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| Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial |
| Wake M, Baur LA, Gerner B, Gibbons K, Gold L, Gunn J, Levickis P, McCallum Z, Naughton G, Sanci L, Ukoumunne OC |
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Record Status 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. CRD summary This study assessed the clinical and economic impact of a surveillance programme, to identify children who were overweight or mildly obese, followed by a structured secondary prevention programme. The authors concluded that primary care screening followed by brief counselling did not improve clinical endpoints and would be expensive if universally implemented. The methods were valid, especially for the clinical analysis, and the conclusions appear to be robust. Type of economic evaluation Cost-effectiveness analysis Study objective This study assessed the clinical and economic impact of a surveillance programme, implemented during general practitioner (GP) visits, to identify children who were overweight or mildly obese and then provide them with structured secondary prevention. Interventions The intervention consisted of primary care screening, followed by a brief structured secondary prevention programme, which consisted of four standard consultations over 12 weeks with the aim of changing nutrition, physical activity, and sedentary behaviour. The comparator was the usual care. Methods Analytical approach:The economic evaluation was carried out alongside a clinical trial with a one-year time horizon. The authors stated that they took the perspective of the health payer.
Effectiveness data:The clinical evidence came from a prospective, randomised controlled trial, which was within a baseline cross-sectional survey of body mass index (BMI). There were 781 eligible children, aged 5 to 10 years, and 258 (registered with 66 GPs) were randomised, with 139 in the intervention group and 119 in the control group. Randomisation was stratified by GP and by child's status of overweight or obese. Outcome assessors were not aware of group assignment. The length of follow-up was one year. The primary endpoint was the BMI which was measured at six and 12 months. Both primary and secondary outcomes were adjusted for socioeconomic disadvantage, age at randomisation, sex, and baseline score for the outcome.
Monetary benefit and utility valuations:Not considered.
Measure of benefit:No summary benefit measure was used and the change in BMI was the key outcome of the clinical analysis.
Cost data:The economic analysis included the resources used to provide the intervention (BMI surveillance, GP recruitment and training, and GP consultations) and these were collected by an audit of GP visits for intervention and control families. The costs were based on appropriate salary scales, travel allowances, and fee rates from the Medicare Benefits Schedule. They were in Australian dollars (AUD) and the price year was 2007.
Analysis of uncertainty:Not carried out. Results The adjusted mean difference in BMI between the intervention group and the control group was -0.12 (95% CI -0.40 to 0.15) at six months and -0.11 (95% CI -0.45 to 0.22) at 12 months, suggesting similar clinical effectiveness and only non-significant improvement with the intervention. Similar results were observed with the secondary outcomes, except for improvements in health-related quality of life, with the intervention, which were significant at both six and 12 months.
The mean cost per child was AUD 1,317 in the intervention group and AUD 81 in the control group. The mean difference was AUD 1,236 (95% CI 1,205 to 1,267). Authors' conclusions The authors concluded that primary care screening, followed by brief counselling, did not improve clinical endpoints and would be expensive if universally implemented. CRD commentary Interventions:The two strategies were appropriate comparators and the key features of the intervention were reported.
Effectiveness/benefits:The clinical trial and analysis was satisfactorily carried out; the design was valid and it was consistent with the scope of this study. Clear details of the randomisation procedure and blinded assessment of clinical outcomes were reported. The size of the sample was appropriate, as it was determined by power calculations. Both unadjusted and adjusted results were reported. The comparability of the groups at baseline, the multicentre design, and the extensive reporting of the follow-up data, were all good. In general, statistical analyses were appropriately performed to account for potential confounding factors and the clinical results appear to have been robust.
Costs:The economic analysis included a limited range of costs that were relevant to the public payer for health services. The unit costs and resource quantities were not reported separately, which reduces the transparency of the analysis. Only a few details of the data sources were given. Statistical analyses of the differences in costs were conducted and alternative scenarios (with different numbers of children per GP) were analysed.
Analysis and results:The results were clearly reported. The costs and benefits were not synthesised, as a cost-consequences analysis was conducted. The issue of uncertainty was not explicitly investigated, but some subsequent analyses were carried out to consider different classifications for obese or overweight children. The authors stated that a limitation of their analysis was that the participating GPs volunteered for the trial, but it is unlikely that this would have strongly influenced the results. Some published trials had shown similar findings, but further studies should evaluate the impact of these life-style interventions over longer periods.
Concluding remarks:The methods were valid, especially for the clinical analysis, and the conclusions appear to be robust. Funding Funded by the Australian National Health and Medical Research Council. Bibliographic details Wake M, Baur LA, Gerner B, Gibbons K, Gold L, Gunn J, Levickis P, McCallum Z, Naughton G, Sanci L, Ukoumunne OC. Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial. BMJ 2009; 339:b3308 Indexing Status Subject indexing assigned by NLM MeSH Body Mass Index; Child; Child, Preschool; Exercise /physiology; Family Practice /economics; Female; Health Care Costs; Humans; Male; Meta-Analysis as Topic; Obesity /economics /prevention & Overweight /economics /prevention & Socioeconomic Factors; Treatment Outcome; control; control AccessionNumber 22009102867 Date bibliographic record published 03/02/2010 Date abstract record published 17/11/2010 |
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