Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.

Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.

The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

/pdf/the-prisma-statement-for-reporting-systematic-reviews-and-3j53e5oe33.pdf

The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.

/pdf/cochrane-handbook-for-systematic-reviews-of-interventions-1xbdy6uvru.pdf

Cochrane Handbook for Systematic Reviews of Interventions

Background. Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. Objective. To develop a checklist for explicit and comprehensive reporting of qualitative studies (indepth interviews and focus groups). Methods. We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Results. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Conclusions. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups

ObjectiveBecause of the pressure for timely, informed decisions in public health
and clinical practice and the explosion of information in the scientific literature,
research results must be synthesized. Meta-analyses are increasingly used
to address this problem, and they often evaluate observational studies. A
workshop was held in Atlanta, Ga, in April 1997, to examine the reporting
of meta-analyses of observational studies and to make recommendations to aid
authors, reviewers, editors, and readers.ParticipantsTwenty-seven participants were selected by a steering committee, based
on expertise in clinical practice, trials, statistics, epidemiology, social
sciences, and biomedical editing. Deliberations of the workshop were open
to other interested scientists. Funding for this activity was provided by
the Centers for Disease Control and Prevention.EvidenceWe conducted a systematic review of the published literature on the
conduct and reporting of meta-analyses in observational studies using MEDLINE,
Educational Research Information Center (ERIC), PsycLIT, and the Current Index
to Statistics. We also examined reference lists of the 32 studies retrieved
and contacted experts in the field. Participants were assigned to small-group
discussions on the subjects of bias, searching and abstracting, heterogeneity,
study categorization, and statistical methods.Consensus ProcessFrom the material presented at the workshop, the authors developed a
checklist summarizing recommendations for reporting meta-analyses of observational
studies. The checklist and supporting evidence were circulated to all conference
attendees and additional experts. All suggestions for revisions were addressed.ConclusionsThe proposed checklist contains specifications for reporting of meta-analyses
of observational studies in epidemiology, including background, search strategy,
methods, results, discussion, and conclusion. Use of the checklist should
improve the usefulness of meta-analyses for authors, reviewers, editors, readers,
and decision makers. An evaluation plan is suggested and research areas are
explored.

https://jamanetwork.com/journals/jama/articlepdf/192614/JST00003.pdf

Meta-analysis of observational studies in epidemiology - A proposal for reporting

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

/pdf/consort-2010-statement-updated-guidelines-for-reporting-4ae3ljk2ki.pdf

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(98)01085-X.pdf

Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses

ContextThe Consolidated Standards for Reporting of Trials (CONSORT) statement
was developed to help improve the quality of reports of randomized controlled
trials (RCTs). To date, a paucity of data exists regarding whether it has
achieved this goal.ObjectiveTo determine whether use of the CONSORT statement is associated with
improvement in the quality of reports of RCTs.Design and SettingComparative before-and-after evaluation in which reports of RCTs published
in 1994 (pre-CONSORT) were compared with RCT reports from the same journals
published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that
adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator).Main Outcome MeasuresNumber of CONSORT items included in a report, frequency of unclear reporting
of allocation concealment, and overall trial quality score based on the Jadad
scale, a 5-point quality assessment instrument.ResultsCompared with 1994, the number of CONSORT checklist items in reports
of RCTs increased in all 4 journals in 1998, and this increase was statistically
significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7;
95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting
of allocation concealment decreased for each of the 4 journals, and this change
was statistically significant for adopters (pre-CONSORT, 61%; mean change, −22%;
95% CI, −38% to −6%). Similarly, 3 of the 4 journals showed an
improvement in the quality score for reports of RCTs, and this increase was
statistically significant for adopter journals overall (pre-CONSORT, 2.7;
mean change, 0.4; 95% CI, 0.1-0.8).ConclusionUse of the CONSORT statement is associated with improvements in the
quality of reports of RCTs.

https://jamanetwork.com/journals/jama/articlepdf/193739/JBR00024.pdf

Use of the CONSORT Statement and Quality of Reports of Randomized Trials: A Comparative Before-and-After Evaluation

Context.—Review articles are important sources of information to help guide decisions
by clinicians, patients, and other decision makers. Ideally, reviews should
include strategies to minimize bias and to maximize precision and be reported
so explicitly that any interested reader would be able to replicate them.Objective.—To compare the methodological and reporting aspects of systematic reviews
and meta-analyses published by the Cochrane Collaboration with those published
in paper-based journals indexed in MEDLINE.Data Sources.—The Cochrane Library, issue 2 of 1995, and a search of MEDLINE restricted
to 1995.Study Selection.—All 36 completed reviews published in the Cochrane Database of Systematic
Reviews and a randomly selected sample of 39 meta-analyses or systematic reviews
published in journals indexed by MEDLINE in 1995.Data Extraction.—Number of authors, trials, and patients; trial sources; inclusion and
exclusion criteria; language restrictions; primary outcome; trial quality
assessment; heterogeneity testing; and effect estimates. Updating by 1997
was evaluated.Results.—Reviews found in MEDLINE included more authors (median, 3 vs 2; P<.001), more trials (median, 13.5 vs 5; P<.001), and more patients (median, 1280 vs 528; P <.001) than Cochrane reviews. More Cochrane reviews, however,
included a description of the inclusion and exclusion criteria (35/36 vs 18/39; P<.001) and assessed trial quality (36/36 vs 12/39; P<.001). No Cochrane reviews had language restrictions
(0/36 vs 7/39; P<.01). There were no differences
in sources of trials, heterogeneity testing, or description of effect estimates.
By June 1997, 18 of 36 Cochrane reviews had been updated vs 1 of 39 reviews
listed in MEDLINE.Conclusions.—Cochrane reviews appear to have greater methodological rigor and are
more frequently updated than systematic reviews or meta-analyses published
in paper-based journals.

https://jamanetwork.com/journals/jama/articlepdf/187764/JPV71036.pdf

Methodology and reports of systematic reviews and meta-analyses: a comparison of Cochrane reviews with articles published in paper-based journals.

Community-based interventions offer a promising solution for reducing child and adolescent unintentional injuries. By focusing on altering behavior, promoting environmental change within the community, or passing and enforcing legislation, these interventions seek to change social norms about acceptable safety behaviors. This article systematically reviews 32 studies that evaluated the impact of community-based injury prevention efforts on childhood injuries, safety behaviors, and the adoption of safety devices. Interventions targeted schools, municipalities, and cities. Most relied on an educational approach, sometimes in combination with legislation or subsidies, to reduce the cost of safety devices such as bicycle helmets. Results indicate that community-based approaches are effective at increasing some safety practices, such as bicycle helmet use and car seat use among children. The evidence is less compelling that such interventions increase child pedestrian safety, increase adolescent vehicle safety by reducing drinking and driving behaviors, or reduce rates of several categories of childhood injuries. Strong evidence supporting the effectiveness of community-based interventions is lacking, in part because few studies used randomized controlled designs or examined injury rates among children and youths as outcome measures. Nonetheless, this review identifies common elements of successful community-based approaches that should be replicated in future studies. First, the use of multiple strategies grounded in a theory of behavior change is critical. Second, to maximize success, interventions should be integrated into the community and approaches should be tailored to meet unique community needs. Third, community stakeholders should be included in the development of community-based strategies. This community involvement and ownership of the intervention increases the likelihood of modeling and peer pressure, leading to widespread adoption of a safety behavior. Finally, when possible, a randomized controlled design should be used to maximize the trustworthiness of reported findings and aid decisions about where to invest resources in community-based approaches to injury prevention.

Alison Jones

Papers

Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses

Use of the CONSORT Statement and Quality of Reports of Randomized Trials: A Comparative Before-and-After Evaluation

Methodology and reports of systematic reviews and meta-analyses: a comparison of Cochrane reviews with articles published in paper-based journals.

Community-based injury prevention interventions.

Assessing the Quality of Reports of Randomised Trials Included in Meta-Analyses: Attitudes, Practice, Evidence and Guides