Review text raditionlobservationalstudiesandand EBM writings have vided guides for detecting nEBM has vet to ge erate a coherent theor igns and dwill continue ngmega-ri decision scie more des have ate the point o care entirely practic and ethc ers in particular.and the n In conclusion,effort well underway in each of the conn in r,no critic ev er sug iding a framey integrating research decision Humans ar need evidence to efectively fiunction in the world hnet25yea by GHG.Bot ed thre sophisticated hierarchy evidence,the need .EBM has buted t Refe gh:Printed b rray,and Coch P1g95 induding discontinued use of mis ention that have est of the tice Thes which has expanded t ich ddy DM. for the need of feoidencetgsedimplemecntationmscencet Cn80:30193-240 al challenges in the nex 8 Guyalt G.Evidence-Bas 114. ch results.ren ns a prob Optin atic revic 3005 ctice guideline ieving n hu this goal will red toward rapid turnaround in cre ting rigo dthe wi auton and ggio LA.Tar that greatly ilitate pdatin in K,Straus SE,Bero L I records rg/10 6736(163592-
Review www.thelancet.com Published online February 16, 2017 http://dx.doi.org/10.1016/S0140-6736(16)31592-6 7 viewed as the natural accompaniment of the human experience. It is true, for instance, that most compelling randomised trials highlighted in EBM-oriented texts have been conducted by the pharmaceutical industry. EBM writings have provided guides for detecting misleading study designs and interpretation—for example, choosing an inferior comparator98 or undertaking mega-trials and then misrepresenting very small eff ects as major breakthroughs.99 The extent to which such warnings and guides have adequately protected clinicians from misleading presentations is at best questionable, and probably limited. EBM practitioners in particular, and the medical community in general, need to continue to push back against these distortions that often result in “too much medicine”.100 However, no critic ever suggested that reliable evidence should not be a key to eff ective problem solving and decision making. Humans are “informavores”101—we need evidence to eff ectively function in the world around us. The next 25 years EBM has disseminated three major tenets: an increasingly sophisticated hierarchy of evidence, the need for systematic summaries of the best evidence to guide care, and the requirement for considering patient values in important clinical decisions. EBM has contributed to, and perhaps spawned, a number of related initiatives. These initiatives include a focus on comparative eff ectiveness research,102 over or under diagnosis and over or under treatment,100 measurements of the quality of care,103 improving publishing standards,104 ensuring all trials are registered,70,105 and avoiding waste in research production, including discontinued use of misguided interventions that have become part of established practice.106 These initiatives refl ect the broad scope of the EBM movement, which has expanded to include disciplines such as nursing, dentistry, public health, and health policy (socalled evidence-based health care), as well as recognition for the need of evidence-based implementation science to ensure optimal function of clinics, hospitals, and health systems.52 EBM will have to address several challenges in the next quarter century. Failure to publish, and indeed suppression of research results, remains a problem. Optimal delivery of clinical care requires far more effi cient production and rapid dissemination of both systematic reviews and practice guidelines.107 Achieving this goal will require further advances in building experienced research teams geared toward rapid turnaround in creating rigorous evidence summaries, automatised and text-mining software,108 and the widespread adoption of electronic platforms that greatly facilitate rapid updating. Dissemination must include patient-friendly and clinician-friendly electronic access on all types of devices, including smart phones, to electronic medical records and, particularly for patients, social media.45,109,110 EBM will need to address the place of evidence generated by so-called big data111 mining in relation to traditional observational studies and randomised trials for the development of a “continuously learning health care system”.112 EBM has yet to generate a coherent theory of health-care decision making113 and will continue to partner with other disciplines, such as cognitive and decision sciences, toward this goal.114 On a more practical level, major challenges remain in providing clinicians with tools to make shared decision making at the point of care entirely practical and effi cient, and a positive experience for both patients and clinicians. In conclusion, eff orts are well underway in each of the problematic areas of EBM, and progress is certain. Whatever the extent of future progress, EBM’s success in providing a framework for fully integrating research evidence into the delivery of health care,115 and raising awareness of the need for consideration of individual patient values and preferences, will remain enduring contributions to clinical medicine and related fi elds. Contributors BD wrote the fi rst draft, which was extensively revised by GHG. Both authors contributed equally to the concept of the paper, data interpretation, and writing. The fi nal version of the paper has been agreed by both authors. Declaration of interests Both authors have devoted signifi cant aspects of their careers to the development of evidence-based practice. References 1 Lind J. A treatise of scurvy. In three parts. Containing an enquiry into the nature, causes and cure, of that disease. Together with a critical and chronological view of what has been published on the subject. Edinburgh: Printed by Sands, Murray, and Cochran, 1753. 2 Matthews JR. 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表1快速评阅文献需要回答的关键问题 问题类型 快速评阅要点 疗效 1.研究类型为系统综述或RCT吗? 2.是否实行分配隐藏和随机分组? 3,对患者的分组,医师和患者是否双盲? 4.除了需要评估的治疗措施外,两组是否得到相同的干预? 5.被研究患者的随访是否完整?失访率有多高? 6.资料总结分析是香否采用意向性分析(TT)分析? 不良反应 1. 研究类型是系统综述、RCT、队列研究、病例-对照研究、或与临床问 题患者特征相同的单个患者随机对照试验( f1)吗?(在不良反应研 究中,RCT研究比较少用,因为常常没有足够的样本量。 2. 患者是否除了特定的治疗不同以外,其他所有重要方面的特征都相 3. 是否用同样的方式测量了两组的治疗和不良反应状况? 4.是否客观地评价了不良反应?评价不良反应是否采用了盲法? 5.随访是否足够长并且完整? 6.关于不良反应的研究结果是否满足了能确定因果关系的原则? 预后 1.研究类型为系统综述或队列研究吗? 2.患者是否具有代表性? 3.随访是否足够长并且完整? 4.失访是否严重?失访的原因是什么? 5.预后指标的定义是否明确?其测量有无偏倚 6.比较时是否控制了混杂因素? 诊断与筛查 1. 研究类型是系统综述或横断面研究吗? 2.患者是否具有代表性? 3 语凳餐套室,金标准试验进行了登立、官法的比软:金标准的使 4.是否每个被测者都做参照试验进行评价? 5.所研究患者样本是否包括临床试验中将使用该诊断试验的各种患者? 6.是否提供了准确性指标估计值的精度?
表 1 快速评阅文献需要回答的关键问题 问题类型 快速评阅要点 疗效 1. 研究类型为系统综述或 RCT 吗? 2. 是否实行分配隐藏和随机分组? 3. 对患者的分组,医师和患者是否双盲? 4. 除了需要评估的治疗措施外,两组是否得到相同的干预? 5. 被研究患者的随访是否完整?失访率有多高? 6. 资料总结分析是否采用意向性分析(ITT)分析? 不良反应 1. 研究类型是系统综述、RCT、队列研究、病例-对照研究、或与临床问 题患者特征相同的单个患者随机对照试验(n-of-1)吗?(在不良反应研 究中,RCT 研究比较少用,因为常常没有足够的样本量。) 2. 患者是否除了特定的治疗不同以外,其他所有重要方面的特征都相 近? 3. 是否用同样的方式测量了两组的治疗和不良反应状况? 4. 是否客观地评价了不良反应?评价不良反应是否采用了盲法? 5. 随访是否足够长并且完整? 6. 关于不良反应的研究结果是否满足了能确定因果关系的原则? 预后 1. 研究类型为系统综述或队列研究吗? 2. 患者是否具有代表性? 3. 随访是否足够长并且完整? 4. 失访是否严重?失访的原因是什么? 5. 预后指标的定义是否明确?其测量有无偏倚? 6. 比较时是否控制了混杂因素? 诊断与筛查 1. 研究类型是系统综述或横断面研究吗? 2. 患者是否具有代表性? 3. 试验是否与“金标准”试验进行了独立、“盲法”的比较?“金标准”的使 用是否合理? 4. 是否每个被测者都做参照试验进行评价? 5. 所研究患者样本是否包括临床试验中将使用该诊断试验的各种患者? 6. 是否提供了准确性指标估计值的精度?