Medication decision-making and adherence in lupus: patient-physician discordance and the impact of previous 'adverse medical experiences'.

OBJECTIVES: Medication adherence is critical in the successful management of lupus. There is very limited existing literature on reasons why non-adherence is not reported. This study explores the impact of current and previous medical experiences on patient satisfaction, adherence and reporting of non-adherence. METHODS: Mixed methodology involved thematic analysis of in-depth interviews (n = 23) to further explore the statistically analysed quantitative survey findings (n = 186). RESULTS: This study identified five themes: (i) physician-patient discordance and a 'hierarchy of evidence' in medication decisions; (ii) the association of adherence with satisfaction with care; (iii) the persisting impact of past adverse medical experiences (AMEs); (iv) the dynamic balance of patient-physician control; and (v) holistic care, beyond a purely medication-based focus. Improving quality of life (43% of participants) and a supportive medical relationship (24%) were the main reasons for adherence. Patient-priorities and self-reported symptoms were perceived as less important to physicians than organ-protection and blood results. Non-reporters of non-adherence, non-adherers and those with past AMEs (e.g. psychosomatic misdiagnoses) had statistically significant lower satisfaction with care. The importance of listening to patients was a key component of every theme, and associated with patient satisfaction and adherence. The mean rating for rheumatologist's listening skills was 2.88 for non-adherers compared with 3.53 for other participants (mean difference 0.65, P = 0.003). CONCLUSION: Patients would like more weight and discussion given to self-reported symptoms and quality of life in medication decisions. Greater understanding and interventions are required to alleviate the persisting impact of past AMEs on some patients' wellbeing, behaviour and current medical relationships.

Physician-patient interaction and medication adherence in lupus nephritis.

OBJECTIVE: The quality of physician-patient interaction can have a significant impact on medication adherence. Little is known about this relationship in patients with lupus nephritis. METHODS: A cross-sectional, quantitative study. Data collected included demographics, current medication, systemic lupus erythematosus disease activity index, medication adherence, beliefs about medicines, shared decision-making, patient-doctor depth of relationship, patient-doctor quality of relationship, interpersonal trust in a physician and illness perceptions. RESULTS: Ninety-eight patients with lupus nephritis completed the questionnaires. Logistic regression indicated that medication adherence was significantly predicted by (a) interpersonal trust in a physician (B = 0.85, Wald 3.94, 95% confidence interval (CI) 1.01, 5.44; P = 0.05); (b) timeline cyclical (B = -0.89, Wald 4.95, 95% CI 0.19, 0.90; P < 0.05) and beliefs about the necessity of medicines (B = 0.75, Wald 4.14, 95% CI 1.03, 4.38; P < 0.05). Mediation analysis showed that beliefs about the necessity of medicines significantly mediated the relationship between trust and medication adherence when adjusted for age (B = 0.48, 95% CI 0.06, 1.08; P < 0.01). A further mediation analysis showed that patient-doctor depth of relationship (B = 0.05, 95% CI 0.01, 0.09; P < 0.001), shared decision-making (B = 0.07, 95% CI 0.01, 0.13; P < 0.001) and patient-doctor quality of relationship (B = 0.08, 95% CI 0.01, 0.16; P < 0.001) significantly mediated the relationship between illness coherence and interpersonal trust in a physician. CONCLUSION: The findings highlighted two key elements: (a) the importance of trust in relation to medication adherence; and (b) a good understanding of patients' illness is linked to a better relationship with their doctor and greater participation in shared decision-making which is associated with increased trust. Tailored psycho-educational interventions could contribute to improving the patient-doctor relationship quality, trust and increased shared decision-making, which, in turn, might improve medication adherence in patients with lupus nephritis.

Fatigue in adults with primary antiphospholipid syndrome: findings from a mixed-methods study.

OBJECTIVE: This study aimed to explore the experience and impact of fatigue in adults with primary antiphospholipid syndrome (pAPS). METHODS: This sequential, explanatory mixed-methods study enrolled adults with a six-month or more history of pAPS. Consenting participants completed the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FS), Multi-Dimensional Perceived Social Support Scale, Patient Health Questionnaire (PHQ9), Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQMETS). Relationships between FS and other variables were explored with multiple linear regression. Interviews were conducted with a subgroup of participants, and the data were analysed thematically. RESULTS: A total of 103 participants were recruited (Mage = 50.3 years; standard deviation = 10.1 years; 18 males). Of these, 62% reported severe fatigue. Greater fatigue was associated with lower mood, physical inactivity, poorer sleep quality and lower perceived social support. The best-fit model explained 56% of the variance in FS (adjusted R2 = 0.560, F(3, 74) = 33.65, p > 0.001) and included PHQ9 and IPAQMETS as significant predictors, and PSQI as a non-significant predictor. Twenty participants completed interviews. Three key themes were identified: characteristics of fatigue, impact on life and coping strategies. CONCLUSION: Fatigue was a common symptom of pAPS and challenging to manage. Other factors, particularly mood and physical activity, influenced fatigue. Evidence-based self-management interventions are needed.

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 relationship between social support and health-related quality of life in patients with antiphospholipid (hughes) syndrome.

OBJECTIVE: Antiphospholipid (Hughes) syndrome (APS) is recognised as a systemic autoimmune disease defined by recurrent thromboembolic events and/or pregnancy morbidity. Little is known about the psychological burden of this long-term condition. This study aims to explore the relationship between social support and health-related quality of life (HRQoL) in patients with APS. METHODS: A total of 270 patients with a clinical diagnosis of APS participated in a cross-sectional online questionnaire survey. Data included demographics, disease-related information, social support and HRQoL. RESULTS: Both perceived and ideal social support were associated with HRQoL in APS. Patients reported receiving insufficient social support. Perceived emotional support was related to physical functioning (B = 7.77, p = .006, 95% CI: 2.25, 13.29); perceived instrumental support was associated with bodily pain (B = 17.52, p <  .001, 95% CI: 11.15, 23.90) and perceived informational support with physical and social functioning (B = -6.30, p = .05, 95% CI: -12.52, -0.08; B = 8.06, p = .02, 95% CI: 1.17, 14.94). Ideal emotional support was related to physical and social functioning (B = 5.80, p = .04, 95% CI: 0.26, 11.34; B = 7.53, p = .04, 95% CI: 0.55, 14.51); ideal instrumental support was associated with mental health (B = 4.73, p = .03, 95% CI: 0.38, 9.07) and ideal informational support with vitality (B = 5.85, p = .01, 95% CI: 1.23, 10.46). CONCLUSION: Social support was linked to HRQoL in patients with APS. Insufficient social support was associated with limitations in various HRQoL domains. Increasing social support especially through provision of disease-specific education might contribute to improving HRQoL in patients with APS. Patient-tailored interventions addressing psychosocial aspects of living with APS are needed to improve patients' psychological and physical status.

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

BACKGROUND: 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 OBJECTIVES: The 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. DESIGN: We held an audio-taped workshop with RA patients. The transcript of the workshop was analysed using thematic content analysis. RESULTS: Five 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. CONCLUSION: This 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.

Motivational interviewing: relevance in the treatment of rheumatoid arthritis?

Advances in pharmacological treatment options in RA have led to a dramatic potential for improvement in patients' physical and psychological status. Despite advances, poor outcomes, including fatigue, pain, reduced physical activity and quality of life, are still observed. Reasons include non-adherence to medication, insufficient knowledge about the disease and lack of support in coping and effectively self-managing their condition. Motivational interviewing (MI) is a person-centred approach that relies on collaboration and empathy aiming to elicit a person's own motivation for behaviour change. It has been implemented in a variety of long-term conditions, addressing issues such as lifestyle changes with beneficial effects, but it is yet to be widely recognized and adopted in the field of rheumatology. This review will explain the techniques underpinning MI and the rationale for adopting this approach in rheumatology with the aim to increase medication adherence and physical activity and improve patients' coping strategies for pain and fatigue.

SafeSpace: what is the feasibility and acceptability of a codesigned virtual reality intervention, incorporating compassionate mind training, to support people undergoing cancer treatment in a clinical setting?

OBJECTIVES: The SafeSpace study codesigned and tested a virtual reality (VR) intervention, incorporating relaxation and compassionate mind training to determine acceptability/feasibility in an oncology setting and evaluate impact on physical/psychological well-being and quality of life. DESIGN: A two-phase study. Phase I determined key characteristics using an experienced-based codesign approach. Phase II evaluated the intervention using various measures and qualitative interviews in a mixed methods approach. Descriptive statistics were used to analyse measures data and framework analysis to analyse interviews. SETTING: A specialist cancer centre, UK. PARTICIPANTS: 11 in phase I and 21 in phase II. Participants were in cancer treatment, recovery or palliative care. PRIMARY AND SECONDARY OUTCOME: Primary outcome: acceptability of the intervention, assessed by >60% uptake of three sessions. SECONDARY OUTCOMES: impact on psychological well-being using EQ-5D/QLQ-C30, Profile of Mood Scale, Warwick and Edinburgh Mental Well-being Scale, Depression and Anxiety Severity Scale 21, Self-Compassion Scale, Acceptance and Action Questionnaire and a locally developed questionnaire to capture self-compassion post use. Physiological impact was assessed by change in heart rate (HR)/HR variability and electrodermal activity (EDA). RESULTS: Twenty participants (mean age=48.7 years; SD=16.87); 65% (n=13) completed three sessions. Mental well-being improved following each use and from baseline to after session 3 (VR 1-z=2.846, p≤0.01; VR 2-z=2.501, p≤0.01; VR 3-z=2.492, p≤0.01). There was statistically significant difference in mean scores for EDA at mid-session and post session compared with pre session (F (1.658, 4.973)=13.364, p<0.05). There was statistically significant reduction in stress levels from baseline to post session 3. Participants found the intervention acceptable and highlighted areas for development. CONCLUSION: The intervention is acceptable and feasible and has shown positive effects on mental well-being/stress in the oncology setting. Larger studies are needed to confirm findings.

The value, impact and role of nurses in rheumatology outpatient care: Critical review of the literature.

BACKGROUND: As rheumatology nurses make substantial contributions to intensive management programmes following 'treat to target' principles of people with rheumatoid arthritis (RA), there is a need to understand the impacts of their involvement. A structured literature review was undertaken of qualitative studies, clinical trials and observational studies to assess the impacts of rheumatology nurses on clinical outcomes and the experiences of patients with RA and to examine the skills and training of the nurses involved. METHOD: A structured literature review was conducted to examine the value, impact and professional role of nurses in RA management. RESULTS: The literature search identified 657 publications, and 20 of them were included comprising: seven qualitative studies (242 patients), nine trials (a total of 2,440 patients) and four observational studies (1,234 patients). In clinical trials, nurses achieved similar patient clinical outcomes to doctors, and nurses also enhanced patients' satisfaction of received care and self-efficacy. In the qualitative studies reviewed, the nurses increased patients' knowledge and promoted their self-management. The observational studies studied examined found that nursing care led to improved patients' global functioning. The nurses in the various studies had a wide range of titles, experiences and training. DISCUSSION: Our structured literature review provides strong evidence that rheumatology nurses are effective in delivering care for RA patients. However, their titles, experience and training were highly variable. CONCLUSION: There is a convincing case to maintain and extend the role of nurses in managing RA, but further work is needed on standardisation of their titles and training.

The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial.

OBJECTIVES: Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions. METHODS: A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data. RESULTS: 459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management. INTERPRETATION: The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.

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.

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.

Overtreatment of COPD with inhaled corticosteroids--implications for safety and costs: cross-sectional observational study.

INTRODUCTION: Combined inhaled long-acting beta-agonists and corticosteroids (LABA+ICS) are costly. They are recommended in severe or very severe chronic obstructive pulmonary disease (COPD). They should not be prescribed in mild or moderate disease. In COPD ICS are associated with side-effects including risk of pneumonia. We quantified appropriateness of prescribing and examined the risks and costs associated with overuse. METHODS: Data were extracted from the electronic and paper records of 41 London general practices (population 310,775) including spirometry, medications and exacerbations. We classified severity, assessed appropriateness of prescribing using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 2009, and performed a sensitivity analysis using the broader recommendations of the 2011 revision. RESULTS: 3537 patients had a diagnosis of COPD. Spirometry was recorded for 2458(69%). 709(29%) did not meet GOLD criteria. 1749(49%) with confirmed COPD were analysed: 8.6% under-treated, 38% over-treated. Over-prescription of ICS in GOLD stage I or II (n=403, 38%) and in GOLD III or IV without exacerbations (n=231, 33.6%) was common. An estimated 12 cases (95%CI 7-19) annually of serious pneumonia were likely among 897 inappropriately treated. 535 cases of overtreatment involved LABA+ICS with a mean per patient cost of £553.56/year (€650.03). Using the broader indications for ICS in the 2011 revised GOLD guideline 25% were still classified as over-treated. The estimated risk of 15 cases of pneumonia (95%CI 8-22) in 1074 patients currently receiving ICS would rise by 20% to 18 (95%CI 9.8-26.7) in 1305 patients prescribed ICS if all with GOLD grade 3 and 4 received LABA+ICS. CONCLUSION: Over-prescription of ICS in confirmed COPD was widespread with considerable potential for harm. In COPD where treatment is often escalated in the hope of easing the burden of disease clinicians should consider both the risks and benefits of treatment and the costs where the benefits are unproven.