Introduction: Noninferiority trials can show that new treatments with slightly less efficacy are safer, cheaper, or easier to administer. However, the conclusions of noninferiority trials depend on robust methodology. Methods: We conducted a 6 year cross-sectional investigation of the methodological quality of oncology noninferiority trials published in the top 10 oncology journals. Four key quality criteria were investigated. Results: Nonefficacy benefits of the new treatment were stated in 88/110 (80.0 %) trials. Justification for the noninferiority margin was provided in 79/110 (71.8 %) trials. Authors most often used previous data as justification for the chosen margin (n = 42). In 15 noninferiority trials the percent preserved effect could be calculated and the median effect preserved was 56.8 %. Conclusions: The oncology noninferiority trials included in our study had key methodological shortcomings, counterbalanced by a clear delineation of expected nonefficacy benefits of the new treatment.

ObjectiveSpin, the misrepresentation and distortion of research findings, has been shown to affect clinical decision making. Spin has been found in randomized controlled trials (RCTs) published in various fields of medicine, but no study has tested for the presence of spin in otolaryngology RCTs. The purpose of this study is to evaluate the abstracts of RCTs found in the otolaryngology literature for spin.MethodsIn this cross‐sectional analysis, we analyzed the abstracts of RCTs for spin using a pilot‐tested form. Double data extraction was performed by two blinded authors, and discrepancies were resolved using mutual discussion.ResultsOut of the 534 PubMed citations retrieved by our search string, 162 parallel‐group RCTs with clearly defined primary and secondary endpoints were identified. Further analysis identified 47 trials with nonsignificant primary outcomes, which were then evaluated for spin. Spin was identified in 33 of the 47 (70%) abstracts. Spin was found in the results sections of 25 (53%) of the included abstracts and was found in the conclusion section of 27 (57%) of the abstracts. Spin was not present in the titles of any of the included studies.ConclusionSpin was common in our sample of otolaryngology RCTs. Spin may potentially create false impressions about the true validity of a drug or intervention. Further research needs to test for potential clinical implications of spin in the otolaryngology literature.Level of EvidenceNALaryngoscope, 129:2036–2040, 2019

Systematic reviews of postoperative pain in children have called into question the consistency of outcomes measured by clinical triallists as well as the measurement instruments used for assessment. Core outcome set methodology may be a solution to improve standardisation. This study provides an evidence-based foundation for the development of a core outcome set for paediatric postoperative pain studies. We searched ClinicalTrials.gov to identify relevant postoperative pain studies in children. The search yielded 300 registered trials. The following data were then extracted from each of the trials: phase of trial; study type; study design; sample size; all outcomes; whether the outcome was listed as primary, secondary, or tertiary; the measurement instrument for each reported outcome; the specific metric for each outcome; and the type of clinical procedure. Following screening, 134 studies were included in our study. Pain measurement was the most commonly reported outcome (n = 123), followed by total postoperative analgesic dosage (n = 83) and side-effects (n = 25). Temporal trends indicated that pain assessment and unexpected events increased in use between 2000 and 2016, whereas postoperative analgesia measurement decreased. We found a lack of standardisation among outcomes and measurement instruments in paediatric postoperative pain studies. Development of a core outcome set may improve the quality of future trials and allow for more accurate study-to-study comparisons.

IntroductionWith efforts to combat opioid use disorder, there is an increased interest in clinical practice guidelines (CPGs) for opioid use disorder treatments. No literature exists examining the quality of systematic reviews used in opioid use disorder CPGs. This study aims to describe the methodological quality and reporting clarity of systematic reviews (SRs) used to create CPGs for opioid use disorder.MethodsFrom June to July 2016 guideline clearinghouses and medical literature databases were searched for relevant CPGs used in the treatment of opioid use disorder. Included CPGs must have been recognized by a national organization. SRs from the reference section of each CPG was scored by using AMSTAR (a measurement tool to assess the methodological quality of systematic reviews) tool and PRISMA (preferred reporting items for systematic reviews and meta-analyses) checklist.ResultsSeventeen CPGs from 2006-2016 were included in the review. From these, 57 unique SRs were extracted. SRS comprised 0.28% to 17.92% of all references found in the CPGs. All SRs obtained moderate or high methodological quality score on the AMSTAR tool. All reviews met at least 70% of PRISMA criteria. In PRISMA, underperforming areas included accurate title labeling, protocol registration, and risk of bias. Underperforming areas in AMSTAR included conflicts of interest, funding, and publication bias. A positive correlation was found between AMSTAR and PRISMA scores (r = .79).ConclusionAlthough the SRs in the CPGs were of good quality, there are still areas for improvement. Systematic reviewers should consult PRISMA and AMSTAR when conducting and reporting reviews. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations, recognizing that the quality of systematic reviews underpinning guidelines does not necessarily correspond to the quality of the guideline itself.

Selective outcome reporting is a form of bias resulting from discrepancies between outcomes presented in a trial's registration and the published report. We investigate this selective bias in obesity clinical trials. A PubMed search was conducted to identify randomized controlled trials (RCTs) published in four obesity journals from 2013 to 2015. Primary, secondary and tertiary outcomes were recorded for each trial and compared to pre-specified outcomes in each trial's registration. Of the 392 identified articles, 142 were included in the final analysis; 22 (15%) RCTs demonstrated major outcome discrepancies between registration and publication: No primary outcomes were demoted to a secondary or tertiary outcome; 14 (36.84%) primary outcomes were omitted; 14 (36.84%) primary outcomes were added: 5 (13.16%) secondary outcomes were upgraded to primary outcomes; and timing of assessment for a primary outcome changed 5 (13.16%) times. Out of the 63 prospectively registered studies, 53 had no discrepancies. A total of 76 of the studies (29.80%) were unregistered or did not have an associated registration number. Our results suggest that selective outcome reporting may be a concern in obesity clinical trials. As selective outcome reporting may distort clinical findings and limit outcomes in systematic reviews, we encourage trialists and journal editors to work towards solutions to mitigate this issue.