Idiopathic primary ovarian insufficiency (POI) is a reproductive disorder characterized by declining ovarian function and impaired fertility. Decreased serum estradiol levels manifest as menopausal symptoms, including vasomotor symptoms, disturbed mood and sleep, and altered libido and sexual function (Touraine et al., 2024). Individuals with POI have increased risk for osteoporosis, cardiovascular disease, potentially accelerated neurodegenerative aging, and increased all-cause mortality risk compared to individuals with normal timing of menopause (Stuenkel and Gompel, 2023; Kirubarajan et al., 2024). The median age of menopause onset is 49–51 years and early menopause is considered to be between 40 and 44 years (te Velde and Pearson, 2002). In contrast, people with primary ovarian insufficiency lose ovarian function and typically end menses before age 40 years (Stuenkel and Gompel, 2023). In aggregate, 3.7% of women worldwide are affected by early menopause or POI (Golezar et al., 2019). Importantly, POI is not prevalent, as it only affects approximately 1% of women younger than 40 years of age (Stuenkel and Gompel, 2023). Moreover, roughly 90% of POI cases are idiopathic and without an underlying etiology (Touraine et al., 2024). So while menopause is an expected event for women, POI is less well understood (EHRE, ASRM, CREWHIRL and IMS Guideline Group on POI et al., 2025). As such, despite the continued growth of specialized fertility clinics (The Lancet, 2024), individuals with POI often experience a lengthy process to be diagnosed (‘diagnostic odyssey’). Such experiences contribute to patient dissatisfaction with care (McDonald et al., 2022).

Notably, POI is associated with diminished health-related-quality of life (HR-QoL) stemming from negative clinical interactions during the diagnostic odyssey, isolation and stigma related to the diagnosis, and impaired ego integrity related to menopausal symptoms (McDonald et al., 2022). As such, individuals with POI have a range of unmet health, information, and psychosocial needs and are often dissatisfied with care. There is a need for more person-centered approaches to POI care to help patients better understand the condition, decrease stigma, and support alternative family planning goals (Martin et al., 2017).

Person-centered care is widely acknowledged as a means to improve a variety of health outcomes, including physical and social well-being, patient knowledge, and satisfaction with care (NEJM Catalyst, 2017). Central elements of person-centered care include collaborative decision-making, accessible care, a holistic view of well-being, consideration of family and cultural values, information-sharing, and recognizing patients and families as full partners in the design and implementation of healthcare (NEJM Catalyst, 2017). Patient and public involvement including co-creation is noted as a means to improve the person-centeredness of care (Manafo et al., 2018; Bombard et al., 2018; Leung et al., 2019; McDonald et al., 2023). Co-creation is a collaborative approach that has been used across a variety of healthcare settings and with diverse patient populations to develop person-centered approaches to care that are responsive to patient-identified needs (McDonald et al., 2023). The approach has been used across numerous countries, cultures, languages, and with patients living with conditions ranging from common to rare (McDonald et al., 2023). It can bring together diverse stakeholders, including healthcare professionals and patients, to provide insights into unmet needs, underserved or marginalized populations, and groups with low satisfaction with healthcare. Co-creation considers patients as equal partners and empowers patients to help improve person-centered healthcare.

To address unmet patient needs and enhance person-centered POI care, we aimed to employ best co-creation practices (McDonald et al., 2023) to develop patient-facing educational materials. We then assessed the acceptability of co-created materials using the Patient Education Materials Assessment Tool for print materials (PEMAT-P) to measure understandability and actionability.

This study involved two phases. The first phase drew on participatory design methodology. Healthcare professionals partnered with patients in a ‘design thinking’ process to co-create patient-facing educational materials (PEM) on POI. The second phase was a cross-sectional descriptive evaluation study that employed multiple methods. Individuals with POI used an online survey to quantitatively evaluate co-created materials and provide qualitative feedback. The study was reviewed and approved by the Mass General Brigham IRB (#2021P003242) and participants provided opt-in informed consent prior to the initiation of study procedures.

We reported on the process and evaluation of co-creating PEM for POI with patients. Employing co-creation best practices (McDonald et al., 2023), partnering with patients, and using the design thinking process produced acceptable, understandable, and actionable patient-facing PEM. Existing literature demonstrates the considerable variety in the populations and conditions who have employed the co-creation process (McDonald et al., 2023) supporting generalizability of the approach.

A robust body of literature underscores that distress is common among individuals struggling with infertility as well as those undergoing fertility treatment (McDonald et al., 2022; Greil, 1997; Van den Broeck et al., 2010). Individuals with POI face unmet health, information, and psychosocial needs that contribute to suboptimal outcomes and poor satisfaction with care (McDonald et al., 2022; Bogart et al., 2022). At a healthcare systems level, there is an urgent need to improve health outcomes, reduce costs, and enhance patient satisfaction. One way to reach these objectives is through a renewed focus on person-centered care (NEJM Catalyst, 2017). Engaging with patients and communities is important for identifying unmet needs and patient priorities to inform more person-centered approaches. Co-creation utilizing ‘best practices’ is a means to enhance person-centered care and develop solutions that are responsive to patient-identified priorities. The example of POI presented herein shows that co-creation is a viable, innovative, and low-cost way for healthcare organizations to respond to patient priorities and enhance person-centered care, thereby contributing to improved patient satisfaction and potentially enhanced health outcomes. Co-creation has been effectively employed other patient populations with reproductive disorders (Dwyer et al., 2021a,b). The evidence-based ‘best practices’ and the co-creation example detailed in this article, can serve as a roadmap for healthcare organizations in future quality improvement projects.

A relative strength of the study is the close adherence to co-creation best practices (McDonald et al., 2023). There are several limitations to this study. In terms of co-creation, we involved two patients throughout the process. However, it is unclear if the process could have been enhanced with additional patient collaborators to enhance the diversity of perspectives, opinions, and lived experiences. We also recognize one of the participants played a dual role, providing two perspectives (patient and genetic counselor) in the challenges in communicating risk that may be different from a lay individual with POI’s experience. Comprehensive care for POI includes a multidisciplinary approach, and the perspectives of specialists including psychologists or fertility counselors could further diversify and enhance the co-creation process. In terms of the evaluation, the number of participants who completed the survey was limited (n = 30), yet the sample size is similar to other reports evaluating PEM (McDonald et al., 2023). As such, results should be considered as pilot study findings. Additionally, the respondents were rather homogenous as most participants were White, well-educated, and had adequate health literacy/numeracy—a bias that has been noted with web-based surveys (Jang and Vorderstrasse, 2019; Patten and Perrin, 2015). The mean age of respondents who completed the evaluation survey was 36.9 ± 6.4 years, which is consistent with the PEM’s focus on topics proximal to the time of diagnosis before 40 years old. PEMAT-P scores neither differed between participants dichotomized according to educational attainment nor health literacy/numeracy. However, caution is warranted in interpreting this observation as relatively few participants had low educational attainment and/or limited health literacy/numeracy. Regardless, it is plausible that the 7th grade reading level of the materials likely contributed to high understandability and acceptability ratings by the vast majority of participants. It is worthwhile to note that there are a number of tools available to assess print materials. While the PEMAT-P is considered a ‘gold standard’ evaluation tool, other approaches, such as the Baker Able Leaflet Design (BALD) method, have a stronger emphasis on layout and design and could have provided different insights than the PEMAT-P.

Notably, the recent emergence of generative artificial intelligence and large language models may hold promise for surmounting health literacy and numeracy barriers in PEM (Kirchner et al., 2023). However, patient involvement is essential to ensure that PEM responds to patient-identified needs. Following refinement based on the evaluation (i.e., PEMAT-P and qualitative comments), the final PEM revised version (Supplementary materials) will be disseminated in two channels. First, PEM will be disseminated to POI patient support organizations. In parallel, dissemination to healthcare providers and patients alike will occur via the P50 Massachusetts General Hospital – Harvard Center for Reproductive Medicine website that was do-designed with patients.¹ The QR code on printed materials will link to the website (co-designed with patients) to provide both overview materials and opportunities to dig deeper into topics and access more detailed information (as identified in qualitative comments). Future directions could include exploring emotional responses to the co-created materials. Indeed, POI and infertility are sensitive topics and people with POI often experience significant psychosocial challenges affecting psychological wellbeing and quality of life (McDonald et al., 2022). It is plausible that people with POI may have different needs and priorities depending on the time from initial diagnosis and life stage. Accordingly examining the materials from a life-stage perspective could help inform more developmentally-tailored approaches to care. While this work followed best practices for co-creating patient-facing educational materials (McDonald et al., 2023), further work could examine how design elements of the materials align with established public health messaging and health communication practices (Zhao, 2020).

Engaging patients in the co-creation process produced PEM that were understandable, actionable, and highly acceptable to patients. The process described herein may serve as a “roadmap” guiding PEM development that can be easily adapted for a variety of healthcare conditions and patient populations. Moreover, co-creation is a patient engagement process that is relevant for developing interventions to address healthcare disparities.