Transforming scientific evidence into better consumer choices

Translational research using evidence-based and comparative effectiveness research continues to evolve, becoming a useful tool in improving informed consent and decision-making in the clinical setting. While in development, emerging technologies, including cellular and molecular biology, are leading to establishing evidence-based dental practices. One emerging technology, which conjoins bench proteomic findings to clinical decision-making for treatment intervention, is the Translational Evidence Mechanism. This mechanism was developed to be a foundation for a compact between researcher, translational researcher, clinician, and patient. The output of such a mechanism is the clinical practice guideline (CPG), an interactive tool for dentists and patients to game evidence in reaching optimum clinical decisions that correspond to individual patient preferences and values. As such, the clinical practice guideline requires the vesting of decision, utility, and cost best evidence. Evidence-based research provides decision data, a first attempt at supporting decision-making by providing best outcome data. Since then comparative effectiveness research has emerged, using systematic review analysis to compare similar treatments or procedures in maximizing the choice of the most effective cost/benefit option within the context of best evidence. With innovation in the clinical practice guideline for optimizing efficacy and comparative effectiveness research, evidence-based practices will shape a new approach to health-based systems that adhere to shared decision-making between bench scientists, healthcare providers and patients.     

An Infrastructure to Advance the Scholarly Work of Staff Nurses

The traditional role of the acute care staff nurse is changing. The new norm establishes an expectation that staff nurses base their practice on best evidence. When evidence is lacking, nurses are charged with using the research process to generate and disseminate new knowledge. This article describes the critical forces behind the transformation of this role and the organizational mission, culture, and capacity required to support practice that is based on science. The vital role of senior nursing leaders, the nurse researcher, and the nursing research committee within the context of a collaborative governance structure is highlighted. Several well-known, evidence-based practice models are presented. Finally, there is a discussion of the infrastructure created by Yale-New Haven Hospital to advance the scholarly work of the nursing staff.     

Exercise-based cardiac rehabilitation in patients with chronic heart failure: a Dutch practice guideline

Rationale

To improve the quality of exercise-based cardiac rehabilitation (CR) in patients with chronic heart failure (CHF) a practice guideline from the Dutch Royal Society for Physiotherapy (KNGF) has been developed.

Guideline development

A systematic literature search was performed to formulate conclusions on the efficacy of exercise-based intervention during all CR phases in patients with CHF. Evidence was graded (1–4) according the Dutch evidence-based guideline development criteria.

Clinical and research recommendations

Recommendations for exercise-based CR were formulated covering the following topics: mobilisation and treatment of pulmonary symptoms (if necessary) during the clinical phase, aerobic exercise, strength training (inspiratory muscle training and peripheral muscle training) and relaxation therapy during the outpatient CR phase, and adoption and monitoring training after outpatient CR.

Applicability and implementation issues

This guideline provides the physiotherapist with an evidence-based instrument to assist in clinical decision-making regarding patients with CHF. The implementation of the guideline in clinical practice needs further evaluation.

Conclusion

This guideline outlines best practice standards for physiotherapists concerning exercise-based CR in CHF patients. Research is needed on strategies to improve monitoring and follow-up of the maintenance of a physical active lifestyle after supervised CR.     

抑郁症治疗的循证医学研究进展

循证医学是近年来国际上临床医学领域迅速发展起来的新学科,已成为当前国际医学研究中的热点之一,是指对病人的诊 断、治疗、预防、康复和其他决策应建立在当前最佳临床研究证据,是遵循证据的临床医学,强调收集最佳证据。其理念的科学性 和有效性迅速渗透到医学领域的众多学科,循证精神卫生也相继提出并发展。抑郁症是由各种原因引起的以抑郁为主要症状的 一组心境障碍或情感性障碍,近几年能够有效运用循证医学方法为治疗抑郁症寻找最佳临床证据,制定循证诊疗指南成为了临 床医生的迫切要求。本文就抑郁症治疗方面的循证医学研究进展做一综述。     

Disseminating the best available evidence: New challenges in public reporting of health care

As a direct benefit of the Health Care Reform Act (2010), concerted effort has been deployed to define and characterize the process by which the best available evidence for diagnosis or treatment intervention prognosis can be obtained. The science of research synthesis in health care has established the systematic research protocol by which randomized clinical trials and other clinical studies must be reviewed and compared for the level and quality of the evidence presented, as well as the consensus of the best available evidence synthesized and shared. This process of systematic review yields a reliable and valid approach in comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions in terms of efficacy, and or of effectiveness. The resulting bioinformation outcome of comparative effectiveness and efficacy research review of the available clinical data is expressed as a consensus of the best available evidence, which finds its way in evidence-based clinical practice guidelines, standards of care and eventually, in policies: hence, the acronym CEERAP (comparative effectiveness and efficacy review and policy). The methodological and the procedural criteria that determine and regulate the public reporting dissemination of this sort of bioinformation, and the extent of benefit to the patient's health literacy, which have remained a bit more elusive to this date, are investigated and discussed in this paper.     

Designing theoretically-informed implementation interventions

Background

A better theoretical base for understanding professional behaviour change is needed to support evidence-based changes in medical practice. Traditionally strategies to encourage changes in clinical practices have been guided empirically, without explicit consideration of underlying theoretical rationales for such strategies. This paper considers a theoretical framework for reasoning from within psychology for identifying individual differences in cognitive processing between doctors that could moderate the decision to incorporate new evidence into their clinical decision-making.

Discussion

Parallel dual processing models of reasoning posit two cognitive modes of information processing that are in constant operation as humans reason. One mode has been described as experiential, fast and heuristic; the other as rational, conscious and rule based. Within such models, the uptake of new research evidence can be represented by the latter mode; it is reflective, explicit and intentional. On the other hand, well practiced clinical judgments can be positioned in the experiential mode, being automatic, reflexive and swift. Research suggests that individual differences between people in both cognitive capacity (e.g., intelligence) and cognitive processing (e.g., thinking styles) influence how both reasoning modes interact. This being so, it is proposed that these same differences between doctors may moderate the uptake of new research evidence. Such dispositional characteristics have largely been ignored in research investigating effective strategies in implementing research evidence. Whilst medical decision-making occurs in a complex social environment with multiple influences and decision makers, it remains true that an individual doctor's judgment still retains a key position in terms of diagnostic and treatment decisions for individual patients. This paper argues therefore, that individual differences between doctors in terms of reasoning are important considerations in any discussion relating to changing clinical practice.

Summary

It is imperative that change strategies in healthcare consider relevant theoretical frameworks from other disciplines such as psychology. Generic dual processing models of reasoning are proposed as potentially useful in identifying factors within doctors that may moderate their individual uptake of evidence into clinical decision-making. Such factors can then inform strategies to change practice.     

Dissemination of evidence-based standards of care

Standards of care pertain to crafting and implementing patient-centered treatment interventions. Standards of care must take into consideration the patient's gender, ethnicity, medical and dental history, insurance coverage (or socioeconomic level, if a private patient), and the timeliness of the targeted scientific evidence. This resolves into a process by which clinical decision-making about the optimal patient-centered treatment relies on the best available research evidence, and all other necessary inputs and factors to provide the best possible treatment. Standards of care must be evidence-based, and not merely based on the evidence - the dichotomy being critical in contemporary health services research and practice. Evidence-based standards of care must rest on the best available evidence that emerges from a concerted hypothesis-driven process of research synthesis and meta-analysis. Health information technology needs to become an every-day reality in health services research and practice to ensure evidence-based standards of care. Current trends indicate that user-friendly methodologies, for the dissemination of evidence-based standards of care, must be developed, tested and distributed. They should include approaches for the quantification and analysis of the textual content of systematic reviews and of their summaries in the form of critical reviews and lay-language summaries.     

Exercise-based cardiac rehabilitation in patients with coronary heart disease: a practice guideline

Background

To improve the quality of exercise-based cardiac rehabilitation (CR) in patients with coronary heart disease (CHD) the CR guideline from the Dutch Royal Society for Physiotherapists (KNGF) has been updated. This guideline can be considered an addition to the 2011 Dutch Multidisciplinary CR guideline, as it includes several novel topics.

Methods

A systematic literature search was performed to formulate conclusions on the efficacy of exercise-based interventions during all CR phases in patients with CHD. Evidence was graded (1–4) according the Dutch evidence-based guideline development (EBRO) criteria. In case of insufficient scientific evidence, recommendations were based on expert opinion. This guideline comprised a structured approach including assessment, treatment and evaluation.

Results

Recommendations for exercise-based CR were formulated covering the following topics: preoperative physiotherapy, mobilisation during the clinical phase, aerobic exercise, strength training, and relaxation therapy during the outpatient rehabilitation phase, and adoption and monitoring of a physically active lifestyle after outpatient rehabilitation.

Conclusions

There is strong evidence for the effectiveness of exercise-based CR during all phases of CR. The implementation of this guideline in clinical practice needs further evaluation as well as the maintenance of an active lifestyle after supervised rehabilitation.     

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

ObjectiveTo provide evidence-based recommendations regarding the use of advanced technology in the management of persons with diabetes mellitus to clinicians, diabetes-care teams, health care professionals, and other stakeholders.MethodsThe American Association of Clinical Endocrinology (AACE) conducted literature searches for relevant articles published from 2012 to 2021. A task force of medical experts developed evidence-based guideline recommendations based on a review of clinical evidence, expertise, and informal consensus, according to established AACE protocol for guideline development.Main Outcome MeasuresPrimary outcomes of interest included hemoglobin A1C, rates and severity of hypoglycemia, time in range, time above range, and time below range.ResultsThis guideline includes 37 evidence-based clinical practice recommendations for advanced diabetes technology and contains 357 citations that inform the evidence base.RecommendationsEvidence-based recommendations were developed regarding the efficacy and safety of devices for the management of persons with diabetes mellitus, metrics used to aide with the assessment of advanced diabetes technology, and standards for the implementation of this technology.ConclusionsAdvanced diabetes technology can assist persons with diabetes to safely and effectively achieve glycemic targets, improve quality of life, add greater convenience, potentially reduce burden of care, and offer a personalized approach to self-management. Furthermore, diabetes technology can improve the efficiency and effectiveness of clinical decision-making. Successful integration of these technologies into care requires knowledge about the functionality of devices in this rapidly changing field. This information will allow health care professionals to provide necessary education and training to persons accessing these treatments and have the required expertise to interpret data and make appropriate treatment adjustments.     

Clinical Decision Support: Effectiveness in Improving Quality Processes and Clinical Outcomes and Factors That May Influence Success

The use of electronic health records has skyrocketed following the 2009 HITECH Act, which provides financial incentives to health care providers for the “meaningful use” of electronic medical record systems. An important component of the “Meaningful Use” legislation is the integration of Clinical Decision Support Systems (CDSS) into the computerized record, providing up-to-date medical knowledge and evidence-based guidance to the physician at the point of care. As reimbursement is increasingly tied to process and clinical outcomes, CDSS will be integral to future medical practice. Studies of CDSS indicate improvement in preventive services, appropriate care, and clinical and cost outcomes with strong evidence for CDSS effectiveness in process measures. Increasing provider adherence to CDSS recommendations is essential in improving CDSS effectiveness, and factors that influence adherence are currently under study.     

转化医学与生物样本库现状

转化医学(translational medicine)是近10年来国际生物医学领域出现的新概念和重点研究方向,其为一种倡导实验室与临床研究双向转化的模式,而这种模式的核心意义之一便体现在协作与资源共享方面。这便促使生物样本库成为了转化医学的战略资源。本文在分析发达国家促进转化医学发展政策的同时分析了生物样本库建设的现状、趋势和问题,旨在为我国制定转化医学发展战略,建设生物样本库,促进转化医学发展提供参考。     

Empirical research in clinical ethics: The ‘committed researcher’ approach

After the ‘empirical turn’ in bioethics, few specific approaches have been developed for doing clinical ethics research in close connection with clinical decision-making on a daily basis. In this paper we describe the ‘committed researcher’ approach to research in clinical ethics that we have developed over the years. After comparing it to two similar research methodological approaches, the ‘embedded researcher’ and ‘deliberative engagement’, we highlight its main features: it is patient-oriented, it is implemented by collegial and multidisciplinary teams, it uses an ethical grid to build the interview guide, and it is geared towards bringing the results to bear on the public debate surrounding the issue at stake. Finally, we position our methodological approach with respect to the ‘is vs. ought’ distinction. We argue that our ‘commitment researcher’ approach to clinical ethics research takes concerned people’s life-building values as the main data, and compares them to the larger normative framework underlying the medical practice at stake.     

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

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.     

A pragmatic cluster randomised trial evaluating three implementation interventions

ABSTRACT: BACKGROUND: Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. METHODS: A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. RESULTS: Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. CONCLUSIONS: This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance. Trial registration ISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE).     

International clinical recommendations on scar management

Many techniques for management of hypertrophic scars and keloids have been proven through extensive use, but few have been supported by prospective studies with adequate control groups. Several new therapies showed good results in small-scale trials, but these have not been repeated in larger trials with long-term follow-up. This article reports a qualitative overview of the available clinical literature by an international panel of experts using standard methods of appraisal. The article provides evidence-based recommendations on prevention and treatment of abnormal scarring and, where studies are insufficient, consensus on best practice. The recommendations focus on the management of hypertrophic scars and keloids, and are internationally applicable in a range of clinical situations. These recommendations support a move to a more evidence-based approach in scar management. This approach highlights a primary role for silicone gel sheeting and intralesional corticosteroids in the management of a wide variety of abnormal scars. The authors concluded that these are the only treatments for which sufficient evidence exists to make evidence-based recommendations. A number of other therapies that are in common use have achieved acceptance by the authors as standard practice. However, it is highly desirable that many standard practices and new emerging therapies undergo large-scale studies with long-term follow-up before being recommended conclusively as alternative therapies for scar management.     

A Critical Analysis and Discussion of Clinical Research Ethics in the Russian Federation and Their Implications for Western Sponsored Trials

Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western‐centric value systems. One of the greatest recipients of this onslaught of Western business and research practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity.     

A brief introduction of meta-analyses in clinical practice and research

With the explosive growth of medical information, it is almost impossible for healthcare providers to review and evaluate all relevant evidence to make the best clinical decisions. Meta-analyses, which summarize all existing evidence and quantitatively synthesize individual studies, have become the best available evidence for informing clinical practice. This article introduces the common methods, steps, principles, strengths and limitations of meta-analyses and aims to help healthcare providers and researchers obtain a basic understanding of meta-analyses in clinical practice and research.     

Improving the care of people with traumatic brain injury through the Neurotrauma Evidence Translation (NET) program: protocol for a program of research

ABSTRACT: The Neurotrauma Evidence Translation (NET) program was funded in 2009 to increase the uptake of research evidence in the clinical care of patients who have sustained traumatic brain injury. This paper reports the rationale and plan for this five-year knowledge translation research program. The overarching aims of the program are threefold: to improve outcomes for people with traumatic brain injury; to create a network of neurotrauma clinicians and researchers with expertise in knowledge translation and evidence-based practice; and to contribute knowledge to the field of knowledge translation research. The program comprises a series of interlinked projects spanning varying clinical environments and disciplines relevant to neurotrauma, anchored within four themes representing core knowledge translation activities: reviewing research evidence; understanding practice; developing and testing interventions for practice change; and building capacity for knowledge translation in neurotrauma. The program uses a range of different methods and study designs, including: an evidence fellowship program; conduct of and training in systematic reviews; mixed method study designs to describe and understand factors that influence current practices (e.g., semistructured interviews and surveys); theory-based methods to develop targeted interventions aiming to change practice; a cluster randomised trial to test the effectiveness of a targeted theory-informed intervention; stakeholder involvement activities; and knowledge translation events such as consensus conferences.     

转化医学：现代医学发展的动力

Translational medicine is a class of medicalresearch that proposes a two-way interaction betweenlaboratory and clinical research[1].Elias A.Zerhouni,the director of the National Institutes of Health(NIH),