Dr. Confounder

Finding holes in blood pressure research affecting patient care. Not medical advice. Not affiliated with any institution. @DrConfounder

Tag: ethics

  • An Unethical Research Proposal

    Wilson LM, Abebe KZ, Anderson TS. How Should Elevated Blood Pressure Be Managed in Hospital? NEJM Evid. 2024 Dec;3(12):EVIDtt2400202. doi: 10.1056/EVIDtt2400202. Epub 2024 Nov 26. PMID: 39589191.

    https://evidence.nejm.org/doi/full/10.1056/EVIDtt2400202

    Inpatient blood pressure management is an interesting topic, because while longitudinal outpatient studies have shown benefit from intensive blood pressure control (if deeply confounded), multiple inpatient studies have shown that any ad hoc blood pressure treatment in non-cardiac patients is associated with multifaceted harm (AKI, MI, stroke, mortality).

    In this “Tomorrow’s Trial” piece published in NEJM Evidence , the authors acknowledge this, but point to a lack of randomized trials to suggest that there may be a hidden benefit in terms of specifically reducing major adverse cardiac events, despite that observational studies have shown such blood pressure control to be associated with increased risk of MI (https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774562) and stroke (https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.17279), with no threshold above which treatment has been shown to be beneficial.

    The authors go on to propose a trial where patients are randomized to one of two arbitrary blood pressure thresholds, 140mmHg or 160mmHg, despite the best evidence to date suggesting that patients in both groups would be at increased risk of harm.

    This violates the principle of equipoise or “genuine uncertainty” (https://www.ahajournals.org/doi/10.1161/circresaha.116.309594) as to the harm/benefit of the intervention. When observational studies predict harm in both arms, the lack of a randomized clinical trial for confirmation does not create clinical equipoise, making the proposed trial unethical.