GENERAL MEDICAL LITERATURE
In this section we offer commentaries on a broad survey of recent articles. Articles are chosen mostly for two reasons: their potential translational value for immediate clinical practice or to help in determining where clinical practice might evolve to. Today’s subjects offer information on a format of clinical trials that is quickly gaining in popularity, address statistical data analyses, and bring to our readers attention attempts to improve trustworthiness of published papers in the fertility field.
Performing Clinical Trials
THE PRAGMATIC CLINICAL TRIAL – As a recent Viewpoint article in JAMA recently pointed out (1), so-called pragmatic clinical trials (PCTs) have become common. They can be defined as having the primary purpose of identifying clinical decision-makers about the comparative balance of benefits, burdens, and risks of a biomedical or behavioral health intervention at an individual or population level. They are usually integrated into routine healthcare delivery, thereby testing an intervention in the “real world.”
In proposing more use of PCTs in clinical medicine, the authors astutely pointed out that they could become even more useful to delivery systems in assessing policies and procedures through relatively minor accommodations of priorities, introduction of more flexibility in the level of evidence a given trial requires, shortening their duration of planning and implementation, etc. Their concluding paragraph is deserving of a direct citation: “Populations in need of health care and the illness and issues that affect them are complex and evolving, as are health care systems. PCTs to guide care must account for this complexity and enable pivoting and learning.”
USING DATA AND STATISTICAL ANALYSIS IN THE FACE OF UNCERTAINTY – A recent book review in Nature magazine attracted our attention because of its subtitle, “A statistician offers a masterful guide to embracing the unknown” (2). And we were not disappointed.
As the author of the review well explained, the book (Spiegelhalter, David. The Art of Uncertainty: How to Navigate Chance, Ignorance, Risk, and Luck. 2024, Pelikan) had nothing to do with medicine or science in general but used forecasting of the 2024 U.S. presidential election as a principal example to demonstrate how data can be used and how statistical analyses can be performed on these data to make informed decisions in the face of uncertainty. And isn’t this exactly what we in medicine are asked to do on a daily basis?
A few points deserve special mention: (i) Uncertainty is a personal phenomenon; it is determined by our own specific interplay between chance, ignorance, risk, and luck. Uncertainty is, therefore, not a characteristic of an event but reflects our own knowledge, perspective, and assumptions we may make to better understand an event and/or predict it.
References
1. Platt et al. JAMA 2024;332(22:1875-1876
2. Min Y. Nature 2025;637:785
Improving Trustworthiness of Published Papers in Ob/Gyn
An editorial in Fertility and Sterility informed us of an interesting and potentially important step several OB/GYN journals and their editors have taken by forming the OB/GYN Editors' Integrity Group (OGEIG) with the purpose of collaborating to improve trustworthiness in published papers (obviously a desirable goal!) (1). The editors have already published collaboratively unified criteria for the publication of randomized controlled trials.
Such criteria, however, already exist, and the criteria they published don’t differ to any significant degree from what most medical journals nowadays are requesting. What we, especially in the infertility field, have been missing in the peer review process is more emphasis on defining patient populations in such trials and – even more importantly – how these data are to be interpreted, i.e., a proper interpretation by authors of which patients their study results are applicable to.
Reference
1. Editorial. Fertil Steril 2025;122(6):965-968