Pam Richards

Patient perspective of measuring treatment efficacy: the rheumatoid arthritis patient priorities for pharmacologic interventions outcomes.

Collaboration with patients with rheumatoid arthritis (RA) highlights that outcomes important to them include fatigue, coping, and life enjoyment. However, these are not commonly measured in clinical trials. There is little evidence about which outcomes patients would prioritize, or what factors influence patients prioritization. Our objective was to develop a complementary core set with patients to promote inclusion of their priority outcomes in pharmacologic interventions.

What outcomes from pharmacologic treatments are important to people with rheumatoid arthritis? Creating the basis of a patient core set

Function, patient global assessment, and pain are routinely measured in rheumatoid arthritis (RA) clinical trials. However, other patient‐reported outcomes identified as important to patients in qualitative studies, such as fatigue and quality of life, are commonly not included, and modern treatment regimens may have changed patients expectations of treatment outcomes. Our objective was to elicit patient priority treatment outcomes for pharmacologic interventions since the common use of anti–tumor necrosis factor (anti‐TNF) therapy, which will form the basis of a core set of patient priorities to complement existing professional core sets.

Shifting normalities: interactions of changing conceptions of a normal life and the normalisation of symptoms in rheumatoid arthritis.

Biographical disruption and related concepts have been widely applied in chronic illness. Different conceptualisations of normalisation have also been proposed in order to explain individuals diverse responses to illness on their biography, but as yet, not clearly related to changing bodily experience or normalisation of symptoms. This article aims to examine the relevance of these concepts in rheumatoid arthritis (RA), an unpredictable autoinflammatory disease characterised by painful and swollen joints, disability, fatigue and joint damage. Interviews were conducted with 23 people living with RA, and analysed using Framework, to enable peoples whole narratives and context to be considered. Six typologies of normality emerged from the data: disrupted; struggling to maintain; fluctuating; resetting; returning; and continuing normality. Multiple normalities were often present in individuals narratives, with one normality typology usually dominating at the time of the interview. The typologies connect to several biographical concepts, and instances of biographical reinstatement were also found, where participants described returning to normal life, through perceived effective medication rather than reconceptualisation of health. The concept of shifting normalities is proposed, providing a dynamic explanatory model of chronic illness that captures the interaction of changing conceptions of a normal life and the normalisation of symptoms.

Self-efficacy as an appraisal that moderates the coping-emotion relationship: Associations among people with rheumatoid arthritis

The way a coping strategy is expressed might depend on the nature of underlying efficacy expectations. For example, a cognitive coping strategy may have different content depending on efficacy beliefs underpinning the strategys formulation and application. As such, self-efficacy (SE), as an appraisal, may moderate relationships between coping and outcomes: coping effects may differ depending on SE. This process was examined in 127 rheumatoid arthritis patients attending routine patient education/self-management programmes. Participants completed questionnaire measures of SE, coping, anxiety and depression at baseline and at 8 weeks follow-up. Regression analyses focused on coping and SE change variables, and their concurrent association with measures of change in anxiety and depression. Results highlighted contributions to these emotional variables from interactions between coping and SE. The nature of associations between coping and emotional outcomes was found to differ according to efficacy appraisals. This may have implications for clinical practice in that the adaptive significance of adjustment efforts may differ according to underlying SE.

Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes

The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced “Truth” statement in the OMERACT Filter.

Sensitivity to change of the Rheumatoid Arthritis Self-Efficacy scale (RASE) and predictors of change in self-efficacy

OBJECTIVESnPatient education in rheumatoid arthritis (RA) aims to improve health outcomes by prompting people to adopt self-management behaviours. One precursor for initiating behaviour change is self-efficacy (SE), a belief that you can do a task. This study tested the sensitivity to change of a new scale to measure SE for self-management in people with RA, the Rheumatoid Arthritis Self-Efficacy scale (RASE). Exploratory analysis examined potential predictors of change in SE.nnnMETHODSnPeople with RA at 11 rheumatology centres, who had accepted an education programme as part of clinical care, completed questionnaires at baseline, and two and eight weeks after their programme end. Programmes were not standardized, as this was a pragmatic study in clinical practice.nnnRESULTSnA total of 128 patients participated. After controlling for baseline scores, the RASE showed small but significant improvements in SE from baseline (RASE 107.57, CI 105.42-109.72) to two weeks after programme end (RASE 110.80, CI 108.60-112.99), and eight weeks (RASE 110.62, CI 108.40-112.85, p<0.001). Standardized response means, calculated both by absolute and percentage change, were 0.339 and 0.371 at two weeks after programme end, and 0.321 and 0.352 at eight weeks. Changes in the RASE were associated with behaviour initiation at two and eight weeks (r=0.419, r=0.342, p<0.001). No substantial predictors of change in SE could be identified.nnnCONCLUSIONSnThe RASE is sensitive to change in a cohort of people with RA in the UK receiving education programmes as routine clinical care. Exploratory analysis did not identify clinical or psychological factors that predict change in SE, suggesting that programmes should not be restricted to particular patients.

Utilizing Qualitative Data from Nominal Groups: Exploring the Influences on Treatment Outcome Prioritization with Rheumatoid Arthritis Patients

The nominal group technique generates quantitative data through a process of experts ranking items of interest. This article focuses on the additional collection of qualitative data from nominal groups with rheumatoid arthritis (RA) patients, used to explore the influences on prioritizing treatment outcomes. Across all groups, the top five outcomes with the highest importance scores were identified as: pain; joint damage; fatigue; activities of daily living; and mobility. Qualitative findings showed that the personal impact of RA influenced decisions on how to rank specific outcomes through four domains: disease impact; adaptation to illness; external resources and stressors; and social expectations.

‘It’s this whole picture, this well-being’: patients’ understanding of ‘feeling well’ with rheumatoid arthritis

Objectives: The aim of this study was to explore the meaning of ‘feeling well’ for people with rheumatoid arthritis (RA). Methods: In-depth interviews were conducted with 23 RA patients, purposively sampled for medication type, disease duration, disease activity, age and gender. Data were analysed using Framework, emphasizing participants’ personal contexts. Results: Well-being was viewed as a broad concept, with ‘feeling well’ being the result of an on-going process to actively engage with a changing body, self and life. Four dimensions emerged: ‘Living in the body’, ‘Being in the mind’, ‘Adapting to illness’ and ‘Being in the world’. The physical impact of RA underpinned the global perception of well-being and was clearly described as linking to the experience of psychological well-being. Physical and psychological wellness was often affected by the individual’s adaptation to RA and personal context (e.g. home environment, broader social attitudes). Discussion: Well-being is a multidimensional concept that is meaningful to RA patients regardless of medication type and disease severity. Patients commonly illustrated a process of actively engaging in cognitive and behavioural adjustments to move towards wellness. Clinical practice and research must take account of the complexity of well-being in long-term conditions, in order to fulfil patients’ expectations.

The impact of patient-perceived restricted access to anti-TNF therapy for rheumatoid arthritis: A qualitative study

OBJECTIVEnTo explore rheumatoid arthritis (RA) patients experience of access to anti-tumour necrosis factor (anti-TNF) therapy in the UK, and of switching therapies after an initial failure.nnnMETHODSnPatients were asked about their experience of accessing, receiving and discontinuing anti-TNF therapy in face-to-face indepth interviews, within the context of the larger study about treatment outcomes. Seventeen individuals with a diagnosis of RA and experience of receiving anti-TNF therapy were interviewed in one hospital trust in England.nnnRESULTSnDifferent emotions (Theme 1) surrounded the process of accessing anti-TNF therapy: hope, desperation, apprehension, anxiety and frustration. Experience of receiving anti-TNF therapy (Theme 2) included not only positive transformation, but also fear of failure and discontinuation. The subsequent value that patients placed on anti-TNF therapy (Theme 3) included having a right to receive therapy and being lucky. These three themes were underpinned by the core category of willing to try anything. Those switching therapies reported increased caution over the possibility of recurring side effects, but some suggestion of benefit. There was a perception that access to anti-TNF therapy was restricted by cost, rather than being recommended for those in clinical need.nnnCONCLUSIONSnAnti-TNF therapies may have a sudden and dramatic impact on RA patients lives that contrast with other available medications. However, the stress of the patients journey through the need to qualify for anti-TNF therapy, and the fear of failing or discontinuation of therapy, should not be underestimated by clinicians.

Nursing sensitive outcomes in patients with rheumatoid arthritis: A systematic literature review

BACKGROUNDnAlthough rheumatology nursing has been shown to be effective in managing patients with rheumatoid arthritis, patient outcomes sensitive to nursing interventions (nursing sensitive outcomes) have not been systematically studied.nnnOBJECTIVESnThe objective of this study was to identify and delineate relevant patient outcomes measured in studies that reported nursing interventions in patients with rheumatoid arthritis.nnnDESIGNnA systematic search was conducted from 1990 to 2016. Inclusion criteria were (i) patients with rheumatoid arthritis, (ii) adult population age ≥16years, (iii) nurse as part of the care team or intervention delivery, (iv) primary research only, (v) English language, and (vi) quantitative studies with nursing sensitive outcomes.nnnDATA SOURCESnMedline, CINAHL, Ovid nursing, Cochrane library and PsycINFO databases were searched for relevant studies.nnnREVIEW METHODSnUsing the predetermined inclusion/exclusion criteria, nine reviewers working in pairs assessed the eligibility of the identified studies based on titles and abstracts. Papers meeting the inclusion criteria were retrieved and full texts were further assessed. Critical Appraisal Skills Programme tools were used to assess the quality of the included studies. Data on nursing sensitive outcomes were extracted independently by two reviewers. The Outcome Measures in Rheumatology comprehensive conceptual framework for health was used to contextualise and present findings.nnnRESULTSnOf the 820 articles retrieved, 7 randomised controlled trials and 3 observational studies met the inclusion criteria. Seventeen nursing sensitive outcomes were identified (disease activity, clinical effects, pain, early morning stiffness duration, fatigue, patient safety issues, function, knowledge, patient satisfaction, confidence in care received, mental health status, self-efficacy, patient attitude/perception of ability to control arthritis, quality of life, health utility, health care resources, death). These fitted into 10 health intervention domains in keeping with the pre-specified conceptual framework for health: disease status, effectiveness, safety, function, knowledge, satisfaction, psychological status, quality of life, cost, death. A total of 59 measurement instruments were identified comprising patient reported outcome measures (n=31), and biologic measures and reports (n=28).nnnCONCLUSIONSnThis review is notable in that it is the first to have identified, and reported, a set of multidimensional outcome measures that are sensitive to nursing interventions in rheumatology specifically. Further research is required to determine a core set of outcomes to be used in all rheumatology nursing intervention studies.