A trial-based economic evaluation of the Restore4Stroke self-management intervention compared to an education-based intervention for stroke patients and their partners.

BACKGROUND: Since stroke survivors are increasingly responsible for managing stroke-related changes in their own health and lifestyle, self-management skills are required. In a recent randomised controlled trial a self-management intervention based on proactive coping action planning (SMI) in comparison with an education-based intervention (EDU) in stroke patients was investigated. However, no relevant treatment effects on the Utrecht Proactive Coping Competence scale (UPCC) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-Participation) were found. The current study is a trial-based economic evaluation from a societal perspective comparing the same interventions (SMI versus EDU). METHODS: UPCC, USER-Participation and EuroQol (EQ-5D-3 L) and costs were measured at baseline, three, six and twelve months after treatment. For the cost-effectiveness analyses, incremental cost effectiveness ratios (ICERs) were calculated for UPCC and USER-Participation. For the cost-utility analyses the incremental cost utility ratio (ICUR) was expressed in cost per Quality Adjusted Life Years (QALYs). Outcomes were tested by means of AN(C)OVA analyses and costs differences by means of bootstrapping. Bootstrapping, sensitivity analyses and a subgroup analysis were performed to test the robustness of the findings. RESULTS: One hundred thirteen stroke patients were included in this study. The mean differences in USER-Participation scores (95%CI:-13.08,-1.61, p-value = .013) were significant different between the two groups, this does not account for UPCC scores (95%CI:-.267, .113, p-value = not significant) and QALYs (p-value = not significant) at 12 months. The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520). Cost-effectiveness analyses showed a mean ICER of 26,514 for the UPCC and 346 for the USER-Participation. Cost-utility analysis resulted in an ICUR of €44,688 per QALY. Assuming a willingness to pay (WTP) threshold of €50,000 per QALY, the probability that SMI will be cost-effective is 52%. Sensitivity analyses and subgroup analysis showed the robustness of the results. CONCLUSIONS: SMI is probably not a cost-effective alternative in comparison with EDU. Based on the current results, the value of implementing SMI for a stroke population is debatable. We recommend further exploration of the potential cost-effectiveness of stroke-specific self-management interventions focusing on different underlying mechanisms and using different control treatments.

ECONOMIC EVALUATION STUDIES OF SELF-MANAGEMENT INTERVENTIONS IN CHRONIC DISEASES: A SYSTEMATIC REVIEW.

BACKGROUND: To our knowledge, there has been no overall systematic review focusing on the methodological quality of full economic evaluation studies of self-management interventions. Our objective was to systematically review the literature of full economic evaluation studies of self-management interventions in adult chronic patients and to investigate their methodological quality and cost-effectiveness. METHODS: A data extraction form was developed to assess general and randomized controlled trial (RCT) -related characteristics, quality, of the RCTs, economic information and quality of the economic evaluation studies by means of a quality assessment (CHEC-list for trial-based studies, adjusted CHEC-list for model-based studies). RESULTS: Twenty-three reports were found. Sixteen studies (73 percent) lack information on the control intervention(s). Only one study fulfilled all three criteria for quality of RCTs and five studies (23 percent) did not meet any of these criteria. This review included one model-based study; the other studies were trial-based economic evaluation studies based on a RCT. Eight studies (35 percent) used a societal perspective and 12 (60 percent) synthesized costs and effects. Seven studies were categorized into the highest category (<15 score), nine studies into the "moderate" group (9-14 score), six studies received a "low" score (<8) on the CHEC-list. Eighteen studies found the self-management intervention(s) to be cost-effective compared with other interventions Conclusions: Self-management interventions for adult chronic patients were heterogeneous and there was no clear, well-considered definition of self-management. Overall, the methodological quality of the full economic evaluation studies was moderate and, therefore, cost-effectiveness results must be interpreted with caution. Future research will benefit from further improvements in methodological quality of both economic study design and analysis, as well as a taxonomy for describing self-management interventions and their contents.

The economic impact of stroke in The Netherlands: the €-Restore4Stroke study.

BACKGROUND: Stroke has a considerable socio-economic impact worldwide and is the leading cause of disabilities in the Western world. Economic studies of stroke focus merely on physical aspects and clinical interventions. To our current knowledge there is no comprehensive economic study investigating the economic impact of stroke including psychological and social aspects. The €-Restore4Stroke project, part of a large comprehensive research programme Restore4Stroke, aims to investigate the total economic impact of stroke in the Netherlands. METHODS: Two trial-based economic evaluation studies will be conducted within the €-Restore4Stroke project: one focussing on a self-management intervention and one on an augmented cognitive behavioural therapy intervention. Both include cost-effectiveness analyses and cost-utility analyses as primary research methods. Furthermore, a cost-of-illness study investigating costs after stroke attached to a cohort study and a record linkage study in which four databases are linked to investigate patterns of health care consumption before and after stroke, are embedded in €-Restore4Stroke. All studies will be performed from a societal perspective. The primary outcome measure for the cost-effectiveness analysis is the increase in health status on the primary outcome scales. Within the cost-utility analysis, the primary outcome measure is quality-adjusted life years (QALYs) for which an indirect preference-based technique will be used. In the self-management study we will also look at the estimation of health effects on informal caregivers. Cost outcomes in the cost-of-illness study will be computed with a cost questionnaire and linkage of several databases will be used to derive outcomes in the record linkage study. DISCUSSION: €-Restore4Stroke will provide new insights and evidence for the economic impact of psychosocial consequences after stroke. Besides being innovative in various ways (i.e. focussing on the chronic phase after stroke and including personal factors as possible determinants of long-term re-integration including quality of life in a prospective longitudinal design), a major strength of €-Restore4Stroke is that we include impact on informal caregivers. The outcomes of this study will provide health care decision makers with valuable and necessary information regarding stroke care related decisions. TRIAL REGISTRATION: NTR3051 (RCT Self-management), NTR2999 (RCT Augmented Cognitive Behavioural Therapy).