SynthesisPloS one2013
Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
Synthesis in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 5 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Non-inferiority trials in clinical ophthalmology: a systematic review.Eye (London, England) · 2025Pooled it
- Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review.JAMA network open · 2021Pooled it
- Pooled it
- Pooled it
- Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review.Trials · 2017Pooled it
- Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial.Thorax · 2020Trial
- Review
- Evaluating a novel, low-cost technique for cervical-spine immobilization for application in resource-limited LMICs: a non-inferiority trial.Spinal cord · 2022Article
- Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions.JAMA internal medicine · 2020Review
- Characteristics, results, and reporting of contemporary surgical trials: A systematic review and analysis.International journal of surgery protocols · 2020Article
- Misrepresentation and distortion of research in biomedical literature.Proceedings of the National Academy of Sciences of the United States of America · 2018Article
- Defining the noninferiority margin and analysing noninferiority: An overview.British journal of clinical pharmacology · 2017Article
- Use of a Spin Strategy Can Result in Unreliable Research Findings.The international journal of neuropsychopharmacology · 2017Article
- Classification and prevalence of spin in abstracts of non-randomized studies evaluating an intervention.BMC medical research methodology · 2015Article
- Interpretation of Results of Studies Evaluating an Intervention Highlighted in Google Health News: A Cross-Sectional Study of News.PloS one · 2015Article
- HIV prevention trial design in an era of effective pre-exposure prophylaxis.HIV clinical trialsReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesNon-inferiority (NI) randomized clinical trials (RCTs) commonly evaluate efficacy of new antiretroviral (ARV) drugs in human immunodeficiency virus (HIV) patients. Their reporting and interpretation have not been systematically evaluated. We evaluated the reporting of NI RCTs in HIV patients according to the CONSORT statement and assessed the degree of misinterpretation of RCTs when NI was inconclusive or not established.
designSystematic review.
methodsPubMed, Web of Science, and Scopus were reviewed until December 2011. Selection and extraction was performed independently by three reviewers.
resultsOf the 42 RCTs (n = 21,919; range 41-3,316) selected, 23 were in ARV-naïve and 19 in ARV-experienced patients. Twenty-seven (64%) RCTs provided information about prior RCTs of the active comparator, and 37 (88%) used 2-sided CIs. Two thirds of trials used a NI margin between 10 and 12%, although only 12 explained the method to determine it. Blinding was used in 9 studies only. The main conclusion was based on both intention-to-treat (ITT) and per protocol (PP) analyses in 5 trials, on PP analysis only in 4 studies, and on ITT only in 31 studies. Eleven of 16 studies with NI inconclusive or not established highlighted NI or equivalence, and distracted readers with positive secondary results.
conclusionsThere is poor reporting and interpretation of NI RCTs performed in HIV patients. Maximizing the reporting of the method of NI margin determination, use of blinding and both ITT and PP analyses, and interpreting negative NI according to actual primary findings will improve the understanding of results and their translation into clinical practice.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.