Assessing the efficacy of the Stop OsteoARthritis (SOAR) program: A randomized delayed-controlled trial in persons at increased risk of early onset post-traumatic knee osteoarthritis.

OBJECTIVE: Assess the efficacy of an 8-week virtual, physiotherapist (PT)-guided knee health program (Stop OsteoARthritis (SOAR)) to improve knee extensor strength in individuals at risk of post-traumatic knee osteoarthritis (PTOA). METHOD: In this superiority, randomized delayed-control trial, persons aged 16-35 years, 1-4 years after a self-reported knee joint injury were randomly assigned (1:1) to receive the SOAR program immediately (experimental group) or after a 9-week delay (control group). SOAR includes 1) one-time Knee Camp (virtual PT-guided group education, knee assessment, 1:1 exercise and physical activity (PA) goal-setting); 2) Weekly personalized home-based exercise and PA program with tracking; 3) Weekly 1:1 PT counseling (virtual). The primary outcome was a change in isokinetic knee extensor strength (baseline to 9-weeks). Additional outcomes included change in self-reported knee-related quality-of-life (QOL), self-efficacy, self-management and kinesiophobia, and PA (accelerometer) at 9 and 18-weeks. Linear regression models estimated the effect of the 8-week intervention at the primary endpoint (9-week). RESULTS: 49 of 54 randomized participants completed the study (91%). Participants were a mean ± standard deviation age of 27 ± 5.0 years, and 2.4 ± 0.9 years post-injury. No mean between group differences for the primary (0.05; 95% confidence interval (CI): -0.10, 0.19) or other outcomes were seen at 9 weeks except for greater improvements in perceived self-management (Partner in Health Scale; 11.3/96, 95%CI: 5.5, 17.1) and kinesiophobia (Tampa Scale of Kinesiophobia; -4.4/33, 95%CI: -7.0, -1.8). CONCLUSION: For active persons with elevated risk of PTOA, an 8-week SOAR program did not change knee-related strength, QOL, self-efficacy, or PA, on average, but may benefit the ability to self-manage knee health and kinesiophobia.

Investigating the Influence of Patient Eligibility Characteristics on the Number of Deferrable Rheumatologist Visits: Planning for a Patient-Initiated Follow-Up Strategy.

OBJECTIVE: Patient-initiated follow-up (PIFU) for rheumatoid arthritis (RA) is a model of care delivery wherein patients contact the clinic when needed instead of having regularly scheduled follow-up. Our objective was to investigate the influence of different patient eligibility characteristics on the number of potentially deferred visits to inform future implementation of a PIFU strategy. METHODS: We conducted a retrospective chart review of 7 rheumatologists' practices at 2 university-based clinics between March 1, 2021, and February 28, 2022. Data extracted included the type and frequency of visits, disease management, comorbidities, and care complexities. Stable disease was defined as remission or low disease activity with no medication changes at all visits. The influence of patient characteristics on the number of deferrable visits in patients with stable disease was explored in 4 criteria sets that were based on early disease duration, medication prescribed, presence of care complexity elements, and comorbidity burden. RESULTS: Records from 770 visits were reviewed from 365 patients with RA (71.5% female, 70% seropositive). Among all criteria sets, the proportion of visits that could be redirected varied between 2.5% and 20.9%. The highest proportion of deferrable visits was achieved when eligibility criteria included only stable disease activity and patients with RA on conventional synthetic disease-modifying antirheumatic drugs or no medications (n = 161, 20.9%). CONCLUSION: PIFU may result in a more efficient use of specialist healthcare resources. However, the applicability of such models of care and the number of deferred visits is highly dependent on patient characteristics used to establish eligibility criteria for that model. These findings should be considered when planning implementation trials.

An Environmental Scan and Appraisal of Patient Online Resources for Managing Rheumatoid Arthritis Flares.

OBJECTIVE: To conduct an environmental scan and appraisal of online patient resources to support rheumatoid arthritis (RA) flare self-management. METHODS: We used the Google search engine (last search March 2023) using the terms "rheumatoid arthritis" and "flare management." Additional searches targeted major arthritis organizations, as well as regional, national, and international resources. Appraisal of the resources was conducted by 2 research team members and 1 patient partner to assess the understandability and actionability of the resource using the Patient Education Materials Assessment Tool (PEMAT). Resources rating ≥ 60% in both domains by either the research team or the patient partner were further considered for content review. During content review, resources were excluded if they contained product advertisements, inaccurate information, or use of noninclusive language. If content review criteria were met, resources were designated as "highly recommended" if both patient partners and researchers' PEMAT ratings were ≥ 60%. If PEMAT ratings were divergent and had a rating ≥ 60% from only 1 group of reviewers, the resource was designated "acceptable." RESULTS: We identified 44 resources; 12 were excluded as they did not pass the PEMAT assessment. Fourteen resources received ratings ≥ 60% on understandability and actionability from both researchers and patient partners; 10 of these were retained following content review as "highly recommended" flare resources. Of the 18 divergent PEMAT ratings, 8 resources were retained as "acceptable" following content review. CONCLUSION: There is high variability in the actionability and understandability of online RA flare materials; only 23% of resources were highly recommended by researchers and patient partners.

Content validity testing of the INTERMED Self-Assessment in a sample of adults with rheumatoid arthritis and rheumatology healthcare providers.

BACKGROUND: Care complexity can occur when patients experience health challenges simultaneously with social barriers including food and/or housing insecurity, lack of transportation or other factors that impact care and patient outcomes. People with rheumatoid arthritis (RA) may experience care complexity due to the chronicity of their condition and other biopsychosocial factors. There are few standardised instruments that measure care complexity and none that measure care complexity specifically in people with RA. OBJECTIVES: We assessed the content validity of the INTERMEDS Self-Assessment (IMSA) instrument that measures care complexity with a sample of adults with RA and rheumatology healthcare providers (HCPs). Cognitive debriefing interviews utilising a reparative framework were conducted. METHODS: Patient participants were recruited through two existing studies where participants agreed to be contacted about future studies. Study information was also shared through email blasts, posters and brochures at rheumatology clinic sites and trusted arthritis websites. Various rheumatology HCPs were recruited through email blasts, and divisional emails and announcements. Interviews were conducted with nine patients living with RA and five rheumatology HCPs. RESULTS: Three main reparative themes were identified: (1) Lack of item clarity and standardisation including problems with item phrasing, inconsistency of the items and/or answer sets and noninclusive language; (2) item barrelling, where items asked about more than one issue, but only allowed a single answer choice; and (3) timeframes presented in the item or answer choices were either too long or too short, and did not fit the lived experiences of patients. Items predicting future healthcare needs were difficult to answer due to the episodic and fluctuating nature of RA. CONCLUSIONS: Despite international use of the IMSA to measure care complexity, patients with RA and rheumatology HCPs in our setting perceived that it did not have content validity for use in RA and that revision for use in this population under a reparative framework was unfeasible. Future instrument development requires an iterative cognitive debriefing and repair process with the population of interest in the early stages to ensure content validity and comprehension. PATIENT OR PUBLIC CONTRIBUTION: Patient and public contributions included both patient partners on the study team and people with RA who participated in the study. Patient partners were involved in study design, analysis and interpretation of the findings and manuscript preparation. Data analysis was structured according to emergent themes of the data that were grounded in patient perspectives and experiences.

Effect of digital monitoring and counselling on self-management ability in patients with rheumatoid arthritis: a randomised controlled trial.

OBJECTIVES: To assess a remote physiotherapist (PT) counselling intervention using self-monitoring tools for improving self-management ability, physical activity participation, and health outcomes in people with rheumatoid arthritis (RA). METHODS: Eligible participants were randomly assigned to receive group education, a Fitbit®, a self-monitoring app, and PT counselling phone calls (Immediate Group). The Delayed Group received a monthly e-newsletter until week 26, and then the intervention. The primary outcome was Patient Activation Measure (PAM-13). Participants were assessed at baseline, 27 weeks (the primary end point) and 53 weeks. Secondary outcomes included disease activity, pain, fatigue, depression, sitting/walking habits, daily physical activity time, and daily awake sedentary time. Generalized Linear Mixed-effect Models (GLMMs) were used to assess the effect of the intervention on the change of each outcome measure from the initiation to 27 weeks after the intervention. RESULTS: Analysis included 131 participants (91.6% women; 80.2% completed during the COVID-19 pandemic). The mean change of PAM-13 at 27 weeks was 4.6 (SD = 14.7) in the Immediate Group vs -1.6 (SD = 12.5) in the Delayed Group. The mean change in Delayed Group at 53 weeks (after the 26-week intervention) was 3.6 (SD = 14.6). Overall, the intervention improved PAM-13 at 27 weeks post-intervention from the GLMM analysis (adjusted coefficient: 5.3; 95% CI: 2.0, 8.7; p = <0.001). Favourable intervention effects were also found in disease activity, fatigue, depression, and self-reported walking habit. CONCLUSION: Remote counselling paired with self-monitoring tools improved self-management ability in people with RA. Findings of secondary outcomes indicate that the intervention had a positive effect on symptom management.

Cost-effectiveness of pharmacogenomic-guided treatment for major depression.

BACKGROUND: Pharmacogenomic testing to identify variations in genes that influence metabolism of antidepressant medications can enhance efficacy and reduce adverse effects of pharmacotherapy for major depressive disorder. We sought to establish the cost-effectiveness of implementing pharmacogenomic testing to guide prescription of antidepressants. METHODS: We developed a discrete-time microsimulation model of care pathways for major depressive disorder in British Columbia, Canada, to evaluate the effectiveness and cost-effectiveness of pharmacogenomic testing from the public payer's perspective over 20 years. The model included unique patient characteristics (e.g., metabolizer phenotypes) and used estimates derived from systematic reviews, analyses of administrative data (2015-2020) and expert judgment. We estimated incremental costs, life-years and quality-adjusted life-years (QALYs) for a representative cohort of patients with major depressive disorder in BC. RESULTS: Pharmacogenomic testing, if implemented in BC for adult patients with moderate-severe major depressive disorder, was predicted to save the health system $956 million ($4926 per patient) and bring health gains of 0.064 life-years and 0.381 QALYs per patient (12 436 life-years and 74 023 QALYs overall over 20 yr). These savings were mainly driven by slowing or avoiding the transition to refractory (treatment-resistant) depression. Pharmacogenomic-guided care was associated with 37% fewer patients with refractory depression over 20 years. Sensitivity analyses estimated that costs of pharmacogenomic testing would be offset within about 2 years of implementation. INTERPRETATION: Pharmacogenomic testing to guide antidepressant use was estimated to yield population health gains while substantially reducing health system costs. These findings suggest that pharmacogenomic testing offers health systems an opportunity for a major value-promoting investment.

Developing the intersectionality supplemented Consolidated Framework for Implementation Research (CFIR) and tools for intersectionality considerations.

BACKGROUND: The concept of intersectionality proposes that demographic and social constructs intersect with larger social structures of oppression and privilege to shape experiences. While intersectionality is a widely accepted concept in feminist and gender studies, there has been little attempt to use this lens in implementation science. We aimed to supplement the Consolidated Framework for Implementation Research (CFIR), a commonly used framework in implementation science, to support the incorporation of intersectionality in implementation science projects by (1) integrating an intersectional lens to the CFIR; and (2) developing a tool for researchers to be used alongside the updated framework. METHODS: Using a nominal group technique, an interdisciplinary framework committee (n = 17) prioritized the CFIR as one of three implementation science models, theories, and frameworks to supplement with intersectionality considerations; the modification of the other two frameworks are described in other papers. The CFIR subgroup (n = 7) reviewed the five domains and 26 constructs in the CFIR and prioritized domains and constructs for supplementation with intersectional considerations. The subgroup then iteratively developed recommendations and prompts for incorporating an intersectional approach within the prioritized domains and constructs. We developed recommendations and prompts to help researchers consider how personal identities and power structures may affect the facilitators and inhibitors of behavior change and the implementation of subsequent interventions. RESULTS: We achieved consensus on how to apply an intersectional lens to CFIR after six rounds of meetings. The final intersectionality supplemented CFIR includes the five original domains, and 28 constructs; the outer systems and structures and the outer cultures constructs were added to the outer setting domain. Intersectionality prompts were added to 13 of the 28 constructs. CONCLUSION: Through an expert-consensus approach, we modified the CFIR to include intersectionality considerations and developed a tool with prompts to help implementation users apply an intersectional lens using the updated framework.

Pharmacogenomic Testing for Major Depression: A Qualitative Study of the Perceptions of People with Lived Experience and Professional Stakeholders.

OBJECTIVES: With increasing evidence for the clinical utility of pharmacogenomic (PGx) testing for depression, there is a growing need to consider issues related to the clinical implementation of this testing. The perspectives of key stakeholders (both people with lived experience [PWLE] and providers) are critical, but not frequently explored. The purpose of this study was to understand how PWLE and healthcare providers/policy experts (P/HCPs) perceive PGx testing for depression, to inform the consideration of clinical implementation within the healthcare system in British Columbia (BC), Canada. METHODS: We recruited two cohorts of participants to complete individual 1-h, semi-structured interviews: (a) PWLE, recruited from patient and research engagement networks and organizations and (b) P/HCPs, recruited via targeted invitation. Interviews were audiotaped, transcribed verbatim, de-identified, and analysed using interpretive description. RESULTS: Seventeen interviews were completed with PWLE (7 with experience of PGx testing for depression; 10 without); 15 interviews were completed with P/HCPs (family physicians, psychiatrists, nurses, pharmacists, genetic counsellors, medical geneticists, lab technologists, program directors, and insurers). Visual models of PWLE's and P/HCP's perceptions of and attitudes towards PGx testing were developed separately, but both were heavily influenced by participants' prior professional and/or personal experiences with depression and/or PGx testing. Both groups expressed a need for evidence and numerous considerations for the implementation of PGx testing in BC, including the requirement for conclusive economic analyses, patient and provider education, technological and clinical support, local testing facilities, and measures to ensure equitable access to testing. CONCLUSIONS: While hopeful about the potential for therapeutic benefit from PGx testing, PWLE and P/HCPs see the need for robust evidence of utility, and BC-wide infrastructure and policies to ensure equitable and effective access to PGx testing. Further research into the accessibility, effectiveness, and cost-effectiveness of various implementation strategies is needed to inform PGx testing use in BC.

Costs of major depression covered / not covered in British Columbia, Canada.

BACKGROUND: Major depressive disorder (MDD) is one of the world's leading causes of disability. Our purpose was to characterize the total costs of MDD and evaluate the degree to which the British Columbia provincial health system meets its objective to protect people from the financial impact of illness. METHODS: We performed a population-based cohort study of adults newly diagnosed with MDD between 2015 and 2020 and followed their health system costs over two years. The expenditure proportion of MDD-related, patient paid costs relative to non-subsistence income was estimated, incidences of financial hardship were identified and the slope index of inequality (SII) between the highest and lowest income groups compared across regions. RESULTS: There were 250,855 individuals diagnosed with MDD in British Columbia over the observation period. Costs to the health system totalled >$1.5 billion (2020 CDN), averaging $138/week for the first 12 weeks following a new diagnosis and $65/week to week 52 and $55/week for weeks 53-104 unless MDD was refractory to treatment ($125/week between week 12-52 and $101/week over weeks 53-104). The proportion of MDD-attributable costs not covered by the health system was 2-15x greater than costs covered by the health system, exceeding $700/week for patients with severe MDD or MDD that was refractory to treatment. Population members in lower-income groups and urban homeowners had disadvantages in the distribution of financial protection received by the health system (SII reached - 8.47 and 15.25, respectively); however, financial hardship and inequities were mitigated province-wide if MDD went into remission (SII - 0.07 to 0.6). CONCLUSIONS: MDD-attributable costs to health systems and patients are highest in the first 12 weeks after a new diagnosis. During this time, lower income groups and homeowners in urban areas run the risk of financial hardship.

Selecting implementation models, theories, and frameworks in which to integrate intersectional approaches.

BACKGROUND: Models, theories, and frameworks (MTFs) provide the foundation for a cumulative science of implementation, reflecting a shared, evolving understanding of various facets of implementation. One under-represented aspect in implementation MTFs is how intersecting social factors and systems of power and oppression can shape implementation. There is value in enhancing how MTFs in implementation research and practice account for these intersecting factors. Given the large number of MTFs, we sought to identify exemplar MTFs that represent key implementation phases within which to embed an intersectional perspective. METHODS: We used a five-step process to prioritize MTFs for enhancement with an intersectional lens. We mapped 160 MTFs to three previously prioritized phases of the Knowledge-to-Action (KTA) framework. Next, 17 implementation researchers/practitioners, MTF experts, and intersectionality experts agreed on criteria for prioritizing MTFs within each KTA phase. The experts used a modified Delphi process to agree on an exemplar MTF for each of the three prioritized KTA framework phases. Finally, we reached consensus on the final MTFs and contacted the original MTF developers to confirm MTF versions and explore additional insights. RESULTS: We agreed on three criteria when prioritizing MTFs: acceptability (mean = 3.20, SD = 0.75), applicability (mean = 3.82, SD = 0.72), and usability (median = 4.00, mean = 3.89, SD = 0.31) of the MTF. The top-rated MTFs were the Iowa Model of Evidence-Based Practice to Promote Quality Care for the 'Identify the problem' phase (mean = 4.57, SD = 2.31), the Consolidated Framework for Implementation Research for the 'Assess barriers/facilitators to knowledge use' phase (mean = 5.79, SD = 1.12), and the Behaviour Change Wheel for the 'Select, tailor, implement interventions' phase (mean = 6.36, SD = 1.08). CONCLUSIONS: Our interdisciplinary team engaged in a rigorous process to reach consensus on MTFs reflecting specific phases of the implementation process and prioritized each to serve as an exemplar in which to embed intersectional approaches. The resulting MTFs correspond with specific phases of the KTA framework, which itself may be useful for those seeking particular MTFs for particular KTA phases. This approach also provides a template for how other implementation MTFs could be similarly considered in the future. TRIAL REGISTRATION: Open Science Framework Registration: osf.io/qgh64.

Experiences of self-care during the COVID-19 pandemic among individuals with rheumatoid arthritis: A qualitative study.

OBJECTIVES: This study aimed to explore the impact of the coronavirus disease 2019 (COVID-19) pandemic on self-care of individuals living with rheumatoid arthritis (RA). METHODS: Guided by a constructivist, qualitative design, we conducted one-to-one in-depth telephone interviews between March and October 2020 with participants with RA purposively sampled for maximum variation in age, sex and education, who were participating in one of two ongoing randomized-controlled trials. An inductive, reflexive thematic analysis approach was used. RESULTS: Twenty-six participants (aged 27-73 years; 23 females) in British Columbia, Canada were interviewed. We identified three themes: (1) Adapting to maintain self-care describes how participants took measures to continue self-care activities while preventing virus transmissions. While spending more time at home, some participants reported improved self-care. (2) Managing emotions describes resilience-building strategies such as keeping perspective, positive reframing and avoiding negative thoughts. Participants described both letting go and maintaining a sense of control to accommodate difficulties and emotional responses. (3) Changing communication with health professionals outlined positive experiences of remote consultations with health professionals, particularly if good relationships had been established prepandemic. CONCLUSION: The insights gained may inform clinicians and researchers on ways to support the self-care strategies of individuals with RA and other chronic illnesses during and after the COVID-19 pandemic. The findings reveal opportunities to further examine remote consultations to optimize patient engagement and care. PATIENT OR PUBLIC CONTRIBUTION: This project is jointly designed and conducted with patient partners in British Columbia, Canada. Patient partners across the United Kingdom also played in a key role in providing interpretations of themes during data analysis.

Development and usability testing of tools to facilitate incorporating intersectionality in knowledge translation.

BACKGROUND: The field of knowledge translation (KT) has been criticized for neglecting contextual and social considerations that influence health equity. Intersectionality, a concept introduced by Black feminist scholars, emphasizes how human experience is shaped by combinations of social factors (e.g., ethnicity, gender) embedded in systemic power structures. Its use has the potential to advance equity considerations in KT. Our objective was to develop and conduct usability testing of tools to support integrating intersectionality in KT through three key phases of KT: identifying the gap; assessing barriers to knowledge use; and selecting, tailoring, and implementing interventions. METHODS: We used an integrated KT approach and assembled an interdisciplinary development committee who drafted tools. We used a mixed methods approach for usability testing with KT intervention developers that included semi-structured interviews and the System Usability Scale (SUS). We calculated an average SUS score for each tool. We coded interview data using the framework method focusing on actionable feedback. The development committee used the feedback to revise tools, which were formatted by a graphic designer. RESULTS: Nine people working in Canada joined the development committee. They drafted an intersectionality primer and one tool that included recommendations, activities, reflection prompts, and resources for each of the three implementation phases. Thirty-one KT intervention developers from three countries participated in usability testing. They suggested the tools to be shorter, contain more visualizations, and use less jargon. Average SUS scores of the draft tools ranged between 60 and 78/100. The development committee revised and shortened all tools, and added two, one-page summary documents. The final toolkit included six documents. CONCLUSIONS: We developed and evaluated tools to help embed intersectionality considerations in KT. These tools go beyond recommending the use of intersectionality to providing practical guidance on how to do this. Future work should develop guidance for enhancing social justice in intersectionality-enhanced KT.

Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial.

BACKGROUND: Knee trauma permanently elevates one's risk for knee osteoarthritis. Despite this, people at-risk of post-traumatic knee osteoarthritis rarely seek or receive care, and accessible and efficacious interventions to promote knee health after injury are lacking. Exercise can ameliorate some mechanisms and independent risk factors for osteoarthritis and, education and action-planning improve adherence to exercise and promote healthy behaviours. METHODS: To assess the efficacy of a virtually-delivered, physiotherapist-guided exercise-based program (SOAR) to improve knee health in persons discharged from care after an activity-related knee injury, 70 people (16-35 years of age, 12-48 months post-injury) in Vancouver Canada will be recruited for a two-arm step-wedged assessor-blinded delayed-control randomized trial. Participants will be randomly allocated to receive the intervention immediately or after a 10-week delay. The program consists of 1) one-time Knee Camp (group education, 1:1 individualized exercise and activity goal-setting); 2) weekly individualized home-based exercise and activity program with tracking, and; 3) weekly 1:1 physiotherapy-guided action-planning with optional group exercise class. Outcomes will be measured at baseline, 9- (primary endpoint), and 18-weeks. The primary outcome is 9-week change in knee extension strength (normalized peak concentric torque; isokinetic dynamometer). Secondary outcomes include 9-week change in moderate-to-vigorous physical activity (accelerometer) and self-reported knee-related quality-of-life (Knee injury and OA Outcome Score subscale) and self-efficacy (Knee Self Efficacy Scale). Exploratory outcomes include 18-week change in primary and secondary outcomes, and 9- and 18- week change in other components of knee extensor and flexor muscle function, hop function, and self-reported symptoms, function, physical activity, social support, perceived self-care and kinesiophobia. Secondary study objectives will assess the feasibility of a future hybrid effectiveness-implementation trial protocol, determine the optimal intervention length, and explore stakeholder experiences. DISCUSSION: This study will assess the efficacy of a novel, virtually-delivered, physiotherapist-guided exercise-based program to optimize knee health in persons at increased risk of osteoarthritis due to a past knee injury. Findings will provide valuable information to inform the management of osteoarthritis risk after knee trauma and the conduct of a future effectiveness-implementation trial. TRIAL REGISTRATION: Clinicaltrials.gov reference: NTC04956393. Registered August 5, 2021, https://clinicaltrials.gov/ct2/show/NCT04956393?term=SOAR&cond=osteoarthritis&cntry=CA&city=Vancouver&draw=2&rank=1.

Shortening and validation of the Patient Engagement In Research Scale (PEIRS) for measuring meaningful patient and family caregiver engagement.

OBJECTIVE: To shorten the Patient Engagement In Research Scale (PEIRS) to its most essential items and evaluate its measurement properties for assessing the degree of patients' and family caregivers' meaningful engagement as partners in research projects. METHODS: A prospective cross-sectional web-based survey in Canada and the USA, and also paper-based in Canada. Participants were patients or family caregivers who had engaged in research projects within the last 3 years, were ≥17 years old, and communicated in English. Extensive psychometric analyses were conducted. RESULTS: 119 participants: 99 from Canada, 74 female, 51 aged 17-35 years and 50 aged 36-65 years, 60 had post-secondary education, and 74 were Caucasian/white. The original 37-item PEIRS was shortened to 22 items (PEIRS-22), mainly because of low inter-item correlations. PEIRS-22 had a single dominant construct that accounted for 55% of explained variance. Analysis of PEIRS-22 scores revealed the following: (1) acceptable floor and ceiling effects (<15%), (2) internal consistency (ordinal alpha = 0.96), (3) structural validity by fit to a Rasch measurement model, (4) construct validity by moderate correlations with the Public and Patient Engagement Evaluation Tool, (5) good test-retest reliability (ICC2,1  = 0.86) and (6) interpretability demonstrated by significant differences among PEIRS-22 scores across three levels of global meaningful engagement in research. CONCLUSIONS: The shortened PEIRS is valid and reliable for assessing the degree of meaningful patient and family caregiver engagement in research. It enables standardized assessment of engagement in research across various contexts. PATIENT OR PUBLIC CONTRIBUTION: A researcher-initiated collaboration, patient partners contributed from study conception to manuscript write-up.

Applying an intersectionality lens to the theoretical domains framework: a tool for thinking about how intersecting social identities and structures of power influence behaviour.

BACKGROUND: A key component of the implementation process is identifying potential barriers and facilitators that need to be addressed. The Theoretical Domains Framework (TDF) is one of the most commonly used frameworks for this purpose. When applying the TDF, it is critical to understand the context in which behaviours occur. Intersectionality, which accounts for the interface between social identity factors (e.g. age, gender) and structures of power (e.g. ageism, sexism), offers a novel approach to understanding how context shapes individual decision-making and behaviour. We aimed to develop a tool to be used alongside applications of the TDF to incorporate an intersectionality lens when identifying implementation barriers and enablers. METHODS: An interdisciplinary Framework Committee (n = 17) prioritized the TDF as one of three models, theories, and frameworks (MTFs) to enhance with an intersectional lens through a modified Delphi approach. In collaboration with the wider Framework Committee, a subgroup considered all 14 TDF domains and iteratively developed recommendations for incorporating intersectionality considerations within the TDF and its domains. An iterative approach aimed at building consensus was used to finalize recommendations. RESULTS: Consensus on how to apply an intersectionality lens to the TDF was achieved after 12 rounds of revision. Two overarching considerations for using the intersectionality alongside the TDF were developed by the group as well as two to four prompts for each TDF domain to guide interview topic guides. Considerations and prompts were designed to assist users to reflect on how individual identities and structures of power may play a role in barriers and facilitators to behaviour change and subsequent intervention implementation. CONCLUSIONS: Through an expert-consensus approach, we developed a tool for applying an intersectionality lens alongside the TDF. Considering the role of intersecting social factors when identifying barriers and facilitators to implementing research evidence may result in more targeted and effective interventions that better reflect the realities of those involved.

An empirically based conceptual framework for fostering meaningful patient engagement in research.

BACKGROUND: Patient engagement in research (PEIR) is promoted to improve the relevance and quality of health research, but has little conceptualization derived from empirical data. OBJECTIVE: To address this issue, we sought to develop an empirically based conceptual framework for meaningful PEIR founded on a patient perspective. METHODS: We conducted a qualitative secondary analysis of in-depth interviews with 18 patient research partners from a research centre-affiliated patient advisory board. Data analysis involved three phases: identifying the themes, developing a framework and confirming the framework. We coded and organized the data, and abstracted, illustrated, described and explored the emergent themes using thematic analysis. Directed content analysis was conducted to derive concepts from 18 publications related to PEIR to supplement, confirm or refute, and extend the emergent conceptual framework. The framework was reviewed by four patient research partners on our research team. RESULTS: Participants' experiences of working with researchers were generally positive. Eight themes emerged: procedural requirements, convenience, contributions, support, team interaction, research environment, feel valued and benefits. These themes were interconnected and formed a conceptual framework to explain the phenomenon of meaningful PEIR from a patient perspective. This framework, the PEIR Framework, was endorsed by the patient research partners on our team. CONCLUSIONS: The PEIR Framework provides guidance on aspects of PEIR to address for meaningful PEIR. It could be particularly useful when patient-researcher partnerships are led by researchers with little experience of engaging patients in research.

Prospective surveillance and targeted physiotherapy for arm morbidity after breast cancer surgery: a pilot randomized controlled trial.

OBJECTIVE: To evaluate prospective surveillance and targeted physiotherapy (PSTP) compared to education (EDU) on the prevalence of arm morbidity and describe the associated program cost. DESIGN: Pilot randomized single-blinded controlled trial. SETTING: Urban with assessments and treatment delivered in hospitals. PARTICIPANTS: Women scheduled for breast cancer surgery. INTERVENTIONS: Participants were randomly assigned (1:1) to PSTP ( n = 21) or EDU ( n = 20) and assessed presurgery and 12 months postsurgery. All participants received usual care, namely, preoperative education and provision of an education booklet with postsurgical exercises. The PSTP group was monitored for arm morbidity every three months and referred for physiotherapy if arm morbidity was identified. The EDU group received three education sessions on nutrition, stress and fatigue management. MAIN OUTCOME MEASURES: Arm morbidity was based on changes in the surgical arm(s) from presurgery in four domains: (1) shoulder range of motion, (2) strength, (3) volume, and (4) upper body function. Complex arm morbidity indicated ≥2 domains impaired. Second, the cost of the PSTP program was described. RESULTS: At 12 months, 18 (49%) participants (10 PSTP and 8 EDU) had arm morbidity, with EDU participants presenting more complex arm morbidity compared to PSTP participants. PSTP participants attended 4.4 of 5 assessments with 90% retention. The PSTP program cost was $150 covered by the Health Care Provider and the Patient Out-of-Pocket Travel cost was CAN$40. CONCLUSION: Our results suggest that PSTP is feasible among women with breast cancer for early identification of arm morbidity. A larger study is needed to determine the cost and effectiveness benefits.

Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study.

BACKGROUND: Current practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive. OBJECTIVE: We aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis. METHODS: We conducted a proof-of-concept randomized controlled trial. The immediate group received a brief education session by a physical therapist, a Fitbit Flex, and four biweekly phone calls for activity counseling. The delayed group received the same intervention 2 months later. Participants were assessed at baseline (T0) and at the end of 2 months (T1), 4 months (T2), and 6 months (T3). Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA ≥3 metabolic equivalents [METs], primary outcome), (2) mean time on MVPA ≥4 METs, (3) mean daily steps, (4) mean time on sedentary activities, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (6) Partners in Health scale. Mixed-effects repeated measures analysis of variance was used to assess five planned contrasts of changes in outcome measures over measurement periods. The five contrasts were (1) immediate T1-T0 vs delayed T1-T0, (2) delayed T2-T1 vs delayed T1-T0, (3) mean of contrast 1 and contrast 2, (4) immediate T1-T0 vs delayed T2-T1, and (5) mean of immediate T2-T1 and delayed T3-T2. The first three contrasts estimate the between-group effects. The latter two contrasts estimate the effect of the 2-month intervention delay on outcomes. RESULTS: We recruited 61 participants (immediate: n=30; delayed: n=31). Both groups were similar in age (immediate: mean 61.3, SD 9.4 years; delayed: mean 62.1, SD 8.5 years) and body mass index (immediate: mean 29.2, SD 5.5 kg/m2; delayed: mean 29.2, SD 4.8 kg/m2). Contrast analyses revealed significant between-group effects in MVPA ≥3 METs (contrast 1 coefficient: 26.6, 95% CI 4.0-49.1, P=.02; contrast 3 coefficient: 26.0, 95% CI 3.1-49.0, P=.03), daily steps (contrast 1 coefficient: 1699.2, 95% CI 349.0-3049.4, P=.02; contrast 2 coefficient: 1601.8, 95% CI 38.7-3164.9, P=.045; contrast 3 coefficient: 1650.5, 95% CI 332.3-2968.7; P=.02), KOOS activity of daily living subscale (contrast 1 coefficient: 6.9, 95% CI 0.1-13.7, P=.047; contrast 3 coefficient: 7.2, 95% CI 0.8-13.6, P=.03), and KOOS quality of life subscale (contrast 1 coefficient: 7.4, 95% CI 0.0-14.7, P=.049; contrast 3 coefficient: 7.3, 95% CI 0.1-14.6, P=.048). We found no significant effect in any outcome measures due to the 2-month delay of the intervention. CONCLUSIONS: Our counseling program improved MVPA ≥3 METs, daily steps, activity of daily living, and quality of life in people with knee osteoarthritis. These findings are important because an active lifestyle is an important component of successful self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT02315664; https://clinicaltrials.gov/ct2/show/NCT02315664 (Archived by WebCite at http://www.webcitation.org/6ynSgUyUC).

Framework for Advancing the Reporting of Patient Engagement in Rheumatology Research Projects.

PURPOSE OF REVIEW: The term "patient engagement in research" refers to patients and their surrogates undertaking roles in the research process beyond those of study participants. This paper proposes a new framework for describing patient engagement in research, based on analysis of 30 publications related to patient engagement. RECENT FINDINGS: Over the past 15 years, patients' perspectives have been instrumental in broadening the scope of rheumatology research and outcome measurement, such as evaluating fatigue in rheumatoid arthritis. Recent reviews, however, highlight low-quality reporting of patient engagement in research. Until we have more detailed information about patient engagement in rheumatology research, our understanding of how patients' perspectives are being integrated into research projects remains limited. When authors follow our guidance on the important components for describing patients' roles and function as "research partners," researchers and other knowledge users will better understand how patients' perspectives were integrated in their research projects.

Patient research partner engagement in OMERACT: Enhancing engagement through the implementation of patient engagement in research tools.

OBJECTIVES: This paper describes the evolution and impact of Patient Research Partners (PRPs) in shaping research within OMERACT and provides a framework to enhance their engagement. This session explored one component of a validated framework to evaluate meaningful patient engagement. It provides insights, identifies opportunities for improvement, and recommends using the Patient Engagement in Research (PEIR) Framework, PEIR Plan Guide (workbook), and PEIRS-22 (scale) to guide and measure PRPs' engagement. METHODS: Before the conference, the team held planning sessions and selected the Feel-Valued component of the PEIR Workbook for exploration. During OMERACT 2023, we discussed this topic using the PEIR Plan Guide in an interactive plenary session. RESULTS: The plenary session produced 72 items from 14 breakout tables addressing PEIR Framework themes. CONCLUSIONS: This paper highlights the role and evolution of PRPs in shaping research within OMERACT. It emphasizes enhancing and accurately measuring PRP engagement through the PEIR Framework, PEIR Plan Guide, and PEIRS-22. The insights and methodologies presented aim to fortify future PRP engagement, ensuring it aligns with OMERACT's principles of patient-centred research.