Sample records for develop clinically evident

  1. The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods.

    PubMed

    Qaseem, Amir; Snow, Vincenza; Owens, Douglas K; Shekelle, Paul

    2010-08-03

    The American College of Physicians (ACP) established its evidence-based clinical practice guidelines program in 1981. The ACP's Guidelines Committee and the staff of the Clinical Programs and Quality of Care Department develop the clinical recommendations. The ACP develops 2 different types of clinical recommendations: clinical practice guidelines and clinical guidance statements. The ACP clinical practice guidelines and guidance statements follow a multistep development process that includes a systematic review of the evidence, deliberation of the evidence by the committee, summary recommendations, and evidence and recommendation grading. All ACP clinical practice guidelines and clinical guidance statements, if not updated, are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

  2. Development of an evidence-based review with recommendations using an online iterative process.

    PubMed

    Rudmik, Luke; Smith, Timothy L

    2011-01-01

    The practice of modern medicine is governed by evidence-based principles. Due to the plethora of medical literature, clinicians often rely on systematic reviews and clinical guidelines to summarize the evidence and provide best practices. Implementation of an evidence-based clinical approach can minimize variation in health care delivery and optimize the quality of patient care. This article reports a method for developing an "Evidence-based Review with Recommendations" using an online iterative process. The manuscript describes the following steps involved in this process: Clinical topic selection, Evidence-hased review assignment, Literature review and initial manuscript preparation, Iterative review process with author selection, and Manuscript finalization. The goal of this article is to improve efficiency and increase the production of evidence-based reviews while maintaining the high quality and transparency associated with the rigorous methodology utilized for clinical guideline development. With the rise of evidence-based medicine, most medical and surgical specialties have an abundance of clinical topics which would benefit from a formal evidence-based review. Although clinical guideline development is an important methodology, the associated challenges limit development to only the absolute highest priority clinical topics. As outlined in this article, the online iterative approach to the development of an Evidence-based Review with Recommendations may improve productivity without compromising the quality associated with formal guideline development methodology. Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.

  3. Developing an evidence-based practice protocol: implications for midwifery practice.

    PubMed

    Carr, K C

    2000-01-01

    Evidence-based practice is defined and its importance to midwifery practice is presented. Guidelines are provided for the development of an evidence-based practice protocol. These include: identifying the clinical question, obtaining the evidence, evaluating the validity and importance of the evidence, synthesizing the evidence and applying it to the development of a protocol or clinical algorithm, and, finally, developing an evaluation plan or measurement strategy to see if the new protocol is effective.

  4. [Evidence-based Chinese medicine:theory and practice].

    PubMed

    Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

    2018-01-01

    The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

  5. The development of evidence-based guidelines in dentistry.

    PubMed

    Faggion, C M

    2013-02-01

    Use of guidelines is an important means of reducing the gap between research and clinical practice. Sound and unbiased information should be available to enable dental professionals to provide better clinical treatment for their patients. The development of clinical guidelines in dentistry should follow standard and transparent methodology. The purpose of this article is to propose important steps for developing evidence-based clinical recommendations in dentistry. Initially, dental guidelines should be extensively sought and assessed to answer focused clinical questions. If there is a paucity of guidelines or if existing guidelines are not of good methodological quality, systematic reviews should be searched or conducted to serve as a basis for the development of evidence-based guidelines. When systematic reviews are produced, they should be rigorous in order to provide the best evidence possible. In the last phase of the process, the overall quality of evidence should be scrutinized and assessed, together with other factors (balance between treatment effects and side effects, patients' values, and cost-effectiveness of therapy) to determine the strength of recommendations. It is expected this approach will result in the development of sound clinical guidelines and consequent improvement of dental treatment.

  6. Enhancing Critical Thinking Via a Clinical Scholar Approach.

    PubMed

    Simpson, Vicki; McComb, Sara A; Kirkpatrick, Jane M

    2017-11-01

    Safety, quality improvement, and a systems perspective are vital for nurses to provide quality evidence-based care. Responding to the call to prepare nurses with these perspectives, one school of nursing used a clinical scholar approach, enhanced by systems engineering to more intentionally develop the ability to clinically reason and apply evidence-based practice. A two-group, repeated-measures control trial was used to determine the effects of systems engineering content and support on nursing students' clinical judgment and critical thinking skills. Findings indicated this approach had a positive effects on student's clinical judgment and clinical reasoning skills. This approach helped students view health care issues from a broader perspective and use evidence to guide solution development, enhancing the focus on evidence-based practice, and quality improvement. Intentional integration of an evidence-based, systems perspective by nursing faculty supports development of nurses who can function safely and effectively in the current health care system. [J Nurs Educ. 2017;56(11):679-682.]. Copyright 2017, SLACK Incorporated.

  7. [The historical background and present development of evidence-based healthcare and clinical nursing].

    PubMed

    Tsai, Jung-Mei

    2014-12-01

    Evidence-based healthcare (EBHC) emphasizes the integration of the best research evidence with patient values, specialist suggestions, and clinical circumstances during the process of clinical decision-making. EBHC is a recognized core competency in modern healthcare. Nursing is a professional discipline of empirical science that thrives in an environment marked by advances in knowledge and technology in medicine as well as in nursing. Clinical nurses must elevate their skills and professional qualifications, provide efficient and quality health services, and promote their proficiency in EBHC. The Institute of Medicine in the United States indicates that evidence-based research results often fail to disseminate efficiently to clinical decision makers. This problem highlights the importance of better promoting the evidence-based healthcare fundamentals and competencies to frontline clinical nurses. This article describes the historical background and present development of evidence-based healthcare from the perspective of modern clinical nursing in light of the importance of evidence-based healthcare in clinical nursing; describes the factors associated with evidence-based healthcare promotion; and suggests strategies and policies that may improve the promotion and application of EBHC in clinical settings. The authors hope that this paper provides a reference for efforts to improve clinical nursing in the realms of EBHC training, promotion, and application.

  8. [Scientific, practical and educational aspects of clinical epidemiology].

    PubMed

    Briko, N I

    2012-01-01

    This article defines clinical epidemiology and describes its goal and objectives. The author claims that clinical epidemiology is a section of epidemiology which underlies the development of evidence-based standards for diagnostics, treatment and prevention and helps to select the appropriate algorithm for each clinical case. The study provides a comprehensive overview of the relationship between clinical epidemiology and evidence-based medicine. Epidemiological research is shown to be methodological basis of clinical epidemiology and evidence-based medicine with randomized controlled trials being the "gold standard" for obtaining reliable data. The key stages in the history of clinical epidemiology are discussed and further development of clinical epidemiology and the integration of courses on clinical epidemiology in education is outlined for progress in medical research and health care practice.

  9. Addressing the leadership gap in medicine: residents' need for systematic leadership development training.

    PubMed

    Blumenthal, Daniel M; Bernard, Ken; Bohnen, Jordan; Bohmer, Richard

    2012-04-01

    All clinicians take on leadership responsibilities when delivering care. Evidence suggests that effective clinical leadership yields superior clinical outcomes. However, few residency programs systematically teach all residents how to lead, and many clinicians are inadequately prepared to meet their day-to-day clinical leadership responsibilities. The purpose of this article is twofold: first, to make the case for the need to refocus residency education around the development of outstanding "frontline" clinical leaders and, second, to provide an evidence-based framework for designing formal leadership development programs for residents. The authors first present a definition of clinical leadership and highlight evidence that effective frontline clinical leadership improves both clinical outcomes and satisfaction for patients and providers. The authors then discuss the health care "leadership gap" and describe barriers to implementing leadership development training in health care. Next, they present evidence that leaders are not just "born" but, rather, can be "made," and offer a set of best practices to facilitate the design of leadership development programs. Finally, the authors suggest approaches to mitigating barriers to implementing leadership development programs and highlight the major reasons why health care delivery organizations, residency programs, and national accreditation bodies must make comprehensive leadership education an explicit goal of residency training.

  10. Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines

    PubMed Central

    Norris, Susan L.; Schulman, Sam; Hirsh, Jack; Eckman, Mark H.; Akl, Elie A.; Crowther, Mark; Vandvik, Per Olav; Eikelboom, John W.; McDonagh, Marian S.; Lewis, Sandra Zelman; Gutterman, David D.; Cook, Deborah J.; Schünemann, Holger J.

    2012-01-01

    Background: To develop the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: ACCP Evidence-Based Clinical Practice Guidelines (AT9), the American College of Chest Physicians (ACCP) assembled a panel of clinical experts, information scientists, decision scientists, and systematic review and guideline methodologists. Methods: Clinical areas were designated as articles, and a methodologist without important intellectual or financial conflicts of interest led a panel for each article. Only panel members without significant conflicts of interest participated in making recommendations. Panelists specified the population, intervention and alternative, and outcomes for each clinical question and defined criteria for eligible studies. Panelists and an independent evidence-based practice center executed systematic searches for relevant studies and evaluated the evidence, and where resources and evidence permitted, they created standardized tables that present the quality of the evidence and key results in a transparent fashion. Results: One or more recommendations relate to each specific clinical question, and each recommendation is clearly linked to the underlying body of evidence. Judgments regarding the quality of evidence and strength of recommendations were based on approaches developed by the Grades of Recommendations, Assessment, Development, and Evaluation Working Group. Panel members constructed scenarios describing relevant health states and rated the disutility associated with these states based on an additional systematic review of evidence regarding patient values and preferences for antithrombotic therapy. These ratings guided value and preference decisions underlying the recommendations. Each topic panel identified questions in which resource allocation issues were particularly important and, for these issues, experts in economic analysis provided additional searches and guidance. Conclusions: AT9 methodology reflects the current science of evidence-based clinical practice guideline development, with reliance on high-quality systematic reviews, a standardized process for quality assessment of individual studies and the body of evidence, an explicit process for translating the evidence into recommendations, disclosure of financial as well as intellectual conflicts of interest followed by management of disclosed conflicts, and extensive peer review. PMID:22315256

  11. The stakeholder approach: a new perspective on developing and marketing clinical trials.

    PubMed

    Droms, Courtney M; Ferguson, Michael; Giuliano, Karen

    2014-01-01

    The use of evidence-based medical practice has become the standard for health care decision-making. Thus, it has become increasingly important for medical device manufactures to provide evidence for the efficacy of their products. As new products, services, and solutions are developed, it is important to perform a stakeholder analysis to assess clinical evidence needs. As evidenced by the variety of stakeholders in clinical trials, we expect that each has different interests in how clinical trials are developed, conducted, and promoted to the general public. This analysis of the stakeholders' concerns provides recommendations for marketing professionals on meeting the needs of these stakeholders.

  12. Evaluation of evidence-based literature and formulation of recommendations for the clinical preventive guidelines for immigrants and refugees in Canada

    PubMed Central

    Tugwell, Peter; Pottie, Kevin; Welch, Vivian; Ueffing, Erin; Chambers, Andrea; Feightner, John

    2011-01-01

    Background: This article describes the evidence review and guideline development method developed for the Clinical Preventive Guidelines for Immigrants and Refugees in Canada by the Canadian Collaboration for Immigrant and Refugee Health Guideline Committee. Methods: The Appraisal of Guidelines for Research and Evaluation (AGREE) best-practice framework was combined with the recently developed Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to produce evidence-based clinical guidelines for immigrants and refugees in Canada. Results: A systematic approach was designed to produce the evidence reviews and apply the GRADE approach, including building on evidence from previous systematic reviews, searching for and comparing evidence between general and specific immigrant populations, and applying the GRADE criteria for making recommendations. This method was used for priority health conditions that had been selected by practitioners caring for immigrants and refugees in Canada. Interpretation: This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition. PMID:20573711

  13. Progress in evidence-based medicine: a quarter century on.

    PubMed

    Djulbegovic, Benjamin; Guyatt, Gordon H

    2017-07-22

    In response to limitations in the understanding and use of published evidence, evidence-based medicine (EBM) began as a movement in the early 1990s. EBM's initial focus was on educating clinicians in the understanding and use of published literature to optimise clinical care, including the science of systematic reviews. EBM progressed to recognise limitations of evidence alone, and has increasingly stressed the need to combine critical appraisal of the evidence with patient's values and preferences through shared decision making. In another progress, EBM incorporated and further developed the science of producing trustworthy clinical practice guidelines pioneered by investigators in the 1980s. EBM's enduring contributions to clinical medicine include placing the practice of medicine on a solid scientific basis, the development of more sophisticated hierarchies of evidence, the recognition of the crucial role of patient values and preferences in clinical decision making, and the development of the methodology for generating trustworthy recommendations. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Evidence-based health care: its place within clinical governance.

    PubMed

    McSherry, R; Haddock, J

    This article explores the principles of evidence-based practice and its role in achieving quality improvements within the clinical governance framework advocated by the recent White Papers 'The New NHS: Modern, Dependable' (Department of Health (DoH), 1997) and 'A First Class Service: Quality in the New NHS' (DoH, 1998a). Within these White Papers there is an emphasis on improving quality of care, treatment and services through employing the principles of clinical governance. A major feature of clinical governance is guaranteeing quality to the public and the NHS, and ensuring that clinical, managerial and educational practice is based on scientific evidence. This article also examines what evidence-based practice is and what processes are required to promote effective healthcare interventions. The authors also look at how clinical governance relates to other methods/systems involved in clinical effectiveness. Finally, the importance for nurses and other healthcare professionals of familiarizing themselves with the development of critical appraisal skills, and their implications for developing evidence-based practice, is emphasized.

  15. Evidence-based Medicine in Pediatric Orthopaedics: Evidence-based Practice Committee Summary of Levels of Evidence, Clinical Practice Guidelines, Appropriate Use Criteria, and Best Practice Guidelines.

    PubMed

    Gandhi, Jigar S; Shea, Kevin G; Sponseller, Paul D; Brighton, Brian K; Ganley, Theodore J

    2018-04-30

    The concept of evidence-based medicine has evolved over the past 2 decades, and has become a cornerstone to clinical decision-making in virtually every aspect of medicine. With a commitment to providing its members with high-quality evidence-based guidelines, the American Academy of Orthopaedic Surgeons has instituted concerted efforts since 2006 to develop clinical practice guidelines (CPGs) and appropriate use criteria (AUCs) for certain orthopaedic conditions. Many of these CPGs and AUCs detail the management of pediatric orthopaedic conditions. By the same token, members of the Pediatric Orthopaedic Society of North America (POSNA) Evidence Based Practice Committee have been publishing succinct evaluations of randomized controlled trials in pediatric orthopaedic surgery to create an evidence-based repository for quick reference to available high-level evidence as well as resource to identify gaps in the current research and identify opportunities for future investigation. In instances where higher-level evidence needed to develop CPGs is not available to address a critically important clinical question, consensus recommendations from experts in the field have been obtained to develop best practice guidelines (BPGs). The purpose of this review is to provide readers with a deeper understanding of the key principles of evidence-based medicine and methodologies used for the development of CPGs, AUCs, and BPGs.

  16. Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

    PubMed Central

    2012-01-01

    Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

  17. mobilityRERC state of the science conference: Considerations for developing an evidence base for wheeled mobility and seating service delivery.

    PubMed

    Cohen, Laura; Greer, Nancy; Berliner, Elise; Sprigle, Stephen

    2013-11-01

    This article, developed as background content for discussion during the Mobility Rehabilitation Engineering Research Center State of the Science Conference, reviews research surrounding wheeled mobility and seating (WMS) service delivery, discusses the challenges of improving clinical decision-making, and discusses research approaches used to study and improve health services in other practice areas that might be leveraged to develop the evidence base for WMS. Narrative literature review. An overview of existing research found general agreement across models of WMS service delivery but little high quality evidence to support the recommended approaches and few studies of the relationship between service delivery steps and individual patient outcomes. The definition of successful clinical decision-making is different for different stakeholders. Clinical decision-making should incorporate the best available evidence along with patient values, preferences, circumstances, and clinical expertise. To advance the evidence base for WMS service delivery, alternatives to randomized controlled trials should be considered and reliable and valid outcome measures developed. Technological advances offer tremendous opportunities for individuals with complex rehabilitation technology needs. However, with ongoing scrutiny of WMS service delivery there is an increased need for evidence to support the clinical decision-making process and to support evidence-based coverage policies for WMS services and technologies. An evidence base for wheeled mobility and seating services is an important component of the clinical decision-making process. At present, there is little evidence regarding essential components of the wheeled mobility and seating evaluation or the relationship between the evaluation process and patient outcomes. Many factors can confound this relationship and present challenges to research in this area. All stakeholders (i.e. clinicians, rehabilitation technology suppliers, manufacturers, researchers, payers, policy makers, and wheelchair users) need to work together to develop and support an evidence base for wheeled mobility and seating service delivery.

  18. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

    PubMed

    Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

    2017-08-01

    Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

  19. Management of Carpal Tunnel Syndrome.

    PubMed

    Mooar, Pekka A; Doherty, William J; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

    2018-03-15

    The American Academy of Orthopaedic Surgeons (AAOS) has developed Appropriate Use Criteria (AUC) for Management of Carpal Tunnel Syndrome. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. To provide the evidence foundation for this AUC, the AAOS Evidence-Based Medicine Unit provided the writing panel and voting panel with the 2016 AAOS Clinical Practice Guideline titled Management of Carpal Tunnel Syndrome Evidence-Based Clinical Practice Guideline. The Management of Carpal Tunnel Syndrome AUC clinical patient scenarios were derived from indications typical of patients with suspected carpal tunnel syndrome in clinical practice, as well as from current evidence-based clinical practice guidelines and supporting literature to identify the appropriateness of treatments. The 135 patient scenarios and 6 treatments were developed by the writing panel, a group of clinicians who are specialists in this AUC topic. Next, a separate, multidisciplinary, voting panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

  20. Prevention of in-hospital falls: development of criteria for the conduct of a multi-site audit.

    PubMed

    Giles, Kristy; Stephenson, Matthew; McArthur, Alexa; Aromataris, Edoardo

    2015-06-01

    Patient falls are a significant issue for hospitals due to the high rates of morbidity and mortality associated with these events, as well as the financial costs for the healthcare system. To establish what constitutes best practice in terms of fall prevention in acute care facilities and use this to inform the development of best practice audit criteria. Criteria for clinical audit were developed from evidence derived from systematic reviews and guidelines. While these were drawn from the best available evidence, they were also developed in conjunction with clinicians undertaking a fall-prevention clinical audit and key stakeholders from the clinical settings to ensure their relevance and applicability to the acute care setting. Current literature recommends a comprehensive and multifactorial approach to fall prevention. Eight audit criteria were derived from the best available evidence including the domains of physical environment, hospital culture and care processes, use of technology and targeted interventions. Existing research evidence and consultation with stakeholders has allowed the development of applicable, evidence-based audit criteria for fall prevention in acute care settings. This model can promote engagement, impact clinical practice and lead to improved outcomes.

  1. Developing evidence-based dentistry skills: how to interpret randomized clinical trials and systematic reviews.

    PubMed

    Kiriakou, Juliana; Pandis, Nikolaos; Madianos, Phoebus; Polychronopoulou, Argy

    2014-10-30

    Decision-making based on reliable evidence is more likely to lead to effective and efficient treatments. Evidence-based dentistry was developed, similarly to evidence-based medicine, to help clinicians apply current and valid research findings into their own clinical practice. Interpreting and appraising the literature is fundamental and involves the development of evidence-based dentistry (EBD) skills. Systematic reviews (SRs) of randomized controlled trials (RCTs) are considered to be evidence of the highest level in evaluating the effectiveness of interventions. Furthermore, the assessment of the report of a RCT, as well as a SR, can lead to an estimation of how the study was designed and conducted.

  2. An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

    PubMed

    Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

    2014-05-01

    Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

  3. Connecting Education to Quality: Engaging Medical Students in the Development of Evidence-Based Clinical Decision Support Tools.

    PubMed

    Crabtree, Elizabeth A; Brennan, Emily; Davis, Amanda; Squires, Jerry E

    2017-01-01

    Evidence-based practice (EBP) skills are crucial for delivering high-quality patient care. It is essential that medical students learn EBP concepts through a practical, in-depth research project. To date, literature on preparing students in this manner is limited. In academic year 2014-2015, the Medical University of South Carolina's (MUSC's) Center for Evidence-Based Practice (now known as the Value Institute) partnered with College of Medicine faculty to revitalize the undergraduate medical student EBP curriculum. Without adding to the number of the lecture hours, the curriculum was restructured to be more process driven, project based, and clinically relevant. The resulting yearlong EBP course partnered small teams of medical students with interprofessional clinical teams to engage the students in developing evidence-based clinical decision support tools. The content developed during the EBP projects is currently being used to develop evidence-based clinical practice guidelines and accompanying order sets. It is likely that this model will serve as a new framework for guideline development and will greatly expand the breadth of evidence-based content currently produced and available for clinicians at the MUSC. It would be feasible to offer a similar course within the MUSC to other disciplines and colleges, or at other institutions, if there were support from administration, interest on the part of clinicians and medical faculty, and individuals with the required expertise available to develop the curriculum and facilitate the course. It is worth considering how to improve the course and evaluating opportunities to implement it within other settings.

  4. Evidence Based Medicine – New Approaches and Challenges

    PubMed Central

    Masic, Izet; Miokovic, Milan; Muhamedagic, Belma

    2008-01-01

    CONFLICT OF INTEREST: NONE DECLARED Evidence based medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information. It is a movement which aims to increase the use of high quality clinical research in clinical decision making. EBM requires new skills of the clinician, including efficient literature-searching, and the application of formal rules of evidence in evaluating the clinical literature. The practice of evidence-based medicine is a process of lifelong, self-directed, problem-based learning in which caring for one’s own patients creates the need for clinically important information about diagnosis, prognosis, therapy and other clinical and health care issues. It is not “cookbook” with recipes, but its good application brings cost-effective and better health care. The key difference between evidence-based medicine and traditional medicine is not that EBM considers the evidence while the latter does not. Both take evidence into account; however, EBM demands better evidence than has traditionally been used. One of the greatest achievements of evidence-based medicine has been the development of systematic reviews and meta-analyses, methods by which researchers identify multiple studies on a topic, separate the best ones and then critically analyze them to come up with a summary of the best available evidence. The EBM-oriented clinicians of tomorrow have three tasks: a) to use evidence summaries in clinical practice; b) to help develop and update selected systematic reviews or evidence-based guidelines in their area of expertise; and c) to enrol patients in studies of treatment, diagnosis and prognosis on which medical practice is based. PMID:24109156

  5. Developing guidelines in low-income and middle-income countries: lessons from Kenya

    PubMed Central

    English, Mike; Irimu, Grace; Nyamai, Rachel; Were, Fred; Garner, Paul; Opiyo, Newton

    2017-01-01

    There are few examples of sustained nationally organised, evidence-informed clinical guidelines development processes in Sub-Saharan Africa. We describe the evolution of efforts from 2005 to 2015 to support evidence-informed decision making to guide admission hospital care practices in Kenya. The approach to conduct reviews, present evidence, and structure and promote transparency of consensus-based procedures for making recommendations improved over four distinct rounds of policy making. Efforts to engage important voices extended from government and academia initially to include multiple professional associations, regulators and practitioners. More than 100 people have been engaged in the decision-making process; an increasing number outside the research team has contributed to the conduct of systematic reviews, and 31 clinical policy recommendations has been developed. Recommendations were incorporated into clinical guideline booklets that have been widely disseminated with a popular knowledge and skills training course. Both helped translate evidence into practice. We contend that these efforts have helped improve the use of evidence to inform policy. The systematic reviews, Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approaches and evidence to decision-making process are well understood by clinicians, and the process has helped create a broad community engaged in evidence translation together with a social or professional norm to use evidence in paediatric care in Kenya. Specific sustained efforts should be made to support capacity and evidence-based decision making in other African settings and clinical disciplines. PMID:28584069

  6. Development and evaluation of online evidence based guideline bank system.

    PubMed

    Park, Myonghwa

    2006-01-01

    The purpose of this study was to develop and evaluate the online evidence-based nursing practice guideline bank system to support the best evidence-based decision in the clinical and community practice settings. The main homepage consisted of seven modules for introduction of site, EBN, guideline bank, guideline development, guideline review, related sites, and community. The major contents in the guidelines were purpose, developer, intended audience, method of development, target population, testing, knowledge components, and evaluation. Electronic versions of the guidelines were displayed by XML, PDF, and PDA versions. The system usability were evaluated by general users, guideline developers, and guideline reviewers on the web and the results showed high scores of satisfaction. This online evidence-based guideline bank system could support nurses' best and cost-effective clinical decision using the sharable standardized guidelines with education module of evidence based nursing.

  7. French national consensus clinical guidelines for the management of ulcerative colitis.

    PubMed

    Peyrin-Biroulet, Laurent; Bouhnik, Yoram; Roblin, Xavier; Bonnaud, Guillaume; Hagège, Hervé; Hébuterne, Xavier

    2016-07-01

    Ulcerative colitis (UC) is a chronic inflammatory bowel disease of multifactorial etiology that primarily affects the colonic mucosa. The disease progresses over time, and clinical management guidelines should reflect its dynamic nature. There is limited evidence supporting UC management in specific clinical situations, thus precluding an evidence-based approach. To use a formal consensus method - the nominal group technique (NGT) - to develop a clinical practice expert opinion to outline simple algorithms and practices, optimize UC management, and assist clinicians in making treatment decisions. The consensus was developed by an expert panel of 37 gastroenterologists from various professional organizations with experience in UC management using the qualitative and iterative NGT, incorporating deliberations based on the European Crohn's and Colitis Organisation recommendations, recent reviews of scientific literature, and pertinent discussion topics developed by a steering committee. Examples of clinical cases for which there are limited evidence-based data from clinical trials were used. Two working groups proposed and voted on treatment algorithms that were then discussed and voted for by the nominal group as a whole, in order to reach a consensus. A clinical practice guideline covering management of the following clinical situations was developed: (i) moderate and severe UC; (ii) acute severe UC; (iii) pouchitis; (iv) refractory proctitis, in the form of treatment algorithms. Given the limited available evidence-based data, a formal consensus methodology was used to develop simple treatment guidelines for UC management in different clinical situations that is now accessible via an online application. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  8. Evidence development and publication planning: strategic process.

    PubMed

    Wittek, Michael R; Jo Williams, Mary; Carlson, Angeline M

    2009-11-01

    A number of decisions in the health care field rely heavily on published clinical evidence. A systematic approach to evidence development and publication planning is required to develop a portfolio of evidence that includes at minimum information on efficacy, safety, durability of effect, quality of life, and economic outcomes. The approach requires a critical assessment of available literature, identification of gaps in the literature, and a strategic plan to fill the gaps to ensure the availability of evidence demanded for clinical decisions, coverage/payment decisions and health technology assessments. The purpose of this manuscript is to offer a six-step strategic process leading to a portfolio of evidence that meets the informational needs of providers, payers, and governmental agencies concerning patient access to a therapy.

  9. A web-based library consult service for evidence-based medicine: Technical development.

    PubMed

    Schwartz, Alan; Millam, Gregory

    2006-03-16

    Incorporating evidence based medicine (EBM) into clinical practice requires clinicians to learn to efficiently gain access to clinical evidence and effectively appraise its validity. Even using current electronic systems, selecting literature-based data to solve a single patient-related problem can require more time than practicing physicians or residents can spare. Clinical librarians, as informationists, are uniquely suited to assist physicians in this endeavor. To improve support for evidence-based practice, we have developed a web-based EBM library consult service application (LCS). Librarians use the LCS system to provide full text evidence-based literature with critical appraisal in response to a clinical question asked by a remote physician. LCS uses an entirely Free/Open Source Software platform and will be released under a Free Software license. In the first year of the LCS project, the software was successfully developed and a reference implementation put into active use. Two years of evaluation of the clinical, educational, and attitudinal impact on physician-users and librarian staff are underway, and expected to lead to refinement and wide dissemination of the system. A web-based EBM library consult model may provide a useful way for informationists to assist clinicians, and is feasible to implement.

  10. Knowledge Translation Tools are Emerging to Move Neck Pain Research into Practice.

    PubMed

    Macdermid, Joy C; Miller, Jordan; Gross, Anita R

    2013-01-01

    Development or synthesis of the best clinical research is in itself insufficient to change practice. Knowledge translation (KT) is an emerging field focused on moving knowledge into practice, which is a non-linear, dynamic process that involves knowledge synthesis, transfer, adoption, implementation, and sustained use. Successful implementation requires using KT strategies based on theory, evidence, and best practice, including tools and processes that engage knowledge developers and knowledge users. Tools can provide instrumental help in implementing evidence. A variety of theoretical frameworks underlie KT and provide guidance on how tools should be developed or implemented. A taxonomy that outlines different purposes for engaging in KT and target audiences can also be useful in developing or implementing tools. Theoretical frameworks that underlie KT typically take different perspectives on KT with differential focus on the characteristics of the knowledge, knowledge users, context/environment, or the cognitive and social processes that are involved in change. Knowledge users include consumers, clinicians, and policymakers. A variety of KT tools have supporting evidence, including: clinical practice guidelines, patient decision aids, and evidence summaries or toolkits. Exemplars are provided of two KT tools to implement best practice in management of neck pain-a clinician implementation guide (toolkit) and a patient decision aid. KT frameworks, taxonomies, clinical expertise, and evidence must be integrated to develop clinical tools that implement best evidence in the management of neck pain.

  11. A Knowledge-based System for Intelligent Support in Pharmacogenomics Evidence Assessment: Ontology-driven Evidence Representation and Retrieval.

    PubMed

    Lee, Chia-Ju; Devine, Beth; Tarczy-Hornoch, Peter

    2017-01-01

    Pharmacogenomics holds promise as a critical component of precision medicine. Yet, the use of pharmacogenomics in routine clinical care is minimal, partly due to the lack of efficient and effective use of existing evidence. This paper describes the design, development, implementation and evaluation of a knowledge-based system that fulfills three critical features: a) providing clinically relevant evidence, b) applying an evidence-based approach, and c) using semantically computable formalism, to facilitate efficient evidence assessment to support timely decisions on adoption of pharmacogenomics in clinical care. To illustrate functionality, the system was piloted in the context of clopidogrel and warfarin pharmacogenomics. In contrast to existing pharmacogenomics knowledge bases, the developed system is the first to exploit the expressivity and reasoning power of logic-based representation formalism to enable unambiguous expression and automatic retrieval of pharmacogenomics evidence to support systematic review with meta-analysis.

  12. Thinking and practice of accelerating transformation of traditional Chinese medicine from experience medicine to evidence-based medicine.

    PubMed

    Liu, Baoyan; Zhang, Yanhong; Hu, Jingqing; He, Liyun; Zhou, Xuezhong

    2011-06-01

    The gradual development of Chinese medicine is based on constant accumulation and summary of experience in clinical practice, but without the benefit of undergoing the experimental medicine stage. Although Chinese medicine has formed a systematic and unique theory system through thousands of years, with the development of evidence-based medicine, the bondage of the research methods of experience medicine to Chinese medicine is appearing. The rapid transition and transformation from experience medicine to evidence-based medicine have become important content in the development of Chinese medicine. According to the features of Chinese medicine, we propose the research idea of "taking two ways simultaneously," which is the study both in the ideal condition and in the real world. Analyzing and constructing the theoretical basis and methodology of clinical research in the real world, and building the stage for research technique is key to the effective clinical research of Chinese medicine. Only by gradually maturing and completing the clinical research methods of the real world could we realize "taking two ways simultaneously" and complementing each other, continuously produce scientific and reliable evidence of Chinese medicine, as well as transform and develop Chinese medicine from experience medicine to evidence-based medicine.

  13. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy.

    PubMed

    Kreiner, D Scott; Hwang, Steven W; Easa, John E; Resnick, Daniel K; Baisden, Jamie L; Bess, Shay; Cho, Charles H; DePalma, Michael J; Dougherty, Paul; Fernand, Robert; Ghiselli, Gary; Hanna, Amgad S; Lamer, Tim; Lisi, Anthony J; Mazanec, Daniel J; Meagher, Richard J; Nucci, Robert C; Patel, Rakesh D; Sembrano, Jonathan N; Sharma, Anil K; Summers, Jeffrey T; Taleghani, Christopher K; Tontz, William L; Toton, John F

    2014-01-01

    The objective of the North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011. The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder. To provide an evidence-based educational tool to assist spine specialists in the diagnosis and treatment of lumbar disc herniation with radiculopathy. Systematic review and evidence-based clinical guideline. This guideline is a product of the Lumbar Disc Herniation with Radiculopathy Work Group of NASS' Evidence-Based Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. A literature search addressing each question and using a specific search protocol was performed on English-language references found in Medline, Embase (Drugs and Pharmacology), and four additional evidence-based databases to identify articles. The relevant literature was then independently rated using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were developed via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Level I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. Twenty-nine clinical questions were formulated and addressed, and the answers are summarized in this article. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. The clinical guideline has been created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with symptomatic lumbar disc herniation with radiculopathy. The entire guideline document, including the evidentiary tables, suggestions for future research, and all the references, is available electronically on the NASS Web site at http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Comparison of Alternative Evidence Summary and Presentation Formats in Clinical Guideline Development: A Mixed-Method Study

    PubMed Central

    Opiyo, Newton; Shepperd, Sasha; Musila, Nyokabi; Allen, Elizabeth; Nyamai, Rachel; Fretheim, Atle; English, Mike

    2013-01-01

    Background Best formats for summarising and presenting evidence for use in clinical guideline development remain less well defined. We aimed to assess the effectiveness of different evidence summary formats to address this gap. Methods Healthcare professionals attending a one-week Kenyan, national guideline development workshop were randomly allocated to receive evidence packaged in three different formats: systematic reviews (SRs) alone, systematic reviews with summary-of-findings tables, and ‘graded-entry’ formats (a ‘front-end’ summary and a contextually framed narrative report plus the SR). The influence of format on the proportion of correct responses to key clinical questions, the primary outcome, was assessed using a written test. The secondary outcome was a composite endpoint, measured on a 5-point scale, of the clarity of presentation and ease of locating the quality of evidence for critical neonatal outcomes. Interviews conducted within two months following completion of trial data collection explored panel members’ views on the evidence summary formats and experiences with appraisal and use of research information. Results 65 (93%) of 70 participants completed questions on the prespecified outcome measures. There were no differences between groups in the odds of correct responses to key clinical questions. ‘Graded-entry’ formats were associated with a higher mean composite score for clarity and accessibility of information about the quality of evidence for critical neonatal outcomes compared to systematic reviews alone (adjusted mean difference 0.52, 95% CI 0.06 to 0.99). There was no difference in the mean composite score between SR with SoF tables and SR alone. Findings from interviews with 16 panelists indicated that short narrative evidence reports were preferred for the improved clarity of information presentation and ease of use. Conclusions Our findings suggest that ‘graded-entry’ evidence summary formats may improve clarity and accessibility of research evidence in clinical guideline development. Trial Registration Controlled-Trials.com ISRCTN05154264 PMID:23372813

  15. Developing evidence-based physical therapy clinical practice guidelines.

    PubMed

    Kaplan, Sandra L; Coulter, Colleen; Fetters, Linda

    2013-01-01

    Recommended strategies for developing evidence-based clinical practice guidelines (CPGs) are provided. The intent is that future CPGs developed with the support of the Section on Pediatrics of the American Physical Therapy Association would consistently follow similar developmental processes to yield consistent quality and presentation. Steps in the process of developing CPGs are outlined and resources are provided to assist CPG developers in carrying out their task. These recommended processes may also be useful to CPG developers representing organizations with similar structures, objectives, and resources.

  16. Chiropractic quality assurance: standards and guidelines

    PubMed Central

    Gatterman, Meridel I; Dobson, Thomas P; LeFevbre, Ron

    2001-01-01

    Chiropractic quality assurance involves development of both clinical guidelines and standards. Confusion generated by poor differentiation of guidelines from standards contributes to mistrust of the guideline development process. Guidelines are considered to be recommendations that allow for flexibility and individual patient differences. Standards are more binding and require a high level of supporting evidence. While guidelines serve as educational tools to improve the quality of practice, standards that outline minimum competency are used more as administrative tools on which to base policy. Barriers to development of clinical guidelines and standards include fear that they will create prescriptive “cookbook” practice, and the distrust that guidelines are developed primarily for cost containment. Clinicians also criticize guidelines developed by academics that don't relate to practice, and those based on evidence that lacks clinical relevance. Conflicting guidelines perceived to be based on strong bias or conflict of interest are also suspect. To reduce barriers to acceptance and implementation, guidelines should be inclusive, patient-centered, and based on a variety of evidence and clinical experience.

  17. Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

    PubMed

    Parkinson, David R; McCormack, Robert T; Keating, Susan M; Gutman, Steven I; Hamilton, Stanley R; Mansfield, Elizabeth A; Piper, Margaret A; Deverka, Patricia; Frueh, Felix W; Jessup, J Milburn; McShane, Lisa M; Tunis, Sean R; Sigman, Caroline C; Kelloff, Gary J

    2014-03-15

    This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

  18. Nursing journal clubs and the clinical nurse specialist.

    PubMed

    Westlake, Cheryl; Albert, Nancy M; Rice, Karen L; Bautista, Cynthia; Close, Jackie; Foster, Jan; Timmerman, Gayle M

    2015-01-01

    The purpose of this article was to describe the clinical nurse specialist's role in developing and implementing a journal club. Tools for critiquing clinical and research articles with an application of each are provided. The journal club provides a forum through which nurses maintain their knowledge base about clinically relevant topics and developments in their specific clinical discipline, analyze and synthesize the relevant scientific literature as evidence, and engage in informal discussions about evidence-based and best practices. The value of journal clubs includes nursing staff education, review of and support for evidence-based practice, promotion of nursing research, and fostering of organization-wide nursing practice changes. The process for establishing a journal club and suggested appraisal tools are discussed. In addition, strategies for overcoming barriers to the implementation of a journal club are outlined. Suggested article review questions and a reporting format for clinical and research articles are provided with examples from 2 articles. Finally, a glossary of terms commonly used by research scientists and manuscript writers are listed and additional resources provided. The clinical nurse specialist's role in developing and implementing a journal club will be facilitated through the use of this article. Enhanced nursing staff education, evidence-based practice, organization-wide nursing practice changes, and nursing research may be conducted following the implementation of a nursing journal club.

  19. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis.

    PubMed

    Kreiner, D Scott; Baisden, Jamie; Mazanec, Daniel J; Patel, Rakesh D; Bess, Robert S; Burton, Douglas; Chutkan, Norman B; Cohen, Bernard A; Crawford, Charles H; Ghiselli, Gary; Hanna, Amgad S; Hwang, Steven W; Kilincer, Cumhur; Myers, Mark E; Park, Paul; Rosolowski, Karie A; Sharma, Anil K; Taleghani, Christopher K; Trammell, Terry R; Vo, Andrew N; Williams, Keith D

    2016-12-01

    The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adult Isthmic Spondylolisthesis features evidence-based recommendations for diagnosing and treating adult patients with isthmic spondylolisthesis. The guideline is intended to reflect contemporary treatment concepts for symptomatic isthmic spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2013. NASS' guideline on this topic is the only guideline on adult isthmic spondylolisthesis accepted in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse. The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with isthmic spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. This is a guideline summary review. This guideline is the product of the Adult Isthmic Spondylolisthesis Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questionsto address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Adult Isthmic Spondylolisthesis guideline was accepted into the National Guideline Clearinghouse and will be updated approximately every 5 years. Thirty-one clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with isthmic spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Evidence flowers: An innovative, visual method of presenting "best evidence" summaries to health professional and lay audiences.

    PubMed

    Babatunde, O O; Tan, V; Jordan, J L; Dziedzic, K; Chew-Graham, C A; Jinks, C; Protheroe, J; van der Windt, D A

    2018-06-01

    Barriers to dissemination and engagement with evidence pose a threat to implementing evidence-based medicine. Understanding, retention, and recall can be enhanced by visual presentation of information. The aim of this exploratory research was to develop and evaluate the accessibility and acceptability of visual summaries for presenting evidence syntheses with multiple exposures or outcomes to professional and lay audiences. "Evidence flowers" were developed as a visual method of presenting data from 4 case scenarios: 2 complex evidence syntheses with multiple outcomes, Cochrane reviews, and clinical guidelines. Petals of evidence flowers were coloured according to the GRADE evidence rating system to display key findings and recommendations from the evidence summaries. Application of evidence flowers was observed during stakeholder workshops. Evaluation and feedback were conducted via questionnaires and informal interviews. Feedback from stakeholders on the evidence flowers collected from workshops, questionnaires, and interviews was encouraging and helpful for refining the design of the flowers. Comments were made on the content and design of the flowers, as well as the usability and potential for displaying different types of evidence. Evidence flowers are a novel and visually stimulating method for presenting research evidence from evidence syntheses with multiple exposures or outcomes, Cochrane reviews, and clinical guidelines. To promote access and engagement with research evidence, evidence flowers may be used in conjunction with other evidence synthesis products, such as (lay) summaries, evidence inventories, rapid reviews, and clinical guidelines. Additional research on potential adaptations and applications of the evidence flowers may further bridge the gap between research evidence and clinical practice. Copyright © 2018 John Wiley & Sons, Ltd.

  1. The Problem: Relevance, Quality, and Homogeneity of Trial Designs, Outcomes, and Reporting.

    PubMed

    Göstemeyer, Gerd; Levey, Colin

    2018-01-01

    Clinical trials are the cornerstone of evidence-based medicine. By directly comparing different interventions they produce evidence on their relative efficacy and effectiveness This, in turn, can inform secondary research and guideline development to facilitate evidence-based clinical decision making. However, the quality of evidence stemming from clinical trials is frequently poor. Here, the pathway of evidence from basic research to the generation of implementable clinical guidelines will be described. Relevant factors related to trial design and reporting, such as the choice of trial comparators, outcomes and outcome measures, will be described and their influence on evidence synthesis will be discussed. Finally, recommendations on how to improve trials in order to increase their usefulness for evidence generation will be given. © 2018 S. Karger AG, Basel.

  2. 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.

  3. A web-based library consult service for evidence-based medicine: Technical development

    PubMed Central

    Schwartz, Alan; Millam, Gregory

    2006-01-01

    Background Incorporating evidence based medicine (EBM) into clinical practice requires clinicians to learn to efficiently gain access to clinical evidence and effectively appraise its validity. Even using current electronic systems, selecting literature-based data to solve a single patient-related problem can require more time than practicing physicians or residents can spare. Clinical librarians, as informationists, are uniquely suited to assist physicians in this endeavor. Results To improve support for evidence-based practice, we have developed a web-based EBM library consult service application (LCS). Librarians use the LCS system to provide full text evidence-based literature with critical appraisal in response to a clinical question asked by a remote physician. LCS uses an entirely Free/Open Source Software platform and will be released under a Free Software license. In the first year of the LCS project, the software was successfully developed and a reference implementation put into active use. Two years of evaluation of the clinical, educational, and attitudinal impact on physician-users and librarian staff are underway, and expected to lead to refinement and wide dissemination of the system. Conclusion A web-based EBM library consult model may provide a useful way for informationists to assist clinicians, and is feasible to implement. PMID:16542453

  4. The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

    PubMed

    Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

    2008-11-01

    This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

  5. Music therapy with disorders of consciousness: current evidence and emergent evidence-based practice.

    PubMed

    Magee, Wendy L; O'Kelly, Julian

    2015-03-01

    Patients with prolonged disorders of consciousness (PDOC) stemming from acquired brain injury present one of the most challenging clinical populations in neurological rehabilitation. Because of the complex clinical presentation of PDOC patients, treatment teams are confronted with many medicolegal, ethical, philosophical, moral, and religious issues in day-to-day care. Accurate diagnosis is of central concern, relying on creative approaches from skilled clinical professionals using combined behavioral and neurophysiological measures. This paper presents the latest evidence for using music as a diagnostic tool with PDOC, including recent developments in music therapy interventions and measurement. We outline standardized clinical protocols and behavioral measures to produce diagnostic outcomes and examine recent research illustrating a range of benefits of music-based methods at behavioral, cardiorespiratory, and cortical levels using video, electrocardiography, and electroencephalography methods. These latest developments are discussed in the context of evidence-based practice in rehabilitation with clinical populations. © 2014 New York Academy of Sciences.

  6. StaR Child Health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials.

    PubMed

    Hartling, L; Wittmeier, K D M; Caldwell, P H; van der Lee, J H; Klassen, T P; Craig, J C; Offringa, M

    2011-11-01

    Standards for Research in (StaR) Child Health was founded in 2009 to address the paucity and shortcomings of pediatric clinical trials. This initiative involves international experts who are dedicated to developing practical, evidence-based standards to enhance the reliability and relevance of pediatric clinical research. Through a systematic "knowledge to action" plan, StaR Child Health will make efforts to improve and expand the evidence base for child health across the world.

  7. “Evidence-Based Dentistry in Oral Surgery: Could We Do Better?”

    PubMed Central

    Nocini, Pier Francesco; Verlato, Giuseppe; Frustaci, Andrea; de Gemmis, Antonio; Rigoni, Giovanni; De Santis, Daniele

    2010-01-01

    Evidence-based Dentistry (EBD), like Evidence-based Medicine (EBM), was born in order to seek the “best available research evidence” in the field of dentistry both in research and clinical routine. But evidence is not clearly measurable in all fields of healthcare: in particular, while drug effect is rather independent from clinician’s characteristics, the effectiveness of surgical procedures is strictly related to surgeon’s expertise, which is difficult to quantify. The research problems of dentistry have a lot in common with other surgical fields, where at the moment the best therapeutic recommendations and guidelines originates from an integration of evidence-based medicine and data from consensus conferences. To cope with these problems, new instruments have been developed, aimed at standardizing clinical procedures (CAD-CAM technology) and at integrating EBM achievements with the opinions of expert clinicians (GRADE System). One thing we have to remember however: it is necessary to use the instruments developed by evidence-based medicine but is impossible to produce sound knowledge without considering clinical expertise and quality of surgical procedures simultaneously. Only in this way we will obtain an evidence-based dentistry both in dental research and clinical practice, which is up to third millennium standards. PMID:20871758

  8. Challenges and opportunities for pediatric severe TBI-review of the evidence and exploring a way forward.

    PubMed

    Bell, Michael J; Adelson, P David; Wisniewski, Stephen R

    2017-10-01

    Traumatic brain injury (TBI) is a leading killer of children in the developed and developing world. Despite evidence-based guidelines and several recent clinical trials, the progress in developing best practices for children with severe TBI has been slow. This article describes (i) the burden of the disease, (ii) the inadequacies of the evidence-based guidelines, (iii) the failure of the largest clinical trials to prove their primary hypotheses, and (iv) possible advances from an observational cohort study called the Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial that has recently completed enrollment.

  9. RAPADAPTE for rapid guideline development: high-quality clinical guidelines can be rapidly developed with limited resources.

    PubMed

    Alper, Brian S; Tristan, Mario; Ramirez-Morera, Anggie; Vreugdenhil, Maria M T; Van Zuuren, Esther J; Fedorowicz, Zbys

    2016-06-01

    Guideline development is challenging, expensive and labor-intensive. A high-quality guideline with 90 recommendations for breast cancer treatment was developed within 6 months with limited resources in Costa Rica. We describe the experience and propose a process others can use and adapt.The ADAPTE method (using existing guidelines to minimize repeating work that has been done) was used but existing guidelines were not current. The method was extended to use databases that systematically identify, appraise and synthesize evidence for clinical application (DynaMed, EBM Guidelines) to provide current evidence searches and critical appraisal of evidence. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. Draft recommendations with supporting evidence were provided to panel members for facilitated voting to target panel discussion to areas necessary for reaching consensus.Training panelists in guideline development methodology facilitated rapid consensus development. Extending 'guideline adaptation' to 'evidence database adaptation' was highly effective and efficient. Methods were created to simplify mapping DynaMed evidence ratings to GRADE ratings. Twelve steps are presented to facilitate rapid guideline development and enable further adaptation by others.This is a case report and the RAPADAPTE method was retrospectively derived. Prospective replication and validation will support advances for the guideline development community. If guideline development can be accelerated without compromising validity and relevance of the resulting recommendations this would greatly improve our ability to impact clinical care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  10. The impact of clinical nurse specialists on clinical pathways in the application of evidence-based practice.

    PubMed

    Gurzick, Martha; Kesten, Karen S

    2010-01-01

    The purpose of this article was to address the call for evidence-based practice through the development of clinical pathways and to assert the role of the clinical nurse specialist (CNS) as a champion in clinical pathway implementation. In the current health care system, providing quality of care while maintaining cost-effectiveness is an ever-growing battle that institutions face. The CNS's role is central to meeting these demands. An extensive literature review has been conducted to validate the use of clinical pathways as a means of improving patient outcomes. This literature also suggests that clinical pathways must be developed, implemented, and evaluated utilizing validated methods including the use of best practice standards. Execution of clinical pathways should include a clinical expert, who has the ability to look at the system as a whole and can facilitate learning and change by employing a multitude of competencies while maintaining a sphere of influence over patient and families, nurses, and the system. The CNS plays a pivotal role in influencing effective clinical pathway development, implementation, utilization, and ongoing evaluation to ensure improved patient outcomes and reduced costs. This article expands upon the call for evidence-based practice through the utilization of clinical pathways to improve patient outcomes and reduce costs and stresses the importance of the CNS as a primary figure for ensuring proper pathway development, implementation, and ongoing evaluation. Copyright 2010 Elsevier Inc. All rights reserved.

  11. National data elements for the clinical management of acute coronary syndromes.

    PubMed

    Chew, Derek P B; Allan, Roger M; Aroney, Constantine N; Sheerin, Noella J

    2005-05-02

    Patients with acute coronary syndromes represent a clinically diverse group and their care remains heterogeneous. These patients account for a significant burden of morbidity and mortality in Australia. Optimal patient outcomes depend on rapid diagnosis, accurate risk stratification and the effective implementation of proven therapies, as advocated by clinical guidelines. The challenge is in effectively applying evidence in clinical practice. Objectivity and standardised quantification of clinical practice are essential in understanding the evidence-practice gap. Observational registries are key to understanding the link between evidence-based medicine, clinical practice and patient outcome. Data elements for monitoring clinical management of patients with acute coronary syndromes have been adapted from internationally accepted definitions and incorporated into the National Health Data Dictionary, the national standard for health data definitions in Australia. Widespread use of these data elements will assist in the local development of "quality-of-care" initiatives and performance indicators, facilitate collaboration in cardiovascular outcomes research, and aid in the development of electronic data collection methods.

  12. Developmental procedures for the clinical practice guidelines for conscious sedation in dentistry for the Korean Academy of Dental Sciences.

    PubMed

    An, So-Youn; Seo, Kwang-Suk; Kim, Seungoh; Kim, Jongbin; Lee, Deok-Won; Hwang, Kyung-Gyun; Kim, Hyun Jeong

    2016-12-01

    Evidence-based clinical practice guidelines (CPGs) are defined as "statements that are scientifically reviewed about evidence and systematically developed to assist in the doctors' and patients' decision making in certain clinical situations." This recommendation aims to promote good clinical practice for the provision of safe and effective practices of conscious sedation in dentistry. The development of this clinical practice guideline was conducted by performing a systematic search of the literature for evidence-based CPGs. Existing guidelines, relevant systematic reviews, policy documents, legislation, or other recommendations were reviewed and appraised. To supplement this information, key questions were formulated by the Guideline Development Group and used as the basis for designing systematic literature search strategies to identify literature that may address these questions. Guideline documents were evaluated through a review of domestic and international databases for the development of a renewing of existing conscious sedation guidelines for dentistry. Clinical practice guidelines were critically appraised for their methodologies using Appraisal of guidelines for research and evaluation (AGREE) II. A total of 12 existing CPGs were included and 13 recommendations were made in a range of general, adult, and pediatric areas. The clinical practice guidelines for conscious sedation will be reviewed in 5 years' time for further updates to reflect significant changes in the field.

  13. Description of a Standardized Treatment Center that Utilizes Evidence-Based Clinic Operations to Facilitate Implementation of an Evidence-Based Treatment

    ERIC Educational Resources Information Center

    Donohue, Brad; Allen, Daniel N.; Romero, Valerie; Hill, Heather H.; Vasaeli, Kathryn; Lapota, Holly; Tracy, Kendra; Gorney, Suzanne; Abdel-al, Ruweida; Caldas, Diana; Herdzik, Karen; Bradshaw, Kelsey; Valdez, Robby; Van Hasselt, Vincent B.

    2009-01-01

    Developers of evidence-based therapies are enhancing methods of teaching therapists to implement "best practices" with integrity. However, there is a relative dearth of information available as to clinic operations and related contextual factors necessary to sustain successful implementation of these treatments. This article describes various…

  14. Role of Clinical Education Experiences on Athletic Training Students' Development of Professional Commitment

    ERIC Educational Resources Information Center

    Mazerolle, Stephanie M.; Dodge, Thomas

    2015-01-01

    Context: Limited evidence exists on the role clinical education can play in the development of athletic training student commitment for the profession. Objective: Investigating the role clinical education experiences play on the development of passion for athletic training. Design: Exploratory qualitative study. Setting: Athletic training…

  15. Co-occurring medical conditions in adults with Down syndrome: A systematic review toward the development of health care guidelines.

    PubMed

    Capone, George T; Chicoine, Brian; Bulova, Peter; Stephens, Mary; Hart, Sarah; Crissman, Blythe; Videlefsky, Andrea; Myers, Katherine; Roizen, Nancy; Esbensen, Anna; Peterson, Moya; Santoro, Stephanie; Woodward, Jason; Martin, Barry; Smith, David

    2018-01-01

    Adults with Down syndrome (DS) represent a unique population who are in need of clinical guidelines to address their medical care. The United States Preventive Service Task Force (USPSTF) has developed criteria for prioritizing conditions of public health importance with the potential for providing screening recommendations to improve clinical care. The quality of existing evidence needed to inform clinical guidelines has not been previously reviewed. Using the National Library of Medicine (NLM) database PubMed, we first identified 18 peer reviewed articles that addressed co-occurring medical conditions in adults with DS. Those conditions discussed in over half of the articles were prioritized for further review. Second, we performed detailed literature searches on these specific conditions. To inform the search strategy and review process a series of key questions were formulated a priori. The quality of available evidence was then graded and knowledge gaps were identified. The number of participating adults and the design of clinical studies varied by condition and were often inadequate for answering all of our key questions. We provide data on thyroid disease, cervical spine disease, hearing impairment, overweight-obesity, sleep apnea, congenital heart disease, and osteopenia-osteoporosis. Minimal evidence demonstrates massive gaps in our clinical knowledge that compromises clinical decision-making and management of these medically complex individuals. The development of evidence-based clinical guidance will require an expanded clinical knowledge-base in order to move forward. © 2017 Wiley Periodicals, Inc.

  16. Clinical practice guideline for Sjögren's syndrome 2017.

    PubMed

    Sumida, Takayuki; Azuma, Naoto; Moriyama, Masafumi; Takahashi, Hiroyuki; Asashima, Hiromitsu; Honda, Fumika; Abe, Saori; Ono, Yuko; Hirota, Tomoya; Hirata, Shintaro; Tanaka, Yoshiya; Shimizu, Toshimasa; Nakamura, Hideki; Kawakami, Atsushi; Sano, Hajime; Ogawa, Yoko; Tsubota, Kazuo; Ryo, Koufuchi; Saito, Ichiro; Tanaka, Akihiko; Nakamura, Seiji; Takamura, Etsuko; Tanaka, Masao; Suzuki, Katsuya; Takeuchi, Tsutomu; Yamakawa, Noriyuki; Mimori, Tsuneyo; Ohta, Akiko; Nishiyama, Susumu; Yoshihara, Toshio; Suzuki, Yasunori; Kawano, Mitsuhiro; Tomiita, Minako; Tsuboi, Hiroto

    2018-05-01

    The objective of this study is to develop clinical practice guideline (CPG) for Sjögren's syndrome (SS) based on recently available clinical and therapeutic evidences. The CPG committee for SS was organized by the Research Team for Autoimmune Diseases, Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW), Japan. The committee completed a systematic review of evidences for several clinical questions and developed CPG for SS 2017 according to the procedure proposed by the Medical Information Network Distribution Service (Minds). The recommendations and their strength were checked by the modified Delphi method. The CPG for SS 2017 has been officially approved by both Japan College of Rheumatology and the Japanese Society for SS. The CPG committee set 38 clinical questions for clinical symptoms, signs, treatment, and management of SS in pediatric, adult and pregnant patients, using the PICO (P: patients, problem, population, I: interventions, C: comparisons, controls, comparators, O: outcomes) format. A summary of evidence, development of recommendation, recommendation, and strength for these 38 clinical questions are presented in the CPG. The CPG for SS 2017 should contribute to improvement and standardization of diagnosis and treatment of SS.

  17. Use of Decision Models in the Development of Evidence-Based Clinical Preventive Services Recommendations: Methods of the U.S. Preventive Services Task Force.

    PubMed

    Owens, Douglas K; Whitlock, Evelyn P; Henderson, Jillian; Pignone, Michael P; Krist, Alex H; Bibbins-Domingo, Kirsten; Curry, Susan J; Davidson, Karina W; Ebell, Mark; Gillman, Matthew W; Grossman, David C; Kemper, Alex R; Kurth, Ann E; Maciosek, Michael; Siu, Albert L; LeFevre, Michael L

    2016-10-04

    The U.S. Preventive Services Task Force (USPSTF) develops evidence-based recommendations about preventive care based on comprehensive systematic reviews of the best available evidence. Decision models provide a complementary, quantitative approach to support the USPSTF as it deliberates about the evidence and develops recommendations for clinical and policy use. This article describes the rationale for using modeling, an approach to selecting topics for modeling, and how modeling may inform recommendations about clinical preventive services. Decision modeling is useful when clinical questions remain about how to target an empirically established clinical preventive service at the individual or program level or when complex determinations of magnitude of net benefit, overall or among important subpopulations, are required. Before deciding whether to use decision modeling, the USPSTF assesses whether the benefits and harms of the preventive service have been established empirically, assesses whether there are key issues about applicability or implementation that modeling could address, and then defines the decision problem and key questions to address through modeling. Decision analyses conducted for the USPSTF are expected to follow best practices for modeling. For chosen topics, the USPSTF assesses the strengths and limitations of the systematically reviewed evidence and the modeling analyses and integrates the results of each to make preventive service recommendations.

  18. Integration of Evidence into a Detailed Clinical Model-based Electronic Nursing Record System

    PubMed Central

    Park, Hyeoun-Ae; Jeon, Eunjoo; Chung, Eunja

    2012-01-01

    Objectives The purpose of this study was to test the feasibility of an electronic nursing record system for perinatal care that is based on detailed clinical models and clinical practice guidelines in perinatal care. Methods This study was carried out in five phases: 1) generating nursing statements using detailed clinical models; 2) identifying the relevant evidence; 3) linking nursing statements with the evidence; 4) developing a prototype electronic nursing record system based on detailed clinical models and clinical practice guidelines; and 5) evaluating the prototype system. Results We first generated 799 nursing statements describing nursing assessments, diagnoses, interventions, and outcomes using entities, attributes, and value sets of detailed clinical models for perinatal care which we developed in a previous study. We then extracted 506 recommendations from nine clinical practice guidelines and created sets of nursing statements to be used for nursing documentation by grouping nursing statements according to these recommendations. Finally, we developed and evaluated a prototype electronic nursing record system that can provide nurses with recommendations for nursing practice and sets of nursing statements based on the recommendations for guiding nursing documentation. Conclusions The prototype system was found to be sufficiently complete, relevant, useful, and applicable in terms of content, and easy to use and useful in terms of system user interface. This study has revealed the feasibility of developing such an ENR system. PMID:22844649

  19. Evidence - based medicine/practice in sports physical therapy.

    PubMed

    Manske, Robert C; Lehecka, B J

    2012-10-01

    A push for the use of evidence-based medicine and evidence-based practice patterns has permeated most health care disciplines. The use of evidence-based practice in sports physical therapy may improve health care quality, reduce medical errors, help balance known benefits and risks, challenge views based on beliefs rather than evidence, and help to integrate patient preferences into decision-making. In this era of health care utilization sports physical therapists are expected to integrate clinical experience with conscientious, explicit, and judicious use of research evidence in order to make clearly informed decisions in order to help maximize and optimize patient well-being. One of the more common reasons for not using evidence in clinical practice is the perceived lack of skills and knowledge when searching for or appraising research. This clinical commentary was developed to educate the readership on what constitutes evidence-based practice, and strategies used to seek evidence in the daily clinical practice of sports physical therapy.

  20. Clinical Practice Guidelines for Delirium Management: Potential Application in Palliative Care

    PubMed Central

    Bush, Shirley H.; Bruera, Eduardo; Lawlor, Peter G.; Kanji, Salmaan; Davis, Daniel H.J.; Agar, Meera; Wright, David; Hartwick, Michael; Currow, David C.; Gagnon, Bruno; Simon, Jessica; Pereira, José L.

    2014-01-01

    Context Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. Objectives This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. Methods We searched PubMed (1990–2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. Results There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from “expert opinion” for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Conclusion Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. PMID:24766743

  1. Folate and carcinogenesis-mechanisms

    USDA-ARS?s Scientific Manuscript database

    A large and growing body of both pre-clinical and clinical studies pertaining to colorectal neoplasms constitutes the most compelling evidence for the protective effect of folate against the development of cancer, although evidence is also accruing in this regard for cancers of the breast, lung, pan...

  2. [Is evidence-based assessment fact or fiction? A bibliometric analysis of three German journals].

    PubMed

    Petermann, Franz; Schüssler, Gerhard; Glaesmer, Heide

    2008-01-01

    Despite the ongoing process for the development and dissemination of empirically supported treatments, little attention has been paid to the development of evidence-based diagnostics. The article aims at evaluating diagnostic procedures and instruments in current clinical research in terms of evidence-based assessment. Volumes 2006 and 2007 of three German psychological journals "Psychotherapeut," "Psychotherapie, Psychosomatik und Medizinische Psychologie," and "Zeitschrift für Psychiatrie, Psychologie und Psychotherapie" were screened for empirical reports and articles dealing with diagnostic issues. 93 articles were identified and evaluated. Most studies used psychometrically valid and established instruments for assessment. However, diagnostic interviews were relatively scarce, as were multimodal assessments. Measures used for outcome evaluation often lacked evidence of sensitivity to change. Clinical assessment to date does not meet criteria for evidence-based diagnostics. Implications for research and guideline development are discussed.

  3. 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.

  4. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

    PubMed

    Garber, Jeffrey R; Cobin, Rhoda H; Gharib, Hossein; Hennessey, James V; Klein, Irwin; Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Singer, Peter A; Woeber, Kenneth A

    2012-12-01

    Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.

  5. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

    PubMed

    Garber, Jeffrey R; Cobin, Rhoda H; Gharib, Hossein; Hennessey, James V; Klein, Irwin; Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Singer, Peter A; Woeber, Kenneth A

    2012-01-01

    Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.

  6. Clinical Teachers' Attitudes toward the Efficacy of Evidence-Based Medicine Workshop and Self-Reported Ability in Evidence-Based Practice in Iran

    ERIC Educational Resources Information Center

    Kouhpayehzadeh, Jalil; Baradaran, Hamid; Arabshahi, Kamran Soltani; Knill-Jones, Robin

    2006-01-01

    Introduction: Evidence-based medicine (EBM) has been introduced in medical schools worldwide, but there is little known about effective methods for teaching EBM skills, particularly in developing countries. This study assesses the impact of an EBM workshop on clinical teachers' attitudes and use of EBM skills. Methods: Seventy-two clinical…

  7. Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

    PubMed

    Matz, Paul G; Meagher, R J; Lamer, Tim; Tontz, William L; Annaswamy, Thiru M; Cassidy, R Carter; Cho, Charles H; Dougherty, Paul; Easa, John E; Enix, Dennis E; Gunnoe, Bryan A; Jallo, Jack; Julien, Terrence D; Maserati, Matthew B; Nucci, Robert C; O'Toole, John E; Rosolowski, Karie; Sembrano, Jonathan N; Villavicencio, Alan T; Witt, Jens-Peter

    2016-03-01

    The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis features evidence-based recommendations for diagnosing and treating degenerative lumbar spondylolisthesis. The guideline updates the 2008 guideline on this topic and is intended to reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of May 2013. The NASS guideline on this topic is the only guideline on degenerative lumbar spondylolisthesis included in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC). The purpose of this guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for patients with degenerative lumbar spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. A systematic review of clinical studies relevant to degenerative spondylolisthesis was carried out. This NASS spondyolisthesis guideline is the product of the Degenerative Lumbar Spondylolisthesis Work Group of NASS' Evidence-Based Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members used the NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Degenerative Lumbar Spondylolisthesis guideline was accepted into the NGC and will be updated approximately every 5 years. Twenty-seven clinical questions were addressed in this guideline update, including 15 clinical questions from the original guideline and 12 new clinical questions. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Twenty-one new or updated recommendations or consensus statements were issued and 13 recommendations or consensus statements were maintained from the original guideline. The clinical guideline was created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with degenerative lumbar spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flow chart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. The PRIME project: developing a patient evidence‐base

    PubMed Central

    Staniszewska, Sophie; Crowe, Sally; Badenoch, Douglas; Edwards, Carol; Savage, Jan; Norman, Will

    2010-01-01

    Abstract Background  The concept of evidence has become firmly rooted in health care, with most importance placed on the outcome of research in clinical and economic spheres. Much less emphasis is placed on the patient’s contribution to evidence which remains relatively vague, of low status and often difficult to integrate with other forms of knowledge. Aim  This article proposes a concept of patient‐based evidence, to complement clinical and economic forms of evidence, and demonstrates one way in which it has been operationalized. The PRIME project developed a patient evidence‐base to capture the lived experience of individuals with myalgic encephalitis (ME) or chronic fatigue syndrome (CFS). Design  Interviews were performed with 40 individuals with ME/CFS who varied in a range of demographic characteristics, including age, gender, and how severely affected individuals were. Results  PRIME has developed a patient evidence‐base which has an extensive array of experiences data to provide researchers, clinicians and others with an in‐depth insight into the lived experience of ME/CFS that can be used and analysed. Data are grouped into a wide range of themes, which can be downloaded and used in a variety of ways as a source of evidence to enable understanding of the lived experience of ME/CFS and so contribute to the development of a more patient‐focused research agenda in ME/CFS. Conclusions  While patient‐based evidence used in the PRIME Project provides a useful start, further work is required to develop this area conceptually and methodologically, particularly in relation to how patient‐based evidence can be considered alongside clinical and economic evidence. PMID:20579119

  9. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

    PubMed Central

    Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

    2012-01-01

    Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

  10. [Which research is needed to support clinical decision-making on integrative medicine? Can comparative effectiveness research close the gap?].

    PubMed

    Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Berman, Brian M

    2013-08-01

    In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

  11. Guidelines for Guidelines: Are They Up to the Task? A Comparative Assessment of Clinical Practice Guideline Development Handbooks

    PubMed Central

    Ansari, Shabnam; Rashidian, Arash

    2012-01-01

    Objectives We conducted a comparative review of clinical practice guideline development handbooks. We aimed to identify the main guideline development tasks, assign weights to the importance of each task using expert opinions and identify the handbooks that provided a comprehensive coverage of the tasks. Methods We systematically searched and included handbooks published (in English language) by national, international or professional bodies responsible for evidenced-based guideline development. We reviewed the handbooks to identify the main guideline development tasks and scored each handbook for each task from 0 (the handbook did not mention the task) to 2 (the task suitably addressed and explained), and calculated a weighted score for each handbook. The tasks included in over 75% of the handbooks were considered as ‘necessary’ tasks. Result Nineteen guideline development handbooks and twenty seven main tasks were identified. The guideline handbooks’ weighted scores ranged from 100 to 220. Four handbooks scored over 80% of the maximum possible score, developed by the National Institute for Health and Clinical Excellence, Swiss Centre for International Health, Scottish Intercollegiate Guidelines Network and World Health Organization. Necessary tasks were: selecting the guideline topic, determining the guideline scope, identifying relevant existing guidelines, involving the consumers, forming guideline development group,, developing clinical questions, systematic search for evidence, selecting relevant evidence, appraising identifies research evidence, making group decision, grading available evidence, creating recommendations, final stakeholder consultation, guideline implementation strategies, updating recommendations and correcting potential errors. Discussion Adequate details for evidence based development of guidelines were still lacking from many handbooks. The tasks relevant to ethical issues and piloting were missing in most handbooks. The findings help decision makers in identifying the necessary tasks for guideline development, provide an updated comparative list of guideline development handbooks, and provide a checklist to assess the comprehensiveness of guideline development processes. PMID:23189167

  12. Acromegaly: an endocrine society clinical practice guideline.

    PubMed

    Katznelson, Laurence; Laws, Edward R; Melmed, Shlomo; Molitch, Mark E; Murad, Mohammad Hassan; Utz, Andrea; Wass, John A H

    2014-11-01

    The aim was to formulate clinical practice guidelines for acromegaly. The Task Force included a chair selected by the Endocrine Society Clinical Guidelines Subcommittee (CGS), five experts in the field, and a methodologist. The authors received no corporate funding or remuneration. This guideline is cosponsored by the European Society of Endocrinology. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The Task Force reviewed primary evidence and commissioned two additional systematic reviews. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society and the European Society of Endocrinology reviewed drafts of the guidelines. Using an evidence-based approach, this acromegaly guideline addresses important clinical issues regarding the evaluation and management of acromegaly, including the appropriate biochemical assessment, a therapeutic algorithm, including use of medical monotherapy or combination therapy, and management during pregnancy.

  13. An Official American Thoracic Society Clinical Practice Guideline: Pediatric Chronic Home Invasive Ventilation

    PubMed Central

    Collaco, Joseph M.; Baker, Christopher D.; Carroll, John L.; Sharma, Girish D.; Brozek, Jan L.; Finder, Jonathan D.; Ackerman, Veda L.; Arens, Raanan; Boroughs, Deborah S.; Carter, Jodi; Daigle, Karen L.; Dougherty, Joan; Gozal, David; Kevill, Katharine; Kravitz, Richard M.; Kriseman, Tony; MacLusky, Ian; Rivera-Spoljaric, Katherine; Tori, Alvaro J.; Ferkol, Thomas; Halbower, Ann C.

    2016-01-01

    Background: Children with chronic invasive ventilator dependence living at home are a diverse group of children with special health care needs. Medical oversight, equipment management, and community resources vary widely. There are no clinical practice guidelines available to health care professionals for the safe hospital discharge and home management of these complex children. Purpose: To develop evidence-based clinical practice guidelines for the hospital discharge and home/community management of children requiring chronic invasive ventilation. Methods: The Pediatric Assembly of the American Thoracic Society assembled an interdisciplinary workgroup with expertise in the care of children requiring chronic invasive ventilation. The experts developed four questions of clinical importance and used an evidence-based strategy to identify relevant medical evidence. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to formulate and grade recommendations. Results: Clinical practice recommendations for the management of children with chronic ventilator dependence at home are provided, and the evidence supporting each recommendation is discussed. Conclusions: Collaborative generalist and subspecialist comanagement is the Medical Home model most likely to be successful for the care of children requiring chronic invasive ventilation. Standardized hospital discharge criteria are suggested. An awake, trained caregiver should be present at all times, and at least two family caregivers should be trained specifically for the child’s care. Standardized equipment for monitoring, emergency preparedness, and airway clearance are outlined. The recommendations presented are based on the current evidence and expert opinion and will require an update as new evidence and/or technologies become available. PMID:27082538

  14. An evidence-based guide to clinical instruction in audiology.

    PubMed

    Mormer, Elaine; Palmer, Catherine; Messick, Cheryl; Jorgensen, Lindsey

    2013-05-01

    A significant portion of the AuD curriculum occurs in clinical settings outside the classroom. Expert clinicians, employed within and outside of the university, are called upon to provide this clinical education. Most have had little or no formal training in clinical teaching yet face pedagogical and logistical challenges when simultaneously providing clinical service and teaching. Training to provide optimal methods and approaches to clinical instruction should be based on research evidence; however, there is a paucity of research in this area within the audiology discipline. This article provides a review of literature supplying evidence for important concepts, elements, and approaches to the clinical instruction process. Additionally, we provide readers with some practical tools with which to facilitate application of optimal clinical teaching principles. We conducted a systematic review of literature on clinical education in audiology and across a wide array of health professions. Through the use of content analysis we identified four elements of the clinical teaching process most critical in examining optimal practices. The elements identified as critical to positive clinical learning outcomes include the establishment of mutual expectations and goals; structured content and delivery of feedback; establishment of a positive instructor/student relationship; and questioning strategies that lead to the development of critical thinking skills. Many disciplines outside of audiology demonstrate robust research activity related to understanding and optimizing the clinical education process. The application of a number of evidence-based clinical teaching principles should allow us to improve student outcomes in audiology. Researchers in our field might consider if and how we should develop our own research literature in clinical education. American Academy of Audiology.

  15. Traditional chinese medicine: an update on clinical evidence.

    PubMed

    Xue, Charlie C L; Zhang, Anthony L; Greenwood, Kenneth M; Lin, Vivian; Story, David F

    2010-03-01

    As an alternative medical system, Traditional Chinese Medicine (TCM) has been increasingly used over the last several decades. Such a consumer-driven development has resulted in introduction of education programs for practitioner training, development of product and practitioner regulation systems, and generation of an increasing interest in research. Significant efforts have been made in validating the quality, effectiveness, and safety of TCM interventions evidenced by a growing number of published trials and systematic reviews. Commonly, the results of these studies were inconclusive due to the lack of quality and quantity of the trials to answer specific and answerable clinical questions. The methodology of a randomized clinical trial (RCT) is not free from bias, and the unique features of TCM (such as individualization and holism) further complicate effective execution of RCTs in TCM therapies. Thus, data from limited RCTs and systematic reviews need to be interpreted with great caution. Nevertheless, until new and specific methodology is developed that can adequately address these methodology challenges for RCTs in TCM, evidence from quality RCTs and systematic reviews still holds the credibility of TCM in the scientific community. This article summarizes studies on TCM utilization, and regulatory and educational development with a focus on updating the TCM clinical evidence from RCTs and systematic reviews over the last decade. The key issues and challenges associated with evidence-based TCM developments are also explored.

  16. Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

    PubMed Central

    Kimmelman, Jonathan; Henderson, Valerie C.

    2015-01-01

    Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

  17. Changing Provider Behavior in the Context of Chronic Disease Management: Focus on Clinical Inertia.

    PubMed

    Lavoie, Kim L; Rash, Joshua A; Campbell, Tavis S

    2017-01-06

    Widespread acceptance of evidence-based medicine has led to the proliferation of clinical practice guidelines as the primary mode of communicating current best practices across a range of chronic diseases. Despite overwhelming evidence supporting the benefits of their use, there is a long history of poor uptake by providers. Nonadherence to clinical practice guidelines is referred to as clinical inertia and represents provider failure to initiate or intensify treatment despite a clear indication to do so. Here we review evidence for the ubiquity of clinical inertia across a variety of chronic health conditions, as well as the organizational and system, patient, and provider factors that serve to maintain it. Limitations are highlighted in the emerging literature examining interventions to reduce clinical inertia. An evidence-based framework to address these limitations is proposed that uses behavior change theory and advocates for shared decision making and enhanced guideline development and dissemination.

  18. Building a Knowledge to Action Program in Stroke Rehabilitation.

    PubMed

    Janzen, Shannon; McIntyre, Amanda; Richardson, Marina; Britt, Eileen; Teasell, Robert

    2016-09-01

    The knowledge to action (KTA) process proposed by Graham et al (2006) is a framework to facilitate the development and application of research evidence into clinical practice. The KTA process consists of the knowledge creation cycle and the action cycle. The Evidence Based Review of Stroke Rehabilitation is a foundational part of the knowledge creation cycle and has helped guide the development of best practice recommendations in stroke. The Rehabilitation Knowledge to Action Project is an audit-feedback process for the clinical implementation of best practice guidelines, which follows the action cycle. The objective of this review was to: (1) contextualize the Evidence Based Review of Stroke Rehabilitation and Rehabilitation Knowledge to Action Project within the KTA model and (2) show how this process led to improved evidence-based practice in stroke rehabilitation. Through this process, a single centre was able to change clinical practice and promote a culture that supports the use of evidence-based practices in stroke rehabilitation.

  19. Clinical practice guidelines for delirium management: potential application in palliative care.

    PubMed

    Bush, Shirley H; Bruera, Eduardo; Lawlor, Peter G; Kanji, Salmaan; Davis, Daniel H J; Agar, Meera; Wright, David Kenneth; Hartwick, Michael; Currow, David C; Gagnon, Bruno; Simon, Jessica; Pereira, José L

    2014-08-01

    Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. We searched PubMed (1990-2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from "expert opinion" for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  20. Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

    PubMed

    Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

    2010-05-01

    This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

  1. [Evidence-based medicine and 'The Cochrane Collaboration'].

    PubMed

    Kawamura, T; Tamakoshi, A; Wakai, K; Ohno, Y

    1999-06-01

    In Evidence-Based Medicine (EBM), a clinical decision is based neither on pathophysiological theories nor personal experience but on the results derived from scientifically designed clinical epidemiological studies (i.e., evidence). EBM is used in various clinical applications, such as therapy, diagnosis, and prognosis prediction. The process includes (1) asking a clinical question consisting of the three elements of "patient", "exposure", and "outcome"; (2) searching for the best evidence using MEDLINE or Cochrane Library; (3) appraising critically the validity of the method and the magnitude and probability of the result; and finally (4) applying the evidence of the patient. In actual clinical practice, clinical expertise and patient preferences should be as much regarded as research evidence. 'The Cochrane Collaboration' supplies systematic reviews of clinical trials carried out all over the world to its consumers. Its fruit, 'The Cochrane Library (CD-ROM),' is a highly valuable resource. 'The Cochrane Collaboration' serves as the infrastructure for EBM. EBM, which was originally developed for the individual patient care, can also be applicable to community- or workplace-healthcare and policy making by governments. Thus, EBM is both a philosophy and a method to provide people with the most appropriate medical practice.

  2. Relationships between evidence-based practice, quality improvement and clinical error experience of nurses in Korean hospitals.

    PubMed

    Hwang, Jee-In; Park, Hyeoun-Ae

    2015-07-01

    This study investigated individual and work-related factors associated with nurses' perceptions of evidence-based practice (EBP) and quality improvement (QI), and the relationships between evidence-based practice, quality improvement and clinical errors. Understanding the factors affecting evidence-based practice and quality improvement activities and their relationships with clinical errors is important for designing strategies to promote evidence-based practice, quality improvement and patient safety. A cross-sectional survey was conducted with 594 nurses in two Korean teaching hospitals using the evidence-based practice Questionnaire and quality improvement scale developed in this study. Four hundred and forty-three nurses (74.6%) returned the completed survey. Nurses' ages and educational levels were significantly associated with evidence-based practice scores whereas age and job position were associated with quality improvement scores. There were positive, moderate correlations between evidence-based practice and quality improvement scores. Nurses who had not made any clinical errors during the past 12 months had significantly higher quality improvement skills scores than those who had. The findings indicated the necessity of educational support regarding evidence-based practice and quality improvement for younger staff nurses who have no master degrees. Enhancing quality improvement skills may reduce clinical errors. Nurse managers should consider the characteristics of their staff when implementing educational and clinical strategies for evidence-based practice and quality improvement. © 2013 John Wiley & Sons Ltd.

  3. The 2014 International Pressure Ulcer Guideline: methods and development.

    PubMed

    Haesler, Emily; Kottner, Jan; Cuddigan, Janet

    2017-06-01

    A discussion of the methodology used to develop the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. (2014). International experts representing National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance developed the second edition of this clinical guideline. Discussion paper - methodology. A comprehensive search for papers published up to July 2013 was conducted in 11 databases and identified 4286 studies. After critical appraisal, 356 studies were included and assigned a level of evidence. Guideline recommendations provide guidance on best practice in pressure ulcer prevention and treatment. Understanding the development process of a guideline increases the meaningfulness of recommendations to clinicians. Five hundred and seventy five recommendations arose from the research and its interpretation. The body of evidence supporting each recommendation was assigned a strength of evidence. A strength of recommendation was assigned to recommendation statements using the GRADE system. Recommendations are primarily supported by a body of evidence rated as C (87% of recommendations), representing low quality and/or indirect evidence (30%) and expert opinion (57%). Two hundred and forty seven recommendations (43%) received a strong recommendation ('Do it'). Recommendations were developed with consideration to research of the highest methodological quality evidence and studies that add to clinical insight and provide guidance for areas of care where minimal research has been conducted. Recommendations in the guideline reflect best practice and should be implemented with consideration to local context and resources and the individual's preferences and needs. © 2016 John Wiley & Sons Ltd.

  4. Cross Talk: The Microbiota and Neurodevelopmental Disorders

    PubMed Central

    Kelly, John R.; Minuto, Chiara; Cryan, John F.; Clarke, Gerard; Dinan, Timothy G.

    2017-01-01

    Humans evolved within a microbial ecosystem resulting in an interlinked physiology. The gut microbiota can signal to the brain via the immune system, the vagus nerve or other host-microbe interactions facilitated by gut hormones, regulation of tryptophan metabolism and microbial metabolites such as short chain fatty acids (SCFA), to influence brain development, function and behavior. Emerging evidence suggests that the gut microbiota may play a role in shaping cognitive networks encompassing emotional and social domains in neurodevelopmental disorders. Drawing upon pre-clinical and clinical evidence, we review the potential role of the gut microbiota in the origins and development of social and emotional domains related to Autism spectrum disorders (ASD) and schizophrenia. Small preliminary clinical studies have demonstrated gut microbiota alterations in both ASD and schizophrenia compared to healthy controls. However, we await the further development of mechanistic insights, together with large scale longitudinal clinical trials, that encompass a systems level dimensional approach, to investigate whether promising pre-clinical and initial clinical findings lead to clinical relevance. PMID:28966571

  5. Integrating health technology assessment requirements in the clinical development of medicines: the experience from NICE scientific advice.

    PubMed

    Maignen, François; Osipenko, Leeza; Pinilla-Dominguez, Pilar; Crowe, Emily

    2017-03-01

    The primary objective of the study was to analyse the proposed clinical development and economic evaluation plans for investigational medicinal products for which pharmaceutical companies have sought health technology assessment (HTA) scientific advice (SA). We have selected and analysed all the scientific advice procedures undertaken by National Institute for Health and Care Excellence (NICE) SA between 1 January 2009 and 3 December 2015 for investigational medicinal products. We have mapped the questions asked by the companies and the areas of advice highlighted in the advice reports to the sections of the NICE methods guide to the technology appraisals (2013). An overwhelming proportion of SA procedures have addressed questions related to the clinical development and specifically the main pivotal efficacy studies. Approximately a quarter of the questions relate to the approaches to economic evaluation. Questions raised in European Medicines Agency-HTA procedures generally focus on clinical efficacy issues whereas cost-effectiveness ones tend to dominate in NICE-only procedures. Our analysis shows that the issues mostly discussed in the HTA SA are the choice of comparator, the generalisability of the clinical trial evidence to the NHS practice and the impact of the clinical trial outcomes on quality of life and survival. Less disagreement with the developers' plans was seen in the choice of clinical endpoints, population definition, position of the technology in the treatment pathway and study design. Scientific advice is designed to improve the quality of evidence and approaches to evidence generation for future regulatory approval and HTA evaluation. Our experience to date suggests that payer requirements are inconsistently integrated in the clinical development programmes. More efforts should be dedicated to demonstrating the clinical value of new medicinal products to patients and key decision-makers.

  6. FRAX(®) Bone Mineral Density Task Force of the 2010 Joint International Society for Clinical Densitometry & International Osteoporosis Foundation Position Development Conference.

    PubMed

    Lewiecki, E Michael; Compston, Juliet E; Miller, Paul D; Adachi, Jonathan D; Adams, Judith E; Leslie, William D; Kanis, John A

    2011-01-01

    FRAX(®) is a fracture risk assessment algorithm developed by the World Health Organization in cooperation with other medical organizations and societies. Using easily available clinical information and femoral neck bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), when available, FRAX(®) is used to predict the 10-year probability of hip fracture and major osteoporotic fracture. These values may be included in country specific guidelines to aid clinicians in determining when fracture risk is sufficiently high that the patient is likely to benefit from pharmacological therapy to reduce that risk. Since the introduction of FRAX(®) into clinical practice, many practical clinical questions have arisen regarding its use. To address such questions, the International Society for Clinical Densitometry (ISCD) and International Osteoporosis Foundations (IOF) assigned task forces to review the best available medical evidence and make recommendations for optimal use of FRAX(®) in clinical practice. Questions were identified and divided into three general categories. A task force was assigned to investigating the medical evidence in each category and developing clinically useful recommendations. The BMD Task Force addressed issues that included the potential use of skeletal sites other than the femoral neck, the use of technologies other than DXA, and the deletion or addition of clinical data for FRAX(®) input. The evidence and recommendations were presented to a panel of experts at the ISCD-IOF FRAX(®) Position Development Conference, resulting in the development of ISCD-IOF Official Positions addressing FRAX(®)-related issues. Copyright © 2011 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

  7. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.

    PubMed

    Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Bryan Rumble, R; Temple-Smolkin, Robyn; B Ventura, Christina; Nowak, Jan A

    2017-05-01

    - To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. - The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. - Twenty-one guideline statements were established. - Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

  8. Integration of fall prevention into state policy in Connecticut.

    PubMed

    Murphy, Terrence E; Baker, Dorothy I; Leo-Summers, Linda S; Bianco, Luann; Gottschalk, Margaret; Acampora, Denise; King, Mary B

    2013-06-01

    To describe the ongoing efforts of the Connecticut Collaboration for Fall Prevention (CCFP) to move evidence regarding fall prevention into clinical practice and state policy. A university-based team developed methods of networking with existing statewide organizations to influence clinical practice and state policy. We describe steps taken that led to funding and legislation of fall prevention efforts in the state of Connecticut. We summarize CCFP's direct outreach by tabulating the educational sessions delivered and the numbers and types of clinical care providers that were trained. Community organizations that had sustained clinical practices incorporating evidence-based fall prevention were subsequently funded through mini-grants to develop innovative interventional activities. These mini-grants targeted specific subpopulations of older persons at high risk for falls. Building collaborative relationships with existing stakeholders and care providers throughout the state, CCFP continues to facilitate the integration of evidence-based fall prevention into clinical practice and state-funded policy using strategies that may be useful to others.

  9. Engaging Clinical Nurses in Quality Improvement Projects.

    PubMed

    Moore, Susan; Stichler, Jaynelle F

    2015-10-01

    Clinical nurses have the knowledge and expertise required to provide efficient and proficient patient care. Time and knowledge deficits can prevent nurses from developing and implementing quality improvement or evidence-based practice projects. This article reviews a process for professional development of clinical nurses that helped them to define, implement, and analyze quality improvement or evidence-based practice projects. The purpose of this project was to educate advanced clinical nurses to manage a change project from inception to completion, using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) Change Acceleration Process as a framework. One-to-one mentoring and didactic in-services advanced the knowledge, appreciation, and practice of advanced practice clinicians who completed multiple change projects. The projects facilitated clinical practice changes, with improved patient outcomes; a unit cultural shift, with appreciation of quality improvement and evidence-based projects; and engagement with colleagues. Project outcomes were displayed in poster presentations at a hospital exposition for knowledge dissemination. Copyright 2015, SLACK Incorporated.

  10. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials-Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance

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

    Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu; Deye, James A.; Vikram, Bhadrasain

    2012-07-01

    Purpose: In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods and Materials: Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such asmore » proton beam therapy, and the international harmonization of clinical trial QA. Results: Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.« less

  11. Redesigning radiotherapy quality assurance: opportunities to develop an efficient, evidence-based system to support clinical trials--report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance.

    PubMed

    Bekelman, Justin E; Deye, James A; Vikram, Bhadrasain; Bentzen, Soren M; Bruner, Deborah; Curran, Walter J; Dignam, James; Efstathiou, Jason A; FitzGerald, T J; Hurkmans, Coen; Ibbott, Geoffrey S; Lee, J Jack; Merchant, Thomas E; Michalski, Jeff; Palta, Jatinder R; Simon, Richard; Ten Haken, Randal K; Timmerman, Robert; Tunis, Sean; Coleman, C Norman; Purdy, James

    2012-07-01

    In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA. Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. AHRQ series paper 2: principles for developing guidance: AHRQ and the effective health-care program.

    PubMed

    Helfand, Mark; Balshem, Howard

    2010-05-01

    This article describes some of the fundamental principles that have been developed to guide the work of producing comparative effectiveness reviews (CERs). We briefly describe the role stakeholders play in providing important insights that inform the evidence-gathering process, and discuss the critical role of analytic frameworks in illuminating the relationship between surrogate measures and health outcomes, providing an understanding of the context in which clinical decisions are made and the uncertainties that underlie clinical controversies. We describe the Effective Health Care program conceptual model for considering different types of evidence that emphasizes minimizing the risk of bias, but places high-quality, highly applicable evidence about effectiveness at the top of the hierarchy. Finally, we briefly describe areas of future methodological research. CERs have become a foundation for decision-making in clinical practice and health policy. To be useful, CERs must approach the evidence from a patient-centered perspective; explore the clinical logic underlying the rationale for a service; cast a broad net with respect to types of evidence, placing a high value on effectiveness and applicability, in addition to internal validity; and, present benefits and harms for treatments and tests in a consistent way.

  13. Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

    PubMed

    Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

    2007-05-01

    The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

  14. [Use of evidence in heath policies and programs contributions of the instituto nacional de salud].

    PubMed

    Gutierrez, Ericson L; Piazza, Marina; Gutierrez-Aguado, Alfonso; Hijar, Gisely; Carmona, Gloria; Caballero, Patricia; Reyes, Nora; Canelo, Carlos; Aparco, Juan Pablo; Tejada, Romina A; Bolaños-Díaz, Rafael; Saravia, Silvia; Gozzer, Ernesto

    2016-01-01

    This article analyzes some examples about how the Ministry of Health of Peru has used evidence for policy and program formulation, implementation and evaluation. It describes the process by which health budget programs are based and strengthened with scientific evidence. Provides an overview about how the development of clinical guidelines methodology is facilitating the generation of high quality evidence based clinical guidelines.It presents some examples of specific information needs of the Ministry of Health to which the Instituto Nacional de Salud has responded, and the impact of that collaboration. Finally, the article proposes future directions for the use of research methodology especially relevant for the development and evaluation of policy and programs, as well as the development of networks of health technology assessment at the national and international level.

  15. Hormonal Replacement in Hypopituitarism in Adults: An Endocrine Society Clinical Practice Guideline.

    PubMed

    Fleseriu, Maria; Hashim, Ibrahim A; Karavitaki, Niki; Melmed, Shlomo; Murad, M Hassan; Salvatori, Roberto; Samuels, Mary H

    2016-11-01

    To formulate clinical practice guidelines for hormonal replacement in hypopituitarism in adults. The participants include an Endocrine Society-appointed Task Force of six experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the Pituitary Society, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the Pituitary Society, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Using an evidence-based approach, this guideline addresses important clinical issues regarding the evaluation and management of hypopituitarism in adults, including appropriate biochemical assessments, specific therapeutic decisions to decrease the risk of co-morbidities due to hormonal over-replacement or under-replacement, and managing hypopituitarism during pregnancy, pituitary surgery, and other types of surgeries.

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

    PubMed

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

    2013-05-22

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

  17. Knowledge Translation in Audiology

    PubMed Central

    Kothari, Anita; Bagatto, Marlene P.; Seewald, Richard; Miller, Linda T.; Scollie, Susan D.

    2011-01-01

    The impetus for evidence-based practice (EBP) has grown out of widespread concern with the quality, effectiveness (including cost-effectiveness), and efficiency of medical care received by the public. Although initially focused on medicine, EBP principles have been adopted by many of the health care professions and are often represented in practice through the development and use of clinical practice guidelines (CPGs). Audiology has been working on incorporating EBP principles into its mandate for professional practice since the mid-1990s. Despite widespread efforts to implement EBP and guidelines into audiology practice, gaps still exist between the best evidence based on research and what is being done in clinical practice. A collaborative dynamic and iterative integrated knowledge translation (KT) framework rather than a researcher-driven hierarchical approach to EBP and the development of CPGs has been shown to reduce the knowledge-to-clinical action gaps. This article provides a brief overview of EBP and CPGs, including a discussion of the barriers to implementing CPGs into clinical practice. It then offers a discussion of how an integrated KT process combined with a community of practice (CoP) might facilitate the development and dissemination of evidence for clinical audiology practice. Finally, a project that uses the knowledge-to-action (KTA) framework for the development of outcome measures in pediatric audiology is introduced. PMID:22194314

  18. Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

    PubMed

    Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

    2016-12-01

    To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

  19. Envisaging the use of evidence-based practice (EBP): how nurse academics facilitate EBP use in theory and practice across Australian undergraduate programmes.

    PubMed

    Malik, Gulzar; McKenna, Lisa; Griffiths, Debra

    2017-09-01

    This paper is drawn from a grounded theory study that aimed to investigate processes undertaken by academics when integrating evidence-based practice into undergraduate curricula. This paper focuses on how nurse academics facilitated students to apply evidence-based practice in theory and practice. Facilitating undergraduate nursing students to develop skills within an evidence-based practice framework is vital to achieving evidence-based care. Studies on evidence-based practice conducted globally suggests that there is a need to investigate approaches used by nurse academics in facilitating students' understanding and use of evidence-based practice during their nurse education. Employing constructivist grounded theory approach, 23 nurse academics across Australian universities were interviewed and nine observed during their teaching. Some study participants shared their unit guides to enrich analysis. Data analysis was performed by following Charmaz's approach of coding procedures; as a result, four categories were constructed. This paper focuses on the category conceptualised as Envisaging the use of evidence-based practice. Findings revealed that most academics-assisted students to use evidence in academic-related activities. Recognising the importance of evidence-based practice in practice, some also expected students to apply evidence-based practice during clinical experiences. However, the level of students' appreciation for evidence-based practice during clinical experiences was unknown to participants and was influenced by practice-related barriers. Acknowledging these challenges, academics were engaged in dialogue with students and suggested the need for academia-practice collaboration in combating the cited barriers. Ensuring academics are supported to emphasise clinical application of evidence-based practice requires strategies at school and practice levels. Faculty development, engagement of clinical nurses with evidence-based practice, supportive culture for nurses and students to apply evidence-based practice principles, and collaboration between academia and practice will make facilitation by academics practical and meaningful for students. Findings from this study point to a number of initiatives for clinical leadership to provide infrastructure and support for academics, practising nurses and undergraduate students to adopt evidence-based practice in practice settings, thereby influencing practice outcomes. © 2016 John Wiley & Sons Ltd.

  20. Multinational evidence-based recommendations for pain management by pharmacotherapy in inflammatory arthritis: integrating systematic literature research and expert opinion of a broad panel of rheumatologists in the 3e Initiative

    PubMed Central

    Colebatch, Alexandra N.; Buchbinder, Rachelle; Edwards, Christopher J.; Adams, Karen; Englbrecht, Matthias; Hazlewood, Glen; Marks, Jonathan L.; Radner, Helga; Ramiro, Sofia; Richards, Bethan L.; Tarner, Ingo H.; Aletaha, Daniel; Bombardier, Claire; Landewé, Robert B.; Müller-Ladner, Ulf; Bijlsma, Johannes W. J.; Branco, Jaime C.; Bykerk, Vivian P.; da Rocha Castelar Pinheiro, Geraldo; Catrina, Anca I.; Hannonen, Pekka; Kiely, Patrick; Leeb, Burkhard; Lie, Elisabeth; Martinez-Osuna, Píndaro; Montecucco, Carlomaurizio; Østergaard, Mikkel; Westhovens, Rene; Zochling, Jane; van der Heijde, Désirée

    2012-01-01

    Objective. To develop evidence-based recommendations for pain management by pharmacotherapy in patients with inflammatory arthritis (IA). Methods. A total of 453 rheumatologists from 17 countries participated in the 2010 3e (Evidence, Expertise, Exchange) Initiative. Using a formal voting process, 89 rheumatologists representing all 17 countries selected 10 clinical questions regarding the use of pain medications in IA. Bibliographic fellows undertook a systematic literature review for each question, using MEDLINE, EMBASE, Cochrane CENTRAL and 2008–09 European League Against Rheumatism (EULAR)/ACR abstracts. Relevant studies were retrieved for data extraction and quality assessment. Rheumatologists from each country used this evidence to develop a set of national recommendations. Multinational recommendations were then formulated and assessed for agreement and the potential impact on clinical practice. Results. A total of 49 242 references were identified, from which 167 studies were included in the systematic reviews. One clinical question regarding different comorbidities was divided into two separate reviews, resulting in 11 recommendations in total. Oxford levels of evidence were applied to each recommendation. The recommendations related to the efficacy and safety of various analgesic medications, pain measurement scales and pain management in the pre-conception period, pregnancy and lactation. Finally, an algorithm for the pharmacological management of pain in IA was developed. Twenty per cent of rheumatologists reported that the algorithm would change their practice, and 75% felt the algorithm was in accordance with their current practice. Conclusions. Eleven evidence-based recommendations on the management of pain by pharmacotherapy in IA were developed. They are supported by a large panel of rheumatologists from 17 countries, thus enhancing their utility in clinical practice. PMID:22447886

  1. Which research is needed to support clinical decision-making on integrative medicine?- Can comparative effectiveness research close the gap?

    PubMed

    Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Bm, Berman

    2012-10-01

    In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of the best care options. This evidence, more generalizable than the evidence generated by traditional randomized controlled trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on comparative effectiveness is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

  2. Consensus Recommendations for Systematic Evaluation of Drug-Drug Interaction Evidence for Clinical Decision Support

    PubMed Central

    Scheife, Richard T.; Hines, Lisa E.; Boyce, Richard D.; Chung, Sophie P.; Momper, Jeremiah; Sommer, Christine D.; Abernethy, Darrell R.; Horn, John; Sklar, Stephen J.; Wong, Samantha K.; Jones, Gretchen; Brown, Mary; Grizzle, Amy J.; Comes, Susan; Wilkins, Tricia Lee; Borst, Clarissa; Wittie, Michael A.; Rich, Alissa; Malone, Daniel C.

    2015-01-01

    Background Healthcare organizations, compendia, and drug knowledgebase vendors use varying methods to evaluate and synthesize evidence on drug-drug interactions (DDIs). This situation has a negative effect on electronic prescribing and medication information systems that warn clinicians of potentially harmful medication combinations. Objective To provide recommendations for systematic evaluation of evidence from the scientific literature, drug product labeling, and regulatory documents with respect to DDIs for clinical decision support. Methods A conference series was conducted to develop a structured process to improve the quality of DDI alerting systems. Three expert workgroups were assembled to address the goals of the conference. The Evidence Workgroup consisted of 15 individuals with expertise in pharmacology, drug information, biomedical informatics, and clinical decision support. Workgroup members met via webinar from January 2013 to February 2014. Two in-person meetings were conducted in May and September 2013 to reach consensus on recommendations. Results We developed expert-consensus answers to three key questions: 1) What is the best approach to evaluate DDI evidence?; 2) What evidence is required for a DDI to be applicable to an entire class of drugs?; and 3) How should a structured evaluation process be vetted and validated? Conclusion Evidence-based decision support for DDIs requires consistent application of transparent and systematic methods to evaluate the evidence. Drug information systems that implement these recommendations should be able to provide higher quality information about DDIs in drug compendia and clinical decision support tools. PMID:25556085

  3. Effect of clinically discriminating, evidence-based checklist items on the reliability of scores from an Internal Medicine residency OSCE.

    PubMed

    Daniels, Vijay J; Bordage, Georges; Gierl, Mark J; Yudkowsky, Rachel

    2014-10-01

    Objective structured clinical examinations (OSCEs) are used worldwide for summative examinations but often lack acceptable reliability. Research has shown that reliability of scores increases if OSCE checklists for medical students include only clinically relevant items. Also, checklists are often missing evidence-based items that high-achieving learners are more likely to use. The purpose of this study was to determine if limiting checklist items to clinically discriminating items and/or adding missing evidence-based items improved score reliability in an Internal Medicine residency OSCE. Six internists reviewed the traditional checklists of four OSCE stations classifying items as clinically discriminating or non-discriminating. Two independent reviewers augmented checklists with missing evidence-based items. We used generalizability theory to calculate overall reliability of faculty observer checklist scores from 45 first and second-year residents and predict how many 10-item stations would be required to reach a Phi coefficient of 0.8. Removing clinically non-discriminating items from the traditional checklist did not affect the number of stations (15) required to reach a Phi of 0.8 with 10 items. Focusing the checklist on only evidence-based clinically discriminating items increased test score reliability, needing 11 stations instead of 15 to reach 0.8; adding missing evidence-based clinically discriminating items to the traditional checklist modestly improved reliability (needing 14 instead of 15 stations). Checklists composed of evidence-based clinically discriminating items improved the reliability of checklist scores and reduced the number of stations needed for acceptable reliability. Educators should give preference to evidence-based items over non-evidence-based items when developing OSCE checklists.

  4. Evaluating clinical librarian services: a systematic review.

    PubMed

    Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

    2011-03-01

      Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

  5. Integrating evidence-based practice into RN-to-BSN clinical nursing education.

    PubMed

    Oh, Eui Geum; Kim, Sunah; Kim, So Sun; Kim, Sue; Cho, Eun Yong; Yoo, Ji-Soo; Kim, Hee Soon; Lee, Ju Hee; You, Mi Ae; Lee, Hyejung

    2010-07-01

    This study examines the effects of integrating evidence-based practice (EBP) into clinical practicum on EBP efficacy and barriers to research utilization among Korean RN-to-BSN students. A one-group pretest-posttest design was used. Eighty-one students were recruited from a school of nursing in Korea. Evidence-based practice clinical practicum was composed of two consecutive programs during one semester. Lectures, individual mentoring on EBP practicum, small group, and wrap-up conferences were provided. Outcomes of EBP efficacy and barriers to research utilization were analyzed using paired t tests for 74 final participants. Evidence-based practice efficacy scores increased significantly (p < 0.05), and the barriers to research utilization scores decreased significantly after the EBP clinical practicum. The results highlight the effectiveness of EBP education among RN-to-BSN students. These results may help health educators develop effective educational strategies to integrate EBP concepts into a clinical practicum. Copyright 2010, SLACK Incorporated.

  6. Occupational Therapy Interventions for People With Alzheimer's Disease.

    PubMed

    Piersol, Catherine Verrier; Jensen, Lou; Lieberman, Deborah; Arbesman, Marian

    Evidence Connection articles provide a clinical application of systematic reviews developed in conjunction with the American Occupational Therapy Association's (AOTA's) Evidence-Based Practice Project. In this Evidence Connection article, we describe a case report of a person with Alzheimer's disease. The occupational therapy assessment and intervention process in the home setting is described. Findings from the systematic reviews on this topic were published in the November/December 2017 issue of the American Journal of Occupational Therapy and in AOTA's Occupational Therapy Practice Guidelines for Adults With Alzheimer's Disease and Related Major Neurocognitive Disorders. Each article in this series summarizes the evidence from the published reviews on a given topic and presents an application of the evidence to a related clinical case. Evidence Connection articles illustrate how the research evidence from the reviews can be used to inform and guide clinical reasoning. Copyright © 2018 by the American Occupational Therapy Association, Inc.

  7. Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework.

    PubMed

    Wilhide Iii, Calvin C; Peeples, Malinda M; Anthony Kouyaté, Robin C

    2016-02-16

    Mobile technology offers new capabilities that can help to drive important aspects of chronic disease management at both an individual and population level, including the ability to deliver real-time interventions that can be connected to a health care team. A framework that supports both development and evaluation is needed to understand the aspects of mHealth that work for specific diseases, populations, and in the achievement of specific outcomes in real-world settings. This framework should incorporate design structure and process, which are important to translate clinical and behavioral evidence, user interface, experience design and technical capabilities into scalable, replicable, and evidence-based mobile health (mHealth) solutions to drive outcomes. The purpose of this paper is to discuss the identification and development of an app intervention design framework, and its subsequent refinement through development of various types of mHealth apps for chronic disease. The process of developing the framework was conducted between June 2012 and June 2014. Informed by clinical guidelines, standards of care, clinical practice recommendations, evidence-based research, best practices, and translated by subject matter experts, a framework for mobile app design was developed and the refinement of the framework across seven chronic disease states and three different product types is described. The result was the development of the Chronic Disease mHealth App Intervention Design Framework. This framework allowed for the integration of clinical and behavioral evidence for intervention and feature design. The application to different diseases and implementation models guided the design of mHealth solutions for varying levels of chronic disease management. The framework and its design elements enable replicable product development for mHealth apps and may provide a foundation for the digital health industry to systematically expand mobile health interventions and validate their effectiveness across multiple implementation settings and chronic diseases.

  8. Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework

    PubMed Central

    Peeples, Malinda M; Anthony Kouyaté, Robin C

    2016-01-01

    Background Mobile technology offers new capabilities that can help to drive important aspects of chronic disease management at both an individual and population level, including the ability to deliver real-time interventions that can be connected to a health care team. A framework that supports both development and evaluation is needed to understand the aspects of mHealth that work for specific diseases, populations, and in the achievement of specific outcomes in real-world settings. This framework should incorporate design structure and process, which are important to translate clinical and behavioral evidence, user interface, experience design and technical capabilities into scalable, replicable, and evidence-based mobile health (mHealth) solutions to drive outcomes. Objective The purpose of this paper is to discuss the identification and development of an app intervention design framework, and its subsequent refinement through development of various types of mHealth apps for chronic disease. Methods The process of developing the framework was conducted between June 2012 and June 2014. Informed by clinical guidelines, standards of care, clinical practice recommendations, evidence-based research, best practices, and translated by subject matter experts, a framework for mobile app design was developed and the refinement of the framework across seven chronic disease states and three different product types is described. Results The result was the development of the Chronic Disease mHealth App Intervention Design Framework. This framework allowed for the integration of clinical and behavioral evidence for intervention and feature design. The application to different diseases and implementation models guided the design of mHealth solutions for varying levels of chronic disease management. Conclusions The framework and its design elements enable replicable product development for mHealth apps and may provide a foundation for the digital health industry to systematically expand mobile health interventions and validate their effectiveness across multiple implementation settings and chronic diseases. PMID:26883135

  9. The Morningside Initiative: Collaborative Development of a Knowledge Repository to Accelerate Adoption of Clinical Decision Support

    DTIC Science & Technology

    2010-01-01

    Comparative Effectiveness Research, or other efforts to determine best practices and to develop guidelines based on meta-analysis and evidence - based medicine . An...authoritative reviews or other evidence - based medicine sources, but they have been made unambiguous and computable – a process which sounds...best practice recommendation created through an evidence - based medicine (EBM) development process. The lifecycle envisions four stages of refinement

  10. Evidence-based dentistry: fundamentals for the dentist.

    PubMed

    Bauer, Janet; Chiappelli, Francesco; Spackman, Sue; Prolo, Paolo; Stevenson, Richard

    2006-06-01

    This article explains the fundamentals of evidence-based dentistry for the dentist. Evidence-based dentistry is a discipline whose primary participant is the translational researcher. Recent developments have emphasized the importance of this discipline (clinical and translational research) for improving health care. The process of evidence-based dentistry is the reciprocation of new and existing evidence between dentists and quantitative and qualitative researchers, facilitated by the translational researcher. The product of this reciprocation is the clinical practice guideline, or best evidence, that provides the patient options in choosing treatments or services. These options are quantified and qualified by decision, utility, and cost data. Using shared decision-making, the dentist and patient arrive at a mutual understanding of which option best meets an acceptable and preferred treatment course that is cost effective. This option becomes the clinical decision.

  11. The use of mechanistic evidence in drug approval.

    PubMed

    Aronson, Jeffrey K; La Caze, Adam; Kelly, Michael P; Parkkinen, Veli-Pekka; Williamson, Jon

    2018-06-11

    The role of mechanistic evidence tends to be under-appreciated in current evidence-based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

  12. Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative

    PubMed Central

    Sivera, Francisca; Andrés, Mariano; Carmona, Loreto; Kydd, Alison S R; Moi, John; Seth, Rakhi; Sriranganathan, Melonie; van Durme, Caroline; van Echteld, Irene; Vinik, Ophir; Wechalekar, Mihir D; Aletaha, Daniel; Bombardier, Claire; Buchbinder, Rachelle; Edwards, Christopher J; Landewé, Robert B; Bijlsma, Johannes W; Branco, Jaime C; Burgos-Vargas, Rubén; Catrina, Anca I; Elewaut, Dirk; Ferrari, Antonio J L; Kiely, Patrick; Leeb, Burkhard F; Montecucco, Carlomaurizio; Müller-Ladner, Ulf; Østergaard, Mikkel; Zochling, Jane; Falzon, Louise; van der Heijde, Désirée M

    2014-01-01

    We aimed to develop evidence-based multinational recommendations for the diagnosis and management of gout. Using a formal voting process, a panel of 78 international rheumatologists developed 10 key clinical questions pertinent to the diagnosis and management of gout. Each question was investigated with a systematic literature review. Medline, Embase, Cochrane CENTRAL and abstracts from 2010–2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, rheumatologists from 14 countries (Europe, South America and Australasia) developed national recommendations. After rounds of discussion and voting, multinational recommendations were formulated. Each recommendation was graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. Combining evidence and clinical expertise, 10 recommendations were produced. One recommendation referred to the diagnosis of gout, two referred to cardiovascular and renal comorbidities, six focused on different aspects of the management of gout (including drug treatment and monitoring), and the last recommendation referred to the management of asymptomatic hyperuricaemia. The level of agreement with the recommendations ranged from 8.1 to 9.2 (mean 8.7) on a 1–10 scale, with 10 representing full agreement. Ten recommendations on the diagnosis and management of gout were established. They are evidence-based and supported by a large panel of rheumatologists from 14 countries, enhancing their utility in clinical practice. PMID:23868909

  13. Neuropsychiatric Clinical Trials: Should They Accommodate Real-World Practices or Set Standards for Clinical Practices?

    PubMed Central

    Becker, Robert E.; Greig, Nigel H.

    2012-01-01

    The fundamental tenet of Evidence-Based Medicine (EBM) is to “integrate the best research evidence with clinical expertise and patient values,”1(p1) a commitment accepted in neuropsychiatry.2,3 The EBM group recognizes various factors that undermine the quality and use of evidence generated in research, “three limitations…to science and medicine-shortage of coherent evidence, difficulties applying evidence in care, and barriers to quality practice-and further impediments to EBM practice-practitioners lacking skills evaluating evidence sources, having limited time, and being unaware of support for EBM working, thus failing to follow its practices.”1(p7) Other risks to validity are less widely acknowledged. Clinical trials (CTs), especially randomized controlled trials (RCTs), and summary reviews of results from more than 1 RCT provide EBM’s gold standard sources for sound evidence.1(pp105-144) Sackett et al 1 and other authors suggest subjecting RCTs and reviews of RCTs to specific tests of validity before the practitioner uses the evidence. We recently compiled additional threats to validity of the neuropsychiatric evidence base,4,5 a list already incomplete in view of recent concerns with industry influence evidenced by ghost authorships 6 and selective reporting.7,8 Each of the factors we compiled potentially affects the reliability and therefore the validity of the RCT evidence base, is not addressed systematically in EBM guidance on how to develop and use the research literature, and potentially impacts neuropsychiatric research by allowing drugs to fail because of the factor functioning as a methodological weakness in clinical studies.5 In this article, we (1) cull from the literature factors that methodologically put clinical research and the evidence base at risk, (2) uncover assumptions that may account for these factors going unnoticed as risks to medicine’s evidence base, and (3) suggest steps to increase the effectiveness of neuropsychiatric drug developments, CTs, and validity and use of the evidence base for practitioners. Specifically, we provide evidence that problems of unreliability caused by human errors and biases currently undermine the validity of psychiatric research. We suggest revisions of some assumptions behind research methods and practices as part of an effort to protect research from these errors and biases.4 PMID:19142109

  14. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists.

    PubMed

    Bahn Chair, Rebecca S; Burch, Henry B; Cooper, David S; Garber, Jeffrey R; Greenlee, M Carol; Klein, Irwin; Laurberg, Peter; McDougall, I Ross; Montori, Victor M; Rivkees, Scott A; Ross, Douglas S; Sosa, Julie Ann; Stan, Marius N

    2011-06-01

    Thyrotoxicosis has multiple etiologies, manifestations, and potential therapies. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions and patient preference. This article describes evidence-based clinical guidelines for the management of thyrotoxicosis that would be useful to generalist and subspeciality physicians and others providing care for patients with this condition. The development of these guidelines was commissioned by the American Thyroid Association in association with the American Association of Clinical Endocrinologists. The American Thyroid Association and American Association of Clinical Endocrinologists assembled a task force of expert clinicians who authored this report. The task force examined relevant literature using a systematic PubMed search supplemented with additional published materials. An evidence-based medicine approach that incorporated the knowledge and experience of the panel was used to develop the text and a series of specific recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach recommended by the Grading of Recommendations, Assessment, Development, and Evaluation Group. Clinical topics addressed include the initial evaluation and management of thyrotoxicosis; management of Graves' hyperthyroidism using radioactive iodine, antithyroid drugs, or surgery; management of toxic multinodular goiter or toxic adenoma using radioactive iodine or surgery; Graves' disease in children, adolescents, or pregnant patients; subclinical hyperthyroidism; hyperthyroidism in patients with Graves' ophthalmopathy; and management of other miscellaneous causes of thyrotoxicosis. One hundred evidence-based recommendations were developed to aid in the care of patients with thyrotoxicosis and to share what the task force believes is current, rational, and optimal medical practice.

  15. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists.

    PubMed

    Bahn, Rebecca S; Burch, Henry B; Cooper, David S; Garber, Jeffrey R; Greenlee, M Carol; Klein, Irwin; Laurberg, Peter; McDougall, I Ross; Montori, Victor M; Rivkees, Scott A; Ross, Douglas S; Sosa, Julie Ann; Stan, Marius N

    2011-01-01

    Thyrotoxicosis has multiple etiologies, manifestations, and potential therapies. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions and patient preference. This article describes evidence-based clinical guidelines for the management of thyrotoxicosis that would be useful to generalist and subspeciality physicians and others providing care for patients with this condition. The development of these guidelines was commissioned by the American Thyroid Association in association with the American Association of Clinical Endocrinologists. The American Thyroid Association and American Association of Clinical Endocrinologists assembled a task force of expert clinicians who authored this report. The task force examined relevant literature using a systematic PubMed search supplemented with additional published materials. An evidence-based medicine approach that incorporated the knowledge and experience of the panel was used to develop the text and a series of specific recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach recommended by the Grading of Recommendations, Assessment, Development, and Evaluation Group. Clinical topics addressed include the initial evaluation and management of thyrotoxicosis; management of Graves' hyperthyroidism using radioactive iodine, antithyroid drugs, or surgery; management of toxic multinodular goiter or toxic adenoma using radioactive iodine or surgery; Graves' disease in children, adolescents, or pregnant patients; subclinical hyperthyroidism; hyperthyroidism in patients with Graves' ophthalmopathy; and management of other miscellaneous causes of thyrotoxicosis. One hundred evidence-based recommendations were developed to aid in the care of patients with thyrotoxicosis and to share what the task force believes is current, rational, and optimal medical practice.

  16. Exploring the contribution of the Clinical Librarian to facilitating evidence-based nursing.

    PubMed

    Tod, Angela M; Bond, Beverly; Leonard, Niamh; Gilsenan, Irene J; Palfreyman, Simon

    2007-04-01

    To examine the potential role of the Clinical Librarian in facilitating evidence-based practice of nurses in acute hospital settings and develop a model for the role. There is a growing policy and professional expectation that nurses will seek out and apply evidence in their clinical practice. Studies have demonstrated that nurses experience barriers in working with an evidence-based approach. The role of Clinical Librarian has been used in other countries and within medicine to overcome some of the barriers to evidence-based practice. There are limitations in the previous work in terms of rigour of evaluation, scope of the Clinical Librarian role and application to nursing in a UK setting. A qualitative consultation of 72 nurses in acute care settings. Six consultation group interviews of between 4-19 participants. Written records were recorded by the scribe. Content analysis was undertaken to identify the range and frequency of comments. Clinical questions currently go unanswered because of barriers of time, skills deficits and access to resources. Literature searching, skills training and evidence dissemination were the main areas of work the staff requested that a Clinical Librarian should undertake. It was anticipated that the Clinical Librarian could interact and work productively with nursing staff with a limited but regular presence on the ward. Interim communication could be via e-mail, phone and written suggestions and requests for work. It was seen to be vital that the Clinical Librarian worked in partnership with staff to build evidence-based practice capacity and ensure clinical relevance of the work. This study has generated the first model for the Clinical Librarian role with an emphasis on nursing. It is derived from the views of clinical nurses. Recommendations are made for the implementation and evaluation of such a role. The Clinical Librarian could be an invaluable support to promoting evidence-based nursing.

  17. Breast cancer: the role of angiogenesis and antiangiogenic therapy.

    PubMed

    Miller, Kathy D; Dul, Carrie L

    2004-10-01

    Angiogenesis plays a role in breast cancer development. Preclinical and clinical evidence is reviewed. Development of targeted antiangiogenic agents provides new challenges to clinical trial design. Current antiangiogenic therapy with traditional agents and novel agents are classified and reviewed.

  18. [Approaches, knowledge and capabilities of nurses and physicians regarding evidence-based clinical practice in the Imbadura province (Ecuador)].

    PubMed

    Molina Mula, Jesús; Muñoz Navarro, Paulina; Vaca Auz, Janeth; Cabascango Cabascango, Carmita; Cabascango Cabascango, Katty

    2015-01-01

    The research raises the need to increase understanding of organizational and personal factors that influence the attitude and aptitude of each professional, with respect to evidence-based clinical practice. The aim of this study is to describe the transfer of knowledge into clinical practice in hospital units in Imbabura (Ecuador) identifying the obstacles to implementing evidence-based clinical practice validated questionnaire EBPQ-19. A cross-sectional observational study was conducted in hospitals of the Ministry of Public Health of Imbabura of Ecuador took place, including a total of 281 nurses and physicians. Nurses and physicians showed positive attitudes toward evidence-based clinical practice (EBCP) and their use to support clinical decision-making. This research evidences perceptions of professionals on strategies for knowledge transfer and obstacles to carry it out. Significant differences between the perception of the use of EBCP strategies between nurses and physicians are observed. Physicians consider they use them frequently, while nurses acknowledge using them less (chi-square: 105.254, P=.018). In conclusion, we can say that these factors should be considered as necessary to improve the quality of care that is provided to users based on the best available evidence. It is necessary to start developing change interventions in this regard to remedy the current situation of clinical practice based not on evidence, but rather on experience only. Experimental studies demonstrating the effectiveness of strategies to eliminate barriers to scientific evidence-based clinical practice should be conducted. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  19. Identifying the effective evidence sources to use in developing Clinical Guidelines for Acute Stroke Management: lived experiences of the search specialist and project manager.

    PubMed

    Parkhill, Anne; Hill, Kelvin

    2009-03-01

    The Australian National Stroke Foundation appointed a search specialist to find the best available evidence for the second edition of its Clinical Guidelines for Acute Stroke Management. To identify the relative effectiveness of differing evidence sources for the guideline update. We searched and reviewed references from five valid evidence sources for clinical and economic questions: (i) electronic databases; (ii) reference lists of relevant systematic reviews, guidelines, and/or primary studies; (iii) table of contents of a number of key journals for the last 6 months; (iv) internet/grey literature; and (v) experts. Reference sources were recorded, quantified, and analysed. In the clinical portion of the guidelines document, there was a greater use of previous knowledge and sources other than electronic databases for evidence, while there was a greater use of electronic databases for the economic section. The results confirmed that searchers need to be aware of the context and range of sources for evidence searches. For best available evidence, searchers cannot rely solely on electronic databases and need to encompass many different media and sources.

  20. Idiopathic inflammatory myositis.

    PubMed

    Tieu, Joanna; Lundberg, Ingrid E; Limaye, Vidya

    2016-02-01

    Knowledge on idiopathic inflammatory myopathy (IIM) has evolved with the identification of myositis-associated and myositis-specific antibodies, development of histopathological classification and the recognition of how these correlate with clinical phenotype and response to therapy. In this paper, we outline key advances in diagnosis and histopathology, including the more recent identification of antibodies associated with immune-mediated necrotising myopathy (IMNM) and inclusion body myositis (IBM). Ongoing longitudinal observational cohorts allow further classification of these patients with IIM, their predicted clinical course and response to specific therapies. Registries have been developed worldwide for this purpose. A challenging aspect in IIM, a multisystem disease with multiple clinical subtypes, has been defining disease status and clinically relevant improvement. Tools for assessing activity and damage are now recognised to be important in determining disease activity and guiding therapeutic decision-making. The International Myositis Assessment and Clinical Studies (IMACS) group has developed such tools for use in research and clinical settings. There is limited evidence for specific treatment strategies in IIM. With significant development in the understanding of IIM and improved classification, longitudinal observational cohorts and trials using validated outcome measures are necessary, to provide important information for evidence-based care in the clinical setting. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

  1. Improving Management of Pediatric Patients with Attention- Deficit/Hyperactivity Disorder at Naval Medical Center Portsmouth

    DTIC Science & Technology

    2004-04-30

    of practice and to facilitate evidence - based medicine a diagnosis of ADHD must be systematic and comprehensive (Institute, 2003). In an effort to meet...Health health care. o’ Clinical practice guidelines are developed and Benefit & GME implemented and clinical care is driven by evidence - based medicine . • Population

  2. Evidence-based clinical policy: case report of a reproducible process to encourage understanding and evaluation of evidence.

    PubMed

    Rikard-Bell, G; Waters, E; Ward, J

    2006-07-01

    We report within a case study a reproducible process to facilitate the explicit incorporation of evidence by a multidisciplinary group into clinical policy development. To support the decision-making of a multidisciplinary Intersectoral Advisory Group (IAG) convened by the Royal Australasian College of Physicians Health Policy Unit, a systematic review of randomized controlled trials about environmental tobacco smoke and smoking cessation interventions in paediatric settings was first undertaken. As reported in detail here, IAG members were then formally engaged in a transparent and replicable process to understand and interpret the synthesized evidence and to proffer their independent reactions regarding policy, practice and research. Our intention was to ensure that all IAG members were democratically engaged and made aware of the available evidence. As clinical policy must engage stakeholder representatives from diverse backgrounds, a process to equalize understanding of the evidence and 'democratize' judgment about its implications is needed. Future research must then examine the benefits of such explicit steps when guidelines, in turn, are implemented. We hypothesize that changes to future practice will be more likely if processes undertaken to develop guidelines are transparent to clinicians and other target groups.

  3. Evidence-Based Medicine in the Education of Psychiatrists

    ERIC Educational Resources Information Center

    Srihari, Vinod

    2008-01-01

    Objective: Evidence-based medicine has an important place in the teaching and practice of psychiatry. Attempts to teach evidence-based medicine skills can be weakened by conceptual confusions feeding a false polarization between traditional clinical skills and evidence-based medicine. Methods: The author develops a broader conception of clinical…

  4. Considering health equity when moving from evidence-based guideline recommendations to implementation: a case study from an upper-middle income country on the GRADE approach

    PubMed Central

    Mosquera, Paola; Alzate, Juan Pablo; Pottie, Kevin; Welch, Vivian; Akl, Elie A; Jull, Janet; Lang, Eddy; Katikireddi, Srinivasa Vittal; Morton, Rachel; Thabane, Lehana; Shea, Bev; Stein, Airton T; Singh, Jasvinder; Florez, Ivan D; Guyatt, Gordon; Schünemann, Holger; Tugwell, Peter

    2017-01-01

    Abstract The availability of evidence-based guidelines does not ensure their implementation and use in clinical practice or policy making. Inequities in health have been defined as those inequalities within or between populations that are avoidable, unnecessary and also unjust and unfair. Evidence-based clinical practice and public health guidelines (‘guidelines’) can be used to target health inequities experienced by disadvantaged populations, although guidelines may unintentionally increase health inequities. For this reason, there is a need for evidence-based clinical practice and public health guidelines to intentionally target health inequities experienced by disadvantaged populations. Current guideline development processes do not include steps for planned implementation of equity-focused guidelines. This article describes nine steps that provide guidance for consideration of equity during guideline implementation. A critical appraisal of the literature followed by a process to build expert consensus was undertaken to define how to include consideration of equity issues during the specific GRADE guideline development process. Using a case study from Colombia we describe nine steps that were used to implement equity-focused GRADE recommendations: (1) identification of disadvantaged groups, (2) quantification of current health inequities, (3) development of equity-sensitive recommendations, (4) identification of key actors for implementation of equity-focused recommendations, (5) identification of barriers and facilitators to the implementation of equity-focused recommendations, (6) development of an equity strategy to be included in the implementation plan, (7) assessment of resources and incentives, (8) development of a communication strategy to support an equity focus and (9) development of monitoring and evaluation strategies. This case study can be used as model for implementing clinical practice guidelines, taking into account equity issues during guideline development and implementation. PMID:29029068

  5. [Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

    PubMed

    Ruiz, Martial; Thibult, François

    2014-06-01

    The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

  6. Claims to the benefits of clinical supervision: A critique of the policy development process and outcomes in New South Wales, Australia.

    PubMed

    White, Edward

    2017-02-01

    The historical development of clinical supervision has been variously interpreted in the international literature. Creditable evidence has accumulated, particularly over the past two decades, to show that clinical supervision has a positive demonstrable effect on supervisees. However, comparatively little research evidence has entered the public domain on any effect that clinical supervision might have on other nominated outcomes. In Australia, developments in clinical supervision were recently prompted by initiatives at national and state levels. Since 2010, lead agencies for these have sought feedback from professional bodies and organizations on a number of inter-related draft policy documents. The present article tracked changes over time between the draft and final versions of these documents in New South Wales, and reviewed the original sources of literature cited within them. The strength of evidence upon which the final published versions were reportedly predicated was scrutinized. Upon examination, claims to the wider benefits of clinical supervision were found to be unconvincingly supported, not least because the examples selected by the agencies from the international literature and cited in their respective documents were either silent, parsimonious, or contradictory. Many claims remain at the level of folklore/hypothetical propositions, therefore, and stay worthy of rigorous empirical testing and faithful public reporting. Such investigations have been acknowledged as notoriously difficult to conduct. The present article identified noteworthy examples in the contemporary literature that signpost robust ways forward for empirical outcomes-orientated research, the findings from which might strengthen the evidence base of future policy documents. © 2017 Australian College of Mental Health Nurses Inc.

  7. Clinical decision rules, spinal pain classification and prediction of treatment outcome: A discussion of recent reports in the rehabilitation literature

    PubMed Central

    2012-01-01

    Clinical decision rules are an increasingly common presence in the biomedical literature and represent one strategy of enhancing clinical-decision making with the goal of improving the efficiency and effectiveness of healthcare delivery. In the context of rehabilitation research, clinical decision rules have been predominantly aimed at classifying patients by predicting their treatment response to specific therapies. Traditionally, recommendations for developing clinical decision rules propose a multistep process (derivation, validation, impact analysis) using defined methodology. Research efforts aimed at developing a “diagnosis-based clinical decision rule” have departed from this convention. Recent publications in this line of research have used the modified terminology “diagnosis-based clinical decision guide.” Modifications to terminology and methodology surrounding clinical decision rules can make it more difficult for clinicians to recognize the level of evidence associated with a decision rule and understand how this evidence should be implemented to inform patient care. We provide a brief overview of clinical decision rule development in the context of the rehabilitation literature and two specific papers recently published in Chiropractic and Manual Therapies. PMID:22726639

  8. Nursing faculty preparedness for clinical teaching.

    PubMed

    Suplee, Patricia Dunphy; Gardner, Marcia; Jerome-D'Emilia, Bonnie

    2014-03-01

    Nursing faculty who teach in clinical settings face complex situations requiring evidence-based educational and evaluative strategies, yet many have had limited preparation for these tasks. A convenience sample of 74 nursing faculty participated in a survey about clinical teaching in prelicensure nursing programs. Most faculty developed teaching skills through conferences (57%), orientation at their educational institution (53%), or exposure in graduate school (38%). Thirty-one percent reported having no preparation for clinical teaching. Faculty felt least prepared to manage students with learning, physical, or emotional disabilities and incivility. Twenty-six percent had no preparation for evaluating students in the clinical setting, and only 17% had worked with a faculty mentor. Few evidence-based teaching strategies were used by the faculty. These findings indicate gaps exist in the preparation of clinical faculty. Graduate education, comprehensive orientation programs, and continuing professional development may help to ensure faculty are effective in managing and evaluating student learning. Copyright 2014, SLACK Incorporated.

  9. Developing Memory Clinics in Primary Care: An Evidence-Based Interprofessional Program of Continuing Professional Development

    ERIC Educational Resources Information Center

    Lee, Linda; Weston, W. Wayne; Hillier, Loretta M.

    2013-01-01

    Introduction: Primary care is challenged to meet the needs of patients with dementia. A training program was developed to increase capacity for dementia care through the development of Family Health Team (FHT)-based interprofessional memory clinics. The interprofessional training program consisted of a 2-day workshop, 1-day observership, and 2-day…

  10. Diagnostic criteria, severity classification and guidelines of systemic sclerosis.

    PubMed

    Asano, Yoshihide; Jinnin, Masatoshi; Kawaguchi, Yasushi; Kuwana, Masataka; Goto, Daisuke; Sato, Shinichi; Takehara, Kazuhiko; Hatano, Masaru; Fujimoto, Manabu; Mugii, Naoki; Ihn, Hironobu

    2018-06-01

    Several effective drugs have been identified for the treatment of systemic sclerosis (SSc). However, in advanced cases, not only their effectiveness is reduced but they may be also harmful due to their side-effects. Therefore, early diagnosis and early treatment is most important for the treatment of SSc. We established diagnostic criteria for SSc in 2003 and early diagnostic criteria for SSc in 2011, for the purpose of developing evaluation of each organ in SSc. Moreover, in November 2013, the American College of Rheumatology and the European Rheumatology Association jointly developed new diagnostic criteria for increasing their sensitivity and specificity, so we revised our diagnostic criteria and severity classification of SSc. Furthermore, we have revised the clinical guideline based on the newest evidence. In particular, the clinical guideline was established by clinical questions based on evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guideline easy to use and reliable based on the newest evidence, and to present guidance as specific as possible for various clinical problems in treatment of SSc. © 2018 Japanese Dermatological Association.

  11. ACR Appropriateness Criteria® Chronic Ankle Pain.

    PubMed

    Chang, Eric Y; Tadros, Anthony S; Amini, Behrang; Bell, Angela M; Bernard, Stephanie A; Fox, Michael G; Gorbachova, Tetyana; Ha, Alice S; Lee, Kenneth S; Metter, Darlene F; Mooar, Pekka A; Shah, Nehal A; Singer, Adam D; Smith, Stacy E; Taljanovic, Mihra S; Thiele, Ralf; Kransdorf, Mark J

    2018-05-01

    Chronic ankle pain is a common clinical problem whose cause is often elucidated by imaging. The ACR Appropriateness Criteria for chronic ankle pain define best practices of image ordering. Clinical scenarios are followed by the imaging choices and their appropriateness. The information is in ordered tables with an accompanying narrative explanation to guide physicians to order the right test. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease.

    PubMed

    Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

    2014-09-01

    Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions - the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1-13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols.

  13. ACR Appropriateness Criteria® Chronic Hip Pain.

    PubMed

    Mintz, Douglas N; Roberts, Catherine C; Bencardino, Jenny T; Baccei, Steven J; Caird, Michelle S; Cassidy, R Carter; Chang, Eric Y; Fox, Michael G; Gyftopoulos, Soterios; Kransdorf, Mark J; Metter, Darlene F; Morrison, William B; Rosenberg, Zehava S; Shah, Nehal A; Small, Kirstin M; Subhas, Naveen; Tambar, Siddharth; Towers, Jeffrey D; Yu, Joseph S; Weissman, Barbara N

    2017-05-01

    Chronic hip pain is a common clinical problem whose cause is often elucidated by imaging. The ACR Appropriateness Criteria for chronic hip pain define best practices of image ordering. Clinical scenarios are followed by the imaging choices and their appropriateness. The information is in ordered tables with an accompanying narrative explanation to guide physicians to order the right test. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  14. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease

    PubMed Central

    Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

    2014-01-01

    Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions – the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1–13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols. PMID:25077519

  15. Physiotherapy in the intensive care unit: an evidence-based, expert driven, practical statement and rehabilitation recommendations

    PubMed Central

    Sommers, Juultje; Engelbert, Raoul HH; Dettling-Ihnenfeldt, Daniela; Gosselink, Rik; Spronk, Peter E; Nollet, Frans; van der Schaaf, Marike

    2015-01-01

    Objective: To develop evidence-based recommendations for effective and safe diagnostic assessment and intervention strategies for the physiotherapy treatment of patients in intensive care units. Methods: We used the EBRO method, as recommended by the ‘Dutch Evidence Based Guideline Development Platform’ to develop an ‘evidence statement for physiotherapy in the intensive care unit’. This method consists of the identification of clinically relevant questions, followed by a systematic literature search, and summary of the evidence with final recommendations being moderated by feedback from experts. Results: Three relevant clinical domains were identified by experts: criteria to initiate treatment; measures to assess patients; evidence for effectiveness of treatments. In a systematic literature search, 129 relevant studies were identified and assessed for methodological quality and classified according to the level of evidence. The final evidence statement consisted of recommendations on eight absolute and four relative contra-indications to mobilization; a core set of nine specific instruments to assess impairments and activity restrictions; and six passive and four active effective interventions, with advice on (a) physiological measures to observe during treatment (with stopping criteria) and (b) what to record after the treatment. Conclusions: These recommendations form a protocol for treating people in an intensive care unit, based on best available evidence in mid-2014. PMID:25681407

  16. Physiotherapy in the intensive care unit: an evidence-based, expert driven, practical statement and rehabilitation recommendations.

    PubMed

    Sommers, Juultje; Engelbert, Raoul H H; Dettling-Ihnenfeldt, Daniela; Gosselink, Rik; Spronk, Peter E; Nollet, Frans; van der Schaaf, Marike

    2015-11-01

    To develop evidence-based recommendations for effective and safe diagnostic assessment and intervention strategies for the physiotherapy treatment of patients in intensive care units. We used the EBRO method, as recommended by the 'Dutch Evidence Based Guideline Development Platform' to develop an 'evidence statement for physiotherapy in the intensive care unit'. This method consists of the identification of clinically relevant questions, followed by a systematic literature search, and summary of the evidence with final recommendations being moderated by feedback from experts. Three relevant clinical domains were identified by experts: criteria to initiate treatment; measures to assess patients; evidence for effectiveness of treatments. In a systematic literature search, 129 relevant studies were identified and assessed for methodological quality and classified according to the level of evidence. The final evidence statement consisted of recommendations on eight absolute and four relative contra-indications to mobilization; a core set of nine specific instruments to assess impairments and activity restrictions; and six passive and four active effective interventions, with advice on (a) physiological measures to observe during treatment (with stopping criteria) and (b) what to record after the treatment. These recommendations form a protocol for treating people in an intensive care unit, based on best available evidence in mid-2014. © The Author(s) 2015.

  17. Development of a real-time clinical decision support system upon the web mvc-based architecture for prostate cancer treatment

    PubMed Central

    2011-01-01

    Background A real-time clinical decision support system (RTCDSS) with interactive diagrams enables clinicians to instantly and efficiently track patients' clinical records (PCRs) and improve their quality of clinical care. We propose a RTCDSS to process online clinical informatics from multiple databases for clinical decision making in the treatment of prostate cancer based on Web Model-View-Controller (MVC) architecture, by which the system can easily be adapted to different diseases and applications. Methods We designed a framework upon the Web MVC-based architecture in which the reusable and extractable models can be conveniently adapted to other hospital information systems and which allows for efficient database integration. Then, we determined the clinical variables of the prostate cancer treatment based on participating clinicians' opinions and developed a computational model to determine the pretreatment parameters. Furthermore, the components of the RTCDSS integrated PCRs and decision factors for real-time analysis to provide evidence-based diagrams upon the clinician-oriented interface for visualization of treatment guidance and health risk assessment. Results The resulting system can improve quality of clinical treatment by allowing clinicians to concurrently analyze and evaluate the clinical markers of prostate cancer patients with instantaneous clinical data and evidence-based diagrams which can automatically identify pretreatment parameters. Moreover, the proposed RTCDSS can aid interactions between patients and clinicians. Conclusions Our proposed framework supports online clinical informatics, evaluates treatment risks, offers interactive guidance, and provides real-time reference for decision making in the treatment of prostate cancer. The developed clinician-oriented interface can assist clinicians in conveniently presenting evidence-based information to patients and can be readily adapted to an existing hospital information system and be easily applied in other chronic diseases. PMID:21385459

  18. Exploring the measurement properties of the osteopathy clinical teaching questionnaire using Rasch analysis.

    PubMed

    Vaughan, Brett

    2018-01-01

    Clinical teaching evaluations are common in health profession education programs to ensure students are receiving a quality clinical education experience. Questionnaires students use to evaluate their clinical teachers have been developed in professions such as medicine and nursing. The development of a questionnaire that is specifically for the osteopathy on-campus, student-led clinic environment is warranted. Previous work developed the 30-item Osteopathy Clinical Teaching Questionnaire. The current study utilised Rasch analysis to investigate the construct validity of the Osteopathy Clinical Teaching Questionnaire and provide evidence for the validity argument through fit to the Rasch model. Senior osteopathy students at four institutions in Australia, New Zealand and the United Kingdom rated their clinical teachers using the Osteopathy Clinical Teaching Questionnaire. Three hundred and ninety-nine valid responses were received and the data were evaluated for fit to the Rasch model. Reliability estimations (Cronbach's alpha and McDonald's omega) were also evaluated for the final model. The initial analysis demonstrated the data did not fit the Rasch model. Accordingly, modifications to the questionnaire were made including removing items, removing person responses, and rescoring one item. The final model contained 12 items and fit to the Rasch model was adequate. Support for unidimensionality was demonstrated through both the Principal Components Analysis/t-test, and the Cronbach's alpha and McDonald's omega reliability estimates. Analysis of the questionnaire using McDonald's omega hierarchical supported a general factor (quality of clinical teaching in osteopathy). The evidence for unidimensionality and the presence of a general factor support the calculation of a total score for the questionnaire as a sufficient statistic. Further work is now required to investigate the reliability of the 12-item Osteopathy Clinical Teaching Questionnaire to provide evidence for the validity argument.

  19. Development of a real-time clinical decision support system upon the Web MVC-based architecture for prostate cancer treatment.

    PubMed

    Lin, Hsueh-Chun; Wu, Hsi-Chin; Chang, Chih-Hung; Li, Tsai-Chung; Liang, Wen-Miin; Wang, Jong-Yi Wang

    2011-03-08

    A real-time clinical decision support system (RTCDSS) with interactive diagrams enables clinicians to instantly and efficiently track patients' clinical records (PCRs) and improve their quality of clinical care. We propose a RTCDSS to process online clinical informatics from multiple databases for clinical decision making in the treatment of prostate cancer based on Web Model-View-Controller (MVC) architecture, by which the system can easily be adapted to different diseases and applications. We designed a framework upon the Web MVC-based architecture in which the reusable and extractable models can be conveniently adapted to other hospital information systems and which allows for efficient database integration. Then, we determined the clinical variables of the prostate cancer treatment based on participating clinicians' opinions and developed a computational model to determine the pretreatment parameters. Furthermore, the components of the RTCDSS integrated PCRs and decision factors for real-time analysis to provide evidence-based diagrams upon the clinician-oriented interface for visualization of treatment guidance and health risk assessment. The resulting system can improve quality of clinical treatment by allowing clinicians to concurrently analyze and evaluate the clinical markers of prostate cancer patients with instantaneous clinical data and evidence-based diagrams which can automatically identify pretreatment parameters. Moreover, the proposed RTCDSS can aid interactions between patients and clinicians. Our proposed framework supports online clinical informatics, evaluates treatment risks, offers interactive guidance, and provides real-time reference for decision making in the treatment of prostate cancer. The developed clinician-oriented interface can assist clinicians in conveniently presenting evidence-based information to patients and can be readily adapted to an existing hospital information system and be easily applied in other chronic diseases.

  20. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications.

    PubMed

    Dweik, Raed A; Boggs, Peter B; Erzurum, Serpil C; Irvin, Charles G; Leigh, Margaret W; Lundberg, Jon O; Olin, Anna-Carin; Plummer, Alan L; Taylor, D Robin

    2011-09-01

    Measurement of fractional nitric oxide (NO) concentration in exhaled breath (Fe(NO)) is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to other ways of assessing airways disease, including asthma. While Fe(NO) measurement has been standardized, there is currently no reference guideline for practicing health care providers to guide them in the appropriate use and interpretation of Fe(NO) in clinical practice. To develop evidence-based guidelines for the interpretation of Fe(NO) measurements that incorporate evidence that has accumulated over the past decade. We created a multidisciplinary committee with expertise in the clinical care, clinical science, or basic science of airway disease and/or NO. The committee identified important clinical questions, synthesized the evidence, and formulated recommendations. Recommendations were developed using pragmatic systematic reviews of the literature and the GRADE approach. The evidence related to the use of Fe(NO) measurements is reviewed and clinical practice recommendations are provided. In the setting of chronic inflammatory airway disease including asthma, conventional tests such as FEV(1) reversibility or provocation tests are only indirectly associated with airway inflammation. Fe(NO) offers added advantages for patient care including, but not limited to (1) detecting of eosinophilic airway inflammation, (2) determining the likelihood of corticosteroid responsiveness, (3) monitoring of airway inflammation to determine the potential need for corticosteroid, and (4) unmasking of otherwise unsuspected nonadherence to corticosteroid therapy.

  1. An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications

    PubMed Central

    Dweik, Raed A.; Boggs, Peter B.; Erzurum, Serpil C.; Irvin, Charles G.; Leigh, Margaret W.; Lundberg, Jon O.; Olin, Anna-Carin; Plummer, Alan L.; Taylor, D. Robin

    2011-01-01

    Background: Measurement of fractional nitric oxide (NO) concentration in exhaled breath (FeNO) is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to other ways of assessing airways disease, including asthma. While FeNO measurement has been standardized, there is currently no reference guideline for practicing health care providers to guide them in the appropriate use and interpretation of FeNO in clinical practice. Purpose: To develop evidence-based guidelines for the interpretation of FeNO measurements that incorporate evidence that has accumulated over the past decade. Methods: We created a multidisciplinary committee with expertise in the clinical care, clinical science, or basic science of airway disease and/or NO. The committee identified important clinical questions, synthesized the evidence, and formulated recommendations. Recommendations were developed using pragmatic systematic reviews of the literature and the GRADE approach. Results: The evidence related to the use of FeNO measurements is reviewed and clinical practice recommendations are provided. Conclusions: In the setting of chronic inflammatory airway disease including asthma, conventional tests such as FEV1 reversibility or provocation tests are only indirectly associated with airway inflammation. FeNO offers added advantages for patient care including, but not limited to (1) detecting of eosinophilic airway inflammation, (2) determining the likelihood of corticosteroid responsiveness, (3) monitoring of airway inflammation to determine the potential need for corticosteroid, and (4) unmasking of otherwise unsuspected nonadherence to corticosteroid therapy. PMID:21885636

  2. Introduction to the special section on developing guidelines for the evidence-based assessment (EBA) of adult disorders.

    PubMed

    Hunsley, John; Mash, Eric J

    2005-09-01

    The goal of this special section is to encourage greater awareness of evidence-based assessment (EBA) in the development of a scientifically supported clinical psychology. In this introductory article, the authors describe the elements that authors in this special section were asked to consider in their focused reviews (including the scope of available psychometric evidence, advancements in psychopathology research, and evidence of attention to factors such as gender, age, and ethnicity in measure validation). The authors then present central issues evident in the articles that deal with anxiety, depression, personality disorders, and couple distress and in the accompanying commentaries. The authors conclude by presenting key themes emerging from the articles in this special section, including gaps in psychometric information, limited information about the utility of assessment, the discrepancy between recommended EBAs and current training and practice, and the need for further data on the process of clinical assessment.

  3. Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Kindler, Hedy L; Ismaila, Nofisat; Armato, Samuel G; Bueno, Raphael; Hesdorffer, Mary; Jahan, Thierry; Jones, Clyde Michael; Miettinen, Markku; Pass, Harvey; Rimner, Andreas; Rusch, Valerie; Sterman, Daniel; Thomas, Anish; Hassan, Raffit

    2018-05-01

    Purpose To provide evidence-based recommendations to practicing physicians and others on the management of malignant pleural mesothelioma. Methods ASCO convened an Expert Panel of medical oncology, thoracic surgery, radiation oncology, pulmonary, pathology, imaging, and advocacy experts to conduct a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and prospective and retrospective comparative observational studies published from 1990 through 2017. Outcomes of interest included survival, disease-free or recurrence-free survival, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. Results The literature search identified 222 relevant studies to inform the evidence base for this guideline. Recommendations Evidence-based recommendations were developed for diagnosis, staging, chemotherapy, surgical cytoreduction, radiation therapy, and multimodality therapy in patients with malignant pleural mesothelioma. Additional information is available at www.asco.org/thoracic-cancer-guidelines and www.asco.org/guidelineswiki .

  4. Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'

    PubMed Central

    2009-01-01

    Background In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy interventional study designs were ranked according to the likelihood that bias had been eliminated and thus it was not ideal to assess studies that addressed other types of clinical questions. This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems. Methods A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period. Results A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed. Conclusion The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required. PMID:19519887

  5. Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

    PubMed

    Sáez-Benito, Loreto; Fernandez-Llimos, Fernando; Feletto, Eleonora; Gastelurrutia, Miguel Angel; Martinez-Martinez, Fernando; Benrimoj, Shalom I

    2013-07-01

    cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

  6. Evidence-based emergency medicine. Creating a system to facilitate translation of evidence into standardized clinical practice: a preliminary report.

    PubMed

    Wright, Stewart W; Trott, Alexander; Lindsell, Christopher J; Smith, Carol; Gibler, W Brian

    2008-01-01

    The Institute of Medicine, through its landmark report concerning errors in medicine, suggests that standardization of practice through systematic development and implementation of evidence-based clinical pathways is an effective way of reducing errors in emergency systems. The specialty of emergency medicine is well positioned to develop a complete system of innovative quality improvement, incorporating best practice guidelines with performance measures and practitioner feedback mechanisms to reduce errors and therefore improve quality of care. This article reviews the construction, ongoing development, and initial impact of such a system at a large, urban, university teaching hospital and at 2 affiliated community hospitals. The Committee for Procedural Quality and Evidence-Based Practice was formed within the Department of Emergency Medicine to establish evidence-based guidelines for nursing and provider care. The committee measures the effect of such guidelines, along with other quality measures, through pre- and postguideline patient care medical record audits. These measures are fed back to the providers in a provider-specific, peer-matched "scorecard." The Committee for Procedural Quality and Evidence-Based Practice affects practice and performance within our department. Multiple physician and nursing guidelines have been developed and put into use. Using asthma as an example, time to first nebulizer treatment and time to disposition from the emergency department decreased. Initial therapeutic agent changed and documentation improved. A comprehensive, guideline-driven, evidence-based approach to clinical practice is feasible within the structure of a department of emergency medicine. High-level departmental support with dedicated personnel is necessary for the success of such a system. Internet site development (available at http://www.CPQE.com) for product storage has proven valuable. Patient care has been improved in several ways; however, consistent and complete change in provider behavior remains elusive. Physician scorecards may play a role in altering these phenomena. Emergency medicine can play a leadership role in the development of quality improvement, error reduction, and pay-for-performance systems.

  7. Korean clinical practice guideline for benign prostatic hyperplasia

    PubMed Central

    Yeo, Jeong Kyun; Choi, Hun; Bae, Jae Hyun; Kim, Jae Heon; Yang, Seong Ok; Oh, Chul Young; Cho, Young Sam; Kim, Kyoung Woo

    2016-01-01

    In 2014, the Korean Urological Association organized the Benign Prostatic Hyperplasia Guideline Developing Committee composed of experts in the field of benign prostatic hyperplasia (BPH) with the participation of the Korean Academy of Family Medicine and the Korean Continence Society to develop a Korean clinical practice guideline for BPH. The purpose of this clinical practice guideline is to provide current and comprehensive recommendations for the evaluation and treatment of BPH. The committee developed the guideline mainly by adapting existing guidelines and partially by using the de novo method. A comprehensive literature review was carried out primarily from 2009 to 2013 by using medical search engines including data from Korea. Based on the published evidence, recommendations were synthesized, and the level of evidence of the recommendations was determined by using methods adapted from the 2011 Oxford Centre for Evidence-Based Medicine. Meta-analysis was done for one key question and four recommendations. A draft guideline was reviewed by expert peer reviewers and discussed at an expert consensus meeting until final agreement was achieved. This evidence-based guideline for BPH provides recommendations to primary practitioners and urologists for the diagnosis and treatment of BPH in men older than 40 years. PMID:26966724

  8. Recommendations for genetic testing to reduce the incidence of anthracycline-induced cardiotoxicity.

    PubMed

    Aminkeng, Folefac; Ross, Colin J D; Rassekh, Shahrad R; Hwang, Soomi; Rieder, Michael J; Bhavsar, Amit P; Smith, Anne; Sanatani, Shubhayan; Gelmon, Karen A; Bernstein, Daniel; Hayden, Michael R; Amstutz, Ursula; Carleton, Bruce C

    2016-09-01

    Anthracycline-induced cardiotoxicity (ACT) occurs in 57% of treated patients and remains an important limitation of anthracycline-based chemotherapy. In various genetic association studies, potential genetic risk markers for ACT have been identified. Therefore, we developed evidence-based clinical practice recommendations for pharmacogenomic testing to further individualize therapy based on ACT risk. We followed a standard guideline development process, including a systematic literature search, evidence synthesis and critical appraisal, and the development of clinical practice recommendations with an international expert group. RARG rs2229774, SLC28A3 rs7853758 and UGT1A6 rs17863783 variants currently have the strongest and the most consistent evidence for association with ACT. Genetic variants in ABCC1, ABCC2, ABCC5, ABCB1, ABCB4, CBR3, RAC2, NCF4, CYBA, GSTP1, CAT, SULT2B1, POR, HAS3, SLC22A7, SCL22A17, HFE and NOS3 have also been associated with ACT, but require additional validation. We recommend pharmacogenomic testing for the RARG rs2229774 (S427L), SLC28A3 rs7853758 (L461L) and UGT1A6*4 rs17863783 (V209V) variants in childhood cancer patients with an indication for doxorubicin or daunorubicin therapy (Level B - moderate). Based on an overall risk stratification, taking into account genetic and clinical risk factors, we recommend a number of management options including increased frequency of echocardiogram monitoring, follow-up, as well as therapeutic options within the current standard of clinical practice. Existing evidence demonstrates that genetic factors have the potential to improve the discrimination between individuals at higher and lower risk of ACT. Genetic testing may therefore support both patient care decisions and evidence development for an improved prevention of ACT. © 2016 The British Pharmacological Society.

  9. EVIDENCE – BASED MEDICINE/PRACTICE IN SPORTS PHYSICAL THERAPY

    PubMed Central

    Lehecka, B.J.

    2012-01-01

    A push for the use of evidence‐based medicine and evidence‐based practice patterns has permeated most health care disciplines. The use of evidence‐based practice in sports physical therapy may improve health care quality, reduce medical errors, help balance known benefits and risks, challenge views based on beliefs rather than evidence, and help to integrate patient preferences into decision‐making. In this era of health care utilization sports physical therapists are expected to integrate clinical experience with conscientious, explicit, and judicious use of research evidence in order to make clearly informed decisions in order to help maximize and optimize patient well‐being. One of the more common reasons for not using evidence in clinical practice is the perceived lack of skills and knowledge when searching for or appraising research. This clinical commentary was developed to educate the readership on what constitutes evidence‐based practice, and strategies used to seek evidence in the daily clinical practice of sports physical therapy. PMID:23091778

  10. Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.

    PubMed

    Merker, Jason D; Oxnard, Geoffrey R; Compton, Carolyn; Diehn, Maximilian; Hurley, Patricia; Lazar, Alexander J; Lindeman, Neal; Lockwood, Christina M; Rai, Alex J; Schilsky, Richard L; Tsimberidou, Apostolia M; Vasalos, Patricia; Billman, Brooke L; Oliver, Thomas K; Bruinooge, Suanna S; Hayes, Daniel F; Turner, Nicholas C

    2018-06-01

    Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

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

    PubMed Central

    2013-01-01

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

  12. False dichotomies: EBM, clinical freedom, and the art of medicine.

    PubMed

    Parker, M

    2005-06-01

    According to numerous commentators, clinical freedom, the art of medicine, and, by implication, a degree of patient welfare, are threatened by evidence based medicine (EBM). As EBM has developed over the last fifteen years, claims about better evidence for medical treatments, and improvements in healthcare delivery, have been matched by critiques of EBM's reductionism and uniformity, its problematic application to individual patients, and its alleged denial of the continuing need for clinical interpretation, insight, and judgment. Most of these attacks on EBM and defences of clinical freedom fail. They are based on erroneous understandings of the relationships between inductive knowledge, clinical uncertainty, and action. Evidence based medicine is a necessary condition for clinical freedom, not a threat to it, and EBM is not something to be balanced with either clinical experience or patient preferences. The art and science of medicine are more conceptually and practically connected than the defenders of clinical freedom, whatever they conceive that to be, are willing to admit.

  13. Systematic review of emergency medicine clinical practice guidelines: Implications for research and policy.

    PubMed

    Venkatesh, Arjun K; Savage, Dan; Sandefur, Benjamin; Bernard, Kenneth R; Rothenberg, Craig; Schuur, Jeremiah D

    2017-01-01

    Over 25 years, emergency medicine in the United States has amassed a large evidence base that has been systematically assessed and interpreted through ACEP Clinical Policies. While not previously studied in emergency medicine, prior work has shown that nearly half of all recommendations in medical specialty practice guidelines may be based on limited or inconclusive evidence. We sought to describe the proportion of clinical practice guideline recommendations in Emergency Medicine that are based upon expert opinion and low level evidence. Systematic review of clinical practice guidelines (Clinical Policies) published by the American College of Emergency Physicians from January 1990 to January 2016. Standardized data were abstracted from each Clinical Policy including the number and level of recommendations as well as the reported class of evidence. Primary outcomes were the proportion of Level C equivalent recommendations and Class III equivalent evidence. The primary analysis was limited to current Clinical Policies, while secondary analysis included all Clinical Policies. A total of 54 Clinical Policies including 421 recommendations and 2801 cited references, with an average of 7.8 recommendations and 52 references per guideline were included. Of 19 current Clinical Policies, 13 of 141 (9.2%) recommendations were Level A, 57 (40.4%) Level B, and 71 (50.4%) Level C. Of 845 references in current Clinical Policies, 67 (7.9%) were Class I, 272 (32.3%) Class II, and 506 (59.9%) Class III equivalent. Among all Clinical Policies, 200 (47.5%) recommendations were Level C equivalent, and 1371 (48.9%) of references were Class III equivalent. Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are expert opinion based. Emergency medicine appears to suffer from an evidence gap that should be prioritized in the national research agenda and considered by policymakers prior to developing future quality standards.

  14. Building clinical networks: a developmental evaluation framework.

    PubMed

    Carswell, Peter; Manning, Benjamin; Long, Janet; Braithwaite, Jeffrey

    2014-05-01

    Clinical networks have been designed as a cross-organisational mechanism to plan and deliver health services. With recent concerns about the effectiveness of these structures, it is timely to consider an evidence-informed approach for how they can be developed and evaluated. To document an evaluation framework for clinical networks by drawing on the network evaluation literature and a 5-year study of clinical networks. We searched literature in three domains: network evaluation, factors that aid or inhibit network development, and on robust methods to measure network characteristics. This material was used to build a framework required for effective developmental evaluation. The framework's architecture identifies three stages of clinical network development; partner selection, network design and network management. Within each stage is evidence about factors that act as facilitators and barriers to network growth. These factors can be used to measure progress via appropriate methods and tools. The framework can provide for network growth and support informed decisions about progress. For the first time in one place a framework incorporating rigorous methods and tools can identify factors known to affect the development of clinical networks. The target user group is internal stakeholders who need to conduct developmental evaluation to inform key decisions along their network's developmental pathway.

  15. Multimodal evaluation and management of children with concussion: using our heads and available evidence.

    PubMed

    Gioia, Gerard A

    2015-01-01

    Significant attention has been focused on concussions in children, but a dearth of research evidence exists supporting clinical evaluation and management. The primary objective of this review paper is to describe a multimodal, developmentally adapted, standardized concussion assessment and active rehabilitation approach for children as young as 5 years old. This study reviews the CDC-funded research programme, including the development of tools for post-concussion symptom assessment involving the child and parent, measurement of specific neurocognitive functions and assessment of dynamic cognitive exertional effects. A clinical approach to active, individualized, moderated concussion rehabilitation management is presented, including a 10-step guide to symptom management, with a specific focus on the school challenges faced by the recovering student. To better inform concussion practice across the developmental age spectrum, a significant need exists for further research evidence to refine clinical assessment methods and develop effective treatment approaches.

  16. Multimodal Evaluation and Management of Children with Concussion: Using our heads and available evidence

    PubMed Central

    Gioia, Gerard A.

    2015-01-01

    Significant attention has been focused on concussions in children but a dearth of research evidence exists supporting clinical evaluation and management. The primary objective of this review paper is to describe a multimodal, developmentally adapted, standardized concussion assessment and active rehabilitation approach for children as young as age five. We review our CDC-funded research program including the development of tools for post-concussion symptom assessment involving the child and parent, measurement of specific neurocognitive functions, and assessment of dynamic cognitive exertional effects. A clinical approach to active, individualized, moderated concussion rehabilitation management is presented, including a ten step guide to symptom management, with a specific focus on the school challenges faced by the recovering student. To better inform concussion practice across the developmental age spectrum, a significant need exists for further research evidence to refine our clinical assessment methods and develop effective treatment approaches. PMID:25356518

  17. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.

    PubMed

    Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Rumble, R Bryan; Temple-Smolkin, Robyn; Ventura, Christina B; Nowak, Jan A

    2017-03-01

    To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Twenty-one guideline statements were established. Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented. Key Words: Molecular diagnostics; Gastrointestinal; Histology; Genetics; Oncology. Copyright © 2017 American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, American Society for Clinical Oncology, and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

  18. Brain SPECT Imaging in Complex Psychiatric Cases: An Evidence-Based, Underutilized Tool

    PubMed Central

    Amen, Daniel G; Trujillo, Manuel; Newberg, Andrew; Willeumier, Kristen; Tarzwell, Robert; Wu, Joseph C; Chaitin, Barry

    2011-01-01

    Over the past 20 years brain Single Photon Emission Computed Tomography (SPECT) imaging has developed a substantial, evidence-based foundation and is now recommended by professional societies for numerous indications relevant to psychiatric practice. Unfortunately, SPECT in clinical practice is utilized by only a handful of clinicians. This article presents a rationale for a more widespread use of SPECT in clinical practice for complex cases, and includes seven clinical applications where it may help optimize patient care. PMID:21863144

  19. Evidence-based clinical practice, [corrected] evidence-based medicine and the Cochrane collaboration.

    PubMed

    Gambrill, E

    1999-03-01

    Encouraging professionals in training and later to consider practice-related research findings when making important clinical decisions is an on-going concern. Evidenced-Based Medicine (EBM) and the Cochrane Collaboration (CC) provide a source of tools and ideas for doing so, as well as a roster of colleagues who share this interest. Evidenced-based medicine involves integrating clinical expertise with the best available external evidence from systematic research as well as considering the values and expectations of patients/clients. Advantage can be taken of educational formats developed in EBM, such as problem-based learning and critical-appraisal workshops in which participants learn how to ask key answerable questions related to important clinical practice questions (e.g., regarding effectiveness, accuracy of assessment measures, prediction, prevention, and quality of clinical practice guidelines) and to access and critically appraise related research. The Cochrane Collaboration is a world-wide network of centers that prepare, maintain, and disseminate high-quality systematic reviews on the efficacy of healthcare. These databases allow access to evidence related to clinical practice decisions. Forging reciprocal working relationships with those involved in EBM reciprocal and the CC should contribute to the pursuit of shared goals such as basing clinical decisions on the best-available evidence and involving clients as informed consumers.

  20. Development of a Clinical Framework for Mirror Therapy in Patients with Phantom Limb Pain: An Evidence-based Practice Approach.

    PubMed

    Rothgangel, Andreas; Braun, Susy; de Witte, Luc; Beurskens, Anna; Smeets, Rob

    2016-04-01

    To describe the development and content of a clinical framework for mirror therapy (MT) in patients with phantom limb pain (PLP) following amputation. Based on an a priori formulated theoretical model, 3 sources of data collection were used to develop the clinical framework. First, a review of the literature took place on important clinical aspects and the evidence on the effectiveness of MT in patients with phantom limb pain. In addition, questionnaires and semi-structured interviews were used to analyze clinical experiences and preferences of physical and occupational therapists and patients suffering from PLP regarding the application of MT. All data were finally clustered into main and subcategories and were used to complement and refine the theoretical model. For every main category of the a priori formulated theoretical model, several subcategories emerged from the literature search, patient, and therapist interviews. Based on these categories, we developed a clinical flowchart that incorporates the main and subcategories in a logical way according to the phases in methodical intervention defined by the Royal Dutch Society for Physical Therapy. In addition, we developed a comprehensive booklet that illustrates the individual steps of the clinical flowchart. In this study, a structured clinical framework for the application of MT in patients with PLP was developed. This framework is currently being tested for its effectiveness in a multicenter randomized controlled trial. © 2015 World Institute of Pain.

  1. Clinical review: Breast development in trans women receiving cross-sex hormones.

    PubMed

    Wierckx, Katrien; Gooren, Louis; T'Sjoen, Guy

    2014-05-01

    In trans women (male-to-female transsexual persons), cross-sex hormone therapy is administered to induce feminization. Breast development is an important part of feminization for most trans women. The aim of this study is to assess the effect of cross-sex hormone therapy on breast development in adult trans women. Additionally, we aimed to investigate the benefit or harm of administration of progestogens on breast development. A review of the literature in Embase, Medline, The Cochrane Library, PsycINFO databases, PubMed, and Web of Knowledge until January 2014. Effects of cross-sex hormone therapy and progestogens on breast development in trans women. Only few studies with low quality of evidence addressed these topics. The available evidence suggests that breast development is insufficient for the majority of trans women and that type and dosage of hormonal therapy seem not to have an important role on final breast size. Our knowledge concerning the natural history and effects of different cross-sex hormone therapies on breast development in trans women is extremely sparse and based on low quality of evidence. Current evidence does not provide evidence that progestogens enhance breast development in trans women. Neither do they prove the absence of such an effect. This prevents us from drawing any firm conclusion at this moment and demonstrates the need for further research to clarify these important clinical questions. © 2014 International Society for Sexual Medicine.

  2. Development and implementation of sepsis alert systems

    PubMed Central

    Harrison, Andrew M.; Gajic, Ognjen; Pickering, Brian W.; Herasevich, Vitaly

    2016-01-01

    Synopsis/Summary Development and implementation of sepsis alert systems is challenging, particularly outside the monitored intensive care unit (ICU) setting. Important barriers to wider use of sepsis alerts include evolving clinical definitions of sepsis, information overload & alert fatigue, due to suboptimal alert performance. Outside the ICU, additional barriers include differences in health care delivery models, charting behaviors, and availability of electronic data. Currently available evidence does not support routine use of sepsis alert systems in clinical practice. However, continuous improvement in both the afferent (data availability and accuracy of detection algorithms) and efferent (evidence-based decision support and smoother integration into clinical workflow) limbs of sepsis alert systems will help translate theoretical advantages into measurable patient benefit. PMID:27229639

  3. Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website.

    PubMed

    Greville-Harris, Maddy; Bostock, Jennifer; Din, Amy; Graham, Cynthia A; Lewith, George; Liossi, Christina; O'Riordan, Tim; White, Peter; Yardley, Lucy; Bishop, Felicity L

    2016-06-10

    According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos. We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial. Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative 'think aloud' study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher. The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients' stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants' experiences of using the website. We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes including patients' knowledge and capacity for making informed choices about placebos.

  4. Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website

    PubMed Central

    Greville-Harris, Maddy; Bostock, Jennifer; Din, Amy; Graham, Cynthia A; Lewith, George; Liossi, Christina; O’Riordan, Tim; White, Peter; Yardley, Lucy

    2016-01-01

    Background According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos. Objective We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial. Methods Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative ‘think aloud’ study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher. Results The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients’ stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants’ experiences of using the website. Conclusions We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes including patients’ knowledge and capacity for making informed choices about placebos. PMID:27288271

  5. Facilitating Adoption of News Tool to Develop Clinical Decision Making

    ERIC Educational Resources Information Center

    Brown, Robin T.

    2017-01-01

    This scholarly project was a non-experimental, pre/post-test design to (a) facilitate the voluntary adoption of the National Early Warning Score (NEWS), and (b) develop clinical decision making (CDM) in one cohort of junior level nursing students participating in a simulation lab. NEWS is an evidence-based predictive scoring tool developed by the…

  6. Evidence-based design and development of a VR-based treadmill system for gait research and rehabilitation of patients with Parkinson's disease.

    PubMed

    Pérez-Sanpablo, Alberto Isaac; González-Mendoza, Arturo; Quiñones-Uriostegui, Ivett; Rodríguez-Reyes, Gerardo; Núñez-Carrera, Lidia; Hernández-Arenas, Claudia; Boll-Woehrlen, Marie Catherine; Alessi Montero, Aldo

    2014-07-01

    Virtual reality (VR) in neurorehabilitation allows to reduce patient's risk and allows him to learn on a faster way. Up to now VR has been used in patients with Parkinson disease (PD) as a research tool and none of the developed systems are used in clinical practice. The goal of this project is to develop a VR-based system for gait therapy, and gait research of patients with PD designed based on published evidence. The developed system uses a digital camera to measure spatiotemporal gait parameters. The software was developed in C#, using Open-Source libraries that facilitates VR programming. The system has potential uses in clinical and research settings.

  7. Integrating research into clinical internship training bridging the science/practice gap in pediatric psychology.

    PubMed

    McQuaid, Elizabeth L; Spirito, Anthony

    2012-03-01

    Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a "capstone experience"; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the "business of science." Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists.

  8. Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings From a Review of the Evidence for an American Pain Society Clinical Practice Guideline.

    PubMed

    Gordon, Debra B; de Leon-Casasola, Oscar A; Wu, Christopher L; Sluka, Kathleen A; Brennan, Timothy J; Chou, Roger

    2016-02-01

    Acute postoperative pain is a common clinical condition that, when poorly controlled, can result in a number of significant negative consequences. The American Pain Society commissioned an evidence-based guideline on the management of postoperative pain to promote evidence-based, safe, and effective perioperative pain management. An interdisciplinary panel developed 31 key questions and inclusion criteria to guide the evidence review. Investigators reviewed 6556 abstracts from multiple electronic databases up to November 2012, an updated evidence review to October 2014, and key references suggested by expert reviewers. More than 800 primary studies not included in a systematic review and 107 systematic reviews were included. Despite a large body of evidence, a number of critical research gaps were identified where only low-quality or insufficient evidence was found to help guide clinical practice recommendations. This report identifies evidence gaps including optimal methods and timing of perioperative patient education, nonpharmacological modalities, combinations of analgesic techniques, monitoring of patient response to treatment, techniques for neuraxial and regional analgesia, and organizational care delivery models. Recommendations to help guide the design of future perioperative studies are offered. Acute postoperative pain is a common clinical condition requiring an evidence-based, planned, and multimodal approach. Despite the plethora of published evidence, much of it is weak and key questions remain unanswered. Researchers are encouraged to work together to produce strong evidence to help guide clinical decisions in perioperative pain management. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  9. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action.

    PubMed

    Rosenfeld, Richard M; Shiffman, Richard N

    2009-06-01

    Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing health-care variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective-or potentially harmful-interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. This manual describes the principles and practices used successfully by the American Academy of Otolaryngology-Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multidisciplinary applicability. The development process, which allows moving from conception to completion in 12 months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. As clinical practice guidelines become more prominent as a key metric of quality health care, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are-and are not-and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals.

  10. Clinical nurse specialists: essential resource for an effective NHS.

    PubMed

    Vidall, Cheryl; Barlow, Helen; Crowe, Maggie; Harrison, Isabel; Young, Annie

    Despite emerging evidence for the clinical and financial efficacy of the clinical nurse specialist (CNS), the provision of this role is patchy across the country. There is also a risk that incumbent CNS' may be redirected to less specialist work in trusts that do not appreciate the full value of the service that these nurses provide. Optimal and equitable patient access to CNS care will require the development of a strong evidence base showing that specialist nurses not only deliver patient-focused care, but that they can also help to meet healthcare managers' objectives of streamlined, cost-effective clinical services.

  11. Psychiatric mental health evidence-based practice.

    PubMed

    Rice, Michael J

    2008-05-01

    This article is the first in a new column focusing on evidence-based practice (EBP) in psychiatric mental health nursing. The EBP movement was strongly influenced by a British epidemiologist, Dr. Cochrane, who advocated care based on randomized clinical controlled trials in the late 1900s. Although the majority of the EBP movement is directed toward developing clinical guidelines, the critical element focuses on the therapeutic relationship and clinical judgment associated with providing care. This column will address a clinical problem, define PICO questions, report knowledge base searches, and present existing evidence. Recommendations will be offered for potential interventions and suggestions for evaluating clinical outcomes. Nurses can no longer view clinical studies as academic exercises discarded on graduation and not applied to the clinical setting. Conscientiously applying what is known about treatments and interventions of ethical, if not legal, value is consistent with the professional definition of care. J Am Psychiatr Nurses Assoc, 2008; 14(2), 107-111. DOI: 10.1177/1078390308315798.

  12. [The added value of information summaries supporting clinical decisions at the point-of-care.

    PubMed

    Banzi, Rita; González-Lorenzo, Marien; Kwag, Koren Hyogene; Bonovas, Stefanos; Moja, Lorenzo

    2016-11-01

    Evidence-based healthcare requires the integration of the best research evidence with clinical expertise and patients' values. International publishers are developing evidence-based information services and resources designed to overcome the difficulties in retrieving, assessing and updating medical information as well as to facilitate a rapid access to valid clinical knowledge. Point-of-care information summaries are defined as web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. Their validity must be assessed against marketing claims that they are evidence-based. We periodically evaluate the content development processes of several international point-of-care information summaries. The number of these products has increased along with their quality. The last analysis done in 2014 identified 26 products and found that three of them (Best Practice, Dynamed e Uptodate) scored the highest across all evaluated dimensions (volume, quality of the editorial process and evidence-based methodology). Point-of-care information summaries as stand-alone products or integrated with other systems, are gaining ground to support clinical decisions. The choice of one product over another depends both on the properties of the service and the preference of users. However, even the most innovative information system must rely on transparent and valid contents. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.

  13. A Paradigm Shift toward Evidence-Based Clinical Practice: Developing a Performance Assessment

    ERIC Educational Resources Information Center

    Wentworth, Nancy; Erickson, Lynnette B.; Lawrence, Barbara; Popham, J. Aaron; Korth, Byran

    2009-01-01

    The Clinical Practice Assessment System (CPAS), developed in response to teacher preparation program accreditation requirements, represents a paradigm shift of one university toward data-based decision-making in teacher education programs. The new assessment system is a scale aligned with INTASC Standards, which allows for observation and…

  14. Development, Impact, and Measurement of Enhanced Physical Diagnosis Skills

    ERIC Educational Resources Information Center

    Smith, Miriam A.; Burton, William B.; Mackay, Meggan

    2009-01-01

    Evidence suggests that the quality and frequency of bedside clinical examination have declined. We undertook the study to (1) determine whether intensive instruction in physical examination enhances medical student skills and (2) develop a tool to evaluate those skills using a modified observed structured clinical examination (OSCE). This was a…

  15. Designing a Clinical Framework to Guide Gross Motor Intervention Decisions for Infants and Young Children with Hypotonia

    ERIC Educational Resources Information Center

    Darrah, Johanna; O'Donnell, Maureen; Lam, Joyce; Story, Maureen; Wickenheiser, Diane; Xu, Kaishou; Jin, Xiaokun

    2013-01-01

    Clinical practice frameworks are a valuable component of clinical education, promoting informed clinical decision making based on the best available evidence and/or clinical experience. They encourage standardized intervention approaches and evaluation of practice. Based on an international project to support the development of an enhanced service…

  16. Reaching beyond the review of research evidence: a qualitative study of decision making during the development of clinical practice guidelines for disease prevention in healthcare.

    PubMed

    Richter Sundberg, Linda; Garvare, Rickard; Nyström, Monica Elisabeth

    2017-05-11

    The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on five decision-criteria: research evidence; curative/preventive effect size, severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives (i.e. a prioritization group) was assigned the task of ranking condition-intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision making process during the two-year development of national guidelines for methods of preventing disease. A qualitative inductive longitudinal case study approach was used to investigate the decision making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis. Conventional and summative qualitative content analysis was used to analyse data. The guideline development model was modified ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs. low adoptability of recommendation; insufficient evidence vs. high urgency to act; and incoherence in assessment and prioritization within and between four different lifestyle areas. The formal guideline development model guided the decision-criteria used, but three new or revised criteria were added by the group: 'clinical knowledge and experience', 'potential guideline consequences' and 'needs of vulnerable groups'. The frequency of the use of various criteria in discussions varied over time. Gender, professional status, and interpersonal skills were perceived to affect individuals' relative influence on group discussions. The study shows that guideline development groups make compromises between rigour and pragmatism. The formal guideline development model incorporated multiple aspects, but offered few details on how the different criteria should be handled. The guideline development model devoted little attention to the role of the decision-model and group-related factors. Guideline development models could benefit from clarifying the role of the group-related factors and non-research evidence, such as clinical experience and ethical considerations, in decision-processes during guideline development.

  17. An academic-health service partnership in nursing: lessons from the field.

    PubMed

    Granger, Bradi B; Prvu-Bettger, Janet; Aucoin, Julia; Fuchs, Mary Ann; Mitchell, Pamela H; Holditch-Davis, Diane; Roth, Deborah; Califf, Robert M; Gilliss, Catherine L

    2012-03-01

    To describe the development of an academic-health services partnership undertaken to improve use of evidence in clinical practice. Academic health science schools and health service settings share common elements of their missions: to educate, participate in research, and excel in healthcare delivery, but differences in the business models, incentives, and approaches to problem solving can lead to differences in priorities. Thus, academic and health service settings do not naturally align their leadership structures or work processes. We established a common commitment to accelerate the appropriate use of evidence in clinical practice and created an organizational structure to optimize opportunities for partnering that would leverage shared resources to achieve our goal. A jointly governed and funded institute integrated existing activities from the academic and service sectors. Additional resources included clinical staff and student training and mentoring, a pilot research grant-funding program, and support to access existing data. Emergent developments include an appreciation for a wider range of investigative methodologies and cross-disciplinary teams with skills to integrate research in daily practice and improve patient outcomes. By developing an integrated leadership structure and commitment to shared goals, we developed a framework for integrating academic and health service resources, leveraging additional resources, and forming a mutually beneficial partnership to improve clinical outcomes for patients. Structurally integrated academic-health service partnerships result in improved evidence-based patient care delivery and in a stronger foundation for generating new clinical knowledge, thus improving patient outcomes. © 2012 Sigma Theta Tau International.

  18. Multidimensional Diagnostic Criteria for Chronic Pain: Introduction to the ACTTION-American Pain Society Pain Taxonomy (AAPT).

    PubMed

    Dworkin, Robert H; Bruehl, Stephen; Fillingim, Roger B; Loeser, John D; Terman, Gregory W; Turk, Dennis C

    2016-09-01

    A variety of approaches have been used to develop diagnostic criteria for chronic pain. The published evidence of the reliability and validity of existing diagnostic criteria is limited, and these criteria have typically not been used in clinical practice. The availability of a widely accepted, consistently applied, and evidence-based taxonomy of diagnostic criteria would improve the quality of clinical research on chronic pain and would be of great value in clinical practice. To address the need for evidence-based diagnostic criteria for the major chronic pain conditions, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration and the American Pain Society (APS) have collaborated on the development of the ACTTION-APS Pain Taxonomy (AAPT). AAPT provides a multidimensional framework that is applied systematically in the development of diagnostic criteria. This article (1) describes the background and rationale for AAPT; (2) presents the AAPT taxonomy and the specific conditions for which diagnostic criteria have been developed (to be published separately); (3) briefly reviews the 5 dimensions that constitute the AAPT multidimensional framework and describes the 7 accompanying articles that discuss these dimensions and other important issues involving AAPT; and (4) provides an overview of next steps, specifically, the general processes by which the initial set of diagnostic criteria (for which the evidence base has been drawn from the literature, systematic reviews, and secondary analyses of existing databases) will undergo additional assessments of reliability and validity. To address the need for evidence-based diagnostic criteria for the major chronic pain conditions, the AAPT provides a multidimensional framework that is applied systematically in the development of diagnostic criteria. The long-term objective of AAPT is to advance the scientific understanding of chronic pain and its treatment. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  19. Deprescribing benzodiazepine receptor agonists: Evidence-based clinical practice guideline.

    PubMed

    Pottie, Kevin; Thompson, Wade; Davies, Simon; Grenier, Jean; Sadowski, Cheryl A; Welch, Vivian; Holbrook, Anne; Boyd, Cynthia; Swenson, Robert; Ma, Andy; Farrell, Barbara

    2018-05-01

    To develop an evidence-based guideline to help clinicians make decisions about when and how to safely taper and stop benzodiazepine receptor agonists (BZRAs); to focus on the highest level of evidence available and seek input from primary care professionals in the guideline development, review, and endorsement processes. The overall team comprised 8 clinicians (1 family physician, 2 psychiatrists, 1 clinical psychologist, 1 clinical pharmacologist, 2 clinical pharmacists, and 1 geriatrician) and a methodologist; members disclosed conflicts of interest. For guideline development, a systematic process was used, including the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Evidence was generated by conducting a systematic review of BZRA deprescribing trials for insomnia, as well as performing a review of reviews of the harms of continued BZRA use and narrative syntheses of patient preferences and resource implications. This evidence and GRADE quality of evidence ratings were used to generate recommendations. The team refined guideline content and recommendations through consensus and synthesized clinical considerations to address front-line clinician questions. The draft guideline was reviewed by clinicians and stakeholders. We recommend that deprescribing (tapering slowly) of BZRAs be offered to elderly adults (≥ 65 years) who take BZRAs, regardless of duration of use, and suggest that deprescribing (tapering slowly) be offered to adults aged 18 to 64 who have used BZRAs for more than 4 weeks. These recommendations apply to patients who use BZRAs to treat insomnia on its own (primary insomnia) or comorbid insomnia where potential underlying comorbidities are effectively managed. This guideline does not apply to those with other sleep disorders or untreated anxiety, depression, or other physical or mental health conditions that might be causing or aggravating insomnia. Benzodiazepine receptor agonists are associated with harms, and therapeutic effects might be short term. Tapering BZRAs improves cessation rates compared with usual care without serious harms. Patients might be more amenable to deprescribing conversations if they understand the rationale (potential for harm), are involved in developing the tapering plan, and are offered behavioural advice. This guideline provides recommendations for making decisions about when and how to reduce and stop BZRAs. Recommendations are meant to assist with, not dictate, decision making in conjunction with patients. Copyright© the College of Family Physicians of Canada.

  20. Linking quality indicators to clinical trials: an automated approach

    PubMed Central

    Coiera, Enrico; Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B.

    2017-01-01

    Abstract Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials, is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of 522 quality of care indicators for 22 common conditions drawn from the CareTrack study were automatically mapped to outcome measures reported in 13 971 trials from ClinicalTrials.gov. Intervention Text mining methods extracted phrases mentioning indicators and outcome phrases, and these were compared using the Levenshtein edit distance ratio to measure similarity. Main Outcome Measure Number of care indicators that mapped to outcome measures in clinical trials. Results While only 13% of the 522 CareTrack indicators were thought to have Level I or II evidence behind them, 353 (68%) could be directly linked to randomized controlled trials. Within these 522, 50 of 70 (71%) Level I and II evidence-based indicators, and 268 of 370 (72%) Level V (consensus-based) indicators could be linked to evidence. Of the indicators known to have evidence behind them, only 5.7% (4 of 70) were mentioned in the trial reports but were missed by our method. Conclusions We automatically linked indicators to clinical trial registrations with high precision. Whilst the majority of quality indicators studied could be directly linked to research evidence, a small portion could not and these require closer scrutiny. It is feasible to support the process of indicator development using automated methods to identify research evidence. PMID:28651340

  1. [Why controlled studies may lead to misleading and unconfirmed therapeutic concepts--a critical view of evidence-based medicine].

    PubMed

    Flachskampf, F A

    2002-03-01

    The concept of evidence-based medicine has gathered widespread support during recent years. While this concept has clear merits in compiling and qualifying up-to-date information for clinical decisions, it should be viewed with caution as the sole valid knowledge source for clinical decision-making. The limitations of such an approach are particularly striking when reviewing two key developments in modern cardiology, fibrinolysis and acute percutaneous intervention in acute myocardial infarction. In both cases, early studies and meta-analyses showed no benefit for these therapeutic interventions over earlier treatment. Only after further refinement (mainly in dosage, time window, concomitant heparin therapy for fibrinolysis, and the introduction of stents and IIb/IIIa inhibitors for acute intervention) did these therapies become universally acknowledged. It is therefore crucial to understand that especially for physicians actively participating in the development of a clinical field clinical decisions cannot be exclusively based on published evidence. Another important problem to consider is the time gap between the emergence of new therapies and the publication and reception by the medical audience, in particular in rapidly evolving fields as cardiology. While it is clear that clinical decision-making must be backed by solid knowledge of the published evidence, in particular the specialist involved in-depth in the field may use not yet proven therapeutic concepts and measures to the patient's advantage.

  2. Evidence mapping: illustrating an emerging methodology to improve evidence-based practice in youth mental health.

    PubMed

    Hetrick, Sarah E; Parker, Alexandra G; Callahan, Patrick; Purcell, Rosemary

    2010-12-01

    Within the field of evidence-based practice, a process termed 'evidence mapping' is emerging as a less exhaustive yet systematic and replicable methodology that allows an understanding of the extent and distribution of evidence in a broad clinical area, highlighting both what is known and where gaps in evidence exist. This article describes the general principles of mapping methodology by using illustrations derived from our experience conducting an evidence map of interventions for youth mental-health disorders. Evidence maps are based on an explicit research question relating to the field of enquiry, which may vary in depth, but should be informed by end-users. The research question then drives the search for, and collection of, appropriate studies utilizing explicit and reproducible methods at each stage. This includes clear definition of components of the research question, development of a thorough and reproducible search strategy, development of explicit inclusion and exclusion criteria, and transparent decisions about the level of information to be obtained from each study. Evidence mapping is emerging as a rigorous methodology for gathering and disseminating up-to-date information to end-users. Thoughtful planning and assessment of available resources (e.g. staff, time, budget) are required by those applying this methodology to their particular field of clinical enquiry given the potential scope of the work. The needs of the end-user need to be balanced with available resources. Information derived needs to be effectively communicated, with the uptake of that evidence into clinical practice the ultimate aim. © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd.

  3. The paradox of natural products as pharmaceuticals. Experimental evidences of a mango stem bark extract.

    PubMed

    Núñez-Sellés, Alberto J; Delgado-Hernández, René; Garrido-Garrido, Gabino; García-Rivera, Dagmar; Guevara-García, Mariela; Pardo-Andreu, Gilberto L

    2007-05-01

    Recent findings regarding basic, pre-clinical and clinical studies on a mango stem bark extract (MSBE) developed in Cuba (Vimang) on an industrial scale are summarized. Ethnomedical studies, extract reproducibility, biological effects and clinical evaluations in terms of patient quality of life are described as experimental evidences to support the statement that natural products, even being a mixture of compounds, could be as effective as "monoceuticals" for medical uses. Discussion about the use of "monoceuticals" versus "natureceuticals" in health care and medicine is based on effectiveness and availability, taking Vimang as an example of a natural product with supported scientific evidence to be used as antioxidant, analgesic, anti-inflammatory and immunomodulator.

  4. Diagnosis of Acute Gout: A Clinical Practice Guideline From the American College of Physicians.

    PubMed

    Qaseem, Amir; McLean, Robert M; Starkey, Melissa; Forciea, Mary Ann

    2017-01-03

    The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the diagnosis of gout. This guideline is based on a systematic review of published studies on gout diagnosis, identified using several databases, from database inception to February 2016. Evaluated outcomes included the accuracy of the test results; intermediate outcomes (results of laboratory and radiographic tests, such as serum urate and synovial fluid crystal analysis and radiographic or ultrasonography changes); clinical decision making (additional testing and pharmacologic or dietary management); short-term clinical (patient-centered) outcomes, such as pain and joint swelling and tenderness; and adverse effects of the tests. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. The target audience for this guideline includes all clinicians, and the target patient population includes adults with joint inflammation suspected to be gout. ACP recommends that clinicians use synovial fluid analysis when clinical judgment indicates that diagnostic testing is necessary in patients with possible acute gout. (Grade: weak recommendation, low-quality evidence).

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2015-12-01

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

  7. Evidence based mental healthcare and service innovation: review of concepts and challenges.

    PubMed

    Kouimtsidis, Ch; John-Smith, St; Kemp, P; Ikkos, G

    2013-01-01

    Health provision systems in the developed western nations are currently facing major financial challenges. In order to meet these challenges, a number of new approaches used to assist the provision of health have been introduced, including the practice of health professionals. These approaches utilize specific methods of data capture and summarization such as: evidence based medicine (EBM) and practice guidelines. Evidence is generated from systematic clinical research as well as reported clinical experience and individually case based empirical evidence. All types of research though (quantitative or qualitative) have limitations. Similarly all types of evidence have advantages and disadvantages and can be complimentary to each other. Evidencebased individual decision (EBID) making is the commonest evidence-based medicine as practiced by the individual clinician in making decisions about the care of the individual patient. It involves integrating individual clinical expertise with the best available external clinical evidence from systematic research. However this sort of evidence-based medicine, focuses excessively on the individual (potentially at the expense of others) in a system with limited budgets. Evidence-based guidelines (EBG) also support the practice of evidence-based medicine but at the organizational or institutional level. The main aim is to identify which interventions, over a range of patients, work best and which is cost-effective in order to guide service development and provision at a strategic level. Doing this effectively is a scientific and statistical skill in itself and the quality of guidelines is based primarily on the quality research evidence. It is important to note that lack of systematic evidence to support an intervention does not automatically mean that an intervention must instantly be abandoned. It is also important that guidelines are understood for what they are, i.e. not rules, or complete statements of knowledge. EBM will never have enough suitable evidence for all and every aspects of health provision in every locality. Innovation signifies a substantial positive change compared to gradual or incremental changes. Innovation using inductive reasoning has to play a major role within health care system and it is applicable to all three level of service provision: clinical practice, policy and organisation structure. The aim of this paper is to examine critically the above concepts and their complimentary role in supporting provision of health care systems which are suitable for the requirements of the population, affordable, deliverable, flexible and adaptable to social changes.

  8. Clinical practice guidelines for the treatment of primary liver cancer with integrative traditional Chinese and Western medicine.

    PubMed

    Ling, Chang-Quan; Fan, Jia; Lin, Hong-Sheng; Shen, Feng; Xu, Zhen-Ye; Lin, Li-Zhu; Qin, Shu-Kui; Zhou, Wei-Ping; Zhai, Xiao-Feng; Li, Bai; Zhou, Qing-Hui

    2018-05-17

    Traditional Chinese medicine (TCM) is an important part of the treatment of primary liver cancer (PLC) in China; however, the current instructions for the integrative use of traditional Chinese and Western medicine for PLC are mostly based on expert opinion. There is no evidence-based guideline for clinical practice in this field. Therefore, the Shanghai Association of Chinese Integrative Medicine has established a multidisciplinary working group to develop this guideline, which focuses on the most important questions about the use of TCM during PLC treatment. This guideline was developed following the methodological process recommended by the World Health Organization Handbook for Guideline Development. Two rounds of questionnaire survey were performed to identify clinical questions; published evidence was searched; the Grading of Recommendations Assessment, Development and Evaluation approach was used to evaluate the body of evidence; and recommendations were formulated by combining the quality of evidence, patient preferences and values, and other risk factors. The guideline was written based on the Reporting Items for Practice Guidelines in Healthcare tool. This guideline contains 10 recommendations related to 8 questions, including recommendations for early treatment by TCM after surgery, TCM combined with transcatheter arterial chemoembolization for advanced PLC, TCM drugs for external use, and acupuncture and moxibustion therapy. Copyright © 2018 Shanghai Changhai Hospital. Published by Elsevier B.V. All rights reserved.

  9. The Utrecht questionnaire (U-CEP) measuring knowledge on clinical epidemiology proved to be valid.

    PubMed

    Kortekaas, Marlous F; Bartelink, Marie-Louise E L; de Groot, Esther; Korving, Helen; de Wit, Niek J; Grobbee, Diederick E; Hoes, Arno W

    2017-02-01

    Knowledge on clinical epidemiology is crucial to practice evidence-based medicine. We describe the development and validation of the Utrecht questionnaire on knowledge on Clinical epidemiology for Evidence-based Practice (U-CEP); an assessment tool to be used in the training of clinicians. The U-CEP was developed in two formats: two sets of 25 questions and a combined set of 50. The validation was performed among postgraduate general practice (GP) trainees, hospital trainees, GP supervisors, and experts. Internal consistency, internal reliability (item-total correlation), item discrimination index, item difficulty, content validity, construct validity, responsiveness, test-retest reliability, and feasibility were assessed. The questionnaire was externally validated. Internal consistency was good with a Cronbach alpha of 0.8. The median item-total correlation and mean item discrimination index were satisfactory. Both sets were perceived as relevant to clinical practice. Construct validity was good. Both sets were responsive but failed on test-retest reliability. One set took 24 minutes and the other 33 minutes to complete, on average. External GP trainees had comparable results. The U-CEP is a valid questionnaire to assess knowledge on clinical epidemiology, which is a prerequisite for practicing evidence-based medicine in daily clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. [A Study of the Evidence-Based Nursing Practice Competence of Nurses and Its Clinical Applications].

    PubMed

    Hsu, Li-Ling; Hsieh, Suh-Ing; Huang, Ya-Hsuan

    2015-10-01

    Nurses must develop competence in evidence-based nursing in order to provide the best practice medical care to patients. Evidence-based nursing uses issue identification, data mining, and information consolidation from the related medical literature to help nurses find the best evidence. Therefore, for medical institutions to provide quality clinical care, it is necessary for nurses to develop competence in evidence-based nursing. This study aims to explore the effect of a fundamental evidence-based nursing course, as a form of educational intervention, on the development of evidence-based nursing knowledge, self-efficacy in evidence-based practice activities, and outcome expectations of evidence-based practice in nurse participants. Further the competence of these nurses in overcoming obstacles in evidence-based nursing practice. This quasi-experimental study used a pre-post test design with a single group of participants. A convenience sample of 34 nurses from a municipal hospital in northern Taiwan received 8 hours of a fundamental evidence-based nursing course over a two-week period. Participants were asked to complete four questionnaires before and after the intervention. The questionnaires measured the participants' basic demographics, experience in mining the medical literature, evidence-based nursing knowledge, self-efficacy in evidence-based practice activities, outcome expectations of evidence-based practice, competence in overcoming obstacles in evidence-based nursing practice, and learning satisfaction. Collected data was analyzed using paired t, Wilcoxon Signed Rank, and McNemar tests to measure the differences among participants' evidence-based nursing knowledge and practice activities before and after the workshop. The nurses demonstrated significantly higher scores from pre-test to post-test in evidence-based nursing knowledge II, self-efficacy in evidence-based nursing practice activities, and outcome expectations of evidence-based practice. Although the differences did not reach statistical significance, the post-test scores were significantly lower than pre-test scores in terms of the measurement of the nurses' obstacles in evidence-based nursing practice, which indicates significant improvements from pre-test to post-test in terms of the competence of participants in overcoming obstacles in evidence-based nursing practice. The intervention was found to be effective in improving the evidence-based nursing knowledge, self-efficacy in evidence-based nursing practice activities, and outcome expectations of evidence-based practice of participants and effective in reducing their obstacles in evidence-based nursing practice. Medical institutions should provide evidence-based nursing courses on a regular basis as a part of in-service education for nurses in order to help nurses develop the evidence-based nursing knowledge and practical competence required to provide quality clinical care.

  11. Advancing the Scientific Foundation for Evidence-Based Practice in Clinical Child and Adolescent Psychology.

    PubMed

    Roberts, Michael C; Blossom, Jennifer B; Evans, Spencer C; Amaro, Christina M; Kanine, Rebecca M

    2017-01-01

    Evidence-based practice (EBP) has become a central focus in clinical child and adolescent psychology. As originally defined, EBP in psychology is the integration of the best available research evidence, patient characteristics, and clinical expertise. Although evidence-based perspectives have garnered widespread acceptance in recent years, there has also been some confusion and disagreement about the 3-part definition of EBP, particularly the role of research. In this article, we first provide a brief review of the development of EBP in clinical child and adolescent psychology. Next, we outline the following 4 points to help clarify the understanding of EBP: (a) knowledge should not be confused with epistemic processes, (b) research on clinician and client factors is needed for EBP, (c) research on assessment is needed for EBP, and (d) the 3-part conceptualization of EBP can serve as a useful framework to guide research. Based on these principles, we put forth a slightly revised conceptualization of EBP, in which the role of research is expanded and more clearly operationalized. Finally, based on our review of the literature, we offer illustrative examples of specific directions for future research to advance the evidence base for EBP in clinical child and adolescent psychology.

  12. Translating knowledge into best practice care bundles: a pragmatic strategy for EBP implementation via moving postprocedural pain management nursing guidelines into clinical practice.

    PubMed

    Saunders, Hannele

    2015-07-01

    To describe quantitative and qualitative best evidence as sources for practical interventions usable in daily care delivery in order to integrate best evidence into clinical decision-making at local practice settings. To illustrate the development, implementation and evaluation of a pain management nursing care bundle based on a clinical practice guideline via a real-world clinical exemplar. Successful implementation of evidence-based practice requires consistent integration of best evidence into daily clinical decision-making. Best evidence comprises high-quality knowledge summarised in systematic reviews and translated into guidelines. However, consistent integration of guidelines into care delivery remains challenging, partly due to guidelines not being in a usable form for daily practice or relevant for the local context. A position paper with a clinical exemplar of a nurse-led, evidence-based quality improvement project to design, implement and evaluate a pain management care bundle translated from a national nursing guideline. A pragmatic approach to integrating guidelines into daily practice is presented. Best evidence from a national nursing guideline was translated into a pain management care bundle and integrated into daily practice in 15 medical-surgical (med-surg) units of nine hospitals of a large university hospital system in Finland. Translation of best evidence from guidelines into usable form as care bundles adapted to the local setting may increase implementation and uptake of guidelines and improve quality and consistency of care delivery. A pragmatic approach to translating a nursing guideline into a pain management care bundle to incorporate best evidence into daily practice may help achieve more consistent and equitable integration of guidelines into care delivery, and better quality of pain management and patient outcomes. © 2015 John Wiley & Sons Ltd.

  13. Evaluation systems for clinical governance development: a comparative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  14. The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints.

    PubMed

    Lassere, Marissa N

    2008-06-01

    There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Section 2 is a systematic, historical review of the biomarker-surrogate endpoint literature with special reference to the nomenclature, the systems of classification and statistical methods developed for their evaluation. In Section 3 an explicit, criterion-based, quantitative, multidimensional hierarchical levels of evidence schema - Biomarker-Surrogacy Evaluation Schema - is proposed to evaluate and co-ordinate the multiple dimensions (biological, epidemiological, statistical, clinical trial and risk-benefit evidence) of the biomarker clinical endpoint relationships. The schema systematically evaluates and ranks the surrogacy status of biomarkers and surrogate endpoints using defined levels of evidence. The schema incorporates the three independent domains: Study Design, Target Outcome and Statistical Evaluation. Each domain has items ranked from zero to five. An additional category called Penalties incorporates additional considerations of biological plausibility, risk-benefit and generalizability. The total score (0-15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. The term ;surrogate' is restricted to markers attaining Levels 1 or 2 only. Surrogacy status of markers can then be directly compared within and across different areas of medicine to guide individual, trial-based or drug-development decisions. This schema would facilitate communication between clinical, researcher, regulatory, industry and consumer participants necessary for evaluation of the biomarker-surrogate-clinical endpoint relationship in their different settings.

  15. Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy

    PubMed Central

    Van der Wees, Philip J; Hendriks, Erik JM; Custers, Jan WH; Burgers, Jako S; Dekker, Joost; de Bie, Rob A

    2007-01-01

    Background Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program. Method Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update. Results Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria. Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved. Conclusion As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program. PMID:18036215

  16. Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy.

    PubMed

    Van der Wees, Philip J; Hendriks, Erik J M; Custers, Jan W H; Burgers, Jako S; Dekker, Joost; de Bie, Rob A

    2007-11-23

    Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program. Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update. Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria. Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved. As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program.

  17. StaR Child Health: improving global standards for child health research.

    PubMed

    Offringa, Martin; Needham, Allison C; Chan, Winnie W Y

    2013-11-01

    Standards for Research (StaR) in Child Health, founded in 2009, addresses the current scarcity of and deficiencies in pediatric clinical trials. StaR Child Health brings together leading international experts devoted to developing practical, evidence-based standards to enrich the reliability and relevance of pediatric clinical research. Through a systematic "knowledge to action" plan, StaR Child Health creates opportunities to improve the evidence base for child health across the world. To date, six standards have been published and four more are under development. It is now time to use these standards. Improving the design, conduct and reporting of pediatric clinical trials will ultimately advance the quality of health care provided to children across the globe. Crown Copyright © 2013. All rights reserved.

  18. Humanistic psychotherapy research 1990-2015: from methodological innovation to evidence-supported treatment outcomes and beyond.

    PubMed

    Angus, Lynne; Watson, Jeanne Cherry; Elliott, Robert; Schneider, Kirk; Timulak, Ladislav

    2015-01-01

    Over the past 25 years, humanistic psychotherapy (HP) researchers have actively contributed to the development and implementation of innovative practice-informed research measures and coding systems. Qualitative and quantitative research findings, including meta-analyses, support the identification of HP approaches as evidence-based treatments for a variety of psychological conditions. Implications for future psychotherapy research, training, and practice are discussed in terms of addressing the persistent disjunction between significant HP research productivity and relatively low support for HP approaches in university-based clinical training programs, funding agencies, and government-supported clinical guidelines. Finally, specific recommendations are provided to further enhance and expand the impact of HP research for clinical training programs and the development of treatment guidelines.

  19. Methodology for AACT evidence-based recommendations on the use of intravenous lipid emulsion therapy in poisoning.

    PubMed

    Gosselin, Sophie; Morris, Martin; Miller-Nesbitt, Andrea; Hoffman, Robert S; Hayes, Bryan D; Turgeon, Alexis F; Gilfix, Brian M; Grunbaum, Ami M; Bania, Theodore C; Thomas, Simon H L; Morais, José A; Graudins, Andis; Bailey, Benoit; Mégarbane, Bruno; Calello, Diane P; Levine, Michael; Stellpflug, Samuel J; Hoegberg, Lotte C G; Chuang, Ryan; Stork, Christine; Bhalla, Ashish; Rollins, Carol J; Lavergne, Valéry

    2015-07-01

    Intravenous lipid emulsion (ILE) therapy is a novel treatment that was discovered in the last decade. Despite unclear understanding of its mechanisms of action, numerous and diverse publications attested to its clinical use. However, current evidence supporting its use is unclear and recommendations are inconsistent. To assist clinicians in decision-making, the American Academy of Clinical Toxicology created a workgroup composed of international experts from various clinical specialties, which includes representatives of major clinical toxicology associations. Rigorous methodology using the Appraisal of Guidelines for Research and Evaluation or AGREE II instrument was developed to provide a framework for the systematic reviews for this project and to formulate evidence-based recommendations on the use of ILE in poisoning. Systematic reviews on the efficacy of ILE in local anesthetic toxicity and non-local anesthetic poisonings as well as adverse effects of ILE are planned. A comprehensive review of lipid analytical interferences and a survey of ILE costs will be developed. The evidence will be appraised using the GRADE system. A thorough and transparent process for consensus statements will be performed to provide recommendations, using a modified Delphi method with two rounds of voting. This process will allow for the production of useful practice recommendations for this therapy.

  20. Assessing Competencies in a Master of Science in Clinical Research Program: The Comprehensive Competency Review.

    PubMed

    Robinson, Georgeanna F W B; Moore, Charity G; McTigue, Kathleen M; Rubio, Doris M; Kapoor, Wishwa N

    2015-12-01

    Competencies in Master of Science Clinical Research programs are becoming increasingly common. However, students and programs can only benefit fully from competency-based education if students' competence is formally assessed. Prior to a summative assessment, students must have at least one formative, formal assessment to be sure they are developing competence appropriate for their stage of training. This paper describes the comprehensive competency review (CCR), a milestone for MS students in Clinical Research at the University of Pittsburgh's Institute for Clinical Research Education. The CCR involves metacognitive reflection of the student's learning as a whole, written evidence of each competency, a narrative explaining the choice of evidence for demonstrating competencies, and a meeting in which two faculty members review the evidence and solicit further oral evidence of competence. CCRs allow for individualized feedback at the midpoint in degree programs, providing students with confidence that they will have the means and strategies to develop competence in all areas by the summative assessment of competence at their thesis defense. CCRs have also provided programmatic insight on the need for curricular revisions and additions. These benefits outweigh the time cost on the part of students and faculty in the CCR process. © 2015 Wiley Periodicals, Inc.

  1. Assessing Competencies in a Master of Science in Clinical Research Program: The Comprehensive Competency Review

    PubMed Central

    Moore, Charity G.; McTigue, Kathleen M.; Rubio, Doris M.; Kapoor, Wishwa N.

    2015-01-01

    Abstract Competencies in Master of Science Clinical Research programs are becoming increasingly common. However, students and programs can only benefit fully from competency‐based education if students’ competence is formally assessed. Prior to a summative assessment, students must have at least one formative, formal assessment to be sure they are developing competence appropriate for their stage of training. This paper describes the comprehensive competency review (CCR), a milestone for MS students in Clinical Research at the University of Pittsburgh's Institute for Clinical Research Education. The CCR involves metacognitive reflection of the student's learning as a whole, written evidence of each competency, a narrative explaining the choice of evidence for demonstrating competencies, and a meeting in which two faculty members review the evidence and solicit further oral evidence of competence. CCRs allow for individualized feedback at the midpoint in degree programs, providing students with confidence that they will have the means and strategies to develop competence in all areas by the summative assessment of competence at their thesis defense. CCRs have also provided programmatic insight on the need for curricular revisions and additions. These benefits outweigh the time cost on the part of students and faculty in the CCR process. PMID:26332763

  2. Evidence-based practice guideline of Chinese herbal medicine for primary open-angle glaucoma (qingfeng -neizhang).

    PubMed

    Yang, Yingxin; Ma, Qiu-Yan; Yang, Yue; He, Yu-Peng; Ma, Chao-Ting; Li, Qiang; Jin, Ming; Chen, Wei

    2018-03-01

    Primary open angle glaucoma (POAG) is a chronic, progressive optic neuropathy. The aim was to develop an evidence-based clinical practice guideline of Chinese herbal medicine (CHM) for POAG with focus on Chinese medicine pattern differentiation and treatment as well as approved herbal proprietary medicine. The guideline development group involved in various pieces of expertise in contents and methods. Authors searched electronic databases include CNKI, VIP, Sino-Med, Wanfang data, PubMed, the Cochrane Library, EMBASE, as well as checked China State Food and Drug Administration (SFDA) from the inception of these databases to June 30, 2015. Systematic reviews and randomized controlled trials of Chinese herbal medicine treating adults with POAG were evaluated. Risk of bias tool in the Cochrane Handbook and evidence strength developed by the GRADE group were applied for the evaluation, and recommendations were based on the findings incorporating evidence strength. After several rounds of Expert consensus, the final guideline was endorsed by relevant professional committees. CHM treatment principle and formulae based on pattern differentiation together with approved patent herbal medicines are the main treatments for POAG, and the diagnosis and treatment focusing on blood related patterns is the major domain. CHM therapy alone or combined with other conventional treatment reported in clinical studies together with Expert consensus were recommended for clinical practice.

  3. The process of collecting and evaluating evidences for the development of Guidelines for the management of rheumatoid arthritis, Japan College of Rheumatology 2014: Utilization of GRADE approach.

    PubMed

    Kojima, Masayo; Nakayama, Takeo; Kawahito, Yutaka; Kaneko, Yuko; Kishimoto, Mitsumasa; Hirata, Shintaro; Seto, Yohei; Endo, Hirahito; Ito, Hiromu; Kojima, Toshihisa; Nishida, Keiichiro; Matsushita, Isao; Tsutani, Kiichiro; Igarashi, Ataru; Kamatani, Naoyuki; Hasegawa, Mieko; Miyasaka, Nobuyuki; Yamanaka, Hisashi

    2016-01-01

    To describe the process of collecting and evaluating evidence for treating rheumatoid arthritis (RA) for developing clinical practice guidelines (CPGs) for rheumatologists in Japan. The task force comprised rheumatologists, epidemiologists, health economists, and patients. First, the critical outcomes were determined according to a three-round Delphi method, and eight topics with 88 clinical questions (CQs) were formulated. A systematic review of CQs was conducted using the Cochran Database of Systematic Reviews, MEDLINE, and Japana Centra Revvo Medicina (2003-2012). A questionnaire survey and focus group interview were performed to capture the patients' values and preferences. Data from the National Health Insurance drug price list and product information provided by pharmaceutical companies were collected to evaluate drug cost and safety. The GRADE approach was used to describe the evidence quality and determine the strength of recommendations. Recommendations were developed using a modified Delphi method by a multidisciplinary panel including patients. Eight meetings and frequent e-mail communications were conducted to draft a quality assessment of evidence and recommendations. For 88 CQs, recommendation statements were determined. Using the GRADE approach, new CPGs successfully addressed important clinical issues for treating RA patients. Timely updating of recommendations should be routinely considered.

  4. Alzheimer’s Disease Drug Development in 2008 and Beyond: Problems and Opportunities

    PubMed Central

    Becker, Robert E.; Greig, Nigel H.

    2008-01-01

    Recently, a number of Alzheimer’s disease (AD) multi-center clinical trials (CT) have failed to provide statistically significant evidence of drug efficacy. To test for possible design or execution flaws we analyzed in detail CTs for two failed drugs that were strongly supported by preclinical evidence and by proven CT AD efficacy for other drugs in their class. Studies of the failed commercial trials suggest that methodological flaws may contribute to the failures and that these flaws lurk within current drug development practices ready to impact other AD drug development [1]. To identify and counter risks we considered the relevance to AD drug development of the following factors: (1) effective dosing of the drug product, (2) reliable evaluations of research subjects, (3) effective implementation of quality controls over data at research sites, (4) resources for practitioners to effectively use CT results in patient care, (5) effective disease modeling, (6) effective research designs. New drugs currently under development for AD address a variety of specific mechanistic targets. Mechanistic targets provide AD drug development opportunities to escape from many of the factors that currently undermine AD clinical pharmacology, especially the problems of inaccuracy and imprecision associated with using rated outcomes. In this paper we conclude that many of the current problems encountered in AD drug development can be avoided by changing practices. Current problems with human errors in clinical trials make it difficult to differentiate drugs that fail to evidence efficacy from apparent failures due to Type II errors. This uncertainty and the lack of publication of negative data impede researchers’ abilities to improve methodologies in clinical pharmacology and to develop a sound body of knowledge about drug actions. We consider the identification of molecular targets as offering further opportunities for overcoming current failures in drug development. PMID:18690832

  5. Management of Osteochondritis Dissecans of the Femoral Condyle.

    PubMed

    Shea, Kevin G; Carey, James L; Brown, Gregory A; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

    2016-09-01

    The American Academy of Orthopaedic Surgeons has developed the Appropriate Use Criteria (AUC) document Management of Osteochondritis Dissecans of the Femoral Condyle. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain the best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The AUC clinical patient scenarios were derived from patient indications that generally accompany osteochondritis dissecans of the femoral condyle, as well as from current evidence-based clinical practice guidelines and supporting literature. The 64 patient scenarios and 12 treatments were developed by the Writing Panel, a group of clinicians who are specialists in this AUC topic. Lastly, a separate, multidisciplinary Voting Panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

  6. Integrating Hyperthermia into Modern Radiation Oncology: What Evidence Is Necessary?

    PubMed Central

    Peeken, Jan C.; Vaupel, Peter; Combs, Stephanie E.

    2017-01-01

    Hyperthermia (HT) is one of the hot topics that have been discussed over decades. However, it never made its way into primetime. The basic biological rationale of heat to enhance the effect of radiation, chemotherapeutic agents, and immunotherapy is evident. Preclinical work has confirmed this effect. HT may trigger changes in perfusion and oxygenation as well as inhibition of DNA repair mechanisms. Moreover, there is evidence for immune stimulation and the induction of systemic immune responses. Despite the increasing number of solid clinical studies, only few centers have included this adjuvant treatment into their repertoire. Over the years, abundant prospective and randomized clinical data have emerged demonstrating a clear benefit of combined HT and radiotherapy for multiple entities such as superficial breast cancer recurrences, cervix carcinoma, or cancers of the head and neck. Regarding less investigated indications, the existing data are promising and more clinical trials are currently recruiting patients. How do we proceed from here? Preclinical evidence is present. Multiple indications benefit from additional HT in the clinical setting. This article summarizes the present evidence and develops ideas for future research. PMID:28713771

  7. A rapid evidence-based service by librarians provided information to answer primary care clinical questions.

    PubMed

    McGowan, Jessie; Hogg, William; Rader, Tamara; Salzwedel, Doug; Worster, Danielle; Cogo, Elise; Rowan, Margo

    2010-03-01

    A librarian consultation service was offered to 88 primary care clinicians during office hours. This included a streamlined evidence-based process to answer questions in fewer than 20 min. This included a contact centre accessed through a Web-based platform and using hand-held devices and computers with Web access. Librarians were given technical training in evidence-based medicine, including how to summarise evidence. To describe the process and lessons learned from developing and operating a rapid response librarian consultation service for primary care clinicians. Evaluation included librarian interviews and a clinician exit satisfaction survey. Clinicians were positive about its impact on their clinical practice and decision making. The project revealed some important 'lessons learned' in the clinical use of hand-held devices, knowledge translation and training for clinicians and librarians. The Just-in-Time Librarian Consultation Service showed that it was possible to provide evidence-based answers to clinical questions in 15 min or less. The project overcame a number of barriers using innovative solutions. There are many opportunities to build on this experience for future joint projects of librarians and healthcare providers.

  8. Underdetermination in evidence-based medicine.

    PubMed

    Chin-Yee, Benjamin H

    2014-12-01

    This article explores the philosophical implications of evidence-based medicine's (EBM's) epistemology in terms of the problem of underdetermination of theory by evidence as expounded by the Duhem-Quine thesis. EBM hierarchies of evidence privilege clinical research over basic science, exacerbating the problem of underdetermination. Because of severe underdetermination, EBM is unable to meaningfully test core medical beliefs that form the basis of our understanding of disease and therapeutics. As a result, EBM adopts an epistemic attitude that is sceptical of explanations from the basic biological sciences, and is relegated to a view of disease at a population level. EBM's epistemic attitude provides a limited research heuristic by preventing the development of a theoretical framework required for understanding disease mechanism and integrating knowledge to develop new therapies. Medical epistemology should remain pluralistic and include complementary approaches of basic science and clinical research, thus avoiding the limited epistemic attitude entailed by EBM hierarchies. © 2014 John Wiley & Sons, Ltd.

  9. Evidence-based practice guidelines: a survey of subcutaneous dexamethasone administration.

    PubMed

    Walker, Jackie; Lane, Pauline; McKenzie, Clare

    2010-10-01

    Searching for good evidence to develop clinical practice guidelines can be challenging, as research may not be published or available. A simple question set the authors on a journey to find evidence related to the nursing administration of subcutaneous dexamethasone in the palliative setting. This article outlines the search for evidence and discusses the survey results to gather expert opinion about the nursing administration of dexamethasone. Survey results indicated that only 39% of community services gave dexamethasone via a bolus injection and 88% gave it via a continuous infusion, mainly for site preservation. The diluents used were water for injection or normal saline. Many procedural aspects were supported by current guidelines, with several services using the New Zealand Waitemata District Health Board's (2008) clinical guidelines. Developing and implementing procedural recommendations for nurses to administer this subcutaneous medication will form the next stage of the project.

  10. Finding 'Evidence of Absence' in Medical Notes: Using NLP for Clinical Inferencing.

    PubMed

    Carter, Marjorie E; Divita, Guy; Redd, Andrew; Rubin, Michael A; Samore, Matthew H; Gupta, Kalpana; Trautner, Barbara W; Gundlapalli, Adi V

    2016-01-01

    Extracting evidence of the absence of a target of interest from medical text can be useful in clinical inferencing. The purpose of our study was to develop a natural language processing (NLP) pipelineto identify the presence of indwelling urinary catheters from electronic medical notes to aid in detection of catheter-associated urinary tract infections (CAUTI). Finding clear evidence that a patient does not have an indwelling urinary catheter is useful in making a determination regarding CAUTI. We developed a lexicon of seven core concepts to infer the absence of a urinary catheter. Of the 990,391 concepts extractedby NLP from a large corpus of 744,285 electronic medical notes from 5589 hospitalized patients, 63,516 were labeled as evidence of absence.Human review revealed three primary causes for false negatives. The lexicon and NLP pipeline were refined using this information, resulting in outputs with an acceptable false positive rate of 11%.

  11. Using computerised decision support to improve compliance of cancer multidisciplinary meetings with evidence-based guidance

    PubMed Central

    Patkar, Vivek; Acosta, Dionisio; Davidson, Tim; Jones, Alison; Fox, John

    2012-01-01

    Objectives The cancer multidisciplinary team (MDT) meeting (MDM) is regarded as the best platform to reduce unwarranted variation in cancer care through evidence-compliant management. However, MDMs are often overburdened with many different agendas and hence struggle to achieve their full potential. The authors developed an interactive clinical decision support system called MATE (Multidisciplinary meeting Assistant and Treatment sElector) to facilitate explicit evidence-based decision making in the breast MDMs. Design Audit study and a questionnaire survey. Setting Breast multidisciplinary unit in a large secondary care teaching hospital. Participants All members of the breast MDT at the Royal Free Hospital, London, were consulted during the process of MATE development and implementation. The emphasis was on acknowledging the clinical needs and practical constraints of the MDT and fitting the system around the team's workflow rather than the other way around. Delegates, who attended MATE workshop at the England Cancer Networks' Development Programme conference in March 2010, participated in the questionnaire survey. Outcome measures The measures included evidence-compliant care, measured by adherence to clinical practice guidelines, and promoting research, measured by the patient identification rate for ongoing clinical trials. Results MATE identified 61% more patients who were potentially eligible for recruitment into clinical trials than the MDT, and MATE recommendations demonstrated better concordance with clinical practice guideline than MDT recommendations (97% of MATE vs 93.2% of MDT; N=984). MATE is in routine use in breast MDMs at the Royal Free Hospital, London, and wider evaluations are being considered. Conclusions Sophisticated decision support systems can enhance the conduct of MDMs in a way that is acceptable to and valued by the clinical team. Further rigorous evaluations are required to examine cost-effectiveness and measure the impact on patient outcomes. The decision support technology used in MATE is generic and if found useful can be applied across medicine. PMID:22734113

  12. Pharmacologic Therapy for Pulmonary Arterial Hypertension in Adults

    PubMed Central

    Taichman, Darren B.; Chung, Lorinda; Klinger, James R.; Lewis, Sandra; Mandel, Jess; Palevsky, Harold I.; Rich, Stuart; Sood, Namita; Rosenzweig, Erika B.; Trow, Terence K.; Yung, Rex; Elliott, C. Gregory; Badesch, David B.

    2014-01-01

    OBJECTIVE: Choices of pharmacologic therapies for pulmonary arterial hypertension (PAH) are ideally guided by high-level evidence. The objective of this guideline is to provide clinicians advice regarding pharmacologic therapy for adult patients with PAH as informed by available evidence. METHODS: This guideline was based on systematic reviews of English language evidence published between 1990 and November 2013, identified using the MEDLINE and Cochrane Library databases. The strength of available evidence was graded using the Grades of Recommendations, Assessment, Development, and Evaluation methodology. Guideline recommendations, or consensus statements when available evidence was insufficient to support recommendations, were developed using a modified Delphi technique to achieve consensus. RESULTS: Available evidence is limited in its ability to support high-level recommendations. Therefore, we drafted consensus statements to address many clinical questions regarding pharmacotherapy for patients with PAH. A total of 79 recommendations or consensus statements were adopted and graded. CONCLUSIONS: Clinical decisions regarding pharmacotherapy for PAH should be guided by high-level recommendations when sufficient evidence is available. Absent higher level evidence, consensus statements based upon available information must be used. Further studies are needed to address the gaps in available knowledge regarding optimal pharmacotherapy for PAH. PMID:24937180

  13. Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges.

    PubMed

    Chen, Yao-Long; Zhao, Chen; Zhang, Li; Li, Bo; Wu, Chuan-Hong; Mu, Wei; Wang, Jia-Ying; Yang, Ke-Hu; Li, You-Ping; Chen, Chiehfeng; Wang, Yong-Yan; Wang, Chen; Bian, Zhao-Xiang; Shang, Hong-Cai

    2018-03-01

    How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.

  14. Model driven development of clinical information sytems using openEHR.

    PubMed

    Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, Jim

    2011-01-01

    openEHR and the recent international standard (ISO 13606) defined a model driven software development methodology for health information systems. However there is little evidence in the literature describing implementation; especially for desktop clinical applications. This paper presents an implementation pathway using .Net/C# technology for Microsoft Windows desktop platforms. An endoscopy reporting application driven by openEHR Archetypes and Templates has been developed. A set of novel GUI directives has been defined and presented which guides the automatic graphical user interface generator to render widgets properly. We also reveal the development steps and important design decisions; from modelling to the final software product. This might provide guidance for other developers and form evidence required for the adoption of these standards for vendors and national programs alike.

  15. Developing clinical strength-of-evidence approach to define HIV-associated malignancies for cancer registration in Kenya.

    PubMed

    Korir, Anne; Mauti, Nathan; Moats, Pamela; Gurka, Matthew J; Mutuma, Geoffrey; Metheny, Christine; Mwamba, Peter M; Oyiro, Peter O; Fisher, Melanie; Ayers, Leona W; Rochford, Rosemary; Mwanda, Walter O; Remick, Scot C

    2014-01-01

    Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a "strength-of-evidence" approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis. The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1) documentation of positive HIV serology; 2) antiretroviral drug prescription; 3) CD4+ lymphocyte count; and 4) WHO HIV clinical stage or immune suppression syndrome (ISS), which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3%) met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association - Kaposi's sarcoma, cervical cancer, non-Hodgkin's and Hodgkin's lymphoma, and conjunctiva carcinoma) and 31% (53) were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27%) cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria. This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease in the backdrop of HIV infection.

  16. Evidence of Virtual Patients as a Facilitative Learning Tool on an Anesthesia Course

    ERIC Educational Resources Information Center

    Leung, Joseph Y. C.; Critchley, Lester A. H.; Yung, Alex L. K.; Kumta, Shekhar M.

    2015-01-01

    Virtual patients are computerised representations of realistic clinical cases. They were developed to teach clinical reasoning skills through delivery of multiple standardized patient cases. The anesthesia course at The Chinese University of Hong Kong developed two novel types of virtual patients, formative assessment cases studies and storyline,…

  17. Development of a tailored strategy to improve postpartum hemorrhage guideline adherence.

    PubMed

    de Visser, Suzan M; Woiski, Mallory D; Grol, Richard P; Vandenbussche, Frank P H A; Hulscher, Marlies E J L; Scheepers, Hubertina C J; Hermens, Rosella P M G

    2018-02-08

    Despite the introduction of evidence based guidelines and practical courses, the incidence of postpartum hemorrhage shows an increasing trend in developed countries. Substandard care is often found, which implies an inadequate implementation in high resource countries. We aimed to reduce the gap between evidence-based guidelines and clinical application, by developing a strategy, tailored to current barriers for implementation. The development of the implementation strategy consisted of three phases, supervised by a multidisciplinary expert panel. In the first phase a framework of the strategy was created, based on barriers to optimal adherence identified among professionals and patients together with evidence on effectiveness of strategies found in literature. In the second phase, the tools within the framework were developed, leading to a first draft. In the third phase the strategy was evaluated among professionals and patients. The professionals were asked to give written feedback on tool contents, clinical usability and inconsistencies with current evidence care. Patients evaluated the tools on content and usability. Based on the feedback of both professionals and patients the tools were adjusted. We developed a tailored strategy to improve guideline adherence, covering the trajectory of the third trimester of pregnancy till the end of the delivery. The strategy, directed at professionals, comprehending three stop moments includes a risk assessment checklist, care bundle and time-out procedure. As patient empowerment tools, a patient passport and a website with patient information was developed. The evaluation among the expert panel showed all professionals to be satisfied with the content and usability and no discrepancies or inconsistencies with current evidence was found. Patients' evaluation revealed that the information they received through the tools was incomplete. The tools were adjusted accordingly to the missing information. A usable, tailored strategy to implement PPH guidelines and practical courses was developed. The next step is the evaluation of the strategy in a feasibility trial. Clinical trial registration: The Fluxim study, registration number: NCT00928863 .

  18. Improving Chronic Diseases Management Through the Development of an Evidence-Based Resource.

    PubMed

    Khalil, Hanan; Chambers, Helen; Munn, Zachary; Porritt, Kylie

    2015-06-01

    There is a large gap between evidence and practice within health care, particularly within the field of chronic disease. To reduce this gap and improve the management of chronic disease, a collaborative partnership between two schools within a large university and two industry partners (a large regional rural hospital and a rural community health center) in rural Victoria, Australia, was developed. The aim of the collaboration was to promote the development of translation science and the implementation of evidence-based health care in chronic disease with a specific focus on developing evidence-based resources that are easily accessed by clinicians. A working group consisting of members of the collaborating organizations and an internationally renowned expert reference group was formed. The group acted as a steering committee and was tasked with developing a taxonomy of the resources. In addition, a peer review process of all resources was established. A corresponding reference group consisting of researchers and clinicians who are clinical experts in various fields was involved in the review process. The resources developed by the group include evidence summaries and recommended practices made available on a web-based database, which can be accessed via subscription by clinicians and researchers worldwide. As of mid-2014, there were 109 new evidence summaries and 25 recommended practices detailing the best available evidence on topics related to chronic disease management including asthma, diabetes, heart failure, dementia, and others. Training sessions and a newsletter were developed for clinicians within the node to enable them to use the content effectively. This paper describes the processes involved in the successful development of the collaborative partnership and its evolution into producing a valuable resource for the translation of evidence into practice in the areas of chronic disease management. The resource developed is being used by clinicians to inform practice and support their clinical decision making. © 2015 Sigma Theta Tau International.

  19. Informatics, evidence-based care, and research; implications for national policy: a report of an American Medical Informatics Association health policy conference.

    PubMed

    Bloomrosen, Meryl; Detmer, Don E

    2010-01-01

    There is an increased level of activity in the biomedical and health informatics world (e-prescribing, electronic health records, personal health records) that, in the near future, will yield a wealth of available data that we can exploit meaningfully to strengthen knowledge building and evidence creation, and ultimately improve clinical and preventive care. The American Medical Informatics Association (AMIA) 2008 Health Policy Conference was convened to focus and propel discussions about informatics-enabled evidence-based care, clinical research, and knowledge management. Conference participants explored the potential of informatics tools and technologies to improve the evidence base on which providers and patients can draw to diagnose and treat health problems. The paper presents a model of an evidence continuum that is dynamic, collaborative, and powered by health informatics technologies. The conference's findings are described, and recommendations on terminology harmonization, facilitation of the evidence continuum in a "wired" world, development and dissemination of clinical practice guidelines and other knowledge support strategies, and the role of diverse stakeholders in the generation and adoption of evidence are presented.

  20. Rising to the challenges of evidence-based medicine: a way forward for acupuncture.

    PubMed

    Godwin, Jacob

    2014-11-01

    Evidence-based medicine offers important opportunities and poses critical challenges to the acupuncture profession. Having a clear understanding of what evidence-based medicine is and what it is not is necessary to understanding how the acupuncture field might benefit by adopting evidence-based medicine as its paradigm. This article discusses the need for the acupuncture field to retool its professional, academic, and clinical apparatuses to produce, critically appraise, and use high-quality scientific evidence in order to develop acupuncture as an evidence-based procedure. Development of evidence-based acupuncture procedures, practice guidelines, and research directives may help acupuncture become a standard therapeutic procedure rather than a complement or alternative to conventional medicine.

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

    ERIC Educational Resources Information Center

    Marshall, Julie; Harding, Sam; Roulstone, Sue

    2017-01-01

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

  2. Creativity in clinical communication: from communication skills to skilled communication.

    PubMed

    Salmon, Peter; Young, Bridget

    2011-03-01

    Medical Education 2011: 45: 217-226 Objectives  The view that training in communication skills produces skilled communication is sometimes criticised by those who argue that communication is individual and intuitive. We therefore examine the validity of the concept of communication as a skill and identify alternative principles to underpin future development of this field. Methods  We critically examine research evidence about the nature of clinical communication, and draw from theory and evidence concerning education and evaluation, particularly in creative disciplines. Results  Skilled communication cannot be fully described using the concept of communication skills. Attempts to do so risk constraining and distorting pedagogical development in communication. Current education practice often masks the difficulties with the concept by introducing subjectivity into the definition and assessment of skills. As all clinical situations differ to some extent, clinical communication is inherently creative. Because it is rarely possible to attribute specific effects to specific elements of communication, communication needs to be taught and evaluated holistically. Conclusions  For communication teaching to be pedagogically and clinically valid in supporting the inherent creativity of clinical communication, it will need to draw from education theory and practice that have been developed in explicitly creative disciplines. © Blackwell Publishing Ltd 2011.

  3. Translating Evidence Into Practice via Social Media: A Mixed-Methods Study.

    PubMed

    Maloney, Stephen; Tunnecliff, Jacqueline; Morgan, Prue; Gaida, Jamie E; Clearihan, Lyn; Sadasivan, Sivalal; Davies, David; Ganesh, Shankar; Mohanty, Patitapaban; Weiner, John; Reynolds, John; Ilic, Dragan

    2015-10-26

    Approximately 80% of research evidence relevant to clinical practice never reaches the clinicians delivering patient care. A key barrier for the translation of evidence into practice is the limited time and skills clinicians have to find and appraise emerging evidence. Social media may provide a bridge between health researchers and health service providers. The aim of this study was to determine the efficacy of social media as an educational medium to effectively translate emerging research evidence into clinical practice. The study used a mixed-methods approach. Evidence-based practice points were delivered via social media platforms. The primary outcomes of attitude, knowledge, and behavior change were assessed using a preintervention/postintervention evaluation, with qualitative data gathered to contextualize the findings. Data were obtained from 317 clinicians from multiple health disciplines, predominantly from the United Kingdom, Australia, the United States, India, and Malaysia. The participants reported an overall improvement in attitudes toward social media for professional development (P<.001). The knowledge evaluation demonstrated a significant increase in knowledge after the training (P<.001). The majority of respondents (136/194, 70.1%) indicated that the education they had received via social media had changed the way they practice, or intended to practice. Similarly, a large proportion of respondents (135/193, 69.9%) indicated that the education they had received via social media had increased their use of research evidence within their clinical practice. Social media may be an effective educational medium for improving knowledge of health professionals, fostering their use of research evidence, and changing their clinical behaviors by translating new research evidence into clinical practice.

  4. Clinical evidence inputs to comparative effectiveness research could impact the development of novel treatments.

    PubMed

    Eber, Michael R; Goldman, Dana P; Lakdawalla, Darius N; Philipson, Tomas J; Pritchard, Daryl; Huesch, Marco; Summers, Nicholas; Linthicum, Mark T; Sullivan, Jeff; Dubois, Robert W

    2015-05-07

    This study aims to analyze the impacts of a range of clinical evidence generation scenarios associated with comparative effectiveness research (CER) on pharmaceutical innovation. We used the Global Pharmaceutical Policy Model to project the effect of changes in pharmaceutical producer costs, revenues and timings on drug innovation and health for the age 55+ populations in the USA and Europe through year 2060 using three clinical scenarios. Changes in producer incentives from widespread CER evidence generation and use had varied but often large predicted impacts on simulated outcomes in 2060. Effect on the number of new drug introductions ranged from a 81.1% reduction to a 45.5% increase, and the effect on population-level life expectancy ranged from a 15.6% reduction to a 11.4% increase compared to baseline estimates. The uncertainty surrounding the consequences of increased clinical evidence generation and use on innovation calls for a carefully measured approach to CER implementation, balancing near-term benefits to spending and health with long-term implications for innovation.

  5. Guidelines: the do's, don'ts and don't knows of feedback for clinical education.

    PubMed

    Lefroy, Janet; Watling, Chris; Teunissen, Pim W; Brand, Paul

    2015-12-01

    The guidelines offered in this paper aim to amalgamate the literature on formative feedback into practical Do's, Don'ts and Don't Knows for individual clinical supervisors and for the institutions that support clinical learning. The authors built consensus by an iterative process. Do's and Don'ts were proposed based on authors' individual teaching experience and awareness of the literature, and the amalgamated set of guidelines were then refined by all authors and the evidence was summarized for each guideline. Don't Knows were identified as being important questions to this international group of educators which if answered would change practice. The criteria for inclusion of evidence for these guidelines were not those of a systematic review, so indicators of strength of these recommendations were developed which combine the evidence with the authors' consensus. A set of 32 Do and Don't guidelines with the important Don't Knows was compiled along with a summary of the evidence for each. These are divided into guidelines for the individual clinical supervisor giving feedback to their trainee (recommendations about both the process and the content of feedback) and guidelines for the learning culture (what elements of learning culture support the exchange of meaningful feedback, and what elements constrain it?) Feedback is not easy to get right, but it is essential to learning in medicine, and there is a wealth of evidence supporting the Do's and warning against the Don'ts. Further research into the critical Don't Knows of feedback is required. A new definition is offered: Helpful feedback is a supportive conversation that clarifies the trainee's awareness of their developing competencies, enhances their self-efficacy for making progress, challenges them to set objectives for improvement, and facilitates their development of strategies to enable that improvement to occur.

  6. Clinical guidelines as a tool for legal liability. An international perspective.

    PubMed

    Davies, Jonathan

    2009-12-01

    Clinical guidelines are statements that have been systematically developed and which aim to assist clinicians in making decisions about treatment for specific conditions. They are linked to evidence and are meant to facilitate good medical practice. A key issue that follows is how lawyers and the courts might use such guidelinesin medical litigation. The multiplicity of opinions and scientific professions requiring expertise might influence the expert submitting an opinion to base his opinion on scientific theses which have not been recognized scientifically, are not based on facts and are not supported by professional literature. Medical evidence has to be methodically based and reliable. In recent years the medical community has developed a new field called "Evidence Based Medicine", meaning, use of medical information based on the best information in the medical literature relevant to the condition being treated. Evidence Based Medicine distinguishes between recognized scientific theories and what is called "Junk Science". Clinical Guidelines are of value in systematizing medical procedures, mainly those which may have legal implications. In other procedures Guidelines may serve the Court as a source of sound information, provided they are the product of a recognized professional body, and proven to bear no relation to a body which may have interests in the delivery of healthcare. Clinical guidelines are set as normative standards and used as a tool to indicate the standard of care at the time. They can be used as a tool for assessment of the questionable conduct. Guidelines are consulted by courts because they provide evidence of standards justified in relation to evidence rather than custom, this helps the courts test the expert evidence that radically strengthen the normative dynamic of the law in actions alleging medical negligence. As clinical practice guidelines become more and more prevalent, some authors believe they will define the requisite "standard of care" for medical treatment and impact medical malpractice litigation. They may even replace expert testimony.

  7. Building the Evidence Base for Decision-making in Cancer Genomic Medicine Using Comparative Effectiveness Research

    PubMed Central

    Goddard, Katrina A.B.; Knaus, William A.; Whitlock, Evelyn; Lyman, Gary H.; Feigelson, Heather Spencer; Schully, Sheri D.; Ramsey, Scott; Tunis, Sean; Freedman, Andrew N.; Khoury, Muin J.; Veenstra, David L.

    2013-01-01

    Background The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty. Objectives To identify approaches to help stakeholders make evidence-based decisions, and to describe potential challenges and opportunities using CER to produce evidence-based guidance. Methods We identified general CER approaches for genomic applications through literature review, the authors’ experiences, and lessons learned from a recent, seven-site CER initiative in cancer genomic medicine. Case studies illustrate the use of CER approaches. Results Evidence generation and synthesis approaches include comparative observational and randomized trials, patient reported outcomes, decision modeling, and economic analysis. We identified significant challenges to conducting CER in cancer genomics: the rapid pace of innovation, the lack of regulation, the limited evidence for clinical utility, and the beliefs that genomic tests could have personal utility without having clinical utility. Opportunities to capitalize on CER methods in cancer genomics include improvements in the conduct of evidence synthesis, stakeholder engagement, increasing the number of comparative studies, and developing approaches to inform clinical guidelines and research prioritization. Conclusions CER offers a variety of methodological approaches to address stakeholders’ needs. Innovative approaches are needed to ensure an effective translation of genomic discoveries. PMID:22516979

  8. Embedding evidence-based practice among nursing undergraduates: Results from a pilot study.

    PubMed

    André, Beate; Aune, Anne G; Brænd, Jorunn A

    2016-05-01

    Evidence-based practice is currently one of the most important developments in health care. Research in nursing science is rapidly growing; however, translating the knowledge based on this research into clinical practice is often hampered, and may be dependent on reflective skills. The aim of this study was to see how undergraduate nursing students in nursing should increase their skills and knowledge related to evidence-based practice through participation in clinical research projects. A qualitative approach was used in collecting and analyzing the data. Students participated in a pilot clinical research project and a received guidance related to their bachelor thesis. After the project was completed, all students filled in a questionnaire. The students' motivation to participate in this study was reported to be high, but they reported low knowledge related to evidence-based practice. All students reported that their attitude towards evidence-based practice changed in a positive direction during their participation in the project. Evidence-based practice influenced nursing practices by putting more focus on critical thinking, increasing pride and giving a sense of ownership in the clinical field. The curricula and the pedagogical perspectives in nursing education can influence the attitude towards evidence-based practice and skills among nursing bachelor students. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Feasibility of Extracting Key Elements from ClinicalTrials.gov to Support Clinicians' Patient Care Decisions.

    PubMed

    Kim, Heejun; Bian, Jiantao; Mostafa, Javed; Jonnalagadda, Siddhartha; Del Fiol, Guilherme

    2016-01-01

    Motivation: Clinicians need up-to-date evidence from high quality clinical trials to support clinical decisions. However, applying evidence from the primary literature requires significant effort. Objective: To examine the feasibility of automatically extracting key clinical trial information from ClinicalTrials.gov. Methods: We assessed the coverage of ClinicalTrials.gov for high quality clinical studies that are indexed in PubMed. Using 140 random ClinicalTrials.gov records, we developed and tested rules for the automatic extraction of key information. Results: The rate of high quality clinical trial registration in ClinicalTrials.gov increased from 0.2% in 2005 to 17% in 2015. Trials reporting results increased from 3% in 2005 to 19% in 2015. The accuracy of the automatic extraction algorithm for 10 trial attributes was 90% on average. Future research is needed to improve the algorithm accuracy and to design information displays to optimally present trial information to clinicians.

  10. Single-Case Research Design: An Alternative Strategy for Evidence-Based Practice

    ERIC Educational Resources Information Center

    Stapleton, Drue; Hawkins, Andrew

    2015-01-01

    Objective: The trend of utilizing evidence-based practice (EBP) in athletic training is now requiring clinicians, researchers, educators, and students to be equipped to both engage in and make judgments about research evidence. Single-case design (SCD) research may provide an alternative approach to develop such skills and inform clinical and…

  11. GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale.

    PubMed

    Welch, Vivian A; Akl, Elie A; Guyatt, Gordon; Pottie, Kevin; Eslava-Schmalbach, Javier; Ansari, Mohammed T; de Beer, Hans; Briel, Matthias; Dans, Tony; Dans, Inday; Hultcrantz, Monica; Jull, Janet; Katikireddi, Srinivasa Vittal; Meerpohl, Joerg; Morton, Rachael; Mosdol, Annhild; Petkovic, Jennifer; Schünemann, Holger J; Sharaf, Ravi N; Singh, Jasvinder A; Stanev, Roger; Tonia, Thomy; Tristan, Mario; Vitols, Sigurd; Watine, Joseph; Tugwell, Peter

    2017-10-01

    This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines. We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Teaching Evidence-Based Medicine at Complementary and Alternative Medicine Institutions: Strategies, Competencies, and Evaluation

    PubMed Central

    Schiffke, Heather; Fleishman, Susan; Haas, Mitch; Cruser, des Anges; LeFebvre, Ron; Sullivan, Barbara; Taylor, Barry; Gaster, Barak

    2014-01-01

    Abstract Background: As evidence-based medicine (EBM) becomes a standard in health care, it is essential that practitioners of complementary and alternative medicine (CAM) become experts in searching and evaluating the research literature. In support of this goal, the National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM) provided R25 funding to nine CAM colleges to develop individual programs focused on teaching EBM. An overarching goal of these research education grants has been to provide CAM faculty and students with the skills they need to apply a rigorous evidence-based perspective to their training and practice. Methods/Results: This paper reviews the competencies and teaching strategies developed and implemented to enhance research literacy at all nine R25-funded institutions. While each institution designed approaches suitable for its research culture, the guiding principles were similar: to develop evidence-informed skills and knowledge, thereby helping students and faculty to critically appraise evidence and then use that evidence to guide their clinical practice. Curriculum development and assessment included faculty-driven learning activities and longitudinal curricular initiatives to encourage skill reinforcement and evaluate progress. Conclusion: As the field of integrative medicine matures, the NIH-NCCAM research education grants provide essential training for future clinicians and clinician-researchers. Building this workforce will facilitate multidisciplinary collaborations that address the unique needs for research that informs integrative clinical practice. PMID:25380144

  13. Applicability of randomized trials in radiation oncology to standard clinical practice.

    PubMed

    Apisarnthanarax, Smith; Swisher-McClure, Samuel; Chiu, Wing K; Kimple, Randall J; Harris, Stephen L; Morris, David E; Tepper, Joel E

    2013-08-15

    Randomized controlled trials (RCTs) are commonly used to inform clinical practice; however, it is unclear how generalizable RCT data are to patients in routine clinical practice. The authors of this report assessed the availability and applicability of randomized evidence guiding medical decisions in a cohort of patients who were evaluated for consideration of definitive management in a radiation oncology clinic. The medical records of consecutive, new patient consultations between January and March 2007 were reviewed. Patient medical decisions were classified as those with (Group 1) or without (Group 2) available, relevant level I evidence (phase 3 RCT) supporting recommended treatments. Group 1 medical decisions were further divided into 3 groups based on the extent of fulfilling eligibility criteria for each RCT: Group 1A included decisions that fulfilled all eligibility criteria; Group 1B, decisions that did not fulfill at least 1 minor eligibility criteria; or Group 1C, decisions that did not fulfill at least 1 major eligibility criteria. Patient and clinical characteristics were tested for correlations with the availability of evidence. Of the 393 evaluable patients, malignancies of the breast (30%), head and neck (18%), and genitourinary system (14%) were the most common presenting primary disease sites. Forty-seven percent of all medical decisions (n = 451) were made without available (36%) or applicable (11%) randomized evidence to inform clinical decision making. Primary tumor diagnosis was significantly associated with the availability of evidence (P < .0001). A significant proportion of medical decisions in an academic radiation oncology clinic were made without available or applicable level I evidence, underscoring the limitations of relying solely on RCTs for the development of evidence-based health care. Copyright © 2013 American Cancer Society.

  14. Development of the Champlain primary care cardiovascular disease prevention and management guideline

    PubMed Central

    Montoya, Lorraine; Liddy, Clare; Hogg, William; Papadakis, Sophia; Dojeiji, Laurie; Russell, Grant; Akbari, Ayub; Pipe, Andrew; Higginson, Lyall

    2011-01-01

    Abstract Problem addressed A well documented gap remains between evidence and practice for clinical practice guidelines in cardiovascular disease (CVD) care. Objective of program As part of the Champlain CVD Prevention Strategy, practitioners in the Champlain District of Ontario launched a large quality-improvement initiative that focused on increasing the uptake in primary care practice settings of clinical guidelines for heart disease, stroke, diabetes, and CVD risk factors. Program description The Champlain Primary Care CVD Prevention and Management Guideline is a desktop resource for primary care clinicians working in the Champlain District. The guideline was developed by more than 45 local experts to summarize the latest evidence-based strategies for CVD prevention and management, as well as to increase awareness of local community-based programs and services. Conclusion Evidence suggests that tailored strategies are important when implementing specific practice guidelines. This article describes the process of creating an integrated clinical guideline for improvement in the delivery of cardiovascular care. PMID:21673196

  15. Integrating Genomics Into Clinical Pediatric Oncology Using the Molecular Tumor Board at the Memorial Sloan Kettering Cancer Center.

    PubMed

    Ortiz, Michael V; Kobos, Rachel; Walsh, Michael; Slotkin, Emily K; Roberts, Stephen; Berger, Michael F; Hameed, Meera; Solit, David; Ladanyi, Marc; Shukla, Neerav; Kentsis, Alex

    2016-08-01

    Pediatric oncologists have begun to leverage tumor genetic profiling to match patients with targeted therapies. At the Memorial Sloan Kettering Cancer Center (MSKCC), we developed the Pediatric Molecular Tumor Board (PMTB) to track, integrate, and interpret clinical genomic profiling and potential targeted therapeutic recommendations. This retrospective case series includes all patients reviewed by the MSKCC PMTB from July 2014 to June 2015. Cases were submitted by treating oncologists and potential treatment recommendations were based upon the modified guidelines of the Oxford Centre for Evidence-Based Medicine. There were 41 presentations of 39 individual patients during the study period. Gliomas, acute myeloid leukemia, and neuroblastoma were the most commonly reviewed cases. Thirty nine (87%) of the 45 molecular sequencing profiles utilized hybrid-capture targeted genome sequencing. In 30 (73%) of the 41 presentations, the PMTB provided therapeutic recommendations, of which 19 (46%) were implemented. Twenty-one (70%) of the recommendations involved targeted therapies. Three (14%) targeted therapy recommendations had published evidence to support the proposed recommendations (evidence levels 1-2), eight (36%) recommendations had preclinical evidence (level 3), and 11 (50%) recommendations were based upon hypothetical biological rationales (level 4). The MSKCC PMTB enabled a clinically relevant interpretation of genomic profiling. Effective use of clinical genomics is anticipated to require new and improved tools to ascribe pathogenic significance and therapeutic actionability. The development of specific rule-driven clinical protocols will be needed for the incorporation and evaluation of genomic and molecular profiling in interventional prospective clinical trials. © 2016 Wiley Periodicals, Inc.

  16. Comparing clinical quality indicators for asthma management in children with outcome measures used in randomised controlled trials: a protocol.

    PubMed

    Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B; Coiera, Enrico

    2015-09-08

    Clinical quality indicators are necessary to monitor the performance of healthcare services. The development of indicators should, wherever possible, be based on research evidence to minimise the risk of bias which may be introduced during their development, because of logistic, ethical or financial constraints alone. The development of automated methods to identify the evidence base for candidate indicators should improve the process of indicator development. The objective of this study is to explore the relationship between clinical quality indicators for asthma management in children with outcome and process measurements extracted from randomised controlled clinical trial reports. National-level indicators for asthma management in children will be extracted from the National Quality Measures Clearinghouse (NQMC) database and the National Institute for Health and Care Excellence (NICE) quality standards. Outcome measures will be extracted from published English language randomised controlled trial (RCT) reports for asthma management in children aged below 12 years. The two sets of measures will be compared to assess any overlap. The study will provide insights into the relationship between clinical quality indicators and measurements in RCTs. This study will also yield a list of measurements used in RCTs for asthma management in children, and will find RCT evidence for indicators used in practice. Ethical approval is not necessary because this study will not include patient data. Findings will be disseminated through peer-reviewed publications. 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.

  17. Development of clinical practice guidelines.

    PubMed

    Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

    2014-01-01

    Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

  18. Report on the RCDS-CDHSRU workshop on developing clinical guidelines/standards of practice.

    PubMed

    Leake, J L; Main, P A; Woodward, G L

    1996-07-01

    Investigators from the Community Dental Health Services Research Unit (CDHSRU) held a workshop to test a model for developing clinical guidelines/standards of practice, which are required under the Regulated Health Professions Legislation. Forty-two individuals from Ontario and Canada, including dentists, representatives of the public, and professionals, participated in the three-day workshop, held under the auspices of the quality assurance committee of the Royal College of Dental Surgeons of Ontario (RCDS). Through direct experience, workshop participants sought to learn each of the steps, as defined by the literature, involved in clinical guideline development. Ultimately, they hoped to recommend steps for RCDS to follow in developing standards of practice. To ensure that a realistic and valid model emerged from the workshop, a real topic, namely the management of smooth surface enamel lesions in permanent teeth, was used to develop and test clinical guidelines. Prior to the workshop, participants were sent literature on one of five aspects of the topic, as well as papers describing the methodology of critically appraising the literature, and partially-completed templates outlining the basic steps to be followed. During the first evening and first morning of the workshop, participants listened to presentations on the development of clinical guidelines, the prevalence of smooth surface lesions, the role of economics in guideline development, and the necessary considerations in writing clinical guidelines. Under the leadership of trained facilitators, they then worked in small groups to write evidence-based recommendations and report them to the other workshop participants for feedback. Using this feedback, they returned to their groups to revise their recommendations and work on the workshop's overall recommendations to the RCDS. The day concluded in the evening, when the workshop facilitators and coordinators met to edit the groups' recommendations into a consistent format for presentation to all participants. On the second morning, the participants attended a plenary session to review the evidence-based recommendations developed by the groups, as well as their overall recommendations on the steps to be followed by the RCDS. Ultimately, workshop participants partially completed the templates and developed preliminary evidence-based recommendations on the management of enamel smooth-surface caries. Based on their experiences, they recommended a seven-step process for the future development of clinical practice guidelines/standards of practice in Ontario. These steps are recommendations only, and are not RCDS policy.

  19. Recommendations for genetic testing to reduce the incidence of anthracycline‐induced cardiotoxicity

    PubMed Central

    Aminkeng, Folefac; Ross, Colin J. D.; Rassekh, Shahrad R.; Hwang, Soomi; Rieder, Michael J.; Bhavsar, Amit P.; Smith, Anne; Sanatani, Shubhayan; Gelmon, Karen A.; Bernstein, Daniel; Hayden, Michael R.; Amstutz, Ursula

    2016-01-01

    Aims Anthracycline‐induced cardiotoxicity (ACT) occurs in 57% of treated patients and remains an important limitation of anthracycline‐based chemotherapy. In various genetic association studies, potential genetic risk markers for ACT have been identified. Therefore, we developed evidence‐based clinical practice recommendations for pharmacogenomic testing to further individualize therapy based on ACT risk. Methods We followed a standard guideline development process, including a systematic literature search, evidence synthesis and critical appraisal, and the development of clinical practice recommendations with an international expert group. Results RARG rs2229774, SLC28A3 rs7853758 and UGT1A6 rs17863783 variants currently have the strongest and the most consistent evidence for association with ACT. Genetic variants in ABCC1, ABCC2, ABCC5, ABCB1, ABCB4, CBR3, RAC2, NCF4, CYBA, GSTP1, CAT, SULT2B1, POR, HAS3, SLC22A7, SCL22A17, HFE and NOS3 have also been associated with ACT, but require additional validation. We recommend pharmacogenomic testing for the RARG rs2229774 (S427L), SLC28A3 rs7853758 (L461L) and UGT1A6*4 rs17863783 (V209V) variants in childhood cancer patients with an indication for doxorubicin or daunorubicin therapy (Level B – moderate). Based on an overall risk stratification, taking into account genetic and clinical risk factors, we recommend a number of management options including increased frequency of echocardiogram monitoring, follow‐up, as well as therapeutic options within the current standard of clinical practice. Conclusions Existing evidence demonstrates that genetic factors have the potential to improve the discrimination between individuals at higher and lower risk of ACT. Genetic testing may therefore support both patient care decisions and evidence development for an improved prevention of ACT. PMID:27197003

  20. Clinical practice guideline development manual: A quality-driven approach for translating evidence into action

    PubMed Central

    Rosenfeld, Richard M.; Shiffman, Richard N.

    2010-01-01

    Background Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing healthcare variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective – or potentially harmful – interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. Purpose This manual describes the principles and practices used successfully by the American Academy of Otolaryngology – Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multi-disciplinary applicability. The development process, which allows moving from conception to completion in twelve months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. Conclusions As clinical practice guidelines become more prominent as a key metric of quality healthcare, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are – and are not – and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals. PMID:19464525

  1. Overcoming regulatory and economic challenges facing pharmacogenomics.

    PubMed

    Cohen, Joshua P

    2012-09-15

    The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. An evidence-based clinical guideline for the use of antithrombotic therapies in spine surgery.

    PubMed

    Bono, Christopher M; Watters, William C; Heggeness, Michael H; Resnick, Daniel K; Shaffer, William O; Baisden, Jamie; Ben-Galim, Peleg; Easa, John E; Fernand, Robert; Lamer, Tim; Matz, Paul G; Mendel, Richard C; Patel, Rajeev K; Reitman, Charles A; Toton, John F

    2009-12-01

    The objective of the North American Spine Society (NASS) Evidence-Based Clinical Guideline on antithrombotic therapies in spine surgery was to provide evidence-based recommendations to address key clinical questions surrounding the use of antithrombotic therapies in spine surgery. The guideline is intended to address these questions based on the highest quality clinical literature available on this subject as of February 2008. The goal of the guideline recommendations was to assist in delivering optimum, efficacious treatment with the goal of preventing thromboembolic events. To provide an evidence-based, educational tool to assist spine surgeons in minimizing the risk of deep venous thrombosis (DVT) and pulmonary embolism (PE). Systematic review and evidence-based clinical guideline. This report is from the Antithrombotic Therapies Work Group of the NASS Evidence-Based Guideline Development Committee. The work group was composed of multidisciplinary spine care specialists, all of whom were trained in the principles of evidence-based analysis. Each member of the group was involved in formatting a series of clinical questions to be addressed by the group. The final questions agreed on by the group are the subject of this report. A literature search addressing each question and using a specific search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology), and four additional, evidence-based databases. The relevant literature was then independently rated by at least three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final grades of recommendation for the answers to each clinical question were arrived at via Web casts among members of the work group using standardized grades of recommendation. When Level I to IV evidence was insufficient to support a recommendation to answer a specific clinical question, expert consensus was arrived at by the work group through the modified nominal group technique and is clearly identified as such in the guideline. Fourteen clinical questions were formulated, addressing issues of incidence of DVT and PE in spine surgery and recommendations regarding utilization of mechanical prophylaxis and chemoprophylaxis in spine surgery. The answers to these 14 clinical questions are summarized in this article. The respective recommendations were graded by the strength of the supporting literature that was stratified by levels of evidence. A clinical guideline addressing the use of antithrombotic therapies in spine surgery has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to assist spine surgeons in minimizing the risk of DVT and PE. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

  3. Development of a kernel function for clinical data.

    PubMed

    Daemen, Anneleen; De Moor, Bart

    2009-01-01

    For most diseases and examinations, clinical data such as age, gender and medical history guides clinical management, despite the rise of high-throughput technologies. To fully exploit such clinical information, appropriate modeling of relevant parameters is required. As the widely used linear kernel function has several disadvantages when applied to clinical data, we propose a new kernel function specifically developed for this data. This "clinical kernel function" more accurately represents similarities between patients. Evidently, three data sets were studied and significantly better performances were obtained with a Least Squares Support Vector Machine when based on the clinical kernel function compared to the linear kernel function.

  4. Clinical practice recommendations for depression.

    PubMed

    Malhi, G S; Adams, D; Porter, R; Wignall, A; Lampe, L; O'Connor, N; Paton, M; Newton, L A; Walter, G; Taylor, A; Berk, M; Mulder, R T

    2009-01-01

    To provide clinically relevant evidence-based recommendations for the management of depression in adults that are informative, easy to assimilate and facilitate clinical decision making. A comprehensive literature review of over 500 articles was undertaken using electronic database search engines (e.g. MEDLINE, PsychINFO and Cochrane reviews). In addition articles, book chapters and other literature known to the authors were reviewed. The findings were then formulated into a set of recommendations that were developed by a multidisciplinary team of clinicians who routinely deal with mood disorders. The recommendations then underwent consultative review by a broader advisory panel that included experts in the field, clinical staff and patient representatives. The clinical practice recommendations for depression (Depression CPR) summarize evidence-based treatments and provide a synopsis of recommendations relating to each phase of the illness. They are designed for clinical use and have therefore been presented succinctly in an innovative and engaging manner that is clear and informative. These up-to-date recommendations provide an evidence-based framework that incorporates clinical wisdom and consideration of individual factors in the management of depression. Further, the novel style and practical approach should promote uptake and implementation.

  5. The Case for Adjunctive Monoclonal Antibody Immunotherapy in Schizophrenia.

    PubMed

    Miller, Brian J; Buckley, Peter F

    2016-06-01

    This article presents the case in favor of clinical trials of adjunctive monoclonal antibody immunotherapy in schizophrenia. Evidence for prenatal and premorbid immune risk factors for the development of schizophrenia in the offspring is highlighted. Then key evidence for immune dysfunction in patients with schizophrenia is considered. Next, previous trials of adjunctive anti-inflammatory or other immunotherapy in schizophrenia are discussed. Then evidence for psychosis as a side effect of immunotherapy for other disorders is discussed. Also presented is preliminary evidence for adjunctive monoclonal antibody immunotherapy in psychiatric disorders. Finally, important considerations in the design and implementation of clinical trials of adjunctive monoclonal antibody immunotherapy in schizophrenia are discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia.

    PubMed

    Boccardi, Marina; Festari, Cristina; Altomare, Daniele; Gandolfo, Federica; Orini, Stefania; Nobili, Flavio; Frisoni, Giovanni B

    2018-04-30

    FDG-PET is frequently used as a marker of synaptic damage to diagnose dementing neurodegenerative disorders. We aimed to adapt the items of evidence quality to FDG-PET diagnostic studies, and assess the evidence available in current literature to assist Delphi decisions for European recommendations for clinical use. Based on acknowledged methodological guidance, we defined the domains, specific to FDG-PET, required to assess the quality of evidence in 21 literature searches addressing as many Population Intervention Comparison Outcome (PICO) questions. We ranked findings for each PICO and fed experts making Delphi decisions for recommending clinical use. Among the 1435 retrieved studies, most lacked validated measures of test performance, an adequate gold standard, and head-to-head comparison of FDG-PET and clinical diagnosis, and only 58 entered detailed assessment. Only two studies assessed the accuracy of the comparator (clinical diagnosis) versus any kind of gold-/reference-standard. As to the index-test (FDG-PET-based diagnosis), an independent gold-standard was available in 24% of the examined papers; 38% used an acceptable reference-standard (clinical follow-up); and 38% compared FDG-PET-based diagnosis only to baseline clinical diagnosis. These methodological limitations did not allow for deriving recommendations from evidence. An incremental diagnostic value of FDG-PET versus clinical diagnosis or lack thereof cannot be derived from the current literature. Many of the observed limitations may easily be overcome, and we outlined them as research priorities to improve the quality of current evidence. Such improvement is necessary to outline evidence-based guidelines. The available data were anyway provided to expert clinicians who defined interim recommendations.

  7. Integrating Research Into Clinical Internship Training Bridging the Science/Practice Gap in Pediatric Psychology

    PubMed Central

    Spirito, Anthony

    2012-01-01

    Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a “capstone experience”; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the “business of science.” Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists. PMID:22286345

  8. Measuring performance to drive improvement: development of a clinical indicator set for general medicine.

    PubMed

    Brand, C; Lam, S K L; Roberts, C; Gorelik, A; Amatya, B; Smallwood, D; Russell, D

    2009-06-01

    There are delays in implementing evidence about effective therapy into clinical practice. Clinical indicators may support implementation of guideline recommendations. To develop and evaluate the short-term impact of a clinical indicator set for general medicine. A set of clinical process indicators was developed using a structured process. The indicator set was implemented between January 2006 and December 2006, using strategies based on evidence about effectiveness and local contextual factors. Evaluation included a structured survey of general medical staff to assess awareness and attitudes towards the programme and qualitative assessment of barriers to implementation. Impact on documentation of adherence to clinical indicators was assessed by auditing a random sample of medical records before (2003-2005) and after (2006) implementation. Clinical indicators were developed for the following areas: venous thromboembolism, cognition, chronic heart failure, chronic obstructive pulmonary disease, diabetes, low trauma fracture, patient written care plans. The programme was well supported and incurred little burden to staff. Implementation occurred largely as planned; however, documentation of adherence to clinical indicators was variable. There was a generally positive trend over time, but for most indicators this was independent of the implementation process and may have been influenced by other system improvement activities. Failure to demonstrate a significant impact during the pilot phase is likely to have been influenced by administrative factors, especially lack of an integrative data documentation and collection process. Successful implementation in phase two is likely to depend upon an effective data collection system integrated into usual care.

  9. Childhood bullying and the association with psychosis in non-clinical and clinical samples: a review and meta-analysis.

    PubMed

    van Dam, D S; van der Ven, E; Velthorst, E; Selten, J P; Morgan, C; de Haan, L

    2012-12-01

    Approximately 11% of schoolchildren are bullied on a regular basis. It has been argued that continuous exposure to stress is related to the development of psychotic symptoms. The current study sought to investigate whether being bullied in childhood is related to the development of psychotic symptoms. A search of PubMed, PsycINFO and EMBASE was conducted. The reference lists of included papers were searched to identify other eligible papers. A meta-analysis was performed on a subgroup of studies. We found four clinical and 10 general population studies that met inclusion criteria. The results of the clinical studies were mixed. However, the results of the non-clinical studies provided more consistent evidence that school bullying is related to the development of non-clinical psychotic symptoms. Stronger associations were found with increased frequency and severity and longer duration of being bullied. We performed a meta-analysis on seven population-based studies, yielding unadjusted and adjusted odds ratios (ORs) of 2.7 [95% confidence interval (CI) 2.1-3.6] and 2.3 (95% CI 1.5-3.4) respectively. Although there is some evidence of an association between bullying and psychosis in clinical samples, the research is too sparse to draw any firm conclusions. However, population-based non-clinical studies support the role of bullying in the development of psychotic symptoms later in life. These findings are consistent with findings of an increased risk of psychotic symptoms among those exposed to other types of abuse.

  10. Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus.

    PubMed

    Conley, Robert B; Dickson, Dane; Zenklusen, Jean Claude; Al Naber, Jennifer; Messner, Donna A; Atasoy, Ajlan; Chaihorsky, Lena; Collyar, Deborah; Compton, Carolyn; Ferguson, Martin; Khozin, Sean; Klein, Roger D; Kotte, Sri; Kurzrock, Razelle; Lin, C Jimmy; Liu, Frank; Marino, Ingrid; McDonough, Robert; McNeal, Amy; Miller, Vincent; Schilsky, Richard L; Wang, Lisa I

    2017-11-16

    The Center for Medical Technology Policy and the Molecular Evidence Development Consortium gathered a diverse group of more than 50 stakeholders to develop consensus on a core set of data elements and values essential to understanding the clinical utility of molecularly targeted therapies in oncology. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

    PubMed

    Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

    2008-08-01

    To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

  12. Reasoning, evidence, and clinical decision-making: The great debate moves forward.

    PubMed

    Loughlin, Michael; Bluhm, Robyn; Buetow, Stephen; Borgerson, Kirstin; Fuller, Jonathan

    2017-10-01

    When the editorial to the first philosophy thematic edition of this journal was published in 2010, critical questioning of underlying assumptions, regarding such crucial issues as clinical decision making, practical reasoning, and the nature of evidence in health care, was still derided by some prominent contributors to the literature on medical practice. Things have changed dramatically. Far from being derided or dismissed as a distraction from practical concerns, the discussion of such fundamental questions, and their implications for matters of practical import, is currently the preoccupation of some of the most influential and insightful contributors to the on-going evidence-based medicine debate. Discussions focus on practical wisdom, evidence, and value and the relationship between rationality and context. In the debate about clinical practice, we are going to have to be more explicit and rigorous in future in developing and defending our views about what is valuable in human life. © 2017 John Wiley & Sons, Ltd.

  13. Diagnosis of Upper-Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of APTA

    PubMed Central

    Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

    2017-01-01

    Introduction: The Oncology Section of APTA developed a clinical practice guideline to aid the clinician in diagnosing secondary upper-quadrant cancer-related lymphedema. Methods: Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in their diagnostic process. Overall, clinical practice recommendations were formulated on the basis of the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. Recommendations: In an effort to make these clinically applicable, recommendations were based on the characteristics as to the location and stage of a patient's upper-quadrant lymphedema. PMID:28748128

  14. Expediting the transfer of evidence into practice: building clinical partnerships*

    PubMed Central

    Rader, Tamara; Gagnon, Anita J.

    2000-01-01

    A librarian/clinician partnership was fostered in one hospital through the formation of the Evidence-based Practice Committee, with an ulterior goal of facilitating the transfer of evidence into practice. The paper will describe barriers to evidence-based practice and outline the committee's strategies for overcoming these barriers, including the development and promotion of a Web-based guide to evidence-based practice specifically designed for clinicians (health professionals). Educational strategies for use of the Web-based guide will also be addressed. Advantages of this partnership are that the skills of librarians in meeting the needs of clinicians are maximized. The evidence-based practice skills of clinicians are honed and librarians make a valuable contribution to the knowledgebase of the clinical staff. The knowledge acquired through the partnership by both clinicians and librarians will increase the sophistication of the dialogue between the two groups and in turn will expedite the transfer of evidence into practice. PMID:10928710

  15. EHR based Genetic Testing Knowledge Base (iGTKB) Development

    PubMed Central

    2015-01-01

    Background The gap between a large growing number of genetic tests and a suboptimal clinical workflow of incorporating these tests into regular clinical practice poses barriers to effective reliance on advanced genetic technologies to improve quality of healthcare. A promising solution to fill this gap is to develop an intelligent genetic test recommendation system that not only can provide a comprehensive view of genetic tests as education resources, but also can recommend the most appropriate genetic tests to patients based on clinical evidence. In this study, we developed an EHR based Genetic Testing Knowledge Base for Individualized Medicine (iGTKB). Methods We extracted genetic testing information and patient medical records from EHR systems at Mayo Clinic. Clinical features have been semi-automatically annotated from the clinical notes by applying a Natural Language Processing (NLP) tool, MedTagger suite. To prioritize clinical features for each genetic test, we compared odds ratio across four population groups. Genetic tests, genetic disorders and clinical features with their odds ratios have been applied to establish iGTKB, which is to be integrated into the Genetic Testing Ontology (GTO). Results Overall, there are five genetic tests operated with sample size greater than 100 in 2013 at Mayo Clinic. A total of 1,450 patients who was tested by one of the five genetic tests have been selected. We assembled 243 clinical features from the Human Phenotype Ontology (HPO) for these five genetic tests. There are 60 clinical features with at least one mention in clinical notes of patients taking the test. Twenty-eight clinical features with high odds ratio (greater than 1) have been selected as dominant features and deposited into iGTKB with their associated information about genetic tests and genetic disorders. Conclusions In this study, we developed an EHR based genetic testing knowledge base, iGTKB. iGTKB will be integrated into the GTO by providing relevant clinical evidence, and ultimately to support development of genetic testing recommendation system, iGenetics. PMID:26606281

  16. EHR based Genetic Testing Knowledge Base (iGTKB) Development.

    PubMed

    Zhu, Qian; Liu, Hongfang; Chute, Christopher G; Ferber, Matthew

    2015-01-01

    The gap between a large growing number of genetic tests and a suboptimal clinical workflow of incorporating these tests into regular clinical practice poses barriers to effective reliance on advanced genetic technologies to improve quality of healthcare. A promising solution to fill this gap is to develop an intelligent genetic test recommendation system that not only can provide a comprehensive view of genetic tests as education resources, but also can recommend the most appropriate genetic tests to patients based on clinical evidence. In this study, we developed an EHR based Genetic Testing Knowledge Base for Individualized Medicine (iGTKB). We extracted genetic testing information and patient medical records from EHR systems at Mayo Clinic. Clinical features have been semi-automatically annotated from the clinical notes by applying a Natural Language Processing (NLP) tool, MedTagger suite. To prioritize clinical features for each genetic test, we compared odds ratio across four population groups. Genetic tests, genetic disorders and clinical features with their odds ratios have been applied to establish iGTKB, which is to be integrated into the Genetic Testing Ontology (GTO). Overall, there are five genetic tests operated with sample size greater than 100 in 2013 at Mayo Clinic. A total of 1,450 patients who was tested by one of the five genetic tests have been selected. We assembled 243 clinical features from the Human Phenotype Ontology (HPO) for these five genetic tests. There are 60 clinical features with at least one mention in clinical notes of patients taking the test. Twenty-eight clinical features with high odds ratio (greater than 1) have been selected as dominant features and deposited into iGTKB with their associated information about genetic tests and genetic disorders. In this study, we developed an EHR based genetic testing knowledge base, iGTKB. iGTKB will be integrated into the GTO by providing relevant clinical evidence, and ultimately to support development of genetic testing recommendation system, iGenetics.

  17. The evidence for chronic traumatic encephalopathy in boxing.

    PubMed

    McCrory, Paul; Zazryn, Tsharni; Cameron, Peter

    2007-01-01

    The sport of boxing has been the source of much debate, with concerns about the neurological risks of participating having led to many calls to ban the sport. This review seeks to establish an evidence base for the development of boxing-related chronic traumatic encephalopathy (CTE) and to determine the relevance of this information to the modern day sport.The clinical features of CTE include various symptoms affecting the pyramidal and extrapyramidal systems, which manifest most often as disturbed gait and coordination, slurred speech and tremors, as well as cerebral dysfunction causing cognitive impairments and neurobehavioural disturbances. Both amateur and professional boxers are potentially at risk of developing CTE. No current epidemiological evidence exists to determine the prevalence of this condition in modern day boxing, despite 17% of professional boxers in Britain with careers in the 1930-50s having clinical evidence of CTE. As medical presence within the sport increases and with modern boxers likely to have shorter careers, a reduced exposure to repetitive head trauma, and improved treatment and understanding of the development of CTE will occur. This should lead to the incidence of CTE diminishing in boxing populations.

  18. Titre and affinity of propylthiouracil-induced anti-myeloperoxidase antibodies are closely associated with the development of clinical vasculitis.

    PubMed

    Ye, Hua; Gao, Ying; Guo, Xiao-Hui; Zhao, Ming-Hui

    2005-10-01

    Substantial evidences suggested that propylthiouracil (PTU) could induced anti-myeloperoxidase (MPO) antibodies in sera from patients with hyperthyroidism, however, only a subgroup of the PTU-induced anti-MPO antibody positive patients developed clinical evident vasculitis. The aim of this study is to compare the titres and affinities of PTU induced anti-MPO antibodies in sera from patients with hyperthyroidism with and without clinical vasculitis. Anti-MPO antibody positive sera from patients diagnosed hyperthyroidism with (n = 13) and without (n = 14) clinical evident vasculitis were collected. The titre was determined by MPO-ELISA and expressed as logarithm value (lgT). The affinity constant (aK) of anti-MPO IgG was measured by antigen inhibition assay. The titre and aK values were compared between patients with and without vasculitis. In patients with vasculitis, the mean lgT of anti-MPO antibodies was 3.62 +/- 0.66; the median aK was 4.47 x 10(7)M(-1). In patients without vasculitis, the mean lgT was 2.54 +/- 0.29; the median aK was 0.14 x 10(7)M(-1), and both were significant lower than those in patients with vasculitis (t = 5.464; P = 0.000 & z = -4.373; P = 0.000, respectively). We concluded that the titre and affinity of anti-MPO antibodies might be associated with the development of clinical vasculitis in patients with PTU-induced ANCA.

  19. Grading the quality of evidence and the strength of recommendations in clinical dentistry: a critical review of 2 prominent approaches.

    PubMed

    Faggion, Clovis Mariano

    2010-06-01

    The objective of this article was to critically review 2 prominent approaches used to grade the quality of evidence and the strength of recommendations. Every year much information becomes available as a result of publication of scientific papers, and clinicians should be able to assess current evidence so they, along with their patients, can make the most appropriate clinical decisions. This is particularly important when there is little or no high-quality evidence available about the subject of interest. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) and the Strength of Recommendation Taxonomy (SORT) were evaluated. Strengths and weaknesses of these 2 systems are discussed, mainly on the basis of their relevance to clinical dentistry. The conclusion was that use of a system for grading the quality of evidence and the strength of recommendations is urgently required because of the great heterogeneity of the quality and type of evidence relating to many dental procedures. Use of such a system will enable clinicians and their patients to make more informed decisions.

  20. [SERV clinical practice guidelines: management of retinal vein occlusion. Sociedad Española de Retina y Vitreo].

    PubMed

    Gómez-Ulla, F; Abraldes, M J; Basauri, E; Fernández, M; García-Layana, A; Gili, P; Montero, J; Nadal, J; Morales, V; Saravia, M; Cabrera, F; Cervera, E

    2010-09-01

    A guidelines for the management of retinal vein occlusion is presented. This is necessary because at this moment several therapeutic alternatives have been developed although their role is not yet sufficiently defined. Review of the literature for evidence published up to date. Relevant literature was identified and the level of evidence graded. Evidence was then assessed for consistency, applicability and clinical impact. The information was contrasted with those guides published in other countries. Taking into account the different options of treatment that are currently used, several modes of action are suggested. The role of the various complementary examinations are discussed and it is recommended that criteria for the treatment are based on clinical, angiographic, and tomographic findings. Although there is no overall consensus, these guidelines promote a good standard of clinical practise and provide an update of the management of retinal vein occlusion. Copyright © 2010. Published by Elsevier Espana.

  1. The use of functional appliances in contemporary orthodontic practice.

    PubMed

    DiBiase, A T; Cobourne, M T; Lee, R T

    2015-02-16

    Functional appliances have been used for over 100 years in orthodontics to correct Class II malocclusion. During this time numerous different systems have been developed often accompanied by claims of modification and enhancement of growth. Recent clinical evidence has questioned whether they really have a lasting influence on facial growth, their skeletal effects appearing to be short term. However, despite these findings, the clinical effectiveness of these appliances is acknowledged and they can be very useful in the correction of sagittal arch discrepancies. This article will discuss the clinical use of functional appliances, the underlying evidence for their use and their limitations.

  2. Rural Doctors' Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study.

    PubMed

    Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

    2016-01-01

    Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. This study aimed to explore the views and experiences of rural doctors' about evidence-based medicine in their daily clinical practice in a rural primary care setting. Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers.

  3. The Global Evidence Mapping Initiative: scoping research in broad topic areas.

    PubMed

    Bragge, Peter; Clavisi, Ornella; Turner, Tari; Tavender, Emma; Collie, Alex; Gruen, Russell L

    2011-06-17

    Evidence mapping describes the quantity, design and characteristics of research in broad topic areas, in contrast to systematic reviews, which usually address narrowly-focused research questions. The breadth of evidence mapping helps to identify evidence gaps, and may guide future research efforts. The Global Evidence Mapping (GEM) Initiative was established in 2007 to create evidence maps providing an overview of existing research in Traumatic Brain Injury (TBI) and Spinal Cord Injury (SCI). The GEM evidence mapping method involved three core tasks:1. Setting the boundaries and context of the map: Definitions for the fields of TBI and SCI were clarified, the prehospital, acute inhospital and rehabilitation phases of care were delineated and relevant stakeholders (patients, carers, clinicians, researchers and policymakers) who could contribute to the mapping were identified. Researchable clinical questions were developed through consultation with key stakeholders and a broad literature search. 2. Searching for and selection of relevant studies: Evidence search and selection involved development of specific search strategies, development of inclusion and exclusion criteria, searching of relevant databases and independent screening and selection by two researchers. 3. Reporting on yield and study characteristics: Data extraction was performed at two levels - 'interventions and study design' and 'detailed study characteristics'. The evidence map and commentary reflected the depth of data extraction. One hundred and twenty-nine researchable clinical questions in TBI and SCI were identified. These questions were then prioritised into high (n = 60) and low (n = 69) importance by the stakeholders involved in question development. Since 2007, 58 263 abstracts have been screened, 3 731 full text articles have been reviewed and 1 644 relevant neurotrauma publications have been mapped, covering fifty-three high priority questions. GEM Initiative evidence maps have a broad range of potential end-users including funding agencies, researchers and clinicians. Evidence mapping is at least as resource-intensive as systematic reviewing. The GEM Initiative has made advancements in evidence mapping, most notably in the area of question development and prioritisation. Evidence mapping complements other review methods for describing existing research, informing future research efforts, and addressing evidence gaps.

  4. The Global Evidence Mapping Initiative: Scoping research in broad topic areas

    PubMed Central

    2011-01-01

    Background Evidence mapping describes the quantity, design and characteristics of research in broad topic areas, in contrast to systematic reviews, which usually address narrowly-focused research questions. The breadth of evidence mapping helps to identify evidence gaps, and may guide future research efforts. The Global Evidence Mapping (GEM) Initiative was established in 2007 to create evidence maps providing an overview of existing research in Traumatic Brain Injury (TBI) and Spinal Cord Injury (SCI). Methods The GEM evidence mapping method involved three core tasks: 1. Setting the boundaries and context of the map: Definitions for the fields of TBI and SCI were clarified, the prehospital, acute inhospital and rehabilitation phases of care were delineated and relevant stakeholders (patients, carers, clinicians, researchers and policymakers) who could contribute to the mapping were identified. Researchable clinical questions were developed through consultation with key stakeholders and a broad literature search. 2. Searching for and selection of relevant studies: Evidence search and selection involved development of specific search strategies, development of inclusion and exclusion criteria, searching of relevant databases and independent screening and selection by two researchers. 3. Reporting on yield and study characteristics: Data extraction was performed at two levels - 'interventions and study design' and 'detailed study characteristics'. The evidence map and commentary reflected the depth of data extraction. Results One hundred and twenty-nine researchable clinical questions in TBI and SCI were identified. These questions were then prioritised into high (n = 60) and low (n = 69) importance by the stakeholders involved in question development. Since 2007, 58 263 abstracts have been screened, 3 731 full text articles have been reviewed and 1 644 relevant neurotrauma publications have been mapped, covering fifty-three high priority questions. Conclusions GEM Initiative evidence maps have a broad range of potential end-users including funding agencies, researchers and clinicians. Evidence mapping is at least as resource-intensive as systematic reviewing. The GEM Initiative has made advancements in evidence mapping, most notably in the area of question development and prioritisation. Evidence mapping complements other review methods for describing existing research, informing future research efforts, and addressing evidence gaps. PMID:21682870

  5. Training in a Clozapine Clinic for Psychiatry Residents: A Plea and Suggestions for Implementation

    ERIC Educational Resources Information Center

    Freudenreich, Oliver; Henderson, David C.; Sanders, Kathy M.; Goff, Donald C.

    2013-01-01

    Objective: The authors sought to develop a model educational clinic and curriculum for psychiatric residents, to increase knowledge and comfort about clozapine prescribing. This matters because clozapine is an important evidence-based treatment for refractory schizophrenia that remains underutilized in clinical practice. Method: This is a…

  6. Evaluating Evidence-Informed Clinical Reasoning Proficiency in Oral Practical Examinations

    ERIC Educational Resources Information Center

    Geisler, Paul R.; Hummel, Chris; Piebes, Sarah

    2014-01-01

    Clinical reasoning is the specific cognitive process used by health care practitioners to formulate accurate diagnoses for complex patient problems and to set up and carry out effective care. Athletic training students and practitioners need to develop and display effective clinical reasoning skills in the assessment of injury and illness as a…

  7. Female Pathological Gamblers--A Critical Review of the Clinical Findings

    ERIC Educational Resources Information Center

    Wenzel, Hanne Gro; Dahl, Alv A.

    2009-01-01

    Recent evidence indicates that more and more women gamble and develop gambling problems and pathological gambling (PG). Research has further indicated that female and male PGs differ in their clinical characteristics. The aim of this study is to do a critical review of the literature concerning clinical characteristics of female pathological…

  8. Toward evidence-based interventions for diverse populations: The San Francisco General Hospital prevention and treatment manuals.

    PubMed

    Muñoz, Ricardo F; Mendelson, Tamar

    2005-10-01

    Clinical trials have seldom included adequate samples of people of color. Therefore, practitioners serving ethnic minorities often do not have access to readily available evidence-based interventions. This article summarizes the development and empirical evaluation of prevention and treatment manuals designed for low-income ethnic minority populations at San Francisco General Hospital. The manuals were often designed by people of color familiar with the communities for which they were developed. Independent research teams in multi-site national and international clinical trials have evaluated many of these manuals with encouraging results. ((c) 2005 APA, all rights reserved).

  9. Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol

    PubMed Central

    2014-01-01

    Background Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard. There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care. Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals. In Australia, the provision of evidence-based care for men with prostate cancer has been identified as a high priority. Clinical audits have shown that fewer than 10% of patients in New South Wales (NSW) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery. This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer. Methods/Design In Phase I, a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation (ACI) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery. The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design. Outcome data (referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy) will be collected through review of patient medical records. In Phase II, mixed methods will be used to identify mechanisms of provider and organisational change. Clinicians’ knowledge and attitudes will be assessed through surveys. Process outcome measures will be assessed through document review. Semi-structured interviews will be conducted to elucidate mechanisms of change. Discussion The study will be one of the first randomised controlled trials to test the effectiveness of clinical networks to lead changes in clinical practice in hospitals treating patients with high-risk cancer. It will additionally provide direction regarding implementation strategies that can be effectively employed to encourage widespread adoption of clinical practice guidelines. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611001251910. PMID:24884877

  10. Translating Evidence Into Practice via Social Media: A Mixed-Methods Study

    PubMed Central

    Tunnecliff, Jacqueline; Morgan, Prue; Gaida, Jamie E; Clearihan, Lyn; Sadasivan, Sivalal; Davies, David; Ganesh, Shankar; Mohanty, Patitapaban; Weiner, John; Reynolds, John; Ilic, Dragan

    2015-01-01

    Background Approximately 80% of research evidence relevant to clinical practice never reaches the clinicians delivering patient care. A key barrier for the translation of evidence into practice is the limited time and skills clinicians have to find and appraise emerging evidence. Social media may provide a bridge between health researchers and health service providers. Objective The aim of this study was to determine the efficacy of social media as an educational medium to effectively translate emerging research evidence into clinical practice. Methods The study used a mixed-methods approach. Evidence-based practice points were delivered via social media platforms. The primary outcomes of attitude, knowledge, and behavior change were assessed using a preintervention/postintervention evaluation, with qualitative data gathered to contextualize the findings. Results Data were obtained from 317 clinicians from multiple health disciplines, predominantly from the United Kingdom, Australia, the United States, India, and Malaysia. The participants reported an overall improvement in attitudes toward social media for professional development (P<.001). The knowledge evaluation demonstrated a significant increase in knowledge after the training (P<.001). The majority of respondents (136/194, 70.1%) indicated that the education they had received via social media had changed the way they practice, or intended to practice. Similarly, a large proportion of respondents (135/193, 69.9%) indicated that the education they had received via social media had increased their use of research evidence within their clinical practice. Conclusions Social media may be an effective educational medium for improving knowledge of health professionals, fostering their use of research evidence, and changing their clinical behaviors by translating new research evidence into clinical practice. PMID:26503129

  11. Pharmacogenomics to Revive Drug Development in Cardiovascular Disease.

    PubMed

    Dubé, Marie-Pierre; de Denus, Simon; Tardif, Jean-Claude

    2016-02-01

    Investment in cardiovascular drug development is on the decline as large cardiovascular outcomes trials require considerable investments in time, efforts and financial resources. Pharmacogenomics has the potential to help revive the cardiovascular drug development pipeline by providing new and better drug targets at an earlier stage and by enabling more efficient outcomes trials. This article will review some of the recent developments highlighting the value of pharmacogenomics for drug development. We discuss how genetic biomarkers can enable the conduct of more efficient clinical outcomes trials by enriching patient populations for good responders to the medication. In addition, we assess past drug development programs which support the added value of selecting drug targets that have established genetic evidence supporting the targeted mechanism of disease. Finally, we discuss how pharmacogenomics can provide valuable evidence linking a drug target to clinically relevant outcomes, enabling novel drug discovery and drug repositioning opportunities.

  12. Evidence based vaccinology.

    PubMed

    Nalin, David R

    2002-02-22

    Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.

  13. Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol.

    PubMed

    Gagnier, Joel J; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Buchbinder, Rachelle

    2017-07-20

    The selection of appropriate outcomes or domains is crucial when designing clinical trials, to appreciate the effects of different interventions, pool results, and make valid comparisons between trials. If the findings are to influence policy and practice, then the chosen outcomes need to be relevant and important to key stakeholders, including patients and the public, healthcare professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. Recent reviews of the measurement properties of patient-reported outcome measures for shoulder disorders revealed a large selection of diverse measures, many with questionable validity, reliability, and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials of shoulder disorders. The purpose of the present project is to develop and disseminate a COS for clinical trials in shoulder disorders. The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence. The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials. There would be an expectation that the core set of outcomes would always be collected and reported, but it would not preclude use of additional outcomes in a particular trial.

  14. Evidence-based practice guideline of Chinese herbal medicine for primary open-angle glaucoma (qingfeng -neizhang)

    PubMed Central

    Yang, Yingxin; Ma, Qiu-yan; Yang, Yue; He, Yu-peng; Ma, Chao-ting; Li, Qiang; Jin, Ming; Chen, Wei

    2018-01-01

    Abstract Background: Primary open angle glaucoma (POAG) is a chronic, progressive optic neuropathy. The aim was to develop an evidence-based clinical practice guideline of Chinese herbal medicine (CHM) for POAG with focus on Chinese medicine pattern differentiation and treatment as well as approved herbal proprietary medicine. Methods: The guideline development group involved in various pieces of expertise in contents and methods. Authors searched electronic databases include CNKI, VIP, Sino-Med, Wanfang data, PubMed, the Cochrane Library, EMBASE, as well as checked China State Food and Drug Administration (SFDA) from the inception of these databases to June 30, 2015. Systematic reviews and randomized controlled trials of Chinese herbal medicine treating adults with POAG were evaluated. Risk of bias tool in the Cochrane Handbook and evidence strength developed by the GRADE group were applied for the evaluation, and recommendations were based on the findings incorporating evidence strength. After several rounds of Expert consensus, the final guideline was endorsed by relevant professional committees. Results: CHM treatment principle and formulae based on pattern differentiation together with approved patent herbal medicines are the main treatments for POAG, and the diagnosis and treatment focusing on blood related patterns is the major domain. Conclusion: CHM therapy alone or combined with other conventional treatment reported in clinical studies together with Expert consensus were recommended for clinical practice. PMID:29595636

  15. Biomarker and Clinical Trial Design Support for Disease-Modifying Therapies: Report of a Survey of the EU/US: Alzheimer's Disease Task Force.

    PubMed

    Cummings, J; Fox, N; Vellas, B; Aisen, P; Shan, G

    2018-01-01

    Disease-modifying therapies are urgently needed for the treatment of Alzheimer's disease (AD). The European Union/United States (EU/US) Task Force represents a broad range of stakeholders including biopharma industry personnel, academicians, and regulatory authorities. The EU/US Task Force represents a community of knowledgeable individuals who can inform views of evidence supporting disease modification and the development of disease-modifying therapies (DMTs). We queried their attitudes toward clinical trial design and biomarkers in support of DMTs. A survey of members of the EU/US Alzheimer's Disease Task Force was conducted. Ninety-three members (87%) responded. The details were analyzed to understand what clinical trial design and biomarker data support disease modification. Task Force members favored the parallel group design compared to delayed start or staggered withdrawal clinical trial designs to support disease modification. Amyloid biomarkers were regarded as providing mild support for disease modification while tau biomarkers were regarded as providing moderate support. Combinations of biomarkers, particularly combinations of tau and neurodegeneration, were regarded as providing moderate to marked support for disease modification and combinations of all three classes of biomarkers were regarded by a majority as providing marked support for disease modification. Task Force members considered that evidence derived from clinical trials and biomarkers supports clinical meaningfulness of an intervention, and when combined with a single clinical trial outcome, nearly all regarded the clinical trial design or biomarker evidence as supportive of disease modification. A minority considered biomarker evidence by itself as indicative of disease modification in prevention trials. Levels of evidence (A,B,C) were constructed based on these observations. The survey indicates the view of knowledgeable stakeholders regarding evidence derived from clinical trial design and biomarkers in support of disease modification. Results of this survey can assist in designing clinical trials of DMTs.

  16. Designing Trials for Testing the Efficacy of Pre- Pro- and Synbiotics

    NASA Astrophysics Data System (ADS)

    Lewis, Stephen; Atkinson, Charlotte

    Providing an evidence base for the rational delivery of medicines and treatments is the cornerstone of modern health care delivery. Much of this evidence base is gained through conducting clinical trials. Superficially, designing a clinical trial seems straightforward. However, in practice many unforeseen difficulties arise with long setting up times, poor recruitment rates and patients or interventions not behaving in the way expected. Unfortunately, clinical trials examining the efficacy of pre-, pro- and synbiotics have developed a reputation for being published in low impact journals and reaching unconvincing conclusions. As a generalization, the reason for this poor reputation is that the trials have tended to be too small and have not used meaningful clinical endpoints.

  17. Royal College of Physicians Intercollegiate Stroke Working Party evidence-based guidelines for the secondary prevention of stroke through nutritional or dietary modification.

    PubMed

    Hookway, C; Gomes, F; Weekes, C E

    2015-04-01

    Each year, 15 million people worldwide and 110,000 people in England have a stroke. Having a stroke increases the risk of having another. There are a number of additional known risk factors that can be modified by diet. The present study aimed to systematically review key nutrients and diets and their role in secondary prevention, as well as provide evidence-based guidelines for use in clinical practice. The work was conducted as part of the process to develop the 4th edition of the Royal College of Physicians' (RCP) National Clinical Guideline (NCG) for Stroke. Questions were generated by the research team, in consultation with the Virtual Stroke Group, an online professional interest group, and the RCP Intercollegiate Stroke Working Party Guideline Development Group. Nine questions covering several individual nutrients and diet combinations were defined and searches conducted up until 31 October 2011 using five electronic databases (Embase, Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library and Web of Science). All included studies were assessed for quality and risk of bias using van Tulder criteria for randomised controlled trials (RCTs) and Quality of Reporting of Meta-analyses (QUORUM) criteria for systematic reviews. Of 4287 abstracts were identified, 79 papers were reviewed and 29 systematic reviews and RCTs were included to provide evidence for the secondary prevention components of the guidelines. For each question, evidence statements, recommendations and practical considerations were developed. This systematic review process has resulted in the development of evidence-based guidelines for use in clinical practice and has identified areas for further research. © 2014 The British Dietetic Association Ltd.

  18. A Critical Review of the Quality of Cough Clinical Practice Guidelines.

    PubMed

    Jiang, Mei; Guan, Wei-Jie; Fang, Zhang-Fu; Xie, Yan-Qing; Xie, Jia-Xing; Chen, Hao; Wei, Dang; Lai, Ke-Fang; Zhong, Nan-Shan

    2016-10-01

    Clinical practice guidelines (CPGs) have been developed to provide health-care practitioners with the best possible evidence, but the quality of these CPGs varies greatly. The goal of this study was to systematically evaluate the quality of cough CPGs and identify gaps limiting evidence-based practice. Systematic searches were conducted to identify cough CPGs in guideline databases, developers' Websites, and Medline. Four reviewers independently evaluated eligible guidelines by using the Appraisal of Guidelines for Research and Evaluation II assessment tool. Agreement among reviewers was measured by using the intraclass correlation coefficient. The number of recommendations, strength of recommendation, and levels of evidence were determined. Fifteen cough CPGs were identified. An overall high degree of agreement among reviewers was observed (intraclass correlation coefficient, 0.82 [95% CI, 0.79-0.85]). The quality ranged from good to acceptable in the scope and purpose (mean, 72%; range, 54%-93%) and clarity and presentation (mean, 68%; range, 50%-90%) domains but not in stakeholder involvement (mean, 36%; range, 18%-90%), rigor of development (mean, 36%; range, 9%-93%), applicability (mean, 23%; range, 9%-83%), and editorial independence domains (mean, 24%; range, 0-96%). Seven guidelines (46.7%) were considered "strongly recommended" or "recommended with modifications" for clinical practice. More than 70% of recommendations were based on nonrandomized studies (Level C, 30.4%) and expert opinion (Level D, 41.3%). The quality of cough CPGs is variable, and recommendations are largely based on low-quality evidence. There is significant room for improvement to develop high-quality guidelines, which urgently warrants first-class research to minimize the vital gaps in the evidence for formulation of cough CPGs. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  19. Developing prehospital clinical practice guidelines for resource limited settings: why re-invent the wheel?

    PubMed

    McCaul, Michael; de Waal, Ben; Hodkinson, Peter; Pigoga, Jennifer L; Young, Taryn; Wallis, Lee A

    2018-02-05

    Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, the volume of literature is not matched by research into alternative methods of CPG development using existing CPG documents-a specific issue for guideline development groups in low- and middle-income countries. We report on how we developed a context specific prehospital CPG using an alternative guideline development method. Difficulties experienced and lessons learnt in applying existing global guidelines' recommendations to a national context are highlighted. The project produced the first emergency care CPG for prehospital providers in Africa. It included > 270 CPGs and produced over 1000 recommendations for prehospital emergency care. We encountered various difficulties, including (1) applicability issues: few pre-hospital CPGs applicable to Africa, (2) evidence synthesis: heterogeneous levels of evidence classifications and (3) guideline quality. Learning points included (1) focusing on key CPGs and evidence mapping, (2) searching other resources for CPGs, (3) broad representation on CPG advisory boards and (4) transparency and knowledge translation. Re-inventing the wheel to produce CPGs is not always feasible. We hope this paper will encourage further projects to use existing CPGs in developing guidance to improve patient care in resource-limited settings.

  20. Towards knowledge-based systems in clinical practice: development of an integrated clinical information and knowledge management support system.

    PubMed

    Kalogeropoulos, Dimitris A; Carson, Ewart R; Collinson, Paul O

    2003-09-01

    Given that clinicians presented with identical clinical information will act in different ways, there is a need to introduce into routine clinical practice methods and tools to support the scientific homogeneity and accountability of healthcare decisions and actions. The benefits expected from such action include an overall reduction in cost, improved quality of care, patient and public opinion satisfaction. Computer-based medical data processing has yielded methods and tools for managing the task away from the hospital management level and closer to the desired disease and patient management level. To this end, advanced applications of information and disease process modelling technologies have already demonstrated an ability to significantly augment clinical decision making as a by-product. The wide-spread acceptance of evidence-based medicine as the basis of cost-conscious and concurrently quality-wise accountable clinical practice suffices as evidence supporting this claim. Electronic libraries are one-step towards an online status of this key health-care delivery quality control environment. Nonetheless, to date, the underlying information and knowledge management technologies have failed to be integrated into any form of pragmatic or marketable online and real-time clinical decision making tool. One of the main obstacles that needs to be overcome is the development of systems that treat both information and knowledge as clinical objects with same modelling requirements. This paper describes the development of such a system in the form of an intelligent clinical information management system: a system which at the most fundamental level of clinical decision support facilitates both the organised acquisition of clinical information and knowledge and provides a test-bed for the development and evaluation of knowledge-based decision support functions.

  1. 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.

  2. Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study.

    PubMed

    Backhouse, Martin E; Wonder, Michael; Hornby, Edward; Kilburg, Anne; Drummond, Michael; Mayer, Friedrich Karl

    2011-06-01

    It is common practice for developers of new health care technologies to engage in early dialogue with the major regulatory agencies; such discussions frequently center around the proposed clinical trial designs to support the registration of new interventions and suggestions on their improvement. Pricing and reimbursement agencies are increasingly using the results from health technology assessments to inform their decision making for new technologies. Such assessments are invariably underpinned by the phase 3 clinical trial evidence which may not provide answers to the key questions. Technology developers are beginning to realize that direct, early dialogue on the evidence requirements of the major pricing and reimbursement agencies, before phase 3 clinical trial designs for their key development compounds have been finalized, may be beneficial. This article reports on the pioneering efforts of one technology developer in seeking early dialogue with seven pricing and reimbursement agencies in five countries globally in 2007-2008 on their likely evidence requirements for a new oral treatment for patients with chronic plaque psoriasis. The pilot project demonstrated that a feasible process of early dialogue could be established, through a face-to-face meeting with prior circulation of a briefing book. Although there was some variation in the advice the similarities far outweighed the differences. More experience of early dialogue needs to be accumulated, involving a wider range of pricing and reimbursement agencies and compounds. The conclusion of this study, however, was that early dialogue can be a worthwhile process for all parties and can lead to a common understanding about evidence development for market access. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. Sleep disturbance in adults with cancer: a systematic review of evidence for best practices in assessment and management for clinical practice.

    PubMed

    Howell, D; Oliver, T K; Keller-Olaman, S; Davidson, J R; Garland, S; Samuels, C; Savard, J; Harris, C; Aubin, M; Olson, K; Sussman, J; MacFarlane, J; Taylor, C

    2014-04-01

    Sleep disturbance is prevalent in cancer with detrimental effects on health outcomes. Sleep problems are seldom identified or addressed in cancer practice. The purpose of this review was to identify the evidence base for the assessment and management of cancer-related sleep disturbance (insomnia and insomnia syndrome) for oncology practice. The search of the health literature included grey literature data sources and empirical databases from June 2004 to June 2012. The evidence was reviewed by a Canadian Sleep Expert Panel, comprised of nurses, psychologists, primary care physicians, oncologists, physicians specialized in sleep disturbances, researchers and guideline methodologists to develop clinical practice recommendations for pan-Canadian use reported in a separate paper. Three clinical practice guidelines and 12 randomized, controlled trials were identified as the main source of evidence. Additional guidelines and systematic reviews were also reviewed for evidence-based recommendations on the assessment and management of insomnia not necessarily in cancer. A need to routinely screen for sleep disturbances was identified and the randomized, controlled trial (RCT) evidence suggests benefits for cognitive behavioural therapy for improving sleep quality in cancer. Sleep disturbance is a prevalent problem in cancer that needs greater recognition in clinical practice and in future research.

  4. Five-year review of an international clinical research-training program

    PubMed Central

    Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe

    2015-01-01

    The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

  5. Five-year review of an international clinical research-training program.

    PubMed

    Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

    2015-01-01

    The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

  6. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative

    PubMed Central

    Visser, K; Katchamart, W; Loza, E; Martinez-Lopez, J A; Salliot, C; Trudeau, J; Bombardier, C; Carmona, L; van der Heijde, D; Bijlsma, J W J; Boumpas, D T; Canhao, H; Edwards, C J; Hamuryudan, V; Kvien, T K; Leeb, B F; Martín-Mola, E M; Mielants, H; Müller-Ladner, U; Murphy, G; Østergaard, M; Pereira, I A; Ramos-Remus, C; Valentini, G; Zochling, J; Dougados, M

    2009-01-01

    Objectives: To develop evidence-based recommendations for the use of methotrexate in daily clinical practice in rheumatic disorders. Methods: 751 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2007–8 consisting of three separate rounds of discussions and Delphi votes. Ten clinical questions concerning the use of methotrexate in rheumatic disorders were formulated. A systematic literature search in Medline, Embase, Cochrane Library and 2005–7 American College of Rheumatology/European League Against Rheumatism meeting abstracts was conducted. Selected articles were systematically reviewed and the evidence was appraised according to the Oxford levels of evidence. Each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. Results: A total of 16 979 references was identified, of which 304 articles were included in the systematic reviews. Ten multinational key recommendations on the use of methotrexate were formulated. Nine recommendations were specific for rheumatoid arthritis (RA), including the work-up before initiating methotrexate, optimal dosage and route, use of folic acid, monitoring, management of hepatotoxicity, long-term safety, mono versus combination therapy and management in the perioperative period and before/during pregnancy. One recommendation concerned methotrexate as a steroid-sparing agent in other rheumatic diseases. Conclusions: Ten recommendations for the use of methotrexate in daily clinical practice focussed on RA were developed, which are evidence based and supported by a large panel of rheumatologists, enhancing their validity and practical use. PMID:19033291

  7. A Clinician-Centered Evaluation of the Usability of AHLTA and Automated Clinical Practice Guidelines at TAMC

    DTIC Science & Technology

    2011-03-31

    evidence based medicine into clinical practice. It will decrease costs and enable multiple stakeholders to work in an open content/source environment to exchange clinical content, develop and test technology and explore processes in applied CDS. Design: Comparative study between the KMR infrastructure and capabilities developed as an open source, vendor agnostic solution for aCPG execution within AHLTA and the current DoD/MHS standard evaluating: H1: An open source, open standard KMR and Clinical Decision Support Engine can enable organizations to share domain

  8. Development, implementation and evaluation of a clinical research engagement and leadership capacity building program in a large Australian health care service.

    PubMed

    Misso, Marie L; Ilic, Dragan; Haines, Terry P; Hutchinson, Alison M; East, Christine E; Teede, Helena J

    2016-01-14

    Health professionals need to be integrated more effectively in clinical research to ensure that research addresses clinical needs and provides practical solutions at the coal face of care. In light of limited evidence on how best to achieve this, evaluation of strategies to introduce, adapt and sustain evidence-based practices across different populations and settings is required. This project aims to address this gap through the co-design, development, implementation, evaluation, refinement and ultimately scale-up of a clinical research engagement and leadership capacity building program in a clinical setting with little to no co-ordinated approach to clinical research engagement and education. The protocol is based on principles of research capacity building and on a six-step framework, which have previously led to successful implementation and long-term sustainability. A mixed methods study design will be used. Methods will include: (1) a review of the literature about strategies that engage health professionals in research through capacity building and/or education in research methods; (2) a review of existing local research education and support elements; (3) a needs assessment in the local clinical setting, including an online cross-sectional survey and semi-structured interviews; (4) co-design and development of an educational and support program; (5) implementation of the program in the clinical environment; and (6) pre- and post-implementation evaluation and ultimately program scale-up. The evaluation focuses on research activity and knowledge, attitudes and preferences about clinical research, evidence-based practice and leadership and post implementation, about their satisfaction with the program. The investigators will evaluate the feasibility and effect of the program according to capacity building measures and will revise where appropriate prior to scale-up. It is anticipated that this clinical research engagement and leadership capacity building program will enable and enhance clinically relevant research to be led and conducted by health professionals in the health setting. This approach will also encourage identification of areas of clinical uncertainty and need that can be addressed through clinical research within the health setting.

  9. A brief report on the development of a theoretically-grounded intervention to promote patient autonomy and self-management of physiotherapy patients: face validity and feasibility of implementation.

    PubMed

    Matthews, James; Hall, Amanda M; Hernon, Marian; Murray, Aileen; Jackson, Ben; Taylor, Ian; Toner, John; Guerin, Suzanne; Lonsdale, Chris; Hurley, Deirdre A

    2015-07-05

    Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient's motivation and maintenance of self-management behaviours can be positively influenced by the clinician's use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.

  10. Neuroprotection and neurotoxicity in the developing brain: an update on the effects of dexmedetomidine and xenon.

    PubMed

    Alam, Azeem; Suen, Ka Chun; Hana, Zac; Sanders, Robert D; Maze, Mervyn; Ma, Daqing

    Growing and consistent preclinical evidence, combined with early clinical epidemiological observations, suggest potentially neurotoxic effects of commonly used anesthetic agents in the developing brain. This has prompted the FDA to issue a safety warning for all sedatives and anesthetics approved for use in children under three years of age. Recent studies have identified dexmedetomidine, the potent α2-adrenoceptor agonist, and xenon, the noble gas, as effective anesthetic adjuvants that are both less neurotoxic to the developing brain, and also possess neuroprotective properties in neonatal and other settings of acute ongoing neurologic injury. Dexmedetomidine and xenon are effective anesthetic adjuvants that appear to be less neurotoxic than other existing agents and have the potential to be neuroprotective in the neonatal and pediatric settings. Although results from recent clinical trials and case reports have indicated the neuroprotective potential of xenon and dexmedetomidine, additional randomized clinical trials corroborating these studies are necessary. By reviewing both the existing preclinical and clinical evidence on the neuroprotective effects of dexmedetomidine and xenon, we hope to provide insight into the potential clinical efficacy of these agents in the management of pediatric surgical patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Opioid analgesics and P-glycoprotein efflux transporters: a potential systems-level contribution to analgesic tolerance.

    PubMed

    Mercer, Susan L; Coop, Andrew

    2011-01-01

    Chronic clinical pain remains poorly treated. Despite attempts to develop novel analgesic agents, opioids remain the standard analgesics of choice in the clinical management of chronic and severe pain. However, mu opioid analgesics have undesired side effects including, but not limited to, respiratory depression, physical dependence and tolerance. A growing body of evidence suggests that P-glycoprotein (P-gp), an efflux transporter, may contribute a systems-level approach to the development of opioid tolerance. Herein, we describe current in vitro and in vivo methodology available to analyze interactions between opioids and P-gp and critically analyze P-gp data associated with six commonly used mu opioids to include morphine, methadone, loperamide, meperidine, oxycodone, and fentanyl. Recent studies focused on the development of opioids lacking P-gp substrate activity are explored, concentrating on structure-activity relationships to develop an optimal opioid analgesic lacking this systems-level contribution to tolerance development. Continued work in this area will potentially allow for delineation of the mechanism responsible for opioid-related P-gp up-regulation and provide further support for evidence based medicine supporting clinical opioid rotation.

  12. ‘Toning’ up hypotonia assessment: A proposal and critique

    PubMed Central

    Joubert, Robin W.E.

    2016-01-01

    Background Clinical assessment of hypotonia is challenging due to the subjective nature of the initial clinical evaluation. This poses dilemmas for practitioners in gaining accuracy, given that the presentation of hypotonia can be either a non-threatening or malevolent sign. The research question posed was how clinical assessment can be improved, given the current contentions expressed in the scientific literature. Objectives This paper describes the development and critique of a clinical algorithm to aid the assessment of hypotonia. Methods An initial exploratory sequential phase, consisting of a systematic review, a survey amongst clinicians and a Delphi process, assisted in the development of the algorithm, which is presented within the framework of the International Classification of Functioning, Disability and Health. The ensuing critique followed a qualitative emergent–systematic focus group design with a purposive sample of 59 clinicians. Data were analysed using semantical content analysis and are presented thematically with analytical considerations. Results This study culminated in the development of an evidence-based clinical algorithm for practice. The qualitative critique of the algorithm considered aspects such as inadequacies, misconceptions and omissions; strengths; clinical use; resource implications; and recommendations. Conclusions The first prototype and critique of a clinical algorithm to assist the clinical assessment of hypotonia in children has been described. Barriers highlighted include aspects related to knowledge gaps of clinicians, issues around user-friendliness and formatting concerns. Strengths identified by the critique included aspects related to the evidence-based nature of the criteria within the algorithm, the suitability of the algorithm in being merged or extending current practice, the potential of the algorithm in aiding more accurate decision-making, the suitability of the algorithm across age groups and the logical flow. These findings provide a starting point towards ascertaining the clinical utility of the algorithm as an essential step towards evidence-based praxis. PMID:28730054

  13. [GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines.

    PubMed

    Morgano, Gian Paolo; Parmelli, Elena; Amato, Laura; Iannone, Primiano; Marchetti, Marco; Moja, Lorenzo; Davoli, Marina; Schünemann, Holger

    2018-05-01

    In the first article in this series we described the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision (EtD) frameworks and their rationale for different types of decisions. In this second article, we describe the use of EtD frameworks for clinical recommendations and how it can help clinicians and patients who use those recommendations. EtD frameworks for clinical practice recommendations provide a structured and transparent approach for guideline panels. The framework helps ensure consideration of key criteria that determine whether an intervention should be recommended and that judgments are informed by the best available evidence. Frameworks are also a way for panels to make guideline users aware of the rationale (justification) for their recommendations.

  14. In the teeth of the evidence: the curious case of evidence-based medicine.

    PubMed

    Davidoff, F

    1999-03-01

    For a very long time, evidence from research has contributed to clinical decision making. Over the past 50 years, however, the nature of clinical research evidence has drastically changed compared with previous eras: its standards are higher, the tools for assembling and analyzing it are more powerful, and the context in which it is used is less authoritarian. The consequence has been a shift in both the concept and the practice of clinical decision making known as evidence-based medicine. Evidence-based decisions, by definition, use the strongest available evidence, are often more quantitatively informed than decisions made in the traditional fashion; and sometimes run counter to expert opinion. The techniques of evidence-based medicine are also helpful in resolving conflicting opinions. Evidence-based medicine did not simply appear in vacuo; its roots extend back at least as far as the great French Encyclopedia of the 18th century, and the subsequent work of Pierre Louis in Paris in the early 19th century. The power of the evidence-based approach has been enhanced in recent years by the development of the techniques of systematic review and meta-analysis. While this approach has its critics, we would all want the best available evidence used in making decisions about our care if we got sick. It is only fair that the patients under our care receive nothing less.

  15. 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

  16. New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs

    PubMed Central

    Beckman, Robert A.; Chen, Cong

    2013-01-01

    Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy, increase the value of cancer medicines, and decrease the size and cost of clinical trials while increasing their chance of success. But predictive biomarkers do not always work. When unsuccessful, they add cost, complexity, and time to drug development. This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes. In the end, the biomarker is emphasized to the extent that it can actually predict. PMID:23489587

  17. Developing Psychosis and Its Risk States Through the Lens of Schizotypy

    PubMed Central

    Debbané, Martin; Eliez, Stephan; Badoud, Deborah; Conus, Philippe; Flückiger, Rahel; Schultze-Lutter, Frauke

    2015-01-01

    Starting from the early descriptions of Kraepelin and Bleuler, the construct of schizotypy was developed from observations of aberrations in nonpsychotic family members of schizophrenia patients. In contemporary diagnostic manuals, the positive symptoms of schizotypal personality disorder were included in the ultra high-risk (UHR) criteria 20 years ago, and nowadays are broadly employed in clinical early detection of psychosis. The schizotypy construct, now dissociated from strict familial risk, also informed research on the liability to develop any psychotic disorder, and in particular schizophrenia-spectrum disorders, even outside clinical settings. Against the historical background of schizotypy it is surprising that evidence from longitudinal studies linking schizotypy, UHR, and conversion to psychosis has only recently emerged; and it still remains unclear how schizotypy may be positioned in high-risk research. Following a comprehensive literature search, we review 18 prospective studies on 15 samples examining the evidence for a link between trait schizotypy and conversion to psychosis in 4 different types of samples: general population, clinical risk samples according to UHR and/or basic symptom criteria, genetic (familial) risk, and clinical samples at-risk for a nonpsychotic schizophrenia-spectrum diagnosis. These prospective studies underline the value of schizotypy in high-risk research, but also point to the lack of evidence needed to better define the position of the construct of schizotypy within a developmental psychopathology perspective of emerging psychosis and schizophrenia-spectrum disorders. PMID:25548386

  18. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma.

    PubMed

    Wall, Christopher J; Lynch, Joan; Harris, Ian A; Richardson, Martin D; Brand, Caroline; Lowe, Adrian J; Sugrue, Michael

    2010-03-01

    Acute compartment syndrome is a serious and not uncommon complication of limb trauma. The condition is a surgical emergency, and is associated with significant morbidity if not managed appropriately. There is variation in management of acute limb compartment syndrome in Australia. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma were developed in accordance with Australian National Health and Medical Research Council recommendations. The guidelines were based on critically appraised literature evidence and the consensus opinion of a multidisciplinary team involved in trauma management who met in a nominal panel process. Recommendations were developed for key decision nodes in the patient care pathway, including methods of diagnosis in alert and unconscious patients, appropriate assessment of compartment pressure, timing and technique of fasciotomy, fasciotomy wound management, and prevention of compartment syndrome in patients with limb injuries. The recommendations were largely consensus based in the absence of well-designed clinical trial evidence. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma have been developed that will support consistency in management and optimize patient health outcomes.

  19. Surgical Management of Osteoarthritis of the Knee.

    PubMed

    Quinn, Robert H; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

    2018-05-01

    The American Academy of Orthopaedic Surgeons has developed Appropriate Use Criteria (AUC) for Surgical Management of Osteoarthritis of the Knee. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The Surgical Management of Osteoarthritis of the Knee AUC clinical patient scenarios were derived from indications of patients under consideration for surgical treatment of osteoarthritis of the knee as well as from current evidence-based clinical practice guidelines and supporting literature to identify the appropriateness of the three treatments. The 864 patient scenarios and 3 treatments were developed by the writing panel, a group of clinicians who are specialists in this AUC topic. Next, a separate, multidisciplinary, voting panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

  20. Development of a theory-informed implementation intervention to improve the triage, treatment and transfer of stroke patients in emergency departments using the Theoretical Domains Framework (TDF): the T3 Trial.

    PubMed

    Craig, Louise E; Taylor, Natalie; Grimley, Rohan; Cadilhac, Dominique A; McInnes, Elizabeth; Phillips, Rosemary; Dale, Simeon; O'Connor, Denise; Levi, Chris; Fitzgerald, Mark; Considine, Julie; Grimshaw, Jeremy M; Gerraty, Richard; Cheung, N Wah; Ward, Jeanette; Middleton, Sandy

    2017-07-17

    Theoretical frameworks and models based on behaviour change theories are increasingly used in the development of implementation interventions. Development of an implementation intervention is often based on the available evidence base and practical issues, i.e. feasibility and acceptability. The aim of this study was to describe the development of an implementation intervention for the T 3 Trial (Triage, Treatment and Transfer of patients with stroke in emergency departments (EDs)) using theory to recommend behaviour change techniques (BCTs) and drawing on the research evidence base and practical issues of feasibility and acceptability. A stepped method for developing complex interventions based on theory, evidence and practical issues was adapted using the following steps: (1) Who needs to do what, differently? (2) Using a theoretical framework, which barriers and enablers need to be addressed? (3) Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? A researcher panel was convened to review the list of BCTs recommended for use and to identify the most feasible and acceptable techniques to adopt. Seventy-six barriers were reported by hospital staff who attended the workshops (step 1: thirteen TDF domains likely to influence the implementation of the T 3 Trial clinical intervention were identified by the researchers; step 2: the researcher panellists then selected one third of the BCTs recommended for use as appropriate for the clinical context of the ED and, using the enabler workshop data, devised enabling strategies for each of the selected BCTs; and step 3: the final implementation intervention consisted of 27 BCTs). The TDF was successfully applied in all steps of developing an implementation intervention for the T 3 Trial clinical intervention. The use of researcher panel opinion was an essential part of the BCT selection process to incorporate both research evidence and expert judgment. It is recommended that this stepped approach (theory, evidence and practical issues of feasibility and acceptability) is used to develop highly reportable implementation interventions. The classifying of BCTs using recognised implementation intervention components will facilitate generalisability and sharing across different conditions and clinical settings.

  1. Bupivacaine, levobupivacaine and ropivacaine: are they clinically different?

    PubMed

    Casati, Andrea; Putzu, Marta

    2005-06-01

    Two new, long-acting local anaesthetics have been developed after the evidence of bupivacaine-related severe toxicity: levobupivacaine and ropivacaine. Both these agents are pure left-isomers and, based on their three-dimensional structure, they have less toxic potential both on the central nervous system and on the heart. Several clinical studies have evaluated their toxicology and clinical profiles: theoretically and experimentally, some differences can be seen, but the reflections of these characteristics into clinical practice have not been evident. Evaluating randomised, controlled trials that have compared these three local anaesthetics, this chapter supports the evidence that both levobupivacaine and ropivacaine have a clinical profile similar to that of racemic bupivacaine, and that the minimal differences observed between the three agents are mainly related to the slightly different anaesthetic potency, with racemic bupivacaine>levobupivacaine>ropivacaine. However, the reduced toxic potential of the two pure left-isomers supports their use in those clinical situations in which the risk of systemic toxicity related to either overdosing or unwanted intravascular injection is high, such as during epidural or peripheral nerve blocks.

  2. Mild cognitive impairment and prospective memory: translating the evidence into neuropsychological practice.

    PubMed

    Kinsella, Glynda J; Pike, Kerryn E; Cavuoto, Marina G; Lee, Stephen D

    2018-04-30

    There has been a recent rapid development of research characterizing prospective memory performance in mild cognitive impairment (MCI) in older age. However, this body of literature remains largely separated from routine clinical practice in neuropsychology. Furthermore, there is emerging evidence of effective interventions to improve prospective memory performance. Therefore, our objective in this article was to offer a clinical neuropsychological perspective on the existing research in order to facilitate the translation of the evidence-base into clinical practice. By conducting a critical review of the existing research related to prospective memory and MCI, we highlight how this data can be introduced into clinical practice, either within diagnostic assessment or clinical management. Prospective memory is impaired in older adults with MCI, with a pattern of performance that helps with differential diagnosis from healthy aging. Clinical neuropsychologists are encouraged to add prospective memory assessment to their toolbox for diagnostic evaluation of clients with MCI. Preliminary findings of prospective memory interventions in MCI are promising, but more work is required to determine how different approaches translate to increasing independence in everyday life.

  3. Comparative Effectiveness Research, Genomics-Enabled Personalized Medicine, and Rapid Learning Health Care: A Common Bond

    PubMed Central

    Ginsburg, Geoffrey S.; Kuderer, Nicole M.

    2012-01-01

    Despite stunning advances in our understanding of the genetics and the molecular basis for cancer, many patients with cancer are not yet receiving therapy tailored specifically to their tumor biology. The translation of these advances into clinical practice has been hindered, in part, by the lack of evidence for biomarkers supporting the personalized medicine approach. Most stakeholders agree that the translation of biomarkers into clinical care requires evidence of clinical utility. The highest level of evidence comes from randomized controlled clinical trials (RCTs). However, in many instances, there may be no RCTs that are feasible for assessing the clinical utility of potentially valuable genomic biomarkers. In the absence of RCTs, evidence generation will require well-designed cohort studies for comparative effectiveness research (CER) that link detailed clinical information to tumor biology and genomic data. CER also uses systematic reviews, evidence-quality appraisal, and health outcomes research to provide a methodologic framework for assessing biologic patient subgroups. Rapid learning health care (RLHC) is a model in which diverse data are made available, ideally in a robust and real-time fashion, potentially facilitating CER and personalized medicine. Nonetheless, to realize the full potential of personalized care using RLHC requires advances in CER and biostatistics methodology and the development of interoperable informatics systems, which has been recognized by the National Cancer Institute's program for CER and personalized medicine. The integration of CER methodology and genomics linked to RLHC should enhance, expedite, and expand the evidence generation required for fully realizing personalized cancer care. PMID:23071236

  4. Late whiplash syndrome: a clinical science approach to evidence-based diagnosis and management.

    PubMed

    Poorbaugh, Keith; Brismée, Jean-Michel; Phelps, Valerie; Sizer, Phillip S

    2008-01-01

    The purpose of this article is to narrow the gap that exists in the clinical application of scientific research and empiric evidence for the evaluation and management of late whiplash. Considering that 14% to 42% of patients are left with chronic symptoms following whiplash injury, it is unlikely that only minor self-limiting injuries result from the typical rear-end impact. As psychosocial issues play a role in the development of persistent whiplash symptoms, discerning the organic conditions from the biopsychosocial factors remains a challenge to clinicians. The term "whiplash" represents the multiple factors associated with the event, injury, and clinical syndrome that are the end-result of a sudden acceleration-deceleration trauma to the head and neck. However, contentions surround the nature of soft-tissue injuries that occur with most motor vehicle accidents and whether these injuries are significant enough to result in chronic pain and limitations. The stark contrast in litigation for whiplash that exists among industrialized nations and less developed countries suggests another factor that could influence one's interpretation of symptoms' chronicity associated with Late Whiplash Syndrome. There are no gold standard tests or imaging techniques that can objectify whiplash-associated disorders. A lack of supporting evidence and disparity in medico-legal issues have created distinct camps in the scientific interpretations and clinical management of late whiplash. It is likely that efforts in research and/or clinical practice will begin to explain the disparity between acute and chronic whiplash syndrome. Recent evidence suggests that Late Whiplash Syndrome should be considered from a different context. The purpose of this article is to expound on several of the significant findings in the literature and offer clinical applications for evaluation and management of Late Whiplash Syndrome.

  5. Reconciling evidence-based medicine and patient-centred care: defining evidence-based inputs to patient-centred decisions.

    PubMed

    Weaver, Robert R

    2015-12-01

    Evidence-based and patient-centred health care movements have each enhanced the discussion of how health care might best be delivered, yet the two have evolved separately and, in some views, remain at odds with each other. No clear model has emerged to enable practitioners to capitalize on the advantages of each so actual practice often becomes, to varying degrees, an undefined mishmash of each. When faced with clinical uncertainty, it becomes easy for practitioners to rely on formulas for care developed explicitly by expert panels, or on the tacit ones developed from experience or habit. Either way, these tendencies towards 'cookbook' medicine undermine the view of patients as unique particulars, and diminish what might be considered patient-centred care. The sequence in which evidence is applied in the care process, however, is critical for developing a model of care that is both evidence based and patient centred. This notion derives from a paradigm for knowledge delivery and patient care developed over decades by Dr. Lawrence Weed. Weed's vision enables us to view evidence-based and person-centred medicine as wholly complementary, using computer tools to more fully and reliably exploit the vast body of collective knowledge available to define patients' uniqueness and identify the options to guide patients. The transparency of the approach to knowledge delivery facilitates meaningful practitioner-patient dialogue in determining the appropriate course of action. Such a model for knowledge delivery and care is essential for integrating evidence-based and patient-centred approaches. © 2015 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

  6. Reflections on clinical practice whilst developing a portfolio of evidence: Perceptions of undergraduate nursing students in the Western Cape, South Africa.

    PubMed

    Ticha, Victoire; Fakude, Lorraine P

    2015-12-09

    In order to develop clinical judgement, nurses should be encouraged to become analytical and critical thinkers. Development of a portfolio of evidence (PoE) of reflection on clinical experiences is one of the strategies that can be used to enhance analytical and critical thinking amongst nursing students. Students' perceptions of the process are important in order to encourage their reflective practice. PoE compilation at a school of nursing at a university in the Western Cape includes evidence of students' clinical learning which they present in a portfolio. The students are expected to reflect on their clinical learning experiences and include these reflections in their portfolios. To describe the perceptions of fourth-year nursing students regarding reflective practice whilst compiling their PoEs. A qualitative design was used to explore the perceptions of registered fourth-year nursing students with regard to their reflective practice whilst compiling their PoEs. Purposive sampling was used for selection of participants. Three focus group discussions were held, each consisting of six to eight participants. Data saturation was reached during the third meeting. Tesch's method of data analysis was used. Findings revealed that reflection enabled the learners to gain experience and identify challenges related to the expected events and tasks carried out at the hospitals and in the classroom whilst developing their PoE. The compilation of a PoE was a good teaching and learning strategy, and the skills, experience and knowledge that the participants in this study acquired boosted their self-esteem, confidence and critical thinking. Reflection also assisted in self-directed learning.

  7. Visualization studies on evidence-based medicine domain knowledge (series 3): visualization for dissemination of evidence based medicine information.

    PubMed

    Shen, Jiantong; Yao, Leye; Li, Youping; Clarke, Mike; Gan, Qi; Li, Yifei; Fan, Yi; Gou, Yongchao; Wang, Li

    2011-05-01

    To identify patterns in information sharing between a series of Chinese evidence based medicine (EBM) journals and the Cochrane Database of Systematic Reviews, to determine key evidence dissemination areas for EBM and to provide a scientific basis for improving the dissemination of EBM research. Data were collected on citing and cited from the Chinese Journal of Evidence-Based Medicine (CJEBM), Journal of Evidence-Based Medicine (JEBMc), Chinese Journal of Evidence Based Pediatrics (CJEBP), and the Cochrane Database of Systematic Reviews (CDSR). Relationships between citations were visualized. High-frequency key words from these sources were identified, to build a word co-occurrence matrix and to map research subjects. CDSR contains a large collection of information of relevance to EBM and its contents are widely cited across many journals, suggesting a well-developed citation environment. The content and citation of the Chinese journals have been increasing in recent years. However, their citation environments are much less developed, and there is a wide variation in the breadth and strength of their knowledge communication, with the ranking from highest to lowest being CJEBM, JEBMc and CJEBP. The content of CDSR is almost exclusively Cochrane intervention reviews examining the effects of healthcare interventions, so it's contribution to EBM is mostly in disease control and treatment. On the other hand, the Chinese journals on evidence-based medicine and practice focused more on areas such as education and research, design and quality of clinical trials, evidence based policymaking, evidence based clinical practice, tumor treatment, and pediatrics. Knowledge and findings of EBM are widely communicated and disseminated. However, citation environments and range of knowledge communication differ greatly between the journals examined in this study. This finds that Chinese EBM has focused mainly on clinical medicine, Traditional Chinese Medicine, pediatrics, tumor treatment, nursing, health economic and management, and medical education. Internationally, EBM research topics have begun to shift, from drug treatment to surgery or other non-pharmacological treatments; from therapy to diagnosis, rehabilitation, and prevention; from evidence based clinical practice to evidence based management and policymaking. The philosophy and method of EBM, evidence production and translation are also shifting from well resourced settings to low- and middle-income countries, especially those in which English is not a major language. © 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  8. Modulation of obesity-induced inflammation by dietary fats: mechanisms and clinical evidence

    PubMed Central

    2014-01-01

    Obesity plays a pivotal role in the development of low-grade inflammation. Dietary fatty acids are important modulators of inflammatory responses. Saturated fatty acids (SFA) and n-6 polyunsaturated fatty acids (PUFA) have been reported to exert pro-inflammatory effects. n-3 PUFA in particular, possess anti-inflammatory properties. Numerous clinical studies have been conducted over decades to investigate the impact of dietary fatty acids on inflammatory response in obese individuals, however the findings remained uncertain. High fat meals have been reported to increase pro-inflammatory responses, however there is limited evidence to support the role of individual dietary fatty acids in a postprandial state. Evidence in chronic studies is contradictory, the effects of individual dietary fatty acids deserves further attention. Weight loss rather than n-3 PUFA supplementation may play a more prominent role in alleviating low grade inflammation. In this context, the present review provides an update on the mechanistic insight and the influence of dietary fats on low grade inflammation, based on clinical evidence from acute and chronic clinical studies in obese and overweight individuals. PMID:24476102

  9. Peyronie’s Disease: AUA Guideline

    PubMed Central

    Nehra, Ajay; Alterowitz, Ralph; Culkin, Daniel J.; Faraday, Martha M.; Hakim, Lawrence S.; Heidelbaugh, Joel J.; Khera, Mohit; Kirkby, Erin; McVary, Kevin T.; Miner, Martin M.; Nelson, Christian J.; Sadeghi-Nejad, Hossein; Seftel, Allen D.; Shindel, Alan W.; Burnett, Arthur L.

    2016-01-01

    Purpose The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of Peyronie’s disease. Materials and Methods A systematic review of the literature using the PubMed®, EMBASE® and Cochrane databases (search dates 1/1/1965 to 1/26/15) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of PD. The review yielded an evidence base of 303 articles after application of inclusion/exclusion criteria. Results The systematic review was used to create guideline statements regarding treatment of PD. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high quality evidence; high certainty), B (moderate quality evidence; moderate certainty), or C (low quality evidence; low certainty). Evidence-based statements of Strong, Moderate, or Conditional Recommendation were developed based on benefits and risks/burdens to patients. Additional consensus statements related to the diagnosis of PD are provided as Clinical Principles and Expert Opinions due to insufficient published evidence. Conclusions There is a continually expanding literature on PD; the Panel notes that this document constitutes a clinical strategy and is not intended to be interpreted rigidly. The most effective approach for a particular patient is best determined by the individual clinician and patient in the context of that patient’s history, values, and goals for treatment. As the science relevant to PD evolves and improves, the strategies presented here will be amended to remain consistent with the highest standards of clinical care. PMID:26066402

  10. Study on Language Rehabilitation for Aphasia.

    PubMed

    Yu, Zeng-Zhi; Jiang, Shu-Jun; Jia, Zi-Shan; Xiao, Hong-Yu; Zhou, Mei-Qi

    2017-06-20

    The aim is to update our clinical recommendations for evidence-based language rehabilitation of people with aphasia, based on a systematic review of the literature from 1999 to 2015. Articles referred to in this systematic review of the Medline and PubMed published in English language literatures were from 1998 to 2015. The terms used in the literature searches were aphasia and evidenced-based. The task force initially identified citations for 51 published articles. Of the 51 articles, 44 studies were selected after further detailed review. Six articles, which were not written in English, and one study related to laryngectomy rehabilitation interventions, were excluded from the study. This study referred to all the important and English literature in full. Aphasia is the linguistic disability, which usually results from injuries to the dominant hemisphere of the brain. The rehabilitation of aphasia is until in the process of being debated and researched. Evidence-based medicine (EBM), EBM based on the clinical evidence, promotes the practice of combining the clinicians' first-hand experience and the existing objective and scientific evidence encouraging making decisions based on both empirical evidence and the scientific evidence. Currently, EBM is being gradually implemented in the clinical practice as the aim of the development of modern medicine. At present, the research for the aphasia rehabilitation mainly focuses on the cognitive language rehabilitation and the intensive treatment and the precise treatment, etc. There is now sufficient information to support evidence-based protocols and implement empirically-supported treatments for linguistic disability after traumatic brain injury and stroke, which can be used to develop linguistic rehabilitation guidelines for patients with aphasia.

  11. Assessment of clinical practice guideline methodology for the treatment of knee osteoarthritis with intra-articular hyaluronic acid.

    PubMed

    Altman, Roy D; Schemitsch, Emil; Bedi, Asheesh

    2015-10-01

    Clinical practice guidelines are of increasing importance in the decision making for the treatment of knee osteoarthritis. Inconsistent recommendations regarding the use of intra-articular hyaluronic acid for the treatment of knee osteoarthritis have led to confusion among treating physicians. Literature search to identify clinical practice guidelines that provide recommendations regarding the use of intra-articular hyaluronic acid treatment for knee osteoarthritis was conducted. Included guidelines were appraised using the AGREE II instrument. Guideline development methodologies, how the results were assessed, the recommendation formation, and work group composition were summarized. Overall, 10 clinical practice guidelines were identified that met our inclusion criteria. AGREE II domain scores were variable across the included guidelines. The methodology utilized across the guidelines was heterogeneous regarding the evidence inclusion criteria, analysis of evidence results, formulation of clinical practice recommendations, and work group composition. The recommendations provided by the guidelines for intra-articular hyaluronic acid treatment for knee osteoarthritis are highly inconsistent as a result of the variability in guideline methodology. Overall, 30% of the included guidelines recommended against the use of intra-articular hyaluronic acid in the treatment of knee osteoarthritis, while 30% deemed the treatment an appropriate intervention under certain scenarios. The remaining 40% of the guidelines provided either an uncertain recommendation or no recommendation at all, based on the high variability in reviewed evidence regarding efficacy and trial quality. There is a need for a standard "appropriate methodology" that is agreed upon for osteoarthritis clinical practice guidelines in order to prevent the development of conflicting recommendations for intra-articular hyaluronic acid treatment for knee osteoarthritis, and to assure that treating physicians who are utilizing these guidelines are making their clinical decisions on the best available evidence. At present, the inconsistent recommendations provided for intra-articular hyaluronic acid treatment make it difficult for clinical professionals to determine its appropriateness when treating patients with knee osteoarthritis. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  12. [Psychotherapeutic Interventions in Acute and Maintenance Treatment of Adult Patients Diagnosed With Schizophrenia].

    PubMed

    García Valencia, Jenny; Ahunca Velásquez, Luisa Fernanda; Bohórquez Peñaranda, Adriana; Gómez Restrepo, Carlos; Jaramillo González, Luis Eduardo; Palacio Acosta, Carlos

    2014-01-01

    To determine the effectiveness of the psychotherapeutic strategies designed to improve the outcomes in adults with schizophrenia in both, acute and stable phase of disease. This evidence is used to propose recommendation in the guidelines of integral attention for the diagnosis, treatment and psychosocial rehabilitation of adults with schizophrenia. A guideline for clinical practice was developed using the methodological framework of the Ministerio de la Protección Social to collect evidence and grading recommendations. A search, evaluation and synthesis of evidence were carried out. The evidence was presented to the Guideline Developing Group and recommendations, employing the GRADE system, were produced. The cognitive behavioral therapy showed higher efficacy, compared with the usual treatment, to reduce positive symptoms, prevent relapses and hospital readmissions and to improve the occupational stats. However, the quality of evidence was low. There was not enough evidence about the efficacy of adherence, psychodynamic and support therapy. Psychotherapeutic management must be offered to the patients with schizophrenia according to their needs and clinical characteristics. Among the different psychotherapeutic modalities, cognitive behavioral therapy is recommended. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  13. Using research evidence in mental health: user-rating and focus group study of clinicians' preferences for a new clinical question-answering service.

    PubMed

    Barley, Elizabeth A; Murray, Joanna; Churchill, Rachel

    2009-12-01

    Clinicians report difficulties using research in their practices. The aim of the study was to describe needs and preferences for a mental health clinical question-answering service designed to assist this process. Multi-disciplinary clinicians participated in a focus group; users of the service supplied feedback. Fifty-four clinicians received answers to 84 questions about mental health treatments. User ratings showed that the answers had multiple uses: informing health care (43), education (22), staff development (28) and research (12), and were considered useful, clear, relevant and helpful. Focus group participants appreciated critically appraised summaries of evidence and stressed the time-saving benefit of the service. Clinicians without a medical training were least confident in applying evidence. Attitudes to research were positive, but concern was expressed about its potential misuse for political purposes. This appeared to arise from an ambiguity around the term 'insufficient evidence', which participants felt is widely misinterpreted as 'evidence of no effect'. A highly valued, responsive service has been developed. A range of clinicians find critically appraised summaries of research useful. Education about the use of research may help clinicians to be more evidence based.

  14. The Collaborative Assessment and Management of Suicidality (CAMS): an evolving evidence-based clinical approach to suicidal risk.

    PubMed

    Jobes, David A

    2012-12-01

    The Collaborative Assessment and Management of Suicidality (CAMS) is an evidence-based clinical intervention that has significantly evolved over 25 years of clinical research. CAMS is best understood as a therapeutic framework that emphasizes a unique collaborative assessment and treatment planning process between the suicidal patient and clinician. This process is designed to enhance the therapeutic alliance and increase treatment motivation in the suicidal patient. Central to the CAMS approach is the use of the Suicide Status Form (SSF), which is a multipurpose clinical assessment, treatment planning, tracking, and outcome tool. The original development of CAMS was largely rooted in SSF-based quantitative and qualitative assessment of suicidal risk. As this line of research progressed, CAMS emerged as a problem-focused clinical intervention that is designed to target and treat suicidal "drivers" and ultimately eliminate suicidal coping. To date, CAMS (and the clinical use of the SSF) has been supported by six published correlational studies and one randomized clinical trial (RCT). Currently, two well-powered RCTs are under way, and various new CAMS-related projects are also being pursued. The clinical and empirical evolution of CAMS-how it was developed and what are the next steps for this clinical approach-are described here. © 2012 The American Association of Suicidology.

  15. Feasibility of Extracting Key Elements from ClinicalTrials.gov to Support Clinicians’ Patient Care Decisions

    PubMed Central

    Kim, Heejun; Bian, Jiantao; Mostafa, Javed; Jonnalagadda, Siddhartha; Del Fiol, Guilherme

    2016-01-01

    Motivation: Clinicians need up-to-date evidence from high quality clinical trials to support clinical decisions. However, applying evidence from the primary literature requires significant effort. Objective: To examine the feasibility of automatically extracting key clinical trial information from ClinicalTrials.gov. Methods: We assessed the coverage of ClinicalTrials.gov for high quality clinical studies that are indexed in PubMed. Using 140 random ClinicalTrials.gov records, we developed and tested rules for the automatic extraction of key information. Results: The rate of high quality clinical trial registration in ClinicalTrials.gov increased from 0.2% in 2005 to 17% in 2015. Trials reporting results increased from 3% in 2005 to 19% in 2015. The accuracy of the automatic extraction algorithm for 10 trial attributes was 90% on average. Future research is needed to improve the algorithm accuracy and to design information displays to optimally present trial information to clinicians. PMID:28269867

  16. General practitioners, complementary therapies and evidence-based medicine: the defence of clinical autonomy.

    PubMed

    Adams, J

    2000-12-01

    Amidst the substantial change currently gripping primary health care are two developments central to contemporary debate regarding the very nature, territory and identity of general practice - the integration of complementary and alternative medicine (CAM) and the rise of evidence-based medicine (EBM). This paper reports findings from a study based upon 25 in-depth interviews with general practitioners (GPs) personally practising complementary therapies alongside more conventional medicine to treat their NHS patients. The paper outlines the GPs' perceptions of EBM, its relationship to their personal development of CAM, and their notions of good clinical practice more generally. Analysis of the GPs' accounts demonstrates how CAM can be seen as a useful resource with which some GPs defend their clinical autonomy from what they perceive to be the threat of EBM. Copyright 2000 Harcourt Publishers Ltd.

  17. [Consumer involvement in the Disease Management Guideline for Asthma--a background report].

    PubMed

    Senger, Sylvia; Lelgemann, Monika; Kopp, Ina

    2006-01-01

    In the past clinical guidelines were mainly developed by experts and in everyday clinical practice almost exclusively used by clinical experts, while issues that were relevant from the patients' (consumers') point of view tended to be neglected. But then, the majority of patient information has not been perceptibly connected to clinical guidelines. Connecting the development of clinical guidelines with the development of patient information publications would make good sense for both products, though. On the one hand, evidence-based treatment guidelines could be made available to the actual target group of the clinical care process--i.e. the patients or consumers--and on the other hand, patient experiences and competencies (social evidence) might inform the production of guidelines. Such a procedure demands the cooperation of clinical experts and patients. So far there are no generally accepted methods in Germany for the practical implementation of consumer involvement on both the organizational and content level with the aim of involving patients in the development process of guidelines as well as the production of the respective patient information versions. Such a methodology shall be established as part of the National Program for Disease Management Guidelines. For the first time in this program, patient involvement is being exercised within the scope of the National Disease Management Guideline for Asthma (NDM Asthma). Here, patients are involved in the NDM development process by providing the opportunity to comment on the consented guideline draft and to participate in the translation of the NDM Asthma into a patient version. The present paper is a background report describing the current state of work and indicating consequences for some future developments.

  18. Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association

    PubMed Central

    Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

    2017-01-01

    Abstract The Oncology Section of the American Physical Therapy Association (APTA) developed a clinical practice guideline to aid the clinician in diagnosing secondary upper quadrant cancer-related lymphedema. Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in the diagnostic process. Overall clinical practice recommendations were formulated based on the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. In an effort to maximize clinical applicability, recommendations were based on the characteristics as to the location and stage of a patient's upper quadrant lymphedema. PMID:28838217

  19. The Zero Suicide Model: Applying Evidence-Based Suicide Prevention Practices to Clinical Care

    PubMed Central

    Brodsky, Beth S.; Spruch-Feiner, Aliza; Stanley, Barbara

    2018-01-01

    Suicide is reaching epidemic proportions, with over 44,000 deaths by suicide in the US, and 800,000 worldwide in 2015. This, despite research and development of evidence-based interventions that target suicidal behavior directly. Suicide prevention efforts need a comprehensive approach, and research must lead to effective implementation across public and mental health systems. A 10-year systematic review of evidence-based findings in suicide prevention summarized the areas necessary for translating research into practice. These include risk assessment, means restriction, evidence-based treatments, population screening combined with chain of care, monitoring, and follow-up. In this article, we review how suicide prevention research informs implementation in clinical settings where those most at risk present for care. Evidence-based and best practices address the fluctuating nature of suicide risk, which requires ongoing risk assessment, direct intervention and monitoring. In the US, the National Action Alliance for Suicide Prevention has put forth the Zero Suicide (ZS) Model, a framework to coordinate a multilevel approach to implementing evidence-based practices. We present the Assess, Intervene and Monitor for Suicide Prevention model (AIM-SP) as a guide for implementation of ZS evidence-based and best practices in clinical settings. Ten basic steps for clinical management model will be described and illustrated through case vignette. These steps are designed to be easily incorporated into standard clinical practice to enhance suicide risk assessment, brief interventions to increase safety and teach coping strategies and to improve ongoing contact and monitoring of high-risk individuals during transitions in care and high risk periods. PMID:29527178

  20. Evidence-Based Implementation: The Role of Sustained Community-Based Practice and Research Partnerships

    PubMed Central

    Kilbourne, Amy M.; Neumann, Mary Spink; Waxmonsky, Jeanette; Bauer, Mark S.; Kim, Hyungin Myra; Pincus, Harold Alan; Thomas, Marshall

    2017-01-01

    This column describes a process for adapting an evidence-based practice in community clinics in which researchers and community providers participated and the resulting framework for implementation of the practice—Replicating Effective Programs–Facilitation. A two-day meeting for the Recovery-Oriented Collaborative Care study was conducted to elicit input from more than 50 stakeholders, including community providers, health care administrators, and implementation researchers. The process illustrates an effective researcher-community partnership in which stakeholders worked together not only to adapt the evidence-based practice to the needs of the clinical settings but also to develop the implementation strategy. PMID:22388527

  1. Experience with the Implementation of Clinical Pharmacy Services and Processes in a University Hospital in Belgium.

    PubMed

    Somers, Annemie; Claus, Barbara; Vandewoude, Koen; Petrovic, Mirko

    2016-03-01

    This article summarizes the experience with the development of clinical pharmacy services in the Ghent University Hospital in Belgium. Implementation of clinical pharmacy services in Belgian hospitals has not been evident because these activities were initially not structurally financed. The aim is to describe the strengths and weaknesses of the clinical pharmacy development process, and the milestones that enhanced the progress. Furthermore, the organisation of clinical pharmacy in the Ghent University Hospital is explained, including back- and front-office activities, seamless pharmaceutical care and medication safety improvement. Some working methods, procedures and tools are explained for different clinical pharmacy services. In particular, the clinical pharmacy projects for geriatric patients as well as the preparation of clinical pharmacy services for the accreditation process are explained. We also reflect on the organisation model and the future development of clinical pharmacy, taking into consideration facilitators and potential barriers.

  2. Multinational evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative.

    PubMed

    Machado, P; Castrejon, I; Katchamart, W; Koevoets, R; Kuriya, B; Schoels, M; Silva-Fernández, L; Thevissen, K; Vercoutere, W; Villeneuve, E; Aletaha, D; Carmona, L; Landewé, R; van der Heijde, D; Bijlsma, J W J; Bykerk, V; Canhão, H; Catrina, A I; Durez, P; Edwards, C J; Mjaavatten, M D; Leeb, B F; Losada, B; Martín-Mola, E M; Martinez-Osuna, P; Montecucco, C; Müller-Ladner, U; Østergaard, M; Sheane, B; Xavier, R M; Zochling, J; Bombardier, C

    2011-01-01

    To develop evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis (UPIA). 697 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2008-9 consisting of three separate rounds of discussions and modified Delphi votes. In the first round 10 clinical questions were selected. A bibliographic team systematically searched Medline, Embase, the Cochrane Library and ACR/EULAR 2007-2008 meeting abstracts. Relevant articles were reviewed for quality assessment, data extraction and synthesis. In the second round each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. A total of 39,756 references were identified, of which 250 were systematically reviewed. Ten multinational key recommendations about the investigation and follow-up of UPIA were formulated. One recommendation addressed differential diagnosis and investigations prior to establishing the operational diagnosis of UPIA, seven recommendations related to the diagnostic and prognostic value of clinical and laboratory assessments in established UPIA (history and physical examination, acute phase reactants, autoantibodies, radiographs, MRI and ultrasound, genetic markers and synovial biopsy), one recommendation highlighted predictors of persistence (chronicity) and the final recommendation addressed monitoring of clinical disease activity in UPIA. Ten recommendations on how to investigate and follow-up UPIA in the clinical setting were developed. They are evidence-based and supported by a large panel of rheumatologists, thus enhancing their validity and practical use.

  3. Introduction to the history and current status of evidence-based korean medicine: a unique integrated system of allopathic and holistic medicine.

    PubMed

    Yin, Chang Shik; Ko, Seong-Gyu

    2014-01-01

    Objectives. Korean medicine, an integrated allopathic and traditional medicine, has developed unique characteristics and has been active in contributing to evidence-based medicine. Recent developments in Korean medicine have not been as well disseminated as traditional Chinese medicine. This introduction to recent developments in Korean medicine will draw attention to, and facilitate, the advancement of evidence-based complementary alternative medicine (CAM). Methods and Results. The history of and recent developments in Korean medicine as evidence-based medicine are explored through discussions on the development of a national standard classification of diseases and study reports, ranging from basic research to newly developed clinical therapies. A national standard classification of diseases has been developed and revised serially into an integrated classification of Western allopathic and traditional holistic medicine disease entities. Standard disease classifications offer a starting point for the reliable gathering of evidence and provide a representative example of the unique status of evidence-based Korean medicine as an integration of Western allopathic medicine and traditional holistic medicine. Conclusions. Recent developments in evidence-based Korean medicine show a unique development in evidence-based medicine, adopting both Western allopathic and holistic traditional medicine. It is expected that Korean medicine will continue to be an important contributor to evidence-based medicine, encompassing conventional and complementary approaches.

  4. Clinical algorithms to aid osteoarthritis guideline dissemination.

    PubMed

    Meneses, S R F; Goode, A P; Nelson, A E; Lin, J; Jordan, J M; Allen, K D; Bennell, K L; Lohmander, L S; Fernandes, L; Hochberg, M C; Underwood, M; Conaghan, P G; Liu, S; McAlindon, T E; Golightly, Y M; Hunter, D J

    2016-09-01

    Numerous scientific organisations have developed evidence-based recommendations aiming to optimise the management of osteoarthritis (OA). Uptake, however, has been suboptimal. The purpose of this exercise was to harmonize the recent recommendations and develop a user-friendly treatment algorithm to facilitate translation of evidence into practice. We updated a previous systematic review on clinical practice guidelines (CPGs) for OA management. The guidelines were assessed using the Appraisal of Guidelines for Research and Evaluation for quality and the standards for developing trustworthy CPGs as established by the National Academy of Medicine (NAM). Four case scenarios and algorithms were developed by consensus of a multidisciplinary panel. Sixteen guidelines were included in the systematic review. Most recommendations were directed toward physicians and allied health professionals, and most had multi-disciplinary input. Analysis for trustworthiness suggests that many guidelines still present a lack of transparency. A treatment algorithm was developed for each case scenario advised by recommendations from guidelines and based on panel consensus. Strategies to facilitate the implementation of guidelines in clinical practice are necessary. The algorithms proposed are examples of how to apply recommendations in the clinical context, helping the clinician to visualise the patient flow and timing of different treatment modalities. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  5. Evidence-based medicine in the treatment of peritoneal carcinomatosis: Past, present, and future.

    PubMed

    Nissan, Aviram; Stojadinovic, Alexander; Garofalo, Alfredo; Esquivel, Jesus; Piso, Pompiliu

    2009-09-15

    The current treatment of peritoneal surface malignancies (PSMs) is moving from a nihilistic approach, into a combined modality approach offering selected patients long-term survival. As primary PSM are rare, extrapolation of data from clinical trials of related disease is necessary to develop treatment guidelines. Secondary PSM are more common, and therefore, treatment guidelines should be developed based on prospective clinical trials. We reviewed the published and ongoing clinical trials studying the treatment of PSM. (c) 2009 Wiley-Liss, Inc.

  6. Clinical Practice Guideline Development Manual, Third Edition: a quality-driven approach for translating evidence into action.

    PubMed

    Rosenfeld, Richard M; Shiffman, Richard N; Robertson, Peter

    2013-01-01

    Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing health care variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective-or potentially harmful-interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. The third edition of this manual describes the principles and practices used successfully by the American Academy of Otolaryngology--Head and Neck Surgery Foundation to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for actionable recommendations with multidisciplinary applicability. The development process emphasizes a logical sequence of key action statements supported by amplifying text, action statement profiles, and recommendation grades linking action to evidence. New material in this edition includes standards for trustworthy guidelines, updated classification of evidence levels, increased patient and public involvement, assessing confidence in the evidence, documenting differences of opinion, expanded discussion of conflict of interest, and use of computerized decision support for crafting actionable recommendations. As clinical practice guidelines become more prominent as a key metric of quality health care, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are--and are not--and how they are best used to improve care. The information in this manual should help clinicians and organizations achieve these goals.

  7. Enhancing clinical decision making: development of a contiguous definition and conceptual framework.

    PubMed

    Tiffen, Jennifer; Corbridge, Susan J; Slimmer, Lynda

    2014-01-01

    Clinical decision making is a term frequently used to describe the fundamental role of the nurse practitioner; however, other terms have been used interchangeably. The purpose of this article is to begin the process of developing a definition and framework of clinical decision making. The developed definition was "Clinical decision making is a contextual, continuous, and evolving process, where data are gathered, interpreted, and evaluated in order to select an evidence-based choice of action." A contiguous framework for clinical decision making specific for nurse practitioners is also proposed. Having a clear and unique understanding of clinical decision making will allow for consistent use of the term, which is relevant given the changing educational requirements for nurse practitioners and broadening scope of practice. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Clinical practice recommendations for bipolar disorder.

    PubMed

    Malhi, G S; Adams, D; Lampe, L; Paton, M; O'Connor, N; Newton, L A; Walter, G; Taylor, A; Porter, R; Mulder, R T; Berk, M

    2009-01-01

    To provide clinically relevant evidence-based recommendations for the management of bipolar disorder in adults that are informative, easy to assimilate and facilitate clinical decision-making. A comprehensive literature review of over 500 articles was undertaken using electronic database search engines (e.g. MEDLINE, PsychINFO and Cochrane reviews). In addition articles, book chapters and other literature known to the authors were reviewed. The findings were then formulated into a set of recommendations that were developed by a multidisciplinary team of clinicians who routinely deal with mood disorders. These preliminary recommendations underwent extensive consultative review by a broader advisory panel that included experts in the field, clinical staff and patient representatives. The clinical practice recommendations for bipolar disorder (bipolar CPR) summarise evidence-based treatments and provide a synopsis of recommendations relating to each phase of the illness. They are designed for clinical use and have therefore been presented succinctly in an innovative and engaging manner that is clear and informative. These up-to-date recommendations provide an evidence-based framework that incorporates clinical wisdom and consideration of individual factors in the management of bipolar disorder. Further, the novel style and practical approach should promote their uptake and implementation.

  9. Characteristics of knowledge content in a curated online evidence library.

    PubMed

    Varada, Sowmya; Lacson, Ronilda; Raja, Ali S; Ip, Ivan K; Schneider, Louise; Osterbur, David; Bain, Paul; Vetrano, Nicole; Cellini, Jacqueline; Mita, Carol; Coletti, Margaret; Whelan, Julia; Khorasani, Ramin

    2018-05-01

    To describe types of recommendations represented in a curated online evidence library, report on the quality of evidence-based recommendations pertaining to diagnostic imaging exams, and assess underlying knowledge representation. The evidence library is populated with clinical decision rules, professional society guidelines, and locally developed best practice guidelines. Individual recommendations were graded based on a standard methodology and compared using chi-square test. Strength of evidence ranged from grade 1 (systematic review) through grade 5 (recommendations based on expert opinion). Finally, variations in the underlying representation of these recommendations were identified. The library contains 546 individual imaging-related recommendations. Only 15% (16/106) of recommendations from clinical decision rules were grade 5 vs 83% (526/636) from professional society practice guidelines and local best practice guidelines that cited grade 5 studies (P < .0001). Minor head trauma, pulmonary embolism, and appendicitis were topic areas supported by the highest quality of evidence. Three main variations in underlying representations of recommendations were "single-decision," "branching," and "score-based." Most recommendations were grade 5, largely because studies to test and validate many recommendations were absent. Recommendation types vary in amount and complexity and, accordingly, the structure and syntax of statements they generate. However, they can be represented in single-decision, branching, and score-based representations. In a curated evidence library with graded imaging-based recommendations, evidence quality varied widely, with decision rules providing the highest-quality recommendations. The library may be helpful in highlighting evidence gaps, comparing recommendations from varied sources on similar clinical topics, and prioritizing imaging recommendations to inform clinical decision support implementation.

  10. The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 3: The Clinical Guidelines.

    PubMed

    Fountoulakis, Konstantinos N; Grunze, Heinz; Vieta, Eduard; Young, Allan; Yatham, Lakshmi; Blier, Pierre; Kasper, Siegfried; Moeller, Hans Jurgen

    2017-02-01

    The current paper introduces the actual International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder. The current clinical guidelines are based on evidence-based data, but they also intend to be clinically useful, while a rigid algorithm was developed on the basis of firm evidence alone. Monotherapy was prioritized over combination therapy. There are separate recommendations for each of the major phases of bipolar disorder expressed as a 5-step algorithm. The current International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder are the most up-to-date guidance and are as evidence based as possible. They also include recommendations concerning the use of psychotherapeutic interventions, again on the basis of available evidence. This adherence of the workgroup to the evidence in a clinically oriented way helped to clarify the role of specific antidepressants and traditional agents like lithium, valproate, or carbamazepine. The additional focus on specific clinical characteristics, including predominant polarity, mixed features, and rapid cycling, is also a novel approach. Many issues need further studies, data are sparse and insufficient, and many questions remain unanswered. The most important and still unmet need is to merge all the guidelines that concern different phases of the illness into a single one and in this way consider BD as a single unified disorder, which is the real world fact. However, to date the research data do not permit such a unified approach. © The Author 2016. Published by Oxford University Press on behalf of CINP.

  11. [Evidence-based medicine - the current self-reflection of an individualised approach to medicine as an action science].

    PubMed

    Behrens, Johann

    2010-01-01

    Evidence-based Medicine (EbM) is the ongoing self-reflection of an individualised approach to medicine in terms of a science that originates from and focuses on clinical decision-making (pragmatic science="Handlungswissenschaft"). EbM is particularly suitable for self-reflecting individualised medicine on the basis of decision-oriented pragmatic science because it consistently distinguishes between external evidence (i.e., other subjects' experience gained through "qualitative" and "quantitative" scientific methods) and internal evidence, i.e., the individual user's, or patient's, own experience manifesting and developing in the individual contact between therapist and patient. Therefore, internal evidence is completely different from the individual clinical experience, expertise, and conviction which therapists contribute to the encounter with clients. A deeper understanding of internal evidence as a result of this encounter has emerged only in the past 15 years. However, it is an integral part of the logic of evidence-based professional decision-making. Scientifically justified beneficial and effective treatment in the individual case cannot be deduced from external evidence but can only be gathered from internal evidence for which the best external evidence available has been utilised. In the past 15 years nursing science has not only carved out the decision-oriented scientific core of evidence-based practice but has also tried to increase the validity of studies on external evidence by employing a combination of 'qualitative' social science studies and clinical epidemiological methods. Copyright © 2010. Published by Elsevier GmbH.

  12. Future Directions for Cardiovascular Disease Comparative Effectiveness Research

    PubMed Central

    Hlatky, Mark A; Douglas, Pamela S; Cook, Nakela L; Wells, Barbara; Benjamin, Emelia J; Dickersin, Kay; Goff, David C; Hirsch, Alan T; Hylek, Elaine M; Peterson, Eric; Roger, Véronique L; Selby, Joseph V; Udelson, James E; Lauer, Michael S

    2012-01-01

    Comparative effectiveness research (CER) aims to provide decision-makers the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart Lung and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address eight clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. PMID:22796257

  13. First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?

    PubMed

    Baylis, Francoise; McLeod, Marcus

    2017-01-01

    A prospective first-in-human Phase 1 CRISPR gene editing trial in the United States for patients with melanoma, synovial sarcoma, and multiple myeloma offers hope that gene editing tools may usefully treat human disease. An overarching ethical challenge with first-in-human Phase 1 clinical trials, however, is knowing when it is ethically acceptable to initiate such trials on the basis of safety and efficacy data obtained from pre-clinical studies. If the pre-clinical studies that inform trial design are themselves poorly designed - as a result of which the quality of pre-clinical evidence is deficient - then the ethical requirement of scientific validity for clinical research may not be satisfied. In turn, this could mean that the Phase 1 clinical trial will be unsafe and that trial participants will be exposed to risk for no potential benefit. To assist sponsors, researchers, clinical investigators and reviewers in deciding when it is ethically acceptable to initiate first-in-human Phase 1 CRISPR gene editing clinical trials, structured processes have been developed to assess and minimize translational distance between pre-clinical and clinical research. These processes draw attention to various features of internal validity, construct validity, and external validity. As well, the credibility of supporting evidence is to be critically assessed with particular attention to optimism bias, financial conflicts of interest and publication bias. We critically examine the pre-clinical evidence used to justify the first-inhuman Phase 1 CRISPR gene editing cancer trial in the United States using these tools. We conclude that the proposed trial cannot satisfy the ethical requirement of scientific validity because the supporting pre-clinical evidence used to inform trial design is deficient. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  14. Do clinicians want recommendations? A multi-center study comparing evidence summaries with and without GRADE recommendations.

    PubMed

    Neumann, Ignacio; Alonso-Coello, Pablo; Vandvik, Per Olav; Agoritsas, Thomas; Mas, Gemma; Akl, Elie A; Brignardello-Petersen, Romina; Emparanza, Jose; McCullagh, Lauren; De Sitio, Catherine; McGinn, Thomas; Almodaimegh, Hind; Almodaimegh, Khalid; Rivera, Solange; Rojas, Luis; Stirnemann, Jérôme; Irani, Jihad; Hlais, Sani; Mustafa, Reem; Bdair, Fadi; Aly, Abdelrahman; Kristiansen, Annette; Izcovich, Ariel; Ramirez, Anggie; Brozek, Jan; Guyatt, Gordon; Schünemann, Holger J

    2018-03-09

    Evidence-based clinical practice guidelines provide recommendations to assist clinicians in decision-making and to reduce the gap between best current research evidence and clinical practice. However, some argue that providing pre-appraised evidence summaries alone, rather than recommendations, is more appropriate. To evaluate clinicians' preferences, understanding of the evidence and intended course of action in response to evidence summaries with and without recommendations. We included practicing clinicians attending educational sessions across 10 countries. Clinicians were randomized to receive relevant clinical scenarios supported by research evidence of low or very-low certainty, and accompanied by either strong or weak recommendations developed with the GRADE system. Within each group, participants were further randomized to receive the recommendation plus the corresponding evidence summary or the evidence summary alone. We evaluated participants' preferences and understanding for the presentation strategy as well as their intended course of action. 189/219 (86%) and 201/248 (81%) participants preferred having recommendations accompanying evidence summaries for both strong and weak recommendations, respectively. Across all scenarios less than half of participants correctly interpreted information provided in the evidences summaries (e.g. estimates of effect, certainty in the research evidence). Presence of a recommendation resulted in a more appropriate intended course of action for two scenarios involving strong recommendations. Evidence summaries alone are not enough to impact clinicians' course of action. Clinicians clearly prefer having recommendations accompanying evidence summaries in the context of low or very-low certainty of evidence (Trial registration NCT02006017). Copyright © 2018 Elsevier Inc. All rights reserved.

  15. Opioid Analgesics and P-glycoprotein Efflux Transporters: A Potential Systems-Level Contribution to Analgesic Tolerance

    PubMed Central

    Mercer, Susan L.; Coop, Andrew

    2012-01-01

    Chronic clinical pain remains poorly treated. Despite attempts to develop novel analgesic agents, opioids remain the standard analgesics of choice in the clinical management of chronic and severe pain. However, mu opioid analgesics have undesired side effects including, but not limited to, respiratory depression, physical dependence and tolerance. A growing body of evidence suggests that P-glycoprotein (P-gp), an efflux transporter, may contribute a systems-level approach to the development of opioid tolerance. Herein, we describe current in vitro and in vivo methodology available to analyze interactions between opioids and P-gp and critically analyze P-gp data associated with six commonly used mu opioids to include morphine, methadone, loperamide, meperidine, oxycodone, and fentanyl. Recent studies focused on the development of opioids lacking P-gp substrate activity are explored, concentrating on structure-activity relationship development to develop an optimal opioid analgesic lacking this systems-level contribution to tolerance development. Continued work in this area will potentially allow for delineation of the mechanism responsible for opioid-related P-gp up-regulation and provide further support for evidence based medicine supporting clinical opioid rotation. PMID:21050174

  16. Parent Refusal of Topical Fluoride for Their Children: Clinical Strategies and Future Research Priorities to Improve Evidence-Based Pediatric Dental Practice.

    PubMed

    Chi, Donald L

    2017-07-01

    A growing number of parents are refusing topical fluoride for their children during preventive dental and medical visits. This nascent clinical and public health problem warrants attention from dental professionals and the scientific community. Clinical and community-based strategies are available to improve fluoride-related communications with parents and the public. In terms of future research priorities, there is a need to develop screening tools to identify parents who are likely to refuse topical fluoride and diagnostic instruments to uncover the reasons for topical fluoride refusal. This knowledge will lead to evidence-based strategies that can be widely disseminated into clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Clinical Definitions of Melioidosis

    PubMed Central

    Cheng, Allen C.; Currie, Bart J.; Dance, David A. B.; Funnell, Simon G. P.; Limmathurotsakul, Direk; Simpson, Andrew J. H.; Peacock, Sharon J.

    2013-01-01

    Clinical definitions of melioidosis and inhalation-acquired melioidosis (Burkholderia pseudomallei infection) are described together with the evidence used to develop these definitions. Such definitions support accurate public health reporting, preparedness planning for deliberate B. pseudomallei release, design of experimental models, and categorization of naturally acquired melioidosis. PMID:23468355

  18. Using spiritual interventions in practice: developing some guidelines from evidence-based practice.

    PubMed

    Hodge, David R

    2011-04-01

    Research indicates that many social work practitioners are interested in using spiritual interventions in clinical settings. Unfortunately, studies also indicate that practitioners have frequently received minimal training on the topic during their graduate education. Drawing from the evidence-based practice movement, this article develops some guidelines to assist practitioners in using spiritual interventions in an ethical, professional manner that fosters client well-being. These guidelines can be summarized under the following four rubrics: (1) client preference, (2) evaluation of relevant research, (3) clinical expertise, and (4) cultural competency. The article concludes by emphasizing that these overlapping guidelines should be considered concurrently, in a manner that privileges clients' needs and desires in the decision-making process.

  19. Review of Virtual Reality Treatment in Psychiatry: Evidence Versus Current Diffusion and Use.

    PubMed

    Mishkind, Matthew C; Norr, Aaron M; Katz, Andrea C; Reger, Greg M

    2017-09-18

    This review provides an overview of the current evidence base for and clinical applications of the use of virtual reality (VR) in psychiatric practice, in context of recent technological developments. The use of VR in psychiatric practice shows promise with much of the research demonstrating clinical effectiveness for conditions including post-traumatic stress disorder, anxiety and phobias, chronic pain, rehabilitation, and addictions. However, more research is needed before the use of VR is considered a clinical standard of practice in some areas. The recent release of first generation consumer VR products signals a change in the viability of further developing VR systems and applications. As applications increase so will the need for good quality research to best understand what makes VR effective, and when VR is not appropriate for clinical services. As the field progresses, it is hopeful that the flexibility afforded by this technology will yield superior outcomes and a better understanding of the underlying mechanisms impacting those outcomes.

  20. Confidence in outcome estimates from systematic reviews used in informed consent.

    PubMed

    Fritz, Robert; Bauer, Janet G; Spackman, Sue S; Bains, Amanjyot K; Jetton-Rangel, Jeanette

    2016-12-01

    Evidence-based dentistry now guides informed consent in which clinicians are obliged to provide patients with the most current, best evidence, or best estimates of outcomes, of regimens, therapies, treatments, procedures, materials, and equipment or devices when developing personal oral health care, treatment plans. Yet, clinicians require that the estimates provided from systematic reviews be verified to their validity, reliability, and contextualized as to performance competency so that clinicians may have confidence in explaining outcomes to patients in clinical practice. The purpose of this paper was to describe types of informed estimates from which clinicians may have confidence in their capacity to assist patients in competent decision-making, one of the most important concepts of informed consent. Using systematic review methodology, researchers provide clinicians with valid best estimates of outcomes regarding a subject of interest from best evidence. Best evidence is verified through critical appraisals using acceptable sampling methodology either by scoring instruments (Timmer analysis) or checklist (grade), a Cochrane Collaboration standard that allows transparency in open reviews. These valid best estimates are then tested for reliability using large databases. Finally, valid and reliable best estimates are assessed for meaning using quantification of margins and uncertainties. Through manufacturer and researcher specifications, quantification of margins and uncertainties develops a performance competency continuum by which valid, reliable best estimates may be contextualized for their performance competency: at a lowest margin performance competency (structural failure), high margin performance competency (estimated true value of success), or clinically determined critical values (clinical failure). Informed consent may be achieved when clinicians are confident of their ability to provide useful and accurate best estimates of outcomes regarding regimens, therapies, treatments, and equipment or devices to patients in their clinical practices and when developing personal, oral health care, treatment plans. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Informing clinical policy decision-making practices in ambulance services.

    PubMed

    Muecke, Sandy; Curac, Nada; Binks, Darryn

    2013-12-01

    This study aims to identify the processes and frameworks that support an evidence-based approach to clinical policy decision-making practices in ambulance services. This literature review focused on: (i) the setting (pre-hospital); and (ii) the process of evidence translation, for studies published after the year 2000. Searches of Medline, CINAHL and Google were undertaken. Reference lists of eligible publications were searched for relevant articles. A total of 954 articles were identified. Of these, 20 full text articles were assessed for eligibility and seven full text articles met the inclusion criteria. Three provided detailed descriptions of the evidence-based practice processes used to inform ambulance service protocol or guideline development or review. There is little published literature that describes the processes involved, and frameworks required, to inform clinical policy decision making within ambulance services. This review found that processes were iterative and involved collaborations across many internal and external stakeholders. In several jurisdictions, these were coordinated by a dedicated team. Success appears dependent on committed leadership and purposive human and structural resources. Although time consuming, structured processes have been developed in some jurisdictions to assist decision-making processes. Further insight is likely to be obtained from literature published by those from other disciplines. © 2013 The Authors. International Journal of Evidence-Based Healthcare © 2013 The Joanna Briggs Institute.

  2. Can we prevent OA? Epidemiology and public health insights and implications.

    PubMed

    Runhaar, Jos; Zhang, Yuqing

    2018-05-01

    This narrative review discusses the potential of prevention of OA in different stages of the disease. The theoretical background for primary prevention (i.e. prevention of occurrence of definite structural or clinical OA in subjects free of the disease) and secondary prevention (i.e. prevention of progression of the disease in subjects with pre-clinical pathological changes to the joint) is provided and evidence for effective strategies is discussed. Since direct evidence for the prevention of OA development and progression is scarce, indirect evidence enhancing our current knowledge on the potential of OA prevention is additionally discussed. Also, implications of preventive strategies for study design and public health are considered. Prevention of OA has great potential, but as deliberated in the current review, there are still large gaps in our current knowledge and the implications of preventive strategies for the development and progression of OA require consideration.

  3. PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms

    PubMed Central

    Shrier, AA; Antonijevic, Z; Beckman, RA; Campbell, RK; Chen, C; Flaherty, KT; Loewy, J; Lacombe, D; Madhavan, S; Selker, HP; Esserman, LJ

    2016-01-01

    Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real‐world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints—aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights. Reduced trial times and costs could enable more indications, reduced development cycle times, and improved system financial sustainability. Challenges to overcome range from statistical to operational to collaborative governance and data exchange. PMID:27643536

  4. Better Together: The Making and Maturation of the Palliative Care Research Cooperative Group.

    PubMed

    Ritchie, Christine L; Pollak, Kathryn I; Kehl, Karen A; Miller, Jeri L; Kutner, Jean S

    2017-06-01

    To describe the growth and outcomes of the Palliative Care Research Cooperative Group (PCRC). Despite advances, significant gaps remain in the evidence base to inform care for people with serious illness. To generate this needed evidence and bolster research capacity, the Palliative Care Research Cooperative (PCRC) group was formed. The PCRC supports investigators in the conduct of multisite clinical studies. After developing a governance structure and completing a proof of concept demonstration study, the PCRC expanded its infrastructure to include additional resource cores (Clinical Studies; Measurement; Data Informatics and Statistics; and Caregiver Studies). The PCRC also supports an Investigator Development Center as many palliative care investigators valued opportunities to advance their skills. Additional key aspects of PCRC resources include a Scientific Review Committee, a Publications Committee, and initiatives to purposefully engage investigators in a community of palliative care science. The PCRC has grown to over 300 members representing more than 130 distinct sites. To date, the PCRC has supported the submission of 51 research applications and has engaged in 27 studies. The PCRC supports investigator research development needs through webinars and clinical trials "intensives." To foster a sense of community, the PCRC has convened biannual meetings, developed special interest groups, and regularly communicates via a newsletter and its website. With a particular focus on facilitating conduct of rigorous multisite clinical studies, the PCRC fosters an engaged multidisciplinary research community, filling an important void in generating and disseminating evidence that informs the provision of high-quality care to people with serious illness.

  5. Development and implementation of a mobile device-based pediatric electronic decision support tool as part of a national practice standardization project.

    PubMed

    McCulloh, Russell J; Fouquet, Sarah D; Herigon, Joshua; Biondi, Eric A; Kennedy, Brandan; Kerns, Ellen; DePorre, Adrienne; Markham, Jessica L; Chan, Y Raymond; Nelson, Krista; Newland, Jason G

    2018-06-07

    Implementing evidence-based practices requires a multi-faceted approach. Electronic clinical decision support (ECDS) tools may encourage evidence-based practice adoption. However, data regarding the role of mobile ECDS tools in pediatrics is scant. Our objective is to describe the development, distribution, and usage patterns of a smartphone-based ECDS tool within a national practice standardization project. We developed a smartphone-based ECDS tool for use in the American Academy of Pediatrics, Value in Inpatient Pediatrics Network project entitled "Reducing Excessive Variation in the Infant Sepsis Evaluation (REVISE)." The mobile application (app), PedsGuide, was developed using evidence-based recommendations created by an interdisciplinary panel. App workflow and content were aligned with clinical benchmarks; app interface was adjusted after usability heuristic review. Usage patterns were measured using Google Analytics. Overall, 3805 users across the United States downloaded PedsGuide from December 1, 2016, to July 31, 2017, leading to 14 256 use sessions (average 3.75 sessions per user). Users engaged in 60 442 screen views, including 37 424 (61.8%) screen views that displayed content related to the REVISE clinical practice benchmarks, including hospital admission appropriateness (26.8%), length of hospitalization (14.6%), and diagnostic testing recommendations (17.0%). Median user touch depth was 5 [IQR 5]. We observed rapid dissemination and in-depth engagement with PedsGuide, demonstrating feasibility for using smartphone-based ECDS tools within national practice improvement projects. ECDS tools may prove valuable in future national practice standardization initiatives. Work should next focus on developing robust analytics to determine ECDS tools' impact on medical decision making, clinical practice, and health outcomes.

  6. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction.

    PubMed

    Parsons, Jonathan P; Hallstrand, Teal S; Mastronarde, John G; Kaminsky, David A; Rundell, Kenneth W; Hull, James H; Storms, William W; Weiler, John M; Cheek, Fern M; Wilson, Kevin C; Anderson, Sandra D

    2013-05-01

    Exercise-induced bronchoconstriction (EIB) describes acute airway narrowing that occurs as a result of exercise. EIB occurs in a substantial proportion of patients with asthma, but may also occur in individuals without known asthma. To provide clinicians with practical guidance, a multidisciplinary panel of stakeholders was convened to review the pathogenesis of EIB and to develop evidence-based guidelines for the diagnosis and treatment of EIB. The evidence was appraised and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Recommendations for the treatment of EIB were developed. The quality of evidence supporting the recommendations was variable, ranging from low to high. A strong recommendation was made for using a short-acting β(2)-agonist before exercise in all patients with EIB. For patients who continue to have symptoms of EIB despite the administration of a short-acting β(2)-agonist before exercise, strong recommendations were made for a daily inhaled corticosteroid, a daily leukotriene receptor antagonist, or a mast cell stabilizing agent before exercise. The recommendations in this Guideline reflect the currently available evidence. New clinical research data will necessitate a revision and update in the future.

  7. Anaesthetic neurotoxicity and neuroplasticity: an expert group report and statement based on the BJA Salzburg Seminar

    PubMed Central

    Jevtovic-Todorovic, V.; Absalom, A. R.; Blomgren, K.; Brambrink, A.; Crosby, G.; Culley, D. J.; Fiskum, G.; Giffard, R. G.; Herold, K. F.; Loepke, A. W.; Ma, D.; Orser, B. A.; Planel, E.; Slikker, W.; Soriano, S. G.; Stratmann, G.; Vutskits, L.; Xie, Z.; Hemmings, H. C.

    2013-01-01

    Although previously considered entirely reversible, general anaesthesia is now being viewed as a potentially significant risk to cognitive performance at both extremes of age. A large body of preclinical as well as some retrospective clinical evidence suggest that exposure to general anaesthesia could be detrimental to cognitive development in young subjects, and might also contribute to accelerated cognitive decline in the elderly. A group of experts in anaesthetic neuropharmacology and neurotoxicity convened in Salzburg, Austria for the BJA Salzburg Seminar on Anaesthetic Neurotoxicity and Neuroplasticity. This focused workshop was sponsored by the British Journal of Anaesthesia to review and critically assess currently available evidence from animal and human studies, and to consider the direction of future research. It was concluded that mounting evidence from preclinical studies reveals general anaesthetics to be powerful modulators of neuronal development and function, which could contribute to detrimental behavioural outcomes. However, definitive clinical data remain elusive. Since general anaesthesia often cannot be avoided regardless of patient age, it is important to understand the complex mechanisms and effects involved in anaesthesia-induced neurotoxicity, and to develop strategies for avoiding or limiting potential brain injury through evidence-based approaches. PMID:23722106

  8. Occupational Therapy Interventions for Adults With Cancer.

    PubMed

    Braveman, Brent; Hunter, Elizabeth G; Nicholson, Jennifer; Arbesman, Marian; Lieberman, Deborah

    This Evidence Connection describes a case report of a man with non-Hodgkin's lymphoma who underwent an allogenic stem cell transplant. The occupational therapy assessment and treatment processes for an outpatient rehabilitation setting are described. Evidence Connection articles provide a clinical application of systematic reviews developed in conjunction with the American Occupational Therapy Association's Evidence-Based Practice Project. Copyright © 2017 by the American Occupational Therapy Association, Inc.

  9. Finding and applying evidence during clinical rounds: the "evidence cart".

    PubMed

    Sackett, D L; Straus, S E

    1998-10-21

    Physicians need easy access to evidence for clinical decisions while they care for patients but, to our knowledge, no investigators have assessed use of evidence during rounds with house staff. To determine if it was feasible to find and apply evidence during clinical rounds, using an "evidence cart" that contains multiple sources of evidence and the means for projecting and printing them. Descriptive feasibility study of use of evidence during 1 month (April 1997) and anonymous questionnaire (May 1997). General medicine inpatient service. Medical students, house staff, fellows, and attending consultant. Evidence cart that included 2 secondary sources developed by the department (critically appraised topics [CATs] and Redbook), Best Evidence, JAMA Rational Clinical Examination series, the Cochrane Library, MEDLINE, a physical examination textbook, a radiology anatomy textbook, and a Simulscope, which allows several people to listen simultaneously to the same signs on physical examination. Number of times sources were used, type of sources searched and success of searches, time needed to search, and whether the search affected patient care. The evidence cart was used 98 times, but could not be taken on bedside rounds because of its bulk; hard copies of several sources were taken instead. When the evidence cart was used during team rounds and student rounds, some sources could be accessed quickly enough (10.2-25.4 seconds) to be practical on our service. Of 98 searches, 79 (81%) sought evidence that could affect diagnostic and/or treatment decisions. Seventy-one (90%) of 79 searches regarding patient management were successful, and when assessed from the perspective of the most junior team members responsible for each patient's evaluation and management, 37 (52%) of the 71 successful searches confirmed their current or tentative diagnostic or treatment plans, 18 (25%) led to a new diagnostic skill, an additional test, or a new management decision, and 16 (23%) corrected a previous clinical skill, diagnostic test, or treatment. When the cart was removed, the perceived need for evidence rose sharply, but a search for it was carried out only 12% of the time (5 searches performed out of the 41 times evidence was needed). Making evidence quickly available to clinicians on a busy medical inpatient service using an evidence cart increased the extent to which evidence was sought and incorporated into patient care decisions.

  10. Clinical imprinting: the impact of early clinical learning on career long professional development in nursing.

    PubMed

    Andrew, Nicola

    2013-05-01

    The literature recognises a relationship between clinical experience and a successful undergraduate experience in nursing; however what constitutes an effective approach remains the subject of debate, particularly in relation to first year of learning. There is evidence from a biological standpoint that early experience impacts on the behavioural development of animals, described by Konrad Lorenz (1903-1989) as 'imprinting'. The concept of imprinting has resonance for nursing. In this article the importance of 'getting it right at the beginning' is explored and what, if anything, Lorenz's theory tells us about the impact of early clinical learning on subsequent professional development. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. Reconciling evidence-based medicine and precision medicine in the era of big data: challenges and opportunities.

    PubMed

    Beckmann, Jacques S; Lew, Daniel

    2016-12-19

    This era of groundbreaking scientific developments in high-resolution, high-throughput technologies is allowing the cost-effective collection and analysis of huge, disparate datasets on individual health. Proper data mining and translation of the vast datasets into clinically actionable knowledge will require the application of clinical bioinformatics. These developments have triggered multiple national initiatives in precision medicine-a data-driven approach centering on the individual. However, clinical implementation of precision medicine poses numerous challenges. Foremost, precision medicine needs to be contrasted with the powerful and widely used practice of evidence-based medicine, which is informed by meta-analyses or group-centered studies from which mean recommendations are derived. This "one size fits all" approach can provide inadequate solutions for outliers. Such outliers, which are far from an oddity as all of us fall into this category for some traits, can be better managed using precision medicine. Here, we argue that it is necessary and possible to bridge between precision medicine and evidence-based medicine. This will require worldwide and responsible data sharing, as well as regularly updated training programs. We also discuss the challenges and opportunities for achieving clinical utility in precision medicine. We project that, through collection, analyses and sharing of standardized medically relevant data globally, evidence-based precision medicine will shift progressively from therapy to prevention, thus leading eventually to improved, clinician-to-patient communication, citizen-centered healthcare and sustained well-being.

  12. Contemporary evidence-based practice in Canadian emergency medical services: a vision for integrating evidence into clinical and policy decision-making.

    PubMed

    Jensen, Jan L; Travers, Andrew H

    2017-05-01

    Nationally, emphasis on the importance of evidence-based practice (EBP) in emergency medicine and emergency medical services (EMS) has continuously increased. However, meaningful incorporation of effective and sustainable EBP into clinical and administrative decision-making remains a challenge. We propose a vision for EBP in EMS: Canadian EMS clinicians and leaders will understand and use the best available evidence for clinical and administrative decision-making, to improve patient health outcomes, the capability and quality of EMS systems of care, and safety of patients and EMS professionals. This vision can be implemented with the use of a structure, process, system, and outcome taxonomy to identify current barriers to true EBP, to recognize the opportunities that exist, and propose corresponding recommended strategies for local EMS agencies and at the national level. Framing local and national discussions with this approach will be useful for developing a cohesive and collaborative Canadian EBP strategy.

  13. Information systems: the key to evidence-based health practice.

    PubMed Central

    Rodrigues, R. J.

    2000-01-01

    Increasing prominence is being given to the use of best current evidence in clinical practice and health services and programme management decision-making. The role of information in evidence-based practice (EBP) is discussed, together with questions of how advanced information systems and technology (IS&T) can contribute to the establishment of a broader perspective for EBP. The author examines the development, validation and use of a variety of sources of evidence and knowledge that go beyond the well-established paradigm of research, clinical trials, and systematic literature review. Opportunities and challenges in the implementation and use of IS&T and knowledge management tools are examined for six application areas: reference databases, contextual data, clinical data repositories, administrative data repositories, decision support software, and Internet-based interactive health information and communication. Computerized and telecommunications applications that support EBP follow a hierarchy in which systems, tasks and complexity range from reference retrieval and the processing of relatively routine transactions, to complex "data mining" and rule-driven decision support systems. PMID:11143195

  14. An integrated model of clinical reasoning: dual-process theory of cognition and metacognition.

    PubMed

    Marcum, James A

    2012-10-01

    Clinical reasoning is an important component for providing quality medical care. The aim of the present paper is to develop a model of clinical reasoning that integrates both the non-analytic and analytic processes of cognition, along with metacognition. The dual-process theory of cognition (system 1 non-analytic and system 2 analytic processes) and the metacognition theory are used to develop an integrated model of clinical reasoning. In the proposed model, clinical reasoning begins with system 1 processes in which the clinician assesses a patient's presenting symptoms, as well as other clinical evidence, to arrive at a differential diagnosis. Additional clinical evidence, if necessary, is acquired and analysed utilizing system 2 processes to assess the differential diagnosis, until a clinical decision is made diagnosing the patient's illness and then how best to proceed therapeutically. Importantly, the outcome of these processes feeds back, in terms of metacognition's monitoring function, either to reinforce or to alter cognitive processes, which, in turn, enhances synergistically the clinician's ability to reason quickly and accurately in future consultations. The proposed integrated model has distinct advantages over other models proposed in the literature for explicating clinical reasoning. Moreover, it has important implications for addressing the paradoxical relationship between experience and expertise, as well as for designing a curriculum to teach clinical reasoning skills. © 2012 Blackwell Publishing Ltd.

  15. A Semantic Web-based System for Mining Genetic Mutations in Cancer Clinical Trials.

    PubMed

    Priya, Sambhawa; Jiang, Guoqian; Dasari, Surendra; Zimmermann, Michael T; Wang, Chen; Heflin, Jeff; Chute, Christopher G

    2015-01-01

    Textual eligibility criteria in clinical trial protocols contain important information about potential clinically relevant pharmacogenomic events. Manual curation for harvesting this evidence is intractable as it is error prone and time consuming. In this paper, we develop and evaluate a Semantic Web-based system that captures and manages mutation evidences and related contextual information from cancer clinical trials. The system has 2 main components: an NLP-based annotator and a Semantic Web ontology-based annotation manager. We evaluated the performance of the annotator in terms of precision and recall. We demonstrated the usefulness of the system by conducting case studies in retrieving relevant clinical trials using a collection of mutations identified from TCGA Leukemia patients and Atlas of Genetics and Cytogenetics in Oncology and Haematology. In conclusion, our system using Semantic Web technologies provides an effective framework for extraction, annotation, standardization and management of genetic mutations in cancer clinical trials.

  16. Joint BAP NAPICU evidence-based consensus guidelines for the clinical management of acute disturbance: De-escalation and rapid tranquillisation.

    PubMed

    Patel, Maxine X; Sethi, Faisil N; Barnes, Thomas Re; Dix, Roland; Dratcu, Luiz; Fox, Bernard; Garriga, Marina; Haste, Julie C; Kahl, Kai G; Lingford-Hughes, Anne; McAllister-Williams, Hamish; O'Brien, Aileen; Parker, Caroline; Paterson, Brodie; Paton, Carol; Posporelis, Sotiris; Taylor, David M; Vieta, Eduard; Völlm, Birgit; Wilson-Jones, Charlotte; Woods, Laura

    2018-06-01

    The British Association for Psychopharmacology and the National Association of Psychiatric Intensive Care and Low Secure Units developed this joint evidence-based consensus guideline for the clinical management of acute disturbance. It includes recommendations for clinical practice and an algorithm to guide treatment by healthcare professionals with various options outlined according to their route of administration and category of evidence. Fundamental overarching principles are included and highlight the importance of treating the underlying disorder. There is a focus on three key interventions: de-escalation, pharmacological interventions pre-rapid tranquillisation and rapid tranquillisation (intramuscular and intravenous). Most of the evidence reviewed relates to emergency psychiatric care or acute psychiatric adult inpatient care, although we also sought evidence relevant to other common clinical settings including the general acute hospital and forensic psychiatry. We conclude that the variety of options available for the management of acute disturbance goes beyond the standard choices of lorazepam, haloperidol and promethazine and includes oral-inhaled loxapine, buccal midazolam, as well as a number of oral antipsychotics in addition to parenteral options of intramuscular aripiprazole, intramuscular droperidol and intramuscular olanzapine. Intravenous options, for settings where resuscitation equipment and trained staff are available to manage medical emergencies, are also included.

  17. 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.

  18. Incidence of thromboembolism after transurethral resection of the prostate (TURP)--a study on TED stocking prophylaxis and literature review.

    PubMed

    Donat, R; Mancey-Jones, B

    2002-01-01

    To assess the incidence of clinically evident pulmonary emboli and deep vein thromboses in patients undergoing transurethral resection of the prostate (TURP) with the routine use of graduated elastic compression stockings (TED) in all patients and the addition of low-dose heparin in selected high-risk patients. A retrospective analysis of clinically evident thromboembolic complications within 4 weeks of operation in 883 patients operated in a single hospital during a 4-year period. Four patients (0.45%) developed pulmonary emboli (PE), of which two (0.23%) were fatal. There was one clinically evident deep vein thrombosis (DVT) in a high-risk patient (0.11%). None of the 14 high-risk patients receiving additional low-dose heparin required a blood transfusion. Clinical thromboembolic complications following TURP are rare. TURP patients have a low risk for DVT, but an intermediate risk for pulmonary emboli. Pulmonary emboli may occur without identifiable risk factors and despite TED stocking prophylaxis.

  19. A critical appraisal of the clinical utility of proton therapy in oncology

    PubMed Central

    Wang, Dongxu

    2015-01-01

    Proton therapy is an emerging technology for providing radiation therapy to cancer patients. The depth dose distribution of a proton beam makes it a preferable radiation modality as it reduces radiation to the healthy tissue outside the tumor, compared with conventional photon therapy. While theoretically beneficial, its clinical values are still being demonstrated from the increasing number of patients treated with proton therapy, from several dozen proton therapy centers around the world. High equipment and facility costs are often the major obstacle for its wider adoption. Because of the high cost and lack of definite clinical evidence of its superiority, proton therapy treatment faces criticism on its cost-effectiveness. Technological development is causing a gradual lowering of costs, and research and clinical studies are providing further evidence on its clinical utility. PMID:26604838

  20. Feasibility of encoding the Institute for Clinical Systems Improvement Depression Guideline using the Omaha System.

    PubMed

    Monsen, Karen A; Neely, Claire; Oftedahl, Gary; Kerr, Madeleine J; Pietruszewski, Pam; Farri, Oladimeji

    2012-08-01

    Evidence-based clinical guidelines are being developed to bridge the gap between research and practice with the goals of improving health care quality and population health. However, disseminating, implementing, and ensuring ongoing use of clinical guidelines in practice settings is challenging. The purpose of this study was to demonstrate the feasibility of encoding evidence-based clinical guidelines using the Omaha System. Clinical documentation with Omaha System-encoded guidelines generates individualized, meaningful data suitable for program evaluation and health care quality research. The use of encoded guidelines within the electronic health record has potential to reinforce use of guidelines, and thus improve health care quality and population health. Research using Omaha System data generated by clinicians has potential to discover new knowledge related to guideline use and effectiveness. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology.

    PubMed

    Esposito, Pasquale; Dal Canton, Antonio

    2014-11-06

    Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings.

  2. Recommendations for Clinical Decision Support Deployment: Synthesis of a Roundtable of Medical Directors of Information Systems

    PubMed Central

    Jenders, Robert A.; Osheroff, Jerome A.; Sittig, Dean F.; Pifer, Eric A.; Teich, Jonathan M

    2007-01-01

    Background: Ample evidence exists that clinical decision support (CDS) can improve clinician performance. Nevertheless, additional evidence demonstrates that clinicians still do not perform adequately in many instances. This suggests an ongoing need for implementation of CDS, in turn prompting development of a roadmap for national action regarding CDS. Objective: Develop practical advice to aid CDS implementation in order to improve clinician performance. Method: Structured group interview during a roundtable discussion by medical directors of information systems (N = 30), with subsequent review by participants and synthesis. Results: Participant consensus was that CDS should be comprehensive and should involve techniques such as order sets and facilitated documentation as well as alerts; should be subject to ongoing feedback; and should flow from and be governed by an organization’s clinical goals. Conclusion: A structured roundtable discussion of clinicians experienced in health information technology can yield practical, consensus advice for implementation of CDS. PMID:18693858

  3. The role of patent ductus arteriosus and its treatments in the development of bronchopulmonary dysplasia

    PubMed Central

    Clyman, Ronald I.

    2013-01-01

    A persistent left-to right shunt through a patent ductus arteriosus (PDA) increases the rate of hydrostatic fluid filtration into the lung’s interstitium, impairs pulmonary mechanics, and prolongs the need for mechanical ventilation. In preclinical trials, pharmacologic PDA closure leads to improved alveolarization and minimizes the impaired postnatal alveolar development that is the pathologic hallmark of the “new bronchopulmonary dysplasia (BPD)”. Although early pharmacologic closure of the PDA decreases the incidence of pulmonary hemorrhage, intraventricular hemorrhage, and the need for PDA ligation, there is little evidence from controlled, clinical trials to support or refute a causal role for the PDA in the development of BPD. On the other hand, evidence from epidemiologic, preclinical, and randomized controlled clinical trials demonstrate that early ductus ligation is an independent risk factor for the development of BPD and may directly contribute to the neonatal morbidities it is trying to prevent. PMID:23582964

  4. Concordance Between Clinical Practice and Published Evidence: Findings From Virginia Commonwealth University School of Dentistry.

    PubMed

    Chiang, Harmeet K; Best, Al M; Sarrett, David C

    2017-09-01

    To evaluate the concordance between clinical practice and published evidence by dental faculty and graduating students of the Virginia Commonwealth University School of Dentistry. A questionnaire previously developed by the National Dental Practice-Based Research Network with 12 clinical scenarios was administered to VCU faculty and graduating students. Responses were scored as either consistent or inconsistent with published evidence and then analyzed for differences between dental faculty, graduating students, and the national results. There were 43 dental faculty members with at least half-time student contact who responded to the survey. Faculty concordance ranged from 33% to 100%, and general practice faculty had the highest concordance (82%). Eighty-five of the graduating class of 98 responded to the survey, and student concordance ranged from 18% to 92% and averaged 67%. General practice faculty had higher concordance with published evidence than recently graduated dental students. Graduating students and dental faculty demonstrated higher concordance with evidence-based practice than practitioners in the National Dental Practice-Based Research Network. General practice dental faculty demonstrated adequate concordance, but students demonstrated only a medium-level concordance. Practitioners involved in teaching dental students are better able to keep up with evolving evidence and are better able to demonstrate evidence-based practice. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. No evidence of early head circumference enlargements in children later diagnosed with autism in Israel.

    PubMed

    Dinstein, Ilan; Haar, Shlomi; Atsmon, Shir; Schtaerman, Hen

    2017-01-01

    Large controversy exists regarding the potential existence and clinical significance of larger brain volumes in toddlers who later develop autism. Assessing this relationship is important for determining the clinical utility of early head circumference (HC) measures and for assessing the validity of the early overgrowth hypothesis of autism, which suggests that early accelerated brain development may be a hallmark of the disorder. We performed a retrospective comparison of HC, height, and weight measurements between 66 toddlers who were later diagnosed with autism and 66 matched controls. These toddlers represent an unbiased regional sample from a single health service provider in the southern district of Israel. On average, participating toddlers had >8 measurements between birth and the age of two, which enabled us to characterize individual HC, height, and weight development with high precision and fit a negative exponential growth model to the data of each toddler with exceptional accuracy. The analyses revealed that HC sizes and growth rates were not significantly larger in toddlers with autism even when stratifying the autism group based on verbal capabilities at the time of diagnosis. In addition, there were no significant correlations between ADOS scores at the time of diagnosis and HC at any time-point during the first 2 years of life. These negative results add to accumulating evidence, which suggest that brain volume is not necessarily larger in toddlers who develop autism. We believe that conflicting results reported in other studies are due to small sample sizes, use of misleading population norms, changes in the clinical definition of autism over time, and/or inclusion of individuals with syndromic autism. While abnormally large brains may be evident in some individuals with autism and more clearly visible in MRI scans, converging evidence from this and other studies suggests that enlarged HC is not a common etiology of the entire autism population. Early HC measures, therefore, offer very limited clinical utility for assessment of autism risk in the general population.

  6. A clinical reasoning model focused on clients' behaviour change with reference to physiotherapists: its multiphase development and validation.

    PubMed

    Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

    2015-05-01

    A biopsychosocial approach and behaviour change strategies have long been proposed to serve as a basis for addressing current multifaceted health problems. This emphasis has implications for clinical reasoning of health professionals. This study's aim was to develop and validate a conceptual model to guide physiotherapists' clinical reasoning focused on clients' behaviour change. Phase 1 consisted of the exploration of existing research and the research team's experiences and knowledge. Phases 2a and 2b consisted of validation and refinement of the model based on input from physiotherapy students in two focus groups (n = 5 per group) and from experts in behavioural medicine (n = 9). Phase 1 generated theoretical and evidence bases for the first version of a model. Phases 2a and 2b established the validity and value of the model. The final model described clinical reasoning focused on clients' behaviour change as a cognitive, reflective, collaborative and iterative process with multiple interrelated levels that included input from the client and physiotherapist, a functional behavioural analysis of the activity-related target behaviour and the selection of strategies for behaviour change. This unique model, theory- and evidence-informed, has been developed to help physiotherapists to apply clinical reasoning systematically in the process of behaviour change with their clients.

  7. Drug interactions among commonly used medications. Chart simplifies data from critical literature review.

    PubMed Central

    Crowther, N. R.; Holbrook, A. M.; Kenwright, R.; Kenwright, M.

    1997-01-01

    OBJECTIVE: To simplify risk assessment, we have developed a way to present critically appraised drug interaction information through a chart. DATA SOURCES: Fifty drugs most frequently prescribed by Canadian family physicians and 16 drugs and substances that frequently interact with these drugs were the basis for a literature review. Drug interaction textbooks and MEDLINE (from 1966 to 1994) were searched for documented interactions. Reports of additive effects and animal or in vitro studies were excluded. STUDY SELECTION: All reports of interactions were evaluated for clinical effect, clinical significance, and quality of evidence. SYNTHESIS: Of the 464 drug-drug or drug-substance pairs evaluated, 387 (83.4%) demonstrated an interaction, 59 (12.7%) documented no effect, and 18 (3.9%) pairs had conflicting evidence. Five percent of interactions were of major clinical significance; only 1.3% were of major clinical significance and supported by good-quality evidence. By using symbols, colours, and legends in a "grid-map" format, a large amount of drug interaction information was reduced to a single-page chart suitable for a desk reference or wall mounting. CONCLUSIONS: Our chart organizes a large amount of drug interaction information in a format that allows for rapid appreciation of outcome, clinical significance, and quality of evidence. PMID:9386884

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

    PubMed

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

    2013-08-01

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

  9. Development of a Search Strategy for an Evidence Based Retrieval Service

    PubMed Central

    Ho, Gah Juan; Liew, Su May; Ng, Chirk Jenn; Hisham Shunmugam, Ranita; Glasziou, Paul

    2016-01-01

    Background Physicians are often encouraged to locate answers for their clinical queries via an evidence-based literature search approach. The methods used are often not clearly specified. Inappropriate search strategies, time constraint and contradictory information complicate evidence retrieval. Aims Our study aimed to develop a search strategy to answer clinical queries among physicians in a primary care setting Methods Six clinical questions of different medical conditions seen in primary care were formulated. A series of experimental searches to answer each question was conducted on 3 commonly advocated medical databases. We compared search results from a PICO (patients, intervention, comparison, outcome) framework for questions using different combinations of PICO elements. We also compared outcomes from doing searches using text words, Medical Subject Headings (MeSH), or a combination of both. All searches were documented using screenshots and saved search strategies. Results Answers to all 6 questions using the PICO framework were found. A higher number of systematic reviews were obtained using a 2 PICO element search compared to a 4 element search. A more optimal choice of search is a combination of both text words and MeSH terms. Despite searching using the Systematic Review filter, many non-systematic reviews or narrative reviews were found in PubMed. There was poor overlap between outcomes of searches using different databases. The duration of search and screening for the 6 questions ranged from 1 to 4 hours. Conclusion This strategy has been shown to be feasible and can provide evidence to doctors’ clinical questions. It has the potential to be incorporated into an interventional study to determine the impact of an online evidence retrieval system. PMID:27935993

  10. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

    PubMed

    Lentine, Krista L; Kasiske, Bertram L; Levey, Andrew S; Adams, Patricia L; Alberú, Josefina; Bakr, Mohamed A; Gallon, Lorenzo; Garvey, Catherine A; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L; Taler, Sandra J; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G; Cheung, Michael; Garg, Amit X

    2017-08-01

    The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a "proof-in-concept" risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided.In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1-S109.

  11. Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies

    PubMed Central

    Hooijmans, Carlijn R.; de Vries, Rob B. M.; Ritskes-Hoitinga, Merel; Rovers, Maroeska M.; Leeflang, Mariska M.; IntHout, Joanna; Wever, Kimberley E.; Hooft, Lotty; de Beer, Hans; Kuijpers, Ton; Macleod, Malcolm R.; Sena, Emily S.; ter Riet, Gerben; Morgan, Rebecca L.; Thayer, Kristina A.; Rooney, Andrew A.; Guyatt, Gordon H.; Schünemann, Holger J.

    2018-01-01

    Laboratory animal studies are used in a wide range of human health related research areas, such as basic biomedical research, drug research, experimental surgery and environmental health. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions. Systematic reviews and meta-analyses are important tools to provide robust and informative evidence summaries of these animal studies. Rating how certain we are about the evidence could provide important information about the translational probability of findings in experimental animal studies to clinical practice and probably improve it. Evidence summaries and certainty in the evidence ratings could also be used (1) to support selection of interventions with best therapeutic potential to be tested in clinical trials, (2) to justify a regulatory decision limiting human exposure (to drug or toxin), or to (3) support decisions on the utility of further animal experiments. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is the most widely used framework to rate the certainty in the evidence and strength of health care recommendations. Here we present how the GRADE approach could be used to rate the certainty in the evidence of preclinical animal studies in the context of therapeutic interventions. We also discuss the methodological challenges that we identified, and for which further work is needed. Examples are defining the importance of consistency within and across animal species and using GRADE’s indirectness domain as a tool to predict translation from animal models to humans. PMID:29324741

  12. Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies.

    PubMed

    Hooijmans, Carlijn R; de Vries, Rob B M; Ritskes-Hoitinga, Merel; Rovers, Maroeska M; Leeflang, Mariska M; IntHout, Joanna; Wever, Kimberley E; Hooft, Lotty; de Beer, Hans; Kuijpers, Ton; Macleod, Malcolm R; Sena, Emily S; Ter Riet, Gerben; Morgan, Rebecca L; Thayer, Kristina A; Rooney, Andrew A; Guyatt, Gordon H; Schünemann, Holger J; Langendam, Miranda W

    2018-01-01

    Laboratory animal studies are used in a wide range of human health related research areas, such as basic biomedical research, drug research, experimental surgery and environmental health. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions. Systematic reviews and meta-analyses are important tools to provide robust and informative evidence summaries of these animal studies. Rating how certain we are about the evidence could provide important information about the translational probability of findings in experimental animal studies to clinical practice and probably improve it. Evidence summaries and certainty in the evidence ratings could also be used (1) to support selection of interventions with best therapeutic potential to be tested in clinical trials, (2) to justify a regulatory decision limiting human exposure (to drug or toxin), or to (3) support decisions on the utility of further animal experiments. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is the most widely used framework to rate the certainty in the evidence and strength of health care recommendations. Here we present how the GRADE approach could be used to rate the certainty in the evidence of preclinical animal studies in the context of therapeutic interventions. We also discuss the methodological challenges that we identified, and for which further work is needed. Examples are defining the importance of consistency within and across animal species and using GRADE's indirectness domain as a tool to predict translation from animal models to humans.

  13. The development of leadership outcome-indicators evaluating the contribution of clinical specialists and advanced practitioners to health care: a secondary analysis.

    PubMed

    Elliott, Naomi; Begley, Cecily; Kleinpell, Ruth; Higgins, Agnes

    2014-05-01

    To report a secondary analysis of data collected from the case study phase of a national study of advanced practitioners and to develop leadership outcome-indicators appropriate for advanced practitioners. In many countries, advanced practitioners in nursing and midwifery have responsibility as leaders for health care development, but without having leadership outcome measures available they are unable to demonstrate the results of their activities. In Ireland, a sequential mixed method research study was used to develop a validated tool for the evaluation of clinical specialists and advanced practitioners. Despite strong evidence of leadership activities, few leadership-specific outcomes were generated from the primary analysis. Secondary analysis of a multiple case study data set. Data set comprised 23 case studies of advanced practitioner/clinical specialists from 13 sites across each region in Ireland from all divisions of the Nursing Board Register. Data were collected 2008-2010. Data sources included non-participant observation (n = 92 hours) of advanced practitioners in practice, interviews with clinicians (n = 21), patients (n = 20) and directors of nursing/midwifery (n = 13) and documents. Analysis focused on leadership outcome-indicator development in line with the National Health Service's Good Indicators Guide. The four categories of leadership outcomes for advanced practitioner developed were as follows: (i) capacity and capability building of multidisciplinary team; (ii) measure of esteem; (iii) new initiatives for clinical practice and healthcare delivery; and (iv) clinical practice based on evidence. The proposed set of leadership outcome-indicators derived from a secondary analysis captures the complexity of leadership in practice. They add to existing clinical outcomes measuring advanced practice. © 2013 John Wiley & Sons Ltd.

  14. Rural Doctors’ Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study

    PubMed Central

    Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

    2016-01-01

    Background Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. Aim This study aimed to explore the views and experiences of rural doctors’ about evidence-based medicine in their daily clinical practice in a rural primary care setting. Methods Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Results Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. Conclusion The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers. PMID:27031700

  15. Intuition and evidence--uneasy bedfellows?

    PubMed Central

    Greenhalgh, Trisha

    2002-01-01

    Intuition is a decision-making method that is used unconsciously by experienced practitioners but is inaccessible to the novice. It is rapid, subtle, contextual, and does not follow simple, cause-and-effect logic. Evidence-based medicine offers exciting opportunities_for improving patient outcomes, but the 'evidence-burdened' approach of the inexperienced, protocol-driven clinician is well documented Intuition is not unscientific. It is a highly creative process, fundamental to hypothesis generation in science. The experienced practitioner should generate and follow clinical hunches as well as (not instead of applying the deductive principles of evidence-based medicine. The educational research literature suggests that we can improve our intuitive powers through systematic critical reflection about intuitive judgements--for example, through creative writing and dialogue with professional colleagues. It is time to revive and celebrate clinical storytelling as a method for professional education and development. The stage is surely set for a new, improved--and, indeed, evidence-based--'Balint'group. PMID:12014539

  16. [Evidence-based medicine--method, critical appraisal and usefulness for professionalized business practice in medical].

    PubMed

    Portwich, P

    2005-05-01

    The concept of evidence-based medicine (EBM) describes 5 steps that lead to a scientifically based solution of clinical problems. EBM is often reduced to the search for the best evidence (randomised controlled trials, meta-analyses) or the introduction of guidelines. This causes criticism and may have consequences for medicine. But EBM also emphasizes the so-called clinical expertise of the doctor, which is important for reference to the individual patient. This point of EBM is being developed further. Connected with the theory of professionalization by U. Oevermann, stressing the importance of hermeneutical competence, EBM turns out to be a sophisticated model of professional medical practice.

  17. Evaluation of Organizational Readiness in Clinical Settings for Social Supporting Evidence-Based Information Seeking Behavior after Introducing IT in a Developing Country.

    PubMed

    Kahouei, Mehdi; Alaei, Safollah; Panahi, Sohaila Sadat Ghazavi Shariat; Zadeh, Jamileh Mahdi

    2015-01-01

    The health sector of Iran has endeavored to encourage physicians and medical students to use research findings in their practice. Remarkable changes have occurred, including: holding computer skills courses, digital library workshops for physicians and students, and establishing websites in hospitals. The findings showed that a small number of the participants completely agreed that they were supported by supervisors and colleagues to use evidence-based information resources in their clinical decisions. Health care organizations in Iran need other organizational facilitators such as social influences, organizational support, leadership, strong organizational culture, and climate in order to implement evidence-based practice.

  18. Implementation Science Supports Core Clinical Competencies: An Overview and Clinical Example.

    PubMed

    Kirchner, JoAnn E; Woodward, Eva N; Smith, Jeffrey L; Curran, Geoffrey M; Kilbourne, Amy M; Owen, Richard R; Bauer, Mark S

    2016-12-08

    Instead of asking clinicians to work faster or longer to improve quality of care, implementation science provides another option. Implementation science is an emerging interdisciplinary field dedicated to studying how evidence-based practice can be adopted into routine clinical care. This article summarizes principles and methods of implementation science, illustrates how they can be applied in a routine clinical setting, and highlights their importance to practicing clinicians as well as clinical trainees. A hypothetical clinical case scenario is presented that explains how implementation science improves clinical practice. The case scenario is also embedded within a real-world implementation study to improve metabolic monitoring for individuals prescribed antipsychotics. Context, recipient, and innovation (ie, the evidence-based practice) factors affected improvement of metabolic monitoring. To address these factors, an external facilitator and a local quality improvement team developed an implementation plan involving a multicomponent implementation strategy that included education, performance reports, and clinician follow-up. The clinic remained compliant with recommended metabolic monitoring at 1-year follow up. Implementation science improves clinical practice by addressing context, recipient, and innovation factors and uses this information to develop and utilize specific strategies that improve clinical practice. It also enriches clinical training, aligning with core competencies by the Accreditation Council for Graduate Medical Education and American Boards of Medical Specialties. By learning how to change clinical practice through implementation strategies, clinicians are more able to adapt in complex systems of practice. © Copyright 2016 Physicians Postgraduate Press, Inc.

  19. Research Trends in Evidence-Based Medicine: A Joinpoint Regression Analysis of More than 50 Years of Publication Data

    PubMed Central

    Hung, Bui The; Long, Nguyen Phuoc; Hung, Le Phi; Luan, Nguyen Thien; Anh, Nguyen Hoang; Nghi, Tran Diem; Van Hieu, Mai; Trang, Nguyen Thi Huyen; Rafidinarivo, Herizo Fabien; Anh, Nguyen Ky; Hawkes, David; Huy, Nguyen Tien; Hirayama, Kenji

    2015-01-01

    Background Evidence-based medicine (EBM) has developed as the dominant paradigm of assessment of evidence that is used in clinical practice. Since its development, EBM has been applied to integrate the best available research into diagnosis and treatment with the purpose of improving patient care. In the EBM era, a hierarchy of evidence has been proposed, including various types of research methods, such as meta-analysis (MA), systematic review (SRV), randomized controlled trial (RCT), case report (CR), practice guideline (PGL), and so on. Although there are numerous studies examining the impact and importance of specific cases of EBM in clinical practice, there is a lack of research quantitatively measuring publication trends in the growth and development of EBM. Therefore, a bibliometric analysis was constructed to determine the scientific productivity of EBM research over decades. Methods NCBI PubMed database was used to search, retrieve and classify publications according to research method and year of publication. Joinpoint regression analysis was undertaken to analyze trends in research productivity and the prevalence of individual research methods. Findings Analysis indicates that MA and SRV, which are classified as the highest ranking of evidence in the EBM, accounted for a relatively small but auspicious number of publications. For most research methods, the annual percent change (APC) indicates a consistent increase in publication frequency. MA, SRV and RCT show the highest rate of publication growth in the past twenty years. Only controlled clinical trials (CCT) shows a non-significant reduction in publications over the past ten years. Conclusions Higher quality research methods, such as MA, SRV and RCT, are showing continuous publication growth, which suggests an acknowledgement of the value of these methods. This study provides the first quantitative assessment of research method publication trends in EBM. PMID:25849641

  20. Implementing clinical guidelines for chronic obstructive pulmonary disease: barriers and solutions

    PubMed Central

    Overington, Jeff D.; Huang, Yao C.; Abramson, Michael J.; Brown, Juliet L.; Goddard, John R.; Bowman, Rayleen V.; Fong, Kwun M.

    2014-01-01

    Chronic obstructive pulmonary disease (COPD) is a complex chronic lung disease characterised by progressive fixed airflow limitation and acute exacerbations that frequently require hospitalisation. Evidence-based clinical guidelines for the diagnosis and management of COPD are now widely available. However, the uptake of these COPD guidelines in clinical practice is highly variable, as is the case for many other chronic disease guidelines. Studies have identified many barriers to implementation of COPD and other guidelines, including factors such as lack of familiarity with guidelines amongst clinicians and inadequate implementation programs. Several methods for enhancing adherence to clinical practice guidelines have been evaluated, including distribution methods, professional education sessions, electronic health records (EHR), point of care reminders and computer decision support systems (CDSS). Results of these studies are mixed to date, and the most effective ways to implement clinical practice guidelines remain unclear. Given the significant resources dedicated to evidence-based medicine, effective dissemination and implementation of best practice at the patient level is an important final step in the process of guideline development. Future efforts should focus on identifying optimal methods for translating the evidence into everyday clinical practice to ensure that patients receive the best care. PMID:25478199

  1. Has evidence-based medicine ever been modern? A Latour-inspired understanding of a changing EBM.

    PubMed

    Wieringa, Sietse; Engebretsen, Eivind; Heggen, Kristin; Greenhalgh, Trish

    2017-10-01

    Evidence-based health care (EBHC), previously evidence-based medicine (EBM), is considered by many to have modernized health care and brought it from an authority-based past to a more rationalist, scientific grounding. But recent concerns and criticisms pose serious challenges and urge us to look at the fundamentals of a changing EBHC. In this paper, we present French philosopher Bruno Latour's vision on modernity as a framework to discuss current changes in the discourse on EBHC/EBM. Drawing on Latour's work, we argue that the early EBM movement had a strong modernist agenda with an aim to "purify" clinical reality into a dichotomy of objective "evidence" from nature and subjective "preferences" from human society and culture. However, we argue that this shift has proved impossible to achieve in reality. Several recent developments appear to point to a demise of purified evidence in the EBHC discourse and a growing recognition-albeit implicit and undertheorized-that evidence in clinical decision making is relentlessly situated and contextual. The unique, individual patient, not abstracted truths from distant research studies, must be the starting point for clinical practice. It follows that the EBHC community needs to reconsider the assumption that science should be abstracted from culture and acknowledge that knowledge from human culture and nature both need translation and interpretation. The implications for clinical reasoning are far reaching. We offer some preliminary principles for conceptualizing EBHC as a "situated practice" rather than as a sequence of research-driven abstract decisions. © 2017 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

  2. Interventions to Modify Health Care Provider Adherence to Asthma Guidelines: A Systematic Review

    PubMed Central

    Okelo, Sande O.; Butz, Arlene M.; Sharma, Ritu; Diette, Gregory B.; Pitts, Samantha I.; King, Tracy M.; Linn, Shauna T.; Reuben, Manisha; Chelladurai, Yohalakshmi

    2013-01-01

    BACKGROUND AND OBJECTIVE: Health care provider adherence to asthma guidelines is poor. The objective of this study was to assess the effect of interventions to improve health care providers’ adherence to asthma guidelines on health care process and clinical outcomes. METHODS: Data sources included Medline, Embase, Cochrane CENTRAL Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, PsycINFO, and Research and Development Resource Base in Continuing Medical Education up to July 2012. Paired investigators independently assessed study eligibility. Investigators abstracted data sequentially and independently graded the evidence. RESULTS: Sixty-eight eligible studies were classified by intervention: decision support, organizational change, feedback and audit, clinical pharmacy support, education only, quality improvement/pay-for-performance, multicomponent, and information only. Half were randomized trials (n = 35). There was moderate evidence for increased prescriptions of controller medications for decision support, feedback and audit, and clinical pharmacy support and low-grade evidence for organizational change and multicomponent interventions. Moderate evidence supports the use of decision support and clinical pharmacy interventions to increase provision of patient self-education/asthma action plans. Moderate evidence supports use of decision support tools to reduce emergency department visits, and low-grade evidence suggests there is no benefit for this outcome with organizational change, education only, and quality improvement/pay-for-performance. CONCLUSIONS: Decision support tools, feedback and audit, and clinical pharmacy support were most likely to improve provider adherence to asthma guidelines, as measured through health care process outcomes. There is a need to evaluate health care provider-targeted interventions with standardized outcomes. PMID:23979092

  3. The Brazilian consensus for the clinical approach and treatment of subclinical hypothyroidism in adults: recommendations of the thyroid Department of the Brazilian Society of Endocrinology and Metabolism.

    PubMed

    Sgarbi, Jose A; Teixeira, Patrícia F S; Maciel, Lea M Z; Mazeto, Glaucia M F S; Vaisman, Mario; Montenegro Junior, Renan M; Ward, Laura S

    2013-04-01

    Subclinical hypothyroidism (SCH), defined as elevated concentrations of thyroid stimulating hormone (TSH) despite normal levels of thyroid hormones, is highly prevalent in Brazil, especially among women and the elderly. Although an increasing number of studies have related SCH to an increased risk of coronary artery disease and mortality, there have been no randomized clinical trials verifying the benefit of levothyroxine treatment in reducing these risks, and the treatment remains controversial. This consensus, sponsored by the Thyroid Department of the Brazilian Society of Endocrinology and Metabolism and developed by Brazilian experts with extensive clinical experience with thyroid diseases, presents these recommendations based on evidence for the clinical management of SCH patients in Brazil. After structuring the clinical questions, the search for evidence in the literature was initially performed in the MedLine-PubMed database and later in the Embase and SciELO - Lilacs databases. The strength of evidence was evaluated according to the Oxford classification system and established based on the experimental design used, considering the best available evidence for each question and the Brazilian experience. The topics covered included SCH definition and diagnosis, natural history, clinical significance, treatment and pregnancy, and the consensus issued 29 recommendations for the clinical management of adult patients with SCH. Treatment with levothyroxine was recommended for all patients with persistent SCH with serum TSH values > 10 mU/L and for certain patient subgroups.

  4. Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.

    PubMed

    Knai, Cécile; Brusamento, Serena; Legido-Quigley, Helena; Saliba, Vanessa; Panteli, Dimitra; Turk, Eva; Car, Josip; McKee, Martin; Busse, Reinhard

    2012-10-01

    The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were 'editorial independence' (with a mean domain score of 41%), 'applicability' (44%), 'stakeholder involvement' (55%), and 'rigour of development' (64%), while 'clarity of presentation' (80%) and 'scope and purpose' (84%) were less problematic. This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and applicability early on in the process. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  5. Multinational evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative

    PubMed Central

    Machado, P; Castrejon, I; Katchamart, W; Koevoets, R; Kuriya, B; Schoels, M; Silva-Fernández, L; Thevissen, K; Vercoutere, W; Villeneuve, E; Aletaha, D; Carmona, L; Landewé, R; van der Heijde, D; Bijlsma, J W J; Bykerk, V; Canhão, H; Catrina, A I; Durez, P; Edwards, C J; Mjaavatten, M D; Leeb, B F; Losada, B; Martín-Mola, E M; Martinez-Osuna, P; Montecucco, C; Müller-Ladner, U; Østergaard, M; Sheane, B; Xavier, R M; Zochling, J; Bombardier, C

    2011-01-01

    Objective To develop evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis (UPIA). Methods 697 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2008–9 consisting of three separate rounds of discussions and modified Delphi votes. In the first round 10 clinical questions were selected. A bibliographic team systematically searched Medline, Embase, the Cochrane Library and ACR/EULAR 2007–2008 meeting abstracts. Relevant articles were reviewed for quality assessment, data extraction and synthesis. In the second round each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. Results A total of 39 756 references were identified, of which 250 were systematically reviewed. Ten multinational key recommendations about the investigation and follow-up of UPIA were formulated. One recommendation addressed differential diagnosis and investigations prior to establishing the operational diagnosis of UPIA, seven recommendations related to the diagnostic and prognostic value of clinical and laboratory assessments in established UPIA (history and physical examination, acute phase reactants, autoantibodies, radiographs, MRI and ultrasound, genetic markers and synovial biopsy), one recommendation highlighted predictors of persistence (chronicity) and the final recommendation addressed monitoring of clinical disease activity in UPIA. Conclusions Ten recommendations on how to investigate and follow-up UPIA in the clinical setting were developed. They are evidence-based and supported by a large panel of rheumatologists, thus enhancing their validity and practical use. PMID:20724311

  6. Student attitudes towards clinical teaching resources in complementary medicine: a focus group examination of Australian naturopathic medicine students.

    PubMed

    Wardle, Jonathan Lee; Sarris, Jerome

    2014-06-01

    Complementary medicine is forming an increasingly large part of health care in developed countries and is increasingly being formally taught in tertiary academic settings. An exploratory study of naturopathic student perceptions of, use of and attitudes towards teaching resources in naturopathic clinical training and education. Focus groups were conducted with current and recent students of 4-year naturopathic degree programmes in Brisbane and Sydney to ascertain how they interact with clinical teaching materials, and their perceptions and attitudes towards teaching materials in naturopathic education. Naturopathic students have a complex and critical relationship with their learning materials. Although naturopathic practice is often defined by traditional evidence, students want information that both supports and is critical of traditional naturopathic practices, and focuses heavily on evidence-based medicine. Students remain largely ambivalent about new teaching technologies and would prefer that these develop organically as an evolution from printed materials, rather than depart from dramatically and radically from these previously established materials. Findings from this study will assist publishers, librarians and academics develop clinical information sources that appropriately meet student expectations and support their learning requirements. © 2014 The authors. Health Information and Libraries Journal © 2014 Health Libraries Group.

  7. Management of Pediatric Supracondylar Humerus Fractures With Vascular Injury.

    PubMed

    Sanders, James O; Heggeness, Michael H; Murray, Jayson N; Pezold, Ryan C; Sevarino, Kaitlyn S

    2016-02-01

    The American Academy of Orthopaedic Surgeons has developed the Appropriate Use Criteria (AUC) document Management of Pediatric Supracondylar Humerus Fractures With Vascular Injury. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain the best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The AUC clinical patient scenarios were derived from patient indications that generally accompany a pediatric supracondylar humerus fracture with vascular injury, as well as from current evidence-based clinical practice guidelines and supporting literature. The 6 patient scenarios and 18 treatments were developed by the Writing Panel, a group of clinicians who are specialists in this AUC topic. Next, the Review Panel, a separate group of volunteer physicians, independently reviewed these materials to ensure that they were representative of patient scenarios that clinicians are likely to encounter in daily practice. Finally, the multidisciplinary Voting Panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

  8. Management of Patients with Orthopaedic Implants Undergoing Dental Procedures.

    PubMed

    Quinn, Robert H; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

    2017-07-01

    The American Academy of Orthopaedic Surgeons, in collaboration with the American Dental Association, has developed Appropriate Use Criteria (AUC) for the Management of Patients with Orthopaedic Implants Undergoing Dental Procedures. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The Management of Patients with Orthopaedic Implants Undergoing Dental Procedures AUC clinical patient scenarios were derived from indications of patients with orthopaedic implants presenting for dental procedures, as well as from current evidence-based clinical practice guidelines and supporting literature to identify the appropriateness of the use of prophylactic antibiotics. The 64 patient scenarios and 1 treatment were developed by the writing panel, a group of clinicians who are specialists in this AUC topic. Next, a separate, multidisciplinary, voting panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

  9. [Evidence-based Risk and Benefit Communication for Shared Decision Making].

    PubMed

    Nakayama, Takeo

    2018-01-01

     Evidence-based medicine (EBM) can be defined as "the integration of the best research evidence with clinical expertise and a patient's unique values and circumstances". However, even with the best research evidence, many uncertainties can make clinical decisions difficult. As the social requirement of respecting patient values and preferences has been increasingly recognized, shared decision making (SDM) and consensus development between patients and clinicians have attracted attention. SDM is a process by which patients and clinicians make decisions and arrive at a consensus through interactive conversations and communications. During the process of SDM, patients and clinicians share information with each other on the goals they hope to achieve and responsibilities in meeting those goals. From the clinician's standpoint, information regarding the benefits and risks of potential treatment options based on current evidence and professional experience is provided to patients. From the patient's standpoint, information on personal values, preferences, and social roles is provided to clinicians. SDM is a sort of "wisdom" in the context of making autonomous decisions in uncertain, difficult situations through interactions and cooperation between patients and clinicians. Joint development of EBM and SDM will help facilitate patient-clinician relationships and improve the quality of healthcare.

  10. Integration of Fall Prevention into State Policy in Connecticut

    ERIC Educational Resources Information Center

    Murphy, Terrence E.; Baker, Dorothy I.; Leo-Summers, Linda S.; Bianco, Luann; Gottschalk, Margaret; Acampora, Denise; King, Mary B.

    2013-01-01

    Purpose of Study: To describe the ongoing efforts of the Connecticut Collaboration for Fall Prevention (CCFP) to move evidence regarding fall prevention into clinical practice and state policy. Methods: A university-based team developed methods of networking with existing statewide organizations to influence clinical practice and state policy.…

  11. Gentamicin in the Clinical Setting

    ERIC Educational Resources Information Center

    Pillers, De-Ann M.; Schleiss, Mark R.

    2005-01-01

    Gentamicin is an aminoglycoside antibiotic that has been a mainstay in pediatric care for decades. Although new antibiotics are constantly under development, gentamicin continues to play an important role in clinical medicine. Although this may be surprising in the context of evidence of an association with hearing loss, both on a toxicity and a…

  12. Preparing Current and Future Practitioners to Integrate Research in Real Practice Settings

    ERIC Educational Resources Information Center

    Thyer, Bruce A.

    2015-01-01

    Past efforts aimed at promoting a better integration between research and practice are reviewed. These include the empirical clinical practice movement (ECP), originating within social work; the empirically supported treatment (EST) initiative of clinical psychology; and the evidence-based practice (EBP) model developed within medicine. The…

  13. Use of Management Pathways or Algorithms in Children With Chronic Cough: CHEST Guideline and Expert Panel Report.

    PubMed

    Chang, Anne B; Oppenheimer, John J; Weinberger, Miles M; Rubin, Bruce K; Weir, Kelly; Grant, Cameron C; Irwin, Richard S

    2017-04-01

    Using management algorithms or pathways potentially improves clinical outcomes. We undertook systematic reviews to examine various aspects in the generic approach (use of cough algorithms and tests) to the management of chronic cough in children (aged ≤ 14 years) based on key questions (KQs) using the Population, Intervention, Comparison, Outcome format. We used the CHEST Expert Cough Panel's protocol for the systematic reviews and the American College of Chest Physicians (CHEST) methodological guidelines and Grading of Recommendations Assessment, Development and Evaluation framework. Data from the systematic reviews in conjunction with patients' values and preferences and the clinical context were used to form recommendations. Delphi methodology was used to obtain the final grading. Combining data from systematic reviews addressing five KQs, we found high-quality evidence that a systematic approach to the management of chronic cough improves clinical outcomes. Although there was evidence from several pathways, the highest evidence was from the use of the CHEST approach. However, there was no or little evidence to address some of the KQs posed. Compared with the 2006 Cough Guidelines, there is now high-quality evidence that in children aged ≤ 14 years with chronic cough (> 4 weeks' duration), the use of cough management protocols (or algorithms) improves clinical outcomes, and cough management or testing algorithms should differ depending on the associated characteristics of the cough and clinical history. A chest radiograph and, when age appropriate, spirometry (pre- and post-β 2 agonist) should be undertaken. Other tests should not be routinely performed and undertaken in accordance with the clinical setting and the child's clinical symptoms and signs (eg, tests for tuberculosis when the child has been exposed). Copyright © 2017 American College of Chest Physicians. All rights reserved.

  14. ACR Appropriateness Criteria® Ovarian Cancer Screening.

    PubMed

    Pandharipande, Pari V; Lowry, Kathryn P; Reinhold, Caroline; Atri, Mostafa; Benson, Carol B; Bhosale, Priyadarshani R; Green, Edward D; Kang, Stella K; Lakhman, Yulia; Maturen, Katherine E; Nicola, Refky; Salazar, Gloria M; Shipp, Thomas D; Simpson, Lynn; Sussman, Betsy L; Uyeda, Jennifer; Wall, Darci J; Whitcomb, Bradford; Zelop, Carolyn M; Glanc, Phyllis

    2017-11-01

    There has been much interest in the identification of a successful ovarian cancer screening test, in particular, one that can detect ovarian cancer at an early stage and improve survival. We reviewed the currently available data from randomized and observational trials that examine the role of imaging for ovarian cancer screening in average-risk and high-risk women. We found insufficient evidence to recommend ovarian cancer screening, when considering the imaging modality (pelvic ultrasound) and population (average-risk postmenopausal women) for which there is the greatest available published evidence; randomized controlled trials have not demonstrated a mortality benefit in this setting. Screening high-risk women using pelvic ultrasound may be appropriate in some clinical situations; however, related data are limited because large, randomized trials have not been performed in this setting. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  15. Gaps in the evidence for prevention and treatment of maternal anaemia: a review of systematic reviews.

    PubMed

    Parker, Jacqui A; Barroso, Filipa; Stanworth, Simon J; Spiby, Helen; Hopewell, Sally; Doree, Carolyn J; Renfrew, Mary J; Allard, Shubha

    2012-06-24

    Anaemia, in particular due to iron deficiency, is common in pregnancy with associated negative outcomes for mother and infant. However, there is evidence of significant variation in management. The objectives of this review of systematic reviews were to analyse and summarise the evidence base, identify gaps in the evidence and develop a research agenda for this important component of maternity care. Multiple databases were searched, including MEDLINE, EMBASE and The Cochrane Library. All systematic reviews relating to interventions to prevent and treat anaemia in the antenatal and postnatal period were eligible. Two reviewers independently assessed data inclusion, extraction and quality of methodology. 27 reviews were included, all reporting on the prevention and treatment of anaemia in the antenatal (n = 24) and postnatal periods (n = 3). Using AMSTAR as the assessment tool for methodological quality, only 12 of the 27 were rated as high quality reviews. The greatest number of reviews covered antenatal nutritional supplementation for the prevention of anaemia (n = 19). Iron supplementation was the most extensively researched, but with ongoing uncertainty about optimal dose and regimen. Few identified reviews addressed anaemia management post-partum or correlations between laboratory and clinical outcomes, and no reviews reported on clinical symptoms of anaemia. The review highlights evidence gaps including the management of anaemia in the postnatal period, screening for anaemia, and optimal interventions for treatment. Research priorities include developing standardised approaches to reporting of laboratory outcomes, and information on clinical outcomes relevant to the experiences of pregnant women.

  16. Inhaled antibiotics in the treatment of non-cystic fibrosis bronchiectasis: clinical and drug delivery perspectives.

    PubMed

    Sugianto, Tiffanie Daisy; Chan, Hak-Kim

    2016-01-01

    Non-cystic fibrosis bronchiectasis (NCFB) is a chronic, progressive, suppurative lung disease characterized by permanent dilatation of bronchial subdivisions, which further causes accumulation of sputum and bacterial infections. The advent of inhaled antibiotics over the past two decades has been expected to effectively attenuate the problem of chronic bacterial infections in CF and NCFB subjects with higher, local drug concentrations and minimal systemic side effects. This review summarizes and evaluates current clinical evidence of efficacy and adverse effects of inhaled antibiotics in NCFB, as well as ongoing preclinical and clinical studies, followed by a discussion of issues and challenges in clinical practice and drug delivery strategies, together with future research directions. The evidence base of the clinical efficacy of inhaled antibiotics in NCFB is limited and the degrees of reported clinical benefits have been modest and conflicting. Challenges surrounding inhaled antibiotics application and development include the lack of knowledge of disease factors and optimum management strategies, unreceptive lung pathophysiology and the lack of factors that support compliance and tolerability. Nonetheless, research continues to give birth to new clinical findings and novel formulations such as combination antibiotics and sustained-release formulations, which add great value to the development of efficacious, safe and convenient inhalable antibiotics of the future.

  17. Information Literacy for Users at the National Medical Library of Cuba: Cochrane Library Course for the Search of Best Evidence for Clinical Decisions

    ERIC Educational Resources Information Center

    Santana Arroyo, Sonia; del Carmen Gonzalez Rivero, Maria

    2012-01-01

    The National Medical Library of Cuba is currently developing an information literacy program to train users in the use of biomedical databases. This paper describes the experience with the course "Cochrane Library: Evidence-Based Medicine," which aims to teach users how to make the best use of this database, as well as the evidence-based…

  18. Evidence-based algorithm for heparin dosing before cardiopulmonary bypass. Part 1: Development of the algorithm.

    PubMed

    McKinney, Mark C; Riley, Jeffrey B

    2007-12-01

    The incidence of heparin resistance during adult cardiac surgery with cardiopulmonary bypass has been reported at 15%-20%. The consistent use of a clinical decision-making algorithm may increase the consistency of patient care and likely reduce the total required heparin dose and other problems associated with heparin dosing. After a directed survey of practicing perfusionists regarding treatment of heparin resistance and a literature search for high-level evidence regarding the diagnosis and treatment of heparin resistance, an evidence-based decision-making algorithm was constructed. The face validity of the algorithm decisive steps and logic was confirmed by a second survey of practicing perfusionists. The algorithm begins with review of the patient history to identify predictors for heparin resistance. The definition for heparin resistance contained in the algorithm is an activated clotting time < 450 seconds with > 450 IU/kg heparin loading dose. Based on the literature, the treatment for heparin resistance used in the algorithm is anti-thrombin III supplement. The algorithm seems to be valid and is supported by high-level evidence and clinician opinion. The next step is a human randomized clinical trial to test the clinical procedure guideline algorithm vs. current standard clinical practice.

  19. Reversal of liver cirrhosis: current evidence and expectations.

    PubMed

    Jung, Young Kul; Yim, Hyung Joon

    2017-03-01

    In the past, liver cirrhosis was considered an irreversible phenomenon. However, many experimental data have provided evidence of the reversibility of liver fibrosis. Moreover, multiple clinical studies have also shown regression of fibrosis and reversal of cirrhosis on repeated biopsy samples. As various etiologies are associated with liver fibrosis via integrated signaling pathways, a comprehensive understanding of the pathobiology of hepatic fibrogenesis is critical for improving clinical outcomes. Hepatic stellate cells play a central role in hepatic fibrogenesis upon their activation from a quiescent state. Collagen and other extracellular material components from activated hepatic stellate cells are deposited on, and damage, the liver parenchyma and vascular structures. Hence, inactivation of hepatic stellate cells can lead to enhancement of fibrolytic activity and could be a potential target of antifibrotic therapy. In this regard, continued efforts have been made to develop better treatments for underlying liver diseases and antifibrotic agents in multiple clinical and therapeutic trials; the best results may be expected with the integration of such evidence. In this article, we present the underlying mechanisms of fibrosis, current experimental and clinical evidence of the reversibility of liver fibrosis/cirrhosis, and new agents with therapeutic potential for liver fibrosis.

  20. Reversal of liver cirrhosis: current evidence and expectations

    PubMed Central

    Jung, Young Kul; Yim, Hyung Joon

    2017-01-01

    In the past, liver cirrhosis was considered an irreversible phenomenon. However, many experimental data have provided evidence of the reversibility of liver fibrosis. Moreover, multiple clinical studies have also shown regression of fibrosis and reversal of cirrhosis on repeated biopsy samples. As various etiologies are associated with liver fibrosis via integrated signaling pathways, a comprehensive understanding of the pathobiology of hepatic fibrogenesis is critical for improving clinical outcomes. Hepatic stellate cells play a central role in hepatic fibrogenesis upon their activation from a quiescent state. Collagen and other extracellular material components from activated hepatic stellate cells are deposited on, and damage, the liver parenchyma and vascular structures. Hence, inactivation of hepatic stellate cells can lead to enhancement of fibrolytic activity and could be a potential target of antifibrotic therapy. In this regard, continued efforts have been made to develop better treatments for underlying liver diseases and antifibrotic agents in multiple clinical and therapeutic trials; the best results may be expected with the integration of such evidence. In this article, we present the underlying mechanisms of fibrosis, current experimental and clinical evidence of the reversibility of liver fibrosis/cirrhosis, and new agents with therapeutic potential for liver fibrosis. PMID:28171717

  1. Promoting evidence-based practice: managing change in the assessment of pressure damage risk.

    PubMed

    Gerrish, K; Clayton, J; Nolan, M; Parker, K; Morgan, L

    1999-11-01

    This study set out to facilitate the development of evidence-based practice in the assessment of pressure damage risk to patients within a large acute hospital. The importance of nursing practice being based on the best available evidence is emphasized in recent health policy. Meeting this objective is not easy as both individual and organizational factors create barriers to the implementation of research findings and the achievement of change. The study was based on an action research model. It comprised three stages: a review of the research evidence; a survey of qualified nurses' knowledge of risk assessment of pressure damage and an audit of record keeping, and a multifaceted approach to achieving change in which researchers, managers, practitioners and clinical nurse specialists worked together collaboratively. The findings from the survey and audit indicated a shortfall in nurses' knowledge of risk assessment of pressure damage and in their record keeping. The researchers, with the help of the clinical nurse specialist, built upon these findings by assisting practitioners and managers to take ownership of the need to base practice on the appropriate evidence. Achieving evidence-based practice is a complex undertaking that requires the development of an evaluative culture and a commitment by practitioners and managers to change practice. Researchers can play a valuable role in facilitating this process.

  2. Rightsizing Projects for Non-Research-Intensive Schools of Nursing via Academic-Clinical Partnerships.

    PubMed

    Kooken, Wendy Carter; Eckhardt, Ann L; McNutt-Dungan, Marianne; Woods, Jonathan

    Most academic-clinical partnerships are described as formal agreements between schools of nursing at research-intensive universities and large teaching hospitals. This article demonstrates less formal versions of academic-clinical partnerships established between a small, private liberal arts university school of nursing and 2 regional clinical agencies. In both exemplars, students, faculty, and staff contributed to evidence-based practice projects. Schools of nursing in non-research-intensive environments can develop right-size academic-clinical partnerships that are beneficial for all parties involved.

  3. Evaluating a standardised clinical assessment tool for pre-registration midwifery students: A cross-sectional survey of midwifery students and midwives in Australia.

    PubMed

    Morrow, Jane; Biggs, Laura; Stelfox, Sara; Phillips, Diane; McKellar, Lois; McLachlan, Helen

    2016-02-01

    Assessment of clinical competence is a core component of midwifery education. Clinical assessment tools have been developed to help increase consistency and overcome subjectivity of assessment. The study had two main aims. The first was to explore midwifery students and educators/clinical midwives' views and experiences of a common clinical assessment tool used for all preregistration midwifery programmes in Victoria and the University of South Australia. The second was to assess the need for changes to the tool to align with developments in clinical practice and evidence-based care. A cross-sectional, web-based survey including Likert-type scales and open-ended questions was utilised. Students enrolled in all four entry pathways to midwifery at seven Victorian and one South Australian university and educators/clinical midwives across both states. One hundred and ninety-one midwifery students' and 86 educators/clinical midwives responded. Overall, students and educators/clinical midwives were positive about the Clinical Assessment Tool with over 90% reporting that it covered the necessary midwifery skills. Students and educators/clinical midwives reported high levels of satisfaction with the content of the learning tools. Only 4% of educators/clinical midwives and 6% of students rated the Clinical Assessment Tool as poor overall. Changes to some learning tools were necessary in order to reflect recent practice and evidence. A common clinical assessment tool for evaluating midwifery students' clinical practice may facilitate the provision of consistent, reliable and objective assessment of student skills and competency. Copyright © 2015 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  4. Development of EBM-CDSS (Evidence-Based Clinical Decision Support System) to AIG Prognostication in Terminally Ill Patients

    DTIC Science & Technology

    2016-03-01

    Mbah, PhD2*, Ambuj Kumar, MD, MPH3, Kim Sehwan, PhD4*, Ronald Schonwetter, MD5* and Benjamin Djulbegovic, MD, PhD6 1Center for Evidence - Based Medicine , University...of South Florida, Tampa, FL 2USF, Tampa, FL 3University of South Florida, College of Medicine, Center for Evidence Based Medicine , Tampa...4HPC healthcare, Tampa, FL 5HPC Healthcare, Tampa, FL 6Center for Evidence - Based Medicine & Health Outcomes Research, University of South

  5. Factors influencing evidence-based practice in prosthetics and orthotics.

    PubMed

    Andrysek, Jan; Christensen, James; Dupuis, Annie

    2011-03-01

    The importance of evidence-based practice is being recognized across a broad range of healthcare disciplines as a means for improving patient outcomes and also efficiently managing healthcare resources. The objective of this work was to obtain information from clinicians about the underlying barriers and facilitators relating to evidence-based practice in prosthetics and orthotics. Cross sectional survey. An internet survey was developed and distributed to 300 prosthetists and orthotists currently practicing in Canada. A principal component factor analysis of the survey results revealed ten primary factors affecting evidence-based practice. These include time constraints, workload and system demands, limited relevant evidence from research, and gaps in skills and knowledge required to perform evidence-based practice. Clinicians value research as a means of improving clinical practice, but they are faced with a number of practical barriers in performing evidence-based practice. This study provides empirical data about the underlying barriers and facilitators relating to evidence-based practice in prosthetics and orthotics. Such data are essential in order to inform those involved in improving existing clinical practices, including educators, professional organizations, and governing bodies.

  6. Creation of a Tool for Assessing Knowledge in Evidence-Based Decision-Making in Practicing Health Care Providers.

    PubMed

    Spurr, Kathy; Dechman, Gail; Lackie, Kelly; Gilbert, Robert

    2016-01-01

    Evidence-based decision-making (EBDM) is the process health care providers (HCPs) use to identify and appraise potential evidence. It supports the integration of best research evidence with clinical expertise and patient values into the decision-making process for patient care. Competence in this process is essential to delivery of optimal care. There is no objective tool that assesses EBDM across HCP groups. This research aimed to develop a content valid tool to assess knowledge of the principles of evidence-based medicine and the EBDM process, for use with all HCPs. A Delphi process was used in the creation of the tool. Pilot testing established its content validity with the added benefit of evaluating HCPs' knowledge of EBDM. Descriptive statistics and multivariate mixed models were used to evaluate individual survey responses in total, as well as within each EBDM component. The tool consisted of 26 multiple-choice questions. A total of 12,884 HCPs in Nova Scotia were invited to participate in the web-based validation study, yielding 818 (6.3%) participants, 471 of whom completed all questions. The mean overall score was 68%. Knowledge in one component, integration of evidence with clinical expertise and patient preferences, was identified as needing development across all HCPs surveyed. A content valid tool for assessing HCP EBDM knowledge was created and can be used to support the development of continuing education programs to enhance EBDM competency.

  7. Clopidogrel and warfarin pharmacogenetic tests: what is the evidence for use in clinical practice?

    PubMed Central

    Shahin, Mohamed H.A.; Johnson, Julie A.

    2013-01-01

    Purpose of review To review the most promising genetic markers associated with the variability in the safety or efficacy of warfarin and clopidogrel and highlight the verification and validation initiatives for translating clopidogrel and warfarin pharmacogenetic tests to clinical practice. Recent findings Rapid advances in pharmacogenetics, continuous decrease in genotyping cost, development of point-of-care devices and the newly established clinical genotyping programs at several institutions hold the promise of individualizing clopidogrel and warfarin based on genotype. Guidelines have been established to assist clinicians in prescribing clopidogrel or warfarin dose based on genotype. However, the clinical utility of clopidogrel and warfarin is still limited. Accordingly, large randomized clinical trials are underway to define the role of clopidogrel and warfarin pharmacogenetics in clinical practice. Summary Pharmacogenetics has offered compelling evidence toward the individualization of clopidogrel and warfarin therapies. The rapid advances in technology make the clinical implementation of clopidogrel and warfarin pharmacogenetics possible. The clinical genotyping programs and the ongoing clinical trials will help in overcoming some of the barriers facing the clinical implementation of clopidogrel and warfarin pharmacogenetics. PMID:23478884

  8. 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

  9. Implementing elements of evidence-based practice into scientist-practitioner training at the University of Nebraska-Lincoln.

    PubMed

    DiLillo, David; McChargue, Dennis

    2007-07-01

    Evidence-based practice (EBP) has become the predominant model of training and is emerging as a common model of practice for many non-psychology health care professions. Recognizing the relevance of EBP to psychology, the American Psychological Association (APA) developed and endorsed an official policy statement on EBP for the practice of professional psychology. There is now a pressing need to consider ways that EBP can inform scientist-practitioner training. The present article proposes clinical competencies associated with the practice of EBP, and describes initial efforts to implement elements of EBP into training at the University of Nebraska-Lincoln. These efforts have occurred in both the classroom and practicum training experiences, and are geared toward helping students become more effective users of the evidence base through their clinical work. Challenges to the implementation of EBP in clinical psychology training are discussed as well.

  10. Large-scale adverse effects related to treatment evidence standardization (LAERTES): an open scalable system for linking pharmacovigilance evidence sources with clinical data.

    PubMed

    2017-03-07

    Integrating multiple sources of pharmacovigilance evidence has the potential to advance the science of safety signal detection and evaluation. In this regard, there is a need for more research on how to integrate multiple disparate evidence sources while making the evidence computable from a knowledge representation perspective (i.e., semantic enrichment). Existing frameworks suggest well-promising outcomes for such integration but employ a rather limited number of sources. In particular, none have been specifically designed to support both regulatory and clinical use cases, nor have any been designed to add new resources and use cases through an open architecture. This paper discusses the architecture and functionality of a system called Large-scale Adverse Effects Related to Treatment Evidence Standardization (LAERTES) that aims to address these shortcomings. LAERTES provides a standardized, open, and scalable architecture for linking evidence sources relevant to the association of drugs with health outcomes of interest (HOIs). Standard terminologies are used to represent different entities. For example, drugs and HOIs are represented in RxNorm and Systematized Nomenclature of Medicine -- Clinical Terms respectively. At the time of this writing, six evidence sources have been loaded into the LAERTES evidence base and are accessible through prototype evidence exploration user interface and a set of Web application programming interface services. This system operates within a larger software stack provided by the Observational Health Data Sciences and Informatics clinical research framework, including the relational Common Data Model for observational patient data created by the Observational Medical Outcomes Partnership. Elements of the Linked Data paradigm facilitate the systematic and scalable integration of relevant evidence sources. The prototype LAERTES system provides useful functionality while creating opportunities for further research. Future work will involve improving the method for normalizing drug and HOI concepts across the integrated sources, aggregated evidence at different levels of a hierarchy of HOI concepts, and developing more advanced user interface for drug-HOI investigations.

  11. ACR Appropriateness Criteria® Headache-Child.

    PubMed

    Hayes, Laura L; Palasis, Susan; Bartel, Twyla B; Booth, Timothy N; Iyer, Ramesh S; Jones, Jeremy Y; Kadom, Nadja; Milla, Sarah S; Myseros, John S; Pakalnis, Ann; Partap, Sonia; Robertson, Richard L; Ryan, Maura E; Saigal, Gaurav; Soares, Bruno P; Tekes, Aylin; Karmazyn, Boaz K

    2018-05-01

    Headaches in children are not uncommon and have various causes. Proper neuroimaging of these children is very specific to the headache type. Care must be taken to choose and perform the most appropriate initial imaging examination in order to maximize the ability to properly determine the cause with minimum risk to the child. This evidence-based report discusses the different headache types in children and provides appropriate guidelines for imaging these children. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. Developing and using a rubric for evaluating evidence-based medicine point-of-care tools.

    PubMed

    Shurtz, Suzanne; Foster, Margaret J

    2011-07-01

    The research sought to establish a rubric for evaluating evidence-based medicine (EBM) point-of-care tools in a health sciences library. The authors searched the literature for EBM tool evaluations and found that most previous reviews were designed to evaluate the ability of an EBM tool to answer a clinical question. The researchers' goal was to develop and complete rubrics for assessing these tools based on criteria for a general evaluation of tools (reviewing content, search options, quality control, and grading) and criteria for an evaluation of clinical summaries (searching tools for treatments of common diagnoses and evaluating summaries for quality control). Differences between EBM tools' options, content coverage, and usability were minimal. However, the products' methods for locating and grading evidence varied widely in transparency and process. As EBM tools are constantly updating and evolving, evaluation of these tools needs to be conducted frequently. Standards for evaluating EBM tools need to be established, with one method being the use of objective rubrics. In addition, EBM tools need to provide more information about authorship, reviewers, methods for evidence collection, and grading system employed.

  13. 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.

  14. Impact of protein D-containing pneumococcal conjugate vaccines on non-typeable Haemophilus influenzae acute otitis media and carriage.

    PubMed

    Clarke, Christopher; Bakaletz, Lauren O; Ruiz-Guiñazú, Javier; Borys, Dorota; Mrkvan, Tomas

    2017-07-01

    Protein D-containing vaccines may decrease acute otitis media (AOM) burden and nasopharyngeal carriage of non-typeable Haemophilus influenzae (NTHi). Protein D-containing pneumococcal conjugate vaccine PHiD-CV (Synflorix, GSK Vaccines) elicits robust immune responses against protein D. However, the phase III Clinical Otitis Media and PneumoniA Study (COMPAS), assessing PHiD-CV efficacy against various pneumococcal diseases, was not powered to demonstrate efficacy against NTHi; only trends of protective efficacy against NTHi AOM in children were shown. Areas covered: This review aims to consider all evidence available to date from pre-clinical and clinical phase III studies together with further evidence emerging from post-marketing studies since PHiD-CV has been introduced into routine clinical practice worldwide, to better describe the clinical utility of protein D in preventing AOM due to NTHi and its impact on NTHi nasopharyngeal carriage. Expert commentary: Protein D is an effective carrier protein in conjugate vaccines and evidence gathered from pre-clinical, clinical and observational studies suggest that it also elicits immune response that can help to reduce the burden of AOM due to NTHi. There remains a need to develop improved vaccines for prevention of NTHi disease, which could be achieved by combining protein D with other antigens.

  15. The Role of Three-Dimensional Scaffolds in Treating Long Bone Defects: Evidence from Preclinical and Clinical Literature-A Systematic Review.

    PubMed

    Roffi, Alice; Krishnakumar, Gopal Shankar; Gostynska, Natalia; Kon, Elizaveta; Candrian, Christian; Filardo, Giuseppe

    2017-01-01

    Long bone defects represent a clinical challenge. Bone tissue engineering (BTE) has been developed to overcome problems associated with conventional methods. The aim of this study was to assess the BTE strategies available in preclinical and clinical settings and the current evidence supporting this approach. A systematic literature screening was performed on PubMed database, searching for both preclinical (only on large animals) and clinical studies. The following string was used: "(Scaffold OR Implant) AND (Long bone defect OR segmental bone defect OR large bone defect OR bone loss defect)." The search retrieved a total of 1573 articles: 51 preclinical and 4 clinical studies were included. The great amount of preclinical papers published over the past few years showed promising findings in terms of radiological and histological evidence. Unfortunately, this in vivo situation is not reflected by a corresponding clinical impact, with few published papers, highly heterogeneous and with small patient populations. Several aspects should be further investigated to translate positive preclinical findings into clinical protocols: the identification of the best biomaterial, with both biological and biomechanical suitable properties, and the selection of the best choice between cells, GFs, or their combination through standardized models to be validated by randomized trials.

  16. Closing the gap between knowledge and clinical application: challenges for genomic translation.

    PubMed

    Burke, Wylie; Korngiebel, Diane M

    2015-01-01

    Despite early predictions and rapid progress in research, the introduction of personal genomics into clinical practice has been slow. Several factors contribute to this translational gap between knowledge and clinical application. The evidence available to support genetic test use is often limited, and implementation of new testing programs can be challenging. In addition, the heterogeneity of genomic risk information points to the need for strategies to select and deliver the information most appropriate for particular clinical needs. Accomplishing these tasks also requires recognition that some expectations for personal genomics are unrealistic, notably expectations concerning the clinical utility of genomic risk assessment for common complex diseases. Efforts are needed to improve the body of evidence addressing clinical outcomes for genomics, apply implementation science to personal genomics, and develop realistic goals for genomic risk assessment. In addition, translational research should emphasize the broader benefits of genomic knowledge, including applications of genomic research that provide clinical benefit outside the context of personal genomic risk.

  17. Developing Medications Targeting Glutamatergic Dysfunction in Autism: Progress to Date

    PubMed Central

    Fung, Lawrence K.; Hardan, Antonio Y.

    2015-01-01

    Pharmacologic treatments targeting specific molecular mechanisms relevant for autism spectrum disorder (ASD) are beginning to emerge in early drug development. This article reviews the evidence for the disruption of glutamatergic neurotransmission in animal models of social deficits and summarizes key pre-clinical and clinical efforts in developing pharmacologic interventions based on modulation of glutamatergic systems in individuals with ASD. Understanding the pathobiology of the glutamatergic system has led to the development of new investigational treatments for individuals with ASD. Specific examples of medications that modulate the glutamatergic system in preclinical and clinical studies are described. Finally, we will discuss the limitations of current strategies and future opportunities in developing medications targeting the glutamatergic system for treating individuals with ASD. PMID:26104862

  18. Health level 7 development framework for medication administration.

    PubMed

    Kim, Hwa Sun; Cho, Hune

    2009-01-01

    We propose the creation of a standard data model for medication administration activities through the development of a clinical document architecture using the Health Level 7 Development Framework process based on an object-oriented analysis and the development method of Health Level 7 Version 3. Medication administration is the most common activity performed by clinical professionals in healthcare settings. A standardized information model and structured hospital information system are necessary to achieve evidence-based clinical activities. A virtual scenario is used to demonstrate the proposed method of administering medication. We used the Health Level 7 Development Framework and other tools to create the clinical document architecture, which allowed us to illustrate each step of the Health Level 7 Development Framework in the administration of medication. We generated an information model of the medication administration process as one clinical activity. It should become a fundamental conceptual model for understanding international-standard methodology by healthcare professionals and nursing practitioners with the objective of modeling healthcare information systems.

  19. [The development of clinical guidelines for the diagnosis and treatment of chronic periodontitis in Belgium].

    PubMed

    Cosyn, Jan; De Bruyn, Hugo

    2008-01-01

    In many disciplines of medicine guidelines are developed for the diagnosis and treatment of disease. These are essentially intended to standardize care and to optimize communication between the general practitioner and the specialist. Guidelines have already been described in the literature for chronic periodontitis. However, given the unique conditions in Belgium, these may not be appropriate for the average dental practice. In this manuscript the development of Belgian clinical guidelines for the diagnosis and treatment of chronic periodontitis is described. Basically, ten clinical questions were used as a basis for a thorough literature search. Evidence-based clinical guidelines were developed and adapted during three peer review sessions. In the final session Belgian specialists, who had all been invited, participated. This made sure that the scientific input was sufficiently transformed into clinical guidelines which are actually feasible today in Belgium.

  20. How Can We Improve Outcomes for Patients and Families Under Palliative Care? Implementing Clinical Audit for Quality Improvement in Resource Limited Settings

    PubMed Central

    Selman, Lucy; Harding, Richard

    2010-01-01

    Palliative care in India has made enormous advances in providing better care for patients and families living with progressive disease, and many clinical services are well placed to begin quality improvement initiatives, including clinical audit. Clinical audit is recognized globally to be essential in all healthcare, as a way of monitoring and improving quality of care. However, it is not common in developing country settings, including India. Clinical audit is a cyclical activity involving: identification of areas of care in need of improvement, through data collection and analysis utilizing an appropriate questionnaire; setting measurable quality of care targets in specific areas; designing and implementing service improvement strategies; and then re-evaluating quality of care to assess progress towards meeting the targets. Outcome measurement is an important component of clinical audit that has additional advantages; for example, establishing an evidence base for the effectiveness of services. In resource limited contexts, outcome measurement in clinical audit is particularly important as it enables service development to be evidence-based and ensures resources are allocated effectively. Key success factors in conducting clinical audit are identified (shared ownership, training, managerial support, inclusion of all members of staff and a positive approach). The choice of outcome measurement tool is discussed, including the need for a culturally appropriate and validated measure which is brief and simple enough to incorporate into clinical practice and reflects the holistic nature of palliative care. Support for clinical audit is needed at a national level, and development and validation of an outcome measurement tool in the Indian context is a crucial next step. PMID:20859465

  1. Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project.

    PubMed

    Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Oude Rengerink, Katrien; Gee, Harry; Mol, Ben W J; Khan, Khalid S

    2009-09-10

    Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education.

  2. Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project

    PubMed Central

    Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Rengerink, Katrien Oude; Gee, Harry; Mol, Ben WJ; Khan, Khalid S

    2009-01-01

    Background Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. Methods We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. Results The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. Conclusion This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education. PMID:19744327

  3. Cultural Norms of Clinical Simulation in Undergraduate Nursing Education

    PubMed Central

    2015-01-01

    Simulated practice of clinical skills has occurred in skills laboratories for generations, and there is strong evidence to support high-fidelity clinical simulation as an effective tool for learning performance-based skills. What are less known are the processes within clinical simulation environments that facilitate the learning of socially bound and integrated components of nursing practice. Our purpose in this study was to ethnographically describe the situated learning within a simulation laboratory for baccalaureate nursing students within the western United States. We gathered and analyzed data from observations of simulation sessions as well as interviews with students and faculty to produce a rich contextualization of the relationships, beliefs, practices, environmental factors, and theoretical underpinnings encoded in cultural norms of the students’ situated practice within simulation. Our findings add to the evidence linking learning in simulation to the development of broad practice-based skills and clinical reasoning for undergraduate nursing students. PMID:28462300

  4. Exploring Nurse Manager Support of Evidence-Based Practice: Clinical Nurse Perceptions.

    PubMed

    Caramanica, Laura; Spiva, LeeAnna

    2018-05-01

    The study identifies what constitutes nurse manager (NM) support and other resources that enable clinical nurses (CNs) to engage in evidence-based practice (EBP). Clinical nurses report that NM support enables them to use EBP but what constitutes NM support is still unclear. Nurse managers, CNs, and EBP mentors received specialized education and use a team approach for EBP. Data were collected preintervention, mid-intervention, and postintervention from observations, interviews, journaling, and surveys. Results demonstrate how NMs can perform their role responsibilities and still engage CNs to develop a spirit of inquiry, seek answers to their clinical questions using EBP, and advance their clinical performance to improve patient outcomes. Four NM supportive behaviors emerged: cultivating a shared EBP vision, ensuring use of EBP, communicating the value of EBP, and providing resources for EBP. Through education and support, NMs describe supportive behaviors necessary for the successful conduction of EBP by CNs.

  5. Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research.

    PubMed

    Coyne, Elisabeth; Grafton, Eileen; Reid, Alayne

    2016-12-01

    Research conducted in the clinical area promotes the delivery of evidence-based patient care. Involving nurses as participants in research is considered essential to link patient care with evidence-based interventions. However recruitment is influenced by nurses' competing demands and understanding engagement strategies may assist future research. This reflective analysis aimed to understand influencing factors and strategies that support successful recruitment nurses in clinical research. A reflective analysis of research notes and focus group data from research with oncology nurses was completed. This research identified that gaining support from key staff, understanding work constraints and developing a rapport with nurses is important. Establishing clear relevance and benefits of the research and being flexible with research requirements enabled nurses to participate in the research. Clear information and a willingness to accommodate the demands and dynamic nature of the environment, ensures ongoing support and engagement of nurses in the clinical setting as participants in research.

  6. Root canal therapy for the prevention of osteonecrosis of the jaws: an evidence-based clinical update.

    PubMed

    Kyrgidis, Athanassios; Arora, Amit; Lyroudia, Kleoniki; Antoniades, Konstantinos

    2010-12-01

    Osteonecrosis of the jaws is an adverse effect of bone preservation treatment. There is a sufficient body of evidence to associate osteonecrosis of the jaws development with dental extractions and trauma caused from ill-fitting dentures. In this review, we critically appraise available evidence about the clinical efficacy of root canal therapy in patients receiving bisphosphonates.We review a series of theories to explain why endodontic treatment is a safe clinical intervention to prevent osteonecrosis of the jaws in patients receiving bisphosphonates. Root canal therapy could postpone or even eradicate the need for dental extractions of carious teeth in patients on bisphosphonates who may develop osteonecrosis of the jaws. Patients receiving bisphosphonates should be offered the full range of preventive care to reduce their risk to both dental caries and periodontal disease, so that the need for both endodontic therapy and dental extractions will be reduced. Implementing such a strategy would require both practitioner and patient education through the combined efforts of medical and dental societies. Such an approach is justified, as the risk of compromising the oral health of patients on bisphosphonates undertaking endodontic treatment is negligible compared with the benefit from avoiding dental extractions.

  7. Evidence appraisal: a scoping review, conceptual framework, and research agenda.

    PubMed

    Goldstein, Andrew; Venker, Eric; Weng, Chunhua

    2017-11-01

    Critical appraisal of clinical evidence promises to help prevent, detect, and address flaws related to study importance, ethics, validity, applicability, and reporting. These research issues are of growing concern. The purpose of this scoping review is to survey the current literature on evidence appraisal to develop a conceptual framework and an informatics research agenda. We conducted an iterative literature search of Medline for discussion or research on the critical appraisal of clinical evidence. After title and abstract review, 121 articles were included in the analysis. We performed qualitative thematic analysis to describe the evidence appraisal architecture and its issues and opportunities. From this analysis, we derived a conceptual framework and an informatics research agenda. We identified 68 themes in 10 categories. This analysis revealed that the practice of evidence appraisal is quite common but is rarely subjected to documentation, organization, validation, integration, or uptake. This is related to underdeveloped tools, scant incentives, and insufficient acquisition of appraisal data and transformation of the data into usable knowledge. The gaps in acquiring appraisal data, transforming the data into actionable information and knowledge, and ensuring its dissemination and adoption can be addressed with proven informatics approaches. Evidence appraisal faces several challenges, but implementing an informatics research agenda would likely help realize the potential of evidence appraisal for improving the rigor and value of clinical evidence. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  8. A prototype system to support evidence-based practice.

    PubMed

    Demner-Fushman, Dina; Seckman, Charlotte; Fisher, Cheryl; Hauser, Susan E; Clayton, Jennifer; Thoma, George R

    2008-11-06

    Translating evidence into clinical practice is a complex process that depends on the availability of evidence, the environment into which the research evidence is translated, and the system that facilitates the translation. This paper presents InfoBot, a system designed for automatic delivery of patient-specific information from evidence-based resources. A prototype system has been implemented to support development of individualized patient care plans. The prototype explores possibilities to automatically extract patients problems from the interdisciplinary team notes and query evidence-based resources using the extracted terms. Using 4,335 de-identified interdisciplinary team notes for 525 patients, the system automatically extracted biomedical terminology from 4,219 notes and linked resources to 260 patient records. Sixty of those records (15 each for Pediatrics, Oncology & Hematology, Medical & Surgical, and Behavioral Health units) have been selected for an ongoing evaluation of the quality of automatically proactively delivered evidence and its usefulness in development of care plans.

  9. A Prototype System to Support Evidence-based Practice

    PubMed Central

    Demner-Fushman, Dina; Seckman, Charlotte; Fisher, Cheryl; Hauser, Susan E.; Clayton, Jennifer; Thoma, George R.

    2008-01-01

    Translating evidence into clinical practice is a complex process that depends on the availability of evidence, the environment into which the research evidence is translated, and the system that facilitates the translation. This paper presents InfoBot, a system designed for automatic delivery of patient-specific information from evidence-based resources. A prototype system has been implemented to support development of individualized patient care plans. The prototype explores possibilities to automatically extract patients’ problems from the interdisciplinary team notes and query evidence-based resources using the extracted terms. Using 4,335 de-identified interdisciplinary team notes for 525 patients, the system automatically extracted biomedical terminology from 4,219 notes and linked resources to 260 patient records. Sixty of those records (15 each for Pediatrics, Oncology & Hematology, Medical & Surgical, and Behavioral Health units) have been selected for an ongoing evaluation of the quality of automatically proactively delivered evidence and its usefulness in development of care plans. PMID:18998835

  10. [GRADE system: classification of quality of evidence and strength of recommendation].

    PubMed

    Aguayo-Albasini, José Luis; Flores-Pastor, Benito; Soria-Aledo, Víctor

    2014-02-01

    The acquisition and classification of scientific evidence, and subsequent formulation of recommendations constitute the basis for the development of clinical practice guidelines. There are several systems for the classification of evidence and strength of recommendations; the most commonly used nowadays is the Grading of Recommendations, Assessment, Development and Evaluation system (GRADE). The GRADE system initially classifies the evidence into high or low, coming from experimental or observational studies; subsequently and following a series of considerations, the evidence is classified into high, moderate, low or very low. The strength of recommendations is based not only on the quality of the evidence, but also on a series of factors such as the risk/benefit balance, values and preferences of the patients and professionals, and the use of resources or costs. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  11. Research as a standard of care in PICU

    PubMed Central

    Zimmerman, Jerry J.; Anand, Kanwaljeet J. S.; Meert, Kathleen L.; Willson, Douglas F.; Newth, Christopher J. L.; Harrison, Rick; Carcillo, Joseph A.; Berger, John; Jenkins, Tammara L.; Nicholson, Carol; Dean, J. Michael

    2016-01-01

    Background Excellence in clinical care coupled with basic and applied research reflects the maturation of a medical subspecialty, advances that field, and provides objective data for identifying best practices. Pediatric intensive care units (PICU) are uniquely suited for conducting translational and clinical research. Moreover, multiple investigations have reported that a majority of parents are interested in their children’s participation in clinical research, even when the research offers no direct benefit to their child. However, such activity may generate ethical conflict with bedside care providers trying to acutely identify the best approach for an individual critically ill child. Ultimately, this conflict may diminish enthusiasm for the generation of scientific evidence that supports application of evidence-based medicine into PICU clinical standard work. Objective Provide an overview of current state PICU clinical research strengths, liabilities, opportunities, and barriers, and contrast this with an established pediatric hematology-oncology iterative research model that constitutes a learning healthcare system. Design Narrative review of medical literature published in English. Conclusions Currently most PICU therapy is not evidence-based. Developing a learning healthcare system in the PICU integrates clinical research into usual practice and fosters a culture of evidence-based learning and continual care improvement. As PICU mortality has significantly decreased, identification and validation of patient-centered, clinically relevant research outcome measures other than mortality is essential for future clinical trial design. Because most pediatric critical illness may be classified as rare diseases, participation in research networks will facilitate iterative, collaborative, multi-institutional investigations that over time identify best practices to improve PICU outcomes. Despite real ethical challenges, critically ill children and their families should have the opportunity to participate in translational/clinical research whenever feasible. PMID:26513203

  12. Clinical leadership in contemporary clinical practice: implications for nursing in Australia.

    PubMed

    Davidson, P M; Elliott, D; Daly, J

    2006-04-01

    Leadership in the clinical practice environment is important to ensure both optimal patient outcomes and successive generations of motivated and enthusiastic clinicians. The present paper seeks to define and describe clinical leadership and identify the facilitators and barriers to clinical leadership. We also describe strategies to develop clinical leaders in Australia. Key drivers to the development of nursing leaders are strategies that recognize and value clinical expertise. These include models of care that highlight the importance of the nursing role; evidence-based practice and measurement of clinical outcomes; strategies to empower clinicians and mechanisms to ensure participation in clinical decision-making. Significant barriers to clinical leadership are organizational structures that preclude nurses from clinical decision making; the national shortage of nurses; fiscal constraints; absence of well evaluated models of care and trends towards less skilled clinicians. Systematic, strategic initiatives are required to nurture and develop clinical leaders. These strategies need to be collegial collaborations between the academic and health care sectors in order to provide a united voice for advancing the nursing profession.

  13. Promoting Tobacco Use Cessation for Lesbian, Gay, Bisexual, and Transgender People

    PubMed Central

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

    2014-01-01

    Context Lesbian, gay, bisexual, and transgender (LGBT) people are at increased risk for the adverse effects of tobacco use given their high prevalence of use, especially smoking. Evidence regarding cessation is limited. To determine if efficacious interventions are available and to aid the development of interventions, a systematic review was conducted of gray and peer-reviewed literature describing clinical, community, and policy interventions as well as knowledge, attitudes, and behaviors regarding tobacco use cessation among LGBT people. Evidence acquisition Eight databases for articles from 1987 to April 23, 2014 were searched. In February–November 2013, authors and researchers were contacted to identify gray literature. Evidence synthesis The search identified 57 records, of which 51 were relevant and 22 were from the gray literature; these were abstracted into evidence tables, and a narrative synthesis was conducted in October–May 2014. Group cessation curricula tailored for LGBT populations were found feasible to implement and show evidence of effectiveness. Community interventions have been implemented by and for LGBT communities; although these interventions showed feasibility, no rigorous outcome evaluations exist. Clinical interventions show little difference between LGBT and heterosexual people. Focus groups suggest that care is needed in selecting messaging used in media campaigns. Conclusions LGBT-serving organizations should implement existing evidence-based tobacco dependence treatment and clinical systems to support treatment of tobacco use. A clear commitment from government and funders is needed to investigate whether sexual orientation and gender identity moderate the impacts of policy interventions, media campaigns, and clinical interventions. PMID:25455123

  14. Assessing young children's intention-reading in authentic communicative contexts: preliminary evidence and clinical utility.

    PubMed

    Greenslade, Kathryn J; Coggins, Truman E

    2014-01-01

    Identifying what a communication partner is looking at (referential intention) and why (social intention) is essential to successful social communication, and may be challenging for children with social communication deficits. This study explores a clinical task that assesses these intention-reading abilities within an authentic context. To gather evidence of the task's reliability and validity, and to discuss its clinical utility. The intention-reading task was administered to twenty 4-7-year-olds with typical development (TD) and ten with autism spectrum disorder (ASD). Task items were embedded in an authentic activity, and they targeted the child's ability to identify the examiner's referential and social intentions, which were communicated through joint attention behaviours. Reliability and construct validity evidence were addressed using established psychometric methods. Reliability and validity evidence supported the use of task scores for identifying children whose intention-reading warranted concern. Evidence supported the reliability of task administration and coding, and item-level codes were highly consistent with overall task performance. Supporting task validity, group differences aligned with predictions, with children with ASD exhibiting poorer and more variable task scores than children with TD. Also, as predicted, task scores correlated significantly with verbal mental age and ratings of parental concerns regarding social communication abilities. The evidence provides preliminary support for the reliability and validity of the clinical task's scores in assessing young children's real-time intention-reading abilities, which are essential for successful interactions in school and beyond. © 2014 Royal College of Speech and Language Therapists.

  15. 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.

  16. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: screening and diagnosis recommendations.

    PubMed

    Mehta, S; Guy, S D; Bryce, T N; Craven, B C; Finnerup, N B; Hitzig, S L; Orenczuk, S; Siddall, P J; Widerström-Noga, E; Casalino, A; Côté, I; Harvey, D; Kras-Dupuis, A; Lau, B; Middleton, J W; Moulin, D E; O'Connell, C; Parrent, A G; Potter, P; Short, C; Teasell, R; Townson, A; Truchon, C; Wolfe, D; Bradbury, C L; Loh, E

    2016-08-01

    Clinical practice guidelines. To develop the first Canadian clinical practice guidelines for screening and diagnosis of neuropathic pain in people with spinal cord injury (SCI). The guidelines are relevant for inpatient and outpatient SCI rehabilitation settings in Canada. The CanPainSCI Working Group reviewed evidence to address clinical questions regarding screening and diagnosis of neuropathic pain after SCI. A consensus process was followed to achieve agreement on recommendations and clinical considerations. Twelve recommendations, based on expert consensus, were developed for the screening and diagnosis of neuropathic pain after SCI. The recommendations address methods for assessment, documentation tools, team member accountability, frequency of screening and considerations for diagnostic investigation. Important clinical considerations accompany each recommendation. The expert Working Group developed recommendations for the screening and diagnosis of neuropathic pain after SCI that should be used to inform practice.

  17. Is High Fidelity Simulation the Most Effective Method for the Development of Non-Technical Skills in Nursing? A Review of the Current Evidence

    PubMed Central

    Lewis, Robin; Strachan, Alasdair; Smith, Michelle McKenzie

    2012-01-01

    Aim: To review the literature on the use of simulation in the development of non-technical skills in nursing Background: The potential risks to patients associated with learning 'at the bedside' are becoming increasingly unacceptable, and the search for innovative education and training methods that do not expose the patient to preventable errors continues. All the evidence shows that a significant proportion of adverse events in health care is caused by problems relating to the application of the 'non-technical' skills of communication, teamwork, leadership and decision-making. Results: Simulation is positively associated with significantly improved interpersonal communication skills at patient handover, and it has also been clearly shown to improve team behaviours in a wide variety of clinical contexts and clinical personnel, associated with improved team performance in the management of crisis situations. It also enables the effective development of transferable, transformational leadership skills, and has also been demonstrated to improve students' critical thinking and clinical reasoning in complex care situations, and to aid in the development of students' self-efficacy and confidence in their own clinical abilities. Conclusion: High fidelity simulation is able to provide participants with a learning environment in which to develop non-technical skills, that is safe and controlled so that the participants are able to make mistakes, correct those mistakes in real time and learn from them, without fear of compromising patient safety. Participants in simulation are also able to rehearse the clinical management of rare, complex or crisis situations in a valid representation of clinical practice, before practising on patients. PMID:22893783

  18. Undergraduate Health Students' Intention to Use Evidence-Based Practice After Graduation: A Systematic Review of Predictive Modeling Studies.

    PubMed

    Ramis, Mary-Anne; Chang, Anne; Nissen, Lisa

    2018-04-01

    Incorporating evidence-based practice (EBP) into clinical decision making and professional practice is a requirement for many health disciplines, yet research across health disciplines on factors that influence and predict student intention to use EBP following graduation has not been previously synthesized. To synthesize research on factors that influence development of EBP behaviors and subsequently predict undergraduate students' intention toward EBP uptake. A systematic review of prediction modeling studies was conducted according to a protocol previously published on the Prospero database: https://www.crd.york.ac.uk/PROSPERO/. The outcome variable was undergraduate students' future use or intention to use EBP. Evidence synthesis methods were guided by resources from the Cochrane Methods Prognosis Group Web site (https://prognosismethods.cochrane.org). Only three studies were found to meet inclusion criteria for the review. Factors relating to EBP capability, EBP attitudes, as well as clinical and academic support were identified as influential toward students' intention to use evidence in practice. Heterogeneity limited data pooling, consequently, results are presented in narrative and tabular form. Although using a developing method, this review presents a unique contribution to further discussions regarding students' intention to use EBP following graduation. Despite limitations, consideration of identified factors for undergraduate curriculum could support student's intention to use EBP in their respective clinical environments. © 2017 Sigma Theta Tau International.

  19. Decreased zinc in the development and progression of malignancy: an important common relationship and potential for prevention and treatment of carcinomas

    PubMed Central

    Costello, Leslie C.; Franklin, Renty B.

    2016-01-01

    Introduction Efficacious chemotherapy does not exist for treatment or prevention of prostate, liver, and pancreatic carcinomas, and some other cancers that exhibit decreased zinc in malignancy. Zinc treatment offers a potential solution; but its support has been deterred by adverse bias. Areas covered 1. The clinical and experimental evidence for the common ZIP transporter/Zn down regulation in these cancers. 2. The evidence for a zinc approach to prevent and/or treat these carcinomas. 3. The issues that introduce bias against support for the zinc approach. Expert opinion ZIP/Zn downregulation is a clinically established common event in prostate, hepatocellular and pancreatic cancers. 2. Compelling evidence supports the plausibility that a zinc treatment regimen will prevent development of malignancy and termination of progressing malignancy in these cancers; and likely other carcinomas that exhibit decreased zinc. 3. Scientifically-unfounded issues that oppose this ZIP/Zn relationship have introduced bias against support for research and funding of a zinc treatment approach. 4. The clinically-established and supporting experimental evidence provide the scientific credibility that should dictate the support for research and funding of a zinc approach for the treatment and possible prevention of these cancers. 5. This is in the best interest of the medical community and the public-at-large. PMID:27885880

  20. [Handbook for the preparation of evidence-based documents. Tools derived from scientific knowledge].

    PubMed

    Carrión-Camacho, M R; Martínez-Brocca, M A; Paneque-Sánchez-Toscano, I; Valencia-Martín, R; Palomino-García, A; Muñoz-Durán, C; Tamayo-López, M J; González-Eiris-Delgado, C; Otero-Candelera, R; Ortega-Ruiz, F; Sobrino-Márquez, J M; Jiménez-García-Bóveda, R; Fernández-Quero, M; Campos-Pareja, A M

    2013-01-01

    This handbook is intended to be an accessible, easy-to-consult guide to help professionals produce or adapt Evidence-Based Documents. Such documents will help standardize both clinical practice and decision-making, the quality always being monitored in such a way that established references are complied with. Evidence-Based Health Care Committee, a member of "Virgen del Rocío" University Hospital quality structure, proposed the preparation of a handbook to produce Evidence-Based Documents including: a description of products, characteristics, qualities, uses, methodology of production, and application scope of every one of them. The handbook consists of seven Evidence-Based tools, one chapter on critical analysis methodology of scientific literature, one chapter with internet resources, and some appendices with different assessment tools. This Handbook provides general practitioners with a great opportunity to improve quality and as a guideline to standardize clinical healthcare, and managers with a strategy to promote and encourage the development of documents in an effort to reduce clinical practice variability, as well as giving patients the opportunity of taking part in planning their own care. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

  1. The nature of the association between childhood ADHD and the development of bipolar disorder: a review of prospective high-risk studies.

    PubMed

    Duffy, Anne

    2012-12-01

    The author reviewed prospective longitudinal studies of the offspring of parents with bipolar disorder to inform our understanding of the nature of the association between childhood ADHD and the risk of developing bipolar disorder in adolescence and young adulthood. A literature review of published prospective cohort studies of the offspring of bipolar parents since 1985 was undertaken using a comprehensive search strategy in several electronic databases. The author provides a qualitative synthesis of results focusing on ADHD and the association with bipolar disorder in prospectively assessed high-risk offspring. These results are discussed in light of findings from other prospective epidemiological and clinical cohort studies. From the reviewed high-risk studies, evidence suggests that the clinical diagnosis of childhood ADHD is not a reliable predictor of the development of bipolar disorder. However, the author found evidence that symptoms of inattention may be part of a mixed clinical presentation during the early stages of evolving bipolar disorder in high-risk offspring, appearing alongside anxiety and depressive symptoms. The author also found preliminary evidence that childhood ADHD may form part of a neurodevelopmental phenotype in offspring at risk for developing a subtype of bipolar disorder unresponsive to lithium stabilization. While childhood ADHD does not appear to be part of the typical developmental illness trajectory of bipolar disorder, subjective problems with attention can form part of the early course, while neurodevelopmental abnormalities may be antecedents in a subgroup of high-risk children.

  2. [Evidence and Evidence Gaps - an Introduction].

    PubMed

    Dreier, G; Löhler, J

    2016-04-01

    Treating patients requires the inclusion of existing evidence in any health care decision, to be able to choose the best diagnosis or treatment measure or to make valid prognosis statements for a particular patient in consideration of the physician's own expertise.The basis are clinical trials, the results of which are ideally gathered in systematic reviews, rated, summarized and published. In addition to the GCP (Good Clinical Practice)-compliant planning, conducting and analysis of clinical studies it is essential, that all study results are made publicly available, in order to avoid publication bias. This includes the public registration of planned and discontinued trials. In the last 25 years, the evidence-based medicine (EbM) has increasingly found its way into clinical practice and research. Here EbM is closely associated with the names Archibald Cochrane and David Sackett. In Germany, both the German Cochrane Centre (DCZ) and the network of evidence-based medicine (DNEbM) were established approximately 15 years ago. In the international Cochrane Collaboration clinicians and other scientists like statisticians interdisciplinary work side by side to develop the methods of evidence-based medicine and to address the topics of evidence generation and processing as well as the transfer of knowledge. Challenge: Existing evidence primarily serves doctors to support their decision-making, but is also the basis for providing scientific proof for a health care intervention's benefit to patients and ultimately payers/health insurances. The closure of existing evidence gaps requires substantial human and financial resources, a complex organizational structure and can only succeed with the involvement of clinical and methodological expertise and specific knowledge in the field of clinical research. In addition, the knowledge must be transferred into practice, using journals, guidelines, conferences, databases, information portals with processed evidence and not least the medical education of students.One problem is the wealth of information, so that in clinical practice there may be gaps in knowledge of actual evidence. Usually it still takes several years until new knowledge is fully implemented in daily practice. The German Society of Otolaryngology, Head and Neck Surgery (DGHNOKHC) and the German professional association of otolaryngologists (BVHNO) have a vested interest in supporting their members in the generation, processing and dissemination of evidence, and to foster the transfer of knowledge into practice. This includes the areas of diagnosis, treatment, prognosis and prevention as well as drug therapies or the application of medical devices or surgical procedures. Crucial is the regular determination of existing evidence gaps, including in the area of already established procedures, which must be followed by a prioritization of research questions and subsequent conduct of clinical research. Only with combined efforts even large trials can be performed, to test therapies and diagnostics for example, also after approval under everyday conditions. Methods, Results and Vision: The executive committees of DGHNOKHC and BVHNO have together founded the German Clinical Trials Unit for Ear, Nose and Throat medicine, Head and Neck Surgery (DSZ-HNO) to assist their members in the identification of evidence gaps and the planning and conduct of systematic reviews and clinical trials. The first projects have been started, including a BMBF(German Ministry for education and research)-funded clinical trial for the treatment of sudden hearing loss and a survey to detect evidence gaps in Otolaryngology. It seems both reasonable and feasible to provide a structure such as a jointly-run study center for doctors in hospitals and medical practices to assist in clinical research and to anchor the principles of evidence-based medicine in daily life. © Georg Thieme Verlag KG Stuttgart · New York.

  3. Development and Validation of a Primary Care-Based Family Health History and Decision Support Program (MeTree)

    PubMed Central

    Orlando, Lori A.; Buchanan, Adam H.; Hahn, Susan E.; Christianson, Carol A.; Powell, Karen P.; Skinner, Celette Sugg; Chesnut, Blair; Blach, Colette; Due, Barbara; Ginsburg, Geoffrey S.; Henrich, Vincent C.

    2016-01-01

    INTRODUCTION Family health history is a strong predictor of disease risk. To reduce the morbidity and mortality of many chronic diseases, risk-stratified evidence-based guidelines strongly encourage the collection and synthesis of family health history to guide selection of primary prevention strategies. However, the collection and synthesis of such information is not well integrated into clinical practice. To address barriers to collection and use of family health histories, the Genomedical Connection developed and validated MeTree, a Web-based, patient-facing family health history collection and clinical decision support tool. MeTree is designed for integration into primary care practices as part of the genomic medicine model for primary care. METHODS We describe the guiding principles, operational characteristics, algorithm development, and coding used to develop MeTree. Validation was performed through stakeholder cognitive interviewing, a genetic counseling pilot program, and clinical practice pilot programs in 2 community-based primary care clinics. RESULTS Stakeholder feedback resulted in changes to MeTree’s interface and changes to the phrasing of clinical decision support documents. The pilot studies resulted in the identification and correction of coding errors and the reformatting of clinical decision support documents. MeTree’s strengths in comparison with other tools are its seamless integration into clinical practice and its provision of action-oriented recommendations guided by providers’ needs. LIMITATIONS The tool was validated in a small cohort. CONCLUSION MeTree can be integrated into primary care practices to help providers collect and synthesize family health history information from patients with the goal of improving adherence to risk-stratified evidence-based guidelines. PMID:24044145

  4. Guiding Principles and Checklist for Population-Based Quality Metrics

    PubMed Central

    Brunelli, Steven M.; Maddux, Franklin W.; Parker, Thomas F.; Johnson, Douglas; Nissenson, Allen R.; Collins, Allan; Lacson, Eduardo

    2014-01-01

    The Centers for Medicare and Medicaid Services oversees the ESRD Quality Incentive Program to ensure that the highest quality of health care is provided by outpatient dialysis facilities that treat patients with ESRD. To that end, Centers for Medicare and Medicaid Services uses clinical performance measures to evaluate quality of care under a pay-for-performance or value-based purchasing model. Now more than ever, the ESRD therapeutic area serves as the vanguard of health care delivery. By translating medical evidence into clinical performance measures, the ESRD Prospective Payment System became the first disease-specific sector using the pay-for-performance model. A major challenge for the creation and implementation of clinical performance measures is the adjustments that are necessary to transition from taking care of individual patients to managing the care of patient populations. The National Quality Forum and others have developed effective and appropriate population-based clinical performance measures quality metrics that can be aggregated at the physician, hospital, dialysis facility, nursing home, or surgery center level. Clinical performance measures considered for endorsement by the National Quality Forum are evaluated using five key criteria: evidence, performance gap, and priority (impact); reliability; validity; feasibility; and usability and use. We have developed a checklist of special considerations for clinical performance measure development according to these National Quality Forum criteria. Although the checklist is focused on ESRD, it could also have broad application to chronic disease states, where health care delivery organizations seek to enhance quality, safety, and efficiency of their services. Clinical performance measures are likely to become the norm for tracking performance for health care insurers. Thus, it is critical that the methodologies used to develop such metrics serve the payer and the provider and most importantly, reflect what represents the best care to improve patient outcomes. PMID:24558050

  5. Support of personalized medicine through risk-stratified treatment recommendations - an environmental scan of clinical practice guidelines

    PubMed Central

    2013-01-01

    Background Risk-stratified treatment recommendations facilitate treatment decision-making that balances patient-specific risks and preferences. It is unclear if and how such recommendations are developed in clinical practice guidelines (CPGs). Our aim was to assess if and how CPGs develop risk-stratified treatment recommendations for the prevention or treatment of common chronic diseases. Methods We searched the United States National Guideline Clearinghouse for US, Canadian and National Institute for Health and Clinical Excellence (United Kingdom) CPGs for heart disease, stroke, cancer, chronic obstructive pulmonary disease and diabetes that make risk-stratified treatment recommendations. We included only those CPGs that made risk-stratified treatment recommendations based on risk assessment tools. Two reviewers independently identified CPGs and extracted information on recommended risk assessment tools; type of evidence about treatment benefits and harms; methods for linking risk estimates to treatment evidence and for developing treatment thresholds; and consideration of patient preferences. Results We identified 20 CPGs that made risk-stratified treatment recommendations out of 133 CPGs that made any type of treatment recommendations for the chronic diseases considered in this study. Of the included 20 CPGs, 16 (80%) used evidence about treatment benefits from randomized controlled trials, meta-analyses or other guidelines, and the source of evidence was unclear in the remaining four (20%) CPGs. Nine CPGs (45%) used evidence on harms from randomized controlled trials or observational studies, while 11 CPGs (55%) did not clearly refer to harms. Nine CPGs (45%) explained how risk prediction and evidence about treatments effects were linked (for example, applying estimates of relative risk reductions to absolute risks), but only one CPG (5%) assessed benefit and harm quantitatively and three CPGs (15%) explicitly reported consideration of patient preferences. Conclusions Only a small proportion of CPGs for chronic diseases make risk-stratified treatment recommendations with a focus on heart disease and stroke prevention, diabetes and breast cancer. For most CPGs it is unclear how risk-stratified treatment recommendations were developed. As a consequence, it is uncertain if CPGs support patients and physicians in finding an acceptable benefit- harm balance that reflects both profile-specific outcome risks and preferences. PMID:23302096

  6. Impact of quality of evidence on the strength of recommendations: an empirical study

    PubMed Central

    Djulbegovic, Benjamin; Trikalinos, Thomas A; Roback, John; Chen, Ren; Guyatt, Gordon

    2009-01-01

    Background Evidence is necessary but not sufficient for decision-making, such as making recommendations by clinical practice guideline panels. However, the fundamental premise of evidence-based medicine (EBM) rests on the assumed link between the quality of evidence and "truth" and/or correctness in making guideline recommendations. If this assumption is accurate, then the quality of evidence ought to play a key role in making guideline recommendations. Surprisingly, and despite the widespread penetration of EBM in health care, there has been no empirical research to date investigating the impact of quality of evidence on the strength of recommendations made by guidelines panels. Methods The American Association of Blood Banking (AABB) has recently convened a 12 member panel to develop clinical practice guidelines (CPG) for the use of fresh-frozen plasma (FFP) for 6 different clinical indications. The panel was instructed that 4 factors should play a role in making recommendation: quality of evidence, uncertainty about the balance between desirable (benefits) and undesirable effects (harms), uncertainty or variability in values and preferences, and uncertainty about whether the intervention represents a wise use of resources (costs). Each member of the panel was asked to make his/her final judgments on the strength of recommendation and the overall quality of the body of evidence. "Voting" was anonymous and was based on the use of GRADE (Grading quality of evidence and strength of recommendations) system, which clearly distinguishes between quality of evidence and strength of recommendations. Results Despite the fact that many factors play role in formulating CPG recommendations, we show that when the quality of evidence is higher, the probability of making a strong recommendation for or against an intervention dramatically increases. Probability of making strong recommendation was 62% when evidence is "moderate", while it was only 23% and 13% when evidence was "low" or "very low", respectively. Conclusion We report the first empirical evaluation of the relationship between quality of evidence pertinent to a clinical question and strength of the corresponding guideline recommendations. Understanding the relationship between quality of evidence and probability of making (strong) recommendation has profound implications for the science of quality measurement in health care. PMID:19622148

  7. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation

    ERIC Educational Resources Information Center

    Al Khalaileh, Murad; Al Qadire, Mohammad; Musa, Ahmad S.; Al-Khawaldeh, Omar A.; Al Qudah, Hani; Alhabahbeh, Atalla

    2016-01-01

    Background: The nursing profession is a combination of theory and practical skill, and nurses are required to generate and develop knowledge through implementing research into clinical practice. Considerable number of barriers could hind implementing research findings into practice. Barriers to research utilisation are not identified in the…

  8. Appropriate Use Criteria for Amyloid PET

    PubMed Central

    Johnson, Keith A.; Minoshima, Satoshi; Bohnen, Nicolaas I.; Donohoe, Kevin J.; Foster, Norman L.; Herscovitch, Peter; Karlawish, Jason H.; Rowe, Christopher C.; Carrillo, Maria C.; Hartley, Dean M.; Hedrick, Saima; Mitchell, Kristi; Pappas, Virginia; Thies, William H.

    2013-01-01

    Positron Emission Tomography (PET) of brain amyloid-beta is a technology that is becoming more available, but its clinical utility in medical practice requires careful definition. In order to provide guidance to dementia care practitioners, patients and caregivers, the Alzheimer Association and the Society of Nuclear Medicine and Molecular Imaging convened the Amyloid Imaging Taskforce (AIT). The AIT considered a broad range of specific clinical scenarios in which amyloid PET could potentially be appropriately used. Peer-reviewed, published literature was searched to ascertain available evidence relevant to these scenarios, and the AIT developed a consensus of expert opinion. While empirical evidence of impact on clinical outcomes is not yet available, a set of specific Appropriate Use Criteria (AUC) were agreed upon that define the types of patients and clinical circumstances in which amyloid PET could be used. Both appropriate and inappropriate uses were considered and formulated, and are reported and discussed here. Because both dementia care and amyloid PET technology are in active development, these AUC will require periodic reassessment. Future research directions are also outlined, including diagnostic utility and patient-centered outcomes. PMID:23360977

  9. Development and implementation of clinical algorithms in occupational health practice.

    PubMed

    Ghafur, Imran; Lalloo, Drushca; Macdonald, Ewan B; Menon, Manju

    2013-12-01

    Occupational health (OH) practice is framed by legal, ethical, and regulatory requirements. Integrating this information into daily practice can be a difficult task. We devised evidence-based framework standards of good practice that would aid clinical management, and assessed their impact. The clinical algorithm was the method deemed most appropriate to our needs. Using "the first OH consultation" as an example, the development, implementation, and evaluation of an algorithm is described. The first OH consultation algorithm was developed. Evaluation demonstrated an overall improvement in recording of information, specifically consent, recreational drug history, function, and review arrangements. Clinical algorithms can be a method for assimilating and succinctly presenting the various facets of OH practice, for use by all OH clinicians as a practical guide and as a way of improving quality in clinical record-keeping.

  10. Maraviroc: the evidence for its potential in the management of HIV

    PubMed Central

    Profit, Louise

    2007-01-01

    Introduction: New antiretroviral agents that are more convenient, better tolerated with fewer short- and long-term side effects, and that have novel resistance patterns are needed at all lines of therapy in patients infected with human immunodeficiency virus (HIV). Therefore, next generation products of current classes and alternative classes of antiretroviral agents are needed. The CC-chemokine receptor 5 (CCR5) antagonists are a novel class of antiretroviral agents that prevent the entry of HIV into host cells by blocking the CCR5 coreceptor. Within this class, maraviroc is the agent furthest along in development. Aims: The aim of this review is to evaluate the emerging evidence for the use of the CCR5 antagonist maraviroc in antiretroviral treatment-naïve and treatment-experienced patients with HIV-1 infection. Evidence review: Preliminary evidence from phase I/IIa short-term studies suggest that maraviroc monotherapy is effective at reducing HIV viral load, and is generally well tolerated. In-vitro evidence suggests that maraviroc will be effective in drug-naïve patients with CCR5-tropic virus, as well as in those with CCR5-tropic virus who have developed HIV resistance to existing antiretroviral regimens. However, it is not known how quickly resistance may develop to maraviroc in clinical practice. Clinical potential: Current evidence supports the continued development of maraviroc as a potentially useful, alternative treatment for the management of HIV infection. Maraviroc monotherapy has a high potency and long half-life, allowing single-pill dosing. Therefore, it is expected that maraviroc will have a beneficial effect on patient adherence and viral load in combination with other antiretroviral agents. Maraviroc is only effective against CCR5-tropic virus, which predominates throughout infection but is more common in patients at the early asymptomatic stage of infection. PMID:21221194

  11. Lost in translation: neuropsychiatric drug development.

    PubMed

    Becker, Robert E; Greig, Nigel H

    2010-12-08

    Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.

  12. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff.

    PubMed

    Gameiro, S; Boivin, J; Dancet, E; de Klerk, C; Emery, M; Lewis-Jones, C; Thorn, P; Van den Broeck, U; Venetis, C; Verhaak, C M; Wischmann, T; Vermeulen, N

    2015-11-01

    Based on the best available evidence in the literature, what is the optimal management of routine psychosocial care at infertility and medically assisted reproduction (MAR) clinics? Using the structured methodology of the Manual for the European Society of Human Reproduction and Embryology (ESHRE) Guideline Development, 120 recommendations were formulated that answered the 12 key questions on optimal management of routine psychosocial care by all fertility staff. The 2002 ESHRE Guidelines for counselling in infertility has been a reference point for best psychosocial care in infertility for years, but this guideline needed updating and did not focus on routine psychosocial care that can be delivered by all fertility staff. This guideline was produced by a group of experts in the field according to the 12-step process described in the ESHRE Manual for Guideline Development. After scoping the guideline and listing a set of 12 key questions in PICO (Patient, Intervention, Comparison and Outcome) format, thorough systematic searches of the literature were conducted; evidence from papers published until April 2014 was collected, evaluated for quality and analysed. A summary of evidence was written in a reply to each of the key questions and used as the basis for recommendations, which were defined by consensus within the guideline development group (GDG). Patient and additional clinical input was collected during the scoping and the review phase of the guideline development. The guideline group, comprising psychologists, two medical doctors, a midwife, a patient representative and a methodological expert, met three times to discuss evidence and reach consensus on the recommendations. 120 recommendations that aim at guiding fertility clinic staff in providing optimal evidence-based routine psychosocial care to patients dealing with infertility and MAR. The guideline is written in two sections. The first section describes patients' preferences regarding the psychosocial care they would like to receive at clinics and how this care is associated with their well-being. The second section of the guideline provides information about the psychosocial needs patients experience across their treatment pathway (before, during and after treatment) and how fertility clinic staff can detect and address these. Needs refer to conditions assumed necessary for patients to have a healthy experience of the fertility treatment. Needs can be behavioural (lifestyle, exercise, nutrition and compliance), relational (relationship with partner if there is one, family friends and larger network, and work), emotional (well-being, e.g. anxiety, depression and quality of life) and cognitive (treatment concerns and knowledge). We identified many areas in care for which robust evidence was lacking. Gaps in evidence were addressed by formulating good practice points, based on the expert opinion of the GDG, but it is critical for such recommendations to be empirically validated. The evidence presented in this guideline shows that providing routine psychosocial care is associated with or has potential to reduce stress and concerns about medical procedures and improve lifestyle outcomes, fertility-related knowledge, patient well-being and compliance with treatment. As only 45 (36.0%) of the 125 recommendations were based on high-quality evidence, the guideline group formulated recommendations to guide future research with the aim of increasing the body of evidence. © The Author 2015. 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.

  13. The dynamic development of gender variability.

    PubMed

    Fausto-Sterling, Anne

    2012-01-01

    We diagram and discuss theories of gender identity development espoused by the clinical groups represented in this special issue. We contend that theories of origin relate importantly to clinical practice, and argue that the existing clinical theories are under-developed. Therefore, we develop a dynamic systems framework for gender identity development. Specifically, we suggest that critical aspects of presymbolic gender embodiment occur during infancy as part of the synchronous interplay of caregiver-infant dyads. By 18 months, a transition to symbolic representation and the beginning of an internalization of a sense of gender can be detected and consolidation is quite evident by 3 years of age. We conclude by suggesting empirical studies that could expand and test this framework. With the belief that better, more explicit developmental theory can improve clinical practice, we urge that clinicians take a dynamic developmental view of gender identity formation into account.

  14. Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline.

    PubMed

    Peters, Anne L; Ahmann, Andrew J; Battelino, Tadej; Evert, Alison; Hirsch, Irl B; Murad, M Hassan; Winter, William E; Wolpert, Howard

    2016-11-01

    To formulate clinical practice guidelines for the use of continuous glucose monitoring and continuous subcutaneous insulin infusion in adults with diabetes. The participants include an Endocrine Society-appointed Task Force of seven experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned one systematic review and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.

  15. Professional excellence and career advancement in nursing: a conceptual framework for clinical leadership development.

    PubMed

    Adeniran, Rita Kudirat; Bhattacharya, Anand; Adeniran, Anthony A

    2012-01-01

    Increasingly, stakeholders in the health care community are recognizing nursing as key to solving the nation's health care issues. This acknowledgment provides a unique opportunity for nursing to demonstrate leadership by developing clinical nurse leaders to collaborate with the multidisciplinary care team in driving evidence-based, safe quality, cost-effective health care services. One approach for nursing success is standardizing the entry-level education for nurses and developing a uniform professional development and career advancement trajectory with appropriate incentives to encourage participation. A framework to guide and provide scientific evidence of how frontline nurses can be engaged will be paramount. The model for professional excellence and career advancement provides a framework that offers a clear path for researchers to examine variables influencing nurses' professional development and career advancement in a systematic manner. Professional Excellence and Career Advancement in Nursing underscores professional preparedness of a registered nurse as central to leadership development. It also describes the elements that influence nurses' participation in professional development and career advancement under 4 main categories emphasizing mentorship and self-efficacy as essential variables.

  16. Challenges Involved in the Development and Delivery of Abuse-deterrent Formulations of Opioid Analgesics.

    PubMed

    Cohen, Joshua P; Mendoza, Mario; Roland, Carl

    2018-02-01

    This commentary examines the development, regulatory, and reimbursement challenges facing abuse-deterrent formulation (ADF) products. In January 2017, the Tufts Center for the Study of Drug Development convened a roundtable to explore clinical development, regulatory, and reimbursement challenges with respect to ADFs of opioid analgesics. Roundtable participants, who included a range of pharmaceutical industry and other experts, discussed multiple challenges. First, several key clinical development challenges were identified and discussed. These challenges pertain to prodrug development and development of deterrents against oral abuse. Second, experts suggested that more clarity is needed from regulatory authorities regarding standards for proving ADF labeling claims and for being rewarded with 3-year data exclusivity. Similarly, given the substantial burdens associated with the development of postapproval evidence generation, experts raised the need for a consistent regulatory policy related to postapproval evidence generation for all ADFs (branded and generic). Third, despite the public health benefits of certain ADF products, current coverage and access policies impede patient access. Payer justification for restrictive policies appears to be based more on budget impact considerations than cost-effectiveness. Fourth, there remains a need to further expand the evidence base regarding clinical and cost-effectiveness as well as abuse deterrence in a real-world setting for all ADF products. Clinical development challenges need to be overcome with respect to novel ADF technologies, such as prodrugs and deterrents against oral abuse. More clarity is needed from regulatory authorities on labeling claims and data exclusivity eligibility with respect to ADFs. Ensuring prescriber training and awareness of various options for treating pain, including ADF products, is an important step, as is educating payers about the public health benefits of ADFs in appropriate subpopulations of pain patients. In addition, physicians may need to incorporate appropriate risk stratification methods. Finally, it is important to establish a level playing field between coverage of ADF and non-ADF products so that non-ADF products are not given preferred formulary placement. Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.

  17. Towards evidence-based computational statistics: lessons from clinical research on the role and design of real-data benchmark studies.

    PubMed

    Boulesteix, Anne-Laure; Wilson, Rory; Hapfelmeier, Alexander

    2017-09-09

    The goal of medical research is to develop interventions that are in some sense superior, with respect to patient outcome, to interventions currently in use. Similarly, the goal of research in methodological computational statistics is to develop data analysis tools that are themselves superior to the existing tools. The methodology of the evaluation of medical interventions continues to be discussed extensively in the literature and it is now well accepted that medicine should be at least partly "evidence-based". Although we statisticians are convinced of the importance of unbiased, well-thought-out study designs and evidence-based approaches in the context of clinical research, we tend to ignore these principles when designing our own studies for evaluating statistical methods in the context of our methodological research. In this paper, we draw an analogy between clinical trials and real-data-based benchmarking experiments in methodological statistical science, with datasets playing the role of patients and methods playing the role of medical interventions. Through this analogy, we suggest directions for improvement in the design and interpretation of studies which use real data to evaluate statistical methods, in particular with respect to dataset inclusion criteria and the reduction of various forms of bias. More generally, we discuss the concept of "evidence-based" statistical research, its limitations and its impact on the design and interpretation of real-data-based benchmark experiments. We suggest that benchmark studies-a method of assessment of statistical methods using real-world datasets-might benefit from adopting (some) concepts from evidence-based medicine towards the goal of more evidence-based statistical research.

  18. Insights from a conference on implementing comparative effectiveness research through shared decision-making

    PubMed Central

    Politi, Mary C; Clayman, Marla L; Fagerlin, Angela; Studts, Jamie L; Montori, Victor

    2013-01-01

    For decades, investigators have conducted innovative research on shared decision-making (SDM), helping patients and clinicians to discuss health decisions and balance evidence with patients' preferences for possible outcomes of options. In addition, investigators have developed and used rigorous methods for conducting comparative effectiveness research (CER), comparing the benefits and risks of different interventions in real-world settings with outcomes that matter to patients and other stakeholders. However, incorporating CER findings into clinical practice presents numerous challenges. In March 2012, we organized a conference at Washington University in St Louis (MO, USA) aimed at developing a network of researchers to collaborate in developing, conducting and disseminating research about the implementation of CER through SDM. Meeting attendees discussed conceptual similarities and differences between CER and SDM, challenges in implementing CER and SDM in practice, specific challenges when engaging SDM with unique populations and examples of ways to overcome these challenges. CER and SDM are related processes that emphasize examining the best clinical evidence and how it applies to real patients in real practice settings. SDM can provide one opportunity for clinicians to discuss CER findings with patients and engage in a dialog about how to manage uncertainty about evidence in order to make decisions on an individual patient level. This meeting highlighted key challenges and suggested avenues to pursue such that CER and SDM can be implemented into routine clinical practice. PMID:23430243

  19. Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare.

    PubMed

    Dolan, James G

    2010-01-01

    Current models of healthcare quality recommend that patient management decisions be evidence-based and patient-centered. Evidence-based decisions require a thorough understanding of current information regarding the natural history of disease and the anticipated outcomes of different management options. Patient-centered decisions incorporate patient preferences, values, and unique personal circumstances into the decision making process and actively involve both patients along with health care providers as much as possible. Fundamentally, therefore, evidence-based, patient-centered decisions are multi-dimensional and typically involve multiple decision makers.Advances in the decision sciences have led to the development of a number of multiple criteria decision making methods. These multi-criteria methods are designed to help people make better choices when faced with complex decisions involving several dimensions. They are especially helpful when there is a need to combine "hard data" with subjective preferences, to make trade-offs between desired outcomes, and to involve multiple decision makers. Evidence-based, patient-centered clinical decision making has all of these characteristics. This close match suggests that clinical decision support systems based on multi-criteria decision making techniques have the potential to enable patients and providers to carry out the tasks required to implement evidence-based, patient-centered care effectively and efficiently in clinical settings.The goal of this paper is to give readers a general introduction to the range of multi-criteria methods available and show how they could be used to support clinical decision-making. Methods discussed include the balance sheet, the even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and the analytic hierarchy process (AHP).

  20. Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare

    PubMed Central

    Dolan, James G.

    2010-01-01

    Current models of healthcare quality recommend that patient management decisions be evidence-based and patient-centered. Evidence-based decisions require a thorough understanding of current information regarding the natural history of disease and the anticipated outcomes of different management options. Patient-centered decisions incorporate patient preferences, values, and unique personal circumstances into the decision making process and actively involve both patients along with health care providers as much as possible. Fundamentally, therefore, evidence-based, patient-centered decisions are multi-dimensional and typically involve multiple decision makers. Advances in the decision sciences have led to the development of a number of multiple criteria decision making methods. These multi-criteria methods are designed to help people make better choices when faced with complex decisions involving several dimensions. They are especially helpful when there is a need to combine “hard data” with subjective preferences, to make trade-offs between desired outcomes, and to involve multiple decision makers. Evidence-based, patient-centered clinical decision making has all of these characteristics. This close match suggests that clinical decision support systems based on multi-criteria decision making techniques have the potential to enable patients and providers to carry out the tasks required to implement evidence-based, patient-centered care effectively and efficiently in clinical settings. The goal of this paper is to give readers a general introduction to the range of multi-criteria methods available and show how they could be used to support clinical decision-making. Methods discussed include the balance sheet, the even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and the analytic hierarchy process (AHP) PMID:21394218

  1. Low back pain-related beliefs and likely practice behaviours among final-year cross-discipline health students.

    PubMed

    Briggs, A M; Slater, H; Smith, A J; Parkin-Smith, G F; Watkins, K; Chua, J

    2013-05-01

    Evidence points to clinicians' beliefs and practice behaviours related to low back pain (LBP), which are discordant with contemporary evidence. While interventions to align beliefs and behaviours with evidence among clinicians have demonstrated effectiveness, a more sustainable and cost-effective approach to positively developing workforce capacity in this area may be to target the emerging workforce. The aim of this study was to investigate beliefs and clinical recommendations for LBP, and their alignment to evidence, in Australian university allied health and medical students. Final-year students in chiropractic, medicine, occupational therapy, pharmacy and physiotherapy disciplines in three Western Australian universities responded to a survey. Demographic data, LBP-related beliefs data [modified Health Care Providers Pain and Impact Relationship Scale (HC-PAIRS) and the Back Pain Beliefs Questionnaire (BBQ)] and activity, rest and work clinical recommendations for an acute LBP clinical vignette were collected. Six hundred two students completed the survey (response rate 74.6%). Cross-discipline differences in beliefs and clinical recommendations were observed (p > 0.001). Physiotherapy and chiropractic students reported significantly more helpful beliefs compared with the other disciplines, while pharmacy students reported the least helpful beliefs. A greater proportion of chiropractic and physiotherapy students reported guideline-consistent recommendations compared with other disciplines. HC-PAIRS and BBQ scores were strongly associated with clinical recommendations, independent to the discipline of study and prior experience of LBP. Aligning cross-discipline university curricula with current evidence may provide an opportunity to facilitate translation of this evidence into practice with a focus on a consistent, cross-discipline approach to LBP management. © 2012 European Federation of International Association for the Study of Pain Chapters.

  2. [Big data from clinical routine].

    PubMed

    Mansmann, U

    2018-04-01

    Over the past 100 years, evidence-based medicine has undergone several fundamental changes. Through the field of physiology, medical doctors were introduced to the natural sciences. Since the late 1940s, randomized and epidemiological studies have come to provide the evidence for medical practice, which led to the emergence of clinical epidemiology as a new field in the medical sciences. Within the past few years, big data has become the driving force behind the vision for having a comprehensive set of health-related data which tracks individual healthcare histories and consequently that of large populations. The aim of this article is to discuss the implications of data-driven medicine, and to examine how it can find a place within clinical care. The EU-wide discussion on the development of data-driven medicine is presented. The following features and suggested actions were identified: harmonizing data formats, data processing and analysis, data exchange, related legal frameworks and ethical challenges. For the effective development of data-driven medicine, pilot projects need to be conducted to allow for open and transparent discussion on the advantages and challenges. The Federal Ministry of Education and Research ("Bundesministerium für Bildung und Forschung," BMBF) Arthromark project is an important example. Another example is the Medical Informatics Initiative of the BMBF. The digital revolution affects clinic practice. Data can be generated and stored in quantities that are almost unimaginable. It is possible to take advantage of this for development of a learning healthcare system if the principles of medical evidence generation are integrated into innovative IT-infrastructures and processes.

  3. Comorbidity of Deployment-Related Posttraumatic Disorders and Their Treatment with Cognitive-Behavioral Group

    DTIC Science & Technology

    2011-04-01

    traumatised soldiers will be presented in this article . Initial experiences with the group therapy program will be discussed. 15. SUBJECT TERMS 16...clinical impression and the SCID-II questionnaire (Structurel Clinical Interview for DSM-IV1) for personality disorders. 89% showed clinical evidence...group therapy, newly developed in Berlin, for traumatised soldiers will be presented in this article . Initial experiences with the group therapy program

  4. Risk factors for suicide in schizophrenia: systematic review and clinical recommendations.

    PubMed

    Popovic, D; Benabarre, A; Crespo, J M; Goikolea, J M; González-Pinto, A; Gutiérrez-Rojas, L; Montes, J M; Vieta, E

    2014-12-01

    To identify risk factors associated with suicide of patients with schizophrenia and provide clinical recommendations, which integrate research findings into a consensus based on clinical experience and evidence. A task force formed of experts and clinicians iteratively developed consensus through serial revisions using the Delphi method. Initial survey items were based on systematic literature review published up to June 2013. Various risk factors were reported to be implicated in suicide in schizophrenia. Our findings indicate that suicide risk in schizophrenia is mainly related to affective symptoms, history of a suicide attempt and number of psychiatric admissions. Other risk factors identified are given by younger age, closeness to illness onset, older age at illness onset, male sex, substance abuse and period during or following psychiatric discharge. Integrating the evidence and the experience of the task force members, a consensus was reached on 14 clinical recommendations. Identification of risk factors for suicide in individuals diagnosed with schizophrenia is imperative to improve clinical management and develop strategies to reduce the incidence of suicide in this population. This study provides the critical overview of available data and clinical recommendations on recognition and management of the above-mentioned risk factors. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. Concepts of Mental Disorders in Trainee Clinical Psychologists.

    PubMed

    Read, R; Moberly, N J; Salter, D; Broome, M R

    2017-03-01

    The models of mental disorders held by all mental health professionals are implicit in their attitudes and inform all aspects of theory and practice. The present study aims to explore the attitudes of trainee clinical psychologists towards mental disorders by building on a study conducted by Harland et al. () with psychiatrists. In so doing, the present study contributes to an evidence base that can inform the development of clinical training programs and multidisciplinary working. The Maudsley Attitude Questionnaire was administered in an online survey of trainee clinical psychologists (n = 289). Analyses of variance revealed main effects of model, and of diagnostic category, and a significant interaction effect between model and diagnostic category. Principal component analysis revealed a biological-psychosocial continuum and cognitive/behavioural and psychodynamic/spiritual dimensions. Comparisons with Harland et al.'s () psychiatrists revealed large differences, particularly in biological and social constructionist model endorsement. Results suggest that the attitudes of psychologists and psychiatrists continue to sit at opposite ends of a biological-psychosocial continuum. However, an area of consensus regarding psychotherapeutic models was indicated. Training courses can be reassured that strong opinions tended to reflect the evidence base. Future research with similarly large representative samples from different disciplines would allow findings of the current study to be better contextualized. Copyright © 2016 John Wiley & Sons, Ltd. The models of mental disorders held by clinical psychologists are implicit in their attitudes and inform all aspects of theory and practice. We found that trainee clinical psychologists continue to favour psychosocial over biological understandings of mental disorders, giving the cognitive, behavioural and psychodynamic models equal value overall, and stronger attitudes were supported by the evidence base. We found that trainee clinical psychologists organized their attitudes around a biological-psychosocial continuum and cognitive/behavioural and psychodynamic/spiritual dimensions. These findings may be useful for those involved in developing clinical training programs and multidisciplinary working because they provide an insight into the attitudes of emerging clinical psychologists. Copyright © 2016 John Wiley & Sons, Ltd.

  6. Integrating clinical and economic evidence in clinical guidelines: More needed than ever!

    PubMed

    Knies, Saskia; Severens, Johan L; Brouwer, Werner B F

    2018-04-26

    In recent years, several expensive new health technologies have been introduced. The availability of those technologies intensifies the discussion regarding the affordability of these technologies at different decision-making levels. On the meso level, both hospitals and clinicians are facing budget constraints resulting in a tension to balance between different patients' interests. As such, it is crucial to make optimal use of the available resources. Different strategies are in place to deal with this problem, but decisions on a macro level on what to fund or not can limit the role and freedom of clinicians in their decisions on a micro level. At the same time, without central guidance regarding such decisions, micro level decisions may lead to inequities and undesirable treatment variation between clinicians and hospitals. The challenge is to find instruments that can balance both levels of decision making. Clinicians are becoming increasingly aware that their decisions to spend more resources (like time and budget) on 1 particular patient group reduce the resources available to other patients. Involving clinicians in thinking about the optimal use of limited resources, also in an attempt to bridge the world of economic reasoning and clinical practice, is crucial therefore. We argue that clinical guidelines may prove a clear vehicle for this by including both clinical and economic evidence to support the recommendations made. The development of such guidelines requires cooperation of clinicians, and health economists are cooperating with each other. The development of clinical guidelines which combine economic and clinical evidence should be stimulated, to balance central guidance and uniformity while maintaining necessary decentralized freedom. This is an opportunity to combine the reality of budgets and opportunity costs with clinical practice. Missing this opportunity risks either variation and inequity or central and necessarily crude measures. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

  7. Dissemination Strategies: The Evolution of Learning Resources on the Evaluation of Delirium, Dementia, and Depression

    ERIC Educational Resources Information Center

    Horvath, Kathy J.; Tumosa, Nina; Thielke, Stephen; Moorer, Julie; Huh, Terri; Cooley, Susan; Craft, Suzanne; Burns, Theressa

    2011-01-01

    Clinicians experience great pressures to provide timely, effective, and evidence-based medical care. Educators can aid these clinicians through the development of new tools that can facilitate timely completion of clinical tasks. These tools should summarize evidence-based information in a convenient format that allows easy use. This article…

  8. The Technology of Evidence-Based Practice: Tools for Navigating the Health Sciences Literature

    ERIC Educational Resources Information Center

    Townsend, Whitney

    2011-01-01

    Medical and health sciences libraries have incorporated the elements of evidence-based practice (EBP) into their reference services, instruction, and online resource development for years. While EBP focuses on the use of medical and health sciences literature in the clinical environment (i.e., making decisions about how to treat a particular…

  9. The ABCs of managing systolic heart failure: Past, present, and future.

    PubMed

    Okwuosa, Ike Stanley; Princewill, Oluseyi; Nwabueze, Chiemeke; Mathews, Lena; Hsu, Steven; Gilotra, Nisha A; Lewsey, Sabra; Blumenthal, Roger S; Russell, Stuart D

    2016-10-01

    Heart failure management is complex and constantly evolving. The American College of Cardiology and the American Heart Association (ACC/AHA) last issued evidence-based guidelines in 2013, and since then, new drugs and devices have been developed. This review presents an evidence-based approach to current heart failure management. Copyright © 2016 Cleveland Clinic.

  10. Balancing health care evidence and art to meet clinical needs: policymakers' perspectives.

    PubMed

    Parker, Louise E; Ritchie, Mona J; Kirchner, Joann E; Owen, Richard R

    2009-12-01

    Rationale, aims and objectives Although many believe that evidence-based practice (EBP) has great potential, critics have identified limitations including a focus on randomized clinical trial (RCT) evidence to the exclusion of other evidence types and a disregard for the art of medicine. Others have argued, however, that proper application of EBP involves reasoned consideration of a wide variety of information; thus, the dichotomy between medical science and art may be false. We explore the views of executive-level policymakers from the Veterans Health Administration, a leader in the EBP movement, regarding what constitutes evidence and the relative importance of evidence versus practical needs when determining clinical policy. Method We conducted 26 semi-structured qualitative interviews and performed a content analysis. Results Although informants generally believed in the value of EBP and the role of RCTs within it, they also valued other types of evidence. Further, they had concerns that were sometimes antithetical with strict adherence to an evidence-based approach. These included practical concerns, fit with organizational values and with local circumstances, resources, political pressures and patient needs. They were especially concerned about how to address medical conditions that affect many individuals or high-risk populations that have no evidence-based treatment. Conclusion When possible, health care practice should be evidence-based. When this is not possible, health care providers must turn to the art of medicine by using consensus-based best practices. Further, it is important for policymakers and researchers to work in concert to develop EBPs that are practical and meet needs.

  11. Royal Australian and New Zealand College of Psychiatrists clinical practice guideline for the management of deliberate self-harm.

    PubMed

    Carter, Gregory; Page, Andrew; Large, Matthew; Hetrick, Sarah; Milner, Allison Joy; Bendit, Nick; Walton, Carla; Draper, Brian; Hazell, Philip; Fortune, Sarah; Burns, Jane; Patton, George; Lawrence, Mark; Dadd, Lawrence; Robinson, Jo; Christensen, Helen

    2016-10-01

    To provide guidance for the organisation and delivery of clinical services and the clinical management of patients who deliberately self-harm, based on scientific evidence supplemented by expert clinical consensus and expressed as recommendations. Articles and information were sourced from search engines including PubMed, EMBASE, MEDLINE and PsycINFO for several systematic reviews, which were supplemented by literature known to the deliberate self-harm working group, and from published systematic reviews and guidelines for deliberate self-harm. Information was reviewed by members of the deliberate self-harm working group, and findings were then formulated into consensus-based recommendations and clinical guidance. The guidelines were subjected to successive consultation and external review involving expert and clinical advisors, the public, key stakeholders, professional bodies and specialist groups with interest and expertise in deliberate self-harm. The Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for deliberate self-harm provide up-to-date guidance and advice regarding the management of deliberate self-harm patients, which is informed by evidence and clinical experience. The clinical practice guidelines for deliberate self-harm is intended for clinical use and service development by psychiatrists, psychologists, physicians and others with an interest in mental health care. The clinical practice guidelines for deliberate self-harm address self-harm within specific population sub-groups and provide up-to-date recommendations and guidance within an evidence-based framework, supplemented by expert clinical consensus. © The Royal Australian and New Zealand College of Psychiatrists 2016.

  12. Refining and validating a conceptual model of Clinical Nurse Leader integrated care delivery.

    PubMed

    Bender, Miriam; Williams, Marjory; Su, Wei; Hites, Lisle

    2017-02-01

    To empirically validate a conceptual model of Clinical Nurse Leader integrated care delivery. There is limited evidence of frontline care delivery models that consistently achieve quality patient outcomes. Clinical Nurse Leader integrated care delivery is a promising nursing model with a growing record of success. However, theoretical clarity is necessary to generate causal evidence of effectiveness. Sequential mixed methods. A preliminary Clinical Nurse Leader practice model was refined and survey items developed to correspond with model domains, using focus groups and a Delphi process with a multi-professional expert panel. The survey was administered in 2015 to clinicians and administrators involved in Clinical Nurse Leader initiatives. Confirmatory factor analysis and structural equation modelling were used to validate the measurement and model structure. Final sample n = 518. The model incorporates 13 components organized into five conceptual domains: 'Readiness for Clinical Nurse Leader integrated care delivery'; 'Structuring Clinical Nurse Leader integrated care delivery'; 'Clinical Nurse Leader Practice: Continuous Clinical Leadership'; 'Outcomes of Clinical Nurse Leader integrated care delivery'; and 'Value'. Sample data had good fit with specified model and two-level measurement structure. All hypothesized pathways were significant, with strong coefficients suggesting good fit between theorized and observed path relationships. The validated model articulates an explanatory pathway of Clinical Nurse Leader integrated care delivery, including Clinical Nurse Leader practices that result in improved care dynamics and patient outcomes. The validated model provides a basis for testing in practice to generate evidence that can be deployed across the healthcare spectrum. © 2016 John Wiley & Sons Ltd.

  13. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    PubMed

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  14. Oral mucositis: etiology, and clinical and pharmaceutical management.

    PubMed

    Zur, Eyal

    2012-01-01

    Oral mucosal damage is one of the common and worst side effects of radiotherapy and chemotherapy treatment for cancer. With prevalence between 10% and 100%, depending on the cytotoxic and/or radiotherapy regimen and patient-associated variables, this morbid condition represents a significant problem in oncology. This article addresses oral mucositis and discusses its prevalence, risk factors, clinical and economical impacts, etiology, and clinical management in view of the most recent evidence. Despite clear progress and the development of clinical guidelines on this topic, what we currently have to offer to patients to manage mucositis and oropharyngeal pain is still inadequate. This article offers two compounded preparations supported by evidence-based data to treat oral mucositis. Expansion of the knowledge of the pathogenesis of mucositis as well as a better insight into individual risk factors will provide opportunities to improve management strategies.

  15. Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention--convened meeting.

    PubMed

    Broussard, Cheryl S; Frey, Meghan T; Hernandez-Diaz, Sonia; Greene, Michael F; Chambers, Christina D; Sahin, Leyla; Collins Sharp, Beth A; Honein, Margaret A

    2014-09-01

    To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy. Published by Elsevier Inc.

  16. Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention—convened meeting

    PubMed Central

    Broussard, Cheryl S.; Frey, Meghan T.; Hernandez-Diaz, Sonia; Greene, Michael F.; Chambers, Christina D.; Sahin, Leyla; Collins Sharp, Beth A.; Honein, Margaret A.

    2015-01-01

    To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy. PMID:24881821

  17. Anatomy and history of an external quality assessment program for interpretative comments in clinical biochemistry.

    PubMed

    Vasikaran, Samuel D

    2015-05-01

    The provision of clinical interpretation of results, either verbally or in the printed report, may be considered an integral part of clinical biochemistry diagnostic service. Proficiency testing or external quality assessment (EQA) of such activity may be useful in education, training, continuing professional development and ensuring the quality of such service. Details of the Patient Report Comments Program (RPCProgram) developed by the Royal College of Pathologists of Australasia (RCPA) Chemical Pathology Quality Assurance Programs Pty Ltd (QAP) is described in this review. The program is aimed at pathologists, clinical scientists and trainees. Registered participants are provided a report with case details and a set of clinical biochemistry results at monthly intervals and submit an interpretative comment for the report. Comments received are broken up into components that are translated into common key phrases. An expert panel evaluates the key phrases, classifies them according to appropriateness and drafts a suggested comment, a case summary and a rationale, which are included in a summary report returned to participants. There is considerable diversity in the quality of interpretative comments received from participants of the PRCProgram. The primary purpose of EQA of interpretative commenting is educational self-assessment, and they are recognized as a continuing professional development activity. Whilst there is some evidence for the utility of interpretative comments in improving patient outcomes, evidence for the utility of EQA in improving quality of comments is awaited. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  18. The Brazilian consensus for the diagnosis and treatment of hyperthyroidism: recommendations by the Thyroid Department of the Brazilian Society of Endocrinology and Metabolism.

    PubMed

    Maia, Ana Luiza; Scheffel, Rafael S; Meyer, Erika Laurini Souza; Mazeto, Glaucia M F S; Carvalho, Gisah Amaral de; Graf, Hans; Vaisman, Mario; Maciel, Lea M Z; Ramos, Helton E; Tincani, Alfio José; Andrada, Nathalia Carvalho de; Ward, Laura S

    2013-04-01

    Hyperthyroidism is characterized by increased synthesis and release of thyroid hormones by the thyroid gland. Thyrotoxicosis refers to the clinical syndrome resulting from excessive circulating thyroid hormones, secondary to hyperthyroidism or due to other causes. This article describes evidence-based guidelines for the clinical management of thyrotoxicosis. This consensus, developed by Brazilian experts and sponsored by the Department of Thyroid Brazilian Society of Endocrinology and Metabolism, aims to address the management, diagnosis and treatment of patients with thyrotoxicosis, according to the most recent evidence from the literature and appropriate for the clinical reality of Brazil. After structuring clinical questions, search for evidence was made available in the literature, initially in the database MedLine, PubMed and Embase databases and subsequently in SciELO - Lilacs. The strength of evidence was evaluated by Oxford classification system was established from the study design used, considering the best available evidence for each question. We have defined 13 questions about the initial clinical approach for the diagnosis and treatment that resulted in 53 recommendations, including the etiology, treatment with antithyroid drugs, radioactive iodine and surgery. We also addressed hyperthyroidism in children, teenagers or pregnant patients, and management of hyperthyroidism in patients with Graves' ophthalmopathy and various other causes of thyrotoxicosis. The clinical diagnosis of hyperthyroidism usually offers no difficulty and should be made with measurements of serum TSH and thyroid hormones. The treatment can be performed with antithyroid drugs, surgery or administration of radioactive iodine according to the etiology of thyrotoxicosis, local availability of methods and preferences of the attending physician and patient.

  19. Clinical leadership and prevention in practice: is a needs led preventive approach to the delivery of care to improve quality, outcomes and value in primary dental care practice a realistic concept?

    PubMed Central

    2015-01-01

    Background There is a need to improve access to, and the quality of, service delivery in NHS primary dental care. Building public health thinking and leadership capacity in clinicians from primary care teams was seen as an underpinning component to achieving this goal. Clinical teams contributed to service redesign concepts and were contractually supported to embrace a preventive approach. Methods Improvement in quality and preventive focus of dental practice care delivery was explored through determining the impact of several projects, to share how evidence, skill mix and clinical leadership could be utilised in design, implementation and measurement of care outcomes in general dental practice in order to champion and advocate change, during a period of substantial change within the NHS system. The projects were: 1. A needs-led, evidence informed preventive care pathway approach to primary dental care delivery with a focus on quality and outcomes. 2. Building clinical leadership to influence and advocate for improved quality of care; and spread of learning through local professional networks. This comprised two separate projects: improved access for very young children called “Baby Teeth DO Matter” and the production of a clinically led, evidence-based guidance for periodontyal treatment in primary care called “Healthy Gums DO Matter”. Results What worked and what hindered progress, is described. The projects developed understanding of how working with ‘local majorities’ of clinicians influenced, adoption and spread of learning, and the impact in prompting wider policy and contract reform in England. Conclusions The projects identified issues that required change to meet population need. Clinicians were allowed to innovate in an evironment working together with commissioners, patients and public health colleagues. Communication and the development of clinical leadership led to the development of an infrastructure to define care pathways and decision points in the patient's journey. PMID:26392019

  20. Clinical leadership and prevention in practice: is a needs led preventive approach to the delivery of care to improve quality, outcomes and value in primary dental care practice a realistic concept?

    PubMed

    Bridgman, Colette; McGrady, Michael G

    2015-01-01

    There is a need to improve access to, and the quality of, service delivery in NHS primary dental care. Building public health thinking and leadership capacity in clinicians from primary care teams was seen as an underpinning component to achieving this goal. Clinical teams contributed to service redesign concepts and were contractually supported to embrace a preventive approach. Improvement in quality and preventive focus of dental practice care delivery was explored through determining the impact of several projects, to share how evidence, skill mix and clinical leadership could be utilised in design, implementation and measurement of care outcomes in general dental practice in order to champion and advocate change, during a period of substantial change within the NHS system. The projects were: 1. A needs-led, evidence informed preventive care pathway approach to primary dental care delivery with a focus on quality and outcomes. 2. Building clinical leadership to influence and advocate for improved quality of care; and spread of learning through local professional networks. This comprised two separate projects: improved access for very young children called “Baby Teeth DO Matter” and the production of a clinically led, evidence-based guidance for periodontyal treatment in primary care called "Healthy Gums DO Matter". What worked and what hindered progress, is described. The projects developed understanding of how working with 'local majorities' of clinicians influenced, adoption and spread of learning, and the impact in prompting wider policy and contract reform in England. The projects identified issues that required change to meet population need. Clinicians were allowed to innovate in an environment working together with commissioners, patients and public health colleagues. Communication and the development of clinical leadership led to the development of an infrastructure to define care pathways and decision points in the patient's journey.

  1. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITYEXECUTIVE SUMMARYComplete Guidelines available at https://www.aace.com/publications/guidelines.

    PubMed

    Garvey, W Timothy; Mechanick, Jeffrey I; Brett, Elise M; Garber, Alan J; Hurley, Daniel L; Jastreboff, Ania M; Nadolsky, Karl; Pessah-Pollack, Rachel; Plodkowski, Raymond

    2016-07-01

    Development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and the American College of Endocrinology (ACE) Board of Trustees and adheres to published AACE protocols for the standardized production of clinical practice guidelines (CPGs). Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors. There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements (85 [53.1%] strong [Grade A], 48 [30.0%] intermediate [Grade B], and 11 [6.9%] weak [Grade C], with 16 [10.0%] based on expert opinion [Grade D]) that build a comprehensive medical care plan for obesity. There were 133 (83.1%) statements based on strong (best evidence level [BEL] 1 = 79 [49.4%]) or intermediate (BEL 2 = 54 [33.7%]) levels of scientific substantiation. There were 34 (23.6%) evidence-based recommendation grades (Grades A-C = 144) that were adjusted based on subjective factors. Among the 1,788 reference citations used in this CPG, 524 (29.3%) were based on strong (evidence level [EL] 1), 605 (33.8%) were based on intermediate (EL 2), and 308 (17.2%) were based on weak (EL 3) scientific studies, with 351 (19.6%) based on reviews and opinions (EL 4). The final recommendations recognize that obesity is a complex, adiposity-based chronic disease, where management targets both weight-related complications and adiposity to improve overall health and quality of life. The detailed evidence-based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity, including screening, diagnosis, evaluation, selection of therapy, treatment goals, and individualization of care. The goal is to facilitate high-quality care of patients with obesity and provide a rational, scientific approach to management that optimizes health outcomes and safety. A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology AMA = American Medical Association BEL = best evidence level BMI = body mass index CCO = Consensus Conference on Obesity CPG = clinical practice guideline CSS = cross-sectional study CVD = cardiovascular disease EL = evidence level FDA = Food and Drug Administration GERD = gastroesophageal reflux disease HDL-c = high-density lipoprotein cholesterol IFG = impaired fasting glucose IGT = impaired glucose tolerance LDL-c = low-density lipoprotein cholesterol MNRCT = meta-analysis of non-randomized prospective or case-controlled trials NE = no evidence PCOS = polycystic ovary syndrome RCT = randomized controlled trial SS = surveillance study U.S = United States.

  2. The potential role of sensory testing, skin biopsy, and functional brain imaging as biomarkers in chronic pain clinical trials: IMMPACT considerations

    PubMed Central

    Smith, Shannon M.; Dworkin, Robert H.; Turk, Dennis C.; Baron, Ralf; Polydefkis, Michael; Tracey, Irene; Borsook, David; Edwards, Robert R.; Harris, Richard E.; Wager, Tor D.; Arendt-Nielsen, Lars; Burke, Laurie B.; Carr, Daniel B.; Chappell, Amy; Farrar, John T.; Freeman, Roy; Gilron, Ian; Goli, Veeraindar; Haeussler, Juergen; Jensen, Troels; Katz, Nathaniel P.; Kent, Jeffrey; Kopecky, Ernest A.; Lee, David A.; Maixner, William; Markman, John D.; McArthur, Justin C.; McDermott, Michael P.; Parvathenani, Lav; Raja, Srinivasa N.; Rappaport, Bob A.; Rice, Andrew S. C.; Rowbotham, Michael C.; Tobias, Jeffrey K.; Wasan, Ajay D.; Witter, James

    2017-01-01

    Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the US Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: (1) sensory testing, (2), skin punch biopsy, and (3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: (1) diagnostic, (2) prognostic, (3) predictive, and (4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. PMID:28254585

  3. Weighing the evidence: Risks and benefits of participatory documentary in corporatized clinics

    PubMed Central

    Hansen, Helena

    2014-01-01

    This paper describes the effects of one U.S.-based public psychiatry clinic’s shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on “evidence based” treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  4. Development and validation of an instrument to measure nurse educator perceived confidence in clinical teaching.

    PubMed

    Nguyen, Van N B; Forbes, Helen; Mohebbi, Mohammadreza; Duke, Maxine

    2017-12-01

    Teaching nursing in clinical environments is considered complex and multi-faceted. Little is known about the role of the clinical nurse educator, specifically the challenges related to transition from clinician, or in some cases, from newly-graduated nurse to that of clinical nurse educator, as occurs in developing countries. Confidence in the clinical educator role has been associated with successful transition and the development of role competence. There is currently no valid and reliable instrument to measure clinical nurse educator confidence. This study was conducted to develop and psychometrically test an instrument to measure perceived confidence among clinical nurse educators. A multi-phase, multi-setting survey design was used. A total of 468 surveys were distributed, and 363 were returned. Data were analyzed using exploratory and confirmatory factor analyses. The instrument was successfully tested and modified in phase 1, and factorial validity was subsequently confirmed in phase 2. There was strong evidence of internal consistency, reliability, content, and convergent validity of the Clinical Nurse Educator Skill Acquisition Assessment instrument. The resulting instrument is applicable in similar contexts due to its rigorous development and validation process. © 2017 The Authors. Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.

  5. Evidence based practice in clinical physiotherapy education: a qualitative interpretive description

    PubMed Central

    2013-01-01

    Background Health care undergraduate students are expected to practice evidence-based after they graduate. Previous research indicates that students face several problems with transferring evidence-based practice to real patient situations. Few studies have explored reasons for this. The aim of this study was to explore beliefs, experiences and attitudes related to third year students’ use of evidence-based practice in clinical physiotherapy education among students, clinical instructors and visiting teachers. Methods In total, six focus group interviews were conducted: three with 16 students, two with nine clinical instructors and one with four visiting teachers. In addition, one individual interview and one interview in a pair were conducted with clinical instructors. Interviewing three different participant-categories ensured comparative analysis and enabled us to exploit differences in perspectives and interactions. Interpretive description guided this process. Results Four integrative themes emerged from the analysis: “attempt to apply evidence-based practice”, “novices in clinical practice”, “prioritize practice experience over evidence-based practice” and “lack role models in evidence-based practice”. Students tried to search for research evidence and to apply this knowledge during clinical placements; a behaviour that indicated a positive attitude towards evidence-based practice. At the same time, students were novices and required basic background information more than research information. As novices they tended to lean on their clinical instructors, and were more eager to gain practical experience than practicing evidence-based; a behaviour that clinical instructors and visiting teachers often supported. Students noticed a lack of an EBP culture. Both students and clinical instructors perceived a need for role models in evidence-based practice. Conclusions Clinical instructors are in a position to influence students during clinical education, and thus, important potential role models in evidence-based practice. Actions from academic and clinical settings are needed to improve competence in evidence-based practice among clinical instructors, and future research is needed to investigate the effect of such efforts on students’ behaviour. PMID:23578211

  6. Evidence based practice in clinical physiotherapy education: a qualitative interpretive description.

    PubMed

    Olsen, Nina R; Bradley, Peter; Lomborg, Kirsten; Nortvedt, Monica W

    2013-04-11

    Health care undergraduate students are expected to practice evidence-based after they graduate. Previous research indicates that students face several problems with transferring evidence-based practice to real patient situations. Few studies have explored reasons for this. The aim of this study was to explore beliefs, experiences and attitudes related to third year students' use of evidence-based practice in clinical physiotherapy education among students, clinical instructors and visiting teachers. In total, six focus group interviews were conducted: three with 16 students, two with nine clinical instructors and one with four visiting teachers. In addition, one individual interview and one interview in a pair were conducted with clinical instructors. Interviewing three different participant-categories ensured comparative analysis and enabled us to exploit differences in perspectives and interactions. Interpretive description guided this process. Four integrative themes emerged from the analysis: "attempt to apply evidence-based practice", "novices in clinical practice", "prioritize practice experience over evidence-based practice" and "lack role models in evidence-based practice". Students tried to search for research evidence and to apply this knowledge during clinical placements; a behaviour that indicated a positive attitude towards evidence-based practice. At the same time, students were novices and required basic background information more than research information. As novices they tended to lean on their clinical instructors, and were more eager to gain practical experience than practicing evidence-based; a behaviour that clinical instructors and visiting teachers often supported. Students noticed a lack of an EBP culture. Both students and clinical instructors perceived a need for role models in evidence-based practice. Clinical instructors are in a position to influence students during clinical education, and thus, important potential role models in evidence-based practice. Actions from academic and clinical settings are needed to improve competence in evidence-based practice among clinical instructors, and future research is needed to investigate the effect of such efforts on students' behaviour.

  7. Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology

    PubMed Central

    Esposito, Pasquale; Dal Canton, Antonio

    2014-01-01

    Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings. PMID:25374819

  8. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research.

    PubMed

    Nates, Joseph L; Nunnally, Mark; Kleinpell, Ruth; Blosser, Sandralee; Goldner, Jonathan; Birriel, Barbara; Fowler, Clara S; Byrum, Diane; Miles, William Scherer; Bailey, Heatherlee; Sprung, Charles L

    2016-08-01

    To update the Society of Critical Care Medicine's guidelines for ICU admission, discharge, and triage, providing a framework for clinical practice, the development of institutional policies, and further research. An appointed Task Force followed a standard, systematic, and evidence-based approach in reviewing the literature to develop these guidelines. The assessment of the evidence and recommendations was based on the principles of the Grading of Recommendations Assessment, Development and Evaluation system. The general subject was addressed in sections: admission criteria and benefits of different levels of care, triage, discharge timing and strategies, use of outreach programs to supplement ICU care, quality assurance/improvement and metrics, nonbeneficial treatment in the ICU, and rationing considerations. The literature searches yielded 2,404 articles published from January 1998 to October 2013 for review. Following the appraisal of the literature, discussion, and consensus, recommendations were written. Although these are administrative guidelines, the subjects addressed encompass complex ethical and medico-legal aspects of patient care that affect daily clinical practice. A limited amount of high-quality evidence made it difficult to answer all the questions asked related to ICU admission, discharge, and triage. Despite these limitations, the members of the Task Force believe that these recommendations provide a comprehensive framework to guide practitioners in making informed decisions during the admission, discharge, and triage process as well as in resolving issues of nonbeneficial treatment and rationing. We need to further develop preventive strategies to reduce the burden of critical illness, educate our noncritical care colleagues about these interventions, and improve our outreach, developing early identification and intervention systems.

  9. Measuring use of research evidence in public health policy: a policy content analysis

    PubMed Central

    2014-01-01

    Background There are few Australian studies showing how research evidence is used to inform the development of public health policy. International research has shown that compensation for injury rehabilitation can have negative impacts on health outcomes. This study examined transport injury compensation policy in the Australian state of Victoria to: determine type and purpose of reference to information sources; and to identify the extent of reference to academic research evidence in transport related injury rehabilitation compensation policy. Methods Quantitative content analysis of injury rehabilitation compensation policies (N = 128) from the Victorian state government transport accident compensation authority. Results The most commonly referenced types of information were Internal Policy (median = 6 references per policy), Clinical/Medical (2.5), and Internal Legislation (1). Academic Research Evidence was the least often referenced source of information. The main purpose of reference to information was to support injury treatment and rehabilitation compensation claims decision-making. Conclusions Transport injury compensation policy development is complex; with multiple sources of information cited including legislation, internal policy, external policy and clinical/medical evidence. There is limited use of academic research evidence in Victorian state government injury treatment and rehabilitation compensation policies. Decisions regarding compensation for injury treatment and rehabilitation services could benefit from greater use of academic research evidence. This study is one of the first to examine the use of research evidence in existing Australian public health policy decision-making using rigorous quantitative methods. It provides a practical example of how use of research evidence in public health policy can be objectively measured. PMID:24886092

  10. A review of evidence of health benefit from artificial neural networks in medical intervention.

    PubMed

    Lisboa, P J G

    2002-01-01

    The purpose of this review is to assess the evidence of healthcare benefits involving the application of artificial neural networks to the clinical functions of diagnosis, prognosis and survival analysis, in the medical domains of oncology, critical care and cardiovascular medicine. The primary source of publications is PUBMED listings under Randomised Controlled Trials and Clinical Trials. The rĵle of neural networks is introduced within the context of advances in medical decision support arising from parallel developments in statistics and artificial intelligence. This is followed by a survey of published Randomised Controlled Trials and Clinical Trials, leading to recommendations for good practice in the design and evaluation of neural networks for use in medical intervention.

  11. Digital Breast Tomosynthesis and the Challenges of Implementing an Emerging Breast Cancer Screening Technology Into Clinical Practice.

    PubMed

    Lee, Christoph I; Lehman, Constance D

    2016-11-01

    Emerging imaging technologies, including digital breast tomosynthesis, have the potential to transform breast cancer screening. However, the rapid adoption of these new technologies outpaces the evidence of their clinical and cost-effectiveness. The authors describe the forces driving the rapid diffusion of tomosynthesis into clinical practice, comparing it with the rapid diffusion of digital mammography shortly after its introduction. They outline the potential positive and negative effects that adoption can have on imaging workflow and describe the practice management challenges when incorporating tomosynthesis. The authors also provide recommendations for collecting evidence supporting the development of policies and best practices. Copyright © 2013 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. Prospects for a Clinical Science of Mindfulness-Based Intervention

    PubMed Central

    Dimidjian, Sona; Segal, Zindel V.

    2017-01-01

    Mindfulness-based interventions are at a pivotal point in their future development. Spurred on by an ever-increasing number of studies and breadth of clinical application, the value of such approaches may appear self-evident. We contend, however, that the public health impact of mindfulness-based interventions can be enhanced significantly by situating this work in a broader framework of clinical psychological science. Utilizing the National Institute of Health stage model (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), we map the evidence base for mindfulness-based cognitive therapy and mindfulness-based stress reduction as exemplars of mindfulness-based interventions. From this perspective, we suggest that important gaps in the current evidence base become apparent and, furthermore, that generating more of the same types of studies without addressing such gaps will limit the relevance and reach of these interventions. We offer a set of 7 recommendations that promote an integrated approach to core research questions, enhanced methodological quality of individual studies, and increased logical links among stages of clinical translation in order to increase the potential of MBIs to impact positively the mental health needs of individuals and communities. PMID:26436311

  13. Male and Couple Fertility Impairment due to HPV-DNA Sperm Infection: Update on Molecular Mechanism and Clinical Impact—Systematic Review

    PubMed Central

    Gizzo, Salvatore; Ferrari, Bruno; Noventa, Marco; Ferrari, Emanuele; Patrelli, Tito Silvio; Gangemi, Michele; Nardelli, Giovanni Battista

    2014-01-01

    Recent evidences identify Human Papillomavirus (HPV) sperm infection as a possible cause of male and couple infertility. It acts through different mechanisms at various steps of human conception and early gestational development. We performed a systematic review to assess the role of HPV semen infection on male and couple infertility. Analysis of available and eligible data does not permit us to fund clear evidences about clinical impact of HPV infection on fertility, although sperm parameters impairment is the most widely recognized effect. Regarding biomolecular implications, the available data are often conflicting. More studies are required to define the role of HPV sperm infection in clinical practice. The great majority of evidences are obtained by in vitro studies and this fact represents a limitation for the clinical management of HPVDNA sperm infection. Understanding the biological significance of HPV-DNA semen infection could permit us to explain most of the idiopathic male and couple infertility, leading to a better management of infertile men and a better timing for sperm banking storage before ART cycles. PMID:24783196

  14. Development and impact of computerised decision support systems for clinical management of depression: A systematic review.

    PubMed

    Triñanes, Yolanda; Atienza, Gerardo; Louro-González, Arturo; de-las-Heras-Liñero, Elena; Alvarez-Ariza, María; Palao, Diego J

    2015-01-01

    One of the proposals for improving clinical practice is to introduce computerised decision support systems (CDSS) and integrate these with electronic medical records. Accordingly, this study sought to systematically review evidence on the effectiveness of CDSS in the management of depression. A search was performed in Medline, EMBASE and PsycInfo, in order to do this. The quality of quantitative studies was assessed using the SIGN method, and qualitative studies using the CASPe checklist. Seven studies were identified (3 randomised clinical trials, 3 non-randomised trials, and one qualitative study). The CDSS assessed incorporated content drawn from guidelines and other evidence-based products. In general, the CDSS had a positive impact on different aspects, such as the screening and diagnosis, treatment, improvement in depressive symptoms and quality of life, and referral of patients. The use of CDSS could thus serve to optimise care of depression in various scenarios by providing recommendations based on the best evidence available and facilitating decision-making in clinical practice. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

  15. How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

    PubMed

    Naci, Huseyin; Ioannidis, John P A

    2015-01-01

    Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

  16. The MRI-Linear Accelerator Consortium: Evidence-Based Clinical Introduction of an Innovation in Radiation Oncology Connecting Researchers, Methodology, Data Collection, Quality Assurance, and Technical Development.

    PubMed

    Kerkmeijer, Linda G W; Fuller, Clifton D; Verkooijen, Helena M; Verheij, Marcel; Choudhury, Ananya; Harrington, Kevin J; Schultz, Chris; Sahgal, Arjun; Frank, Steven J; Goldwein, Joel; Brown, Kevin J; Minsky, Bruce D; van Vulpen, Marco

    2016-01-01

    An international research consortium has been formed to facilitate evidence-based introduction of MR-guided radiotherapy (MR-linac) and to address how the MR-linac could be used to achieve an optimized radiation treatment approach to improve patients' survival, local, and regional tumor control and quality of life. The present paper describes the organizational structure of the clinical part of the MR-linac consortium. Furthermore, it elucidates why collaboration on this large project is necessary, and how a central data registry program will be implemented.

  17. The clinical significance of creativity in bipolar disorder

    PubMed Central

    Murray, Greg; Johnson, Sheri L.

    2012-01-01

    Clinical implications of the high rates of creativity within bipolar disorder (BD) have not been explored. The aim of this review is to outline these implications by (i) reviewing evidence for the link between creativity and BD, (ii) developing a provisional model of mechanisms underpinning the creativity–BD link, (iii) describing unique challenges faced by creative-BD populations, and (iv) systematically considering evidence-based psychosocial treatments in the light of this review. While more research into the creativity–BD nexus is urgently required, treatment outcomes will benefit from consideration of this commonly occurring phenotype. PMID:20579791

  18. Advances in evidence-based cancer adoptive cell therapy.

    PubMed

    Ge, Chunlei; Li, Ruilei; Song, Xin; Qin, Shukui

    2017-04-01

    Adoptive cell therapy (ACT) has been developed in cancer treatment by transferring/infusing immune cells into cancer patients, which are able to recognize, target, and destroy tumor cells. Recently, sipuleucel-T and genetically-modified T cells expressing chimeric antigen receptors (CAR) show a great potential to control metastatic castration-resistant prostate cancer and hematologic malignancies in clinic. This review summarized some of the major evidence-based ACT and the challenges to improve cell quality and reduce the side effects in the field. This review also provided future research directions to make sure ACT widely available in clinic.

  19. How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

    PubMed

    Sawata, Hiroshi; Tsutani, Kiichiro

    2011-06-29

    Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test). Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

  20. Paediatric Intestinal Pseudo-obstruction: Evidence and Consensus-based Recommendations From an ESPGHAN-Led Expert Group.

    PubMed

    Thapar, Nikhil; Saliakellis, Efstratios; Benninga, Marc A; Borrelli, Osvaldo; Curry, Joe; Faure, Christophe; De Giorgio, Roberto; Gupte, Girish; Knowles, Charles H; Staiano, Annamaria; Vandenplas, Yvan; Di Lorenzo, Carlo

    2018-06-01

    Chronic intestinal pseudo-obstructive (CIPO) conditions are considered the most severe disorders of gut motility. They continue to present significant challenges in clinical care despite considerable recent progress in our understanding of pathophysiology, resulting in unacceptable levels of morbidity and mortality. Major contributors to the disappointing lack of progress in paediatric CIPO include a dearth of clarity and uniformity across all aspects of clinical care from definition and diagnosis to management. In order to assist medical care providers in identifying, evaluating, and managing children with CIPO, experts in this condition within the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition as well as selected external experts, were charged with the task of developing a uniform document of evidence- and consensus-based recommendations. Ten clinically relevant questions addressing terminology, diagnostic, therapeutic, and prognostic topics were formulated. A systematic literature search was performed from inception to June 2017 using a number of established electronic databases as well as repositories. The approach of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to evaluate outcome measures for the research questions. Levels of evidence and quality of evidence were assessed using the classification system of the Oxford Centre for Evidence-Based Medicine (diagnosis) and the GRADE system (treatment). Each of the recommendations were discussed, finalized, and voted upon using the nominal voting technique to obtain consensus. This evidence- and consensus-based position paper provides recommendations specifically for chronic intestinal pseudo-obstruction in infants and children. It proposes these be termed paediatric intestinal pseudo-obstructive (PIPO) disorders to distinguish them from adult onset CIPO. The manuscript provides guidance on the diagnosis, evaluation, and treatment of children with PIPO in an effort to standardise the quality of clinical care and improve short- and long-term outcomes. Key recommendations include the development of specific diagnostic criteria for PIPO, red flags to alert clinicians to the diagnosis and guidance on the use of available investigative modalities. The group advocates early collaboration with expert centres where structured diagnosis and management is guided by a multi-disciplinary team, and include targeted nutritional, medical, and surgical interventions as well as transition to adult services. This document is intended to be used in daily practice from the time of first presentation and definitive diagnosis PIPO through to the complex management and treatment interventions such as intestinal transplantation. Significant challenges remain to be addressed through collaborative clinical and research interactions.

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