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Published on: May 24, 2020
Insights
The quality of scientific studies on oral contraceptives and thromboembolism significantly impacts reported incidence rates. Higher quality research shows a greater risk, challenging current low-incidence findings.
Area of Science:
- Medical research methodology
- Pharmacovigilance
- Epidemiology
Background:
- The relationship between oral contraceptives and thromboembolic episodes has been debated, with studies examining retrospective and prospective data.
- Previous analyses, such as those by Drill and Calhoun, have cited various articles to support their conclusions on the incidence of these events.
Purpose of the Study:
- To critically evaluate the scientific merit of studies cited in the discussion of oral contraceptives and thromboembolism.
- To assess whether the quality of scientific evidence influences the reported incidence of thromboembolic episodes.
Main Methods:
- Review and re-evaluation of scientific articles previously cited in discussions on oral contraceptives and thromboembolism.
- Ranking of selected articles based on scientific merit concerning the embolism problem.
- Analysis of the correlation between study quality, reported thromboembolism incidence, and sample size.
Main Results:
- Many cited articles lacked the rigor of research reports, with some offering only general, non-quantitative comments.
- When ranked by scientific quality, studies with higher merit reported a greater incidence of thromboembolism.
- Higher quality studies also tended to involve fewer subjects.
Conclusions:
- The overall reported incidence of thromboembolic episodes may be underestimated due to the inclusion of less rigorous studies with large sample sizes.
- There is a potential bias in current assessments of oral contraceptive risks, necessitating a re-evaluation based on higher-quality scientific evidence.
Abstract:
The article by Drill and Calhoun (219: 583, 1972) and subsequent comments (220: 416, 1972, and 221: 194, 1972) on the problem of thromboembolic episodes and oral contraceptives consider at length the problems of retrospective and prospective studies. If the critical standards presented had been applied to the articles cited by Drill and Calhoun, there would not have been much left to discuss. The citations of Goldzieher and of Tyler, for example, are not to research reports but to short sections of articles of a very general nature. Tyler's comments are not even quantitative. 10 of the 15 articles cited by Drill and Calhoun in their principle tabulation (Table 3) were readily available to me. When I arranged these articles in order of scientific merit as regards the embolism problem, it became apparent that the better the quality of the scientific effort, the higher was the reported incidence of thromboembolism and the lower the number of subjects. It is very possible that the inclusion of a few casual reports with large numbers of subjects is producing an erroneous, low, overall incidence of thromboembolic episodes.
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