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.

Investigating the disjoint between education and health policy for infant feeding among teenage mothers in South Africa: a case for intersectoral work.

BACKGROUND: Many low-and-middle-income countries, including South Africa, have high rates of teenage pregnancy. Following the World Health Organisation recommendations, South African health policy on infant feeding promotes exclusive breastfeeding until six months of age, with gradual weaning. At the same time, South Africa's education department, in the interest of learners, promotes adolescents' early return to school post-partum. Yet infant feeding at school is currently not perceived as a realistic option. METHODS: Recognising his this policy tension, we aimed to explore how policies are interpreted and implemented by the health and education sectors through interviews with key informants who produce, interpret and implement these policies. Using an interview guide developed for this study, we conducted in-depth interviews with 24 health policy makers, managers in both sectors, school principals and nursing staff who manage adolescent mothers (aged 16-19) and their babies. Data was analysed using thematic analysis. RESULTS: Informants from both sectors expressed discomfort at pregnant learners remaining in school late in pregnancy and were uncertain about policy regarding when to return to school and how long to breast-feed. Educators reported that new mothers typically returned to school within a fortnight after delivery and that breastfeeding was not common. While health professionals highlighted the benefits of extended breastfeeding for infants and mothers, they recognised the potential conflict between the need for the mother to return to school and the recommendation for longer breastfeeding. Additionally, the need for ongoing support of young mothers and their families was highlighted. CONCLUSIONS: Our findings suggest educators should actively encourage school attendance in a healthy pregnant adolescent until delivery with later return to school, and health providers should focus attention on breastfeeding for the initial 4-6 weeks postpartum, followed by guided support of formula-feeding. We encourage the active engagement of adolescents' mothers and extended families who are often involved in infant feeding and care decisions. Education and health departments must engage to facilitate the interests of both the mother and infant: some exclusive infant feeding together with a supported return to school for the adolescent mother.

2019 EULAR points to consider for non-physician health professionals to prevent and manage fragility fractures in adults 50 years or older.

OBJECTIVE: To establish European League Against Rheumatism (EULAR) points to consider for non-physician health professionals to prevent and manage fragility fractures in adults 50 years or older. METHODS: Points to consider were developed in accordance with EULAR standard operating procedures for EULAR-endorsed recommendations, led by an international multidisciplinary task force, including patient research partners and different health professionals from 10 European countries. Level of evidence and strength of recommendation were determined for each point to consider, and the mean level of agreement among the task force members was calculated. RESULTS: Two overarching principles and seven points to consider were formulated based on scientific evidence and the expert opinion of the task force. The two overarching principles focus on shared decisions between patients and non-physician health professionals and involvement of different non-physician health professionals in prevention and management of fragility fractures. Four points to consider relate to prevention: identification of patients at risk of fracture, fall risk evaluation, multicomponent interventions to prevent primary fracture and discouragement of smoking and overuse of alcohol. The remaining three focus on management of fragility fractures: exercise and nutritional interventions, the organisation and coordination of multidisciplinary services for post-fracture models of care and adherence to anti-osteoporosis medicines. The mean level of agreement among the task force for the overarching principles and the points to consider ranged between 8.4 and 9.6. CONCLUSION: These first EULAR points to consider for non-physician health professionals to prevent and manage fragility fractures in adults 50 years or older serve to guide healthcare practice and education.

The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial.

OBJECTIVES: To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA). METHODS: A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment. RESULTS: We randomized 349 participants to SSM (n = 116), SSM+S (n = 116) or SSM+PS (n = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM -0.5 (95% CI: -1.4, 0.4), P = 0.255; SSM+PS vs SSM -0.1 (95% CI: -1.0, 0.8), P = 0.829; and SSM+S vs SSM+PS -0.4 (95% CI: -1.4, 0.5), P = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685. CONCLUSION: There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists. TRIAL REGISTRATION: ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).

Understanding the impact of systemic lupus erythematosus on work amongst South Asian people in the UK: An explorative qualitative study.

SLE has a range of fluctuating symptoms affecting individuals and their ability to work. Although South Asian (SA) patients are at increased risk of developing SLE there is limited knowledge of the impact on employment for these patients in the UK. Understanding ethnicity and disease-specific issues are important to ensure patients are adequately supported at work. Semi-structured interviews were conducted with patients of SA origin to explore how SLE impacted on their employment. Thematic analysis was used to analyse the data which are reported following COREQ guidelines. Ten patients (8 female; 2 male) were recruited from three rheumatology centres in the UK and interviewed between November 2019 and March 2020. Patients were from Indian (n = 8) or Pakistani (n = 2) origin and worked in a range of employment sectors. Four themes emerged from the data: (1) Disease related factors; (2) Employment related factors; (3) Cultural and interpersonal factors impacting on work ability; (4) Recommendations for improvement. Patients' ability to work was affected by variable work-related support from their hospital clinicians, low awareness of SLE and variable support from their employers, and cultural barriers in their communities that could affect levels of family support received. These findings highlight the need for additional support for SA patients with SLE in the workplace.

Socioeconomic inequalities in access and use of skilled birth attendants during childbirth in Ghana: a decomposition analysis.

BACKGROUND: Equitable access to skilled birth attendance during delivery is vital for reducing global maternal deaths to 70 deaths per 100, 000 to achieve the Sustainable Development Goals (SDGs) by 2030. Although several initiatives have been implemented to reduce maternal mortality in Ghana, inequalities in access to skilled birth attendance during delivery still exist among women of different socioeconomic groups. This study assesses the socioeconomic inequalities in access and use of skilled birth attendants during delivery in Ghana. METHODS: Research was conducted through literature reviews and document reviews, and a secondary data analysis of the 2014 Ghana Demographic and Health Survey (GDHS), a nationally representative survey. A total of 1305 women aged 15-49 years, who had a live birth the year before to the survey in the presence of a skilled birth attendant were analysed using concentration indices and curves. The indices were further decomposed to identify the major socioeconomic factors contributing most to the inequalities. RESULTS: The results found that access to skilled birth attendants was more among women from rich households showing a pro-rich utilization. The decomposition analysis revealed that household wealth index, educational level of both mother and husband/partner, area of residence and mother's health insurance coverage were the major contributing factors to socioeconomic inequalities in accessing skilled birth attendants during child delivery among Ghanaian women. CONCLUSION: This study confirms that a mother's socioeconomic status is vital to reducing maternal deaths. Therefore, it is worthy to focus attention on policy interventions to reduce the observed inequalities as revealed in the study.

Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis.

BACKGROUND: Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. METHODS: A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0-10) at 12 weeks, analysed using linear regression and intention to treat principles. RESULTS: Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: - 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. CONCLUSION: The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. FUNDING: National Institute for Health Research. TRIAL REGISTRATION: ISRCTN, ISRCTN25892131 ; Registered 05/09/2016: retrospectively registered.

Health care providers' perspectives of diet-related non-communicable disease in South Africa.

BACKGROUND: In South Africa, diet-related non-communicable diseases (dr-NCDs) place a significant burden on individuals, households and the health system. In this article, we investigate the experiences of eight key informants within the public sector health care system (nurse, doctor and dietician), in order to reflect on their experiences treating dr-NCDs. METHODS: We interviewed eight key informants who were central to the primary care service for at least 40,000 people living in a low-income neighbourhood of Cape Town, South Africa. In previous work, we had interviewed and conducted ethnographic research focused on dr-NCDs in the same neighbourhood. We then conducted a thematic analysis of these interviews. RESULTS: The perspectives of key informants within the public sector therefore offered insights into tensions and commonalities between individual, neighbourhood and health systems perspectives. In particular, the rising prevalence of dr-NCDs alarmed providers. They identified changing diet as an important factor driving diabetes and high blood pressure in particular. Health care practitioners focused primarily on patients' individual responsibility to eat a healthy diet and adhere to treatment. A marked lack of connection between health and social services at the local level, and a shortage of dieticians, meant that doctors provided rapid, often anecdotal dietary advice. The single dietician for the district was ill-equipped to connect dr-NCDs with the upstream determinants of health. While providers often had empathy and understanding of patients' circumstances, their training and context had not equipped them to translate that understanding into a clinical context. Providers seemingly could not reconcile their empathy with their perception of dr-NCDs as a failure of prudence or responsibility by patients. Significant shortcomings within health systems and social services make reflexive practice very difficult. CONCLUSIONS: Supporting health care providers in understanding context, through approaches such as translational competency, while strengthening both health and social services, are vital given the high burden of NCDs in South Africa.

Building research capacity in musculoskeletal health: qualitative evaluation of a graduate nurse and allied health professional internship programme.

BACKGROUND: Evidence based practice enhances service planning and delivery, clinical decision making and patient care. However, health professionals often lack the time and opportunity to access or generate evidence. Research capacity building is thus an important mechanism for improving health service delivery. This study evaluates the effectiveness of a UK-wide Nurse and Allied Health Professional musculoskeletal research internship programme in which graduates applied to undertake their internship through one of five Higher Education Institutions. The evaluation explores the experiences of interns and their mentors. METHODS: Sixteen new graduates completed the internship programme (September 2015 - August 2018). Twelve interns and thirteen mentors participated in the evaluation. The evaluation used qualitative asynchronous email-based interviews to explore the experiences of interns and mentors. Interpretive phenomenological analysis of coded transcripts identified principal themes. RESULTS: Early research outputs from the interns include three peer reviewed publications and 21 conference abstract presentations. Two interns were in full time research at the time of interview or had a research component in their clinical role. Nine interns in clinical posts disclosed plans to return to research in the near future. Seven themes were identified: the impact on interns' careers; personal impact (for example, influence on self-confidence); impact on clinical practice; drivers for applying; intervention design (for example, attitudes concerning the timing and duration of the intervention); mentorship and networking (including general support provided and quality of career advice); challenges. CONCLUSION: The internship programme is an effective model in building research capacity in musculoskeletal research for Nurses and Allied Health Professionals, influencing careers, building confidence and improving clinical practice. The internship programme has the potential to be replicable to other clinical contexts nationally and internationally.

Food insecurity in relation to obesity in peri-urban Cape Town, South Africa: Implications for diet-related non-communicable disease.

In urban informal areas of South Africa, obesity and hunger represent two sides of food insecurity. Despite this, public health and clinical obesity interventions focus on nutrition education, implying dietary choice and thereby overlooking food insecurity. The objective of this paper is to explore peri-urban residents' perspectives of changing food environments, framed by the Food Aid Organization (FAO) definition of food security and demonstrating the interconnectedness of dimensions of food security. We conducted three-part in-depth interviews with 21 participants and nine focus group discussions with a total of 57 participants, consisting primarily of women aged 20-84, in a peri-urban township and informal settlement outside of Cape Town, South Africa. Participants' encounters in clinical settings framed choice as a driver of diet-related non-communicable disease (NCD). Yet participants lacked economic access to food, particularly at the end of the month. Diets consisted of fewer green leafy vegetables relative to their diets in rural areas, despite affirming a preference for these foods. They described consuming more meat, which was also perceived as unhealthy. Based on self-report, residents within this peri-urban area of South Africa were food insecure: they lacked access to food at specific times of the month, they were unable to consume foods they preferred, and they felt that their diets were neither nutritious nor enabled an active and healthy life. When viewed in terms of multiple facets of food security, participants' concurrent experiences of hunger and obesity were unsurprising. Health interventions related to diet should incorporate an understanding of food security as shaped by the interactions of access, availability, utilization and stability.

Return to work after carpal tunnel release surgery: a qualitative interview study.

BACKGROUND: Carpal tunnel syndrome is a common nerve compression disorder which affects hand sensation and function. Carpal tunnel release surgery (CTR) is frequently performed to alleviate these symptoms. For many CTR patients, surgery occurs during their working lifetime, but there is currently no evidence-based guidance to inform clinicians or patients when it might be safe to return to different types of work afterwards. The aim of this qualitative study was to explore the return to work experiences of patients who had recently undergone CTR. METHODS: Semi-structured 1:1 interviews were conducted with a subgroup of participants recruited to a multi-centre prospective cohort study. Interviewees were purposely selected to represent a range of demographic, clinical and occupational characteristics. All had recently undergone CTR and had returned to work. Interviews were audio recorded, transcribed verbatim and analysed using the framework method. Participants were recruited until data saturation was achieved. RESULTS: Fourteen participants were interviewed: 11 women (median age 49 years, range 27-61) and 3 men (age range 51-68 years). Three key themes were identified. Theme 1 centred on the level of functional disability experienced immediately after surgery. There was an expectation that CTR would be a 'minor' procedure, but this did not match the participants' experiences. Theme 2 explored the desire for validation for the time away from work, with participants recalling a need to justify their work absence to themselves as well as to their employers. Theme 3 focused on the participants' reflections of handing their return to work and function, with many reporting uncertainties about what constituted appropriate activity loads and durations. There was a desire for specific information relating to individual work roles. CONCLUSION: Individual return to work decision-making was largely influenced by the recommendations received. According to the views of participants, clinicians may be able to prepare patients better pre-operatively, especially with respect to function in the immediate post-operative period and by providing return to work guidance that can be tailored for individual work roles.

Perceptions of weight in relation to health, hunger, and belonging among women in periurban South Africa.

Obesity among South African women represents an important dimension of noncommunicable disease (NCD) risk. Experiences of weight are an under-explored frame of reference for intervention. Using three-part in-depth interviews with 20 women and 9 focus groups with a total of 57 women (N = 77) in one low-income neighborhood, I relate women's positive perceptions of fatness to belonging and experiences of hunger. Aware of public health obesity messaging, participants tried to lose weight, yet stress and food scarcity impacted weight gain. Whereas public health interventions focus on behavior, responses to NCDs must recognize the role of food systems and poverty in shaping risk profiles.

Adolescent girls' perceptions of breastfeeding in two low-income periurban communities in South Africa.

In South Africa, exclusive breastfeeding rates are low, and rates of teenage pregnancy are high. Educational policy enables mothers' return to school, which conflicts with policy emphasizing exclusive breastfeeding. We elicited adolescent women's perceptions and experiences of infant feeding choices, and conducted six focus groups (N = 57) in two periurban settlements. Participants knew arguments in favor of and against breast and formula-feeding, but in practice, mixed feeding occurred early after birth. While completion of high school was emphasized, exclusive breastfeeding was viewed as impractical. Congruent education policies and infant feeding policies/guidelines must address the constraints and contexts of adolescent mothers.

2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis.

Regular physical activity (PA) is increasingly promoted for people with rheumatic and musculoskeletal diseases as well as the general population. We evaluated if the public health recommendations for PA are applicable for people with inflammatory arthritis (iA; Rheumatoid Arthritis and Spondyloarthritis) and osteoarthritis (hip/knee OA) in order to develop evidence-based recommendations for advice and guidance on PA in clinical practice. The EULAR standardised operating procedures for the development of recommendations were followed. A task force (TF) (including rheumatologists, other medical specialists and physicians, health professionals, patient-representatives, methodologists) from 16 countries met twice. In the first TF meeting, 13 research questions to support a systematic literature review (SLR) were identified and defined. In the second meeting, the SLR evidence was presented and discussed before the recommendations, research agenda and education agenda were formulated. The TF developed and agreed on four overarching principles and 10 recommendations for PA in people with iA and OA. The mean level of agreement between the TF members ranged between 9.8 and 8.8. Given the evidence for its effectiveness, feasibility and safety, PA is advocated as integral part of standard care throughout the course of these diseases. Finally, the TF agreed on related research and education agendas. Evidence and expert opinion inform these recommendations to provide guidance in the development, conduct and evaluation of PA-interventions and promotion in people with iA and OA. It is advised that these recommendations should be implemented considering individual needs and national health systems.

Measuring hand grip strength in rheumatoid arthritis.

Rheumatoid arthritis (RA) is a systemic inflammatory disease with a particular predilection for causing pain, deformity and functional limitation affecting the hands. Measures of the severity of RA, such as the disease activity score with 28 joint count may not fully reflect the regional impact of RA on the hands. Hand grip strength measurements are a form of objective assessment that focuses specifically on the hands in RA. This review explores what is currently known about the assessment of hand grip strength; what it may indicate, how it is measured, some of the practical aspects and challenges associated with performing these tests, and how this information can be applied in a clinical setting. It summarises the role that grip strength has in assessing patients with RA and finishes with some recommendations for how to use grip strength measurements in clinical practice, and what direction future research might take.

An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing.

BACKGROUND: The Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, progressive 12-week exercise program for people with hand problems due to rheumatoid arthritis. The program was shown to be clinically and cost-effective in a large clinical trial and is recommended by the UK National Institute for Health and Care Excellence (NICE) guidelines for rheumatoid arthritis in adults. OBJECTIVE: We have developed an online version of the SARAH program (mySARAH) to make the SARAH program widely accessible to people with rheumatoid arthritis. The purposes of this study were to develop mySARAH and to evaluate and address its usability issues. METHODS: We developed mySARAH using a three-step process and gaining feedback from patient contributors. After initial development, mySARAH was tested in two iterative usability cycles in nine participants using a simplified think-aloud protocol and self-reported questionnaires. We also evaluated if participants executed the SARAH exercises correctly after watching the exercise videos included on the website. RESULTS: A preliminary version of mySARAH consisting of six sessions over a 12-week period and delivered via text, exercise videos, images, exercise plan form, exercise calendar, and links to additional information on rheumatoid arthritis was developed. Five participants (1 male; 4 females; median age 64 years) and four participants (four females; median age 64.5 years) took part in the first and second usability testing cycles respectively. Usability issues identified from Cycle 1 such as having a navigation tutorial video and individualised feedback on pain levels were addressed prior to Cycle 2. The need for more instructions to complete the mySARAH patient forms was identified in Cycle 2 and was rectified. Self-reports from both cycles indicated that participants found the program useful and easy to use and were confident in performing the SARAH exercises themselves. Eight of the nine participants correctly demonstrated all the exercises. CONCLUSIONS: mySARAH is the first online hand exercise intervention for people with rheumatoid arthritis. We actively involved target users in the development and usability evaluation and ensured mySARAH met their needs and preferences.

A Qualitative study of language barriers between South African health care providers and cross-border migrants.

BACKGROUND: Communication with health care providers represents an essential part of access to health care for the over 230 million cross-border migrants around the world. In this article, we explore the complexity of health communication from the perspective of cross-border migrants seeking antenatal care in Cape Town, South Africa in order to highlight the importance of high quality medical interpretation. METHODS: As part of a broader study of migrant maternal and infant nutrition, we conducted a secondary data analysis of semi-structured in-depth interviews (N = 23) with Congolese (n = 7), Somali (n = 8) and Zimbabwean (n = 8) women living in Cape Town, as well as nine focus group discussions (including men: n = 3 and women: n = 6) were conducted with migrant Somalis, Congolese, and Zimbabweans (N = 48). We first used content analysis to gather all data related to language and communication. We then analysed this data thematically. RESULTS: Zimbabwean participants described how the inability to speak the local South African language (IsiXhosa) gave rise to labelling and stereotyping by healthcare staff. Congolese and Somali participants described medical procedures, including tubal ligation, which were performed without consent. Partners often tried to play the role of interpreter, which resulted in loss of income and non-professional medical interpretation. Participants' highlighted fears over unwanted procedures or being unable to access care. Challenges of communication without a common language (and without professional medical interpretation), rather than outright denial of care by healthcare professionals, mediated these encounters. CONCLUSION: Although there are several factors impeding cross-border migrants' access to health care, effective communication is a prerequisite for quality care. Free-to-patient professional medical interpretation would not only benefit migrant populations but would benefit the broader community where language and health literacy are barriers to accessing health care. Novel approaches to language access may include technology-enabled professional interpretation.

The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial).

BACKGROUND: Arthritis gloves are regularly provided as part of the management of people with rheumatoid arthritis (RA) and undifferentiated (early) inflammatory arthritis (IA). Usually made of nylon and elastane (i.e. Lycra®), these arthritis gloves apply pressure with the aims of relieving hand pain, stiffness and improving hand function. However, a systematic review identified little evidence supporting their use. We therefore designed a trial to compare the effectiveness of the commonest type of arthritis glove provided in the United Kingdom (Isotoner gloves) (intervention) with placebo (control) gloves (i.e. larger arthritis gloves providing similar warmth to the intervention gloves but minimal pressure only) in people with these conditions. METHODS: Participants aged 18 years and over with RA or IA and persistent hand pain will be recruited from National Health Service Trusts in the United Kingdom. Following consent, participants will complete a questionnaire booklet, then be randomly allocated to receive intervention or placebo arthritis gloves. Within three weeks, they will be fitted with the allocated gloves by clinical specialist rheumatology occupational therapists. Twelve weeks (i.e. the primary endpoint) after completing the baseline questionnaire, participants will complete a second questionnaire, including the same measures plus additional questions to explore adherence, benefits and problems with glove-wear. A sub-sample of participants from each group will be interviewed at the end of their participation to explore their views of the gloves received. The clinical effectiveness and cost-effectiveness of the intervention, compared to placebo gloves, will be evaluated over 12 weeks. The primary outcome measure is hand pain during activity. Qualitative interviews will be thematically analysed. DISCUSSION: This study will evaluate the commonest type of arthritis glove (Isotoner) provided in the NHS (i.e. the intervention) compared to a placebo glove. The results will help occupational therapists, occupational therapy services and people with arthritis make informed choices as to the value of arthritis gloves. If effective, arthritis gloves should become more widely available in the NHS to help people with RA and IA manage hand symptoms and improve performance of daily activities, work and leisure. If not, services can determine whether to cease supplying these to reduce service costs. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN25892131 Registered 05/09/2016.