Cost-effectiveness of an activating intervention by social workers for patients with minor mental disorders on sick leave: a randomized controlled trial

BACKGROUND: Sickness absence often occurs in patients with emotional distress or minor mental disorders. In several European countries, these patients are over-represented among those receiving illness benefits, and interventions are needed. The aim of this study was to evaluate the cost-effectiveness of an intervention conducted by social workers, designed to reduce sick leave duration in patients absent from work owing to emotional distress or minor mental disorders. METHODS: In this Randomized Controlled Trial, patients were recruited by GPs. The intervention group (N = 98) received an activating, structured treatment by social workers, the control group (N = 96) received routine GP care. Sick leave duration, clinical symptoms, and medical consumption (consumption of medical staffs' time as well as consumption of drugs) were measured at baseline and 3, 6, and 18 months later. RESULTS: Neither for sick leave duration nor for clinical improvement over time were significant differences found between the groups. Also the associated costs were not significantly lower in the intervention group. CONCLUSIONS: Compared with usual GP care, the activating social work intervention was not superior in reducing sick leave duration, improving clinical symptoms, and decreasing medical consumption. It was also not cost-effective compared with GP routine care in the treatment of minor mental disorders. Therefore, further implementation of the intervention is not justified. Potentially, programmes aimed at reducing sick leave duration in patients with minor mental disorders carried out closer to the workplace (e.g. by occupational physicians) are more successful than programmes in primary care.     

Cost‐effectiveness Analysis and Insurance Coverage: Solving a Puzzle

The conventional model for the use of cost‐effectiveness analysis for health programs involves determining whether the cost per unit of effectiveness of the program is lower than some socially determined maximum acceptable cost per unit of effectiveness. If a program is better by this criterion, the policy implication is that it should be implemented by full coverage of its cost by insurance; if not, the program should not be implemented. This paper examines the unanswered question of how cost‐effectiveness analysis should be performed and interpreted when insurance coverage may involve cost sharing. It explores the question of how cost sharing should be related to the magnitude of a cost‐effectiveness ratio. A common view that cost sharing should vary inversely with program cost‐effectiveness is shown to be incorrect. A key issue in correct analysis is whether there is heterogeneity in marginal effectiveness of care that cannot be perceived by the social planner but is known by the demander. It is possible that some programs that would fail the social efficiency test at full coverage will be acceptable with positive cost sharing. Combining individual and social preferences affects both the choice of programs and the extent of cost sharing. Copyright © 2014 John Wiley & Sons, Ltd.     

Cost‐effectiveness of Weight Watchers and the Lighten Up to a Healthy Lifestyle program

Objective: Intensive weight loss programs that incorporate dietary counselling and exercise advice are popular and are supported by evidence of immediate weight loss benefits. We evaluate the cost‐effectiveness of two weight loss programs, Lighten Up to a Healthy Lifestyle and Weight Watchers. Methods: Health gains from prevention of chronic disease are modelled over the lifetime of the Australian population. These results are combined with estimates of intervention costs and cost offsets (due to reduced rates of lifestyle‐related diseases) to determine the dollars per disability‐adjusted life year (DALY) averted by each intervention program, from an Australian health sector perspective. Results: Both weight loss programs produced small improvements in population health compared to current practice. The time and travel associated with attending group‐counselling sessions, however, was costly for patients, and overall the cost‐effectiveness ratios for Lighten Up ($130,000/DALY) and Weight Watchers ($140,000/DALY) were high. Conclusion: Based on current evidence, these intensive behavioural counselling interventions are not very cost‐effective strategies for reducing obesity, and the potential benefits for population health are small. Implications: It will be critical to consider other strategies (e.g. changing the ‘obesogenic’ environment) or explore alternative methods of intervention delivery (e.g. Internet) to see if they offer a more cost‐effective approach by effectively reaching a high number of people at a low cost.     

Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders

Background  

The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD). The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders.     

Cost‐effectiveness of asthma clinic approach in the management of chronic asthma in Australia

Objectives: To compare cost‐effectiveness of an asthma clinic that would provide education, promotion of self‐monitoring of symptoms, regular review of treatment by a medical practitioner and a written asthma action plan to current practice in Australia. Methods: A decision tree model was used to compare treatment and improved management using asthma clinics under three scenarios: 1) intervention reduces only emergency department visits; 2) in addition, it leads to a reduction in days out of role; and 3) it also reduces unplanned general practitioner visits and hospitalisations. Evidence from existing published studies was used for asthma incidence, duration, treatment practices and health seeking behaviours. Costs for one year were estimated based on an asthma clinic trial in Australia. Results: The estimated $274 million annual cost of asthma clinics is much greater than the potential cost savings of $11 million resulting from reduced emergency department visits, and an overall potential cost saving of $85 million resulting from decreased GP visits and hospitalisations. The incremental cost‐effective ratio (ICER) is $24,000 if a reduction in days out of role is quantified as a health benefit in estimating disability‐adjusted life years (DALY). If a potential $85 million in cost‐savings from decreased emergency department visits, GP visits and hospitalisation is taken into account, the ICER drops to $17,000 per DALY averted. Conclusions: An asthma clinic as an intervention for improving self‐management may be cost‐effective in Australia if multiple benefits can be achieved. Implications: A large‐scale asthma clinic trial and long‐term evaluation of benefits are necessary to obtain stronger evidence on the benefit of asthma clinic approach in Australia.     

Cost-effectiveness of follow-up contact for a postal survey: a randomised controlled trial

Objective: This study examines the effectiveness and costs of follow‐up phone calls in improving response rates to a community survey. Methods: Non‐responders to a postal survey were randomly allocated to receive a phone call or no phone call. The resources used for the development and implementation of the survey were documented. The response rates and cost per level of follow‐up contact examined. Results: Follow‐up phone calls led to a statistical significant increase in the number of responses to a community‐wide survey, relative to no phone call. This relative increase in responses (n=62 for the follow‐up phone call group versus n=1 for controls), did not increase the absolute survey response rate sufficiently (from 38.5% for two mailed surveys to 39.8% for two mailed surveys plus a phone call) to justify the phone call costs. Scenario analyses show increasing the initial response rate by 10% and conducting a second mailed survey achieves greater marginal cost savings than increasing the response rate to the second mailout or the follow‐up phone calls. Conclusions: These results suggest a follow‐up phone call was not cost effective. Survey research ought to primarily focus on obtaining optimal initial response rates by using strategies identified in a Cochrane meta‐analytic review.     

Cost‐effectiveness of Occupational Therapy in Older People: Systematic Review of Randomized Controlled Trials

A systematic review of the cost‐effectiveness of occupational therapy for older people was conducted. MEDLINE, CINAHL, Web of Science, PsycINFO, Cochrane Library, OT seeker and unpublished trials registers were searched. Reference lists of all potentially eligible studies were searched with no language restrictions. We included trial‐based full economic evaluations that considered both costs and outcomes in occupational therapy for older people compared with standard care (i.e. other therapy) or no intervention. We reviewed each trial for methodological quality using the Cochrane risk of bias tool and assessed the quality of economic evaluations using a Drummond checklist. In the results of this review, we included five eligible studies (1–5) that were randomized controlled trials with high‐quality economic evaluation. Two studies were full economic evaluations of interventions for fall prevention (1 and 2); two studies were full economic evaluations of preventive occupational therapy interventions (3 and 4; one was a comparison of an occupational therapy group with a social work group); one study was a full economic evaluation of occupational therapy for individuals with dementia (5). Two of the studies (one was preventive occupational therapy [3] and the other was occupational therapy for dementia [5]) found a significant effect and confirmed the cost‐effectiveness of occupational therapy for older people compared with the control group. These studies found that occupational therapy for older people was clinically effective and cost‐effective in comparison with standard care or other therapies. With reference to their clinical implication, these intervention studies (using a client‐centred approach) suggested potentially cost‐effective means to motivate clients to maintain their own health. However, this review has limitations because of the high heterogeneity of the reviewed studies on full economic evaluations of occupational therapy for older people. Future studies on the cost‐effectiveness of occupational therapy in older people are strongly warranted. Copyright © 2015 John Wiley & Sons, Ltd.     

The CORE study—An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized‐controlled trial

BackgroundMental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited.ObjectiveThe aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery‐orientation of services led to greater psychosocial recovery outcomes for service users.DesignA stepped wedge cluster randomized‐controlled trial was conducted.Setting and ParticipantsFour Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia.Main Outcome MeasuresThe 24‐item Revised Recovery Assessment Scale (RAS‐R) measured individual psychosocial recovery.ResultsA total of 841 observations were completed with 287 service users. The intention‐to‐treat analysis found RAS‐R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS‐R score was −1.70 (95% confidence interval: −3.81 to 0.40; p = .11).DiscussionThis first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms.ConclusionsMore attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed.Patient and Public InvolvementThe State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived‐experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.     

The (cost‐)effectiveness of preventive,integrated care for community‐dwelling frail older people: A systematic review

Integrated care is increasingly promoted as an effective and cost‐effective way to organise care for community‐dwelling frail older people with complex problems but the question remains whether high expectations are justified. Our study aims to systematically review the empirical evidence for the effectiveness and cost‐effectiveness of preventive, integrated care for community‐dwelling frail older people and close attention is paid to the elements and levels of integration of the interventions. We searched nine databases for eligible studies until May 2016 with a comparison group and reporting at least one outcome regarding effectiveness or cost‐effectiveness. We identified 2,998 unique records and, after exclusions, selected 46 studies on 29 interventions. We assessed the quality of the included studies with the Effective Practice and Organization of Care risk‐of‐bias tool. The interventions were described following Rainbow Model of Integrated Care framework by Valentijn. Our systematic review reveals that the majority of the reported outcomes in the studies on preventive, integrated care show no effects. In terms of health outcomes, effectiveness is demonstrated most often for seldom‐reported outcomes such as well‐being. Outcomes regarding informal caregivers and professionals are rarely considered and negligible. Most promising are the care process outcomes that did improve for preventive, integrated care interventions as compared to usual care. Healthcare utilisation was the most reported outcome but we found mixed results. Evidence for cost‐effectiveness is limited. High expectations should be tempered given this limited and fragmented evidence for the effectiveness and cost‐effectiveness of preventive, integrated care for frail older people. Future research should focus on unravelling the heterogeneity of frailty and on exploring what outcomes among frail older people may realistically be expected.     

Investigation of the effects of Chlorella vulgaris as an adjunctive therapy for dyslipidemia: Results of a randomised open‐label clinical trial

Aim: Chlorella vulgaris is a unicellular green microalga with several pharmacological activities including anti‐hyperlipidemic effects. In spite of interesting preclinical findings, the clinical efficacy of C. vulgaris in dyslipidemia—whether alone or in combination with statins—has not been clarified. The present study aimed to investigate the impact of supplementation with C. vulgaris as an adjunctive therapy to atorvastatin in dyslipidemic subjects. Methods: In a randomised, open‐label clinical trial, 100 dyslipidemic subjects were randomly assigned to: (i) Chlorella group (n = 50, dropouts = 24), receiving C. vulgaris (600 mg/day) + atorvastatin (20 mg/day) for 8 weeks; or (ii) atorvastatin group (n = 50, dropouts = 13), receiving only atorvastatin (20 mg/day) for 8 weeks. Lipid profile and biomarkers of muscular, hepatic and renal injury were determined at baseline and at the end of the trial. Results: There were significant reductions in serum total cholesterol (P < 0.001), low‐density lipoprotein cholesterol (P < 0.001) and triglycerides (P= 0.006 in Chlorella and P= 0.004 in atorvastatin group) in both groups. No significant change in serum high‐density lipoprotein cholesterol levels was observed in any of the groups. Serum aspartate aminotransferase levels were raised in both Chlorella (P= 0.034) and atorvastatin (P= 0.002) groups, whereas alkaline phosphatase was only elevated in the Chlorella group (P= 0.028). In comparison with baseline values, no significant change was observed in serum levels of alanine aminotransferase, creatine phosphokinase, creatinine, blood urea nitrogen and fasting blood sugar. Conclusion: Based on the results, addition of C. vulgaris to atorvastatin therapy for 8 weeks does not appear to be associated with an improved control of serum lipid profile.     

Reference‐based multiple imputation for missing data sensitivity analyses in trial‐based cost‐effectiveness analysis

Missing data are a common issue in cost‐effectiveness analysis (CEA) alongside randomised trials and are often addressed assuming the data are ‘missing at random’. However, this assumption is often questionable, and sensitivity analyses are required to assess the implications of departures from missing at random. Reference‐based multiple imputation provides an attractive approach for conducting such sensitivity analyses, because missing data assumptions are framed in an intuitive way by making reference to other trial arms. For example, a plausible not at random mechanism in a placebo‐controlled trial would be to assume that participants in the experimental arm who dropped out stop taking their treatment and have similar outcomes to those in the placebo arm. Drawing on the increasing use of this approach in other areas, this paper aims to extend and illustrate the reference‐based multiple imputation approach in CEA. It introduces the principles of reference‐based imputation and proposes an extension to the CEA context. The method is illustrated in the CEA of the CoBalT trial evaluating cognitive behavioural therapy for treatment‐resistant depression. Stata code is provided. We find that reference‐based multiple imputation provides a relevant and accessible framework for assessing the robustness of CEA conclusions to different missing data assumptions.     

Meta‐analysis of clinical trials with early stopping: an investigation of potential bias

Clinical trials that stop early for benefit have a treatment difference that overestimates the true effect. The consequences of this fact have been extensively debated in the literature. Some researchers argue that early stopping, or truncation, is an important source of bias in treatment effect estimates, particularly when truncated studies are incorporated into meta‐analyses. Such claims are bound to lead some systematic reviewers to consider excluding truncated studies from evidence synthesis. We therefore investigated the implications of this strategy by examining the properties of sequentially monitored studies conditional on reaching the final analysis. As well as estimation bias, we studied information bias measured by the difference between standard measures of statistical information, such as sample size, and the actual information based on the conditional sampling distribution. We found that excluding truncated studies leads to underestimation of treatment effects and overestimation of information. Importantly, the information bias increases with the estimation bias, meaning that greater estimation bias is accompanied by greater overweighting in a meta‐analysis. Simulations of meta‐analyses confirmed that the bias from excluding truncated studies can be substantial. In contrast, when meta‐analyses included truncated studies, treatment effect estimates were essentially unbiased. Previous analyses comparing treatment effects in truncated and non‐truncated studies are shown not to be indicative of bias in truncated studies. We conclude that early stopping of clinical trials is not a substantive source of bias in meta‐analyses and recommend that all studies, both truncated and non‐truncated, be included in evidence synthesis. Copyright © 2013 John Wiley & Sons, Ltd.