Implementing strategies to improve uptake of patient-reported outcome measures (PROMs) in gender-affirming care: a mixed-methods implementation study.

IMPORTANCE: The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is an evidence-based resource, which was developed in response to international calls for improved patient-reported outcome measure (PROM) implementation in gender-affirming care. The PG-PROM-GAC has the potential to improve PROM implementation; however, its real-world effectiveness has not yet been investigated. OBJECTIVE: Investigate effectiveness and fidelity of three implementation strategies from the PG-PROM-GAC in a real-world gender clinic setting. DESIGN: Interrupted time series mixed-methods study investigating response rates to a PROM deployed alongside implementation strategies from the PG-PROM-GAC; and open-ended feedback on the fidelity and effectiveness of implementation strategies. SETTING: Participants were recruited from a National Health Service (NHS) gender clinic. PARTICIPANTS: Eligible participants were being seen at an NHS gender clinic for an appointment during the study period, and were invited to participate in this study via email. INTERVENTION: Three implementation strategies from the PG-PROM-GAC deployed alongside a PROM. MAIN OUTCOMES AND MEASURES: Response rates were calculated at 2-week intervals, in line with the deployment of each implementation strategy. Open-ended responses were thematically analysed by two researchers following guidance from implementation science and interpretation from Normalisation Process Theory. RESULTS: A total of 28 participants were included in this study with a mean (SD) age of 39 (17) years. In general, participants rated education material for PROMs as the most important for PROM implementation, and accessibility options for PROMs as the second most important. Response rates to PROM completion dropped as the study progressed, as the burden of reviewing implementation strategies increased. Results were used to construct recommendations for future PROM implementation efforts. CONCLUSIONS AND RELEVANCE: The PG-PROM-GAC and implementation strategy materials developed from this study (ie, educational video on PROMs co-developed with key stakeholders) can be used by clinicians, researchers and policymakers to lead PROM implementation efforts in gender-affirming care.

Developing feasible and acceptable strategies for integrating the use of patient-reported outcome measures (PROMs) in gender-affirming care: An implementation study.

OBJECTIVE: Use CFIR guidance to create comprehensive, evidence-based, feasible, and acceptable gender-affirming care PROM implementation strategies. DESIGN, SETTING, PARTICIPANTS: A 3-Phase participatory process was followed to design feasible and acceptable strategies for integrating PROMs in gender-affirming care. In Phase 1, barriers and enablers to PROM implementation for gender-affirming care were identified from a previous systematic review and our prior qualitative study. We used the CFIR-ERIC tool to match previously identified barriers and enablers with expert-endorsed implementation strategies. In Phase 2, implementation strategy outputs from CFIR-ERIC were organised according to cumulative percentage value. In Phase 3, gender-affirming care PROM implementation strategies underwent iterative refinement based on rounds of stakeholder feedback with seven patient and public partners and a gender-affirming healthcare professional. RESULTS: The systematic review and qualitative study identified barriers and enablers to PROM implementation spanning all five CFIR domains, and 30 CFIR constructs. The top healthcare professional-relevant strategies to PROM implementation from the CFIR-ERIC output include: identifying and preparing implementation champions, collecting feedback on PROM implementation, and capturing and sharing local knowledge between clinics on implementation. Top patient-relevant strategies include: having educational material on PROMs, ensuring adaptability of PROMs, and collaborating with key local organisations who may be able to support patients. CONCLUSIONS: This study developed evidence-based, feasible, and acceptable strategies for integrating PROMs in gender-affirming care, representing evidence from a systematic review of 286 international articles, a qualitative study of 24 gender-affirming care patients and healthcare professionals, and iteration from 7 patient and public partners and a gender-affirming healthcare professional. The finalised strategies include patient- and healthcare professional-relevant strategies for implementing PROMs in gender-affirming care. Clinicians and researchers can select and tailor implementation strategies best applying to their gender-affirming care setting.

Patient and healthcare professional perspectives on the Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC): analysis of open-ended responses from patients and healthcare professionals.

IMPORTANCE: Several international calls have been made for evidence-based patient-reported outcome measure (PROM) implementation for gender-affirming care. The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is a resource which can help guide PROM implementation efforts, developed using a three-phase participatory research approach with transgender and gender-diverse (TGD) patients and gender-affirming healthcare professionals. However, thoughts and perspectives from TGD patients and gender-affirming healthcare professionals on the PG-PROM-GAC need to be investigated. OBJECTIVE: Investigate patient and healthcare professional perspectives on the PG-PROM-GAC through analysis of open-ended survey results. DESIGN: Qualitative study analysing open-ended responses from TGD patients and gender-affirming healthcare professionals. SETTING: Participants were recruited from a UK National Health System (NHS) gender clinic. PARTICIPANTS: Patients receiving care at an NHS gender clinic and healthcare professionals working at an NHS gender clinic were eligible for participation. Eligible participants were invited to participate in this study via email. INTERVENTION: Participants were sent an open-ended survey to collect responses on the PG-PROM-GAC. MAIN OUTCOMES AND MEASURES: Data were thematically analysed by two independent researchers and interpreted following guidance from established methods in implementation science. RESULTS: A total of 64 TGD patients and 9 gender-affirming healthcare professionals responded to the open-ended survey (mean (SD) age: 35 (16) and 48 (8), respectively). Four main themes emerged from the data: overall opinions and support for the PG-PROM-GAC, presentation of the PG-PROM-GAC, impact of gender clinic resources on PROM implementation and impact of PROM selection on implementation. Data were used to iterate the PG-PROM-GAC in response to participant feedback. CONCLUSIONS AND RELEVANCE: The PG-PROM-GAC is an acceptable and feasible resource that can be used by clinicians, researchers and policymakers to guide PROM implementation for gender-affirming care settings, helping to align gender-affirming care with patient needs.

Pre- and post-COVID-19 gender trends in authorship for paediatric radiology articles worldwide: a systematic review.

BACKGROUND: Gender inequalities in academic medicine persist despite progress over the past decade. Evidence-based targeted interventions are needed to reduce gender inequalities. OBJECTIVE: This systematic review aimed to investigate the impact of COVID-19 on gender trends in authorship of paediatric radiology research worldwide. MATERIALS AND METHODS: This prospectively registered, PRISMA-compliant systematic review searched the following databases: PubMed, MEDLINE, Web of Science, and Scopus from January 1, 2018, to May 29, 2023, with no restrictions on country of origin. Screening and data extraction occurred independently and in duplicate. Gender of first, last, and corresponding authors were determined using an artificial intelligence-powered, validated, multinational database ( www.genderize.io ). Two time periods were categorised according to the Johns Hopkins Center for Systems Science and Engineering: pre-COVID (prior to March 2020) and peak and post-COVID (March 2020 onwards). One-sample binomial testing was used to analyse proportion of authorship based on gender. Categorical variables were described as frequencies and percentages, and compared using testing chi-square or Fisher exact testing, with a threshold of P<0.05 representing statistical significance. RESULTS: In total, 922 articles were included with 39 countries represented. A statistically significant difference in authorship based on gender persisted during the peak and post-COVID time period (March 2020 onwards) where women represented a statistically significant lower proportion of last (35.5%) and corresponding (42.7%) authors (P<0.001, P=0.001, respectively). Statistically significant differences for first authors were not found in either period (P=0.08 and P=0.48). CONCLUSION: This study identifies differences in gender trends for authorship in paediatric radiology research worldwide. Future efforts to increase authorship by women are needed.

Patient and healthcare professional perspectives on implementing patient-reported outcome measures in gender-affirming care: a qualitative study.

OBJECTIVES: Patient and healthcare professional perspectives are needed to develop a gender-affirming care patient-reported outcome measure (PROM) implementation plan. We aimed to identify top considerations relevant to gender-affirming care PROM implementation from patient and healthcare professional perspectives. DESIGN, SETTINGS AND PARTICIPANTS: This qualitative study conducted in the UK between January and April 2023 includes focus groups with a patient sample diverse in age and gender identity, and a healthcare professional sample diverse in age and role. Established methods in implementation science and the Consolidated Framework for Implementation Research were used to create interview guides, and analyse data. Focus groups were audio recorded, transcribed verbatim and analysed by two independent researchers. Patient and healthcare professional focus groups were conducted separately. PRIMARY OUTCOME MEASURES: Patient and healthcare professional perspectives on PROM implementation were explored through focus groups and until data saturation. RESULTS: A total of 7 virtual focus groups were conducted with 24 participants (14 patients, mean (SD) age, 43 (14.5); 10 healthcare professionals, mean (SD) age, 46 (11.3)). From patient perspectives, key barriers to PROM implementation were mistrust with PROMs, lack of accessibility, burden, and lack of communication on why PROMs are important and how they will help care. From healthcare professional perspectives, key barriers to PROM implementation were lack of accessibility, burden with PROM administration and scoring, costs of implementation (financial and time), and lack of communication on what PROMs are and how they benefit service provision. CONCLUSION: Gender-affirming care PROM implementation must address: patient mistrust with PROMs, accessibility, communication on what PROMs are and how they can be used, reducing burden, and hybridised implementation. These factors may also be applicable to other clinical areas interested in implementing PROMs.

Implementation of Patient-Reported Outcome Measures for Gender-Affirming Care Worldwide: A Systematic Review.

Importance: Gender-affirming care is a key clinical area that can benefit from implementation of patient-reported outcome measures (PROMs). Identifying barriers to and enablers of PROM implementation is needed to develop an evidence-based implementation strategy. Objective: To identify (1) PROMs previously implemented for gender-affirming care and constructs measured, (2) how patients completed PROMs and how results were reported and used, and (3) barriers to and enablers of PROM implementation. Evidence Review: In this systematic review, PubMed, Embase, MEDLINE, PsycINFO, CINAHL, and Web of Science were searched from inception to October 25, 2021, and updated on December 16, 2022. Gray literature was searched through gray literature database, online search engine, and targeted website searching. Inclusion criteria were (1) original articles of (2) a formally developed PROM or ad hoc instrument administered for gender-affirming care to (3) patients accessing gender-affirming care. The Critical Appraisal Skills Programme tool was used to evaluate quality of included studies. This review was registered on PROSPERO (CRD42021233080). Findings: In total, 286 studies were included, representing 85 395 transgender and nonbinary patients from more than 30 countries. A total of 205 different PROMs were used in gender-affirming care. No studies described using an implementation science theory, model, or framework to support PROM deployment. Key barriers to PROM implementation included issues with evidence strength and quality of the PROM, engaging participants, and PROM complexity. Key enablers of PROM implementation included using PROMs validated for gender-affirming care, implementing PROMs able to be deployed online or in person, implementing PROMs that are shorter and reduce patient burden, engaging key stakeholders and participants as part of developing an implementation plan, and organizational climate. Conclusions and Relevance: In this systematic review of barriers to and enablers of PROM implementation in gender-affirming care, PROM implementation was inconsistent and did not follow evidence-based approaches in implementation science. There was also a lack of patient input in creating implementation strategies, suggesting a need for patient-centered approaches to PROM implementation. Frameworks created from these results can be used to develop evidence-based PROM implementation initiatives for gender-affirming care and have potential generalizability for other clinical areas interested in implementing PROMs.

Pharmacological Treatments for Localized Provoked Vulvodynia: A Scoping Review.

Introduction: Localized provoked vulvodynia (LPV) is a chronic pain condition without an identifiable cause that is localized to a portion of the vulva and provoked by pressure or touch. LPV is a commonly occurring but poorly understood condition lacking consensus on management. Method: This scoping review used Arksey and O'Malley's approach to identify and evaluate literature published between 2010 and 2023 that addressed the question: What is the current evidence on the efficacy or effectiveness of pharmacological treatments in the management of LPV? Results: This review evaluated 18 papers reporting on the efficacy or effectiveness of oral, topical, and injectable medications. Seven of the studies were randomized controlled trials. Oral gabapentin and oral desipramine showed some improvement in sexual function compared to placebo. Small sample sizes and methodological issues limited confidence in interpreting findings. Pain was reduced in descriptive studies of tricyclic antidepressants, milnacipran, injectable anesthetics, and botulinum toxin. Where pain did not improve with treatment, some oral medications improved participants' mood and sexual function. Some topical agents may be effective in reducing peripherally mediated neuropathic pain. Botulinum toxin was the most well-studied injectable but yielded mixed outcomes related to pain, quality of life, and sexual function. Conclusion: There is a lack of convincing evidence to draw conclusions about the efficacy or effectiveness of pharmacological therapies for LPV. The breadth of therapies for treating LPV warrants the development of evidence-based, consensus guidelines for measuring treatment outcomes and improving comparisons across studies. Recommendations for research include addressing methodological shortcomings and diversifying the participant pool to increase the generalizability of findings.