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Frontiers in Public Health 2023The representativeness of participants is crucial to ensure external validity of clinical trials. We focused on the randomized clinical trials which assessed COVID-19...
OBJECTIVE
The 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).
METHODS
We 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.
RESULTS
Sixty 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.
CONCLUSIONS
Axes 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.
Topics: Female; Humans; Male; COVID-19; COVID-19 Vaccines; Ethnicity; Gender Identity; Clinical Trials as Topic; Diversity, Equity, Inclusion
PubMed: 36891333
DOI: 10.3389/fpubh.2023.1069357 -
BMJ Global Health Feb 2023The number of children in sexual minority parent families has increased. This systematic review aims to synthesise the evidence of disparities in family outcomes between... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The number of children in sexual minority parent families has increased. This systematic review aims to synthesise the evidence of disparities in family outcomes between sexual minority and heterosexual families and to identify specific social risk factors of poor family outcomes.
METHODS
We systematically searched PubMed, the Web of Science, Embase, the Cochrane Library and APA PsycNet for original studies that compared family outcomes between sexual minority and heterosexual families. Two reviewers independently selected studies and assessed the risk of bias of included studies. Narrative synthesis and meta-analysis were conducted to synthesise evidence.
RESULTS
Thirty-four articles were included. The narrative synthesis results revealed several significant findings for children's gender role behaviour and gender identity/sexual orientation outcomes. Overall, 16 of 34 studies were included in the meta-analyses. The quantitative synthesis results suggested that sexual minority families may perform better in children's psychological adjustment and parent-child relationship than heterosexual families (standardised mean difference (SMD) -0.13, 95% CI -0.20 to -0.05; SMD 0.13, 95% CI 0.06 to 0.20), but not couple relationship satisfaction (SMD 0.26, 95% CI -0.13 to 0.64), parental mental health (SMD 0.00, 95% CI -0.16 to 0.16), parenting stress (SMD 0.01, 95% CI -0.20 to 0.22) or family functioning (SMD 0.18, 95% CI -0.11 to 0.46).
CONCLUSION
Most of the family outcomes are similar between sexual minority and heterosexual families, and sexual minority families have even better outcomes in some domains. Relevant social risk factors of poor family outcomes included stigma and discrimination, poor social support and marital status, etc. The next step is to integrate multiple aspects of support and multilevel interventions to reduce the adverse effects on family outcomes with a long-term goal of influencing policy and law making for better services to individuals, families, communities and schools.
Topics: Male; Humans; Female; Heterosexuality; Gender Identity
PubMed: 36878725
DOI: 10.1136/bmjgh-2022-010556 -
International Journal of Environmental... Dec 2022Although capable of mobilizing significant resilience factors to face stigma and discrimination, transgender and gender diverse (TGD) children and adolescents tend to... (Review)
Review
Gender Felt Pressure, Affective Domains, and Mental Health Outcomes among Transgender and Gender Diverse (TGD) Children and Adolescents: A Systematic Review with Developmental and Clinical Implications.
Although capable of mobilizing significant resilience factors to face stigma and discrimination, transgender and gender diverse (TGD) children and adolescents tend to suffer from more adverse mental health outcomes compared to their cisgender counterparts. The minority stressors that this population faces are mainly due to the gender-based pressure to conform to their assigned gender. This systematic review was aimed at assessing the potential mental health issues that affect the TGD population. The literature search was conducted in three databases; namely, Scopus, PubMed, and Web of Science, based on the PRISMA guidelines. The 33 articles included in the systematic review pointed out how TGD children and adolescents experience high levels of anxiety and depression, as well as other emotional and behavioral problems, such as eating disorders and substance use. Resilience factors have been also pointed out, which aid this population in facing these negative mental health outcomes. The literature review highlighted that, on the one hand, TGD individuals appear to exhibit high levels of resilience; nonetheless, health disparities exist for TGD individuals compared with the general population, which are mainly attributable to the societal gender pressure to conform to their assigned gender. Considerations for research and clinical practice are provided.
Topics: Humans; Child; Adolescent; Transgender Persons; Transsexualism; Anxiety; Substance-Related Disorders; Outcome Assessment, Health Care; Gender Identity
PubMed: 36613106
DOI: 10.3390/ijerph20010785 -
Journal of Racial and Ethnic Health... Dec 2023Individuals from Black and Hispanic backgrounds represent a minority of the overall US population, yet are the populations most affected by the disease of obesity and... (Review)
Review
A Systematic Review on Participant Diversity in Clinical Trials-Have We Made Progress for the Management of Obesity and Its Metabolic Sequelae in Diet, Drug, and Surgical Trials.
OBJECTIVE
Individuals from Black and Hispanic backgrounds represent a minority of the overall US population, yet are the populations most affected by the disease of obesity and its comorbid conditions. Black and Hispanic individuals remain underrepresented among participants in obesity clinical trials, despite the mandate by the National Institutes of Health (NIH) Revitalization Act of 1993. This systematic review evaluates the racial, ethnic, and gender diversity of clinical trials focused on obesity at a national level.
METHODS
Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic review of clinicaltrials.gov, PubMed, Cochrane Central, and Web of Science was undertaken to locate phase 3 and phase 4 clinical trials on the topic of obesity that met associated inclusion/exclusion criteria. Ultimately, 18 studies were included for review.
RESULTS
White non-Hispanic individuals represented the majority of clinical trial participants, as did females. No study classified participants by gender identity. Reporting of race/ethnicity was not uniform, with noted variability among racial/ethnic subgroups.
CONCLUSIONS
Our findings suggest that disparities remain in the diverse racial, ethnic, and gender representation of participants engaged in clinical trials on obesity relative to the prevalence of obesity in underrepresented populations. Commitment to inclusive and intentional recruiting practices is needed to increase the representation of underrepresented groups, thus increasing the generalizability of future research.
Topics: Humans; Male; Female; Gender Identity; Ethnicity; Obesity; Diet; White
PubMed: 36536164
DOI: 10.1007/s40615-022-01487-0 -
Journal of Medical Internet Research Sep 2022Lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals are at higher risk of poor mental health and well-being. Social media platforms can provide LGBTQ... (Review)
Review
BACKGROUND
Lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals are at higher risk of poor mental health and well-being. Social media platforms can provide LGBTQ youths with a space that counters heteronormative environments and potentially supports mental health and well-being. Mental health includes an individual's state of psychological and emotional well-being and not merely the absence of mental disorders.
OBJECTIVE
We sought to identify how LGBTQ youths and adolescents use social media for connection with other LGBTQ peers and groups, identity development, and social support and how these affect mental health and well-being.
METHODS
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) procedures were used to guide this review. Searches were conducted in ACM Digital Library, CINAHL, Ovid Embase, Ovid MEDLINE, and Web of Science in March 2021. This review focused on LGBTQ youths aged 10 to 24 years. Included peer-reviewed studies must comprise social media; explore peer connection, identity development, or social support; and be published from 2012 onward. In total, 2 researchers extracted data and performed quality assessments independently using the Newcastle-Ottawa Scale for quantitative articles and the Critical Appraisal Skills Programme for qualitative articles. Qualitative synthesis was performed on articles that satisfied the eligibility criteria.
RESULTS
A total of 26 studies (n=15, 58% qualitative; n=8, 31% quantitative; n=3, 12% mixed methods) met the inclusion criteria. Of the 8 quantitative studies, 6 (75%) were cross-sectional, and 2 (25%) were cohort studies. All studies ranged from moderate to high quality. Social media was a popular tool used by LGBTQ youths to connect with LGBTQ communities. In qualitative data, we found that LGBTQ youths negotiated and explored identity and obtained support from peers on social media. Instagram, Tumblr, and Twitter were commonly used to access LGBTQ content owing to ease of anonymity. Identity management was the most studied social media affordance, important to LGBTQ youths for strategic disclosure. Key strategies for managing identities included being anonymous, censoring locations or content, restricting audiences, and using multiple accounts. Quantitative studies (3/8, 38%) showed that social media was associated with reduced mental health concerns and increased well-being among LGBTQ youths. Mental health concerns arising from social media use were attributed to discrimination, victimization, and policies that did not accommodate changed identities.
CONCLUSIONS
We found that social media may support the mental health and well-being of LGBTQ youths through peer connection, identity management, and social support, but findings were limited by weaknesses in the evidence. More robust and longitudinal studies are needed to determine the relationship between social media use and LGBTQ mental health, particularly among adolescents. The findings may inform interventions to promote social media health literacy and the mental health and well-being of this vulnerable group.
TRIAL REGISTRATION
PROSPERO CRD42020222535; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=222535.
Topics: Adolescent; Female; Gender Identity; Humans; Sexual Behavior; Sexual and Gender Minorities; Social Media; Transgender Persons
PubMed: 36129741
DOI: 10.2196/38449 -
Clinical Journal of the American... Sep 2022Gender-affirming hormone therapy modifies body composition and lean muscle mass in transgender persons. We sought to characterize the change in serum creatinine, other... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVES
Gender-affirming hormone therapy modifies body composition and lean muscle mass in transgender persons. We sought to characterize the change in serum creatinine, other kidney function biomarkers, and GFR in transgender persons initiating masculinizing and feminizing gender-affirming hormone therapy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
We searched PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov from inception to September 16, 2020 for randomized controlled trials, observational studies, and case series that evaluated the change in serum creatinine, other kidney function biomarkers, and GFR before and after the initiation of gender-affirming hormone therapy in adult transgender persons. Two reviewers independently screened and abstracted data, and disagreements were resolved by a third reviewer. A random effects meta-analysis was performed to determine the change in outcomes over follow-up of 3, 6, and 12 months.
RESULTS
Of the 4758 eligible studies, 26 met the inclusion criteria, including nine studies that recruited 488 transgender men and 593 women in which data were meta-analyzed. There was heterogeneity in study design, populations, gender-affirming hormone therapy routes, and dosing. At 12 months after initiating gender-affirming hormone therapy, serum creatinine increased by 0.15 mg/dl (95% confidence interval, 0.00 to 0.29) in 370 transgender men and decreased by -0.05 mg/dl (95% confidence interval, -0.16 to 0.05) in 361 transgender women. No study reported the effect of gender-affirming hormone therapy on albuminuria, proteinuria, cystatin C, or measured GFR.
CONCLUSIONS
Gender-affirming hormone therapy increases serum creatinine in transgender men and does not affect serum creatinine in transgender women. The effect on gender-affirming hormone therapy on other kidney function biomarkers and measured GFR is unknown.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
Change in Kidney Function Biomarkers in Transgender Persons on Gender Affirmation Hormone Therapy-A Systematic Review and Meta-Analysis, CRD42020214248.
Topics: Male; Adult; Humans; Female; Creatinine; Transsexualism; Biomarkers; Hormones; Kidney
PubMed: 35973728
DOI: 10.2215/CJN.01890222 -
International Journal of Environmental... Jul 2022Mothers', fathers', or guardians' support for disclosures of diverse gender identity has significant relationships with decreased suicidality for transgender children... (Review)
Review
Mothers', fathers', or guardians' support for disclosures of diverse gender identity has significant relationships with decreased suicidality for transgender children and adolescents. They play an essential role in facing transphobia, protecting trans children, and strengthening the expression of their identity. These guardians need structural, emotional, and informative support; they need to be prepared to recognize and manage of their own feelings, as well as deal with the challenges that come with new social contexts of transphobia in schools, health institutions, and other community spaces. This study aimed to analyze the scientific evidence on the dynamics of secondary social networks to support mothers, fathers, or guardians of transgender children and adolescents. This is a systematic review of qualitative studies, guided by PRISMA guidelines. Controlled and free vocabularies were used to survey the primary studies in the following databases: EMBASE; Scopus; MEDLINE; Cumulative Index to Nursing and Allied Health Literature (CINAHL); PsycInfo; Latin American and Caribbean Literature in Health Sciences (LILACS); and Web of Science. A total of 28 articles made up the final sample of this review. Secondary social networks were described as fragile, characterized by conflicting and broken ties with healthcare services and professionals, isolation and unpreparedness from schools, and emotional and informational support from peer groups and some qualified healthcare professionals. The literature shows the potential of the dynamics of secondary social support networks; however, it presented the unpreparedness of professionals and institutional policies for welcoming transgender children and adolescents and their families, with the peer group being the main emotional and informative support network.
Topics: Adolescent; Child; Fathers; Female; Gender Identity; Humans; Male; Mothers; Social Networking; Social Support; Transgender Persons
PubMed: 35886503
DOI: 10.3390/ijerph19148652 -
International Journal of Environmental... Jun 2022Mothers, fathers, or guardians of children and adolescents who do not identify with the gender they were assigned at birth face barriers in their social network to... (Review)
Review
Mothers, fathers, or guardians of children and adolescents who do not identify with the gender they were assigned at birth face barriers in their social network to recognize their children's gender identity. This study aimed to analyze the scientific evidence on the dynamics of primary social networks to support mothers, fathers, or guardians of transgender children and adolescents. This is a systematic review of qualitative studies guided by the PRISMA guidelines. Controlled and free vocabulary were used to survey the studies in the EMBASE, Scopus, MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo, Latin American and Caribbean Literature in Health Sciences (LILACS), and Web of Science databases. A total of 21 studies composed the final sample. Primary social networks were described as fragile and conflicting family/blood relationship ties with disapproval, isolation, rejection, a lack of understanding, and feelings of exclusion were expressed. Some have lost friends, reported tension in marriage and with relatives, and were commonly treated with hostility and harassment. Social transition does take place in the mutual context of struggle and resistance which demands a support network for parents or guardians.
Topics: Adolescent; Child; Fathers; Female; Gender Identity; Humans; Infant, Newborn; Male; Mothers; Social Networking; Transgender Persons
PubMed: 35805599
DOI: 10.3390/ijerph19137941 -
Academic Medicine : Journal of the... Dec 2022To identify exemplary medical education curricula, operationalized as curricula evaluating knowledge retention and/or clinical skills acquisition, for health care for...
PURPOSE
To identify exemplary medical education curricula, operationalized as curricula evaluating knowledge retention and/or clinical skills acquisition, for health care for sexual and gender minoritized (SGM) individuals and individuals born with a difference in sex development (DSD).
METHOD
The authors conducted a systematic review of the literature using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches were performed in PubMed/MEDLINE, The Cochrane Library, Web of Science, ERIC, Embase, PsycINFO, and the gray literature to identify studies that (1) pertained to undergraduate and/or graduate medical education, (2) addressed education on health care of SGM/DSD individuals, and (3) assessed knowledge retention and/or clinical skills acquisition in medical trainees. The final searches were run in March 2019 and rerun before final analyses in June and October 2020.
RESULTS
Of 670 full-text articles reviewed, 7 met the inclusion criteria. Five of the 7 studies assessed trainee knowledge retention alone, 1 evaluated clinical skills acquisition alone, and 1 evaluated both outcomes. Studies covered education relevant to transgender health, endocrinology for patients born with DSDs, and HIV primary care. Only 1 study fully mapped to the Association of American Medical Colleges (AAMC) SGM/DSD competency recommendations. Six studies reported institutional funding and development support. No studies described teaching SGM/DSD health care for individuals with multiply minoritized identities or engaging the broader SGM/DSD community in medical education curriculum development and implementation.
CONCLUSIONS
Curriculum development in SGM/DSD health care should target knowledge retention and clinical skills acquisition in line with AAMC competency recommendations. Knowledge and skill sets for responsible and equitable care are those that account for structures of power and oppression and cocreate curricula with people who are SGM and/or born with DSDs.
Topics: Humans; Clinical Competence; Curriculum; Sexual and Gender Minorities; Gender Identity; Minority Health
PubMed: 35703197
DOI: 10.1097/ACM.0000000000004768 -
AIDS Patient Care and STDs Jun 2022HIV pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV; however, PrEP use among transgender individuals remains low. We conducted a systematic review...
HIV pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV; however, PrEP use among transgender individuals remains low. We conducted a systematic review to identify barriers and facilitators to PrEP uptake, adherence, and persistence among transgender individuals in the United States. We conducted a literature search in PubMed and CINAHL databases in March 2021 and followed PRISMA guidelines. Studies were eligible if they were published in a peer-reviewed journal and reported interest, uptake, adherence, and/or persistence of PrEP use among transgender individuals. Articles that did not disaggregate results for transgender participants were excluded. Data from included articles were coded using content analysis and narratively synthesized using a framework matrix. We screened 254 unique articles published after US Food and Drug Administration approval of PrEP, and 33 articles were included in the review. Five themes were identified in the literature, including (1) PrEP concentrations were lower among individuals taking feminizing hormones, but the difference did not appear clinically significant; (2) concerns regarding interactions between gender-affirming hormone therapy and PrEP remain a large barrier; (3) PrEP initiation may facilitate increased self-advocacy and self-acceptance; (4) lack of trust in medical institutions impacts PrEP uptake; and (5) social networks have a significant influence on PrEP knowledge, interest, and adherence. Additional research is needed involving transgender men and nonbinary persons, and efforts to improve PrEP persistence among the transgender community are needed. Training health care providers to provide inclusive and affirming care is perhaps one of the strongest areas for intervention to increase PrEP uptake and persistence.
Topics: Anti-HIV Agents; HIV Infections; Homosexuality, Male; Humans; Male; Pre-Exposure Prophylaxis; Transgender Persons; Transsexualism; United States
PubMed: 35687813
DOI: 10.1089/apc.2021.0236