Added: Kallie Meas - Date: 06.11.2021 12:30 - Views: 25925 - Clicks: 5905
Some research articles refer to this latter variable as sex, others refer to it as gender. As one of the first pieces of data reported, the importance of including sex appears undisputed.
But what does the sex-gender category really entail, and how should it be reported? With emerging evidence that both sex and gender have an effect, for instance, on how an individual selects, responds to, metabolizes, and adheres to a particular drug regimen, 1 there is an ethical and scientific imperative to report to whom research apply. This Viewpoint explains the contexts in which sex and gender are relevant and provides suggestions for improving reporting of this characteristic.
Two common questions asked by clinical researchers are 1 Should the sex or gender of the study participants be reported? The answers depend on whether biological or psychosocial factors are under study. Sex and gender are not mutually exclusive. They are integrally related and influence health in different ways. Sex is reflected physiologically by the gon, sex hormones, external genitalia, and internal reproductive organs.
The terms male and female text sex numbers be used when describing the sex of human participants or other sex-related biological or physiological factors. A 2-step approach to questioning has been proposed, whereby participants are asked both their sex ased at birth and their current gender identity.
NIH policies to enhance reproducibility through rigor and transparency require that researchers address and report relevant biological variables, such as sex, in human and vertebrate animal studies. However, in most research studies, it is not possible to conduct detailed genetic evaluation to determine the genetic make-up of all participants. Authors reporting the of clinical trials should analyze and report data separately for male and female study participants.
One reason is to avoid drawing incorrect conclusions. The effects of an intervention in one sex might be greater than in the other; toxicity might differ; symptom profiles might differ; or one sex might experience more adverse effects. For example, gender, independent of sex, predicts poor outcomes after acute coronary syndrome. Another text sex numbers to report data by sex, gender, or both is to facilitate meta-analysis. When no differences exist, and even when studies are underpowered, the raw data should be presented to allow for meta-analysis by sex, gender, or both and can inform sample size calculations for future studies.
A third reason is to reduce waste in research.
Repeating a trial because relevant studies did not disaggregate study participants and report by sex, by gender, or both is unethical. Following this logic, all tables and figures in the section of a manuscript should clearly identify the magnitude of effect according to sex, gender, or both.
The Table shows an example of how to specify and report sex and gender in a clinical research article. Practical issues regarding how to structure demographic data lead to bigger questions about what to study and why. For example, how do sex and gender affect health, separately and collectively? Is the basis of the pathology attributable to genes, sex hormones, gender-related environmental exposures, or some combination of these factors?
As questions concerning sex and gender are refined, new methods will need to be developed, including text sex numbers ways to ascertain data about these variables and statistically analyze them. Many journals, including JAMAare requiring more transparency and rigor in reporting of such data. Sex is recognized implicitly as an important factor in clinical research. More work is needed to standardize the way sex and gender are reported and elucidate the way these characteristics function independently and together to influence health and health care.
The following recommendations for reporting in research articles may improve understanding and comparability across studies, and help deliver truly personalized medicine: 1 use the terms sex when reporting biological factors and gender when reporting gender identity or psychosocial or cultural factors; 2 disaggregate demographic and all outcome data by sex, gender, or both; 3 report the methods used to obtain information on sex, gender, or both; and 4 note all limitations of these methods.
Views 72, Citations View Metrics. November 8, Marianne J. Legato, MD; Paula A. View Large Download. The Bigger Picture. Conclusion and Recommendations. Back to top Article Information. Franconi F, Campesi I. Sex and gender influences on pharmacological response: an overview.
Expert Rev Clin Pharmacol. PubMed Google Scholar Crossref. Accessed September 4, Canadian Institutes of Health Research. Integrating Sex and Gender in Health Research. Accessed August 9, Res Integr Peer Rev. Schiebinger L, Stefanick ML. Gender matters in biological research and medical practice.
J Am Coll Cardiol. Sex and gender diversity among transgender persons in Ontario, Canada: from a respondent-driven sampling survey. J Sex Res. Sex versus gender-related characteristics: which predicts outcome after acute coronary syndrome in the young? Learn more. Purchase access Subscribe to the journal. Rent this article from DeepDyve. Get free access to newly published articles. Create a personal to register for alerts with links to free full-text articles.
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