scholarly journals A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1322
Author(s):  
Shirin Heidari ◽  
Alice Palmer-Ross ◽  
Tracey Goodman
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Data ◽  
Vaccine Hesitancy ◽  
Sex And Gender ◽  
Quality Of Reporting ◽  
Vaccine Trials ◽  
And Gender ◽  
Sex And Gender Differences

Sex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically review published COVID-19 vaccine trials, both interventional and observational, to assess the quality of reporting of sex and gender. Of the 75 clinical trials on COVID-19 vaccines included in this review, only 24% presented their main outcome data disaggregated by sex, and only 13% included any discussion of the implications of their study for women and men. Considering the sex differences in adverse events after vaccination, and the gendered aspects of vaccine hesitancy, these oversights in clinical research on vaccines have implications for recovery from the COVID-19 pandemic and for wider public health.

scholarly journals Lack of consideration of sex and gender in clinical trials for COVID-19

2020 ◽  
Author(s):  
Emer Brady ◽  
Mathias Wullum Nielsen ◽  
Jens Peter Andersen ◽  
Sabine Oertelt-Prigione
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Sex And Gender ◽  
Therapeutic Approaches ◽  
Planning Stage ◽  
New Therapeutic Approaches ◽  
Analysis Phase ◽  
Potential Risks ◽  
And Gender ◽  
Sex And Gender Differences

Sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences characterize the frequency and severity of pharmacological side effects. A large number of clinical trials are ongoing to develop new therapeutic approaches and vaccines for COVID-19. We investigated the inclusion of sex and/or gender in currently registered studies on ClinicalTrials.gov. Only 416 (16.7%) of the 2,484 registered SARS-CoV-2/COVID-19 trials mention sex/gender as recruitment criterion and only 103 (4.1%) allude to sex/gender in the description of the analysis phase. None of the 11 clinical trials published in scientific journals on June 2020 reported sex-disaggregated results. Hence, lack of consideration upon registration does not seem to be corrected during trial execution and reporting. Given the biological relevance and the potential risks of unwanted side effects, we urge researchers to focus on sex-disaggregated analyses already at the planning stage of COVID-19 trials.

scholarly journals Lack of consideration of sex and gender in COVID-19 clinical studies

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Emer Brady ◽  
Mathias Wullum Nielsen ◽  
Jens Peter Andersen ◽  
Sabine Oertelt-Prigione
Keyword(s):  
Clinical Trials ◽  
Scientific Journals ◽  
Sex And Gender ◽  
Therapeutic Approaches ◽  
New Therapeutic Approaches ◽  
Subgroup Analyses ◽  
Analytical Variable ◽  
And Gender ◽  
Sex And Gender Differences ◽  
Representative Samples

AbstractSex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences influence the frequency and severity of pharmacological side effects. A large number of clinical trials to develop new therapeutic approaches and vaccines for COVID-19 are ongoing. We investigated the inclusion of sex and/or gender in COVID-19 studies on ClinicalTrials.gov, collecting data for the period January 1, 2020 to January 26, 2021. Here, we show that of the 4,420 registered SARS-CoV-2/COVID-19 studies, 935 (21.2%) address sex/gender solely in the context of recruitment, 237 (5.4%) plan sex-matched or representative samples or emphasized sex/gender reporting, and only 178 (4%) explicitly report a plan to include sex/gender as an analytical variable. Just eight (17.8%) of the 45 COVID-19 related clinical trials published in scientific journals until December 15, 2020 report sex-disaggregated results or subgroup analyses.

Sex and Gender Differences

2012 ◽  
Vol 220 (2) ◽  
pp. 57-60 ◽  
Author(s):  
Markus Hausmann ◽  
Barbara Schober
Keyword(s):  
Gender Differences ◽  
Sex And Gender ◽  
And Gender ◽  
Sex And Gender Differences

scholarly journals Influence of sex and gender on the management of late-stage knee osteoarthritis

2021 ◽  
Author(s):  
B. Moretti ◽  
A. Spinarelli ◽  
G. Varrassi ◽  
L. Massari ◽  
A. Gigante ◽  
...  
Keyword(s):  
Gender Differences ◽  
Knee Osteoarthritis ◽  
Healthcare Professionals ◽  
Pain Tolerance ◽  
Exact Nature ◽  
Sex And Gender ◽  
Physician Practices ◽  
Knee Oa ◽  
And Gender ◽  
Sex And Gender Differences

Abstract Purpose The exact nature of sex and gender differences in knee osteoarthritis (OA) among patient candidates for total knee arthroplasty (TKA) remains unclear and requires better elucidation to guide clinical practice. The purpose of this investigation was to survey physician practices and perceptions about the influence of sex and gender on knee OA presentation, care, and outcomes after TKA. Methods The survey questions were elaborated by a multidisciplinary scientific board composed of 1 pain specialist, 4 orthopedic specialists, 2 physiatrists, and 1 expert in gender medicine. The survey included 5 demographic questions and 20 topic questions. Eligible physician respondents were those who treat patients during all phases of care (pain specialists, orthopedic specialists, and physiatrists). All survey responses were anonymized and handled via remote dispersed geographic participation. Results Fifty-six physicians (71% male) accepted the invitation to complete the survey. In general, healthcare professionals expressed that women presented worse symptomology, higher pain intensity, and lower pain tolerance and necessitated a different pharmacological approach compared to men. Pain and orthopedic specialists were more likely to indicate sex and gender differences in knee OA than physiatrists. Physicians expressed that the absence of sex and gender-specific instruments and indications is an important limitation on available studies. Conclusions Healthcare professionals perceive multiple sex and gender-related differences in patients with knee OA, especially in the pre- and perioperative phases of TKA. Sex and gender bias sensitivity training for physicians can potentially improve the objectivity of care for knee OA among TKA candidates.

Disability and quality of life in patients with low back pain: Focus on sex and gender: A cross-sectional study

2021 ◽  
pp. 1-8
Author(s):  
Yen-Mou Lu ◽  
Chung-Hwan Chen ◽  
Yi-Jing Lue
Keyword(s):  
Quality Of Life ◽  
Low Back Pain ◽  
Back Pain ◽  
Gender Identity ◽  
Gender Role ◽  
Low Back ◽  
Sex And Gender ◽  
Cross Sectional ◽  
And Gender

BACKGROUND: Sex and gender affect responses to pain, but little is known about disability and quality of life. OBJECTIVES: To investigate the effects of sex and gender on disability and health-related quality of life (HRQOL) in patients with low back pain. METHODS: Ninety-three patients with low back pain were included in this cross-sectional survey study. Disability, HRQOL and gender identity were respectively assessed with the Oswestry Disability Index, Short Form-36 and Bem Sex Role Inventory. The participants were classified into four gender role orientations (masculinity, femininity, androgyny and undifferentiated). One-way analysis of variance was used to analyze both the sex and the gender role orientation. RESULTS: Females had higher disability than males (p< 0.05), but in gender identity, no significant difference was found. Seven domains of HRQOL were lower than the healthy norms. Males experienced greater impacts than females on vitality and mental health (p< 0.05). For gender identity, five domains of HRQOL had significant differences (p< 0.05). Masculinity orientation had the least impact on four domains (p< 0.05), while undifferentiated orientation had the largest impact on all domains. CONCLUSION: Sex and gender effects can be used to analyze disability and HRQOL in patients with low back pain. Females have higher disability, while HRQOL is greatly influenced by different gender role orientations.

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