Journal of clinical epidemiology
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Review
Most noninferiority trials were not designed to preserve active comparator treatment effects.
To evaluate whether noninferiority trials are designed to adequately preserve the historical treatment effect of their active comparators. ⋯ Most noninferiority trials published in major medical journals could allow erroneous declarations of noninferiority.
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The determinants of guideline panels' recommendations remain uncertain. The objective of this study was to investigate factors considered by members of 8 panels convened by the American Society of Hematology (ASH) to develop guidelines using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. ⋯ GRADE's conceptual framework proved, in general, to be highly associated with SOR. Failure of certainty of evidence to be associated with SOR against an intervention, suggest the need for improvements in the process.
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To document reporting of study characteristics of randomized controlled trials (RCTs) in the four leading general medical journals and to appraise the generalizability of the evidence. ⋯ Almost all RCTs showed deficiencies in description of patient selection and study setting and in reporting of patient characteristics related to functioning, comorbidities, and to behavioral, environmental, and inequity factors. The findings indicate that generalizability of this evidence may be limited. The benchmarking method can be used for planning and appraisal of clinical trials and systematic reviews.
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To determine how often stepped-wedge cluster randomized controlled trials reach their planned sample size, and what reasons are reported for choosing a stepped-wedge trial design. ⋯ About half of recently published stepped-wedge trials reached their planned sample size indicating that recruitment is also a major problem in these trials. Still, the stepped-wedge trial design can yield practical, ethical, and methodological advantages.
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To synthesize the measurement properties of six health-related quality of life instruments (Short Form 36 [SF-36], Short Form 12 [SF-12], EuroQol 5D-3L [EQ-5D-3L], EuroQol 5D-5L [EQ-5D-5L], Nottingham Health Profile (NHP), and Patient-Reported Outcome Measurement Information System Global Health [PROMIS-GH-10]) in patients with low back pain (LBP). ⋯ Documentation of the measurement properties of health-related quality of life instruments in LBP is incomplete. Future clinimetric studies should prioritize content validity.