Psycho-oncology trials largely ignore sex and gender reporting standards, review finds

Randomized controlled trials of psycho-oncology interventions are failing to integrate sex and gender into their reporting, according to a systematic review of 404 trials indexed in PubMed and published between 2020 and 2025. The study, published in the journal Biology of Sex Differences, evaluated adherence to the Sex and Gender Equity in Research (SAGER) guidelines and found that more than half of the trials—55.2 percent, or 223 of 404—did not use sex and gender terminology correctly. The authors conclude that sex and gender are not systematically integrated into psycho-oncology intervention research.

In this review, adherence was coded dichotomously at the item level and summarized using total scores. For studies that included multiple sexes or genders, the mean SAGER adherence score was 1.23 out of a possible 13, with a standard deviation of 0.88. For studies that included only one sex or gender, the mean adherence score was 0.90 out of a possible 3, with a standard deviation of 0.81.

The review also examined whether reporting quality varied by tumor entity. The authors additionally ran exploratory regression models to identify correlates of reporting quality. These analyses indicated no association between the SAGER adherence score and publication year, sample size, or journal impact factor.

The review’s highlights note widespread misuse of the terms “sex” and “gender,” which the authors interpret as indicating persistent conceptual and terminological gaps in the field.

Another key finding was the scarcity of sex- and gender-disaggregated outcomes. The authors state that inadequate adherence and limited sex- and gender-disaggregated reporting hinder evaluation of efficacy and safety across groups, reducing the rigor, generalizability, and equity of the evidence.

The authors frame these shortcomings as structural rather than isolated. In their conclusion, they write that the deficiencies reflect structural deficiencies rather than isolated study-level limitations, reducing the interpretability and practical usability of psycho-oncology evidence for diverse patient populations.

To address the problem, the authors call for strengthening mandatory reporting standards, editorial enforcement, and targeted training. According to the authors, these measures are essential to support more transparent, clinically relevant, and equitable psycho-oncology research and care.

The review’s scope is worth noting. It included only randomized controlled trials of psycho-oncology interventions indexed in PubMed and published between 2020 and 2025, and it assessed reporting quality rather than the validity of the underlying clinical findings. The SAGER items were scored dichotomously, meaning each item was judged as either adhered to or not. The regression analyses were described as exploratory, and they examined only publication year, sample size, and journal impact factor as potential correlates of adherence. The findings therefore characterize reporting practices in this specific body of trials rather than drawing conclusions about the effectiveness of any psycho-oncology intervention.

Subject of Research: Quality of sex and gender reporting in randomized controlled trials of psycho-oncology interventions

Article Title: Quality of sex and gender reporting in psycho-oncology trials: a systematic review

Article References: Birke, J., Söller, J., & Ludwig, S. (2026). Quality of sex and gender reporting in psycho-oncology trials: a systematic review. Biology of Sex Differences. https://doi.org/10.1186/s13293-026-01007-3

Image Credits: AI Generated

DOI: 10.1186/s13293-026-01007-3

Keywords: psycho-oncology, sex and gender reporting, SAGER guidelines, systematic review, randomized controlled trials, reporting quality, Biology of Sex Differences, health equity, cancer research, research methodology, Quality, gender