Strategies for enhancing the representation of women in clinical trials: an evidence map.

BACKGROUND: Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials. METHODS: We used evidence mapping methodology to examine the breadth of relevant literature. We developed an a priori protocol and followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis where applicable. We searched MEDLINE® (via PubMed) and EMBASE (via Elsevier) databases from inception through April 4, 2023, and used standardized procedures incorporating duplication and data verification. We included articles that described strategies to improve the recruitment and retention of women in clinical trials. RESULTS: We identified 122 articles describing recruitment and retention strategies for 136 trials (377,595 women). Only one article distinguished between the sex and gender identity of participants, and none defined their use of the terms such as "women" or "female". The majority of articles (95%) described recruitment for only women, and 64% were conducted in the USA. Ninety-two articles (75%) described strategies in the context of sex-specific conditions (e.g., gynecologic diagnosis). The majority of included articles evaluated a behavioral intervention (52%), with 23% evaluating pharmacologic interventions and 4% invasive interventions. The most common trial phase for reported strategies was during outreach to potential participants (116 articles), followed by intervention delivery (76), enrollment (40), outcomes assessment (21), analysis and interpretation (3), and dissemination (4). We describe specific types of strategies within each of these phases. CONCLUSIONS: Most of the existing literature describing strategies to improve the inclusion of women draws from trials for sex-specific conditions and is largely related to outreach to potential participants. There is little information about how and if studies have attempted to proportionally increase the inclusion of women in trials with both men and women or those focused on invasive and pharmacologic interventions. Future work in this area should focus on how to increase the participation of women in mixed-sex studies and on those areas with remaining inequities in trial participation.

Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design.

Qualitative rapid analysis is one of many rapid research approaches that offer a solution to the problem of time constrained health services evaluations and avoids sacrificing the richness of qualitative data that is needed for intervention design. We describe modifications to an established team-based, rapid analysis approach that we used to rapidly collect and analyze semi-structured interview data for a developmental formative evaluation of a cardiovascular disease prevention intervention. Over 18 weeks, we conducted and analyzed 35 semi-structured interviews that were conducted with patients and health care providers in the Veterans Health Administration to identify targets for adapting the intervention in preparation for a clinical trial. We identified 12 key themes describing actionable targets for intervention modification. We highlight important methodological decisions that allowed us to maintain rigor when using qualitative rapid analysis for intervention adaptation and we provide practical guidance on the resources needed to execute similar qualitative studies. We additionally reflect on the benefits and challenges of the described approach when working within a remote research team environment.ClinicalTrials.gov: NCT04545489.

Exploring the importance of predisposing, enabling, and need factors for promoting Veteran engagement in mental health therapy for post-traumatic stress: a multiple methods study.

PURPOSE: This study explored Veteran and family member perspectives on factors that drive post-traumatic stress disorder (PTSD) therapy engagement within constructs of the Andersen model of behavioral health service utilization. Despite efforts by the Department of Veterans Affairs (VA) to increase mental health care access, the proportion of Veterans with PTSD who engage in PTSD therapy remains low. Support for therapy from family members and friends could improve Veteran therapy use. METHODS: We applied a multiple methods approach using data from VA administrative data and semi-structured individual interviews with Veterans and their support partners who applied to the VA Caregiver Support Program. We integrated findings from a machine learning analysis of quantitative data with findings from a qualitative analysis of the semi-structured interviews. RESULTS: In quantitative models, Veteran medical need for health care use most influenced treatment initiation and retention. However, qualitative data suggested mental health symptoms combined with positive Veteran and support partner treatment attitudes motivated treatment engagement. Veterans indicated their motivation to seek treatment increased when family members perceived treatment to be of high value. Veterans who experienced poor continuity of VA care, group, and virtual treatment modalities expressed less care satisfaction. Prior marital therapy use emerged as a potentially new facilitator of PTSD treatment engagement that warrants more exploration. CONCLUSIONS: Our multiple methods findings represent Veteran and support partner perspectives and show that amid Veteran and organizational barriers to care, attitudes and support of family members and friends still matter. Family-oriented services and intervention could be a gateway to increase Veteran PTSD therapy engagement.

Mental health therapy for veterans with PTSD as a family affair: A qualitative inquiry into how family support and social norms influence veteran engagement in care.

Social support is important for posttraumatic stress disorder (PTSD) recovery and emerging literature indicate that social support could increase engagement in PTSD therapy. However, there is a need to understand how and why family involvement can increase treatment engagement to inform strategies used in clinical practice. This study explores how individuals with PTSD and family members of individuals with PTSD experience therapy and how social interactions help or hinder therapy engagement. We interviewed 18 U.S. military veterans who had been referred for psychotherapy for PTSD in the Veterans Health Administration and 13 family members and used rapid content analysis to identify themes. We found that engaging in therapy was a family-level decision that participants expected to improve family life. Veterans were motivated to seek treatment to protect their relationships with loved ones. Family members generally encouraged veterans to seek treatment. Specifically, family members who viewed PTSD as a treatable illness versus a static aspect of the veteran's personality expressed positive attitudes about the effectiveness of therapy for reducing symptoms. Veterans whose social networks included individuals with prior military or trauma-related experiences reported that their loved ones possessed more understanding of PTSD and described positive subjective norms around therapy. Family members are often embedded in the therapy process because PTSD has a profound impact on the family. Positive subjective norms for therapy are created by family encouragement and may influence veteran perceptions about the value of treatment. Family members should be engaged early in mental health therapy and to the extent desired by the patient and family member. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Influence of family planning and immunization services integration on contraceptive use and family planning information and knowledge among clients: A cross-sectional analysis in urban Nigeria.

Reproductive autonomy necessitates that women have access to high quality family planning information and services. Additionally, closely spaced pregnancies increase maternal and infant morbidity and mortality. Although integrating family planning into child immunization services may increase access to information and services and postpartum contraceptive use, evidence on how integration affects service delivery and health outcomes is scarce. One limitation of previous studies is the use of binary integration measures. To address this limitation, this study applied Provider and Facility Integration Index scores to estimate associations between integration and contraceptive use, receipt of family planning information, and knowledge of family planning services availability. This study leveraged pooled cross-sectional health facility client exit interview data collected from 2,535 women in Nigeria. Provider and Facility Integration Index scores were calculated (0-10, 0 = low, 10 = high) for each facility (N = 94). The Provider Integration Index score measures provider skills and practices that support integrated service delivery; the Facility Integration Index score measures facility norms that support integrated service delivery. Logistic regression models identified associations between Provider and Facility Integration Index scores and (a) contraceptive use among postpartum women, (b) receipt of family planning information during immunization visits, and (c) correct identification of family planning service availability. Overall, 46% of women were using any method of contraception, 51% received family planning information during the immunization appointment, and 83% correctly identified family planning service availability at the facility. Mean Provider and Facility Integration Index scores were 6.46 (SD = 0.21) and 7.27 (SD = 0.18), respectively. Provider and Facility Integration Index scores were not significantly associated with postpartum contraceptive use. Facility Integration Index scores were negatively associated with receipt of family planning information. Provider Integration Index scores were positively associated with correct identification of family planning service availability. Our results challenge the position that integration provides a clear path to improved outcomes. The presence of facility and provider attributes that support integration may not result in the delivery of integrated care.

Women Veterans' Healthcare Needs, Utilization, and Preferences in Veterans Affairs Primary Care Settings.

BACKGROUND: The Veterans Health Administration (VA) is the largest integrated health system in the US and provides access to comprehensive primary care. Women Veterans are the fastest growing segment of new VA users, yet little is known about the characteristics of those who routinely access VA primary care in general or by age group. OBJECTIVE: Describe healthcare needs, utilization, and preferences of women Veterans who routinely use VA primary care. PARTICIPANTS: 1,391 women Veterans with 3+ primary care visits within the previous year in 12 VA medical centers (including General Primary Care Clinics, General Primary Care Clinics with designated space for women, and Comprehensive Women's Health Centers) in nine states. METHODS: Cross-sectional survey (45% response rate) of sociodemographic characteristics, health status (including chronic disease, mental health, pain, and trauma exposure), utilization, care preferences, and satisfaction. Select utilization data were extracted from administrative data. Analyses were weighted to the population of routine users and adjusted for non-response in total and by age group. KEY RESULTS: While 43% had health coverage only through VA, 62% received all primary care in VA. In the prior year, 56% used VA mental healthcare and 78% used VA specialty care. Common physical health issues included hypertension (42%), elevated cholesterol (39%), pain (35%), and diabetes (16%). Many screened positive for PTSD (41%), anxiety (32%), and depression (27%). Chronic physical and mental health burdens varied by age. Two-thirds (62%) had experienced military sexual trauma. Respondents reported satisfaction with VA women's healthcare and preference for female providers. CONCLUSIONS: Women Veterans who routinely utilize VA primary care have significant multimorbid physical and mental health conditions and trauma histories. Meeting women Veterans' needs across the lifespan will require continued investment in woman-centered primary care, including integrated mental healthcare and emphasis on trauma-informed, age-specific care, guided by women's provider preferences.

Examining Pregnant Veterans' Acceptance and Beliefs Regarding the COVID-19 Vaccine.

BACKGROUND: Pregnant persons have received mixed messages regarding whether or not to receive COVID-19 vaccines as limited data are available regarding vaccine safety for pregnant and lactating persons and breastfeeding infants. OBJECTIVE: The aims of this study were to examine pregnant Veteran's acceptance of COVID-19 vaccines, along with perceptions and beliefs regarding vaccine safety and vaccine conspiracy beliefs. DESIGN AND PARTICIPANTS: We conducted a cross-sectional survey of pregnant Veterans enrolled in VA care who were taking part in an ongoing cohort study at 15 VA medical centers between January and May 2021. MAIN MEASURES: Pregnant Veterans were asked whether they had been offered the COVID-19 vaccine during pregnancy, and whether they chose to accept or refuse it. Additional questions focused on perceptions of COVID-19 vaccine safety and endorsements of vaccine knowledge and conspiracy beliefs. Logistic regression was utilized to examine predictors of acceptance of a vaccine during pregnancy. KEY RESULTS: Overall, 72 pregnant Veterans were offered a COVID-19 vaccine during pregnancy; over two-thirds (69%) opted not to receive a vaccine. Reasons for not receiving a vaccine included potential effects on the baby (64%), side effects for oneself (30%), and immunity from a past COVID-19 infection (12%). Those who received a vaccine had significantly greater vaccine knowledge and less belief in vaccine conspiracy theories. Greater knowledge of vaccines in general (aOR: 1.78; 95% CI: 1.2-2.6) and lower beliefs in vaccine conspiracies (aOR: 0.76; 95% CI: 0.6-0.9) were the strongest predictors of acceptance of a COVID-19 vaccine during pregnancy. CONCLUSIONS: Our study provides important insights regarding pregnant Veterans' decisions to accept the COVID-19 vaccine, and reasons why they may choose not to accept the vaccine. Given the high endorsement of vaccine conspiracy beliefs, trusted healthcare providers should have ongoing, open discussions about vaccine conspiracy beliefs and provide additional information to dispel these beliefs.

Sufficiency of Health Information During Pregnancy: What's Missing and for Whom? A Cross-Sectional Analysis Among Veterans.

Background: Women Veterans often experience trauma and physical and mental health conditions that increase risk of adverse pregnancy outcomes. Information provision during pregnancy may facilitate improved outcomes. However, little evidence exists about information women Veterans receive during pregnancy, and their perceptions of it. Materials and Methods: We recruited pregnant Veterans from 15 Veterans Affairs medical centers. Through telephone surveys, women (N = 851) provided information about sociodemographic characteristics, military service, health, and pregnancy experiences. We asked postpartum women whether, during pregnancy, they received sufficient information about nine health topics. We calculated a composite score (range: 0-9) that reflected sufficiency of information received. Multivariable logistic regression models identified determinants of perceived sufficiency of information. Results: Mean age was 32.1 years. Most reported being White (56.3%), non-Hispanic (80.3%), married/living with a partner (85.1%), and employed (54.4%). Most (54.6%) had been diagnosed with depression (54.6%); one-quarter reported current depressive symptoms. Mean sufficiency of information score was 6.9. Topics that women most reported they did not receive sufficient information on included, what to expect during delivery (32.3%) and how their spouse/partner might support them during labor (40.3%). History of depression (ß = -0.35, p = 0.03), current depressive symptoms (ß = -0.66, p = 0.001), military sexual trauma (ß = 0.37, p = 0.03), and experience of violence (ß = 0.66, p = 0.03) were associated with lower sufficiency of information scores. Conclusion: Results indicate need for enhanced and tailored provision of information for Veterans during pregnancy, particularly among those with experience of trauma, past depression diagnoses, and current depressive symptoms. This may include optimizing care coordination and increasing access to childbirth education classes and doula support.

Facility-level characteristics associated with family planning and child immunization services integration in urban areas of Nigeria: a longitudinal analysis.

BACKGROUND: Unmet need for postpartum contraception is high. Integration of family planning with routine child immunization services may help to satisfy unmet need. However, evidence about the determinants and effects of integration has been inconsistent, and more evidence is required to ascertain whether and how to invest in integration. In this study, facility-level family planning and immunization integration index scores are used to: (1) determine whether integration changes over time and (2) identify whether facility-level characteristics, including exposure to the Nigerian Urban Reproductive Health Initiative (NURHI), are associated with integration across facilities in six urban areas of Nigeria. METHODS: This study utilizes health facility data collected at baseline (n = 400) and endline (n = 385) for the NURHI impact evaluation. Difference-in-differences models estimate the associations between facility-level characteristics, including exposure to NURHI, and Provider and Facility Integration Index scores. The two outcome measures, Provider and Facility Integration Index scores, reflect attributes that support integrated service delivery. These indexes, which range from 0 (low) to 10 (high), were constructed using principal component analysis. Scores were calculated for each facility. Independent variables are (1) time period, (2) whether the facility received the NURHI intervention, and (3) additional facility-level characteristics. RESULTS: Within intervention facilities, mean Provider Integration Index scores were 6.46 at baseline and 6.79 at endline; mean Facility Integration Index scores were 7.16 (baseline) and 7.36 (endline). Within non-intervention facilities, mean Provider Integration Index scores were 5.01 at baseline and 6.25 at endline; mean Facility Integration Index scores were 5.83 (baseline) and 6.12 (endline). Provider Integration Index scores increased significantly (p = 0.00) among non-intervention facilities. Facility Integration Index scores did not increase significantly in either group. Results identify facility-level characteristics associated with higher levels of integration, including smaller family planning client load, family planning training among providers, and public facility ownership. Exposure to NURHI was not associated with integration index scores. CONCLUSION: Programs aiming to increase integration of family planning and immunization services should monitor and provide targeted support for the implementation of a well-defined integration strategy that considers the influence of facility characteristics and concurrent initiatives.

Development of integration indexes to determine the extent of family planning and child immunization services integration in health facilities in urban areas of Nigeria.

BACKGROUND: Integrating family planning into child immunization services may address unmet need for contraception by offering family planning information and services to postpartum women during routine child immunization visits. However, policies and programs promoting integration are often based on insubstantial or conflicting evidence about its effects on service delivery and health outcomes. While integration models vary, many studies measure integration as binary (a facility is integrated or not) rather than a multidimensional and varying continuum. It is thus challenging to ascertain the determinants and effects of integrated service delivery. This study creates Facility and Provider Integration Indexes, which measure capacity to support integrated family planning and child immunization services and applies them to analyze the extent of integration across 400 health facilities. METHODS: This study utilizes cross-sectional health facility (N = 400; 58% hospitals, 42% primary healthcare centers) and healthcare provider (N = 1479) survey data that were collected in six urban areas of Nigeria for the impact evaluation of the Nigerian Urban Reproductive Health Initiative. Principal Component Analysis was used to develop Provider and Facility Integration Indexes that estimate the extent of integration in these health facilities. The Provider Integration Index measures provider skills and practices that support integrated service delivery while the Facility Integration Index measures facility norms that support integrated service delivery. Index scores range from zero (low) to ten (high). RESULTS: Mean Provider Integration Index score is 5.42 (SD 3.10), and mean Facility Integration Index score is 6.22 (SD 2.72). Twenty-three percent of facilities were classified as having low Provider Integration scores, 32% as medium, and 45% as high. Fourteen percent of facilities were classified as having low Facility Integration scores, 38% as medium, and 48% as high. CONCLUSION: Many facilities in our sample have achieved high levels of integration, while many others have not. Results suggest that using more nuanced measures of integration may (a) more accurately reflect true variation in integration within and across health facilities, (b) enable more precise measurement of the determinants or effects of integration, and (c) provide more tailored, actionable information about how best to improve integration. Overall, results reinforce the importance of utilizing more nuanced measures of facility-level integration.

Health systems research in fragile and conflict affected states: a qualitative study of associated challenges.

BACKGROUND: High quality health systems research (HSR) in fragile and conflict-affected states (FCAS) is essential to guiding the policies and programmes that will improve access to health services and, ultimately, health outcomes. Yet, conducting HSR in FCAS is challenging. An understanding of these challenges is essential to tackling them and to supporting research conducted in these complex environments. Led by the Thematic Working Group on Health Systems in FCAS, the primary aim of this study was to develop a research agenda on HSR in FCAS. The secondary aim was to identify the challenges associated with conducting HSR in these contexts. This paper presents these challenges. METHODS: Guided by a purposely-selected steering group, this qualitative study collected respondents' perspectives through an online survey (n = 61) and a group discussion at the Third Global Symposium on HSR in September 2014 (n = 11). Respondents with knowledge and/or experience of HSR in FCAS were intentionally recruited. RESULTS: Of those ever involved in HSR in FCAS (45/61, 75%), almost all (98%) experienced challenges in conducting their research. Challenges fall under three broad thematic areas: (1) lack of appropriate support; (2) complex local research environment, including access constraints, weak local research capacity, collaboration challenges and lack of trust in the research process; and (3) limited research application, including rapidly outdated findings and lack of engagement with the research process and results. CONCLUSIONS: This study shows that those familiar with HSR in FCAS face many challenges in gaining support for and in conducting and applying high-quality research. There is a need for more sustainable support, including commitment to and long-term funding of HSR in FCAS; investment in capacity building within FCAS to meet the challenges related to implementation of research in these complex environments; relationship and trust building among stakeholders involved in HSR, particularly between local and international researchers and between researchers and participants; and innovative and flexible approaches to research design and implementation in these insecure and rapidly changing contexts.