Patient involvement in the development of a handbook for moderate rheumatoid arthritis

Self-management is a key recommendation for people with rheumatoid arthritis (RA). Educational materials may support self-management, and increasingly patients are becoming involved with the development of these materials. The TITRATE trial compares the effectiveness of intensive management to standard care in patients with moderate RA across England. As part of the intensive management intervention, participants are given a handbook.Aim and objectivesThe aim of this study was to develop a handbook to support the intensive management. The objectives were to: (i) involve patients in the identification of relevant information for inclusion in the TITRATE handbook; (ii) ensure the content of the handbook is acceptable and accessible.DesignWe held an audio-taped workshop with RA patients. The transcript of the workshop was analysed using thematic content analysis.ResultsFive main themes were identified as follows: ‘rheumatoid arthritis treatment, perceptions of rheumatoid arthritis, the importance of individualized goals, benefits of self-management and the patient handbook’. Feedback from the workshop was incorporated into the handbook, and patients’ anonymous testimonies were added.ConclusionThis study demonstrates that patient contribution to the development of educational material to support intensive management of RA is both feasible and valuable. A qualitative evaluation of the use and impact of the handbook with patients and practitioners is planned on completion of the TITRATE trial

Intensive therapy for moderate established rheumatoid arthritis: the TITRATE research programme

BackgroundRheumatoid arthritis is a major inflammatory disorder and causes substantial disability. Treatment goals span minimising disease activity, achieving remission and decreasing disability. In active rheumatoid arthritis, intensive management achieves these goals. As many patients with established rheumatoid arthritis have moderate disease activity, the TITRATE (Treatment Intensities and Targets in Rheumatoid Arthritis ThErapy) programme assessed the benefits of intensive management.ObjectivesTo (1) define how to deliver intensive therapy in moderate established rheumatoid arthritis; (2) establish its clinical effectiveness and cost-effectiveness in a trial; and (3) evaluate evidence supporting intensive management in observational studies and completed trials.DesignObservational studies, secondary analyses of completed trials and systematic reviews assessed existing evidence about intensive management. Qualitative research, patient workshops and systematic reviews defined how to deliver it. The trial assessed its clinical effectiveness and cost-effectiveness in moderate established rheumatoid arthritis.SettingObservational studies (in three London centres) involved 3167 patients. These were supplemented by secondary analyses of three previously completed trials (in centres across all English regions), involving 668 patients. Qualitative studies assessed expectations (nine patients in four London centres) and experiences of intensive management (15 patients in 10 centres across England). The main clinical trial enrolled 335 patients with diverse socioeconomic deprivation and ethnicity (in 39 centres across all English regions).ParticipantsPatients with established moderately active rheumatoid arthritis receiving conventional disease-modifying drugs.InterventionsIntensive management used combinations of conventional disease-modifying drugs, biologics (particularly tumour necrosis factor inhibitors) and depot steroid injections; nurses saw patients monthly, adjusted treatment and provided supportive person-centred psychoeducation. Control patients received standard care.Main outcome measuresDisease Activity Score for 28 joints based on the erythrocyte sedimentation rate (DAS28-ESR)-categorised patients (active to remission). Remission (DAS28-ESR ResultsEvaluation of existing evidence for intensive rheumatoid arthritis management showed the following. First, in observational studies, DAS28-ESR scores decreased over 10–20 years, whereas remissions and treatment intensities increased. Second, in systematic reviews of published trials, all intensive management strategies increased remissions. Finally, patients with high disability scores had fewer remissions. Qualitative studies of rheumatoid arthritis patients, workshops and systematic reviews helped develop an intensive management pathway. A 2-day training session for rheumatology practitioners explained its use, including motivational interviewing techniques and patient handbooks. The trial screened 459 patients and randomised 335 patients (168 patients received intensive management and 167 patients received standard care). A total of 303 patients provided 12-month outcome data. Intention-to-treat analysis showed intensive management increased DAS28-ESR 12-month remissions, compared with standard care (32% vs. 18%, odds ratio 2.17, 95% confidence interval 1.28 to 3.68; p = 0.004), and reduced fatigue [mean difference –18, 95% confidence interval –24 to –11 (scale 0–100); p LimitationsThe main limitations comprised (1) using single time point remissions rather than sustained responses, (2) uncertainty about benefits of different aspects of intensive management and differences in its delivery across centres, (3) doubts about optimal treatment of patients unresponsive to intensive management and (4) the lack of formal international definitions of ‘intensive management’.ConclusionThe benefits of intensive management need to be set against its additional costs. These were relatively high. Not all patients benefited. Patients with high pretreatment physical disability or who were substantially overweight usually did not achieve remission.Future workFurther research should (1) identify the most effective components of the intervention, (2) consider its most cost-effective delivery and (3) identify alternative strategies for patients not responding to intensive management.Trial registrationCurrent Controlled Trials ISRCTN70160382.FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 8. See the NIHR Journals Library website for further project information.NIH

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial.

BACKGROUND: Uncontrolled active rheumatoid arthritis can lead to increasing disability and reduced quality of life over time. 'Treating to target' has been shown to be effective in active established disease and also in early disease. However, there is a lack of nationally agreed treatment protocols for patients with established rheumatoid arthritis who have intermediate disease activity. This trial is designed to investigate whether intensive management of disease leads to a greater number of remissions at 12 months. Levels of disability and quality of life, and acceptability and cost-effectiveness of the intervention will also be examined. METHODS: The trial is a 12-month, pragmatic, randomised, open-label, two-arm, parallel-group, multicentre trial undertaken at specialist rheumatology centres across England. Three hundred and ninety-eight patients with established rheumatoid arthritis will be recruited. They will currently have intermediate disease activity (disease activity score for 28 joints assessed using an erythrocyte sedimentation rate of 3.2 to 5.1 with at least three active joints) and will be taking at least one disease-modifying anti-rheumatic drug. Participants will be randomly selected to receive intensive management or standard care. Intensive management will involve monthly clinical reviews with a specialist health practitioner, where drug treatment will be optimised and an individualised treatment support programme delivered based on several principles of motivational interviewing to address identified problem areas, such as pain, fatigue and adherence. Standard care will follow standard local pathways and will be in line with current English guidelines from the National Institute for Health and Clinical Excellence. Patients will be assessed initially and at 6 and 12 months through self-completed questionnaires and clinical evaluation. DISCUSSION: The trial will establish whether the known benefits of intensive treatment strategies in active rheumatoid arthritis are also seen in patients with established rheumatoid arthritis who have moderately active disease. It will evaluate both the clinical and cost-effectiveness of intensive treatment. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN70160382 . Registered on 16 January 2014.MRC Funding: MC_UP_1302/3 NIHR Funding: RP-PG-0610-1006

The Evidence Base for Psychological Interventions for Rheumatoid Arthritis: A Systematic Review of Reviews

Background Psychological interventions are an important but often overlooked adjunctive treatment option for patients with rheumatoid arthritis. Findings from systematic reviews of psychological interventions for this patient group are conflicting. A systematic review of reviews can explain inconsistencies between studies and provide a clearer understanding of the effects of interventions. Objectives To: 1) determine the effectiveness of psychological interventions in improving biopsychosocial outcomes for adults with rheumatoid arthritis, 2) determine the relationship between the intensity of the psychological interventions (number of sessions, duration of sessions, duration of intervention) on outcomes, and 3) assess the impact of comparator group (usual care, education only) on outcomes. Design We conducted a systematic review of reviews using the following inclusion criteria: 1) randomised controlled trials of psychological interventions (including cognitive behavioural therapy, supportive counselling, psychotherapy, self-regulatory techniques, mindfulness-based cognitive therapy and disclosure therapy) provided as an adjunct to medication, 2) included rheumatoid arthritis patients aged ≥ 18 years, 3) reported findings for at least 1 of the primary outcomes: pain, fatigue, psychological status, functional disability and disease activity and 4) were published in English between January 2000 and March 2015 (updated Data sources We searched in MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. Reference lists were searched for additional reviews. Review methods Study selection and 50% of the quality assessments were performed by two independent reviewers. Methodological quality was measured using the Assessment of Multiple Systematic Reviews checklist. Data extraction was conducted by one reviewer using a predesigned data extraction form. Results Eight systematic reviews met inclusion criteria (one review was excluded due to its low-quality score). Small post intervention improvements in patient global assessment, functional disability, pain, fatigue, anxiety and depression were observed. The effect on coping, self-efficacy and physical activity was greater. Improvements in depression, coping and physical activity were maintained (8.5–14 months). Interventions delivered over a longer period with a maintenance component appeared more effective. Attention, education, and placebo control groups produced some improvements but not as large as those produced by the psychological interventions. Conclusions Psychological interventions result in small to moderate improvements in biopsychosocial outcomes for patients with rheumatoid arthritis in addition to those achieved by standard care. Several priorities for future research were identified, including determining the cost effectiveness of non-psychologically trained health professionals delivering psychological interventions. Abbreviations AMSTAR, Assessment of Multiple Systematic Reviews; CBT, cognitive behavioural therapy; MIm, otivational interviewing; OMERACT, outcome measures in rheumatology; OT, occupational therapy; RA, rheumatoid arthritis; RCT, randomized controlled trial; TAU, treatment as usua

Physician-patient communication in rheumatology: a systematic review

The nature of physician–patient interaction can have a significant impact on patient outcomes through information-sharing and disease-specific education that can enhance patients’ active involvement in their care. The aim of this systematic review was to examine all the empirical evidence pertaining to aspects of physician–patient communication and its impact on patient outcomes. A systematic search of five electronic databases (MEDLINE, PsycINFO, EMBASE, CINAHL, and Web of Science) was undertaken from earliest record to December 2016. Studies were eligible if they: (1) included adult participants (18 years or over) with a diagnosis of a rheumatic condition; (2) were of quantitative, qualitative or mixed methods design; (4) were surveys, observational and interventional studies; (5) were published in the English language; and (6) reported findings on either various physician–patient communication aspects alone or in combination with physical and psychological outcomes. Searches identified 455 papers. Following full-text retrieval and assessment for eligibility and quality, ten studies were included in the review; six quantitative, one mixed methods, and three qualitative papers. Higher levels of trust in the physician and active patient participation in the medical consultation were linked to lower disease activity, better global health, less organ damage accrual, greater treatment satisfaction with fewer side effects from the medication, more positive beliefs about control over the disease, and about current and future health. Future research could focus on the design and implementation of interventions incorporating communications skills and patient-education training

The evidence base for psychological interventions for rheumatoid arthritis: a systematic review of reviews

Background: Psychological interventions are an important but often overlooked adjunctive treatment option for patients with rheumatoid arthritis. Findings from systematic reviews of psychological interventions for this patient group are conflicting. A systematic review of reviews can explain inconsistencies between studies and provide a clearer understanding of the effects of interventions. Objectives: To: 1) determine the effectiveness of psychological interventions in improving biopsychosocial outcomes for adults with rheumatoid arthritis, 2) determine the relationship between the intensity of the psychological interventions (number of sessions, duration of sessions, duration of intervention) on outcomes, and 3) assess the impact of comparator group (usual care, education only) on outcomes. Design: We conducted a systematic review of reviews using the following inclusion criteria: 1) randomised controlled trials of psychological interventions (including cognitive behavioural therapy, supportive counselling, psychotherapy, self-regulatory techniques, mindfulness-based cognitive therapy and disclosure therapy) provided as an adjunct to medication, 2) included rheumatoid arthritis patients aged ≥ 18 years, 3) reported findings for at least 1 of the primary outcomes: pain, fatigue, psychological status, functional disability and disease activity and 4) were published in English between January 2000 and March 2015 (updated January 2018). Data sources: We searched in MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. Reference lists were searched for additional reviews. Review methods: Study selection and 50% of the quality assessments were performed by two independent reviewers. Methodological quality was measured using the Assessment of Multiple Systematic Reviews checklist. Data extraction was conducted by one reviewer using a predesigned data extraction form. Results: Eight systematic reviews met inclusion criteria (one review was excluded due to its low-quality score). Small post intervention improvements in patient global assessment, functional disability, pain, fatigue, anxiety and depression were observed. The effect on coping, self-efficacy and physical activity was greater. Improvements in depression, coping and physical activity were maintained (8.5-14 months). Interventions delivered over a longer period with a maintenance component appeared more effective. Attention, education, and placebo control groups produced some improvements but not as large as those produced by the psychological interventions. Conclusions: Psychological interventions result in small to moderate improvements in biopsychosocial outcomes for patients with rheumatoid arthritis in addition to those achieved by standard care. Several priorities for future research were identified, including determining the cost effectiveness of non-psychologically trained health professionals delivering psychological interventions