ReviewTrials2025
Safety outcome trials in four mainline medical journals 30 years apart: a narrative review and the need for the transparency of informed consents.
Review in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Ethical Challenges in Research Involving Hospitalized Patients: A Phenomenological Study.Health care analysis : HCA : journal of health philosophy and policy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt was our impression that safety outcome trials were getting more frequent, raising ethical issues mainly related to patient autonomy. We and others had also proposed this autonomy would be best served if wording of the informed consents would be in the public domain.
methodsInitially two observers and an arbiter tabulated the main aims of randomized controlled trials (RCTs) published in 1990-1991 vs. 2019-2020 as efficacy, safety, or undecided in four mainline medical journals, from the websites. A pragmatic design as well as other salient features was also tabulated. After noting too many trials were categorized as undecided, two additional independent observers and the arbiter did a reassessment.
resultsIn our reassessment of 889 RCTs, 309 in earlier and 580 in the later time period, 828 (93%) were categorized as efficacy and 47 (5%) as a safety trial. We were undecided in 14 (2%) trials. The proportion of safety outcome trials between the two time periods were similar [14/309 (5%) vs. 33/580 (6%)] while RCTs of any category conducted in the critical care settings notably increased in time [12/309 (4%) vs. 52/580 (9%) OR 2.4; 1.3-4.6]. Death was a primary outcome measure in 0/14 among the earlier and 16/33 (49%) among the later safety outcome trials. Stroke in 9 and myocardial infarction in 8 safety outcome trials were additional primary outcome measures in the same group. There were 2 pragmatic trials in the earlier and 93 in the later period.
conclusionAlthough we did not observe a differential increase among the safety outcome trials of all categories, those in critical care settings had significantly increased in time. So did the safety outcome trials with primary outcome measures like death, myocardial infarction, and stroke as well as randomized controlled trials with a pragmatic design. These raise the issue of autonomy related to how clearly the sought-after safety through designing empirical studies primarily to quantitate harm had been worded to the trial participants in plain language. We maintain this issue cannot be adequately addressed unless the informed consent forms, especially for safety outcome trials, are in the public domain.
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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.