Sudeep S. Gill, Paula A. Rochon, Jerry H. Gurwitz, Nathan Herrmann, Susan E. Bronskill, Robin Mason, Wei Wu, Nishila Mehta, Craig Rodrigues, Manpreet Lamba, Suzanne Day, An-Wen Chan
Objectives
To improve the value of research for older adults, we examine sex-specific reporting of data from drug trials for the management of dementia. These data are important because they may influence considerations ranging from the health of populations to shared decision-making by individual patient and caregiver about the risk and benefit of a drug therapy.
Methods
Randomized controlled trials of cholinesterase inhibitors (i.e., donepezil, rivastigmine, or galantamine) with clinical outcomes were identified from searches of MEDLINE, EMBASE, and the Cochrane Library. Sex-specific data were extracted from nine sections (title, abstract, introduction, methods, outcomes, results, discussion, limitations, and conclusion). Among the donepezil trials only, more detailed harms data were obtained.
Findings
Thirty-three randomized controlled trials were identified evaluating 15,971 participants (9,103 (57%) female). Trials were highly cited (median citations 158, interquartile range 62–441) and published in high impact journals (median impact factor 7.4, interquartile range 3.4–8.2). Sex was not mentioned in the title, introduction, limitations, or conclusion section of any trial. Only three trials (9%) mentioned sex in the abstract (all as a demographic characteristic), and 8 (24%) in the methods. Almost all (32 (97%)) trials mentioned sex in the results as a demographic variable. One trial reported a sex difference for a secondary outcome. Among the 16 trials studying donepezil, adverse events were frequently reported and often dose-related. No trial provided sex-specific reporting of adverse events.
Conclusions
There is an almost complete lack of sex-specific reporting of data in clinical trials for dementia drug therapies, and no sex-specific reporting of adverse events. Sex-specific reporting of data should be required in drug trials to increase research value and ultimately inform more tailored prescribing for older adults.
