ArticleBMJ open2013
Comparing hormone therapy effects in two RCTs and two large observational studies that used similar methods for comprehensive data collection and outcome assessment.
Article in BMJ open, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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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
7 citing papers in PubMed, 8 citations in OpenAlex.
- Innovation in the Design of Clinical Trials for Infectious Diseases: Focusing on Patients Over Pathogens.Pharmaceutical medicine · 2025Review
- Renin-angiotensin-system inhibition in the context of corona virus disease-19: experimental evidence, observational studies, and clinical implications.Heart failure reviews · 2021Review
- The Weight of Evidence From Electrophysiology, Observational, and Cardiovascular End Point Studies Demonstrates the Safety of Azithromycin.Clinical and translational science · 2021Review
- Evaluating Anti-Infective Drugs in the Resistant Pathogen Setting: Can we Use External Controls?Statistical communications in infectious diseases · 2017Article
- Article
- Outcome Assessments in Clinical Trials of Cryptococcal Meningitis: Considerations on Use of Early Fungicidal Activity as a Potential Surrogate Endpoint for All-Cause Mortality.Current treatment options in infectious diseases · 2014Article
- Fallacies in medical practice: Renin-angiotensin-aldosterone system inhibition and COVID-19 as a Paradigm.Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheoreseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesProspective observational studies (OSs) that collect adequate information about confounders can validly assess treatment consequences. However, what constitutes adequate information is unknown. This study investigated whether the extensive information collected by the Women's Health Initiative (WHI) in two OSs and two randomised controlled trials (RCTs) was adequate.
designSecondary analysis of WHI data. Cox regression was used to select from all baseline risk factors those that best predicted outcome. Cox regression that included these risk factors was used for two types of analyses: (1) comparing RCT and OS assessments of the effects of hormone therapy on outcome for participants with specific characteristics and (2) evaluating whether adjustment for measured confounders could eliminate outcome differences among datasets.
settingThe WHI included more than 800 baseline risk factors and outcomes during a median follow-up of 8 years.
participants151 870 postmenopausal women ages 50-79. PRIMARY AND SECONDARY OUTCOME MEASURES: Myocardial infarction and stroke.
resultsRCT and OS results differed for the association of hormone therapy with outcome after adjusting for confounding factors and stratifying on factors that were hypothesised to modulate the effects of hormone therapy (eg, age and time since menopause) or that empirically modulated the effects of hormone therapy in this dataset (eg, blood pressure, previous coronary revascularisation and private medical insurance). Some of the four WHI datasets had significantly worse outcomes than others even after adjusting for risk and stratifying by type of hormone therapy, for example, the risk-adjusted HR for myocardial infarction was 1.37 (p<0.0001) in an RCT placebo group compared with an OS group not taking hormone therapy.
conclusionsApparently the WHI did not collect sufficient information to give reliable assessments of treatment effects. If the WHI did not collect sufficient data, it is likely that few OSs collect sufficient information.
Identifiers
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.