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This Position Paper from the Academy of Nutrition Sciences is the third in a series which describe the nature of the scientific evidence and frameworks that underpin nutrition recommendations for health. This paper focuses on evidence which guides the application of dietary recommendations for individuals. In some situations, modified nutrient intake becomes essential to prevent deficiency, optimise development and health, or manage symptoms and disease progression. Disease and its treatment can also affect taste, appetite and ability to access and prepare foods, with associated financial impacts. Therefore, the practice of nutrition and dietetics must integrate and apply the sciences of food, nutrition, biology, physiology, behaviour, management, communication and society to achieve and maintain human health. Thus, there is huge complexity in delivering evidence-based nutrition interventions to individuals. This paper examines available frameworks for appraising the quality and certainty of nutrition research evidence, the development nutrition practice guidelines to support evidence implementation in practice and the influence of other sources of nutrition information and misinformation. The paper also considers major challenges in applying research evidence to an individual and suggests consensus recommendations to begin to address these challenges in the future. Our recommendations target three groups; those who deliver nutrition interventions to individuals, those funding, commissioning or undertaking research aimed at delivering evidence-based nutrition practice, and those disseminating nutritional information to individuals.

Background: Health policy-makers must often make decisions in compressed time frames and with limited resources. Hence, rapid reviews have become a pragmatic alternative to comprehensive systematic reviews. However, it is important that rapid review methods remain rigorous to support good policy development and decisions. There is currently little evidence about which streamlined steps in a rapid review are less likely to introduce unacceptable levels of uncertainty while still producing a product that remains useful to policy-makers., Methods: This paper summarizes current research describing commonly used methods and practices that are used to conduct rapid reviews and presents key considerations and options to guide methodological choices for a rapid review., Results: The most important step for a rapid review is for an experienced research team to have early and ongoing engagement with the people who have requested the review. A clear research protocol, derived from a needs assessment conducted with the requester, serves to focus the review, defines the scope of the rapid review, and guides all subsequent steps. Common recommendations for rapid review methods include tailoring the literature search in terms of databases, dates, and languages. Researchers can consider using a staged search to locate high-quality systematic reviews and then subsequently published primary studies. The approaches used for study screening and selection, data extraction, and risk-of-bias assessment should be tailored to the topic, researcher experience, and available resources. Many rapid reviews use a single reviewer for study selection, risk-of-bias assessment, or data abstraction, sometimes with partial or full verification by a second reviewer. Rapid reviews usually use a descriptive synthesis method rather than quantitative meta-analysis. Use of brief report templates and standardized production methods helps to speed final report publication., Conclusions: Researchers conducting rapid reviews need to make transparent methodological choices, informed by stakeholder input, to ensure that rapid reviews meet their intended purpose. Transparency is critical because it is unclear how or how much streamlined methods can bias the conclusions of reviews. There are not yet internationally accepted standards for conducting or reporting rapid reviews. Thus, this article proposes interim guidance for researchers who are increasingly employing these methods., (© 2022. The Author(s).)

The low quality of included trials, insufficient rigour in review methodology, ignorance of key pain issues, small size, and over-optimistic judgements about the direction and magnitude of treatment effects all devalue systematic reviews, supposedly the 'gold standard' of evidence. Available evidence indicates that almost all systematic reviews in the published literature contain fatal flaws likely to make their conclusions incorrect and misleading. Only 3 in every 100 systematic reviews are deemed to have adequate methods and be clinically useful. Examples of research waste and questionable ethical standards abound: most trials have little hope of providing useful results, and systematic review of hopeless trials inspires no confidence. We argue that results of most systematic reviews should be dismissed. Forensically critical systematic reviews are essential tools to improve the quality of trials and should be encouraged and protected., (© 2022 European Pain Federation - EFIC®.)

Neonatal and infantile cholestasis (NIC) can represent the onset of a surgically correctable disease and of a genetic or metabolic disorder worthy of medical treatment. Timely recognition of NIC and identification of the underlying etiology are paramount to improve outcomes. Upon invitation by the Italian National Institute of Health (ISS), an expert working grouped was formed to formulate evidence-based positions on current knowledge about the diagnosis of NIC. A systematic literature search was conducted to collect evidence about epidemiology, etiology, clinical aspects and accuracy of available diagnostic tests in NIC. Evidence was scored using the GRADE system. All recommendations were approved by a panel of experts upon agreement of at least 75% of the members. The final document was approved by all the panel components. This position document summarizes the collected statements and defines the best-evidence diagnostic approach to cholestasis in the first year of life., (Copyright © 2021. Published by Elsevier Ltd.)

Objective: To share the experience of promoting GRADE in China., Study Design and Setting: We designed the study and collected data on the following three aspects of the GRADE in China: the key activities related to GRADE, the main achievements of the GRADE, and potential challenges and future opportunities., Results: Three GRADE centres have been established in China since 2011. Seventeen articles of the GRADE working group have been translated and published in Chinese, and 31 articles have been written by Chinese scientists in Chinese to introduce and interpret the GRADE approach so far. More than 50 GRADE workshops and meetings have been held by GRADE centres in China, covering two-thirds of all provinces and autonomous regions of China. The percentages of societies from the Chinese Medical Association (CMA) and the Chinese Medical Doctor Association (CMDA) that used the GRADE system to develop guidelines were 30% and 18%, respectively., Conclusion: Over the past decade, China has made progress in promoting the GRADE system and Chinese GRADE centres have made a significant contribution., (Copyright © 2021. Published by Elsevier Inc.)

Objective: To describe and record the evolution of EBM in China., Study Design and Setting: We conducted the study following the general methodology of oral history. The interviews were done at Lanzhou University, between 18 th and 22 nd April 2019 using pre-defined questions. All interviews were videorecorded. Two investigators extracted and analyzed the information from the interviews independently., Results: One international expert and ten Chinese experts participated in the interviews. After the introduction of EBM in China in the mid-1990s, more than 20 EBM centres have been established. According to the interviewees, Gordon Guyatt, David Sackett and Iain Chalmers are the international experts who played the most important role in the development of EBM in China. China has contributed to EBM on the international level by conducting systematic reviews, developing reporting checklists, and introducing the principles of EBM into Traditional Medicine. The Chinese Cochrane Centre and the EBM Centre of Lanzhou University were ranked the top two EBM Centres in China by the interviewees., Conclusion: EBM has been developing in China for nearly a quarter of a century. Many achievements have been reached, however, EBM is still facing many challenges in China, including shortages of funding support and personnel, as well as limited local high-quality evidence., Competing Interests: Competing interest The authors declare that they have no competing interests., (Copyright © 2021. Published by Elsevier Inc.)

Competing Interests: Competing interests: DN has received expenses and fees for his media work. He holds grant funding from the NIHR School of Primary Care Research and the Royal College of General Practitioners. On occasion, he receives expenses for teaching EBM. ISW reports personal fees from various universities and hospitals around Indonesia for teaching EBM, outside the submitted work. SC occasionally receives expenses for teaching EBM at academic conferences and hospitals around Japan. EJ receives a regular income for his employed NHS work through Yealm Medical Centre and PenARC. He receives expenses for teaching EBM. In March 2019 he received a one-off consultancy fee for 2-days work for Zavamed (work unrelated to this article). PH works as a teacher in EBP and is currently conducting a PhD research that is funded by Avans University of Applied Science. He receives expenses for lectures at seminars and workshops on EBP. HA has received funding from Health Education England to attend the EBHC 2019 meeting. She is also a visiting tutor of Evidence-Based Child Health at the UCL Great Ormond Street Institute of Child Health, London. RCB works as a teacher in EBP and receives a regular income for her employed NIPH (Department of Reviews and health technology assessments) work. None to declare – AL, WMB, C-CC, FB, CE, HTM, SGJ, RT, M-LELB, LP, AKS, PGvP, FB, KAOT, LA.

Objectives: There is considerable actual and potential waste in research. Evidence-based research ensures worthwhile and valuable research. The aim of this series, which this article introduces, is to describe the evidence-based research approach., Study Design and Setting: In this first article of a three-article series, we introduce the evidence-based research approach. Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner., Results: We describe evidence-based research and provide an overview of the approach of systematically and transparently using previous research before starting a new study to justify and design the new study (article #2 in series) and-on study completion-place its results in the context with what is already known (article #3 in series)., Conclusion: This series introduces evidence-based research as an approach to minimize unnecessary and irrelevant clinical health research that is unscientific, wasteful, and unethical., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background and Objective: There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context., Study Design and Setting: EBR is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this third and final article of a series, we describe how to use the context of existing evidence to reach and present a trustworthy and useful conclusion when reporting results from a new clinical study., Results: We describe a method, the EBR approach, that by using a systematic and transparent consideration of earlier similar studies when interpreting and presenting results from a new original study will ensure usefulness of the conclusion., Conclusion: Using an EBR approach will improve the usefulness of a clinical study by providing the context to draw more valid conclusions and explicit information about new research needs., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value., Study Design and Setting: Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study., Results: Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies., Conclusion: Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

In the age of Evidence-Based Medicine, Clinical Guidelines (CGs) are recognized to be an indispensable tool to support physicians in their daily clinical practice. Medical Informatics is expected to play a relevant role in facilitating diffusion and adoption of CGs. However, the past pioneering approaches, often fragmented in many disciplines, did not lead to solutions that are actually exploited in hospitals. Process Mining for Healthcare (PM4HC) is an emerging discipline gaining the interest of healthcare experts, and seems able to deal with many important issues in representing CGs. In this position paper, we briefly describe the story and the state-of-the-art of CGs, and the efforts and results of the past approaches of medical informatics. Then, we describe PM4HC, and we answer questions like how can PM4HC cope with this challenge? Which role does PM4HC play and which rules should be employed for the PM4HC scientific community?

Background: Health professionals sometimes do not use the best evidence to treat their patients, in part due to unconscious acts of omission and information overload. Reminders help clinicians overcome these problems by prompting them to recall information that they already know, or by presenting information in a different and more accessible format. Manually-generated reminders delivered on paper are defined as information given to the health professional with each patient or encounter, provided on paper, in which no computer is involved in the production or delivery of the reminder. Manually-generated reminders delivered on paper are relatively cheap interventions, and are especially relevant in settings where electronic clinical records are not widely available and affordable. This review is one of three Cochrane Reviews focused on the effectiveness of reminders in health care., Objectives: 1. To determine the effectiveness of manually-generated reminders delivered on paper in changing professional practice and improving patient outcomes. 2. To explore whether a number of potential effect modifiers influence the effectiveness of manually-generated reminders delivered on paper., Search Methods: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers on 5 December 2018. We searched grey literature, screened individual journals, conference proceedings and relevant systematic reviews, and reviewed reference lists and cited references of included studies., Selection Criteria: We included randomised and non-randomised trials assessing the impact of manually-generated reminders delivered on paper as a single intervention (compared with usual care) or added to one or more co-interventions as a multicomponent intervention (compared with the co-intervention(s) without the reminder component) on professional practice or patients' outcomes. We also included randomised and non-randomised trials comparing manually-generated reminders with other quality improvement (QI) interventions., Data Collection and Analysis: Two review authors screened studies for eligibility and abstracted data independently. We extracted the primary outcome as defined by the authors or calculated the median effect size across all reported outcomes in each study. We then calculated the median percentage improvement and interquartile range across the included studies that reported improvement related outcomes, and assessed the certainty of the evidence using the GRADE approach., Main Results: We identified 63 studies (41 cluster-randomised trials, 18 individual randomised trials, and four non-randomised trials) that met all inclusion criteria. Fifty-seven studies reported usable data (64 comparisons). The studies were mainly located in North America (42 studies) and the UK (eight studies). Fifty-four studies took place in outpatient/ambulatory settings. The clinical areas most commonly targeted were cardiovascular disease management (11 studies), cancer screening (10 studies) and preventive care (10 studies), and most studies had physicians as their target population (57 studies). General management of a clinical condition (17 studies), test-ordering (14 studies) and prescription (10 studies) were the behaviours more commonly targeted by the intervention. Forty-eight studies reported changes in professional practice measured as dichotomous process adherence outcomes (e.g. compliance with guidelines recommendations), 16 reported those changes measured as continuous process-of-care outcomes (e.g. number of days with catheters), eight reported dichotomous patient outcomes (e.g. mortality rates) and five reported continuous patient outcomes (e.g. mean systolic blood pressure). Manually-generated reminders delivered on paper probably improve professional practice measured as dichotomous process adherence outcomes) compared with usual care (median improvement 8.45% (IQR 2.54% to 20.58%); 39 comparisons, 40,346 participants; moderate certainty of evidence) and may make little or no difference to continuous process-of-care outcomes (8 comparisons, 3263 participants; low certainty of evidence). Adding manually-generated paper reminders to one or more QI co-interventions may slightly improve professional practice measured as dichotomous process adherence outcomes (median improvement 4.24% (IQR -1.09% to 5.50%); 12 comparisons, 25,359 participants; low certainty of evidence) and probably slightly improve professional practice measured as continuous outcomes (median improvement 0.28 (IQR 0.04 to 0.51); 2 comparisons, 12,372 participants; moderate certainty of evidence). Compared with other QI interventions, manually-generated reminders may slightly decrease professional practice measured as process adherence outcomes (median decrease 7.9% (IQR -0.7% to 11%); 14 comparisons, 21,274 participants; low certainty of evidence). We are uncertain whether manually-generated reminders delivered on paper, compared with usual care or with other QI intervention, lead to better or worse patient outcomes (dichotomous or continuous), as the certainty of the evidence is very low (10 studies, 13 comparisons). Reminders added to other QI interventions may make little or no difference to patient outcomes (dichotomous or continuous) compared with the QI alone (2 studies, 2 comparisons). Regarding resource use, studies reported additional costs per additional point of effectiveness gained, but because of the different currencies and years used the relevance of those figures is uncertain. None of the included studies reported outcomes related to harms or adverse effects., Authors' Conclusions: Manually-generated reminders delivered on paper as a single intervention probably lead to small to moderate increases in outcomes related to adherence to clinical recommendations, and they could be used as a single QI intervention. It is uncertain whether reminders should be added to other QI intervention already in place in the health system, although the effects may be positive. If other QI interventions, such as patient or computerised reminders, are available, they should be preferred over manually-generated reminders, but under close evaluation in order to decrease uncertainty about their potential effect., (Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: WHO has recognised the need to ensure that guideline processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable. Along with decision-making criteria that require findings from effectiveness reviews, WHO is increasingly using evidence derived from qualitative evidence syntheses (QES) to inform the values, acceptability, equity and feasibility implications of its recommendations. This is the first in a series of three papers examining the use of QES in developing clinical and health systems guidelines., Methods: WHO convened a group of methodologists involved in developing recent (2010-2018) guidelines that were informed by QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. Our aim in this paper is to (1) describe and discuss how the findings of QES can inform the scope of a guideline and (2) develop findings for key guideline decision-making criteria., Results: QES resulted in the addition of new outcomes that are directly relevant to service users, a stronger evidence base for decisions about how much effective interventions and related outcomes are valued by stakeholders in a range of contexts, and a more complete database of summary evidence for guideline panels to consider, linked to decisions about values, acceptability, feasibility and equity., Conclusions: Rigorously conducted QES can be a powerful means of improving the relevance of guidelines, and of ensuring that the concerns of stakeholders, at all levels of the healthcare system and from a wide range of settings, are taken into account at all stages of the process.

Background: This is the third in a series of three papers describing the use of qualitative evidence syntheses (QES) to inform the development of clinical and health systems guidelines. WHO has recognised the need to improve its guideline methodology to ensure that decision-making processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable to end users. In addition to the standard data on effectiveness, WHO guidelines increasingly use evidence derived from QES to provide information on acceptability and feasibility and to develop important implementation considerations., Methods: WHO convened a group drawn from the technical teams involved in formulating recent (2010-2018) guidelines employing QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. As members of WHO guideline technical teams, our aim in this paper is to explore how we have used findings from QES to develop implementation considerations for these guidelines., Results: For each guideline, in addition to using systematic reviews of effectiveness, the technical teams used QES to gather evidence of the acceptability and feasibility of interventions and, in some cases, equity issues and the value people place on different outcomes. This evidence was synthesised using standardised processes. The teams then used the QES to identify implementation considerations combined with other sources of information and input from experts., Conclusions: QES were useful sources of information for implementation considerations. However, several issues for further development remain, including whether researchers should use existing health systems frameworks when developing implementation considerations; whether researchers should take confidence in the evidence into account when developing implementation considerations; whether qualitative evidence that reveals implementation challenges should lead guideline panels to make conditional recommendations or only point to implementation considerations; and whether guideline users find it helpful to have challenges pointed out to them or whether they also need solutions. Finally, we need to explore how QES findings can be incorporated into derivative products to aid implementation.

Background: WHO has recognised the need to improve its guideline methodology to ensure that guideline decision-making processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable. To help achieve this, WHO guidelines now typically enhance intervention effectiveness data with evidence on a wider range of decision-making criteria, including how stakeholders value different outcomes, equity, gender and human rights impacts, and the acceptability and feasibility of interventions. Qualitative evidence syntheses (QES) are increasingly used to provide evidence on this wider range of issues. In this paper, we describe and discuss how to use the findings from QES to populate decision-making criteria in evidence-to-decision (EtD) frameworks. This is the second in a series of three papers that examines the use of QES in developing clinical and health system guidelines., Methods: WHO convened a writing group drawn from the technical teams involved in its recent (2010-2018) guidelines employing QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development., Results: We describe a step-wise approach to populating EtD frameworks with QES findings. This involves allocating findings to the different EtD criteria (how stakeholders value different outcomes, equity, acceptability and feasibility, etc.), weaving the findings into a short narrative relevant to each criterion, and inserting this summary narrative into the corresponding 'research evidence' sections of the EtD. We also identify areas for further methodological research, including how best to summarise and present qualitative data to groups developing guidelines, how these groups draw on different types of evidence in their decisions, and the extent to which our experiences are relevant to decision-making processes in fields other than health., Conclusions: This paper shows the value of incorporating QES within a guideline development process, and the roles that qualitative evidence can play in integrating the views and experiences of relevant stakeholders, including groups who may not be otherwise represented in the decision-making process.

Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility., Competing Interests: Competing interests: All authors are members of the GRADE Working Group and conduct scholarly activity or professional services related to the concepts in this article. BSA and PO are employed by EBSCO Information Services and IK is employed by Duodecim Medical Publications Ltd., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

It is evident from reviewing scientific literature that the quality of argumentation in some areas of medical research has deteriorated during the last decades. Publication of a series of questionable reliability has continued without making references to the published criticism; examples are discussed in this review. Another tendency is that drugs without proven efficiency are advertised, corresponding products patented and marketed as evidence-based medications. Professional publications are required to register drugs and dietary supplements to obtain permissions for the practical use; and such papers appeared, sometimes being of questionable reliability. Several examples are discussed in this review when substances without proven effects were patented and introduced into practice being supported by publications of questionable reliability. Some of the topics are not entirely clear; and the arguments provided here can induce a constructive discussion., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

In recent decades, evidence-based medicine has become one of the foundations of clinical practice, making it necessary that healthcare practitioners develop keen critical appraisal skills for scientific papers. Worksheets to guide clinicians through this critical appraisal are often used in journal clubs, a key part of continuing medical education. A similar need is arising for health professionals to develop skills in the critical appraisal of medical ethics papers. Medicine is increasingly ethically complex, and there is a growing medical ethics literature that modern practitioners need to be able to use in their practice. In addition, clinical ethics services are commonplace in healthcare institutions, and the lion's share of the work done by these services is done by clinicians in addition to their usual roles. Education to support this work is important. In this paper, we present a worksheet designed to help busy healthcare practitioners critically appraise ethics papers relevant to clinical practice. In the first section, we explain what is different about ethics papers. We then describe how to work through the steps in our critical appraisal worksheet: identifying the point at issue; scrutinising definitions; dissecting the arguments presented; considering counterarguments; and finally deciding on relevance. Working through this reflective worksheet will help healthcare practitioners to use the ethics literature effectively in clinical practice. We also intend it to be a shared evaluative tool that can form the basis of professional discussion such as at ethics journal clubs. Practising these critical reasoning skills will also increase practitioners' capacity to think through difficult ethical decisions in daily clinical practice., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted., Methods: The task force was composed of the leadership team of ISPOR's ePRO Working Group and members of another group (i.e., ePRO Consensus Development Working Group) that had already begun to develop recommendations regarding ePRO good research practices. The resulting task force membership reflected a broad array of backgrounds, perspectives, and expertise that enriched the development of this report. The prior work became the starting point for the Task Force report. A subset of the task force members became the writing team that prepared subsequent iterations of the report that were distributed to the full task force for review and feedback. In addition, review beyond the task force was sought and obtained. Along with a presentation and discussion period at an ISPOR meeting, a draft version of the full report was distributed to roughly 220 members of a reviewer group. The reviewer group comprised individuals who had responded to an emailed invitation to the full membership of ISPOR. This Task Force report reflects the extensive internal and external input received during the 16-month good research practices development process. RESULTS/RECOMMENDATIONS: An ePRO questionnaire that has been adapted from a paper-based questionnaire ought to produce data that are equivalent or superior (e.g., higher reliability) to the data produced from the original paper version. Measurement equivalence is a function of the comparability of the psychometric properties of the data obtained via the original and adapted administration mode. This comparability is driven by the amount of modification to the content and format of the original paper PRO questionnaire required during the migration process. The magnitude of a particular modification is defined with reference to its potential effect on the content, meaning, or interpretation of the measure's items and/or scales. Based on the magnitude of the modification, evidence for measurement equivalence can be generated through combinations of the following: cognitive debriefing/testing, usability testing, equivalence testing, or, if substantial modifications have been made, full psychometric testing. As long as only minor modifications were made to the measure during the migration process, a substantial body of existing evidence suggests that the psychometric properties of the original measure will still hold for the ePRO version. Hence, an evaluation limited to cognitive debriefing and usability testing only may be sufficient. However, where more substantive changes in the migration process has occurred, confirming that the adaptation to the ePRO format did not introduce significant response bias and that the two modes of administration produce essentially equivalent results is necessary. Recommendations regarding the study designs and statistical approaches for assessing measurement equivalence are provided., Conclusions: The electronic administration of PRO measures offers many advantages over paper administration. We provide a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.

Objective: To perform a thorough assessment of the recently published Mint Trials in order to illustrate how to read and analyze a study critically, according to principles of evidence-based medicine., Design: Narrative review., Method: We have applied the recently published guidelines for composing and assessing studies on the treatment of pain to a recently published article describing a large study that claimed its "findings do not support the use of radiofrequency denervation to treat chronic low back pain." These guidelines describe the critical components of a high-quality manuscript that allows communication of all relevant information from authors to readers., Results: Application of evidence-based medicine principles to the publication describing the Mint Trials reveals significant issues with the methodology and conclusions drawn by the authors. A thorough assessment demonstrates issues with inclusion/exclusion criteria, diagnostic block protocols, radiofrequency neurotomy technique, co-interventions, outcome measurement, power analysis, study sample characteristics, data analysis, and loss to follow-up. A failure to definitively establish a diagnosis, combined with use of an inadequate technique for radiofrequency neurotomy and numerous other methodological flaws, leaves the reader unable to draw meaningful conclusions from the study data., Conclusions: Critical analysis, rooted in principles of evidence-based medicine, must be employed by writers and readers alike in order to encourage transparency and ensure that appropriate conclusions are drawn from study data.

Background: Overviews of systematic reviews (SRs) attempt to systematically retrieve and summarise the results of multiple systematic reviews. This is the second of two papers from a study aiming to develop a comprehensive evidence map of the methods used in overviews. Our objectives were to (a) develop a framework of methods for conducting, interpreting and reporting overviews (stage I)-the Methods for Overviews of Reviews (MOoR) framework-and (b) to create an evidence map by mapping studies that have evaluated overview methods to the framework (stage II). In the first paper, we reported findings for the four initial steps of an overview (specification of purpose, objectives and scope; eligibility criteria; search methods; data extraction). In this paper, we report the remaining steps: assessing risk of bias; synthesis, presentation and summary of the findings; and assessing certainty of the evidence arising from the overview., Methods: In stage I, we identified cross-sectional studies, guidance documents and commentaries that described methods proposed for, or used in, overviews. Based on these studies, we developed a framework of possible methods for overviews, categorised by the steps in conducting an overview. Multiple iterations of the framework were discussed and refined by all authors. In stage II, we identified studies evaluating methods and mapped these evaluations to the framework., Results: Forty-two stage I studies described methods relevant to one or more of the latter steps of an overview. Six studies evaluating methods were included in stage II. These mapped to steps involving (i) the assessment of risk of bias (RoB) in SRs (two SRs and three primary studies, all reporting evaluation of RoB tools) and (ii) the synthesis, presentation and summary of the findings (one primary study evaluating methods for measuring overlap)., Conclusion: Many methods have been described for use in the latter steps in conducting an overview; however, evaluation and guidance for applying these methods is sparse. The exception is RoB assessment, for which a multitude of tools exist-several with sufficient evaluation and guidance to recommend their use. Evaluation of other methods is required to provide a comprehensive evidence map.

Rationale and Objectives: We aimed to determine if both evidence level (EL) as well as clinical efficacy (CE) of imaging manuscripts have changed over the last 20 years., Materials and Methods: With our review of medical literature, Institutional Review Board approval was waived, and no informed consent was required. Using Web of Science, we determined the 10 highest impact factor imaging journals. For each journal the 10 most cited and 10 average cited papers were compared for the following years: 1994, 1998, 2002, 2006, 2010, and 2014. EL was graded using the same criteria as the Journal of Bone and Joint Surgery (Wright et al., 2003). CE was graded using the criteria of Thornbury and Fryback (1991). Statistical software R and package lme4 were used to fit mixed regression models with fixed effects for group, year, and a random effect for journal., Results: EL has improved -0.03 every year on average (P < .001). The more cited papers had better ELs (group effect = -0.23, SE 0.09, P = .011). CE is lower in top cited compared to average cited articles, although the differences were not statistically significant (group effect = -0.14, SE = 0.09, P = .16). CE level increased modestly in both groups over this 20-year time period (0.06 per year, SE = 0.007, P < .001)., Conclusion: Over the last 20 years, imaging journal articles have improved modestly in quality of evidence, as measured by EL and CE., (Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

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

Objectives: This article provides reviewers with guidance on methods for identifying and processing evidence to understand intervention implementation., Study Design and Setting: Strategies, tools, and methods are applied to the systematic review process to illustrate how process and implementation can be addressed using quantitative, qualitative, and other sources of evidence (i.e., descriptive textual and nonempirical)., Results: Reviewers can take steps to navigate the heterogeneity and level of uncertainty present in the concepts, measures, and methods used to assess implementation. Activities can be undertaken in advance of a Cochrane quantitative review to develop program theory and logic models that situate implementation in the causal chain. Four search strategies are offered to retrieve process and implementation evidence. Recommendations are made for addressing rigor or risk of bias in process evaluation or implementation evidence. Strategies are recommended for locating and extracting data from primary studies. The basic logic is presented to assist reviewers to make initial review-level judgments about implementation failure and theory failure., Conclusion: Although strategies, tools, and methods can assist reviewers to address process and implementation using quantitative, qualitative, and other forms of evidence, few exemplar reviews exist. There is a need for further methodological development and trialing of proposed approaches., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this article, we report updated guidance from the group on approaches, methods, and tools, which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations. We draw on conceptual analyses of mixed methods systematic review designs and the range of methods and tools that have been used in published reviews that have successfully integrated different types of evidence. We outline five key methods and tools as devices for integration which vary in terms of the levels at which integration takes place; the specialist skills and expertise required within the review team; and their appropriateness in the context of limited evidence. In situations where the requirement is the integration of qualitative and process evidence within intervention effectiveness reviews, we recommend the use of a sequential approach. Here, evidence from each tradition is synthesized separately using methods consistent with each tradition before integration takes place using a common framework. Reviews which integrate qualitative and process evaluation evidence alongside quantitative evidence on intervention effectiveness in a systematic way are rare. This guidance aims to support review teams to achieve integration and we encourage further development through reflection and formal testing., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's relevance component., Methods: We developed the relevance component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual relevance component within several qualitative evidence syntheses before agreeing on the current definition and principles for application., Results: When applying CERQual, we define relevance as the extent to which the body of data from the primary studies supporting a review finding is applicable to the context (perspective or population, phenomenon of interest, setting) specified in the review question. In this paper, we describe the relevance component and its rationale and offer guidance on how to assess relevance in the context of a review finding. This guidance outlines the information required to assess relevance, the steps that need to be taken to assess relevance and examples of relevance assessments., Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of relevance in the context of the CERQual approach. Assessing the relevance component requires consideration of potentially important contextual factors at an early stage in the review process. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on making an overall assessment of confidence in a review finding and creating a CERQual Evidence Profile and a CERQual Summary of Qualitative Findings table., Methods: We developed this guidance by examining the methods used by other GRADE approaches, gathering feedback from relevant research communities and developing consensus through project group meetings. We then piloted the guidance on several qualitative evidence syntheses before agreeing on the approach., Results: Confidence in the evidence is an assessment of the extent to which a review finding is a reasonable representation of the phenomenon of interest. Creating a summary of each review finding and deciding whether or not CERQual should be used are important steps prior to assessing confidence. Confidence should be assessed for each review finding individually, based on the judgements made for each of the four CERQual components. Four levels are used to describe the overall assessment of confidence: high, moderate, low or very low. The overall CERQual assessment for each review finding should be explained in a CERQual Evidence Profile and Summary of Qualitative Findings table., Conclusions: Structuring and summarising review findings, assessing confidence in those findings using CERQual and creating a CERQual Evidence Profile and Summary of Qualitative Findings table should be essential components of undertaking qualitative evidence syntheses. This paper describes the end point of a CERQual assessment and should be read in conjunction with the other papers in the series that provide information on assessing individual CERQual components.

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on a probable fifth component, dissemination bias. Given its exploratory nature, we are not yet able to provide guidance on applying this potential component of the CERQual approach. Instead, we focus on how dissemination bias might be conceptualised in the context of qualitative research and the potential impact dissemination bias might have on an overall assessment of confidence in a review finding. We also set out a proposed research agenda in this area., Methods: We developed this paper by gathering feedback from relevant research communities, searching MEDLINE and Web of Science to identify and characterise the existing literature discussing or assessing dissemination bias in qualitative research and its wider implications, developing consensus through project group meetings, and conducting an online survey of the extent, awareness and perceptions of dissemination bias in qualitative research., Results: We have defined dissemination bias in qualitative research as a systematic distortion of the phenomenon of interest due to selective dissemination of studies or individual study findings. Dissemination bias is important for qualitative evidence syntheses as the selective dissemination of qualitative studies and/or study findings may distort our understanding of the phenomena that these syntheses aim to explore and thereby undermine our confidence in these findings. Dissemination bias has been extensively examined in the context of randomised controlled trials and systematic reviews of such studies. The effects of potential dissemination bias are formally considered, as publication bias, within the GRADE approach. However, the issue has received almost no attention in the context of qualitative research. Because of very limited understanding of dissemination bias and its potential impact on review findings in the context of qualitative evidence syntheses, this component is currently not included in the GRADE-CERQual approach., Conclusions: Further research is needed to establish the extent and impacts of dissemination bias in qualitative research and the extent to which dissemination bias needs to be taken into account when we assess how much confidence we have in findings from qualitative evidence syntheses.

Background: The GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) relevance, (3) coherence and (4) adequacy of data. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's coherence component., Methods: We developed the coherence component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual coherence component within several qualitative evidence syntheses before agreeing on the current definition and principles for application., Results: When applying CERQual, we define coherence as how clear and cogent the fit is between the data from the primary studies and a review finding that synthesises that data. In this paper, we describe the coherence component and its rationale and offer guidance on how to assess coherence in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess coherence, the steps that need to be taken to assess coherence and examples of coherence assessments., Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of coherence in the context of the CERQual approach. We suggest that threats to coherence may arise when the data supporting a review finding are contradictory, ambiguous or incomplete or where competing theories exist that could be used to synthesise the data. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations; (2) coherence; (3) adequacy of data; and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's adequacy of data component., Methods: We developed the adequacy of data component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual adequacy of data component within several qualitative evidence syntheses before agreeing on the current definition and principles for application., Results: When applying CERQual, we define adequacy of data as an overall determination of the degree of richness and the quantity of data supporting a review finding. In this paper, we describe the adequacy component and its rationale and offer guidance on how to assess data adequacy in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess data adequacy, the steps that need to be taken to assess data adequacy, and examples of adequacy assessments., Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of adequacy in the context of the CERQual approach. We approach assessments of data adequacy in terms of the richness and quantity of the data supporting each review finding, but do not offer fixed rules regarding what constitutes sufficiently rich data or an adequate quantity of data. Instead, we recommend that this assessment is made in relation to the nature of the finding. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase.

Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's methodological limitations component., Methods: We developed the methodological limitations component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual methodological limitations component within several qualitative evidence syntheses before agreeing on the current definition and principles for application., Results: When applying CERQual, we define methodological limitations as the extent to which there are concerns about the design or conduct of the primary studies that contributed evidence to an individual review finding. In this paper, we describe the methodological limitations component and its rationale and offer guidance on how to assess methodological limitations of a review finding as part of the CERQual approach. This guidance outlines the information required to assess methodological limitations component, the steps that need to be taken to assess methodological limitations of data contributing to a review finding and examples of methodological limitation assessments., Conclusions: This paper provides guidance for review authors and others on undertaking an assessment of methodological limitations in the context of the CERQual approach. More work is needed to determine which criteria critical appraisal tools should include when assessing methodological limitations. We currently recommend that whichever tool is used, review authors provide a transparent description of their assessments of methodological limitations in a review finding. We expect the CERQual approach and its individual components to develop further as our experiences with the practical implementation of the approach increase.

In this article we signpost readers to 10 papers we consider essential reading for anyone starting out on an evidence-based medicine journey. We have considered papers consisting a mix of old and new, seminal and cutting-edge that offer insight into what evidence-based medicine is, where it came from, why it matters and what it has achieved. This is balanced against some of the common criticisms of evidence-based medicine and efforts to tackle them. We have also highlighted papers acknowledging the importance of teaching and learning of the principles of evidence-based medicine and how health professionals can better use evidence in clinical decisions with patients., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Overviews of systematic reviews attempt to systematically retrieve and summarise the results of multiple systematic reviews. Methods for conducting, interpreting and reporting overviews are in their infancy. To date, there has been no evidence map of the methods used in overviews, thus making it difficult to determine the gaps and priorities for methods research. Our objectives were to develop and populate a comprehensive framework of methods for conducting, interpreting and reporting overviews (stage I) and to create an evidence map by mapping studies that have evaluated overview methods to the framework (stage II)., Methods: We searched methods collections (e.g. Cochrane Methodology Register, Meth4ReSyn library, AHRQ Effective Health Care Program) to identify eligible studies for both stages of this research. In stage I, cross-sectional studies, guidance documents and commentaries that described methods proposed for, or used in, overviews were used to develop and populate the framework of methods. Drafts and multiple iterations of the framework were discussed and refined by all authors. In stage II, we identified and described studies evaluating overview methods and mapped these evaluations to the framework., Results: In this paper, we present results for the four initial steps of conducting an overview: (a) specification of the purpose, objectives and scope, (b) specification of the eligibility criteria, (c) search methods and (d) data extraction. Twenty-nine studies mentioned or described methods relevant to one or more of these steps. In the developed framework, identified methods and approaches were grouped according to the steps an overview author would need to undertake. Fifteen studies evaluated identified methods, all of which mapped to the search methods step. These studies either reported the development and evaluation of a new search filter to retrieve systematic reviews or compared the performance of multiple filters., Conclusion: Gaps in the evaluation of methods were found for the majority of steps in the framework. More empirical studies are needed to evaluate the methods outlined and provide a comprehensive evidence map. The framework is useful for planning these evaluations and for planning methods required to deal with challenges that arise when conducting an overview.

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

Pragmatic trials may deliver real-world evidence on the added value of new medications compared with usual care and inform decision making earlier in development. This fifth paper in a series on pragmatic trials in the Journal discusses usual care as a comparator and the allocation of treatment strategies. The allocation and implementation of treatment strategies should resemble clinical practice as closely as possible. Randomization at the level of the site, as opposed to at the individual level, may be preferred. Data analysis according to the intention-to-treat principle is recommended, and crossover between treatment arms and strong treatment preferences may be accounted for in the study design in specific situations. Although usual care is the comparator of choice, this may differ substantially between centers and countries complicating comparator choice. Using clinical guidelines to define usual care can be helpful in standardizing comparator treatments; however, this may decrease the applicability of the results to real-life settings. Conversely, using multiple usual-care treatment arms will increase the complexity of the study. The specific objectives of the trial and design choices should be discussed with all stakeholders to realize the full potential of the pragmatic trial., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the series (see Box) discusses different types of outcomes and their suitability for pragmatic trials, design choices for measuring these outcomes, and their implications and challenges. Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results, and routinely collected outcomes should be prioritized. Typical outcomes include mortality, morbidity, functional status, well-being, and resource use. Surrogate endpoints are typically avoided as primary outcome. It is important to measure outcomes over a relevant time horizon and obtain valid and precise results. As pragmatic trials are often open label, a less subjective outcome can reduce bias. Methods that decrease bias or enhance precision of the results, such as standardization and blinding of outcome assessment, should be considered when a high risk of bias or high variability is expected. The selection of outcomes in pragmatic trials should be relevant for decision making and feasible in terms of executing the trial in the context of interest. Therefore, this should be discussed with all stakeholders as early as feasible to ensure the relevance of study results for decision making in clinical practice and the ability to perform the study., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

not available.

Purpose: The European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA) congress is an important venue, and the research presented can be a critical source of information used to impact clinical decisions and health policies. The purpose of this study was to evaluate the level of evidence of clinical free papers presented at the ESSKA congress from 2008 to 2016. Moreover, this study evaluated whether there were any changes in the distribution of level of evidence over time., Methods: Two reviewers screened the free papers presented at the ESSKA biannual congresses 2008-2016 for clinical evidence. Clinical papers included observational studies and trials involving direct interaction between an investigator and human subjects. Biomechanical studies, technique demonstrations, cadaveric studies, and panel discussions were excluded. The reviewers independently graded their level of evidence from level I (e.g. high-quality randomized trials) to level IV (e.g. case series and reports) using the classification system published by the American Academy of Orthopaedic Surgeons., Results: Of 1036 free papers that were identified, 729 met the inclusion criteria and were evaluated. Overall, 18% of studies were level I, 24% level II, 25% level III, and 33% level IV evidence. There was a significant improvement in level of evidence over time (p < 0.0001), with the proportion of level I studies increasing most dramatically (9% in 2008, 20% in 2012, 24% in 2016). Free papers studying the knee had higher levels of evidence than those evaluating other joints (p = 0.002)., Conclusion: The level of evidence of clinical free papers presented at the ESSKA congress between 2008 and 2016 is high relative to other orthopaedic meetings. Moreover, there has been a significant improvement in the level of evidence over time., Level of Evidence: Systematic review, Level IV.

Antiresorptive agent-related osteonecrosis of the jaw (ARONJ) is an intractable, though rare, complication in cancer patients with bone metastases and patients with osteoporosis who are treated with antiresorptive agents, including bisphosphonates and denosumab. Despite the more than 10 years that have passed since the first cases of bisphosphonate-related osteonecrosis of the jaw (BRONJ) were reported, our understanding of the epidemiology and pathophysiology of ARONJ remains limited, and data supported by evidence-based medicine are still sparse. However, the diagnosis and staging of ARONJ, identification of risk factors, and development of preventive and therapeutic approaches have advanced significantly over the past decade. The Position Paper 2017 is an updated version of the Position Paper 2010 of the Japanese Allied Committee on Osteonecrosis of the Jaw, which now comprises six Japanese academic societies. The Position Paper 2017 describes a new diagnostic definition for ARONJ, as proposed by the American Association of Oral and Maxillofacial Surgeons (AAOMS), summarizes our current understanding of the pathophysiology of ARONJ based on a literature search, and suggests methods for physicians and dentists/oral surgeons to manage the disease. In addition, the appropriateness of discontinuing antiresorptive medications (drug holiday) before, during, and after invasive dental treatments is discussed extensively. More importantly, the manuscript also proposes, for the first time, the importance of interactive communication and cooperation between physicians and dentists/oral surgeons for the successful treatment of ARONJ. The Position Paper 2017 is intended to serve as a guide for improving the management of ARONJ patients in Japan.