Systematic Review of Sex-Specific Reporting of Data: Cholinesterase Inhibitor Example

Nishila Mehta; Craig Rodrigues; Manpreet Lamba; Wei Wu; Susan E Bronskill; Nathan Herrmann; Sudeep S Gill; An-Wen Chan; Robin Mason; Suzanne Day; Jerry H Gurwitz; Paula A Rochon

doi:10.1111/jgs.15020

Systematic Review of Sex-Specific Reporting of Data: Cholinesterase Inhibitor Example

J Am Geriatr Soc. 2017 Oct;65(10):2213-2219. doi: 10.1111/jgs.15020. Epub 2017 Aug 18.

Authors

Nishila Mehta¹, Craig Rodrigues², Manpreet Lamba³, Wei Wu⁴, Susan E Bronskill^{4

5

6}, Nathan Herrmann⁷, Sudeep S Gill^{5

8}, An-Wen Chan^{4

6

9}, Robin Mason⁴, Suzanne Day⁴, Jerry H Gurwitz¹⁰, Paula A Rochon^{4

5

6

9}

Affiliations

¹ Faculty of Health, York University, Toronto, Ontario, Canada.
² Medical Sciences, Western University, London, Ontario, Canada.
³ McMaster University, Hamilton, Ontario, Canada.
⁴ Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada.
⁵ Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
⁶ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
⁷ Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
⁸ Department of Medicine, Queen's University, Kingston, Ontario, Canada.
⁹ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁰ Division of Geriatric Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.

PMID: 28832937
DOI: 10.1111/jgs.15020

Abstract

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.

Keywords: cholinesterase inhibitors; randomized controlled trials; sex-specific reporting; systematic review.

Publication types

Review
Systematic Review

MeSH terms

Aged
Aged, 80 and over
Cholinesterase Inhibitors / administration & dosage
Cholinesterase Inhibitors / adverse effects*
Dementia / drug therapy*
Female
Humans
Journal Impact Factor
Male
Randomized Controlled Trials as Topic
Research Design*
Sex Factors*

Substances

Cholinesterase Inhibitors