Improving Diverse and Equitable Involvement of Patients and Caregivers in Research in CKD: Report of a Better Evidence and Translation-Chronic Kidney Disease (BEAT-CKD) Workshop.

Patient and caregiver involvement can enhance the uptake and impact of research, but the involvement of patients and caregivers who are underserved and marginalized is often limited. A better understanding of how to make involvement in research more broadly accessible, supportive, and inclusive for patients with chronic kidney disease (CKD) and caregivers is needed. We conducted a national workshop involving patients, caregivers, clinicians, and researchers from across Australia to identify strategies to increase the diversity of patients and caregivers involved in CKD research. Six themes were identified. Building trust and a sense of safety was considered pivotal to establishing meaningful relationships to support knowledge exchange. Establishing community and connectedness was expected to generate a sense of belonging to motivate involvement. Balancing stakeholder goals, expectations, and responsibilities involved demonstrating commitment and transparency by researchers. Providing adequate resources and support included strategies to minimize the burden of involvement for patients and caregivers. Making research accessible and relatable was about nurturing patient and caregiver interest by appealing to intrinsic motivators. Adapting to patient and caregiver needs and preferences required tailoring the approach for individuals and the target community. Strategies and actions to support these themes may support more diverse and equitable involvement of patients and caregivers in research in CKD.

Strategies to promote implementation of core outcomes for medication adherence trials in rheumatology: A report from the OMERACT-Adherence Group.

OBJECTIVES: To identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions. METHODS: Preliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions. RESULTS: Implementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers. CONCLUSION: Ongoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS.

Evolving and evaluating the OMERACT fellows program: insights and implications from OMERACT 2023 fellows.

OBJECTIVE: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program. METHODS: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program. RESULTS: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions. CONCLUSION: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT.

Healthcare professionals' perspectives and experiences of osteoporosis medication treatment: a qualitative systematic review.

This systematic review aimed to explore healthcare professionals' (HCPs) experiences and perspectives of osteoporosis medication treatment through thematic synthesis of qualitative studies. We found themes about how osteoporosis is perceived as a disease, treatment decision-making and what empowers HCPs to provide the best possible care. PURPOSE: The systematic review aimed to describe the perspectives and experiences of HCPs regarding osteoporosis medication treatment. METHODS: We performed searches in four electronic databases (Medline, Embase, PsycINFO and CINAHL) from database inception until May 2023 in any language. Data was analysed through inductive thematic synthesis. RESULTS: We included 27 primary studies that incorporated the views of 495 different HCPs. The following themes were identified: low-priority disease, challenges in treatment decision-making, minimising drug burden, conscious of communication barriers, fragmented care and advice, confidence through experience and collaboration. CONCLUSIONS: HCPs were enthusiastic about optimising osteoporosis care through interprofessional collaboration and expertise, as well as educating and monitoring patients on treatment. They advocated for safety, comfort and reducing overall drug burden, especially in older patients with comorbidities. However, they had differences in opinions regarding who has responsibility for diagnosing and treating osteoporosis and struggled to provide the best possible care due to competing priorities, limited time and lack of adequate knowledge or evidence. The findings highlight the important and complementary role of different HCPs in osteoporosis treatment through a multidisciplinary model of care.

Perspectives and experiences of COVID-19 vaccination in people with autoimmune and inflammatory rheumatic disease.

OBJECTIVE: People with autoimmune and inflammatory rheumatic disease (AIIRD) are at an increased risk of morbidity from COVID-19. While COVID-19 vaccination is effective at reducing disease complications, there have been significant levels of vaccine hesitancy in people with AIIRD. We aimed to understand vaccine hesitancy and promote shared decision-making by describing the experiences and perspectives of people with AIIRD who had concerns with COVID-19 vaccinations. METHODS: Adults with AIIRD on immunosuppressive medications who expressed concerns regarding the COVID-19 vaccination were purposively sampled until thematic saturation. Individual semi-structured interviews were conducted and analysed using reflexive thematic analysis. RESULTS: Sixteen adults with an AIIRD were interviewed. Thematic analysis yielded four themes: heightened sense of vulnerability; determining individual suitability; desperate for freedom and relief; deterred by scepticism. CONCLUSIONS: The perspectives of people with AIIRD towards the COVID-19 vaccination were shaped by a sense of vulnerability. The decision-making experience was challenging, resulting from struggles with handling information, dealing with external pressures, and facing negativity. PRACTICE IMPLICATIONS: A collaborative approach, involving close family and friends and avoiding negativity and pressure can improve engagement and support decision-making around COVID-19 vaccination. Clearly addressing potential risks of vaccination may prevent subsequent regret and hesitancy if they arise.

Patient experiences of continuous glucose monitoring and sensor-augmented insulin pump therapy for diabetes: A systematic review of qualitative studies.

AIMS: Blood glucose control is central to the management of diabetes, and continuous glucose monitoring (CGM) improves glycemic control. We aimed to describe the perspectives of people with diabetes using CGM. MATERIALS AND METHODS: We performed a systematic review of qualitative studies. RESULTS: Fifty-four studies involving 1845 participants were included. Six themes were identified: gaining control and convenience (reducing pain and time, safeguarding against complications, achieving stricter glucose levels, and sharing responsibility with family); motivating self-management (fostering ownership, and increasing awareness of glycemic control); providing reassurance and freedom (attaining peace of mind, and restoring social participation); developing confidence (encouraged by the endorsement of others, gaining operational skills, customizing settings for ease of use, and trust in the device); burdened with device complexities (bewildered by unfamiliar technology, reluctant to rely on algorithms, overwhelmed by data, frustrated with malfunctioning and inaccuracy, distressed by alerts, and bulkiness of machines interfering with lifestyle); and excluded by barriers to access (constrained by cost, lack of suppliers). CONCLUSIONS: CGM can improve self-management and confidence in patients managing diabetes. However, the technical issues, uncertainty in readings, and cost may limit the uptake. Education and training from the health professionals may help to reduce the practical and psychological burden for better patient outcomes.

Safer medicines To reduce falls and refractures for OsteoPorosis (#STOP): a study protocol for a randomised controlled trial of medical specialist-initiated pharmacist-led medication management reviews in primary care.

INTRODUCTION: Minimal trauma fractures (MTFs) often occur in older patients with osteoporosis and may be precipitated by falls risk-increasing drugs. One category of falls risk-increasing drugs of concern are those with sedative/anticholinergic properties. Collaborative medication management services such as Australia's Home Medicine Review (HMR) can reduce patients' intake of sedative/anticholinergics and improve continuity of care. This paper describes a protocol for an randomised controlled trial to determine the efficacy of an HMR service for patients who have sustained MTF. METHOD AND ANALYSIS: Eligible participants are as follows: ≥65 years of age, using ≥5 medicines including at least one falls risk-increasing drug, who have sustained an MTF and under treatment in one of eight Osteoporosis Refracture Prevention clinics in Australia. Consenting participants will be randomised to control (standard care) or intervention groups. For the intervention group, medical specialists will refer to a pharmacist for HMR focused on reducing falls risk predominately through making recommendations to reduce falls risk medicines, and adherence to antiosteoporosis medicines. Twelve months from treatment allocation, comparisons between groups will be made. The main outcome measure is participants' cumulative exposure to sedative and anticholinergics, using the Drug Burden Index. Secondary outcomes include medication adherence, emergency department visits, hospitalisations, falls and mortality. Economic evaluation will compare the intervention strategy with standard care. ETHICS AND DISSEMINATION: Approval was obtained via the New South Wales Research Ethics and Governance Information System (approval number: 2021/ETH12003) with site-specific approvals granted through Human Research Ethics Committees for each research site. Study outcomes will be published in peer-reviewed journals. It will provide robust insight into effectiveness of a pharmacist-based intervention on medicine-related falls risk for patients with osteoporosis. We anticipate that this study will take 2 years to fully accrue including follow-up. TRIAL REGISTRATION NUMBER: ACTRN12622000261718.

Perspectives and Experiences of Self-monitoring of Blood Pressure Among Patients With Hypertension: A Systematic Review of Qualitative Studies.

BACKGROUND: Self-monitoring of blood pressure is a key strategy in managing hypertension but may be challenging and burdensome for patients. The aim of the study was to describe the perspectives and experiences of self-monitoring of blood pressure in patients with hypertension. METHODS: MEDLINE, Embase, PsycINFO, and CINAHL were searched from database inception to March 2022. We used thematic synthesis to analyze the data. RESULTS: Thirty-five studies involving 872 patients aged 18-95 years were included. Four themes were identified: enabling autonomy and empowerment of own health (allowing access to comprehensive and accurate data, bolstering motivation for lifestyle changes, encouraging diligence in medication taking, gaining interest in self-management, and increasing awareness of health status); providing reassurance and convenience (instilling a sense of security, readiness for troubleshooting, and reducing the frequency of clinical appointments); triggering confusion and stress (anxiety and panic over "bad" numbers, constant reminder of illness identity, disregarded by clinicians, lack of confidence in interpreting and responding to results, redundancy of continuous monitoring, and uncertainties around targets and frequency of measures, concerns of unreliability); financial and operational burden of device (vulnerability preventing use, or unsustainable cost). CONCLUSIONS: Inadequate knowledge about the benefits of lowering blood pressure, home blood pressure monitoring, blood pressure goals, and interpretation of blood pressure values, limited access to home blood pressure monitoring devices, and psychological burden with home blood pressure monitoring limit home blood pressure monitoring.

Frailty and risk of subsequent fracture among older adults presenting to hospital with a minimal trauma fracture.

We investigated frailty and refracture risk among older adults with a minimal trauma fracture. After adjusting for age, sex, and site of initial fracture, increasing frailty was associated with an increased risk subsequent fracture. These results indicate the need to routinely screen for frailty following an initial fracture among older adults. INTRODUCTION: Minimal trauma fractures are common among older adults, and frailty increases risk of an initial minimal trauma fracture. This study was undertaken to estimate the risk of subsequent fracture based on frailty status at the time of an initial fracture. METHODS: The study population was older adults presenting to hospital, aged 60 years or more, with a minimal trauma fracture. Frailty was estimated using a cumulative deficit approach. The risk of subsequent fracture based on increasing cumulative frailty deficit item group, adjusted for sex, age, and site of initial fracture, was estimated using Cox's proportional hazard model. RESULTS: Between January 2014 and December 2020, 12,115 older adults presented to hospital (8371 women [69%]), with an initial minimal trauma fracture. The average age was 80 years (SD 9.5). Subsequent fractures identified during the follow-up period occurred in 1137 (9.4%) of study participants. The incidence of subsequent fracture ranged from 25.0 per 1000 older adults (95% confidence interval (CI) 22.4 to 27.8) among the lowest frailty deficit group (1 deficit item) to 31.8 per 1000 (95% CI 28.0 to 35.8) among the highest frailty deficit group (4 to 12 deficit items). After adjusting for age, sex, and site of initial fracture, an increasing number of frailty deficit items was associated with increased risk subsequent fracture (p-value for trend = 0.008). CONCLUSION: Our results indicate that following an initial minimal trauma fracture, frailty independently increases the risk of a subsequent fracture. Therefore, it is important at the time of an initial fracture that older women and men are screened for the presence of frailty, and models of care are implemented to reduce the risk of subsequent fracture among this vulnerable group of older adults.

The role of community pharmacists in delivering interventions for osteoporosis: A systematic review.

BACKGROUND: Osteoporosis is a major public health concern, given that disease prevalence is expected to substantially increase due to the aging population. Community pharmacists can play a key role in the identification and management of chronic diseases. OBJECTIVES: The purpose of this systematic review was to present an overview of the literature on the role of community pharmacists in providing osteoporosis interventions to patients. The secondary objective was to assess the impact of these interventions on patient outcomes. METHODS: A literature search was conducted in Embase, CINAHL, Scopus, MEDLINE, and Web of Science from database inception to March 2021. The search was limited to human studies in the English language. Primary studies were included if they described or assessed a patient-directed osteoporosis intervention conducted by community pharmacists. The following data were extracted and tabulated: citation, study location, study design, subject, number of participants, nature of intervention, classification of intervention, outcome measures, measurement methods, findings, and effect. Risk of bias was assessed using the Cochrane Risk of Bias tool for randomized trials (RoB 2) and Risk of Bias in Non-randomized Studies (ROBINS-I). RESULTS: Twenty-one studies were included in this review. The main interventions were education, screening, and medication management. Nineteen of these studies reported patient outcomes, all yielding positive outcomes. Outcomes included increased physician follow-up, risk factor reduction, increased osteoporosis knowledge, increased medication adherence, identification of medication-related problems, and positive patient-reported experience measures (PREMs). Three studies were considered to have a moderate risk of bias, whereas the remaining 18 studies had a high risk of bias. CONCLUSION: There is some evidence that pharmacist-led osteoporosis interventions have a positive impact on patient outcomes. More high-quality studies using objective outcome measures are needed to determine whether this translates into clinical outcomes such as decreased hospitalization and fractures.

Patient and Caregiver Experiences and Attitudes about Their Involvement in Research in Chronic Kidney Disease.

BACKGROUND AND OBJECTIVES: Although patient and caregiver involvement in research is widely advocated to improve the relevance and uptake of study findings, barriers and uncertainties in achieving this goal remain. This study aimed to describe patient and caregiver experiences and perspectives of their previous involvement in research, to inform strategies to strengthen patient involvement in research. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Semistructured interviews were conducted with 23 adult patients with CKD and caregivers who had previously been involved in research, from Australia, the United States, the United Kingdom, and Denmark. Transcripts were analyzed thematically. RESULTS: We identified six themes: grappling with CKD diagnosis (overwhelmed by the burden of illness, silenced by stigma and shame, absence of advocacy, and awareness), bearing the responsibility for involvement (autonomy in their own care, forced to be proactive to access opportunities, infrastructural support to connect researchers and patients), battling big agendas (struggling in a system of disincentive, changing research culture, becoming equals), seeing the person behind the patient (harnessing broader knowledge, expertise, skills and interests, understanding patient needs, motivations for involvement), sensitivity to complexities of payment (accounting for individual circumstances, denoting value, enabling diverse involvement), and championing the patient voice (links to important stakeholders, drivers of innovation, responsibility to end users). CONCLUSIONS: The burden of CKD, limited opportunities, and power asymmetry between patients/caregivers and researchers were challenges to meaningful involvement in research. Building trust, awareness of opportunities, and recognizing the broad expertise and value of patients/caregivers, including and beyond their illness experience, may better support patient and caregiver involvement in research in CKD.

Preferences for Biologic Treatment in Patients With Psoriatic Arthritis: A Discrete Choice Experiment.

OBJECTIVE: We aimed to assess patient preferences for the characteristics and outcomes of biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) to manage psoriatic arthritis. METHODS: We conducted a discrete choice experiment in patients with psoriatic arthritis from 3 rheumatology centers in Sydney, Australia. We assessed preferences for different attributes of biologic medications. The route and frequency of medications had a range of 5 levels, and the following 7 attributes had a range of 3 levels: the ability to attend to normal activities, improvements in joint pain, enthesitis and skin disease, chance of disease remission, risk of infection, and risk of severe adverse events. Multinomial logit models including a latent class model were used to calculate preferences. RESULTS: Of the 150 participants, 58.3% were female, with a median age of 53.5 years. The attributes in order of preference using the ß coefficient in absolute values (95% confidence interval [95% CI]) were as follows: oral route compared to subcutaneous and intravenous routes (ß coefficient 1.00 [fixed parameter]), avoiding severe side effects (ß coefficient 0.72 [95% CI 0.50, 0.95]), increasing ability to attend to normal activities (ß coefficient 0.66 [95% CI 0.36, 0.96]), avoiding infections (ß coefficient 0.38 [95% CI 0.23, 0.53]), improvement in enthesitis pain (ß coefficient 0.28 [95% CI 0.20, 0.36]), improvement in psoriasis (ß coefficient 0.28 [95% CI 0.20, 0.36]), increasing chance of remission (ß coefficient 0.27 [95% CI 0.19, 0.36]), and improvement in joint pain (ß coefficient 0.26 [95% CI 0.00, 0.52]). CONCLUSION: When choosing biologic medications, patients with psoriatic arthritis preferred oral medications. Patients prioritized avoiding severe complications, maintaining the ability to attend to work and normal activities, and avoiding infection over clinical measures of efficacy.

Patients' Perspectives on Shared Decision-Making About Medications in Psoriatic Arthritis: An Interview Study.

OBJECTIVE: Decision-making regarding medications to manage psoriatic arthritis (PsA) is complex because of multiple disease manifestations and comorbidities. Fear of side effects from systemic medications and misalignment in priorities between patients with PsA and rheumatologists makes shared decision-making challenging. We aimed to describe the perspectives of patients with PsA on shared decision-making regarding medication taking. METHODS: Face-to-face semistructured interviews were conducted with 25 adult patients with PsA in Australia. Transcripts were thematically analyzed. RESULTS: Five themes were identified: lacking agency in decision-making (denied choice, knowledge asymmetry, desperation and necessity, restricted by unfair eligibility criteria, automated approach); overwhelmed by potential harms (daunted by aggressive therapy, anticipating lifestyle disruption from side effects, jeopardizing fertility and pregnancy, avoiding relapse); gaining confidence (discernible benefit in function and mental health, sharpening knowledge over time, expertise of family and peers, empowered by information); opting for alternatives (pursuing normality, suspicion of over-medicalization, seeking comprehensive solutions); and developing trust and fortifying collaboration (assurance through a personable approach, seeking consistency, supported in decisional power, resolution through respectful negotiation). CONCLUSION: Patients with PsA lack agency in making treatment decisions and are overwhelmed by the potential harms of systemic medication. Improving knowledge and trust with medical teams in a supportive and collaborative environment, and strategies for managing risks and side effects may improve decision-making about pharmacologic management of PsA.

Rapid Review of Medication Taking (Adherence) Among Patients With Rheumatic Diseases During the COVID-19 Pandemic.

OBJECTIVE: We aimed to identify, appraise, synthesize, and contextualize rapidly emerging reports on medication taking (adherence) among patients with rheumatic diseases during the COVID-19 pandemic. METHODS: We searched MEDLINE, EMBASE, and CINAHL for peer-reviewed communications, letters, and articles published during the COVID-19 pandemic evaluating medication taking among individuals with rheumatic diseases. We appraised assessment and reporting of medication adherence according to established definitions of 3 distinct problems of medication taking (i.e., noninitiation, poor implementation, and discontinuation) and pooled findings using random-effects models. RESULTS: We included 31 peer-reviewed studies in our synthesis from various jurisdictions, of which 25 described medication taking among rheumatology patients and 6 described medication prescribing among rheumatology providers. The pooled prevalence of overall medication nonadherence was 14.8% (95% confidence interval [95% CI] 12.3-17.2) and that of medication discontinuation (i.e., stopping of prescriptions) and poor implementation (i.e., not taking medication at the dose/frequency prescribed) as 9.5% (95% CI 5.1-14.0) and 9.6% (95% CI 6.2-13.0), respectively. Noninitiation (i.e., not starting/not filling new prescriptions) was not addressed. CONCLUSION: Medication taking among individuals with rheumatic diseases during the COVID-19 pandemic varies globally. Unclear reporting and extensive variation in research methods between studies create barriers to research replication, comparison, and generalization to specific patient populations. Future research in this area should use consistent and transparent approaches to defining and measuring medication taking problems to ensure that findings appropriately describe the epidemiology of medication adherence and have the potential to identify modifiable targets for improving patient care.

Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis.

BACKGROUND: Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). METHODS: We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. RESULTS: From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13-37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. CONCLUSIONS: Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.

Researchers' perspectives on methodological challenges and outcomes selection in interventional studies targeting medication adherence in rheumatic diseases: an OMERACT-adherence study.

BACKGROUND: Research on adherence interventions in rheumatology is limited by methodological issues, particularly heterogeneous outcomes. We aimed to describe researchers' experiences with conducting interventional studies targeting medication adherence in rheumatology and their perspectives on establishing core outcomes. METHODS: Semi-structured interviews using audio conference were conducted with researchers who had conducted an adherence study of any design in the past 10 years. Data collection and thematic analysis were performed iteratively, until saturation. RESULTS: We interviewed 13 researchers, most of whom worked in academia and specialized in epidemiology and/or health services research. We identified three themes: 1) improving measurement of adherence (considering all phases of adherence, using appropriate and relevant measures, and establishing clinically meaningful thresholds); 2) challenges in designing and appraising adherence intervention studies (considering the confusion over a plethora of outcomes, difficulties with powering studies to demonstrate meaningful changes, and suboptimal descriptions of adherence interventions in published studies); and 3) advancing outcome assessment in adherence intervention studies (capturing rationale for developing a core domain set as well as recommendations and anticipated challenges by participants). CONCLUSIONS: Uniquely gathering perspectives from international adherence researchers, our findings led to researcher-informed recommendations for improving adherence research including specifying the targeted adherence phase in designing interventions and studies and providing a glossary of terms to promote consistency in reporting. We also identified recommendations for developing a core domain set for interventional studies targeting medication adherence including involvement of patients, clinicians, and other stakeholders and methodological and practical considerations to establish rigor and support uptake.

Patient Perspectives on Outcome Domains of Medication Adherence Trials in Inflammatory Arthritis: An International OMERACT Focus Group Study.

OBJECTIVE: To describe the perspectives of patients with inflammatory arthritis (IA) on outcome domains of trials evaluating medication adherence interventions. METHODS: Adult patients (≥ 18 yrs) with IA taking disease-modifying antirheumatic drugs from centers across Australia, Canada, and the Netherlands participated in 6 focus groups to discuss outcome domains that they consider important when participating in medication adherence trials. We analyzed the transcripts using inductive thematic analysis. RESULTS: Of the 38 participants, 23 (61%) had rheumatoid arthritis and 21 (55%) were female. The mean age was 57.3 ± (SD 15.0) years. Improved outcome domains that patients wanted from participating in an adherence trial were categorized into 5 types: medication adherence, adherence-related factors (supporting adherence; e.g., medication knowledge), pathophysiology (e.g., physical functioning), life impact (e.g., ability to work), and economic impact (e.g., productivity loss). Three overarching themes reflecting why these outcome domains matter to patients were identified: how taking medications could improve patients' emotional and physical fitness to maintain their social function; how improving knowledge and confidence in self-management increases patients' trust and motivation to take medications as agreed with minimal risk of harms; and how respect and reassurance, reflecting health care that values patients' opinions and is sensitive to patients' individual goals, could improve medication-taking behavior. CONCLUSION: Patients value various outcome domains related to their overall well-being, confidence in medication use, and patient-healthcare provider relationships to be evaluated in future adherence trials.

Perspectives of solid organ transplant recipients on medicine-taking: Systematic review of qualitative studies.

Medicine-taking among transplant recipients is a complex and ubiquitous task with significant impacts on outcomes. This study aimed to describe the perspectives and experiences of medicine-taking in adult solid organ transplant recipients. Electronic databases were searched to July 2020, and thematic synthesis was used to analyze the data. From 119 studies (n = 2901), we identified six themes: threats to identity and ambitions (impaired self-image, restricting goals and roles, loss of financial independence); navigating through uncertainty and distrust (lacking tangible/perceptible benefits, unprepared for side effects, isolation in decision-making); alleviating treatment burdens (establishing and mastering routines, counteracting side effects, preparing for the unexpected); gaining and seeking confidence (clarity with knowledge, reassurance through collective experiences, focusing on the future outlook); recalibrating to a new normal posttransplant (adjusting to ongoing dependence on medications, in both states of illness and health, unfulfilled expectations); and preserving graft survival (maintaining the ability to participate in life, avoiding rejection, enacting a social responsibility of giving back). Transplant recipients take medications to preserve graft function, but dependence on medications jeopardizes their sense of normality. Interventions supporting the adaptation to medicine-taking and addressing treatment burdens may improve patient satisfaction and capacities to take medications for improved outcomes.

Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.

OBJECTIVE: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions. METHODS: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set. RESULTS: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention. CONCLUSION: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.