a kick-off meeting, including a competitive feedback report of the baseline measurements, and education of healthcare workers and patients. Additional strategies based on the baseline data and local conditions are optional. The primary endpoint is the percentage of catheters with an inappropriate indication on the day of data collection before and after the de-implementation strategy. Secondary endpoints are catheter-related infections or other complications, catheter re-insertion rate, length of hospital (and ICU) stay and mortality. In addition, the cost-effectiveness of the de-implementation strategy will be calculated. This study aims to reduce the use of urinary and intravenous catheters with an inappropriate indication, and as a result reduce the catheter-related complications. If (cost-) effective it provides a tool for a nationwide approach to reduce catheter-related infections and other complications. Dutch trial registry: NTR6015 . Registered 9 August 2016.

Investigations of the surface activation of thermoplastic polymers by atmospheric pressure plasma treatment with a stationary plasma jet

NASA Astrophysics Data System (ADS)

Moritzer, Elmar; Nordmeyer, Timo; Leister, Christian; Schmidt, Martin Andreas; Grishin, Artur; Knospe, Alexander

2016-03-01

The production of high-quality thermoplastic parts often requires an additional process step after the injection molding stage. This may be a coating, bonding process or a 2K-injection moulding process. A commonly used process to improve the bond strength is atmospheric pressure plasma treatment. A variety of applications are realized with the aid of CNC systems. Although they ensure excellent reproducibility, they make it difficult to implement inline applications. This paper therefore examines the possibility of surface treatment using a stationary plasma jet. However, before it is possible to integrate this technology into a production process, preliminary trials need to be carried out to establish which factors influence the process. Experimental tests were performed using a special test set-up, enabling geometric, plasma-specific parameters to be identified. These results can help with the practical integration of this technology into existing production processes.

Magnetic Resonance-Guided High Intensity Focused Ultrasound Ablation of Breast Cancer.

PubMed

Knuttel, Floortje M; van den Bosch, Maurice A A J

2016-01-01

This chapter describes several aspects of MR-HIFU treatment for breast cancer. The current and future applications, technical developments and clinical results are discussed. MR-HIFU ablation is under investigation for the treatment of breast cancer, but is not yet ready for clinical implementation. Firstly, the efficacy of MR-HIFU ablation should be investigated in large trials. The existing literature shows that results of initial, small studies are moderate, but opportunities for improvement are available. Careful patient selection, taking treatment margins into account and using a dedicated breast system might improve treatment outcomes. MRI-guidance has proven to be beneficial for the accuracy and safety of HIFU treatments because of its usefulness before, during and after treatments. In conclusion, MR-HIFU is promising for the treatment of breast cancer and might lead to a change in breast cancer care in the future.

Web-scale discovery in an academic health sciences library: development and implementation of the EBSCO Discovery Service.

PubMed

Thompson, Jolinda L; Obrig, Kathe S; Abate, Laura E

2013-01-01

Funds made available at the close of the 2010-11 fiscal year allowed purchase of the EBSCO Discovery Service (EDS) for a year-long trial. The appeal of this web-scale discovery product that offers a Google-like interface to library resources was counter-balanced by concerns about quality of search results in an academic health science setting and the challenge of configuring an interface that serves the needs of a diverse group of library users. After initial configuration, usability testing with library users revealed the need for further work before general release. Of greatest concern were continuing issues with the relevance of items retrieved, appropriateness of system-supplied facet terms, and user difficulties with navigating the interface. EBSCO has worked with the library to better understand and identify problems and solutions. External roll-out to users occurred in June 2012.

Effect of milk protein addition to a carbohydrate-electrolyte rehydration solution ingested after exercise in the heat.

PubMed

James, Lewis J; Clayton, David; Evans, Gethin H

2011-02-01

The present study examined the effects of milk protein on rehydration after exercise in the heat, via the comparison of energy- and electrolyte content-matched carbohydrate and carbohydrate-milk protein solutions. Eight male subjects lost 1·9 (SD 0·2) % of their body mass by intermittent exercise in the heat and rehydrated with 150% of their body mass loss with either a 65 g/l carbohydrate solution (trial C) or a 40 g/l carbohydrate, 25 g/l milk protein solution (trial CP). Urine samples were collected before and after exercise and for 4 h after rehydration. Total cumulative urine output after rehydration was greater for trial C (1212 (SD 310) ml) than for trial CP (931 (SD 254) ml) (P < 0·05), and total fluid retention over the study was greater after ingestion of drink CP (55 (SD 12) %) than that after ingestion of drink C (43 (SD 15) %) (P < 0·05). At the end of the study period, whole body net fluid balance (P < 0·05) was less negative for trial CP (-0·26 (SD 0·27) litres) than for trial C (-0·52 (SD 0·30) litres), and although net negative for both the trials, it was only significantly negative after ingestion of drink C (P < 0·05). The results of the present study suggest that when matched for energy density and fat content, as well as for Na and K concentration, and when ingested after exercise-induced dehydration, a carbohydrate-milk protein solution is better retained than a carbohydrate solution. These results suggest that gram-for-gram, milk protein is more effective at augmenting fluid retention than carbohydrate.

Changing Operating Room Culture: Implementation of a Postoperative Debrief and Improved Safety Culture.

PubMed

Magill, Stephen T; Wang, Doris D; Rutledge, W Caleb; Lau, Darryl; Berger, Mitchel S; Sankaran, Sujatha; Lau, Catherine Y; Imershein, Sarah G

2017-11-01

Patient safety is foundational to neurosurgical care. Postprocedural "debrief" checklists have been proposed to improve patient safety, but data about their use in neurosurgery are limited. Here, we implemented an initiative to routinely perform postoperative debriefs and evaluated the impact of debriefing on operating room (OR) safety culture. A 10-question safety attitude questionnaire (SAQ) was sent to neurosurgical OR staff at a major academic medical center before and 18 months after the implementation of a postoperative debriefing initiative. Rates of debrief compliance and changes in attitudes before and after the survey were evaluated. The survey used a Likert scale and analyzed with standard statistical methods. After the debrief initiative, the rate of debriefing increased from 51% to 86% of cases for the neurosurgery service. Baseline SAQ responses found that neurosurgeons had a more favorable perception of OR safety than did anesthesiologists and nurses. After implementation of the postoperative debriefing process, perceptions of OR safety significantly improved for neurosurgeons, anesthesiologists, and nurses. Furthermore, the disparity between nurses and surgeons was no longer significant. After debrief implementation, neurosurgical OR staff had improved perceptions of patient safety compared with surgical services that did not commonly perform debriefing. Debriefing identified OR efficiency concerns in 26.9% of cases, and prevention of potential adverse events/near misses was reported in 8% of cases. Postoperative debriefing can be effectively introduced into the OR and improves the safety culture after implementation. Debriefing is an effective tool to identify OR inefficiencies and potential adverse events. Copyright © 2017 Elsevier Inc. All rights reserved.

Dynamics of attentional deployment during saccadic programming.

PubMed

Castet, Eric; Jeanjean, Sébastien; Montagnini, Anna; Laugier, Danièle; Masson, Guillaume S

2006-03-03

The dynamics of attentional deployment before saccade execution was studied with a dual-task paradigm. Observers made a horizontal saccade whose direction was indicated by a symbolic precue and had to discriminate the orientation of a Gabor patch displayed at different delays after the precue (but before saccade onset). The patch location relative to the saccadic target was indicated to observers before each block. Therefore, on each trial, observers were informed simultaneously about the respective absolute locations of the saccadic and perceptual targets. The main result is that orientational acuity improved over a period of 150-200 ms after the precue onset at the saccadic target location, where overall performance is best, and at distant locations. This effect is due to attentional factors rather than to an alerting effect. It is also dependent on the efficiency of the temporal masks displayed before and after the Gabor patches.

Effects of experimentally enhanced flows on fishes of a small Texas (U.S.A.) stream: Assessing the impact of interbasin transfer

USGS Publications Warehouse

Matthews, W.J.; Schorr, M.S.; Meador, M.R.

1996-01-01

1. Completion of a large interbasin water transfer system in northern Texas (U.S.A.) provided the opportunity to test the effects of pre-planned, experimental increases (??? ??30) in flow on the fish fauna of a small, low-gradient, natural stream that was included as part of the conveyance system. Water from Lake Texoma (Red River basin) was pumped via a 16-km pipeline to the headwaters of Sister Grove Creek (Trinity River basin), which then carried the donor water 50 km downstream to Lake Lavon. 2. Baseline (pre-transfer) data on the composition of fish assemblages at seven stations on the creek or at its confluence with the receiving reservoir were collected monthly for 3 years, and similar data were collected for 2 years during and after trial flows of Lake Texoma water to Sister Grove Creek. We also documented fish abundance at five creek stations immediately before and after three trial flow periods of 10-14 days each in summer and autumn. 3. Multivariate analysis of all routine monthly samples over the 5-year pre- and posttransfer period showed moderate changes in the fish fauna of the creek after initiation of the trial flows. Samples taken within a week before and after the artificial high flows showed little overall change in abundance of individual fish species, but at some stations the quantitative or qualitative change in composition of the local assemblage was substantial. 4. The trial flows lasted 2 weeks or less. Long-term effects of water transfer on the fish fauna of Sister Grove Creek can only be determined after the conveyance system goes into normal operation, with periods of artificial flow of longer duration.

Evaluation of the Effects of Pinus koraiensis Needle Extracts on Serum Lipid and Oxidative Stress in Adults with Borderline Dyslipidemia: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

PubMed Central

Kim, Hyerang; Choue, Ryowon

2016-01-01

Background. Dyslipidemia has been well-known as a common metabolic disorder contributing to cardiovascular disease. The aim of this study was to evaluate the effect of the Pinus koraiensis needle extracts (PKE) on the blood cholesterol and oxidative stress. Method. We conducted a 12-week randomized, double-blinded controlled trial to examine the effect of PKE on blood lipid profiles in adults with borderline dyslipidemia. Thirty-three eligible persons were recruited and randomly assigned into PKE (n = 20) and placebo groups (n = 13). Serum lipids including total cholesterol, low-density lipoprotein- (LDL-) cholesterol, high-density lipoprotein- (HDL-) cholesterol, very low-density lipoprotein- (VLDL-) cholesterol, and triglyceride were measured before and after trial. Serum insulin, glucose, and antioxidant indicators were also analyzed before and after trial and anthropometry and blood pressure were measured every 4 weeks. Results. After 12 weeks, PKE statically significant decreases in systolic blood pressure (p < 0.05) and waist circumference (p < 0.05) were observed. Also, VLDL-cholesterol significantly decreased (from 24.4 ± 10.0 mg/dL at baseline to 18.4 ± 4.1 mg/dL after 12 weeks) (p < 0.05) and superoxide dismutase (SOD) increased (6.12 ± 0.41 U/mL to 9.06 ± 0.62 U/mL) (p < 0.01) in PKE group. However, after adjustment with WC, VLDL-cholesterol was not significant between groups (p = 0.095) and while SOD remained significant between groups (p = 0.013). Conclusion. The results show that PKE was effective in improving the superoxide dismutase in the individuals with borderline dyslipidemia. PMID:27610187

Strabismus surgery before versus after completion of amblyopia therapy in children

PubMed Central

Korah, Sanita; Philip, Swetha; Jasper, Smitha; Antonio-Santos, Aileen; Braganza, Andrew

2015-01-01

Background Normal visual development occurs when the brain is able to integrate the visual input from each of the two eyes to form a single three-dimensional image. The process of development of complete three-dimensional vision begins at birth and is almost complete by 24 months of age. The development of this binocular vision is hindered by any abnormality that prevents the brain from receiving a clear, similar image from each eye, due to decreased vision (e.g. amblyopia), or due to misalignment of the two eyes (strabismus or squint) in infancy and early childhood. Currently, practice patterns for management of a child with both strabismus and amblyopia are not standardized. Objectives To study the functional and anatomic (ocular alignment) outcomes of strabismus surgery before completion of amblyopia therapy as compared with surgery after completion of amblyopia therapy in children under seven years of age. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2014), EMBASE (January 1980 to July 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to July 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 24 July 2014. A manual search for articles from a review of the references of the selected publications and conference abstracts was completed to identify any additional relevant studies. Selection criteria We searched for randomized controlled trials (RCTs) that provided data on strabismus surgery in children less than seven years of age, performed after initiation of, but before completion of amblyopia therapy, as compared with strabismus surgery after completion of amblyopia therapy. Data collection and analysis Two authors independently assessed studies identified from the electronic and manual searches. Main results There were no RCTs that fit our inclusion criteria and so no analysis was possible. Authors’ conclusions As there are no RCTs currently available and the best existing evidence is only from non-randomized studies, there is a need for prospective RCTs to investigate strabismus surgery in the presence of strabismic amblyopia. The optimal timing of when to perform strabismus surgery in children with amblyopia is unknown. PMID:25315969

Dietary chromium tripicolinate supplementation reduces glucose concentrations and improves glucose tolerance in normal-weight cats.

PubMed

Appleton, D J; Rand, J S; Sunvold, G D; Priest, J

2002-03-01

The effect of dietary chromium supplementation on glucose and insulin metabolism in healthy, non-obese cats was evaluated. Thirty-two cats were randomly divided into four groups and fed experimental diets consisting of a standard diet with 0 ppb (control), 150 ppb, 300 ppb, or 600 ppb added chromium as chromium tripicolinate. Intravenous glucose tolerance, insulin tolerance and insulin sensitivity tests with minimal model analysis were performed before and after 6 weeks of feeding the test diets. During the glucose tolerance test, glucose concentrations, area under the glucose concentration-time curve, and glucose half-life (300 ppb only), were significantly lower after the trial in cats supplemented with 300 ppb and 600 ppb chromium, compared with values before the trial. Fasting glucose concentrations measured on a different day in the biochemistry profile were also significantly lower after supplementation with 600 ppb chromium. There were no significant differences in insulin concentrations or indices in either the glucose or insulin tolerance tests following chromium supplementation, nor were there any differences between groups before or after the dietary trial.Importantly, this study has shown a small but significant, dose-dependent improvement in glucose tolerance in healthy, non-obese cats supplemented with dietary chromium. Further long-term studies are warranted to determine if the addition of chromium to feline diets is advantageous. Cats most likely to benefit are those with glucose intolerance and insulin resistance from lack of exercise, obesity and old age. Healthy cats at risk of glucose intolerance and diabetes from underlying low insulin sensitivity or genetic factors may also benefit from long-term chromium supplementation. Copyright 2002 ESFM and AAFP.

The use of benzodiazepine monotherapy for major depression before and after implementation of guidelines for benzodiazepine use.

PubMed

Lai, I-C; Wang, M-T; Wu, B-J; Wu, H-H; Lian, P-W

2011-10-01

The Department of Health (DOH) in Taiwan issued the 'Guidelines for Benzodiazepine Use in Sedation and Hypnosis' in March 2004, which clearly stated that benzodiazepines (BZDs) should not be used alone for the treatment of depression. However, the extent to which clinicians comply with the BZD guidelines was not known. This study aimed to evaluate whether sole prescribing of BZDs for major depression decreased after the implementation of the BZD guidelines. This was a retrospective longitudinal trend analysis by analyzing the Longitudinal Health Insurance Database (LHID) from September 2002 to September 2005. The LHID contains all claims data from a random sample of 1,000,000 beneficiaries of the universal National Health Insurance programme in Taiwan. The 3-year study period was divided equally into six periods, before and after the implementation of the guidelines respectively. For each period, the proportion of patients with major depression (ICD-9-CM code 296.2x, 296.3x) treated with BZDs without any concomitant antidepressant was calculated in order to conduct a trend analysis. A total of 5463 prescriptions of BZDs solely used for major depression were observed in the entire study period. In more than 80% of the BZD prescriptions in which BZDs were used alone for major depression, they were prescribed at doses higher than one prescribed daily dose/defined daily dose and were supplied for more than 7 days. The number of outpatients with major depression ranged from 2137 to 3326 during the 12 periods. The proportion of depressed patients treated with BZDs alone per 3 months (i.e., the non-compliance rate) fluctuated from 6·7% to 9·4% before implementation of the guidelines, and from 8·0% to 9·4% after implementation, in outpatient settings. In addition, the guideline non-adherence rates in inpatient settings varied from 7·0% to 11·8% and from 7·8% to 12·6% before and after the implementation of the BZD guidelines respectively. Further trend analyses indicated that the implementation of the guidelines was not associated with a reduced rate of sole prescribing of BZDs for major depression in either inpatient (P = 0·083) or outpatient settings (P = 0·925). The formulation and implementation of the BZD guidelines appear not to be associated with a reduced rate of sole prescribing of BZDs for major depression, and more comprehensive efforts are required. © 2010 The Authors. JCPT © 2010 Blackwell Publishing Ltd.

Prevention of Low Back Pain in the Military: A Randomized Clinical Trial

DTIC Science & Technology

2009-06-01

interventions and strategies that are implemented during the acute episode of low back injury, before chronic symptoms occur.1 Secondary prevention reduces...SERIOUS SPINAL PATHOLOGY IN PATIENTS PRESENTING TO PRIMARY CARE WITH ACUTE LOW BACK PAIN Henschke N, Maher C, Refshauge KM, Herbert RD, Cumming R...physiotherapists, general prac- titioners, chiropractors) for acute low back pain. At the initial consul- tation clinicians recorded responses to 25

Effects of a direct refill program for automated dispensing cabinets on medication-refill errors.

PubMed

Helmons, Pieter J; Dalton, Ashley J; Daniels, Charles E

2012-10-01

The effects of a direct refill program for automated dispensing cabinets (ADCs) on medication-refill errors were studied. This study was conducted in designated acute care areas of a 386-bed academic medical center. A wholesaler-to-ADC direct refill program, consisting of prepackaged delivery of medications and bar-code-assisted ADC refilling, was implemented in the inpatient pharmacy of the medical center in September 2009. Medication-refill errors in 26 ADCs from the general medicine units, the infant special care unit, the surgical and burn intensive care units, and intermediate units were assessed before and after the implementation of this program. Medication-refill errors were defined as an ADC pocket containing the wrong drug, wrong strength, or wrong dosage form. ADC refill errors decreased by 77%, from 62 errors per 6829 refilled pockets (0.91%) to 8 errors per 3855 refilled pockets (0.21%) (p < 0.0001). The predominant error type detected before the intervention was the incorrect medication (wrong drug, wrong strength, or wrong dosage form) in the ADC pocket. Of the 54 incorrect medications found before the intervention, 38 (70%) were loaded in a multiple-drug drawer. After the implementation of the new refill process, 3 of the 5 incorrect medications were loaded in a multiple-drug drawer. There were 3 instances of expired medications before and only 1 expired medication after implementation of the program. A redesign of the ADC refill process using a wholesaler-to-ADC direct refill program that included delivery of prepackaged medication and bar-code-assisted refill significantly decreased the occurrence of ADC refill errors.

The US Air Force Suicide Prevention Program: Implications for Public Health Policy

PubMed Central

Pflanz, Steven; Talcott, Gerald W.; Campise, Rick L.; Lavigne, Jill E.; Bajorska, Alina; Tu, Xin; Caine, Eric D.

2010-01-01

Objectives. We evaluated the effectiveness of the US Air Force Suicide Prevention Program (AFSPP) in reducing suicide, and we measured the extent to which air force installations implemented the program. Methods. We determined the AFSPP's impact on suicide rates in the air force by applying an intervention regression model to data from 1981 through 2008, providing 16 years of data before the program's 1997 launch and 11 years of data after launch. Also, we measured implementation of program components at 2 points in time: during a 2004 increase in suicide rates, and 2 years afterward. Results. Suicide rates in the air force were significantly lower after the AFSPP was launched than before, except during 2004. We also determined that the program was being implemented less rigorously in 2004. Conclusions. The AFSPP effectively prevented suicides in the US Air Force. The long-term effectiveness of this program depends upon extensive implementation and effective monitoring of implementation. Suicides can be reduced through a multilayered, overlapping approach that encompasses key prevention domains and tracks implementation of program activities. PMID:20466973

Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010.

PubMed

Mallick, Tarun K; Mosquera, Alexis; Zinderman, Craig E; St Martin, Laura; Wise, Robert P

2012-06-01

Processors distributed about 1.5 million human tissue allografts in the U.S. in 2007. The potential for transmitting infections through allografts concerns clinicians and patients. In 2005, FDA implemented Current Good Tissue Practice (CGTP) rules requiring tissue establishments to report to FDA certain serious infections after allograft transplantations. We describe infection reports following tissue transplants received by FDA from 2005 through June, 2010, and compare reporting before and after implementation of CGTP rules. We identified reports received by FDA from January 2001 through June, 2010, for infections in human tissue recipients, examining the reports by tissue type, organism, time to onset, severity, and reporter characteristics. Among 562 reports, 83 (20.8/year) were received from 2001-2004, before the CGTP rules, 43 in the 2005 transition year, and 436 (96.9/year) from 2006 through June, 2010, after the rules. Tissue processors accounted for 84.2% of reports submitted after the rules, compared to 26.5% previously. Bacterial infections were the most commonly reported organisms before (64.6%) and after (62.2%) the new rules. Afterward, 2.5% (11) of reports described deaths, and 33.7% (147) involved hospitalizations. Before the rules, 13% (11) described deaths, and another 72% involved hospitalizations. Reports received by the FDA quadrupled since 2005, suggesting that CGTP regulations have contributed to increased reporting and improved tissue safety surveillance. However, these data do not confirm that the reported infections were caused by suspect tissues; most reports may represent routine post-surgical infections not actually due to allografts.

Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

PubMed

Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

2014-07-01

The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

Role of Muscarinic Acetylcholine Receptors in Serial Feature-Positive Discrimination Task during Eyeblink Conditioning in Mice

PubMed Central

Rahman, Md. Ashrafur; Tanaka, Norifumi; Usui, Koji; Kawahara, Shigenori

2016-01-01

We investigated the role of muscarinic acetylcholine receptors (mAChRs) in eyeblink serial feature-positive discrimination learning in mice using the mAChR antagonist. A 2-s light cue was delivered 5 or 6 s before the presentation of a 350-ms tone paired with a 100-ms periorbital electrical shock (cued trial) but not before the tone-alone presentation (non-cued trial). Mice received 30 cued and 30 non-cued trials each day in a random order. We found that saline-injected control mice were successfully discriminating between cued and non-cued trials within a few days of conditioning. The mice responded more frequently to the tone in cued trials than in non-cued trials. Analysis of conditioned response (CR) dynamics revealed that the CR onset latency was shorter in cued trials than in non-cued trials, despite the CR peak amplitude not differing significantly between the two conditions. In contrast, scopolamine-injected mice developed an equal number of CRs with similar temporal patterns irrespective of the presence of the cue during the 7 days of conditioning, indicating in a failure to acquire conditional discrimination. In addition, the scopolamine administration to the control mice after they had successfully acquired discrimination did not impair the conditional discrimination and expression of pre-acquired CR. These results suggest that mAChRs may play a pivotal role in memory formation in the conditional brain state associated with the feature cue; however they are unlikely to be involved in the development of discrimination after conditional memory had formed in the serial feature-positive discrimination task during eyeblink conditioning. PMID:26808980

Contracting out to improve the use of clinical health services and health outcomes in low- and middle-income countries.

PubMed

Odendaal, Willem A; Ward, Kim; Uneke, Jesse; Uro-Chukwu, Henry; Chitama, Dereck; Balakrishna, Yusentha; Kredo, Tamara

2018-04-03

Contracting out of governmental health services is a financing strategy that governs the way in which public sector funds are used to have services delivered by non-governmental health service providers (NGPs). It represents a contract between the government and an NGP, detailing the mechanisms and conditions by which the latter should provide health care on behalf of the government. Contracting out is intended to improve the delivery and use of healthcare services. This Review updates a Cochrane Review first published in 2009. To assess effects of contracting out governmental clinical health services to non-governmental service provider/s, on (i) utilisation of clinical health services; (ii) improvement in population health outcomes; (iii) improvement in equity of utilisation of these services; (iv) costs and cost-effectiveness of delivering the services; and (v) improvement in health systems performance. We searched CENTRAL, MEDLINE, Embase, NHS Economic Evaluation Database, EconLit, ProQuest, and Global Health on 07 April 2017, along with two trials registers - ClinicalTrials.gov and the International Clinical Trials Registry Platform - on 17 November 2017. Individually randomised and cluster-randomised trials, controlled before-after studies, interrupted time series, and repeated measures studies, comparing government-delivered clinical health services versus those contracted out to NGPs, or comparing different models of non-governmental-delivered clinical health services. Two authors independently screened all records, extracted data from the included studies and assessed the risk of bias. We calculated the net effect for all outcomes. A positive value favours the intervention whilst a negative value favours the control. Effect estimates are presented with 95% confidence intervals. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and we prepared a Summary of Findings table. We included two studies, a cluster-randomised trial conducted in Cambodia, and a controlled before-after study conducted in Guatemala. Both studies reported that contracting out over 12 months probably makes little or no difference in (i) immunisation uptake of children 12 to 24 months old (moderate-certainty evidence), (ii) the number of women who had more than two antenatal care visits (moderate-certainty evidence), and (iii) female use of contraceptives (moderate-certainty evidence).The Cambodia trial reported that contracting out may make little or no difference in the mortality over 12 months of children younger than one year of age (net effect = -4.3%, intervention effect P = 0.36, clustered standard error (SE) = 3.0%; low-certainty evidence), nor to the incidence of childhood diarrhoea (net effect = -16.2%, intervention effect P = 0.07, clustered SE = 19.0%; low-certainty evidence). The Cambodia study found that contracting out probably reduces individual out-of-pocket spending over 12 months on curative care (net effect = $ -19.25 (2003 USD), intervention effect P = 0.01, clustered SE = $ 5.12; moderate-certainty evidence). The included studies did not report equity in the use of clinical health services and in adverse effects. This update confirms the findings of the original review. Contracting out probably reduces individual out-of-pocket spending on curative care (moderate-certainty evidence), but probably makes little or no difference in other health utilisation or service delivery outcomes (moderate- to low-certainty evidence). Therefore, contracting out programmes may be no better or worse than government-provided services, although additional rigorously designed studies may change this result. The literature provides many examples of contracting out programmes, which implies that this is a feasible response when governments fail to provide good clinical health care. Future contracting out programmes should be framed within a rigorous study design to allow valid and reliable measures of their effects. Such studies should include qualitative research that assesses the views of programme implementers and beneficiaries, and records implementation mechanisms. This approach may reveal enablers for, and barriers to, successful implementation of such programmes.

Motivating students to read the textbook before class

NASA Astrophysics Data System (ADS)

Pepper, Rachel E.

2016-11-01

Many faculty in STEM courses assign textbook reading in advance of lecture, yet evidence shows few students actually read the textbook. Those students that do read often do so only after the material has been presented in class. Preparing for class by reading the textbook beforehand improves student learning and is particularly critical for classes that employ active engagement strategies. Here I present strategies I have used to successfully motivate my students to read the textbook before class in physics classes ranging from introductory algebra-based physics to advanced courses for physics majors. In the introductory course, I used pre-class reading quizzes, a common strategy that has been shown effective in previous studies, but one that is somewhat time-consuming to implement. In my more advanced courses I used reading reflections, which required considerably less time. While it was typical for less than 25% of students to read the textbook before I implemented reading quizzes or reflections, after implementing these strategies 70-90% of students reported reading the textbook before class most of the time. Students also report finding both the readings themselves and the quizzes and reflections valuable for their learning.

Public smoking ban and socioeconomic inequalities in smoking prevalence and cessation: a cross-sectional population-based study in Geneva, Switzerland (1995-2014).

PubMed

Sandoval, José Luis; Leão, Teresa; Cullati, Stéphane; Theler, Jean-Marc; Joost, Stéphane; Humair, Jean-Paul; Gaspoz, Jean-Michel; Guessous, Idris

2018-01-26

Smoking bans were suggested to reduce smoking prevalence and increase quit ratio but their equity impact remains unclear. We aimed to characterise the socioeconomic status (SES)-related inequalities in smoking prevalence and quit ratio before and after the implementation of a public smoking ban. We included data from 17 544 participants in the population-based cross-sectional Bus Santé study in Geneva, Switzerland, between 1995 and 2014. We considered educational attainment (primary, secondary and tertiary) as a SES indicator. Outcomes were smoking prevalence (proportion of current smokers) and quit ratio (ex-smokers to ever-smokers ratio). We used segmented linear regression to assess the overall impact of smoking ban on outcome trends. We calculated the relative (RII) and slope (SII, absolute difference) indexes of inequality, quantifying disparities between educational groups in outcomes overall (1995-2014), before and after ban implementation (November 2009). Least educated participants displayed higher smoking prevalence (RII=2.04, P<0.001; SII=0.15, P<0.001) and lower quit ratio (RII=0.73, P<0.001; SII=-0.18, P<0.001). As in other studies, smoking ban implementation coincided with a temporary reduction of smoking prevalence (P=0.003) and increase in quit ratio (P=0.02), with a progressive return to preban levels. Inequalities increased (P<0.05) in relative terms for smoking prevalence (RII before =1.84, P<0.001 and RII after =3.01, P<0.001) and absolute terms for both outcomes (smoking prevalence: SII before =0.14, P<0.001 and SII after =0.19, P<0.001; quit ratio: SII before =-0.15, P<0.001 and SII after =-0.27, P<0.001). Implementation of a public smoking ban coincided with a short-lived decrease in smoking prevalence and increase in quit ratio but also with a widening in SES inequalities in smoking-related outcomes. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The effects of neuromuscular training on knee joint motor control during sidecutting in female elite soccer and handball players.

PubMed

Zebis, Mette K; Bencke, Jesper; Andersen, Lars L; Døssing, Simon; Alkjaer, Tine; Magnusson, S Peter; Kjaer, Michael; Aagaard, Per

2008-07-01

The project aimed to implement neuromuscular training during a full soccer and handball league season and to experimentally analyze the neuromuscular adaptation mechanisms elicited by this training during a standardized sidecutting maneuver known to be associated with non-contact anterior cruciate ligament (ACL) injury. The players were tested before and after 1 season without implementation of the prophylactic training and subsequently before and after a full season with the implementation of prophylactic training. A total of 12 female elite soccer players and 8 female elite team handball players aged 26 +/- 3 years at the start of the study. The subjects participated in a specific neuromuscular training program previously shown to reduce non-contact ACL injury. Neuromuscular activity at the knee joint, joint angles at the hip and knee, and ground reaction forces were recorded during a sidecutting maneuver. Neuromuscular activity in the prelanding phase was obtained 10 and 50 ms before foot strike on a force plate and at 10 and 50 ms after foot strike on a force plate. Neuromuscular training markedly increased before activity and landing activity electromyography (EMG) of the semitendinosus (P < 0.05), while quadriceps EMG activity remained unchanged. Neuromuscular training increased EMG activity for the medial hamstring muscles, thereby decreasing the risk of dynamic valgus. This observed neuromuscular adaptation during sidecutting could potentially reduce the risk for non-contact ACL injury.

Effect of Transcutaneous Electric Nerve Stimulation on Pain after Total Knee Arthroplasty: A Blind Randomized Controlled Trial.

PubMed

Beckwée, David; Bautmans, Ivan; Lefeber, Nina; Lievens, Pierre; Scheerlinck, Thierry; Vaes, Peter

2018-02-01

Transcutaneous electric nerve stimulation (TENS) has proven to be effective for postsurgical pain relief. However, there is a lack of well-constructed clinical trials investigating the effect of TENS after total knee arthroplasty (TKA). In addition, previous investigations reported that low- and high-frequency TENSs produced analgesic tolerance after 4 or 5 days of treatment. The aim of this study is to explore the effect of burst TENS on pain during hospitalization after TKA and to investigate whether burst TENS produces analgesic tolerance after 4 or 5 days of treatment. This stratified, triple blind, randomized controlled trial was approved by the University Hospital Brussels. Sixty-eight subjects were screened for eligibility before surgery; 54 were found eligible and 53 were included in the analyses. Patients were allocated to either a burst TENS or sham burst TENS group. TENS was applied daily during continuous passive mobilization. Knee pain intensity, knee range of motion, and analgesic consumption were assessed daily. Patients received burst TENS ( N  = 25) or sham burst TENS ( N  = 28). No significant differences in knee pain intensity were found between the groups ( p  > 0.05). Within the TENS and the sham TENS groups, the difference in knee pain before and after treatment did not evolve over time ( p  > 0.05). This study found no effects of burst TENS compared with sham burst TENS on pain during hospitalization after TKA. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Experimental Effects of Acute Exercise and Meditation on Parameters of Cognitive Function.

PubMed

Edwards, Meghan K; Loprinzi, Paul D

2018-05-29

Single bouts of aerobic exercise and meditation have been shown to improve cognitive function. Yet to be examined in the literature, we sought to examine the effects of a combination of acute bouts of aerobic exercise and meditation on cognitive function among young adults. Participants ( n = 66, mean (SD) age = 21 (2)) were randomly assigned to walk then meditate, meditate then walk, or to sit (inactive control). All walking and meditation bouts were 10 min in duration. Participants' cognition was monitored before and after the intervention using Identification, Set Shifting, Stroop, and Trail Making tasks. Additionally, a subjective assessment of cognitive function was implemented before and after the intervention. Significant group by time interaction effects were observed when examining the Stroop congruent trials ( P = 0.05). Post hoc paired t -tests revealed that reaction time significantly decreased from baseline to post-intervention in both combination groups ( P < 0.001 for both), but not in the control group ( P = 0.09). Regarding all other cognitive assessments, there were no significant group by time interaction effects ( P > 0.05). Cognitive function was not substantially affected by a combination of brief meditation and exercise, though there is evidence to suggest that this combination may have beneficial effects on certain aspects of cognition. Future work should be conducted to evaluate the influences of different doses of exercise and meditation on cognitive functioning.

A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery.

PubMed

Donnenfeld, Eric D; Holland, Edward J; Solomon, Kerry D; Fiore, Jay; Gobbo, Anthony; Prince, Jessica; Sandoval, Helga P; Shull, Emily R; Perry, Henry D

2011-10-01

To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery. Multicenter, randomized, contralateral-eye, double-masked trial. Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery. Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P < .001), respectively. Endothelial cell density was 195.52 cells/mm(2) higher in difluprednate-treated eyes at day 30 (P < .001). Retinal thickness at day 15 was 7.74 μm less in difluprednate-treated eyes (P = .011). In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

Vitamin C–enriched gelatin supplementation before intermittent activity augments collagen synthesis12

PubMed Central

Shaw, Gregory; Lee-Barthel, Ann; Ross, Megan LR; Wang, Bing; Baar, Keith

2017-01-01

Background: Musculoskeletal injuries are the most common complaint in active populations. More than 50% of all injuries in sports can be classified as sprains, strains, ruptures, or breaks of musculoskeletal tissues. Nutritional and/or exercise interventions that increase collagen synthesis and strengthen these tissues could have an important effect on injury rates. Objective: This study was designed to determine whether gelatin supplementation could increase collagen synthesis. Design: Eight healthy male subjects completed a randomized, double-blinded, crossover-design study in which they consumed either 5 or 15 g of vitamin C–enriched gelatin or a placebo control. After the initial drink, blood was taken every 30 min to determine amino acid content in the blood. A larger blood sample was taken before and 1 h after consumption of gelatin for treatment of engineered ligaments. One hour after the initial supplement, the subjects completed 6 min of rope-skipping to stimulate collagen synthesis. This pattern of supplementation was repeated 3 times/d with ≥6 h between exercise bouts for 3 d. Blood was drawn before and 4, 24, 48, and 72 h after the first exercise bout for determination of amino-terminal propeptide of collagen I content. Results: Supplementation with increasing amounts of gelatin increased circulating glycine, proline, hydroxyproline, and hydroxylysine, peaking 1 h after the supplement was given. Engineered ligaments treated for 6 d with serum from samples collected before or 1 h after subjects consumed a placebo or 5 or 15 g gelatin showed increased collagen content and improved mechanics. Subjects who took 15 g gelatin 1 h before exercise showed double the amino-terminal propeptide of collagen I in their blood, indicating increased collagen synthesis. Conclusion: These data suggest that adding gelatin to an intermittent exercise program improves collagen synthesis and could play a beneficial role in injury prevention and tissue repair. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12616001092482. PMID:27852613

Vitamin C-enriched gelatin supplementation before intermittent activity augments collagen synthesis.

PubMed

Shaw, Gregory; Lee-Barthel, Ann; Ross, Megan Lr; Wang, Bing; Baar, Keith

2017-01-01

Musculoskeletal injuries are the most common complaint in active populations. More than 50% of all injuries in sports can be classified as sprains, strains, ruptures, or breaks of musculoskeletal tissues. Nutritional and/or exercise interventions that increase collagen synthesis and strengthen these tissues could have an important effect on injury rates. This study was designed to determine whether gelatin supplementation could increase collagen synthesis. Eight healthy male subjects completed a randomized, double-blinded, crossover-design study in which they consumed either 5 or 15 g of vitamin C-enriched gelatin or a placebo control. After the initial drink, blood was taken every 30 min to determine amino acid content in the blood. A larger blood sample was taken before and 1 h after consumption of gelatin for treatment of engineered ligaments. One hour after the initial supplement, the subjects completed 6 min of rope-skipping to stimulate collagen synthesis. This pattern of supplementation was repeated 3 times/d with ≥6 h between exercise bouts for 3 d. Blood was drawn before and 4, 24, 48, and 72 h after the first exercise bout for determination of amino-terminal propeptide of collagen I content. Supplementation with increasing amounts of gelatin increased circulating glycine, proline, hydroxyproline, and hydroxylysine, peaking 1 h after the supplement was given. Engineered ligaments treated for 6 d with serum from samples collected before or 1 h after subjects consumed a placebo or 5 or 15 g gelatin showed increased collagen content and improved mechanics. Subjects who took 15 g gelatin 1 h before exercise showed double the amino-terminal propeptide of collagen I in their blood, indicating increased collagen synthesis. These data suggest that adding gelatin to an intermittent exercise program improves collagen synthesis and could play a beneficial role in injury prevention and tissue repair. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12616001092482. © 2017 American Society for Nutrition.

Improving palliative care provision in primary care: a pre- and post-survey evaluation among PaTz groups.

PubMed

van der Plas, Annicka Gm; Pasman, H Roeline W; Schweitzer, Bart; Onwuteaka-Philipsen, Bregje D

2018-05-01

In PaTz (PAlliatieve Thuis Zorg, palliative care at home), modelled after the Gold Standards Framework, GPs and community nurses meet on a regular basis to identify patients with palliative care needs (the PaTz register), and to discuss care for these patients. To study the effects of the implementation of PaTz, and provide additional analyses on two important elements: the PaTz register and patient discussions. A pre- and post-evaluation among Dutch GPs ( n = 195 before the start of PaTz; n = 166, 1 year after the start of PaTz). The GPs also provided data on recently deceased patients ( n = 460 before the start of PaTz; n = 305 14 months after the start of PaTz). GPs from all 37 PaTz groups filled in questionnaires. Pre- and post-test differences were analysed using multilevel analyses to adjust for PaTz group. Identification of patients with palliative care needs was done systematically for more patients after implementation of PaTz compared with before (54.3% versus 17.6%). After implementation, 64.8% of deceased patients had been included on the PaTz register. For these patients, when compared with patients not included on the PaTz register, preferred place of death was more likely to be known (88.1% of patients not on the register and 97.3% of deceased patients included on the register), GPs were more likely to have considered a possible death sooner (>1 month before death: 53.0% and 80.2%), and conversations on life expectancy, physical complaints, existential issues, and possibilities of care occurred more often (60.8% and 81.3%; 68.6% and 86.1%; 22.5% and 34.2%; 60.8% and 84.0%, respectively). Implementation of PaTz improved systematic identification of palliative care patients within the GP practice. Use of the PaTz register has added value. © British Journal of General Practice 2018.

Treatment outcomes after implementation of an adapted WHO protocol for severe sepsis and septic shock in Haiti.

PubMed

Papali, Alfred; Eoin West, T; Verceles, Avelino C; Augustin, Marc E; Nathalie Colas, L; Jean-Francois, Carl H; Patel, Devang M; Todd, Nevins W; McCurdy, Michael T

2017-10-01

The World Health Organization (WHO) has developed a simplified algorithm specific to resource-limited settings for the treatment of severe sepsis emphasizing early fluids and antibiotics. However, this protocol's clinical effectiveness is unknown. We describe patient outcomes before and after implementation of an adapted WHO severe sepsis protocol at a community hospital in Haiti. Using a before-and-after study design, we retrospectively enrolled 99 adult Emergency Department patients with severe sepsis from January through March 2012. After protocol implementation in January 2014, we compared outcomes to 67 patients with severe sepsis retrospectively enrolled from February to April 2014. We defined sepsis according to the WHO's Integrated Management of Adult Illness guidelines and severe sepsis as sepsis plus organ dysfunction. After protocol implementation, quantity of fluid administered increased and the physician's differential diagnoses more often included sepsis. Patients were more likely to have follow-up vital signs taken sooner, a radiograph performed, and a lactic acid tested. There were no improvements in mortality, time to fluids or antimicrobials. Use of a simplified sepsis protocol based primarily on physiologic parameters allows for substantial improvements in process measures in the care of severely septic patients in a resource-constrained setting. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of carbohydrate ingestion 15 min before exercise on endurance running capacity.

PubMed

Tokmakidis, Savvas P; Karamanolis, Ioannis A

2008-06-01

This study examined the effects of pre-exercise carbohydrate ingestion on exercise metabolism and endurance running capacity. Eleven active subjects (VO(2) (max) 49.0 +/- 1.7 mL x kg(-1) x min(-1), mean +/- SE) performed two exercise trials 15 min after ingesting glucose (G; 1 g x kg body mass(-1)) and placebo (CON). Each subject ran on a level treadmill for 5 min at 60%, 45 min at 70%, and then at 80% of VO(2) (max) until exhaustion. Serum glucose and plasma insulin reached their peak concentrations (p < 0.01) 15 min after glucose ingestion and declined at the onset of exercise. Serum glycerol concentrations were lower (p < 0.01) in the G trial than in the CON trial after 30 min of exercise to exhaustion. In addition, after 45 min of exercise to exhaustion, the levels of free fatty acids were lower in G than in CON (p < 0.05). No differences were observed in carbohydrate oxidation rates during exercise between treatments (G, 2.53 +/- 0.08 g x min(-1); CON, 2.40 +/- 0.09 g x min(-1)). Time to exhaustion was 12.8% longer in G (p < 0.01) than in CON. These results suggest that glucose ingestion 15 min before prolonged exercise provides an additional carbohydrate source to the exercising muscle, thus improving endurance running capacity.

The effect of open and closed endotracheal tube suctioning system on respiratory parameters of infants undergoing mechanical ventilation

PubMed Central

Taheri, Parvin; Asgari, Narges; Mohammadizadeh, Majid; Golchin, Mehri

2012-01-01

Aims: Mechanical ventilation is used for some infants in neonatal intensive care units (NICU) due to many physiological and clinical causes. Since these patients have endotracheal tubes, cleaning and keeping the airways open through suctioning should be done to increase oxygenation. This study aimed to evaluate effect of open and closed suctioning methods on respiratory parameters of infants undergoing mechanical ventilation. Materials and Methods: In this crossover clinical trial, 44 infants were selected among those undergone mechanical ventilation in NICU of Isfahan's Al-Zahra Hospital using convenience sampling method. The subjects were randomly divided into two groups. In the first group, open suctioning was carried out and after three hours of cleaning, closed suctioning was done. In the second group, closed suctioning was firstly done and following three hours of cleaning, open suctioning was implemented. Respiratory rate (RR) and percentage of arterial blood oxygen saturation was measured before, during and after each type of suctioning. Data were analyzed using repeated measures ANOVA and independent student's t-test. Findings: There was a significant difference between mean respiratory rate and arterial blood oxygen saturation in infants before, during and after the closed and open suctioning. The percentage of arterial blood oxygen saturation had a significant reduction in open method compared to closed method during suctioning and immediately after it. RR three minutes after suctioning showed a significant reduction in both steps in open method compared to closed method. Conclusions: Close method caused fewer changes in hemodynamic status of infants. Therefore, in order to prevent respiratory complications in infants, nurses are recommended to perform the endotracheal tube suctioning by closed method. PMID:23493041

Movement plans for posture selection do not transfer across hands

PubMed Central

Schütz, Christoph; Schack, Thomas

2015-01-01

In a sequential task, the grasp postures people select depend on their movement history. This motor hysteresis effect results from the reuse of former movement plans and reduces the cognitive cost of movement planning. Movement plans for hand trajectories not only transfer across successive trials, but also across hands. We therefore asked whether such a transfer would also be found in movement plans for hand postures. To this end, we designed a sequential, continuous posture selection task. Participants had to open a column of drawers with cylindrical knobs in ascending and descending sequences. A hand switch was required in each sequence. Hand pro/supination was analyzed directly before and after the hand switch. Results showed that hysteresis effects were present directly before, but absent directly after the hand switch. This indicates that, in the current study, movement plans for hand postures only transfer across trials, but not across hands. PMID:26441734

Behavioral and Emotional Problems Associated With Convergence Insufficiency in Children: An Open Trial.

PubMed

Borsting, Eric; Mitchell, G Lynn; Arnold, L Eugene; Scheiman, Mitchell; Chase, Christopher; Kulp, Marjean; Cotter, Susan

2016-10-01

This study investigated behavioral and emotional characteristics of children with convergence insufficiency (CI), before and after treatment with office-based vergence accommodative therapy (OBVAT). Parents of 44 children ages 9 to 17 years with symptomatic CI completed the Conners 3 ADHD Index and the Child Behavior Checklist (CBCL) before and after OBVAT. Pre-treatment scores were compared with normative data and post-treatment scores were compared with baseline using the Wilcoxon sign rank test. Following OBVAT, CI children showed a significant mean improvement (p < .0001, effect size of 0.58) on the Conners 3 ADHD Index with the largest changes occurring in the 23 children who scored the highest at baseline. On the CBCL, anxious/depressed, somatic, and internalizing problems improved significantly (p < .001, effect sizes of -0.36, -1.15, and -0.67, respectively). In an open trial, attention and internalizing problems improved significantly following treatment for CI. © The Author(s) 2013.

Interrupting seasonal transmission of Schistosoma haematobium and control of soil-transmitted helminthiasis in northern and central Côte d'Ivoire: a SCORE study protocol.

PubMed

Tian-Bi, Yves-Nathan T; Ouattara, Mamadou; Knopp, Stefanie; Coulibaly, Jean T; Hürlimann, Eveline; Webster, Bonnie; Allan, Fiona; Rollinson, David; Meïté, Aboulaye; Diakité, Nana R; Konan, Cyrille K; N'Goran, Eliézer K; Utzinger, Jürg

2018-01-29

To achieve a world free of schistosomiasis, the objective is to scale up control and elimination efforts in all endemic countries. Where interruption of transmission is considered feasible, countries are encouraged to implement a comprehensive intervention package, including preventive chemotherapy, information, education and communication (IEC), water, sanitation and hygiene (WASH), and snail control. In northern and central Côte d'Ivoire, transmission of Schistosoma haematobium is seasonal and elimination might be achieved. In a cluster-randomised trial, we will assess different treatment schemes to interrupt S. haematobium transmission and control soil-transmitted helminthiasis over a 3-year period. We will compare the impact of (i) arm A: annual mass drug administration (MDA) with praziquantel and albendazole before the peak schistosomiasis transmission season; (ii) arm B: annual MDA after the peak schistosomiasis transmission season; (iii) arm C: two yearly treatments before and after peak schistosomiasis transmission; and (iv) arm D: annual MDA before peak schistosomiasis transmission, coupled with chemical snail control using niclosamide. The prevalence and intensity of S. haematobium and soil-transmitted helminth infections will be assessed using urine filtration and Kato-Katz thick smears, respectively, in six administrative regions in northern and central parts of Côte d'Ivoire. Once a year, urine and stool samples will be collected and examined from 50 children aged 5-8 years, 100 children aged 9-12 years and 50 adults aged 20-55 years in each of 60 selected villages. Changes in S. haematobium and soil-transmitted helminth prevalence and intensity will be assessed between years and stratified by intervention arm. In the 15 villages randomly assigned to intervention arm D, intermediate host snails will be collected three times per year, before niclosamide is applied to the selected freshwater bodies. The snail abundance and infection rates over time will allow drawing inference on the force of transmission. This cluster-randomised intervention trial will elucidate whether in an area with seasonal transmission, the four different treatment schemes can interrupt S. haematobium transmission and control soil-transmitted helminthiasis. Lessons learned will help to guide schistosomiasis control and elimination programmes elsewhere in Africa. ISRCTN ISRCTN10926858 . Registered 21 December 2016. Retrospectively registered.

Effect of Tdap when administered before, with or after the 13-valent pneumococcal conjugate vaccine (coadministered with the quadrivalent meningococcal conjugate vaccine) in adults: A randomised controlled trial.

PubMed

Tashani, M; Alfelali, M; Barasheed, O; Alqahtani, A S; Heron, L; Wong, M; Rashid, H; Booy, R

2016-11-21

Sequential or co-administration of vaccines has potential to alter the immune response to any of the antigens. Existing literature suggests that prior immunisation of tetanus/diphtheria-containing vaccines can either enhance or suppress immune response to conjugate pneumococcal or meningococcal vaccines. We examined this interaction among adult Australian travellers before attending the Hajj pilgrimage 2014. We also investigated tolerability of these vaccines separately and concomitantly. We randomly assigned each participant to one of three vaccination schedules. Group A received adult tetanus, diphtheria and acellular pertussis vaccine (Tdap) 3-4weeks before receiving CRM197-conjugated 13-valent pneumococcal vaccine (PCV13) and CRM197-conjugated quadrivalent meningococcal vaccine (MCV4). Group B received all three vaccines on one day. Group C received PCV13 and MCV4 3-4weeks before Tdap. Blood samples collected at baseline, each vaccination visit and 3-4weeks after vaccination were tested using the pneumococcal opsonophagocytic assay (OPA) and by ELISA for diphtheria and tetanus antibodies. Funding for meningococcal serology was not available. Participants completed symptom diaries after each vaccination. A total of 111 participants aged 18-64 (median 40) years were recruited. No statistically significant difference was detected across the three groups in achieving OPA titre ⩾1:8 post vaccination. However, compared to other groups, Group A had a statistically significant lower number of subjects achieving ⩾4-fold rise in serotype 3, and also significantly lower geometric mean titres (GMTs) to six (of 13) pneumococcal serotypes (3, 5, 18C, 4, 19A and 9V). Group C (given prior PCV13 and MVC4) had statistically significant higher pre-Tdap geometric mean concentration (GMC) of anti-diphtheria IgG; however, there was no difference across the three groups following Tdap. Anti-tetanus IgG GMCs were similar across the groups before and after Tdap. No serious adverse events were reported. In conclusion, Tdap vaccination 3-4weeks before concomitant administration of PCV13 and MCV4 significantly reduced the antibody response to six of the 13 pneumococcal serotypes in adults. The trial is registered at the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000536763. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cost study : before, during and after AOS implementation (October 1996 - May 1999)

DOT National Transportation Integrated Search

This study compared AATA operating costs over two different time periods: before and during AOS installation. While neither additional operating costs nor operating costs savings were traceable to AOS at this time, the implications of this report, wh...

Implementation of an image sharing system significantly reduced repeat computed tomographic imaging in a regional trauma system.

PubMed

Banerjee, Aman; Zosa, Brenda M; Allen, Debra; Wilczewski, Patricia A; Ferguson, Robert; Claridge, Jeffrey A

2016-01-01

The practice of repeating computed tomography (re-CT) is common among trauma patients transferred between hospitals incurring additional cost and radiation exposure. This study sought to evaluate the effectiveness of implementing modern cloud-based technology (lifeIMAGE) across a regional trauma system to reduce the incidence of re-CT imaging. This is a prospective interventional study to evaluate outcomes after implementation of lifeIMAGE in January 2012. Key outcomes were rates of CT imaging, including the rates and costs of re-CT from January 2009 through December 2012. There were 1,081 trauma patients transferred from participating hospitals during the study period (657 patients before and 425 patients after implementation), with the overall re-CT rate of 20.5%. Rates of any CT imaging at referring hospitals decreased (62% vs. 55%, p < 0.05) and also decreased at the accepting regional Level I center (58% vs. 52%, p < 0.05) following system implementation. There were 639 patients (59%) who had CT imaging performed before transfer (404 patients before and 235 patients after implementation). Of these patients, the overall re-CT rate decreased from 38.4% to 28.1% (p = 0.01). Rates of re-CT of the head (21% vs. 11%, p = 0.002), chest (7% vs. 3%, p = 0.05), as well as abdomen and pelvis (12% vs. 5%, p = 0.007) were significantly reduced following system implementation. The cost of repeat imaging per patient was significantly lower following system implementation (mean charges, $1,046 vs. $589; p < 0.001). These results were more pronounced in a subgroup of patients with an Injury Severity Score (ISS) of greater than 14, with a reduction in overall re-CT rate from 51% to 30% (p = 0.03). The implementation of modern cloud-based technology across the regional trauma system resulted in significant reductions in re-CT imaging and cost. Therapeutic/care management study, level IV; economic analysis, level IV.

User perception and experience of the introduction of a novel critical care patient viewer in the ICU setting.

PubMed

Dziadzko, Mikhail A; Herasevich, Vitaly; Sen, Ayan; Pickering, Brian W; Knight, Ann-Marie A; Moreno Franco, Pablo

2016-04-01

Failure to rapidly identify high-value information due to inappropriate output may alter user acceptance and satisfaction. The information needs for different intensive care unit (ICU) providers are not the same. This can obstruct successful implementation of electronic medical record (EMR) systems. We evaluated the implementation experience and satisfaction of providers using a novel EMR interface-based on the information needs of ICU providers-in the context of an existing EMR system. This before-after study was performed in the ICU setting at two tertiary care hospitals from October 2013 through November 2014. Surveys were delivered to ICU providers before and after implementation of the novel EMR interface. Overall satisfaction and acceptance was reported for both interfaces. A total of 246 before (existing EMR) and 115 after (existing EMR+novel EMR interface) surveys were analyzed. 14% of respondents were prescribers and 86% were non-prescribers. Non-prescribers were more satisfied with the existing EMR, whereas prescribers were more satisfied with the novel EMR interface. Both groups reported easier data gathering, routine tasks & rounding, and fostering of team work with the novel EMR interface. This interface was the primary tool for 18% of respondents after implementation and 73% of respondents intended to use it further. Non-prescribers reported an intention to use this novel interface as their primary tool for information gathering. Compliance and acceptance of new system is not related to previous duration of work in ICU, but ameliorates with the length of EMR interface usage. Task-specific and role-specific considerations are necessary for design and successful implementation of a EMR interface. The difference in user workflows causes disparity of the way of EMR data usage. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Decreased Surgical Site Infection Rate in Hysterectomy: Effect of a Gynecology-Specific Bundle.

PubMed

Andiman, Sarah E; Xu, Xiao; Boyce, John M; Ludwig, Elizabeth M; Rillstone, Heidi R W; Desai, Vrunda B; Fan, Linda L

2018-06-01

We implemented a hysterectomy-specific surgical site infection prevention bundle after a higher-than-expected surgical site infection rate was identified at our institution. We evaluate how this bundle affected the surgical site infection rate, length of hospital stay, and 30-day postoperative readmission rate. This is a quality improvement study featuring retrospective analysis of a prospectively implemented, multidisciplinary team-designed surgical site infection prevention bundle that consisted of chlorhexidine-impregnated preoperative wipes, standardized aseptic surgical preparation, standardized antibiotic dosing, perioperative normothermia, surgical dressing maintenance, and direct feedback to clinicians when the protocol was breached. There were 2,099 hysterectomies completed during the 33-month study period. There were 61 surgical site infections (4.51%) in the pre-full bundle implementation period and 14 (1.87%) in the post-full bundle implementation period; we found a sustained reduction in the proportion of patients experiencing surgical site infection during the last 8 months of the study period. After adjusting for clinical characteristics, patients who underwent surgery after full implementation were less likely to develop a surgical site infection (adjusted odds ratio [OR] 0.46, P=.01) than those undergoing surgery before full implementation. Multivariable regression analysis showed no statistically significant difference in postoperative days of hospital stay (adjusted mean ratio 0.95, P=.09) or rate of readmission for surgical site infection-specific indication (adjusted OR 2.65, P=.08) between the before and after full-bundle implementation periods. The multidisciplinary implementation of a gynecologic perioperative surgical site infection prevention bundle was associated with a significant reduction in surgical site infection rate in patients undergoing hysterectomy.

Altering school climate through school-wide Positive Behavioral Interventions and Supports: findings from a group-randomized effectiveness trial.

PubMed

Bradshaw, Catherine P; Koth, Christine W; Thornton, Leslie A; Leaf, Philip J

2009-06-01

Positive Behavioral Interventions and Supports (PBIS) is a universal, school-wide prevention strategy that is currently implemented in over 7,500 schools to reduce disruptive behavior problems. The present study examines the impact of PBIS on staff reports of school organizational health using data from a group-randomized controlled effectiveness trial of PBIS conducted in 37 elementary schools. Longitudinal multilevel analyses on data from 2,596 staff revealed a significant effect of PBIS on the schools' overall organizational health, resource influence, staff affiliation, and academic emphasis over the 5-year trial; the effects on collegial leadership and institutional integrity were significant when implementation fidelity was included in the model. Trained schools that adopted PBIS the fastest tended to have higher levels of organizational health at baseline, but the later-implementing schools tended to experience the greatest improvements in organizational health after implementing PBIS. This study indicated that changes in school organizational health are important consequences of the PBIS whole-school prevention model, and may in turn be a potential contextual mediator of the effect of PBIS on student performance.

Hemoglobin levels and prevalence of anemia in pregnant women assisted in primary health care services, before and after fortification of flour.

PubMed

Araújo, Claudia Regina Marchiori Antunes; Uchimura, Taqueco Teruya; Fujimori, Elizabeth; Nishida, Fernanda Shizue; Veloso, Giovanna Batista Leite; Szarfarc, Sophia Cornblutz

2013-06-01

We evaluated hemoglobin-Hb levels and prevalence of anemia in pregnant women before and after fortification of flour. It was developed a study to evaluate intervention, of the type before and after, with independent population samples. Study was conducted in primary health care services in Maringá, PR. We assessed 366 and 419 medical records, Before and After implementation of fortification. Pregnant women with Hb < 11g/dL were considered anemic. Data were submitted to multiple linear regression analysis. There was low prevalence of anemia affecting 12.3% and 9.4% pregnant women Before and After fortification (p > 0.05), but the Group After the fortification had higher Hb levels (p < 0.05). Hb levels associated with Group, gestational age, previous pregnancy number, employment and marital status (p < 0.05). Although the fortification of flour may have had role in increasing the mean hemoglobin, we need consider the contribution of other variables not investigated.

When is the best moment to apply photobiomodulation therapy (PBMT) when associated to a treadmill endurance-training program? A randomized, triple-blinded, placebo-controlled clinical trial.

PubMed

Miranda, Eduardo Foschini; Tomazoni, Shaiane Silva; de Paiva, Paulo Roberto Vicente; Pinto, Henrique Dantas; Smith, Denis; Santos, Larissa Aline; de Tarso Camillo de Carvalho, Paulo; Leal-Junior, Ernesto Cesar Pinto

2018-05-01

Photobiomodulation therapy (PBMT) employing low-level laser therapy (LLLT) and/or light emitting diode therapy (LEDT) has emerged as an electrophysical intervention that could be associated with aerobic training to enhance beneficial effects of aerobic exercise. However, the best moment to perform irradiation with PBMT in aerobic training has not been elucidated. The aim of this study was to assess the effects of PBMT applied before and/or after each training session and to evaluate outcomes of the endurance-training program associated with PBMT. Seventy-seven healthy volunteers completed the treadmill-training protocol performed for 12 weeks, with 3 sessions per week. PBMT was performed before and/or after each training session (17 sites on each lower limb, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm infrared LEDs, and 4 × 640 nm red LEDs, dose of 30 J per site). Volunteers were randomized in four groups according to the treatment they would receive before and after each training session: PBMT before + PBMT after, PBMT before + placebo after, placebo before + PBMT after, and placebo before + placebo after. Assessments were performed before the start of the protocol and after 4, 8, and 12 weeks of training. Primary outcome was time until exhaustion; secondary outcome measures were oxygen uptake and body fat. PBMT applied before and after aerobic exercise training sessions (PBMT before + PBMT after group) significantly increased (p < 0.05) the percentage of change of time until exhaustion and oxygen uptake compared to the group treated with placebo before and after aerobic exercise training sessions (placebo before + placebo after group) at 4th, 8th, and 12th week. PBMT applied before and after aerobic exercise training sessions (PBMT before + PBMT after group) also significantly improved (p < 0.05) the percentage of change of body fat compared to the group treated with placebo before and after aerobic exercise training sessions (placebo before + placebo after group) at 8th and 12th week. PBMT applied before and after sessions of aerobic training during 12 weeks can increase the time-to-exhaustion and oxygen uptake and also decrease the body fat in healthy volunteers when compared to placebo irradiation before and after exercise sessions. Our outcomes show that PBMT applied before and after endurance-training exercise sessions lead to improvement of endurance three times faster than exercise only.

Trial protocol: a clustered, randomised, longitudinal, type 2 translational trial of alcohol consumption and alcohol-related harm among adolescents in Australia.

PubMed

Rowland, B; Abraham, C; Carter, R; Abimanyi-Ochom, J; Kelly, A B; Kremer, P; Williams, J W; Smith, R; Hall, J K; Wagner, D; Renner, H; Hosseini, T; Osborn, A; Mohebbi, M; Toumbourou, J W

2018-04-27

This cluster randomised control trial is designed to evaluate whether the Communities That Care intervention (CTC) is effective in reducing the proportion of secondary school age adolescents who use alcohol before the Australian legal purchasing age of 18 years. Secondary outcomes are other substance use and antisocial behaviours. Long term economic benefits of reduced alcohol use by adolescents for the community will also be assessed. Fourteen communities and 14 other non-contiguous communities will be matched on socioeconomic status (SES), location, and size. One of each pair will be randomly allocated to the intervention in three Australian states (Victoria, Queensland and Western Australia). A longitudinal survey will recruit grade 8 and 10 students (M = 15 years old, N = 3500) in 2017 and conduct follow-up surveys in 2019 and 2021 (M = 19 years old). Municipal youth populations will also be monitored for trends in alcohol-harms using hospital and police administrative data. Community-led interventions that systematically and strategically implement evidence-based programs have been shown to be effective in producing population-level behaviour change, including reduced alcohol and drug use. We expect that the study will be associated with significant effects on alcohol use amongst adolescents because interventions adopted within communities will be based on evidence-based practices and target specific problems identified from surveys conducted within each community. The trial was retrospectively registered in September, 2017 ( ACTRN12616001276448 ), as communities were selected prior to trial registration; however, participants were recruited after registration. Findings will be disseminated in peer-review journals and community fora.

Hypofractionated IMRT of the Prostate Bed After Radical Prostatectomy: Acute Toxicity in the PRIAMOS-1 Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Katayama, Sonja, E-mail: sonja.katayama@med.uni-heidelberg.de; Striecker, Thorbjoern; Kessel, Kerstin

Purpose: Hypofractionated radiation therapy as primary treatment for prostate cancer is currently being investigated in large phase 3 trials. However, there are few data on postoperative hypofractionation. The Radiation therapy for the Prostate Bed With or Without the Pelvic Lymph Nodes (PRIAMOS 1) trial was initiated as a prospective phase 2 trial to assess treatment safety and toxicity of a hypofractionated intensity modulated radiation therapy (IMRT) of the prostate bed. Methods and Materials: From February to September 2012, 40 patients with indications for adjuvant or salvage radiation therapy were enrolled. One patient dropped out before treatment. Patients received 54 Gy inmore » 18 fractions to the prostate bed with IMRT and daily image guidance. Gastrointestinal (GI) and genitourinary (GU) toxicities (according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0) were recorded weekly during treatment and 10 weeks after radiation therapy. Results: Overall acute toxicity was favorable, with no recorded adverse events grade ≥3. Acute GI toxicity rates were 56.4% (grade 1) and 17.9% (grade 2). Acute GU toxicity was recorded in 35.9% of patients (maximum grade 1). Urinary stress incontinence was not influenced by radiation therapy. The incidence of grade 1 urinary urge incontinence increased from 2.6% before to 23.1% 10 weeks after therapy, but grade 2 urge incontinence remained unchanged. Conclusions: Postoperative hypofractionated IMRT of the prostate bed is tolerated well, with no severe acute side effects.« less

Perceived impact of the 80-hour workweek: five years later.

PubMed

Dozois, Eric J; Holubar, Stefan D; Tsikitis, Vassiliki L; Malireddy, Kishore; Cima, Robert R; Farley, David R; Larson, David W

2009-09-01

We aimed to assess perceptions of the effects of the 80-hour workweek (80hWW) restriction on patient care, education, and resident quality of life. In April 2007, attending surgeons and residents in nine surgical specialties at our institution were surveyed. Respondents were categorized into three groups: (1) attending surgeons; (2) residents beginning their training before the 80hWW implementation (ResBefore); and (3) residents beginning training after the 80hWW implementation (ResAfter). Differences between groups were assessed with univariate analysis. The overall response rate was 57%. A minority in all three groups (< or =33%) believed the 80hWW improved patient care. Fifteen percent of attending surgeons, 30% of ResBefore, and 67% of ResAfter believed patients were safer (P < 0.001). Eighty-three percent of attending surgeons, 74% of ResBefore, and 41% of ResAfter (P < 0.001) believed continuity of care was compromised. All groups (> or =84%) agreed that midlevel providers were now critical to successfully deliver health care (P = 0.40). Fewer attending surgeons (21%) and ResBefore (29%) perceived improvements in education compared with ResAfter (68%; P <0.001). A majority perceived improved work-life balance for residents (attending surgeons [85%], ResBefore [71%], and ResAfter [92%]; P = 0.008), but 76% of attending surgeons reported decreased job satisfaction. We showed a discrepancy between perceptions of attending surgeons and residents regarding the effect of the 80hWW on patient care and surgical education. Quality of life was improved for residents but not for attending surgeons. The impact of the 80hWW on patient care and surgical education needs to be quantified.

Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study

PubMed Central

Collins, Gary S; Boutron, Isabelle; Yu, Ly-Mee; Cook, Jonathan; Shanyinde, Milensu; Wharton, Rose; Shamseer, Larissa; Altman, Douglas G

2014-01-01

Objective To investigate the effectiveness of open peer review as a mechanism to improve the reporting of randomised trials published in biomedical journals. Design Retrospective before and after study. Setting BioMed Central series medical journals. Sample 93 primary reports of randomised trials published in BMC-series medical journals in 2012. Main outcome measures Changes to the reporting of methodological aspects of randomised trials in manuscripts after peer review, based on the CONSORT checklist, corresponding peer reviewer reports, the type of changes requested, and the extent to which authors adhered to these requests. Results Of the 93 trial reports, 38% (n=35) did not describe the method of random sequence generation, 54% (n=50) concealment of allocation sequence, 50% (n=46) whether the study was blinded, 34% (n=32) the sample size calculation, 35% (n=33) specification of primary and secondary outcomes, 55% (n=51) results for the primary outcome, and 90% (n=84) details of the trial protocol. The number of changes between manuscript versions was relatively small; most involved adding new information or altering existing information. Most changes requested by peer reviewers had a positive impact on the reporting of the final manuscript—for example, adding or clarifying randomisation and blinding (n=27), sample size (n=15), primary and secondary outcomes (n=16), results for primary or secondary outcomes (n=14), and toning down conclusions to reflect the results (n=27). Some changes requested by peer reviewers, however, had a negative impact, such as adding additional unplanned analyses (n=15). Conclusion Peer reviewers fail to detect important deficiencies in reporting of the methods and results of randomised trials. The number of these changes requested by peer reviewers was relatively small. Although most had a positive impact, some were inappropriate and could have a negative impact on reporting in the final publication. PMID:24986891

The Effectiveness of Mindfulness-Based Cognitive Group Therapy on Marital Satisfaction and General Health in Woman With Infertility.

PubMed

Abedi Shargh, Najmeh; Bakhshani, Nour Mohammad; Mohebbi, Mohammad Davoud; Mahmudian, Khadije; Ahovan, Masood; Mokhtari, Mojgan; Gangali, Alireza

2015-08-06

Infertility affects around 80 million people around the world and it has been estimated that psychological problems in infertile couples is within the range of 25-60%. The purpose of this study was to determine the effectiveness of Mindfulness-based cognitive group therapy on consciousness regarding marital satisfaction and general health in woman with infertility. Recent work is a clinical trial with a pre/posttest plan for control group. Covering 60 women who were selected by in access method and arranged randomly in interference (30) and control (30) groups. Before and after implementation of independent variable, all subjects were measured in both groups using Enrich questionnaire and marital satisfaction questionnaire. Results of covariance analysis of posttest, after controlling the scores of pretest illustrated the meaningful difference of marital satisfaction and mental health scores in interference and control groups after treatment and the fact that MBCT treatment in infertile women revealed that this method has an appropriate contribution to improvement of marital satisfaction and mental health. Necessary trainings for infertile people through consultation services can improve their mental health and marital satisfaction and significantly help reducing infertile couples' problems.

Evaluation of Helping Babies Breathe Quality Improvement Cycle (HBB-QIC) on retention of neonatal resuscitation skills six months after training in Nepal.

PubMed

Kc, Ashish; Wrammert, Johan; Nelin, Viktoria; Clark, Robert B; Ewald, Uwe; Peterson, Stefan; Målqvist, Mats

2017-04-11

Each year 700,000 infants die due to intrapartum-related complications. Implementation of Helping Babies Breathe (HBB)-a simplified neonatal resuscitation protocol in low-resource clinical settings has shown to reduce intrapartum stillbirths and first-day neonatal mortality. However, there is a lack of evidence on the effect of different HBB implementation strategies to improve and sustain the clinical competency of health workers on bag-and-mask ventilation. This study was conducted to evaluate the impact of multi-faceted implementation strategy for HBB, as a quality improvement cycle (HBB-QIC), on the retention of neonatal resuscitation skills in a tertiary hospital of Nepal. A time-series design was applied. The multi-faceted intervention for HBB-QIC included training, daily bag-and-mask skill checks, preparation for resuscitation before every birth, self-evaluation and peer review on neonatal resuscitation skills, and weekly review meetings. Knowledge and skills were assessed through questionnaires, skill checklists, and Objective Structured Clinical Examinations (OSCE) before implementation of the HBB-QIC, immediately after HBB training, and again at 6 months. Means were compared using paired t-tests, and associations between skill retention and HBB-QIC components were analyzed using logistic regression analysis. One hundred thirty seven health workers were enrolled in the study. Knowledge scores were higher immediately following the HBB training, 16.4 ± 1.4 compared to 12.8 ± 1.6 before (out of 17), and the knowledge was retained 6 months after the training (16.5 ± 1.1). Bag-and-mask skills improved immediately after the training and were retained 6 months after the training. The retention of bag-and-mask skills was associated with daily bag-and-mask skill checks, preparation for resuscitation before every birth, use of a self-evaluation checklist, and attendance at weekly review meetings. The implementation strategies with the highest association to skill retention were daily bag-and-mask skill checks (RR-5.1, 95% CI 1.9-13.5) and use of self-evaluation checklists after every delivery (RR-3.8, 95% CI 1.4-9.7). Health workers who practiced bag-and-mask skills, prepared for resuscitation before every birth, used self-evaluation checklists, and attended weekly review meetings were more likely to retain their neonatal resuscitation skills. Further studies are required to evaluate HBB-QIC in primary care settings, where the number of deliveries is gradually increasing. ISRCTN97846009 . Date of Registration- 15 August 2012.

Travel by Walking Before and After School Increases Physical Activity among Adolescent Girls

PubMed Central

Catellier, Diane J.; Pfeiffer, Karin; Schmitz, Kathryn H.; Conway, Terry; Going, Scott; Ward, Dianne; Strikmiller, Patty; Treuth, Margarita S.

2008-01-01

Objective To examine how travel by walking before and after school contributes to total physical activity of adolescent girls. Design Cross-sectional sample. Setting 36 middle schools from Arizona, Maryland, Minnesota, New Orleans, San Diego and South Carolina participating in the Trial of Activity for Adolescent Girls (TAAG). Participants 1721 6th grade girls consented to participate; adequate information was available for 1596 (93%) of participants. Main outcome measure Travel by walking before school, after school, and before and after school combined, assessed from the 3-Day Physical Activity Recall (3DPAR). Mean minutes of physical activity, measured by accelerometry, were estimated for total physical activity (light, moderate, vigorous), moderate to vigorous activity (MVPA), and MVPA (3 MET). Results Travel by walking was reported by 14% of participants before and 18% after school. Girls who reported “travel by walking” before and after school (combined) had 13.7 (95% confidence interval [CI], 1.2 – 26.3) more minutes of total PA and 4.7 (95% CI, 2.2 – 7.2) more minutes of MVPA than girls who did not report this activity. Before school and after school walkers (but not both) accumulated 2.5 (95% CI, 0.10 – 4.9) and 2.2 (95% CI, 0.24 – 4.2) more minutes of MVPA on an average weekday, respectively, than non-walkers. Conclusions Our results provide evidence that walking for transportation before and after school increases weekday minutes of total physical activity and MVPA for middle school girls. PMID:17283300

The effects of salmeterol on power output in nonasthmatic athletes.

PubMed

McDowell, S L; Fleck, S J; Storms, W W

1997-04-01

Salmeterol xinafoate is a new aerosol inhalant that is used in the treatment of asthma. It is currently banned by the International Olympic Committee because of the concern that it may lend an unfair competitive advantage to the user. The purpose of this study was to determine whether salmeterol improves short-term anaerobic performance in elite nonasthmatic track cyclists. Eleven elite track cyclists volunteered to perform a 30-second all-out cycle ergometer test 3 hours after receiving either 42 micrograms of salmeterol xinafoate or placebo applied in a double-blind crossover procedure. During the ergometer test, peak power output, total work, time to peak power, and percent fatigue (decline in power output) were measured. Pulmonary measurements were also taken before and at various time points after inhalation and the ergometer test. A methacholine challenge was administered to each subject before participation in the study to ensure that none of the subjects had any reactive airway diseases. There were no significant differences (p > 0.05) between the placebo and salmeterol trials for peak power output, total work performed during the 30-second test, percent fatigue, and time to peak power. No differences between trials were observed for the pulmonary function test variables at any of the time points. Blood lactate concentrations before and after administration of drug or placebo were also not significantly different between trials. Additionally, salmeterol did not affect the maximal heart rate achieved during the test as compared with the placebo. Short-term salmeterol use within the prescribed dosage was not shown to increase short-term power output in nonasthmatic cyclists.

Healthcare Applications of Smart Watches

PubMed Central

Lu, Tsung-Chien; Fu, Chia-Ming; Ma, Matthew Huei-Ming; Fang, Cheng-Chung

2016-01-01

Summary Objective The aim of this systematic review is to synthesize research studies involving the use of smart watch devices for healthcare. Materials and Methods The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was chosen as the systematic review methodology. We searched PubMed, CINAHL Plus, EMBASE, ACM, and IEEE Xplore. In order to include ongoing clinical trials, we also searched ClinicalTrials.gov. Two investigators evaluated the retrieved articles for inclusion. Discrepancies between investigators regarding article inclusion and extracted data were resolved through team discussion. Results 356 articles were screened and 24 were selected for review. The most common publication venue was in conference proceedings (13, 54%). The majority of studies were published or presented in 2015 (19, 79%). We identified two registered clinical trials underway. A large proportion of the identified studies focused on applications involving health monitoring for the elderly (6, 25%). Five studies focused on patients with Parkinson’s disease and one on cardiac arrest. There were no studies which reported use of usability testing before implementation. Discussion Most of the reviewed studies focused on the chronically ill elderly. There was a lack of detailed description of user-centered design or usability testing before implementation. Based on our review, the most commonly used platform in healthcare research was that of the Android Wear. The clinical application of smart watches as assistive devices deserves further attention. Conclusion Smart watches are unobtrusive and easy to wear. While smart watch technology supplied with biosensors has potential to be useful in a variety of healthcare applications, rigorous research with their use in clinical settings is needed. PMID:27623763

Healthcare Applications of Smart Watches. A Systematic Review.

PubMed

Lu, Tsung-Chien; Fu, Chia-Ming; Ma, Matthew Huei-Ming; Fang, Cheng-Chung; Turner, Anne M

2016-09-14

The aim of this systematic review is to synthesize research studies involving the use of smart watch devices for healthcare. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was chosen as the systematic review methodology. We searched PubMed, CINAHL Plus, EMBASE, ACM, and IEEE Xplore. In order to include ongoing clinical trials, we also searched ClinicalTrials.gov. Two investigators evaluated the retrieved articles for inclusion. Discrepancies between investigators regarding article inclusion and extracted data were resolved through team discussion. 356 articles were screened and 24 were selected for review. The most common publication venue was in conference proceedings (13, 54%). The majority of studies were published or presented in 2015 (19, 79%). We identified two registered clinical trials underway. A large proportion of the identified studies focused on applications involving health monitoring for the elderly (6, 25%). Five studies focused on patients with Parkinson's disease and one on cardiac arrest. There were no studies which reported use of usability testing before implementation. Most of the reviewed studies focused on the chronically ill elderly. There was a lack of detailed description of user-centered design or usability testing before implementation. Based on our review, the most commonly used platform in healthcare research was that of the Android Wear. The clinical application of smart watches as assistive devices deserves further attention. Smart watches are unobtrusive and easy to wear. While smart watch technology supplied with biosensors has potential to be useful in a variety of healthcare applications, rigorous research with their use in clinical settings is needed.

Cutaneous fungal microbiome: Malassezia yeasts in seborrheic dermatitis scalp in a randomized, comparative and therapeutic trial

PubMed Central

Kamamoto, C. S. L.; Nishikaku, A. S.; Gompertz, O. F.; Melo, A. S.; Hassun, K. M.; Bagatin, E.

2017-01-01

ABSTRACT Malassezia spp in skin microbiome scalp has been implicated in seborrheic dermatitis pathogenesis. Thus, treatment based in antifungal combined to topical keratolitic agents have been indicated as well as oral isotretinoin as it reduces the sebum production, glandular's size and possesses anti-inflammatory properties. This randomized, comparative and therapeutic trial aimed toper form the genotypic identification of Malassezia species before and after low-dose oral isotretinoin or topical antifungal treatments for moderate to severe seborrhea and/or seborrheic dermatitis on scalp. Scales and sebum of the scalp were seeded in the middle of modified Dixon and incubated at 32°C. For genotypic identification polymerase chain reaction primers for the ITS and D1/D2 ribossomal DNA were used and followed by samples sequencing. The procedure was conducted before and after therapeutic and randomized intervention for moderate to severe seborrhea/seborrheic dermatitis on the scalp, including oral isotretinoin, 10 mg, every other day and anti-seborrheic shampoo (piroctone olamine), over six months. The M. globosa and M. restricta were the most frequent species isolated on the scalp before and after both treatments. Other non-Malassezia species were also identified. The Malassezia spp. were maintained in the scalp after both treatments that were equally effective for the control of seborrhea/seborrheic dermatitis clinical signs. PMID:29484095

Effect of hand and foot surface stroke massage on anxiety and vital signs in patients with acute coronary syndrome: A randomized clinical trial.

PubMed

Alimohammad, Hasheminia Seyyed; Ghasemi, Zahra; Shahriar, Salehi; Morteza, Sedehi; Arsalan, Khaledifar

2018-05-01

Anxiety affects various body systems, which leads to an increase in respiratory rate, heart rate, blood pressure, and myocardial oxygen demand. The aim of this study was to investigate the effect of hand and foot surface stroke massage on the level of anxiety and vital signs in patients with acute coronary syndrome (ACS). The single-blind clinical trial was performed on 70 patients with ACS. The patients were randomly assigned to the case and control groups. Anxiety levels were controlled 30 min before and 15 min after the intervention. The vital signs were checked in the two groups before, immediately after, 60 min, and 90 min after the intervention. The data were analyzed using SPSS software, descriptive statistics (mean ± standard deviation), independent t-test, paired t-test, and chi-square test. No significant difference was observed in the patients' levels of anxiety, systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse rate before the intervention. However, after the intervention, the mean changes in the levels of anxiety, blood pressure, heart rate, and respiratory rate were significant. Hand and foot massage can be a useful nursing intervention in attenuating anxiety levels and improving the vital signs in patients. Copyright © 2018. Published by Elsevier Ltd.

Moving to patient reported collection of race and ethnicity data: implementation and impact in ten hospitals.

PubMed

Berry, Carolyn; Kaplan, Sue A; Mijanovich, Tod; Mayer, Andrea

2014-01-01

The purpose of this paper is to examine the feasibility of collecting standardized, patient reported race and ethnicity (RE) data in hospitals, and to assess the impact on data quality and utility. Part of a larger evaluation that included a comprehensive assessment. Sites documented RE data collection procedures before and after program implementation. Primary data collected through qualitative interviewing with key respondents in ten hospitals to assess implementation. Nine hospitals provided RE data on the same patients before and after implementation new data collection procedures were implemented to assess impact. Implementation went smoothly in nine of ten hospitals and had substantial effects on the hospital staff awareness on the potential for disparities within their hospitals. New procedures had minimal impact on characterization of readmitted patients. This study demonstrated that it is feasible for staff in a diverse group of hospitals to implement systematic, internally standardized methods to collect self-reported RE data from patients. Although this study found little impact patients' demographic characterizations, other benefits included greater awareness of and attention to disparities, uncovering small pockets of minorities, and dramatically increased RE data use in quality improvement efforts.

Estimated Effect of Inactivated Poliovirus Vaccine Campaigns, Nigeria and Pakistan, January 2014-April 2016.

PubMed

Shirreff, George; Wadood, Mufti Zubair; Vaz, Rui Gama; Sutter, Roland W; Grassly, Nicholas C

2017-02-01

In 2014, inactivated poliovirus vaccine (IPV) campaigns were implemented in Nigeria and Pakistan after clinical trials showed that IPV boosts intestinal immunity in children previously given oral poliovirus vaccine (OPV). We estimated the effect of these campaigns by using surveillance data collected during January 2014-April 2016. In Nigeria, campaigns with IPV and trivalent OPV (tOPV) substantially reduced the incidence of poliomyelitis caused by circulating serotype-2 vaccine-derived poliovirus (incidence rate ratio [IRR] 0.17 for 90 days after vs. 90 days before campaigns, 95% CI 0.04-0.78) and the prevalence of virus in environmental samples (prevalence ratio [PR] 0.16, 95% CI 0.02-1.33). Campaigns with tOPV alone resulted in similar reductions (IRR 0.59, 95% CI 0.18-1.97; PR 0.45, 95% CI 0.21-0.95). In Pakistan, the effect of IPV+tOPV campaigns on wild-type poliovirus was not significant. Results suggest that administration of IPV alongside OPV can decrease poliovirus transmission if high vaccine coverage is achieved.

Estimated Effect of Inactivated Poliovirus Vaccine Campaigns, Nigeria and Pakistan, January 2014–April 2016

PubMed Central

Shirreff, George; Wadood, Mufti Zubair; Vaz, Rui Gama; Sutter, Roland W.

2017-01-01

In 2014, inactivated poliovirus vaccine (IPV) campaigns were implemented in Nigeria and Pakistan after clinical trials showed that IPV boosts intestinal immunity in children previously given oral poliovirus vaccine (OPV). We estimated the effect of these campaigns by using surveillance data collected during January 2014–April 2016. In Nigeria, campaigns with IPV and trivalent OPV (tOPV) substantially reduced the incidence of poliomyelitis caused by circulating serotype-2 vaccine–derived poliovirus (incidence rate ratio [IRR] 0.17 for 90 days after vs. 90 days before campaigns, 95% CI 0.04–0.78) and the prevalence of virus in environmental samples (prevalence ratio [PR] 0.16, 95% CI 0.02–1.33). Campaigns with tOPV alone resulted in similar reductions (IRR 0.59, 95% CI 0.18–1.97; PR 0.45, 95% CI 0.21–0.95). In Pakistan, the effect of IPV+tOPV campaigns on wild-type poliovirus was not significant. Results suggest that administration of IPV alongside OPV can decrease poliovirus transmission if high vaccine coverage is achieved. PMID:27861118

The Impact of School Socioeconomic Status on Student Lunch Consumption after Implementation of the Texas Public School Nutrition Policy

ERIC Educational Resources Information Center

Cullen, Karen Weber; Watson, Kathleen B.; Fithian, Ashley R.

2009-01-01

Background: This study compares the impact of the Texas Public School Nutrition Policy on lunch consumption of low- and middle-income students in sixth through eighth grades. Methods: Students in 1 middle socioeconomic status (SES) and 1 low SES school completed lunch food records before (2001/2002) and after (2005/2006) implementation of the…

Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients.

PubMed

Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

2016-01-01

Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0-10) numerical rating scale at three months post-mastectomy. Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Clinicaltrials.gov NCT01536314.

Clinical trials in predementia stages of Alzheimer disease.

PubMed

Pillai, Jagan A; Cummings, Jeffrey L

2013-05-01

Effective treatments of Alzheimer disease (AD) dementia are an urgent necessity. There is a growing consensus that effective disease-modifying treatment before the onset of clinical dementia and slowing the progression of mild symptoms are needed after recent setbacks in AD therapeutics. The identification of at-risk and preclinical AD populations is becoming important for targeting primary and secondary prevention clinical trials in AD. This article reviews the strategies and challenges in targeting at-risk and preclinical AD populations for a new generation of AD clinical trials. Design, outcome measures, and complexities in successfully completing a clinical trial targeting this population are reviewed. Copyright © 2013 Elsevier Inc. All rights reserved.

Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption

PubMed Central

Bar, K.J.; Sneller, M.C.; Harrison, L.J.; Justement, J.S.; Overton, E.T.; Petrone, M.E.; Salantes, D.B.; Seamon, C.A.; Scheinfeld, B.; Kwan, R.W.; Learn, G.H.; Proschan, M.A.; Kreider, E.F.; Blazkova, J.; Bardsley, M.; Refsland, E.W.; Messer, M.; Clarridge, K.E.; Tustin, N.B.; Madden, P.J.; Oden, K.S.; O’Dell, S.J.; Jarocki, B.; Shiakolas, A.R.; Tressler, R.L.; Doria-Rose, N.A.; Bailer, R.T.; Ledgerwood, J.E.; Capparelli, E.V.; Lynch, R.M.; Graham, B.S.; Moir, S.; Koup, R.A.; Mascola, J.R.; Hoxie, J.A.; Fauci, A.S.; Tebas, P.; Chun, T.-W.

2017-01-01

BACKGROUND The discovery of potent and broadly neutralizing antibodies (bNAbs) against human immunodeficiency virus (HIV) has made passive immunization a potential strategy for the prevention and treatment of HIV infection. We sought to determine whether passive administration of VRC01, a bNAb targeting the HIV CD4-binding site, can safely prevent or delay plasma viral rebound after the discontinuation of antiretroviral therapy (ART). METHODS We conducted two open-label trials (AIDS Clinical Trials Group [ACTG] A5340 and National Institutes of Health [NIH] 15-I-0140) of the safety, side-effect profile, pharmacokinetic properties, and antiviral activity of VRC01 in persons with HIV infection who were undergoing interruption of ART. RESULTS A total of 24 participants were enrolled, and one serious alcohol-related adverse event occurred. Viral rebound occurred despite plasma VRC01 concentrations greater than 50 μg per milliliter. The median time to rebound was 4 weeks in the A5340 trial and 5.6 weeks in the NIH trial. Study participants were more likely than historical controls to have viral suppression at week 4 (38% vs. 13%, P = 0.04 by a two-sided Fisher’s exact test in the A5340 trial; and 80% vs. 13%, P<0.001 by a two-sided Fisher’s exact test in the NIH trial) but the difference was not significant at week 8. Analyses of virus populations before ART as well as before and after ART interruption showed that VRC01 exerted pressure on rebounding virus, resulting in restriction of recrudescent viruses and selection for preexisting and emerging antibody neutralization–resistant virus. CONCLUSIONS VRC01 slightly delayed plasma viral rebound in the trial participants, as compared with historical controls, but it did not maintain viral suppression by week 8. In the small number of participants enrolled in these trials, no safety concerns were identified with passive immunization with a single bNAb (VRC01). (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTG A5340 and NIH 15-I-0140 ClinicalTrials.gov numbers, NCT02463227 and NCT02471326.) PMID:27959728

Time trend of injection drug errors before and after implementation of bar-code verification system.

PubMed

Sakushima, Ken; Umeki, Reona; Endoh, Akira; Ito, Yoichi M; Nasuhara, Yasuyuki

2015-01-01

Bar-code technology, used for verification of patients and their medication, could prevent medication errors in clinical practice. Retrospective analysis of electronically stored medical error reports was conducted in a university hospital. The number of reported medication errors of injected drugs, including wrong drug administration and administration to the wrong patient, was compared before and after implementation of the bar-code verification system for inpatient care. A total of 2867 error reports associated with injection drugs were extracted. Wrong patient errors decreased significantly after implementation of the bar-code verification system (17.4/year vs. 4.5/year, p< 0.05), although wrong drug errors did not decrease sufficiently (24.2/year vs. 20.3/year). The source of medication errors due to wrong drugs was drug preparation in hospital wards. Bar-code medication administration is effective for prevention of wrong patient errors. However, ordinary bar-code verification systems are limited in their ability to prevent incorrect drug preparation in hospital wards.

Use of the Dye Stain Assay and Ultraviolet Light Test for Assessing Vaginal Insertion of Placebo-filled Applicators Before and After Sex

PubMed Central

Keller, Marla J.; Buckley, Niall; Katzen, Lauren L.; Walsh, Jennifer; Friedland, Barbara; Littlefield, Sarah; Lin, Juan; Xue, Xiaonan; Cornelison, Terri; Herold, Betsy C.; Einstein, Mark H.

2014-01-01

Background Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or pre-sex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. Methods Healthy monogamous couples received Microlax®-type applicators filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert one dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen followed by UV then DSA and scored by two readers. Positive and negative controls were randomly included in applicator batches. Results Fifteen couples completed the study. Each female returned at least six applicators over a 30-day period. The sensitivity for insertion of post-sex applicators was higher for UV (97%) compared to DSA (90%) and the specificity was similar (≥96%). For pre-sex applicators, the sensitivity and specificity were higher for DSA (100%) compared to UV testing (87% sensitivity, 96% specificity). Among returned post-sex applicators, 95% tested positive by UV compared to 87% by DSA. Agreement between readers was significantly better on the pre-sex applicators for DSA than for UV and for post-sex readings agreement was less than half that for UV, although the results were not statistically significant. Conclusions Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex. PMID:24220355

Effect of green tea on metabolic and hormonal aspect of polycystic ovarian syndrome in overweight and obese women suffering from polycystic ovarian syndrome: A clinical trial.

PubMed

Tehrani, Hatav Gasemi; Allahdadian, Maryam; Zarre, Farzane; Ranjbar, Hanie; Allahdadian, Fateme

2017-01-01

Polycystic ovarian syndrome (PCOS) is the common cause of Oligo-ovulation. This syndrome causes long-term metabolic issues as well as increase the risk of diabetes type 2, hypertension, dyslipidemia, and cardiovascular disease. The current research aimed to study the effect of green tea on weight and hormonal changes of women suffering from PCOS. This two group, double-blind, randomized clinical trial was conducted in Isfahan city. Overweight women suffering from PCOS ( n = 60) were randomly divided into two groups. Green tea was prescribed to the experimental group, and placebo was prescribed to the control group. Free testosterone hormones and fasting insulin were compared in both groups at the beginning and 12 weeks after the study commencement. The weight of participants of both groups was also measured before and after the study. The statistical data were analyzed by SPSS software and paired t -test. The paired t -test showed that there was no significant difference in the mean weight of both groups before the intervention ( P = 0.812), but the difference was significant after the intervention ( P = 0.031). There was no significant difference in the mean fasting insulin of both groups before the intervention ( P = 0.352), but the difference was significant after the intervention ( P < 0.0001). Moreover, there was no significant difference in the mean free testosterone level of both groups before the intervention ( P = 0.638), but the difference was significant after the intervention ( P < 0.0001). The consumption of green tea by overweight and obese women suffering from PCOS leads to weight loss, a decrease in fasting insulin, and a decrease in the level of free testosterone.

Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol.

PubMed

Chibwesha, Carla J; Ford, Catherine E; Mollan, Katie R; Stringer, Jeffrey S A

2016-08-01

In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible. The study uses a randomized, controlled design to test whether the Alere q platform for HIV DNA polymerase chain reaction (PCR) testing improves outcomes of HIV-infected children in Zambia. We aim to enroll 2867 HIV-exposed infants aged 4-12 weeks and to follow those who are HIV infected for 12 months as they receive HIV care at 6 public health facilities in Lusaka. The trial's primary endpoint is the proportion of HIV-infected infants in each study arm who start ART and remain alive, in care, and virally suppressed 12 months after their diagnostic blood draw. Our trial will provide evidence for the incremental benefit of implementing a POC EID strategy in low-resource settings where only off-site PCR services are currently available. The results will be useful in guiding future decisions regarding investments in POC virologic testing as part of overall pediatric AIDS mitigation strategies in sub-Saharan Africa. clinicaltrials.gov NCT02682810.

Knowledge transfer for the management of dementia: a cluster-randomised trial of blended learning in general practice

PubMed Central

2010-01-01

Background The implementation of new medical knowledge into general practice is a complex process. Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to-practice gap. The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles (QCs) and QCs alone. Methods In this cluster-randomised trial with QCs as clusters and general practitioners (GPs) as participants, 389 GPs from 26 QCs in the western part of Germany were invited to participate. Data on the GPs' knowledge were obtained at three points in time by means of a questionnaire survey. Primary outcome was the knowledge gain before and after the interventions. A subgroup analysis of the users of the online modules was performed. Results 166 GPs were available for analysis and filled out a knowledge test at least two times. A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches. However, there was no significant difference between the groups. A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores. Conclusion A blended learning approach was not superior to a QCs approach for improving knowledge about dementia management. However, a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge. Trial registration Current Controlled Trials ISRCTN36550981. PMID:20047652

A Local School District Implements a State Mandated Instructional Program on AIDS Prevention.

ERIC Educational Resources Information Center

Hall, Janie L.

Implementation of an Acquired Immune Deficiency Syndrome (AIDS) education program in Oklahoma is briefly outlined in the areas of the state mandate, local implementation, teacher training, parent meetings, and short and long courses. A study of the level of student knowledge about AIDS before and after instruction is described. Subjects were 7,145…

Assessing the Feasibility of a Multi-Program School-Based Intervention to Promote Physical Activity and Healthful Eating in Middle Schools Prior to Wide-Scale Implementation

ERIC Educational Resources Information Center

Greaney, Mary; Hardwick, Cary K.; Mezgebu, Solomon; Lindsay, Ana C.; Roover, Michelle L.; Peterson, Karen E.

2007-01-01

Background: University-community partnerships can support schools in implementing evidence-based responses to youth obesity trends. An inter-organizational partnership was established to implement and evaluate the Healthy Choices Collaborative Intervention (HCCI). HCCI combines an interdisciplinary curriculum, before/after school activities, and…

Retrospective survey of the efficacy of mandatory implementation of the Essential Medicine Policy in the primary healthcare setting in China: failure to promote the rational use of antibiotics in clinics.

PubMed

Xiao, Yonghong; Wang, Jin; Shen, Ping; Zheng, Beiwen; Zheng, Yingdong; Li, Lanjuan

2016-10-01

The objective of this study was to understand the impact of implementation of the Essential Medicine Policy (EMP) on the rational use of antibiotics in primary medical institutions in China. A retrospective survey was conducted in 39 primary medical institutions to compare the efficacy of EMP in rational antibiotic use. All institutions completed the survey 1 year before and 1 year after implementation of the EMP. In particular, antibiotic use and its rationality were closely examined. The institutions mainly dealt with common diseases, especially non-infectious chronic diseases. Antibiotic usage was very inappropriate both before and after EMP implementation. Before and after EMP implementation, respectively, the median outpatient cost was US$6.34 and US$5.05, 52.50% (2005/3819) and 53.41% (1865/3492) of the outpatient prescriptions contained antibiotics, and 76.23% (1132/1485) and 78.83% (1106/1403) of inpatients were administered antibiotics. In addition, 98.38% (425/432) and 97.52% (512/525) of surgical inpatients were administered antibiotics, respectively, and 80.76% (638/790) and 75.19% (503/669) of patients with a cold were prescribed antibiotics, respectively. The most commonly used antibiotics were broad-spectrum and injectable agents, including cephalosporins, fluoroquinolones and penicillins. This profile showed little change following implementation of the EMP. In conclusion, inappropriate antibiotic use is a serious problem in primary medical institutions in China. Whilst enforcing the EMP reduced the cost of medical services, it had little effect on promoting the rational use of antibiotics. Copyright © 2016 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

A randomized controlled trial of aspirin and exertional heat stress activation of platelets in firefighters during exertion in thermal protective clothing.

PubMed

Hostler, David; Suyama, Joe; Guyette, Francis X; Moore, Charity G; Pryor, Riana R; Khorana, Priya; McEntire, Serina J; Comer, Diane; Reis, Steven E

2014-01-01

Platelet aggregation is enhanced in firefighters following short bouts of work in thermal protective clothing (TPC). We sought to determine if aspirin therapy before and/or following exertion in TPC prevents platelet activation. In a double-blind, placebo-controlled study, 102 firefighters were randomized to receive daily therapy (81 mg aspirin or placebo) for 14 days before and a single dose (325 mg aspirin or placebo) following exercise in TPC resulting in four potential assignments: aspirin before and after exercise (AA), placebo before and after exercise (PP), aspirin before and placebo after exercise (AP), and placebo before and aspirin after exercise (PA). Platelet closure time (PCT) was measured with a platelet function analyzer before the 2-week treatment, after the 2 week treatment period, immediately after exercise, and 30, 60, and 90 minutes later. Baseline PCT did not differ between groups. PCT changed over time in all four groups (p < 0.001) rising to a median of >300 seconds [IQR 99, 300] in AA and >300 [92, 300] in AP prior to exercise. Following exercise, median PCT decreased to in all groups. Median PCT returned to >300 seconds 30 minutes later in AA and AP and rose to 300 seconds in PA 60 minutes after exercise. Daily aspirin therapy blunts platelet activation during exertional heat stress and single-dose aspirin therapy following exertional heat stress reduces platelet activation within 60 minutes.

The effect of inhalation aromatherapy with damask rose (Rosa damascena) essence on the pain intensity after dressing in patients with burns: A clinical randomized trial

PubMed Central

Bikmoradi, Ali; Harorani, Mehdi; Roshanaei, Ghodratollah; Moradkhani, Shirin; Falahinia, Golam Hossein

2016-01-01

Background: Pain is one of the common problems encountered by patients with burns, which increases after each dressing. This study aimed to investigate the effect of inhalation aromatherapy with damask rose essence on the pain of patients with burns that is caused after dressing. Materials and Methods: A randomized clinical trial was conducted on 50 patients with second- and third-degree burn wounds. The baseline pain of the patients was assessed 30 min before they entered into the dressing room on the first and second days of intervention. The patients in the experimental group inhaled five drops of damask rose essence 40% in distilled water, while those in the control group inhaled five drops of distilled water as placebo. The pain intensity was assessed using Visual Analogue Scale at 15 and 30 min after the patients exited from the dressing room. Data were analyzed by SPSS (version 18) using descriptive and inferential statistics. Results: There was significant difference between the mean of pain intensity before and after intervention at 15 and 30 min after dressing (P < 0.001). Moreover, there was significant difference in reduction of pain intensity before and after aromatherapy in the experimental group (P < 0.05). Also, there was a significant reduction in severity of pain after dressing in the experimental group compared with the control group (P < 0.05). Conclusions: Inhalation aromatherapy with damask rose could be effective for relieving the pain caused after dressing in patients with burns. Therefore, it could be suggested as a complementary therapy in burn patients for pain relief. PMID:27186201

Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial.

PubMed

Salehi, Zeinab; Roayaei, Mahnaz

2015-01-01

Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after - before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after - before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy.

Costs and effects of a state-wide health promotion program in primary schools in Germany – the Baden-Württemberg Study: A cluster-randomized, controlled trial

PubMed Central

Kesztyüs, Tibor; Kilian, Reinhold; Steinacker, Jürgen M

2017-01-01

Aim To evaluate the cost-effectiveness of the state-wide implementation of the health promotion program “Join the Healthy Boat” in primary schools in Germany. Methods Cluster-randomized intervention trial with wait-list control group. Anthropometric data of 1733 participating children (7.1 ± 0.6 years) were taken by trained staff before and after a one year intervention period in the academic year 2010/11. Parents provided information about the health status, and the health behaviour of their children and themselves, parental anthropometrics, and socio-economic background variables. Incidence of abdominal obesity, defined as waist-to-height ratio (WHtR) ≥ 0.5, was determined. Generalized linear models were applied to account for the clustering of data within schools, and to adjust for baseline-values. Losses to follow-up and missing data were analysed. From a societal perspective, the overall costs, costs per pupil, and incremental cost-effectiveness ratio (ICER) to identify the costs per case of averted abdominal obesity were calculated. Results The final regression model for the incidence of abdominal obesity shows lower odds for the intervention group after an adjustment for grade, gender, baseline WHtR, and breakfast habits (odds ratio = 0.48, 95% CI [0.25; 0.94]). The intervention costs per child/year were €25.04. The costs per incidental case of averted abdominal obesity varied between €1515 and €1993, depending on the different dimensions of the target group. Conclusion This study demonstrates the positive effects of state-wide, school-based health promotion on incidental abdominal obesity, at affordable costs and with proven cost-effectiveness. These results should support allocative decisions of policymakers. An early start to the prevention of abdominal obesity is of particular importance because of its close relationship to non-communicable diseases. Trial registration German Clinical Trials Register (DRKS), Freiburg University, Germany, DRKS-ID: DRKS00000494. PMID:28222101

Reproductive Health of Women in Rural Areas of East Azerbaijan – Iran, before and after Implementation of rural Family Physician Program: an Ecologic Study

PubMed Central

Alizadeh, Mahasti; Jabbari Birami, Hossein; Moradi, Siavash

2015-01-01

Introduction: Implementation of rural family physician program in Iran in 2005 has been evaluated and shown that this program has been led to some improvements in health indicators. In this study, some reproductive health (RH) indicators were compared before and after implementation of this program in rural areas of East Azerbaijan, Iran. Methods: In this ecologic- time trend study, the data of 191075 births of rural women of East Azerbaijan from 2001 to 2010 was extracted from vital horoscope (ZIJ) and used for calculation of 20 important RH indicators. The paired t-test and correlation analysis wear used for data analysis. Results: Some indicators such as adolescent marriage rate, adolescent birth and over 35 year olds birth rate were increased after rural family physician program implementation in 2005. Also stillbirth rate and unsafe delivery were decreased during this period. There was a significant correlation between increasing adolescent birth rate and increasing low birth weight deliveries (r= 0.911, P= 0.031) and also between increasing over 35 year olds birth rate and increasing neonatal mortality rate in term of prematurity and congenital malformations (r= 0.912, P= 0.031) after program implementation. Conclusion: Perinatal care and safe delivery even for pregnancies outside the typical child-bearing ages are promoting after implementation of rural family physician program in East Azerbaijan. Also decreasing unsafe delivery and stillbirth rate can be considered as achievements of running this program in this province. PMID:26744731

Protocol of a cluster randomised stepped-wedge trial of behavioural interventions targeting amphetamine-type stimulant use and sexual risk among female entertainment and sex workers in Cambodia

PubMed Central

Page, Kimberly; Stein, Ellen S; Carrico, Adam W; Evans, Jennifer L; Sokunny, Muth; Nil, Ean; Ngak, Song; Sophal, Chhit; McCulloch, Charles; Maher, Lisa

2016-01-01

Introduction HIV risk among female entertainment and sex workers (FESW) remains high and use of amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster randomised stepped wedge trial (The Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) study) to test sequentially delivered behavioural interventions targeting ATS use. Methods and analysis The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with 4 weeks of cognitive-behavioural group aftercare (AC) among FESW who use ATS. The primary goal is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in 10 provinces where order of delivery was randomised. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and drug use behaviours are conducted prior to implementation, and at three 6-month intervals after completion. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalisation of the trial. Statistical power and sample size calculations were based on expected changes in ATS use and unprotected sex at the population level as well as within subjects. Ethics and dissemination Ethical approvals were granted by the Cambodia National Ethics Committee; University of New Mexico; University of California, San Francisco; and FHI360. The trial is registered with ClinicalTrials.gov. Dissemination of process indicators during the multiyear trial is carried out through annual in-country Stakeholder Meetings. Provincial ‘Close-Out’ forums are held at the conclusion of data collection in each province. When analysis is completed, dissemination meetings will be held in Cambodia with stakeholders, including community-based discussion sessions, policy briefs and results published and presented in the HIV prevention scientific journals and conferences. Conclusions CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia. Results Will inform both CCT+AC implementation in low and middle-income countries and programmes designed to reach FESW. Trial registration number NCT01835574; Pre-results. PMID:27160844

Supporting breastfeeding In Local Communities (SILC) in Victoria, Australia: a cluster randomised controlled trial

PubMed Central

McLachlan, Helen L; Forster, Della A; Amir, Lisa H; Cullinane, Meabh; Shafiei, Touran; Watson, Lyndsey F; Ridgway, Lael; Cramer, Rhian L; Small, Rhonda

2016-01-01

Objectives Breastfeeding has significant health benefits for mothers and infants. Despite recommendations from the WHO, by 6 months of age 40% of Australian infants are receiving no breast milk. Increased early postpartum breastfeeding support may improve breastfeeding maintenance. 2 community-based interventions to increase breastfeeding duration in local government areas (LGAs) in Victoria, Australia, were implemented and evaluated. Design 3-arm cluster randomised trial. Setting LGAs in Victoria, Australia. Participants LGAs across Victoria with breastfeeding initiation rates below the state average and > 450 births/year were eligible for inclusion. The LGA was the unit of randomisation, and maternal and child health centres in the LGAs comprised the clusters. Interventions Early home-based breastfeeding support by a maternal and child health nurse (home visit, HV) with or without access to a community-based breastfeeding drop-in centre (HV+drop-in). Main outcome measures The proportion of infants receiving ‘any’ breast milk at 3, 4 and 6 months (women's self-report). Findings 4 LGAs were randomised to the comparison arm and provided usual care (n=41 clusters; n=2414 women); 3 to HV (n=32 clusters; n=2281 women); and 3 to HV+drop-in (n=26 clusters; 2344 women). There was no difference in breastfeeding at 4 months in either HV (adjusted OR 1.04; 95% CI 0.84 to 1.29) or HV+drop-in (adjusted OR 0.92; 95% CI 0.78 to 1.08) compared with the comparison arm, no difference at 3 or 6 months, nor in any LGA in breastfeeding before and after the intervention. Some issues were experienced with intervention protocol fidelity. Conclusions Early home-based and community-based support proved difficult to implement. Interventions to increase breastfeeding in complex community settings require sufficient time and partnership building for successful implementation. We cannot conclude that additional community-based support is ineffective in improving breastfeeding maintenance given the level of adherence to the planned protocol. Trial registration number ACTRN12611000898954; Results. PMID:26832427

[Changes in hospitality workers' expectations and attitudes after the implementation of the Spanish smoking law].

PubMed

Martínez-Sánchez, Jose M; Fenández, Esteve; Fu, Marcela; Pérez-Ríos, Mónica; Schiaffino, Anna; López, María J; Alonso, Begoña; Saltó, Esteve; Nebot, Manel; Borràs, Josep M

2010-01-01

To assess changes in hospitality workers' expectations and attitudes towards the Spanish smoking law before and 2 years after the smoking ban. We performed a longitudinal study of a cohort (n=431) of hospitality workers in five regions in Spain before the law came into effect and 24 months later. Expectations and attitudes towards the ban and knowledge about the effect of second-hand smoke on health were compared before and after the ban. We recruited 431 hospitality workers in the baseline survey and 219 were followed-up 24 months later (overall follow-up rate of 50.8%). The percentage of hospitality workers who knew the law was 79.0% before it was passed and was 94.1% 24 months later (p<0.05). We observed an increase in support to the smoke-free ban in all public places, including bars and restaurants (54.1% to 65.8%; p<0.05). The percentages of support for the current ban, perception of compliance with the ban by employees and customers, and knowledge of the effect of second-hand smoke on health also increased. Knowledge and support to the Spanish smoking law among hospitality workers increased 2 years after the implementation of the ban. Copyright 2009 SESPAS. Published by Elsevier Espana. All rights reserved.

The effectiveness of policy changes designed to increase the attendance rate for outpatient retinopathy of prematurity (ROP) screening examinations.

PubMed

Barry, Gerard P; Tauber, Kate; Emmanuel, Gregory; Horgan, Michael J; Simon, John W

2013-06-01

To determine the effectiveness of a series of policy changes designed to increase the attendance rate for outpatient retinopathy of prematurity (ROP) screening examinations. We retrospectively reviewed the records of consecutive neonatal intensive care unit patients before and after the implementation of policy changes. Policy changes included parent education forms, streamlined scheduling, and creation of a log for all patients seen. The primary outcome measure was attendance rates for the first outpatient appointment after discharge. The Fisher exact test was used to compare rates between the two groups. Before the policy was implemented, 22 of 52 (42%) neonates and their caregivers attended their first outpatient ROP screening examination on the recommended date. This rate improved significantly after policy implementation, when 46 of 57 (81%) neonates and their caregivers were seen on the recommended date (P < 0.01). The number of patients who ultimately met the criteria for conclusion of acute retinal screening examinations also significantly improved, from 47 of 52 (90%) of neonates in the pre-implementation group to 57 of 57 (100%) in the post-implementation group (P = 0.02). The attendance rates for initial outpatient ROP examinations and the number of patients who ultimately met criteria for conclusion of acute retinal screening examinations significantly improved after the implementation of new policies. Copyright © 2013 American Association for Pediatric Ophthalmology and Strabismus. Published by Mosby, Inc. All rights reserved.

Prevalence of surgical site infections before and after the implementation of a multimodal infection control programme.

PubMed

Barchitta, Martina; Matranga, Domenica; Quattrocchi, Annalisa; Bellocchi, Patrizia; Ruffino, Maria; Basile, Guido; Agodi, Antonella

2012-03-01

In order to assess the prevalence of surgical site infections (SSIs) before and after the implementation of a multimodal infection control programme including the realization of a campaign to increase compliance with guidelines for antimicrobial prophylaxis, we designed and conducted the present study involving all 20 of the surgical departments of a large teaching hospital in Catania, Italy. SSI definitions of the Hospital in Europe Link for Infection Control through Surveillance (HELICS) protocol were used in four 1 day point-prevalence surveys. After the first survey, an infection control programme was implemented involving the active commitment of surgeons and infection control staff. Overall, a total of 600 surgical patients were enrolled. A significant decreasing trend in the SSI rate (from 16.4 to 8.2 per 100 surgical patients, P=0.018) was shown. After multivariate analysis, significant risk factors for SSI were identified: age >31 years, kidney insufficiency and infection at admission. Taking into account the indication and the timing of administration of antibiotic prophylaxis, in the four surveys prophylaxis was administered inappropriately in 55.3% of surgical procedures. The approach used in this study remains a feasible method of evaluating the burden of SSIs using repeated prevalence surveys. The results provide evidence of a significant decreasing trend in the SSI rate following the infection control intervention. Furthermore, our study underlines the need to develop evidence-based guidelines in collaboration with surgeons, to achieve consensus before implementation in order to improve compliance with antimicrobial prophylaxis and, finally, decrease SSI rates.

Effect of Caffeine on near Maximal Blood Pressure and Blood Pressure Recovery in Physically-Active, College-Aged Females

PubMed Central

CONNAHAN, LAURA E.; OTT, CHRISTOPHER A.; BARRY, VAUGHN W.

2017-01-01

The purpose of this study is to determine how caffeine affects exercise blood pressure (BP) and active and passive recovery BP after vigorous intensity exercise in physically active college-aged females. Fifteen physically active, ACSM stratified low-risk females (age (y): 23.53 ± 4.07, weight (kg): 60.34 ± 3.67, height (cm): 165.14 ± 7.20, BMI (kg/m2): 22.18 ± 1.55) participated in two Bruce protocol exercise tests. Before each test participants consumed 1) a placebo or 2) 3.3 mg·kg−1 of caffeine at least one hour before exercise in a counterbalanced double-blinded fashion. After reaching 85% of their age-predicted maximum heart rate, BP was taken and participants began an active (i.e. walking) recovery phase for 6 minutes followed by a passive (i.e. sitting) recovery phase. BP was assessed every two minutes in each phase. Recovery times were assessed until active and passive BP equaled 20 mmHg and 10 mmHg above resting, respectively. Participants completed each test 1–2 weeks a part. Maximal systolic and diastolic blood pressures were not significantly different between the two trials. Active recovery, passive recovery, and total recovery times were all significantly longer during the caffeine trial than the placebo trial. Furthermore, the time to reach age-predicted maximum heart rate was significantly shorter in the placebo trial than the caffeine trial. While caffeine consumption did not significantly affect maximal blood pressure, it did affect active and passive recovery time following vigorous intensity exercise in physically active females. Exercise endurance also improved after consuming caffeine in this population. PMID:28344739

Effect of Caffeine on near Maximal Blood Pressure and Blood Pressure Recovery in Physically-Active, College-Aged Females.

PubMed

Connahan, Laura E; Ott, Christopher A; Barry, Vaughn W

2017-01-01

The purpose of this study is to determine how caffeine affects exercise blood pressure (BP) and active and passive recovery BP after vigorous intensity exercise in physically active college-aged females. Fifteen physically active, ACSM stratified low-risk females (age (y): 23.53 ± 4.07, weight (kg): 60.34 ± 3.67, height (cm): 165.14 ± 7.20, BMI (kg/m 2 ): 22.18 ± 1.55) participated in two Bruce protocol exercise tests. Before each test participants consumed 1) a placebo or 2) 3.3 mg·kg -1 of caffeine at least one hour before exercise in a counterbalanced double-blinded fashion. After reaching 85% of their age-predicted maximum heart rate, BP was taken and participants began an active (i.e. walking) recovery phase for 6 minutes followed by a passive (i.e. sitting) recovery phase. BP was assessed every two minutes in each phase. Recovery times were assessed until active and passive BP equaled 20 mmHg and 10 mmHg above resting, respectively. Participants completed each test 1-2 weeks a part. Maximal systolic and diastolic blood pressures were not significantly different between the two trials. Active recovery, passive recovery, and total recovery times were all significantly longer during the caffeine trial than the placebo trial. Furthermore, the time to reach age-predicted maximum heart rate was significantly shorter in the placebo trial than the caffeine trial. While caffeine consumption did not significantly affect maximal blood pressure, it did affect active and passive recovery time following vigorous intensity exercise in physically active females. Exercise endurance also improved after consuming caffeine in this population.

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial

PubMed Central

2014-01-01

Background Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners’ adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners’ adherence to guidelines. Methods/Design A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care. The study will involve 18 general practices (9 in the intervention group and 9 in the control group) in Poland, each with at least 80 identified (at the baseline) patients with diagnosed COPD. The nine control practices will provide usual care without any interventions. Tailored interventions to implement four recommendations will be delivered in the remaining nine practices. At follow-up after nine months, data will be collected for all 18 general practices. The primary outcome measure is physicians’ adherence to all four recommendations: brief anti-smoking advice, dyspnea assessment, care checklist utilization and demonstration to patients of correct inhaler use. This measurement will be based on data extracted from identified patients’ records. Additionally, we will survey and interview patients with chronic obstructive pulmonary disease about the process of care. Discussion The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care. Trial registration This trial has been registered with Clinical Trials Protocol Registration System. Trial number: NCT01893476. PMID:24708623