Alexandria K. Mickler

Objective We sought to develop consensus recommendations for improved measurement of contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials to build upon previous standardization efforts. Study Design We undertook a virtual consensus-building process using a modified Delphi approach, incorporating aspects of Nominal Group Technique and the Jandhyala method. The process consisted of four half-day meetings, developing recommendations within five topical working groups, a series of consensus questionnaires to assess recommendation agreement on a 4-point Likert-like scale, and opportunities for input and feedback throughout the process. Recommendations required at least 75% consensus to be included. Results Our interdisciplinary group—from 26 organizations and 13 countries in five global regions across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies— developed 44 consensus recommendations. These included recommendations on standardization, patient-reported outcome measure development aligned with current regulatory guidance, trial design, protocol development, participant recruitment, data collection, data analysis, and areas for exploratory research. Seven recommendations were deemed a priority by over 85% of our group. Conclusion Using a formal consensus-building process, we reached high levels of agreement around recommendations for more standardized and patient-centered measurement of CIMCs in contraceptive clinical trials, now and in the future. Implications statement Consensus recommendations on measuring bleeding changes and related outcomes in contraceptive clinical trials can improve reporting of standardized, patient-centered outcomes in future product labeling. These improvements can enable providers to offer more relevant counseling on contraceptives and permit greater comparability and data synthesis across trials to inform clinical guidance.

Despite the importance of menstruation and the menstrual cycle to health, human rights, and sociocultural and economic wellbeing, the study of menstrual health suffers from a lack of funding, and research remains fractured across many disciplines. We sought to systematically review validated approaches to measure four aspects of changes to the menstrual cycle—bleeding, blood, pain, and perceptions—caus ed by any source and used within any field. We then evaluated the measure quality and utility for clinical trials of the identified instruments. We searched MEDLINE, Embase, and four instrument databases and included peer-reviewed articles published between 2006 and 2023 that reported on the development or validation of instruments assessing menstrual changes using quantitative or mixed-methods methodology. From a total of 8,490 articles, 8,316 were excluded, yielding 174 articles reporting on 94 instruments. Almost half of articles were from the United States or United Kingdom and over half of instruments were only in English, Spanish, French, or Portuguese. Most instruments measured bleeding parameters, uterine pain, or perceptions, but few assessed characteristics of blood. Nearly 60% of instruments were developed for populations with menstrual or gynecologic disorders or symptoms. Most instruments had fair or good measure quality or clinical trial utility; however, most instruments lacked evidence on responsiveness, question sensitivity and/or transferability, and only three instruments had good scores of both quality and utility. Although we took a novel, transdisciplinary approach, our systematic review found important gaps in the literature and instrument landscape, pointing towards a need to examine the menstrual cycle in a more comprehensive, inclusive, and standardized way. Our findings can inform the development of new or modified instruments, which—if used across the many fields that study menstrual health and within clinical trials—can contribute to a more systemic and holistic understanding of menstruation and the menstrual cycle.

Contraceptive self-care interventions are a promising approach to improving reproductive health. Reproductive empowerment, the capacity of individuals to achieve their reproductive goals, is recognised as a component of self-care. An improved understanding of the relationship between self-care and empowerment is needed to advance the design, implementation and scale-up of self-care interventions. We conducted a systematic review of the peer-reviewed and grey literature published from 2010 through 2020 to assess the relationship between reproductive empowerment and access, acceptability, use or intention to use contraceptive self-care. Our review adheres to PRISMA guidelines and is registered in PROSPERO (ID CRD42020205235). A total of 3036 unique records were screened and 37 studies met our inclusion criteria. Most studies were conducted in high-income countries, were cross-sectional and had high risk of bias. Almost half included only women. Over 80% investigated male condoms. All but one study focused on use of self-care. We found positive relationships between condom use self-efficacy and use of/intention to use condoms. We found similar evidence for other self-care contraceptive methods, but the low number of studies and quality of the evidence precludes drawing strong conclusions. Few studies assessed causal relationships between empowerment and self-care, indicating that further research is warranted. Other underexplored areas include research on power with influential groups besides sexual partners, methods other than condoms, and access and acceptability of contraceptive self-care. Research using validated empowerment measures should be conducted in diverse geographies and populations including adolescents and men.

Background Since 2009, the International Conference on Family Planning (ICFP) has served as an opportunity for the global reproductive health community to share FP advances and practice lessons in the areas of research, programming, and advocacy. The purpose of this paper was to synthesize the key results and findings presented by members of the FP community at the 2018 ICFP Conference. Methods More than 700 abstracts from all 15 conference tracks were reviewed and 64 abstracts total were selected for this paper based on the novelty and urgency of the findings. The content analysis of conference abstracts were grouped into six final thematic areas. Results 1) Investing in family planning for a lifetime of returns. FP continues to face a shortage of funding. Domestically based and locally owned funding models provide alternative financing solutions. 2) Addressing inequities in family planning for key populations. Various populations still face challenges in accessing FP. Youth-inclusive and user-centered programming show promise in addressing such challenges. 3) Reproductive justice, Unsafe abortions tend to be more common among younger, poor, uneducated and rural women. Legislation is still needed to facilitate a culture of safe abortions. 4) Couple dynamics and decision-making. Couples who share equitable responsibility in decision-making processes are more likely to use contraceptives; couple disagreement influences women’s decisions to covertly use FP. 5) Male involvement in programming. Male champions can successfully promote uptake of FP. Gender-transformative programming promotes gender equity and impacts behavior change. 6) Breakthroughs in novel contraceptives and systems improvement in family planning. Recent advances include user-centered contraceptive technologies that allow for self-administration and information systems which optimize supply chain management. Conclusion The research, advocacy, and programmatic abstracts at ICFP 2018 highlighted research advances, showcased implementation science wins, and provided evidence of critical knowledge gaps in global FP access and use

More than 7.3 million older adults in the United States have difficulty leaving their homes or are completely homebound, yet little data exist on the experiences of homebound older adults and their caregivers. We conducted 30 semi-structured qualitative interviews with homebound older adults and caregivers recruited through home-based medical care practices in Baltimore and San Francisco. Thematic template analyses revealed that homebound older adults experience varying degrees of independence in activities of daily living, although their degree of dependence increases over time. Caregivers have a multifaceted, round-the-clock role. Both patients and caregivers experience burdens including social isolation and guilt. Navigating medical care and caregiving was further complicated by the complexity of the U.S. health care system; however, home-based medical care was viewed as a high-quality alternative to hospitals or nursing homes. Our findings suggest that providers and health care systems should expand the availability and accessibility of home-based care and improve caregiver support opportunities.

The COVID-19 pandemic has substantially strained health systems across the globe. In particular, documented disruptions to voluntary family planning and reproductive health care due to competing health priorities, service disruptions, stockouts, and lockdowns are significantly impacting reproductive, maternal, newborn, and child health. As governments and family planning programmes grapple with how best to respond to the direct and indirect effects of the pandemic on family planning and reproductive health (FP/RH), the implementation and adaptation of evidence-based practices is crucial. In this commentary, we outline applications of the High Impact Practices in Family Planning (HIPs) towards COVID-19 response efforts. The HIPs are a set of evidence-based family planning practices which reflect global expert consensus on what works in family planning programming. Drawing upon preliminary COVID-19 data, documented experiences from prior health emergencies, and recommended programme adaptations from a variety of global health partners, we outline situations where specific HIPs may assist family planning programme managers in developing context-specific and evidence-based responses to COVID-19-related impacts on FP/RH, with the ultimate goal of ensuring the accessibility, availability, and continuity of voluntary family planning services across the world.

Since 2009, the International Conference on Family Planning (ICFP) has served as an opportunity for the global reproductive health community to share FP advances and practice lessons in the areas of research, programming, and advocacy. The key takeaways from all 15 tracks were grouped into six thematic areas: 1) Investing in family planning for a lifetime of returns. FP may yield different health and monetary benefits but continues to face a shortage of funding, although locally owned models provide alternative financing solutions. 2) Addressing inequities in family planning for adolescents, youth, and key populations. Marginalized populations and youth still face challenges in accessing FP. Youth-inclusive and user-centered programming show promise in addressing such challenges. 3) Reproductive justice: Abortion care, family planning, and women’s wellbeing. Unsafe abortions tend to be more common among younger, poor, uneducated and rural women. Promising evidence show that providers may effectively shift from unsafe practices of dilation and curettage to safer manual vacuum aspiration or misoprostol. 4) Couple dynamics and family planning decision-making. Couples who share everyday life decision-making are more likely to use contraceptives; couple discordance on childbearing and fertility decisions directly influence women’s decisions to covertly use FP. 5) Male involvement in FP programming. Male champions and advocates can successfully promote couple uptake of FP. Gender-transformative programming promotes gender equity and can directly impact behavior change. 6) Breakthroughs in novel contraceptives and systems improvement in family planning. User-centered contraceptive technologies and information systems present an opportunity to facilitate self-care and optimal supply chain management. ICFP 2018 highlighted research advances, implementation science wins, and critical knowledge gaps in global FP access and use. More research is needed to determine the scalability of novel technologies, more effective programming and service delivery models to ensure multisectoral knowledge translation and utilization by policymakers.