RESUMO
OBJECTIVES: To identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modifications. METHODS: We included documents written in English and published after 2010 that explicitly commented on SPIRIT 2013 or CONSORT 2010. We searched four bibliographic databases (Embase and MEDLINE to June 2022; Web of Science and Google Scholar to April 2022) and other sources (e.g., the EQUATOR Network website, the BMC Blog Network, and the BMJ rapid response section). Two authors independently assessed documents for eligibility and extracted data on basic characteristics and the wording of the main comments. We categorized comments as 'suggestion for modification to the wording of an existing guideline item,' 'suggestion for a new item,' or 'reflections on challenges or strengths.' We provided a summary and examples of the proposed suggestions and categorized comments into those that were directly linked to empirical investigations, were continuations of previous methodological discussions, or reflected new methodological developments. RESULTS: We assessed full text of 2,320 potentially eligible documents and included 93 documents with 114 comments. In total, 37 comments suggested modifications to existing guideline items. The participant flow section of CONSORT 2010 received the most comments (eight comments made different suggestions, e.g., one comment suggested to add numbers on nonrandomized screened participants). There were 46 comments suggesting new items. Multiple suggestions were related to trial interventions (eight comments made different suggestions, e.g., one comment suggested to add content on cointerventions), blinding (six comments suggested to add content on risk of unblinding), statistical methods (five comments made different suggestions, e.g., one comment suggested to add content on blinding of statisticians), and participant flow (seven comments made different suggestions, e.g., three comments suggested to add content on missing data). Half (53%) of the suggestions were directly linked to empirical investigations. Six (7%) suggestions were continuations of previous methodological discussions and five (6%) suggestions reflected new methodological developments related to conflicts of interest and funding, data sharing, and patient and public involvement. CONCLUSION: The issues raised provide context to authors, peer reviewers, editors, and readers of trials using SPIRIT 2013 and CONSORT 2010 and inform the planned updates of the core guidelines.
Assuntos
Projetos de Pesquisa , Redação , Humanos , Padrões de ReferênciaRESUMO
OBJECTIVE: To investigate the association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. DESIGN: Systematic review. ELIGIBILITY CRITERIA: Studies that compared the association between conflicts of interest and favourable recommendations of drugs or devices (eg, recommending a drug) in clinical guidelines, advisory committee reports, opinion pieces (eg, editorials), or narrative reviews. DATA SOURCES: PubMed, Embase, Cochrane Methodology Register (from inception to February 2020), reference lists, Web of Science, and grey literature. DATA EXTRACTION AND ANALYSIS: Two authors independently extracted data and assessed the methodological quality of the studies. Pooled relative risks and 95% confidence intervals were estimated using random effects models (relative risk >1 indicates that documents with conflicts of interest more often had favourable recommendations than documents with no conflicts of interest). Financial and non-financial conflicts of interest were analysed separately, and the four types of documents were analysed separately (preplanned) and combined (post hoc). RESULTS: 21 studies that analysed 106 clinical guidelines, 1809 advisory committee reports, 340 opinion pieces, and 497 narrative reviews were included. Unpublished data were received for 11 studies (eight full datasets and three summary datasets). 15 studies showed risk of confounding because the compared documents could differ in factors other than conflicts of interest (eg, different drugs used for different populations). The relative risk for associations between financial conflicts of interest and favourable recommendations for clinical guidelines was 1.26 (95% confidence interval 0.93 to 1.69; four studies of 86 clinical guidelines), for advisory committee reports was 1.20 (0.99 to 1.45; four studies of 629 advisory committee reports), for opinion pieces was 2.62 (0.91 to 7.55; four studies of 284 opinion pieces), and for narrative reviews was 1.20 (0.97 to 1.49; four studies of 457 narrative reviews). An analysis of all four types of documents combined supported these findings (1.26, 1.09 to 1.44). In one study that investigated specialty interests, the association between including radiologists as authors of guidelines and recommending routine breast cancer was: relative risk 2.10, 95% confidence interval 0.92 to 4.77; 12 clinical guidelines). CONCLUSIONS: We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. Limitations of this review were risk of confounding in the included studies and the statistical imprecision of individual analyses of each document type. It is not certain whether non-financial conflicts of interest influence recommendations. SYSTEMATIC REVIEW REGISTRATION: Cochrane Methodology Review Protocol MR000040.