Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial.

BACKGROUND: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE). METHODS: The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned. DISCUSSION: Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting. TRIAL REGISTRATION: ClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Effectiveness of Nonpharmacologic Interventions for Decreasing Fatigue in Adults With Systemic Lupus Erythematosus: A Systematic Review.

OBJECTIVE: Survival of patients with systemic lupus erythematosus (SLE) has significantly improved over the past decades. As SLE patients live longer they inevitably experience a range of clinical manifestations and somatic symptoms. Quality of life may also be impacted through a range of subjective indicators. Among these parameters, fatigue is the most prevalent complaint. Nonpharmacologic strategies seem regularly utilized for fatigue management in SLE; however, their real effects are not known. METHODS: A systematic review was conducted to analyze the effectiveness of nonpharmacologic interventions to reduce fatigue in SLE patients. Medline/PreMedline, Embase, PsycINFO, SCI-EXPANDED, Social Sciences Citation Index, and the Cochrane Library were searched (June 2014). Studies were included and assessed for quality if they fulfilled prespecified criteria. RESULTS: A total of 12 studies were finally included (n = 549): 7 randomized trials, 1 nonrandomized trial, and 4 prospective observational studies. They assessed 5 main intervention categories: exercise, behavioral and psychological approaches, diets, acupuncture, and phototherapy. All interventions produced reductions in fatigue, as measured using at least 1 instrument. Aerobic exercise was found to be effective and suitable for reducing fatigue, but results were not always consistent across instruments used. The diversity of psychological interventions limits the significance of the results; however, data point to a positive impact on fatigue. There are still few data on the effect of acupuncture, diets, and ultraviolet A radiation. CONCLUSION: Studies are few and heterogeneous; however, nonpharmacologic interventions applied to SLE patients can be effective in reducing fatigue.