Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.

BACKGROUND: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors' experiences of the RAFT programme. DESIGN: A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. SETTING: Seven hospital rheumatology units in England and Wales. PARTICIPANTS: Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. INTERVENTIONS: RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care - brief discussion of a RA fatigue self-management booklet with the research nurse. MAIN OUTCOME MEASURES: Primary - fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. RESULTS: A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (-1.36 units; p < 0.001) and the control interventions (-0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference -0.59 units, 95% confidence interval (CI) -1.11 to -0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (-0.49 units, 95% CI -0.83 to -0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference -3.42 units, 95% CI -6.44 to - 0.39 units, p = 0.03; living with fatigue: adjusted mean difference -1.19 units, 95% CI -2.17 to -0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference -0.91 units, 95% CI -1.58 to -0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI -£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI -0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28-35% at the National Institute for Health and Care Excellence's thresholds of £20,000-30,000 per QALY. Tutors felt that the RAFT programme's CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors' wider clinical practice. LIMITATIONS: Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. CONCLUSIONS: The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. FUTURE WORK: Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52709998. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.

Rheumatoid arthritis (RA) is a lifelong inflammatory condition affecting multiple joints, with fatigue as a major consequence. Cognitive­behavioural therapy (CBT) helps patients work out links between symptoms, behaviours and thoughts driving those behaviours (e.g. why someone pushes on when exhausted), and understanding these links helps patients make changes. A CBT programme for groups of RA patients, facilitated by a psychologist, reduces fatigue impact. However, few rheumatology teams have psychologists. The study tested whether or not rheumatology nurses and occupational therapists (OTs) could facilitate the programme [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive­behavioural (CB) approaches] after brief training. The study compared the RAFT programme with usual care for RA fatigue (i.e. a short discussion of an arthritis fatigue booklet). All 333 patients received usual care, and then half of the patients were allocated (by chance) to also attend the seven-session RAFT programme. The study compared the RAFT programme with usual care for effects on fatigue, quality of life, cost and value for money. In addition, the rheumatology nurse and OT RAFT tutors were interviewed for their views on the RAFT programme. The study found that patients' fatigue impact was reduced by both the RAFT programme and usual care at 6 months and 2 years, but patients undertaking the RAFT programme improved significantly more than those receiving usual care alone. Differences were seen for improvements in fatigue impact, fatigue coping, emotional fatigue and living with fatigue. Patients were very satisfied with the RAFT programme and attended most of the sessions. The study found no significant difference between the NHS costs of the RAFT programme and usual care. Neither the RAFT programme nor usual care changed quality of life; therefore, standard value-for-money tests showed no difference between them. Tutors found that the CB questioning approach of the RAFT programme was different from their usual problem-solving style, but helped patients make life changes, and the new CB skills improved tutors' wider clinical practice. In conclusion, the trial has shown that the RAFT programme has a small to medium effect on reducing fatigue impact in patients with RA and is a potentially low-cost intervention that can be delivered by rheumatology nurses and OTs rather than a psychologist.

Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT).

INTRODUCTION: Fatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue. METHODS AND ANALYSIS: LIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls. ETHICS APPROVAL AND DISSEMINATION: Ethical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants. TRIAL REGISTRATION NUMBER: NCT03248518; Pre-results.

The revised Bristol Rheumatoid Arthritis Fatigue measures and the Rheumatoid Arthritis Impact of Disease scale: validation in six countries.

Objective: To evaluate the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ), the revised Bristol Rheumatoid Arthritis Numerical Rating Scales (BRAF-NRS V2) and the Rheumatoid Arthritis Impact of Disease (RAID) scale in six countries. Methods: We surveyed RA patients in France, Germany, The Netherlands, Spain, Sweden and the UK, including the HAQ, 36-item Short Form Health Survey (SF-36) and potential revisions of the BRAF-NRS coping and Spanish RAID coping items. Factor structure and internal consistency were examined by factor analysis and Cronbach's α and construct validity by Spearman's correlation. Results: A total of 1276 patients participated (76% female, 25% with a disease duration <5 years, median HAQ 1.0). The original BRAF-MDQ four-factor structure and RAID single-factor structure were confirmed in every country with ⩾66% of variation in items explained by each factor and all item factor loadings of 0.71-0.98. Internal consistency for the BRAF-MDQ total and subscales was a Cronbach's α of 0.75-0.96 and for RAID, 0.93-0.96. Fatigue construct validity was shown for the BRAF-MDQ and BRAF-NRS severity and effect scales, correlated internally with SF-36 vitality and with RAID fatigue (r = 0.63-0.93). Broader construct validity for the BRAFs and RAID was shown by correlation with each other, HAQ and SF-36 domains (r = 0.46-0.82), with similar patterns in individual countries. The revised BRAF-NRS V2 Coping item had stronger validity than the original in all analyses. The revised Spanish RAID coping item performed as well as the original. Conclusion: Across six European countries, the BRAF-MDQ identifies the same four aspects of fatigue, and along with the RAID, shows strong factor structure and internal consistency and moderate-good construct validity. The revised BRAF-NRS V2 shows improved construct validity and replaces the original.

The experience of foot problems and decisions to access foot care in patients with rheumatoid arthritis: a qualitative study.

BACKGROUND: Although foot problems are common in rheumatoid arthritis (RA), the consequences of foot problems from the patient perspective have not been fully explored. The aims of this study were to explore the experience of foot problems and decisions to access foot care services or not in patients with RA. METHODS: Semi structured, one-to-one interviews with patients recruited from 2 UK rheumatology units, purposively sampled for self-reported foot problems and a range of personal/disease characteristics. Inductive thematic analysis was used, with rigour provided by multiple independent analysers. Emerging themes were discussed and agreed by all authors. RESULTS: Twelve patients participated: 7 female; mean age 56 years (29-72); mean disease duration 12 years (2-27), 5 had accessed foot care services. The 'Impact' of foot problems was substantial and formed the underpinning theme, comprising three organising themes: 'Foot symptoms'; 'Consequences'; and 'Cost'. Foot symptoms such as pain and numbness required self-management, and affected daily life (walking, working) leading to social and emotional costs. The global theme, 'Decision to access foot care or not', also comprised three organising themes: 'Access perceived unnecessary' (no problem, can cope); 'Access hindered by patients' perception'; and 'Access supported by patient and clinician'. Decisions to access foot care or not were complex and influenced by patient beliefs regarding possible treatments and how to access these, and hindered by patient perceptions that their feet were ignored by rheumatology clinicians. Positive experience of foot care encouraged continued utilisation but negative experiences contributed to patients' decisions to discontinue foot care services. CONCLUSIONS: Foot problems are important issues for patients and impact on many aspects of their physical, social and emotional lives. Patients who had accessed foot care services prioritised their foot problems as an important health care need. However, for others who would like foot care services, personal knowledge and values, and perceived barriers in clinical practice, appear to interact to inhibit foot care access. The extent which these interactions affect overall access to foot care in RA patients in general now needs to be quantified to help to inform and improve the effectiveness of the organisation and delivery of foot care.

"You Obviously Just Have to Put on a Brave Face": A Qualitative Study of the Experiences and Coping Styles of Men With Rheumatoid Arthritis.

OBJECTIVE: To explore the experiences, coping styles, and support preferences of male rheumatoid arthritis (RA) patients. METHODS: Six focus groups comprised 22 men with RA. Transcripts were analyzed using inductive thematic analysis. RESULTS: Three overarching themes describe the experiences, coping styles, and support preferences of men with RA. In "challenges to masculinity," the men described a "reduction in strength and abilities," which can lead to loss of independence, "challenges to masculine identity and role," and "loss of power and control." Coping by "getting through life with RA" meant dealing with RA by "just getting on with it," "information seeking," engaging in "destructive behaviors," and "withdrawing socially." Preferred "sources of support" tended not to include friends, as they were perceived to lack understanding or support. For acceptable support the men reported a preference for information-giving sessions rather than a discussion group, but there was no agreement on whether these should be mixed-sex or men only, or who should run the sessions. CONCLUSION: Male patients reported a range of coping styles and support preferences to address their experiences of living with RA, many of which may not be shared with women. Further research is needed to investigate whether these findings exist in a larger sample and whether the support preferences of men with RA are broadly different from those of women with RA to decide whether there is a clinical need to design a service for the potentially different needs of men.

Identifying different typologies of experiences and coping strategies in men with rheumatoid arthritis: a Q-methodology study.

OBJECTIVE: To identify typologies of experiences and coping strategies of men with rheumatoid arthritis (RA). DESIGN: Q-methodology (a qualitative and quantitative approach to grouping people according to their subjective opinion). Men with RA sorted 64 statements relating to their experience of living with RA according to level of agreement across a normal distribution grid. Data were examined using Q-factor analysis. SETTING: Rheumatology outpatient departments in the UK. PARTICIPANTS: 30 of 65 invited men with RA participated in this study (46%). RESULTS: All participants ranked highly the need to be well informed about their medication and the importance of keeping a positive attitude. 2 factors describing the experiences and coping strategies of male patients living with RA were identified: factor A: 'acknowledge, accept and adapt' (n=14) take a proactive approach to managing the impact of RA and find different ways of doing things; while factor B: 'trying to match up to a macho ideal' (n=8) are determined to continue with their pre-RA lives, and therefore push themselves to carry on even if this causes them pain. They are frustrated and angry due to the impact of RA but they internalise this rather than directing it at others. CONCLUSIONS: While some men adapt to their RA by renegotiating their masculine identity, others struggle to relinquish their traditional masculine roles. Further research is needed to identify whether the finding that there are 2 distinct groups of men with RA can be generalised, and if so whether the differences can be explained by clinical, social or psychological factors, which may inform different therapeutic approaches.

Patient preferences for psychological support in inflammatory arthritis: a multicentre survey.

OBJECTIVES: Inflammatory arthritis (IA) can lead to anxiety, depression, pain and fatigue. Psychological support can improve quality of life and self-management; and European and American guidelines recommend support be offered. This study examined patient views on psychological support for their IA. METHODS: A questionnaire designed by researchers, patient partners and clinicians was administered to 2280 patients with IA. RESULTS: 1210 patients responded (53%): 74% women; mean age 59 years (SD 12.7); patient global 5 (2.3); disease duration <5 years (41%), 5-10 (20%), >10 (39%). Only 23% reported routinely being asked about social and emotional issues by a rheumatology professional, but 46% would like the opportunity to discuss psychological impact. If offered, 66% of patients reported they would use a self-management/coping clinic (63% pain management, 60% occupational therapy, 48% peer support groups, 46% patient education, 46% psychology/counselling). Patients want support with managing the impact of pain and fatigue (82%), managing emotions (57%), work and leisure (52%), relationships (37%) and depression (34%). Preferences are for support to be delivered by the rheumatology team (nurse 74%, doctor 55%) and general practitioners (GPs) (51%). Only 6% of patients stated that social and emotional issues were not relevant. CONCLUSIONS: Demand for psychological support is high; however, less than a quarter of patients reported being asked about social and emotional issues, suggesting a gap between needs and provision. The preference is for delivery from rheumatology clinicians and GPs, and research should establish whether they have the skills and resources to meet patients' needs.

Updating the OMERACT filter: implications of filter 2.0 to select outcome instruments through assessment of "truth": content, face, and construct validity.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity. METHODS: Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved. RESULTS: The case studies showed that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address. CONCLUSION: These issues will require resolution to reach consensus on how Truth will be assessed for the proposed Filter 2.0 framework, for instruments to be endorsed by OMERACT.

It's like a juggling act: rheumatoid arthritis patient perspectives on daily life and flare while on current treatment regimes.

OBJECTIVE: The objective of this study was to explore patients' experiences of RA daily life while on modern treatments. METHODS: The methods of this study comprised semi-structured interviews with 15 RA patients, analysed using inductive thematic analysis. RESULTS: Four themes suggest patients experience life with RA along a continuum from RA in the background to the foreground of their lives, underpinned by constant actions to maintain balance. Living with RA in the background shows patients experience continuous, daily symptoms, which they mediate through micromanagement (mediating the impact of RA on daily life), while learning to incorporate RA into their identity (redefining me). RA moving into the foreground shows patients experience fluctuating symptoms (unwelcome reminders) that may or may not lead to a flare (trying to make sense of fluctuation). Dealing with RA in the foreground shows how patients attempt to manage RA flares (trying to regain control) and decide to seek medical help only after feeling they are losing control. Patients employ a stepped approach to self-management (mediation ladder) as symptoms increase, with seeking medical help often seen as the last resort. Patients seek to find a balance between managing their fluctuating RA and living their daily lives. CONCLUSION: Patients move back and forth along a continuum of RA in the background vs the foreground by balancing self-management of symptoms and everyday life. Clinicians need to appreciate that daily micromanagement is needed, even on current treatment regimes. Further research is needed to quantify the level and impact of daily symptoms and identify barriers and facilitators to seeking help.

'To suddenly have a name for this thing was wonderful': the patient's experience of receiving a diagnosis of systemic lupus erythematosus.

OBJECTIVES: The aim of this study was to explore the patient's perception of receiving a diagnosis of systemic lupus erythematosus (lupus) and reports on their experience of the period between onset of symptoms and receiving a definitive diagnosis. METHODS: Focus groups were conducted in seven rheumatology centres. Forty-three participants were purposively selected and data were subjected to thematic deductive analysis. RESULTS: Focus group data generated three major themes. 'Diagnostic uncertainty and misdiagnosis' describes the frustration for many of experiencing years of often debilitating symptoms that have gone unacknowledged by health professionals and misunderstood by themselves. Some experienced the trauma of being misdiagnosed, which impacted on how they adjusted to their final diagnosis of lupus. 'Consequences of receiving a diagnosis' highlights the feelings of relief for participants at finally having a diagnosis, despite its implications. However, the manner in which this knowledge was delivered was often inappropriate and unsupported, affecting how they adjusted to future management of their condition. 'Impact on individuals' lives' explores how many felt empowered by finally receiving recognition for their symptoms, but the diagnosis of a relatively unknown condition with often invisible symptoms impacted on the response and support they received from those around them. CONCLUSION: It is essential health professionals have a greater understanding of the patient experience prior to receiving a diagnosis of lupus. The individual experience from symptom onset to diagnosis has a direct impact on the patient's subsequent acceptance of their diagnosis and response to management and therefore justifies the need for further research in this field.

OMERACT 10 Patient Perspective Virtual Campus: valuing health; measuring outcomes in rheumatoid arthritis fatigue, RA sleep, arthroplasty, and systemic sclerosis; and clinical significance of changes in health.

This workshop reviewed progress in a number of areas related to patient perspective outcomes that were not specifically included within other areas of the program. A substantial review of the work of the valuing health outcomes group (the "QALY" working group) with participation and feedback from the plenary audience resulted in guidance to refocus on the use of patient preferences in the elaboration of more robust outcome measures for patient-reported outcomes and life impact measures. Progress and developments in the areas of fatigue and sleep in rheumatoid arthritis, outcome measures in hip and knee arthroplasty clinical trials, and scleroderma were outlined, and the challenge of truly understanding the nature of clinically important improvement was reviewed.

Evaluation of the Personal Impact Health Assessment Questionnaire (PI HAQ) to capture the impact of disability in osteoarthritis.

AIM: Measuring facts about disability may not reflect their personal impact. An individualized values instrument has been used to weight difficulty in performing activities of daily living in rheumatoid arthritis, and calculate personal impact (Personal Impact Health Assessment Questionnaire; PI HAQ). This study aimed to evaluate the PI HAQ in osteoarthritis (OA). STUDY DESIGN: Study 1: 51 people with OA completed short and long versions of the value instrument at 0 and 1 week. Study 2: 116 people with OA completed the short value instrument, disability and psychological measures at 0 and 4 weeks. RESULTS: Study 1: The eight-category and 20-item value instruments correlated well (r = 0.85) and scores differed by just 2.7%. The eight-category instrument showed good internal consistency reliability (Cronbach's alpha = 0.85) and moderate one-week test-retest reliability (r = 0.68, Wilcoxon signed-rank test p = 0.16, intra-class correlation coefficient [ICC] 0.62). Study 2: Values for disability were not associated with disability severity or clinical status. After weighting disability by value, the resulting PI HAQ scores were significantly associated with dissatisfaction with disability, perceived increase in disability, poor clinical status and life dissatisfaction, and differed significantly between people with high and low clinical status (convergent and discriminant construct validity). There was moderate association with the disease repercussion profile disability subscale (r = 0.511; p < 0.001) (criterion validity). The PI HAQ was stable over four weeks (ICC 0.81). CONCLUSIONS: These studies provide an initial evaluation of an instrument to measure the personal impact of disability in people with OA, setting disability within a personal context. Further studies, including sensitivity to change, are required.

Progress on incorporating the patient perspective in outcome assessment in rheumatology and the emergence of life impact measures at OMERACT 9.

The Patient Perspective Workshop included over 100 researchers and 18 patient participants from 8 countries. Following preconference reading and short plenary presentations, breakout groups considered work undertaken on measurement of sleep, assessing interventions to develop the effective consumer, and assessing psychological and educational interventions. The workshop explored the best way to identify other outcome domains (and instruments) that should be measured in observational or interventional studies with broader intentions than simply altering outcomes captured in the traditional "core set" plus fatigue. Four sleep questionnaires showed promise and will be the subject of further study. The Effective Consumer scale (EC-17) was reviewed and the concept Effective Consumer was well received. Participants thought it worthwhile to measure the skills and attributes of an effective consumer and develop an intervention that would include education in all of the scale's categories. Assessment of educational and psychological interventions requires a wider set of instruments than is currently used; these should relate to the purpose of the intervention. This principle was extended to include wider measures of the impact of disease on life, as indicated in the International Classification of Functioning, Disability and Health. Life impact measure sets covering domains appropriate to different rheumatic conditions and focused on different interventions might be defined by future OMERACT consensus. Measurement instruments within these domains that are valid for use in rheumatic conditions can then be identified and, in the case of psychological and educational interventions, chosen to fit with the purpose of the intervention.

Progress since OMERACT 6 on including patient perspective in rheumatoid arthritis outcome assessment.

The first OMERACT Patient Perspective Workshop took place at OMERACT 6 in 2002. Through a series of meetings and discussion sessions a research agenda emerged and this report outlines progress made on this agenda. Work on identifying novel outcomes, instruments, and methods has shown similarities across European countries in the importance patients with rheumatoid arthritis (RA) attach to specific outcomes, in particular fatigue. Validation of an appropriate instrument to measure fatigue in patients with RA is currently being investigated. Frequent or repeated real-time assessment of symptoms such as pain and fatigue is becoming possible using electronic systems. An OMERACT Patient Panel has been established, and has produced a glossary for patients involved in supporting clinical research. In some centers, efforts are being made to provide Patient Research Partners with knowledge and skills that will enhance their contribution, and some of these approaches will be incorporated into OMERACT 7. The research agenda that was developed during the first Patient Perspective Workshop has stimulated new work in several areas. In addition, international attention has been drawn to the need to make sure that the patient's perspective is not lost among the technical expertise of rheumatology.

Incorporating the patient perspective into outcome assessment in rheumatoid arthritis--progress at OMERACT 7.

The Patient Perspective Workshop at OMERACT 7 addressed the question of assessing the outcomes of intervention in rheumatoid arthritis (RA) from the perspective of those who experience the disease. A particular emphasis at this workshop was placed on fatigue, but other areas included well-being, real-time assessment, patient priorities, and needs in early and late disease. Through a series of overview presentations, discussion groups, and plenary sessions, workshop participants (who included 19 patients) clarified what is known and what are the outstanding issues for future research. The importance of further work on clarifying the validity of fatigue measurements in RA has been confirmed, and with at least one suitable instrument available there will be strong pressure to include fatigue in a redefined core set of outcome measures in RA. In the other 4 areas covered there are important issues that can be addressed by enquiry and experiment and that together provide a challenging research agenda. At the final plenary session the OMERACT conference endorsed, by a large majority, the proposal that fatigue may warrant consideration for inclusion in the OMERACT core set for RA.

Patient initiated outpatient follow up in rheumatoid arthritis: six year randomised controlled trial.

OBJECTIVES: To determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist. DESIGN: Two year randomised controlled trial extended to six years. SETTING: Rheumatology outpatient department in teaching hospital. PARTICIPANTS: 209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04). CLINICAL OUTCOME: pain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis. RESULTS: Participants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001). CONCLUSIONS: Over six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.