Management of refractory disease and persistent symptoms in inflammatory arthritis: qualitative framework analysis of interviews with patients and healthcare professionals.

Objectives: This study aims to explore patients' and clinicians' experiences in managing and living with refractory disease (RD) and persistent physical and emotional symptoms (PPES) in patients with RA or polyarticular JIA from their perspectives through interviews and/or focus groups. Methods: A qualitative exploration with 25 patients and 32 multidisciplinary rheumatology healthcare professionals (HCPs) was conducted to obtain participants respective understanding and experiences of managing RD/PPES and its impact on the patient-professional relationship. A pragmatic epistemology approach with framework analysis was employed. Results: Four key themes were identified from both patients and professionals in the management of RD/PPES: risk/perpetuating factors/triggers; need for a patient-centred holistic approach to care, diagnosis and treatment; discordance and impact on the patient-practitioner relationship and current problems in managing RD/PPES. These themes covered 22 subthemes, with none being patient specific and seven being HCP specific. Suggestions for potential management strategies were highlighted throughout, such as involving other specialties or a multidisciplinary team, assessing/treating patient-reported outcome measures and psychosocial factors, patient (re)education, need for adjustments/aids or adaptations, checking the diagnosis and further investigations/imaging and optimizing medications. Conclusion: Management strategies need to be developed that enable appropriate treatment plans for those with RD/PPES that account for wider biopsychosocial factors beyond inflammation and reduce discordance in the patient-practitioner relationship.

Ongoing shielding behavior one year post COVID-19: results from a longitudinal study of patients with inflammatory arthritis.

Many patients with inflammatory arthritis (IA) were instructed to shield during the COVID-19 pandemic. Despite the ending of lockdowns and vaccination, large proportions of IA patients were continuing to shield when it is no longer needed. Given the detrimental effects of shielding on mental and physical health, understanding the rates and reasons for shielding is needed to help clinicians advise patients accordingly. This study was a 12-month prospective study following participants with IA during the COVID-19 pandemic. The proportions of IA patients shielding at each time point were calculated. Additionally, regressions and odds ratios for shielding were determined to assess medication type, mental health, and risk perception. While the extent of shielding fluctuated over the year of lockdowns, nearly all IA patients (93.5%) were still engaging in some shielding in 2021, with nearly half (43%) still shielding most or all of the time. Medications that were previously considered higher risk were not significantly associated with higher rates of shielding (OR = 1.60, p = 0.29), but greater symptoms of depression in June 2020 (OR = 1.07, p = 0.03) was both associated with increased the odds of shielding in June 2021. The high rates of IA patients continuing to shield in 2021 put more strain on patients and professionals as social isolation is linked with worsening mental and physical health, as well as greater difficulty with self-management. It is important for clinicians to be aware of this trend to ease the stress on patients.

Mental health, quality of life and self-management behaviours: online evaluation of inflammatory arthritis patients over 1 year of COVID-19 lockdowns.

Objective: Patients with inflammatory arthritis were especially vulnerable to the psychosocial and health impacts of coronavirus disease 2019 (COVID-19) and the lockdowns. This study investigated the impact of these changes on mental health, physical health and quality of life for inflammatory arthritis patients over 1 year following the initial lockdown in the UK. Methods: Three hundred and thirty-eight participants with inflammatory arthritis completed an ambidirectional study consisting of online questionnaires at four time points for 1 year. The questionnaires assessed demographic information, inflammatory arthritis condition, mental health, physical symptoms, self-management behaviours, COVID-19 status and impacts. Means, linear regressions and structural equation modelling for mediations were conducted over 12 months. Results: Physical health concerns peaked during June 2020, then declined, but did not return to baseline. Depression was associated with worse quality of life at baseline, as shown by the beta coefficient, (ß= 0.94, P < 0.01), September (ß = 0.92, P < 0.01), November (ß= 0.77, P < 0.01) and 1 year (ß = 0.77, P < 0.01). Likewise, anxiety was associated with worse quality of life at baseline (ß = 1.92, P < 0.01), September (ß = 2.06, P < 0.01), November (ß = 1.66, P = 0.03) and 1 year (ß = 1.51, P = 0.02). The association between depression and quality of life was mediated by physical activity (ß= 0.13, P < 0.01) at baseline. The association between anxiety and quality of life was also mediated by physical activity (ß = 0.25, P = 0.04) at baseline. Conclusion: Physical health continued to be worse 1 year later compared with before the COVID-19 lockdowns in patients with inflammatory arthritis. Mental health showed long-term effects on quality of life, with an impact for ≥12 months. Lastly, physical activity mediated between mental health and quality of life in the short term.

Refractory inflammatory arthritis definition and model generated through patient and multi-disciplinary professional modified Delphi process.

OBJECTIVE: Various definitions have been proposed for Refractory Disease in people with Rheumatoid Arthritis; however, none were generated for Polyarticular Juvenile Idiopathic Arthritis or involving adult and paediatric multidisciplinary healthcare professionals and patients. The study aim is to redefine Refractory Disease, using Delphi methodology. METHODS: Three rounds of surveys (one nominal group and two online (2019-2020)) to achieve consensus using a predetermined cut-off were conducted voting on: a) name, b) treatment and inflammation, c) symptoms and impact domains, and d) rating of individual components within domains. Theoretical application of the definition was conducted through a scoping exercise. RESULTS: Votes were collected across three rounds from Patients, Researchers and nine multi-disciplinary healthcare professional groups (n = 106). Refractory Inflammatory Arthritis was the most popular name. Regarding treatment and inflammation, these were voted to be kept broad rather than specifying numbers/cut-offs. From 10 domains identified to capture symptoms and disease impact, six domains reached consensus for inclusion: 1) Disease Activity, 2) Joint Involvement, 3) Pain, 4) Fatigue, 5) Functioning and Quality of Life, and 6) Disease-Modifying Anti-Rheumatic Drug Experiences. Within these domains, 18 components, from an initial pool (n = 73), were identified as related and important to capture multi-faceted presentation of Refractory Inflammatory Arthritis, specifically in Rheumatoid Arthritis and Polyarticular Juvenile Idiopathic Arthritis. Feasibility of the revised definition was established (2022-2023) with good utility as was applied to 82% of datasets (n = 61) incorporating 20 outcome measures, with two further measures added to increase its utility and coverage of Pain and Fatigue. CONCLUSION: Refractory Inflammatory Arthritis has been found to be broader than not achieving low disease activity, with wider biopsychosocial components and factors incorporating Persistent Inflammation or Symptoms identified as important. This definition needs further refinement to assess utility as a classification tool to identify patients with unmet needs.

The challenge of exercise (non-)adherence: a scoping review of methods and techniques applied to improve adherence to physical activity and exercise in people with inflammatory arthritis.

Objectives: The aims were to explore the nature of methods/techniques applied to improve adherence to physical activity (PA) and exercise in people with inflammatory arthritis and to identify whether studies were theory based and/or used behaviour change techniques (BCTs). Methods: Searches were undertaken of English language articles within four databases: Embase, Medline, PsycINFO and Cochrane. Articles were included if they assessed adherence to a PA and/or exercise intervention. A narrative synthesis of the findings is reported. Results: Of 1909 studies screened, 18 studies met inclusion criteria. Adherence was most frequently included as a secondary outcome. Reporting of adherence measures was poor, in that 13 studies did not use a validated measure of adherence, with only three validated measures being identified. The majority of studies were not theory driven (n = 13), although the health belief model was the most used theoretical framework (n = 5). Only two studies mentioned both theory and BCTs. Four studies reported components that were mapped onto BCTs, with goal setting being the most prevalent. Conclusion: This scoping review found that adherence to PA and/or exercise interventions was rarely the focus of research, despite its importance in maintaining health in people with inflammatory arthritis. Where research has been conducted in this area, serious shortcomings were revealed, in that psychological theory, evidence-based BCTs derived from theory and valid adherence measures were not used to inform intervention design and target adherence, meaning that interventions were suboptimal. These results suggest that there is considerable room for improvement and that more high-quality research is required to investigate determinants of adherence and develop impactful interventions.

The impact of consecutive COVID-19 lockdowns in England on mental wellbeing in people with inflammatory arthritis.

BACKGROUND: During the first UK COVID-19 lockdown, studies identified over half of inflammatory arthritis (IA) patients in the UK reported a worsening of emotional distress. Given the prolonged nature of the pandemic, and the strict 'shielding' restrictions imposed on 'extremely clinically vulnerable' populations, it is likely that the implementation of the second lockdown period in England, during November 2020, may also have had a negative impact on the mental health of IA patients. The aim of this study was to qualitatively explore the impact of consecutive lockdown periods on mental wellbeing in people with IA. METHODS: Nine IA patients took part in semi-structured telephone interviews at both baseline (June/July 2020) and follow-up (November 2020). The interview schedule, which was developed and piloted with a Patient Research Partner, explored patient experiences and mental health impacts of the COVID-19 lockdown periods. Interviews were analysed using inductive thematic analysis. RESULTS: Five males and four females, with rheumatoid arthritis, psoriatic arthritis, or spondylarthritis, aged between 24-79 years (mean = 49.9, SD = 20.9) were included in the sample. Four main themes impacting on mental wellbeing were identified from the data: (1) Pandemic fatigue versus pandemic acclimatisation, (2) Social interaction and isolation, (3) Clarity of information, (4) Seasonal changes. CONCLUSION: The first two COVID-19 lockdown periods in England had an ongoing impact on the mental health of patients with IA. Healthcare professionals, in conjunction with government support, should ensure that adequate information and mental health resources are available to support IA patients during periods of ongoing restrictions, whilst also continuing to encourage behaviours which promote good mental health and wellbeing.

The impact of COVID-19 on clinical care, self-management and mental health of patients with inflammatory arthritis.

OBJECTIVES: The coronavirus disease 2019 (COVID-19) lockdown and ongoing restrictions in the UK affected access to clinical care, self-management and mental health for many patients with inflammatory arthritis. The aim of this study was to determine the impact of lockdown on inflammatory arthritis clinical care, self-management, disease outcomes and mental health. METHODS: In total, 338 people with inflammatory arthritis participated in a prospective study, completing a series of online questionnaires. The questionnaires assessed demographics, inflammatory arthritis condition and management, clinical care, quality of life and mental health. Visual analogue scales (VASs) were completed at each assessment. Linear regression, controlling for confounders, was conducted to determine factors associated with physical and mental health outcomes. RESULTS: More than half of participants reported worsening VAS by >10 points for patient global assessment (PGA), pain, fatigue and emotional distress during the initial lockdown. Changes in clinical care were associated with worse PGA (b = 8.95, P = 0.01), pain (b = 7.13, P = 0.05), fatigue (b = 17.01, P < 0.01) and emotional distress (b = 12.78, P < 0.01). Emotional distress and depression were also associated with worse outcomes in PGA, pain and fatigue, whereas loneliness was not. In contrast, physical activity seemed to mitigate these effects. Loneliness did not show any associations with outcomes. Over time, these effects decreased or disappeared. CONCLUSION: Changes to clinical care owing to lockdown were associated with worse disease outcomes in patients with inflammatory arthritis. There has also been a clear impact on mental health, with possibly complex relationships between mental health and psychosocial factors. Physical activity emerged as a key influence on disease outcomes and mental health.

The impact of COVID-19 on self-management behaviours and healthcare access for people with inflammatory arthritis.

BACKGROUND: Inflammatory arthritis (IA) patients have been identified as at greater risk of severe illness from COVID-19. It is likely that lockdown restrictions (enforced by the UK government in response to the COVID-19 pandemic) and subsequent changes made to healthcare provision could impact patients' abilities to effectively manage their condition. The aim of this study was to qualitatively explore the impact of COVID-19 on self-management behaviours and healthcare access for people with IA. METHODS: Semi-structured interviews were conducted with 21 IA patients in June-July 2020, with nine follow-up interviews in November 2020. Interview schedules were developed with a Patient Research Partner and explored participants' experiences of the COVID-19 pandemic. Interviews were conducted via telephone and analysed using inductive thematic analysis. RESULTS: Participants were aged between 24 and 79 years (mean = 50.1, SD = 15.8), largely female (71%) and White British (86%). Four initial themes were identified: (1) Impact of COVID-19 on medication adherence, (2) Impact of COVID-19 on physical activity, (3) Impact of COVID-19 on diet, and (4) Impact of COVID-19 on healthcare access and delivery. Subthemes focused on positive and negative changes made to these areas, as well as behaviours which remained consistent. Follow-up interviews highlighted differences in participants' experiences during the two lockdown periods. CONCLUSION: COVID-19 has affected patients' abilities to manage their IA. Healthcare professionals need to recognise the ongoing impact of COVID-19 on patient self-management and healthcare access to ensure that adequate understanding and support is available to patients who may have inadequate disease control as a result.

Considerations and priorities for incorporating the patient perspective on remission in rheumatoid arthritis: An OMERACT 2020 special interest group report.

OBJECTIVE: To determine how best to incorporate the patient perspective into rheumatoid arthritis remission criteria. METHODS: At OMERACT 2020, several studies, including a longitudinal multi-centre study testing the validity of adding patient-valued domains to the ACR/EULAR criteria, were presented and discussed by the virtual Special Interest Group. RESULTS: Overall consensus was that there is insufficient evidence to change the remission criteria at this point. Future work should focus on measurement of the new domain of independence, clarifying the value of the patient global assessment, and optimizing the input of domains that patients value in the criteria. CONCLUSION: Incorporating the patient perspective into remission criteria should be further explored.

Summarizing current refractory disease definitions in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis: systematic review.

OBJECTIVES: To identify how refractory disease (or relevant terminology variations) in RA and polyarticular JIA (polyJIA) is defined and establish the key components of such definitions. METHODS: Searches were undertaken of English-language articles within six medical databases, including manual searching, from January 1998 to March 2020 (PROSPERO: CRD42019127142). Articles were included if they incorporated a definition of refractory disease, or non-response, in RA/polyJIA, with clear components to the description. Qualitative content analysis was undertaken to describe refractory disease in RA/polyJIA and classify each component within each definition. RESULTS: Of 6251 studies screened, 646 met the inclusion criteria; 581 of these applied non-response criteria while 65 provided refractory disease definitions/descriptions. From the non-response studies, 39 different components included various disease activity measures, emphasizing persistent disease activity and symptoms, despite treatment with one or more biologic DMARD (bDMARD). From papers with clear definitions for refractory disease, 41 components were identified and categorized into three key themes: resistance to multiple drugs with different mechanisms of action, typically two or more bDMARDs; persistence of symptoms and disease activity; and other contributing factors. The most common term used was 'refractory' (80%), while only 16.9% reported explicitly how their definition was generated (e.g. clinical experience or statistical methods). CONCLUSION: Refractory disease is defined as resistance to multiple drugs with different mechanisms of action by persistence of physical symptoms and high disease activity, including contributing factors. A clear unifying definition needs implementing, as the plethora of different definitions makes study comparisons and appropriate identification of patients difficult.

Association of Anxiety With Pain and Disability but Not With Increased Measures of Inflammation in Adolescent Patients With Juvenile Idiopathic Arthritis.

OBJECTIVE: To explore whether anxiety and depression are associated with clinical measures of disease for adolescent patients with juvenile idiopathic arthritis (JIA) and whether anxiety and depression are associated with increased peripheral proinflammatory cytokine levels in adolescent patients with JIA and in healthy adolescent controls. METHODS: A total of 136 patients with JIA and 88 healthy controls ages 13-18 years completed questionnaires on anxiety and depressive symptoms. For patients with JIA, pain, disability, physician global assessment (using a visual analog scale [VAS]), and number of joints with active inflammation (active joint count) were recorded. In a subsample, we assessed lipopolysaccharide-stimulated interleukin 6 (IL-6) production from peripheral blood mononuclear cells, serum IL-6, cortisol, and C-reactive protein levels. Data were analyzed by linear regression analysis. RESULTS: Levels of anxiety and depressive symptoms in patients with JIA were not significantly different than those in healthy controls. For patients with JIA, anxiety was significantly associated with disability (ß = 0.009, P = 0.002), pain (ß = 0.029, P = 0.011), and physician global assessment VAS (ß = 0.019, P = 0.012), but not with active joint count (ß = 0.014, P = 0.120). Anxiety was not associated with any laboratory measures of inflammation for JIA patients. These relationships were also true for depressive symptoms. For healthy controls, there was a trend toward an association of anxiety (but not depressive symptoms) with stimulated IL-6 (ß = 0.004, P = 0.052). CONCLUSION: Adolescent patients with JIA experience equivalent levels of anxiety and depressive symptoms as healthy adolescents. For adolescent patients with JIA, anxiety and depressive symptoms are associated with pain, disability, and physician global assessment VAS, but not with inflammation.

Development of a benchmarking toolkit for adolescent and young adult rheumatology services (BeTAR).

BACKGROUND: Young people (YP; 12-24 years old) with rheumatic diseases face many challenges associated with chronic illness in addition to the physiological and psychosocial changes of adolescence. Timely access to developmentally appropriate multidisciplinary care is key to successfully managing rheumatic diseases, but gaps in the care of this vulnerable age group still exist. This study aimed to develop a benchmarking toolkit to enable comparative evaluation of YP rheumatology services in order to promote best practice and reduce variations in service delivery. METHODS: A staged and consultative method was used across a broad group of stakeholders in the UK (YP, parents/other carers, and healthcare professionals, HCPs) to develop this toolkit, with reference to pre-existing standards of YP-friendly healthcare. Eighty-seven YP (median age 19 years, range 12-24 years) and 26 rheumatology HCPs with 1-34 years of experience caring for YP have participated. RESULTS: Thirty quality criteria were identified, which were grouped into four main domains: assessment and treatment, information and involvement, accessibility and environment, and continuity of care. Two toolkit versions, one to be completed by HCPs and one to be completed by patients, were developed. These were further refined by relevant groups and face validity was confirmed. CONCLUSIONS: A toolkit has been developed to systematically evaluate and benchmark YP rheumatology services, which is key in setting standards of care, identifying targets for improvement and facilitating research. Engagement from YP, clinical teams, and commissioners with this tool should facilitate investigation of variability in levels of care and drive quality improvement.

Developing and Evaluating JIApp: Acceptability and Usability of a Smartphone App System to Improve Self-Management in Young People With Juvenile Idiopathic Arthritis.

BACKGROUND: Flare-ups in juvenile idiopathic arthritis (JIA) are characterized by joint pain and swelling and often accompanied with fatigue, negative emotions, and reduced participation in activities. To minimize the impact of JIA on the physical and psychosocial development and well-being of young people (YP), it is essential to regularly monitor disease activity and side effects, as well as to support self-management such as adherence to treatment plans and engagement in general health-promoting behaviors. Smartphone technology has the potential to engage YP with their health care through convenient self-monitoring and easy access to information. In addition, having a more accurate summary of self-reported fluctuations in symptoms, behaviors, and psychosocial problems can help both YP and health care professionals (HCPs) better understand the patient's condition, identify barriers to self-management, and assess treatment effectiveness and additional health care needs. No comprehensive smartphone app has yet been developed in collaboration with YP with JIA, their parents, and HCPs involved in their care. OBJECTIVES: The objective of this study was to design, develop, and evaluate the acceptability and usability of JIApp, a self-management smartphone app system for YP with JIA and HCPs. METHODS: We used a qualitative, user-centered design approach involving YP, parents, and HCPs from the rheumatology team. The study was conducted in three phases: (1) phase I focused on developing consensus on the features, content, and design of the app; (2) phase II was used for further refining and evaluating the app prototype; and (3) phase III focused on usability testing of the app. The interview transcripts were analyzed using qualitative content analysis. RESULTS: A total of 29 YP (aged 10-23, median age 17) with JIA, 7 parents, and 21 HCPs were interviewed. Major themes identified as the ones that helped inform app development in phase I were: (1) remote monitoring of symptoms, well-being, and activities; (2) treatment adherence; and (3) education and support. During phase II, three more themes emerged that informed further refinement of the app prototype. These included (4) adapting a reward system to motivate end users for using the app; (5) design of the app interface; and (6) clinical practice integration. The usability testing during phase III demonstrated high rates of overall satisfaction and further affirmed the content validity of the app. CONCLUSIONS: We present the development and evaluation of a smartphone app to encourage self-management and engagement with health care for YP with JIA. The app was found to have high levels of acceptability and usability among YP and HCPs and has the potential to improve health care and outcomes for this age group. Future feasibility testing in a prospective study will firmly establish the reliability, efficacy, and cost-effectiveness of such an app intervention for patients with arthritis.

A multicentre validation of Metasin: a molecular assay for the intraoperative assessment of sentinel lymph nodes from breast cancer patients.

AIMS: Treatment strategies for breast cancer continue to evolve. No uniformity exists in the UK for the management of node-positive breast cancer patients. Most centres continue to use conventional histopathology of sampled sentinel lymph nodes (SLNs), which requires delayed axillary clearance in up to 25% of patients. Some use touch imprint cytology or frozen section for intraoperative testing, although both have inherent sensitivity issues. An intraoperative molecular diagnostic approach helps to overcome some of these limitations. The aim of this study was to assess the clinical effectiveness of Metasin, a molecular method for the intraoperative evaluation of SLNs. METHODS AND RESULTS: RNA from 3296 lymph nodes from 1836 patients undergoing SLN assessment was analysed with Metasin. Alternate slices of tissue were examined in parallel by histology. Cases deemed to be discordant were analysed by protein gel electrophoresis. There was concordance between Metasin and histology in 94.1% of cases, with a sensitivity of 92% [95% confidence interval (CI) 88-94%] and a specificity of 97% (95% CI 95-97%). Positive and negative predictive values were 88% and 98%, respectively. Over half of the discordant cases (4.4%) were ascribed to tissue allocation bias (TAB). CONCLUSIONS: Clinical validation of the Metasin assay suggests that it is sufficiently sensitive and specific to make it fit for purpose in the intraoperative setting.

Noise at night in hospital general wards: a mapping of the literature.

English NHS inpatient surveys consistently identify that noise at night in hospitals and its impact on patients' sleep is a persisting problem that needs addressing. To identify how noise at night in hospital affects patients on general wards and the range of interventions aimed at reducing the problem, a systematic mapping of the literature was undertaken. All primary studies and relevant literature published January 2003-July 2013 were included. Key issues identified in the literature included noise levels and causes, impact on patient experience, and lack of staff awareness. Interventions to reduce noise were targeted at staff education, behaviour modification, care organisation and environmental solutions. The scoping suggested that when compared with specialist units, there is little evidence on effective interventions reducing disturbance from night-time noise on general wards. The available evidence suggests a whole systems approach should be adopted to aid quality sleep and promote recovery.

Self-management for people with long-term neurological conditions.

Although English government policy has encouraged the implementation of self-management programmes in services for people with long-term conditions, the evidence for their efficacy has been limited. People with long-term neurological conditions use community-based health services including community nursing, and have particular needs in regards to self-management. This article provides an overview of the evidence for the effectiveness of self-management interventions for people with long-term neurological conditions, in particular those with stroke, Parkinson's disease and multiple sclerosis. The current need for better interventions is highlighted, particularly the importance of providing condition-specific information and deliverance of interventions in a group setting to improve self-management outcomes. In response to weaknesses of previous self-management interventions for this population, an innovative Hertfordshire Neurological Service self-management programme is discussed, and the implications for future research are described.