Making space for patients' preferences in precision medicine: a qualitative study exploring perspectives of patients with rheumatoid arthritis.

OBJECTIVE: Precision medicine in rheumatoid arthritis (RA) creates new opportunities to involve patients in early identification of accurate indicators of health trajectories. The aim of this study was to explore patient perspectives on patient-centredness in precision medicine for RA treatment. DESIGN: Semistructured interviews were conducted to explore patients' perspectives on a new personalised approach to RA treatment. The interview guide was developed together with patient research partners and health care professionals. SETTING: An invitation to the interviews was sent through a mobile application. The interviews were one-on-one, using an interview guide with open-ended questions. Interviews were conducted digitally (October 2020-February 2021) via Zoom or telephone, depending on each participant's preferences. PARTICIPANTS: Patients with RA (N=12) were purposively recruited. Patients were eligible if they had an RA diagnosis, were aged 18-80 years, and understood and expressed themselves in Swedish. Participants and researchers did not know each other prior to the interviews. RESULTS: Participants expressed desires and needs for patients to have an active role in precision medicine by making shared treatment decisions together with a healthcare professional. In order for that to work, patients need information on potential treatment options, an ability to express their preferences, an individual treatment plan and identification of personal treatment goals. Patients also identified two requirements of healthcare professional in precision medicine: a safe environment to express personal matters and two-way communication with healthcare professionals. CONCLUSION: Communication between patients and healthcare professionals needs to be more focused on patients' individual treatment preferences and expressed needs, in order to increase patient-centredness in treatment decisions, so shared decision-making can become a reality. More research is needed to design multifaceted implementation strategies to support patients and healthcare professionals to increase patient-centredness throughout treatment personalisation.

The impact of COVID-19 on clinical research: the PIPPRA and MEDRA experience.

Background: Coronavirus disease 2019 (COVID-19) has had a significant impact on clinical research. This paper aims to provide an insight into how the COVID-19 pandemic, associated public health restrictions and international guidance on the conduct of clinical research impacted two clinical rheumatology research trials - the Physiotherapist-led Intervention to Promote Physical Activity in Rheumatoid Arthritis (PIPPRA) and the MEDiterranean diet in Rheumatoid Arthritis (MEDRA) projects. Methods: The March 2019 public health restrictions imposed to mitigate the risk of COVID-19 occurred at a time when PIPPRA was in the process of delivering assessment and intervention on a face-to-face basis (n=48) and MEDRA had commenced recruitment. Participants in PIPPRA and MEDRA had a diagnosis of rheumatoid arthritis, with some being immunosuppressed and thus at a higher risk for COVID-19. The decision-making processes of both trials is outlined to demonstrate the required amendments to continue in the context of the COVID-19 pandemic. Results: Amendments to PIPPRA and MEDRA trial protocols were agreed and received ethical and funder approval. Both trials switched from a face-to-face delivery to a telehealth using online platforms. The PIPPRA study was paused for five months (April-August 2020), resulting in n=33 (60%) negative deviations from assessment protocol. MEDRA switched from face-to-face to online recruitment with 20% (n=35/44) negative deviations in recruitment. Of the n=18 participants who consented to participating in a face-to-face trial, just n=2 (11%) opted to engage with telehealth delivery of the intervention. MEDRA assessment and intervention deviations were 100% as no sessions were completed as planned in 2020. Conclusions: The COVID-19 pandemic has severely impacted the PIPPRA and MEDRA clinical trials. Moving face-to-face clinical research to telehealth delivery may not be the panacea it is purported to be. Our experiences may be of benefit to researchers, clinicians, and funders in seeking to continue clinical research during a global pandemic.

The Experience of people with rheumatoid arthritis living with fatigue: a qualitative metasynthesis.

OBJECTIVES: To identify, appraise and synthesise qualitative studies on the experience of living with rheumatoid arthritis (RA)-related fatigue. METHODS: We conducted a qualitative metasynthesis encompassing a systematic literature search in February 2017, for studies published in the past 15 years, in PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, SveMed, PsychINFO and Web of Science. To be included, the studies had to report the experience of living with fatigue among adults with RA. The analysis and synthesis followed Malterud's systematic text condensation. RESULTS: Eight qualitative articles were included, based on 212 people with RA (69% women) and aged between 20 and 83 years old. The synthesis resulted in the overall theme 'A vicious circle of an unpredictable symptom'. In addition, the synthesis derived four subthemes: 'being alone with fatigue'; 'time as a challenge'; 'language as a tool for increased understanding' and 'strategies to manage fatigue'. Fatigue affects all areas of everyday life for people with RA. They strive to plan and prioritise, pace, relax and rest. Furthermore, they try to make use of a variety of words and metaphors to explain to other people that they experience that RA-related fatigue is different from normal tiredness. Despite this, people with RA-related fatigue experience feeling alone with their symptom and they develop their own strategies to manage fatigue in their everyday life. CONCLUSIONS: The unpredictability of RA-related fatigue is dominant, pervasive and is experienced as a vicious circle, which can be described in relation to its physical, cognitive, emotional and social impact. It is important for health professionals to acknowledge and address the impact of fatigue on the patients' everyday lives. Support from health professionals to manage fatigue and develop strategies to increase physical activity and maintain work is important for people with RA-related fatigue.

Protocol for evaluating and implementing a pragmatic value-based healthcare management model for patients with inflammatory arthritis: a Danish population-based regional cohort and qualitative implementation study.

INTRODUCTION: The provision of healthcare for patients with inflammatory arthritis occurs in the context of somewhat conflicting targets, values and drivers. Therefore, there is a need for introducing 'value-based healthcare' defined as the value of patient relevant health outcomes in relation to costs. This term is a central part of tomorrow's healthcare sector, especially for rheumatic diseases, yet the transition is a huge challenge, as it will impact the development, delivery and assessment of healthcare. AIMS: The aim of this study is to compare medical and patient evaluated impact of the traditional settlement and financing production (DAGS) controlled healthcare setting with a value-based and patient-centred adjunctive to standard care. METHODS AND ANALYSIS: Patients with inflammatory arthritis receiving treatment in routine care at the outpatient clinics in the Capital Region of Denmark will prospectively and consecutively be enrolled in a Non-Intervention-Study framework providing a pragmatic value-based management model. A Danish reference cohort, used for comparison will be collected as part of routine clinical care. The enrolment period will be from 1 June 2018 until 31December 2023. Baseline and follow-up visits will be according to routine clinical care. Registry data will be obtained directly from patients and include personal, clinical and outcomes information. The study results will be reported in accordance with the STROBE statement. ETHICS AND DISSEMINATION: The study has been notified to the Danish Data Protection Agency and granted authorisation for the period June 2018 to January 2025 (pending). Informed consent will be obtained from all patients before enrolment in the study. The study is approved by the ethics committee, Capital Region of Denmark (H-18013158). Results of the study will be disseminated through publication in international peer-reviewed journals.

A survey across four European countries to determine rheumatology health professionals' awareness of physical activity measures in people with inflammatory joint diseases.

OBJECTIVES: The objectives of this study were to determine rheumatology health professionals' (HPs)' awareness of and confidence in using physical activity (PA) measures in people with inflammatory joint diseases (IJDs), their own self-reported PA levels and to identify HP-related educational needs. METHODS: Rheumatology HPs in Denmark, Sweden, Ireland and Belgium participated in an on-line survey. Descriptive statistics and latent class analysis (LCA) were undertaken SPSS (v21and SASv9.4) to describe data aggregates and range and to identify subclasses of groups with respect to use of PA measures. RESULTS: 322 (n=322, 75.5% women) HPs responded from Denmark (n=50, 15.5%), Sweden (n=66, 20.5%), Ireland (n=28, 8.7%) and Belgium (n=178, 55.3%) and the majority of respondents (n=286, 91.7%) reported it was important to measure PA in people with IJDs. Only 28.2% of HPs used simple body worn sensors to measure PA levels in their patients. The majority were interested in on-line education on measuring PA (82.9%). LCA, used to generate classes of PA measures employed by HPs, revealed three distinct classes reflecting differences in self-reported PA levels, awareness of PA measures, further education requirements and professional background. CONCLUSIONS: The majority of respondents reported that they considered measuring PA as important in people with IJDs; however, the majority lacked confidence in how to measure it. There was strong interest in further education around measuring PA. Three distinct respondent classes were identified to inform targeted education on how to measure PA.