Observer Use of Standardized Observation Protocols in Consequential Observation Systems

ERIC Educational Resources Information Center

Bell, Courtney A.; Yi, Qi; Jones, Nathan D.; Lewis, Jennifer M.; McLeod, Monica; Liu, Shuangshuang

2014-01-01

Evidence from a handful of large-scale studies suggests that although observers can be trained to score reliably using observation protocols, there are concerns related to initial training and calibration activities designed to keep observers scoring accurately over time (e.g., Bell, et al, 2012; BMGF, 2012). Studies offer little insight into how…

An approach for setting evidence-based and stakeholder-informed research priorities in low- and middle-income countries.

PubMed

Rehfuess, Eva A; Durão, Solange; Kyamanywa, Patrick; Meerpohl, Joerg J; Young, Taryn; Rohwer, Anke

2016-04-01

To derive evidence-based and stakeholder-informed research priorities for implementation in African settings, the international research consortium Collaboration for Evidence-Based Healthcare and Public Health in Africa (CEBHA+) developed and applied a pragmatic approach. First, an online survey and face-to-face consultation between CEBHA+ partners and policy-makers generated priority research areas. Second, evidence maps for these priority research areas identified gaps and related priority research questions. Finally, study protocols were developed for inclusion within a grant proposal. Policy and practice representatives were involved throughout the process. Tuberculosis, diabetes, hypertension and road traffic injuries were selected as priority research areas. Evidence maps covered screening and models of care for diabetes and hypertension, population-level prevention of diabetes and hypertension and their risk factors, and prevention and management of road traffic injuries. Analysis of these maps yielded three priority research questions on hypertension and diabetes and one on road traffic injuries. The four resulting study protocols employ a broad range of primary and secondary research methods; a fifth promotes an integrated methodological approach across all research activities. The CEBHA+ approach, in particular evidence mapping, helped to formulate research questions and study protocols that would be owned by African partners, fill gaps in the evidence base, address policy and practice needs and be feasible given the existing research infrastructure and expertise. The consortium believes that the continuous involvement of decision-makers throughout the research process is an important means of ensuring that studies are relevant to the African context and that findings are rapidly implemented.

Evidence-based protocol for structural rehabilitation of the spine and posture: review of clinical biomechanics of posture (CBP®) publications

PubMed Central

Oakley, Paul A.; Harrison, Donald D.; Harrison, Deed E.; Haas, Jason W.

2005-01-01

BACKGROUND Although practice protocols exist for SMT and functional rehabilitation, no practice protocols exist for structural rehabilitation. Traditional chiropractic practice guidelines have been limited to acute and chronic pain treatment, with limited inclusion of functional and exclusion of structural rehabilitation procedures. OBJECTIVE (1) To derive an evidence-based practice protocol for structural rehabilitation from publications on Clinical Biomechanics of Posture (CBP®) methods, and (2) to compare the evidence for Diversified, SMT, and CBP®. METHODS Clinical control trials utilizing CBP® methods and spinal manipulative therapy (SMT) were obtained from searches in Mantis, CINAHL, and Index Medicus. Using data from SMT review articles, evidence for Diversified Technique (as taught in chiropractic colleges), SMT, and CBP® were rated and compared. RESULTS From the evidence from Clinical Control Trials on SMT and CBP®, there is very little evidence support for Diversified (our rating = 18), as taught in chiropractic colleges, for the treatment of pain subjects, while CBP® (our rating = 46) and SMT for neck pain (rating = 58) and low back pain (our rating = 202) have evidence-based support. CONCLUSIONS While CBP® Technique has approximately as much evidence-based support as SMT for neck pain, CBP® has more evidence to support its methods than the Diversified technique taught in chiropractic colleges, but not as much as SMT for low back pain. The evolution of chiropractic specialization has occurred, and doctors providing structural-based chiropractic care require protocol guidelines for patient quality assurance and standardization. A structural rehabilitation protocol was developed based on evidence from CBP® publications. PMID:17549209

Feasibility of Providing Safe Mouth Care and Collecting Oral and Fecal Microbiome Samples from Nursing Home Residents with Dysphagia: Proof of Concept Study.

PubMed

Jablonski, Rita A; Winstead, Vicki; Azuero, Andres; Ptacek, Travis; Jones-Townsend, Corteza; Byrd, Elizabeth; Geisinger, Maria L; Morrow, Casey

2017-09-01

Individuals with dysphagia who reside in nursing homes often receive inadequate mouth care and experience poor oral health. From a policy perspective, the combination of absent evidence-based mouth care protocols coupled with insufficient dental coverage create a pool of individuals at great risk for preventable infectious illnesses that contribute to high health care costs. The purpose of the current study was to determine (a) the safety of a mouth care protocol tailored for individuals with dysphagia residing in nursing homes without access to suction equipment, and (b) the feasibility of collecting oral and fecal samples for microbiota analyses. The mouth care protocol resulted in improved oral hygiene without aspiration, and oral and fecal samples were safely collected from participants. Policies supporting ongoing testing of evidence-based mouth care protocols for individuals with dysphagia are important to improve quality, demonstrate efficacy, and save health care costs. [Journal of Gerontological Nursing, 43(9), 9-15.]. Copyright 2017, SLACK Incorporated.

The citation of relevant systematic reviews and randomised trials in published reports of trial protocols.

PubMed

Pandis, Nikolaos; Fleming, Padhraig S; Koletsi, Despina; Hopewell, Sally

2016-12-07

It is important that planned randomised trials are justified and placed in the context of the available evidence. The SPIRIT guidelines for reporting clinical trial protocols recommend that a recent and relevant systematic review should be included. The aim of this study was to assess the use of the existing evidence in order to justify trial conduct. Protocols of randomised trials published over a 1-month period (December 2015) indexed in PubMed were obtained. Data on trial characteristics relating to location, design, funding, conflict of interest and type of evidence included for trial justification was extracted in duplicate and independently by two investigators. The frequency of citation of previous research including relevant systematic reviews and randomised trials was assessed. Overall, 101 protocols for RCTs were identified. Most proposed trials were parallel-group (n = 74; 73.3%). Reference to an earlier systematic review with additional randomised trials was found in 9.9% (n = 10) of protocols and without additional trials in 30.7% (n = 31), while reference was made to randomised trials in isolation in 21.8% (n = 22). Explicit justification for the proposed randomised trial on the basis of being the first to address the research question was made in 17.8% (n = 18) of protocols. A randomised controlled trial was not cited in 10.9% (95% CI: 5.6, 18.7) (n = 11), while in 8.9% (95% CI: 4.2, 16.2) (n = 9) of the protocols a systematic review was cited but did not inform trial design. A relatively high percentage of protocols of randomised trials involves prior citation of randomised trials, systematic reviews or both. However, improvements are required to ensure that it is explicit that clinical trials are justified and shaped by contemporary best evidence.

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

28 CFR 115.221 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault... for investigating allegations of sexual abuse, the agency shall follow a uniform evidence protocol... developed after 2011. (c) The agency shall offer all victims of sexual abuse access to forensic medical...

28 CFR 115.121 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic... sexual abuse in its lockups, the agency shall follow a uniform evidence protocol that maximizes the... lockup detainees shall receive basic training regarding how to detect and respond to victims of sexual...

28 CFR 115.121 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic... sexual abuse in its lockups, the agency shall follow a uniform evidence protocol that maximizes the... lockup detainees shall receive basic training regarding how to detect and respond to victims of sexual...

28 CFR 115.321 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential... or otherwise based on the most recent edition of the U.S. Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic Examinations, Adults...

28 CFR 115.321 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential... or otherwise based on the most recent edition of the U.S. Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic Examinations, Adults...

28 CFR 115.21 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential.... (c) The agency shall offer all victims of sexual abuse access to forensic medical examinations...

28 CFR 115.221 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault... for investigating allegations of sexual abuse, the agency shall follow a uniform evidence protocol... developed after 2011. (c) The agency shall offer all victims of sexual abuse access to forensic medical...

28 CFR 115.221 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault... for investigating allegations of sexual abuse, the agency shall follow a uniform evidence protocol... developed after 2011. (c) The agency shall offer all victims of sexual abuse access to forensic medical...

28 CFR 115.21 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential.... (c) The agency shall offer all victims of sexual abuse access to forensic medical examinations...

28 CFR 115.121 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic... sexual abuse in its lockups, the agency shall follow a uniform evidence protocol that maximizes the... lockup detainees shall receive basic training regarding how to detect and respond to victims of sexual...

28 CFR 115.321 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential... or otherwise based on the most recent edition of the U.S. Department of Justice's Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic Examinations, Adults...

28 CFR 115.21 - Evidence protocol and forensic medical examinations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Office on Violence Against Women publication, “A National Protocol for Sexual Assault Medical Forensic... allegations of sexual abuse, the agency shall follow a uniform evidence protocol that maximizes the potential.... (c) The agency shall offer all victims of sexual abuse access to forensic medical examinations...

Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review.

PubMed

Gillman, Anna; Winkler, Renata; Taylor, Nicholas F

2017-06-01

The Frazier Free Water Protocol was developed with the aim of providing patients with dysphagia an option to consume thin (i.e. unthickened) water in-between mealtimes. A systematic review was conducted of research published in peer-reviewed journals. An electronic search of the EMBASE, CINAHL and MEDLINE databases was completed up to July 2016. A total of 8 studies were identified for inclusion: 5 randomised controlled trials, 2 cohort studies with matched cases and 1 single group pre-post intervention prospective study. A total of 215 rehabilitation inpatients and 30 acute patients with oropharyngeal dysphagia who required thickened fluids or were to remain 'nil by mouth', as determined by bedside swallow assessment and/or videofluoroscopy/fiberoptic endoscopic evaluation of swallowing, were included. Meta-analyses of the data from the rehabilitation studies revealed (1) low-quality evidence that implementing the protocol did not result in increased odds of having lung complications and (2) low-quality evidence that fluid intake may increase. Patients' perceptions of swallow-related quality of life appeared to improve. This review has found that when the protocol is closely adhered to and patients are carefully selected using strict exclusion criteria, including an evaluation of their cognition and mobility, adult rehabilitation inpatients with dysphagia to thin fluids can be offered the choice of implementing the Free Water Protocol. Further research is required to determine if the Free Water Protocol can be implemented in settings other than inpatient rehabilitation.

Altered Mental Status: Current Evidence-based Recommendations for Prehospital Care.

PubMed

Sanello, Ashley; Gausche-Hill, Marianne; Mulkerin, William; Sporer, Karl A; Brown, John F; Koenig, Kristi L; Rudnick, Eric M; Salvucci, Angelo A; Gilbert, Gregory H

2018-05-01

In the United States emergency medical services (EMS) protocols vary widely across jurisdictions. We sought to develop evidence-based recommendations for the prehospital evaluation and treatment of a patient with an acute change in mental status and to compare these recommendations against the current protocols used by the 33 EMS agencies in the State of California. We performed a literature review of the current evidence in the prehospital treatment of a patient with altered mental status (AMS) and augmented this review with guidelines from various national and international societies to create our evidence-based recommendations. We then compared the AMS protocols of each of the 33 EMS agencies for consistency with these recommendations. The specific protocol components that we analyzed were patient assessment, point-of-care tests, supplemental oxygen, use of standardized scoring, evaluating for causes of AMS, blood glucose evaluation, toxicological treatment, and pediatric evaluation and management. Protocols across 33 EMS agencies in California varied widely. All protocols call for a blood glucose check, 21 (64%) suggest treating adults at <60mg/dL, and half allow for the use of dextrose 10%. All the protocols recommend naloxone for signs of opioid overdose, but only 13 (39%) give specific parameters. Half the agencies (52%) recommend considering other toxicological causes of AMS, often by using the mnemonic AEIOU TIPS. Eight (24%) recommend a 12-lead electrocardiogram; others simply suggest cardiac monitoring. Fourteen (42%) advise supplemental oxygen as needed; only seven (21%) give specific parameters. In terms of considering various etiologies of AMS, 25 (76%) give instructions to consider trauma, 20 (61%) to consider stroke, and 18 (55%) to consider seizure. Twenty-three (70%) of the agencies have separate pediatric AMS protocols; others include pediatric considerations within the adult protocol. Protocols for patients with AMS vary widely across the State of California. The evidence-based recommendations that we present for the prehospital diagnosis and treatment of this condition may be useful for EMS medical directors tasked with creating and revising these protocols.

Evidence-Based Psychosocial Treatments for Child and Adolescent Depression

ERIC Educational Resources Information Center

David-Ferdon, Corinne; Kaslow, Nadine J.

2008-01-01

The evidence-base of psychosocial treatment outcome studies for depressed youth conducted since 1998 is examined. All studies for depressed children meet Nathan and Gorman's (2002) criteria for Type 2 studies whereas the adolescent protocols meet criteria for both Type 1 and Type 2 studies. Based on the Task Force on the Promotion and…

Optimal early active mobilisation protocol after extensor tendon repairs in zones V and VI: A systematic review of literature.

PubMed

Collocott, Shirley Jf; Kelly, Edel; Ellis, Richard F

2018-03-01

Early mobilisation protocols after repair of extensor tendons in zone V and VI provide better outcomes than immobilisation protocols. This systematic review investigated different early active mobilisation protocols used after extensor tendon repair in zone V and VI. The purpose was to determine whether any one early active mobilisation protocol provides superior results. An extensive literature search was conducted to identify articles investigating the outcomes of early active mobilisation protocols after extensor tendon repair in zone V and VI. Databases searched were AMED, Embase, Medline, Cochrane and CINAHL. Studies were included if they involved participants with extensor tendon repairs in zone V and VI in digits 2-5 and described a post-operative rehabilitation protocol which allowed early active metacarpophalangeal joint extension. Study designs included were randomised controlled trials, observational studies, cohort studies and case series. The Structured Effectiveness Quality Evaluation Scale was used to evaluate the methodological quality of the included studies. Twelve articles met the inclusion criteria. Two types of early active mobilisation protocols were identified: controlled active motion protocols and relative motion extension splinting protocols. Articles describing relative motion extension splinting protocols were more recent but of lower methodological quality than those describing controlled active motion protocols. Participants treated with controlled active motion and relative motion extension splinting protocols had similar range of motion outcomes, but those in relative motion extension splinting groups returned to work earlier. The evidence reviewed suggested that relative motion extension splinting protocols may allow an earlier return to function than controlled active motion protocols without a greater risk of complication.

Evidence-based recommendations for bowel cleansing before colonoscopy in children: a report from a national working group.

PubMed

Turner, D; Levine, A; Weiss, B; Hirsh, A; Shamir, R; Shaoul, R; Berkowitz, D; Bujanover, Y; Cohen, S; Eshach-Adiv, O; Jamal, Gera; Kori, M; Lerner, A; On, A; Rachman, L; Rosenbach, Y; Shamaly, H; Shteyer, E; Silbermintz, A; Yerushalmi, B

2010-12-01

There are no current recommendations for bowel cleansing before colonoscopy in children. The Israeli Society of Pediatric Gastroenterology and Nutrition (ISPGAN) established an iterative working group to formulate evidence-based guidelines for bowel cleansing in children prior to colonoscopy. Data were collected by systematic review of the literature and via a national-based survey of all endoscopy units in Israel. Based on the strength of evidence, the Committee reached consensus on six recommended protocols in children. Guidelines were finalized after an open audit of ISPGAN members. Data on 900 colonoscopies per year were accrued, which represents all annual pediatric colonoscopies performed in Israel. Based on the literature review, the national survey, and the open audit, several age-stratified pediatric cleansing protocols were proposed: two PEG-ELS protocols (polyethylene-glycol with electrolyte solution); Picolax-based protocol (sodium picosulphate with magnesium citrate); sodium phosphate protocol (only in children over the age of 12 years who are at low risk for renal damage); stimulant laxative-based protocol (e. g. bisacodyl); and a PEG 3350-based protocol. A population-based analysis estimated that the acute toxicity rate of oral sodium phosphate is at most 3/7320 colonoscopies (0.041 %). Recommendations on diet and enema use are provided in relation to each proposed protocol. There is no ideal bowel cleansing regimen and, thus, various protocols are in use. We propose several evidence-based protocols to optimize bowel cleansing in children prior to colonoscopy and minimize adverse events. © Georg Thieme Verlag KG Stuttgart · New York.

Exploring Multi-Level System Factors Facilitating Educator Training and Implementation of Evidence-Based Practices (EBP): A Study Protocol

ERIC Educational Resources Information Center

Stahmer, Aubyn C.; Suhrheinrich, Jessica; Schetter, Patricia L.; Hassrick, Elizabeth McGee

2018-01-01

This study examines how system-wide (i.e., region, district, and school) mechanisms such as leadership support, training requirements, structure, collaboration, and education affect the use of evidence-based practices (EBPs) in schools and how this affects the outcomes for students with autism spectrum disorder (ASD). Despite growing evidence for…

Prevention and assessment of infectious diseases among children and adult migrants arriving to the European Union/European Economic Association: a protocol for a suite of systematic reviews for public health and health systems

PubMed Central

Mayhew, Alain D; Morton, Rachael L; Greenaway, Christina; Akl, Elie A; Rahman, Prinon; Zenner, Dominik; Pareek, Manish; Tugwell, Peter; Welch, Vivian; Meerpohl, Joerg; Alonso-Coello, Pablo; Hui, Charles; Biggs, Beverley-Ann; Requena-Méndez, Ana; Agbata, Eric; Noori, Teymur; Schünemann, Holger J

2017-01-01

Introduction The European Centre for Disease Prevention and Control is developing evidence-based guidance for voluntary screening, treatment and vaccine prevention of infectious diseases for newly arriving migrants to the European Union/European Economic Area. The objective of this systematic review protocol is to guide the identification, appraisal and synthesis of the best available evidence on prevention and assessment of the following priority infectious diseases: tuberculosis, HIV, hepatitis B, hepatitis C, measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis (polio), Haemophilus influenza disease, strongyloidiasis and schistosomiasis. Methods and analysis The search strategy will identify evidence from existing systematic reviews and then update the effectiveness and cost-effectiveness evidence using prospective trials, economic evaluations and/or recently published systematic reviews. Interdisciplinary teams have designed logic models to help define study inclusion and exclusion criteria, guiding the search strategy and identifying relevant outcomes. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Ethics and dissemination There are no ethical or safety issues. We anticipate disseminating the findings through open-access publications, conference abstracts and presentations. We plan to publish technical syntheses as GRADEpro evidence summaries and the systematic reviews as part of a special edition open-access publication on refugee health. We are following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols reporting guideline. This protocol is registered in PROSPERO: CRD42016045798. PMID:28893741

From workshop to work practice: An exploration of context and facilitation in the development of evidence-based practice.

PubMed

Ellis, Isabelle; Howard, Peter; Larson, Ann; Robertson, Jeanette

2005-01-01

This article examines the process of translating evidence into practice using a facilitation model developed by the Western Australian Centre for Evidence Based Nursing and Midwifery. Using the conceptual framework Promoting Action on Research Implementation in Health Services (PARIHS), the aims of the study were (1) to explore the relative and combined importance of context and facilitation in the successful implementation of a new evidence-based clinical practice protocol and (2) to examine the establishment of more lasting change to individuals and organizations that resulted in greater incorporation of the principles of evidence-based practice (EBP). A pre-workshop, semi-structured telephone survey with 16 nurse managers in six rural hospitals; a summative evaluation immediately post-workshop with 54 participants; and follow-up, semi-structured interviews with 23 workshop participants. The contexts in each of the participating hospitals were very different; of the six hospitals, only one had not implemented the new protocol. Five had reviewed their practices and brought them in line with the protocol developed at the workshop. The rate of adoption varied considerably from 2 weeks to months. The participants reported being better informed about EBP in general and were positive about their ability to improve their practice and search more efficiently for best practice information. Underlying motivations for protocol development should be included in the PARIHS framework. IMPLICATIONS FOR EDUCATION: Good facilitation appears to be more influential than context in overcoming the barriers to the uptake of EBP.

Early Versus Delayed Motion After Rotator Cuff Repair: A Systematic Review of Overlapping Meta-analyses.

PubMed

Houck, Darby A; Kraeutler, Matthew J; Schuette, Hayden B; McCarty, Eric C; Bravman, Jonathan T

2017-10-01

Previous meta-analyses have been conducted to compare outcomes of early versus delayed motion after rotator cuff repair. To conduct a systematic review of overlapping meta-analyses comparing early versus delayed motion rehabilitation protocols after rotator cuff repair to determine which meta-analyses provide the best available evidence. Systematic review. A systematic review was performed by searching PubMed and Cochrane Library databases. Search terms included "rotator cuff repair," "early passive motion," "immobilization," "rehabilitation protocol," and "meta-analysis." Results were reviewed to determine study eligibility. Patient outcomes and structural healing were extracted from these meta-analyses. Meta-analysis quality was assessed using the Oxman-Guyatt and Quality of Reporting of Meta-analyses (QUOROM) systems. The Jadad decision algorithm was then used to determine which meta-analyses provided the best level of evidence. Seven meta-analyses containing a total of 5896 patients met the eligibility criteria (1 Level I evidence, 4 Level II evidence, 2 Level III evidence). None of these meta-analyses found immobilization to be superior to early motion; however, most studies suggested that early motion would increase range of motion (ROM), thereby reducing time of recovery. Three of these studies suggested that tear size contributed to the choice of rehabilitation to ensure proper healing of the shoulder. A study by Chan et al in 2014 received the highest QUOROM and Oxman-Guyatt scores, and therefore this meta-analysis appeared to have the highest level of evidence. Additionally, a study by Riboh and Garrigues in 2014 was selected as the highest quality study in this systematic review according to the Jadad decision algorithm. The current, best available evidence suggests that early motion improves ROM after rotator cuff repair but increases the risk of rotator cuff retear. Lower quality meta-analyses indicate that tear size may provide a better strategy in determining the correct rehabilitation protocol.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

PubMed

Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

2016-11-01

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

Altered Mental Status: Current Evidence-based Recommendations for Prehospital Care

PubMed Central

Sanello, Ashley; Mulkerin, William; Sporer, Karl A.; Brown, John F.; Koenig, Kristi L.; Rudnick, Eric M.; Salvucci, Angelo A.; Gilbert, Gregory H.

2018-01-01

Introduction In the United States emergency medical services (EMS) protocols vary widely across jurisdictions. We sought to develop evidence-based recommendations for the prehospital evaluation and treatment of a patient with an acute change in mental status and to compare these recommendations against the current protocols used by the 33 EMS agencies in the State of California. Methods We performed a literature review of the current evidence in the prehospital treatment of a patient with altered mental status (AMS) and augmented this review with guidelines from various national and international societies to create our evidence-based recommendations. We then compared the AMS protocols of each of the 33 EMS agencies for consistency with these recommendations. The specific protocol components that we analyzed were patient assessment, point-of-care tests, supplemental oxygen, use of standardized scoring, evaluating for causes of AMS, blood glucose evaluation, toxicological treatment, and pediatric evaluation and management. Results Protocols across 33 EMS agencies in California varied widely. All protocols call for a blood glucose check, 21 (64%) suggest treating adults at <60mg/dL, and half allow for the use of dextrose 10%. All the protocols recommend naloxone for signs of opioid overdose, but only 13 (39%) give specific parameters. Half the agencies (52%) recommend considering other toxicological causes of AMS, often by using the mnemonic AEIOU TIPS. Eight (24%) recommend a 12-lead electrocardiogram; others simply suggest cardiac monitoring. Fourteen (42%) advise supplemental oxygen as needed; only seven (21%) give specific parameters. In terms of considering various etiologies of AMS, 25 (76%) give instructions to consider trauma, 20 (61%) to consider stroke, and 18 (55%) to consider seizure. Twenty-three (70%) of the agencies have separate pediatric AMS protocols; others include pediatric considerations within the adult protocol. Conclusion Protocols for patients with AMS vary widely across the State of California. The evidence-based recommendations that we present for the prehospital diagnosis and treatment of this condition may be useful for EMS medical directors tasked with creating and revising these protocols. PMID:29760852

An Evaluation Protocol for Selection of Educational Technologies for Students with Developmental Disabilities: A Demonstration Study Using iPad Apps

ERIC Educational Resources Information Center

Arthanat, Sajay; Curtin, Christine; Kontak, David

2015-01-01

Mainstream technologies are widely being employed in inclusive and special education classrooms to accommodate the learning needs of students. As the evidence of their effectiveness evolves, educators and school-based therapists need tools and documentable strategies for their implementation. This research presents an evaluation protocol to guide…

The Relationships between Coaching and Instruction in the Primary Grades: Evidence from High-Poverty Schools

ERIC Educational Resources Information Center

Walpole, Sharon; McKenna, Michael C.; Uribe-Zarain, Ximena; Lamitina, David

2010-01-01

In this study of 116 high-poverty schools, we explored teaching and coaching in grades K-3. We developed and validated observation protocols for both coaching and teaching. Exploratory and confirmatory factor analyses were computed to identify and confirm factors that explained the protocol data. Three coaching factors were identified in both…

Cardiac Mitochondria l Membrane Stability after Deep Hypothermia using a Xenon Clathrate Cryostasis Protocol – an Electron Microscopy Study

PubMed Central

Sheleg, Sergey; Hixon, Hugh; Cohen, Bruce; Lowry, David; Nedzved, Mikhail

2008-01-01

We investigated a new cryopreservation method using xenon, a clathrate-forming gas, under medium pressure (100psi). The objective of the study was to determine whether this cryostasis protocol could protect cardiac mitochondria at cryogenic temperatures (below 100 degrees Celsius).We analyzed transmission electron microscopy images to obtain information about changes in mitochondrial morphology induced by cryopreservation of the hearts. Our data showed absence of mitochondrial swelling, rupture of inner and outer membranes, and leakage of mitochondrial matrix into the cytoplasm after applying this cryostasis protocol. The electron microscopy results provided the first evidence that a cryostasis protocol using xenon as a clathrate-forming gas under pressure may have protective effects on intracellular membranes. This cryostasis technology may find applications in developing new approaches for long-term cryopreservation protocols. PMID:18787624

Applying Adult Ventilator-associated Pneumonia Bundle Evidence to the Ventilated Neonate.

PubMed

Weber, Carla D

2016-06-01

Ventilator-associated pneumonia (VAP) in neonates can be reduced by implementing preventive care practices. Implementation of a group, or bundle, of evidence-based practices that improve processes of care has been shown to be cost-effective and to have better outcomes than implementation of individual single practices. The purpose of this article is to describe a safe, effective, and efficient neonatal VAP prevention protocol developed for caregivers in the neonatal intensive care unit (NICU). Improved understanding of VAP causes, effects of care practices, and rationale for interventions can help reduce VAP risk to neonatal patients. In order to improve care practices to affect VAP rates, initial and annual education occurred on improved protocol components after surveying staff practices and auditing documentation compliance. In 2009, a tertiary care level III NICU in the Midwestern United States had 14 VAP cases. Lacking evidence-based VAP prevention practices for neonates, effective adult strategies were modified to meet the complex needs of the ventilated neonate. A protocol was developed over time and resulted in an annual decrease in VAP until rates were zero for 20 consecutive months from October 2012 to May 2014. This article describes a VAP prevention protocol developed to address care practices surrounding hand hygiene, intubation, feeding, suctioning, positioning, oral care, and respiratory equipment in the NICU. Implementation of this VAP prevention protocol in other facilities with appropriate monitoring and tracking would provide broader support for standardization of care. Individual components of this VAP protocol could be studied to strengthen the inclusion of each; however, bundled interventions are often considered stronger when implemented as a whole.

Prevention and assessment of infectious diseases among children and adult migrants arriving to the European Union/European Economic Association: a protocol for a suite of systematic reviews for public health and health systems.

PubMed

Pottie, Kevin; Mayhew, Alain D; Morton, Rachael L; Greenaway, Christina; Akl, Elie A; Rahman, Prinon; Zenner, Dominik; Pareek, Manish; Tugwell, Peter; Welch, Vivian; Meerpohl, Joerg; Alonso-Coello, Pablo; Hui, Charles; Biggs, Beverley-Ann; Requena-Méndez, Ana; Agbata, Eric; Noori, Teymur; Schünemann, Holger J

2017-09-11

The European Centre for Disease Prevention and Control is developing evidence-based guidance for voluntary screening, treatment and vaccine prevention of infectious diseases for newly arriving migrants to the European Union/European Economic Area. The objective of this systematic review protocol is to guide the identification, appraisal and synthesis of the best available evidence on prevention and assessment of the following priority infectious diseases: tuberculosis, HIV, hepatitis B, hepatitis C, measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis (polio), Haemophilus influenza disease, strongyloidiasis and schistosomiasis. The search strategy will identify evidence from existing systematic reviews and then update the effectiveness and cost-effectiveness evidence using prospective trials, economic evaluations and/or recently published systematic reviews. Interdisciplinary teams have designed logic models to help define study inclusion and exclusion criteria, guiding the search strategy and identifying relevant outcomes. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. There are no ethical or safety issues. We anticipate disseminating the findings through open-access publications, conference abstracts and presentations. We plan to publish technical syntheses as GRADEpro evidence summaries and the systematic reviews as part of a special edition open-access publication on refugee health. We are following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols reporting guideline. This protocol is registered in PROSPERO: CRD42016045798. © 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.

Identifying Evidence-Based Educational Practices: Which Research Designs Provide Findings That Can Influence Social Change?

ERIC Educational Resources Information Center

Schirmer, Barbara R.; Lockman, Alison S.; Schirmer, Todd N.

2016-01-01

We conducted this conceptual study to determine if the Institute of Education Sciences/National Science Foundation pipeline of evidence guidelines could be applied as a protocol that researchers could follow in establishing evidence of effective instructional practices. To do this, we compared these guidelines, new drug development process, and…

Oral medications including clomiphene citrate or aromatase inhibitors with gonadotropins for controlled ovarian stimulation in women undergoing in vitro fertilisation.

PubMed

Kamath, Mohan S; Maheshwari, Abha; Bhattacharya, Siladitya; Lor, Kar Yee; Gibreel, Ahmed

2017-11-02

Gonadotropins are the most commonly used medications for controlled ovarian stimulation in in vitro fertilisation (IVF). However, they are expensive and invasive, and are associated with the risk of ovarian hyperstimulation syndrome (OHSS). Recent calls for more patient-friendly regimens have led to growing interest in the use of clomiphene citrate (CC) and aromatase inhibitors with or without gonadotropins to reduce the burden of hormonal injections. It is currently unknown whether regimens using CC or aromatase inhibitors such as letrozole (Ltz) are as effective as gonadotropins alone. To determine the effectiveness and safety of regimens including oral induction medication (such as clomiphene citrate or letrozole) versus gonadotropin-only regimens for controlled ovarian stimulation in IVF or intracytoplasmic sperm injection (ICSI) treatment. We searched the following databases: Cochrane Gynaecology and Fertility Group Specialised Register (searched January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL CRSO), MEDLINE (1946 to January 2017), Embase (1980 to January 2017), and reference lists of relevant articles. We also searched trials registries ClinicalTrials.gov (clinicaltrials.gov/) and the World Health Organization International Clinical Trials Registry Platform (www.who.int/trialsearch/Default.aspx). We handsearched relevant conference proceedings. We included randomized controlled trials (RCTs). The primary outcomes were live-birth rate (LBR) and OHSS. Three review authors independently assessed trial eligibility and risk of bias. We calculated risk ratios (RR) and Peto odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We analyzed the general population of women undergoing IVF treatment and (as a separate analysis) women identified as poor responders. We assessed the overall quality of the evidence using the GRADE approach. We included 27 studies in the updated review. Most of the new trials in the updated review included poor responders and evaluated Ltz protocols. We could perform meta-analysis with data from 22 studies including a total of 3599 participants. The quality of the evidence for different comparisons ranged from low to moderate. The main limitations in the quality of the evidence were risk of bias associated with poor reporting of study methods, and imprecision.In the general population of women undergoing IVF, it is unclear whether CC or Ltz used with or without gonadotropins compared to use of gonadotropins along with gonadotropin-releasing hormone (GnRH) agonists or antagonists resulted in a difference in live birth (RR 0.92, 95% CI 0.66 to 1.27, 4 RCTs, n = 493, I 2 = 0%, low-quality evidence) or clinical pregnancy rate (RR 1.00, 95% CI 0.86 to 1.16, 12 RCTs, n = 1998, I 2 = 3%, moderate-quality evidence). This means that for a typical clinic with 23% LBR using a GnRH agonist regimen, switching to CC or Ltz protocols would be expected to result in LBRs between 15% and 30%. Clomiphene citrate or Ltz protocols were associated with a reduction in the incidence of OHSS (Peto OR 0.21, 95% CI 0.11 to 0.41, 5 RCTs, n = 1067, I 2 = 0%, low-quality evidence). This means that for a typical clinic with 6% prevalence of OHSS associated with a GnRH regimen, switching to CC or Ltz protocols would be expected to reduce the incidence to between 0.5% and 2.5%. We found evidence of an increase in cycle cancellation rate with the CC protocol compared to gonadotropins in GnRH protocols (RR 1.87, 95% CI 1.43 to 2.45, 9 RCTs, n = 1784, I 2 = 61%, low-quality evidence). There was moderate quality evidence of a decrease in the mean number of ampoules used,) and mean number of oocytes collected with CC with or without gonadotropins compared to the gonadotropins in GnRH agonist protocols, though data were too heterogeneous to pool.Similarly, in the poor-responder population, it is unclear whether there was any difference in rates of live birth (RR 1.16, 95% CI 0.49 to 2.79, 2 RCTs, n = 357, I 2 = 38%, low-quality evidence) or clinical pregnancy (RR 0.85, 95% CI 0.64 to 1.12, 8 RCTs, n = 1462, I 2 = 0%, low-quality evidence) following CC or Ltz with or without gonadotropin versus gonadotropin and GnRH protocol. This means that for a typical clinic with a 5% LBR in the poor responders using a GnRH protocol, switching to CC or Ltz protocols would be expected to yield LBRs between 2% to 14%. There was low quality evidence that the CC or Ltz protocols were associated with an increase in the cycle cancellation rate (RR 1.46, 95% CI 1.18 to 1.81, 10 RCTs, n = 1601, I 2 = 64%) and moderate quality evidence of a decrease in the mean number of gonadotropin ampoules used and the mean number of oocytes collected, though data were too heterogeneous to pool. The adverse effects of these protocols were poorly reported. In addition, data on foetal abnormalities following use of CC or Ltz protocols are lacking. We found no conclusive evidence indicating that clomiphene citrate or letrozole with or without gonadotropins differed from gonadotropins in GnRH agonist or antagonist protocols with respect to their effects on live-birth or pregnancy rates, either in the general population of women undergoing IVF treatment or in women who were poor responders. Use of clomiphene or letrozole led to a reduction in the amount of gonadotropins required and the incidence of OHSS. However, use of clomiphene citrate or letrozole may be associated with a significant increase in the incidence of cycle cancellations, as well as reductions in the mean number of oocytes retrieved in both the general IVF population and the poor responders. Larger, high-quality randomized trials are needed to reach a firm conclusion before they are adopted into routine clinical practice.

Moving Triadic Gaze Intervention Into Practice: Measuring Clinician Attitude and Implementation Fidelity

PubMed Central

Olswang, Lesley B.; Greenslade, Kathryn; Pinder, Gay Lloyd; Dowden, Patricia; Madden, Jodi

2017-01-01

Purpose This research investigated a first step in implementing the dynamic assessment (DA) component of Triadic Gaze Intervention (Olswang, Feuerstein, Pinder, & Dowden, 2013; Olswang et al., 2014), an evidence-based protocol for teaching early signals of communication to young children with physical disabilities. Clinician attitudes about adopting external evidence into practice and implementation fidelity in DA protocol delivery were examined following training. Method Seven early intervention clinicians from multiple disciplines were trained to deliver the four essential elements of the DA protocol: (a) provide communication opportunity, (b) recognize child's potentially communicative signal, (c) shape child's signal toward triadic gaze, and (d) reinforce with play. Clinician attitude regarding adopting evidence into practice was measured at baseline and follow-up, with the Evidence-Based Practice Attitude Scale (Aarons, 2004). Implementation fidelity in delivering the protocol was measured for adherence (accuracy) and competence (quality) during trial implementation. Results Clinicians' attitudes about trying new evidence that at first was perceived as incongruent with their practice improved over the course of the research. Clinicians demonstrated strong adherence to the DA protocol; however, competence varied across clinicians and appeared related to child performance. Conclusions The results provided insight into moving Triadic Gaze Intervention into practice and yielded valuable information regarding the implementation process, with implications for future research. PMID:28525577

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Melis-Dankers, Bart J M; van Rens, Ger H M B

2010-03-10

Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. http://www.trialregister.nl, identifier: NTR1031.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

PubMed Central

2010-01-01

Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

Methodology of a systematic review.

PubMed

Linares-Espinós, E; Hernández, V; Domínguez-Escrig, J L; Fernández-Pello, S; Hevia, V; Mayor, J; Padilla-Fernández, B; Ribal, M J

2018-05-03

The objective of evidence-based medicine is to employ the best scientific information available to apply to clinical practice. Understanding and interpreting the scientific evidence involves understanding the available levels of evidence, where systematic reviews and meta-analyses of clinical trials are at the top of the levels-of-evidence pyramid. The review process should be well developed and planned to reduce biases and eliminate irrelevant and low-quality studies. The steps for implementing a systematic review include (i) correctly formulating the clinical question to answer (PICO), (ii) developing a protocol (inclusion and exclusion criteria), (iii) performing a detailed and broad literature search and (iv) screening the abstracts of the studies identified in the search and subsequently of the selected complete texts (PRISMA). Once the studies have been selected, we need to (v) extract the necessary data into a form designed in the protocol to summarise the included studies, (vi) assess the biases of each study, identifying the quality of the available evidence, and (vii) develop tables and text that synthesise the evidence. A systematic review involves a critical and reproducible summary of the results of the available publications on a particular topic or clinical question. To improve scientific writing, the methodology is shown in a structured manner to implement a systematic review. Copyright © 2018 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Systematic review of catatonia treatment.

PubMed

Pelzer, Anne Cm; van der Heijden, Frank Mma; den Boer, Erik

2018-01-01

To investigate the evidence-based treatment of catatonia in adults. The secondary aim is to develop a treatment protocol. A systematic review of published treatment articles (case series, cohort or randomized controlled studies) which examined the effects of particular interventions for catatonia and/or catatonic symptoms in adult populations and used valid outcome measures was performed. The articles for this review were selected by searching the electronic databases of the Cochrane Library, MEDLINE, EMBASE and PSYCHINFO. Thirty-one articles met the inclusion criteria. Lorazepam and electroconvulsive therapy (ECT) proved to be the most investigated treatment interventions. The response percentages in Western studies varied between 66% and 100% for studies with lorazepam, while in Asian and Indian studies, they were 0% and 100%. For ECT, the response percentages are 59%-100%. There does not seem to be evidence for the use of antipsychotics in catatonic patients without any underlying psychotic disorder. Lorazepam and ECT are effective treatments for which clinical evidence is found in the literature. It is not possible to develop a treatment protocol because the evidence for catatonia management on the basis of the articles reviewed is limited. Stringent treatment studies on catatonia are warranted.

Systematic review of catatonia treatment

PubMed Central

Pelzer, Anne CM; van der Heijden, Frank MMA; den Boer, Erik

2018-01-01

Objective To investigate the evidence-based treatment of catatonia in adults. The secondary aim is to develop a treatment protocol. Materials and methods A systematic review of published treatment articles (case series, cohort or randomized controlled studies) which examined the effects of particular interventions for catatonia and/or catatonic symptoms in adult populations and used valid outcome measures was performed. The articles for this review were selected by searching the electronic databases of the Cochrane Library, MEDLINE, EMBASE and PSYCHINFO. Results Thirty-one articles met the inclusion criteria. Lorazepam and electroconvulsive therapy (ECT) proved to be the most investigated treatment interventions. The response percentages in Western studies varied between 66% and 100% for studies with lorazepam, while in Asian and Indian studies, they were 0% and 100%. For ECT, the response percentages are 59%–100%. There does not seem to be evidence for the use of antipsychotics in catatonic patients without any underlying psychotic disorder. Conclusion Lorazepam and ECT are effective treatments for which clinical evidence is found in the literature. It is not possible to develop a treatment protocol because the evidence for catatonia management on the basis of the articles reviewed is limited. Stringent treatment studies on catatonia are warranted. PMID:29398916

Apples to apples: the origin and magnitude of differences in asbestos cancer risk estimates derived using varying protocols.

PubMed

Berman, D Wayne

2011-08-01

Given that new protocols for assessing asbestos-related cancer risk have recently been published, questions arise concerning how they compare to the "IRIS" protocol currently used by regulators. The newest protocols incorporate findings from 20 additional years of literature. Thus, differences between the IRIS and newer Berman and Crump protocols are examined to evaluate whether these protocols can be reconciled. Risks estimated by applying these protocols to real exposure data from both laboratory and field studies are also compared to assess the relative health protectiveness of each protocol. The reliability of risks estimated using the two protocols are compared by evaluating the degree with which each potentially reproduces the known epidemiology study risks. Results indicate that the IRIS and Berman and Crump protocols can be reconciled; while environment-specific variation within fiber type is apparently due primarily to size effects (not addressed by IRIS), the 10-fold (average) difference between amphibole asbestos risks estimated using each protocol is attributable to an arbitrary selection of the lowest of available mesothelioma potency factors in the IRIS protocol. Thus, the IRIS protocol may substantially underestimate risk when exposure is primarily to amphibole asbestos. Moreover, while the Berman and Crump protocol is more reliable than the IRIS protocol overall (especially for predicting amphibole risk), evidence is presented suggesting a new fiber-size-related adjustment to the Berman and Crump protocol may ultimately succeed in reconciling the entire epidemiology database. However, additional data need to be developed before the performance of the adjusted protocol can be fully validated. © 2011 Society for Risk Analysis.

The impact of cash transfers on social determinants of health and health inequalities in Sub-Saharan Africa: a systematic review protocol.

PubMed

Owusu-Addo, Ebenezer; Renzaho, Andre M N; Mahal, Ajay S; Smith, Ben J

2016-07-13

There is increasing pressure to address the social determinants of health (SDoH) and health inequities through the implementation of culturally acceptable interventions particularly in Sub-Saharan Africa (SSA) where health outcomes are generally poor. Available evaluation research on cash transfers (CTs) suggests that the programs may influence the wider determinants of health in SSA; yet, there has been no attempt to synthesize the evidence regarding their contribution to tackling the SDoH and health inequalities. To date, nearly all the reviews on CTs' impact on health have predominantly featured evidence from Latin America with limited transferability to the social, cultural, and political environments in SSA. Therefore, the aim of this study is to undertake a systematic review to assess the role of CTs in tackling the wider determinants of health and health inequalities in SSA. A systematic review of published and unpublished literature on CTs' impact on health and health determinants covering the period 2000-2016 will be undertaken. Studies will be considered for inclusion if they present quantitative or qualitative data, including all relevant study designs. The SDoH conceptual framework will be used to guide the data extraction process. EPPI Reviewer software will be used for data management and analysis. Studies included in the review will be analyzed by narrative synthesis and/or meta-analysis as appropriate for the nature of the data retrieved. This review will provide empirical evidence on the impact of CTs on SDoH to inform CT policy, implementation, and research in SSA. The protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). This protocol has been registered with the PROSPERO international prospective register of systematic reviews, reference CRD42015025015 .

National Urea Cycle Disorders Foundation

MedlinePlus

... questions, NUCDF has collaborated with clinical investigators to design a patient-centered research study to gather evidence- ... UCDC). The UCDC will be assist in study design as well as protocol review. Pre-clinical research ...

Development of a neuro early mobilisation protocol for use in a neuroscience intensive care unit.

PubMed

Brissie, Megan A; Zomorodi, Meg; Soares-Sardinha, Sharmila; Jordan, J Dedrick

2017-10-01

Through evaluation of the literature and working with a team of multidisciplinary healthcare providers, our objective was to refine an interprofessional Neuro Early Mobilisation Protocol for complex patients in the Neuroscience Intensive Care Unit. Using the literature as a guide, key stakeholders, from multiple professions, designed and refined a Neuro Early Mobilisation Protocol. This project took place at a large academic medical center in the southeast United States classified as both a Level I Trauma Center and Comprehensive Stroke Center. Goals for protocol development were to: (1) simplify the protocol to allow for ease of use, (2) make the protocol more generalizable to the patient population cared for in the Neuroscience Intensive Care Unit, (3) receive feedback from those using the original protocol on ways to improve the protocol and (4) ensure patients were properly screened for inclusion and exclusion in the protocol. Using expert feedback and the evidence, an evidence-based Neuro Early Mobilisation Protocol was created for use with all patients in the Neuroscience Intensive Care Unit. Future work will consist of protocol implementation and evaluation in order to increase patient mobilisation in the Neuroscience Intensive Care Unit. Copyright © 2017 Elsevier Ltd. All rights reserved.

Neurofeedback Treatment and Posttraumatic Stress Disorder: Effectiveness of Neurofeedback on Posttraumatic Stress Disorder and the Optimal Choice of Protocol.

PubMed

Reiter, Karen; Andersen, Søren Bo; Carlsson, Jessica

2016-02-01

Neurofeedback is an alternative, noninvasive approach used in the treatment of a wide range of neuropsychiatric disorders, including posttraumatic stress disorder (PTSD). Many different neurofeedback protocols and methods exist. Likewise, PTSD is a heterogeneous disorder. To review the evidence on effectiveness and preferred protocol when using neurofeedback treatment on PTSD, a systematic search of PubMed, PsychInfo, Embase, and Cochrane databases was undertaken. Five studies were included in this review. Neurofeedback had a statistically significant effect in three studies. Neurobiological changes were reported in three studies. Interpretation of results is, however, limited by differences between the studies and several issues regarding design. The optimistic results presented here qualify neurofeedback as probably efficacious for PTSD treatment.

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol.

PubMed

Blom, Kimberly C; Farina, Sasha; Gomez, Yessica-Haydee; Campbell, Norm R C; Hemmelgarn, Brenda R; Cloutier, Lyne; McKay, Donald W; Dawes, Martin; Tobe, Sheldon W; Bolli, Peter; Gelfer, Mark; McLean, Donna; Bartlett, Gillian; Joseph, Lawrence; Featherstone, Robin; Schiffrin, Ernesto L; Daskalopoulou, Stella S

2015-04-01

Despite progress in automated blood pressure measurement (BPM) technology, there is limited research linking hard outcomes to automated office BPM (OBPM) treatment targets and thresholds. Equivalences for automated BPM devices have been estimated from approximations of standardized manual measurements of 140/90 mmHg. Until outcome-driven targets and thresholds become available for automated measurement methods, deriving evidence-based equivalences between automated methods and standardized manual OBPM is the next best solution. The MeasureBP study group was initiated by the Canadian Hypertension Education Program to close this critical knowledge gap. MeasureBP aims to define evidence-based equivalent values between standardized manual OBPM and automated BPM methods by synthesizing available evidence using a systematic review and individual subject-level data meta-analyses. This manuscript provides a review of the literature and MeasureBP study protocol. These results will lay the evidenced-based foundation to resolve uncertainties within blood pressure guidelines which, in turn, will improve the management of hypertension.

Perioperative management of external fixation in staged protocols: an international survey.

PubMed

Hodel, Sandro; Link, Björn-Christian; Babst, Reto; Mallee, W H; Posso, Philippe; Beeres, Frank J P

2018-05-01

Despite the frequent use of external fixation, various regimes of antibiotic prophylaxis, surgical technique and postoperative pin care exist and underline the lack of current evidence. The aim of the study was to assess the variability or consensus in perioperative protocols to prevent implant-associated infections for temporary external fixation in closed fractures of the extremities. A 26-question survey was sent to 170 members of the Traumaplatform. The survey included questions concerning demographics, level of training, type of training and perioperative protocols as: antibiotic prophylaxis, intraoperative management, disinfection and postoperative pin site care. All responses were statistically analysed, and intraoperative measures rated on a 5-point Likert scale. The responses of fifty orthopaedic trauma and general surgeons (response rate, 29.4%) were analysed. The level of experience was more than 5 years in 92% (n = 46) with up to 50 closed fractures of the extremities annually treated with external fixation in 80% (n = 40). Highest consensus could be identified in the following perioperative measures: preoperative antibiotic prophylaxis with a second-generation cephalosporin (86%, n = 43), changing gloves if manipulation of the external fixator is necessary during surgery (86%, n = 43; 4.12 points on the Likert scale), avoid overlapping of the pin sites with the definitive implant site (94%, n = 47; 4.12 points on the Likert scale) and soft tissue protection with a drill sleeve (83.6%, n = 41). Our survey could identify some general principles, which were rated as important by a majority of the respondents. Futures studies' focus should elucidate the role of perioperative antibiotics and different disinfection protocols on implant-associated infections after temporary external fixation in staged protocols. This study provides Level IV evidence according to Oxford centre for evidence-based medicine.

Nasoalveolar molding in cleft care: is it efficacious?

PubMed

Abbott, Megan M; Meara, John G

2012-09-01

In the era of evidence-based medicine, new treatment protocols and interventions should be routinely evaluated for their efficacy by reviewing the available evidence. In the cleft literature, nasoalveolar molding has garnered attention over the last decade as a new option for improving nasal form and symmetry before primary surgical repair. Systematic review of the evidence is, however, currently lacking. This review evaluates whether nasoalveolar molding can improve nasal symmetry and form toward the norm, as well as whether nasoalveolar molding demonstrates advantages over other protocols in achieving this goal. A literature search of five databases plus relevant reference lists retrieved 98 articles regarding nasoalveolar molding, 21 of which reported objective outcome measures of nasal symmetry and form, and six of which were able to be given evidence level ratings, all in the unilateral cleft population. Statistical analysis was not possible given the range of techniques and outcomes. Studies of bilateral cleft were not given evidence level ratings, given the inability to separate the effects of nasoalveolar molding from other primary nasal interventions in studies that would have otherwise been rated. In unilateral cleft lip-cleft palate, there was some evidence that nasoalveolar molding may improve nasal outcomes, though comparison with other techniques was limited. Despite a relative paucity of high-level evidence, nasoalveolar molding appears to be a promising technique that deserves further study.

IN-HOME EXPOSURE THERAPY FOR VETERANS WITH POST TRAUMATIC STRESS DISORDER

DTIC Science & Technology

2016-10-01

study protocol. 5 Our treatment clinicians are providing the manual-guided evidence - based PE PTSD intervention. Therapists attend a weekly PE...with PTSD confirming the noninferiority of using CVT to deliver an evidence - based treatment (EBT) for PTSD, Cognitive Processing Therapy (CPT; Resick...g. Treatment clinicians will conduct a manual-guided evidence based PTSD intervention, Prolonged Exposure Therapy (PE), with approximately 175

Diffusion Kurtosis Imaging Detects Microstructural Alterations in Brain of α-Synuclein Overexpressing Transgenic Mouse Model of Parkinson's Disease: A Pilot Study.

PubMed

Khairnar, Amit; Latta, Peter; Drazanova, Eva; Ruda-Kucerova, Jana; Szabó, Nikoletta; Arab, Anas; Hutter-Paier, Birgit; Havas, Daniel; Windisch, Manfred; Sulcova, Alexandra; Starcuk, Zenon; Rektorova, Irena

2015-11-01

Evidence suggests that accumulation and aggregation of α-synuclein contribute to the pathogenesis of Parkinson's disease (PD). The aim of this study was to evaluate whether diffusion kurtosis imaging (DKI) will provide a sensitive tool for differentiating between α-synuclein-overexpressing transgenic mouse model of PD (TNWT-61) and wild-type (WT) littermates. This experiment was designed as a proof-of-concept study and forms a part of a complex protocol and ongoing translational research. Nine-month-old TNWT-61 mice and age-matched WT littermates underwent behavioral tests to monitor motor impairment and MRI scanning using 9.4 Tesla system in vivo. Tract-based spatial statistics (TBSS) and the DKI protocol were used to compare the whole brain white matter of TNWT-61 and WT mice. In addition, region of interest (ROI) analysis was performed in gray matter regions such as substantia nigra, striatum, hippocampus, sensorimotor cortex, and thalamus known to show higher accumulation of α-synuclein. For the ROI analysis, both DKI (6 b-values) protocol and conventional (2 b-values) diffusion tensor imaging (cDTI) protocol were used. TNWT-61 mice showed significant impairment of motor coordination. With the DKI protocol, mean, axial, and radial kurtosis were found to be significantly elevated, whereas mean and radial diffusivity were decreased in the TNWT-61 group compared to that in the WT controls with both TBSS and ROI analysis. With the cDTI protocol, the ROI analysis showed decrease in all diffusivity parameters in TNWT-61 mice. The current study provides evidence that DKI by providing both kurtosis and diffusivity parameters gives unique information that is complementary to cDTI for in vivo detection of pathological changes that underlie PD-like symptomatology in TNWT-61 mouse model of PD. This result is a crucial step in search for a candidate diagnostic biomarker with translational potential and relevance for human studies.

Guidelines for randomized clinical trial protocol content: a systematic review

PubMed Central

2012-01-01

Background All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. Methods We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Results Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed. PMID:23006870

Guidelines for randomized clinical trial protocol content: a systematic review.

PubMed

Tetzlaff, Jennifer M; Chan, An-Wen; Kitchen, Jessica; Sampson, Margaret; Tricco, Andrea C; Moher, David

2012-09-24

All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

Soil examination for a forensic trace evidence laboratory-Part 3: A proposed protocol for the effective triage and management of soil examinations.

PubMed

Woods, Brenda; Lennard, Chris; Kirkbride, K Paul; Robertson, James

2016-05-01

In the past, forensic soil examination was a routine aspect of forensic trace evidence examinations. The apparent need for soil examinations then went through a period of decline and with it the capability of many forensic laboratories to carry out soil examinations. In more recent years, interest in soil examinations has been renewed due-at least in part-to soil examinations contributing to some high profile investigations. However, much of this renewed interest has been in organisations with a primary interest in soil and geology rather than forensic science. We argue the need to reinstate soil examinations as a trace evidence sub-discipline within forensic science laboratories and present a pathway to support this aim. An examination procedure is proposed that includes: (i) appropriate sample collection and storage by qualified crime scene examiners; (ii) exclusionary soil examinations by trace evidence scientists within a forensic science laboratory; (iii) inclusionary soil examinations by trace evidence scientists within a forensic science laboratory; and (iv) higher-level examination of soils by specialist soil scientists and palynologists. Soil examinations conducted by trace evidence scientists will be facilitated if the examinations are conducted using the instrumentation routinely used by these examiners. Hence, the proposed examination protocol incorporates instrumentation in routine use in a forensic trace evidence laboratory. Finally, we report on an Australian soil scene variability study and a blind trial that demonstrate the utility of the proposed protocol for the effective triage and management of soil samples by forensic laboratories. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review.

PubMed

Sousa-Santos, A R; Amaral, T F

2017-10-16

Hand grip strength (HGS) is used for the diagnosis of sarcopenia and frailty. Several factors have been shown to influence HGS values during measurement. Therefore, variations in the protocols used to assess HGS, as part of the diagnosis of sarcopenia and frailty, may lead to the identification of different individuals with low HGS, introducing bias. The aim of this systematic review is to gather all the relevant studies that measured HGS to diagnose sarcopenia and frailty and to identify the differences between the protocols used. A systematic review was carried out following the recommendations of The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement. PubMed and Web of Science were systematically searched, until August 16, 2016. The evidence regarding HGS measurement protocols used to diagnose sarcopenia and frailty was summarised and the most recent protocols regarding the procedure were compared. From the described search 4393 articles were identified. Seventy-two studies were included in this systematic review, in which 37 referred to sarcopenia articles, 33 to frailty and two evaluated both conditions. Most studies presented limited information regarding the protocols used. The majority of the studies included did not describe a complete procedure of HGS measurement. The high heterogeneity between the protocols used, in sarcopenia and frailty studies, create an enormous difficulty in drawing comparative conclusions among them.

How blockchain-timestamped protocols could improve the trustworthiness of medical science

PubMed Central

Irving, Greg; Holden, John

2017-01-01

Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies. PMID:27239273

Jack Healy Remembers - Anecdotal Evidence for the Origin of the Approximate 24-hour Urine Sampling Protocol Used for Worker Bioassay Monitoring

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

Carbaugh, Eugene H.

2008-10-01

The origin of the approximate 24-hour urine sampling protocol used at Hanford for routine bioassay is attributed to an informal study done in the mid-1940s. While the actual data were never published and have been lost, anecdotal recollections by staff involved in the initial bioassay program design and administration suggest that the sampling protocol had a solid scientific basis. Numerous alternate methods for normalizing partial day samples to represent a total 24-hour collection have since been proposed and used, but no one method is obviously preferred.

How blockchain-timestamped protocols could improve the trustworthiness of medical science.

PubMed

Irving, Greg; Holden, John

2016-01-01

Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols.

PubMed

Bleakley, C M; McDonough, S M; MacAuley, D C; Bjordal, J

2006-08-01

The use of cryotherapy in the management of acute soft tissue injury is largely based on anecdotal evidence. Preliminary evidence suggests that intermittent cryotherapy applications are most effective at reducing tissue temperature to optimal therapeutic levels. However, its efficacy in treating injured human subjects is not yet known. To compare the efficacy of an intermittent cryotherapy treatment protocol with a standard cryotherapy treatment protocol in the management of acute ankle sprains. Sportsmen (n = 44) and members of the general public (n = 45) with mild/moderate acute ankle sprains. Subjects were randomly allocated, under strictly controlled double blind conditions, to one of two treatment groups: standard ice application (n = 46) or intermittent ice application (n = 43). The mode of cryotherapy was standardised across groups and consisted of melting iced water (0 degrees C) in a standardised pack. Function, pain, and swelling were recorded at baseline and one, two, three, four, and six weeks after injury. Subjects treated with the intermittent protocol had significantly (p<0.05) less ankle pain on activity than those using a standard 20 minute protocol; however, one week after ankle injury, there were no significant differences between groups in terms of function, swelling, or pain at rest. Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury.

Circadian temperature rhythms of older people

NASA Technical Reports Server (NTRS)

Monk, T. H.; Buysse, D. J.; Reynolds, C. F. 3rd; Kupfer, D. J.; Houck, P. R.

1995-01-01

This collection of studies had the aim of exploring whether older (77+ years) men and women have circadian body temperature rhythms different from those of younger adults. A total of 20 older men and 28 older women were compared with either 22 young men or 14 middle-aged men in four protocols; all but the first protocol using a subset of the sample. The four protocols were: 1) 24 h, and 2) 72 h data collections on a normal laboratory routine (sleeping at night); 3) between 36 h and 153 h of field data collection at home; and 4) 36 h of a constant conditions routine (wakeful bedrest under temporal isolation) in the laboratory. There was some evidence for an age-related phase advance in temperature rhythm, especially for the older men on a normal routine, though this was not present in the constant conditions protocol, where 5 of the older subjects showed major delays in the timing of the body temperature trough (10:00 or later). There was no statistically significant evidence from any of the protocols that older subjects generally had lower temperature rhythm amplitudes than younger adults. Only when older men were compared with younger men in 24-h rhythm amplitude by simple t-test did any comparison involving amplitude achieve statistical significance (p < 0.05).

Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires : A Systematic Review of Surgical Never Events.

PubMed

Hempel, Susanne; Maggard-Gibbons, Melinda; Nguyen, David K; Dawes, Aaron J; Miake-Lye, Isomi; Beroes, Jessica M; Booth, Marika J; Miles, Jeremy N V; Shanman, Roberta; Shekelle, Paul G

2015-08-01

Serious, preventable surgical events, termed never events, continue to occur despite considerable patient safety efforts. To examine the incidence and root causes of and interventions to prevent wrong-site surgery, retained surgical items, and surgical fires in the era after the implementation of the Universal Protocol in 2004. We searched 9 electronic databases for entries from 2004 through June 30, 2014, screened references, and consulted experts. Two independent reviewers identified relevant publications in June 2014. One reviewer used a standardized form to extract data and a second reviewer checked the data. Strength of evidence was established by the review team. Data extraction was completed in January 2015. Incidence of wrong-site surgery, retained surgical items, and surgical fires. We found 138 empirical studies that met our inclusion criteria. Incidence estimates for wrong-site surgery in US settings varied by data source and procedure (median estimate, 0.09 events per 10,000 surgical procedures). The median estimate for retained surgical items was 1.32 events per 10,000 procedures, but estimates varied by item and procedure. The per-procedure surgical fire incidence is unknown. A frequently reported root cause was inadequate communication. Methodologic challenges associated with investigating changes in rare events limit the conclusions of 78 intervention evaluations. Limited evidence supported the Universal Protocol (5 studies), education (4 studies), and team training (4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent retained surgical items by using data-matrix-coded sponge-counting systems (5 pertinent studies). Evidence for preventing surgical fires was insufficient, and intervention effects were not estimable. Current estimates for wrong-site surgery and retained surgical items are 1 event per 100,000 and 1 event per 10,000 procedures, respectively, but the precision is uncertain, and the per-procedure prevalence of surgical fires is not known. Root-cause analyses suggest the need for improved communication. Despite promising approaches and global Universal Protocol evaluations, empirical evidence for interventions is limited.

Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain?

PubMed Central

Ezenwa, Miriam O.; Molokie, Robert E.; Wang, Zaijie Jim; Yao, Yingwei; Suarez, Marie L.; Pullum, Cherese; Schlaeger, Judith M.; Fillingim, Roger B.; Wilkie, Diana J.

2014-01-01

Objectives Pain is the hallmark symptom of sickle cell disease (SCD), yet the types of pain that these patients experience, and the underlying mechanisms, have not been well characterized. The study purpose was to determine the safety and utility of a mechanical and thermal quantitative sensory testing (QST) protocol and the feasibility of utilizing neuropathic pain questionnaires among adults with SCD. Methods A convenience sample (N=25, 18 women, mean age 38.5 ± 12.5 [20–58 years]) completed self-report pain and quality-of-life tools. Subjects also underwent testing with the TSA-II NeuroSensory Analyzer and calibrated von Frey microfilaments. Results We found that the QST protocol was safe and did not stimulate a SCD pain crisis. There was evidence of central sensitization (n=15), peripheral sensitization (n=1), a mix of central and peripheral sensitization (n=8), or no sensitization (n=1). The neuropathic pain self-report tools were feasible with evidence of construct validity; 40% of the subjects reported S-LANSS scores that were indicative of neuropathic pain and had evidence of central, peripheral or mixed sensitization. Discussion The QST protocol can be safely conducted in adults with SCD and provides evidence of central or peripheral sensitization, which is consistent with a neuropathic component to SCD pain. These findings are novel, warrant a larger confirmatory study, and indicate the need for normative QST data from African American adults and older adults. PMID:25581383

Measurement properties of maximal cardiopulmonary exercise tests protocols in persons after stroke: A systematic review.

PubMed

Wittink, Harriet; Verschuren, Olaf; Terwee, Caroline; de Groot, Janke; Kwakkel, Gert; van de Port, Ingrid

2017-11-21

To systematically review and critically appraise the literature on measurement properties of cardiopulmonary exercise test protocols for measuring aerobic capacity, VO2max, in persons after stroke. PubMed, Embase and Cinahl were searched from inception up to 15 June 2016. A total of 9 studies were identified reporting on 9 different cardiopulmonary exercise test protocols. VO2max measured with cardiopulmonary exercise test and open spirometry was the construct of interest. The target population was adult persons after stroke. We included all studies that evaluated reliability, measurement error, criterion validity, content validity, hypothesis testing and/or responsiveness of cardiopulmonary exercise test protocols. Two researchers independently screened the literature, assessed methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist and extracted data on measurement properties of cardiopulmonary exercise test protocols. Most studies reported on only one measurement property. Best-evidence synthesis was derived taking into account the methodological quality of the studies, the results and the consistency of the results. No judgement could be made on which protocol is "best" for measuring VO2max in persons after stroke due to lack of high-quality studies on the measurement properties of the cardiopulmonary exercise test.

Sub-Symptomatic Aerobic Exercise for Patients with Post-Concussion Syndrome: A Critically Appraised Topic.

PubMed

Ritter, Katrina G; Hussey, Matthew J; Valovich McLeod, Tamara C

2017-09-27

Clinical Scenario: Patients who experience prolonged concussion symptoms can be diagnosed with Post-Concussion Syndrome (PCS) when those symptoms persist past 4 weeks. Aerobic exercise protocols have been shown to be effective in improving physical and mental aspects of health. Emerging research suggests that aerobic exercise maybe useful as a treatment for PCS, where exercise allows patients to feel less isolated and more active during the recovery process. Is aerobic exercise more beneficial in reducing symptoms than current standard care in patients with prolonged symptoms or PCS lasting longer than 4 weeks? Summary of Key Findings: After a thorough literature search, 4 studies were selected relevant to the clinical question. Of the 4 studies, 1 was a randomized control trial and 3 were case series. All 4 studies investigate aerobic exercise protocol as treatment for PCS. 1-4 Three articles demonstrated a greater rate of symptom improvement from baseline assessment to follow-up after a controlled sub-symptomatic aerobic exercise program. 2-4 One study showed a decrease in symptoms in the aerobic exercise group compared to the full body stretching group. 1 Clinical Bottom Line: There is moderate evidence to support sub-symptomatic aerobic exercise as a treatment of PCS, therefore it should be considered as a clinical option for reducing PCS and prolonged concussion symptoms. A previously validated protocol, such as the Buffalo Concussion Treadmill Test, Balke Protocol, or Rating of Perceived Exertion (RPE) as mentioned in this critically appraised topic should be used to measure baseline values and treatment progression. Strength of Recommendation: Level C evidence exists that aerobic exercise protocol is more effective than the current standard of care in treating PCS.

Surgical Technical Evidence Review of Hip Fracture Surgery Conducted for the AHRQ Safety Program for Improving Surgical Care and Recovery

PubMed Central

Siletz, Anaar; Faltermeier, Claire; Singer, Emily S.; Hu, Q. Lina; Ko, Clifford Y.; Kates, Stephen L.; Maggard-Gibbons, Melinda; Wick, Elizabeth

2018-01-01

Background: Enhanced recovery pathways (ERPs) have been shown to improve patient outcomes in a variety of contexts. This review summarizes the evidence and defines a protocol for perioperative care of patients with hip fracture and was conducted for the Agency for Healthcare Research and Quality safety program for improving surgical care and recovery. Study Design: Perioperative care was divided into components or “bins.” For each bin, a semisystematic review of the literature was conducted using MEDLINE with priority given to systematic reviews, meta-analyses, and randomized controlled trials. Observational studies were included when higher levels of evidence were not available. Existing guidelines for perioperative care were also incorporated. For convenience, the components of care that are under the auspices of anesthesia providers will be reported separately. Recommendations for an evidence-based protocol were synthesized based on review of this evidence. Results: Eleven bins were identified. Preoperative risk factor bins included nutrition, diabetes mellitus, tobacco use, and anemia. Perioperative management bins included thromboprophylaxis, timing of surgery, fluid management, drain placement, early mobilization, early alimentation, and discharge criteria/planning. Conclusions: This review provides the evidence basis for an ERP for perioperative care of patients with hip fracture. PMID:29844947

The implementation and evaluation of an evidence-based statewide prehospital pain management protocol developed using the national prehospital evidence-based guideline model process for emergency medical services.

PubMed

Brown, Kathleen M; Hirshon, Jon Mark; Alcorta, Richard; Weik, Tasmeen S; Lawner, Ben; Ho, Shiu; Wright, Joseph L

2014-01-01

In 2008, the National Highway Traffic Safety Administration funded the development of a model process for the development and implementation of evidence-based guidelines (EBGs) for emergency medical services (EMS). We report on the implementation and evaluation of an evidence-based prehospital pain management protocol developed using this model process. An evidence-based protocol for prehospital management of pain resulting from injuries and burns was reviewed by the Protocol Review Committee (PRC) of the Maryland Institute for Emergency Medical Services Systems (MIEMSS). The PRC recommended revisions to the Maryland protocol that reflected recommendations in the EBG: weight-based dosing and repeat dosing of morphine. A training curriculum was developed and implemented using Maryland's online Learning Management System and successfully accessed by 3,941 paramedics and 15,969 BLS providers. Field providers submitted electronic patient care reports to the MIEMSS statewide prehospital database. Inclusion criteria were injured or burned patients transported by Maryland ambulances to Maryland hospitals whose electronic patient care records included data for level of EMS provider training during a 12-month preimplementation period and a 12-month postimplementation period from September 2010 through March 2012. We compared the percentage of patients receiving pain scale assessments and morphine, as well as the dose of morphine administered and the use of naloxone as a rescue medication for opiate use, before and after the protocol change. No differences were seen in the percentage of patients who had a pain score documented or the percent of patients receiving morphine before and after the protocol change, but there was a significant increase in the total dose and dose in mg/kg administered per patient. During the postintervention phase, patients received an 18% higher total morphine dose and a 14.9% greater mg/kg dose. We demonstrated that the implementation of a revised statewide prehospital pain management protocol based on an EBG developed using the National Prehospital Evidence-based Guideline Model Process was associated with an increase in dosing of narcotic pain medication consistent with that recommended by the EBG. No differences were seen in the percentage of patients receiving opiate analgesia or in the documentation of pain scores.

Evidence or eminence in abdominal surgery: Recent improvements in perioperative care

PubMed Central

Segelman, Josefin; Nygren, Jonas

2014-01-01

Repeated surveys from Europe, the United States, Australia, and New Zealand have shown that adherence to an evidence-based perioperative care protocol, such as Enhanced Recovery After Surgery (ERAS), has been generally low. It is of great importance to support the implementation of the ERAS protocol as it has been shown to improve outcomes after a number of surgical procedures, including major abdominal surgery. However, despite an increasing awareness of the importance of structured perioperative management, the implementation of this complex protocol has been slow. Barriers to implementation involve both patient- and staff-related factors as well as practice-related issues and resources. To support efficient and successful implementation, further educational and structural measures have to be made on a national or regional level to improve the standard of general health care. Besides postoperative morbidity, biological and physiological variables have been quite commonly reported in previous ERAS studies. Little information, however, has been obtained on cost-effectiveness, long-term outcomes, quality of life and patient-related outcomes, and these issues remain important areas of research for future studies. PMID:25469030

Review of Evidence for Adult Diabetic Ketoacidosis Management Protocols.

PubMed

Tran, Tara T T; Pease, Anthony; Wood, Anna J; Zajac, Jeffrey D; Mårtensson, Johan; Bellomo, Rinaldo; Ekinci, Elif I I

2017-01-01

Diabetic ketoacidosis (DKA) is an endocrine emergency with associated risk of morbidity and mortality. Despite this, DKA management lacks strong evidence due to the absence of large randomised controlled trials (RCTs). To review existing studies investigating inpatient DKA management in adults, focusing on intravenous (IV) fluids; insulin administration; potassium, bicarbonate, and phosphate replacement; and DKA management protocols and impact of DKA resolution rates on outcomes. Ovid Medline searches were conducted with limits "all adult" and published between "1973 to current" applied. National consensus statements were also reviewed. Eligibility was determined by two reviewers' assessment of title, abstract, and availability. A total of 85 eligible articles published between 1973 and 2016 were reviewed. The salient findings were (i) Crystalloids are favoured over colloids though evidence is lacking. The preferred crystalloid and hydration rates remain contentious. (ii) IV infusion of regular human insulin is preferred over the subcutaneous route or rapid acting insulin analogues. Administering an initial IV insulin bolus before low-dose insulin infusions obviates the need for supplemental insulin. Consensus-statements recommend fixed weight-based over "sliding scale" insulin infusions although evidence is weak. (iii) Potassium replacement is imperative although no trials compare replacement rates. (iv) Bicarbonate replacement offers no benefit in DKA with pH > 6.9. In severe metabolic acidosis with pH < 6.9, there is lack of both data and consensus regarding bicarbonate administration. (v) There is no evidence that phosphate replacement offers outcome benefits. Guidelines consider replacement appropriate in patients with cardiac dysfunction, anaemia, respiratory depression, or phosphate levels <0.32 mmol/L. (vi) Upon resolution of DKA, subcutaneous insulin is recommended with IV insulin infusions ceased with an overlap of 1-2 h. (vii) DKA resolution rates are often used as end points in studies, despite a lack of evidence that rapid resolution improves outcome. (viii) Implementation of DKA protocols lacks strong evidence for adherence but may lead to improved clinical outcomes. There are major deficiencies in evidence for optimal management of DKA. Current practice is guided by weak evidence and consensus opinion. All aspects of DKA management require RCTs to affirm or redirect management and formulate consensus evidence-based practice to improve patient outcomes.

Clinical pathways for acute coronary syndromes in China: protocol for a hospital quality improvement initiative.

PubMed

Rong, Ye; Turnbull, Fiona; Patel, Anushka; Du, Xin; Wu, Yangfeng; Gao, Runlin

2010-09-01

Clinical pathways have been shown to be effective in improving quality of care for patients admitted to hospital for acute coronary syndromes (ACS) in high-income countries. However, their utility has not formally been evaluated in low- or middle-income countries. The Clinical Pathways for Acute Coronary Syndromes in China program is a 7-year study with the overall goal of reducing evidence-practice gaps in the management of patients admitted to hospitals in China with suspected ACS. The program comprises 2 phases: a prospective survey of current management of ACS patients to identify the areas that evidence-based patient care can be potentially improved, and a quality care initiative to maximize the use of evidence-based investigations and treatments for ACS patients in China. In this article, we outline the details of the study protocol, including key aspects of the development, implementation, and evaluation of the quality improvement initiative (clinical pathway) for management of patients with suspected ACS.

Data Set for Pathology Reporting of Cutaneous Invasive Melanoma

PubMed Central

Judge, Meagan J.; Evans, Alan; Frishberg, David P.; Prieto, Victor G.; Thompson, John F.; Trotter, Martin J.; Walsh, Maureen Y.; Walsh, Noreen M.G.; Ellis, David W.

2013-01-01

An accurate and complete pathology report is critical for the optimal management of cutaneous melanoma patients. Protocols for the pathologic reporting of melanoma have been independently developed by the Royal College of Pathologists of Australasia (RCPA), Royal College of Pathologists (United Kingdom) (RCPath), and College of American Pathologists (CAP). In this study, data sets, checklists, and structured reporting protocols for pathologic examination and reporting of cutaneous melanoma were analyzed by an international panel of melanoma pathologists and clinicians with the aim of developing a common, internationally agreed upon, evidence-based data set. The International Collaboration on Cancer Reporting cutaneous melanoma expert review panel analyzed the existing RCPA, RCPath, and CAP data sets to develop a protocol containing “required” (mandatory/core) and “recommended” (nonmandatory/noncore) elements. Required elements were defined as those that had agreed evidentiary support at National Health and Medical Research Council level III-2 level of evidence or above and that were unanimously agreed upon by the review panel to be essential for the clinical management, staging, or assessment of the prognosis of melanoma or fundamental for pathologic diagnosis. Recommended elements were those considered to be clinically important and recommended for good practice but with lesser degrees of supportive evidence. Sixteen core/required data elements for cutaneous melanoma pathology reports were defined (with an additional 4 core/required elements for specimens received with lymph nodes). Eighteen additional data elements with a lesser level of evidentiary support were included in the recommended data set. Consensus response values (permitted responses) were formulated for each data item. Development and agreement of this evidence-based protocol at an international level was accomplished in a timely and efficient manner, and the processes described herein may facilitate the development of protocols for other tumor types. Widespread utilization of an internationally agreed upon, structured pathology data set for melanoma will lead not only to improved patient management but is a prerequisite for research and for international benchmarking in health care. PMID:24061524

Improving preterm infant outcomes: implementing an evidence-based oral feeding advancement protocol in the neonatal intensive care unit.

PubMed

Kish, Mary Z

2014-10-01

The ability of a preterm infant to exclusively oral feed is a necessary standard for discharge readiness from the neonatal intensive care unit (NICU). Many of the interventions related to oral feeding advancement currently employed for preterm infants in the NICU are based on individual nursing observations and judgment. Studies involving standardized feeding protocols for oral feeding advancement have been shown to decrease variability in feeding practices, facilitate shortened transition times from gavage to oral feedings, improve bottle feeding performance, and significantly decrease the length of stay (LOS) in the NICU. This project critically evaluated the implementation of an oral feeding advancement protocol in a 74-bed level III NICU in an attempt to standardize the process of advancing oral feedings in medically stable preterm infants. A comprehensive review of the literature identified key features for successful oral feeding in preterm infants. Strong levels of evidence suggested an association between both nonnutritive sucking (NNS) opportunities and standardized feeding advancement protocols with successful oral feeding in preterm infants. These findings prompted a pilot practice change using a feeding advancement protocol and consisted of NNS and standardized oral feeding advancement opportunities. Time to exclusive oral feedings and LOS were compared pre- and postprotocol implementation during more than a 2-month evaluation period. Infants using NNS and the standardized oral feeding advancement protocol had an observed reduction in time to exclusive oral feedings and LOS, although statistical significance was not achieved.

Quality of life and myelomeningocele: an ethical and evidence-based analysis of the Groningen Protocol.

PubMed

Barry, Sean

2010-01-01

In 2005, a group of pediatricians at the University Medical Center in Groningen, The Netherlands, published the Groningen Protocol (GP) for Euthanasia in Newborns. This protocol is a set of guidelines devised in 2001 to clarify and facilitate the assessment of clinically stable neonates deemed to be in unbearable suffering for whom the prognosis is felt to be hopeless. At the time of publication, the GP had been in use for 7 years, and 22 patients, all with diagnosed myelomeningocele (MMC), had met the selection criteria for euthanasia by lethal injection. MMC is the most common neurological congenital anomaly, affecting approximately 300,000 newborns yearly worldwide. Neurosurgeons have a unique perspective on this disease and therefore an important voice, given the significant role they have in caring for these patients at all stages of their lives. This paper reviews the principal ethical arguments presented to date in the literature regarding the GP. It also provides an evidence-based critique of the GP in light of quality-of-life studies addressing adults with MMC, and ascertains whether or not the GP meets the criteria for an evidence-based guideline. Copyright © 2011 S. Karger AG, Basel.

Complete radiotherapy response in rectal cancer: A review of the evidence.

PubMed

Couch, Daniel G; Hemingway, David M

2016-01-14

Complete response to chemoradiotherapy for rectal cancer is becoming a common clinical entity. Techniques to diagnose complete response and how to survey these patients without operative intervention are still unclear. We review the most recent evidence. Barriers to firm conclusions regarding this are heterogeneity of diagnostic definitions, differing surveillance protocols, and a lack of randomised studies.

Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

PubMed

González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

2015-10-31

Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed. ClinicalTrials.gov NCT02345668 . Registered 27 July 2015.

Weight training in youth-growth, maturation, and safety: an evidence-based review.

PubMed

Malina, Robert M

2006-11-01

To review the effects of resistance training programs on pre- and early-pubertal youth in the context of response, potential influence on growth and maturation, and occurrence of injury. Evidence-based review. Twenty-two reports dealing with experimental resistance training protocols, excluding isometric programs, in pre- and early-pubertal youth, were reviewed in the context of subject characteristics, training protocol, responses, and occurrence of injury. Experimental programs most often used isotonic machines and free weights, 2- and 3-day protocols, and 8- and 12-week durations, with significant improvements in muscular strength during childhood and early adolescence. Strength gains were lost during detraining. Experimental resistance training programs did not influence growth in height and weight of pre- and early-adolescent youth, and changes in estimates of body composition were variable and quite small. Only 10 studies systematically monitored injuries, and only three injuries were reported. Estimated injury rates were 0.176, 0.053, and 0.055 per 100 participant-hours in the respective programs. Experimental training protocols with weights and resistance machines and with supervision and low instructor/participant ratios are relatively safe and do not negatively impact growth and maturation of pre- and early-pubertal youth.

Developing an evidence-based nursing protocol on wound drain management for total joint arthroplasty.

PubMed

Tsang, Lap Fung

2015-05-01

Although various drains have long been used for many years in total joint replacement, there is a paucity of evidence for the benefit of drain applications. Evidence suggests inconsistent practice in the use of drainage systems, whether intermittently applying suction or free of suction in the application of drainage systems, as well as the optimal timing for wound drain removal. It aimed to perform a systematic review to develop an evidence-based nursing protocol to manage wound drainage following total joint arthroplasty. A comprehensive systematic review of available evidence up to 2013. Searches of the EMBASE, Cochrane library, CINAHL, Medline electronic databases and an internet search by Yahoo and Google engine returned 2840 records, of which 11 met the inclusion criteria for this review. A further two papers were obtained through scanning the reference lists of those articles included from the initial literature search. Different clamping times were retrieved from the literature. A protocol was adapted for clinical application according to the summary of the retrieved information. It is suggested that clamping is performed 1 h after the insertion of suction drains post-operatively in the operating theatre. Wound drains should be clamped for 1 h if blood loss is more than 600 ml in 6 h in first 24 h. Wound drains should be clamped for 1 h if blood loss is more than 800 ml in 8 h thereafter. It is suggested that the drainage reservoir bottle should be mark and findings recorded in line with the principle of drain clamping. This means that the amount of drainage is measured and recorded every 6 h in first 24 h and every 8 h thereafter. It is suggested that wound drains should be remove before 48 h after TJR. If blood loss is less than 50 ml in past 6 h or less than 70 ml in past 8 h, the drain should be remove and the wound site should be monitored closely. This paper has guided nurses to develop an evidence-based protocol to improve patient care on wound drain management. Further study is necessary to evaluate the effectiveness of the protocol. Copyright © 2014 Elsevier Ltd. All rights reserved.

Process and Outcome of Fecal Microbiota Transplants in Patients With Recurrent Clostridium difficile Infection: A Prospective Study.

PubMed

Walton, Janice; Burns, Denise; Gaehle, Kay E

The incidence of Clostridium difficile infection is on the rise worldwide, causing high mortality rates and costing patients, hospitals, and insurance companies millions of dollars annually. Fecal microbiota transplants successfully treat recurrent C. difficile infections unresponsive to standard pharmacologic treatment such as flagyl, vancomycin, or rifaximin. Evidence in the literature provided the foundation for the development and refinement of this fecal microbiota transplant protocol. During the initial phase of the project, the protocol included patient selection criteria, donor screening/selection, infection control, fecal processing and delivery, and patient pre and postprocedure education. This article highlights the second phase of prospective testing of a nurse-driven protocol to implement fecal microbiota transplantation in patients with recurrent C. difficile infection. All stages of the protocol are explained as well as rationale for component parts to achieve successful patient outcomes when the protocol is carefully followed.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Switching From Age-Based Stimulus Dosing to Dose Titration Protocols in Electroconvulsive Therapy: Empirical Evidence for Better Patient Outcomes With Lower Peak and Cumulative Energy Doses.

PubMed

O'Neill-Kerr, Alex; Yassin, Anhar; Rogers, Stephen; Cornish, Janie

2017-09-01

The aim of this study was to test the proposition that adoption of a dose titration protocol may be associated with better patient outcomes, at lower treatment dose, and with comparable cumulative dose to that in patients treated using an age-based stimulus dosing protocol. This was an analysis of data assembled from archived records and based on cohorts of patients treated respectively on an age-based stimulus dosing protocol and on a dose titration protocol in the National Health Service in England. We demonstrated a significantly better response in the patient cohort treated with dose titration than with age-based stimulus dosing. Peak doses were less and the total cumulative dose was less in the dose titration group than in the age-based stimulus dosing group. Our findings are consistent with superior outcomes in patients treated using a dose titration protocol when compared with age-based stimulus dosing in a similar cohort of patients.

Methods for the evaluation of hospital cooperation activities (Systematic review protocol).

PubMed

Rotter, Thomas; Popa, Daniela; Riley, Beatrice; Ellermann, Tim; Ryll, Ulrike; Burazeri, Genc; Daemen, Piet; Peeters, Guy; Brand, Helmut

2012-02-10

Hospital partnerships, mergers and cooperatives are arrangements frequently seen as a means of improving health service delivery. Many of the assumptions used in planning hospital cooperatives are not stated clearly and are often based on limited or poor scientific evidence. This is a protocol for a systematic review, following the Cochrane EPOC methodology. The review aims to document, catalogue and synthesize the existing literature on the reported methods for the evaluation of hospital cooperation activities as well as methods of hospital cooperation. We will search the Database of Abstracts of Reviews of Effectiveness, the Effective Practice and Organisation of Care Register, the Cochrane Central Register of Controlled Trials and bibliographic databases including PubMed (via NLM), Web of Science, NHS EED, Business Source Premier (via EBSCO) and Global Health for publications that report on methods for evaluating hospital cooperatives, strategic partnerships, mergers, alliances, networks and related activities and methods used for such partnerships. The method proposed by the Cochrane EPOC group regarding randomized study designs, controlled clinical trials, controlled before and after studies, and interrupted time series will be followed. In addition, we will also include cohort, case-control studies, and relevant non-comparative publications such as case reports. We will categorize and analyze the review findings according to the study design employed, the study quality (low versus high quality studies) and the method reported in the primary studies. We will present the results of studies in tabular form. Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin hospital cooperation activities as defined in this protocol. As a result, the review will provide an evidence base for partnerships, alliances or other fields of cooperation in a hospital setting. PROSPERO registration number: CRD42011001579.

Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability

PubMed Central

Botella, Cristina; Serrano, Berenice; Baños, Rosa M; Garcia-Palacios, Azucena

2015-01-01

Introduction The essential feature of post-traumatic stress disorder (PTSD) is the development of characteristic symptoms following exposure to one or more traumatic events. According to evidence-based intervention guidelines and empirical evidence, one of the most extensively researched and validated treatments for PTSD is prolonged exposure to traumatic events; however, exposure therapy can present some limitations. Virtual reality (VR) can help to improve prolonged exposure because it creates fictitious, safe, and controllable situations that can enhance emotional engagement and acceptance. Objective In addition to carrying out a review to evaluate the efficacy of VR exposure-based therapy (VR-EBT) for the treatment of PTSD, the aim of this study was to contribute to analyzing the use of VR-EBT by: first, evaluating the adequacy of psychological treatment protocols that use VR-EBT to treat PTSD; and second, analyzing the acceptability of VR-EBT. Method We performed a replica search with descriptors and databases used in two previous reviews and updated to April 2015. Next, we carried out an evaluation of the efficacy, adequacy, and acceptability of VR-EBT protocols. Results Results showed that VR-EBT was effective in the treatment of PTSD. The findings related to adequacy showed that not all studies using VR-EBT reported having followed the clinical guidelines for evidence-based interventions in the treatment of PTSD. Regarding acceptability, few studies evaluated this subject. However, the findings are very promising, and patients reported high acceptability and satisfaction with the inclusion of VR in the treatment of PTSD. Conclusion The main weaknesses identified in this review focus on the need for more controlled studies, the need to standardize treatment protocols using VR-EBT, and the need to include assessments of acceptability and related variables. Finally, this paper highlights some directions and future perspectives for using VR-EBT in PTSD treatment. PMID:26491332

Protocol for the systematic review of the prevention, treatment and public health management of impetigo, scabies and fungal skin infections in resource-limited settings.

PubMed

May, Philippa; Bowen, Asha; Tong, Steven; Steer, Andrew; Prince, Sam; Andrews, Ross; Currie, Bart; Carapetis, Jonathan

2016-09-23

Impetigo, scabies, and fungal skin infections disproportionately affect populations in resource-limited settings. Evidence for standard treatment of skin infections predominantly stem from hospital-based studies in high-income countries. The evidence for treatment in resource-limited settings is less clear, as studies in these populations may lack randomisation and control groups for cultural, ethical or economic reasons. Likewise, a synthesis of the evidence for public health control within endemic populations is also lacking. We propose a systematic review of the evidence for the prevention, treatment and public health management of skin infections in resource-limited settings, to inform the development of guidelines for the standardised and streamlined clinical and public health management of skin infections in endemic populations. The protocol has been designed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement. All trial designs and analytical observational study designs will be eligible for inclusion. A systematic search of the peer-reviewed literature will include PubMed, Excertpa Medica and Global Health. Grey literature databases will also be systematically searched, and clinical trials registries scanned for future relevant studies. The primary outcome of interest will be the clinical cure or decrease in prevalence of impetigo, scabies, crusted scabies, tinea capitis, tinea corporis or tinea unguium. Two independent reviewers will perform eligibility assessment and data extraction using standardised electronic forms. Risk of bias assessment will be undertaken by two independent reviewers according to the Cochrane Risk of Bias tool. Data will be tabulated and narratively synthesised. We expect there will be insufficient data to conduct meta-analysis. The final body of evidence will be reported against the Grades of Recommendation, Assessment, Development and Evaluation grading system. The evidence derived from the systematic review will be used to inform the development of guidelines for the management of skin infections in resource-limited settings. The evidence derived will be intended for use by clinicians, public health practitioners and policy makers in the treatment of skin infections and the development of skin infection control programmes. The review will identify any gaps in the current evidence to provide direction for future research. PROSPERO CRD42015029453.

An Evidence-Based Protocol for Antibiotic Use Prior to Cystoscopy Decreases Antibiotic Use without Impacting Post-Procedural Symptomatic Urinary Tract Infection Rates.

PubMed

Gregg, Justin R; Bhalla, Rohan G; Cook, J Paul; Kang, Caroline; Dmochowski, Roger; Talbot, Thomas R; Barocas, Daniel A

2018-04-01

Symptomatic urinary tract infection is a complication of office based cystourethroscopy. Studies are mixed regarding the efficacy of antibiotic prophylaxis to prevent urinary tract infections. Our aim was to develop and evaluate an evidence-based protocol that reduces unnecessary antibiotic use while avoiding an increase in urinary tract infections. We created a clinic antibiogram based on all urology office visits performed during a 2-year period. Bacterial resistance rates, institutional risk related data and clinical guidelines were applied to create a protocol for antibiotic administration before cystourethroscopy. We then analyzed 1,245 consecutive patients without a renal transplant who underwent outpatient cystourethroscopy, including 610 after protocol initiation. Urinary tract infection rates and antibiotic use were analyzed for an association with the protocol change using the Fisher exact test. Cultures had an overall 20% rate of resistance to fluoroquinolones, representing 40% of the cultures that grew Escherichia coli. Before the protocol change 602 of 635 patients (94.8%) received a preprocedural antibiotic compared to 426 of 610 (69.9%) after protocol initiation (p <0.01). A total of 19 patients (3.0%) had a symptomatic urinary tract infection prior to the protocol change while 16 (2.6%) had a urinary tract infection after the change (p = 0.69). Regarding resistance, fluoroquinolone resistant organisms grew in the cultures of 12 of 19 patients (63.2%) with a urinary tract infection before the protocol change compared to 5 of 16 (31.3%) with a urinary tract infection after the change. Recent antibiotic administration, hospitalization and chronic catheterization were associated with urinary tract infection in the entire cohort (all p ≤0.01). A local antibiogram with infection related risk data effectively risk stratifies patients before cystourethroscopy, decreasing the use of antibiotics without increasing the rate of symptomatic urinary tract infection. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Eliciting improved quantitative judgements using the IDEA protocol: A case study in natural resource management.

PubMed

Hemming, Victoria; Walshe, Terry V; Hanea, Anca M; Fidler, Fiona; Burgman, Mark A

2018-01-01

Natural resource management uses expert judgement to estimate facts that inform important decisions. Unfortunately, expert judgement is often derived by informal and largely untested protocols, despite evidence that the quality of judgements can be improved with structured approaches. We attribute the lack of uptake of structured protocols to the dearth of illustrative examples that demonstrate how they can be applied within pressing time and resource constraints, while also improving judgements. In this paper, we demonstrate how the IDEA protocol for structured expert elicitation may be deployed to overcome operational challenges while improving the quality of judgements. The protocol was applied to the estimation of 14 future abiotic and biotic events on the Great Barrier Reef, Australia. Seventy-six participants with varying levels of expertise related to the Great Barrier Reef were recruited and allocated randomly to eight groups. Each participant provided their judgements using the four-step question format of the IDEA protocol ('Investigate', 'Discuss', 'Estimate', 'Aggregate') through remote elicitation. When the events were realised, the participant judgements were scored in terms of accuracy, calibration and informativeness. The results demonstrate that the IDEA protocol provides a practical, cost-effective, and repeatable approach to the elicitation of quantitative estimates and uncertainty via remote elicitation. We emphasise that i) the aggregation of diverse individual judgements into pooled group judgments almost always outperformed individuals, and ii) use of a modified Delphi approach helped to remove linguistic ambiguity, and further improved individual and group judgements. Importantly, the protocol encourages review, critical appraisal and replication, each of which is required if judgements are to be used in place of data in a scientific context. The results add to the growing body of literature that demonstrates the merit of using structured elicitation protocols. We urge decision-makers and analysts to use insights and examples to improve the evidence base of expert judgement in natural resource management.

Effect of Dysphagia Screening Strategies on Clinical Outcomes After Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke.

PubMed

Smith, Eric E; Kent, David M; Bulsara, Ketan R; Leung, Lester Y; Lichtman, Judith H; Reeves, Mathew J; Towfighi, Amytis; Whiteley, William N; Zahuranec, Darin B

2018-03-01

Dysphagia screening protocols have been recommended to identify patients at risk for aspiration. The American Heart Association convened an evidence review committee to systematically review evidence for the effectiveness of dysphagia screening protocols to reduce the risk of pneumonia, death, or dependency after stroke. The Medline, Embase, and Cochrane databases were searched on November 1, 2016, to identify randomized controlled trials (RCTs) comparing dysphagia screening protocols or quality interventions with increased dysphagia screening rates and reporting outcomes of pneumonia, death, or dependency. Three RCTs were identified. One RCT found that a combined nursing quality improvement intervention targeting fever and glucose management and dysphagia screening reduced death and dependency but without reducing the pneumonia rate. Another RCT failed to find evidence that pneumonia rates were reduced by adding the cough reflex to routine dysphagia screening. A smaller RCT randomly assigned 2 hospital wards to a stroke care pathway including dysphagia screening or regular care and found that patients on the stroke care pathway were less likely to require intubation and mechanical ventilation; however, the study was small and at risk for bias. There were insufficient RCT data to determine the effect of dysphagia screening protocols on reducing the rates of pneumonia, death, or dependency after stroke. Additional trials are needed to compare the validity, feasibility, and clinical effectiveness of different screening methods for dysphagia. © 2018 American Heart Association, Inc.

Surgical Technical Evidence Review of Hip Fracture Surgery Conducted for the AHRQ Safety Program for Improving Surgical Care and Recovery.

PubMed

Siletz, Anaar; Childers, Christopher P; Faltermeier, Claire; Singer, Emily S; Hu, Q Lina; Ko, Clifford Y; Kates, Stephen L; Maggard-Gibbons, Melinda; Wick, Elizabeth

2018-01-01

Enhanced recovery pathways (ERPs) have been shown to improve patient outcomes in a variety of contexts. This review summarizes the evidence and defines a protocol for perioperative care of patients with hip fracture and was conducted for the Agency for Healthcare Research and Quality safety program for improving surgical care and recovery. Perioperative care was divided into components or "bins." For each bin, a semisystematic review of the literature was conducted using MEDLINE with priority given to systematic reviews, meta-analyses, and randomized controlled trials. Observational studies were included when higher levels of evidence were not available. Existing guidelines for perioperative care were also incorporated. For convenience, the components of care that are under the auspices of anesthesia providers will be reported separately. Recommendations for an evidence-based protocol were synthesized based on review of this evidence. Eleven bins were identified. Preoperative risk factor bins included nutrition, diabetes mellitus, tobacco use, and anemia. Perioperative management bins included thromboprophylaxis, timing of surgery, fluid management, drain placement, early mobilization, early alimentation, and discharge criteria/planning. This review provides the evidence basis for an ERP for perioperative care of patients with hip fracture.

Extraordinary Claims Require Extraordinary Evidence: The Case of Non-Local Perception, a Classical and Bayesian Review of Evidences

PubMed Central

Tressoldi, Patrizio E.

2011-01-01

Starting from the famous phrase “extraordinary claims require extraordinary evidence,” we will present the evidence supporting the concept that human visual perception may have non-local properties, in other words, that it may operate beyond the space and time constraints of sensory organs, in order to discuss which criteria can be used to define evidence as extraordinary. This evidence has been obtained from seven databases which are related to six different protocols used to test the reality and the functioning of non-local perception, analyzed using both a frequentist and a new Bayesian meta-analysis statistical procedure. According to a frequentist meta-analysis, the null hypothesis can be rejected for all six protocols even if the effect sizes range from 0.007 to 0.28. According to Bayesian meta-analysis, the Bayes factors provides strong evidence to support the alternative hypothesis (H1) over the null hypothesis (H0), but only for three out of the six protocols. We will discuss whether quantitative psychology can contribute to defining the criteria for the acceptance of new scientific ideas in order to avoid the inconclusive controversies between supporters and opponents. PMID:21713069

Structural barriers in access to medical marijuana in the USA-a systematic review protocol.

PubMed

Valencia, Celina I; Asaolu, Ibitola O; Ehiri, John E; Rosales, Cecilia

2017-08-07

There are 43 state medical marijuana programs in the USA, yet limited evidence is available on the demographic characteristics of the patient population accessing these programs. Moreover, insights into the social and structural barriers that inform patients' success in accessing medical marijuana are limited. A current gap in the scientific literature exists regarding generalizable data on the social, cultural, and structural mechanisms that hinder access to medical marijuana among qualifying patients. The goal of this systematic review, therefore, is to identify the aforementioned mechanisms that inform disparities in access to medical marijuana in the USA. This scoping review protocol outlines the proposed study design for the systematic review and evaluation of peer-reviewed scientific literature on structural barriers to medical marijuana access. The protocol follows the guidelines set forth by the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) checklist. The overarching goal of this study is to rigorously evaluate the existing peer-reviewed data on access to medical marijuana in the USA. Income, ethnic background, stigma, and physician preferences have been posited as the primary structural barriers influencing medical marijuana patient population demographics in the USA. Identification of structural barriers to accessing medical marijuana provides a framework for future policies and programs. Evidence-based policies and programs for increasing medical marijuana access help minimize the disparity of access among qualifying patients.

An Argument Approach to Observation Protocol Validity

ERIC Educational Resources Information Center

Bell, Courtney A.; Gitomer, Drew H.; McCaffrey, Daniel F.; Hamre, Bridget K.; Pianta, Robert C.; Qi, Yi

2012-01-01

This article develops a validity argument approach for use on observation protocols currently used to assess teacher quality for high-stakes personnel and professional development decisions. After defining the teaching quality domain, we articulate an interpretive argument for observation protocols. To illustrate the types of evidence that might…

Redactions in protocols for drug trials: what industry sponsors concealed.

PubMed

Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

Camino Verde (The Green Way): evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial.

PubMed

Andersson, Neil; Arostegui, Jorge; Nava-Aguilera, Elizabeth; Harris, Eva; Ledogar, Robert J

2017-05-30

Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate), in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. The Camino Verde (Green Way) is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137-140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3-9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples) and entomological indices between intervention and control sites. Our hypothesis is that informed community mobilisation adds effectiveness in controlling dengue. ISRCTN27581154 .

Cochrane Qualitative and Implementation Methods Group guidance series-paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis.

PubMed

Harris, Janet L; Booth, Andrew; Cargo, Margaret; Hannes, Karin; Harden, Angela; Flemming, Kate; Garside, Ruth; Pantoja, Tomas; Thomas, James; Noyes, Jane

2018-05-01

This paper updates previous Cochrane guidance on question formulation, searching, and protocol development, reflecting recent developments in methods for conducting qualitative evidence syntheses to inform Cochrane intervention reviews. Examples are used to illustrate how decisions about boundaries for a review are formed via an iterative process of constructing lines of inquiry and mapping the available information to ascertain whether evidence exists to answer questions related to effectiveness, implementation, feasibility, appropriateness, economic evidence, and equity. The process of question formulation allows reviewers to situate the topic in relation to how it informs and explains effectiveness, using the criterion of meaningfulness, appropriateness, feasibility, and implementation. Questions related to complex questions and interventions can be structured by drawing on an increasingly wide range of question frameworks. Logic models and theoretical frameworks are useful tools for conceptually mapping the literature to illustrate the complexity of the phenomenon of interest. Furthermore, protocol development may require iterative question formulation and searching. Consequently, the final protocol may function as a guide rather than a prescriptive route map, particularly in qualitative reviews that ask more exploratory and open-ended questions. Copyright © 2017 Elsevier Inc. All rights reserved.

Is it really good to talk? Testing the impact of providing concurrent verbal protocols on driving performance.

PubMed

Salmon, Paul Matthew; Goode, Natassia; Spiertz, Antje; Thomas, Miles; Grant, Eryn; Clacy, Amanda

2017-06-01

Questions have been raised regarding the impact that providing concurrent verbal protocols has on task performance in various settings; however, there has been little empirical testing of this in road transport. The aim of this study was to examine the impact of providing concurrent verbal protocols on driving performance. Participants drove an instrumented vehicle around a set route, twice whilst providing a concurrent verbal protocol, and twice without. A comparison revealed no differences in behaviour related to speed, braking and steering wheel angle when driving mid-block, but a significant difference in aspects of braking and acceleration at roundabouts. When not providing a verbal protocol, participants were found to brake harder on approach to a roundabout and accelerate more heavily coming out of roundabouts. It is concluded that providing verbal protocols may have a positive effect on braking and accelerating. Practical implications related to driver training and future research are discussed. Practitioner Summary: Verbal protocol analysis is used by ergonomists to understand aspects of cognition and decision-making during complex tasks such as driving and control room operation. This study examines the impact that it has on driving performance, providing evidence to support its continued use in ergonomics applications.

Complete radiotherapy response in rectal cancer: A review of the evidence

PubMed Central

Couch, Daniel G; Hemingway, David M

2016-01-01

Complete response to chemoradiotherapy for rectal cancer is becoming a common clinical entity. Techniques to diagnose complete response and how to survey these patients without operative intervention are still unclear. We review the most recent evidence. Barriers to firm conclusions regarding this are heterogeneity of diagnostic definitions, differing surveillance protocols, and a lack of randomised studies. PMID:26811600

Measuring the Effect of Soil-Transmitted Helminth Infections on Cognitive Function in Children: Systematic Review and Critical Appraisal of Evidence.

PubMed

Owada, Kei; Nielsen, Mark; Lau, Colleen L; Clements, Archie C A; Yakob, Laith; Soares Magalhães, Ricardo J

2017-01-01

Recently the role of soil-transmitted helminth (STH) infections in children's cognitive developmental impairment has been under scrutiny. We conducted a systematic review of the evidence for associations between STH infections and cognitive function of children using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol. We aimed to identify the domains of cognitive function in three age strata (<24months, 24-59months and ≥60months) and critically appraise the general design protocol of the studies, with a focus on the cognitive function measurement tools used. A total of 42 papers fulfilled the inclusion criteria, including 10 studies from a recent Cochrane review. Our findings demonstrate variation in tested domains, lack of consistency in the use of measurement tools and analysis of results. Cognitive function measures in children aged under 59months have been mainly limited to domains of gross motor, fine motor and language skills, whereas in children aged 60months and above most studies tested domains such as memory and processing speed. Even within the same age group the results on the association between STH infections and measures of cognitive development were often conflicting. The current study highlights the need for methodological consensus in the use of measurement tools and data analysis protocols if the effect of STH infections on cognitive function domains in children is to be correctly established. This will be an imperative next step to generate conclusive evidence of the role of STH infections in cognitive development in children. Copyright © 2017 Elsevier Ltd. All rights reserved.

Majority of systematic reviews published in high-impact journals neglected to register the protocols: a meta-epidemiological study.

PubMed

Tsujimoto, Yasushi; Tsujimoto, Hiraku; Kataoka, Yuki; Kimachi, Miho; Shimizu, Sayaka; Ikenoue, Tatsuyoshi; Fukuma, Shingo; Yamamoto, Yosuke; Fukuhara, Shunichi

2017-04-01

To describe the registration of systematic review (SR) protocols and examine whether or not registration reduced the outcome reporting bias in high-impact journals. We searched MEDLINE via PubMed to identify SRs of randomized controlled trials of interventions. We included SRs published between August 2009 and June 2015 in the 10 general and internal medicinal journals with the highest impact factors in 2013. We examined the proportion of SR protocol registration and investigated the relationship between registration and outcome reporting bias using multivariable logistic regression. Among the 284 included reviews, 60 (21%) protocols were registered. The proportion of registration increased from 5.6% in 2009 to 27% in 2015 (P for trend <0.001). Protocol registration was not associated with outcome reporting bias (adjusted odds ratio [OR] 0.85, 95% confidence interval [CI] 0.39-1.86). The association between Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) adherence and protocol registration was not statistically significant (OR 1.09, 95% CI 0.59-2.01). Six years after the launch of the PRISMA statement, the proportion of protocol registration in high-impact journals has increased some but remains low. The present study found no evidence suggesting that protocol registration reduced outcome reporting bias. Copyright © 2017 Elsevier Inc. All rights reserved.

Straight Talk About Birth Control: A Contraceptive Education Protocol for Home Care.

PubMed

Schoenberg, Leslie

Home healthcare providers play a critical role in the prevention of unintended pregnancies by providing evidence-based contraception education during home visits. This article describes an innovative and comprehensive contraception protocol that was developed for Nurse-Family Partnership to improve contraception education for home healthcare patients. The protocol focused on increasing uptake of long-acting reversible contraception (LARC) for high-risk prenatal and postpartum home healthcare patients. The protocol was designed to reduce early subsequent pregnancies and thereby improve outcomes for mothers and their infants. An evidence-based translation project was designed and piloted in three California counties. The protocol consisted of a contraception education module for nurses and a patient education toolkit. The toolkit included an interactive patient education workbook emphasizing LARC methods for nurses to complete with their patients along with other teaching tools. The project was evaluated using pre- and posttest surveys that measured changes in nurses' knowledge, attitudes, and practice before, after, and 2 months after implementation. Outcomes revealed the following statistically significant results: (a) nurses' knowledge doubled at the first posttest and persisted at 2 months, (b) nurses' attitudes improved on two of the three measures, and (c) there was a 17.7% increase in the frequency of LARC birth control education 2 months after implementation. An evidence-based contraception protocol can promote acceptance of LARC methods and improve home healthcare clinician comfort with and frequency of birth control education.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

PubMed

Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

2018-02-06

Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

Diagnostic and Therapeutic Knowledge and Practices in the Management of Congenital Syphilis by Pediatricians in Public Maternity Hospitals in Brazil.

PubMed

Dos Santos, Raquel Rodrigues; Niquini, Roberta Pereira; Bastos, Francisco Inácio; Domingues, Rosa Maria Soares Madeira

2017-01-01

The study aimed to assess conformity with Brazil's standard protocol for diagnostic and therapeutic practices in the management of congenital syphilis by pediatricians in public maternity hospitals. A cross-sectional study was conducted in 2015 with 41 pediatricians working in all the public maternity hospitals in Teresina, the capital of Piauí State, Northeast Brazil, through self-completed questionnaires. The study assessed the conformity of knowledge and practices according to the Brazilian Ministry of Health protocols. The study has made evident low access to training courses (54%) and insufficient knowledge of the case definition of congenital syphilis (42%) and rapid tests for syphilis (39%). Flaws were observed in the diagnostic workup and treatment of newborns. Requesting VDRL (88%) and correct treatment of neurosyphilis (88%) were the practices that showed the highest conformity with standard protocols. Low conformity with protocols leads to missed opportunities for identifying and adequately treating congenital syphilis. Based on the barriers identified in the study, better access to diagnostic and treatment protocols, improved recording on prenatal cards and hospital patient charts, availability of tests and medicines, and educational work with pregnant women should be urgently implemented, aiming to reverse the currently inadequate management of congenital syphilis and to curb its spread.

Does an oral care protocol reduce VAP in patients with a tracheostomy?

PubMed

Conley, Patricia; McKinsey, David; Graff, Jason; Ramsey, Anthony R

2013-07-01

Several studies have demonstrated that oral care with chlorhexidine gluconate (CHG) 0.12% solution reduces the incidence of ventilator-associated pneumonia (VAP) in mechanically ventilated patients with endotracheal tubes in the ICU. Minimal evidence shows the effectiveness of any oral care protocols in preventing VAP in mechanically ventilated patients with tracheostomies in a step-down or progressive care unit (PCU). To determine the effectiveness of an oral care protocol in reducing the VAP rate in mechanically ventilated patients with tracheostomies in the PCU. A 12-month prospective study was conducted on 75 mechanically ventilated patients who had tracheostomies. The oral care protocol consisted of tooth brushing with toothpaste and applying CHG 0.12% solution every 12 hours. At the conclusion of the study, the VAP rate in the study population was compared with the National Health and Safety Network (NHSN) report for 2009 benchmark of 1.5 per 1,000 ventilator days. After the oral care protocol was implemented in the PCU, the VAP rate was 1.1 per 1,000 ventilator days over 12 months, compared with the NHSN report for 2009 of 1.5 per 1,000 ventilator days. Tooth brushing with toothpaste and applying CHG 0.12% solution may be an effective oral care protocol to reduce the VAP rate in patients in PCUs with tracheostomies who are being mechanically ventilated.

The effect of relational training on intelligence quotient: a case study.

PubMed

Vizcaíno-Torres, Rosa M; Ruiz, Francisco J; Luciano, Carmen; López-López, Juan C; Barbero-Rubio, Adrián; Gil, Enriquel

2015-01-01

Relational training protocols based on Relational Frame Theory (RFT) are showing promising results in increasing intelligence quotient. This case study aimed at analyzing the effect of a training protocol in fluency and flexibility in relational responding on intelligence quotient with a 4-year-old child. The child’s cognitive and psychomotor development was evaluated before and after the implementation of the training protocol using the McCarthy’s Aptitudes and Psychomotricity Scale (MSCA). The training protocol consisted of a multiple-exemplar-training (MET) in relational framing in accordance with COORDINATION (Phases 1 and 2), OPPOSITION (Phase 3 and 4), and COMPARISON (Phases 5 and 6). The MET protocol was implemented in approximately 12 hours throughout five and one half months. The training was effective in establishing relational responding in OPPOSITION and COMPARISON frames as well as in promoting fluency and flexibility in all the three types of trained relations. After this training, the child showed an increase above 1.5 SD in the General Cognitive Index of the MSCA (from 106 to 131). This case study adds further empirical evidence of the potential of RFT training to improve cognitive abilities and intelligence.

Assisted closed-loop optimization of SSVEP-BCI efficiency

PubMed Central

Fernandez-Vargas, Jacobo; Pfaff, Hanns U.; Rodríguez, Francisco B.; Varona, Pablo

2012-01-01

We designed a novel assisted closed-loop optimization protocol to improve the efficiency of brain-computer interfaces (BCI) based on steady state visually evoked potentials (SSVEP). In traditional paradigms, the control over the BCI-performance completely depends on the subjects' ability to learn from the given feedback cues. By contrast, in the proposed protocol both the subject and the machine share information and control over the BCI goal. Generally, the innovative assistance consists in the delivery of online information together with the online adaptation of BCI stimuli properties. In our case, this adaptive optimization process is realized by (1) a closed-loop search for the best set of SSVEP flicker frequencies and (2) feedback of actual SSVEP magnitudes to both the subject and the machine. These closed-loop interactions between subject and machine are evaluated in real-time by continuous measurement of their efficiencies, which are used as online criteria to adapt the BCI control parameters. The proposed protocol aims to compensate for variability in possibly unknown subjects' state and trait dimensions. In a study with N = 18 subjects, we found significant evidence that our protocol outperformed classic SSVEP-BCI control paradigms. Evidence is presented that it takes indeed into account interindividual variabilities: e.g., under the new protocol, baseline resting state EEG measures predict subjects' BCI performances. This paper illustrates the promising potential of assisted closed-loop protocols in BCI systems. Probably their applicability might be expanded to innovative uses, e.g., as possible new diagnostic/therapeutic tools for clinical contexts and as new paradigms for basic research. PMID:23443214

Assisted closed-loop optimization of SSVEP-BCI efficiency.

PubMed

Fernandez-Vargas, Jacobo; Pfaff, Hanns U; Rodríguez, Francisco B; Varona, Pablo

2013-01-01

We designed a novel assisted closed-loop optimization protocol to improve the efficiency of brain-computer interfaces (BCI) based on steady state visually evoked potentials (SSVEP). In traditional paradigms, the control over the BCI-performance completely depends on the subjects' ability to learn from the given feedback cues. By contrast, in the proposed protocol both the subject and the machine share information and control over the BCI goal. Generally, the innovative assistance consists in the delivery of online information together with the online adaptation of BCI stimuli properties. In our case, this adaptive optimization process is realized by (1) a closed-loop search for the best set of SSVEP flicker frequencies and (2) feedback of actual SSVEP magnitudes to both the subject and the machine. These closed-loop interactions between subject and machine are evaluated in real-time by continuous measurement of their efficiencies, which are used as online criteria to adapt the BCI control parameters. The proposed protocol aims to compensate for variability in possibly unknown subjects' state and trait dimensions. In a study with N = 18 subjects, we found significant evidence that our protocol outperformed classic SSVEP-BCI control paradigms. Evidence is presented that it takes indeed into account interindividual variabilities: e.g., under the new protocol, baseline resting state EEG measures predict subjects' BCI performances. This paper illustrates the promising potential of assisted closed-loop protocols in BCI systems. Probably their applicability might be expanded to innovative uses, e.g., as possible new diagnostic/therapeutic tools for clinical contexts and as new paradigms for basic research.

Penile Improvement Protocol in Postoperative Management of Patients Undergoing Metoidioplasty.

PubMed

Cohanzad, Shahryar

2016-12-01

To introduce a postoperative protocol to optimize the final size of the penis in patients undergoing metoidioplasty. Fourteen patients with the mean age of 29.3 years (8-40 ± 11.7), ten female transsexuals (46 xx karyotype) and four with 5-alpha-reductase deficiency syndrome (5ARDS) who had undergone extensive metoidioplasty entered a penile improvement protocol (PIP) between 2007 and 2015 at a specialized clinic in a general hospital in Tehran, Iran. Subjects were thoroughly instructed, rehearsed on the protocol and closely followed for 24 weeks. Written informed consent was obtained from all participants. We adapted a popular device, the so-called penile traction device, to accommodate the size of the neo-penis. All patients achieved an increase in their penile length with a mean of 28.42 mm (21-47 ± 6.86). Two subjects developed penile bruises and edema during the protocol implementation. No significant procedural complications were detected in the remaining 12 participants. PIP can be an effective step in increasing the size of the neo-penis in patients who have undergone metoidioplasty. We suggest this procedure to be seriously considered in postoperative management of well-informed and motivated patients to improve the final penile length and function in this population. Larger studies are needed to further validate this protocol. This journal requires that the authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Using Certification to Promote Uptake of Real-World Evidence by Payers.

PubMed

Segal, Jodi B; Kallich, Joel D; Oppenheim, Emma R; Garrison, Louis P; Iqbal, Sheikh Usman; Kessler, Marla; Alexander, G Caleb

2016-03-01

Most randomized controlled trials are unable to generate information about a product's real-world effectiveness. Therefore, payers use real-world evidence (RWE) generated in observational studies to make decisions regarding formulary inclusion and coverage. While some payers generate their own RWE, most cautiously rely on RWE produced by manufacturers who have a strong financial interest in obtaining coverage for their products. We propose a process by which an independent body would certify observational studies as generating valid and unbiased estimates of the effectiveness of the intervention under consideration. This proposed process includes (a) establishing transparent criteria for assessment, (b) implementing a process for receipt and review of observational study protocols from interested parties, (c) reviewing the submitted protocol and requesting any necessary revisions, (d) reviewing the study results, (e) assigning a certification status to the submitted evidence, and (f) communicating the certification status to all who seek to use this evidence for decision making. Accrediting organizations such as the National Center for Quality Assurance and the Joint Commission have comparable goals of providing assurance about quality to those who look to their accreditation results. Although we recognize potential barriers, including a slowing of evidence generation and costs, we anticipate that processes can be streamlined, such as when familiar methods or familiar datasets are used. The financial backing for such activities remains uncertain, as does identification of organizations that might serve this certification function. We suggest that the rigor and transparency that will be required with such a process, and the unassailable evidence that it will produce, will be valuable to decision makers.

Thinking Out Loud while Studying Text: Rehearsing Key Ideas.

ERIC Educational Resources Information Center

Muth, K. Denise; And Others

1988-01-01

A study involving 32 undergraduate students was conducted to identify mechanisms by which instructional objectives affect learning. Protocols for thinking out loud were examined for evidence of rehearsal activity. Results suggest that instructional objectives enhanced real-time rehearsal activity, recall, and reading time. (TJH)

New phytochemicals as potential human anti-aging compounds: Reality, promise, and challenges.

PubMed

Corrêa, Rúbia C G; Peralta, Rosane M; Haminiuk, Charles W I; Maciel, Giselle Maria; Bracht, Adelar; Ferreira, Isabel C F R

2018-04-13

Aging is an inevitable process influenced by genetic, lifestyle, and environmental factors. Indirect evidence shows that several phytochemicals can have anti-aging capabilities, although direct evidence in this field is still limited. This report aims to provide a critical review on aspects related to the use of novel phytochemicals as anti-aging agents, to discuss the obstacles found when performing most anti-aging study protocols in humans, and to analyze future perspectives. In addition to the extensively studied resveratrol, epicatechin, quercetin, and curcumin, new phytochemicals have been reported to act as anti-aging agents, such as the amino acid L-theanine isolated from green tea, and the lignans arctigenin and matairesinol isolated from Arctium lappa seeds. Furthermore, this review discusses the application of several new extracts rich in phytochemicals with potential use in anti-aging therapies. Finally, this review also discusses the most important biomarkers to test anti-aging interventions, the necessity of conducting epidemiological studies and the need of clinical trials with adequate study protocols for humans.

Contextual information management: An example of independent-checking in the review of laboratory-based bloodstain pattern analysis.

PubMed

Osborne, Nikola K P; Taylor, Michael C

2018-05-01

This article describes a New Zealand forensic agency's contextual information management protocol for bloodstain pattern evidence examined in the laboratory. In an effort to create a protocol that would have minimal impact on current work-flow, while still effectively removing task-irrelevant contextual information, the protocol was designed following an in-depth consultation with management and forensic staff. The resulting design was for a protocol of independent-checking (i.e. blind peer-review) where the checker's interpretation of the evidence is conducted in the absence of case information and the original examiner's notes or interpretation(s). At the conclusion of a ten-case trial period, there was widespread agreement that the protocol had minimal impact on the number of people required, the cost, or the time to complete an item examination. The agency is now looking to adopt the protocol into standard operating procedures and in some cases the protocol has been extended to cover other laboratory-based examinations (e.g. fabric damage, shoeprint examination, and physical fits). The protocol developed during this trial provides a useful example for agencies seeking to adopt contextual information management into their workflow. Copyright © 2018 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

The role of physical therapy and rehabilitation after lumbar fusion surgery for degenerative disease: a systematic review.

PubMed

Madera, Marcella; Brady, Jeremy; Deily, Sylvia; McGinty, Trent; Moroz, Lee; Singh, Devender; Tipton, George; Truumees, Eeric

2017-06-01

OBJECTIVE The purpose of this study was to provide a systematic and comprehensive review of the existing literature regarding postfusion rehabilitation. METHODS Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the authors conducted an exhaustive review of multiple electronic databases. Potential articles were screened using inclusion/exclusion criteria. Two authors independently analyzed these studies using predefined data fields, including study quality indicators such as level of evidence and availability of accepted patient-reported outcomes measures. These findings were synthesized in a narrative format. A third author resolved disagreements regarding the inclusion of a study. RESULTS Twenty-one articles with I or II levels of evidence were included in the review. The authors divided the findings of the literature review into several groups: rehabilitation terminology, timing and duration of postfusion rehabilitation, the need for rehabilitation relative to surgery-related morbidity, rehabilitation's relationship to outcomes, and cognitive and psychosocial aspects of postsurgical rehabilitation. Current evidence generally supports formal rehabilitation after lumbar fusion surgery. Starting physical therapy at the 12-week postoperative mark results in better outcomes at lower cost than an earlier, 6-week start. Where available, psychosocial support improves outcomes. However, a number of the questions could not be answered with high-grade evidence. In these cases, the authors used "best evidence available" to make recommendations. There are many cases in which different types of caregivers use clinical terminology differently. The data supporting an optimal protocol for postfusion rehabilitation remains elusive but, using the data available, the authors have crafted recommendations and a model protocol, which is currently undergoing prospective study. CONCLUSIONS Rehabilitation has long been a common feature in the postoperative management of patients undergoing spinal fusion. Although caregivers from multiple disciplines agree that the majority of their patients will benefit from this effort, the supporting data remain sparse. In creating a model protocol for postlumbar fusion rehabilitation, the authors hope to share a starting point for future postoperative lumbar fusion rehabilitation research.

Evidence of Absence software

USGS Publications Warehouse

Dalthorp, Daniel; Huso, Manuela M. P.; Dail, David; Kenyon, Jessica

2014-01-01

Evidence of Absence software (EoA) is a user-friendly application used for estimating bird and bat fatalities at wind farms and designing search protocols. The software is particularly useful in addressing whether the number of fatalities has exceeded a given threshold and what search parameters are needed to give assurance that thresholds were not exceeded. The software is applicable even when zero carcasses have been found in searches. Depending on the effectiveness of the searches, such an absence of evidence of mortality may or may not be strong evidence that few fatalities occurred. Under a search protocol in which carcasses are detected with nearly 100 percent certainty, finding zero carcasses would be convincing evidence that overall mortality rate was near zero. By contrast, with a less effective search protocol with low probability of detecting a carcass, finding zero carcasses does not rule out the possibility that large numbers of animals were killed but not detected in the searches. EoA uses information about the search process and scavenging rates to estimate detection probabilities to determine a maximum credible number of fatalities, even when zero or few carcasses are observed.

A Unique Approach to Dissemination of Evidence-Based Protocols: A Successful CAUTI Reduction Pilot.

PubMed

Dols, Jean Dowling; White, Sondra K; Timmons, Amy L; Bush, Michelle; Tripp, Joanne; Childers, Amanda Kay; Mathers, Nicholas; Tobias, Maria M

2016-01-01

A unique approach to disseminate an evidence-based protocol for urinary catheter management was led by a staff-driven catheter-associated urinary tract infection (CAUTI) reduction team in one hospital. The nurseeducators, faculty from a local university, and the facility's clinical nurse leader mentored the team. As an approachto reduce CAUTIs in the transplant care and intensive care units, the team developed an interdisciplinary CAUTIEducation Fair, which provided a safe, nonthreateningenvironment to unlearn prior behaviors and showcompetency in new evidence-based ones.

The cumulative effect of multiple critical care protocols on length of stay in a geriatric trauma population.

PubMed

Frederickson, Tiffany A; Renner, Catherine Hackett; Swegle, James R; Sahr, Sheryl M

2013-01-01

The elderly individuals are the most rapidly growing cohort within the US population, and a corresponding increase is being seen in elderly trauma patients. Elderly patients are more likely to have a hospital length of stay (LOS) in excess of 10 days. They account for 60% of total ICU days. Length of stay is frequently used as a proxy measure for improvement in injury outcomes, changes in quality of care, and hospital outcomes. Patient care protocols are typically created from evidence-based guidelines that serve to reduce variation in care from patient to patient. Patient care protocols have been found to positively impact patient care with reduced duration of mechanical ventilation, shorter LOS in the ICU and shorter overall hospitalization time, reduced mortality, and reduced health care costs. The following study was designed to assess the impact of the implementation of 4 patient care protocols within an elderly trauma population. We hypothesized that the implementation of these protocols would have a beneficial impact on patient care that could be measured by a decrease in hospital LOS. An archival, retrospective pretest/posttest study was performed on elderly trauma patients. The new protocols helped guide practical changes in care that resulted in a 32% decrease in LOS for our elderly trauma patients which exceeds the 25% decrease found in other studies. Additionally, the "Other" category for each variable was less frequently used in the post-protocol phase than in the pre-protocol phase, suggesting a spillover effect on the level of detail recorded in the patient chart. With less variation in practices in the post-protocol phase, Injury Severity score, and admission systolic blood pressure emerged as significant predictors of LOS.

Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

PubMed

Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

2017-10-01

Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

Barriers and enablers in primary care clinicians' management of osteoarthritis: protocol for a systematic review and qualitative evidence synthesis.

PubMed

Egerton, T; Diamond, L; Buchbinder, R; Bennell, K; Slade, S C

2016-05-27

Osteoarthritis is a highly prevalent and disabling condition. Primary care management of osteoarthritis is generally suboptimal despite evidence for several modestly effective interventions and the availability of high-quality clinical practice guidelines. This report describes a planned study to synthesise the views of primary care clinicians on the barriers and enablers to following recommended management of osteoarthritis, with the aim of providing new interpretations that may facilitate the uptake of recommended treatments, and in turn improve patient care. A systematic review and meta-synthesis of qualitative studies. 5 databases will be searched using key search terms for qualitative research, evidence-based practice, clinical practice guidelines, osteoarthritis, beliefs, perceptions, barriers, enablers and adherence. A priori inclusion/exclusion criteria include availability of data from primary care clinicians, reports on views regarding management of osteoarthritis, and studies using qualitative methods for both data collection and analysis. At least 2 independent reviewers will identify eligible reports, conduct a critical appraisal of study conduct, extract data and synthesise reported findings and interpretations. Synthesis will follow thematic analysis within a grounded theory framework of inductive coding and iterative theme identification. The reviewers plus co-authors will contribute to the meta-synthesis to find new themes and theories. The Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach will be used to determine a confidence profile of each finding from the meta-synthesis. The protocol has been registered on PROSPERO and is reported using the Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols (PRISMA-P) guidelines. Ethical approval is not required. The systematic review will be published in a peer-reviewed journal. The results will help to inform policy and practice and assist in the optimisation of management for people with osteoarthritis. CRD42015027543. 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/

Cervical Spine Clearance in Pediatric Trauma Centers: The Need for Standardization and an Evidence-based Protocol.

PubMed

Pannu, Gurpal S; Shah, Mitesh P; Herman, Marty J

Cervical spine clearance in the pediatric trauma patient represents a particularly challenging task. Unfortunately, standardized clearance protocols for pediatric cervical clearance are poorly reported in the literature and imaging recommendations demonstrate considerable variability. With the use of a web-based survey, this study aims to define the methods utilized by pediatric trauma centers throughout North America. Specific attention was given to the identification of personnel responsible for cervical spine care, diagnostic imaging modalities used, and the presence or absence of a written pediatric cervical spine clearance protocol. A 10-question electronic survey was given to members of the newly formed Pediatric Cervical Spine Study Group, all of whom are active POSNA members. The survey was submitted via the online service SurveyMonkey (https://www.surveymonkey.com/r/7NVVQZR). The survey assessed the respondent's institution demographics, such as trauma level and services primarily responsible for consultation and operative management of cervical spine injuries. In addition, respondents were asked to identify the protocols and primary imaging modality used for cervical spine clearance. Finally, respondents were asked if their institution had a documented cervical spine clearance protocol. Of the 25 separate institutions evaluated, 21 were designated as level 1 trauma centers. Considerable variation was reported with regards to the primary service responsible for cervical spine clearance. General Surgery/Trauma (44%) is most commonly the primary service, followed by a rotating schedule (33%), Neurosugery (11%), and Orthopaedic Surgery (8%). Spine consults tend to be seen most commonly by a rotating schedule of Orthopaedic Surgery and Neurosurgery. The majority of responding institutions utilize computed tomographic imaging (46%) as the primary imaging modality, whereas 42% of hospitals used x-ray primarily. The remaining institutions reported using a combination of x-ray and computed tomographic imaging. Only 46% of institutions utilize a written, standardized pediatric cervical spine clearance protocol. This study demonstrates a striking variability in the use of personnel, imaging modalities and, most importantly, standardized protocol in the evaluation of the pediatric trauma patient with a potential cervical spine injury. Cervical spine clearance protocols have been shown to decrease the incidence of missed injuries, minimize excessive radiation exposure, decrease the time to collar removal, and lower overall associated costs. It is our opinion that development of a task force or multicenter research protocol that incorporates existing evidence-based literature is the next best step in improving the care of children with cervical spine injuries. Level 4-economic and decision analyses.

Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols

PubMed Central

Bleakley, C M; McDonough, S M; MacAuley, D C

2006-01-01

Background The use of cryotherapy in the management of acute soft tissue injury is largely based on anecdotal evidence. Preliminary evidence suggests that intermittent cryotherapy applications are most effective at reducing tissue temperature to optimal therapeutic levels. However, its efficacy in treating injured human subjects is not yet known. Objective : To compare the efficacy of an intermittent cryotherapy treatment protocol with a standard cryotherapy treatment protocol in the management of acute ankle sprains. Subjects Sportsmen (n  =  44) and members of the general public (n  =  45) with mild/moderate acute ankle sprains. Methods Subjects were randomly allocated, under strictly controlled double blind conditions, to one of two treatment groups: standard ice application (n  =  46) or intermittent ice application (n  =  43). The mode of cryotherapy was standardised across groups and consisted of melting iced water (0°C) in a standardised pack. Function, pain, and swelling were recorded at baseline and one, two, three, four, and six weeks after injury. Results Subjects treated with the intermittent protocol had significantly (p<0.05) less ankle pain on activity than those using a standard 20 minute protocol; however, one week after ankle injury, there were no significant differences between groups in terms of function, swelling, or pain at rest. Conclusion Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury. PMID:16611722

Components of an Anticancer Diet: Dietary Recommendations, Restrictions and Supplements of the Bill Henderson Protocol

PubMed Central

Mannion, Cynthia; Page, Stacey; Bell, Laurie Heilman; Verhoef, Marja

2010-01-01

The use of complementary and alternative medicines including dietary supplements, herbals and special diets to prevent or treat disease continues to be popular. The following paper provides a description of an alternative dietary approach to the self-management and treatment of cancer, the Bill Henderson Protocol (BHP). This diet encourages daily intake of raw foods, a combination of cottage cheese and flaxseed oil and a number of supplements. Some foods and food groups are restricted (e.g., gluten, meat, dairy). Early background theory that contributed to the protocol’s development is presented as is a summary of relevant evidence concerning the anti-cancer fighting properties of the individual components. Supplement intake is considered in relation to daily recommended intakes. Challenges and risks to protocol adherence are discussed. As with many complementary and alternative interventions, clear evidence of this dietary protocol’s safety and efficacy is lacking. Consumers of this protocol may require guidance on the ability of this protocol to meet their individual nutritional needs. PMID:22254073

[The ISP (Safe Insertion of PICCs) protocol: a bundle of 8 recommendations to minimize the complications related to the peripherally inserted central venous catheters (PICC)].

PubMed

Emoli, Alessandro; Cappuccio, Serena; Marche, Bruno; Musarò, Andrea; Scoppettuolo, Giancarlo; Pittiruti, Mauro

2014-01-01

The ISP (Safe Insertion of PICCs) protocol: a bundle of 8 recommendations to minimize the complications related to the peripherally inserted central venous catheters (PICC). The insertion of a peripherally inserted central venous catheter (PICC) is not without risks. The Italian Group for the Study of Long-Term Central Venous Access Devices (GAVeCeLT) has developed a protocol (SIP: Safe Implantation of PICCs) with the aim of minimizing the risks which may be associated with the placement of PICCs. The protocol is based on recommendations available in the literature and on the main clinical practice guidelines. The SIP protocol, a bundle of evidence-based recommendations, it is is easy to use, inexpensive, and cost-effective. If routinely used and carefully inplemented, it greatly reduces complications such as failure of venipuncture, accidental arterial puncture, damage of median nerve, infection and catheter related venous thrombosis.

The Wiley Protocol: an analysis of ethical issues.

PubMed

Rosenthal, M Sara

2008-01-01

: This review explores the ethical issues surrounding an unregulated protocol that is advertised to women through consumer books, the popular press, and the Internet, known as the Wiley Protocol. : A content analysis of relevant documents was conducted, followed by telephone interviews with investigators and former participants to verify facts. : The Wiley Protocol is an example of unregulated research involving potentially unsafe doses of bioidentical hormones applied to an unselected population of women. This protocol fails to use research ethics guidelines such as informed consent, investigator expertise, sound methodology, standardized data collection, and data safety monitoring. : Clinical ethics breaches include lack of full disclosure of risks, coercive influences, as well as misinformation about the study goals and safety. Breaches of professional ethics include conflicts of interest with respect to financial incentives, patient accrual, and inadequate standards of awareness and proficiency among participating investigators. It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for these ethical violations.

Weightbearing Versus Nonweightbearing After Meniscus Repair.

PubMed

VanderHave, Kelly L; Perkins, Crystal; Le, Michael

2015-01-01

Optimal rehabilitation after meniscal repair remains controversial. To review the current literature on weightbearing status after meniscal repairs and to provide evidence-based recommendations for postoperative rehabilitation. MEDLINE (January 1, 1993 to July 1, 2014) and Embase (January 1, 1993 to July 1, 2014) were queried with use of the terms meniscus OR/AND repair AND rehabilitation. Included studies were those with levels of evidence 1 through 4, with minimum 2 years follow-up and in an English publication. Systematic review. Level 4. Demographics and clinical and radiographic outcomes of meniscus repair at a minimum of 2 years follow-up were extracted. Successful clinical outcomes ranged from 70% to 94% with conservative rehabilitation. More recent studies using an accelerated rehabilitation protocol with full weightbearing and early range of motion reported 64% to 96% good results. Outcomes after both conservative (restricted weightbearing) protocols and accelerated rehabilitation (immediate weightbearing) yielded similar good to excellent results; however, lack of similar objective criteria and consistency among surgical techniques and existing studies makes direct comparison difficult. © 2015 The Author(s).

Individualized music for dementia: Evolution and application of evidence-based protocol.

PubMed

Gerdner, Linda A

2012-04-22

The theory-based intervention of individualized music has been evaluated clinically and empirically leading to advancement and refinement of an evidence-based protocol, currently in its 5th edition. An expanded version of the protocol was written for professional health care providers with a consumer version tailored for family caregivers. The underlying mid-range theory is presented along with a seminal study that was followed by further research in the United States, Canada, Great Britain, France, Sweden, Norway, Japan and Taiwan. Key studies are summarized. Given its efficacy when implemented by research staff, studies have advanced to testing the intervention under real-life conditions when implemented and evaluated by trained nursing assistants in long-term care facilities and visiting family members. In addition, one study evaluated the implementation of music by family members in the home setting. Initial research focused on agitation as the dependent variable with subsequent research indicating a more holistic response such as positive affect, expressed satisfaction, and meaningful interaction with others. The article advances by describing on-line programs designed to train health care professionals in the assessment, implementation and evaluation of individualized music. In addition, Gerdner has written a story for a picture book intended for children and their families (in press). The story models principles of individualized music to elicit positive memories, reduce anxiety and agitation, and promote communication. The article concludes with implications for future research.

Individualized music for dementia: Evolution and application of evidence-based protocol

PubMed Central

Gerdner, Linda A

2012-01-01

The theory-based intervention of individualized music has been evaluated clinically and empirically leading to advancement and refinement of an evidence-based protocol, currently in its 5th edition. An expanded version of the protocol was written for professional health care providers with a consumer version tailored for family caregivers. The underlying mid-range theory is presented along with a seminal study that was followed by further research in the United States, Canada, Great Britain, France, Sweden, Norway, Japan and Taiwan. Key studies are summarized. Given its efficacy when implemented by research staff, studies have advanced to testing the intervention under real-life conditions when implemented and evaluated by trained nursing assistants in long-term care facilities and visiting family members. In addition, one study evaluated the implementation of music by family members in the home setting. Initial research focused on agitation as the dependent variable with subsequent research indicating a more holistic response such as positive affect, expressed satisfaction, and meaningful interaction with others. The article advances by describing on-line programs designed to train health care professionals in the assessment, implementation and evaluation of individualized music. In addition, Gerdner has written a story for a picture book intended for children and their families (in press). The story models principles of individualized music to elicit positive memories, reduce anxiety and agitation, and promote communication. The article concludes with implications for future research. PMID:24175165

Acupuncture improves cognitive function: A systematic review☆

PubMed Central

Leung, Mason Chin Pang; Yip, Ka Keung; Lam, Chung Tsung; Lam, Ka Shun; Lau, Wai; Yu, Wing Lam; Leung, Amethyst King Man; So, Kwok-fai

2013-01-01

BACKGROUND: Acupuncture has been used as a treatment for cognitive impairment. OBJECTIVE: This review assesses clinical evidence for or against acupuncture as a treatment for cognitive impairment. This review also discusses the proposed mechanism(s) that could link acupuncture to improved cognitive function. METHODS: We searched the literature using PolyUone search from its inception to January 2013, with full text available and language limited to English. Levels of evidence were examined using Oxford Centre for Evidence-based Medicine–Levels of Evidence (March, 2009). RESULTS: Twelve studies met the inclusion criteria: 3 human studies and 9 animal studies. Levels of evidence ranged from level 1b to level 5. CONCLUSION: Most animal studies demonstrated a positive effect of acupuncture on cognitive impairment. However, the results of human studies were inconsistent. Further high-quality human studies with greater statistical power are needed to determine the effectiveness of acupuncture and an optimal protocol. PMID:25206464

The relationship between childhood body weight and dental caries experience: an umbrella systematic review protocol.

PubMed

Carson, Susan J; Abuhaloob, Lamis; Richards, Derek; Hector, Mark P; Freeman, Ruth

2017-10-25

Obesity and dental caries are global public health problems which can impact in childhood and throughout the life course. In simple terms, childhood dental caries and body weight are linked via the common risk factor of diet. An association between dental caries and obesity has been described in a number of studies and reviews. However, similarly, a relationship has also been noted between low body weight and caries experience in children. This protocol will provide the framework for an umbrella review to address the following question: Does the available evidence support a relationship between dental caries experience and body weight in the child population? This review protocol outlines the process to carry out an umbrella systematic review which will synthesise previous reviews of childhood dental caries experience and body weight. An umbrella review methodology will be used to examine the methodological and reporting quality of existing reviews. The final umbrella review aims to aggregate the available evidence in order to provide a summary for policymakers and to inform healthcare interventions. PROSPERO CRD42016047304.

Communication of scientific uncertainty: international case studies on the development of folate and vitamin D Dietary Reference Values.

PubMed

Brown, Kerry A; de Wit, Liesbeth; Timotijevic, Lada; Sonne, Anne-Mette; Lähteenmäki, Liisa; Brito Garcia, Noé; Jeruszka-Bielak, Marta; Sicińska, Ewa; Moore, Alana N; Lawrence, Mark; Raats, Monique M

2015-06-01

Transparent evidence-based decision making has been promoted worldwide to engender trust in science and policy making. Yet, little attention has been given to transparency implementation. The degree of transparency (focused on how uncertain evidence was handled) during the development of folate and vitamin D Dietary Reference Values was explored in three a priori defined areas: (i) value request; (ii) evidence evaluation; and (iii) final values. Qualitative case studies (semi-structured interviews and desk research). A common protocol was used for data collection, interview thematic analysis and reporting. Results were coordinated via cross-case synthesis. Australia and New Zealand, Netherlands, Nordic countries, Poland, Spain and UK. Twenty-one interviews were conducted in six case studies. Transparency of process was not universally observed across countries or areas of the recommendation setting process. Transparency practices were most commonly seen surrounding the request to develop reference values (e.g. access to risk manager/assessor problem formulation discussions) and evidence evaluation (e.g. disclosure of risk assessor data sourcing/evaluation protocols). Fewer transparency practices were observed to assist with handling uncertainty in the evidence base during the development of quantitative reference values. Implementation of transparency policies may be limited by a lack of dedicated resources and best practice procedures, particularly to assist with the latter stages of reference value development. Challenges remain regarding the best practice for transparently communicating the influence of uncertain evidence on the final reference values. Resolving this issue may assist the evolution of nutrition risk assessment and better inform the recommendation setting process.

Traditional Chinese medicine for knee osteoarthritis: An overview of systematic review.

PubMed

Yang, Min; Jiang, Li; Wang, Qing; Chen, Hao; Xu, Guihua

2017-01-01

Traditional Chinese medicine (TCM) has been accepted as a complementary therapy for knee osteoarthritis. However, the efficacy and safety of the intervention were still conflicting and uncertain. Meanwhile, the quality of methodology and evidence in the field was unknown. To summarize the characteristics and critically evaluate the quality of methodology, as well as the evidence of systematic reviews (SRs) on TCM for knee osteoarthritis. Five electronic databases were searched from inception to April 2016. The methodological quality of the included studies was assessed by AMSTAR and ROBIS. The quality of the evidence was determined using the GRADE approach. Ten SRs were included. The conclusions suggest that TCM provides potential benefits for patients with knee osteoarthritis. These benefits include pain relief, functional improvement, and presence of few adverse events. Limitations of the methodological quality mainly included the lack of a-priori protocol or protocol registration and incomprehensive literature search. A list of excluded studies was also not provided. The overall quality of evidence in the SRs was poor, ranging from "very low" to "low," mainly because of the serious risk of bias of original trials, inconsistencies, and imprecision in the outcomes. TCM generally appears to be effective for knee osteoarthritis treatment. However, the evidence is not robust enough because of the methodological flaws in SRs. Hence, these conclusions on available SRs should be treated with caution for clinical practice.

Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study

PubMed Central

Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

2017-01-01

Introduction The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. Methods and analysis This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support–experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). Ethics and dissemination The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. PMID:28647721

Mentorship in nursing academia: a systematic review protocol.

PubMed

Nowell, Lorelli; White, Deborah E; Mrklas, Kelly; Norris, Jill M

2015-02-21

Mentorship is perceived as vital to attracting, training, and retaining nursing faculty members and to maintaining high-quality education programs. While there is emerging evidence to support the value of mentorship in academic medicine, the extant state of the evidence for mentorship in nursing academia has not been established. We describe a protocol for a mixed-methods systematic review to critically appraise the evidence for mentorship in nursing academia. Studies examining the effectiveness of mentorship interventions with nursing faculty who teach in registered nursing education programs will be included. Mentee, mentor, and nursing education institutional outcomes will be explored. Quantitative, qualitative, and mixed method studies will be eligible for inclusion, without restrictions on publication status, year of publication, or language. We will search electronic databases (for example, MEDLINE, CINAHL, ERIC) and gray literature (for example, conference proceedings, key journals, relevant organizational websites) for relevant citations. Using pilot-tested screening and data extraction forms, two reviewers will independently review the studies in three steps: (1) abstract/title screening, (2) full-text screening of accepted studies, and (3) data extraction of accepted studies. Studies will be aggregated for meta-synthesis (qualitative) and meta-analysis (quantitative), should the data permit. This study is the first systematic review of existing global evidence for mentorship in nursing academia. It will help identify key evidence gaps and inform the development and implementation of mentorship interventions. The mentorship outcomes that result from this review could be used to guide the practice of mentorship to increase positive outcomes for nursing faculty and the students they teach and ultimately effect improvements for the patients they care for. This review will also identify key considerations for future research on mentorship in nursing academia and the enhancement of nursing science.

Osteogenic differentiation of equine adipose tissue derived mesenchymal stem cells using CaCl2.

PubMed

Elashry, Mohamed I; Baulig, Nadine; Heimann, Manuela; Bernhardt, Caroline; Wenisch, Sabine; Arnhold, Stefan

2018-04-01

Adipose tissue derived mesenchymal stem cells (ASCs) may be used to cure bone defects after osteogenic differentiation. In this study we tried to optimize osteogenic differentiation for equine ASCs using various concentrations of CaCl 2 in comparison to the standard osteogenic protocol. ASCs were isolated from subcutaneous adipose tissue from mixed breed horses. The osteogenic induction protocols were (1) the standard osteogenic medium (OM) composed of dexamethasone, ascorbic acid and β-glycerol phosphate; (2) CaCl 2 based protocol composed of 3, 5 and 7.5mM CaCl 2 . Differentiation and proliferation were evaluated at 7, 10, 14 and 21days post-differentiation induction using the alizarin red staining (ARS) detecting matrix calcification. Semi-quantification of cell protein content, ARS and alkaline phosphatase activity (ALP) were performed using an ELISA reader. Quantification of the transcription level for the common osteogenic markers alkaline phosphatase (ALP) and Osteopontin (OP) was performed using RT-qPCR. In the presence of CaCl 2 , a concentration dependent effect on the osteogenic differentiation capacity was evident by the ARS evaluation and OP gene expression. We provide evidence that 5 and 7mM CaCl 2 enhance the osteogenic differentiation compared to the OM protocol. Although, there was a clear commitment of ASCs to the osteogenic fate in the presence of 5 and 7mM CaCl 2 , cell proliferation was increased compared to OM. We report that an optimized CaCl 2 protocol reliably influences ASCs osteogenesis while conserving the proliferation capacity. Thus, using these protocols provide a platform for using ASCs as a cell source in bone tissue engineering. Copyright © 2017 Elsevier Ltd. All rights reserved.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

PubMed Central

Agot, Kawango

2017-01-01

Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54) PMID:28274904

Establishing evidence-based training in cognitive behavioral therapy: A review of current empirical findings and theoretical guidance.

PubMed

Rakovshik, Sarah G; McManus, Freda

2010-07-01

Cognitive behavior therapy's (CBT) demonstrated efficacy has prompted calls for its increased dissemination to routine clinical practice settings. For the widespread dissemination of CBT to be successful in achieving effects similar to the original efficacy trials, there must also be effective dissemination of CBT training practices. However, as yet, CBT training is not evidence-based. This review examines what can be learned from existing research into the efficacy and effectiveness of CBT training. Due to the paucity of research specifically investigating CBT training, CBT effectiveness and dissemination studies are also examined to glean information about potentially effective training practices. In order to draw conclusions about effective training practices, comparisons are drawn between studies according to the clinical outcomes that they achieved. Training approaches are compared according to dose and active training elements, and theoretical models of learning are applied to interpret the findings. The limitations of the existing literature are discussed, as well as recommendations for improving training research to meet the standards evident in treatment trials (e.g., random allocation, control conditions, self-report and blind assessment, and adherence monitoring). Finally, the process of developing efficacious CBT treatment protocols is offered as a template for developing evidence-based CBT training protocols. 2010 Elsevier Ltd. All rights reserved.

How do nurses, midwives and health visitors contribute to protocol-based care? A synthesis of the UK literature.

PubMed

Ilott, Irene; Booth, Andrew; Rick, Jo; Patterson, Malcolm

2010-06-01

To explore how nurses, midwives and health visitors contribute to the development, implementation and audit of protocol-based care. Protocol-based care refers to the use of documents that set standards for clinical care processes with the intent of reducing unacceptable variations in practice. Documents such as protocols, clinical guidelines and care pathways underpin evidence-based practice throughout the world. An interpretative review using the five-stage systematic literature review process. The data sources were the British Nursing Index, CINAHL, EMBASE, MEDLINE and Web of Science from onset to 2005. The Journal of Integrated Care Pathways was hand searched (1997-June 2006). Thirty three studies about protocol-based care in the United Kingdom were appraised using the Qualitative Assessment and Review Instrument (QARI version 2). The literature was synthesized inductively and deductively, using an official 12-step guide for development as a framework for the deductive synthesis. Most papers were descriptive, offering practitioner knowledge and positive findings about a locally developed and owned protocol-based care. The majority were instigated in response to clinical need or service re-design. Development of protocol-based care was a non-linear, idiosyncratic process, with steps omitted, repeated or completed in a different order. The context and the multiple purposes of protocol-based care influenced the development process. Implementation and sustainability were rarely mentioned, or theorised as a change. The roles and activities of nurses were so understated as to be almost invisible. There were notable gaps in the literature about the resource use costs, the engagement of patients in the decision-making process, leadership and the impact of formalisation and new roles on inter-professional relations. Documents that standardise clinical care are part of the history of nursing as well as contemporary evidence-based care and expanded roles. Considering the proliferation and contested nature of protocol-based care, the dearth of literature about the contribution, experience and outcomes for nurses, midwives and health visitors is noteworthy and requires further investigation. (c) 2010 Elsevier Ltd. All rights reserved.

Does surgical sympathectomy improve clinical outcomes in patients with refractory angina pectoris?

PubMed

Holland, Luke C; Navaratnarajah, Manoraj; Taggart, David P

2016-04-01

A best evidence topic in cardiothoracic surgery was written according to a structured protocol. The question addressed was: In patients with angina pectoris refractory to medical therapy, does surgical sympathectomy improve clinical outcomes? A total of 528 papers were identified using the search protocol described, of which 6 represented the best evidence to answer the clinical question. There were 5 case series and 1 prospective cohort study. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. All 5 of the case series demonstrated an improvement in symptoms, exercise tolerance or quality of life in patients undergoing surgical sympathectomy. An early case series investigating an open approach had a high morbidity and mortality rate, but the 4 other series used a minimally invasive technique and had low morbidity and zero perioperative mortality rates. The cohort study compared surgical sympathectomy with transmyocardial laser revascularization (TMR) and concluded TMR to be superior. However, this study looked only at unilateral sympathectomy, whereas all 5 case series focused on bilateral surgery. We conclude that the best currently available evidence does suggest that patients report an improvement in their symptoms and quality of life following surgical sympathectomy, but the low level of this evidence does not allow for a statistically proved recommendation. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

NASA Exercise Physiology and Countermeasures Project Overview

NASA Technical Reports Server (NTRS)

Loerch, Linda; Ploutz-Snyder, Lori

2009-01-01

Efficient exercise countermeasures are necessary to offset or minimize spaceflight-induced deconditioning and to maximize crew performance of mission tasks. These countermeasure protocols should use the fewest crew and vehicle resources. NASA s Exercise Physiology and Countermeasures (ExPC) Project works to identify, collect, interpret, and summarize evidence that results in effective exercise countermeasure protocols which protect crew health and performance during International Space Station (ISS) and future exploration-class missions. The ExPC and NASA s Human Research Program are sponsoring multiple studies to evaluate and improve the efficacy of spaceflight exercise countermeasures. First, the Project will measure maximal aerobic capacity (VO2max) during cycle ergometry before, during, and after ISS missions. Second, the Project is sponsoring an evaluation of a new prototype harness that offers improved comfort and increased loading during treadmill operations. Third, the Functional Tasks Test protocol will map performance of anticipated lunar mission tasks with physiologic systems before and after short and long-duration spaceflight, to target system contributions and the tailoring of exercise protocols to maximize performance. In addition to these studies that are actively enrolling crewmember participants, the ExPC is planning new studies that include an evaluation of a higher-intensity/lower-volume exercise countermeasure protocol aboard the ISS using the Advanced Resistive Exercise Device and second-generation treadmill, studies that evaluate bone loading during spaceflight exercise, and ground-based studies that focus on fitness for duty standards required to complete lunar mission tasks and for which exercise protocols need to protect. Summaries of these current and future studies and strategies will be provided to international colleagues for knowledge sharing and possible collaboration.

Prevention of cervical cancer in HIV-seropositive women from developing countries: a systematic review protocol.

PubMed

Mapanga, Witness; Elhakeem, Ahmed; Feresu, Shingairai A; Maseko, Fresier; Chipato, Tsungai

2017-04-24

Over 85% of cervical cancer cases and deaths occur in developing countries. HIV-seropositive women are more likely to develop precancerous lesions that lead to cervical cancer than HIV-negative women. However, the literature on cervical cancer prevention in seropositive women in developing countries has not been reviewed. The aim of this study is to systematically review cervical cancer prevention modalities available for HIV-seropositive women in developing countries. This protocol was developed by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement, and the systematic review will be reported in accordance with the PRISMA guidelines. Embase, MEDLINE, PubMed, CINAHL and Cochrane Library will be searched from inception up to date of final search, and additional studies will be located through citation and reference list tracking. Eligible studies will be randomised controlled trials, prospective and retrospective cohort studies, case-control and cross-sectional studies carried out in developing countries. Studies will be included if they are published in English and examine cervical cancer prevention modalities in HIV-seropositive women. Results will be summarised in tables and, where appropriate, combined using meta-analysis. This review will address the gap in evidence by systematically reviewing the published literature on the different prevention modalities being used to prevent cervical cancer in HIV-seropositive women in developing countries. The findings may be used to inform evidence-based guidelines for prevention of cervical cancer in seropositive women as well as future research. PROSPERO CRD42017054678 .

Addressing the potential adverse effects of school-based BMI assessments on children's wellbeing.

PubMed

Gibbs, Lisa; O'Connor, Thea; Waters, Elizabeth; Booth, Michael; Walsh, Orla; Green, Julie; Bartlett, Jenny; Swinburn, Boyd

2008-01-01

INTRODUCTION. Do child obesity prevention research and intervention measures have the potential to generate adverse concerns about body image by focussing on food, physical activity and body weight? Research findings now demonstrate the emergence of body image concerns in children as young as 5 years. In the context of a large school-community-based child health promotion and obesity prevention study, we aimed to address the potential negative effects of height and weight measures on child wellbeing by developing and implementing an evidence-informed protocol to protect and prevent body image concerns. fun 'n healthy in Moreland! is a cluster randomised controlled trial of a child health promotion and obesity prevention intervention in 23 primary schools in an inner urban area of Melbourne, Australia. Body image considerations were incorporated into the study philosophies, aims, methods, staff training, language, data collection and reporting procedures of this study. This was informed by the published literature, professional body image expertise, pilot testing and implementation in the conduct of baseline data collection and the intervention. This study is the first record of a body image protection protocol being an integral part of the research processes of a child obesity prevention study. Whilst we are yet to measure its impact and outcome, we have developed and tested a protocol based on the evidence and with support from stakeholders in order to minimise the adverse impact of study processes on child body image concerns.

Pre-cooling for endurance exercise performance in the heat: a systematic review

PubMed Central

2012-01-01

Background Endurance exercise capacity diminishes under hot environmental conditions. Time to exhaustion can be increased by lowering body temperature prior to exercise (pre-cooling). This systematic literature review synthesizes the current findings of the effects of pre-cooling on endurance exercise performance, providing guidance for clinical practice and further research. Methods The MEDLINE, EMBASE, CINAHL, Web of Science and SPORTDiscus databases were searched in May 2012 for studies evaluating the effectiveness of pre-cooling to enhance endurance exercise performance in hot environmental conditions (≥ 28°C). Studies involving participants with increased susceptibility to heat strain, cooling during or between bouts of exercise, and protocols where aerobic endurance was not the principle performance outcome were excluded. Potential publications were assessed by two independent reviewers for inclusion and quality. Means and standard deviations of exercise performance variables were extracted or sought from original authors to enable effect size calculations. Results In all, 13 studies were identified. The majority of studies contained low participant numbers and/or absence of sample size calculations. Six studies used cold water immersion, four crushed ice ingestion and three cooling garments. The remaining study utilized mixed methods. Large heterogeneity in methodological design and exercise protocols was identified. Effect size calculations indicated moderate evidence that cold water immersion effectively improved endurance performance, and limited evidence that ice slurry ingestion improved performance. Cooling garments were ineffective. Most studies failed to document or report adverse events. Low participant numbers in each study limited the statistical power of certain reported trends and lack of blinding could potentially have introduced either participant or researcher bias in some studies. Conclusions Current evidence indicates cold water immersion may be the most effective method of pre-cooling to improve endurance performance in hot conditions, although practicality must be considered. Ice slurry ingestion appears to be the most promising practical alternative. Interestingly, cooling garments appear of limited efficacy, despite their frequent use. Mechanisms behind effective pre-cooling remain uncertain, and optimal protocols have yet to be established. Future research should focus on standardizing exercise performance protocols, recruiting larger participant numbers to enable direct comparisons of effectiveness and practicality for each method, and ensuring potential adverse events are evaluated. PMID:23249542

Transitions of care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): a study of protocols in Greater London.

PubMed

Singh, Swaran P; Paul, Moli; Ford, Tamsin; Kramer, Tami; Weaver, Tim

2008-06-23

Although young people's transition from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. A questionnaire survey (Jan-April 2005) of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Forty two of the 65 teams contacted (65%) responded to the survey. Teams varied in type (generic/targeted/in-patient), catchment area (locality-based, wider or national) and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0-70, SD 14.5, n = 37) was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0-50, SD 9.5, n = 33). In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in protocol-sharing organisational units and transition process suggest that practice may vary. There is discontinuity of care provision for some patients who 'graduate' from CAMHS services but are not accepted by adult services.

Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): A study of protocols in Greater London

PubMed Central

Singh, Swaran P; Paul, Moli; Ford, Tamsin; Kramer, Tami; Weaver, Tim

2008-01-01

Background Although young people's transition from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. Methods A questionnaire survey (Jan-April 2005) of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Results Forty two of the 65 teams contacted (65%) responded to the survey. Teams varied in type (generic/targeted/in-patient), catchment area (locality-based, wider or national) and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0–70, SD 14.5, n = 37) was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0–50, SD 9.5, n = 33). In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. Conclusion At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in protocol-sharing organisational units and transition process suggest that practice may vary. There is discontinuity of care provision for some patients who 'graduate' from CAMHS services but are not accepted by adult services. PMID:18573214

Protocol for the systematic review of the reporting of transoral robotic surgery.

PubMed

Main, Barry G; Blencowe, Natalie S; Howes, Noah; Cousins, Sian; Avery, Kerry N L; Gormley, Alexander; Radford, Phil; Elliott, Daisy; Byrne, Benjamin; Wilson, Nicholas; Hinchliffe, Robert; Blazeby, Jane M

2018-01-23

Transoral robotic surgery (TORS) has been adopted in some parts of the world as an innovative approach to the resection of oropharyngeal tumours. The development, details and outcomes of early-to-later phase evaluation of this technique and the quality of evidence to support its adoption into practice have hitherto not been summarised. The aim of this review is to identify and summarise the early and later phase studies of, and evidence for, TORS and to understand how early phase studies report intervention development, governance procedures and selection and reporting of outcomes to optimise methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice. The protocol has been written in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist. Electronic searches in OVID SP versions of Medline and EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews from the start of indexing to 30 April 2017 will identify studies reporting TORS. At least two independent researchers will identify studies for inclusion. Two researchers will extract data from each paper. Studies will be categorised into IDEAL stages of study design from 'pre-IDEAL' to randomised controlled trials (stage 3). Data will be collected about the (1) novel intervention and criteria for modification, (2) governance arrangements and patient information provision, (3) outcome domains selected and reported and (4) quality of study design, conduct and reporting. Descriptive statistics and a narrative synthesis will be presented. The results of this systematic review will be presented at relevant conferences. The methods will be used to inform future reviews exploring other novel surgical innovations. The findings will be published in a peer-reviewed journal. This study does not require ethical approval. © 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 scale of the evidence base on the health effects of conventional yogurt consumption: findings of a scoping review

PubMed Central

Glanville, Julie M.; Brown, Sam; Shamir, Raanan; Szajewska, Hania; Eales, Jacqualyn F.

2015-01-01

Background: The health effects of conventional yogurt have been investigated for over a century; however, few systematic reviews have been conducted to assess the extent of the health benefits of yogurt. Objective: The aim of this scoping review was to assess the volume of available evidence on the health effects of conventional yogurt. Methods: The review was guided by a protocol agreed a priori and informed by an extensive literature search conducted in November 2013. Randomized controlled trials were selected and categorized according to the eligibility criteria established in the protocol. Results: 213 studies were identified as relevant to the scoping question. The number of eligible studies identified for each outcome were: bone health (14 studies), weight management and nutrition related health outcomes (81 studies), metabolic health (6 studies); cardiovascular health (57 studies); gastrointestinal health (24 studies); cancer (39 studies); diabetes (13 studies), Parkinson's disease risk (3 studies), all-cause mortality (3 studies), skin complaints (3 studies), respiratory complaints (3 studies), joint pain/function (2 studies); the remaining 8 studies reported a variety of other outcomes. For studies of a similar design and which assessed the same outcomes in similar population groups, we report the potential for the combining of data across studies in systematic reviews. Conclusions: This scoping review has revealed the extensive evidence base for many outcomes which could be the focus of systematic reviews exploring the health effects of conventional yogurt consumption. PMID:26578956

Addressing the evidence to practice gap for complex interventions in primary care: a systematic review of reviews protocol.

PubMed

Lau, Rosa; Stevenson, Fiona; Ong, Bie Nio; Dziedzic, Krysia; Eldridge, Sandra; Everitt, Hazel; Kennedy, Anne; Kontopantelis, Evangelos; Little, Paul; Qureshi, Nadeem; Rogers, Anne; Treweek, Shaun; Peacock, Richard; Murray, Elizabeth

2014-06-23

Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the 'second translational gap' and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care. This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or commissioning managers and policymakers. Protocol registration number (PROSPERO CRD42014009410). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Application of theory to enhance audit and feedback interventions to increase the uptake of evidence-based transfusion practice: an intervention development protocol.

PubMed

Gould, Natalie J; Lorencatto, Fabiana; Stanworth, Simon J; Michie, Susan; Prior, Maria E; Glidewell, Liz; Grimshaw, Jeremy M; Francis, Jill J

2014-07-29

Audits of blood transfusion demonstrate around 20% transfusions are outside national recommendations and guidelines. Audit and feedback is a widely used quality improvement intervention but effects on clinical practice are variable, suggesting potential for enhancement. Behavioural theory, theoretical frameworks of behaviour change and behaviour change techniques provide systematic processes to enhance intervention. This study is part of a larger programme of work to promote the uptake of evidence-based transfusion practice. The objectives of this study are to design two theoretically enhanced audit and feedback interventions; one focused on content and one on delivery, and investigate the feasibility and acceptability. Study A (Content): A coding framework based on current evidence regarding audit and feedback, and behaviour change theory and frameworks will be developed and applied as part of a structured content analysis to specify the key components of existing feedback documents. Prototype feedback documents with enhanced content and also a protocol, describing principles for enhancing feedback content, will be developed. Study B (Delivery): Individual semi-structured interviews with healthcare professionals and observations of team meetings in four hospitals will be used to specify, and identify views about, current audit and feedback practice. Interviews will be based on a topic guide developed using the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. Analysis of transcripts based on these frameworks will form the evidence base for developing a protocol describing an enhanced intervention that focuses on feedback delivery. Study C (Feasibility and Acceptability): Enhanced interventions will be piloted in four hospitals. Semi-structured interviews, questionnaires and observations will be used to assess feasibility and acceptability. This intervention development work reflects the UK Medical Research Council's guidance on development of complex interventions, which emphasises the importance of a robust theoretical basis for intervention design and recommends systematic assessment of feasibility and acceptability prior to taking interventions to evaluation in a full-scale randomised study. The work-up includes specification of current practice so that, in the trials to be conducted later in this programme, there will be a clear distinction between the control (usual practice) conditions and the interventions to be evaluated.

The Effects of Alternative Resuscitation Strategies on Acute Kidney Injury in Patients with Septic Shock.

PubMed

Kellum, John A; Chawla, Lakhmir S; Keener, Christopher; Singbartl, Kai; Palevsky, Paul M; Pike, Francis L; Yealy, Donald M; Huang, David T; Angus, Derek C

2016-02-01

Septic shock is a common cause of acute kidney injury (AKI), and fluid resuscitation is a major part of therapy. To determine if structured resuscitation designed to alter fluid, blood, and vasopressor use affects the development or severity of AKI or outcomes. Ancillary study to the ProCESS (Protocolized Care for Early Septic Shock) trial of alternative resuscitation strategies (two protocols vs. usual care) for septic shock. We studied 1,243 patients and classified AKI using serum creatinine and urine output. We determined recovery status at hospital discharge, examined rates of renal replacement therapy and fluid overload, and measured biomarkers of kidney damage. Among patients without evidence of AKI at enrollment, 37.6% of protocolized care and 38.1% of usual care patients developed kidney injury (P = 0.90). AKI duration (P = 0.59) and rates of renal replacement therapy did not differ between study arms (6.9% for protocolized care and 4.3% for usual care; P = 0.08). Fluid overload occurred in 8.3% of protocolized care and 6.3% of usual care patients (P = 0.26). Among patients with severe AKI, complete and partial recovery was 50.7 and 13.2% for protocolized patients and 49.1 and 13.4% for usual care patients (P = 0.93). Sixty-day hospital mortality was 6.2% for patients without AKI, 16.8% for those with stage 1, and 27.7% for stages 2 to 3. In patients with septic shock, AKI is common and associated with adverse outcomes, but it is not influenced by protocolized resuscitation compared with usual care.

Effects of physical therapy for the management of patients with ankylosing spondylitis in the biological era.

PubMed

Giannotti, Erika; Trainito, Sabina; Arioli, Giovanni; Rucco, Vincenzo; Masiero, Stefano

2014-09-01

Exercise is considered a fundamental tool for the management of ankylosing spondylitis (AS), in combination with pharmacological therapy that with the advent of biological therapy has improved dramatically the control of signs and symptoms of this challenging disease. Current evidence shows that a specific exercise protocol has not been validated yet. The purpose of this review is to update the most recent evidence (July 2010-November 2013) about physiotherapy in AS, analyzing the possible role and synergistic interactions between exercise and biological drugs. From 117 studies initially considered, only 15 were included in the review. The results support a multimodal approach, including educational sessions, conducted in a group setting, supervised by a physiotherapist and followed by a maintaining home-based regimen. Spa exercise and McKenzie, Heckscher, and Pilates methods seem promising in AS rehabilitation, but their effectiveness should be further investigated in future randomized controlled trials (RCTs). When performed in accordance with the American College of Sports Medicine guidelines, cardiovascular training has been proven safe and effective and should be included in AS rehabilitation protocols. Exercise training plays an important role in the biological era, being now applicable to stabilized patients, leading ultimately to a better management of AS by physiatrists and rheumatologists throughout the world. On the basis of the current evidence, further research should aim to determine which exercise protocols should be recommended.

78 FR 12764 - Draft Office of Health Assessment and Translation Approach for Systematic Review and Evidence...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... Approach--February 2013 might be needed, OHAT plans to apply it to two case-study evaluations. One case... Availability: Draft OHAT Approach--February 2013 will be available by February 26, 2013, and case-study... framework, describe the contents in the case-study protocols, and respond to questions from the public on...

Effects of the Saluda Prevention Program: A Review of Controlled Evaluation Studies

ERIC Educational Resources Information Center

Espada-Sánchez, José P.; Hernández-Serrano, Olga

2015-01-01

The objective of the present study is to review the evidence on the effectiveness concerning the Saluda program, a school-based substance use prevention protocol used amongst adolescents. We provide a description of the program content and the results from nine controlled trials evaluating the program effectiveness. Participants were Spanish…

Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

PubMed

Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

2018-03-26

Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

The Length of Child Anxiety Treatment in a Regional Health System.

PubMed

Whiteside, Stephen P H; Ale, Chelsea M; Young, Brennan; Olsen, Mark W; Biggs, Bridget K; Gregg, Melissa S; Geske, Jennifer R; Homan, Kendra

2016-12-01

Anxiety disorders are often undertreated due to unsuccessful dissemination of evidence-based treatments (EBTs). Lack of empirical data regarding the typical length of treatment in clinical settings may hamper the development of clinically relevant protocols. The current study examined billing records for 335 children ages 7-17 years to quantify the treatment received for newly diagnosed anxiety disorders within a regional health system. The vast majority of patients did not receive a sufficient number of appointments to complete the typical cognitive behavioral therapy protocol or reach the sessions introducing exposure. Although half of the sample received pharmacotherapy, the vast majority received fewer follow-up appointments than participants in pharmacotherapy research studies. Further, the type of treatment (i.e., number of sessions and medication) differed depending on utilization of specialty care. These results underscore the need to develop brief and flexible EBT protocols that can be standardized and implemented in community practice.

Management of elderly patients with glioblastoma-multiforme-a systematic review.

PubMed

Almadani, Asmaa; Sanjay, Dixit; Chris, Rowland-Hill; Shailendra, Achawal; Chitoor, Rajaraman; Gerry, O'Reilly; Robin, Highley; Masood, Hussain; Louise, Baker; Lynne, Gill; Holly, Morris; Mohan, Hingorani

2018-03-09

The management of elderly patients with glioblastoma-multiforme (GBM) remains poorly defined with many experts in the past advocating best supportive care, in view of limited evidence on efficacy of more aggressive treatment protocols. There is randomised evidence (NORDIC and NA-O8 studies) to support the use of surgery followed by adjuvant monotherapy with either radiotherapy (RT) using hypofractionated regimes (e.g. 36 Gy in 6 fractions OR 40 Gy in 15 fractions) or chemotherapy with temozolomide (TMZ) in patients expressing methylation of promoter for O 6 -methylguanine-DNA methyltransferase enzyme. However, the role of combined-modality therapy involving the use of combined RT and TMZ protocols has remained controversial with data from the EORTC (European Organisation for Research and Treatment of Cancer)-NCIC (National Cancer Institute of Canada) studies indicating that patients more than 65 years of age may not benefit significantly from combining standard RT fractionation using 60 Gy in 30 fractions with concurrent and adjuvant TMZ. More recently, randomised data has emerged on combining hypofractionated RT with concurrent and adjuvant TMZ. We provide a comprehensive review of literature with the aim of defining an evidence-based algorithm for management of elderly glioblastoma-multiforme population.

The utilization of unified protocols in behavioral cognitive therapy in transdiagnostic group subjects: A clinical trial.

PubMed

de Ornelas Maia, Ana Claudia Corrêa; Nardi, Antonio Egidio; Cardoso, Adriana

2015-02-01

The practicing of protocols based on behavioral cognitive therapy (CBT) have been frequently used in the last decades and adapted to better manage the necessities of patients and providers. The goal is to build a treatment that is evidence-based - for that reason the unified protocol for multiple emotional disorders (transdiagnostics) have been utilized to simplify treatment - without losing scientific traits. The main goal of this study is to evaluate the unified protocol in groups of patients with depression and anxiety disorders. In a pool of 48 subjects, divided in two groups, one was submitted to 12 intervention sessions of the unified protocol while the other was solely given medication. MINI, BAI and BDI were the instruments used at the beginning and at the end of treatment. The results were highly significant (p<0.001) in as much as with the improvement of anxiety and depressive disorders as it was in the group which was treated with the unified protocol compared with the group which was only given medication Limitations of this study were the number of sample participants and the non-randomization of subjects in both groups. Group therapy has not been largely implemented though it is deemed very useful for treatments when the unified protocol is used in transdiagnostic patients. Not only does it allow for emotional stabilizing and socialization but it also enables subjects with an altruistic feeling amongst themselves. Copyright © 2014 Elsevier B.V. All rights reserved.

The APOSTEL recommendations for reporting quantitative optical coherence tomography studies.

PubMed

Cruz-Herranz, Andrés; Balk, Lisanne J; Oberwahrenbrock, Timm; Saidha, Shiv; Martinez-Lapiscina, Elena H; Lagreze, Wolf A; Schuman, Joel S; Villoslada, Pablo; Calabresi, Peter; Balcer, Laura; Petzold, Axel; Green, Ari J; Paul, Friedemann; Brandt, Alexander U; Albrecht, Philipp

2016-06-14

To develop consensus recommendations for reporting of quantitative optical coherence tomography (OCT) study results. A panel of experienced OCT researchers (including 11 neurologists, 2 ophthalmologists, and 2 neuroscientists) discussed requirements for performing and reporting quantitative analyses of retinal morphology and developed a list of initial recommendations based on experience and previous studies. The list of recommendations was subsequently revised during several meetings of the coordinating group. We provide a 9-point checklist encompassing aspects deemed relevant when reporting quantitative OCT studies. The areas covered are study protocol, acquisition device, acquisition settings, scanning protocol, funduscopic imaging, postacquisition data selection, postacquisition data analysis, recommended nomenclature, and statistical analysis. The Advised Protocol for OCT Study Terminology and Elements recommendations include core items to standardize and improve quality of reporting in quantitative OCT studies. The recommendations will make reporting of quantitative OCT studies more consistent and in line with existing standards for reporting research in other biomedical areas. The recommendations originated from expert consensus and thus represent Class IV evidence. They will need to be regularly adjusted according to new insights and practices. © 2016 American Academy of Neurology.

Effective components of exercise and physical activity-related behaviour-change interventions for chronic non-communicable diseases in Africa: protocol for a systematic mixed studies review with meta-analysis

PubMed Central

Igwesi-Chidobe, Chinonso N; Godfrey, Emma L; Kengne, Andre P

2015-01-01

Introduction Chronic non-communicable diseases (NCDs) account for a high burden of mortality and morbidity in Africa. Evidence-based clinical guidelines recommend exercise training and promotion of physical activity behaviour changes to control NCDs. Developing such interventions in Africa requires an understanding of the essential components that make them effective in this context. This is a protocol for a systematic mixed studies review that aims to determine the effective components of exercise and physical activity-related behaviour-change interventions for chronic diseases in Africa, by combining quantitative and qualitative research evidence from studies published until July 2015. Methods and analysis We will conduct a detailed search to identify all published and unpublished studies that assessed the effects of exercise and physical activity-related interventions or the experiences/perspectives of patients to these interventions for NCDs from bibliographic databases and the grey literature. Bibliographic databases include MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), PsycINFO, CINAHL and Web of Science. We will include the following African regional databases: African Index Medicus (AIM) and AFROLIB, which is the WHO's regional office database for Africa. The databases will be searched from inception until 18 July 2015. Appraisal of study quality will be performed after results synthesis. Data synthesis will be performed independently for quantitative and qualitative data using a mixed methods sequential explanatory synthesis for systematic mixed studies reviews. Meta-analysis will be conducted for the quantitative studies, and thematic synthesis for qualitative studies and qualitative results from the non-controlled observational studies. The primary outcome will include exercise adherence and physical activity behaviour changes. This review protocol is reported according to Preferred Reporting Items for Systematic reviews and Meta-Analysis protocols (PRISMA-P) 2015 guidelines. Ethics and dissemination There is no ethical requirement for this study, as it utilises published data. This review is expected to inform the development of exercise and physical activity-related behaviour-change interventions in Africa, and will be presented at conferences, and published in peer reviewed journals and a PhD thesis at King's College London. Protocol registration number This study was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 22 January 2015 (registration number: PROSPERO 2015: CRD42015016084). PMID:26270945

Protocols for treating patients with end-stage renal disease: a survey of nephrology fellowships.

PubMed

Perry, Maureen Munnelly; Howell, Scott; Patel, Nipa

2017-03-01

Approximately 14% of Americans are living with chronic kidney disease (CKD). The prevalence of end-stage renal disease (ESRD), the result of progressing CKD continues to rise by 21,000 per year. Currently, the only antibiotic prophylaxis guidelines for patients with ESRD undergoing dental treatment were published by the AHA in 2003. Presented in three parts, the first and second parts of this study found no consistent protocols amongst U.S. dental schools and U.S. GPRs and AEGDs, respectively. The goal of the third part of the project was to determine the current protocol being used to treat ESRD patients at U.S. nephrology fellowship programs. An 18 multiple-choice question survey was e-mailed to 130 directors of nephrology fellowships within the U.S. regarding renal treatment protocol details and antibiotic prophylaxis for patients with renal disease. Note that, 34.6% of respondents reported having an established renal treatment protocol. For programs with a protocol, 69% of programs reported following AHA guidelines. There is a lack of consistent, established protocols amongst U.S. nephrology fellowships. It is suggested that updated and evidence based guidelines for the safe treatment of patients be developed. © 2016 Special Care Dentistry Association and Wiley Periodicals, Inc.

Study protocol of a randomized controlled trial comparing integrative body-mind-spirit intervention and cognitive behavioral therapy in fostering quality of life of patients with lung cancer and their family caregivers.

PubMed

Lau, Bobo Hi-Po; Chow, Amy Y M; Wong, Daniel F K; Chan, Jessie S M; Chan, Celia H Y; Ho, Rainbow T H; So, Tsz-Him; Lam, Tai-Chung; Lee, Victor Ho-Fun; Lee, Anne W M; Chow, Sau Fong; Chan, Cecilia L W

2018-01-01

Compared to cancers at other sites, lung cancer often results in greater psychosocial distress to both the patients and their caregivers, due to the poor prognosis and survival rate, as well as the heavy symptom burden. In recent years, making protocols of proposed or on-going studies publicly available via clinical trial registries and/or peer-reviewed journals has benefited health sciences with timely communication of the latest research trends and improved transparency in reporting. However, such practice is yet to be a common sight in evidence-informed social work. Hence, this paper discusses the value of publishing protocols in social work research and presents the protocol of a randomized controlled trial that compares the effectiveness of integrative body-mind-spirit intervention with cognitive behavioral therapy for enhancing quality of life of patients with lung cancer and their family caregivers. The data collection process was still on-going at the time of manuscript submission.

The effectiveness of evidence summaries on health policymakers and health system managers use of evidence from systematic reviews: a systematic review.

PubMed

Petkovic, Jennifer; Welch, Vivian; Jacob, Maria Helena; Yoganathan, Manosila; Ayala, Ana Patricia; Cunningham, Heather; Tugwell, Peter

2016-12-09

Systematic reviews are important for decision makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which make them hard to use for decision-making. There are many organizations that develop and disseminate derivative products, such as evidence summaries, from systematic reviews for different populations or subsets of decision makers. This systematic review aimed to (1) assess the effectiveness of evidence summaries on policymakers' use of the evidence and (2) identify the most effective summary components for increasing policymakers' use of the evidence. We present an overview of the available evidence on systematic review derivative products. We included studies of policymakers at all levels as well as health system managers. We included studies examining any type of "evidence summary," "policy brief," or other products derived from systematic reviews that presented evidence in a summarized form. The primary outcomes were the (1) use of systematic review summaries in decision-making (e.g., self-reported use of the evidence in policymaking and decision-making) and (2) policymakers' understanding, knowledge, and/or beliefs (e.g., changes in knowledge scores about the topic included in the summary). We also assessed perceived relevance, credibility, usefulness, understandability, and desirability (e.g., format) of the summaries. Our database search combined with our gray literature search yielded 10,113 references after removal of duplicates. From these, 54 were reviewed in full text, and we included six studies (reported in seven papers) as well as protocols from two ongoing studies. Two studies assessed the use of evidence summaries in decision-making and found little to no difference in effect. There was also little to no difference in effect for knowledge, understanding or beliefs (four studies), and perceived usefulness or usability (three studies). Summary of findings tables and graded entry summaries were perceived as slightly easier to understand compared to complete systematic reviews. Two studies assessed formatting changes and found that for summary of findings tables, certain elements, such as reporting study event rates and absolute differences, were preferred as well as avoiding the use of footnotes. Evidence summaries are likely easier to understand than complete systematic reviews. However, their ability to increase the use of systematic review evidence in policymaking is unclear. The protocol was published in the journal Systematic Reviews (2015;4:122).

Development of Seasonal Influenza Vaccination Recommendations: Relevance and Influence of the Evidence on the Decision-Making Process in France and the Netherlands.

PubMed

Silva, Maria Laura; Paget, W John; Mosnier, Anne; Buthion, Valérie; Cohen, Jean Marie; Perrier, Lionel; Späth, Hans Martin

2016-01-01

Target groups for seasonal influenza vaccination are defined at the country level and are based on several factors. However, little is known about the national decision-making procedures. The purpose of this study was to compare the evidence used for the development of recommendations and its impact on the choice of target groups in France and the Netherlands. A preliminary documentary analysis identified institutions to include in the assessment: governmental authorities, research institutions, associations, and manufacturers. At least one expert from each group was invited to our study. Thirty-three semi-structured interviews were conducted in 2013 (16 France, 17 the Netherlands). We used NVivo10® to perform a thematic content analysis. Clinical/epidemiological studies were the evidence most used in both countries. Economic models were increasingly being used; these had greater influence on the decision making in the Netherlands than in France, probably because of the presence of a modeler. Generally, the quality of the evidence used was poor, although no systematic use of standard protocol for its assessment was observed. A general protocol was sometimes used in France; however, the personal judgment of the experts was crucial for the assessment in both countries. There were differences in the target groups, for example, pregnant women, recommended only in France. France and the Netherlands use similar evidence for developing vaccination recommendations, although different decisions are sometimes made regarding target groups. This could be associated with the lack of systematic standard appraisals, increasing the influence of the experts' judgment on decision making. The development of standards for the appraisal of evidence is recommended. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

"May I Buy a Pack of Marlboros, Please?" A Systematic Review of Evidence to Improve the Validity and Impact of Youth Undercover Buy Inspections.

PubMed

Lee, Joseph G L; Gregory, Kyle R; Baker, Hannah M; Ranney, Leah M; Goldstein, Adam O

2016-01-01

Most smokers become addicted to tobacco products before they are legally able to purchase these products. We systematically reviewed the literature on protocols to assess underage purchase and their ecological validity. We conducted a systematic search in May 2015 in PubMed and PsycINFO. We independently screened records for inclusion. We conducted a narrative review and examined implications of two types of legal authority for protocols that govern underage buy enforcement in the United States: criminal (state-level laws prohibiting sales to youth) and administrative (federal regulations prohibiting sales to youth). Ten studies experimentally assessed underage buy protocols and 44 studies assessed the association between youth characteristics and tobacco sales. Protocols that mimicked real-world youth behaviors were consistently associated with substantially greater likelihood of a sale to a youth. Many of the tested protocols appear to be designed for compliance with criminal law rather than administrative enforcement in ways that limited ecological validity. This may be due to concerns about entrapment. For administrative enforcement in particular, entrapment may be less of an issue than commonly thought. Commonly used underage buy protocols poorly represent the reality of youths' access to tobacco from retailers. Compliance check programs should allow youth to present themselves naturally and attempt to match the community's demographic makeup.

"May I Buy a Pack of Marlboros, Please?" A Systematic Review of Evidence to Improve the Validity and Impact of Youth Undercover Buy Inspections

PubMed Central

Lee, Joseph G. L.; Gregory, Kyle R.; Baker, Hannah M.; Ranney, Leah M.; Goldstein, Adam O.

2016-01-01

Most smokers become addicted to tobacco products before they are legally able to purchase these products. We systematically reviewed the literature on protocols to assess underage purchase and their ecological validity. We conducted a systematic search in May 2015 in PubMed and PsycINFO. We independently screened records for inclusion. We conducted a narrative review and examined implications of two types of legal authority for protocols that govern underage buy enforcement in the United States: criminal (state-level laws prohibiting sales to youth) and administrative (federal regulations prohibiting sales to youth). Ten studies experimentally assessed underage buy protocols and 44 studies assessed the association between youth characteristics and tobacco sales. Protocols that mimicked real-world youth behaviors were consistently associated with substantially greater likelihood of a sale to a youth. Many of the tested protocols appear to be designed for compliance with criminal law rather than administrative enforcement in ways that limited ecological validity. This may be due to concerns about entrapment. For administrative enforcement in particular, entrapment may be less of an issue than commonly thought. Commonly used underage buy protocols poorly represent the reality of youths' access to tobacco from retailers. Compliance check programs should allow youth to present themselves naturally and attempt to match the community’s demographic makeup. PMID:27050671

Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders.

PubMed

Gros, Daniel F

2014-12-15

Considerable attention has focused on the growing need for evidence-based psychotherapy for veterans with affective disorders within the Department of Veteran Affairs. Despite, and possibly due to, the large number of evidence-based protocols available, several obstacles remain in their widespread delivery within Veterans Affairs Medical Centers. In part as an effort to address these concerns, newer transdiagnostic approaches to psychotherapy have been developed to provide a single treatment that is capable of addressing several, related disorders. The goal of the present investigation was to develop and evaluate a transdiagnostic psychotherapy, Transdiagnostic Behavior Therapy (TBT), in veterans with affective disorders. Study 1 provided initial support for transdiagnostic presentation of evidence-based psychotherapy components in veterans with principal diagnoses of affective disorders (n=15). These findings were used to inform the development of the TBT protocol. In Study 2, an initial evaluation of TBT was completed in a second sample of veterans with principal diagnoses of affective disorders (n=29). The findings of Study 2 demonstrated significant improvements in symptoms of depression, anxiety, stress, posttraumatic stress, and related impairment across participants with various principal diagnoses. Together, the investigation provided preliminary support for effectiveness of TBT in veterans with affective disorders. Published by Elsevier Ireland Ltd.

Interventions for the prevention of OHSS in ART cycles: an overview of Cochrane reviews.

PubMed

Mourad, Selma; Brown, Julie; Farquhar, Cindy

2017-01-23

Ovarian hyperstimulation syndrome (OHSS) in assisted reproductive technology (ART) cycles is a treatment-induced disease that has an estimated prevalence of 20% to 33% in its mild form and 3% to 8% in its moderate or severe form. These numbers might even be higher for high-risk women such as those with polycystic ovaries or a high oocyte yield from ovum pickup. The objective of this overview is to identify and summarise all evidence from Cochrane systematic reviews on interventions for prevention or treatment of moderate, severe and overall OHSS in couples with subfertility who are undergoing ART cycles. Published Cochrane systematic reviews reporting on moderate, severe or overall OHSS as an outcome in ART cycles were eligible for inclusion in this overview. We also identified Cochrane submitted protocols and title registrations for future inclusion in the overview. The evidence is current to 12 December 2016. We identified reviews, protocols and titles by searching the Cochrane Gynaecology and Fertility Group Database of Systematic Reviews and Archie (the Cochrane information management system) in July 2016 on the effectiveness of interventions for outcomes of moderate, severe and overall OHSS. We undertook in duplicate selection of systematic reviews, data extraction and quality assessment. We used the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool to assess the quality of included reviews, and we used GRADE methods to assess the quality of the evidence for each outcome. We summarised the characteristics of included reviews in the text and in additional tables. We included a total of 27 reviews in this overview. The reviews were generally of high quality according to AMSTAR ratings, and included studies provided evidence that ranged from very low to high in quality. Ten reviews had not been updated in the past three years. Seven reviews described interventions that provided a beneficial effect in reducing OHSS rates, and we categorised one additional review as 'promising'. Of the effective interventions, all except one had no detrimental effect on pregnancy outcomes. Evidence of at least moderate quality indicates that clinicians should consider the following interventions in ART cycles to reduce OHSS rates.• Metformin treatment before and during an ART cycle for women with PCOS (moderate-quality evidence).• Gonadotrophin-releasing hormone (GnRH) antagonist protocol in ART cycles (moderate-quality evidence).• GnRH agonist (GnRHa) trigger in donor oocyte or 'freeze-all' programmes (moderate-quality evidence). Evidence of low or very low quality suggests that clinicians should consider the following interventions in ART cycles to reduce OHSS rates.• Clomiphene citrate for controlled ovarian stimulation in ART cycles (low-quality evidence).• Cabergoline around the time of human chorionic gonadotrophin (hCG) administration or oocyte pickup in ART cycles (low-quality evidence).• Intravenous fluids (plasma expanders) around the time of hCG administration or oocyte pickup in ART cycles (very low-quality evidence).• Progesterone for luteal phase support in ART cycles (low-quality evidence).• Coasting (withholding gonadotrophins) - a promising intervention that needs to be researched further for reduction of OHSS.On the basis of this overview, we must conclude that evidence is currently insufficient to support the widespread practice of embryo cryopreservation. Currently, 27 reviews in the Cochrane Library were conducted to report on or to try to report on OHSS in ART cycles. We identified four review protocols but no new registered titles that can potentially be included in this overview in the future. This overview provides the most up-to-date evidence on prevention of OHSS in ART cycles from all currently published Cochrane reviews on ART. Clinicians can use the evidence summarised in this overview to choose the best treatment regimen for individual patients - a regimen that not only reduces the chance of developing OHSS but does not compromise other outcomes such as pregnancy or live birth rate. Review results, however, are limited by the lack of recent primary studies or updated reviews. Furthermore, this overview can be used by policymakers in developing local and regional protocols or guidelines and can reveal knowledge gaps for future research.

Improving the quality of perinatal mental health: a health visitor-led protocol.

PubMed

Lewis, Anne; Ilot, Irene; Lekka, Chrysanthi; Oluboyede, Yemi

2011-02-01

The mental health of mothers is of significant concern to community practitioners. This paper reports on a case study exploring the success factors of a well established, health visitor-led protocol to identify and treat women with mild to moderate depression. Data were collected through interviews with a purposive sample of 12 community practitioners, a focus group of four health visitors and observation of a multidisciplinary steering group meeting. The protocol was described as an evidence-based tool and safety net that could be used flexibly to support clinical judgments and tailored to individual needs. Success factors included frontline clinician engagement and ownership, continuity of leadership to drive development and maintain momentum, comprehensive and on-going staff training, and strategic support for the protocol as a quality indicator at a time of organisational change. Quality and clinical leadership are continuing policy priorities. The protocol enabled frontline staff to lead a service innovation, providing a standardised multiprofessional approach to women's mental health needs through effective support, advice and treatment that can be measured and quality assured.

Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: Alternative versus standard stimulation protocols; the study protocol of the STIM-trial.

PubMed

Dahhan, T; Balkenende, E M E; Beerendonk, C C M; Fleischer, K; Stoop, D; Bos, A M E; Lambalk, C B; Schats, R; van Golde, R J T; Schipper, I; Louwé, L A; Cantineau, A E P; Smeenk, J M J; de Bruin, J P; Reddy, N; Kopeika, Y; van der Veen, F; van Wely, M; Linn, S C; Goddijn, M

2017-10-01

Chemotherapy for breast cancer may have a negative impact on reproductive function due to gonadotoxicity. Fertility preservation via banking of oocytes or embryos after ovarian stimulation with FSH can increase the likelihood of a future live birth. It has been hypothesized that elevated serum estrogen levels during ovarian stimulation may induce breast tumour growth. This has led to the use of alternative stimulation protocols with addition of tamoxifen or letrozole. The effectiveness of these stimulation protocols in terms of oocyte yield is unknown. Randomized open-label trial comparing ovarian stimulation plus tamoxifen and ovarian stimulation plus letrozole with standard ovarian stimulation in the course of fertility preservation. The study population consists of women with breast cancer who opt for banking of oocytes or embryos, aged 18-43years at randomisation. Primary outcome is the number of oocytes retrieved at follicle aspiration. Secondary outcomes are number of mature oocytes retrieved, number of oocytes or embryos banked and peak E2 levels during ovarian stimulation. Concerning the lack of evidence on which stimulation protocol should be used in women with breast cancer and the growing demand for fertility preservation, there is an urgent need to undertake this study. By performing this study, we will be able to closely monitor the effects of various stimulation protocols in women with breast cancer and pave the way for long term follow up on the safety of this procedure in terms of breast cancer prognosis. NTR4108. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical Effectiveness of Incentive Spirometry for the Prevention of Postoperative Pulmonary Complications.

PubMed

Eltorai, Adam E M; Szabo, Ashley L; Antoci, Valentin; Ventetuolo, Corey E; Elias, Jack A; Daniels, Alan H; Hess, Dean R

2018-03-01

Incentive spirometry (IS) is commonly prescribed to reduce pulmonary complications, despite limited evidence to support its benefits and a lack of consensus on optimal protocols for its use. Although numerous studies and meta-analyses have examined the effects of IS on patient outcomes, there is no clear evidence establishing its benefit to prevent postoperative pulmonary complications. Clinical practice guidelines advise against the routine use of IS in postoperative care. Until evidence of benefit from well-designed clinical trials becomes available, the routine use of IS in postoperative care is not supported by high levels of evidence. Copyright © 2018 by Daedalus Enterprises.

Traditional Chinese medicine for knee osteoarthritis: An overview of systematic review

PubMed Central

Wang, Qing; Chen, Hao

2017-01-01

Background Traditional Chinese medicine (TCM) has been accepted as a complementary therapy for knee osteoarthritis. However, the efficacy and safety of the intervention were still conflicting and uncertain. Meanwhile, the quality of methodology and evidence in the field was unknown. Objective To summarize the characteristics and critically evaluate the quality of methodology, as well as the evidence of systematic reviews (SRs) on TCM for knee osteoarthritis. Methods Five electronic databases were searched from inception to April 2016. The methodological quality of the included studies was assessed by AMSTAR and ROBIS. The quality of the evidence was determined using the GRADE approach. Results Ten SRs were included. The conclusions suggest that TCM provides potential benefits for patients with knee osteoarthritis. These benefits include pain relief, functional improvement, and presence of few adverse events. Limitations of the methodological quality mainly included the lack of a-priori protocol or protocol registration and incomprehensive literature search. A list of excluded studies was also not provided. The overall quality of evidence in the SRs was poor, ranging from “very low” to “low,” mainly because of the serious risk of bias of original trials, inconsistencies, and imprecision in the outcomes. Conclusions TCM generally appears to be effective for knee osteoarthritis treatment. However, the evidence is not robust enough because of the methodological flaws in SRs. Hence, these conclusions on available SRs should be treated with caution for clinical practice. PMID:29267324

Validity Evidence and Scoring Guidelines for Standardized Patient Encounters and Patient Notes From a Multisite Study of Clinical Performance Examinations in Seven Medical Schools.

PubMed

Park, Yoon Soo; Hyderi, Abbas; Heine, Nancy; May, Win; Nevins, Andrew; Lee, Ming; Bordage, Georges; Yudkowsky, Rachel

2017-11-01

To examine validity evidence of local graduation competency examination scores from seven medical schools using shared cases and to provide rater training protocols and guidelines for scoring patient notes (PNs). Between May and August 2016, clinical cases were developed, shared, and administered across seven medical schools (990 students participated). Raters were calibrated using training protocols, and guidelines were developed collaboratively across sites to standardize scoring. Data included scores from standardized patient encounters for history taking, physical examination, and PNs. Descriptive statistics were used to examine scores from the different assessment components. Generalizability studies (G-studies) using variance components were conducted to estimate reliability for composite scores. Validity evidence was collected for response process (rater perception), internal structure (variance components, reliability), relations to other variables (interassessment correlations), and consequences (composite score). Student performance varied by case and task. In the PNs, justification of differential diagnosis was the most discriminating task. G-studies showed that schools accounted for less than 1% of total variance; however, for the PNs, there were differences in scores for varying cases and tasks across schools, indicating a school effect. Composite score reliability was maximized when the PN was weighted between 30% and 40%. Raters preferred using case-specific scoring guidelines with clear point-scoring systems. This multisite study presents validity evidence for PN scores based on scoring rubric and case-specific scoring guidelines that offer rigor and feedback for learners. Variability in PN scores across participating sites may signal different approaches to teaching clinical reasoning among medical schools.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

PubMed

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54). ©Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles M Cleland, Peter Cherutich, James N Kiarie, Alfred Osoti, Connie L Celum, Jared M Baeten, Ruth Nduati, John Kinuthia, Timothy B Hallett, Ramzi Alsallaq, Ann E Kurth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2017.

Variability of DKA Management Among Pediatric Emergency Room and Critical Care Providers: A Call for More Evidence-Based and Cost-Effective Care?

PubMed

Clark, Matthew G; Dalabih, Abdallah

2014-09-01

Management protocols have been shown to be effective in the pediatric emergency medicine (PEM) and pediatric critical care (PCC) settings. Treatment protocols define clear goals which are achieved with consistency in implementation. Over the last decade, many new recommendations have been proposed on managing diabetic ketoacidosis (DKA). Although no perfect set of guidelines exist, many institutions are developing DKA treatment protocols. We sought to determine the variability between institutions in implementation of these protocols.

Development of an alcohol withdrawal protocol: CNS collaborative exemplar.

PubMed

Phillips, Susan; Haycock, Camille; Boyle, Deborah

2006-01-01

The purpose of this process improvement project was to develop an Alcohol Withdrawal Syndrome (AWS) management protocol for acute care. The prevalence of alcohol abuse in our society presents challenges for health professionals, and few nurses have received formal education on the identification and treatment of AWS, which has frequently resulted in ineffective, nonstandardized care. However, nurses practicing in medical-surgical, emergency, trauma, and critical care settings must be astute in the assessment and management of AWS. DESIGN/BACKGROUND/RATIONALE: Following an analysis of existing management protocols, a behavioral health clinical nurse specialist was asked to lead a work team composed of physicians, pharmacists, and nurses to develop a new evidence-based alcohol withdrawal protocol for acute care. By implementing a standardized assessment tool and treatment protocol, clinical nurse specialists empowered nursing staff with strategies to prevent the serious medical complications associated with AWS. FINDINGS/OUTCOMES: The development and integration of a safe and effective treatment protocol to manage AWS was facilitated by collaborative, evidence-based decision making. Clinical experience and specialty expertise were integrated by clinical nurse specialists skilled in group dynamics, problem-solving, and the implementation of change. Improving care of patients in AWS is an exemplar for clinical nurse specialist roles as change agent and patient advocate.

Cognitive-Behavioral Therapy for Depression in an Older Gay Man: A Clinical Case Study

ERIC Educational Resources Information Center

Satterfield, Jason M.; Crabb, Rebecca

2010-01-01

Although strong evidence supports cognitive-behavioral therapy for late-life depression and depression in racial and ethnic minorities, there are no empirical studies on the treatment of depression in older sexual minorities. Three distinct literatures were tapped to create a depression treatment protocol for an older gay male. Interventions were…

Ethical dilemmas in genetic testing: examples from the Cuban program for predictive diagnosis of hereditary ataxias.

PubMed

Mariño, Tania Cruz; Armiñán, Rubén Reynaldo; Cedeño, Humberto Jorge; Mesa, José Miguel Laffita; Zaldivar, Yanetza González; Rodríguez, Raúl Aguilera; Santos, Miguel Velázquez; Mederos, Luis Enrique Almaguer; Herrera, Milena Paneque; Pérez, Luis Velázquez

2011-06-01

Predictive testing protocols are intended to help patients affected with hereditary conditions understand their condition and make informed reproductive choices. However, predictive protocols may expose clinicians and patients to ethical dilemmas that interfere with genetic counseling and the decision making process. This paper describes ethical dilemmas in a series of five cases involving predictive testing for hereditary ataxias in Cuba. The examples herein present evidence of the deeply controversial situations faced by both individuals at risk and professionals in charge of these predictive studies, suggesting a need for expanded guidelines to address such complexities.

Transcranial direct current stimulation improves neurorehabilitation of task-specific dystonia: a pilot study.

PubMed

Rosset-Llobet, Jaume; Fàbregas-Molas, Sílvia; Pascual-Leone, Alvaro

2014-03-01

Sensory-motor returning (SMR) can help the symptoms of task-specific focal hand dystonia. However, effects vary across patients and take many sessions. Here, we present proof of principle evidence that transcranial direct current stimulation (tDCS) can enhance these effects. We compared the effects of a combined tDCS-SMR protocol (n=4 patients) with the efficacy of SMR alone (n=30 patients). All 4 patients treated with the combined protocol showed greater improvement than those undergoing SMR alone. Results encourage a larger, parallel-group clinical trial with sham tDCS control.

Oncosurgical Management of Liver Limited Stage IV Colorectal Cancer: Preliminary Data and Protocol for a Randomized Controlled Trial.

PubMed

Sutton, Paul; Vimalachandran, Dale; Poston, Graeme; Fenwick, Stephen; Malik, Hassan

2018-05-09

Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer-related death in the United Kingdom. Almost 15% of patients have metastases on presentation. An increasing number of surgical strategies and better neoadjuvant treatment options are responsible for more patients undergoing resection of liver metastases, with prolonged survival in a select group of patients who present with synchronous disease. It is clear that the optimal strategy for the management of these patients remains unclear, and there is certainly a complete absence of Level 1 evidence in the literature. The objective of this study is to undertake preliminary work and devise an outline trial protocol to inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We have undertaken some preliminary work and begun the process of designing a randomized controlled trial and present a draft trial protocol here. This study is at the protocol development stage only, and as such no results are available. There is no funding in place for this study, and no anticipated start date. We have presented preliminary work and an outline trial protocol which we anticipate will inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We do not believe that the trial we have designed will answer the most significant clinical questions, nor that it is feasible to be delivered within the United Kingdom's National Health Service at this current time. ©Paul Sutton, Dale Vimalachandran, Graeme Poston, Stephen Fenwick, Hassan Malik. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.05.2018.

Effect of Fatigue Protocols on Lower Limb Neuromuscular Function and Implications for Anterior Cruciate Ligament Injury Prevention Training: A Systematic Review.

PubMed

Barber-Westin, Sue D; Noyes, Frank R

2017-12-01

Approximately two-thirds of anterior cruciate ligament (ACL) tears are sustained during noncontact situations when an athlete is cutting, pivoting, decelerating, or landing from a jump. Some investigators have postulated that fatigue may result in deleterious alterations in lower limb biomechanics during these activities that could increase the risk of noncontact ACL injuries. However, prior studies have noted a wide variation in fatigue protocols, athletic tasks studied, and effects of fatigue on lower limb kinetics and kinematics. First, to determine if fatigue uniformly alters lower limb biomechanics during athletic tasks that are associated with noncontact ACL injuries. Second, to determine if changes should be made in ACL injury prevention training programs to alter the deleterious effects of fatigue on lower limb kinetics and kinematics. Systematic review; Level of evidence, 4. A systematic review of the literature using MEDLINE was performed. Key terms were fatigue, neuromuscular, exercise, hop test, and single-legged function tests. Inclusion criteria were original research studies involving healthy participants, use of a fatigue protocol, study of at least 1 lower limb task that involved landing from a hop or jump or cutting, and analysis of at least 1 biomechanical variable. Thirty-seven studies involving 806 athletes (485 female, 321 male; mean age, 22.7 years) met the inclusion criteria. General fatigue protocols were used in 20 investigations, peripheral protocols were used in 17 studies, and 21 different athletic tasks were studied (13 single-legged, 8 double-legged). There was no consistency among investigations regarding the effects of fatigue on hip, knee, or ankle joint angles and moments or surface electromyography muscle activation patterns. The fatigue protocols typically did not produce statistically significant changes in ground-reaction forces. Published fatigue protocols did not uniformly produce alterations in lower limb neuromuscular factors that heighten the risk of noncontact ACL injuries. Therefore, justification does not currently exist for major changes in ACL injury prevention training programs to account for potential fatigue effects. However, the effect of fatigue related to ACL injuries is worthy of further investigation, including the refinement of protocols and methods of analysis.

Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study.

PubMed

Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

2017-06-24

The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support-experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. © 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.

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.

PubMed

Dalziel, Stuart R; Furyk, Jeremy; Bonisch, Megan; Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Donath, Susan; Sharpe, Cynthia; Harvey, Simon; Davidson, Andrew; Craig, Simon; Phillips, Natalie; George, Shane; Rao, Arjun; Cheng, Nicholas; Zhang, Michael; Sinn, Kam; Kochar, Amit; Brabyn, Christine; Babl, Franz E

2017-06-22

Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).

Cognitive-Behavioral Therapy for Depression in an Older Gay Man: A Clinical Case Study

PubMed Central

Satterfield, Jason M.; Crabb, Rebecca

2012-01-01

Although strong evidence supports cognitive-behavioral therapy for late-life depression and depression in racial and ethnic minorities, there are no empirical studies on the treatment of depression in older sexual minorities. Three distinct literatures were tapped to create a depression treatment protocol for an older gay male. Interventions were deduced from the late-life depression literature, culturally adapted CBT protocols for racial minorities, and the emerging social and developmental psychological theories for lesbian, gay, and bisexual populations. Specific treatment interventions, processes, and outcomes are described to illustrate how these literatures may be used to provide more culturally appropriate and effective health care for the growing, older sexual minority population. PMID:23144559

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

PubMed

Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

2018-02-02

The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

Anomalous Aortic Origin of Coronary Arteries in the Young: Echocardiographic Evaluation With Surgical Correlation.

PubMed

Lorber, Richard; Srivastava, Shubhika; Wilder, Travis J; McIntyre, Susan; DeCampli, William M; Williams, William G; Frommelt, Peter C; Parness, Ira A; Blackstone, Eugene H; Jacobs, Marshall L; Mertens, Luc; Brothers, Julie A; Herlong, J René

2015-11-01

This study sought to compare findings from institutional echocardiographic reports with imaging core laboratory (ICL) review of corresponding echocardiographic images and operative reports in 159 patients with anomalous aortic origin of a coronary artery (AAOCA). The study also sought to develop a "best practice" protocol for imaging and interpreting images in establishing the diagnosis of AAOCA. AAOCA is associated with sudden death in the young. Underlying anatomic risk factors that can cause ischemia-related events include coronary arterial ostial stenosis, intramural course of the proximal coronary within the aortic wall, interarterial course, and potential compression between the great arteries. Consistent protocols for diagnosing and evaluating these features are lacking, potentially precluding the ability to risk stratify patients based on evidence and plan surgical strategy. For a prescribed set of anatomic AAOCA features, percentages of missing data in institutional echocardiographic reports were calculated. For each feature, agreement among institutional echocardiographic reports, ICL review of images, and surgical reports was evaluated using the weighted kappa statistic. An echocardiographic imaging protocol was developed heuristically to reduce differences between institutional reports and ICL review. A total of 13%, 33%, and 62% of echocardiograms were missing images enabling diagnosis of intra-arterial course, proximal intramural course, and high ostial takeoff, respectively. There was poor agreement between institutional reports and ICL review for diagnosis of origin of coronary artery, interarterial course, intramural course, and acute angle takeoff (kappa = 0.74, 0.11, -0.03, 0.13, respectively). Surgical findings were also significantly different from those of reports, and to a lesser extent ICL reviews. The resulting protocol contains technical recommendations for imaging each of these features. Poor agreement between institutional reports and ICL review for AAOCA suggests need for an imaging protocol to permit evidence-based risk stratification and surgical planning. Even then, delineation of echocardiographic details in AAOCA will remain imperfect. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

PubMed

Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

2017-08-04

Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated. Findings have the potential to improve both jail- and community-based treatment services for adults with CODs as well as inform methods for conducting rigorous pilot implementation and evaluation research in correctional settings and as inmates re-enter the community. Findings will contribute to a growing area of work focused on interrupting the cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among adults with CODs. ClinicalTrials.gov, NCT02214667 . Registered on 10 August 2014.

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.

PubMed

Shamseer, Larissa; Moher, David; Clarke, Mike; Ghersi, Davina; Liberati, Alessandro; Petticrew, Mark; Shekelle, Paul; Stewart, Lesley A

2015-01-02

Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially prompt collaboration. Evidence documenting the existence of selective reporting and excessive duplication of reviews on the same or similar topics is accumulating and many calls have been made in support of the documentation and public availability of review protocols. Several efforts have emerged in recent years to rectify these problems, including development of an international register for prospective reviews (PROSPERO) and launch of the first open access journal dedicated to the exclusive publication of systematic review products, including protocols (BioMed Central's Systematic Reviews). Furthering these efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international group of experts has created a guideline to improve the transparency, accuracy, completeness, and frequency of documented systematic review and meta-analysis protocols--PRISMA-P (for protocols) 2015. The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol.This PRISMA-P 2015 Explanation and Elaboration paper provides readers with a full understanding of and evidence about the necessity of each item as well as a model example from an existing published protocol. This paper should be read together with the PRISMA-P 2015 statement. Systematic review authors and assessors are strongly encouraged to make use of PRISMA-P when drafting and appraising review protocols. © BMJ Publishing Group Ltd 2014.

Hypertension study in anaesthetized rabbits: protocol proposal for AT1 antagonists screening.

PubMed

Politi, Aggeliki P; Zervou, Maria V; Triantafyllidi, Helen; Zoumpoulakis, Panagiotis G; Mavromoustakos, Thomas M; Zoga, Anastasia A; Moutevelis-Minakakis, Panagiota; Kokotos, George; Iliodromitis, Efstathios K; Kremastinos, Dimitris Th

2010-06-01

The aim of this study was to establish an optimized fast and safe protocol for the pharmacological screening of AT(1) antagonists. The pharmaceutical prototype AT(1) antagonist losartan, its active metabolite EXP3174 and the synthetic compound MMK1 were analysed in order to validate the protocol. Ang II was continuously infused while the animals received the drugs in two procedures. In the post-treatment procedure drugs were administered either in a single bolus dose or in a sequential manner. When losartan was administered in a single bolus dose, efficacy was evident until the 7th min (p=0.012) whilst EXP3174 infusion extended the efficiency up to the end of the study (p=0.006). In addition, the sequential injections of losartan prolonged the inhibitory time interval until the end of the study (p=0.045). In the pre-treatment procedure, results suggested a dose-dependent inhibitory effect for both antagonists. The pressor response to Ang II was unchanged after MMK1 administration either in the post- or in the pre-treatment mode. The proposed protocol appears to be safe, simple and fast for the pharmacological screening of AT(1) antagonists and enables the evaluation of new antagonists using lower doses than any other reported in the literature.

The implementation and adherence to evidence-based protocols for psychotherapy for depression: the perspective of therapists in Dutch specialized mental healthcare.

PubMed

Bruijniks, Sanne J E; Franx, Gerdien; Huibers, Marcus J H

2018-06-14

Although psychotherapy is an effective treatment for depression, a large number of patients still do not receive care according to the protocols that are used in clinical trials. Instead, patients often receive a modified version of the original intervention. It is not clear how and when treatment protocols are used or modified in the Dutch specialized mental health care and whether these changes lead to suboptimal adherence to treatment protocols. In the context of an ongoing multicenter trial that investigates whether twice-weekly sessions of protocolized interpersonal psychotherapy (IPT) and cognitive behavioral therapy (CBT) for depression lead to better treatment outcomes compared to once-weekly sessions, two focus groups using semi-structured interviews were organized. Aims were to increase insight in the adherence to and modifications of CBT and IPT protocols in the Dutch specialized mental health care for depression. Participants were fifteen therapists from seven mental health locations part of five mental health organizations. Verbatim transcripts were coded and analyzed using qualitative software. Three themes emerged: modification as the common practice, professional and patient factors influencing the adherence to protocols and organizational boundaries and flexibility. Treatment modification appeared to happen on a frequent basis, even in the context of a trial. Definitions of treatment modifications were multiple and varied from using intuition to flexible use of the same protocol. Therapist training and supervision, the years of work experience and individual characteristics of the therapist and the patient were mentioned to influence the adherence to protocols. Modifications of the therapists depended very much on the culture within the mental health locations, who differed in terms of the flexibility offered to therapists to choose and modify treatment protocols. Not all treatment modifications were in line with existing evidence or guidelines. Regular supervision, team meetings and a shared vision were identified as crucial factors to increase adherence to treatment protocols, whereas additional organizational factors, among which a change of mindset, may facilitate adequate implementation.

A randomized controlled study comparing internet-based cognitive behavioral therapy and counselling by standard care for fear of birth - A study protocol.

PubMed

Ternström, Elin; Hildingsson, Ingegerd; Haines, Helen; Karlström, Annika; Sundin, Örjan; Ekdahl, Johanna; Segeblad, Birgitta; Larsson, Birgitta; Rondung, Elisabet; Rubertsson, Christine

2017-10-01

Fear of birth is a concern that requires evidence based treatment. The aim of this study is to present the protocol of a randomized controlled multi-center trial to compare internet-based cognitive therapy with counseling as standard care for pregnant women reporting fear of birth. Participants will be recruited in mid-pregnancy. Women who score 60 or above on the Fear of Birth Scale will be offered to participate in this study. Data will be collected by questionnaires including validated instruments at baseline and follow-ups at gestational weeks 30 and 36, two months and one year after birth. The primary outcome will be level of fear of birth measured with the Fear of Birth Scale at 36 weeks of gestation. Secondary outcome measures are level of fear of birth at two months and one year after giving birth, preferences for mode of birth, requests for elective cesarean section, compliance and satisfaction with treatment and birth outcomes. A power calculation based on a 20% reduction of fear implies that approximately 200 will be included in the trial. The study outlined in this protocol will be the first randomized controlled trial comparing internet-based cognitive therapy with counseling for women reporting fear of birth. An effective treatment may result in better overall health for women with fear of birth and a reduction in cesarean sections for non-medical reasons. Evidence regarding treatment options of fear of birth will also provide a greater choice for women. Copyright © 2017 Elsevier B.V. All rights reserved.

Virtual reality and cognitive rehabilitation: a review of current outcome research.

PubMed

Larson, Eric B; Feigon, Maia; Gagliardo, Pablo; Dvorkin, Assaf Y

2014-01-01

Recent advancement in the technology of virtual reality (VR) has allowed improved applications for cognitive rehabilitation. The aim of this review is to facilitate comparisons of therapeutic efficacy of different VR interventions. A systematic approach for the review of VR cognitive rehabilitation outcome research addressed the nature of each sample, treatment apparatus, experimental treatment protocol, control treatment protocol, statistical analysis and results. Using this approach, studies that provide valid evidence of efficacy of VR applications are summarized. Applications that have not yet undergone controlled outcome study but which have promise are introduced. Seventeen studies conducted over the past eight years are reviewed. The few randomized controlled trials that have been completed show that some applications are effective in treating cognitive deficits in people with neurological diagnoses although further study is needed. Innovations requiring further study include the use of enriched virtual environments that provide haptic sensory input in addition to visual and auditory inputs and the use of commercially available gaming systems to provide tele-rehabilitation services. Recommendations are offered to improve efficacy of rehabilitation, to improve scientific rigor of rehabilitation research and to broaden access to the evidence-based treatments that this research has identified.

Validating an Observation Protocol to Measure Special Education Teacher Effectiveness

ERIC Educational Resources Information Center

Johnson, Evelyn S.; Semmelroth, Carrie L.

2015-01-01

This study used Kane's (2013) Interpretation/Use Argument (IUA) to measure validity on the Recognizing Effective Special Education Teachers (RESET) observation tool. The RESET observation tool is designed to evaluate special education teacher effectiveness using evidence-based instructional practices as the basis for evaluation. In alignment with…

Student Career Decisions: The Limits of Rationality.

ERIC Educational Resources Information Center

Baumgardner, Steve R.; Rappoport, Leon

This study compares modes of cognitive functioning revealed in student selection of a college major. Students were interviewed in-depth concerning reasons for their choice of majors. Protocol data suggested two distinct modes of thinking were evident on an analytic-intuitive dimension. For operational purposes analytic thinking was defined by…

Secondary cancers among children with acute lymphoblastic leukaemia treated by the Tokyo Children's Cancer Study Group protocols: a retrospective cohort study.

PubMed

Ishida, Yasushi; Maeda, Miho; Urayama, Kevin Y; Kiyotani, Chikako; Aoki, Yuki; Kato, Yoko; Goto, Shoko; Sakaguchi, Sachi; Sugita, Kenichi; Tokuyama, Mika; Nakadate, Naoya; Ishii, Eizaburo; Tsuchida, Masahiro; Ohara, Akira

2014-01-01

With improvement in survival, it is important to evaluate the impact of treatment on secondary cancers in acute lymphoblastic leukaemia (ALL) survivors. A retrospective cohort study comprising 2918 children diagnosed with ALL and enrolled on Tokyo Children's Cancer Study Group (TCCSG) protocols between 1984 and 2005 was conducted to evaluate the incidence of secondary cancers and associated factors including treatment protocol, cranial irradiation and other characteristics of the primary ALL. Thirty-seven patients developed secondary cancers, including acute myeloid leukaemia (n = 11), myelodysplastic syndrome (n = 5), non-Hodgkin lymphoma (n = 2), brain tumours (n = 13) and other solid carcinomas (n = 6) within a median follow-up duration of 9·5 years. The cumulative incidence of any secondary cancers was 1·0% (95% confidence interval (CI), 0·7-1·4%) at 10 years and 2·4% (95% CI, 1·5-3·7%) at 20 years, respectively. Standardized incidence rate ratio of secondary cancers was 9·3 (95% CI, 6·5-12·8). Multivariate analyses showed an increased risk of secondary cancers associated with the recent treatment protocol and cranial irradiation. There was no evidence of a reduction in secondary cancer incidence despite marked decreases in cranial irradiation use in the recent protocols. © 2013 John Wiley & Sons Ltd.

In preparation of the nationwide dissemination of the school-based obesity prevention program DOiT: stepwise development applying the intervention mapping protocol.

PubMed

van Nassau, Femke; Singh, Amika S; van Mechelen, Willem; Brug, Johannes; Chin A Paw, Mai J M

2014-08-01

The school-based Dutch Obesity Intervention in Teenagers (DOiT) program is an evidence-based obesity prevention program. In preparation for dissemination throughout the Netherlands, this study aimed to adapt the initial program and to develop an implementation strategy and materials. We revisited the Intervention Mapping (IM) protocol, using results of the previous process evaluation and additional focus groups and interviews with students, parents, teachers, and professionals. The adapted 2-year DOiT program consists of a classroom, an environmental and a parental component. The year 1 lessons aim to increase awareness and knowledge of healthy behaviors. The lessons in year 2 focus on the influence of the (obesogenic) environment. The stepwise development of the implementation strategy resulted in objectives that support teachers' implementation. We developed a 7-step implementation strategy and supporting materials by translating the objectives into essential elements and practical strategies. This study illustrates how revisiting the IM protocol resulted in an adapted program and tailored implementation strategy based on previous evaluations as well as input from different stakeholders. The stepwise development of DOiT can serve as an example for other evidence-based programs in preparation for wider dissemination. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

A less intensive bracing protocol for pectus carinatum.

PubMed

Wahba, George; Nasr, Ahmed; Bettolli, Marcos

2017-11-01

Despite the widespread use of bracing to correct Pectus carinatum (PC) there is no consensus in the number of hours per day patients are instructed to wear the brace. In our practice, we use a less rigorous protocol of 8-12h/day. We sought to evaluate our results and those in the literature to determine whether more intensive usage is necessary. We reviewed the outcomes of patients with PC treated at our institution between 2012 and 2015. We searched MEDLINE, EMBASE and Web of Science for studies describing the use of bracing to correct PC. Seventy-five patients presented with PC at our institution. Among those who were offered bracing and had adequate follow-up (n=32), the success rate (full correction or improvement) was 90.6%. The compliance rate was 93.8%. Fifteen studies met our inclusion criteria. Our pooled data combining our results with those of other published data showed that less intensive brace usage (<12h/day), when compared to more intensive usage (≥12h/day), is associated with higher patient compliance (89.6% vs. 81.1%) with a similar time to correction (7.3 vs 7.1months) and success rate (85.3% vs. 83.5%). Implementing a less intensive bracing protocol for PC is successful, efficient and improves compliance. Clinical Research. Oxford Centre for Evidence-Based Medicine Level-of-Evidence rating: Level IV. Copyright © 2017 Elsevier Inc. All rights reserved.

Protocol for a systematic review of psychological interventions for cancer-related fatigue in post-treatment cancer survivors.

PubMed

Corbett, Teresa; Devane, Declan; Walsh, Jane C; Groarke, AnnMarie; McGuire, Brian E

2015-12-04

Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. Some evidence has been reported for interventions for fatigue during active treatment. However, to date, there is no systematic review on psychological interventions for fatigue after the completion of curative treatment for cancer. This is a protocol for a systematic review that aims to evaluate the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database. We will search the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and relevant sources of grey literature. Randomised controlled trials (RCTs) which have evaluated psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, will be included. Two review authors will independently extract data from the selected studies and assess the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Most existing evidence on cancer-related fatigue is from those in active cancer treatment. This systematic review and meta-analysis will build upon previous evaluations of psychological interventions in people during and after cancer treatment. With the growing need for stage-specific research in cancer, this review seeks to highlight a gap in current practice and to strengthen the evidence base of randomised controlled trials in the area. PROSPERO CRD42014015219.

Prehospital Care for the Adult and Pediatric Seizure Patient: Current Evidence-based Recommendations.

PubMed

Silverman, Eric C; Sporer, Karl A; Lemieux, Justin M; Brown, John F; Koenig, Kristi L; Gausche-Hill, Marianne; Rudnick, Eric M; Salvucci, Angelo A; Gilbert, Greg H

2017-04-01

We sought to develop evidence-based recommendations for the prehospital evaluation and treatment of adult and pediatric patients with a seizure and to compare these recommendations against the current protocol used by the 33 emergency medical services (EMS) agencies in California. We performed a review of the evidence in the prehospital treatment of patients with a seizure, and then compared the seizure protocols of each of the 33 EMS agencies for consistency with these recommendations. We analyzed the type and route of medication administered, number of additional rescue doses permitted, and requirements for glucose testing prior to medication. The treatment for eclampsia and seizures in pediatric patients were analyzed separately. Protocols across EMS Agencies in California varied widely. We identified multiple drugs, dosages, routes of administration, re-dosing instructions, and requirement for blood glucose testing prior to medication delivery. Blood glucose testing prior to benzodiazepine administration is required by 61% (20/33) of agencies for adult patients and 76% (25/33) for pediatric patients. All agencies have protocols for giving intramuscular benzodiazepines and 76% (25/33) have protocols for intranasal benzodiazepines. Intramuscular midazolam dosages ranged from 2 to 10 mg per single adult dose, 2 to 8 mg per single pediatric dose, and 0.1 to 0.2 mg/kg as a weight-based dose. Intranasal midazolam dosages ranged from 2 to 10 mg per single adult or pediatric dose, and 0.1 to 0.2 mg/kg as a weight-based dose. Intravenous/intrasosseous midazolam dosages ranged from 1 to 6 mg per single adult dose, 1 to 5 mg per single pediatric dose, and 0.05 to 0.1 mg/kg as a weight-based dose. Eclampsia is specifically addressed by 85% (28/33) of agencies. Forty-two percent (14/33) have a protocol for administering magnesium sulfate, with intravenous dosages ranging from 2 to 6 mg, and 58% (19/33) allow benzodiazepines to be administered. Protocols for a patient with a seizure, including eclampsia and febrile seizures, vary widely across California. These recommendations for the prehospital diagnosis and treatment of seizures may be useful for EMS medical directors tasked with creating and revising these protocols.

Do Studies on Cortical Plasticity Provide a Rationale for Using Non-Invasive Brain Stimulation as a Treatment for Parkinson’s Disease Patients?

PubMed Central

Koch, Giacomo

2013-01-01

Animal models of Parkinson’s disease (PD) have shown that key mechanisms of cortical plasticity such as long-term potentiation (LTP) and long-term depression (LTD) can be impaired by the PD pathology. In humans protocols of non-invasive brain stimulation, such as paired associative stimulation (PAS) and theta-burst stimulation (TBS), can be used to investigate cortical plasticity of the primary motor cortex. Through the amplitude of the motor evoked potential these transcranial magnetic stimulation methods allow to measure both LTP-like and LTD-like mechanisms of cortical plasticity. So far these protocols have reported some controversial findings when tested in PD patients. While various studies described evidence for reduced LTP- and LTD-like plasticity, others showed different results, demonstrating increased LTP-like and normal LTD-like plasticity. Recent evidence provided support to the hypothesis that these different patterns of cortical plasticity likely depend on the stage of the disease and on the concomitant administration of l-DOPA. However, it is still unclear how and if these altered mechanisms of cortical plasticity can be taken as a reliable model to build appropriate protocols aimed at treating PD symptoms by applying repetitive sessions of repetitive TMS (rTMS) or transcranial direct current stimulation (tDCS). The current article will provide an up-to-date overview of these issues together with some reflections on future studies in the field. PMID:24223573

Critical examination of evidence for the nutritional status of children in Papua New Guinea - a systematic review.

PubMed

McGlynn, Peter J; Renzaho, Andre μΝ; Pham, Minh D; Toole, Mike; Fisher, Jane; Luchters, Stanley

2018-01-01

Undernutrition remains a significant cause of childhood illness, poor growth, development, and death in Papua New Guinea (PNG). Studies on child nutritional outcomes in PNG vary by design, measurement protocols and quality. We conducted a systematic review to assess the evidence for the prevalence of child undernutrition across different study populations, geographical locations and time periods. Six electronic databases and additional grey literature were searched for articles describing the nutritional status by wasting, stunting and underweight, of PNG children under five years of age, published between 1990 and April 2015. Prevalence data using different scales of measurement and reference populations were standardized according to WHO protocols. The search yielded 566 articles, of which, 31 studies met the inclusion criteria. The prevalence of child undernutrition varied from 1% to 76% for wasting (median 11%), 5% to 92% for stunting (median 51%), and 14% to 59% for underweight (median 32%). Wide variations exist according to the index used for measurement, the population characteristics and the geographical region in which they live. Prevalence estimates increase significantly when data using different scales of measurement and population references are standardized to the WHO protocols. Child undernutrition in PNG is regionally variable due to a complex interplay of poverty, disease, food-security, cultural, environmental and sociopolitical issues requiring a complex mix of solutions by governments, health systems and local communities. Area- specific surveys using multiple measures are necessary to inform local solutions for this important problem.

Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol).

PubMed

Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Sari, Nazmi; Harrison, Liz; Jeffery, Cathy; Kutz, Mareike; Khan, Mohammad F; Flynn, Rachel

2014-09-19

Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer's needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case-control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. PROSPERO CRD42014008853.

Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol)

PubMed Central

2014-01-01

Background Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer’s needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. Methods This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case–control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Discussion Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. Systematic review registration PROSPERO CRD42014008853 PMID:25238974

Effects of transcutaneous electrical nerve stimulation (TENS) on proinflammatory cytokines: protocol for systematic review.

PubMed

Almeida, Tábata Cristina do Carmo; Figueiredo, Francisco Winter Dos Santos; Barbosa Filho, Valter Cordeiro; de Abreu, Luiz Carlos; Fonseca, Fernando Luiz Affonso; Adami, Fernando

2017-07-11

Pain reduction can be achieved by lowering proinflammatory cytokine levels in the blood. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive physiotherapeutic resource for pain management, but evidence on the effectiveness of this device at reducing proinflammatory cytokines in the blood is unclear. This study systematically reviews the literature on the effect of TENS on proinflammatory cytokines. A systematic review protocol was developed based on searches of articles in six electronic databases and references of retrieved articles, contact with authors, and repositories of clinical trials. Eligibility criteria: publication in peer-reviewed journals, randomized clinical trials, use of TENS in the experimental group, and pre- and post-measurements of proinflammatory cytokines in the blood. Selection of the studies and extraction of the data will be carried out by two reviewers independently. Characteristics of the study, participants, interventions and outcomes were extracted and described. Assessments were performed on the risk of bias, level of evidence and the size of the intervention effect in the studies, according to GRADE guidelines and the Cochrane Handbook for Systematic Reviews. Clinical and statistical assessments compared the effects of the interventions (meta-analysis), taking into consideration any influencing characteristics of the studies (e.g., methods and application sites). We anticipate that this review will strengthen evidence-based knowledge of the effect of TENS on proinflammatory cytokines and, as a result, direct new studies to benefit patients with specific pathologies. PROSPERO, CRD42017060379 .

Is there a social gradient of sarcopenia? A meta-analysis and systematic review protocol.

PubMed

Green, Darci; Duque, Gustavo; Fredman, Nick; Rizvi, Aoun; Brennan-Olsen, Sharon Lee

2018-01-13

Sarcopenia (or loss of muscle mass and function) is a relatively new area within the field of musculoskeletal research and medicine. Investigating whether there is a social gradient, including occupation type and income level, of sarcopenia, as observed for other diseases, will contribute significantly to the limited evidence base for this disease. This new information may inform the prevention and management of sarcopenia and widen the evidence base to support existing and future health campaigns. We will conduct a systematic search of the databases PubMed, Ovid, CINAHL, Scopus and EMBASE to identify articles that investigate associations between social determinants of health and sarcopenia in adults aged 50 years and older. Eligibility of the selected studies will be determined by two independent reviewers. The methodological quality of eligible studies will be assessed according to predetermined criteria. Established statistical methods to identify and control for heterogeneity will be used, and where appropriate, we will conduct a meta-analysis. In the event that heterogeneity prevents numerical synthesis, a best evidence analysis will be employed. This systematic review protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols reporting guidelines and will be registered with the International Prospective Register of Systematic Reviews (PROSPERO). This systematic review will use published data, thus ethical permissions will not be required. In addition to peer-reviewed publication, our results will be presented at (inter)national conferences relevant to the field of sarcopenia, ageing and/or musculoskeletal health and disseminated both electronically and in print. CRD42017072253. © 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.

Pediatric Burn Reconstruction: Focus on Evidence.

PubMed

Fisher, Mark

2017-10-01

In this article, the author surveys the best available evidence to guide decision-making in pediatric burn reconstruction. Evidence-based protocols are examined in the context of optimizing form and function in children who have sustained burn injury. Copyright © 2017 Elsevier Inc. All rights reserved.

Interventions for the prevention of cardiovascular diseases: a protocol for a systematic review of economic evaluations in low-income and middle-income countries.

PubMed

Aminde, Leopold Ndemnge; Veerman, Lennert

2016-12-21

Low-income and middle-income countries (LMICs) are experiencing a growing disease burden due to cardiovascular and other chronic non-communicable diseases. Interventions for the control of these diseases are paramount; however, these countries are faced with competing health and financial needs. There is an urgent need for quality evidence on cost-effective strategies to address these chronic diseases. We aim to synthesise the current literature on economic evaluations of interventions for primary and secondary cardiovascular disease prevention in LMICs. A systematic review of studies (published and unpublished) in LMICs up to 30 October 2016 will be conducted. The following databases will be searched: PubMed/MEDLINE, EMBASE, SCOPUS, CINAHL, Web of Science, EconLit, NHS Economic Evaluations Database (NHS EED). Data sources specific to African literature, such as the WHO AFROLIB, Africa Index Medicus and African Journals online (AJOL) as well as grey literature, will also be searched. 2 reviewers shall independently screen potential articles for inclusion and disagreements shall be resolved by consensus. Quality appraisal of studies shall be done using Drummond's checklist for economic evaluation of studies. A descriptive synthesis of the evidence obtained is planned. The primary outcomes will be costs per life years gained or unit of clinical outcome, cost per quality-adjusted life years or disability-adjusted life years. This systematic review protocol has been prepared according to the Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols (PRISMA-P) 2015 statement. Ethics approval is not required considering that this is a protocol for a systematic review of published studies. Results from this review will be disseminated via conference presentations and peer-reviewed journal publications. CRD42016043510. 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/.

An evaluation of two large scale demand side financing programs for maternal health in India: the MATIND study protocol.

PubMed

Sidney, Kristi; de Costa, Ayesha; Diwan, Vishal; Mavalankar, Dileep V; Smith, Helen

2012-08-27

High maternal mortality in India is a serious public health challenge. Demand side financing interventions have emerged as a strategy to promote access to emergency obstetric care. Two such state run programs, Janani Suraksha Yojana (JSY)and Chiranjeevi Yojana (CY), were designed and implemented to reduce financial access barriers that preclude women from obtaining emergency obstetric care. JSY, a conditional cash transfer, awards money directly to a woman who delivers in a public health facility. This will be studied in Madhya Pradesh province. CY, a voucher based program, empanels private obstetricians in Gujarat province, who are reimbursed by the government to perform deliveries of socioeconomically disadvantaged women. The programs have been in operation for the last seven years. The study outlined in this protocol will assess and compare the influence of the two programs on various aspects of maternal health care including trends in program uptake, institutional delivery rates, maternal and neonatal outcomes, quality of care, experiences of service providers and users, and cost effectiveness. The study will collect primary data using a combination of qualitative and quantitative methods, including facility level questionnaires, observations, a population based survey, in-depth interviews, and focus group discussions. Primary data will be collected in three districts of each province. The research will take place at three levels: the state health departments, obstetric facilities in the districts and among recently delivered mothers in the community. The protocol is a comprehensive assessment of the performance and impact of the programs and an economic analysis. It will fill existing evidence gaps in the scientific literature including access and quality to services, utilization, coverage and impact. The implementation of the protocol will also generate evidence to facilitate decision making among policy makers and program managers who currently work with or are planning similar programs in different contexts.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence

PubMed Central

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-01-01

Introduction Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. Methods and analysis A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in ‘patient safety’ and ‘economic analyses’ has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. Trial registration number CRD42017057853. PMID:28821527

The effects of sweep numbers per average and protocol type on the accuracy of the p300-based concealed information test.

PubMed

Dietrich, Ariana B; Hu, Xiaoqing; Rosenfeld, J Peter

2014-03-01

In the first of two experiments, we compared the accuracy of the P300 concealed information test protocol as a function of numbers of trials experienced by subjects and ERP averages analyzed by investigators. Contrary to Farwell et al. (Cogn Neurodyn 6(2):115-154, 2012), we found no evidence that 100 trial based averages are more accurate than 66 or 33 trial based averages (all numbers led to accuracies of 84-94 %). There was actually a trend favoring the lowest trial numbers. The second study compared numbers of irrelevant stimuli recalled and recognized in the 3-stimulus protocol versus the complex trial protocol (Rosenfeld in Memory detection: theory and application of the concealed information test, Cambridge University Press, New York, pp 63-89, 2011). Again, in contrast to expectations from Farwell et al. (Cogn Neurodyn 6(2):115-154, 2012), there were no differences between protocols, although there were more irrelevant stimuli recognized than recalled, and irrelevant 4-digit number group stimuli were neither recalled nor recognized as well as irrelevant city name stimuli. We therefore conclude that stimulus processing in the P300-based complex trial protocol-with no more than 33 sweep averages-is adequate to allow accurate detection of concealed information.

A privacy preserving protocol for tracking participants in phase I clinical trials.

PubMed

El Emam, Khaled; Farah, Hanna; Samet, Saeed; Essex, Aleksander; Jonker, Elizabeth; Kantarcioglu, Murat; Earle, Craig C

2015-10-01

Some phase 1 clinical trials offer strong financial incentives for healthy individuals to participate in their studies. There is evidence that some individuals enroll in multiple trials concurrently. This creates safety risks and introduces data quality problems into the trials. Our objective was to construct a privacy preserving protocol to track phase 1 participants to detect concurrent enrollment. A protocol using secure probabilistic querying against a database of trial participants that allows for screening during telephone interviews and on-site enrollment was developed. The match variables consisted of demographic information. The accuracy (sensitivity, precision, and negative predictive value) of the matching and its computational performance in seconds were measured under simulated environments. Accuracy was also compared to non-secure matching methods. The protocol performance scales linearly with the database size. At the largest database size of 20,000 participants, a query takes under 20s on a 64 cores machine. Sensitivity, precision, and negative predictive value of the queries were consistently at or above 0.9, and were very similar to non-secure versions of the protocol. The protocol provides a reasonable solution to the concurrent enrollment problems in phase 1 clinical trials, and is able to ensure that personal information about participants is kept secure. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Minimization of Hypoglycemia as an Adverse Event During Insulin Infusion: Further Refinement of the Yale Protocol.

PubMed

Marvin, Michael R; Inzucchi, Silvio E; Besterman, Brian J

2016-08-01

The management of hyperglycemia in the intensive care unit has been a controversial topic for more than a decade, with target ranges varying from 80-110 mg/dL to <200 mg/dL. Multiple insulin infusion protocols exist, including several computerized protocols, which have attempted to achieve these targets. Importantly, compliance with these protocols has not been a focus of clinical studies. GlucoCare™, a Food and Drug Administration (FDA)-cleared insulin-dosing calculator, was originally designed based on the Yale Insulin Infusion Protocol to target 100-140 mg/dL and has undergone several modifications to reduce hypoglycemia. The original Yale protocol was modified from 100-140 mg/dL to a range of 120-140 mg/dL (GlucoCare 120-140) and then to 140 mg/dL (GlucoCare 140, not a range but a single blood glucose [BG] level target) in an iterative and evidence-based manner to eliminate hypoglycemia <70 mg/dL. The final modification [GlucoCare 140(B)] includes the addition of bolus insulin "midprotocol" during an insulin infusion to reduce peak insulin rates for insulin-resistant patients. This study examined the results of these protocol modifications and evaluated the role of compliance with the protocol in the incidence of hypoglycemia <70 mg/dL. Protocol modifications resulted in mean BG levels of 133.4, 136.4, 143.8, and 146.4 mg/dL and hypoglycemic BG readings <70 mg/dL of 0.998%, 0.367%, 0.256%, and 0.04% for the 100-140, 120-140, 140, and 140(B) protocols, respectively (P < 0.001). Adherence to the glucose check interval significantly reduced the incidence of hypoglycemia (P < 0.001). Protocol modifications led to a reduction in peak insulin infusion rates (P < 0.001) and the need for dextrose-containing boluses (P < 0.001). This study demonstrates that refinements in protocol design can improve glucose control in critically ill patients and that the use of GlucoCare 140(B) can eliminate all significant hypoglycemia while achieving mean glucose levels between 140 and 150 mg/dL. In addition, attention to the timely performance of glucose levels can also reduce hypoglycemic events.

Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger.

PubMed

Scherer, Andrea G; White, Ian K; Shaikh, Kashif A; Smith, Jodi L; Ackerman, Laurie L; Fulkerson, Daniel H

2017-07-01

OBJECTIVE The risk of venous thromboembolism (VTE) from deep venous thrombosis (DVT) is significant in neurosurgical patients. VTE is considered a leading cause of preventable hospital deaths and preventing DVT is a closely monitored quality metric, often tied to accreditation, hospital ratings, and reimbursement. Adult protocols include prophylaxis with anticoagulant medications. Children's hospitals may adopt adult protocols, although the incidence of DVT and the risk or efficacy of treatment is not well defined. The incidence of DVT in children is likely less than in adults, although there is very little prospectively collected information. Most consider the risk of DVT to be extremely low in children 12 years of age or younger. However, this consideration is based on tradition and retrospective reviews of trauma databases. In this study, the authors prospectively evaluated pediatric patients undergoing a variety of elective neurosurgical procedures and performed Doppler ultrasound studies before and after surgery. METHODS A total of 100 patients were prospectively enrolled in this study. All of the patients were between the ages of 1 month and 12 years and were undergoing elective neurosurgical procedures. The 91 patients who completed the protocol received a bilateral lower-extremity Doppler ultrasound examination within 48 hours prior to surgery. Patients did not receive either medical or mechanical DVT prophylaxis during or after surgery. The ultrasound examination was repeated within 72 hours after surgery. An independent, board-certified radiologist evaluated all sonograms. We prospectively collected data, including potential risk factors, details of surgery, and details of the clinical course. All patients were followed clinically for at least 1 year. RESULTS There was no clinical or ultrasound evidence of DVT or VTE in any of the 91 patients. There was no clinical evidence of VTE in the 9 patients who did not complete the protocol. CONCLUSIONS In this prospective study, no DVTs were found in 91 patients evaluated by ultrasound and 9 patients followed clinically. While the study is underpowered to give a definitive incidence, the data suggest that the risk of DVT and VTE is very low in children undergoing elective neurosurgical procedures. Prophylactic protocols designed for adults may not apply to pediatric patients. Clinical trial registration no.: NCT02037607 (clinicaltrials.gov).

A comparison of sennosides-based bowel protocols with and without docusate in hospitalized patients with cancer.

PubMed

Hawley, Philippa Helen; Byeon, Jai Jun

2008-05-01

Constipation is a common and distressing condition in patients with cancer, especially those taking opioid analgesics. Many institutions prevent and treat constipation with titrated laxatives, which is known as a bowel protocol. An effective and well-tolerated bowel protocol is a very important component of cancer care, and there is little evidence on which to base selection of the most appropriate agents. This study compares a protocol of the stimulant laxative sennosides alone with a protocol of sennosides plus the stool softener docusate, in hospitalized patients at an oncology center. The docusate-containing protocol had an initial docusate-only step for patients not taking opioids, and four to six 100-mg capsules of docusate sodium in addition to the sennosides for the rest of the protocol. Thirty patients received the sennosides-only (S) protocol and 30 the sennosides plus docusate (DS) protocol. The efficacy and adverse effects of the protocols were monitored for 5-12 days. The two protocols were used sequentially, creating two cohorts, one on each protocol. Eighty percent of patients were taking oral opioids and 72% were admitted for symptom control/supportive care. Over a total of 488 days of observation it was found that the S protocol produced more bowel movements than the DS protocol, and in the symptom control/supportive care patients this difference was statistically significant (p < 0.05). In the S group admitted for symptom control/supportive care 62.5% had a bowel movement more than 50% of days, as compared with 32% in those receiving the DS protocol. Fifty-seven percent of the DS group required additional interventions (lactulose, suppositories or enemas) compared to 40% in the S group. Cramps were reported equally by 3 (10%) patients in each group. Eight patients (27%) experienced diarrhea in the S group compared to 4 (13%) in the DS group. The addition of the initial docusate-only step and adding docusate 400-600 mg/d to the sennosides did not reduce bowel cramps, and was less effective in inducing laxation than the sennosides-only protocol. Further research into the appropriate use of docusate and into the details of bowel protocol design are required.

Variability of United States Online Rehabilitation Protocols for Proximal Hamstring Tendon Repair.

PubMed

Lightsey, Harry M; Kantrowitz, David E; Swindell, Hasani W; Trofa, David P; Ahmad, Christopher S; Lynch, T Sean

2018-02-01

The optimal postoperative rehabilitation protocol following repair of complete proximal hamstring tendon ruptures is the subject of ongoing investigation, with a need for more standardized regimens and evidence-based modalities. To assess the variability across proximal hamstring tendon repair rehabilitation protocols published online by United States (US) orthopaedic teaching programs. Cross-sectional study. Online proximal hamstring physical therapy protocols from US academic orthopaedic programs were reviewed. A web-based search using the search term complete proximal hamstring repair rehabilitation protocol provided an additional 14 protocols. A comprehensive scoring rubric was developed after review of all protocols and was used to assess each protocol for both the presence of various rehabilitation components and the point at which those components were introduced. Of 50 rehabilitation protocols identified, 35 satisfied inclusion criteria and were analyzed. Twenty-five protocols (71%) recommended immediate postoperative bracing: 12 (34%) prescribed knee bracing, 8 (23%) prescribed hip bracing, and 5 (14%) did not specify the type of brace recommended. Fourteen protocols (40%) advised immediate nonweightbearing with crutches, while 16 protocols (46%) permitted immediate toe-touch weightbearing. Advancement to full weightbearing was allowed at a mean of 7.1 weeks (range, 4-12 weeks). Most protocols (80%) recommended gentle knee and hip passive range of motion and active range of motion, starting at a mean 1.4 weeks (range, 0-3 weeks) and 4.0 weeks (range, 0-6 weeks), respectively. However, only 6 protocols (17%) provided specific time points to initiate full hip and knee range of motion: a mean 8.0 weeks (range, 4-12 weeks) and 7.8 weeks (range, 0-12 weeks), respectively. Considerable variability was noted in the inclusion and timing of strengthening, stretching, proprioception, and cardiovascular exercises. Fifteen protocols (43%) required completion of specific return-to-sport criteria before resuming training. Marked variability is found in both the composition and timing of rehabilitation components across the various complete proximal hamstring repair rehabilitation protocols published online. This finding mirrors the variability of proposed rehabilitation protocols in the professional literature and represents an opportunity to improve patient care.

A Pilot Systematic Review and Meta-Analysis on the Effectiveness of Problem Based Learning.

ERIC Educational Resources Information Center

Newman, Mark

This paper reports on the development and piloting of a systematic review and meta analysis of research on the effectiveness of problem based learning (PBL). The systematic review protocol was pilot tested with a sample of studies cited as providing "evidence" about the effectiveness of PBL. From the 5 studies mentioned in the sample of reviews,…

Collaborating with community-based services to promote evidence-based practice: Process description of a national initiative to improve services for youth with mental health and substance use problems.

PubMed

Henderson, Joanna L; Chaim, Gloria; Brownlie, E B

2017-08-01

Many youth with significant mental health (MH) and/or substance use (SU) difficulties do not receive specialized services. Collaboration between service providers, researchers, and other stakeholders is essential to improve youth service system capacity to provide evidence-based services to meet the complex array of needs of youth. Facilitators and barriers of implementing evidence-based practice have been identified, but few studies provide examples of the processes of collaboration and implementation for youth MH services. This study explicates the design features and implementation processes of a project to improve screening activities in youth services. These processes supported the building of 16 collaborative networks of service providers from diverse youth-serving sectors (e.g., MH, youth justice, child welfare) in urban, rural, suburban, and remote Canadian communities. These cross-sectoral networks implemented an evidence-based practice (screening youth aged 12-24 years for MH and SU problems using the Global Assessment of Individual Needs-Short Screener [GAIN-SS]) across their services. Materials and resources were provided by a centralized research team. Core project components were standardized and adherence to these components was monitored. Over 800 service providers participated in cross-sectoral networks, capacity-building events, joint data analysis, or interpretation and recommendation sessions. Across the 89 participating agencies, service providers for 84% of participating youth implemented the evidence-based practice accurately in accordance with project protocols, with 98% of positive screens reviewed and addressed according to organizational protocols. Service provider feedback is reported. Facilitators, barriers, and implications of promoting implementation of evidence-based practices across sites and sectors are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A realistic evaluation: the case of protocol-based care

PubMed Central

2010-01-01

Background 'Protocol based care' was envisioned by policy makers as a mechanism for delivering on the service improvement agenda in England. Realistic evaluation is an increasingly popular approach, but few published examples exist, particularly in implementation research. To fill this gap, within this paper we describe the application of a realistic evaluation approach to the study of protocol-based care, whilst sharing findings of relevance about standardising care through the use of protocols, guidelines, and pathways. Methods Situated between positivism and relativism, realistic evaluation is concerned with the identification of underlying causal mechanisms, how they work, and under what conditions. Fundamentally it focuses attention on finding out what works, for whom, how, and in what circumstances. Results In this research, we were interested in understanding the relationships between the type and nature of particular approaches to protocol-based care (mechanisms), within different clinical settings (context), and what impacts this resulted in (outcomes). An evidence review using the principles of realist synthesis resulted in a number of propositions, i.e., context, mechanism, and outcome threads (CMOs). These propositions were then 'tested' through multiple case studies, using multiple methods including non-participant observation, interviews, and document analysis through an iterative analysis process. The initial propositions (conjectured CMOs) only partially corresponded to the findings that emerged during analysis. From the iterative analysis process of scrutinising mechanisms, context, and outcomes we were able to draw out some theoretically generalisable features about what works, for whom, how, and what circumstances in relation to the use of standardised care approaches (refined CMOs). Conclusions As one of the first studies to apply realistic evaluation in implementation research, it was a good fit, particularly given the growing emphasis on understanding how context influences evidence-based practice. The strengths and limitations of the approach are considered, including how to operationalise it and some of the challenges. This approach provided a useful interpretive framework with which to make sense of the multiple factors that were simultaneously at play and being observed through various data sources, and for developing explanatory theory about using standardised care approaches in practice. PMID:20504293

Developing a guideline for clinical trial protocol content: Delphi consensus survey

PubMed Central

2012-01-01

Background Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols. Methods Panellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance) and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages. Results Ninety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater), 13 of moderate importance (median 6 or 7) and 12 of low importance (median less than or equal to 5) for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions. Conclusions This Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of a guideline for protocol content. PMID:23006145

Implementing clinical protocols in oncology: quality gaps and the learning curve phenomenon.

PubMed

Kedikoglou, Simos; Syrigos, Konstantinos; Skalkidis, Yannis; Ploiarchopoulou, Fani; Dessypris, Nick; Petridou, Eleni

2005-08-01

The quality improvement effort in clinical practice has focused mostly on 'performance quality', i.e. on the development of comprehensive, evidence-based guidelines. This study aimed to assess the 'conformance quality', i.e. the extent to which guidelines once developed are correctly and consistently applied. It also aimed to assess the existence of quality gaps in the treatment of certain patient segments as defined by age or gender and to investigate methods to improve overall conformance quality. A retrospective audit of clinical practice in a well-defined oncology setting was undertaken and the results compared to those obtained from prospectively applying an internally developed clinical protocol in the same setting and using specific tools to increase conformance quality. All indicators showed improvement after the implementation of the protocol that in many cases reached statistical significance, while in the entire cohort advanced age was associated (although not significantly) with sub-optimal delivery of care. A 'learning curve' phenomenon in the implementation of quality initiatives was detected, with all indicators improving substantially in the second part of the prospective study. Clinicians should pay separate attention to the implementation of chosen protocols and employ specific tools to increase conformance quality in patient care.

Interdisciplinary collaboration in the use of a music-with-movement intervention to promote the wellbeing of people with dementia and their families: Development of an evidence-based intervention protocol.

PubMed

Lai, Claudia K Y; Lai, Daniel L L; Ho, Jacqueline S C; Wong, Kitty K Y; Cheung, Daphne S K

2016-03-01

The music-with-movement intervention is particularly suitable for people with dementia because their gross motor ability is preserved until the later stage of dementia. This study examines the effect of music-with-movement on reducing anxiety, sleep disturbances, and improving the wellbeing of people with dementia. This paper reports the first stage of the study - developing the intervention protocol that staff can use to teach family caregivers. A registered music therapist developed a music-with-movement protocol and taught staff of two social service centers over five weekly 1.5 h sessions, with center-in-charges (social workers and occupational therapists) and our research team joining these sessions to provide comments from their professional perspective. Each discipline had different expectations about the content; therefore, numerous meetings and discussions were held to bridge these differences and fine-tune the protocol. Few healthcare professionals doubt the merits of interdisciplinary collaboration at all levels of health promotion. In practice, interdisciplinary collaboration is complex and requires commitment. Openness and persistence is required from all stakeholders to achieve a successful intervention for consumers. © 2015 Wiley Publishing Asia Pty Ltd.

Components of Effective Cognitive-Behavioral Therapy for Pediatric Headache: A Mixed Methods Approach

PubMed Central

Law, Emily F.; Beals-Erickson, Sarah E.; Fisher, Emma; Lang, Emily A.; Palermo, Tonya M.

2017-01-01

Internet-delivered treatment has the potential to expand access to evidence-based cognitive-behavioral therapy (CBT) for pediatric headache, and has demonstrated efficacy in small trials for some youth with headache. We used a mixed methods approach to identify effective components of CBT for this population. In Study 1, component profile analysis identified common interventions delivered in published RCTs of effective CBT protocols for pediatric headache delivered face-to-face or via the Internet. We identified a core set of three treatment components that were common across face-to-face and Internet protocols: 1) headache education, 2) relaxation training, and 3) cognitive interventions. Biofeedback was identified as an additional core treatment component delivered in face-to-face protocols only. In Study 2, we conducted qualitative interviews to describe the perspectives of youth with headache and their parents on successful components of an Internet CBT intervention. Eleven themes emerged from the qualitative data analysis, which broadly focused on patient experiences using the treatment components and suggestions for new treatment components. In the Discussion, these mixed methods findings are integrated to inform the adaptation of an Internet CBT protocol for youth with headache. PMID:29503787

Components of Effective Cognitive-Behavioral Therapy for Pediatric Headache: A Mixed Methods Approach.

PubMed

Law, Emily F; Beals-Erickson, Sarah E; Fisher, Emma; Lang, Emily A; Palermo, Tonya M

2017-01-01

Internet-delivered treatment has the potential to expand access to evidence-based cognitive-behavioral therapy (CBT) for pediatric headache, and has demonstrated efficacy in small trials for some youth with headache. We used a mixed methods approach to identify effective components of CBT for this population. In Study 1, component profile analysis identified common interventions delivered in published RCTs of effective CBT protocols for pediatric headache delivered face-to-face or via the Internet. We identified a core set of three treatment components that were common across face-to-face and Internet protocols: 1) headache education, 2) relaxation training, and 3) cognitive interventions. Biofeedback was identified as an additional core treatment component delivered in face-to-face protocols only. In Study 2, we conducted qualitative interviews to describe the perspectives of youth with headache and their parents on successful components of an Internet CBT intervention. Eleven themes emerged from the qualitative data analysis, which broadly focused on patient experiences using the treatment components and suggestions for new treatment components. In the Discussion, these mixed methods findings are integrated to inform the adaptation of an Internet CBT protocol for youth with headache.

GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type.

PubMed

Lambalk, C B; Banga, F R; Huirne, J A; Toftager, M; Pinborg, A; Homburg, R; van der Veen, F; van Wely, M

2017-09-01

Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist was not the only variable between the compared study arms. The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. The Cochrane Menstrual Disorders and Subfertility Review Group specialized register of controlled trials and Pubmed and Embase databases were searched from inception until June 2016. Eligible trials were those that compared GnRH antagonist protocols and standard long GnRH agonist protocols in couples undergoing IVF or ICSI. The primary outcome was ongoing pregnancy rate. Secondary outcomes were: live birth rate, clinical pregnancy rate, number of oocytes retrieved and safety with regard to ovarian hyperstimulation syndrome (OHSS). Separate comparisons were performed for the general IVF population, women with PCOS and women with poor ovarian response. Pre-planned subgroup analyses were performed for various antagonist treatment schedules. We included 50 studies. Of these, 34 studies reported on general IVF patients, 10 studies reported on PCOS patients and 6 studies reported on poor responders. In general IVF patients, ongoing pregnancy rate was significantly lower in the antagonist group compared with the agonist group (RR 0.89, 95% CI 0.82-0.96). In women with PCOS and in women with poor ovarian response, there was no evidence of a difference in ongoing pregnancy between the antagonist and agonist groups (RR 0.97, 95% CI 0.84-1.11 and RR 0.87, 95% CI 0.65-1.17, respectively). Subgroup analyses for various antagonist treatment schedules compared to the long protocol GnRH agonist showed a significantly lower ongoing pregnancy rate when the oral hormonal programming pill (OHP) pretreatment was combined with a flexible protocol (RR 0.74, 95% CI 0.59-0.91) while without OHP, the RR was 0.84, 95% CI 0.71-1.0. Subgroup analysis for the fixed antagonist schedule demonstrated no evidence of a significant difference with or without OHP (RR 0.94, 95% CI 0.79-1.12 and RR 0.94, 95% CI 0.83-1.05, respectively). Antagonists resulted in significantly lower OHSS rates both in the general IVF patients and in women with PCOS (RR 0.63, 95% CI 0.50-0.81 and RR 0.53, 95% CI 0.30-0.95, respectively). No data on OHSS was available from trials in poor responders. In a general IVF population, GnRH antagonists are associated with lower ongoing pregnancy rates when compared to long protocol agonists, but also with lower OHSS rates. Within this population, antagonist treatment prevents one case of OHSS in 40 patients but results in one less ongoing pregnancy out of every 28 women treated. Thus standard use of the long GnRH agonist treatment is perhaps still the approach of choice for prevention of premature luteinization. In couples with PCOS and poor responders, GnRH antagonists do not seem to compromise ongoing pregnancy rates and are associated with less OHSS and therefore could be considered as standard treatment. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Evaluation of an adult insulin infusion protocol at an academic medical center.

PubMed

Petrov, Katerina I; Burns, Tammy L; Drincic, Andjela

2012-05-01

Acknowledging evidence of possible detrimental effects of tightly controlled blood glucose levels, the American Association of Clinical Endocrinologists and the American Diabetes Association published a consensus statement recommending less strict control for most diabetic patients. As a result of these recommendations, our academic center at Creighton University Medical Center revised its adult insulin infusion protocol to target blood glucose levels ranging from 120 to 180 mg/dL for regular (standard) glycemic control and 80 to 120 mg/dL for tight control; previous targets had ranged from 80 to 180 mg/dL and 70 to 110 mg/dL, respectively. The primary objective was to evaluate the time that blood glucose values were within the target range for patients receiving the new protocol, compared with patients receiving the previous protocol. Our study was designed to evaluate the effectiveness and safety of the revised protocol. Using a retrospective chart review, we collected data for 4 months from patients on the old insulin protocol (May to August 2009) and for 4 months from patients on the new protocol (September to December 2009). Secondary endpoints included the number of hypoglycemic episodes (blood glucose below 70 mg/dL) and severe hypoglycemic episodes (blood glucose 40 mg/dL or lower) experienced by patients receiving the new insulin protocol compared with those receiving the former protocol. Patient characteristics were similar at baseline. Blood glucose values stayed within the target range for a significantly shorter time with the new protocol than with the former protocol (44.6% vs. 56.8%, respectively; P < 0.001), probably because of the narrower target range in the revised protocol. No statistically significant differences in hypoglycemia were observed after the protocol was changed. Hypoglycemia occurred in 31% of the former-protocol patients compared with 18% of the revised-protocol patients. Severe hypoglycemia was experienced by 2.1% of patients on the old protocol and by 3.1% of patients on the new protocol. Rates of severe hypoglycemia were low (2.6%) with the original protocol. Patients' blood glucose levels were within the target range for a shorter time with the new protocol. Fewer episodes of hypoglycemia were recorded with the new protocol, but rates of severe hypoglycemia were similar with both protocols.

Systematic review of whole body vibration exercises in the treatment of cerebral palsy: Brief report.

PubMed

Sá-Caputo, Danúbia C; Costa-Cavalcanti, Rebeca; Carvalho-Lima, Rafaelle P; Arnóbio, Adriano; Bernardo, Raquel M; Ronikeile-Costa, Pedro; Kutter, Cristiane; Giehl, Paula M; Asad, Nasser R; Paiva, Dulciane N; Pereira, Heloisa V F S; Unger, Marianne; Marin, Pedro J; Bernardo-Filho, Mario

2016-10-01

Whole body vibration (WBV) is increasingly being used to improve balance and motor function and reduce the secondary complications associated with cerebral palsy (CP). The purpose of this study was to systematically appraise published research regarding the effects of static and/or dynamic exercise performed on a vibrating platform on gait, strength, spasticity and bone mineral density (BMD) within this population. Systematic searches of six electronic databases identified five studies that met our inclusion criteria (2 at Level II and 3 at Level III-2). Studies were analysed to determine: (a) participant characteristics; (b) optimal exercise and WBV treatment protocol; (c) effect on gait, strength, spasticity and BMD; and (d) the outcome measures used to evaluate effect. As data was not homogenous a meta-analysis was not possible. Several design limitations were identified and intervention protocols are poorly described. The effects on strength, gait, spasticity and BMD in persons with CP remain inconclusive with weak evidence that WBV may improve selected muscle strength and gait parameters and that prolonged exposure may improve BMD; there is currently no evidence that WBV can reduce spasticity. The evidence for exercise performed on a vibrating platform on mobility, strength, spasticity and BMD in CP remains scant and further larger scale investigations with controlled parameters to better understand the effects of WBV exercises in this population is recommended.

Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Colorectal Surgery.

PubMed

Ban, Kristen A; Gibbons, Melinda M; Ko, Clifford Y; Wick, Elizabeth C; Cannesson, Maxime; Scott, Michael J; Grant, Michael C; Wu, Christopher L

2018-04-11

The Agency for Healthcare Research and Quality, in partnership with the American College of Surgeons and the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, has developed the Safety Program for Improving Surgical Care and Recovery (ISCR), which is a national effort to disseminate best practices in perioperative care to more than 750 hospitals across multiple procedures in the next 5 years. The program will integrate evidence-based processes central to enhanced recovery and prevention of surgical site infection, venous thromboembolic events, catheter-associated urinary tract infections with socioadaptive interventions to improve surgical outcomes, patient experience, and perioperative safety culture. The objectives of this review are to evaluate the evidence supporting anesthesiology components of colorectal (CR) pathways and to develop an evidence-based CR protocol for implementation. Anesthesiology protocol components were identified through review of existing CR enhanced recovery pathways from several professional associations/societies and expert feedback. These guidelines/recommendations were supplemented by evidence made further literature searches. Anesthesiology protocol components were identified spanning the immediate preoperative, intraoperative, and postoperative phases of care. Components included carbohydrate loading, reduced fasting, multimodal preanesthesia medication, antibiotic prophylaxis, blood transfusion, intraoperative fluid management/goal-directed fluid therapy, normothermia, a standardized intraoperative anesthesia pathway, and standard postoperative multimodal analgesic regimens.

A Comparison of More and Less Aggressive Bone Debridement Protocols for the Treatment of Open Supracondylar Femur Fractures

PubMed Central

Ricci, William M.; Collinge, Cory; Streubel, Philipp N.; McAndrew, Christopher M.; Gardner, Michael J.

2014-01-01

Objectives This study compared results of aggressive and nonaggressive debridement protocols for the treatment of high energy open supracondylar femur fractures after the primary procedure, with respect to the requirement for secondary bone grafting procedures, and deep infection. Design Retrospective review Setting Level I and Level II Trauma Centers Patients/Participants Twenty-nine consecutive patients with high grade open (Gustilo Types II and III) supracondylar femur fractures (OTA/AO 33A and C) treated with debridement and locked plating. Intervention Surgeons at two different Level I trauma centers had different debridement protocols for open supracondylar femur fractures. One center used a More Aggressive (MA)protocol in their patients (n=17) that included removal of all devitalized bone and placement of antibiotic cement spacers to fill large segmental defects. The other center used a Less Aggressive (LA) protocol in their patients (n=12) that included debridement of grossly contaminated bone with retention of other bone fragments and no use of antibiotic cement spacers. All other aspects of the treatment protocol at the two centers were similar: definitive fixation with locked plates in all cases; IV antibiotics were used until definitive wound closure; and weight bearing was advanced upon clinical and radiographic evidence of fracture healing. Main Outcome Measurements Healing after the primary procedure, requirement for secondary bone grafting procedures, and the presence of deep infection. Results Demographics were similar between included patients at each center with regard to: age; gender; rate of open fractures; open fracture classification; mechanism; and smoking (p>.05). Patients at the MA center were more often diabetic (p<.05).Cement spacers to fill segmental defects were used more often after MA debridement (35% vs 0%, p<0.006) and more patients had a plan for staged bone grafting after MA debridement (71% vs 8%, p<0.006). Healing after the index fixation procedure occurred more often after LA debridement (92% vs 35%, p<0.003). There was no difference in infection rate between the two protocols: 25% with the LA protocol; and 18% with the MA protocol, (p=0.63). All patients in both groups eventually healed and were without evidence of infection at an average of 1.8 years of follow-up. Conclusion The degree to which bone should be debrided after a high energy, high grade, open supracondylar femur fracture is a matter of surgeon judgment and falls along a continuous spectrum. Based on the results of the current study, the theoretic tradeoff between infection risk and osseous healing potential, seems to favor a less aggressive approach towards bone debridement in the initial treatment. PMID:23760177

A comparison of more and less aggressive bone debridement protocols for the treatment of open supracondylar femur fractures.

PubMed

Ricci, William M; Collinge, Cory; Streubel, Philipp N; McAndrew, Christopher M; Gardner, Michael J

2013-12-01

This study compared results of aggressive and nonaggressive debridement protocols for the treatment of high-energy, open supracondylar femur fractures after the primary procedure, with respect to the requirement for secondary bone grafting procedures, and deep infection. Retrospective review. Level I and level II trauma centers. Twenty-nine consecutive patients with high-grade, open (Gustilo types II and III) supracondylar femur fractures (OTA/AO 33A and C) treated with debridement and locked plating. Surgeons at 2 different level I trauma centers had different debridement protocols for open supracondylar femur fractures. One center used a more aggressive (MA) protocol in their patients (n = 17) that included removal of all devitalized bone and placement of antibiotic cement spacers to fill large segmental defects. The other center used a less aggressive (LA) protocol in their patients (n = 12) that included debridement of grossly contaminated bone with retention of other bone fragments and no use of antibiotic cement spacers. All other aspects of the treatment protocol at the 2 centers were similar: definitive fixation with locked plates in all cases, IV antibiotics were used until definitive wound closure, and weight bearing was advanced upon clinical and radiographic evidence of fracture healing. Healing after the primary procedure, requirement for secondary bone grafting procedures, and the presence of deep infection. Demographics were similar between included patients at each center with regard to age, gender, rate of open fractures, open fracture classification, mechanism, and smoking (P > 0.05). Patients at the MA center were more often diabetic (P < 0.05). Cement spacers to fill segmental defects were used more often after MA debridement (35% vs. 0%, P < 0.006), and more patients had a plan for staged bone grafting after MA debridement (71% vs. 8%, P < 0.006). Healing after the index fixation procedure occurred more often after LA debridement (92% vs. 35%, P < 0.003). There was no difference in infection rate between the 2 protocols: 25% with the LA protocol and 18% with the MA protocol (P = 0.63). All patients in both groups eventually healed and were without evidence of infection at an average of 1.8 years of follow-up. The degree to which bone should be debrided after a high-energy, high-grade, open supracondylar femur fracture is a matter of surgeon judgment and falls along a continuous spectrum. Based on the results of the current study, the theoretic trade-off between infection risk and osseous healing potential seems to favor an LA approach toward bone debridement in the initial treatment. Therapeutic level III.

Ginger as an antiemetic modality for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis.

PubMed

Lee, Jiyeon; Oh, Heeyoung

2013-03-01

To evaluate the effect of ginger as an antiemetic modality for the control of chemotherapy-induced nausea and vomiting (CINV). Databases searched included MEDLINE® (PubMed), Embase, CINAHL®, Cochrane Central Register of Controlled Trials, Korean Studies Information Service System, Research Information Sharing Service by the Korean Education and Research Information Service, and Dissertation Central. A systematic review was conducted of five randomized, controlled trials involving 872 patients with cancer. Ginger was compared with placebo or metoclopramide. The participant characteristics, chemotherapy regimen and antiemetic control, ginger preparation and protocol, measurements, results of the studies, adherence to the treatment protocol, and side effects were reviewed systematically. The incidence and severity of acute and delayed CINV were subject to meta-analysis. The incidence of acute nausea (p = 0.67), incidence of acute vomiting (p = 0.37), and severity of acute nausea (p = 0.12) did not differ significantly between the ginger and control groups. Current evidence does not support the use of ginger for the control of CINV. Ginger did not contribute to control of the incidence of acute nausea and vomiting or of the severity of acute nausea. Ginger has long been regarded as a traditional antiemetic modality, but its effectiveness remains to be established. The findings of this study could be incorporated into clinical guidelines, such as the Oncology Nursing Society's Putting Evidence Into Practice resources. Current evidence supports the need for more methodologically rigorous studies in this area. Although ginger is known as a traditional antiemetic, current evidence does not support the effect of ginger in CINV control. The findings of this study inform healthcare providers that its effectiveness remains to be established from methodologically rigorous future trials.

Prevention and treatment of hand oedema after stroke.

PubMed

Kuppens, Stefanie P M; Pijlman, Hanneke C P; Hitters, Minou W M G C; van Heugten, Caroline M

2014-01-01

As there is no evidence for a specific treatment for post-stroke-induced hand oedema, rehabilitation centre Blixembosch formalized a best practice protocol. We investigated whether the Blixembosch hand oedema protocol is usable in daily practice and leads to lower incidence (prevention) and shorter duration (treatment) compared with care as usual. In a non-randomised comparative trial, we investigated 206 post-stroke patients admitted to two Dutch rehabilitation centres. Hand volumes were measured at least bi-weekly using a volumeter. Treatment was started according the protocol (Blixembosch) or following care as usual (Leijpark). Usability was assessed with a survey among professionals. In the Blixembosch group, 16% developed oedema after admission, compared with 21% in the control group (p = 0.019). Average duration of oedema (both developed before and after admission) was 6.5 weeks in the Blixembosch group compared with 3.1 weeks in the control group (p = 0.000). Professionals were positive about the protocol. The study showed that the protocol is usable in daily practice and has a small beneficial effect on hand oedema incidence rates compared with care as usual. The negative effect on duration of hand oedema could also be caused by the difference in prognosis between the two groups.

Study protocol: implementation of a computer-assisted intervention for autism in schools: a hybrid type II cluster randomized effectiveness-implementation trial.

PubMed

Pellecchia, Melanie; Beidas, Rinad S; Marcus, Steven C; Fishman, Jessica; Kimberly, John R; Cannuscio, Carolyn C; Reisinger, Erica M; Rump, Keiran; Mandell, David S

2016-11-25

The number of children diagnosed with autism has rapidly outpaced the capacities of many public school systems to serve them, especially under-resourced, urban school districts. The intensive nature of evidence-based autism interventions, which rely heavily on one-to-one delivery, has caused schools to turn to computer-assisted interventions (CAI). There is little evidence regarding the feasibility, effectiveness, and implementation of CAI in public schools. While CAI has the potential to increase instructional time for students with autism, it may also result in unintended consequences such as reduction in the amount of interpersonal (as opposed to computerized) instruction students receive. The purpose of this study is to test the effectiveness of one such CAI-TeachTown-its implementation, and its effects on teachers' use of other evidence-based practices. This study protocol describes a type II hybrid cluster randomized effectiveness-implementation trial. We will train and coach 70 teachers in autism support classrooms in one large school district in the use of evidence-based practices for students with autism. Half of the teachers then will be randomly selected to receive training and access to TeachTown: Basics, a CAI for students with autism, for the students in their classrooms. The study examines: (1) the effectiveness of TeachTown for students with autism; (2) the extent to which teachers implement TeachTown the way it was designed (i.e., fidelity); and (3) whether its uptake increases or reduces the use of other evidence-based practices. This study will examine the implementation of new technology for children with ASD in public schools and will be the first to measure the effectiveness of CAI. As importantly, the study will investigate whether adding a new technology on top of existing practices increases or decreases their use. This study presents a unique method to studying both the implementation and exnovation of evidence-based practices for children with autism in school settings. NCT02695693 . Retrospectively registered on July 8, 2016.

Dual trigger of triptorelin and HCG optimizes clinical outcome for high ovarian responder in GnRH-antagonist protocols.

PubMed

Li, Saijiao; Zhou, Danni; Yin, Tailang; Xu, Wangming; Xie, Qingzhen; Cheng, Dan; Yang, Jing

2018-01-12

In this paper, a retrospective cohort study was conducted to the high ovarian responders in GnRH-antagonist protocols of IVF/ICSI cycles. The purpose of the study is to investigate whether dual triggering of final oocyte maturation with a combination of gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (HCG) can improve the clinical outcome compared with traditional dose (10000IU) HCG trigger and low-dose (8000IU) HCG trigger for high ovarian responders in GnRH-antagonist in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles. Our study included 226 couples with high ovarian responders in GnRH-antagonist protocols of IVF/ICSI cycles. Standard dosage of HCG trigger (10000 IU of recombinant HCG) versus dual trigger (0.2 mg of triptorelin and 2000 IU of recombinant HCG) and low-dose HCG trigger (8000IU of recombinant HCG) were used for final oocyte maturation. Our main outcome measures were high quality embryo rate, the number of usable embryos, the risk of OHSS, duration of hospitalization and incidence rate of complications. Our evidence demonstrated that dual trigger is capable of preventing severe OHSS while still maintaining excellent high quality embryo rate in in high ovarian responders of GnRH-antagonist protocols.

Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol

PubMed Central

Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

2014-01-01

Introduction A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. Methods and analysis We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. Ethics and dissemination The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. Trial registration number UKCRN Study ID: 15939. PMID:25146718

Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol.

PubMed

Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

2014-08-21

A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. UKCRN Study ID: 15939. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Psychosocial and career outcomes of peer mentorship in medical resident education: a systematic review protocol.

PubMed

Pethrick, Helen; Nowell, Lorelli; Oddone Paolucci, Elizabeth; Lorenzetti, Liza; Jacobsen, Michele; Clancy, Tracey; Lorenzetti, Diane L

2017-08-31

Many medical residents lack ready access to social and emotional supports that enable them to successfully cope with the challenges associated with medical residency. This absence of support has been shown to lead to high levels of burnout, decreased mental wellbeing, and difficulty mastering professional competencies in this population. While there is emerging evidence that peer mentoring can be an important source of psychosocial and career-related support for many individuals, the extent of the evidence regarding the benefits of peer mentorship in medical residency education has not yet been established. We describe a protocol for a systematic review to assess the effects of peer mentoring on medical residents' mental wellbeing, social connectedness, and professional competencies. Studies included in this review will be those that report on peer-mentoring relationships among medical residents. Quantitative, qualitative, and mixed-methods studies will be eligible for inclusion. No date or language limits will be applied. We will search EMBASE, MEDLINE, PsychINFO, Web of Science, Scopus, ERIC, Education Research Complete, and Academic Research Complete databases to identify relevant studies. Two authors will independently assess all abstracts and full-text studies for inclusion and study quality and extract study data in duplicate. This is the first systematic review to explicitly explore the role of peer mentoring in the context of medical residency education. We anticipate that the findings from this review will raise awareness of the benefits and challenges associated with peer-mentoring relationships, further the development and implementation of formal peer-mentoring programs for medical residents, and, through identifying gaps in the existing literature, inform future research efforts. This protocol has not been registered in PROSPERO or any other publicly accessible registry.

Plasma transfusion for patients with severe hemorrhage: what is the evidence?

PubMed

Callum, Jeannie L; Rizoli, Sandro

2012-05-01

The following review will detail the current knowledge in massive hemorrhage with regard to the pathophysiology of the coagulation disturbance, the role of plasma, the role of alternatives to plasma, and the clinical value of having a massive transfusion protocol. The coagulation disturbance in trauma patients is more than just the result of consumption of clotting factors at sites of injury and dilution from the infusion of intravenous fluids and red blood cells (RBCs). Even before substantial amounts of fluid resuscitation and RBC transfusion, one-quarter of trauma patients already have abnormal coagulation variables. There is an apparent role for the activation of protein C, hypofibrinogenemia, and fibrin(gen)olysis in the coagulation disturbance after trauma and massive hemorrhage. None of these three disturbances would be completely mitigated by the use of plasma alone, suggesting that there may be an opportunity to improve care of these patients with alternative strategies, such as fibrinogen concentrates and antifibrinolytics. Despite numerous retrospective cohort studies evaluating 1:1 plasma to RBC formula-driven resuscitation, the overall clinical value of this approach is unclear. Studies have even raised concerns regarding a potential increase in morbidity associated with this approach, particularly for patients overtriaged to 1:1 where a massive transfusion is unlikely. We also do not have sufficient evidence to recommend either goal-directed therapy with thromboelastography or early use of fibrinogen replacement, with either cryoprecipitate or fibrinogen concentrates. We have high-quality data that argue against the role for recombinant Factor VIIa that should prompt removal of this strategy from existing protocols. In contrast, we have high-level evidence that all bleeding trauma patients should receive tranexamic acid as soon as possible after injury. This therapy must be included in hemorrhage protocols. If we are to improve the care of massively bleeding patients on a firm scientific ground, we will need large-scale randomized trials to delineate the role of coagulation replacement and the utility of laboratory monitoring. But even until these trials are completed, it is clear that a massive transfusion protocol is needed in all hospitals that manage bleeding patients, to ensure a prompt and coordinated response to hemorrhage. © 2012 American Association of Blood Banks.

Maternal-Fetal Monitoring of Opioid-Exposed Pregnancies: Analysis of a Pilot Community-Based Protocol and Review of the Literature.

PubMed

Ryan, Gareth; Dooley, Joe; Windrim, Rory; Bollinger, Megan; Gerber Finn, Lianne; Kelly, Len

2017-06-01

To describe/analyse a novel, community-based prenatal monitoring protocol for opioid-exposed pregnancies developed by our centre in 2014 to optimize prenatal care for this population. A literature review of published monitoring protocols for this population is also presented. Retrospective comparison of pre-protocol (n = 215) and post-protocol (n = 251) cohorts. Medline and Embase were searched between 2000-2016 using MeSH terms: [fetal monitoring OR prenatal care] AND [opioid-related disorders OR substance-related disorders] in Medline and [fetal monitoring OR prenatal care] AND [opiate addiction OR substance abuse] in Embase, producing 518 results. Thirteen studies included protocols for monitoring opioid-exposed pregnancies. No comprehensive monitoring protocols with high-quality supporting evidence were found. We evaluated 466 opioid-exposed pregnancies, 215 before and 251 after introduction of the protocol. Since implementation, there was a significant increase in the number of opioid-exposed patients who have underwent urine drug screening (72.6% to 89.2%, P < 0.0001); a significant reduction in the number of urine drug screenings positive for illicit opioids (50.2% to 29.1%, P < 0.0001); and a significant increase in the number of patients who discontinued illicit opioid use by the time of delivery (24.7% to 39.4%, P < 0.01). There was no difference in the CS rate (27.4% vs. 26.3%, P > 0.05). There were no observed differences in the rate of preterm birth, birth weight <2500 g, or Apgar score <7 (P > 0.05). Care of women with increased opioid use during pregnancy is an important but under-studied health issue. A novel protocol for focused antenatal care provision for women with opioid-exposed pregnancies improves standard of care and maternal/fetal outcomes. Copyright © 2017. Published by Elsevier Inc.

The impact of SNP fingerprinting and parentage analysis on the effectiveness of variety recommendations in cacao

USDA-ARS?s Scientific Manuscript database

Evidence for the impact of mislabeling and/or pollen contamination on consistency of field performance has been lacking to reinforce the need for strict adherence to quality control protocols in cacao seed garden and germplasm plot management. The present study used SNP fingerprinting at 64 loci to ...

Methodology for Evaluating an Adaptation of Evidence-Based Drug Abuse Prevention in Alternative Schools

ERIC Educational Resources Information Center

Hopson, Laura M.; Steiker, Lori K. H.

2008-01-01

The purpose of this article is to set forth an innovative methodological protocol for culturally grounding interventions with high-risk youths in alternative schools. This study used mixed methods to evaluate original and adapted versions of a culturally grounded substance abuse prevention program. The qualitative and quantitative methods…

A Qualitative Analysis of an Advanced Practice Nurse-Directed Transitional Care Model Intervention

ERIC Educational Resources Information Center

Bradway, Christine; Trotta, Rebecca; Bixby, M. Brian; McPartland, Ellen; Wollman, M. Catherine; Kapustka, Heidi; McCauley, Kathleen; Naylor, Mary D.

2012-01-01

Purpose: The purpose of this study was to describe barriers and facilitators to implementing a transitional care intervention for cognitively impaired older adults and their caregivers lead by advanced practice nurses (APNs). Design and Methods: APNs implemented an evidence-based protocol to optimize transitions from hospital to home. An…

Evaluating community health centers’ adoption of a new global capitation payment (eCHANGE) study protocol

PubMed Central

Angier, H; O’Malley, JP; Marino, M; McConnell, KJ; Cottrell, E; Jacob, RL; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, SR; DeVoe, JE

2017-01-01

Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon’s Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. PMID:27836506

Aromatherapy for managing menopausal symptoms: A protocol for systematic review and meta-analysis.

PubMed

Choi, Jiae; Lee, Hye Won; Lee, Ju Ah; Lim, Hyun-Ja; Lee, Myeong Soo

2018-02-01

Aromatherapy is often used as a complementary therapy for women's health. This systematic review aims to evaluate the therapeutic effects of aromatherapy as a management for menopausal symptoms. Eleven electronic databases will be searched from inception to February 2018. Randomized controlled trials that evaluated any type of aromatherapy against any type of control in individuals with menopausal symptoms will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool. Two authors will independently assess each study for eligibility and risk of bias and to extract data. This study will provide a high quality synthesis of current evidence of aromatherapy for menopausal symptoms measured with Menopause Rating Scale, the Kupperman Index, the Greene Climacteric Scale, or other validated questionnaires. The conclusion of our systematic review will provide evidence to judge whether aromatherapy is an effective intervention for patient with menopausal women. Ethical approval will not be required, given that this protocol is for a systematic review. The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. PROSPERO CRD42017079191.

Evaluating community health centers' adoption of a new global capitation payment (eCHANGE) study protocol.

PubMed

Angier, H; O'Malley, J P; Marino, M; McConnell, K J; Cottrell, E; Jacob, R L; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, S R; DeVoe, J E

2017-01-01

Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon's Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. Copyright © 2016 Elsevier Inc. All rights reserved.

Establishing core outcome sets for phenylketonuria (PKU) and medium-chain Acyl-CoA dehydrogenase (MCAD) deficiency in children: study protocol for systematic reviews and Delphi surveys.

PubMed

Potter, Beth K; Hutton, Brian; Clifford, Tammy J; Pallone, Nicole; Smith, Maureen; Stockler, Sylvia; Chakraborty, Pranesh; Barbeau, Pauline; Garritty, Chantelle M; Pugliese, Michael; Rahman, Alvi; Skidmore, Becky; Tessier, Laure; Tingley, Kylie; Coyle, Doug; Greenberg, Cheryl R; Korngut, Lawrence; MacKenzie, Alex; Mitchell, John J; Nicholls, Stuart; Offringa, Martin; Schulze, Andreas; Taljaard, Monica

2017-12-19

Inherited metabolic diseases (IMD) are a large group of rare single-gene disorders that are typically diagnosed early in life. There are important evidence gaps related to the comparative effectiveness of therapies for IMD, which are in part due to challenges in conducting randomized controlled trials (RCTs) for rare diseases. Registry-based RCTs present a unique opportunity to address these challenges provided the registries implement standardized collection of outcomes that are important to patients and their caregivers and to clinical providers and healthcare systems. Currently there is no core outcome set (COS) for studies evaluating interventions for paediatric IMD. This protocol outlines a study that will establish COS for each of two relatively common IMD in children, phenylketonuria (PKU) and medium-chain acyl-CoA dehydrogenase (MCAD) deficiency. This two-part study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative. Part 1 includes a rapid review and development of an evidence map to identify a comprehensive listing of outcomes reported in past studies of PKU and MCAD deficiency. The review follows established methods for knowledge synthesis, including a comprehensive search strategy, two stages of screening citations against inclusion/exclusion criteria by two reviewers working independently, and extraction of important data elements from eligible studies, including details of the outcomes collected and outcome measurement instruments. The review findings will inform part 2 of our study, a set of Delphi surveys to establish consensus on the highest priority outcomes for each condition. Healthcare providers, families of children with PKU or MCAD deficiency, and health system decision-makers will be invited to participate in two to three rounds of Delphi surveys. The design of the surveys will involve parents of children with IMD who are part of a family advisory forum. This protocol is a crucial step in developing the capacity to launch RCTs with meaningful outcomes that address comparative effectiveness questions in the field of paediatric IMD. Such trials will contribute high-quality evidence to inform decision-making by patients and their family members, clinicians, and policy-makers.

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research.

PubMed

Turcios, Jacqueline; Cook, Barbara; Irwin, Julia; Rispoli, Taylor; Landi, Nicole

2017-07-31

This paper includes a detailed description of a familiarization protocol, which is used as an integral component of a larger research protocol to collect electroencephalography (EEG) data and Event-Related Potentials (ERPs). At present, the systems available for the collection of high-quality EEG/ERP data make significant demands on children with developmental disabilities, such as those with an Autism Spectrum Disorder (ASD). Children with ASD may have difficulty adapting to novel situations, tolerating uncomfortable sensory stimuli, and sitting quietly. This familiarization protocol uses Evidence-Based Practices (EBPs) to increase research participants' knowledge and understanding of the specific activities and steps of the research protocol. The tools in this familiarization protocol are a social narrative, a visual schedule, the Premack principle, role-playing, and modeling. The goal of this familiarization protocol is to increase understanding and agency and to potentially reduce anxiety for child participants, resulting in a greater likelihood of the successful completion of the research protocol for the collection of EEG/ERP data.

The expanding cognitive-behavioural therapy treatment umbrella for the anxiety disorders: disorder-specific and transdiagnostic approaches.

PubMed

Rector, Neil A; Man, Vincent; Lerman, Bethany

2014-06-01

Cognitive-behavioural therapy (CBT) is an empirically supported treatment for anxiety disorders. CBT treatments are based on disorder-specific protocols that have been developed to target individual anxiety disorders, despite that anxiety disorders frequently co-occur and are comorbid with depression. Given the high rates of diagnostic comorbidity, substantial overlap in dimensional symptom ratings, and extensive evidence that the mood and anxiety disorders share a common set of psychological and biological vulnerabilities, transdiagnostic CBT protocols have recently been developed to treat the commonalities among the mood and anxiety disorders. We conducted a selective review of empirical developments in the transdiagnostic CBT treatment of anxiety and depression (2008-2013). Preliminary evidence suggests that theoretically based transdiagnostic CBT approaches lead to large treatment effects on the primary anxiety disorder, considerable reduction of diagnostic comorbidity, and some preliminary effects regarding the impact on the putative, shared psychological mechanisms. However, the empirical literature remains tentative owing to relatively small samples, limited direct comparisons with disorder-specific CBT protocols, and the relative absence of the study of disorder-specific compared with shared mechanisms of action in treatment. We conclude with a treatment conceptualization of the new transdiagnostic interventions as complementary, rather than contradictory, to disorder-specific CBT.

Use of a standardized JaCVAM in vivo rat comet assay protocol to assess the genotoxicity of three coded test compounds; ampicillin trihydrate, 1,2-dimethylhydrazine dihydrochloride, and N-nitrosodimethylamine.

PubMed

McNamee, J P; Bellier, P V

2015-07-01

As part of the Japanese Center for the Validation of Alternative Methods (JaCVAM)-initiative international validation study of the in vivo rat alkaline comet assay (comet assay), our laboratory examined ampicillin trihydrate (AMP), 1,2-dimethylhydrazine dihydrochloride (DMH), and N-nitrosodimethylamine (NDA) using a standard comet assay validation protocol (v14.2) developed by the JaCVAM validation management team (VMT). Coded samples were received by our laboratory along with basic MSDS information. Solubility analysis and range-finding experiments of the coded test compounds were conducted for dose selection. Animal dosing schedules, the comet assay processing and analysis, and statistical analysis were conducted in accordance with the standard protocol. Based upon our blinded evaluation, AMP was not found to exhibit evidence of genotoxicity in either the rat liver or stomach. However, both NDA and DMH were observed to cause a significant increase in % tail DNA in the rat liver at all dose levels tested. While acute hepatoxicity was observed for these compounds in the high dose group, in the investigators opinion there were a sufficient number of consistently damaged/measurable cells at the medium and low dose groups to judge these compounds as genotoxic. There was no evidence of genotoxicity from either NDA or DMH in the rat stomach. In conclusion, our laboratory observed increased DNA damage from two blinded test compounds in rat liver (later identified as genotoxic carcinogens), while no evidence of genotoxicity was observed for the third blinded test compound (later identified as a non-genotoxic, non-carcinogen). This data supports the use of a standardized protocol of the in vivo comet assay as a cost-effective alternative genotoxicity assay for regulatory testing purposes. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

SLOWLY REPEATED EVOKED PAIN (SREP) AS A MARKER OF CENTRAL SENSITIZATION IN FIBROMYALGIA: DIAGNOSTIC ACCURACY AND RELIABILITY IN COMPARISON WITH TEMPORAL SUMMATION OF PAIN.

PubMed

de la Coba, Pablo; Bruehl, Stephen; Gálvez-Sánchez, Carmen María; Reyes Del Paso, Gustavo A

2018-05-01

This study examined the diagnostic accuracy and test-retest reliability of a novel dynamic evoked pain protocol (slowly repeated evoked pain; SREP) compared to temporal summation of pain (TSP), a standard index of central sensitization. Thirty-five fibromyalgia (FM) and 30 rheumatoid arthritis (RA) patients completed, in pseudorandomized order, a standard mechanical TSP protocol (10 stimuli of 1s duration at the thenar eminence using a 300g monofilament with 1s interstimulus interval) and the SREP protocol (9 suprathreshold pressure stimuli of 5s duration applied to the fingernail with a 30s interstimulus interval). In order to evaluate reliability for both protocols, they were repeated in a second session 4-7 days later. Evidence for significant pain sensitization over trials (increasing pain intensity ratings) was observed for SREP in FM (p<.001) but not in RA (p=.35), whereas significant sensitization was observed in both diagnostic groups for the TSP protocol (p's<.008). Compared to TSP, SREP demonstrated higher overall diagnostic accuracy (87.7% vs. 64.6%), greater sensitivity (0.89 vs. 0.57), and greater specificity (0.87 vs. 0.73) in discriminating between FM and RA patients. Test-retest reliability of SREP sensitization was good in FM (ICCs: 0.80), and moderate in RA (ICC: 0.68). SREP seems to be a dynamic evoked pain index tapping into pain sensitization that allows for greater diagnostic accuracy in identifying FM patients compared to a standard TSP protocol. Further research is needed to study mechanisms underlying SREP and the potential utility of adding SREP to standard pain evaluation protocols.

Job Knowledge Test Design: A Cognitively-Oriented Approach

DTIC Science & Technology

1993-07-01

protocol analyses and related methods. We employed a plan-goal graph representation to capture the knowledge content and goal structure of the studied task...between job knowledge and hands-on performance from previous studies was .38. For the subset of Marines in this sample who had recently been examined...the job knowledge test provided similar results to conventional, total number correct scoring. Conclusion The evidence provided by this study supports

Motor-based intervention protocols in treatment of childhood apraxia of speech (CAS)

PubMed Central

Maas, Edwin; Gildersleeve-Neumann, Christina; Jakielski, Kathy J.; Stoeckel, Ruth

2014-01-01

This paper reviews current trends in treatment for childhood apraxia of speech (CAS), with a particular emphasis on motor-based intervention protocols. The paper first briefly discusses how CAS fits into the typology of speech sound disorders, followed by a discussion of the potential relevance of principles derived from the motor learning literature for CAS treatment. Next, different motor-based treatment protocols are reviewed, along with their evidence base. The paper concludes with a summary and discussion of future research needs. PMID:25313348

Parental intimate partner homicide and its consequences for children: protocol for a population-based study.

PubMed

Alisic, Eva; Groot, Arend; Snetselaar, Hanneke; Stroeken, Tielke; van de Putte, Elise

2015-07-29

The loss of a parent due to intimate partner homicide has a major impact on children. Professionals involved have to make far-reaching decisions regarding placement, guardianship, mental health care and contact with the perpetrating parent, without an evidence base to guide these decisions. We introduce a study protocol to a) systematically describe the demographics, circumstances, mental health and wellbeing of children bereaved by intimate partner homicide and b) build a predictive model of factors associated with children's mental health and wellbeing after intimate partner homicide. This study focuses on children bereaved by parental intimate partner homicide in the Netherlands over a period of 20 years (1993 - 2012). It involves an incidence study to identify all Dutch intimate partner homicide cases between 1993 and 2012 by which children have been bereaved; systematic case reviews to describe the demographics, circumstances and care trajectories of these children; and a mixed-methods study to assess mental health, wellbeing, and experiences regarding decisions made and care provided. Clinical experience and initial research suggest that the children involved often need long-term intensive mental health and case management. The costs of these services are extensive and the stakes are high. This study lays the foundation for an international dataset and evidence-informed decision making.

Should the diagnostic and therapeutic protocols for adrenal incidentalomas be changed?

PubMed

Mateo-Gavira, Isabel; Vilchez-López, Francisco Javier; Larrán-Escandón, Laura; Ojeda-Schuldt, María Belén; Tinoco, Cristina López; Aguilar-Diosdado, Manuel

2015-01-01

The prevalence of adrenal incidentalomas is increasing with the aging of the population and the use of high resolution imaging technics. Current protocols propose a comprehensive monitoring of their functional and morphological state, but with no conclusive clinical evidence that endorses it. Retrospective study of 96 patients diagnosed with adrenal incidentaloma between 2008 and 2012. We evaluated clinical, functional and imaging at baseline and during follow-up. Initially, 9 cases were surgically removed: 4 due to hyperfunction (2 Cushing syndromes and 2 pheochromocytomas) and 5 due to size larger than 4cm. During follow-up one case of pheochromocytoma was diagnosed and another grew more than 1cm, needing surgery. In 98.86% of nonfunctional and benign lesions, there was no functional and/or morphological changes in the final evaluation. The results of our study challenge the validity of current diagnostic-therapeutic protocols of incidentalomas, which should be reassessed in prospective studies taking into account efficiency characteristics. Copyright © 2013 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Developing and refining the methods for a 'one-stop shop' for research evidence about health systems.

PubMed

Lavis, John N; Wilson, Michael G; Moat, Kaelan A; Hammill, Amanda C; Boyko, Jennifer A; Grimshaw, Jeremy M; Flottorp, Signe

2015-02-25

Policymakers, stakeholders and researchers have not been able to find research evidence about health systems using an easily understood taxonomy of topics, know when they have conducted a comprehensive search of the many types of research evidence relevant to them, or rapidly identify decision-relevant information in their search results. To address these gaps, we developed an approach to building a 'one-stop shop' for research evidence about health systems. We developed a taxonomy of health system topics and iteratively refined it by drawing on existing categorization schemes and by using it to categorize progressively larger bundles of research evidence. We identified systematic reviews, systematic review protocols, and review-derived products through searches of Medline, hand searches of several databases indexing systematic reviews, hand searches of journals, and continuous scanning of listservs and websites. We developed an approach to providing 'added value' to existing content (e.g., coding systematic reviews according to the countries in which included studies were conducted) and to expanding the types of evidence eligible for inclusion (e.g., economic evaluations and health system descriptions). Lastly, we developed an approach to continuously updating the online one-stop shop in seven supported languages. The taxonomy is organized by governance, financial, and delivery arrangements and by implementation strategies. The 'one-stop shop', called Health Systems Evidence, contains a comprehensive inventory of evidence briefs, overviews of systematic reviews, systematic reviews, systematic review protocols, registered systematic review titles, economic evaluations and costing studies, health reform descriptions and health system descriptions, and many types of added-value coding. It is continuously updated and new content is regularly translated into Arabic, Chinese, English, French, Portuguese, Russian, and Spanish. Policymakers and stakeholders can now easily access and use a wide variety of types of research evidence about health systems to inform decision-making and advocacy. Researchers and research funding agencies can use Health Systems Evidence to identify gaps in the current stock of research evidence and domains that could benefit from primary research, systematic reviews, and review overviews.

Using Practice-Based Evidence to Improve Supportive Care Practices to Reduce Central Line-Associated Bloodstream Infections in a Pediatric Oncology Unit [Formula: see text].

PubMed

Linder, Lauri A; Gerdy, Cheryl; Abouzelof, Rouett; Wilson, Andrew

Children with cancer are a subset of patients with central lines with distinct risk factors for infection including periods of prolonged neutropenia and compromised mucous membrane integrity. This article relates the implementation of principles of practice-based evidence to identify interventions in addition to best practice maintenance care bundles to reduce central line-associated bloodstream infections involving viridans group streptococci and coagulase-negative staphylococci on an inpatient pediatric oncology unit. Review of individual events combined with review of current clinical practice guided the development of structured protocols emphasizing routine oral care and general supportive cares. Key principles of the protocols emphasized a 1-2-3 mnemonic and included daily bathing, twice daily oral care, and out-of-bed activity 3 times daily. Poisson regression identified a significant main effect for time period for central line-associated bloodstream infection rates involving both viridans group streptococci and coagulase-negative staphylococci. Significant differences were present between the preintervention baseline and implementation of the supportive care protocols. Project outcomes demonstrate the added value of using principles of practice-based evidence to guide the development of interventions to improve clinical care when evidence-based sources are limited.

Anterior Cruciate Ligament Reconstruction Rehabilitation

PubMed Central

Wright, Rick W.; Haas, Amanda K.; Anderson, Joy; Calabrese, Gary; Cavanaugh, John; Hewett, Timothy E.; Lorring, Dawn; McKenzie, Christopher; Preston, Emily; Williams, Glenn; Amendola, Annunziato

2015-01-01

Context: Anterior cruciate ligament (ACL) reconstruction rehabilitation has evolved over the past 20 years. This evolution has been driven by a variety of level 1 and level 2 studies. Evidence Acquisition: The MOON Group is a collection of orthopaedic surgeons who have developed a prospective longitudinal cohort of the ACL reconstruction patients. To standardize the management of these patients, we developed, in conjunction with our physical therapy committee, an evidence-based rehabilitation guideline. Study Design: Clinical review. Level of Evidence: Level 2. Results: This review was based on 2 systematic reviews of level 1 and level 2 studies. Recently, the guideline was updated by a new review. Continuous passive motion did not improve ultimate motion. Early weightbearing decreases patellofemoral pain. Postoperative rehabilitative bracing did not improve swelling, pain range of motion, or safety. Open chain quadriceps activity can begin at 6 weeks. Conclusion: High-level evidence exists to determine appropriate ACL rehabilitation guidelines. Utilizing this protocol follows the best available evidence. PMID:26131301

The Scene of the Crime: Classroom Integration of Biosafety, Microscopy & Forensics

ERIC Educational Resources Information Center

Green, Michelle L.; Novakofski, Jan; Green, Ryan W.; Manjerovic, Mary Beth; Mateus-Pinilla, Nohra

2014-01-01

Providing both introductory information and biosecurity protocols in laboratory, farm, and field settings is central to student learning and safety. However, even when clear protocols are provided, students do not fully understand the consequences of their actions. We present a crime scene that requires evidence investigation to improve basic…

Hip arthroscopy protocol: expert opinions on post-operative weight bearing and return to sports guidelines.

PubMed

Rath, Ehud; Sharfman, Zachary T; Paret, Matan; Amar, Eyal; Drexler, Michael; Bonin, Nicolas

2017-01-01

The objectives of this study are to survey the weight-bearing limitation practices and delay for returning to running and impact sports of high volume hip arthroscopy orthopedic surgeons. The study was designed in the form of expert survey questionnaire. Evidence-based data are scares regarding hip arthroscopy post-operative weight-bearing protocols. An international cross-sectional anonymous Internet survey of 26 high-volume hip arthroscopy specialized surgeons was conducted to report their weight-bearing limitations and rehabilitation protocols after various arthroscopic hip procedures. The International Society of Hip Arthroscopy invited this study. The results were examined in the context of supporting literature to inform the studies suggestions. Four surgeons always allow immediate weight bearing and five never offer immediate weight bearing. Seventeen surgeons provide weight bearing depending on the procedures performed: 17 surgeons allowed immediate weight bearing after labral resection, 10 after labral repair and 8 after labral reconstruction. Sixteen surgeons allow immediate weight bearing after psoas tenotomy. Twenty-one respondents restrict weight bearing after microfracture procedures for 3-8 weeks post-operatively. Return to running and impact sports were shorter for labral procedures and bony procedures and longer for cartilaginous and capsular procedures. Marked variability exists in the post-operative weight-bearing practices of hip arthroscopy surgeons. This study suggests that most surgeons allow immediate weight bearing as tolerated after labral resection, acetabular osteoplasty, chondroplasty and psoas tenotomy. For cartilage defect procedures, 6 weeks or more non-weight bearing is suggested depending on the area of the defect and lateral central edge angle. Delayed return to sports activities is suggested after microfracture procedures. The level of evidence was Level V expert opinions.

Hip arthroscopy protocol: expert opinions on post-operative weight bearing and return to sports guidelines

PubMed Central

Rath, Ehud; Paret, Matan; Amar, Eyal; Drexler, Michael; Bonin, Nicolas

2017-01-01

Abstract The objectives of this study are to survey the weight-bearing limitation practices and delay for returning to running and impact sports of high volume hip arthroscopy orthopedic surgeons. The study was designed in the form of expert survey questionnaire. Evidence-based data are scares regarding hip arthroscopy post-operative weight-bearing protocols. An international cross-sectional anonymous Internet survey of 26 high-volume hip arthroscopy specialized surgeons was conducted to report their weight-bearing limitations and rehabilitation protocols after various arthroscopic hip procedures. The International Society of Hip Arthroscopy invited this study. The results were examined in the context of supporting literature to inform the studies suggestions. Four surgeons always allow immediate weight bearing and five never offer immediate weight bearing. Seventeen surgeons provide weight bearing depending on the procedures performed: 17 surgeons allowed immediate weight bearing after labral resection, 10 after labral repair and 8 after labral reconstruction. Sixteen surgeons allow immediate weight bearing after psoas tenotomy. Twenty-one respondents restrict weight bearing after microfracture procedures for 3–8 weeks post-operatively. Return to running and impact sports were shorter for labral procedures and bony procedures and longer for cartilaginous and capsular procedures. Marked variability exists in the post-operative weight-bearing practices of hip arthroscopy surgeons. This study suggests that most surgeons allow immediate weight bearing as tolerated after labral resection, acetabular osteoplasty, chondroplasty and psoas tenotomy. For cartilage defect procedures, 6 weeks or more non-weight bearing is suggested depending on the area of the defect and lateral central edge angle. Delayed return to sports activities is suggested after microfracture procedures. The level of evidence was Level V expert opinions. PMID:28630722

Effects of oncological care pathways in primary and secondary care on patient, professional, and health systems outcomes: protocol for a systematic review and meta-analysis.

PubMed

van Hoeve, Jolanda C; Vernooij, Robin W M; Lawal, Adegboyega K; Fiander, Michelle; Nieboer, Peter; Siesling, Sabine; Rotter, Thomas

2018-03-27

The high impact of a cancer diagnosis on patients and their families and the increasing costs of cancer treatment call for optimal and efficient oncological care. To improve the quality of care and to minimize healthcare costs and its economic burden, many healthcare organizations introduce care pathways to improve efficiency across the continuum of cancer care. However, there is limited research on the effects of cancer care pathways in different settings. The aim of this systematic review and meta-analysis described in this protocol is to synthesize existing literature on the effects of oncological care pathways. We will conduct a systematic search strategy to identify all relevant literature in several biomedical databases, including Cochrane library, MEDLINE, Embase, and CINAHL. We will follow the methodology of Cochrane Effective Practice and Organisation of Care (EPOC), and we will include randomized trials, non-randomized trials, controlled before-after studies, and interrupted time series studies. In addition, we will include full economic evaluations (cost-effectiveness analyses, cost-utility analyses, and cost-benefit analyses), cost analyses, and comparative resource utilization studies, if available. Two reviewers will independently screen all studies and evaluate those included for risk of bias. From these studies, we will extract data regarding patient, professional, and health systems outcomes. Our systematic review will follow the PRISMA set of items for reporting in systematic reviews and meta-analyses. Following the protocol outlined in this article, we aim to identify, assess, and synthesize all available evidence in order to provide an evidence base on the effects of oncological care pathways as reported in the literature. PROSPERO CRD42017057592 .

A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial.

PubMed

Chesnut, Randall M; Bleck, Thomas P; Citerio, Giuseppe; Classen, Jan; Cooper, D James; Coplin, William M; Diringer, Michael N; Grände, Per-Olof; Hemphill, J Claude; Hutchinson, Peter J; Le Roux, Peter; Mayer, Stephan A; Menon, David K; Myburgh, John A; Okonkwo, David O; Robertson, Claudia S; Sahuquillo, Juan; Stocchetti, Nino; Sung, Gene; Temkin, Nancy; Vespa, Paul M; Videtta, Walter; Yonas, Howard

2015-11-15

Widely-varying published and presented analyses of the Benchmark Evidence From South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial of intracranial pressure (ICP) monitoring have suggested denying trial generalizability, questioning the need for ICP monitoring in severe traumatic brain injury (sTBI), re-assessing current clinical approaches to monitored ICP, and initiating a general ICP-monitoring moratorium. In response to this dissonance, 23 clinically-active, international opinion leaders in acute-care sTBI management met to draft a consensus statement to interpret this study. A Delphi method-based approach employed iterative pre-meeting polling to codify the group's general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of more than 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83% to 100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that the BEST TRIP trial: 1) studied protocols, not ICP-monitoring per se; 2) applies only to those protocols and specific study groups and should not be generalized to other treatment approaches or patient groups; 3) strongly calls for further research on ICP interpretation and use; 4) should be applied cautiously to regions with much different treatment milieu; 5) did not investigate the utility of treating monitored ICP in the specific patient group with established intracranial hypertension; 6) should not change the practice of those currently monitoring ICP; and 7) provided a protocol, used in non-monitored study patients, that should be considered when treating without ICP monitoring. Consideration of these statements can clarify study interpretation.

Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

PubMed

Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

2017-05-25

In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

"Not just another Wii training": a graded Wii protocol to increase physical fitness in adolescent girls with probable developmental coordination disorder-a pilot study.

PubMed

Bonney, Emmanuel; Rameckers, Eugene; Ferguson, Gillian; Smits-Engelsman, Bouwien

2018-02-22

Adolescents with low motor competence participate less in physical activity and tend to exhibit decreased physical fitness compared to their peers with high motor competence. It is therefore essential to identify new methods of enhancing physical fitness in this population. Active video games (AVG) have been shown to improve motor performance, yet investigations of its impact on physical fitness are limited. The objective of this study was to examine the impact of the graded Wii protocol in adolescent girls with probable Developmental Coordination Disorder (p-DCD). A single-group pre-post design was conducted to assess the impact of a newly developed Wii protocol in adolescent girls attending school in a low income community of Cape Town, South Africa. Sixteen participants (aged 13-16 years) with p-DCD (≤16th percentile on the MABC-2 test) were recruited. Participants received 45 min Wii training for 14 weeks. Outcome measures included the six-minute walk distance and repeated sprint ability. Information on heart rate, enjoyment and perceived exertion ratings were also collected. Significant improvements in aerobic and anaerobic fitness were observed. The participants reported high enjoyment scores and low perceived exertion ratings. The graded Wii protocol was easily adaptable and required little resources (space, equipment and expertise) to administer. The findings provide preliminary evidence to support the use of the graded Wii protocol for promoting physical fitness in adolescent girls with p-DCD. Further studies are needed to confirm these results and to validate the clinical efficacy of the protocol in a larger sample with a more robust design.

The effectiveness and cost-effectiveness of shared care: protocol for a realist review.

PubMed

Hardwick, Rebecca; Pearson, Mark; Byng, Richard; Anderson, Rob

2013-02-12

Shared care (an enhanced information exchange over and above routine outpatient letters) is commonly used to improve care coordination and communication between a specialist and primary care services for people with long-term conditions. Evidence of the effectiveness and cost-effectiveness of shared care is mixed. Informed decision-making for targeting shared care requires a greater understanding of how it works, for whom it works, in what contexts and why. This protocol outlines how realist review methods can be used to synthesise evidence on shared care for long-term conditions.A further aim of the review is to explore economic evaluations of shared care. Economic evaluations are difficult to synthesise due to problems in accounting for contextual differences that impact on resource use and opportunity costs. Realist review methods have been suggested as a way to overcome some of these issues, so this review will also assess whether realist review methods are amenable to synthesising economic evidence. Database and web searching will be carried out in order to find relevant evidence to develop and test programme theories about how shared care works. The review will have two phases. Phase 1 will concentrate on the contextual conditions and mechanisms that influence how shared care works, in order to develop programme theories, which partially explain how it works. Phase 2 will focus on testing these programme theories. A Project Reference Group made up of health service professionals and people with actual experience of long-term conditions will be used to ground the study in real-life experience. Review findings will be disseminated through local and sub-national networks for integrated care and long-term conditions. This realist review will explore why and for whom shared care works, in order to support decision-makers working to improve the effectiveness of care for people outside hospital. The development of realist review methods to take into account cost and cost-effectiveness evidence is particularly innovative and challenging, and if successful will offer a new approach to synthesising economic evidence. This systematic review protocol is registered on the PROSPERO database (registration number: CRD42012002842).

Perforated Sigmoid Diverticular Disease: a Management Protocol

PubMed Central

Moin, Thajammul

2008-01-01

Background: To develop an evidence-based protocol for the management of perforated sigmoid diverticular disease. Methods: A search of the literature was undertaken. All publications pertaining to perforated sigmoid diverticular disease were analyzed and then categorized according to their level of evidence. Recommendations were then made on the basis of this. Results: Multiple case reports suggest that primary closure of perforation of sigmoid diverticula is safe in the absence of peritoneal contamination. Conclusions: A 2-stage laparoscopic approach incorporating the principles of damage limitation surgery may be a safe strategy in the management of perforated diverticular disease. PMID:18435896

Use of an evidence-based protocol to screen for sleep-disordered breathing in a heart failure disease management clinic.

PubMed

Garner, Shelby L; Traverse, Ramona D

2014-01-01

Undiagnosed and untreated sleep-disordered breathing can lead to negative health outcomes and increased utilization of health resources among patients with heart failure. The purpose of this evidence-based practice project was to implement and evaluate a new multifaceted sleep-disordered breathing screening protocol in a heart failure disease management clinic. The combined use of a symptoms questionnaire, the Epworth sleepiness scale, and overnight pulse oximetry was significantly more effective in identifying patients with a positive diagnosis of sleep-disordered breathing than using the Epworth sleepiness scale alone (P < .05).

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Stabilizing Group Treatment for Complex Posttraumatic Stress Disorder Related to Childhood Abuse Based on Psycho-Education and Cognitive Behavioral Therapy: A Pilot Study

ERIC Educational Resources Information Center

Dorrepaal, Ethy; Thomaes, Kathleen; Smit, Johannes H.; van Balkom, Anton J. L. M.; van Dyck, Richard; Veltman, Dick J.; Draijer, Nel

2010-01-01

Objective: This study tests a Stabilizing Group Treatment protocol, designed for the management of the long-term sequelae of child abuse, that is, Complex Posttraumatic Stress Disorder (Complex PTSD). Evidence-based treatment for this subgroup of PTSD patients is largely lacking. This stabilizing treatment aims at improving Complex PTSD using…

Everything should be as simple as possible, but no simpler: towards a protocol for accumulating evidence regarding the active content of health behaviour change interventions.

PubMed

Peters, Gjalt-Jorn Ygram; de Bruin, Marijn; Crutzen, Rik

2015-01-01

There is a need to consolidate the evidence base underlying our toolbox of methods of behaviour change. Recent efforts to this effect have conducted meta-regressions on evaluations of behaviour change interventions, deriving each method's effectiveness from its association to intervention effect size. However, there are a range of issues that raise concern about whether this approach is actually furthering or instead obstructing the advancement of health psychology theories and the quality of health behaviour change interventions. Using examples from theory, the literature and data from previous meta-analyses, these concerns and their implications are explained and illustrated. An iterative protocol for evidence base accumulation is proposed that integrates evidence derived from both experimental and applied behaviour change research, and combines theory development in experimental settings with theory testing in applied real-life settings. As evidence gathered in this manner accumulates, a cumulative science of behaviour change can develop.

Everything should be as simple as possible, but no simpler: towards a protocol for accumulating evidence regarding the active content of health behaviour change interventions

PubMed Central

Peters, Gjalt-Jorn Ygram; de Bruin, Marijn; Crutzen, Rik

2015-01-01

There is a need to consolidate the evidence base underlying our toolbox of methods of behaviour change. Recent efforts to this effect have conducted meta-regressions on evaluations of behaviour change interventions, deriving each method's effectiveness from its association to intervention effect size. However, there are a range of issues that raise concern about whether this approach is actually furthering or instead obstructing the advancement of health psychology theories and the quality of health behaviour change interventions. Using examples from theory, the literature and data from previous meta-analyses, these concerns and their implications are explained and illustrated. An iterative protocol for evidence base accumulation is proposed that integrates evidence derived from both experimental and applied behaviour change research, and combines theory development in experimental settings with theory testing in applied real-life settings. As evidence gathered in this manner accumulates, a cumulative science of behaviour change can develop. PMID:25793484

Training response inhibition to reduce food consumption: Mechanisms, stimulus specificity and appropriate training protocols.

PubMed

Adams, Rachel C; Lawrence, Natalia S; Verbruggen, Frederick; Chambers, Christopher D

2017-02-01

Training individuals to inhibit their responses towards unhealthy foods has been shown to reduce food intake relative to a control group. Here we aimed to further explore these effects by investigating the role of stimulus devaluation, training protocol, and choice of control group. Restrained eaters received either inhibition or control training using a modified version of either the stop-signal or go/no-go task. Following training we measured implicit attitudes towards food (Study 1) and food consumption (Studies 1 and 2). In Study 1 we used a modified stop-signal training task with increased demands on top-down control (using a tracking procedure and feedback to maintain competition between the stop and go processes). With this task, we found no evidence for an effect of training on implicit attitudes or food consumption, with Bayesian inferential analyses revealing substantial evidence for the null hypothesis. In Study 2 we removed the feedback in the stop-signal training to increase the rate of successful inhibition and revealed a significant effect of both stop-signal and go/no-go training on food intake (compared to double-response and go training, respectively) with a greater difference in consumption in the go/no-go task, compared with the stop-signal task. However, results from an additional passive control group suggest that training effects could be partly caused by increased consumption in the go control group whereas evidence for reduced consumption in the inhibition groups was inconclusive. Our findings therefore support evidence that inhibition training tasks with higher rates of inhibition accuracy are more effective, but prompt caution for interpreting the efficacy of laboratory-based inhibition training as an intervention for behaviour change. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Development of a Protocol for Epidemiologal Studies of Whole-Body Vibration and Musculoskeletal Disorders of the Lower Back

NASA Astrophysics Data System (ADS)

Magnusson, M. L.; Pope, M. H.; Hulshof, C. T. J.; Bovenzi, M.

1998-08-01

It seems evident from a large number of studies that there is a positive relationship between exposure to whole body vibration (WBV) and the occurrence of low back pain. There are existing standards for evaluating the human exposure to WBV, which are based on other factors than the effect of musculoskeletal disorders. Several national and international standards also exist for evaluating human exposure to WBV. The exposure limit values or health guidance caution zones included in some of these standards are not or only to a limited extent based on systematic epidemiological investigations. It has not yet been possible to establish a clear exposure-response relationship. There are many confounding or contributing factors which influence the hazards to workers caused by exposure to WBV. Reliable methods for the detection and prevention of injury due to vibration exposure at work, alone or in combination with other risk factors, need to be implemented. The aim of this paper was to design a protocol and a questionnaire for conducting collaborative studies of WBV and musculoskeletal back disorders. The protocol will be tested in a pilot study before it will be used in multi-center studies.

A Method of Managing Severe Traumatic Brain Injury in the Absence of Intracranial Pressure Monitoring: The Imaging and Clinical Examination Protocol.

PubMed

Chesnut, Randall M; Temkin, Nancy; Dikmen, Sureyya; Rondina, Carlos; Videtta, Walter; Petroni, Gustavo; Lujan, Silvia; Alanis, Victor; Falcao, Antonio; de la Fuenta, Gustavo; Gonzalez, Luis; Jibaja, Manuel; Lavarden, Arturo; Sandi, Freddy; Mérida, Roberto; Romero, Ricardo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Chaddock, Kelley

2018-01-01

The imaging and clinical examination (ICE) algorithm used in the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial is the only prospectively investigated clinical protocol for traumatic brain injury management without intracranial pressure (ICP) monitoring. As the default literature standard, it warrants careful evaluation. We present the ICE protocol in detail and analyze the demographics, outcome, treatment intensity, frequency of intervention usage, and related adverse events in the ICE-protocol cohort. The 167 ICE protocol patients were young (median 29 years) with a median Glasgow Coma Scale motor score of 4 but with anisocoria or abnormal pupillary reactivity in 40%. This protocol produced outcomes not significantly different from those randomized to the monitor-based protocol (favorable 6-month extended Glasgow Outcome Score in 39%; 41% mortality rate). Agents commonly employed to treat suspected intracranial hypertension included low-/moderate-dose hypertonic saline (72%) and mannitol (57%), mild hyperventilation (adjusted partial pressure of carbon dioxide 30-35 mm Hg in 73%), and pressors to maintain cerebral perfusion (62%). High-dose hyperosmotics or barbiturates were uncommonly used. Adverse event incidence was low and comparable to the BEST TRIP monitored group. Although this protocol should produce similar/acceptable results under circumstances comparable to those in the trial, influences such as longer pre-hospital times and non-specialist transport personnel, plus an intensive care unit model of aggressive physician-intensive care by small groups of neurotrauma-focused intensivists, which differs from most high-resource models, support caution in expecting the same results in dissimilar settings. Finally, this protocol's ICP-titration approach to suspected intracranial hypertension (vs. crisis management for monitored ICP) warrants further study.

Comparing the World Health Organization-versus China-recommended protocol for first-trimester medical abortion: a retrospective analysis.

PubMed

Ngo, Thoai D; Park, Min Hae; Xiao, Yuanhong

2012-01-01

To compare the effectiveness, in terms of complete abortion, of the World Health Organization (WHO)- and the China-recommended protocol for first-trimester medical abortion. A retrospective analysis of clinical data from women presenting for first trimester medical abortion between January 2009 and August 2010 at reproductive health clinics in Qingdao, Xi'an, Nanjing, Nanning, and Zhengzhou was conducted. One clinic in Qingdao administered the WHO-recommended protocol (200 mg mifepristone orally followed by 0.8 mg misoprostol buccally 36-48 hours later). Four clinics in the other locations provided the China-recommended procedure (Day 1: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 2: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 3: 0.6 mg oral misoprostol). Data on reproductive and demographic characteristics were extracted from clinic records, and complete termination was determined on day 14 (post-mifepristone administration). A total of 337 women underwent early medical abortion (167 WHO- and 170 China-recommended procedures). Complete abortion was significantly higher among women who had the WHO protocol than those who received the China protocol (91.0% vs 77.7%, respectively; P < 0.001). Women using the China-recommended protocol were three times more likely to require an additional dose of misoprostol than women using the WHO protocol (21.8% vs 7.8%, respectively; P < 0.001), and had significantly more bleeding on the day of misoprostol administration (12.5 mL vs 18.5 mL; P < 0.001). This clinical audit provides preliminary evidence suggesting the WHO-recommended protocol may be more effective than the China-recommended protocol for early medical abortion. A larger scale study is necessary to compare the methods' effectiveness and acceptability.

Wound-healing outcomes using standardized assessment and care in clinical practice.

PubMed

Bolton, Laura; McNees, Patrick; van Rijswijk, Lia; de Leon, Jean; Lyder, Courtney; Kobza, Laura; Edman, Kelly; Scheurich, Anne; Shannon, Ron; Toth, Michelle

2004-01-01

Wound-healing outcomes applying standardized protocols have typically been measured within controlled clinical trials, not natural settings. Standardized protocols of wound care have been validated for clinical use, creating an opportunity to measure the resulting outcomes. Wound-healing outcomes were explored during clinical use of standardized validated protocols of care based on patient and wound assessments. This was a prospective multicenter study of wound-healing outcomes management in real-world clinical practice. Healing outcomes from March 26 to October 31, 2001, were recorded on patients in 3 long-term care facilities, 1 long-term acute care hospital, and 12 home care agencies for wounds selected by staff to receive care based on computer-generated validated wound care algorithms. After diagnosis, wound dimensions and status were assessed using a tool adapted from the Pressure Sore Status Toolfor use on all wounds. Wound, ostomy, and continence nursing professionals accessed consistent protocols of care, via telemedicine in home care or paper forms in long-term care. A physician entered assessments into a desktop computer in the wound clinic. Based on evidence that healing proceeds faster with fewer infections in environments without gauze, the protocols generally avoided gauze dressings. Most of the 767 wounds selected to receive the standardized-protocols of care were stage III-IV pressure ulcers (n = 373; mean healing time 62 days) or full-thickness venous ulcers (n = 124; mean healing time 57 days). Partial-thickness wounds healed faster than same-etiology full-thickness wounds. These results provide benchmarks for natural-setting healing outcomes and help to define and address wound care challenges. Outcomes primarily using nongauze protocols of care matched or surpassed best previously published results on similar wounds using gauze-based protocols of care, including protocols applying gauze impregnated with growth factors or other agents.

A national evaluation of a dissemination and implementation initiative to enhance primary care practice capacity and improve cardiovascular disease care: the ESCALATES study protocol.

PubMed

Cohen, Deborah J; Balasubramanian, Bijal A; Gordon, Leah; Marino, Miguel; Ono, Sarah; Solberg, Leif I; Crabtree, Benjamin F; Stange, Kurt C; Davis, Melinda; Miller, William L; Damschroder, Laura J; McConnell, K John; Creswell, John

2016-06-29

The Agency for Healthcare Research and Quality (AHRQ) launched the EvidenceNOW Initiative to rapidly disseminate and implement evidence-based cardiovascular disease (CVD) preventive care in smaller primary care practices. AHRQ funded eight grantees (seven regional Cooperatives and one independent national evaluation) to participate in EvidenceNOW. The national evaluation examines quality improvement efforts and outcomes for more than 1500 small primary care practices (restricted to those with fewer than ten physicians per clinic). Examples of external support include practice facilitation, expert consultation, performance feedback, and educational materials and activities. This paper describes the study protocol for the EvidenceNOW national evaluation, which is called Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES). This prospective observational study will examine the portfolio of EvidenceNOW Cooperatives using both qualitative and quantitative data. Qualitative data include: online implementation diaries, observation and interviews at Cooperatives and practices, and systematic assessment of context from the perspective of Cooperative team members. Quantitative data include: practice-level performance on clinical quality measures (aspirin prescribing, blood pressure and cholesterol control, and smoking cessation; ABCS) collected by Cooperatives from electronic health records (EHRs); practice and practice member surveys to assess practice capacity and other organizational and structural characteristics; and systematic tracking of intervention delivery. Quantitative, qualitative, and mixed methods analyses will be conducted to examine how Cooperatives organize to provide external support to practices, to compare effectiveness of the dissemination and implementation approaches they implement, and to examine how regional variations and other organization and contextual factors influence implementation and effectiveness. ESCALATES is a national evaluation of an ambitious large-scale dissemination and implementation effort focused on transforming smaller primary care practices. Insights will help to inform the design of national health care practice extension systems aimed at supporting practice transformation efforts in the USA. NCT02560428 (09/21/15).

The Role of Plasma and Urine Metabolomics in Identifying New Biomarkers in Severe Newborn Asphyxia: A Study of Asphyxiated Newborn Pigs following Cardiopulmonary Resuscitation.

PubMed

Sachse, Daniel; Solevåg, Anne Lee; Berg, Jens Petter; Nakstad, Britt

2016-01-01

Optimizing resuscitation is important to prevent morbidity and mortality from perinatal asphyxia. The metabolism of cells and tissues is severely disturbed during asphyxia and resuscitation, and metabolomic analyses provide a snapshot of many small molecular weight metabolites in body fluids or tissues. In this study metabolomics profiles were studied in newborn pigs that were asphyxiated and resuscitated using different protocols to identify biomarkers for subject characterization, intervention effects and possibly prognosis. A total of 125 newborn Noroc pigs were anesthetized, mechanically ventilated and inflicted progressive asphyxia until asystole. Pigs were randomized to resuscitation with a FiO2 0.21 or 1.0, different duration of ventilation before initiation of chest compressions (CC), and different CC to ventilation ratios. Plasma and urine samples were obtained at baseline, and 2 h and 4 h after return of spontaneous circulation (ROSC, heart rate > = 100 bpm). Metabolomics profiles of the samples were analyzed by nuclear magnetic resonance spectroscopy. Plasma and urine showed severe metabolic alterations consistent with hypoxia and acidosis 2 h and 4 h after ROSC. Baseline plasma hypoxanthine and lipoprotein concentrations were inversely correlated to the duration of hypoxia sustained before asystole occurred, but there was no evidence for a differential metabolic response to the different resuscitation protocols or in terms of survival. Metabolic profiles of asphyxiated newborn pigs showed severe metabolic alterations. Consistent with previously published reports, we found no evidence of differences between established and alternative resuscitation protocols. Lactate and pyruvate may have a prognostic value, but have to be independently confirmed.

Overcoming recruitment challenges in palliative care clinical trials.

PubMed

LeBlanc, Thomas W; Lodato, Jordan E; Currow, David C; Abernethy, Amy P

2013-11-01

Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.

A comparative study of the use of the Istanbul Protocol amongst civil society organizations in low-income countries.

PubMed

Kelly, Toby; Jensen, Steffen; Koch Andersen, Morten; Christiansen, Catrine; Sharma, Jeevan Raj

2016-01-01

The Istanbul Protocol (IP) is one of the great success stories of the global anti-torture movement, setting out universal guidelines for the production of rigorous, objective and reliable evidence about allegations of torture and ill-treatment. The IP is explicitly designed to outline 'minimum standards for States'. However, it is all too often left to civil society organizations to investigate allegations of torture and ill-treatment. In this context, important questions remain as to how and where the IP can be used best by such organizations. These questions are particularly acute in situations where human rights groups may have limited institutional capacity. This paper explores the practical challenges faced by civil society in using the IP in Low-Income Countries. It is based on qualitative research in three case studies: Nepal, Kenya and Bangladesh. This research involved over 80 interviews with human rights practitioners. The conclusions of the paper are that the Istanbul Protocol provides a useful framework for documentation, but more comprehensive forms of documentation will often be limited to a very small - albeit important - number of legal cases. In many cases, the creation of precise and standardized forms of evidence is not necessarily the most effective form of documentation for redress or accountability. In the absence of legal systems willing and able to respond effectively to allegations of torture and ill-treatment, there are severe limitations on the practical effectiveness of detailed and technical forms of documentation.

An evaluation of pre-hospital emergency medical systems for suspected ST-elevation myocardial infarction in Colorado.

PubMed

Engelman, Glenn H; Carry, Patrick M; Kubes, Kyle M; Gleason, Michael J

2016-11-01

Patients presenting with ST-elevation myocardial infarction (STEMI) benefit from rapid cardiac reperfusion therapy. Emergency medical service (EMS) agencies can improve patient outcomes by calling STEMI alerts to the receiving facility. The aim of this study was to evaluate the use of pre-hospital activation systems for suspected ST-elevation myocardial infarctions (STEMI) throughout Colorado. A cross sectional, survey design was utilized to collect all data from EMS agencies in Colorado. A univariable logistic regression model was used to identify factors predictive of an agency reporting that they utilize a STEMI activation protocol. 84.5% [95% CI: 78.3 to 90.7%] of agencies included indicate that they utilize a STEMI activation protocol. Based on the logistic regression analysis, the number of EMT employees was significantly associated with whether or not an agency indicates that they utilize a STEMI activation protocol. For every 10% increase in the number of EMTs employed by an EMS agency, there was a 3.0 [95% CI: 1.5 to 6.0, p = 0.0012] fold increase in the odds of the agency indicating they utilize a STEMI activation protocol. Our study provides evidence that larger agencies are more likely to utilize a STEMI activation protocol. In areas without a STEMI system of care, improvements in smaller agencies that cover more ground (with longer transport times) should be the focus for protocol implementation. Based on the current prevalence of such training, competency based training in reading ST-elevations on ECG should be considered by EMS agencies.

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

PubMed

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

A systematic review of dental disease management in cancer patients.

PubMed

Hong, Catherine H L; Hu, Shijia; Haverman, Thijs; Stokman, Monique; Napeñas, Joel J; Braber, Jacolien Bos-den; Gerber, Erich; Geuke, Margot; Vardas, Emmanouil; Waltimo, Tuomas; Jensen, Siri Beier; Saunders, Deborah P

2018-01-01

This systematic review aims to update on the prevalence of odontogenic-related infections and the efficacy of dental strategies in preventing dental-related complications in cancer patients since the 2010 systematic review. A literature search was conducted in the databases MEDLINE/PubMed and EMBASE for articles published between 1 January 2009 and 30 June 2016. Each study was assessed by 2 reviewers and the body of evidence for each intervention was assigned an evidence level. After examination of the abstracts and full-text articles, 59 articles satisfied the inclusion criteria. The weighted prevalence of dental infections and pericoronitis during cancer therapy was 5.4 and 5.3%, respectively. The frequency of dental-related infections during intensive chemotherapy after complete, partial, and minimal pre-cancer dental evaluation/treatment protocols ranged from 0 to 4%. Protocols involving third molars extractions had the highest complications (40%). In view of the low prevalence of infections and the potential for complications after third molar extractions, it is suggested that partial dental evaluation/treatment protocols prior to intensive chemotherapy; whereby minor caries (within dentin), asymptomatic third molars or asymptomatic teeth without excessive probing depth (<8 mm), mobility (mobility I or II) or with periapical lesions of <5 mm were observed; is a viable option when there is insufficient time for complete dental evaluation/treatment protocols. The use of chlorhexidine, fluoride mouth rinses as well as composite resin, resin-modified glass ionomer cement (GIC), and amalgam restorations over conventional GIC in post head and neck radiation patients who are compliant fluoride users is recommended.

Surgeon preferences regarding antibiotic prophylaxis for ballistic fractures.

PubMed

Marecek, Geoffrey S; Earhart, Jeffrey S; Gardner, Michael J; Davis, Jason; Merk, Bradley R

2016-06-01

Scant evidence exists to support antibiotic use for low velocity ballistic fractures (LVBF). We therefore sought to define current practice patterns. We hypothesized that most surgeons prescribe antibiotics for LVBF, prescribing is not driven by institutional protocols, and that decisions are based on protocols utilized for blunt trauma. A web-based questionnaire was emailed to the membership of the Orthopaedic Trauma Association (OTA). The questionnaire included demographic information and questions about LVBF treatment practices. Two hundred and twenty surgeons responded. One hundred and fifty-four (70 %) respondents worked at a Level-1 trauma center, 176 (80 %) had received fellowship education in orthopaedic trauma and 104 (47 %) treated at least 10 ballistic fractures annually. Responses were analyzed with SAS 9.3 for Windows (SAS Institute Inc, Cary, NC). One hundred eighty-six respondents (86 %) routinely provide antibiotics for LVBF. Those who did not were more apt to do so for intra-articular fractures (8/16, 50 %) and pelvic fractures with visceral injury (10/16, 63 %). Most surgeons (167, 76 %) do not believe the Gustilo-Anderson classification applies to ballistic fractures, and (20/29, 70 %) do not base their antibiotic choice on the classification system. Few institutions (58, 26 %) have protocols guiding antibiotic use for LVBF. Routine antibiotic use for LVBF is common; however, practice is not dictated by institutional protocol. Although antibiotic use generally follows current blunt trauma guidelines, surgeons do not base their treatment decisions the Gustilo-Anderson classification. Given the high rate of antibiotic use for LVBF, further study should focus on providing evidence-based treatment guidelines.

Evidence-Based Assessment in Case Management to Improve Abnormal Cancer Screen Follow-Up

ERIC Educational Resources Information Center

Vourlekis, Betsy; Ell, Kathleen; Padgett, Deborah

2005-01-01

The authors describe an evidence-based assessment protocol for intensive case management to improve screening diagnostic follow-up developed through a research project in breast and cervical cancer early detection funded by the Centers for Disease Control and Prevention. Three components of an evidence-based approach to assessment are presented…

Synthesizing Quantitative Evidence for Evidence-based Nursing: Systematic Review.

PubMed

Oh, Eui Geum

2016-06-01

As evidence-based practice has become an important issue in healthcare settings, the educational needs for knowledge and skills for the generation and utilization of healthcare evidence are increasing. Systematic review (SR), a way of evidence generation, is a synthesis of primary scientific evidence, which summarizes the best evidence on a specific clinical question using a transparent, a priori protocol driven approach. SR methodology requires a critical appraisal of primary studies, data extraction in a reliable and repeatable way, and examination for validity of the results. SRs are considered hierarchically as the highest form of evidence as they are a systematic search, identification, and summarization of the available evidence to answer a focused clinical question with particular attention to the methodological quality of studies or the credibility of opinion and text. The purpose of this paper is to introduce an overview of the fundamental knowledge, principals and processes in SR. The focus of this paper is on SR especially for the synthesis of quantitative data from primary research studies that examines the effectiveness of healthcare interventions. To activate evidence-based nursing care in various healthcare settings, the best and available scientific evidence are essential components. This paper will include some examples to promote understandings. Copyright © 2016. Published by Elsevier B.V.

National Football League Head, Neck and Spine Committee's Concussion Diagnosis and Management Protocol: 2017-18 season.

PubMed

Ellenbogen, Richard G; Batjer, Hunt; Cardenas, Javier; Berger, Mitchel; Bailes, Julian; Pieroth, Elizabeth; Heyer, Robert; Theodore, Nicholas; Hsu, Wellington; Nabel, Elizabeth; Maroon, Joe; Cantu, Robert; Barnes, Ronnie; Collins, James; Putukian, Margot; Lonser, Russell; Solomon, Gary; Sills, Allen

2018-03-16

One of the National Football League's (NFL) Head, Neck and Spine Committee's principal goals is to create a 'best practice' protocol for concussion diagnosis and management for its players. The science related to concussion diagnosis and management continues to evolve, thus the protocol has evolved contemporaneously. The Fifth International Conference on Concussion in Sport was held in Berlin in 2016, and guidelines for sports concussion diagnosis and management were revised and refined. The NFL Head, Neck and Spine Committee has synthesised the most recent empirical evidence for sports concussion diagnosis and management including the Berlin consensus statement and tailored it to the game played in the NFL. One of the goals of the Committee is to provide a standardised, reliable, efficient and evidence-based protocol for concussion diagnosis and management that can be applied in this professional sport during practice and game day. In this article, the end-of-season version of the 2017-18 NFL Concussion Diagnosis and Management Protocol is described along with its clinical rationale. Immediate actions for concussion programme enhancement and research are reviewed. It is the Committee's expectation that the protocol will undergo refinement and revision over time as the science and clinical practice related to concussion in sports crystallise. © 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.

A practical overview of how to conduct a systematic review.

PubMed

Davis, Dilla

2016-11-16

With an increasing focus on evidence-based practice in health care, it is important that nurses understand the principles underlying systematic reviews. Systematic reviews are used in healthcare to present a comprehensive, policy-neutral, transparent and reproducible synthesis of evidence. This article provides a practical overview of the process of undertaking systematic reviews, explaining the rationale for each stage. It provides guidance on the standard methods applicable to every systematic review: writing and registering a protocol; planning a review; searching and selecting studies; data collection; assessing the risk of bias; and interpreting results.

Impact of a pharmacist-driven warfarin management protocol on achieving therapeutic International Normalized Ratios.

PubMed

Downing, Amanda; Mortimer, Molly; Hiers, Jill

2016-03-01

Warfarin is a high alert medication and a challenge to dose and monitor. Pharmacist-driven warfarin management has been shown to decrease the time international normalized ratio (INR) is out of range, which may reduce undesired outcomes. The purpose of this study is to assess the effect of the implementation of a pharmacist-driven warfarin management protocol on the achievement of therapeutic INRs. A warfarin management protocol was developed using evidence based literature and similar protocols from other institutions. Pharmacists utilized the protocol to provide patient specific warfarin dosing upon provider referral. To evaluate the protocol's impact, a retrospective chart review pre- and post-implementation was completed for admitted patients receiving warfarin. Three hundred twenty-seven charts were reviewed for pre- and post-implementation data. INRs within therapeutic range increased from 27.8% before protocol implementation to 38.5% after implementation. There was also a reduction in subtherapeutic INRs (55.3% pre to 39% post) and supratherapeutic INRs 5 or above (3.7% pre to 2.6% post). Supratherapeutic INRs between 3 and 5 did increase from 13.2% before protocol implementation to 19.9% in the pharmacist managed group. In addition to reducing the time to achievement of therapeutic INRs by 0.5 days, implementation of the protocol resulted in an increased the number of patients with at least one therapeutic INR during admission (35% pre to 40% post). The implementation of a pharmacist-driven warfarin dosing protocol increased therapeutic INRs, and decreased the time to therapeutic range, as well as the proportion of subtherapeutic INRs and supratherapeutic INRs 5 or greater. Additional benefits of the protocol include documentation of Joint Commission National Patient Safety Goal compliance, promotion of interdisciplinary collaboration and increased continuity of care. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Evaluation of an electronic health record-supported obesity management protocol implemented in a community health center: a cautionary note.

PubMed

Steglitz, Jeremy; Sommers, Mary; Talen, Mary R; Thornton, Louise K; Spring, Bonnie

2015-07-01

Primary care clinicians are well-positioned to intervene in the obesity epidemic. We studied whether implementation of an obesity intake protocol and electronic health record (EHR) form to guide behavior modification would facilitate identification and management of adult obesity in a Federally Qualified Health Center serving low-income, Hispanic patients. In three studies, we examined clinician and patient outcomes before and after the addition of the weight management protocol and form. In the Clinician Study, 12 clinicians self-reported obesity management practices. In the Population Study, BMI and order data from 5000 patients and all 40 clinicians in the practice were extracted from the EHR preintervention and postintervention. In the Exposure Study, EHR-documented outcomes for a sub-sample of 46 patients actually exposed to the obesity management form were compared to matched controls. Clinicians reported that the intake protocol and form increased their performance of obesity-related assessments and their confidence in managing obesity. However, no improvement in obesity management practices or patient weight-loss was evident in EHR records for the overall clinic population. Further analysis revealed that only 55 patients were exposed to the form. Exposed patients were twice as likely to receive weight-loss counseling following the intervention, as compared to before, and more likely than matched controls. However, their obesity outcomes did not differ. Results suggest that an obesity intake protocol and EHR-based weight management form may facilitate clinician weight-loss counseling among those exposed to the form. Significant implementation barriers can limit exposure, however, and need to be addressed. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Apical negative pressure irrigation versus syringe irrigation: a systematic review of cleaning and disinfection of the root canal system.

PubMed

Konstantinidi, E; Psimma, Z; Chávez de Paz, L E; Boutsioukis, C

2017-11-01

The aim of this study was to systematically review and critically analyse the published data on the treatment outcome (primary outcome) and on the cleaning and disinfection of root canals (secondary outcomes) achieved by negative pressure irrigation as compared to syringe irrigation. An electronic search was conducted in EMBASE, LILACS, PubMed, SciELO, Scopus and Web of Knowledge using both free-text keywords and controlled vocabulary. Additional studies were sought through hand searching of endodontic journals and of the relevant chapters of endodontic textbooks. No language restriction was imposed. The retrieved studies were screened by two reviewers according to predefined criteria. Included studies were critically appraised and the extracted data were arranged in tables. The electronic search and hand search retrieved 489 titles. One clinical study and 14 in vitro studies were finally included in the review; none of these studies assessed treatment outcome, four studies assessed the antimicrobial effect, seven studies evaluated the removal of pulp tissue remnants, and four studies investigated the removal of hard tissue debris or both hard tissue debris and pulp tissue remnants. Poor standardization and description of the protocols was evident. Inconclusive results were reported about the cleaning and disinfection accomplished by the two irrigation methods. Negative pressure irrigation was more effective under certain conditions when compared to suboptimal syringe irrigation; however, the variability of the protocols hindered quantitative synthesis. There is insufficient evidence to claim general superiority of any one of these methods. The level of the available evidence is low, and the conclusions should be interpreted with caution. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Regulation of human retinal blood flow by endothelin-1.

PubMed

Polak, Kaija; Luksch, Alexandra; Frank, Barbara; Jandrasits, Kerstin; Polska, Elzbieta; Schmetterer, Leopold

2003-05-01

There is evidence from in vitro and animal studies that endothelin is a major regulator of retinal blood flow. We set out to characterize the role of the endothelin-system in the blood flow control of the human retina. Two studies in healthy subjects were performed. The study design was randomized, placebo-controlled, double-masked, balanced, two-way crossover in protocol A and three way-way crossover in protocol B. In protocol A 18 healthy male subjects received intravenous endothelin-1 (ET-1) in a dose of 2.5 ng kg (-1)min(-1) for 30 min or placebo on two different study days and retinal vessel diameters were measured. In protocol B 12 healthy male subjects received ET-1 in stepwise increasing doses of 0, 1.25, 2.5 and 5 ng kg (-1)min(-1) (each infusion step over 20 min) in co-infusion with the specific ET(A)-receptor antagonist BQ123 (60 microg min (-1)) or placebo or BQ123 alone investigating retinal vessel diameters, retinal blood velocity and retinal blood flow. Measurements of retinal vessel size were done with the Zeiss retinal vessel analyzer. Measurements of blood velocities were done with bi-directional laser Doppler velocimetry. From these measurements retinal blood flow was calculated. In protocol A exogenous ET-1 tended to decrease retinal arterial diameter, but this effect was not significant versus placebo. No effect on retinal venous diameter was seen. In protocol B retinal venous blood velocity and retinal blood flow was significantly reduced after administration of exogenous ET-1. These effects were significantly blunted when BQ-123 was co-administered. By contrast, BQ-123 alone had no effect on retinal hemodynamic parameters. Concluding, BQ123 antagonizes the effects of exogenously administered ET-1 on retinal blood flow in healthy subjects. In addition, the results of the present study are compatible with the hypothesis that ET-1 exerts its vasoconstrictor effects in the retina mainly on the microvessels.

Family Carers' Experiences Using Support Services in Europe: Empirical Evidence from the EUROFAMCARE Study

ERIC Educational Resources Information Center

Lamura, Giovanni; Mnich, Eva; Nolan, Mike; Wojszel, Beata; Krevers, Barbro; Mestheneos, Liz; Dohner, Hanneli

2008-01-01

Purpose: This article explores the experiences of family carers of older people in using support services in six European countries: Germany, Greece, Italy, Poland, Sweden, and the UK. Design and Methods: Following a common protocol, data were collected from national samples of approximately 1,000 family carers per country and clustered into…

Sensemaking as a Trigger for Change in University Emergency Response Routines: Ethnographic and Case Study Analyses of a Residential Life Department

ERIC Educational Resources Information Center

Molina, Danielle Knabjian

2010-01-01

In light of incidents like the Virginia Tech massacre, there is growing need for scholarship on emergency management in higher education. Traditional literature has typically focused on locating breakdowns, blame, and accountability by questioning whether emergency responses evidence departures from protocol. Yet, experience teaches that adhering…

From policy to practice: implementing frontline community health services for substance dependence--study protocol.

PubMed

Gill, Kathryn J; Campbell, Emily; Gauthier, Gail; Xenocostas, Spyridoula; Charney, Dara; Macaulay, Ann C

2014-08-20

Substance abuse is a worldwide public health concern. Extensive scientific research has shown that screening and brief interventions for substance use disorders administered in primary care provide substantial benefit at relatively low cost. Frontline health clinicians are well placed to detect and treat patients with substance use disorders. Despite effectiveness shown in research, there are many factors that impact the implementation of these practices in real-world clinical practice. Recently, the Ministry of Health and Social Services in Quebec, Canada, issued two policy documents aimed at introducing screening and early intervention for substance abuse into frontline healthcare clinics in Quebec. The current research protocol was developed in order to study the process of implementation of evidence-based addiction treatment practices at three primary care clinics in Montreal (Phase 1). In addition, the research protocol was designed to examine the efficacy of overall policy implementation, including barriers and facilitators to addictions program development throughout Quebec (Phase 2). Phase 1 will provide an in-depth case study of knowledge translation and implementation. The study protocol will utilize an integrated knowledge translation strategy to build collaborative mechanisms for knowledge exchange between researchers, addiction specialists, and frontline practitioners (guided by the principles of participatory-action research), and directly examine the process of knowledge uptake and barriers to transfer using both qualitative and quantitative methodologies. Evaluation will involve multiple measures, time points and domains; program uptake and effectiveness will be determined by changes in healthcare service delivery, sustainability and outcomes. In Phase 2, qualitative methods will be utilized to examine the contextual facilitators and barriers that frontline organizations face in implementing services for substance dependence. Phase 2 will provide the first study exploring the wide-scale implementation of frontline services for substance dependence in the province of Quebec and yield needed information about how to effectively implement mandated policies into clinical practice and impact public health. Findings from this research program will contribute to the understanding of factors associated with implementation of frontline services for substance dependence and help to inform future policy and organizational support for the implementation of evidence-based practices.

Evidence supporting the need for a common soil monitoring protocol

Treesearch

Derrick A. Reeves; Mark D. Coleman; Deborah S. Page-Dumroese

2013-01-01

Many public land management agencies monitor forest soils for levels of disturbance related to management activities. Although several soil disturbance monitoring protocols based on visual observation have been developed to assess the amount and types of disturbance caused by forest management, no common method is currently used on National Forest lands in the United...

Factors associated with neonatal pneumonia in India: protocol for a systematic review and planned meta-analysis.

PubMed

Nair, Sreekumaran; Lewis, Leslie Edward; Godinho, Myron Anthony; Murthy, Shruti; Lakiang, Theophilus; Venkatesh, Bhumika T

2018-01-10

India accounts for more neonatal deaths than any other country. There is a lack of consolidated evidence from India regarding the determining factors of pneumonia in neonates. This systematic review is aimed to consolidate and appraise the evidence on risk factors and determinants of pneumonia among neonates in India. This protocol is part of a project consisting of three reviews (two systematic reviews and one scoping review) and a qualitative study on neonatal pneumonia in India. English language observational studies which report risk factors and determinants of neonatal pneumonia in India will be eligible for inclusion. Electronic searching of nine databases, and hand searching will be done. Two authors will independently conduct screening (title, abstract and full-text stages), extract data and assess risk of bias. A meta-analysis is planned to be performed with random-effects model. A narrative synthesis will be used to summarise the characteristics and findings of the review, if a meta-analysis cannot be performed. If there are more than 10 studies, publication bias will be assessed. Sensitivity and subgroup analysis will performed based on data availability. The quality of our review will be assessed by using 'Assessing the Methodological quality of Systematic Reviews' and 'Grades of Recommendation, Assessment, Development and Evaluation'. The protocol of the entire project has been approved by the host institution's ethics body (Institutional Ethics Committee, Manipal University, Manipal, India), and the 'Health Ministry Screening Committee' under the Ministry of Health and Family Welfare, Government of India. The study findings will be disseminated among relevant stakeholders using knowledge dissemination workshops, policy briefs, publications, etc. CRD42016044019. © 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.

Factors associated with neonatal pneumonia in India: protocol for a systematic review and planned meta-analysis

PubMed Central

Nair, Sreekumaran; Lewis, Leslie Edward; Godinho, Myron Anthony; Murthy, Shruti; Lakiang, Theophilus; Venkatesh, Bhumika T

2018-01-01

Introduction India accounts for more neonatal deaths than any other country. There is a lack of consolidated evidence from India regarding the determining factors of pneumonia in neonates. This systematic review is aimed to consolidate and appraise the evidence on risk factors and determinants of pneumonia among neonates in India. Methods and analysis This protocol is part of a project consisting of three reviews (two systematic reviews and one scoping review) and a qualitative study on neonatal pneumonia in India. English language observational studies which report risk factors and determinants of neonatal pneumonia in India will be eligible for inclusion. Electronic searching of nine databases, and hand searching will be done. Two authors will independently conduct screening (title, abstract and full-text stages), extract data and assess risk of bias. A meta-analysis is planned to be performed with random-effects model. A narrative synthesis will be used to summarise the characteristics and findings of the review, if a meta-analysis cannot be performed. If there are more than 10 studies, publication bias will be assessed. Sensitivity and subgroup analysis will performed based on data availability. The quality of our review will be assessed by using ‘Assessing the Methodological quality of Systematic Reviews’ and ‘Grades of Recommendation, Assessment, Development and Evaluation’. Ethics and dissemination The protocol of the entire project has been approved by the host institution’s ethics body (Institutional Ethics Committee, Manipal University, Manipal, India), and the ‘Health Ministry Screening Committee’ under the Ministry of Health and Family Welfare, Government of India. The study findings will be disseminated among relevant stakeholders using knowledge dissemination workshops, policy briefs, publications, etc. PROSPERO registration number CRD42016044019. PMID:29326186

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Protocol-based care: the standardisation of decision-making?

PubMed

Rycroft-Malone, Jo; Fontenla, Marina; Seers, Kate; Bick, Debra

2009-05-01

To explore how protocol-based care affects clinical decision-making. In the context of evidence-based practice, protocol-based care is a mechanism for facilitating the standardisation of care and streamlining decision-making through rationalising the information with which to make judgements and ultimately decisions. However, whether protocol-based care does, in the reality of practice, standardise decision-making is unknown. This paper reports on a study that explored the impact of protocol-based care on nurses' decision-making. Theoretically informed by realistic evaluation and the promoting action on research implementation in health services framework, a case study design using ethnographic methods was used. Two sites were purposively sampled; a diabetic and endocrine unit and a cardiac medical unit. Within each site, data collection included observation, postobservation semi-structured interviews with staff and patients, field notes, feedback sessions and document review. Data were inductively and thematically analysed. Decisions made by nurses in both sites were varied according to many different and interacting factors. While several standardised care approaches were available for use, in reality, a variety of information sources informed decision-making. The primary approach to knowledge exchange and acquisition was person-to-person; decision-making was a social activity. Rarely were standardised care approaches obviously referred to; nurses described following a mental flowchart, not necessarily linked to a particular guideline or protocol. When standardised care approaches were used, it was reported that they were used flexibly and particularised. While the logic of protocol-based care is algorithmic, in the reality of clinical practice, other sources of information supported nurses' decision-making process. This has significant implications for the political goal of standardisation. The successful implementation and judicious use of tools such as protocols and guidelines will likely be dependant on approaches that facilitate the development of nurses' decision-making processes in parallel to paying attention to the influence of context.

Evaluation of platelet adhesion and activation on polymers: Round-robin study to assess inter-center variability.

PubMed

Braune, S; Sperling, C; Maitz, M F; Steinseifer, U; Clauser, J; Hiebl, B; Krajewski, S; Wendel, H P; Jung, F

2017-10-01

The regulatory agencies provide recommendations rather than protocols or standard operation procedures for the hemocompatibility evaluation of novel materials e.g. for cardiovascular applications. Thus, there is a lack of specifications with regard to test setups and procedures. As a consequence, laboratories worldwide perform in vitro assays under substantially different test conditions, so that inter-laboratory and inter-study comparisons are impossible. Here, we report about a prospective, randomized and double-blind multicenter trial which demonstrates that standardization of in vitro test protocols allows a reproducible assessment of platelet adhesion and activation from fresh human platelet rich plasma as possible indicators of the thrombogenicity of cardiovascular implants. Standardization of the reported static in vitro setup resulted in a laboratory independent scoring of the following materials: poly(dimethyl siloxane) (PDMS), poly(ethylene terephthalate) (PET) and poly(tetrafluoro ethylene) (PTFE). The results of this in vitro study provide evidence that inter-laboratory and inter-study comparisons can be achieved for the evaluation of the adhesion and activation of platelets on blood-contacting biomaterials by stringent standardization of test protocols. Copyright © 2017 Elsevier B.V. All rights reserved.

An experimental investigation of masking in the US FDA adverse event reporting system database.

PubMed

Wang, Hsin-wei; Hochberg, Alan M; Pearson, Ronald K; Hauben, Manfred

2010-12-01

A phenomenon of 'masking' or 'cloaking' in pharmacovigilance data mining has been described, which can potentially cause signals of disproportionate reporting (SDRs) to be missed, particularly in pharmaceutical company databases. Masking has been predicted theoretically, observed anecdotally or studied to a limited extent in both pharmaceutical company and health authority databases, but no previous publication systematically assesses its occurrence in a large health authority database. To explore the nature, extent and possible consequences of masking in the US FDA Adverse Event Reporting System (AERS) database by applying various experimental unmasking protocols to a set of drugs and events representing realistic pharmacovigilance analysis conditions. This study employed AERS data from 2001 through 2005. For a set of 63 Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms (PTs), disproportionality analysis was carried out with respect to all drugs included in the AERS database, using a previously described urn-model-based algorithm. We specifically sought masking in which drug removal induced an increase in the statistical representation of a drug-event combination (DEC) that resulted in the emergence of a new SDR. We performed a series of unmasking experiments selecting drugs for removal using rational statistical decision rules based on the requirement of a reporting ratio (RR) >1, top-ranked statistical unexpectedness (SU) and relatedness as reflected in the WHO Anatomical Therapeutic Chemical level 4 (ATC4) grouping. In order to assess the possible extent of residual masking we performed two supplemental purely empirical analyses on a limited subset of data. This entailed testing every drug and drug group to determine which was most influential in uncovering masked SDRs. We assessed the strength of external evidence for a causal association for a small number of masked SDRs involving a subset of 29 drugs for which level of evidence adjudication was available from a previous study. The original disproportionality analysis identified 8719 SDRs for the 63 PTs. The SU-based unmasking protocols generated variable numbers of masked SDRs ranging from 38 to 156, representing a 0.43-1.8% increase over the number of baseline SDRs. A significant number of baseline SDRs were also lost in the course of our experiments. The trend in the number of gained SDRs per report removed was inversely related to the number of lost SDRs per protocol. Both the number and nature of the reports removed influenced the number of gained SDRs observed. The purely empirical protocols unmasked up to ten times as many SDRs. None of the masked SDRs had strong external evidence supporting a causal association. Most involved associations for which there was no external supporting evidence or were in the original product label. For two masked SDRs, there was external evidence of a possible causal association. We documented masking in the FDA AERS database. Attempts at unmasking SDRs using practically implementable protocols produced only small changes in the output of SDRs in our analysis. This is undoubtedly related to the large size and diversity of the database, but the complex interdependencies between drugs and events in authentic spontaneous reporting system (SRS) databases, and the impact of measures of statistical variability that are typically used in real-world disproportionality analysis, may be additional factors that constrain the discovery of masked SDRs and which may also operate in pharmaceutical company databases. Empirical determination of the most influential drugs may uncover significantly more SDRs than protocols based on predetermined statistical selection rules but are impractical except possibly for evaluating specific events. Routine global exercises to elicit masking, especially in large health authority databases are not justified based on results available to date. Exercises to elicit unmasking should be driven by prior knowledge or obvious data imbalances.

Using an intervention mapping approach to develop a discharge protocol for intensive care patients.

PubMed

van Mol, Margo; Nijkamp, Marjan; Markham, Christine; Ista, Erwin

2017-12-19

Admission into an intensive care unit (ICU) may result in long-term physical, cognitive, and emotional consequences for patients and their relatives. The care of the critically ill patient does not end upon ICU discharge; therefore, integrated and ongoing care during and after transition to the follow-up ward is pivotal. This study described the development of an intervention that responds to this need. Intervention Mapping (IM), a six-step theory- and evidence-based approach, was used to guide intervention development. The first step, a problem analysis, comprised a literature review, six semi-structured telephone interviews with former ICU-patients and their relatives, and seven qualitative roundtable meetings for all eligible nurses (i.e., 135 specialized and 105 general ward nurses). Performance and change objectives were formulated in step two. In step three, theory-based methods and practical applications were selected and directed at the desired behaviors and the identified barriers. Step four designed a revised discharge protocol taking into account existing interventions. Adoption, implementation and evaluation of the new discharge protocol (IM steps five and six) are in progress and were not included in this study. Four former ICU patients and two relatives underlined the importance of the need for effective discharge information and supportive written material. They also reported a lack of knowledge regarding the consequences of ICU admission. 42 ICU and 19 general ward nurses identified benefits and barriers regarding discharge procedures using three vignettes framed by literature. Some discrepancies were found. For example, ICU nurses were skeptical about the impact of writing a lay summary despite extensive evidence of the known benefits for the patients. ICU nurses anticipated having insufficient skills, not knowing the patient well enough, and fearing legal consequences of their writings. The intervention was designed to target the knowledge, attitudes, self-efficacy, and perceived social influence. Building upon IM steps one to three, a concept discharge protocol was developed that is relevant and feasible within current daily practice. Intervention mapping provided a comprehensive framework to improve ICU discharge by guiding the development process of a theory- and empirically-based discharge protocol that is robust and useful in practice.

Moving forward: response to "Studying eyewitness investigations in the field".

PubMed

Ross, Stephen J; Malpass, Roy S

2008-02-01

Field studies of eyewitness identification are richly confounded. Determining which confounds undermine interpretation is important. The blind administration confound in the Illinois study is said to undermine it's value for understanding the relative utility of simultaneous and sequential lineups. Most criticisms of the Illinois study focus on filler identifications, and related inferences about the importance of the blind confound. We find no convincing evidence supporting this line of attack and wonder at filler identifications as the major line of criticism. More debilitating problems impede using the Illinois study to address the simultaneous versus sequential lineup controversy: inability to estimate guilt independent of identification evidence, lack of protocol compliance monitoring, and assessment of lineups quality. Moving forward requires removing these limitations.

Clinician adoption patterns and patient outcome results in use of evidence-based nursing plans of care.

PubMed

Kim, Tae Youn; Lang, Norma M; Berg, Karen; Weaver, Charlotte; Murphy, Judy; Ela, Sue

2007-10-11

Delivery of safe, effective and appropriate health care is an imperative facing health care organizations globally. While many initiatives have been launched in a number of countries to address this need from a medical perspective, a similar focus for generating evidence-based nursing knowledge has been missing. This paper reports on a collaborative evidence-based practice (EBP) research initiative that adds nursing knowledge into computerized care protocols. Here, a brief overview of the study's aims, purpose and methodology is presented as well as results of data analysis and lessons learned. The research team examined nurses' adoption patterns of EBP recommendations with respect to activity tolerance using four-month patient data collected from a pilot hospital. Study findings indicate a need for more focus on the system design and implementation process with the next rollout phase to promote evidence-based nursing practice.

Analysis of the Impact of Rosuvastatin on Bacterial Mevalonate Production Using a UPLC-Mass Spectrometry Approach.

PubMed

Nolan, J A; Kinsella, M; Hill, C; Joyce, S A; Gahan, C G M

2016-07-01

Statins are widely prescribed cholesterol-lowering medications and act through inhibition of the human enzyme 3-methylglutaryl coenzyme A reductase (HMG-R) which produces mevalonate (MVAL), a key substrate for cholesterol biosynthesis. Some important microbial species also express an isoform of HMG-R; however, the nature of the interaction between statins and bacteria is currently unclear and studies would benefit from protocols to quantify MVAL in complex microbial environments. The objective of this study was to develop a protocol for the analytical quantification of MVAL in bacterial systems and to utilise this approach to analyse the effects of Rosuvastatin (RSV) on bacterial MVAL formation. To determine the effective concentration range of RSV, we examined the dose-dependent inhibition of growth in the HMG-R(+) bacterial pathogens Listeria monocytogenes, Staphylococcus aureus and Enterococcus faecium at various concentrations of pure RSV. Growth inhibition generally correlated with a reduction in bacterial MVAL levels, particularly in culture supernatants at high RSV concentrations, as determined using our ultra-performance liquid chromatography mass spectrometry protocol. This work therefore outlines a refined protocol for the analysis of MVAL in microbial cultures and provides evidence for statin-mediated inhibition of bacterial HMG-R. Furthermore, we show that MVAL is readily transported and secreted from bacterial cells into the growth media.

Clinical Applicability and Cutoff Values for an Unstructured Neuropsychological Assessment Protocol for Older Adults with Low Formal Education

PubMed Central

de Paula, Jonas Jardim; Bertola, Laiss; Ávila, Rafaela Teixeira; Moreira, Lafaiete; Coutinho, Gabriel; de Moraes, Edgar Nunes; Bicalho, Maria Aparecida Camargos; Nicolato, Rodrigo; Diniz, Breno Satler; Malloy-Diniz, Leandro Fernandes

2013-01-01

Background and Objectives The neuropsychological exam plays a central role in the assessment of elderly patients with cognitive complaints. It is particularly relevant to differentiate patients with mild dementia from those subjects with mild cognitive impairment. Formal education is a critical factor in neuropsychological performance; however, there are few studies that evaluated the psychometric properties, especially criterion related validity, neuropsychological tests for patients with low formal education. The present study aims to investigate the validity of an unstructured neuropsychological assessment protocol for this population and develop cutoff values for clinical use. Methods and Results A protocol composed by the Rey-Auditory Verbal Learning Test, Frontal Assessment Battery, Category and Letter Fluency, Stick Design Test, Clock Drawing Test, Digit Span, Token Test and TN-LIN was administered to 274 older adults (96 normal aging, 85 mild cognitive impairment and 93 mild Alzheimer`s disease) with predominantly low formal education. Factor analysis showed a four factor structure related to Executive Functions, Language/Semantic Memory, Episodic Memory and Visuospatial Abilities, accounting for 65% of explained variance. Most of the tests showed a good sensitivity and specificity to differentiate the diagnostic groups. The neuropsychological protocol showed a significant ecological validity as 3 of the cognitive factors explained 31% of the variance on Instrumental Activities of Daily Living. Conclusion The study presents evidence of the construct, criteria and ecological validity for this protocol. The neuropsychological tests and the proposed cutoff values might be used for the clinical assessment of older adults with low formal education. PMID:24066031

Treatment options and barriers to case management of neonatal pneumonia in India: a protocol for a scoping review.

PubMed

Nair, N Sreekumaran; Lewis, Leslie Edward; Murthy, Shruti; Godinho, Myron Anthony; Lakiang, Theophilus; Venkatesh, Bhumika T

2017-09-15

India contributes to the highest neonatal deaths globally. Case management is said to be the cornerstone of pneumonia control. Much of the published evidence focuses on children aged 1 to 59 months. This scoping review, thus, aims to identify the treatment options for and barriers to case management of neonatal pneumonia in India. This protocol is part of a series of three reviews on neonatal pneumonia in India. Studies addressing treatment of or barriers to case management of neonatal pneumonia in Indian context, published in English in peer-reviewed and indexed journals will be eligible for inclusion. Electronic search will be conducted on nine databases. Hand searching and snowballing will be done for published and grey literature. Selection of studies will be done in title, abstract and full-text stages. A narrative summary will be performed to summarise the details of evidence. As this is a review involving analysis of secondary data which is available in the public domain and does not involve human participants, ethical approval was not required. The findings of the study will be shared with all stakeholders of this research. Knowledge dissemination workshops will be conducted with relevant stakeholders to ultimately transfer the evidence tailored to the stakeholder (eg, policy briefs, publications, information booklets and so on). PROSPERO 2016: CRD42016045449. © 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.

The Promoting Effective Advance Care for Elders (PEACE) randomized pilot study: theoretical framework and study design.

PubMed

Allen, Kyle R; Hazelett, Susan E; Radwany, Steven; Ertle, Denise; Fosnight, Susan M; Moore, Pamela S

2012-04-01

Practice guidelines are available for hospice and palliative medicine specialists and geriatricians. However, these guidelines do not adequately address the needs of patients who straddle the 2 specialties: homebound chronically ill patients. The purpose of this article is to describe the theoretical basis for the Promoting Effective Advance Care for Elders (PEACE) randomized pilot study. PEACE is an ongoing 2-group randomized pilot study (n=80) to test an in-home interdisciplinary care management intervention that combines palliative care approaches to symptom management, psychosocial and emotional support, and advance care planning with geriatric medicine approaches to optimizing function and addressing polypharmacy. The population comprises new enrollees into PASSPORT, Ohio's community-based, long-term care Medicaid waiver program. All PASSPORT enrollees have geriatric/palliative care crossover needs because they are nursing home eligible. The intervention is based on Wagner's Chronic Care Model and includes comprehensive interdisciplinary care management for these low-income frail elders with chronic illnesses, uses evidence-based protocols, emphasizes patient activation, and integrates with community-based long-term care and other community agencies. Our model, with its standardized, evidence-based medical and psychosocial intervention protocols, will transport easily to other sites that are interested in optimizing outcomes for community-based, chronically ill older adults. © Mary Ann Liebert, Inc.

The use of pedometers for monitoring physical activity in children and adolescents: measurement considerations.

PubMed

Clemes, Stacy A; Biddle, Stuart J H

2013-02-01

Pedometers are increasingly being used to measure physical activity in children and adolescents. This review provides an overview of common measurement issues relating to their use. Studies addressing the following measurement issues in children/adolescents (aged 3-18 years) were included: pedometer validity and reliability, monitoring period, wear time, reactivity, and data treatment and reporting. Pedometer surveillance studies in children/adolescents (aged: 4-18 years) were also included to enable common measurement protocols to be highlighted. In children > 5 years, pedometers provide a valid and reliable, objective measure of ambulatory activity. Further evidence is required on pedometer validity in preschool children. Across all ages, optimal monitoring frames to detect habitual activity have yet to be determined; most surveillance studies use 7 days. It is recommended that standardized wear time criteria are established for different age groups, and that wear times are reported. As activity varies between weekdays and weekend days, researchers interested in habitual activity should include both types of day in surveillance studies. There is conflicting evidence on the presence of reactivity to pedometers. Pedometers are a suitable tool to objectively assess ambulatory activity in children (> 5 years) and adolescents. This review provides recommendations to enhance the standardization of measurement protocols.

Factors influencing early rehabilitation after THA: a systematic review.

PubMed

Sharma, Vivek; Morgan, Patrick M; Cheng, Edward Y

2009-06-01

A wide variation exists in rehabilitation after total hip arthroplasty (THA) in part due to a paucity of evidence-based literature. We asked whether a minimally invasive surgical approach, a multimodal approach to pain control with revised anesthesia protocols, hip restrictions, or preoperative physiotherapy achieved a faster rehabilitation and improved immediate short-term outcome. We conducted a systematic review of 16 level I and II studies after a strategy-based search of English literature on OVID Medline, PubMed, CINAHL, Cochrane, and EMBASE databases. We defined the endpoint of assessment as independent ambulation and ability to perform activities of daily living. Literature supports the use of a multimodal pain control to improve patient compliance in accelerated rehabilitation. Multimodal pain control with revised anesthesia protocols and accelerated rehabilitation speeds recovery after minimally invasive THA compared to the standard approach THA, but a smaller incision length or minimally invasive approach does not demonstrably improve the short-term outcome. Available studies justify no hip restrictions following an anterolateral approach but none have examined the question for a posterior approach. Preoperative physiotherapy may facilitate faster postoperative functional recovery but multicenter and well-designed prospective randomized studies with outcome measures are necessary to confirm its efficacy. Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Methods for Evaluating the Content, Usability, and Efficacy of Commercial Mobile Health Apps

PubMed Central

Silfee, Valerie J; Waring, Molly E; Boudreaux, Edwin D; Sadasivam, Rajani S; Mullen, Sean P; Carey, Jennifer L; Hayes, Rashelle B; Ding, Eric Y; Bennett, Gary G; Pagoto, Sherry L

2017-01-01

Commercial mobile apps for health behavior change are flourishing in the marketplace, but little evidence exists to support their use. This paper summarizes methods for evaluating the content, usability, and efficacy of commercially available health apps. Content analyses can be used to compare app features with clinical guidelines, evidence-based protocols, and behavior change techniques. Usability testing can establish how well an app functions and serves its intended purpose for a target population. Observational studies can explore the association between use and clinical and behavioral outcomes. Finally, efficacy testing can establish whether a commercial app impacts an outcome of interest via a variety of study designs, including randomized trials, multiphase optimization studies, and N-of-1 studies. Evidence in all these forms would increase adoption of commercial apps in clinical practice, inform the development of the next generation of apps, and ultimately increase the impact of commercial apps. PMID:29254914

Meeting Our Standards for Educational Justice: Doing Our Best with the Evidence

ERIC Educational Resources Information Center

Joyce, Kathryn E.; Cartwright, Nancy

2018-01-01

The United States considers educating all students to a threshold of adequate outcomes to be a central goal of educational justice. The No Child Left Behind Act introduced evidence-based policy and accountability protocols to ensure that all students receive an education that enables them to meet adequacy standards. Unfortunately, evidence-based…

Strategies for research engagement of clinicians in allied health (STRETCH): a mixed methods research protocol.

PubMed

Mickan, Sharon; Wenke, Rachel; Weir, Kelly; Bialocerkowski, Andrea; Noble, Christy

2017-09-11

Allied health professionals (AHPs) report positive attitudes to using research evidence in clinical practice, yet often lack time, confidence and skills to use, participate in and conduct research. A range of multifaceted strategies including education, mentoring and guidance have been implemented to increase AHPs' use of and participation in research. Emerging evidence suggests that knowledge brokering activities have the potential to support research engagement, but it is not clear which knowledge brokering strategies are most effective and in what contexts they work best to support and maintain clinicians' research engagement. This protocol describes an exploratory concurrent mixed methods study that is designed to understand how allied health research fellows use knowledge brokering strategies within tailored evidence-based interventions, to facilitate research engagement by allied health clinicians. Simultaneously, a realist approach will guide a systematic process evaluation of the research fellows' pattern of use of knowledge brokering strategies within each case study to build a programme theory explaining which knowledge brokering strategies work best, in what contexts and why. Learning and behavioural theories will inform this critical explanation. An explanation of how locally tailored evidence-based interventions improve AHPs use of, participation in and leadership of research projects will be summarised and shared with all participating clinicians and within each case study. It is expected that local recommendations will be developed and shared with medical and nursing professionals in and beyond the health service, to facilitate building research capacity in a systematic and effective way. © 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.

Rural Indonesian health care workers' constructs of infection prevention and control knowledge.

PubMed

Marjadi, Brahmaputra; McLaws, Mary-Louise

2010-06-01

Understanding the constructs of knowledge behind clinical practices in low-resource rural health care settings with limited laboratory facilities and surveillance programs may help in designing resource-appropriate infection prevention and control education. Multiple qualitative methods of direct observations, individual and group focus discussions, and document analysis were used to examine health care workers' knowledge of infection prevention and control practices in intravenous therapy, antibiotic therapy, instrument reprocessing, and hand hygiene in 10 rural Indonesian health care facilities. Awareness of health care-associated infections was low. Protocols were in the main based on verbal instructions handed down through the ranks of health care workers. The evidence-based knowledge gained across professional training was overridden by empiricism, nonscientific modifications, and organizational and societal cultures when resources were restricted or patients demanded inappropriate therapies. This phenomenon remained undetected by accreditation systems and clinical educators. Rural Indonesian health care workers would benefit from a formal introduction to evidence-based practice that would deconstruct individual protocols that include nonscientific knowledge. To achieve levels of acceptable patient safety, protocols would have to be both evidence-based and resource-appropriate. Copyright 2010 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Treatment of Pediatric Bipolar Disorder: A Review

PubMed Central

Washburn, Jason J.; West, Amy E.; Heil, Jennifer A.

2011-01-01

Aim To review the diagnosis and the pharmacologic and psychosocial interventions for pediatric bipolar disorder (PBD). Methods A comprehensive literature review of studies discussing the diagnosis and treatment of PBD was conducted. Results A context for understanding controversies and difficulties in the diagnosis of PBD is provided. An evidence-based assessment protocol for PBD is reviewed. The evidence for the following three categories of pharmacologic interventions are reviewed: Lithium, antiepileptics, and second generation antipsychotics. Algorithms for medication decisions are briefly reviewed. Existing psychosocial treatments and the evidence for those treatments are also reviewed. Conclusion Despite recent developments in understanding the phenomenology of PBD and in identifying pharmacologic and psychosocial interventions, critical gaps remain. PMID:21822352

Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

PubMed

Brehmer, Jess L; Husband, Jeffrey B

2014-10-01

There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

Effects of quadriceps strength after static and dynamic whole-body vibration exercise.

PubMed

Bush, Jill A; Blog, Gabriel L; Kang, Jie; Faigenbaum, Avery D; Ratamess, Nicholas A

2015-05-01

Numerous studies have shown performance benefits including whole-body vibration (WBV) as a training modality or an acute exercise protocol when used as a component of the resistance training program. Some studies have indicated that performing dynamic exercises as compared with static position exercises while exposed to WBV might be beneficial; however, evidence is lacking. Thus, the purpose of this study was to determine if an acute bout of dynamic versus static squats performed during WBV results in increase in quadriceps force production by means of dynamic isokinetic knee extension and flexion exercise. Nonresistance-trained healthy young men and women (N = 21) of 18-25 years participated in 4 protocols with 2-week rest in-between. Protocol 1 consisted of 5 sets of 10 dynamic squats without vibration; Protocol 2: 5 sets of 30-second static squats without vibration; Protocol 3: 5 sets of 10 dynamic squats with 30-Hz WBV for a total of 2.5 minutes; and Protocol 4: 5 sets of 30-second static squats with 30-Hz WBV for a total of 2.5 minutes. Prestrength tests (1 set of 4 repetitions at 100° · s(-1) for the knee extension exercise) was performed within 5 minutes of starting each protocol, and poststrength testing was performed within 1 minute of completing each protocol. Strength outcomes were analyzed by repeated measures analysis of variance with a significance level set at p ≤ 0.05. A significant decrease in strength was observed after dynamic and static squats without WBV (p = 0.002); an increase in strength after dynamic squats with WBV (p = 0.003); and a decrease in strength after static squats with WBV (p = 0.003). The inclusion of WBV to dynamic resistance exercise can be an added modality to increase strength. Whole-body vibration can have varied effects in altering muscle strength in untrained individuals according to the type of resistance training performed. As a dynamic squat with WBV seems to immediately potentiate neuromuscular functioning, the combination of dynamic exercises and WBV could be used as a potential warm-up procedure before resistance exercise.

Diagnostic protocol for gestational diabetes mellitus (GDM) (IADPSG/ADA, 2011): influence on the occurrence of GDM and mild gestational hyperglycemia (MGH) and on the perinatal outcomes.

PubMed

Sirimarco, Mariana Pinto; Guerra, Helena Maciel; Lisboa, Eduardo Guimarães; Vernini, Joice Monalisa; Cassetari, Bianca Nicolosi; de Araujo Costa, Roberto Antonio; Rudge, Marilza Vieira Cunha; de Mattos Paranhos Calderon, Iracema

2017-01-01

In August 2011, the Specialized Center for Diabetes and Pregnancy of the Botucatu Medical School/Unesp adopted a new diagnostic protocol for gestational diabetes mellitus, recommended by the American Diabetes Association and the International Association of the Diabetes and Pregnancy Study Group. The glycemic profile was evaluated using the 75-g oral glucose tolerance test (OGTT) used to diagnose mild gestational hyperglycemia, recognized and treated in our department as gestational diabetes mellitus. The cost-effectiveness of the new guidelines and the continued need for the evaluation of the glycemic profile, as part of our Service protocol, are controversial and require further investigation. We aimed to assess the impact of the new guidelines on the evaluation of mild gestational hyperglycemia and gestational diabetes mellitus, the incidence of adverse perinatal outcomes, and the association between the 75-g OGTT and the glycemic profile for the diagnosis of mild gestational hyperglycemia. This cross-sectional study was performed identifying a convenience sample of pregnant women and their newborns. The women used our Service for diagnostic procedures, prenatal care and delivery, both before (January 2008 to August 14, 2011) and after (August 15, 2011 to December 2014) the protocol modification. The following variables were compared, following stratification according to diagnostic protocol: prevalence of gestational diabetes mellitus and mild gestational hyperglycemia, newborns large for gestational age, macrosomia, first cesarean delivery, and newborn hospital stay. Statistical analysis was performed using Poisson regression, the Student's t test, the Chi square or Fisher's exact test and risk estimate. The statistical significance threshold was set at 95% (p < 0.05). The new protocol resulted in an 85% increase in the number of women with GDM, but failed to identify 17.3% of pregnant women classified as having mild gestational hyperglycemia, despite a normal 75-g OGTT. The new guidelines did not affect perinatal outcome. These results support the validity of maintaining the glycemic profile as part of the diagnostic protocol at our hospital. Large multicenter studies with an adequate sample size are required for conclusive evidence on the cost-effectiveness of the new protocol.

Health Worker Compliance with a 'Test And Treat' Malaria Case Management Protocol in Papua New Guinea.

PubMed

Pulford, Justin; Smith, Iso; Mueller, Ivo; Siba, Peter M; Hetzel, Manuel W

2016-01-01

The Papua New Guinea (PNG) Department of Health introduced a 'test and treat' malaria case management protocol in 2011. This study assesses health worker compliance with the test and treat protocol on a wide range of measures, examines self-reported barriers to health worker compliance as well as health worker attitudes towards the test and treat protocol. Data were collected by cross-sectional survey conducted in randomly selected primary health care facilities in 2012 and repeated in 2014. The combined survey data included passive observation of current or recently febrile patients (N = 771) and interviewer administered questionnaires completed with health workers (N = 265). Across the two surveys, 77.6% of patients were tested for malaria infection by rapid diagnostic test (RDT) or microscopy, 65.6% of confirmed malaria cases were prescribed the correct antimalarials and 15.3% of febrile patients who tested negative for malaria infection were incorrectly prescribed an antimalarial. Overall compliance with a strictly defined test and treat protocol was 62.8%. A reluctance to test current/recently febrile patients for malaria infection by RDT or microscopy in the absence of acute malaria symptoms, reserving recommended antimalarials for confirmed malaria cases only and choosing to clinically diagnose a malaria infection, despite a negative RDT result were the most frequently reported barriers to protocol compliance. Attitudinal support for the test and treat protocol, as assessed by a nine-item measure, improved across time. In conclusion, health worker compliance with the full test and treat malaria protocol requires improvement in PNG and additional health worker support will likely be required to achieve this. The broader evidence base would suggest any such support should be delivered over a longer period of time, be multi-dimensional and multi-modal.

Health Worker Compliance with a ‘Test And Treat’ Malaria Case Management Protocol in Papua New Guinea

PubMed Central

Pulford, Justin; Smith, Iso; Mueller, Ivo; Siba, Peter M.; Hetzel, Manuel W.

2016-01-01

The Papua New Guinea (PNG) Department of Health introduced a ‘test and treat’ malaria case management protocol in 2011. This study assesses health worker compliance with the test and treat protocol on a wide range of measures, examines self-reported barriers to health worker compliance as well as health worker attitudes towards the test and treat protocol. Data were collected by cross-sectional survey conducted in randomly selected primary health care facilities in 2012 and repeated in 2014. The combined survey data included passive observation of current or recently febrile patients (N = 771) and interviewer administered questionnaires completed with health workers (N = 265). Across the two surveys, 77.6% of patients were tested for malaria infection by rapid diagnostic test (RDT) or microscopy, 65.6% of confirmed malaria cases were prescribed the correct antimalarials and 15.3% of febrile patients who tested negative for malaria infection were incorrectly prescribed an antimalarial. Overall compliance with a strictly defined test and treat protocol was 62.8%. A reluctance to test current/recently febrile patients for malaria infection by RDT or microscopy in the absence of acute malaria symptoms, reserving recommended antimalarials for confirmed malaria cases only and choosing to clinically diagnose a malaria infection, despite a negative RDT result were the most frequently reported barriers to protocol compliance. Attitudinal support for the test and treat protocol, as assessed by a nine-item measure, improved across time. In conclusion, health worker compliance with the full test and treat malaria protocol requires improvement in PNG and additional health worker support will likely be required to achieve this. The broader evidence base would suggest any such support should be delivered over a longer period of time, be multi-dimensional and multi-modal. PMID:27391594

Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension.

PubMed

Pini, Claudio; Pastori, Marco; Baccheschi, Jordan; Omboni, Stefano; Parati, Gianfranco

2007-06-01

There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.

Exertional Tolerance Assessments After Mild Traumatic Brain Injury: A Systematic Review.

PubMed

Quatman-Yates, Catherine; Bailes, Anna; Constand, Sara; Sroka, Mary Claire; Nissen, Katharine; Kurowski, Brad; Hugentobler, Jason

2018-05-01

To review the literature to identify and summarize strategies for evaluating responses to physical exertion after mild traumatic brain injury (mTBI) for clinical and research purposes. PubMed and EBSCOhost through December 31, 2016. Two independent reviewers selected studies based on the following criteria: (1) inclusion of participants with mTBI/concussion, (2) use of a measurement of physiological or psychosomatic response to exertion, (3) a repeatable description of the exertion protocol was provided, (4) a sample of at least 10 participants with a mean age between 8 and 65 years, and (5) the article was in English. The search process yielded 2685 articles, of which 14 studies met the eligibility requirements. A quality assessment using a checklist was conducted for each study by 2 independent study team members and verified by a third team member. Data were extracted by one team member and verified by a second team member. A qualitative synthesis of the studies revealed that most protocols used a treadmill or cycle ergometer as the exercise modality. Protocol methods varied across studies including differences in initial intensity determination, progression parameters, and exertion duration. Common outcome measures were self-reported symptoms, heart rate, and blood pressure. The strongest evidence indicates that exertional assessments can provide important insight about mTBI recovery and should be administered using symptoms as a guide. Additional studies are needed to verify optimal modes and protocols for post-mTBI exertional assessments. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A protocol for systematic reviews of Ayurveda treatments

PubMed Central

Narahari, Saravu R; Aggithaya, Madhur Guruprasad; Suraj, Kumbla R.

2010-01-01

This protocol is intended primarily for Ayurveda doctors who wish to take up systematic reviews along with an expert who has experience in doing such reviews. We have structured this protocol by incorporating the principles of patient treatment in Ayurveda, within the Cochrane framework, using Vitiligo as a model. The treatment section provides a comprehensive list of classical medicines used in the treatment of the disease. This will help in increasing the search terms. Such a list also helps to determine the needs of individualized treatment principles used in the trial and to assess the confounding factors. The search strategy includes an extensive listing of eastern data bases and hand searching. In Ayurveda, the titles of articles are not in the Population, Intervention, Control, and Outcome (PICO) pattern and sometimes the title and methodology do not tally. Therefore, a search of all types of studies is necessary to pool all the relevant publications. A data extraction form is proposed for use in assessing the quality of Ayurvedic studies. The form provides a template for performing evidence reviews of Ayurvedic interventions. PMID:21455455

Challenging traditional activity limits after coronary artery bypass graft surgery: a simulated lawn-mowing activity.

PubMed

Adams, Jenny; Pullum, Gwen; Stafford, Pamala; Hanners, Nava; Hartman, Julie; Strauss, Danielle; Hubbard, Matt; Lawrence, Anne; Anderson, Valerie; McCullough, Tiffany

2008-01-01

Physician advice and restrictions to patients following a cardiac event can, in some instances, lead patients to be fearful regarding their activities even to the point of inactivity. The purpose of this study was to test whether lawn mowing, one of the activities most strongly discouraged after coronary artery bypass surgery, could be safely performed in a supervised setting. Subjects participated in a 6-session simulated lawn-mowing protocol, calibrated to match the push and pull forces of using an outdoor nonpropelled lawn mower. Plain chest radiographs were taken before and after the protocol period. During each session, subjects' sternums were carefully palpated and electrocardiograms, heart rates, and blood pressures were monitored. None of the 13 subjects experienced adverse arrhythmia events or detrimental heart rate, blood pressure, or sternal palpation findings that led to study discontinuation. The radiographs taken after protocol completion showed stable sternal wires with no evidence of sternal dehiscence. Simulated lawn mowing did not negatively affect the sternal incision, electrocardiogram findings, blood pressure, or heart rate in this small sample.

Perioperative management of trauma patients admitted on clopidogrel (Plavix). A survey of orthopaedic departments across the United Kingdom.

PubMed

Inman, Dominic S; Michla, Yusuf; Partington, Paul F

2007-05-01

Clopidogrel (Plavix) is an anti-platelet drug recommended as lifelong treatment by NICE for all patients following stroke, MI, and peripheral vascular disease. It is also indicated for short-term use following cardiac stent insertion. It irreversibly inhibits platelets for up to 7 days. Current recommendations are to stop treatment 7 days before elective surgery. Current evidence shows that delay to surgery more than 4 days in patients with hip fractures increases postoperative mortality. To determine current practice of orthopaedic surgeons in their management of patients taking clopidogrel admitted following a hip fracture to trauma units in the UK with respect to its peri-operative withdrawal and subsequent timing of surgery. To perform a review of the available literature and produce a suggested protocol for the peri-operative management of this rapidly increasing cohort of patients. National postal survey. Orthopaedic consultants representing each unit receiving trauma patients in the United Kingdom. There was a 57% response rate (139/244 UK trauma units). 41% (56) stop clopidogrel and operate immediately, 11% (15) stop clopidogrel for between 5 and 10 days pre-operatively, 10% (14) stop clopidogrel for 10 days preoperatively, 19% (26) continue clopidogrel and operate immediately, 19% (26) have another protocol. 15% (20) have written departmental guidelines. 2%(3) quoted published evidence for their practice. This study demonstrates that there are a wide variety of practices, largely based on anecdotal evidence. Most units (85%) have no formal guidelines. There is evidence in the cardiac literature of increased intra-operative bleeding in patients operated on while taking clopidogrel. There is likely to be an exponential rise in such patients presenting to trauma units and further research is required to guide best practice. Following review of the literature we propose an interim protocol for the withdrawal and resumption of clopidogrel peri-operatively in patients with hip fractures.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

PubMed

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-08-18

Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. CRD42017057853. © 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.

Evidence-Based Clinical Recommendations for the Administration of the Sequential Motion Rates Task

ERIC Educational Resources Information Center

Icht, Michal; Ben-David, Boaz M.

2018-01-01

The sequential motion rates (SMR) task, that involves rapid and accurate repetitions of a syllable sequence, /pataka/, is a commonly used evaluation tool for oro-motor abilities. Although the SMR is a well-known tool, some aspects of its administration protocol are unspecified. We address the following factors and their role in the SMR protocol:…

Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol

PubMed Central

Underwood, Sonia M.; Matz, Rebecca L.; Posey, Lynmarie A.; Carmel, Justin H.; Caballero, Marcos D.; Fata-Hartley, Cori L.; Ebert-May, Diane; Jardeleza, Sarah E.; Cooper, Melanie M.

2016-01-01

Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of “three-dimensional learning” is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not. PMID:27606671

Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol.

PubMed

Laverty, James T; Underwood, Sonia M; Matz, Rebecca L; Posey, Lynmarie A; Carmel, Justin H; Caballero, Marcos D; Fata-Hartley, Cori L; Ebert-May, Diane; Jardeleza, Sarah E; Cooper, Melanie M

2016-01-01

Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of "three-dimensional learning" is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not.

Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review

PubMed Central

Tibbles, Alana; Topolovec-Vranic, Jane

2017-01-01

Neurofeedback therapy (NFT) has been used within a number of populations however it has not been applied or thoroughly examined as a form of cognitive rehabilitation within a stroke population. Objectives for this systematic review included: i) identifying how NFT is utilized to treat cognitive deficits following stroke, ii) examining the strength and quality of evidence to support the use of NFT as a form of cognitive rehabilitation therapy (CRT) and iii) providing recommendations for future investigations. Searches were conducted using OVID (Medline, Health Star, Embase + Embase Classic) and PubMed databases. Additional searches were completed using the Cochrane Reviews library database, Google Scholar, the University of Toronto online library catalogue, ClinicalTrials.gov website and select journals. Searches were completed Feb/March 2015 and updated in June/July/Aug 2015. Eight studies were eligible for inclusion in this review. Studies were eligible for inclusion if they: i) were specific to a stroke population, ii) delivered CRT via a NFT protocol, iii) included participants who were affected by a cognitive deficit(s) following stroke (i.e. memory loss, loss of executive function, speech impairment etc.). NFT protocols were highly specific and varied within each study. The majority of studies identified improvements in participant cognitive deficits following the initiation of therapy. Reviewers assessed study quality using the Downs and Black Checklist for Measuring Study Quality tool; limited study quality and strength of evidence restricted generalizability of conclusions regarding the use of this therapy to the greater stroke population. Progression in this field requires further inquiry to strengthen methodology quality and study design. Future investigations should aim to standardize NFT protocols in an effort to understand the dose-response relationship between NFT and improvements in functional outcome. Future investigations should also place a large emphasis on long-term participant follow-up. PMID:28510578

Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review.

PubMed

Renton, Tian; Tibbles, Alana; Topolovec-Vranic, Jane

2017-01-01

Neurofeedback therapy (NFT) has been used within a number of populations however it has not been applied or thoroughly examined as a form of cognitive rehabilitation within a stroke population. Objectives for this systematic review included: i) identifying how NFT is utilized to treat cognitive deficits following stroke, ii) examining the strength and quality of evidence to support the use of NFT as a form of cognitive rehabilitation therapy (CRT) and iii) providing recommendations for future investigations. Searches were conducted using OVID (Medline, Health Star, Embase + Embase Classic) and PubMed databases. Additional searches were completed using the Cochrane Reviews library database, Google Scholar, the University of Toronto online library catalogue, ClinicalTrials.gov website and select journals. Searches were completed Feb/March 2015 and updated in June/July/Aug 2015. Eight studies were eligible for inclusion in this review. Studies were eligible for inclusion if they: i) were specific to a stroke population, ii) delivered CRT via a NFT protocol, iii) included participants who were affected by a cognitive deficit(s) following stroke (i.e. memory loss, loss of executive function, speech impairment etc.). NFT protocols were highly specific and varied within each study. The majority of studies identified improvements in participant cognitive deficits following the initiation of therapy. Reviewers assessed study quality using the Downs and Black Checklist for Measuring Study Quality tool; limited study quality and strength of evidence restricted generalizability of conclusions regarding the use of this therapy to the greater stroke population. Progression in this field requires further inquiry to strengthen methodology quality and study design. Future investigations should aim to standardize NFT protocols in an effort to understand the dose-response relationship between NFT and improvements in functional outcome. Future investigations should also place a large emphasis on long-term participant follow-up.

A comprehensive study on the relationship between the image quality and imaging dose in low-dose cone beam CT

NASA Astrophysics Data System (ADS)

Yan, Hao; Cervino, Laura; Jia, Xun; Jiang, Steve B.

2012-04-01

While compressed sensing (CS)-based algorithms have been developed for the low-dose cone beam CT (CBCT) reconstruction, a clear understanding of the relationship between the image quality and imaging dose at low-dose levels is needed. In this paper, we qualitatively investigate this subject in a comprehensive manner with extensive experimental and simulation studies. The basic idea is to plot both the image quality and imaging dose together as functions of the number of projections and mAs per projection over the whole clinically relevant range. On this basis, a clear understanding of the tradeoff between the image quality and imaging dose can be achieved and optimal low-dose CBCT scan protocols can be developed to maximize the dose reduction while minimizing the image quality loss for various imaging tasks in image-guided radiation therapy (IGRT). Main findings of this work include (1) under the CS-based reconstruction framework, image quality has little degradation over a large range of dose variation. Image quality degradation becomes evident when the imaging dose (approximated with the x-ray tube load) is decreased below 100 total mAs. An imaging dose lower than 40 total mAs leads to a dramatic image degradation, and thus should be used cautiously. Optimal low-dose CBCT scan protocols likely fall in the dose range of 40-100 total mAs, depending on the specific IGRT applications. (2) Among different scan protocols at a constant low-dose level, the super sparse-view reconstruction with the projection number less than 50 is the most challenging case, even with strong regularization. Better image quality can be acquired with low mAs protocols. (3) The optimal scan protocol is the combination of a medium number of projections and a medium level of mAs/view. This is more evident when the dose is around 72.8 total mAs or below and when the ROI is a low-contrast or high-resolution object. Based on our results, the optimal number of projections is around 90 to 120. (4) The clinically acceptable lowest imaging dose level is task dependent. In our study, 72.8 mAs is a safe dose level for visualizing low-contrast objects, while 12.2 total mAs is sufficient for detecting high-contrast objects of diameter greater than 3 mm.

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

PubMed

Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

2016-04-12

This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

"Nothing Works!" A Case Study Using Cognitive-Behavioral Interventions to Engage Parents, Educators, and Children in the Management of Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Levine, Eva S.; Anshel, Daphne J.

2011-01-01

Attention-deficit/hyperactivity disorder (ADHD) remains one of the most prevalent mental health diagnoses identified in school-age children. Affected children show an increased risk for school failure, social difficulties, and the development of psychiatric comorbidities. Despite the availability of evidence-based behavioral protocols for managing…

Teaching Social Skills to Students with Autism Spectrum Disorders: Efficacy of a Social Learning Approach

ERIC Educational Resources Information Center

Bellinger, Jillian M.

2012-01-01

As the number of children diagnosed with an autism spectrum disorder (ASD) is rising, there is increasing demand for evidence-based interventions that are efficient and easy to implement in school settings. The purpose of the current study was to evaluate the effectiveness of an intervention protocol featuring guided practice, coaching, modeling,…

Interactions of oxidized multiwalled carbon nanotube with cadmium on zebrafish cell line: The influence of two co-exposure protocols on in vitro toxicity tests.

PubMed

Morozesk, Mariana; Franqui, Lidiane S; Mansano, Adrislaine S; Martinez, Diego Stéfani T; Fernandes, Marisa N

2018-05-05

The widespread production and application of carbon nanotubes (CNT) have raising concerns about their release into the environment and, the joint toxicity of CNT with pre-existing contaminants needs to be assessed. This is the first study that investigated the co-exposure of oxidized multiwalled carbon nanotubes (ox-MWCNT) and cadmium (Cd) using a zebrafish liver cell line (ZFL). Two in vitro co-exposure protocols differing by the order of ox-MWCNT interaction with Cd and fetal bovine serum (FBS) proteins were evaluated. Ox-MWCNT was physical and chemical characterized and its adsorption capacity and colloidal stability in cell culture medium was determined in both protocols. Cytotoxicity was investigated by MTT, neutral red, trypan blue, lactate dehydrogenase assays and the necrosis and apoptosis events were determined using flow cytometer. The Cd presence in medium did not interfere in the protein corona composition of MWCNT but the order of interaction of FBS and Cd interfered in its colloidal stability and metal adsorption rate. The ox-MWCNT increased Cd toxicity at low concentration probably by a "Trojan horse" and/or synergistic effect, and induced apoptosis and necrosis in ZFL cells. Although it was not observed differences of toxicity between protocols, the interaction of ox-MWCNT first with Cd led to its precipitation in cell culture medium and, as a consequence, to a possible false viability result by neutral red assay. Taken together, it was evident that the order of compounds interactions disturbs the colloidal stability and affects the in vitro toxicological assays. Considering that Protocol A showed more ox-MWCNT stability after interaction with Cd, this protocol is recommended to be adopted in future studies. Copyright © 2018 Elsevier B.V. All rights reserved.

The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance: evidence of validity.

PubMed

Frisoni, Giovanni B; Jack, Clifford R; Bocchetta, Martina; Bauer, Corinna; Frederiksen, Kristian S; Liu, Yawu; Preboske, Gregory; Swihart, Tim; Blair, Melanie; Cavedo, Enrica; Grothe, Michel J; Lanfredi, Mariangela; Martinez, Oliver; Nishikawa, Masami; Portegies, Marileen; Stoub, Travis; Ward, Chadwich; Apostolova, Liana G; Ganzola, Rossana; Wolf, Dominik; Barkhof, Frederik; Bartzokis, George; DeCarli, Charles; Csernansky, John G; deToledo-Morrell, Leyla; Geerlings, Mirjam I; Kaye, Jeffrey; Killiany, Ronald J; Lehéricy, Stephane; Matsuda, Hiroshi; O'Brien, John; Silbert, Lisa C; Scheltens, Philip; Soininen, Hilkka; Teipel, Stefan; Waldemar, Gunhild; Fellgiebel, Andreas; Barnes, Josephine; Firbank, Michael; Gerritsen, Lotte; Henneman, Wouter; Malykhin, Nikolai; Pruessner, Jens C; Wang, Lei; Watson, Craig; Wolf, Henrike; deLeon, Mony; Pantel, Johannes; Ferrari, Clarissa; Bosco, Paolo; Pasqualetti, Patrizio; Duchesne, Simon; Duvernoy, Henri; Boccardi, Marina

2015-02-01

An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. Fourteen tracers segmented 10 Alzheimer's Disease Neuroimaging Initiative (ADNI) cases scanned at 1.5 T and 3T following local protocols, qualified for segmentation based on the HarP through a standard web-platform and resegmented following the HarP. The five most accurate tracers followed the HarP to segment 15 ADNI cases acquired at three time points on both 1.5 T and 3T. The agreement among tracers was relatively low with the local protocols (absolute left/right ICC 0.44/0.43) and much higher with the HarP (absolute left/right ICC 0.88/0.89). On the larger set of 15 cases, the HarP agreement within (left/right ICC range: 0.94/0.95 to 0.99/0.99) and among tracers (left/right ICC range: 0.89/0.90) was very high. The volume variance due to different tracers was 0.9% of the total, comparing favorably to variance due to scanner manufacturer (1.2), atrophy rates (3.5), hemispheric asymmetry (3.7), field strength (4.4), and significantly smaller than the variance due to atrophy (33.5%, P < .001), and physiological variability (49.2%, P < .001). The HarP has high measurement stability compared with local segmentation protocols, and good reproducibility within and among human tracers. Hippocampi segmented with the HarP can be used as a reference for the qualification of human tracers and automated segmentation algorithms. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance: Evidence of validity

PubMed Central

Frisoni, Giovanni B.; Jack, Clifford R.; Bocchetta, Martina; Bauer, Corinna; Frederiksen, Kristian S.; Liu, Yawu; Preboske, Gregory; Swihart, Tim; Blair, Melanie; Cavedo, Enrica; Grothe, Michel J.; Lanfredi, Mariangela; Martinez, Oliver; Nishikawa, Masami; Portegies, Marileen; Stoub, Travis; Ward, Chadwich; Apostolova, Liana G.; Ganzola, Rossana; Wolf, Dominik; Barkhof, Frederik; Bartzokis, George; DeCarli, Charles; Csernansky, John G.; deToledo-Morrell, Leyla; Geerlings, Mirjam I.; Kaye, Jeffrey; Killiany, Ronald J.; Lehéricy, Stephane; Matsuda, Hiroshi; O'Brien, John; Silbert, Lisa C.; Scheltens, Philip; Soininen, Hilkka; Teipel, Stefan; Waldemar, Gunhild; Fellgiebel, Andreas; Barnes, Josephine; Firbank, Michael; Gerritsen, Lotte; Henneman, Wouter; Malykhin, Nikolai; Pruessner, Jens C.; Wang, Lei; Watson, Craig; Wolf, Henrike; deLeon, Mony; Pantel, Johannes; Ferrari, Clarissa; Bosco, Paolo; Pasqualetti, Patrizio; Duchesne, Simon; Duvernoy, Henri; Boccardi, Marina

2015-01-01

Background An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. Methods Fourteen tracers segmented 10 Alzheimer's Disease Neuroimaging Initiative (ADNI) cases scanned at 1.5 T and 3T following local protocols, qualified for segmentation based on the HarP through a standard web-platform and resegmented following the HarP. The five most accurate tracers followed the HarP to segment 15 ADNI cases acquired at three time points on both 1.5 T and 3T. Results The agreement among tracers was relatively low with the local protocols (absolute left/right ICC 0.44/0.43) and much higher with the HarP (absolute left/right ICC 0.88/0.89). On the larger set of 15 cases, the HarP agreement within (left/right ICC range: 0.94/0.95 to 0.99/0.99) and among tracers (left/right ICC range: 0.89/0.90) was very high. The volume variance due to different tracers was 0.9% of the total, comparing favorably to variance due to scanner manufacturer (1.2), atrophy rates (3.5), hemispheric asymmetry (3.7), field strength (4.4), and significantly smaller than the variance due to atrophy (33.5%, P < .001), and physiological variability (49.2%, P < .001). Conclusions The HarP has high measurement stability compared with local segmentation protocols, and good reproducibility within and among human tracers. Hippocampi segmented with the HarP can be used as a reference for the qualification of human tracers and automated segmentation algorithms. PMID:25267715

Does chlorhexidine prevent dry socket?

PubMed

Richards, Derek

2012-01-01

The BBO (Bibliografia Brasileira de Odontologia), Biomed Central, Cochrane Library, Directory of Open Access Journals, LILACS, Open-J-Gate, OpenSIGLE, PubMed, Sabinet and Science-Direct databases were searched. Articles were selected for review from the search results on the basis of their compliance with the broad inclusion criteria: relevant to the review question; and prospective two-arm (or more) clinical study. The primary outcome measure was the incidence of AO reported at the patient level. Two reviewers (VY and SM) independently extracted data and assessed the quality of the accepted articles. Individual dichotomous datasets for the control and test group were extracted from each article. Where possible, missing data were calculated from information given in the text or tables. In addition, authors were contacted in order to obtain missing information. Datasets were assessed for their clinical and methodological heterogeneity following Cochrane guidelines. Meta-analysis was conducted with homogeneous datasets. Publication bias was assessed by use of a funnel plot and Egger's regression. Ten randomised trials were included; almost all involved the removal of third molars. Only two of six identified application protocols (single application of chlorhexidine 0.2% gel or multiple application of 0.12% rinse versus placebo) were found to significantly decrease the incidence of AO. Within the limitations of this review, only two of six identified application protocols were found to significantly decrease the incidence of AO. The evidence for both protocols is weak and may be challenged on the grounds of high risk of selection, detection/performance and attrition bias. This systematic review could not identify sufficient evidence supporting the use of chlorhexidine for the prevention of AO. Chlorhexidine seems not to cause any significantly higher adverse reactions than placebo. Future high-quality randomised control trials are needed to provide conclusive evidence on this topic.

Application of evidence-based dentistry: from research to clinical periodontal practice.

PubMed

Kwok, Vivien; Caton, Jack G; Polson, Alan M; Hunter, Paul G

2012-06-01

Dentists need to make daily decisions regarding patient care, and these decisions should essentially be scientifically sound. Evidence-based dentistry is meant to empower clinicians to provide the most contemporary treatment. The benefits of applying the evidence-based method in clinical practice include application of the most updated treatment and stronger reasoning to justify the treatment. A vast amount of information is readily accessible with today's digital technology, and a standardized search protocol can be developed to ensure that a literature search is valid, specific and repeatable. It involves developing a preset question (population, intervention, comparison and outcome; PICO) and search protocol. It is usually used academically to perform commissioned reviews, but it can also be applied to answer simple clinical queries. The scientific evidence thus obtained can then be considered along with patient preferences and values, clinical patient circumstances and the practitioner's experience and judgment in order to make the treatment decision. This paper describes how clinicians can incorporate evidence-based methods into patient care and presents a clinical example to illustrate the process. © 2012 John Wiley & Sons A/S.

The National Expert Standard Pressure Ulcer Prevention in Nursing and pressure ulcer prevalence in German health care facilities: a multilevel analysis.

PubMed

Wilborn, Doris; Grittner, Ulrike; Dassen, Theo; Kottner, Jan

2010-12-01

The objective of this study was to describe the relationship between the German National Expert Standard Pressure Ulcer Prevention and the pressure ulcer prevalence in German nursing homes and hospitals. The patient outcome pressure ulcer does not only depend on individual characteristics of patients, but also on institutional factors. In Germany, National Expert Standards are evidence-based instruments that build the basis of continuing improvement in health care quality. It is expected that after having implemented the National Expert Standard Pressure Ulcer Prevention, the number of pressure ulcers should decrease in health care institutions. The analysed data were obtained from two cross-sectional studies from 2004-2005. A multilevel analysis was performed to show the impact of the National Expert Standard Pressure Ulcer Prevention on pressure ulcer prevalence. A total of 41.5% of hospitals and 38.8% of the nursing homes claimed to use the National Expert Standard in the process of developing their local protocols. The overall pressure ulcer prevalence grade 2-4 was 4.7%. Adjusted for hospital departments, survey year and individual characteristics, there was no significant difference in the prevalence of pressure ulcers between institutions that refer to the National Expert Standard or those referring to other sources in developing their local protocols (OR=1.14, 95% CI=0.90-1.44). There was no empirical evidence demonstrating that local protocols of pressure ulcer prevention based on the National Expert Standard were superior to local protocols which refer other sources of knowledge with regard to the pressure ulcer prevalence. The use of the National Expert Standard Pressure Ulcer Prevention can neither be recommended nor be refused. The recent definition of implementation of Expert Standards should be mandatory for all health care institutions which introduce Expert Standards. © 2010 Blackwell Publishing Ltd.

The Role of Plasma and Urine Metabolomics in Identifying New Biomarkers in Severe Newborn Asphyxia: A Study of Asphyxiated Newborn Pigs following Cardiopulmonary Resuscitation

PubMed Central

Sachse, Daniel; Solevåg, Anne Lee; Berg, Jens Petter; Nakstad, Britt

2016-01-01

Background Optimizing resuscitation is important to prevent morbidity and mortality from perinatal asphyxia. The metabolism of cells and tissues is severely disturbed during asphyxia and resuscitation, and metabolomic analyses provide a snapshot of many small molecular weight metabolites in body fluids or tissues. In this study metabolomics profiles were studied in newborn pigs that were asphyxiated and resuscitated using different protocols to identify biomarkers for subject characterization, intervention effects and possibly prognosis. Methods A total of 125 newborn Noroc pigs were anesthetized, mechanically ventilated and inflicted progressive asphyxia until asystole. Pigs were randomized to resuscitation with a FiO2 0.21 or 1.0, different duration of ventilation before initiation of chest compressions (CC), and different CC to ventilation ratios. Plasma and urine samples were obtained at baseline, and 2 h and 4 h after return of spontaneous circulation (ROSC, heart rate > = 100 bpm). Metabolomics profiles of the samples were analyzed by nuclear magnetic resonance spectroscopy. Results Plasma and urine showed severe metabolic alterations consistent with hypoxia and acidosis 2 h and 4 h after ROSC. Baseline plasma hypoxanthine and lipoprotein concentrations were inversely correlated to the duration of hypoxia sustained before asystole occurred, but there was no evidence for a differential metabolic response to the different resuscitation protocols or in terms of survival. Conclusions Metabolic profiles of asphyxiated newborn pigs showed severe metabolic alterations. Consistent with previously published reports, we found no evidence of differences between established and alternative resuscitation protocols. Lactate and pyruvate may have a prognostic value, but have to be independently confirmed. PMID:27529347

Impact of Sleep Telemedicine Protocol in Management of Sleep Apnea: A 5-Year VA Experience.

PubMed

Baig, Mirza M; Antonescu-Turcu, Andrea; Ratarasarn, Kavita

2016-05-01

There is growing evidence that demonstrates an important role for telemedicine technologies in enhancing healthcare delivery. A comprehensive sleep telemedicine protocol was implemented at the Veterans Administration Medical Center (VAMC), Milwaukee, WI, in 2008 in an effort to improve access to sleep specialty care. The telemedicine protocol relied heavily on sleep specialist interventions based on chart review (electronic consult [e-consult]). This was done in response to long wait time for sleep clinic visits as well as delayed sleep study appointments. Since 2008 all consults are screened by sleep service to determine the next step in intervention. Based on chart review, the following steps are undertaken: (1) eligibility for portable versus in-lab sleep study is determined, and a sleep study order is placed accordingly, (2) positive airway pressure (PAP) therapy is prescribed for confirmed sleep apnea, and (3) need for in-person evaluation in the sleep clinic is determined, and the visit is scheduled. This study summarizes the 5-year trend in various aspects of access to sleep care after implementation of sleep telemedicine protocol at the Milwaukee VAMC. This is a retrospective system efficiency study. The electronic medical record was interrogated 5 years after starting the sleep telemedicine protocol to study annual trends in the following outcomes: (1) interval between sleep consult and prescription of PAP equipment, (2) total sleep consults, and (3) sleep clinic wait time. Two part-time sleep physicians provided sleep-related care at the Milwaukee VAMC between 2008 and 2012. During this period, the interval between sleep consult and PAP prescription decreased from ≥60 days to ≤7 days. This occurred in spite of an increase in total sleep consults and sleep studies. There was also a significant increase in data downloads, indicating overall improved follow-up. There was no change in clinic wait time of ≥60 days. Implementation of a sleep telemedicine protocol at the Milwaukee VAMC was associated with increased efficiency of sleep services. Timeliness of sleep management interventions for sleep apnea improved in spite of the increased volume of service.

WHO Mental Health Gap Action Programme (mhGAP) Intervention Guide: a systematic review of evidence from low and middle-income countries.

PubMed

Keynejad, Roxanne C; Dua, Tarun; Barbui, Corrado; Thornicroft, Graham

2018-02-01

Despite mental, neurological and substance use (MNS) disorders being highly prevalent, there is a worldwide gap between service need and provision. WHO launched its Mental Health Gap Action Programme (mhGAP) in 2008, and the Intervention Guide (mhGAP-IG) in 2010. mhGAP-IG provides evidence-based guidance and tools for assessment and integrated management of priority MNS disorders in low and middle-income countries (LMICs), using clinical decision-making protocols. It targets a non-specialised primary healthcare audience, but has also been used by ministries, non-governmental organisations and academics, for mental health service scale-up in 90 countries. This review aimed to identify evidence to date for mhGAP-IG implementation in LMICs. We searched MEDLINE, Embase, PsycINFO, Web of Knowledge/Web of Science, Scopus, CINAHL, LILACS, SciELO/Web of Science, Cochrane, Pubmed databases and Google Scholar for studies reporting evidence, experience or evaluation of mhGAP-IG in LMICs, in any language. Data were extracted from included papers, but heterogeneity prevented meta-analysis. We conducted a systematic review of evidence to date, of mhGAP-IG implementation and evaluation in LMICs. Thirty-three included studies reported 15 training courses, 9 clinical implementations, 3 country contextualisations, 3 economic models, 2 uses as control interventions and 1 use to develop a rating scale. Our review identified the importance of detailed reports of contextual challenges in the field, alongside detailed protocols, qualitative studies and randomised controlled trials. The mhGAP-IG literature is substantial, relative to other published evaluations of clinical practice guidelines: an important contribution to a neglected field. © 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.

Evaluation of forensic DNA mixture evidence: protocol for evaluation, interpretation, and statistical calculations using the combined probability of inclusion.

PubMed

Bieber, Frederick R; Buckleton, John S; Budowle, Bruce; Butler, John M; Coble, Michael D

2016-08-31

The evaluation and interpretation of forensic DNA mixture evidence faces greater interpretational challenges due to increasingly complex mixture evidence. Such challenges include: casework involving low quantity or degraded evidence leading to allele and locus dropout; allele sharing of contributors leading to allele stacking; and differentiation of PCR stutter artifacts from true alleles. There is variation in statistical approaches used to evaluate the strength of the evidence when inclusion of a specific known individual(s) is determined, and the approaches used must be supportable. There are concerns that methods utilized for interpretation of complex forensic DNA mixtures may not be implemented properly in some casework. Similar questions are being raised in a number of U.S. jurisdictions, leading to some confusion about mixture interpretation for current and previous casework. Key elements necessary for the interpretation and statistical evaluation of forensic DNA mixtures are described. Given the most common method for statistical evaluation of DNA mixtures in many parts of the world, including the USA, is the Combined Probability of Inclusion/Exclusion (CPI/CPE). Exposition and elucidation of this method and a protocol for use is the focus of this article. Formulae and other supporting materials are provided. Guidance and details of a DNA mixture interpretation protocol is provided for application of the CPI/CPE method in the analysis of more complex forensic DNA mixtures. This description, in turn, should help reduce the variability of interpretation with application of this methodology and thereby improve the quality of DNA mixture interpretation throughout the forensic community.

Developing a Taxonomy of Dark Triad Triggers at Work – A Grounded Theory Study Protocol

PubMed Central

Nübold, Annika; Bader, Josef; Bozin, Nera; Depala, Romil; Eidast, Helena; Johannessen, Elisabeth A.; Prinz, Gerhard

2017-01-01

In past years, research and corporate scandals have evidenced the destructive effects of the dark triad at work, consisting of narcissism (extreme self-centeredness), psychopathy (lack of empathy and remorse) and Machiavellianism (a sense of duplicity and manipulativeness). The dark triad dimensions have typically been conceptualized as stable personality traits, ignoring the accumulating evidence that momentary personality expressions – personality states – may change due to the characteristics of the situation. The present research protocol describes a qualitative study that aims to identify triggers of dark triad states at work by following a grounded theory approach using semi-structured interviews. By building a comprehensive categorization of dark triad triggers at work scholars may study these triggers in a parsimonious and structured way and organizations may derive more effective interventions to buffer or prevent the detrimental effects of dark personality at work. PMID:28326048

Enhanced Recovery after Emergency Surgery: A Systematic Review.

PubMed

Paduraru, Mihai; Ponchietti, Luca; Casas, Isidro Martinez; Svenningsen, Peter; Zago, Mauro

2017-04-01

To evaluate the current scientific evidence for the applicability, safety and effectiveness of pathways of enhanced recovery after emergency surgery (ERAS). We undertook a search using PubMed and Cochrane databases for ERAS protocols in emergency cases. The search generated 65 titles; after eliminating the papers not meeting search criteria, we selected 4 cohort studies and 1 randomized clinical trial (RCT). Data extracted for analysis consisted of: patient age, type of surgery performed, ERAS elements implemented, surgical outcomes in terms of postoperative complications, mortality, length of stay (LOS) and readmission rate. The number of ERAS items applied was good, ranging from 11 to 18 of the 20 recommended by the ERAS Society. The implementation resulted in fewer postoperative complications. LOS for ES patients was shorter when compared to conventional care. Mortality, specifically reported in three studies, was equal or lower with ERAS. Readmission rates varied widely and were generally higher for the intervention group but without statistical significance. The studies reviewed agreed that ERAS in emergency surgery (ES) was feasible and safe with generally better outcomes. Lower compliance with some of the ERAS items shows the need for the protocol to be adapted to ES patients. More evidence is clearly required as to what can improve outcomes and how this can be formulated into an effective care pathway for the heterogeneous ES patient.

The Active plus protocol: systematic development of two theory- and evidence-based tailored physical activity interventions for the over-fifties.

PubMed

van Stralen, Maartje M; Kok, Gerjo; de Vries, Hein; Mudde, Aart N; Bolman, Catherine; Lechner, Lilian

2008-12-04

Limited data are available on the development, implementation and evaluation processes of physical activity promotion programmes among older adults. More integrative insights into interventions describing the planned systematic development, implementation and evaluation are needed. The purpose of this study is to give an integrative insight into the development of the Active plus programme applying the six-step Intervention Mapping protocol. The Active plus programme consisted of two theory- and evidence-based tailored physical activity promotion interventions, both comprising three tailored letters delivered over four months and aimed at raising awareness of insufficient physical activity, and stimulating physical activity initiation and maintenance among the over-fifties. The first intervention, the basic tailored intervention, provided tailored letters that intervened on the psychosocial determinants of physical activity. The second intervention, the intervention plus, provided the same tailored information but additionally provided tailored information about physical activity opportunities in the specific environment in which the older adults lived. This environment-based component also provided access to a forum and e-buddy system on a website. A plan for implementation and evaluation is also described. The planned development of the Active plus programme resulted in two theory- and evidence-based tailored physical activity interventions targeted at the over-fifties. Dutch Trial Register NTR 920.

Training of lay health educators to implement an evidence-based behavioral weight loss intervention in rural senior centers.

PubMed

Krukowski, Rebecca A; Lensing, Shelly; Love, Sharhonda; Prewitt, T Elaine; Adams, Becky; Cornell, Carol E; Felix, Holly C; West, Delia

2013-02-01

Lay health educators (LHEs) offer great promise for facilitating the translation of evidence-based health promotion programs to underserved areas; yet, there is little guidance on how to train LHEs to implement these programs, particularly in the crucial area of empirically validated obesity interventions. This article describes experiences in recruiting, training, and retaining 20 LHEs who delivered a 12-month evidence-based behavioral lifestyle intervention (based on the Diabetes Prevention Program) in senior centers across a rural state. A mixed method approach was used which incorporated collecting the folllowing: quantitative data on sociodemographic characteristics of LHEs; process data related to training, recruitment, intervention implementation, and retention of LHEs; and a quantitative program evaluation questionnaire, which was supplemented by a qualitative program evaluation questionnaire. Descriptive statistics were calculated for quantitative data, and qualitative data were analyzed using content analysis. The training program was well received, and the LHEs effectively recruited participants and implemented the lifestyle intervention in senior centers following a structured protocol. The methods used in this study produced excellent long-term retention of LHEs and good adherence to intervention protocol, and as such may provide a model that could be effective for others seeking to implement LHE-delivered health promotion programs.

Interim pressure garment therapy (4-6 mmHg) and its effect on donor site healing in burn patients: study protocol for a randomised controlled trial.

PubMed

Donovan, Michelle L; Muller, Michael J; Simpson, Claire; Rudd, Michael; Paratz, Jennifer

2016-04-26

Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24-40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4-6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient's scar outcomes for donor sites. This study protocol outlines a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites. This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months. This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh. No known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimisation. Australian New Zealand Clinical Trials Registry identifier ACTRN12610000127000 . Registered 8 Mar 2010.

Association between physical activity, sedentary behavior, and fitness with health related quality of life in healthy children and adolescents: A protocol for a systematic review and meta-analysis.

PubMed

Bermejo-Cantarero, Alberto; Álvarez-Bueno, Celia; Martinez-Vizcaino, Vicente; García-Hermoso, Antonio; Torres-Costoso, Ana Isabel; Sánchez-López, Mairena

2017-03-01

Health related quality of life (HRQoL) is a subjective, multidimensional and changing over time construct. When HRQoL is decreased, a child is less likely to be able to develop normally and mature into a healthy adult. Physical inactivity is a priority public health problem. Evidence suggests how even moderate levels of physical activity or high fitness levels are associated with benefits for the health in children and adolescents. The aims of this systematic review are to examine the evidence about the relationship between physical activity, sedentary behavior, and fitness with HRQoL, and estimate the effects of interventions that have tested the effectiveness of the increase of the physical activity, the improvement of the physical fitness or the avoidance of sedentary behaviors in HRQoL in healthy subjects aged under 18 years old. This systematic review and meta-analysis protocol was conducted following the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. To identify relevant studies, the following electronic databases will be searched: MEDLINE, EMBASE, Cochrane Database, Web of Science, and PEDro. Reference lists of relevant studies will be examined for links to potential related articles. The methodological quality of the observational included studies will be scored using a quality assessment checklist. For the intervention studies, the risk of bias will be estimated using The Cochrane Collaboration tool for assessing risk of bias. Reviewers will determine whether a meta-analysis is possible when data have been extracted. If it is, subgroup analyses will be carried out by age and socioeconomic status, and by the different dimensions of the HRQoL. If is not possible, a descriptive analysis will be conducted. To our knowledge, this systematic review and meta-analysis will be the first that synthesizes the existing results about the relationship between physical activity, sedentary behavior, physical fitness, and HRQoL, and the effect of physical activity interventions on HRQoL, in healthy subjects under 18 years old. This study will clarify this relationship and will provide evidence for decision-making. Limitations may include the quality of the selected studies and their characteristics. Only studies published in English and Spanish will be included. PROSPERO CRD42015025823.

Use of Comparative Case Study Methodology for US Public Health Policy Analysis: A Review.

PubMed

Dinour, Lauren M; Kwan, Amy; Freudenberg, Nicholas

There is growing recognition that policies influence population health, highlighting the need for evidence to inform future policy development and reform. This review describes how comparative case study methodology has been applied to public health policy research and discusses the methodology's potential to contribute to this evidence. English-language, peer-reviewed articles published between 1995 and 2012 were sought from 4 databases. Articles were included if they described comparative case studies addressing US public health policy. Two researchers independently assessed the 20 articles meeting review criteria. Case-related characteristics and research design tactics utilized to minimize threats to reliability and validity, such as the use of multiple sources of evidence and a case study protocol, were extracted from each article. Although comparative case study methodology has been used to analyze a range of public health policies at all stages and levels, articles reported an average use of only 3.65 (out of 10) research design tactics. By expanding the use of accepted research design tactics, public health policy researchers can contribute to expanding the evidence needed to advance health-promoting policies.

Mars Sample Handling Protocol Workshop Series: Workshop 4

NASA Technical Reports Server (NTRS)

Race Margaret S. (Editor); DeVincenzi, Donald L. (Editor); Rummel, John D. (Editor); Acevedo, Sara E. (Editor)

2001-01-01

In preparation for missions to Mars that will involve the return of samples to Earth, it will be necessary to prepare for the receiving, handling, testing, distributing, and archiving of martian materials here on Earth. Previous groups and committees have studied selected aspects of sample return activities, but specific detailed protocols for the handling and testing of returned samples must still be developed. To further refine the requirements for sample hazard testing and to develop the criteria for subsequent release of sample materials from quarantine, the NASA Planetary Protection Officer convened a series of workshops in 2000-2001. The overall objective of the Workshop Series was to produce a Draft Protocol by which returned martian sample materials can be assessed for biological hazards and examined for evidence of life (extant or extinct) while safeguarding the purity of the samples from possible terrestrial contamination. This report also provides a record of the proceedings of Workshop 4, the final Workshop of the Series, which was held in Arlington, Virginia, June 5-7, 2001. During Workshop 4, the sub-groups were provided with a draft of the protocol compiled in May 2001 from the work done at prior Workshops in the Series. Then eight sub-groups were formed to discuss the following assigned topics: Review and Assess the Draft Protocol for Physical/Chemical Testing Review and Assess the Draft Protocol for Life Detection Testing Review and Assess the Draft Protocol for Biohazard Testing Environmental and Health/Monitoring and Safety Issues Requirements of the Draft Protocol for Facilities and Equipment Contingency Planning for Different Outcomes of the Draft Protocol Personnel Management Considerations in Implementation of the Draft Protocol Draft Protocol Implementation Process and Update Concepts This report provides the first complete presentation of the Draft Protocol for Mars Sample Handling to meet planetary protection needs. This Draft Protocol, which was compiled from deliberations and recommendations from earlier Workshops in the Series, represents a consensus that emerged from the discussions of all the sub-groups assembled over the course of the five Workshops of the Series. These discussions converged on a conceptual approach to sample handling, as well as on specific analytical requirements. Discussions also identified important issues requiring attention, as well as research and development needed for protocol implementation.

Review and Synthesize Completed Research Through Systematic Review.

PubMed

Hopp, Lisa; Rittenmeyer, Leslie

2015-10-01

The evidence-based health care movement has generated new opportunity for scholars to generate synthesized sources of evidence. Systematic reviews are rigorous forms of synthesized evidence that scholars can conduct if they have requisite skills, time, and access to excellent library resources. Systematic reviews play an important role in synthesizing what is known and unknown about a particular health issue. Thus, they have a synergistic relationship with primary research. They can both inform clinical decisions when the evidence is adequate and identify gaps in knowledge to inform research priorities. Systematic reviews can be conducted of quantitative and qualitative evidence to answer many types of questions. They all share characteristics of rigor that arise from a priori protocol development, transparency, exhaustive searching, dual independent reviewers who critically appraise studies using standardized tools, rigor in synthesis, and peer review at multiple stages in the conduct and reporting of the systematic review. © The Author(s) 2015.

VAC protocol for treatment of dogs with stage III hemangiosarcoma.

PubMed

Alvarez, Francisco J; Hosoya, Kenji; Lara-Garcia, Ana; Kisseberth, William; Couto, Guillermo

2013-01-01

Hemangiosarcomas (HSAs) are aggressive tumors with a high rate of metastasis. Clinical stage has been considered a negative prognostic factor for survival. The study authors hypothesized that the median survival time (MST) of dogs with metastatic (stage III) HSA treated with a vincristine, doxorubicin, and cyclophosphamide (VAC) chemotherapy protocol would not be different than those with stage I/II HSA. Sixty-seven dogs with HSA in different anatomic locations were evaluated retrospectively. All dogs received the VAC protocol as an adjuvant to surgery (n = 50), neoadjuvant (n = 3), or as the sole treatment modality (n = 14). There was no significant difference (P = 0.97) between the MST of dogs with stage III and stage I/II HSA. For dogs presenting with splenic HSA alone, there was no significant difference between the MST of dogs with stage III and stage I/II disease (P = 0.12). The overall response rate (complete response [CR] and partial response [PR]) was 86%). No unacceptable toxicities were observed. Dogs with stage III HSA treated with the VAC protocol have a similar prognosis to dogs with stage I/II HSA. Dogs with HSA and evidence of metastases at the time of diagnosis should not be denied treatment.

Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol

PubMed Central

Kovic, Bruno; Guyatt, Gordon; Brundage, Michael; Thabane, Lehana; Bhatnagar, Neera; Xie, Feng

2016-01-01

Introduction There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology. Methods and analysis Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit. Discussion Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically important in interpreting results of oncology trials. Systematic evidence produced from our study will contribute to improvement of patient care and practice of evidence-based medicine in oncology. PMID:27591026

A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.

PubMed

Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M

2017-07-18

Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop and test a tailored, enhanced implementation strategy. ClinicalTrials.gov, NCT03075085.

A Systematic Review Protocol on the Use of Online Learning versus Blended Learning for Teaching Clinical Skills to Undergraduate Health Professional Students

ERIC Educational Resources Information Center

McCutcheon, Karen; Lohan, Maria; Traynor, Marian

2016-01-01

Aim: This paper is a review protocol that will be used to identify, critically appraise and synthesise the best current evidence relating to the use of online learning and blended learning approaches in teaching clinical skills in undergraduate health professionals. Background: Although previous systematic reviews on online learning vs. face to…

Toward a bioethical framework for antibiotic use, antimicrobial resistance and for empirically designing ethically robust strategies to protect human health: a research protocol

PubMed Central

Martins Pereira, Sandra; de Sá Brandão, Patrícia Joana; Araújo, Joana; Carvalho, Ana Sofia

2017-01-01

Introduction Antimicrobial resistance (AMR) is a challenging global and public health issue, raising bioethical challenges, considerations and strategies. Objectives This research protocol presents a conceptual model leading to formulating an empirically based bioethics framework for antibiotic use, AMR and designing ethically robust strategies to protect human health. Methods Mixed methods research will be used and operationalized into five substudies. The bioethical framework will encompass and integrate two theoretical models: global bioethics and ethical decision-making. Results Being a study protocol, this article reports on planned and ongoing research. Conclusions Based on data collection, future findings and using a comprehensive, integrative, evidence-based approach, a step-by-step bioethical framework will be developed for (i) responsible use of antibiotics in healthcare and (ii) design of strategies to decrease AMR. This will entail the analysis and interpretation of approaches from several bioethical theories, including deontological and consequentialist approaches, and the implications of uncertainty to these approaches. PMID:28459355

Using semantics for representing experimental protocols.

PubMed

Giraldo, Olga; García, Alexander; López, Federico; Corcho, Oscar

2017-11-13

An experimental protocol is a sequence of tasks and operations executed to perform experimental research in biological and biomedical areas, e.g. biology, genetics, immunology, neurosciences, virology. Protocols often include references to equipment, reagents, descriptions of critical steps, troubleshooting and tips, as well as any other information that researchers deem important for facilitating the reusability of the protocol. Although experimental protocols are central to reproducibility, the descriptions are often cursory. There is the need for a unified framework with respect to the syntactic structure and the semantics for representing experimental protocols. In this paper we present "SMART Protocols ontology", an ontology for representing experimental protocols. Our ontology represents the protocol as a workflow with domain specific knowledge embedded within a document. We also present the S ample I nstrument R eagent O bjective (SIRO) model, which represents the minimal common information shared across experimental protocols. SIRO was conceived in the same realm as the Patient Intervention Comparison Outcome (PICO) model that supports search, retrieval and classification purposes in evidence based medicine. We evaluate our approach against a set of competency questions modeled as SPARQL queries and processed against a set of published and unpublished protocols modeled with the SP Ontology and the SIRO model. Our approach makes it possible to answer queries such as Which protocols use tumor tissue as a sample. Improving reporting structures for experimental protocols requires collective efforts from authors, peer reviewers, editors and funding bodies. The SP Ontology is a contribution towards this goal. We build upon previous experiences and bringing together the view of researchers managing protocols in their laboratory work. Website: https://smartprotocols.github.io/ .

Constant Observation of Suicidal Patients: The Intervention We Love to Hate.

PubMed

Russ, Mark J

2016-09-01

Constant observation (CO) of psychiatric inpatients at risk for suicidal behavior has been criticized in the literature because of the absence of demonstrable effectiveness, associated costs, staff and patient acceptance, and related issues. Our inability to demonstrate effectiveness, however, is an ethical conundrum that cannot readily be solved. Frequent and often vociferous references in the literature to the absence of an evidence base for this intervention carries the risk that CO may be underutilized in particular clinical circumstances with untoward results. A case is made for shifting focus from the lack of evidence supporting CO to agreement on an observation protocol that achieves the desired goal of maximizing patient safety. A sample protocol is presented.

Early Versus Late Weight-Bearing Protocols for Surgically Managed Posterior Wall Acetabular Fractures.

PubMed

Heare, Austin; Kramer, Nicholas; Salib, Christopher; Mauffrey, Cyril

2017-07-01

Despite overall improved outcomes with open reduction and internal fixation of acetabular fractures, posterior wall fractures show disproportionately poor results. The effect of weight bearing on outcomes of fracture management has been investigated in many lower extremity fractures, but evidence-based recommendations in posterior wall acetabular fractures are lacking. The authors systematically reviewed the current literature to determine if a difference in outcome exists between early and late postoperative weight-bearing protocols for surgically managed posterior wall acetabular fractures. PubMed and MEDLINE were searched for posterior wall acetabular fracture studies that included weight-bearing protocols and Merle d'Aubigné functional scores. Twelve studies were identified. Each study was classified as either early or late weight bearing. Early weight bearing was defined as full, unrestricted weight bearing at or before 12 weeks postoperatively. Late weight bearing was defined as restricted weight bearing for greater than 12 weeks postoperatively. The 2 categories were then compared by functional score using a 2-tailed t test and by complication rate using chi-square analysis. Six studies (152 fractures) were placed in the early weight-bearing category. Six studies (302 fractures) were placed in the late weight-bearing category. No significant difference in Merle d'Aubigné functional scores was found between the 2 groups. No difference was found regarding heterotopic ossification, avascular necrosis, superficial infections, total infections, or osteoarthritis. This systematic review found no difference in functional outcome scores or complication rates between early and late weight-bearing protocols for surgically treated posterior wall fractures. [Orthopedics. 2017: 40(4):e652-e657.]. Copyright 2017, SLACK Incorporated.

Ghost Authorship in Industry-Initiated Randomised Trials

PubMed Central

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2007-01-01

Background Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. Methods and Findings We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994–1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%–87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%–98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Conclusions Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available. PMID:17227134

Ghost authorship in industry-initiated randomised trials.

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2007-01-01

Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%-87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%-98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available.

Evaluation of a discharge education protocol for pediatric patients with gastrostomy tubes.

PubMed

Schweitzer, Michelle; Aucoin, Julia; Docherty, Sharron L; Rice, Henry E; Thompson, Julie; Sullivan, Dori Taylor

2014-01-01

To evaluate the impact of a preprocedure education protocol for children who receive a gastrostomy tube (GT). A preintervention-postintervention design, using surveys and comparison between preprotocol and postprotocol cohorts, was used to evaluate the effect of implementation of a standardized GT education protocol with 26 subjects on caregiver, patient, and provider outcomes. The use of a preprocedure education protocol resulted in improved patient outcomes and increased caregiver knowledge and confidence and was considered a positive change by the providers. Often education is a forgotten part of a medical procedure, and the importance of education is typically only recognized after an adverse event occurs. Establishing a standardized evidence-based education protocol for GT care improves overall care and satisfaction. Use of a systematic and family-centered interdisciplinary approach markedly improves patient care. Copyright © 2014 National Association of Pediatric Nurse Practitioners. Published by Mosby, Inc. All rights reserved.

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study.

PubMed

Upadhyay, Ushma D; Johns, Nicole E; Combellick, Sarah L; Kohn, Julia E; Keder, Lisa M; Roberts, Sarah C M

2016-08-01

In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization. We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%-5.3%) in the prelaw period to 6.2% (95% CI: 5.5%-8.0%) in the postlaw period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%-10.0%) in the prelaw period and 15.6% (95% CI: 13.8%-17.3%) in the postlaw period (p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%-22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%-5.6%) 3 y after (2014) (p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law. Ohio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated.

Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study).

PubMed

Alkhaffaf, Bilal; Glenny, Anne-Marie; Blazeby, Jane M; Williamson, Paula; Bruce, Iain A

2017-08-09

Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.

Comparing the World Health Organization-versus China-recommended protocol for first-trimester medical abortion: a retrospective analysis

PubMed Central

Ngo, Thoai D; Park, Min Hae; Xiao, Yuanhong

2012-01-01

Objective To compare the effectiveness, in terms of complete abortion, of the World Health Organization (WHO)- and the China-recommended protocol for first-trimester medical abortion. Methods A retrospective analysis of clinical data from women presenting for first trimester medical abortion between January 2009 and August 2010 at reproductive health clinics in Qingdao, Xi’an, Nanjing, Nanning, and Zhengzhou was conducted. One clinic in Qingdao administered the WHO-recommended protocol (200 mg mifepristone orally followed by 0.8 mg misoprostol buccally 36–48 hours later). Four clinics in the other locations provided the China-recommended procedure (Day 1: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 2: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 3: 0.6 mg oral misoprostol). Data on reproductive and demographic characteristics were extracted from clinic records, and complete termination was determined on day 14 (post-mifepristone administration). Results A total of 337 women underwent early medical abortion (167 WHO- and 170 China-recommended procedures). Complete abortion was significantly higher among women who had the WHO protocol than those who received the China protocol (91.0% vs 77.7%, respectively; P < 0.001). Women using the China-recommended protocol were three times more likely to require an additional dose of misoprostol than women using the WHO protocol (21.8% vs 7.8%, respectively; P < 0.001), and had significantly more bleeding on the day of misoprostol administration (12.5 mL vs 18.5 mL; P < 0.001). Conclusion This clinical audit provides preliminary evidence suggesting the WHO-recommended protocol may be more effective than the China-recommended protocol for early medical abortion. A larger scale study is necessary to compare the methods’ effectiveness and acceptability. PMID:22505831

Measurement of fecal elastase improves performance of newborn screening for cystic fibrosis.

PubMed

Barben, Juerg; Rueegg, Corina S; Jurca, Maja; Spalinger, Johannes; Kuehni, Claudia E

2016-05-01

The aim of newborn screening (NBS) for CF is to detect children with 'classic' CF where early treatment is possible and improves prognosis. Children with inconclusive CF diagnosis (CFSPID) should not be detected, as there is no evidence for improvement through early treatment. No algorithm in current NBS guidelines explains what to do when sweat test (ST) fails. This study compares the performance of three different algorithms for further diagnostic evaluations when first ST is unsuccessful, regarding the numbers of children detected with CF and CFSPID, and the time until a definite diagnosis. In Switzerland, CF-NBS was introduced in January 2011 using an IRT-DNA-IRT algorithm followed by a ST. In children, in whom ST was not possible (no or insufficient sweat), 3 different protocols were applied between 2011 and 2014: in 2011, ST was repeated until it was successful (protocol A), in 2012 we proceeded directly to diagnostic DNA testing (protocol B), and 2013-2014, fecal elastase (FE) was measured in the stool, in order to determine a pancreas insufficiency needing immediate treatment (protocol C). The ratio CF:CFSPID was 7:1 (27/4) with protocol A, 2:1 (22/10) with protocol B, and 14:1 (54/4) with protocol C. The mean time to definite diagnosis was significantly shorter with protocol C (33days) compared to protocol A or B (42 and 40days; p=0.014 compared to A, and p=0.036 compared to B). The algorithm for the diagnostic part of the newborn screening used in the CF centers is important and affects the performance of a CF-NBS program with regard to the ratio CF:CFSPID and the time until definite diagnosis. Our results suggest to include FE after initial sweat test failure in the CF-NBS guidelines to keep the proportion of CFSPID low and the time until definite diagnosis short. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Concordance and Reliability of Photogrammetric Protocols for Measuring the Cervical Lordosis Angle: A Systematic Review of the Literature.

PubMed

de Albuquerque, Priscila Maria Nascimento Martins; de Alencar, Geisa Guimarães; de Oliveira, Daniela Araújo; de Siqueira, Gisela Rocha

2018-01-01

The aim of this study was to examine and interpret the concordance, accuracy, and reliability of photogrammetric protocols available in the literature for evaluating cervical lordosis in an adult population aged 18 to 59 years. A systematic search of 6 electronic databases (MEDLINE via PubMed, LILACS, CINAHL, Scopus, ScienceDirect, and Web of Science) located studies that assessed the reliability and/or concordance and/or accuracy of photogrammetric protocols for evaluating cervical lordosis, compared with radiography. Articles published through April 2016 were selected. Two independent reviewers used a critical appraisal tool (QUADAS and QAREL) to assess the quality of the selected studies. Two studies were included in the review and had high levels of reliability (intraclass correlation coefficient: 0.974-0.98). Only 1 study assessed the concordance between the methods, which was calculated using Pearson's correlation coefficient. To date, the accuracy of photogrammetry has not been investigated thoroughly. We encountered no study in the literature that investigated the accuracy of photogrammetry in diagnosing hyperlordosis of cervical spine. However, both current studies report high levels of intra- and interrater reliability. To increase the level of evidence of photogrammetry in the evaluation of cervical lordosis, it is necessary to conduct further studies using a larger sample to increase the external validity of the findings. Copyright © 2018. Published by Elsevier Inc.

Different horse's paces during hippotherapy on spatio-temporal parameters of gait in children with bilateral spastic cerebral palsy: A feasibility study.

PubMed

Antunes, Fabiane Nunes; Pinho, Alexandre Severo do; Kleiner, Ana Francisca Rozin; Salazar, Ana Paula; Eltz, Giovana Duarte; de Oliveira Junior, Alcyr Alves; Cechetti, Fernanda; Galli, Manuela; Pagnussat, Aline Souza

2016-12-01

Hippotherapy is often carried out for the rehabilitation of children with Cerebral Palsy (CP), with the horse riding at a walking pace. This study aimed to explore the immediate effects of a hippotherapy protocol using a walk-trot pace on spatio-temporal gait parameters and muscle tone in children with Bilateral Spastic CP (BS-CP). Ten children diagnosed with BS-CP and 10 healthy aged-matched children (reference group) took part in this study. The children with BS-CP underwent two sessions of hippotherapy for one week of washout between them. Two protocols (lasting 30min) were applied on separate days: Protocol 1: the horse's pace was a walking pace; and Protocol 2: the horse's pace was a walk-trot pace. Children from the reference group were not subjected to treatment. A wireless inertial measurement unit measured gait spatio-temporal parameters before and after each session. The Modified Ashworth Scale was applied for muscle tone measurement of hip adductors. The participants underwent the gait assessment on a path with surface irregularities (ecological context). The comparisons between BS-CP and the reference group found differences in all spatio-temporal parameters, except for gait velocity. Within-group analysis of children with BS-CP showed that the swing phase did not change after the walk pace and after the walk-trot pace. The percentage of rolling phase and double support improved after the walk-trot. The spasticity of the hip adductors was significantly reduced as an immediate result of both protocols, but this decrease was more evident after the walk-trot. The walk-trot protocol is feasible and is able to induce an immediate effect that improves the gait spatio-temporal parameters and the hip adductors spasticity. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized controlled comparison of flushing protocols in home care patients with peripherally inserted central catheters.

PubMed

Lyons, Margaret G; Phalen, Ann G

2014-01-01

Research has failed to demonstrate an optimal flushing solution or frequency for central catheters. In a 2002 study of 50 000 home care patients, catheter dysfunction with loss of patency was the most common complication and occurred in 29% of the peripherally inserted central catheters (PICCs) tracked. With the advent of the Affordable Care Act and the promise of expanded home care services, this study offers evidence as to a preferred flushing protocol to prevent catheter patency complications for home infusion patients with PICCs. This prospective, randomized, 1-way, single-blinded posttest with control group study was performed to compare 3 commonly used flushing protocols in home infusion patients with PICCs. The independent variable was the flushing protocol, and dependent variables included the development of patency-related complications and other significant issues such as sluggishness, occlusion, missed medication doses, catheter replacement, additional nursing visits, and the use of alteplase (Cathflo Activase). Each of the study groups had patients who experienced 1 or more patency-related complications. Additional factors that may affect catheter function, including patient age, gender, diagnosis, therapy type, frequency of catheter use, catheter brand/size/number of lumens, concomitant use of anticoagulant medications, and whether PICCs were used for routine lab testing, were analyzed, and no statistical significance was determined. Catheter dwell time (catheter days) was statistically significant (p = .003, confidence interval = 95%; assuming equal variance) and confirmed the assumption that the longer a home care patient's catheter was in place, the more complications occurred. There were no cases of heparin allergy, heparin-induced thrombocytopenia, or line infection. The data provide some evidence to support the elimination of heparin flushing in home care patients with PICCs, although data in the saline-only group that related to additional registered nurse visits to assess PICC patency and the use of alteplase (Cathflo Activase) were trending toward significance because this group experienced a higher incidence of these complications than both the heparin groups. These findings should not be translated to home care patients with cancer or pregnancy diagnoses because these populations were excluded from this study. More studies of this topic area should be initiated. Please see video abstract, Supplemental Digital Content 1, for more information (http://links.lww.com/JIN/A3).

Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database

PubMed Central

Schmitz, Christoph; Császár, Nikolaus B. M.; Milz, Stefan; Schieker, Matthias; Maffulli, Nicola; Rompe, Jan-Dirk; Furia, John P.

2015-01-01

Background Extracorporeal shock wave therapy (ESWT) is an effective and safe non-invasive treatment option for tendon and other pathologies of the musculoskeletal system. Sources of data This systematic review used data derived from the Physiotherapy Evidence Database (PEDro; www.pedro.org.au, 23 October 2015, date last accessed). Areas of agreement ESWT is effective and safe. An optimum treatment protocol for ESWT appears to be three treatment sessions at 1-week intervals, with 2000 impulses per session and the highest energy flux density the patient can tolerate. Areas of controversy The distinction between radial ESWT as ‘low-energy ESWT’ and focused ESWT as ‘high-energy ESWT’ is not correct and should be abandoned. Growing points There is no scientific evidence in favour of either radial ESWT or focused ESWT with respect to treatment outcome. Areas timely for developing research Future randomized controlled trials should primarily address systematic tests of the aforementioned optimum treatment protocol and direct comparisons between radial and focused ESWT. PMID:26585999

Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation.

PubMed

Chacko, Anil; Isham, Andrew; Cleek, Andrew F; McKay, Mary M

2016-01-01

Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventions that focus on assisting parents to utilize effective skills to modify children's problematic behaviors are first-line interventions for the treatment of DBDs. Although efficacious, the effects of these interventions are often attenuated by poor implementation of the skills learned during treatment by parents, often referred to as between-session homework. The multiple family group (MFG) model is an evidence-based, skills-based intervention model for the treatment of DBDs in school-age youth residing in urban, socio-economically disadvantaged communities. While data suggest benefits of MFG on DBD behaviors, similar to other skill-based interventions, the effects of MFG are mitigated by the poor homework implementation, despite considerable efforts to support parents in homework implementation. This paper focuses on the study protocol for the development and preliminary evaluation of a theory-based, smartphone mobile health (mHealth) application (My MFG) to support homework implementation by parents participating in MFG. This paper describes a study design proposal that begins with a theoretical model, uses iterative design processes to develop My MFG to support homework implementation in MFG through a series of pilot studies, and a small-scale pilot randomised controlled trial to determine if the intervention can demonstrate change (preliminary efficacy) of My MFG in outpatient mental health settings in socioeconomically disadvantaged communities. This preliminary study aims to understand the implementation of mHealth methods to improve the effectiveness of evidence-based interventions in routine outpatient mental health care settings for youth with disruptive behavior and their families. Developing methods to augment the benefits of evidence-based interventions, such as MFG, where homework implementation is an essential mediator of treatment benefits is critical to full adoption/implementation of these intervention in routine practice settings and maximizing benefits for youth with DBDs and their families. ClinicalTrials.gov NCT01917838.

Effects of clinical pathways for chronic obstructive pulmonary disease (COPD) on patient, professional and systems outcomes: protocol for a systematic review.

PubMed

Plishka, Christopher; Rotter, Thomas; Kinsman, Leigh; Hansia, Mohammed Rashaad; Lawal, Adegboyega; Goodridge, Donna; Penz, Erika; Marciniuk, Darcy D

2016-08-11

Chronic obstructive pulmonary disease (COPD) is a respiratory syndrome characterized by progressive, partially reversible airway obstruction and lung hyperinflation. COPD has a substantial burden which is seen in both patient quality of life and healthcare costs. One proposed method of minimizing this burden is the implementation of clinical pathways (CPWs). CPWs aim to guide evidence-based practice and improve the interaction between health services. They bring the best available evidence to a range of healthcare professionals by adapting evidence-based clinical guidelines to a local context and detailing the essential steps in the assessment and care of patients. The aim of this systematic review is to synthesize existing literature on the effects of CPWs for the treatment or management of COPD. We will screen search hits from search strategies developed for a Cochrane Effective Practice and Organisation of Care (EPOC) systematic review on the use of CPWs in primary care and a Cochrane EPOC review on the use of CPWs in hospitals. These searches were run in a range of databases. Studies will be screened independently by two reviewers. All studies identified by our search strategy will be considered regardless of study design as long as they meet the operational definition for clinical pathways developed by Kinsman et al. (BMC Medicine 8, 2010) and focus on the treatment or management of COPD. All included studies will be evaluated for risk of bias utilizing methodologies set out by the Cochrane collaboration. Data regarding patient, professional and systems outcomes will be extracted from all included studies. Data will be presented in both narrative and tabular form. The systematic review outlined in this protocol aims to identify, assess and synthesise all available evidence on the effects of CPWs regarding the treatment and management of COPD. As a result, this review will provide an evidence base for decision makers regarding the practicality, cost effectiveness, patient benefit and best practices regarding the implementation of CPWs for the care of COPD.

A cross-sectional survey of supports for evidence-informed decision-making in healthcare organisations: a research protocol.

PubMed

Ouimet, Mathieu; Lavis, John N; Léon, Grégory; Ellen, Moriah E; Bédard, Pierre-Olivier; Grimshaw, Jeremy M; Gagnon, Marie-Pierre

2014-10-09

This protocol builds on the development of a) a framework that identified the various supports (i.e. positions, activities, interventions) that a healthcare organisation or health system can implement for evidence-informed decision-making (EIDM) and b) a qualitative study that showed the current mix of supports that some Canadian healthcare organisations have in place and the ones that are perceived to facilitate the use of research evidence in decision-making. Based on these findings, we developed a web survey to collect cross-sectional data about the specific supports that regional health authorities and hospitals in two Canadian provinces (Ontario and Quebec) have in place to facilitate EIDM. This paper describes the methods for a cross-sectional web survey among 32 regional health authorities and 253 hospitals in the provinces of Quebec and Ontario (Canada) to collect data on the current mix of organisational supports that these organisations have in place to facilitate evidence-informed decision-making. The data will be obtained through a two-step survey design: a 10-min survey among CEOs to identify key units and individuals in regard to our objectives (step 1) and a 20-min survey among managers of the key units identified in step 1 to collect information about the activities performed by their unit regarding the acquisition, assessment, adaptation and/or dissemination of research evidence in decision-making (step 2). The study will target three types of informants: CEOs, library/documentation centre managers and all other key managers whose unit is involved in the acquisition, assessment, adaptation/packaging and/or dissemination of research evidence in decision-making. We developed an innovative data collection system to increase the likelihood that only the best-informed respondent available answers each survey question. The reporting of the results will be done using descriptive statistics of supports by organisation type and by province. This study will be the first to collect and report large-scale cross-sectional data on the current mix of supports health system organisations in the two most populous Canadian provinces have in place for evidence-informed decision-making. The study will also provide useful information to researchers on how to collect organisation-level data with reduced risk of self-reporting bias.

An Alpha and Theta Intensive and Short Neurofeedback Protocol for Healthy Aging Working-Memory Training

PubMed Central

Reis, Joana; Portugal, Ana Maria; Fernandes, Luís; Afonso, Nuno; Pereira, Mariana; Sousa, Nuno; Dias, Nuno S.

2016-01-01

The present study tested the effects of an intensive and short alpha and theta neurofeedback (NF) protocol in working memory (WM) performance in a healthy elder population and explored the effects of a multimodal approach, by supplementing NF with cognitive tasks. Participants were allocated to four groups: NF (N = 9); neurofeedback supplemented with cognitive training (NFCT) (N = 8); cognitive training (CT) (N = 7) and sham neurofeedback (Sham-NF) (N = 6). The intervention consisted in 30-min sessions for 8 days. The NF group presented post intervention increases of alpha and theta relative power as well as performance in the matrix rotation task. In addition, a successful up training of frontal theta showed positive correlation with an improvement of post-training alpha and a better performance in the matrix rotation task. The results presented herein suggest that an intensive and short NF protocol enables elders to learn alpha and theta self-modulation and already presents moderate improvements in cognition and basal EEG. Also, CT group showed moderate performance gains on the cognitive tasks used during the training sessions but no clear improvements on neurophysiology and behavioral measurements were observed. This study represents a first attempt to study the effects of an intensive and short NF protocol in WM performance of elders. The evidence presented here suggests that an intensive and short NF intervention could be a valid alternative for introduction of older populations to NF methodologies. PMID:27458369

Mapping Evidence-Based Treatments for Children and Adolescents: Application of the Distillation and Matching Model to 615 Treatments from 322 Randomized Trials

ERIC Educational Resources Information Center

Chorpita, Bruce F.; Daleiden, Eric L.

2009-01-01

This study applied the distillation and matching model to 322 randomized clinical trials for child mental health treatments. The model involved initial data reduction of 615 treatment protocol descriptions by means of a set of codes describing discrete clinical strategies, referred to as practice elements. Practice elements were then summarized in…

In Preparation of the Nationwide Dissemination of the School-Based Obesity Prevention Program DOiT: Stepwise Development Applying the Intervention Mapping Protocol

ERIC Educational Resources Information Center

van Nassau, Femke; Singh, Amika S.; van Mechelen, Willem; Brug, Johannes; Chin A. Paw, Mai J. M.

2014-01-01

Background: The school-based Dutch Obesity Intervention in Teenagers (DOiT) program is an evidence-based obesity prevention program. In preparation for dissemination throughout the Netherlands, this study aimed to adapt the initial program and to develop an implementation strategy and materials. Methods: We revisited the Intervention Mapping (IM)…

Toward a New Process-Based Indicator for Measuring Writing Fluency: Evidence from L2 Writers' Think-Aloud Protocols

ERIC Educational Resources Information Center

Abdel Latif, Muhammad M.

2009-01-01

This article reports on a study aimed at testing the hypothesis that, because of strategic and temporal variables, composing rate and text quantity may not be valid measures of writing fluency. A second objective was to validate the mean length of writers' translating episodes as a process-based indicator that mirrors their fluent written…

The Symptomatic Persian Gulf Veterans Protocol: An Analysis of Risk Factors with an Immunologic and Neuropsychiatric Assessment

DTIC Science & Technology

2001-01-01

for these complaints and include exposure and infection with mycoplasma or related organisms and alterations in immunological responsiveness. To...of mycoplasma or ureaplasma organisms by culture and PCR revealed no discernable significant differences. Similarly, no significant differences have...suggest increased exposure to mycoplasma . 6. Body: This study will determine whether specific in-vitro immunological abnormalities or evidence of

Acute effects of various weighted bat warm-up protocols on bat velocity.

PubMed

Reyes, G Francis; Dolny, Dennis

2009-10-01

Although research has provided evidence of increased muscular performance following a facilitation set of resistance exercise, this has not been established for use prior to measuring baseball bat velocity. The purpose of this study was to determine the effectiveness of selected weighted bat warm-up protocols to enhance bat velocity in collegiate baseball players. Nineteen collegiate baseball players (age = 20.15 +/- 1.46 years) were tested for upper-body strength by a 3-repetition maximum (RM) bench press (mean = 97.98 +/- 14.54 kg) and mean bat velocity. Nine weighted bat warm-up protocols, utilizing 3 weighted bats (light = 794 g; standard = 850 g; heavy = 1,531 g) were swung in 3 sets of 6 repetitions in different orders. A control trial involved the warm-up protocol utilizing only the standard bat. Pearson product correlation revealed a significant relationship between 3RM strength and pretest bat velocity (r = 0.51, p = 0.01). Repeated measures analysis of variance (ANOVA) revealed no significant treatment effects of warm-up protocol on bat velocity. However, the order of standard, light, heavy bat sequence resulted in the greatest increase in bat velocity (+6.03%). These results suggest that upper-body muscle strength influences bat velocity. It appears that the standard, light, heavy warm-up order may provide the greatest benefit to increase subsequent bat velocity and may warrant use in game situations.

Protocol for a qualitative synthesis of barriers and facilitators in implementing guidelines for diagnosis of tuberculosis.

PubMed

Ochodo, Eleanor; Kredo, Tamara; Young, Taryn; Wiysonge, Charles Shey

2017-06-09

Despite the introduction of new tests and guidelines for diagnosis of tuberculosis (TB), worldwide case detection rate of TB is still suboptimal. This could be in part explained by the poor implementation of TB diagnostic guidelines. We aim to identify, appraise and synthesise qualitative evidence exploring the barriers and facilitators to implementing TB diagnostic guidelines. A systematic review of qualitative studies will be conducted. Relevant electronic databases will be searched and studies included based on predefined inclusion criteria. We will also search reference lists, grey literature, conduct forward citation searches and contact relevant content experts. An adaptation of the Critical Appraisal Skills Programme tool will be used to assess the methodological quality of included studies. Two authors will review the search output, extract data and assess methodological quality independently, resolving any disagreements by consensus. We will use the thematic framework analysis approach based on the Supporting the Use of Research Evidence thematic framework to analyse and synthesise our data. We will apply the Confidence in the Evidence from Reviews of Qualitative research approach to transparently assess our confidence in the findings of the systematic review. This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42016039790 TRIAL REGISTRATION NUMBER: PROSPERO 2016: CRD42016039790. Available from http://www.crd.york.ac.uk/PROSPERO/. © 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.

Treatment algorithms and protocolized care.

PubMed

Morris, Alan H

2003-06-01

Excess information in complex ICU environments exceeds human decision-making limits and likely contributes to unnecessary variation in clinical care, increasing the likelihood of clinical errors. I reviewed recent critical care clinical trials searching for information about the impact of protocol use on clinically pertinent outcomes. Several recently published clinical trials illustrate the importance of distinguishing efficacy and effectiveness trials. One of these trials illustrates the danger of conducting effectiveness trials before the efficacy of an intervention is established. The trials also illustrate the importance of distinguishing guidelines and inadequately explicit protocols from adequately explicit protocols. Only adequately explicit protocols contain enough detail to lead different clinicians to the same decision when faced with the same clinical scenario. Differences between guidelines and protocols are important. Guidelines lack detail and provide general guidance that requires clinicians to fill in many gaps. Computerized or paper-based protocols are detailed and, when used for complex clinical ICU problems, can generate patient-specific, evidence-based therapy instructions that can be carried out by different clinicians with almost no interclinician variability. Individualization of patient therapy can be preserved by these protocols when they are driven by individual patient data. Explicit decision-support tools (eg, guidelines and protocols) have favorable effects on clinician and patient outcomes and can reduce the variation in clinical practice. Guidelines and protocols that aid ICU decision makers should be more widely distributed.

Study protocol: DEcisions in health Care to Introduce or Diffuse innovations using Evidence (DECIDE).

PubMed

Turner, Simon; Morris, Stephen; Sheringham, Jessica; Hudson, Emma; Fulop, Naomi J

2016-04-05

A range of evidence informs healthcare decision-making, from formal research findings to 'soft intelligence' or local data, as well as practical experience or tacit knowledge. However, cultural and organisational factors often prevent the translation of such evidence into practice. Using a multi-level framework, this project will analyse how interactions between the evidence available and processes at the micro (individual/group) and meso (organisational/system) levels influence decisions to introduce or diffuse innovations in acute and primary care within the National Health Service in the UK. This study will use a mixed methods design, combining qualitative and quantitative methods, and involves four interdependent work streams: (1) rapid evidence synthesis of relevant literature with stakeholder feedback; (2) in-depth case studies of 'real-world' decision-making in acute and primary care; (3) a national survey and discrete choice experiment; and (4) development of guidance for decision-makers and evaluators to support the use of evidence in decision-making. This study will enhance the understanding of decision-makers' use of diverse forms of evidence. The findings will provide insights into how and why some evidence does inform decisions to introduce healthcare innovations, and why barriers persist in other cases. It will also quantify decision-makers' preferences, including the 'tipping point' of evidence needed to shift stakeholders' views. Practical guidance will be shared with healthcare decision-makers and evaluators on uses of evidence to enable the introduction and diffusion of innovation.

Nurse clinic versus home delivery of evidence-based community leg ulcer care: A randomized health services trial

PubMed Central

Harrison, Margaret B; Graham, Ian D; Lorimer, Karen; VandenKerkhof, Elizabeth; Buchanan, Maureen; Wells, Phil S; Brandys, Tim; Pierscianowski, Tadeusz

2008-01-01

Background International studies report that nurse clinics improve healing rates for the leg ulcer population. However, these studies did not necessarily deliver similar standards of care based on evidence in the treatment venues (home and clinic). A rigorous evaluation of home versus clinic care is required to determine healing rates with equivalent care and establish the acceptability of clinic-delivered care. Methods Health Services RCT was conducted where mobile individuals were allocated to either home or nurse clinic for leg ulcer management. In both arms, care was delivered by specially trained nurses, following an evidence protocol. Primary outcome: 3-month healing rates. Secondary outcomes: durability of healing (recurrence), time free of ulcers, HRQL, satisfaction, resource use. Data were collected at base-line, every 3 months until healing occurred, with 1 year follow-up. Analysis was by intention to treat. Results 126 participants, 65 randomized to receive care in their homes, 61 to nurse-run clinics. No differences found between groups at baseline on socio-demographic, HRQL or clinical characteristics. mean age 69 years, 68% females, 84% English-speaking, half with previous episode of ulceration, 60% ulcers at inclusion < 5 cm2 for < 6 months. No differences in 3-month healing rates: clinic 58.3% compared to home care at 56.7% (p = 0.5) or in secondary outcomes. Conclusion Our findings indicate that organization of care not the setting where care is delivered influences healing rates. Key factors are a system that supports delivery of evidence-based recommendations with care being provided by a trained nursing team resulting in equivalent healing rates, HRQL whether care is delivered in the home or in a community nurse-led clinic. Trial registration ClinicalTrials.gov Protocol Registration System: NCT00656383 PMID:19036149

Formative research to develop theory-based messages for a Western Australian child drowning prevention television campaign: study protocol

PubMed Central

Denehy, Mel; Crawford, Gemma; Leavy, Justine; Nimmo, Lauren; Jancey, Jonine

2016-01-01

Introduction Worldwide, children under the age of 5 years are at particular risk of drowning. Responding to this need requires the development of evidence-informed drowning prevention strategies. Historically, drowning prevention strategies have included denying access, learning survival skills and providing supervision, as well as education and information which includes the use of mass media. Interventions underpinned by behavioural theory and formative evaluation tend to be more effective, yet few practical examples exist in the drowning and/or injury prevention literature. The Health Belief Model and Social Cognitive Theory will be used to explore participants' perspectives regarding proposed mass media messaging. This paper describes a qualitative protocol to undertake formative research to develop theory-based messages for a child drowning prevention campaign. Methods and analysis The primary data source will be focus group interviews with parents and caregivers of children under 5 years of age in metropolitan and regional Western Australia. Qualitative content analysis will be used to analyse the data. Ethics and dissemination This study will contribute to the drowning prevention literature to inform the development of future child drowning prevention mass media campaigns. Findings from the study will be disseminated to practitioners, policymakers and researchers via international conferences, peer and non-peer-reviewed journals and evidence summaries. The study was submitted and approved by the Curtin University Human Research Ethics Committee. PMID:27207621

Impact of trauma system structure on injury outcomes: a systematic review protocol.

PubMed

Moore, Lynne; Champion, Howard; O'Reilly, Gerard; Leppaniemi, Ari; Cameron, Peter; Palmer, Cameron; Abu-Zidan, Fikri M; Gabbe, Belinda; Gaarder, Christine; Yanchar, Natalie; Stelfox, Henry Thomas; Coimbra, Raul; Kortbeek, John; Noonan, Vanessa; Gunning, Amy; Leenan, Luke; Gordon, Malcolm; Khajanchi, Monty; Shemilt, Michèle; Porgo, Valérie; Turgeon, Alexis F

2017-01-21

Injury represents one of the greatest public health challenges of our time with over 5 million deaths and 100 million people temporarily or permanently disabled every year worldwide. The effectiveness of trauma systems in decreasing injury mortality and morbidity has been well demonstrated. However, the organisation of trauma care varies significantly across trauma systems and we know little about which components of trauma systems contribute to their effectiveness. The objective of the study described in this protocol is to systematically review evidence of the impact of trauma system components on clinically significant outcomes including mortality, function and disability, quality of life, and resource utilization. We will perform a systematic review of studies evaluating the association between at least one trauma system component (e.g. accreditation by a central agency, interfacility transfer agreements) and at least one injury outcome (e.g. mortality, disability, resource use). We will search MEDLINE, EMBASE, COCHRANE central, and BIOSIS/Web of Knowledge databases, thesis holdings, key injury organisation websites and conference proceedings for eligible studies. Pairs of independent reviewers will evaluate studies for eligibility and extract data from included articles. Methodological quality will be evaluated using elements of the ROBINS-I tool and the Cochrane risk of bias tool for non-randomized and randomized studies, respectively. Strength of evidence will be evaluated using the GRADE tool. We expect to advance knowledge on the components of trauma systems that contribute to their effectiveness. This may lead to recommendations on trauma system structure that will help policy-makers make informed decisions as to where resources should be focused. The review may also lead to specific recommendations for future research efforts. This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 28-06-2016. PROSPERO 2016:CRD42016041336 Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016041336 .

Effective components of exercise and physical activity-related behaviour-change interventions for chronic non-communicable diseases in Africa: protocol for a systematic mixed studies review with meta-analysis.

PubMed

Igwesi-Chidobe, Chinonso N; Godfrey, Emma L; Kengne, Andre P

2015-08-12

Chronic non-communicable diseases (NCDs) account for a high burden of mortality and morbidity in Africa. Evidence-based clinical guidelines recommend exercise training and promotion of physical activity behaviour changes to control NCDs. Developing such interventions in Africa requires an understanding of the essential components that make them effective in this context. This is a protocol for a systematic mixed studies review that aims to determine the effective components of exercise and physical activity-related behaviour-change interventions for chronic diseases in Africa, by combining quantitative and qualitative research evidence from studies published until July 2015. We will conduct a detailed search to identify all published and unpublished studies that assessed the effects of exercise and physical activity-related interventions or the experiences/perspectives of patients to these interventions for NCDs from bibliographic databases and the grey literature. Bibliographic databases include MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), PsycINFO, CINAHL and Web of Science. We will include the following African regional databases: African Index Medicus (AIM) and AFROLIB, which is the WHO's regional office database for Africa. The databases will be searched from inception until 18 July 2015. Appraisal of study quality will be performed after results synthesis. Data synthesis will be performed independently for quantitative and qualitative data using a mixed methods sequential explanatory synthesis for systematic mixed studies reviews. Meta-analysis will be conducted for the quantitative studies, and thematic synthesis for qualitative studies and qualitative results from the non-controlled observational studies. The primary outcome will include exercise adherence and physical activity behaviour changes. This review protocol is reported according to Preferred Reporting Items for Systematic reviews and Meta-Analysis protocols (PRISMA-P) 2015 guidelines. There is no ethical requirement for this study, as it utilises published data. This review is expected to inform the development of exercise and physical activity-related behaviour-change interventions in Africa, and will be presented at conferences, and published in peer reviewed journals and a PhD thesis at King's College London. This study was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 22 January 2015 (registration number: PROSPERO 2015: CRD42015016084). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A research protocol for developing a Point-Of-Care Key Evidence Tool 'POCKET': a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics.

PubMed

Huddy, Jeremy R; Ni, Melody; Mavroveli, Stella; Barlow, James; Williams, Doris-Ann; Hanna, George B

2015-07-10

Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS). A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise. The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer-reviewed publication, academic conferences and formal presentations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Do different maxillary expansion appliances influence the outcomes of the treatment?

PubMed

Algharbi, Muteb; Bazargani, Farhan; Dimberg, Lillemor

2018-01-23

There is no consensus in the literature regarding which rapid maxillary expansion (RME) design or activation rate benefits the patients the most. Therefore, the primary aim of this systematic review was to see whether there is a difference in the skeletal and dentoalveolar effects of different RME appliances in children and growing adolescents. The secondary aim was to see whether these effects are different when using different activation protocols for these appliances. The search was done in three databases (PubMed, Cochrane Library, and Web of Science). The following inclusion criteria were used: randomized controlled trial, prospective controlled studies, 15 or more patients in each study, human subjects up to 18 years of age, and RME effects had to be assessed by computed tomography/cone beam computed tomography. Quality of the methodology was classified according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines as high, moderate, or low. The search resulted in 145 titles and abstracts; 109 of them were excluded based on pre-established criteria. Thirty-six full-text articles were assessed for eligibility and 18 of which satisfied the inclusion criteria. Finally, seven articles were deemed eligible for full inclusion and revealed that all appliances and protocols showed significant expansion in the mid-palatal suture. No evidence was found for the cause of dental tipping. In this systematic review, having different age groups in each study and using different anatomical landmarks and outcome measures for assessing the skeletal and dental effects made it difficult to conduct a meta-analysis. There is moderate evidence that all designs produce significant expansion at the mid-palatal suture. However, lack of studies comparing appliances and protocols has been found. Finally, no evidence-based conclusions could be drawn about the appliance effect on teeth tipping. No appliance appears to be superior when it comes to expansion in the mid-palatal suture. Therefore, the tooth-borne appliance might be preferable until further high-quality studies conclude otherwise. The project was funded through the Department of Orthodontics, Postgraduate Dental Education Center, Region Örebro County, Örebro, Sweden. This systematic review was not registered in any external databases. © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

Practical guidance for the implementation of stress echocardiography.

PubMed

Suzuki, Kengo; Hirano, Yutaka; Yamada, Hirotsugu; Murata, Mitsushige; Daimon, Masao; Takeuchi, Masaaki; Seo, Yoshihiro; Izumi, Chisato; Akaishi, Makoto

2018-06-06

Exercise stress testing has been widely undertaken for the diagnosis of heart diseases. The accurate assessment of clinical conditions can be conducted by comparing the findings obtained from the results of stress echocardiography with the changes in the blood/heart rate and electrocardiograms. Numerous overseas studies have reported the utility of stress echocardiography in diagnosing myocardial ischemia; in Japan, the use of this modality for this purpose was included in the national health insurance reimbursable list in 2012. Nevertheless, stress echocardiography is far from being a widespread practice in Japan. This might be due to insufficient equipment (e.g., ergometers, space for test implementation) at each medical institution, shortage of technicians and sonographers who are well experienced and who are responsible for obtaining images during stress testing. The other possible reasons include the limited evidence available in Japan and the lack of a standardized testing protocol. Further dissemination of the practice of exercise stress echocardiography in this country is deemed necessary to establish satisfactory evidence for the use of stress echocardiography in the Japanese population. To this end, efforts are underway to develop a standardized protocol and report format to be adopted throughout Japan. We here present a guideline created by the Guideline Development Committee of the Japanese Society of Echocardiography that describes safe and effective stress echocardiography protocols and report formats. The readers are encouraged to perform exercise stress echocardiography using the proposed template for consensus document and report attached to this guideline.

Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported?-two systematic reviews.

PubMed

Farid-Kapadia, Mufiza; Joachim, Kariym C; Balasingham, Chrinna; Clyburne-Sherin, April; Offringa, Martin

2017-03-06

Evidence suggests that newborn and child health systematic reviews and meta-analyses exhibit poor quality in reporting. The "Preferred Reporting Items in Systematic Review and Meta-Analysis" (PRISMA) and PRISMA-Protocols (PRISMA-P) checklists have been developed to improve the reporting of systematic review results and protocols, respectively. We aimed to evaluate the clarity and transparency in reporting of child-centric items in child health systematic reviews (SRs) and SR protocols and to identify areas where reporting could be strengthened. Two preliminary lists of potential child-centric reporting items were used to examine current reporting. The Cochrane, DARE, MEDLINE, and EMBASE libraries were searched from 2010 to 2014 for systematic reviews that included children. Each report and protocol that met the inclusion criteria had their quality of reporting assessed by their reporting of child-centric items. Quality of reporting was assessed per whether one third, one to two thirds, or more than two thirds of papers complied with potential child-centric potential modifications/extensions to PRISMA and were analyzed by the following: (i) paper type (i.e., report vs. protocol), (ii) publication type (i.e., Cochrane vs. non-Cochrane), and (iii) population type (i.e., child-only vs. mixed populations vs. family/maternal). Of the 414 eligible articles, 248 reports and 76 protocols were included. In 21 of 24 potential SR reporting items and 13 of 14 potential SR protocol reporting items, less than two thirds of papers met the child-centric reporting item requirements. Mixed population studies displayed significantly poorer reporting in comparison to child-only and family/maternal intervention studies for 11 potential SR reporting items (p < 0.05) and five potential SR protocol items (p < 0.05). When comparing non-Cochrane to Cochrane reports and protocols, five items in both lists were found to perform significantly poorer in non-Cochrane reports (p < 0.05). Significant differences in reporting quality were found in three of 14 items shared between the potential SR reporting items and potential SR protocol reporting items (p < 0.05). Newborn and child health systematic reviews and meta-analyses exhibit incomplete reporting, thereby hindering prudent decision-making by healthcare providers and policy makers. These results provide a rationale for the implementation of child-centric extensions and modifications to current PRISMA and PRISMA-P, such as to improve reporting in this population.

The effect of personalized versus standard patient protocols for radiostereometric analysis (RSA).

PubMed

Muharemovic, O; Troelsen, A; Thomsen, M G; Kallemose, T; Gosvig, K K

2018-05-01

Increasing pressure in the clinic requires a more standardized approach to radiostereometric analysis (RSA) imaging. The aim of this study was to investigate whether implementation of personalized RSA patient protocols could increase image quality and decrease examination time and the number of exposure repetitions. Forty patients undergoing primary total hip arthroplasty were equally randomized to either a case or a control group. Radiographers in the case group were assisted by personalized patient protocols containing information about each patient's post-operative RSA imaging. Radiographers in the control group used a standard RSA protocol. At three months, radiographers in the case group significantly reduced (p < 0.001) the number of exposures by 1.6, examination time with 19.2 min, and distance between centrum of prosthesis and centrum of calibration field with 34.1 mm when compared to post-operative (baseline) results. At twelve months, the case group significantly reduced (p < 0.001) number of exposures by two, examination time with 22.5 min, and centrum of prosthesis to centrum of calibration field distance with 43.1 mm when compared to baseline results. No significant improvements were found in the control group at any time point. There is strong evidence that personalized RSA patient protocols have a positive effect on image quality and radiation dose savings. Implementation of personal patient protocols as a RSA standard will contribute to the reduction of examination time, thus ensuring a cost benefit for department and patient safety. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial

PubMed Central

Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

2015-01-01

Objective To test whether community mobilization adds effectiveness to conventional dengue control. Design Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Setting Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Participants Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85 182 residents in 18 838 households. Interventions A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention—chemical-free prevention of mosquito reproduction—to its own circumstances. All clusters continued the government run dengue control program. Main outcome measures Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. Results With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited (house index) (44.1%, 13.6% to 74.7%), fewer containers with larvae or pupae among containers examined (container index) (36.7%, 24.5% to 44.8%), fewer containers with larvae or pupae among houses visited (Breteau index) (35.1%, 16.7% to 55.5%), and fewer pupae per person (51.7%, 36.2% to 76.1%). The numbers needed to treat were 30 (95% confidence interval 20 to 59) for a lower risk of infection in children, 71 (48 to 143) for fewer reports of dengue illness, 17 (14 to 20) for the house index, 37 (35 to 67) for the container index, 10 (6 to 29) for the Breteau index, and 12 (7 to 31) for fewer pupae per person. Secondary per protocol analysis showed no serological evidence of a protective effect of temephos. Conclusions Evidence based community mobilization can add effectiveness to dengue vector control. Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement. Trial registration ISRCTN27581154 PMID:26156323

Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial.

PubMed

Andersson, Neil; Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de Los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

2015-07-08

To test whether community mobilization adds effectiveness to conventional dengue control. Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85,182 residents in 18,838 households. A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention-chemical-free prevention of mosquito reproduction-to its own circumstances. All clusters continued the government run dengue control program. Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited (house index) (44.1%, 13.6% to 74.7%), fewer containers with larvae or pupae among containers examined (container index) (36.7%, 24.5% to 44.8%), fewer containers with larvae or pupae among houses visited (Breteau index) (35.1%, 16.7% to 55.5%), and fewer pupae per person (51.7%, 36.2% to 76.1%). The numbers needed to treat were 30 (95% confidence interval 20 to 59) for a lower risk of infection in children, 71 (48 to 143) for fewer reports of dengue illness, 17 (14 to 20) for the house index, 37 (35 to 67) for the container index, 10 (6 to 29) for the Breteau index, and 12 (7 to 31) for fewer pupae per person. Secondary per protocol analysis showed no serological evidence of a protective effect of temephos. Evidence based community mobilization can add effectiveness to dengue vector control. Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement. ISRCTN27581154. © Andersson et al 2015.

Antenatal magnesium sulfate is beneficial or harmful in very preterm and extremely preterm neonates: a new insight.

PubMed

Garg, Bhawan Deep

2018-01-17

To evaluate whether antenatal MgSO 4 is beneficial or harmful in very preterm and extremely preterm neonates. We retrieved published literature through searches of PubMed or Medline, CINAHL, and the Cochrane Library. Results were restricted to systematic reviews, meta-analysis, randomized controlled trials (RCTs), and relevant observational studies. Evidence revealed that antenatal MgSO 4 has neuroprotective role in preterm neonates and it decreased the risk of cerebral palsy and gross motor dysfunction. Evidences regarding association of antenatal MgSO 4 with feed intolerance, NEC and SIP were from cohort studies and controversial. We should continue use antenatal MgSO 4 to all eligible patients according to protocol till the more robust evidence will suggest association with gastrointestinal complications. In the meantime, we should have a high index of suspicion of gastrointestinal complications in extremely preterms particularly <26 weeks of gestation.

Association between obesity and depression in patients with diabetes mellitus type 2; a study protocol.

PubMed

De la Cruz-Cano, Eduardo; Tovilla-Zarate, Carlos Alfonso; Reyes-Ramos, Emilio; Gonzalez-Castro, Thelma Beatriz; Juarez-Castro, Isela; López-Narváez, Maria Lilia; Fresan, Ana

2015-01-01

Diabetes mellitus and depression are highly prevalent conditions throughout the world and have significant impact on health outcomes. It has been estimated that diabetes mellitus type 2 affects about 246 million people in the world; nevertheless, incidence varies among countries. There is evidence that depression is associated with a poor metabolic control in patients with type 2 diabetes mellitus that present other health problems (such as hypertension and obesity). The aim of this study protocol is to determine if obesity increases the risk for depression in patient with diabetes type 2. The analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).The studies suitable for inclusion will be assessed by the Newcastle-Ottawa Scale (NOS) to determine their methodological quality. To identify the studies of interest, we will search on PubMed and EBSCO databases. We will use the following keyword combinations: "Diabetes Mellitus type 2 AND obesity AND depression", "depression AND Diabetes Mellitus type 2", "Diabetes Mellitus type 2 AND body mass index cross sectional study", "depression AND obesity cross-sectional study". Causes for exclusion will be publications that studied patients diagnosed with diabetes mellitus type 1; articles that focused on the treatment and complications of diabetes mellitus type 2; publications that have studied other clinical or psychiatric conditions (for instance, seizure disorder or history of schizophrenia, bipolar disorder, psychotic symptoms or dementia). The results of this study will form the basis for a better understanding of the association between obesity and depression in patients with diabetes mellitus type 2, and will allow development of prediction tools and better interventions. It is evident that several modifiable and non-modifiable risk factors play an important role in the pathogenesis of diabetes among population. Currently, evidence for the deleterious effects of diabetes mellitus type 2 are based on cross-sectional or other observational designs. Therefore, this study will have important implications for future research and public health guidance.

Provider report of the existence of detection and care of perinatal depression: quantitative evidence from public obstetric units in Mexico.

PubMed

Castro, Filipa de; Place, Jean Marie; Allen-Leigh, Betania; Rivera-Rivera, Leonor; Billings, Deborah

2016-08-01

To provide evidence on perinatal mental healthcare in Mexico. Descriptive and bivariate analyses of data from a cross-sectional probabilistic survey of 211 public obstetric units. Over half (64.0%) of units offer mental healthcare; fewer offer perinatal depression (PND) detection (37.1%) and care (40.3%). More units had protocols/guidelines for PND detection and for care, respectively, in Mexico City-Mexico state (76.7%; 78.1%) than in Southern (26.5%; 36.4%), Northern (27.3%; 28.1%) and Central Mexico (50.0%; 52.7%). Protocols and provider training in PND, implementation of brief screening tools and psychosocial interventions delivered by non-clinical personnel are needed.

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

PubMed

Wang, Shengjun; Jiang, Hongli; Yu, Qin; She, Bin; Mao, Bing

2017-01-05

The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.

Digital breast tomosynthesis (DBT): recommendations from the Italian College of Breast Radiologists (ICBR) by the Italian Society of Medical Radiology (SIRM) and the Italian Group for Mammography Screening (GISMa).

PubMed

Bernardi, Daniela; Belli, Paolo; Benelli, Eva; Brancato, Beniamino; Bucchi, Lauro; Calabrese, Massimo; Carbonaro, Luca A; Caumo, Francesca; Cavallo-Marincola, Beatrice; Clauser, Paola; Fedato, Chiara; Frigerio, Alfonso; Galli, Vania; Giordano, Livia; Giorgi Rossi, Paolo; Golinelli, Paola; Morrone, Doralba; Mariscotti, Giovanna; Martincich, Laura; Montemezzi, Stefania; Naldoni, Carlo; Paduos, Adriana; Panizza, Pietro; Pediconi, Federica; Querci, Fiammetta; Rizzo, Antonio; Saguatti, Gianni; Tagliafico, Alberto; Trimboli, Rubina M; Zappa, Marco; Zuiani, Chiara; Sardanelli, Francesco

2017-10-01

This position paper, issued by ICBR/SIRM and GISMa, summarizes the evidence on DBT and provides recommendations for its use. In the screening setting, DBT in adjunct to digital mammography (DM) increased detection rate by 0.5-2.7‰ and decreased false positives by 0.8-3.6% compared to DM alone in observational and double-testing experimental studies. The reduction in recall rate could be less prominent in those screening programs which already have low recall rates with DM. The increase in radiation exposure associated with DM/DBT protocols has been solved by the introduction of synthetic mammograms (sDM) reconstructed from DBT datasets. Thus, whenever possible, sDM/DBT should be preferred to DM/DBT. However, before introducing DBT as a routine screening tool for average-risk women, we should wait for the results of randomized controlled trials and for a statistically significant and clinically relevant reduction in the interval cancer rate, hopefully associated with a reduction in the advanced cancer rate. Otherwise, a potential for overdiagnosis and overtreatment cannot be excluded. Studies exploring this issue are ongoing. Screening of women at intermediate risk should follow the same recommendations, with particular protocols for women with previous BC history. In high-risk women, if mammography is performed as an adjunct to MRI or in the case of MRI contraindications, sDM/DBT protocols are suggested. Evidence exists in favor of DBT usage in women with clinical symptoms/signs and asymptomatic women with screen-detected findings recalled for work-up. The possibility to perform needle biopsy or localization under DBT guidance should be offered when DBT-only findings need characterization or surgery.

EVIDENCE-BASED PROTOCOLS

PubMed Central

Beissner, Katherine L.; Bach, Eileen; Murtaugh, Christopher M.; Trifilio, MaryGrace; Henderson, Charles R.; Barrón, Yolanda; Trachtenberg, Melissa A.; Reid, M. Carrington

2017-01-01

Activity-limiting pain is common among older home care patients and pain management is complicated by the high prevalence of physical frailty and multimorbidity in the home care population. A comparative effectiveness study was undertaken at a large urban home care agency to examine an evidence-based pain self-management program delivered by physical therapists (PTs). This article focuses on PT training, methods implemented to reinforce content after training and to encourage uptake of the program with appropriate patients, and therapists’ fidelity to the program. Seventeen physical therapy teams were included in the cluster randomized controlled trial, with 8 teams (155 PTs) assigned to a control and 9 teams (165 PTs) assigned to a treatment arm. Treatment therapists received interactive training over two sessions, with a follow-up session 6 months later. Additional support was provided via emails, e-learning materials including videos, and a therapist manual. Program fidelity was assessed by examining PT pain documentation in the agency’s electronic health record. PT feedback on the program was obtained via semistructured surveys. There were no between-group differences in the number of PTs documenting program elements with the exception of instruction in the use of imagery, which was documented by a higher percentage of intervention therapists (p = 0.002). PTs felt comfortable teaching the program elements, but cited time as the biggest barrier to implementing the protocol. Possible explanations for study results suggesting limited adherence to the program protocol by intervention-group PTs include the top-down implementation strategy, competing organizational priorities, program complexity, competing patient priorities, and inadequate patient buy-in. Implications for the implementation of complex new programs in the home healthcare setting are discussed. PMID:28157776

Targeted agents for patients with advanced/metastatic pancreatic cancer: A protocol for systematic review and network meta-analysis.

PubMed

Di, Baoshan; Pan, Bei; Ge, Long; Ma, Jichun; Wu, Yiting; Guo, Tiankang

2018-03-01

Pancreatic cancer (PC) is a devastating malignant tumor. Although surgical resection may offer a good prognosis and prolong survival, approximately 80% patients with PC are always diagnosed as unresectable tumor. National Comprehensive Cancer Network's (NCCN) recommended gemcitabine-based chemotherapy as efficient treatment. While, according to recent studies, targeted agents might be a better available option for advanced or metastatic pancreatic cancer patients. The aim of this systematic review and network meta-analysis will be to examine the differences of different targeted interventions for advanced/metastatic PC patients. We will conduct this systematic review and network meta-analysis using Bayesian method and according to Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. To identify relevant studies, 6 electronic databases including PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of science, CNKI (Chinese National Knowledge Infrastructure), and CBM (Chinese Biological Medical Database) will be searched. The risk of bias in included randomized controlled trials (RCTs) will be assessed using the Cochrane Handbook version 5.1.0. And we will use GRADE approach to assess the quality of evidence from network meta-analysis. Data will be analyzed using R 3.4.1 software. To the best of our knowledge, this systematic review and network meta-analysis will firstly use both direct and indirect evidence to compare the differences of different targeted agents and targeted agents plus chemotherapy for advanced/metastatic pancreatic cancer patients. This is a protocol of systematic review and meta-analysis, so the ethical approval and patient consent are not required. We will disseminate the results of this review by submitting to a peer-reviewed journal.

Effect of Linguistic and Musical Experience on Distributional Learning of Nonnative Lexical Tones

ERIC Educational Resources Information Center

Ong, Jia Hoong; Burnham, Denis; Escudero, Paola; Stevens, Catherine J.

2017-01-01

Purpose: Evidence suggests that extensive experience with lexical tones or musical training provides an advantage in perceiving nonnative lexical tones. This investigation concerns whether such an advantage is evident in learning nonnative lexical tones based on the distributional structure of the input. Method: Using an established protocol,…

Bone and bone turnover.

PubMed

Crofton, Patricia M

2009-01-01

Children with cancer are exposed to multiple influences that may adversely affect bone health. Some treatments have direct deleterious effects on bone whilst others may have indirect effects mediated through various endocrine abnormalities. Most clinical outcome studies have concentrated on survivors of acute lymphoblastic leukaemia (ALL). There is now good evidence that earlier treatment protocols that included cranial irradiation with doses of 24 Gy or greater may result in growth hormone deficiency and low bone mineral density (BMD) in the lumbar spine and femoral neck. Under current protocols, BMD decreases during intensive chemotherapy and fracture risk increases. Although total body BMD may eventually return to normal after completion of chemotherapy, lumbar spine trabecular BMD may remain low for many years. The implications for long-term fracture risk are unknown. Risk factors for low BMD include high dose methotrexate, higher cumulative doses of glucocorticoids, male gender and low physical activity. BMD outcome in non-ALL childhood cancers has been less well studied but there is evidence that survivors of childhood brain or bone tumours, and survivors of bone marrow transplants for childhood malignancy, all have a high risk of long-term osteopenia. Long-term follow-up is required, with appropriate treatment of any endocrine abnormalities identified. Copyright (c) 2009 S. Karger AG, Basel.

Merging Theoretical Models and Therapy Approaches in the Context of Internet Gaming Disorder: A Personal Perspective.

PubMed

Young, Kimberly S; Brand, Matthias

2017-01-01

Although, it is not yet officially recognized as a clinical entity which is diagnosable, Internet Gaming Disorder (IGD) has been included in section III for further study in the DSM-5 by the American Psychiatric Association (APA, 2013). This is important because there is increasing evidence that people of all ages, in particular teens and young adults, are facing very real and sometimes very severe consequences in daily life resulting from an addictive use of online games. This article summarizes general aspects of IGD including diagnostic criteria and arguments for the classification as an addictive disorder including evidence from neurobiological studies. Based on previous theoretical considerations and empirical findings, this paper examines the use of one recently proposed model, the Interaction of Person-Affect-Cognition-Execution (I-PACE) model, for inspiring future research and for developing new treatment protocols for IGD. The I-PACE model is a theoretical framework that explains symptoms of Internet addiction by looking at interactions between predisposing factors, moderators, and mediators in combination with reduced executive functioning and diminished decision making. Finally, the paper discusses how current treatment protocols focusing on Cognitive-Behavioral Therapy for Internet addiction (CBT-IA) fit with the processes hypothesized in the I-PACE model.

Merging Theoretical Models and Therapy Approaches in the Context of Internet Gaming Disorder: A Personal Perspective

PubMed Central

Young, Kimberly S.; Brand, Matthias

2017-01-01

Although, it is not yet officially recognized as a clinical entity which is diagnosable, Internet Gaming Disorder (IGD) has been included in section III for further study in the DSM-5 by the American Psychiatric Association (APA, 2013). This is important because there is increasing evidence that people of all ages, in particular teens and young adults, are facing very real and sometimes very severe consequences in daily life resulting from an addictive use of online games. This article summarizes general aspects of IGD including diagnostic criteria and arguments for the classification as an addictive disorder including evidence from neurobiological studies. Based on previous theoretical considerations and empirical findings, this paper examines the use of one recently proposed model, the Interaction of Person-Affect-Cognition-Execution (I-PACE) model, for inspiring future research and for developing new treatment protocols for IGD. The I-PACE model is a theoretical framework that explains symptoms of Internet addiction by looking at interactions between predisposing factors, moderators, and mediators in combination with reduced executive functioning and diminished decision making. Finally, the paper discusses how current treatment protocols focusing on Cognitive-Behavioral Therapy for Internet addiction (CBT-IA) fit with the processes hypothesized in the I-PACE model. PMID:29104555

Fostering critical thinking and collaborative learning skills among medical students through a research protocol writing activity in the curriculum.

PubMed

Sahoo, Soumendra; Mohammed, Ciraj Ali

2018-06-01

This intervention was aimed to analyse the effect of academic writing and journal critiquing as educational approaches in improving critical thinking and collaborative learning among undergraduate medical students. A research proposal writing format was created for the 4th year medical students of Melaka Manipal Medical College, Malaysia during their ophthalmology clinical postings. The students worked in small groups and developed research protocols through an evidence based approach. This was followed by writing reflective summaries in academic portfolios about the activity undertaken. A mixed methods study was designed to explore the possible role of collaborative research proposal writing in enhancing critical thinking and collaborative learning. Analysis of reflections submitted by 188 medical students after the intervention indicate that majority of them found an improvement in their skills of critical thinking and collaborative learning as a result of research protocol writing. All participants agreed that the model helped in applying concepts to new situations in the form of designing their own study, which reflected in enhanced higher order cognitive skills. This study shows that the introduction of a structured module in the core medical curriculum that focuses on research writing skills embedded with collaborative and reflective practices can enhance collaborative learning, critical thinking, and reasoning among medical students.

A scoping review of the psychological responses to interval exercise: is interval exercise a viable alternative to traditional exercise?

PubMed

Stork, Matthew J; Banfield, Laura E; Gibala, Martin J; Martin Ginis, Kathleen A

2017-12-01

While considerable evidence suggests that interval exercise confers numerous physiological adaptations linked to improved health, its psychological consequences and behavioural implications are less clear and the subject of intense debate. The purpose of this scoping review was to catalogue studies investigating the psychological responses to interval exercise in order to identify what psychological outcomes have been assessed, the research methods used, and the results. A secondary objective was to identify research issues and gaps. Forty-two published articles met the review inclusion/exclusion criteria. These studies involved 1258 participants drawn from various active/inactive and healthy/unhealthy populations, and 55 interval exercise protocols (69% high-intensity interval training [HIIT], 27% sprint interval training [SIT], and 4% body-weight interval training [BWIT]). Affect and enjoyment were the most frequently studied psychological outcomes. Post-exercise assessments indicate that overall, enjoyment of, and preferences for interval exercise are equal or greater than for continuous exercise, and participants can hold relatively positive social cognitions regarding interval exercise. Although several methodological issues (e.g., inconsistent use of terminology, measures and protocols) and gaps (e.g., data on adherence and real-world protocols) require attention, from a psychological perspective, the emerging data support the viability of interval exercise as an alternative to continuous exercise.

Physiotherapy for Ankylosing Spondylitis: Systematic Review and a Proposed Rehabilitation Protocol.

PubMed

Sharan, Deepak; Rajkumar, Joshua S

2017-01-01

Ankylosing Spondylitis (AS) is a chronic inflammatory disease with gradual onset, largely affecting the axial skeleton. As leads to varying degrees of restricted spinal mobility, pain and loss of functional capacity. Rehabilitation, especially physiotherapy and exercises, are considered integral components of its management. Various rehabilitation modalities are available for the benefit of individuals with AS, but a sequenced protocol has not been reported. A scientific review was performed using the following search engines: MEDLINE (Pubmed), COCHRANE Library and Physiotherapy Evidence Database (PEDro). Studies, which had at least one of the groups receiving rehabilitation, and the major outcomes studied including pain, stiffness, mobility (spine and chest wall) and physical function (disease activity, ADL, QOL and global function) were selected. A total of 28 studies were shortlisted for the review which included a total of 1926 subjects with AS. The review of literature showed that individuals with AS had beneficial effects from exercise programmes compared to no exercise. Patient education, active involvement and motivation of individuals with AS played an important role in the overall treatment outcomes. Based on the review, a four-phase sequenced rehabilitation protocol has been laid down for the benefit of individuals with AS. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The cost-effectiveness of an intensive treatment protocol for severe dyslexia in children.

PubMed

Hakkaart-van Roijen, Leona; Goettsch, Wim G; Ekkebus, Michel; Gerretsen, Patty; Stolk, Elly A

2011-08-01

Studies of interventions for dyslexia have focused entirely on outcomes related to literacy. In this study, we considered a broader picture assessing improved quality of life compared with costs. A model served as a tool to compare costs and effects of treatment according to a new protocol and care as usual. Quality of life was measured and valued by proxies using a general quality-of-life instrument (EQ-5D). We considered medical cost and non-medical cost (e.g. remedial teaching). The model computed cost per successful treatment and cost per quality adjusted life year (QALY) in time. About 75% of the total costs was related to diagnostic tests to distinguish between children with severe dyslexia and children who have reading difficulties for other reasons. The costs per successful treatment of severe dyslexia were €36 366. Successful treatment showed a quality-of-life gain of about 11%. At primary school, the average cost per QALY for severe dyslexia amounted to €58 647. In the long term, the cost per QALY decreased to €26 386 at secondary school and €17 663 thereafter. The results of this study provide evidence that treatment of severe dyslexia is cost-effective when the investigated protocol is followed. Copyright © 2011 John Wiley & Sons, Ltd.

A Protocol for Advanced Psychometric Assessment of Surveys

PubMed Central

Squires, Janet E.; Hayduk, Leslie; Hutchinson, Alison M.; Cranley, Lisa A.; Gierl, Mark; Cummings, Greta G.; Norton, Peter G.; Estabrooks, Carole A.

2013-01-01

Background and Purpose. In this paper, we present a protocol for advanced psychometric assessments of surveys based on the Standards for Educational and Psychological Testing. We use the Alberta Context Tool (ACT) as an exemplar survey to which this protocol can be applied. Methods. Data mapping, acceptability, reliability, and validity are addressed. Acceptability is assessed with missing data frequencies and the time required to complete the survey. Reliability is assessed with internal consistency coefficients and information functions. A unitary approach to validity consisting of accumulating evidence based on instrument content, response processes, internal structure, and relations to other variables is taken. We also address assessing performance of survey data when aggregated to higher levels (e.g., nursing unit). Discussion. In this paper we present a protocol for advanced psychometric assessment of survey data using the Alberta Context Tool (ACT) as an exemplar survey; application of the protocol to the ACT survey is underway. Psychometric assessment of any survey is essential to obtaining reliable and valid research findings. This protocol can be adapted for use with any nursing survey. PMID:23401759

Prebreathe Protocol for Extravehicular Activity Technical Consultation Report

NASA Technical Reports Server (NTRS)

Ross, Jerry; Duncan, Michael

2008-01-01

In the performance of EVA by that National Aeronautics and Space Administration (NASA) astronauts, there exists a risk of DCS as the suit pressure is reduced to 4.3 pounds per square inch, absolute (psia) from the International Space Station (ISS) pressure of 14.7 psia. Several DCS-preventive procedures have been developed and implemented. Each of these procedures involve the use of oxygen (O2) prebreathe to effectively washout tissue nitrogen (N2).The management of the ISS Programs convened an expert independent peer review Team to conduct a review of the Decompression Sickness (DCS) risks associated with the Extra Vehicular Activity (EVA) Campout Prebreathe (PB) protocol for its consideration for use on future missions. The major findings and recommendations of the expert panel are: There is no direct experimental data to confirm the potential DCS risks of the Campout PB protocol. However, based on model data, statistical probability, physiology, and information derived from similar PB protocols, there is no compelling evidence to suggest that the Campout PB protocol is less safe than the other NASA approved PB protocols.

Using Lean Quality Improvement Tools to Increase Delivery of Evidence-Based Tobacco Use Treatment in Hospitalized Neurosurgical Patients.

PubMed

Sisler, Laurel; Omofoye, Oluwaseun; Paci, Karina; Hadar, Eldad; Goldstein, Adam O; Ripley-Moffitt, Carol

2017-12-01

Health care providers routinely undertreat tobacco dependence, indicating a need for innovative ways to increase delivery of evidence-based care. Lean, a set of quality improvement (QI) tools used increasingly in health care, can help streamline processes, create buy-in for use of evidence-based practices, and lead to the identification of solutions on the basis of a problem's root causes. To date, no published research has examined the use of Lean tools in tobacco dependence. A 12-month QI project using Lean tools was conducted to increase delivery of evidence-based tobacco use treatment (TUT) to hospitalized neurosurgical patients. The study team developed a nicotine replacement therapy (NRT) and counseling protocol for neurosurgery inpatients who indicated current tobacco use and used Lean tools to increase protocol adherence. Rates of NRT prescription, referrals to counseling, and follow-up phone calls were compared pre- and postintervention. Secondary measures included patient satisfaction with intervention, quit rates, and reduction rates at 4 weeks postdischarge. Referrals to counseling doubled from 31.7% at baseline to 62.0% after implementation of the intervention, and rates of nicotine replacement therapy (NRT) prescriptions during hospitalization and at discharge increased from 15.3% to 28.5% and 9.0% to 19.3%, respectively. Follow-up phone call rates also dramatically increased. The majority of satisfaction survey respondents indicated that counseling had a positive or neutral impact on stress level and overall satisfaction. Lean tools can dramatically increase use of evidence-based TUT in hospitalized patients. This project is easily replicable by professionals seeking to improve delivery of tobacco treatment. These findings may be particularly helpful to inpatient surgical departments that have traditionally been reticent to prescribe NRT. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

Continuous passive motion and physical therapy (CPM) versus physical therapy (PT) versus delayed physical therapy (DPT) after surgical release for elbow contractures; a study protocol for a prospective randomized controlled trial.

PubMed

Viveen, Jetske; Doornberg, Job N; Kodde, Izaak F; Goossens, Pjotr; Koenraadt, Koen L M; The, Bertram; Eygendaal, Denise

2017-11-22

The elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. Conservative treatment includes physical therapy, intra-articular injections with corticosteroids and a static progressive or dynamic splinting program. If conservative treatment fails, an operative release of the posttraumatic stiff elbow is often performed. The best Evidence-Based rehabilitation protocol for patients after an operative release is unknown to date and differs per surgeon, hospital and country. Options include early- or delayed motion supervised by a physical therapist, immediate continuous passive motion (CPM), (night) splinting and a static progressive or dynamic splinting program. The SET-Study (Stiff Elbow Trial) is a single-centre, prospective, randomized controlled trial. The primary objective of this study is to compare the active Range of Motion (ROM) (flexion arc and rotational arc) twelve months after surgery between three groups. The first group will receive in-hospital CPM in combination with early motion Physical Therapy (PT) supervised by a physical therapist, the second group will receive only in-hospital early motion PT supervised by a physical therapist and the third group will receive outpatient supervised PT from postoperative day seven till ten. Secondary outcome measures will be Patient Reported Outcome Measures (PROMs) including the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), the quick Disabilities of Arm, Shoulder and Hand (qDASH) score, Visual Analogue pain Scale in rest and activity (VAS), Pain Catastrophizing Scale (PCS), the Short Form (SF)-36, the Centre for Epidemiological Studies Depression Scale Revised (CESD-R) and the Work Rehabilitation Questionnaire (WORQ) for the upper limb. A successful completion of this trial will provide evidence on the best rehabilitation protocol in order to (re)gain optimal motion after surgical release of the stiff elbow. The trial is registered at the Dutch Trial Register: NTR6067 , 31-8-2016.

Consensus Recommendations of the Multiple Sclerosis Study Group and Portuguese Neuroradiological Society for the Use of the Magnetic Resonance Imaging in Multiple Sclerosis in Clinical Practice: Part 1.

PubMed

Abreu, Pedro; Pedrosa, Rui; Sá, Maria José; Cerqueira, João; Sousa, Lívia; Da Silva, Ana Martins; Pinheiro, Joaquim; De Sá, João; Batista, Sónia; Simões, Rita Moiron; Pereira, Daniela Jardim; Vilela, Pedro; Vale, José

2018-05-30

Magnetic resonance imaging is established as a recognizable tool in the diagnosis and monitoring of multiple sclerosis patients. In the present, among multiple sclerosis centers, there are different magnetic resonance imaging sequences and protocols used to study multiple sclerosis that may hamper the optimal use of magnetic resonance imaging in multiple sclerosis. In this context, the Group of Studies of Multiple Sclerosis and the Portuguese Society of Neuroradiology, after a joint discussion, appointed a committee of experts to create recommendations adapted to the national reality on the use of magnetic resonance imaging in multiple sclerosis. The purpose of this document is to publish the first Portuguese consensus recommendations on the use of magnetic resonance imaging in multiple sclerosis in clinical practice. The Group of Studies of Multiple Sclerosis and the Portuguese Society of Neuroradiology, after discussion of the topic in national meetings and after a working group meeting held in Figueira da Foz on May 2017, have appointed a committee of experts that have developed by consensus several standard protocols on the use of magnetic resonance imaging in the diagnosis and follow-up of multiple sclerosis. The document obtained was based on the best scientific evidence and expert opinion. Subsequently, the majority of Portuguese multiple sclerosis consultants and departments of neuroradiology scrutinized and reviewed the consensus paper; comments and suggestions were considered. Technical magnetic resonance imaging protocols regarding diagnostic, monitoring and the recommended information to be included in the magnetic resonance imaging report will be published in a separate paper. We provide some practical guidelines to promote standardized strategies to be applied in the clinical practice setting of Portuguese healthcare professionals regarding the use of magnetic resonance imaging in multiple sclerosis. We hope that these first Portuguese magnetic resonance imaging guidelines, based in the best available clinical evidence and practices, will serve to optimize multiple sclerosis management and improve multiple sclerosis patient care across Portugal.

Quality of Mobile Phone and Tablet Mobile Apps for Speech Sound Disorders: Protocol for an Evidence-Based Appraisal.

PubMed

Furlong, Lisa M; Morris, Meg E; Erickson, Shane; Serry, Tanya A

2016-11-29

Although mobile apps are readily available for speech sound disorders (SSD), their validity has not been systematically evaluated. This evidence-based appraisal will critically review and synthesize current evidence on available therapy apps for use by children with SSD. The main aims are to (1) identify the types of apps currently available for Android and iOS mobile phones and tablets, and (2) to critique their design features and content using a structured quality appraisal tool. This protocol paper presents and justifies the methods used for a systematic review of mobile apps that provide intervention for use by children with SSD. The primary outcomes of interest are (1) engagement, (2) functionality, (3) aesthetics, (4) information quality, (5) subjective quality, and (6) perceived impact. Quality will be assessed by 2 certified practicing speech-language pathologists using a structured quality appraisal tool. Two app stores will be searched from the 2 largest operating platforms, Android and iOS. Systematic methods of knowledge synthesis shall include searching the app stores using a defined procedure, data extraction, and quality analysis. This search strategy shall enable us to determine how many SSD apps are available for Android and for iOS compatible mobile phones and tablets. It shall also identify the regions of the world responsible for the apps' development, the content and the quality of offerings. Recommendations will be made for speech-language pathologists seeking to use mobile apps in their clinical practice. This protocol provides a structured process for locating apps and appraising the quality, as the basis for evaluating their use in speech pathology for children in English-speaking nations. ©Lisa M Furlong, Meg E Morris, Shane Erickson, Tanya A Serry. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.11.2016.

Impact of body size, nutrition and socioeconomic position in early life on the epigenome: a systematic review protocol.

PubMed

Maddock, Jane; Wulaningsih, Wahyu; Hardy, Rebecca

2017-07-05

Body size, nutrition and socioeconomic position (SEP) in early life have been associated with a range of later life health outcomes. Epigenetic regulation is one mechanism through which these early life factors may impact later life health. The aim of this review protocol is to outline procedures to document the influence of body size, nutrition and SEP in early life on the epigenome. MEDLINE, Embase and BIOSIS will be systematically searched using pre-defined keywords. Additional studies will be identified through manual searching of reference lists. Two independent researchers will assess the eligibility and quality of each study, with disagreements being resolved through discussion or a third reviewer. Studies will be included if they have epigenetic markers measured either at the same time as, or after, the early life exposure and, have a measure of body size, nutrition or SEP in early life (up to 12 years), are in the English language and are from a sample of community-dwelling participants. This protocol will be used to collate the evidence for the effect of early life factors on the epigenome. Findings will form a component of a wider research study examining epigenetic responses to exposures in early life and over the life course and its impact on healthy ageing using data from population-based cohort studies. PROSPERO CRD42016050193.

Impact of a Noninvasive Ventilation Protocol in Hospitalized Children With Acute Respiratory Failure.

PubMed

Jalil, Yorschua; Damiani, Felipe; Astudillo, Claudia; Villarroel, Gregory; Barañao, Patricio; Bustos, Edson; Silva, Alejandra; Mendez, Mireya

2017-12-01

Noninvasive ventilation (NIV) has proven to be useful in the management of children with acute respiratory failure as a result of acute lower respiratory infection. Despite this, evidence addressing the initiation and/or discontinuation criteria of NIV in children remains limited. The objective of this study was to evaluate the usefulness and clinical impact of an NIV protocol in hospitalized children with acute respiratory failure because of acute lower respiratory infection. A randomized controlled clinical trial was carried out among subjects admitted during the winter season at Hospital Josefina Martinez between May and October of 2013. Inclusion criteria were age 3 months to 2 y, diagnosis of acute lower respiratory infection and requiring NIV according to a Modified Wood Scale score of ≥ 4 points. Subjects were randomized to NIV management according to medical criteria (control group) or to protocolized management of NIV (protocol group). Hours of NIV, hospital stay, and supplemental oxygen use after discontinuation of NIV, severity changes after NIV initiation, respiratory symptoms, and proportion of intubations were considered as events of interest. A total of 23 subjects were analyzed in the control group and 24 were analyzed in the protocol group. Hours of hospital stay, NIV, and supplemental oxygen post-NIV were not significantly different between groups ( P = .70, .69, and .68, respectively). There were also no differences in intubation rate (3 of 29 for the control group and 2 of 31 for the protocol group). For the total sample there was a statistically significant decrease in the Modified Wood Scale score after 1 h of NIV ( P < .001). A similar result was observed when performing a stratified intragroup analysis. We observed that the implementation of an NIV management protocol that integrates initiation and discontinuation criteria for NIV is feasible. However, its use showed no advantages over a non-protocolized strategy. Copyright © 2017 by Daedalus Enterprises.

47 CFR 51.305 - Interconnection.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., interconnection with the incumbent LEC's network: (1) For the transmission and routing of telephone exchange... interface or protocol standards shall constitute evidence of the substantial similarity of network...

47 CFR 51.305 - Interconnection.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., interconnection with the incumbent LEC's network: (1) For the transmission and routing of telephone exchange... interface or protocol standards shall constitute evidence of the substantial similarity of network...

47 CFR 51.305 - Interconnection.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., interconnection with the incumbent LEC's network: (1) For the transmission and routing of telephone exchange... interface or protocol standards shall constitute evidence of the substantial similarity of network...

47 CFR 51.305 - Interconnection.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., interconnection with the incumbent LEC's network: (1) For the transmission and routing of telephone exchange... interface or protocol standards shall constitute evidence of the substantial similarity of network...

A Guide to Writing a Qualitative Systematic Review Protocol to Enhance Evidence-Based Practice in Nursing and Health Care.

PubMed

Butler, Ashleigh; Hall, Helen; Copnell, Beverley

2016-06-01

The qualitative systematic review is a rapidly developing area of nursing research. In order to present trustworthy, high-quality recommendations, such reviews should be based on a review protocol to minimize bias and enhance transparency and reproducibility. Although there are a number of resources available to guide researchers in developing a quantitative review protocol, very few resources exist for qualitative reviews. To guide researchers through the process of developing a qualitative systematic review protocol, using an example review question. The key elements required in a systematic review protocol are discussed, with a focus on application to qualitative reviews: Development of a research question; formulation of key search terms and strategies; designing a multistage review process; critical appraisal of qualitative literature; development of data extraction techniques; and data synthesis. The paper highlights important considerations during the protocol development process, and uses a previously developed review question as a working example. This paper will assist novice researchers in developing a qualitative systematic review protocol. By providing a worked example of a protocol, the paper encourages the development of review protocols, enhancing the trustworthiness and value of the completed qualitative systematic review findings. Qualitative systematic reviews should be based on well planned, peer reviewed protocols to enhance the trustworthiness of results and thus their usefulness in clinical practice. Protocols should outline, in detail, the processes which will be used to undertake the review, including key search terms, inclusion and exclusion criteria, and the methods used for critical appraisal, data extraction and data analysis to facilitate transparency of the review process. Additionally, journals should encourage and support the publication of review protocols, and should require reference to a protocol prior to publication of the review results. © 2016 Sigma Theta Tau International.

Semantic Technologies and Bio-Ontologies.

PubMed

Gutierrez, Fernando

2017-01-01

As information available through data repositories constantly grows, the need for automated mechanisms for linking, querying, and sharing data has become a relevant factor both in research and industry. This situation is more evident in research fields such as the life sciences, where new experiments by different research groups are constantly generating new information regarding a wide variety of related study objects. However, current methods for representing information and knowledge are not suited for machine processing. The Semantic Technologies are a set of standards and protocols that intend to provide methods for representing and handling data that encourages reusability of information and is machine-readable. In this chapter, we will provide a brief introduction to Semantic Technologies, and how these protocols and standards have been incorporated into the life sciences to facilitate dissemination and access to information.

PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research.

PubMed

Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

2016-04-18

Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly developed with all relevant stakeholders, will be disseminated through peer-reviewed journals as well as national and international conference presentations. Endorsement of the checklist will be sought simultaneously in multiple journals. 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/

PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research

PubMed Central

Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

2016-01-01

Introduction Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. Methods and analysis This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. Ethics and Dissemination This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly developed with all relevant stakeholders, will be disseminated through peer-reviewed journals as well as national and international conference presentations. Endorsement of the checklist will be sought simultaneously in multiple journals. PMID:27091820

Frozen embryo transfer: a review on the optimal endometrial preparation and timing.

PubMed

Mackens, S; Santos-Ribeiro, S; van de Vijver, A; Racca, A; Van Landuyt, L; Tournaye, H; Blockeel, C

2017-11-01

What is the optimal endometrial preparation protocol for a frozen embryo transfer (FET)? Although the optimal endometrial preparation protocol for FET needs further research and is yet to be determined, we propose a standardized timing strategy based on the current available evidence which could assist in the harmonization and comparability of clinic practice and future trials. Amid a continuous increase in the number of FET cycles, determining the optimal endometrial preparation protocol has become paramount to maximize ART success. In current daily practice, different FET preparation methods and timing strategies are used. This is a review of the current literature on FET preparation methods, with special attention to the timing of the embryo transfer. Literature on the topic was retrieved in PubMed and references from relevant articles were investigated until June 2017. The number of high quality randomized controlled trials (RCTs) is scarce and, hence, the evidence for the best protocol for FET is poor. Future research should compare both the pregnancy and neonatal outcomes between HRT and true natural cycle (NC) FET. In terms of embryo transfer timing, we propose to start progesterone intake on the theoretical day of oocyte retrieval in HRT and to perform blastocyst transfer at hCG + 7 or LH + 6 in modified or true NC, respectively. As only a few high quality RCTs on the optimal preparation for FET are available in the existing literature, no definitive conclusion for benefit of one protocol over the other can be drawn so far. Caution when using HRT for FET is warranted since the rate of early pregnancy loss is alarmingly high in some reports. S.M. is funded by the Research Fund of Flanders (FWO). H.T. and C.B. report grants from Merck, Goodlife, Besins and Abbott during the conduct of the study. Not applicable. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Clinician Adoption Patterns and Patient Outcome Results in Use of Evidence-Based Nursing Plans of Care

PubMed Central

Kim, Tae Youn; Lang, Norma M.; Berg, Karen; Weaver, Charlotte; Murphy, Judy; Ela, Sue

2007-01-01

Delivery of safe, effective and appropriate health care is an imperative facing health care organizations globally. While many initiatives have been launched in a number of countries to address this need from a medical perspective, a similar focus for generating evidence-based nursing knowledge has been missing [1]. This paper reports on a collaborative evidence-based practice (EBP) research initiative that adds nursing knowledge into computerized care protocols. Here, a brief overview of the study’s aims, purpose and methodology is presented as well as results of data analysis and lessons learned. The research team examined nurses’ adoption patterns of EBP recommendations with respect to activity tolerance using four-month patient data collected from a pilot hospital. Study findings indicate a need for more focus on the system design and implementation process with the next rollout phase to promote evidence-based nursing practice. PMID:18693871

Enhanced Recovery after Emergency Surgery: A Systematic Review

PubMed Central

Paduraru, Mihai; Ponchietti, Luca; Casas, Isidro Martinez; Svenningsen, Peter; Zago, Mauro

2017-01-01

Objective: To evaluate the current scientific evidence for the applicability, safety and effectiveness of pathways of enhanced recovery after emergency surgery (ERAS). Methods: We undertook a search using PubMed and Cochrane databases for ERAS protocols in emergency cases. The search generated 65 titles; after eliminating the papers not meeting search criteria, we selected 4 cohort studies and 1 randomized clinical trial (RCT). Data extracted for analysis consisted of: patient age, type of surgery performed, ERAS elements implemented, surgical outcomes in terms of postoperative complications, mortality, length of stay (LOS) and readmission rate. Results: The number of ERAS items applied was good, ranging from 11 to 18 of the 20 recommended by the ERAS Society. The implementation resulted in fewer postoperative complications. LOS for ES patients was shorter when compared to conventional care. Mortality, specifically reported in three studies, was equal or lower with ERAS. Readmission rates varied widely and were generally higher for the intervention group but without statistical significance. Conclusions: The studies reviewed agreed that ERAS in emergency surgery (ES) was feasible and safe with generally better outcomes. Lower compliance with some of the ERAS items shows the need for the protocol to be adapted to ES patients. More evidence is clearly required as to what can improve outcomes and how this can be formulated into an effective care pathway for the heterogeneous ES patient. PMID:28507993

The efficacy of the addition of the Pilates method over a minimal intervention in the treatment of chronic nonspecific low back pain: a study protocol of a randomized controlled trial☆

PubMed Central

Miyamoto, Gisela C.; Costa, Leonardo O.P.; Galvanin, Thalissa; Cabral, Cristina M.N.

2011-01-01

Objective There is little high-quality evidence on the efficacy of the Pilates-based exercises for the treatment of chronic nonspecific low back pain. Therefore, the objective of this paper is to present a study protocol to investigate the efficacy of adding Pilates-based exercises to a minimum intervention in patients with chronic non-specific low back pain. Methods This randomized controlled trial will recruit 86 patients of both sexes, aged between 18 and 60 years, with chronic non-specific low back pain. The participants will be randomly allocated into 2 treatment groups: the Booklet Group, which will receive a booklet with postural orientations, and the Pilates Group, which will receive the same booklet in addition to a Pilates-based exercises program. The general and specific functional capacities of the patient, kinesiophobia, pain intensity, and the global perceived effect will be evaluated by a blinded assessor before randomization and at 6 weeks and 6 months after randomization. In addition, the expectations of the participants and their confidence in the treatment will be evaluated before the randomization and after the first treatment session, respectively. Conclusions It is hoped that the results of this study will provide high-quality evidence on the usefulness of Pilates-based exercises in the treatment of chronic non-specific low back pain. PMID:22654682

Adolescent pedometer protocols: examining reactivity, tampering and participants' perceptions.

PubMed

Scott, Joseph John; Morgan, Philip James; Plotnikoff, Ronald Cyril; Trost, Stewart Graeme; Lubans, David Revalds

2014-01-01

The aim of this study was to investigate adolescents' potential reactivity and tampering while wearing pedometers by comparing different monitoring protocols to accelerometer output. The sample included adolescents (N = 123, age range = 14-15 years) from three secondary schools in New South Wales, Australia. Schools were randomised to one of the three pedometer monitoring protocols: (i) daily sealed (DS) pedometer group, (ii) unsealed (US) pedometer group or (iii) weekly sealed (WS) pedometer group. Participants wore pedometers (Yamax Digi-Walker CW700, Yamax Corporation, Kumamoto City, Japan) and accelerometers (Actigraph GT3X+, Pensacola, USA) simultaneously for seven days. Repeated measures analysis of variance was used to examine potential reactivity. Bivariate correlations between step counts and accelerometer output were calculated to explore potential tampering. The correlation between accelerometer output and pedometer steps/day was strongest among participants in the WS group (r = 0.82, P ≤ 0.001), compared to the US (r = 0.63, P ≤ 0.001) and DS (r = 0.16, P = 0.324) groups. The DS (P ≤ 0.001) and US (P = 0.003), but not the WS (P = 0.891), groups showed evidence of reactivity. The results suggest that reactivity and tampering does occur in adolescents and contrary to existing research, pedometer monitoring protocols may influence participant behaviour.

Qualitative and quantitative assessment of single fingerprints in forensic DNA analysis.

PubMed

Ostojic, Lana; Klempner, Stacey A; Patel, Rosni A; Mitchell, Adele A; Axler-DiPerte, Grace L; Wurmbach, Elisa

2014-11-01

Fingerprints and touched items are important sources of DNA for STR profiling, since this evidence can be recovered in a wide variety of criminal offenses. However, there are some fundamental difficulties in working with these samples, including variability in quantity and quality of extracted DNA. In this study, we collected and analyzed over 700 fingerprints. We compared a commercially available extraction protocol (Zygem) to two methods developed in our laboratory, a simple one-tube protocol and a high sensitivity protocol (HighSens) that includes additional steps to concentrate and purify the DNA. The amplification protocols tested were AmpFLSTR® Identifiler® using either 28 or 31 amplification cycles, and Identifiler® Plus using 32 amplification cycles. We found that the HighSens and Zygem extraction methods were significantly better in their DNA yields than the one-tube method. Identifiler® Plus increased the quality of the STR profiles for the one-tube extraction significantly. However, this effect could not be verified for the other extraction methods. Furthermore, microscopic analysis of single fingerprints revealed that some individuals tended to shed more material than others onto glass slides. However, a dense deposition of skin flakes did not strongly correlate with a high quality STR profile. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Is the Stretta procedure as effective as the best medical and surgical treatments for gastro-oesophageal reflux disease? A best evidence topic.

PubMed

Das, Bibek; Reddy, Marcus; Khan, Omar A

2016-06-01

A best evidence topic in surgery was written according to a structured protocol. The question addressed whether the Stretta(®) procedure is as effective as the best medical and surgical treatments for patients with symptoms of gastro-oesophageal reflux disease (GORD). One hundred and forty Stretta-related papers were identified using the reported search, of which five represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group, study type, relevant outcomes and results of these papers are tabulated. One study was a randomised controlled trial comparing Stretta with proton pump inhibitors (PPIs), and four were prospective observational studies that compared Stretta with laparoscopic fundoplication. These studies provide limited evidence that Stretta is as effective as medical therapy at controlling symptoms of GORD and may allow some patients to reduce their PPI use, but laparoscopic fundoplication appears to be more effective than Stretta though with a higher rate of adverse events. Further studies are required to determine the long-term efficacy of Stretta compared to the current best medical and surgical treatments. Copyright © 2016. Published by Elsevier Ltd.

Rapid Evidence Review of Mobile Applications for Self-management of Diabetes.

PubMed

Veazie, Stephanie; Winchell, Kara; Gilbert, Jennifer; Paynter, Robin; Ivlev, Ilya; Eden, Karen B; Nussbaum, Kerri; Weiskopf, Nicole; Guise, Jeanne-Marie; Helfand, Mark

2018-05-08

Patients with diabetes lack information on which commercially available applications (apps) improve diabetes-related outcomes. We conducted a rapid evidence review to examine features, clinical efficacy, and usability of apps for self-management of type 1 and type 2 diabetes in adults. Ovid/Medline and the Cochrane Database of Systematic Reviews were searched for systematic reviews and technology assessments. Reference lists of relevant systematic reviews were examined for primary studies. Additional searches for primary studies were conducted online, through Ovid/Medline, Embase, CINAHL, and ClinicalTrials.gov . Studies were evaluated for eligibility based on predetermined criteria, data were extracted, study quality was assessed using a risk of bias tool, information on app features was collected, and app usability was assessed. Results are summarized qualitatively. Fifteen articles evaluating 11 apps were identified: six apps for type 1 and five apps for type 2 diabetes. Common features of apps included setting reminders and tracking blood glucose and hemoglobin A1c (HbA1c), medication use, physical activity, and weight. Compared with controls, use of eight apps, when paired with support from a healthcare provider or study staff, improved at least one outcome, most often HbA1c. Patients did not experience improvements in quality of life, blood pressure, or weight, regardless of app used or type of diabetes. Study quality was variable. Of the eight apps available for usability testing, two were scored "acceptable," three were "marginal," and three were "not acceptable." Limited evidence suggests that use of some commercially available apps, when combined with additional support from a healthcare provider or study staff, may improve some short-term diabetes-related outcomes. The impact of these apps on longer-term outcomes is unclear. More rigorous and longer-term studies of apps are needed. This review was funded by the Agency for Healthcare Research and Quality (AHRQ). The protocol is available at: http://www.effectivehealthcare.ahrq.gov/topics/diabetes-mobile-devices/research-protocol .

Racism as a determinant of health: a protocol for conducting a systematic review and meta-analysis.

PubMed

Paradies, Yin; Priest, Naomi; Ben, Jehonathan; Truong, Mandy; Gupta, Arpana; Pieterse, Alex; Kelaher, Margaret; Gee, Gilbert

2013-09-23

Racism is increasingly recognized as a key determinant of health. A growing body of epidemiological evidence shows strong associations between self-reported racism and poor health outcomes across diverse minority groups in developed countries. While the relationship between racism and health has received increasing attention over the last two decades, a comprehensive meta-analysis focused on the health effects of racism has yet to be conducted. The aim of this review protocol is to provide a structure from which to conduct a systematic review and meta-analysis of studies that assess the relationship between racism and health. This research will consist of a systematic review and meta-analysis. Studies will be considered for review if they are empirical studies reporting quantitative data on the association between racism and health for adults and/or children of all ages from any racial/ethnic/cultural groups. Outcome measures will include general health and well-being, physical health, mental health, healthcare use and health behaviors. Scientific databases (for example, Medline) will be searched using a comprehensive search strategy and reference lists will be manually searched for relevant studies. In addition, use of online search engines (for example, Google Scholar), key websites, and personal contact with experts will also be undertaken. Screening of search results and extraction of data from included studies will be independently conducted by at least two authors, including assessment of inter-rater reliability. Studies included in the review will be appraised for quality using tools tailored to each study design. Summary statistics of study characteristics and findings will be compiled and findings synthesized in a narrative summary as well as a meta-analysis. This review aims to examine associations between reported racism and health outcomes. This comprehensive and systematic review and meta-analysis of empirical research will provide a rigorous and reliable evidence base for future research, policy and practice, including information on the extent of available evidence for a range of racial/ethnic minority groups.

Brain Monitoring with Electroencephalography and the Electroencephalogram-Derived Bispectral Index During Cardiac Surgery

PubMed Central

Kertai, Miklos D.; Whitlock, Elizabeth L.; Avidan, Michael S.

2011-01-01

Cardiac surgery presents particular challenges for the anesthesiologist. In addition to standard and advanced monitors typically used during cardiac surgery, anesthesiologists may consider monitoring the brain with raw or processed electroencephalography (EEG). There is strong evidence that a protocol incorporating the processed EEG Bispectral Index (BIS) decreases the incidence intraoperative awareness compared with standard practice. However there is conflicting evidence that incorporating the BIS into cardiac anesthesia practice improves “fast-tracking,” decreases anesthetic drug use, or detects cerebral ischemia. Recent research, including many cardiac surgical patients, shows that a protocol based on BIS monitoring is not superior to a protocol based on end tidal anesthetic concentration monitoring in preventing awareness. There has been a resurgence of interest in the anesthesia literature in limited montage EEG monitoring, including nonproprietary processed indices. This has been accompanied by research showing that with structured training, anesthesiologists can glean useful information from the raw EEG trace. In this review, we discuss both the hypothesized benefits and limitations of BIS and frontal channel EEG monitoring in the cardiac surgical population. PMID:22253267

Successful implementation of a perioperative glycemic control protocol in cardiac surgery: barrier analysis and intervention using lean six sigma.

PubMed

Martinez, Elizabeth A; Chavez-Valdez, Raul; Holt, Natalie F; Grogan, Kelly L; Khalifeh, Katherine W; Slater, Tammy; Winner, Laura E; Moyer, Jennifer; Lehmann, Christoph U

2011-01-01

Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

Successful Implementation of a Perioperative Glycemic Control Protocol in Cardiac Surgery: Barrier Analysis and Intervention Using Lean Six Sigma

PubMed Central

Martinez, Elizabeth A.; Chavez-Valdez, Raul; Holt, Natalie F.; Grogan, Kelly L.; Khalifeh, Katherine W.; Slater, Tammy; Winner, Laura E.; Moyer, Jennifer; Lehmann, Christoph U.

2011-01-01

Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period. PMID:22091218

Comparing a Mobile Decision Support System Versus the Use of Printed Materials for the Implementation of an Evidence-Based Recommendation: Protocol for a Qualitative Evaluation.

PubMed

Camacho, Jhon; Medina Ch, Ana María; Landis-Lewis, Zach; Douglas, Gerald; Boyce, Richard

2018-04-13

The distribution of printed materials is the most frequently used strategy to disseminate and implement clinical practice guidelines, although several studies have shown that the effectiveness of this approach is modest at best. Nevertheless, there is insufficient evidence to support the use of other strategies. Recent research has shown that the use of computerized decision support presents a promising approach to address some aspects of this problem. The aim of this study is to provide qualitative evidence on the potential effect of mobile decision support systems to facilitate the implementation of evidence-based recommendations included in clinical practice guidelines. We will conduct a qualitative study with two arms to compare the experience of primary care physicians while they try to implement an evidence-based recommendation in their clinical practice. In the first arm, we will provide participants with a printout of the guideline article containing the recommendation, while in the second arm, we will provide participants with a mobile app developed after formalizing the recommendation text into a clinical algorithm. Data will be collected using semistructured and open interviews to explore aspects of behavioral change and technology acceptance involved in the implementation process. The analysis will be comprised of two phases. During the first phase, we will conduct a template analysis to identify barriers and facilitators in each scenario. Then, during the second phase, we will contrast the findings from each arm to propose hypotheses about the potential impact of the system. We have formalized the narrative in the recommendation into a clinical algorithm and have developed a mobile app. Data collection is expected to occur during 2018, with the first phase of analysis running in parallel. The second phase is scheduled to conclude in July 2019. Our study will further the understanding of the role of mobile decision support systems in the implementation of clinical practice guidelines. Furthermore, we will provide qualitative evidence to aid decisions made by low- and middle-income countries' ministries of health about investments in these technologies. ©Jhon Camacho, Ana María Medina Ch, Zach Landis-Lewis, Gerald Douglas, Richard Boyce. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.04.2018.

Predicting implementation from organizational readiness for change: a study protocol

PubMed Central

2011-01-01

Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities), and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities). Convergent and discriminant validities will test associations between organizational readiness and different aspects of job satisfaction: satisfaction with leadership, which should be highly correlated with readiness, versus satisfaction with salary, which should be less correlated with readiness. Content validity will be assessed using an expert panel and modified Delphi technique. Discussion We propose a comprehensive protocol for validating a survey instrument for assessing organizational readiness to change that specifically addresses key threats of bias related to halo effect, method bias and questions of construct validity that often go unexplored in research using measures of organizational constructs. PMID:21777479

A Balanced Protocol for Return to School for Children and Youth Following Concussive Injury.

PubMed

DeMatteo, Carol; Stazyk, Kathy; Giglia, Lucy; Mahoney, William; Singh, Sheila K; Hollenberg, Robert; Harper, Jessica A; Missiuna, Cheryl; Law, Mary; McCauley, Dayle; Randall, Sarah

2015-07-01

Few protocols exist for returning children/youth to school after concussion. Childhood concussion can significantly affect school performance, which is vital to social development, academic learning, and preparation for future roles. The goal of this knowledge translation research was to develop evidence based materials to inform physicians about pediatric concussion. The Return to School (RTS) concussion protocol was developed following the National Institute for Health and Care Excellence procedures. Based on a scoping review, and stakeholder opinions, an RTS protocol was developed for children/youth. This unique protocol focuses on school adaptation in 4 main areas: (a) timetable/attendance, (b) curriculum, (c) environmental modifications, and (d) activity modifications. A balance of cognitive rest and timely return to school need to be considered for returning any student to school after a concussion. Implementation of these new recommendations may be an important tool in prevention of prolonged absence from school and academic failure while supporting brain recovery. © The Author(s) 2015.

Obtaining continuous BrAC/BAC estimates in the field: A hybrid system integrating transdermal alcohol biosensor, Intellidrink smartphone app, and BrAC Estimator software tools.

PubMed

Luczak, Susan E; Hawkins, Ashley L; Dai, Zheng; Wichmann, Raphael; Wang, Chunming; Rosen, I Gary

2018-08-01

Biosensors have been developed to measure transdermal alcohol concentration (TAC), but converting TAC into interpretable indices of blood/breath alcohol concentration (BAC/BrAC) is difficult because of variations that occur in TAC across individuals, drinking episodes, and devices. We have developed mathematical models and the BrAC Estimator software for calibrating and inverting TAC into quantifiable BrAC estimates (eBrAC). The calibration protocol to determine the individualized parameters for a specific individual wearing a specific device requires a drinking session in which BrAC and TAC measurements are obtained simultaneously. This calibration protocol was originally conducted in the laboratory with breath analyzers used to produce the BrAC data. Here we develop and test an alternative calibration protocol using drinking diary data collected in the field with the smartphone app Intellidrink to produce the BrAC calibration data. We compared BrAC Estimator software results for 11 drinking episodes collected by an expert user when using Intellidrink versus breath analyzer measurements as BrAC calibration data. Inversion phase results indicated the Intellidrink calibration protocol produced similar eBrAC curves and captured peak eBrAC to within 0.0003%, time of peak eBrAC to within 18min, and area under the eBrAC curve to within 0.025% alcohol-hours as the breath analyzer calibration protocol. This study provides evidence that drinking diary data can be used in place of breath analyzer data in the BrAC Estimator software calibration procedure, which can reduce participant and researcher burden and expand the potential software user pool beyond researchers studying participants who can drink in the laboratory. Copyright © 2017. Published by Elsevier Ltd.

Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature

PubMed Central

Jureidini, Jon N.; Parry, Peter I.; Spielmans, Glen I.; Healy, David

2011-01-01

Background Aripiprazole, a second-generation antipsychotic medication, has been increasingly used in the maintenance treatment of bipolar disorder and received approval from the U.S. Food and Drug Administration for this indication in 2005. Given its widespread use, we sought to critically review the evidence supporting the use of aripiprazole in the maintenance treatment of bipolar disorder and examine how that evidence has been disseminated in the scientific literature. Methods and Findings We systematically searched multiple databases to identify double-blind, randomized controlled trials of aripiprazole for the maintenance treatment of bipolar disorder while excluding other types of studies, such as open-label, acute, and adjunctive studies. We then used a citation search to identify articles that cited these trials and rated the quality of their citations. Our evidence search protocol identified only two publications, both describing the results of a single trial conducted by Keck et al., which met criteria for inclusion in this review. We describe four issues that limit the interpretation of that trial as supporting the use of aripiprazole for bipolar maintenance: (1) insufficient duration to demonstrate maintenance efficacy; (2) limited generalizability due to its enriched sample; (3) possible conflation of iatrogenic adverse effects of abrupt medication discontinuation with beneficial effects of treatment; and (4) a low overall completion rate. Our citation search protocol yielded 80 publications that cited the Keck et al. trial in discussing the use of aripiprazole for bipolar maintenance. Of these, only 24 (30%) mentioned adverse events reported and four (5%) mentioned study limitations. Conclusions A single trial by Keck et al. represents the entirety of the literature on the use of aripiprazole for the maintenance treatment of bipolar disorder. Although careful review identifies four critical limitations to the trial's interpretation and overall utility, the trial has been uncritically cited in the subsequent scientific literature. Please see later in the article for the Editors' Summary PMID:21559324

Effect modification of FADS2 polymorphisms on the association between breastfeeding and intelligence: protocol for a collaborative meta-analysis

PubMed Central

Hartwig, Fernando Pires; Davies, Neil Martin; Horta, Bernardo Lessa; Victora, Cesar Gomes; Davey Smith, George

2016-01-01

Introduction Evidence from observational studies and randomised controlled trials suggests that breastfeeding is positively associated with IQ, possibly because breast milk is a source of long-chain polyunsaturated fatty acids. Different studies have detected gene-breastfeeding interactions involving FADS2 variants and intelligence. However, findings are inconsistent regarding the direction of such effect modification. Methods/design To clarify how FADS2 and breastfeeding interact in their association with IQ, we are conducting a consortium-based meta-analysis of independent studies. Results produced by each individual study using standardised analysis scripts and harmonised data will be used. Inclusion criteria: breastfeeding, IQ and either rs174575 or rs1535 polymorphisms available; and being of European ancestry. Exclusion criteria: twin studies; only poorly imputed genetic data available; or unavailability of proper ethics approval. Studies will be invited based on being known to have at least some of the required data, or suggested by participating studies as potentially eligible. This inclusive approach will favour achieving a larger sample size and be less prone to publication bias. Discussion Improving current understanding of FADS2-breastfeeding interaction may provide important biological insights regarding the importance of long-chain polyunsaturated fatty acids for the breastfeeding-IQ association. This meta-analysis will help to improve such knowledge by replicating earlier studies, conducting additional analysis and evaluating different sources of heterogeneity. Publishing this protocol will minimise the possibility of bias due to post hoc changes to the analysis protocol. PMID:27311901

Impact of a virtual reality-based intervention on motor performance and balance of a child with cerebral palsy: a case study

PubMed Central

Pavão, Silvia Leticia; Arnoni, Joice Luiza Bruno; de Oliveira, Alyne Kalyane Câmara; Rocha, Nelci Adriana Cicuto Ferreira

2014-01-01

OBJECTIVE: To verify the effect of an intervention protocol using virtual reality (VR) on the motor performance and balance of a child with cerebral palsy (CP). CASE DESCRIPTION: To comply with the proposed objectives, a 7-year old child with spastic hemiplegic cerebral palsy (CP), GMFCS level I, was submitted to a physiotherapy intervention protocol of 12 45-minute sessions, twice a week, using virtual reality-based therapy. The protocol used a commercially-available console (XBOX(r)360 Kinect(r)) able to track and reproduce body movements on a screen. Prior to the intervention protocol, the child was evaluated using the Motor Development Scale (MDS) and the Pediatric Balance Scale (PBS) in order to assess motor development and balance, respectively. Two baseline assessments with a 2-week interval between each other were carried out for each tool. Then, the child was re-evaluated after the twelfth session. The results showed no changes in the two baseline scores. After the intervention protocol, the child improved his scores in both tools used: the PBS score increased by 3 points, reaching the maximal score, and the MDS increased from a much inferior motor performance to just an inferior motor performance. COMMENTS: The evidence presented in this case supports the use of virtual reality as a promising tool to be incorporated into the rehabilitation process of patients with neuromotor dysfunction. PMID:25511004

Protocol for obtaining platelet-rich plasma (PRP), platelet-poor plasma (PPP), and thrombin for autologous use.

PubMed

Franco, Diogo; Franco, Talita; Schettino, Angélica Maria; Filho, João Medeiros Tavares; Vendramin, Fabiel Spani

2012-10-01

Plasma has been widely studied and used in many different situations to speed up healing with better tissue adherence and hemostasis. Research projects are now attempting to isolate platelet-rich plasma (PRP) and platelet-poor plasma (PPP), making better use of their properties, particularly during operations and for wounds that are slow to heal. In view of the wide diversity of industrial machines and extraction protocols, together with the variety of industrially produced biologic glues, this article suggests an option for obtaining PRP, PPP, and human thrombin for autologous use. A way of obtaining PRP, PPP, and thrombin is reproduced through a protocol defined and established by the authors. Autologous thrombin and plasma were obtained through the collection and successive centrifugation of ten whole blood samples, until the desired hemocomponents were isolated, followed by quantitative and qualitative analyses of the elements obtained. The mean platelet concentration obtained was 6.03 × 10(8) platelets/ml, with a mean thrombin concentration of 33.54 nM, both values compatible with reports in the literature when different protocols are applied. The protocol described is a good option for the preparation and application of PRP, PPP, and autologous thrombin, particularly as they can be obtained simultaneously, eliminating the possibilities of viral contamination and allergic reactions. Moreover, the cost of this procedure is low, it is easy to perform, and replicable. This journal requires that authors assign a level of evidence to each article.

Do evidence summaries increase policy-makers' use of evidence from systematic reviews: A systematic review protocol.

PubMed

Petkovic, Jennifer; Welch, Vivian; Tugwell, Peter

2015-09-28

Systematic reviews are important for decision-makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which makes them hard to use for decision-making. There are many organizations that develop and disseminate derivative products, such as evidence summaries, from systematic reviews for different populations or subsets of decision-makers. This systematic review will assess the effectiveness of systematic review summaries on increasing policymakers' use of systematic review evidence and to identify the components or features of these summaries that are most effective. We will include studies of policy-makers at all levels as well as health-system managers. We will include studies examining any type of "evidence summary," "policy brief," or other products derived from systematic reviews that present evidence in a summarized form. The primary outcomes are the following: (1) use of systematic review summaries decision-making (e.g., self-reported use of the evidence in policy-making, decision-making) and (2) policy-maker understanding, knowledge, and/or beliefs (e.g., changes in knowledge scores about the topic included in the summary). We will conduct a systematic review of randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), controlled before-after studies (CBA), and interrupted time series (ITS) studies. The results of this review will inform the development of future systematic review summaries to ensure that systematic review evidence is accessible to and used by policy-makers making health-related decisions.

Evidence and evidence gaps of laryngeal cancer surgery

PubMed Central

Wiegand, Susanne

2016-01-01

Surgical treatment of laryngeal cancer has been established for decades. In addition to total laryngectomy, which was first performed in 1873, a large number or organ preservation surgical techniques, like open partial laryngectomy, transoral laser microsurgery, and transoral robotic surgery have been developed. Studies on laryngeal cancer surgery are mainly retrospective case series and cohort studies. The evolution of chemoradiation protocols and their analysis in prospective randomized trials have led to an increasing acceptance of non-surgical treatment procedures. In addition to an improvement of prognosis, in recent years the preservation of function and maintenance of life quality after primary therapy of laryngeal cancer has increasingly become the focus of therapy planning. Significant late toxicity after chemoradiation has been identified as an important issue. This leads to a reassessment of surgical concepts and initiation of studies on laryngeal cancer surgery which was additionally stimulated by the advent of transoral robotic surgery in the US. Improving the evidence base of laryngeal cancer surgery by successful establishment of surgical trials should be the future goal. PMID:28025603

Frequency of "Pocket" Hematoma in Patients Receiving Vitamin K Antagonist and Antiplatelet Therapy at the Time of Pacemaker or Cardioverter Defibrillator Implantation (from the POCKET Study).

PubMed

Malagù, Michele; Trevisan, Filippo; Scalone, Antonella; Marcantoni, Lina; Sammarco, Giuseppe; Bertini, Matteo

2017-04-01

In patients undergoing cardiac device implantation, anticoagulant and antiplatelet therapy are associated with an increased risk of pocket hematoma. In case of vitamin K antagonist therapy, a strategy of continued warfarin with no heparin bridge showed a reduction of pocket hematoma. Evidence regarding antiplatelet therapy management is limited. This is a single-center observational study which reflects our systematic approach to the problem. In 2012, we proposed an improved management protocol for anticoagulant and antiplatelet therapy (no-bridge protocol) based on individual thromboembolic risk stratification, noninterruption of oral anticoagulation, no bridge with heparin and elastic adherence compression bandage. The primary end point was the incidence of clinically significant pocket hematoma in the first 30 days after implantation. A total of 1,035 patients were enrolled, of whom 522 received the standard management and 513 the new protocol. The primary end point occurred in 34 patients of the standard management group and 8 patients of the no-bridge protocol group (6.5% vs 1.6%, p <0.001). Patients in the standard management group had a higher incidence of pocket infections (2.3% vs 0.6%, p = 0.02), lead dislodgements (4.8% vs 2.1%, p = 0.02), and thromboembolic events (1.3% vs 0.0%, p <0.01). On a multivariate analysis, heparin and coronary artery disease were independent predictors of pocket hematoma (relative risk [RR] 3.48, 95% confidence interval [CI] 1.55 to 7.83 and RR 2.43, 95% CI 1.25 to 4.76, respectively), whereas the no-bridge protocol was associated with a reduction of pocket hematoma (RR 0.33, 95% CI 0.14 to 0.76). New anticoagulant and antiplatelet therapy management protocol was associated with a reduced incidence of clinically significant pocket hematomas, thromboembolic events, pocket infections, and lead dislodgements. Copyright © 2017 Elsevier Inc. All rights reserved.

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa; Knight, Laura D; Rechnitzer, Thomas; Forsyth, Adrienne; Mourtzakis, Marina; Presneill, Jeffrey; MacIsaac, Christopher

2018-01-01

Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes. This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

Acupuncture for common cold: A systematic review and meta-analyze protocol.

PubMed

Cheng, Ying; Gao, Bifeng; Jin, Yuhao; Xu, Na; Guo, Taipin

2018-03-01

The common cold (CC) is the most common syndromes of infection in human beings, but there is currently no special treatment. For this reason, acupuncture is used to relieve the symptoms of the CC. Acupuncture is a traditional Chinese medicine (TCM) therapy that has been used for over 2000 years to treat various diseases. However, few studies have provided evidence for the efficacy and safety of acupuncture for the CC. This study aims to evaluate the effectiveness and safety of acupuncture on CC periods and its symptoms. The following electronic databases will be searched for studies conducted through January 1, 2019: Web of Science, Cochrane Library, EBASE, World Health Organization International Clinical Trials Registry Platform, Springer, Wan-fang database, Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP), China National Knowledge Infrastructure (CNKI), and other sources. All randomized controlled trials on acupuncture for common cold will be included. Risk of bias will be assessed using the Cochrane risk of bias assessment tool, while RevMan V.5.3.5 software will be implemented for the assessment of bias risk, data synthesis, subgroup analysis, and meta-analyses if conditions are met. Continuous outcomes will be presented as mean difference (MD) or standard mean difference (SMD), while dichotomous data will be expressed as relative risk. A high-quality synthesis of current evidence of acupuncture for CC will be stated from several aspect using subjective reports and objective measures of performance. The reduction rate of common cold symptoms after initial treatment, resolved cold symptoms, and reduced cold duration will be collected. This protocol will present the evidence of whether acupuncture therapy is an effective intervention for CC.

Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review.

PubMed

Chou, Roger; Dana, Tracy; Bougatsos, Christina; Blazina, Ian; Starmer, Amy J; Reitel, Katie; Buckley, David I

2013-07-02

Pressure ulcers are associated with substantial health burdens but may be preventable. To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk. MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists. Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes. Multiple investigators abstracted and checked study details and quality using predefined criteria. One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions. Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings. More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.

Development and feasibility testing of an intervention to support active lifestyles in youths with type 1 diabetes-the ActivPals programme: a study protocol.

PubMed

Mitchell, Fiona; Kirk, Alison; Robertson, Kenneth; Reilly, John J

2016-01-01

The global incidence of type 1 diabetes is rising, and youths with type 1 diabetes continue to suffer poorer health than peers without diabetes. Evidence suggests youths with type 1 diabetes have physical activity (PA) levels well below the recommendations for health and have high levels of sedentary behaviour. An active lifestyle is therefore recommended to improve health. There is limited research showing effective lifestyle behaviour change in this population; therefore, an evidence gap exists between the need to promote physical activity in type 1 diabetes care and lack of understanding on how to do this. This protocol paper describes a feasibility and pilot study of the ActivPals programme-an intervention to support active lifestyles in youths with type 1 diabetes. Key intervention components have been identified from preliminary work (individual and family focus, peer mentoring, technology integration and improved communication and understanding) and are being developed into a pragmatic randomised controlled trial (RCT) supported by recruitment pathways. A steering group of health care professionals and managers will refine the intervention to patient needs. A pilot trial is providing data on intervention implementation, acceptability and feasibility. Twenty youths with type 1 diabetes are being recruited and randomised into an intervention or control group. Physical activity is being measured objectively using the Actigraph GT3X+ monitor at baseline and 1-month follow-up. Contextual factors associated with intervention delivery are being explored. This study will contribute to the development of evidence-based, user-informed and pragmatic interventions leading to healthier lifestyles in youths with type 1 diabetes.

Considerations for the design and execution of protocols for animal research and treatment to improve reproducibility and standardization: "DEPART well-prepared and ARRIVE safely".

PubMed

Smith, M M; Clarke, E C; Little, C B

2017-03-01

To review the factors in experimental design that contribute to poor translation of pre-clinical research to therapies for patients with osteoarthritis (OA) and how this might be improved. Narrative review of the literature, and evaluation of the different stages of design conduct and analysis of studies using animal models of OA to define specific issues that might reduce quality of evidence and how this can be minimised. Preventing bias and improving experimental rigour and reporting are important modifiable factors to improve translation from pre-clinical animal models to successful clinical trials of therapeutic agents. Despite publication and adoption by many journals of guidelines such as Animals in Research: Reporting In Vivo Experiments (ARRIVE), experimental animal studies published in leading rheumatology journals are still deficient in their reporting. In part, this may be caused by researchers first consulting these guidelines after the completion of experiments, at the time of publication. This review discusses factors that can (1) bias the outcome of experimental studies using animal models of osteoarthritis or (2) alter the quality of evidence for translation. We propose a checklist to consult prior to starting experiments; in the Design and Execution of Protocols for Animal Research and Treatment (DEPART). Following DEPART during the design phase will enable completion of the ARRIVE checklist at the time of publication, and thus improve the quality of evidence for inclusion of experimental animal research in meta-analyses and systematic reviews: "DEPART well-prepared and ARRIVE safely". Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Using concurrent think-aloud and protocol analysis to explore student nurses' social learning information communication technology knowledge and skill development.

PubMed

Todhunter, Fern

2015-06-01

Observations obtained through concurrent think-aloud and protocol analysis offer new understanding about the influence of social learning on student nurses' acquisition of Information and Communication Technology (ICT) knowledge and skills. The software used provides a permanent record of the underpinning study method, events and analyses. The emerging themes reflect the dimensions of social engagement, and the characteristics of positive and negative reactions to ICT. The evidence shows that given the right conditions, stronger learners will support and guide their peers. To explore the use of concurrent think-aloud and protocol analysis as a method to examine how student nurses approach ICT. To identify the benefits and challenges of using observational technology to capture learning behaviours. To show the influence of small group arrangement and student interactions on their ICT knowledge and skills development. Previous studies examining social interaction between students show how they work together and respond to interactive problem solving. Social interaction has been shown to enhance skills in both ICT and collaborative decision making. Structured observational analysis using concurrent think-aloud and protocol analysis. Students displayed varying degrees of pastoral support and emotional need, leadership, reflection, suggestion and experimentation skills. Encouraging student nurses to work in small mixed ability groups can be conducive for social and ICT skill and knowledge development. Observational software gives a permanent record of the proceedings. Copyright © 2015 Elsevier Ltd. All rights reserved.

Comparison of cervical os versus vaginal evidentiary findings during sexual assault exam.

PubMed

Morgan, Jean A

2008-04-01

Evidence collection post sexual assault varies across the nation. The Ohio Department of Health has a standardized kit for evidence collection used during the forensic exams of sexual assault survivors. The protocol includes obtaining 4 swabs: 2 from the vaginal pooled fluid and 2 from the cervical area. The purpose is to determine if augmenting the state protocol with cervical os swabs and a comparison slide will improve evidentiary findings in adolescent and adult female rape survivors. A descriptive study of 30 months for sexual assault female survivors over the age of 13 treated at a level II emergency department by a trained sexual assault nurse examiner (SANE). The comparisons of cervical os specimens versus vaginal pool findings were analyzed by the Canton-Stark County Crime Laboratory (C-SCCL). Eighty-six cases were completed. After investigation, local law enforcement officials turned in 36 kits (42%) to be processed at the C-SCCL for the standard vaginal pool swabs and slide. The average estimated time interval between assault and treatment time was 20.46 hours (range, 2.83 to 80.83 hours). The average age of the survivor was 23.7 years, (range, 15 to 48). Eight percent (3/36) had only cervical os semen evidentiary findings. Forty-four percent (16/36) had positive semen evidentiary findings in vaginal pool and cervical os. Successful convictions were aided by the cervical os research study, especially because vaginal pool evidence diminishes when collected after 24 hours, but may be present longer in the cervical os.

Rational prescribing in paediatrics in a resource-limited setting.

PubMed

Risk, Rachel; Naismith, Hamish; Burnett, Alexander; Moore, Sophie E; Cham, Mamady; Unger, Stefan

2013-07-01

There is evidence of inappropriate medication use, causing unnecessary costs for health systems, particularly those with limited resources. Overprescription is commonly reported and can lead to antibiotic resistance. Prescribing patterns differ between countries; little is known about paediatric prescribing practices in Africa. To investigate prescribing practices in children in The Gambia, West Africa. A retrospective survey of prescribing practices in children under 5 years of age based on WHO protocol DAP/93.1 was conducted. Twenty government-run health centres across all six regions in The Gambia were assessed. The first 10 encounters each month in 2010 were recorded. For each encounter, patient demographics, diagnoses and medications were recorded as per protocol. Two thousand and four hundred patient encounters were included. The mean number of medications per encounter was 2.2 (median 2.0, IQR 2.0-3.0). Across different geographical regions within The Gambia antibiotics were prescribed in 63.4% (IQR 62.8-65.8%) and micronutrients in 21.7% (IQR 15.3-27.1%) of patient encounters. There was evidence of high antibiotic prescription in children with cough and coryzal symptoms (54.5%; IQR 35.8-59.0%) and simple diarrhoea without dehydration (44.8%; IQR 36.7-61.3%). 74.8% (IQR 71.8-76.1%) of medications were prescribed generically. The study showed an overprescription of antibiotics and substantial usage of micronutrients despite a lack of international evidence-based guidelines. Cost-effective interventions to improve prescribing practices are called for and more studies with a focus on rational prescribing in paediatrics in low-income settings are urgently required to fill the gap in current knowledge.

Identification of a sulfate metabolite of PCB 11 in human serum

PubMed Central

Grimm, Fabian A.; Lehmler, Hans-Joachim; Koh, Wen Xin; DeWall, Jeanne; Teesch, Lynn M.; Hornbuckle, Keri C.; Thorne, Peter S.; Robertson, Larry W.; Duffel, Michael W.

2016-01-01

Despite increasing evidence for a major role for sulfation in the metabolism of lower-chlorinated polychlorinated biphenyls in vitro and in vivo, and initial evidence for potential bioactivities of the resulting sulfate ester metabolites, the formation of PCB sulfates in PCB exposed human populations had not been explored. The primary goal of this study was to determine if PCB sulfates, and potentially other conjugated PCB derivatives, are relevant classes of PCB metabolites in the serum of humans with known exposures to PCBs. In order to detect and quantify dichlorinated PCB sulfates in serum samples of 46 PCB-exposed individuals from either rural or urban communities, we developed a high-resolution mass spectrometry-based protocol using 4-PCB 11 sulfate as a model compound. The method also allowed the preliminary analysis of these 46 human serum extracts for the presence of other metabolites, such as glucuronic acid conjugates and hydroxylated PCBs. Sulfate ester metabolites derived from dichlorinated PCBs were detectable and quantifiable in more than 20 % of analyzed serum samples. Moreover, we were able to utilize this method to detect PCB glucuronides and hydroxylated PCBs, albeit at lower frequencies than PCB sulfates. Altogether, our results provide initial evidence for the presence of PCB sulfates in human serum. Considering the inability of previously employed analytical protocols for PCBs to extract these sulfate ester metabolites and the concentrations of these metabolites observed in our current study, our data support the hypothesis that total serum levels of PCB metabolites in exposed individuals may have been underestimated in the past. PMID:27816204

Identification of a sulfate metabolite of PCB 11 in human serum.

PubMed

Grimm, Fabian A; Lehmler, Hans-Joachim; Koh, Wen Xin; DeWall, Jeanne; Teesch, Lynn M; Hornbuckle, Keri C; Thorne, Peter S; Robertson, Larry W; Duffel, Michael W

2017-01-01

Despite increasing evidence for a major role for sulfation in the metabolism of lower-chlorinated polychlorinated biphenyls in vitro and in vivo, and initial evidence for potential bioactivities of the resulting sulfate ester metabolites, the formation of PCB sulfates in PCB exposed human populations had not been explored. The primary goal of this study was to determine if PCB sulfates, and potentially other conjugated PCB derivatives, are relevant classes of PCB metabolites in the serum of humans with known exposures to PCBs. In order to detect and quantify dichlorinated PCB sulfates in serum samples of 46 PCB-exposed individuals from either rural or urban communities, we developed a high-resolution mass spectrometry-based protocol using 4-PCB 11 sulfate as a model compound. The method also allowed the preliminary analysis of these 46 human serum extracts for the presence of other metabolites, such as glucuronic acid conjugates and hydroxylated PCBs. Sulfate ester metabolites derived from dichlorinated PCBs were detectable and quantifiable in more than 20% of analyzed serum samples. Moreover, we were able to utilize this method to detect PCB glucuronides and hydroxylated PCBs, albeit at lower frequencies than PCB sulfates. Altogether, our results provide initial evidence for the presence of PCB sulfates in human serum. Considering the inability of previously employed analytical protocols for PCBs to extract these sulfate ester metabolites and the concentrations of these metabolites observed in our current study, our data support the hypothesis that total serum levels of PCB metabolites in exposed individuals may have been underestimated in the past. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effect of rehabilitation length of stay on outcomes in individuals with traumatic brain injury or spinal cord injury: a systematic review protocol.

PubMed

Lamontagne, Marie-Eve; Gagnon, Cynthia; Allaire, Anne-Sophie; Noreau, Luc

2013-07-20

Rehabilitation interventions are a key component of the services required by individuals with neurotrauma to recover or compensate for altered abilities and achieve optimal social participation. Primary studies have produced evidence of the effect of rehabilitation length of stay on individuals with neurotrauma. However, to date no systematic review of this evidence has been performed. This makes it difficult for managers and clinicians to base their rehabilitation practices upon evidence. Supported by a committee of stakeholders, we will search electronic databases for research articles examining the association between length of stay or intensity of inpatient rehabilitation services and outcomes or the determinants of inpatient rehabilitation length of stay in adults with neurotrauma published after January 1990. Two researchers will independently screen the article titles and abstracts for inclusion. Two reviewers will independently extract the data. Primary outcomes of interest will be level of function, participation and return to work. If the data allow it, a meta-analysis of the studies will be performed. The results of this systematic review will clarify the factors that influence length of stay and intensity of rehabilitation services for individuals with TBI and SCI. They will give clinicians indications for optimal length of stay in these patient populations, contributing to better quality of care and better functional results. This review protocol has been registered on the PROSPERO database (CRD42012003120) and is available at http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42012003120.

Identifying and prioritising systematic review topics with public health stakeholders: A protocol for a modified Delphi study in Switzerland to inform future research agendas

PubMed Central

Mütsch, Margot; Kien, Christina; Gerhardus, Ansgar; Lhachimi, Stefan K

2017-01-01

Introduction The Cochrane Collaboration aims to produce relevant and top priority evidence that responds to existing evidence gaps. Hence, research priority setting (RPS) is important to identify which potential research gaps are deemed most important. Moreover, RPS supports future health research to conform both health and health evidence needs. However, studies that are prioritising systematic review topics in public health are surprisingly rare. Therefore, to inform the research agenda of Cochrane Public Health Europe (CPHE), we introduce the protocol of a priority setting study on systematic review topics in several European countries, which is conceptualised as pilot. Methods and analysis We will conduct a two-round modified Delphi study in Switzerland, incorporating an anonymous web-based questionnaire, to assess which topics should be prioritised for systematic reviews in public health. In the first Delphi round public health stakeholders will suggest relevant assessment criteria and potential priority topics. In the second Delphi round the participants indicate their (dis)agreement to the aggregated results of the first round and rate the potential review topics with the predetermined criteria on a four-point Likert scale. As we invite a wide variety of stakeholders we will compare the results between the different stakeholder groups. Ethics and dissemination We have received ethical approval from the ethical board of the University of Bremen, Germany (principal investigation is conducted at the University of Bremen) and a certificate of non-objection from the Canton of Zurich, Switzerland (fieldwork will be conducted in Switzerland). The results of this study will be further disseminated through peer reviewed publication and will support systematic review author groups (i.a. CPHE) to improve the relevance of the groups´ future review work. Finally, the proposed priority setting study can be used as a framework by other systematic review groups when conducting a priority setting study in a different context. PMID:28780546

Part II: The Effects of Aromatherapy and Guided Imagery for the Symptom Management of Anxiety, Pain, and Insomnia in Critically Ill Patients: An Integrative Review of Current Literature.

PubMed

Meghani, Naheed; Tracy, Mary Fran; Hadidi, Niloufar Niakosari; Lindquist, Ruth

This review is part II of a 2-part series that presents evidence on the effectiveness of aromatherapy and guided imagery for the symptom management of anxiety, pain, and insomnia in adult critically ill patients. Evidence from this review supports the use of aromatherapy for management of pain, insomnia, and anxiety in critically ill patients. Evidence also supports the use of guided imagery for managing these symptoms in critical care; however, the evidence is sparse, mixed, and weak. More studies with larger samples and stronger designs are needed to further establish efficacy of guided imagery for the management of anxiety, pain, and insomnia of critically ill patients; to accomplish this, standardized evidence-based intervention protocols to ensure comparability and to establish optimal effectiveness are needed. Discussion and recommendations related to the use of these therapies in practice and needs for future research in these areas were generated.

An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol.

PubMed

Maru, Sheela; Nirola, Isha; Thapa, Aradhana; Thapa, Poshan; Kunwar, Lal; Wu, Wan-Ju; Halliday, Scott; Citrin, David; Schwarz, Ryan; Basnett, Indira; Kc, Naresh; Karki, Khem; Chaudhari, Pushpa; Maru, Duncan

2018-03-29

Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia's poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community health workers are an important cadre in low-income countries where human resources for health and health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to health care access. Recent case studies of large community health worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such community health worker systems can change health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a community health worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child health intervention as it is scaled up in rural Nepal. We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child health intervention and the implementation process via a professional community health worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized community health worker cadre delivering evidence-based reproductive, maternal, newborn, and child health interventions to the country's rural population. ClinicalTrials.gov Identifier: NCT03371186 , registered 04 December 2017, retrospectively registered.

Is there more than one circadian clock in humans? Evidence from fractional desynchronization studies.

PubMed Central

Folkard, S; Minors, D S; Waterhouse, J M

1984-01-01

Three groups of four healthy volunteers lived in an isolation unit for 24 days. During this time they lived by a clock which, unknown to themselves, ran progressively faster so that, by real time, the 'day' decreased from 24.0 to 22.0 h in length. Throughout this protocol, the subjects lived a regular regimen of sleep, waking and meals based upon their 'local' time clock. They collected regular urine samples that were analysed for a variety of constituents. Rectal temperature was also recorded automatically throughout. The effects of such a protocol upon circadian rhythmicity in these variables were investigated by a variety of techniques including cosinor analysis. The results showed that the temperature rhythm was less able to adjust to a shortening 'day' than were the urinary variables, with the possible exception of potassium; that is, the protocol forced an internal desynchronization to exist between different variables. These results are discussed in terms of both the possibility that more than one internal circadian clock might exist and the direct effect that sleep exerts upon the expression of circadian rhythms. PMID:6512693

Mirror neuron system and observational learning: behavioral and neurophysiological evidence.

PubMed

Lago-Rodriguez, Angel; Lopez-Alonso, Virginia; Fernández-del-Olmo, Miguel

2013-07-01

Three experiments were performed to study observational learning using behavioral, perceptual, and neurophysiological data. Experiment 1 investigated whether observing an execution model, during physical practice of a transitive task that only presented one execution strategy, led to performance improvements compared with physical practice alone. Experiment 2 investigated whether performing an observational learning protocol improves subjects' action perception. In experiment 3 we evaluated whether the type of practice performed determined the activation of the Mirror Neuron System during action observation. Results showed that, compared with physical practice, observing an execution model during a task that only showed one execution strategy does not provide behavioral benefits. However, an observational learning protocol allows subjects to predict more precisely the outcome of the learned task. Finally, intersperse observation of an execution model with physical practice results in changes of primary motor cortex activity during the observation of the motor pattern previously practiced, whereas modulations in the connectivity between primary and non primary motor areas (PMv-M1; PPC-M1) were not affected by the practice protocol performed by the observer. Copyright © 2013 Elsevier B.V. All rights reserved.

Correction of Grade 2 Spondylolisthesis Following a Non-Surgical Structural Spinal Rehabilitation Protocol Using Lumbar Traction: A Case Study and Selective Review of Literature

PubMed Central

Fedorchuk, Curtis; Lightstone, Douglas F; McRae, Christi; Kaczor, Derek

2017-01-01

Objective Discuss the use of non-surgical spinal rehabilitation protocol in the case of a 69-year-old female with a grade 2 spondylolisthesis. A selective literature review and discussion are provided. Clinical Features A 69-year-old female presented with moderate low back pain (7/10 pain) and severe leg cramping (7/10 pain). Initial lateral lumbar x-ray revealed a grade 2 spondylolisthesis at L4-L5 measuring 13.3 mm. Interventions and Outcomes The patient completed 60 sessions of Mirror Image® spinal exercises, adjustments, and traction over 45 weeks. Post-treatment lateral lumbar x-ray showed a decrease in translation of L4-L5 from 13.3 mm to 2.4 mm, within normal limits. Conclusions This case provides the first documented evidence of a non-surgical or chiropractic treatment, specifically Chiropractic BioPhysics®, protocols of lumbar spondylolisthesis where spinal alignment was corrected. Additional research is needed to investigate the clinical implications and treatment methods. PMID:29299090

A Pediatric Intensive Care Unit Bedside Computer Clinical Decision Support Protocol for Hyperglycemia Is Feasible, Safe and Offers Advantages

PubMed Central

Lanspa, Michael J.; Wilson, Emily L.; Sward, Katherine A.; Jephson, Al; Larsen, Gitte Y.; Morris, Alan H.

2017-01-01

Abstract Background: Computer clinical decision support (CDS) systems are uncommon in the pediatric intensive care unit (PICU), despite evidence suggesting they improve outcomes in adult ICUs. We reasoned that a bedside CDS protocol for intravenous insulin titration, eProtocol-insulin, would be feasible and safe in critically ill children. Methods: We retrospectively reviewed data from non-diabetic children admitted to the PICU with blood glucose (BG) ≥140 mg/dL who were managed with intravenous insulin by either unaided clinician titration or eProtocol-insulin. Primary outcomes were BG measurements in target range (80–110 mg/dL) and severe hypoglycemia (BG ≤40 mg/dL); secondary outcomes were 60-day mortality and PICU length of stay. We assessed bedside nurse satisfaction with the eProtocol-insulin protocol by using a 5-point Likert scale and measured clinician compliance with eProtocol-insulin recommendations. Results: Over 5 years, 69 children were titrated with eProtocol-insulin versus 104 by unaided clinicians. eProtocol-insulin achieved target range more frequently than clinician titration (41% vs. 32%, P < 0.001). Severe hypoglycemia was uncommon in both groups (4.3% of patients in eProtocol-insulin, 8.7% in clinician titration, P = 0.37). There were no differences in mean time to BG target or median BG between the groups. Mortality was 23% in both groups. Clinician compliance with eProtocol-insulin recommendations was 89%. Nurses believed that eProtocol-insulin was easy to understand and safer than clinician titration. Conclusions: eProtocol-insulin is safe for titration of intravenous insulin in critically ill children. Clinical research protocols and quality improvement initiatives aimed at optimizing BG control should utilize detailed computer protocols that enable replicable clinician decisions. PMID:28248127

'Fast cast' and 'needle Tenotomy' protocols with the Ponseti method to improve clubfoot management in Bangladesh.

PubMed

Evans, Angela; Chowdhury, Mamun; Rana, Sohel; Rahman, Shariar; Mahboob, Abu Hena

2017-01-01

The management of congenital talipes equino varus ( clubfoot deformity ) has been transformed in the last 20 years as surgical correction has been replaced by the non-surgical Ponseti method. The Ponseti method, consists of corrective serial casting followed by maintenance bracing, and has been repeatedly demonstrated to give best results - regarded as the 'gold standard' treatment for paediatric clubfoot. To develop the study protocol Level 2 evidence was used to modify the corrective casting phase of the Ponseti method in children aged up to 12 months. Using Level 4 evidence, the percutaneous Achilles tenotomy (PAT) was performed using a 19-gauge needle instead of a scalpel blade, a technique found to reduce bleeding and scarring. A total of 123 children participated in this study; 88 male, 35 female. Both feet were affected in 67 cases, left only in 22 cases, right only in 34 cases. Typical clubfeet were found in 112/123 cases, six atypical, five syndromic. The average age at first cast was 51 days (13-240 days).The average number of casts applied was five (2-10 casts). The average number of days between the first cast and brace was 37.8 days (10-122 days), including 21 days in a post-PAT cast. Hence, average time of corrective casts was 17 days.Parents preferred the reduced casting time, and were less concerned about unseen skin wounds.PAT was performed in 103/123 cases, using the needle technique. All post tenotomy casts were in situ for three weeks. Minor complications occurred in seven cases - four cases had skin lesions, three cases disrupted casting phase. At another site, 452 PAT were performed using the needle technique. The 'fast cast' protocol Ponseti casting was successfully used in infants aged less than 8 months. Extended manual manipulation of two minutes was the essential modification. Parents preferred the faster treatment phase, and ability to closer observe the foot and skin. The treating physiotherapists preferred the 'fast cast' protocol, achieving better correction with less complication. The needle technique for PAT is a further improvement for the Ponseti method.

Exercise for methamphetamine dependence: rationale, design, and methodology.

PubMed

Mooney, Larissa J; Cooper, Christopher; London, Edythe D; Chudzynski, Joy; Dolezal, Brett; Dickerson, Daniel; Brecht, Mary-Lynn; Peñate, Jose; Rawson, Richard A

2014-01-01

Effective pharmacotherapies to treat methamphetamine (MA) dependence have not been identified, and behavioral therapies are marginally effective. Based on behavioral studies demonstrating the potential efficacy of aerobic exercise for improving depressive symptoms, anxiety, cognitive deficits, and substance use outcomes, the study described here is examining exercise as a potential treatment for MA-dependent individuals. This study is randomizing 150 participants with MA dependence at a residential treatment facility for addictive disorders to receive either a thrice-weekly structured aerobic and resistance exercise intervention or a health education condition. Recruitment commenced in March, 2010. Enrollment and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates. Seeking evidence for a possibly effective adjunct to traditional behavioral approaches for treatment of MA dependence, this study is assessing the ability of an 8-week aerobic and resistance exercise protocol to reduce relapse to MA use during a 12-week follow-up period after discharge from residential-based treatment. The study also is evaluating improvements in health and functional outcomes during and after the protocol. This paper describes the design and methods of the study. Copyright © 2013 Elsevier Inc. All rights reserved.

An updated protocol for a systematic review of implementation-related measures.

PubMed

Lewis, Cara C; Mettert, Kayne D; Dorsey, Caitlin N; Martinez, Ruben G; Weiner, Bryan J; Nolen, Elspeth; Stanick, Cameo; Halko, Heather; Powell, Byron J

2018-04-25

Implementation science is the study of strategies used to integrate evidence-based practices into real-world settings (Eccles and Mittman, Implement Sci. 1(1):1, 2006). Central to the identification of replicable, feasible, and effective implementation strategies is the ability to assess the impact of contextual constructs and intervention characteristics that may influence implementation, but several measurement issues make this work quite difficult. For instance, it is unclear which constructs have no measures and which measures have any evidence of psychometric properties like reliability and validity. As part of a larger set of studies to advance implementation science measurement (Lewis et al., Implement Sci. 10:102, 2015), we will complete systematic reviews of measures that map onto the Consolidated Framework for Implementation Research (Damschroder et al., Implement Sci. 4:50, 2009) and the Implementation Outcomes Framework (Proctor et al., Adm Policy Ment Health. 38(2):65-76, 2011), the protocol for which is described in this manuscript. Our primary databases will be PubMed and Embase. Our search strings will be comprised of five levels: (1) the outcome or construct term; (2) terms for measure; (3) terms for evidence-based practice; (4) terms for implementation; and (5) terms for mental health. Two trained research specialists will independently review all titles and abstracts followed by full-text review for inclusion. The research specialists will then conduct measure-forward searches using the "cited by" function to identify all published empirical studies using each measure. The measure and associated publications will be compiled in a packet for data extraction. Data relevant to our Psychometric and Pragmatic Evidence Rating Scale (PAPERS) will be independently extracted and then rated using a worst score counts methodology reflecting "poor" to "excellent" evidence. We will build a centralized, accessible, searchable repository through which researchers, practitioners, and other stakeholders can identify psychometrically and pragmatically strong measures of implementation contexts, processes, and outcomes. By facilitating the employment of psychometrically and pragmatically strong measures identified through this systematic review, the repository would enhance the cumulativeness, reproducibility, and applicability of research findings in the rapidly growing field of implementation science.

Identifying the domains of context important to implementation science: a study protocol.

PubMed

Squires, Janet E; Graham, Ian D; Hutchinson, Alison M; Michie, Susan; Francis, Jill J; Sales, Anne; Brehaut, Jamie; Curran, Janet; Ivers, Noah; Lavis, John; Linklater, Stefanie; Fenton, Shannon; Noseworthy, Thomas; Vine, Jocelyn; Grimshaw, Jeremy M

2015-09-28

There is growing recognition that "context" can and does modify the effects of implementation interventions aimed at increasing healthcare professionals' use of research evidence in clinical practice. However, conceptual clarity about what exactly comprises "context" is lacking. The purpose of this research program is to develop, refine, and validate a framework that identifies the key domains of context (and their features) that can facilitate or hinder (1) healthcare professionals' use of evidence in clinical practice and (2) the effectiveness of implementation interventions. A multi-phased investigation of context using mixed methods will be conducted. The first phase is a concept analysis of context using the Walker and Avant method to distinguish between the defining and irrelevant attributes of context. This phase will result in a preliminary framework for context that identifies its important domains and their features according to the published literature. The second phase is a secondary analysis of qualitative data from 13 studies of interviews with 312 healthcare professionals on the perceived barriers and enablers to their application of research evidence in clinical practice. These data will be analyzed inductively using constant comparative analysis. For the third phase, we will conduct semi-structured interviews with key health system stakeholders and change agents to elicit their knowledge and beliefs about the contextual features that influence the effectiveness of implementation interventions and healthcare professionals' use of evidence in clinical practice. Results from all three phases will be synthesized using a triangulation protocol to refine the context framework drawn from the concept analysis. The framework will then be assessed for content validity using an iterative Delphi approach with international experts (researchers and health system stakeholders/change agents). This research program will result in a framework that identifies the domains of context and their features that can facilitate or hinder: (1) healthcare professionals' use of evidence in clinical practice and (2) the effectiveness of implementation interventions. The framework will increase the conceptual clarity of the term "context" for advancing implementation science, improving healthcare professionals' use of evidence in clinical practice, and providing greater understanding of what interventions are likely to be effective in which contexts.

Enhanced Weight based DSR for Mobile Ad Hoc Networks

NASA Astrophysics Data System (ADS)

Verma, Samant; Jain, Sweta

2011-12-01

Routing in ad hoc network is a great problematic, since a good routing protocol must ensure fast and efficient packet forwarding, which isn't evident in ad hoc networks. In literature there exists lot of routing protocols however they don't include all the aspects of ad hoc networks as mobility, device and medium constraints which make these protocols not efficient for some configuration and categories of ad hoc networks. Thus in this paper we propose an improvement of Weight Based DSR in order to include some of the aspects of ad hoc networks as stability, remaining battery power, load and trust factor and proposing a new approach Enhanced Weight Based DSR.

Current protocols in the management of oral submucous fibrosis: An update.

PubMed

Arakeri, Gururaj; Rai, Kirthi Kumar; Boraks, George; Patil, Shekar Gowda; Aljabab, Abdulsalam S; Merkx, M A W; Carrozzo, Marco; Brennan, Peter A

2017-07-01

Oral submucous fibrosis (OSMF) is a debilitating condition of oral cavity which has significant potential for malignant transformation. In spite of over 20 years of research, the pathogenesis of the condition is still obscure and no single management modality is effective. Many OSMF treatment protocols have been proposed to alleviate the signs and symptoms of the disorder and there is overwhelming evidence that as areca nut is primary cause, stopping its use may have a considerable effect on symptoms rather than reversing pre-existing fibrosis. We present a review of the current protocols for managing OSMF. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Is alternate rapid maxillary expansion and constriction an effective protocol in the treatment of Class III malocclusion? A systematic review

PubMed Central

Pithon, Matheus Melo; Santos, Nathalia de Lima; dos Santos, Camila Rangel Barreto; Baião, Felipe Carvalho Souza; Pinheiro, Murilo Costa Rangel; Matos, Manoel; Souza, Ianderlei Andrade; de Paula, Rafael Pereira

2016-01-01

ABSTRACT Introduction: the treatment of Class III malocclusion in early age is one of the greatest challenges for orthodontists, and the establishment of more effective treatment method is a constant concern for these professionals. Thus, the objective of this systematic review is to verify the effectiveness of the therapy protocol for alternate rapid maxillary expansion and constriction (Alt-RAMEC) in the early treatment of Class III malocclusion. Methods: searches were performed in the following electronic databases: Cochrane Library, Medline (EBSCO and PubMed), SciELO, LILACS and Scopus. The following inclusion criteria were used: in vivo studies conducted with early intervention (patient in craniofacial development phase) with the use of the Alt-RAMEC protocol. Reviews, case reports, editorials, and studies with syndromic patients or under use of systemic drug were excluded. Duplicates were also excluded. The studies were assessed for methodological quality using the Cochrane tool for assessment of risk of bias, and classified as high or low risk of bias. Results: 53 articles were found. Duplicates exclusion was thus performed and 35 articles remained. After inclusion analysis, only 5 matched the criteria. Two articles were classified as low risk of bias and three as high risk of bias. It was observed that the Alt-RAMEC enable protraction in less time and with better results, promoting greater effectiveness in the protraction treatment of Class III malocclusion. Conclusions: Although there is positive evidence of the effectiveness of early treatment with the Alt-RAMEC protocol in patients with Class III malocclusion, further studies are needed to confirm its effectiveness using long-term methodology. PMID:28125138

Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients.

PubMed

Altunkan, Sekip; Iliman, Nevzat; Altunkan, Erkan

2008-04-01

Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.

Physical Therapy Protocol After Hip Arthroscopy

PubMed Central

Domb, Benjamin G.; Sgroi, Terrance A.; VanDevender, Jeremy C.

2016-01-01

Context: Femoroacetabular impingement (FAI) was first described by Ganz in 2003 and is a significant cause of decreased function and mobility. Femoroacetabular impingement must be treated in an individualized, goal-oriented, stepwise fashion. This protocol was developed with biomechanical considerations of soft tissue and bony structures surrounding the hip joint. Evidence Acquisition: The PubMed database was searched for scientific and review articles from the years 2000 to 2015 utilizing the search terms: hip rehabilitation, femoroacetabular impingement, and arthroscopy. Study Design: Clinical review. Level of Evidence: Level 5. Results: Five hundred ninety-five of 738 patients were available for follow-up showing improvement from preoperative to 2-year follow-up of 61.29 to 82.02 for modified Harris Hip Score (mHHS), 62.79 to 83.04 for Hip Outcome Score–Activities of Daily Living (HOS-ADL), 40.96 to 70.07 for Hip Outcome Score–Sport-Specific Subscale (HOS-SSS), and 57.97 to 80.41 for Non-Arthritic Hip Score (NAHS); visual analog scale (VAS) scores decreased from 5.86 preoperatively to 2.94 postoperatively. Conclusion: Following a structured, criteria-based program, appropriate patients undergoing hip arthroscopy may achieve excellent outcomes and return to full independent activities of daily living as well as sport. PMID:27173983

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention.

PubMed

Sgambato, Michele R; Cunha, Diana B; Henriques, Viviana T; Estima, Camilla C P; Souza, Bárbara S N; Pereira, Rosangela A; Yokoo, Edna M; Paravidino, Vitor B; Sichieri, Rosely

2016-08-17

The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls) in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

A novel ultrafast-low-dose computed tomography protocol allows concomitant coronary artery evaluation and lung cancer screening.

PubMed

Gaudio, Carlo; Petriello, Gennaro; Pelliccia, Francesco; Tanzilli, Alessandra; Bandiera, Alberto; Tanzilli, Gaetano; Barillà, Francesco; Paravati, Vincenzo; Pellegrini, Massimo; Mangieri, Enrico; Barillari, Paolo

2018-05-08

Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. We tested diagnostic ability and radiation exposure of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. We studied 30 current or former heavy smoker subjects with suspected or known coronary artery disease who underwent CT assessment of both coronary arteries and thoracic area (Revolution CT, General Electric). A new ultrafast-low-dose single protocol was used for ECG-gated helical acquisition of the heart and the whole chest. A single IV iodine bolus (70-90 ml) was used. All patients with CT evidence of coronary stenosis underwent also invasive coronary angiography. All the coronary segments were assessable in 28/30 (93%) patients. Only 8 coronary segments were not assessable in 2 patients due to motion artefacts (assessability: 98%; 477/485 segments). In the assessable segments, 20/21 significant stenoses (> 70% reduction of vessel diameter) were correctly diagnosed. Pulmonary nodules were detected in 5 patients, thus requiring to schedule follow-up surveillance CT thorax. Effective dose was 1.3 ± 0.9 mSv (range: 0.8-3.2 mSv). Noteworthy, no contrast or radiation dose increment was required with the new protocol as compared to conventional coronary CT protocol. The novel ultrafast-low-dose CT protocol allows lung cancer screening at time of coronary artery evaluation. The new approach might enhance the cost-effectiveness of coronary CT in heavy smokers with suspected or known coronary artery disease.

Implementation of a Total Hip Arthroplasty Care Pathway at a High-Volume Health System: Effect on Length of Stay, Discharge Disposition, and 90-Day Complications.

PubMed

Featherall, Joseph; Brigati, David P; Faour, Mhamad; Messner, William; Higuera, Carlos A

2018-06-01

Standardized care pathways are evidence-based algorithms for optimizing an episode of care. Despite the theoretical promise of care pathways, there is an inconsistent literature demonstrating improvements in patient care. The authors hypothesized that implementing a care pathway, across 11 hospitals, would decrease hospital length of stay (LOS), decrease postoperative complications at 90 days, and increase discharges to home. A multidisciplinary team developed an evidence-based care pathway for total hip arthroplasty (THA) perioperative care. All patients receiving THA in 2013 (pre-protocol, historical control), 2014 (transition), and 2015 (full protocol implementation) were included in the analysis. Multivariable regression assessed the relationship of the care pathway to 90-day postoperative complications, LOS, and discharge disposition. Cost savings were estimated using previously published postarthroplasty episode and per diem hospital costs. A total of 6090 primary THAs were conducted during the study period. After adjusting for the covariates, the full protocol implementation was associated with a decrease in LOS (mean ratio, 0.747; 95% confidence interval [CI; 0.727, 0.767]) and an increase in discharges to home (odds ratio, 2.079; 95% CI [1.762, 2.456]). The full protocol implementation was not associated with a change in 90-day complications (odds ratio, 1.023; 95% CI [0.841, 1.245]). Payer-perspective-calculated theoretical cost savings, including both index admission and postdischarge costs, were $2533 per patient. The THA care pathway implementation was successful in reducing LOS and increasing discharges to home. The care pathway was not associated with a change in 90-day complications; further targeted interventions in this area are needed. Despite care standardization efforts, high-volume hospitals and surgeons had higher performance. Extrapolation of theoretical cost savings indicates that widespread THA care pathway adoption could lead to national healthcare savings of $1.2 billion annually. Copyright © 2018 Elsevier Inc. All rights reserved.

Mapping the implementation of evidence-based nutritional management in primary health care settings: a scoping review protocol.

PubMed

Oliveira, Nara Leticia Zandonadi de; Agreli, Heloise Lima Fernandes; Matsumoto, Karen Dos Santos; Peduzzi, Marina

2018-05-01

The objective of this scoping review is to systematically map and categorize the wide variety of interventions and programs that might be classified under the umbrella term "evidence-based nutritional management in primary healthcare". The development of this scoping review will provide a better understanding of how evidence-based nutritional management has been implemented by healthcare professionals in primary health care settings, especially of barriers and facilitators to implementing evidence-based nutritional management. Therefore, three research questions were chosen to guide the scoping review.

Venous Access Devices: Clinical Rounds

PubMed Central

Matey, Laurl; Camp-Sorrell, Dawn

2016-01-01

Nursing management of venous access devices (VADs) requires knowledge of current evidence, as well as knowledge of when evidence is limited. Do you know which practices we do based on evidence and those that we do based on institutional history or preference? This article will present complex VAD infection and occlusion complications and some of the controversies associated with them. Important strategies for identifying these complications, troubleshooting, and evaluating the evidence related to lack of blood return, malposition, infection, access and maintenance protocols, and scope of practice issues are presented. PMID:28083553

Adverse childhood experience and asthma onset: a systematic review.

PubMed

Exley, Daniel; Norman, Alyson; Hyland, Michael

2015-06-01

Adverse childhood experiences such as abuse and neglect are associated with subsequent immune dysregulation. Some studies show an association between adverse childhood experiences and asthma onset, although significant disparity in results exists in the published literature. We aimed to review available studies employing a prospective design that investigates associations between adverse childhood experience and asthma. A search protocol was developed and studies were drawn from four electronic journal databases. Studies were selected in accordance with pre-set inclusion criteria and relevant data were extracted. 12 studies, assessing data from a total of 31 524 individuals, were identified that investigate the impact of a range of adverse childhood experiences on the likelihood of developing asthma. Evidence suggests that chronic stress exposure and maternal distress in pregnancy operate synergistically with known triggers such as traffic-related air pollution to increase asthma risk. Chronic stress in early life is associated with an increased risk of asthma onset. There is evidence that adverse childhood experience increases the impact of traffic-related air pollution and inconsistent evidence that adverse childhood experience has an independent effect on asthma onset. Copyright ©ERS 2015.

Economics methods in Cochrane systematic reviews of health promotion and public health related interventions.

PubMed

Shemilt, Ian; Mugford, Miranda; Drummond, Michael; Eisenstein, Eric; Mallender, Jacqueline; McDaid, David; Vale, Luke; Walker, Damian

2006-11-15

Provision of evidence on costs alongside evidence on the effects of interventions can enhance the relevance of systematic reviews to decision-making. However, patterns of use of economics methods alongside systematic review remain unclear. Reviews of evidence on the effects of interventions are published by both the Cochrane and Campbell Collaborations. Although it is not a requirement that Cochrane or Campbell Reviews should consider economic aspects of interventions, many do. This study aims to explore and describe approaches to incorporating economics methods in a selection of Cochrane systematic reviews in the area of health promotion and public health, to help inform development of methodological guidance on economics for reviewers. The Cochrane Database of Systematic Reviews was searched using a search strategy for potential economic evaluation studies. We included current Cochrane reviews and review protocols retrieved using the search that are also identified as relevant to health promotion or public health topics. A reviewer extracted data which describe the economics components of included reviews. Extracted data were summarised in tables and analysed qualitatively. Twenty-one completed Cochrane reviews and seven review protocols met inclusion criteria. None incorporate formal economic evaluation methods. Ten completed reviews explicitly aim to incorporate economics studies and data. There is a lack of transparent reporting of methods underpinning the incorporation of economics studies and data. Some reviews are likely to exclude useful economics studies and data due to a failure to incorporate search strategies tailored to the retrieval of such data or use of key specialist databases, and application of inclusion criteria designed for effectiveness studies. There is a need for consistency and transparency in the reporting and conduct of the economics components of Cochrane reviews, as well as regular dialogue between Cochrane reviewers and economists to develop increased capacity for economic analyses alongside such reviews. Use of applicable economics methods in Cochrane reviews can help provide the international context within which economics data can be interpreted and assessed as a preliminary to full economic evaluation.

The role of academic health centres in building equitable health systems: a systematic review protocol

PubMed Central

Edelman, Alexandra; Taylor, Judy; Ovseiko, Pavel V; Topp, Stephanie M

2017-01-01

Introduction Academic health centres (AHCs) are complex organisations often defined by their ‘tripartite’ mission: to achieve high standards of clinical care, undertake clinical and laboratory research and educate health professionals. In the last decade, AHCs have moved away from what was a dominant focus on high impact (clinical) interventions for individuals, towards a more population-oriented paradigm requiring networked institutions and responsiveness to a range of issues including distribution of health outcomes and health determinants. Reflective of this paradigm shift is a growing interest in the role of AHCs in addressing health disparities and improving health system equity. This protocol outlines a systematic review that seeks to synthesise and critically appraise the current state of evidence on the role of AHCs in contributing to equitable health systems locally and globally. Methods and analysis Electronic searches will be conducted on a pilot list of bibliographic databases, including Google Scholar, Scopus, MEDLINE, PsycInfo, CINAHL, ERIC, ProQuest Dissertations & Theses, Cochrane Library, Evidence Based Medicine Reviews, Campbell Library and A+ Education, from 1 January 2000 to 31 December 2016. Apart from studies reporting clinical interventions or trials, all types of published peer-reviewed and grey literature will be included in the review. The single screening method will be employed in selecting studies, with two additional reviewers consulted where allocation is unclear. Quality and relevance appraisal utilising Joanna Briggs Institute critical appraisal tools will follow data extraction to a preprepared template. Thematic synthesis will be undertaken to develop descriptive themes and inform analysis. Ethics and dissemination As the review is focused on the analysis of secondary data, it does not require ethics approval. The results of the study will be disseminated through articles in peer-reviewed journals and trade publications as well as presentations at relevant national and international conferences. Results will be further disseminated through networks and associations of AHCs. Protocol registration International Prospective Register for Systematic Reviews (PROSPERO) number CRD42016051802. PMID:28554932