A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials.
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ABSTRACT:
SUBMITTER: Heidari S
PROVIDER: S-EPMC8622702 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe novel coronavirus 2019 (COVID-19) pandemic has mobilized global research at an unprecedented scale. While challenges associated with the COVID-19 trial landscape have been discussed previously, no comprehensive reviews have been conducted to assess the reporting, design, and data sharing practices of randomized controlled trials (RCTs).PurposeThe purpose of this review was to gain insight into the current landscape of reporting, methodological design, and data sharing practices for COVID-19 RCTs.Data sourcesWe conducted three searches to identify registered clinical trials, peer-reviewed publications, and pre-print publications.Study selectionAfter screening eight major trial registries and 7844 records, we identified 178 registered trials and 38 publications describing 35 trials, including 25 peer-reviewed publications and 13 pre-prints.Data extractionTrial ID, registry, location, population, intervention, control, study design, recruitment target, actual recruitment, outcomes, data sharing statement, and time of data sharing were extracted.Data synthesisOf 178 registered trials, 112 (62.92%) were in hospital settings, median planned recruitment was 100 participants (IQR: 60, 168), and the majority (n = 166, 93.26%) did not report results in their respective registries. Of 35 published trials, 31 (88.57%) were in hospital settings, median actual recruitment was 86 participants (IQR: 55.5, 218), 10 (28.57%) did not reach recruitment targets, and 27 trials (77.14%) reported plans to share data.ConclusionsThe findings of our study highlight limitations in the design and reporting practices of COVID-19 RCTs and provide guidance towards more efficient reporting of trial results, greater diversity in patient settings, and more robust data sharing.
| S-EPMC7834682 | biostudies-literature
Project description:BackgroundSex and gender are believed to influence vaccine response. Yet, the relationship between sex and gender and COVID-19 vaccine efficacy is poorly understood and remains under-investigated.MethodsWe conducted a systematic review to determine whether and to what extent post-approval COVID-19 vaccine effectiveness (VE) studies report sex-disaggregated VE data. We searched four publication and pre-publication databases and additional grey literature sources for relevant published/preprint studies released between 1 January 2020 and 1 October 2021 (i.e., pre-Omicron era). We included observational studies providing VE estimates for one or more licensed/approved COVID-19 vaccines and including both males and females. Two reviewers independently assessed study eligibility, extracted data, and assessed risk-of-bias through a modified version of Cochrane's ROBINS-I tool. A qualitative data synthesis was performed.ResultsHere we show that, among 240 eligible publications, 68 (28.3%) do not report the sex distribution among participants. Only 21/240 (8.8%) studies provide sex-disaggregated VE estimates, and high between-study heterogeneity regarding design, target population, outcomes, and vaccine type/timing prevent the assessment of sex in determining COVID-19 VE across studies.ConclusionsOur findings indicate that few COVID-19 vaccine research publications account for sex. Improved adherence to recommended reporting guidelines will ensure that the evidence generated can be used to better understand the relationship between sex and gender and VE.
| S-EPMC10196298 | biostudies-literature
Project description:ImportanceSince the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials.ObjectiveTo investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US.Data sourcesIdentified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022.Study selectionIncluded studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included.Data extraction and synthesisData on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19.Main outcomes and measuresSex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19.ResultsOverall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P < .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P < .001).Conclusions and relevanceIn this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found. Strategies to better ensure diverse representation in COVID-19 studies are needed, especially for prevention trials.
| S-EPMC9857303 | biostudies-literature
Project description:BackgroundDespite growing recognition of the importance of sex and gender considerations in health research, they are rarely integrated into research design and reporting. We sought to assess the integration of sex, as a biological attribute, and gender, as a socially constructed identity, in published reporting guidelines.MethodsWe conducted a systematic review of published reporting guidelines listed on the EQUATOR website ( www.equator-nework.org ) from inception until December 2018. We selected all reporting guidelines (original and extensions) listed in the EQUATOR library. We used EndNote Citation Software to build a database of the statements of each guideline identified as a "full bibliographic reference" and retrieved the full texts. Reviewers independently extracted the data on use of sex and gender terms from the checklist/abstract/main text of guidelines. Data were analyzed using descriptive statistics and narrative synthesis.ResultsA total of 407 reporting guidelines were included; they were published between 1995 and 2018. Of the 407 guidelines, 235 (57.7%) mentioned at least one of the sex- and gender-related words. In the checklist of the reporting guidelines (n = 363), "sex" and "gender" were mentioned in 50 (13.8%) and 40 (11%), respectively. Only one reporting guideline met our criteria (nonbinary, appropriate categorization, and non-interchangeability) for correct use of sex and gender concepts. Trends in the use of "sex" and "gender" in the checklists showed that the use of "sex" only started in 2003, while "gender" has been in use since 1996.ConclusionsWe assessed the integration of sex and gender in reporting guidelines based on the use of sex- and gender-related words. Our findings showed a low use and integration of sex and gender concepts and their incorrect use. Authors of reporting guidelines should reduce this gap for a better use of research knowledge. Trial registration PROSPERO no. CRD42019136491.
| S-EPMC8605583 | biostudies-literature
Project description:This systematic review evaluated the reporting quality of COVID-19 vaccine randomized controlled trials (RCTs). Relevant RCTs published between July 20, 2020 and June 11, 2021 were identified in the PubMed database by two independent reviewers. Study quality was evaluated with the 2010 AND 2001 Consolidated Standards of Reporting Trials (CONSORT) adherence scores. A total of 22 RCTs were included. The median CONSORT adherence score according to the 2010 criteria was 21 (range, 12-25), thus indicating that 75% of the items in more than half of the RCTs had clear reports. Univariate analysis showed that CONSORT adherence scores were not predicted by category; analysis of variance also showed no significant difference between groups. Our results indicated that the overall quality of COVID-19 vaccine RCTs was very good. Current evidence indicates that a variety of COVID-19 vaccines are effective. No RCTs have reported serious adverse effects such as mortality.
| S-EPMC8993078 | biostudies-literature
Project description:ObjectiveThe representativeness of participants is crucial to ensure external validity of clinical trials. We focused on the randomized clinical trials which assessed COVID-19 vaccines to assess the reporting of age, sex, gender identity, race, ethnicity, obesity, sexual orientation, and socioeconomic status in the results (description of the participants' characteristics, loss of follow-up, stratification of efficacy and safety results).MethodsWe searched the following databases for randomized clinical trials published before 1st February 2022: PubMed, Scopus, Web of Science, and Excerpta Medica. We included peer-reviewed articles written in English or Spanish. Four researchers used the Rayyan platform to filter citations, first reading the title and abstract, and then accessing the full text. Articles were excluded if both reviewers agreed, or if a third reviewer decided to discard them.ResultsSixty three articles were included, which assessed 20 different vaccines, mainly in phase 2 or 3. When describing the participants' characteristics, all the studies reported sex or gender, 73.0% race, ethnicity, 68.9% age groups, and 22.2% obesity. Only one article described the age of participants lost to follow-up. Efficacy results were stratified by age in 61.9%, sex or gender in 26.9%, race and/or, ethnicity in 9.5%, and obesity in 4.8% of the articles. Safety results were stratified by age in 41.0%, and by sex or gender in 7.9% of the analysis. Reporting of gender identity, sexual orientation or socioeconomic status of participants was rare. Parity was reached in 49.2% of the studies, and sex-specific outcomes were mentioned in 22.9% of the analysis, most of the latter were related to females' health.ConclusionsAxes of social inequity other than age and sex were hardly reported in randomized clinical trials that assessed COVID-19 vaccines. This undermines their representativeness and external validity and sustains health inequities.
| S-EPMC9987589 | biostudies-literature
Project description:To successfully mitigate the extraordinary devastation caused by the Coronavirus disease 2019 (COVID-19) pandemic, it is crucial to identify important risk factors for this disease. One such neglected health determinant is the sex of the patient. This is an essential clinical characteristic, as it can factor into a patient's clinical management and preventative measures. Some clinical studies have shown disparities in the proportion between males and females that have more severe clinical outcomes or, subsequently, die from this disease. However, this association has not been unequivocally established. Thus, the purpose of this investigation was to examine the association between male sex and COVID-19 severity. We systematically reviewed the literature, identified studies that matched predetermined selection criteria, and performed a meta-analysis to evaluate the proportion of males among four disease severity categories. Appropriate assessment strategies were implemented to assess and minimize potential biases. The results of this meta-analysis indicated that males constituted a significantly higher proportion of those who had adverse clinical outcomes and died from COVID-19. As the coronavirus spread from the East to the West, male sex remained a consistent risk factor. Our results support the establishment of the male sex as an important risk factor for this disease. Early identification and appropriate medical care for males with lab-confirmed COVID-19 may substantially change the course of clinical prognosis, resulting in greater numbers of lives saved.
| S-EPMC7331754 | biostudies-literature
Project description:Assessing the quality of evidence from vaccine clinical trials is essential to ensure the safety and efficacy of the vaccine and further enhance public acceptance. This study aims to summarize and critically evaluate the quality of harm reporting on randomized controlled trials for the COVID-19 vaccine and determine the factors associated with reporting quality. We systematically searched the literature using PRISMA guidelines for randomized controlled trials (RCT) on COVID-19 Vaccine until 30 December 2021. Published articles were searched from electronic databases such as PubMed, Science Direct, Google Scholar, and Bibliovid. Bias analysis was performed using RoB-2 tools. The quality of reporting was assessed by the Consolidated Standards of Reporting Trials (CONSORT) harm extension modified into 21 items. A total of 61 RCT studies (402,014 patients) were analyzed. Over half the studies demonstrated adequate reporting (59.02%), and 21 studies (34.4%) reported a low risk of bias. All studies reported death and serious adverse events (AEs), but only six studies mentioned how to handle the recurrent AEs. Reporting of AEs in subgroup analysis was also poor (25%). The RCTs on the COVID-19 vaccine were less biased with good quality on reporting harm based on the modified CONSORT harm extension. However, study quality must be considered, especially for a balance of information between effectivity and safety.
| S-EPMC8875800 | biostudies-literature
Project description:BACKGROUND:Epidemiological differences between men and women have been reported with regards to sepsis, influenza and severe coronavirus infections including SARS-CoV and MERS-CoV. AIM:To systematically review the literature relating to men versus women on SARS-CoV-2 in order to seek differences in disease characteristics (e.g. infectivity, severity) and outcomes (e.g. mortality). METHODS:We searched 3 electronic databases up or observational studies reporting differences between men and women in the SARS-CoV-2 disease characteristics stated. We identified and included 47 studies, reporting data for 21,454 patients mainly from China. RESULTS:The unadjusted mortality rates of men were higher than those of women, with a mortality OR 0.51 [0.42, 0.61] (p<0.001) for women. The proportion of men presenting with severe disease and admitted to the intensive care unit (ICU) was also higher than that of women (OR 0.75 [0.60-0.93] p<0.001 and OR 0.45 [0.40-0.52] p<0.001 respectively). Adjusted analyses could not be conducted due to lack of data. CONCLUSION:COVID-19 may be associated with worse outcomes in males than in females. However, until more detailed data are provided in further studies enabling adjusted analysis, this remains an unproven assumption.
| S-EPMC7608911 | biostudies-literature
Project description:BackgroundSince the outbreak of coronavirus disease 2019 (COVID-19), many researchers in China have performed related clinical research. However, systematic reviews of the registered clinical trials are still lacking. Therefore, we conducted a systematic review of clinical trials for COVID-19 to summarize their characteristics.MethodsThis study is based on the PRISMA recommendations in the Cochrane handbook. The Chinese Clinical Registration Center and the ClinicalTrials.gov databases were searched to identify registered clinical trials related to COVID-19. The retrieval inception date was February 9, 2020. Two researchers independently selected the literature based on the inclusion and exclusion criteria, extracted data, and evaluated the risk of bias.ResultsA total of 75 registered clinical trials (63 interventional studies and 12 observational studies) for COVID-19 were identified. The majority of clinical trials were sponsored by Chinese hospitals. Only 11 trials have begun to recruit patients, and none of the registered clinical trials have been completed; 34 trials were early clinical exploratory trials or in the pre-experiment stage, 13 trials were phase III, and four trials were phase IV. The intervention methods included traditional Chinese medicine in 26 trials, Western medicine in 30 trials, and integrated traditional Chinese medicine and Western medicine in 19 trials. The subjects were primarily non-critical adult patients (≥ 18 years old). The median sample size of the trials was 100 (IQR: 60-200), and the median length of the trial periods was 179 d (IQR: 94-366 d). The main outcomes were clinical observation and examinations. Overall, the methodological quality of both the interventional trials and observational studies was low.ConclusionsIntensive clinical trials on the treatment of COVID-19 using traditional Chinese medicine and Western medicine are ongoing or will be performed in China. However, based on the uncertain methodological quality, small sample size, and long trial duration, we will not be able to obtain reliable, high-quality clinical evidence regarding the treatment of COVID-19 in the near future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for clinical trials of COVID-19 in the future.
| S-EPMC7338108 | biostudies-literature