Cited by 452Meta-analysis and systematic reviewsPharmaceutical industry and healthcareStatistical Methods in Clinical Trials

Reporting bias in medical research - a narrative review

Open access
McGauran, Natalie, Wieseler, Beate, Kreis, Julia, Schüler, Yvonne-Beatrice, Kölsch, Heike, Kaiser, Thomas·2010·Trials

Abstract

Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors. The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting. We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is. For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles.We identified reporting bias in 40 indications comprising around 50 different pharmacological, surgical (e.g. vacuum-assisted closure therapy), diagnostic (e.g. ultrasound), and preventive (e.g. cancer vaccines) interventions. Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions: depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma. Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication. The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions.In conclusion, reporting bias is a widespread phenomenon in the medical literature. Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale. This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/1745-6215-11-37

Cites

223 of 223 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

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?

  • The medical literature represents a biased subset of existing data, potentially leading to overestimation of benefits, underestimation of harms, and detrimental impact on patient care and research.

    “Overall, the medical literature represents a biased subset of existing data, potentially leading to overestimation of benefits, underestimation of harms, and a detrimental impact on patient care and research.112 117 118”

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

2 retracted

Flagged first, then by citations

Research works printed but not linked: 7

  1. Institute for Quality and Efficiency in Health Care General methods: version 3.0 http://www.iqwig.de/download/IQWiG_General_methods_V-3-0.pdf Last update 27 May 2008 [accessed 22 Feb 2010] 27403465
  2. National Institute for Health and Clinical Excellence Guide to the methods of technology appraisal. London 2008 27905712
  3. Mathews A Martinez B E-mails suggest Merck knew Vioxx's dangers at early stage Wall Street Journal 2004 A1
  4. Institute for Quality and Efficiency in Health Care Bupropion, mirtazapine and reboxetine in the treatment of depression: executive summary of preliminary report; commission no A05-20C http://www.iqwig.de/download/A05-20C_Executive_summary_Bupropion_mirtazapine_and_reboxetine_in_the_treatment_of_depression.pdf Last update 29 May 2009 [accessed 26 Feb 2010] 23101069
  5. King RT Jr Bitter pill: how a drug firm paid for university study, then undermined it Wall Street Journal 1996 1 A13
  6. Herxheimer A Mintzes B Antidepressants and adverse effects in young patients: uncovering the evidence CMAJ 2004 170 487 489 14970096 PMC332715
  7. West RR Jones DA Publication bias in statistical overview of trials: example of psychological rehabilitation following myocardial infarction [Abstract] Proceedings of the 2nd International Conference on the Scientific Basis of Health Services and 5th Annual Cochrane Colloquium; 1997 Oct 8-12; Amsterdam. Amsterdam 1999 17

Cited by

Sorted by citations

Authors
McGauran, N., Wieseler, B., Kreis, J., Schüler, Y.-B., Kölsch, H., & Kaiser, T.
Affiliations
Institute for Quality and Efficiency in Health Care (DE)
Corresponding author
McGauran, Natalie
Venue
Trials
Published
2010-04-13
Volume
11
Issue
1
Pages
37-37
ISSN
1745-6215 (ISSN-L)
OpenAlex
W2130998313
Cited by
452
References
223
Citations by year
2026: 13 · 2025: 18 · 2024: 15 · 2023: 29 · 2022: 23 · 2021: 31 · 2020: 40 · 2019: 28 · 2018: 38 · 2017: 26 · 2016: 26 · 2015: 33 · 2014: 24 · 2013: 35 · 2012: 35
FWCI
9.37
Type
journal article
Language
en
Open access
Locations
  • Trials (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
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
reporting bias, publication bias, selective outcome reporting
MeSH terms
Animals, Consumer Product Safety, Humans, Periodicals as Topic, Registries, Truth Disclosure, Reproducibility of Results, Treatment Outcome, Publication Bias, Evidence-Based Medicine, Databases as Topic, Access to Information, Biomedical Research

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