In total, 629 patients were recruited between April 2003 and March 2005 (fig 2). We have discussed some of the reasons for not taking part in REPORT elsewhere.25,31
Reasons included problems with access (no local course available, course times unsuitable, lack of provision for those with disabilities); poor current health state; a feeling that they were already effective self‐managers; dislike of the group approach; or insufficient motivation to commit to a 6‐week course. A total of 521 (83%) patients returned 6‐month assessments (although completion of individual scales varied slightly). There were no marked differences in baseline characteristics (table 1). Approximately one third of patients reported preferences to enter the EPP immediately, half were indifferent, and the remainder reported preferences for the wait list control.
Figure 2Consolidated Standards of Reporting Trials diagram showing patient flow through the Research into Expert Patients—Outcomes in a Randomised Trial.
Table 1Baseline demographic and health characteristics
There was differential attrition, with 79.2% of 6‐month assessments returned by the intervention group and 86.4% by the controls (difference 7.2%, 95% CI 1.3% to 13%). Stepwise logistic regression analysis was used to estimate the probability of return on the basis of patient characteristics. Return was significantly more likely from patients who were older, had the condition longer, owned their own home or had certain types of condition (musculoskeletal, circulatory, respiratory). The inverse of these probabilities was assigned as weights.
On primary outcomes (table 2), the intervention patients reported considerably higher scores for overall self‐efficacy and energy, but reported no differences in healthcare utilisation. On secondary outcomes, intervention patients reported considerably fewer social role limitations, better psychological well‐being, lower health distress, more exercise and relaxation, and greater partnership with clinicians. There were no differences between groups on general health, pain, diet, use of complementary products or information seeking.
Table 2Outcomes at 6‐month follow‐up
To explore whether the intervention effect, when significant, varied between conditions, patients were classified into eight conditions (table 1) and the interaction between condition and trial group added to the primary analysis. The trial was not powered to detect interactions, so a criterion of p<0.15 was used to warrant further investigation.29
There were no significant differences between subgroups on any primary outcomes, and only one secondary outcome met the criterion (partnership with clinicians, p
None of the results relating to the primary outcome were influenced substantively by the sensitivity analyses. In the secondary outcomes, the sensitivity analysis with seasonality and time between recruitment and follow‐up as additional covariates, the intervention group scored significantly higher on general health than the controls (p
0.037). In the sensitivity analysis with Strategic Health Authority as an additional covariate, the increase in exercise in the intervention group was no longer statistically significant (p
Data on all major categories of health services utilisation are provided in table 3, with conventional measures of significance and effect size statistics for comparative purposes. There was a difference in QALYs of 0.02 (95% CI 0.007 to 0.034, adjusted for baseline characteristics) in favour of the intervention group, and a reduced cost of £27 ($53; €41) (95% CI £368 ($721; €557) to £422 ($827; €639)). Thus the intervention group were associated with a better QALY profile as well as a small reduction in costs. Although there is considerable uncertainty around the estimates of costs and QALYs, if decision‐makers are willing to pay £20
91 and €30
282) per QALY,32
there is a 70% probability that the intervention is cost effective. Full details of the economic analysis will be presented elsewhere, including appropriate sensitivity analyses.
Table 3Mean resource use over the 6‐month period*