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Guidelines for Reporting Meta-Epidemiological Methodology Research

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EBM Primer Evid Based Med: first published as 10.1136/ebmed-2017-110713 on 12 July 2017. Downloaded from Guidelines for reporting meta-epidemiological methodology research Mohammad Hassan Murad, Zhen Wang 10.1136/ebmed-2017-110713 Abstract The goal is generally broad but often focuses on exam- Published research should be reported to evidence users ining the impact of certain characteristics of clinical studies on the observed effect, describing the distribu- Evidence-Based Practice with clarity and transparency that facilitate optimal tion of research evidence in a specific setting, exam- Center, Mayo Clinic, Rochester, appraisal and use of evidence and allow replication Minnesota, USA by other researchers. Guidelines for such reporting ining heterogeneity and exploring its causes, identifying are available for several types of studies but not for and describing plausible biases and providing empirical meta-epidemiological methodology studies. Meta- evidence for hypothesised associations. Unlike classic Correspondence to: epidemiological studies adopt a systematic review epidemiology, the unit of analysis for meta-epidemio- Dr Mohammad Hassan Murad, or meta-analysis approach to examine the impact logical studies is a study, not a patient. The outcomes Evidence-based Practice Center, of certain characteristics of clinical studies on the of meta-epidemiological studies are usually not clinical Mayo Clinic, 200 First Street 6–8 observed effect and provide empirical evidence for outcomes. SW, Rochester, MN 55905, USA; hypothesised associations. The unit of analysis in meta- In this guide, we adapt the items used in the PRISMA murad. mohammad@ mayo. edu 9 epidemiological studies is a study, not a patient. The statement for reporting systematic reviews and outcomes of meta-epidemiological studies are usually meta-analysis to fit the setting of meta- epidemiological not clinical outcomes. In this guideline, we adapt items studies. The rationale for starting with PRISMA is that from the Preferred Reporting Items for Systematic meta-epidemiological research requires a systematic Reviews and Meta-analyses (PRISMA) to fit the context approach (ie, a systematic review) to select data (the of meta-epidemiological studies. input for methodological analysis). The overarching goal of this guideline is to improve the transparency and clarity of healthcare research. Published research should be reported to evidence users with clarity and transparency to facilitate optimal Examples of meta-epidemiological studies appraisal and use of evidence and allow replication by Analysis of Cochrane systematic reviews showed that other researchers. However, for a variety of reasons, the trials with inadequate or unclear allocation concealment literature is commonly viewed as poorly reported with yielded larger estimates of effect relative to controlled critical information missing from published reports. trials with adequate allocation concealment.10 In a This necessitated the development of reporting guide- second meta-epidemiological study, non-blinded trials lines. Currently, there are guidelines for reporting of complementary medicine exaggerated the effect randomised trials (CONSORT), observational studies size by an average of 0.56 SD (95% CI –0.71 to –0.41) http://ebm.bmj.com/ 11 (STROBE), systematic reviews (Preferred Reporting Items compared with blinded trials. A third example is a for Systematic Reviews and Meta-analyses (PRISMA)), study that explored the effect of trials stopped early for 12 case reports (CARE), qualitative research (SRQR), diag- benefit on future research. In a fourth example, it was nostic and prognostic studies (STARD), quality improve- shown that in almost 30% of endocrinology studies, ment studies (SQUIRE), economic evaluations (CHEERS), the largest treatment effect was observed in the first animal preclinical studies (ARRIVE), study protocols or second published studies (ie, earlier studies, when (SPIRIT) and clinical practice guidelines (AGREE). studies were ordered chronologically using the date of on September 24, 2021 by guest. Protected copyright. 13 These guidelines are catalogued on the website of the publication). EQUATOR Network (Enhancing the QUAlity and Trans- parency Of health Research).1 The EQUATOR Network Proposed reporting guidelines is an international initiative that seeks to improve We have adapted items of the PRISMA statement to fit the reliability and value of health research litera- a meta-epidemiological study. The items are categorised ture by promoting transparent and accurate reporting according to the title, abstract, introduction, methods, and wider use of robust reporting guidelines. Some of results, conclusion and funding and are supported by these reporting guidelines have extensions for subtypes rationale and examples. of research (eg, PRISMA-Equity is used for equity-fo- cused systematic reviews). Some function as a tool for Title and abstract reporting and a tool for assessing the methodological Both the title and abstract should identify the report quality (eg, AGREE-II is used to evaluate the rigour and as a meta-epidemiological study, for example, ‘Early the reporting of clinical practice guidelines). studies reported extreme findings with large variability: Meta-epidemiological studies are a fairly new type a meta-epidemiologic study in the field of endocri- of study that has been increasingly published in the nology’. 13 The rationale for this identification is to last two decades,2–4 with no clear reporting standards. improve indexing and facilitate retrieval. It also helps Sometimes called methodology research, meta-epidemi- clinicians searching for systematic reviews about clin- ological research adopts a systematic review or meta- ical topics to quickly find relevant evidence and avoid analysis to provide data for methodological analysis.5 reviewing additional non-clinical meta-epidemiological Evid Based Med August 2017 | volume 22 | number 4 | 139 EBM Primer Evid Based Med: first published as 10.1136/ebmed-2017-110713 on 12 July 2017. Downloaded from studies. The abstract should also include a structured Results summary with subheadings that provide the context, The results section should include the results of the hypothesis, methods, data sources, results, limitations study selection process (how many studies, how many and conclusions of meta-epidemiological studies. Varia- patients, etc). Different from PRISMA, study and patient tions of these subheadings are acceptable. The rationale characteristics need to be tailored to the meta-epide- for having this information in the abstract relates to miological question at hand. Therefore, it may not be the fact that many readers only read the abstract. These important to know patients' age, comorbidities and requirements are similar to PRISMA. settings in some questions (although such characteris- tics may be important in other questions). For example, the meta-epidemiological study showing that trials with Introduction inadequate allocation concealment yielded larger esti- The introduction should include the rationale and mates of effects (relative to trials with adequate alloca- objectives of the study. This requirement is similar to tion concealment) does not necessarily have to describe PRISMA. However, it is more important to explicitly patients’ characteristics or comorbidities in each indi- state the hypothesis being tested in meta-epidemi- vidual trial.10 Publication bias should be evaluated and ological studies compared with a systematic review reported similar to PRISMA recommendations. summarising evidence about the effectiveness of an intervention (which may or may not have a clear Discussion and conclusions hypothesis and primarily aim at empirically evaluating As with PRISMA, the discussion section should include a clinical outcome). summary of the main findings and comparison with existing knowledge and should also include the limita- Methods tions and strengths of the meta-epidemiological study. The methods section should specify if the meta-epidemi- Limitations at a study level may not be important (as in ological study follows a priori established protocol and clinical systematic reviews); however, limitations at the clarify the eligibility criteria, information sources, search level of the meta-epidemiological study are important. methods, study selection and data collection process, The quality of evidence is a highly important step in data items collected, summary measures and synthesis a systematic review reporting on a treatment effect15 methods (including assumptions and computational and is critical for decision making but also may not be approximations and methods of additional analyses such relevant to a meta-epidemiological study. Investigators as sensitivity, subgroup or meta-regression analyses). should, however, inform readers of their certainty in the These requirements are similar to PRISMA. However, results, even if this was determined narratively16 because registration of protocols may not be needed, particularly formal approaches15 are intended to rate the certainty of since systematic reviews registration sites are geared evidence about interventions. Lastly, systematic reviews more towards clinical questions. Search strategy in a of clinical questions should include in their discussion meta-epidemiological study is different because it is not the implication of their findings on future research and driven by a clinical question. Evaluating and reporting current clinical practice. Meta-epidemiological
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