Quality of Reporting of Randomized Trials as a Measure of Methodologic Quality
Abstract
Context The evaluation of the methodologic quality of randomized controlled trials (RCTs) is central to evidence-based health care. Important methodologic detail may, however, be omitted from published reports, and the quality of reporting is therefore often used as a proxy measure for methodologic quality. We examined the relationship between reporting quality and methodologic quality of published RCTs. Methods Study of 60 reports of placebo-controlled trials published in English-language journals from 1985 to 1997. Reporting quality was measured using a 25-item scale based on the 1996 issue of the Consolidated Standards of Reporting Trials (CONSORT). Concealment of allocation, appropriate blinding, and analysis according to the intention-to-treat principle were indicators of methodologic quality. Methodologic quality was compared between groups of trials defined by reporting quality scores of low, intermediate, and high. Reporting quality scores were compared between groups defined by high and low methodologic quality. Results Among 23 trials of low reporting quality (median score, 9 [range, 3.5-10.5]), allocation concealment was unclear for all but 1 trial, but there were 16 trials (70%) with adequate blinding and 9 trials (39%) that had been analyzed according to the intention-to-treat principle. Among 18 trials of high reporting quality (median score, 18 [range 16.5-22.0]), there were 8 trials (44%) with adequate allocation concealment, 16 trials (89%) with adequate blin…
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Adequate reporting of quality indicators is a validated measure of the quality of trial conduct, strongly related to the internal validity of randomized controlled trials.
“Adequate reporting of quality indicators is a validated measure of the quality of trial conduct, strongly related to the internal validity of randomized controlled trials (51).”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [51]
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- Authors
- Huwiler-Müntener, K.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2002-06-05
- Volume
- 287
- Issue
- 21
- Pages
- 2801
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W1965476565
- Cited by
- 397
- References
- 8
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2023: 5 · 2022: 7 · 2021: 3 · 2020: 14 · 2019: 12 · 2018: 17 · 2017: 17 · 2016: 13 · 2015: 18 · 2014: 22 · 2013: 35 · 2012: 24
- FWCI
- 30.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- reporting quality, methodological quality, randomized controlled trials, CONSORT, allocation concealment, blinding, intention-to-treat analysis
- MeSH terms
- Publishing, Quality Control, Writing, Randomized Controlled Trials as Topic
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