Canadian Journal of Public Health tells researchers to address sex, gender in trials

The Canadian Journal of Public Health now requires all authors to explain how they've addressed sex and gender in their research.

Some clinical trials recruit only men and then apply those findings to women, too, said Jacqueline Gahagan, a board member at the journal.

"If we want to see appropriate use of finite tax resources, we need to make sure that decisions are based on the best possible evidence — and from our perspective you can't make those decisions if you're excluding roughly 50 per cent of the population," Gahagan told CBC Nova Scotia's Information Morning on Wednesday.

She's also the director of Dalhousie University's gender and health promotion unit. She announced the change on the journal's website. 

HIV studies left out women

She knows well the problems caused by only including men in clinical trials. Her PhD research looked into a mystery: HIV-positive women stopped taking their medication at higher rates than men. 

"Women, unlike men, had issues around menstrual cycles," she said. "The side effects were making it incredibly difficult for them to adhere to that particular drug."

But none of that showed up in the trials on men and the research did not make it clear that no women were included. The studies left out women because if they got pregnant or had their period it would create "hormonal noise" that could affect the trials, Gahagan said. 

'Bits and bobs'

Some heart disease studies also leave out women and then give advice that doesn't work as well as it does for men.

Gahagan said trials should also clearly distinguish gender from sex. Gender is the "socially regulated expectations" for males and females, she said. Sex is your "bits and bobs."

"It's basically disentangling the different social factors versus biological or physiological factors that impact on health," she said.  

International issue

The journal does so with four questions for researchers:

"1. Are sex (biological) considerations taken into account in this manuscript? Yes/No

2. Are gender (socio-cultural) considerations taken into account in this manuscript? Yes/No

3. If YES, please describe how sex and/or gender considerations are considered in your manuscript 

4. If NO, please explain why sex and/or gender considerations are not applicable in your manuscript."

Said Gahagan: "What's interesting about the editorial policy is that it's not just in Canada. This is an international issue about making sure the evidence that is in peer-reviewed journals reflects the reality of both men and women. You can't do that if women are not included in those trials."

'That becomes problematic'

It adds to work done by the Canadian Institutes of Health Research, which requires people seeking funding to spell out how they address sex and gender in their research methodology.

Including it in peer-reviewed articles ensures it's done and shared with others, Gahagan said. 

"If you are assuming that evidence base is the cutting edge, and yet there is no discussion of sex and gender, no sex de-segregated data, no discussion about social implications about how that drug treatment or that particular health issue differs for men and women, that becomes problematic," she said.

She hopes the journal's decision inspires others to take similar steps.