Cited by 129Meta-analysis and systematic reviewsPharmaceutical industry and healthcareStatistical Methods in Clinical Trials

Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications

Open access
Wieseler, B., Kerekes, M. F., Vervoelgyi, V., McGauran, N., Kaiser, T.·2012·BMJ

Abstract

Objective To investigate to what extent three types of documents for reporting clinical trials provide sufficient information for trial evaluation. Design Retrospective analysis Data sources Primary studies and corresponding documents (registry reports, clinical study reports, journal publications) from 16 health technology assessments of drugs conducted by the German Institute for Quality and Efficiency in Health Care between 2006 and February 2011. Data analysis We assessed reporting quality for each study and each available document for six items on methods and six on outcomes, and dichotomised them as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of studies with complete reporting for methods and outcomes, per item and overall, and compared the findings. Results We identified 268 studies. Publications, study reports and registry reports were available for 192 (72%), 101 (38%), and 78 (29%) studies, respectively. Reporting quality was highest in study reports, which overall provided complete information for 90% of items (1086/1212). Registry reports provided more complete information on outcomes than on methods (overall 330/468 (71%) v 147/468 (31%)); the same applied to publications (594/1152 (52%) v 458/1152 (40%)). In the matched pairs analysis, reporting quality was poorer in registry reports than in study reports for overall methods and outcomes (P Conclusion Registry reports and publications insufficiently repo…

Integrity signals

Registry

Crossref · 10.1136/bmj.d8141

Cites

37 of 37 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

We couldn’t retrieve this paper’s full text, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • High quality protocols and statistical analysis plans contain relevant information on study design and conduct that is often not reported in journal publications or trial registries.

    “High quality protocols and statistical analysis plans contain relevant information on study design and conduct that is often not reported in journal publications or trial registries.79 80”

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
Wieseler, B., Kerekes, M. F., Vervoelgyi, V., McGauran, N., & Kaiser, T.
Affiliations
Institute for Quality and Efficiency in Health Care (DE)
Corresponding author
Wieseler, B.
Venue
BMJ
Publisher
BMJ
Published
2012-01-03
Volume
344
Issue
jan03 1
Pages
d8141-d8141
ISSN
  • 0007-1447 (ISSN-L)
  • 0959-8138
  • 1468-5833
OpenAlex
W2051457518
Cited by
129
References
37
Citations by year
2026: 1 · 2025: 3 · 2024: 4 · 2023: 6 · 2022: 7 · 2021: 31 · 2020: 16 · 2019: 6 · 2018: 8 · 2017: 7 · 2016: 7 · 2015: 12 · 2014: 8 · 2013: 7 · 2012: 6
FWCI
12.05
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
trial reporting quality, clinical study reports, journal publishing, health technology assessment, drug trials, reporting guidelines
MeSH terms
Drug Evaluation, Periodicals as Topic, Registries, Retrospective Studies, Randomized Controlled Trials as Topic, Research Report

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review