|Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial
|Taylor SJ, Sohanpal R, Bremner SA, Devine A, McDaid D, Fernandez JL, Griffiths CJ, Eldridge S
This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn.
This study evaluated a pilot Chronic Disease Self-Management Programme, called Better Living with Long-term Airways disease, for patients with chronic obstructive pulmonary disease (COPD). It found that the programme, by tutors with COPD, was feasible, could improve health outcomes, and was likely to be cost-effective, but a larger trial was needed. The study was generally well reported and the authors reached appropriately cautious conclusions, considering the small sample, short follow-up, and incomplete trial participation rates.
Type of economic evaluation
The goal was to evaluate a pilot Chronic Disease Self-Management Programme, for patients with chronic obstructive pulmonary disease (COPD).
The pilot programme was called Better Living with Long-term Airways disease (BELLA). Patients either received BELLA plus usual care, or usual care alone. For usual care, doctors were monitored to assess their achievement of the usual COPD management protocols.
BELLA was delivered by two trained peer tutors, who had COPD, in a three-hour interactive session, once a week, for seven weeks. Tutors modelled behaviour, addressed educational needs, and helped patients to set goals and monitor their achievement. Patients were encouraged to join support groups after the seven weeks. Those who attended five or more sessions were defined as course completers.
The analysis was based on a randomised controlled trial of 116 patients. The authors stated that they took a health care provider perspective.
Patients were recruited from 10 general practices in an area with a high rate of COPD. Recruitment methods and, exclusion and inclusion criteria were stated. They were randomised in a two to one ratio between BELLA and control, and analysed in the group they were randomised to, on an available case basis. Primary care teams were unaware of participant allocation. BELLA outcomes were measured at baseline, two months after course completion, and six months after completion. Control outcomes were measured at around the same times. The outcomes were scores on the St. George's Respiratory Questionnaire (SGRQ), the EQ-5D, the Hospital Anxiety and Depression Scale (HADS), and the Stanford self-efficacy and self-management scales for managing disease, exercise, and communicating with physicians.
Monetary benefit and utility valuations:
Utility scores were collected, using the EQ-5D, at baseline, and two and six months after course completion. Questionnaires were completed by patients at home, with assistance available from a researcher who was not involved in delivering BELLA. UK tariffs were used to value the EQ-5D scores.
Measure of benefit:
Quality-adjusted life-years were the summary measure of benefit. Patients who died or were lost to follow-up were excluded from the QALY calculations.
The costs were reported as intervention costs and health care service costs. BELLA costs included the charges from the Expert Patients Programme Community Interest Company, who developed the programme, and the costs of training the peer tutors. For health care services, the resource use was from patient records, and the unit costs were from 2007 to 2008 UK reference costs, 2008 Personal Social Services Research Unit (PSSRU) data, and the 2008 British National Formulary. The costs were reported in UK £.
Analysis of uncertainty:
A probabilistic sensitivity analysis was conducted, by bootstrapping the results for 1,000 repetitions, with imputation for missing values. The results of the bootstrapping were shown on a cost-effectiveness plane and as a cost-effectiveness acceptability curve.
The mean cost per person was £877 with BELLA, and £395 with control. The mean QALYs per person were 0.682 with BELLA, and 0.569 with control.
The incremental cost-effectiveness ratio for BELLA, compared with usual care, was £11,710 per QALY gained.
The cost-effectiveness acceptability curve showed that BELLA was cost-effective in 75% of simulations, at a willingness-to-pay of £20,000 per QALY gained, and 86% of simulations at a willingness-to-pay of £30,000 per QALY gained.
The authors concluded that their pilot study indicated that a COPD-specific self-management course, by tutors with COPD, was feasible, could improve health outcomes, and was likely to be cost-effective, but a larger trial was needed.
The interventions were well reported. The pragmatic approach to COPD usual care, in which the treatments were not prespecified, was likely to have represented the usual practice.
The reporting of the clinical effectiveness data was sufficient. The authors acknowledged that there were small baseline differences between the intervention groups, but they did not report controlling for them. The effect of adjusting for baseline differences on the results of the analysis, is unknown. They acknowledged that the small number of participants and short time frame made it difficult to ascertain the long-term benefits of BELLA. Patient records were analysed on an available-case basis, which could bias the results as it is unknown why cases were missing, but the rates of missing cases were similar for both groups, and data were imputed in the sensitivity analysis.
The costs were reported in detail, with separate resource items and unit costs, using event data from the trial and appropriate UK reference costs. They appear to have been appropriate for the stated health care perspective. The price year was not explicitly reported, but the cost sources all related to 2008. The longest follow-up was six months, so discounting was not necessary. The authors acknowledged that the data were short term.
Analysis and results:
The reporting was generally good. Bootstrapping and imputation of missing values are good ways to assess uncertainty, but the method of imputation was not reported, which could affect the uncertainty on the cost-effectiveness plane, and the cost-effectiveness acceptability curve. The authors reached an appropriately cautious conclusion, and noted the weaknesses in their study, such as the small sample and short follow-up. They recommended areas to explore in future studies, which had to have larger samples to reach reliable conclusions. The significant number of patients who did not attend sessions needed to be addressed.
The study was generally well reported. The authors reached appropriately cautious conclusions that considered the small sample, short follow-up, and incomplete participation rates in the trial.
Taylor SJ, Sohanpal R, Bremner SA, Devine A, McDaid D, Fernandez JL, Griffiths CJ, Eldridge S. Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial. British Journal of General Practice 2012; 62(603): e687-e695
Subject indexing assigned by NLM
Adult; Aged; Cost-Benefit Analysis; England; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Outcome Assessment (Health Care) /statistics & Patient Education as Topic /economics /methods; Pilot Projects; Primary Health Care /economics /methods; Program Evaluation; Pulmonary Disease, Chronic Obstructive /economics /physiopathology /therapy; Quality of Life; Quality-Adjusted Life Years; Respiratory Function Tests; Self Care /economics /methods; Self Efficacy; Surveys and Questionnaires; numerical data
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Date abstract record published