Assessing glucocorticoid toxicity: Are the measures sensitive enough?

The Glucocorticoid Toxicity Index (GTI) is a composite instrument designed to capture change in glucocorticoid-related morbidity over time.1 It was developed through consensus methods and multi-criteria decisions among 19 medical specialists, with relative domain weights decided via clinician consensus.2 The GTI has now been used in more than 45 studies, including 12 phase 3 clinical trials.1The GTI comprises eight domains: body mass index, blood pressure, glucose tolerance, lipid metabolism, glucocorticoid myopathy, skin toxicity, neuropsychiatric effects and infections. Two overall scores are calculated: the cumulative worsening score (CWS), which includes transient and permanent GC toxicity from baseline to specific time points, and the Aggregate Improvement Score (AIS), which accounts for improvement as well as worsening GC-toxicity.1 In The Lancet Rheumatology, Naomi Patel and colleagues3 present an analysis of domain scores of the GTI using data from the phase 3 ADVOCATE trial.4 In a clinical trial context where the GTI is used to produce repeated measures to demonstrate differences between (and within) groups of patients taking different dosages of glucocorticoids, and to measure the impact of steroid sparing agents, it is expected to have a high level of measurement validity and reliability

Qualitative interview study of rheumatology patients’ experiences of COVID-19 shielding to explore the physical and psychological impact and identify associated support needs

Objective Many clinically extremely vulnerable rheumatology patients have only recently ceased shielding from COVID-19, while some continue to minimise in-person contact. The objective of this study was to understand the impact of shielding and associated support needs in patients with rheumatic conditions and to understand how rheumatology teams can meet these needs both currently and in future pandemics. Design, Participants and Setting The study was conducted in the Southwest of England using a case-study design. The participants were 15 patients with rheumatic conditions who were advised to shield and/or chose to shield at any time during the COVID-19 pandemic. Methods Qualitative data collected via telephone and online semi-structured interviews and analysed using reflexive thematic analysis. Results Fifteen interviews were conducted. Three main themes represent the data: ‘Just shove them over there in the corner’ captures changes in patients’ self-perception. They felt different to most other people, vulnerable and left behind. The initial sense of shock was followed by a sense of loss as changes became long term. ‘A long and lonely road’ captures patients’ psychological isolation due to a perceived lack of understanding and support. This included having to prove their health status and justify their shielding behaviours, which impacted their relationships. At times, they felt abandoned by their healthcare providers. ‘You can’t just flip a switch’ captures the difficulty of getting back to pre-pandemic normal after shielding. Patients did not recognise themselves physically and mentally. They wanted to collaborate with health professionals and identified the need for specific guidance to support their recovery. Conclusion Patients are dealing with lasting physical and mental effects from shielding and consequences of delayed healthcare. Health professionals need time and resources to ask about patients’ well-being, identify their health needs and refer/signpost to appropriate sources of support

Comment on: Benchmarking tocilizumab use for giant cell arteritis

It is with great interest we read the editorial on tocilizumab (TCZ) use in giant cell arteritis (GCA) published on 9th May, 2022 by Conway et al [1]. We write to share some of our data to add weight to the views expressed, particularly in relation to use of TCZ beyond one yearin refractory cases with visual involvement

Mixed methods study of clinicians' perspectives on barriers to implementation of treat to target in psoriatic arthritis

Objectives: In treat to target (T2T), the patient is treated to reach and maintain specified and sequentially measured goals, such as remission or low disease activity. T2T in psoriatic arthritis (PsA) has demonstrated improved clinical and patient-reported outcomes and is recommended in European guidelines. However, most clinicians do not use T2T in PsA. This study examined the barriers and enablers to implementation in practice. Methods: Sequential mixed methods comprising a qualitative design (interviews and focus group) to inform a quantitative design (survey). Qualitative data were analysed thematically, and quantitative statistics were analysed descriptively. Results: Nineteen rheumatology clinicians participated in telephone interviews or a face-to-face focus group. An overarching theme 'Complexity' (including 'PsA vs Rheumatoid Arthritis', 'Measurement' and 'Resources') and an underpinning theme 'Changes to current practice' (including 'Reluctance due to organisational factors' and 'Individual determination to make changes') were identified. 153 rheumatology clinicians responded to an online survey. Barriers included limited clinical appointment time to collect outcome data (54.5%) and lack of training in assessing skin disease (35%). Enablers included provision of a protocol (86.4%), a local implementation lead (80.9%), support in clinic to measure outcomes (83.3%) and training in T2T (69.8%). The importance of regular audit with feedback, specialist PsA clinics and a web-based electronic database linked to hospital/national information technology (IT) systems were also identified as enablers. Conclusions: Implementation of T2T in PsA requires an integrated approach to address the support, training and resource needs of individual clinicians, rheumatology teams, local IT systems and service providers to maximise success

Systemic vasculitis and patient-reported outcomes: how the assessment of patient preferences and perspectives could improve outcomes.

The systemic vasculitides are a group of multisystem diseases, which can be life and organ threatening. High-dose immunosuppressants are required to control inflammation in vital organs, such as the kidneys, lungs, skin, joints, and eyes. Patients report a range of impacts on their health-related quality of life due to symptoms, irreversible damage, and the adverse effects of medications. The measurement of patient perspectives within clinical studies in vasculitis is essential to capture outcomes of greatest importance to patients. Validated generic, disease-specific and symptom-specific patient-reported outcomes available for use in patients with systemic vasculitis are reviewed here

Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases

Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Grouphas been working to develop a core domain set to measure the impact of GCs on patients living with rheumaticand musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trialsmeasuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight,fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precisedefinitions of all mandatory domains within the core domain set.Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making ofall stakeholder groups (patient research partners, health care professionals, clinician researchers, industrymembers and methodologists) to develop detailed definitions for the broad domain, target domain and domaincomponents, taking into consideration sources of variability that could affect measurement of the domain. Theworking group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, todevelop a rich definition of ‘what’ is to be measured.Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings toestablish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains wereprimarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which wasprimarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and languagebarriers. The domain definitions will form the foundation for instrument selection and the initial step of domain /concept match and content validity in the OMERACT pillar of ‘truth’ before moving on to feasibility anddiscrimination.Conclusion: The OMERACT GC Impact Working Group has developed and agreed upon detailed domain definitions for core domains. Future steps of the working group are to select instruments and develop the core outcom

The OMERACT emerging leaders program: The good, the bad, and the future

The Journal of Rheumatology Copyright © 2019. All rights reserved. Objective. To describe the experience of the first OMERACT Emerging Leaders Program (ELP). Methods. A Delphi process identified positive aspects, areas for improvement, and future directions. Core items were defined as essential if they received ≥ 70% ratings. Results. Participants valued relatable/accessible mentors (100%), including an OMERACT Executive mentor (100%), and a support network of peers (90%). Key items for future development were funding support (100%) and developing knowledge about OMERACT processes (90%) and politics (80%). Conclusion. The ELP has the potential to provide targeted training for early career researchers to develop relevant skills for future leadership roles within OMERACT

The patient perspective of nurse-led care in early rheumatoid arthritis: A systematic review of qualitative studies with thematic analysis

Introduction: Management of rheumatoid arthritis has changed dramatically over the last decade and is characterised by early start of intensive treatment and tight monitoring of disease activity until remission. The role of nurse-led care at early stage of disease is not well understood.Aims: To develop an understanding of rheumatology nurse-led care from the perspective of patients with early rheumatoid arthritis.Methods: A systematic review of qualitative studies, reported in line with PRISMA checklist. In March 2019, the following databases were searched: MEDLINE, EMBASE, CINAHL, PsycINFO and OpenGrey. Studies were included if they: included adults with rheumatoid arthritis; were qualitative studies with data on patients' perspectives of nurse-led care; and published in peer-reviewed journals, in English, between 2010-2019. Due to few studies in early rheumatoid arthritis, inclusion was extended to adults with established rheumatoid arthritis. Two reviewers screened abstracts and full texts. Joanna Briggs Institute Critical Appraisal Tool was used for quality assessment. Thematic synthesis was conducted according to the framework of Thomas and Harden (2008).Results: The search identified 1034 records. After screening and assessing for eligibility, eight qualitative studies were included in the review (133 patients). Three themes were identified from the synthesis. Nurse-led care was seen to provide professional expertise in planning and delivery of care. A person-centred approach was used combined with good communication skills, thus creating a positive therapeutic environment. Nurse-led care was described as providing a sense of empowerment and psychological support.Conclusion: Patients with rheumatoid arthritis are supportive of nurse-led care. They value its professionalism and person-centred approach which provide a sense of security and confidence.Relevance to clinical practice: The findings outline ingredients of nurse-led care that are important to patients. These can inform nurses' professional development plans, service improvement and the competence framework for rheumatology nursing

Health related quality of life in ANCA associated vasculitis and item generation for a disease specific patient reported outcome measure

ABSTRACTObjective: The anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAVs) are multisystem diseases of the small blood vessels. Patients experience irreversible damage and psychological effects from AAV and its treatment. An international collaboration was created to investigate the impact of AAV on health-related quality of life (HRQoL), and develop a disease-specific patient-reported outcome measure to assess outcomes of importance to patients.Methods: Patients with AAV from the UK, US, and Canada were interviewed to identify salient aspects of HRQoL affected by AAV. The study was overseen by a steering committee including four patient research partners. Purposive sampling of interviewees ensured representation of a range of disease manifestations and demographics. Inductive analysis was used to identify themes of importance to patients; these were further confirmed by a free-listing exercise in the US. Individual themes were recast into candidate items, which were scrutinized by patients, piloted through cognitive interviews and received a linguistic and translatability evaluation. Results: Fifty interviews, conducted to saturation, with patients from the UK, US and Canada, identified 55 individual themes of interest within seven broad domains: general health perceptions, impact on function, psychological perceptions, social perceptions, social contact, social role and symptoms. Individual themes were constructed into >100 candidate questionnaire items which were then reduced and refined to 35 candidate items.Conclusion: This is the largest international qualitative analysis of health related quality of life in ANCA associated vasculitis to date, the results have underpinned the development of 35 candidate items for a disease-specific, patient-reported outcome questionnaire