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Open Access

Peer-reviewed

Research Article

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

  • Rakhshan Kamran ,

    Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Software, Writing – original draft, Writing – review & editing

    rakhshan.kamran@hertford.ox.ac.uk, kamranr@mcmaster.ca

    Affiliations Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada

    ⨯
  • Liam Jackman,

    Roles Data curation, Formal analysis, Investigation, Methodology, Writing – review & editing

    Affiliation Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    ⨯
  • Anna Laws,

    Roles Data curation, Formal analysis, Investigation, Project administration, Writing – review & editing

    Affiliation Northern Region Gender Dysphoria Service, Newcastle, United Kingdom

    ⨯
  • Melissa Stepney,

    Roles Conceptualization, Formal analysis, Methodology, Project administration, Supervision, Writing – review & editing

    Affiliation Department of Psychiatry, University of Oxford, Oxford, United Kingdom

    ⨯
  • Conrad Harrison,

    Roles Writing – review & editing

    Affiliation Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom

    ⨯
  • Abhilash Jain,

    Roles Supervision, Writing – review & editing

    Affiliation Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom

    ⨯
  • Jeremy Rodrigues

    Roles Conceptualization, Data curation, Supervision, Writing – review & editing

    Affiliations Warwick Clinical Trials Unit, University of Warwick, Warwick, United Kingdom, Department of Plastic Surgery, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, United Kingdom

    ⨯

Abstract

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.

Citation: Kamran R, Jackman L, Laws A, Stepney M, Harrison C, Jain A, et al. (2024) Developing feasible and acceptable strategies for integrating the use of patient-reported outcome measures (PROMs) in gender-affirming care: An implementation study. PLoS ONE 19(4): e0301922. https://doi.org/10.1371/journal.pone.0301922

Editor: Lea Sacca, Florida Atlantic University Charles E Schmidt College of Medicine, UNITED STATES

Received: August 9, 2023; Accepted: March 21, 2024; Published: April 16, 2024

Copyright: © 2024 Kamran et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the manuscript and its Supporting Information files.

Funding: Rakhshan Kamran is funded by an NIHR Doctoral Research Fellowship (NIHR301792). The funding source had no involvement in the study.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Gender-affirming care includes a range of psychosocial, hormonal, and surgical care offered to affirm and support a person’s experience of their gender when it is different from sex assigned at birth. Gender-affirming care is life-saving treatment, which can reduce a person’s gender dysphoria and decrease suicidality, depression, and anxiety [1]. In order to plan for and provide effective gender-affirming care that aligns with a patient’s goals, values, and priorities, the needs and experiences of the individual must be explored holistically and in a patient-centred manner [1]. Patient-reported outcome measures (PROMs) may help with this [1, 2].

PROMs are self-report questionnaires that measure how patients feel and function [3]. A few examples of diverse PROMs used across various clinical areas include: the Patient Health Questionnaire (PHQ-9) used to measure degree of depression [4]; the Oxford Hip Score to measure outcomes following total hip replacement [5]; and the World Health Organization Quality of Life instrument (WHOQOL) which measures quality of life [6]. The benefits of PROMs are well researched and include improvements in communication between patients and clinicians [7], satisfaction with care [8], health outcomes [9], the detection of issues that might otherwise go unaddressed [10], and mortality [11]. For gender-affirming care, PROMs could facilitate better patient-provider communication and shared decision-making, enable the challenging of bias and/or discriminatory practice, and assist evaluating care delivery to inform service improvement [12]. A few examples of key PROMs for gender-affirming care include the Gender Congruence and Life Satisfaction Scale (GCLS) [13] and the Utrecht Gender Dysphoria Scale (UGDS) [14]. These PROMs can be integrated in gender-affirming care as part of initial baseline assessments, to monitor patients’ progress during follow-up visits, to support shared decision-making during appointments, and to augment discussions between clinicians, and patients, in general.

Despite these benefits, PROM uptake is limited, with some clinical areas reporting that 1% of clinicians use PROMs [15–18]. Many PROM implementation initiatives fail due to a lack of evidence-based implementation strategies [19–21]. Indeed, several international bodies have called for evidence-based patient-reported outcome measure (PROM) implementation to improve gender-affirming care globally [1, 2, 22–24].

Implementation science offers established methods for categorising barriers and enablers to implementation of innovations, as well as identifying strategies for addressing the barriers and leveraging the enablers [25]. The Consolidated Framework for Implementation Research (CFIR) is an implementation science “meta-framework” that categorises barriers and enablers to implementation across five domains: outer setting, inner setting, innovation, individuals, and implementation process (Table 1) [26]. Domains are further subdivided into more specific constructs [26]. A previous systematic review [12] and qualitative study [27] conducted by our team categorized patient- and healthcare professional-reported barriers and enablers to implementing PROMs in gender-affirming care, in keeping with CFIR domains. The next step forward is to develop evidence-based implementation strategies that can address these barriers and enablers.

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Table 1. CFIR domains and definitions from Damschroder et al. 2022 [26].

https://doi.org/10.1371/journal.pone.0301922.t001

The CFIR- Expert Recommendations for Implementing Change (ERIC) tool can be used to link identified barriers and enablers to create an implementation strategy [28]. The CFIR-ERIC tool is a Microsoft Excel spreadsheet where barriers and enablers to implementation, categorised according to CFIR constructs, can be inputted. The CFIR constructs are inputted as rows, and for each of the ERIC strategies, listed as columns, the Excel spreadsheet provides an output representing the cumulative percentage of implementation experts agreeing that this ERIC strategy would be effective at addressing the barrier related to the constructs entered. The ERIC strategies were developed through a modified Delphi process, compiling 73 implementation strategies from 169 implementation experts, and has been widely applied to implementation strategy design [28, 29]. The ERIC strategies were developed first, and then later were linked to CFIR constructs via the CFIR-ERIC tool. The CFIR-ERIC tool outputs provide key evidence-based strategies which can be linked to address specific implementation barriers and enablers [30, 31]. As the outputs from CFIR-ERIC are generic in nature, it is important to tailor the strategies to a specific context for acceptability and feasibility using input from key stakeholders.

The aim of this study is to use CFIR guidance to create comprehensive and evidence-based PROM implementation strategies for gender-affirming care, which may also have potential generalizability to other clinical areas.

Materials and methods

Designing feasible and acceptable strategies for integrating PROMs in gender-affirming care

We followed a 3-Phase participatory process to designing feasible and acceptable strategies for integrating PROMs in Gender-Affirming Care using CFIR guidance (Fig 1).

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Fig 1. Diagram of 3-phased participatory research process to create feasible and acceptable strategies for integrating PROMs in gender-affirming care.

https://doi.org/10.1371/journal.pone.0301922.g001

Phase 1

Barriers and enablers to PROM implementation for gender-affirming care were identified from our previous systematic review including 286 articles worldwide with no restrictions on date or language of publication, and our prior qualitative study that sought to understand the experiences of 14 gender-diverse patients seeking gender affirming care, and 10 interdisciplinary healthcare professionals [12, 27]. Results from the systematic review and qualitative study were organised according to CFIR construct and synthesised and prepared to be inputted into the CFIR-ERIC tool by two researchers (RK, LJ) (S1 Appendix).

Phase 2

The data from Phase 1 were categorised with the CFIR-ERIC tool, which was used to match barriers and enablers to potential components of the implementation strategy. This was done with Excel (version 16.67) by two researchers (RK, LJ). Specifically, two researchers (RK, LJ) worked in collaboration to enter data into the CFIR-ERIC tool, which matched barriers and enablers to implementation strategies (CFIR-ERIC output is available in S2 Appendix). Implementation strategy components were organised according to cumulative percentage value from the CFIR-ERIC tool, and refined for the context of PROM implementation in gender-affirming care by two researchers (RK, LJ) (S3 Appendix). Specifically, terminology used in gender-affirming care and with PROMs was used to tailor the general statements outputted from CFIR-ERIC to the context of PROM implementation in gender-affirming care by two researchers (RK, LJ).

Phase 3

The gender-affirming care PROM implementation strategies underwent iterative refinement based on rounds of stakeholder feedback. The gender-affirming care PROM implementation strategy developed through the CFIR-ERIC tool in Phase 2 was reviewed in sequence by seven patient and public partners representing members of the transgender and nonbinary community, and a gender-affirming care healthcare professional with expertise in PROM use for clinical practice (AL). These stakeholders were sent the gender-affirming care PROM implementation strategies and asked to provide written feedback on the acceptability and feasibility of the implementation strategies. S4 Appendix includes the feedback form used by stakeholders. The feedback from stakeholders was used to refine the implementation strategies. The implementation strategies underwent four rounds of iteration (two rounds with patient and public partners, and two rounds with a gender-affirming care healthcare professional) before all stakeholders were in consensus on the final strategies. The rounds of iteration were asynchronous: after each round of feedback, the implementation strategies were revised to respond to feedback raised. Afterwards, the revised implementation strategies were sent for another round of feedback from stakeholders. Patients and healthcare professionals were able to comment on all strategies. Consensus was reached when all key stakeholders agreed on the final implementation strategies and did not have any additional feedback to provide. Disagreements during the rounds of feedback were handled through discussion as a team. The finalised feasible and acceptable strategies for integrating PROMs in gender-affirming care represent evidence from a systematic review of 286 international articles, a qualitative study of 24 gender-affirming care patients and healthcare professionals, and input from 7 patient and public partners and a gender-affirming healthcare professional.

Patient and public involvement

We conducted this research in partnership with seven patient and public partners, representing members of the transgender and nonbinary community. Patient and public partners were recruited through community support groups and national transgender charity organisations in the UK. Patient and public partners confirmed relevance of the research aim to create feasible and acceptable strategies for integrating the use of PROMs in gender-affirming care, and were involved in research to ensure applicability and feasibility of the implementation strategies.

Ethics

This study was reviewed by the Clinical Trials and Research Governance Department, University of Oxford, classified as service improvement and exempt from university sponsorship or ethics committee review. This categorisation was independently ratified by the Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust where the study was independently reviewed and registered: SER-22-027. Service users who had provided written consent to take part in service improvement projects with Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust were contacted and invited to take part in this study. Data collection began 1 May 2023 and ended 1 August 2023.

Reporting

Reporting follows the Standards for Reporting Implementation Studies (StaRI) guideline [32].

Results

Phase 1

The systematic review and qualitative study conducted previously by our team [12, 17] identified barriers and enablers to PROM implementation spanning all five CFIR domains, and 30 CFIR constructs. The systematic review and qualitative study had overlap in identifying barriers and enablers. However, the qualitative study offered additional information and explanation on the barriers and enablers to PROM implementation from the patient perspective, which was lacking in the systematic review. In summary, the key enablers identified from the systematic review and qualitative study were: adapting PROMs to be completed online and in-person, ensuring PROMs are not overly complex (too lengthy, difficult to score), ensuring PROMs are accessible to patients (i.e., those with sight issues, neurodivergence, intellectual disabilities), having a process in place to handle critical PROM responses, providing patients and healthcare providers information on what PROMs are and why they are important, and identifying implementation team members at the clinic who can facilitate implementation. S1 Appendix provides the complete list of barriers and enablers to PROM implementation for gender-affirming care identified from our previous systematic review and qualitative study.

Phase 2

The implementation strategies outputted by the CFIR-ERIC organized by cumulative percent are available in S2 Appendix. S3 Appendix displays the implementation strategies tailored for the context of gender-affirming care. The top healthcare professional-relevant enablers include: identify and preparing implementation champions, collect feedback on PROM implementation, and capture and share local knowledge between clinics on PROM implementation. The top patient-relevant enablers include: having educational material on PROMs, ensuring adaptability of PROMs, and collaborating with key local organisations who may be able to support patients to complete PROMs.

Phase 3

The finalised strategies for integrating PROMs in gender-affirming care are available in below (Tables 2 and 3). These tables detail patient- and healthcare professional-relevant strategies for implementing PROMs in gender-affirming care, organised into two tables (one table outlines patient-relevant strategies, and the other outlines healthcare professional-relevant strategies). Each row for both tables details a PROM implementation strategy which was created using evidence from a systematic review, qualitative study, and iterative refinement with patients and gender-affirming healthcare professionals.

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Table 2. Patient-Relevant strategies for integrating PROMs in gender-affirming care.

https://doi.org/10.1371/journal.pone.0301922.t002

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Table 3. Healthcare professional-relevant strategies for integrating PROMs in gender-affirming care.

https://doi.org/10.1371/journal.pone.0301922.t003

Discussion

This study has developed feasible and acceptable strategies for integrating the use of PROMs in gender-affirming care (Tables 2 and 3) which can be used by clinicians interested in implementing PROMs for their gender-affirming care setting globally. Global clinical guidelines and international studies suggest that PROMs are essential for measuring patient outcomes of gender-affirming care [1, 12]. In the UK in particular, there is an urgent need for improving patient outcomes and relationships/trust with clinicians. We followed organised methods and specific models and processes for developing the PROM implementation strategies as described by CFIR. The strategies developed from this study can be distributed to and used by clinicians and researchers to select and tailor implementation strategies best applying to their setting. Increased clinician training to raise awareness of these strategies may also help to increase skill development to maximize use and uptake of strategies. The strategies outlined can be used as a checklist to ensure a gender-affirming care clinic is maximising potential for PROM implementation. The strategies can also be used to guide a staff meeting on implementing PROMs for a specific gender-affirming care setting.

Past research on PROM implementation has focused on other clinical areas, such as an integrated pain network [33], outpatient medical oncology [34], general outpatient clinics [35], and primary care [36]. In past research, CFIR was successfully used to plan and assess PROM implementation and linking barriers and enablers to identified implementation strategies [37]. The constructs of acceptability and feasibility were evaluated by key stakeholders when developing past PROM implementation strategies in other clinical areas [38, 39]. Recommendations have also been made in a review of PROM implementation for PROM implementation strategies to be co-developed with clinicians and patients [37]. Our study provides the first set of feasible and acceptable implementation strategies for PROM implementation for the clinical area of gender-affirming care. The PROM implementation strategies developed from our study follows recommendations from past research and uses evidence-based and implementation science theory-, model- and framework-informed methods [26, 40–42].

The implementation strategies developed from this study has implications for policy, clinical practice, and research globally. Commissioners and policy-makers can use the strategies to inform PROM implementation policy for gender-affirming care. In clinical practice, our strategies can be used to help ensure gender-affirming care aligns with patient needs that leads to urgently needed improvements in care. Some of our findings may also be of interest to researchers aiming to minimise missing data for PROMs and improve PROM response rate for studies [43].

Strengths of this study include developing a theory-, model-, and framework-informed approach to developing implementation strategies to improve PROM uptake, in line with evidence-based recommendations for implementation studies in this area [37]. Our study followed established approaches in implementation science, along with established strategy development and reporting guidelines [28, 32]. The implementation strategies from this study considered diverse and international perspectives, informed by a systematic review representing 286 studies and 85, 395 patients worldwide, and an in-depth qualitative study representing 14 patients and 10 interdisciplinary healthcare providers. Further, each phase of this research was conducted in partnership with seven patient and public partners representing the gender-affirming care community.

Limitations of this study is a lack of racial and ethnic diversity in the patient qualitative sample [27]. Future research should aim to assess the appropriateness and feasibility of the implementation strategies with ethnically diverse patient groups. Secondly, the implementation strategies developed from this study must be specified and operationalized to enable implementation for each setting. Proctor’s guidance [44] can be used to enable this for future implementation work around PROMs for different gender-affirming care settings.

Conclusion

This study presents evidence-based, feasible, and acceptable strategies for integrating the use of PROMs in gender-affirming care. The developed strategies can be used by clinicians, policy-makers, and researchers to lead PROM implementation efforts for gender-affirming care with potential generalisability to other clinical areas. The strategies can be used to enhance patient-centeredness of gender-affirming care, as emphasised from international standard of care, and ensure PROM benefits are realised while minimising research waste associated with lack of PROM uptake.

Supporting information

S1 Appendix. Synthesised barriers and enablers to PROM implementation for gender-affirming care organised by CFIR domain.

https://doi.org/10.1371/journal.pone.0301922.s001

(DOCX)

S2 Appendix. CFIR-ERIC output.

https://doi.org/10.1371/journal.pone.0301922.s002

(XLSX)

S3 Appendix. Tailored gender-affirming care PROM implementation strategies.

https://doi.org/10.1371/journal.pone.0301922.s003

(DOCX)

S4 Appendix. Feedback form for acceptability and feasibility of PROM implementation strategies.

https://doi.org/10.1371/journal.pone.0301922.s004

(DOCX)

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