Risk of Bias and Quality of Reporting in Colon and Rectal Cancer Systematic Reviews Cited by National Comprehensive Cancer Network Guidelines.

INTRODUCTION: Given the changing landscape of colorectal cancer, systematic reviews are likely to play a key role in advancing the understanding of prevention, diagnosis, and treatment. METHODS: We conducted a cross-sectional investigation of the risk of bias and reporting quality of systematic reviews referenced by colon and rectal cancer National Comprehensive Cancer Network (NCCN) guidelines. We used two widely accepted tools: Risk of Bias in Systematic reviews (ROBIS) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). RESULTS: Using ROBIS, only 3 (4.8%) systematic reviews were judged with low risk of bias, 35 (55.6%) systematic reviews were judged with unclear risk of bias, and 25 (39.7%) systematic reviews were judged with high risk of bias. Across all systematic reviews, the individual bias domains at the highest risk of bias were domains 1 (protocol and eligibility criteria) and 2 (methods to identify and select studies). Across all studies, the median adherence to PRISMA was 74.1% (IQR 69.2-80.0%), corresponding to approximately 20 of 27 items. CONCLUSIONS: Systematic reviews cited in NCCN guidelines for colon and rectal cancer are frequently at unclear or high risk of bias and do not report key systematic review items that are important for the critical appraisal of results.

Evaluation of spin in oncology clinical trials.

PURPOSE: Spin, the misrepresentation of research findings, in clinical trial abstract has been shown to influence how oncologist rate a drug's efficacy. MATERIALS AND METHODS: We searched PubMed for clinical trials published in ten key journals in 2017. Our primary objectives were to assess the frequency and manifestations of spin in the abstracts of those clinical trials that measured both overall survival and at least one surrogate efficacy endpoints. RESULTS: 124 trials were included for analysis. We found evidence of spin in 46 of 124 (37.1%, 95% CI 29.1%-45.9%) trial abstracts. Spin in the abstract results was most often due to authors emphasizing a statistically significant subgroup analysis (n = 6). Spin in the abstract conclusions was most often due to authors relying on a statistically significant surrogate endpoint to highlight the bioefficacy of the intervention (n = 17). CONCLUSION: Spin is prevalent in the abstracts of oncology clinical trials that measure OS and a surrogate endpoint. The conclusion sections of abstracts were most prone to contain spin. When OS was the primary endpoint, spin was primarily used to distract from the nonsignificant OS data. To mitigate unintentional hype for cancer therapies, we recommend authors structure their conclusions around patient-important outcomes.

Evaluation of spin within abstracts in obesity randomized clinical trials: A cross-sectional review.

This is a cross-sectional analysis of spin in randomized controlled trial (RCT) abstracts published in top-ranked obesity and general medicine journals. The top seven obesity and four general medicine journals were searched from 1 January 2016 to 31 December 2017. To be included in this study, a trial must be an RCT with non-significant primary endpoint (P > 0.05), exclusively randomize subjects with overweight or obesity or have a primary endpoint of weight loss. These studies were analysed by two reviewers for spin in the abstract. The primary endpoint of our investigation was the frequency and type of spin. The secondary endpoint was to assess whether funding source was associated with the presence of spin. Our PubMed search yielded 1143 articles. Primary screening excluded 992 articles, and full-text evaluation excluded an additional 106. Overall, 45 articles were included. Spin was identified in 21 of the 45 (46.7%) abstracts analysed. Evidence of spin was found in 17 (37.8%) abstract result sections and 11 (24.4%) abstract conclusion sections. Of the 39 RCTs reporting a clinical trial registry, 6 (15.4%) had evidence of selective reporting bias. Our study found that obesity medicine RCTs from top-ranked journals with non-significant primary endpoints published in 2016 and 2017 frequently have spin in their abstracts. Abstracts with evidence of spin may influence a reader's perception of new drugs or procedures. These results warrant a careful review of future RCTs, but may not be generalizable to RCTs published in lower-ranked journals.

A comparison of matched interim analysis publications and final analysis publications in oncology clinical trials.

Background: Progression-free survival is an increasingly popular surrogate end point for overall survival. The strength of correlation between the two end points varies, raising questions about the correlation between results of interim analyses that report mature progression-free survival data with the subsequent final publication that report overall survival. Methods: We searched PubMed from 2005 to 2015 for randomized controlled trials that measured both progression-free survival and overall survival. We matched interim publications that reported mature progression-free survival data with their final analyses that reported overall survival. We included 25 matched pairs and 8 unmatched interim analyses whose final analyses are not published. Our primary objectives are to compare interim publications with matched final publications in terms of journal prominence and Altmetric score and to compare progression-free survival and overall survival effect sizes. Results: All interim analyses (n = 33) were prespecified and there was a statistically significant progression-free survival benefit in 31 (93.9%). Only eight matched final analyses had statistically significant overall survival data. Interim analyses were more often published in top-5 general medicine journals (P < 0.01) but not in top-5 oncology journals (P = 0.26). Altmetric scores were higher in interim analyses (P < 0.01). Progression-free survival effect sizes from interim analyses were a median of 31% larger than overall survival effect sizes from final analyses. Conclusion: Interim analyses with progression-free survival data may generate hype in oncology, as evidenced by journal impact factors and Altmetric scores. The cause of this hype may be due, in part, to large progression-free survival effect sizes. Regardless, in trials that investigate progression-free and overall survival, publishing interim analyses with mature progression-free survival data apart from the final analyses with mature overall survival should be cautioned.

Methodological quality, completeness of reporting and use of systematic reviews as evidence in clinical practice guidelines for paediatric overweight and obesity.

Paediatric obesity rates remain high despite extensive efforts to prevent and treat obesity in children. We investigated the quality of the methodology and reporting within systematic reviews (SRs) underpinning paediatric content in US clinical practice guidelines (CPGs). In June 2016 we searched guideline clearinghouses and professional organization websites for guidelines published by national or professional organizations in the United States from January 2007 onwards. In our primary, a priori analysis, we used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (A Measurement Tool to Assess Systematic Reviews) instruments to score SRs and meta-analyses that included paediatric populations and were cited by included CPGs. In a secondary, post hoc analysis, we determined the extent to which US CPGs use available, relevant SRs and meta-analyses compared with non-US CPGs. Eight US-based CPGs with 27 references to 22 unique SRs were found. AMSTAR and PRISMA scores were low overall, with only three SRs having 'high' methodological quality. Items dealing with bias assessments and search strategies had especially low scores. US CPGs were also older on average and cited fewer SRs than their international counterparts. Low quality scores and dated guidelines should be a cause for concern among practicing clinicians and a call to action for future guideline developers, publishers and research institutions.

Hematology journals do not sufficiently adhere to reporting guidelines: a systematic review.

Essentials Reporting guidelines and trial/review registration aim to limit bias in research. We systematically reviewed hematology journals to examine the use of these policies. Forty-eight percent of journals made no use of these policies. Improving the use of reporting guidelines will improve research for all stakeholders. SUMMARY: Background Reporting guidelines and trial/review registration policies have been instituted in order to minimize bias and improve research practices. Objective The objective of this study was to investigate the policies of hematology journals concerning reporting guideline adoption and trial/review registration. Methods We performed a web-based data abstraction from the Instructions for Authors of 67 hematology journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports to identify whether each journal required, recommended or made no mention of the following reporting guidelines: EQUATOR, ICMJE, CONSORT, MOOSE, QUOROM, PRISMA, STARD, STROBE, ARRIVE and CARE. We also extracted whether journals required or recommended trial or systematic review registration. We e-mailed editors three times to determine which types of studies their journal accepts. Results Forty-eight per cent (32/67) of hematology journals do not adhere to any reporting guidelines. For responding journals, the QUOROM statement, MOOSE, CARE and PROSPERO were the least often mentioned, whereas the ICMJE guidelines, CONSORT statement and general trial registration were most often mentioned. Discussion Reporting guidelines are infrequently required or recommended by hematology journals. Furthermore, few require clinical trial or systematic review database registration. A higher rate of adherence to reporting guidelines can prevent bias from entering the literature. Participation from all stakeholders, including authors and journal editors, to improve reporting guideline and policy practices is required.

Do emergency medicine journals promote trial registration and adherence to reporting guidelines? A survey of "Instructions for Authors".

BACKGROUND: The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. METHODS: We performed a web-based data abstraction from the "Instructions for Authors" of the 27 Emergency Medicine journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports and Google Scholar Metrics h5-index to identify whether each journal required, recommended, or made no mention of the following reporting guidelines: EQUATOR Network, ICMJE, ARRIVE, CARE, CONSORT, STARD, TRIPOD, CHEERS, MOOSE, STROBE, COREQ, SRQR, SQUIRE, PRISMA-P, SPIRIT, PRISMA, and QUOROM. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross-tabulations and descriptive statistics were calculated using IBM SPSS 22. RESULTS: Of the 27 emergency medicine journals, 11 (11/27, 40.7%) did not mention a single guideline within their "Instructions for Authors," while the remaining 16 (16/27, 59.3%) mentioned one or more guidelines. The QUOROM statement and SRQR were not mentioned by any journals whereas the ICMJE guidelines (18/27, 66.7%) and CONSORT statement (15/27, 55.6%) were mentioned most often. Of the 27 emergency medicine journals, 15 (15/27, 55.6%) did not mention trial or review registration, while the remaining 12 (12/27, 44.4%) at least mentioned one of the two. Trial registration through ClinicalTrials.gov was mentioned by seven (7/27, 25.9%) journals while the WHO registry was mentioned by four (4/27, 14.8%). Twelve (12/27, 44.4%) journals mentioned trial registration through any registry platform. DISCUSSION: The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. In this study, there was not a single reporting guideline mentioned in more than half of the journals. This undermines efforts of other journals to improve the completeness and transparency of research reporting. CONCLUSIONS: Reporting guidelines are infrequently required or recommended by emergency medicine journals. Furthermore, few require clinical trial registration. These two mechanisms may limit bias and should be considered for adoption by journal editors in emergency medicine. TRIAL REGISTRATION: UMIN000022486.