A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis: a cost-effectiveness analysis.

OBJECTIVE: To determine whether a patient-initiated DMARD self-monitoring service for people on MTX is a cost-effective model of care for patients with RA or PsA. METHODS: An economic evaluation was undertaken alongside a randomized controlled trial involving 100 patients. Outcome measures were quality of life and ESR assessed at baseline and post-intervention. Costs were calculated for healthcare usage using a United Kingdom National Health Service economic perspective. Sensitivity analysis was performed to explore the impact of nurse-led telephone helplines. Uncertainty around the cost-effectiveness ratios was estimated by bootstrapping and analysing the cost-effectiveness planes. RESULTS: Fifty-two patients received the intervention and 48 usual care. The difference in mean cost per case indicated that the intervention was £263 more expensive (P < 0.001; 95% CI: £149.14, £375.86) when the helpline costs were accounted for and £94 cheaper (P = 0.08; 95% CI: -£199.26, £10.41) when these costs were absorbed by the usual service. There were, however, statistically significant savings for the patient (P = 0.02; 95% CI: -£28.98, £3.00). When costs and effectiveness measures of ESR and quality of life measured, using the Short Form-12v1, were combined this did not show the patient-initiated service to be cost-effective at a statistically significant level. CONCLUSION: This patient-initiated service led to reductions in primary and secondary healthcare services that translated into reduced costs, in comparison with usual care, but were not cost-effective. Further work is needed to establish how nurse-led telephone triage services are integrated into rheumatology services and the associated costs of setting up and delivering them. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, ISRCTN21613721.

Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis.

BACKGROUND: Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear. STUDY DESIGN: Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial. SETTING & PARTICIPANTS: Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers. INTERVENTION: Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions. OUTCOMES & MEASUREMENTS: Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention. RESULTS: 235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (P<0.001) among patients randomly assigned to HED-SMART. In contrast, IDWG in controls showed no change except at 3 months, when it worsened significantly. Improvements in mineral markers were noted in the HED-SMART arm at 3 months (P<0.001) and in potassium concentrations (P<0.001) at 9 months. Phosphate concentrations improved in HED-SMART at 3 months (P=0.03), but these effects were not maintained at 9 months postintervention. Significant differences between the arms were found for the secondary outcomes of self-reported adherence, self-management skills, and self-efficacy at all time points. LIMITATIONS: Low proportion of patients with diabetes. CONCLUSIONS: HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care. TRIAL REGISTRATION: Registered at ISRCTN with study number ISRCTN31434033.

Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial.

OBJECTIVE: To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions. DESIGN: A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively. SETTING: Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems. PARTICIPANTS: Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009. MAIN OUTCOME MEASURES: Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale). RESULTS: In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480 ≤ P ≤ 0.904) or available case (0.181 ≤ P ≤ 0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273 ≤ P ≤ 0.761; available case cohort 0.145 ≤ P ≤ 0.696). CONCLUSIONS: Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients. TRIAL REGISTRATION: ISRCTN43002091.

Religious/spiritual coping resources and their relationship with adjustment in patients newly diagnosed with breast cancer in the UK.

BACKGROUND: Religious/spiritual resources may serve multiple functions in adjustment to cancer. However, there is very little evidence of the importance of religious/spiritual variables outside the USA. This paper reports the cross-sectional data of a longitudinal study examining the beneficial and harmful effects of religious/spiritual coping resources on adjustment in the first year after a breast cancer diagnosis. METHOD: One hundred and fifty-five patients newly diagnosed with breast cancer were assessed after surgery. Several aspects of religiousness/spirituality in relation to anxiety and depression were examined: religiosity/spirituality, strength of faith, belief in God, private and public practices, spiritual involvement, perceived spiritual support and positive and negative religious coping strategies. Non-religious coping, social support and optimism were also assessed. RESULTS: 'Feeling punished and abandoned by God' significantly explained 5% of the variance in increased levels of anxiety but was partially mediated by denial coping. It was also partially mediated by acceptance coping, lowering levels of anxiety. Feeling punished and abandoned by God was a significant independent predictor of depressed mood, explaining 4% of the variance. CONCLUSION: Using religious/spiritual resources in the coping process during the early stages of breast cancer may play an important role in the adjustment process in patients with breast cancer. Patients may benefit from having their spiritual needs addressed as experiencing some form of religious/spiritual struggle may serve as a barrier to illness adjustment. Implications for research and clinical practices are discussed.

Psycho-education programme for temporomandibular disorders: a pilot study.

BACKGROUND: Temporomandibular disorders (TMDs) are by far the most predominant condition affecting the temporomandibular joint (TMJ), however many patients have mild self-limiting symptoms and should not be referred for specialist care. The aim of this pilot study was to develop a simple, cost-effective management programme for TMDs using CD-ROM. 41 patients (age 18-70) participated in this study, patients were divided into three groups: the 1st group were involved in an attention placebo CD-ROM (contain anatomical information about the temporomandibular system), the 2nd group received information on CD-ROM designed to increase their control and self efficacy, while the 3rd group received the same programme of the 2nd group added to it an introduction to self-relaxing techniques followed by audio tape of progressive muscle relaxation exercises. Each of the groups was asked to complete a number of questionnaires on the day of initial consultation and six weeks afterwards. RESULTS: The two experimental groups (2nd & 3rd) were equally effective in reducing pain, disability and distress, and both were more effective than the attention placebo group (1st), however the experimental groups appeared to have improved at follow-up relative to the placebo-group in terms of disability, pain and depressed mood. CONCLUSION: This pilot study demonstrates the feasibility and acceptability of the design. A full, randomized, controlled trial is required to confirm the efficacy of the interventions developed here.

Do religious/spiritual coping strategies affect illness adjustment in patients with cancer? A systematic review of the literature.

The present paper systematically reviews studies examining the potential beneficial or harmful effects of religious/spiritual coping with cancer. Using religion and spirituality as resources in coping may be specifically prevalent in patients with cancer considering the potentially life-threatening nature of the illness. Religious/spiritual coping may also serve multiple functions in long-term adjustment to cancer such as maintaining self-esteem, providing a sense of meaning and purpose, giving emotional comfort and providing a sense of hope. Seventeen papers met the inclusion criteria of which seven found some evidence for the beneficial effect of religious coping, but one of these also found religious coping to be detrimental in a sub-sample of their population. A further three studies found religious coping to be harmful and seven found non-significant results. However, many studies suffered from serious methodological problems, especially in the manner in which religious coping was conceptualised and measured. The studies also failed to control for possible influential variables such as stage of illness and perceived social support. Due to this, any firm conclusions about the possible beneficial or harmful effects of religious coping with cancer is lacking. These problems are discussed and suggestions for future studies are made.