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      Collecting and analysing cost data for complex public health trials: reflections on practice

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          Abstract

          Background

          Current guidelines for the conduct of cost-effectiveness analysis (CEA) are mainly applicable to facility-based interventions in high-income settings. Differences in the unit of analysis and the high cost of data collection can make these guidelines challenging to follow within public health trials in low- and middle- income settings.

          Objective

          This paper reflects on the challenges experienced within our own work and proposes solutions that may be useful to others attempting to collect, analyse, and compare cost data between public health research sites in low- and middle-income countries.

          Design

          We describe the generally accepted methods (norms) for collecting and analysing cost data in a single-site trial from the provider perspective. We then describe our own experience applying these methods within eight comparable cluster randomised, controlled, trials. We describe the strategies used to maximise adherence to the norm, highlight ways in which we deviated from the norm, and reflect on the learning and limitations that resulted.

          Results

          When the expenses incurred by a number of small research sites are used to estimate the cost-effectiveness of delivering an intervention on a national scale, then deciding which expenses constitute ‘start-up’ costs will be a nontrivial decision that may differ among sites. Similarly, the decision to include or exclude research or monitoring and evaluation costs can have a significant impact on the findings. We separated out research costs and argued that monitoring and evaluation costs should be reported as part of the total trial cost. The human resource constraints that we experienced are also likely to be common to other trials. As we did not have an economist in each site, we collaborated with key personnel at each site who were trained to use a standardised cost collection tool. This approach both accommodated our resource constraints and served as a knowledge sharing and capacity building process within the research teams.

          Conclusions

          Given the practical reality of conducting randomised, controlled trials of public health interventions in low- and middle- income countries, it is not always possible to adhere to prescribed guidelines for the analysis of cost effectiveness. Compromises are frequently required as researchers seek a pragmatic balance between rigor and feasibility. There is no single solution to this tension but researchers are encouraged to be mindful of the limitations that accompany compromise, whilst being reassured that meaningful analyses can still be conducted with the resulting data.

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          Most cited references45

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          Recommendations of the Panel on Cost-effectiveness in Health and Medicine.

          To develop consensus-based recommendations for the conduct of cost-effectiveness analysis (CEA). This article, the second in a 3-part series, describes the basis for recommendations constituting the reference case analysis, the set of practices developed to guide CEAs that inform societal resource allocation decisions, and the content of these recommendations. The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS). The panel reviewed the theoretical foundations of CEA, current practices, and alternative methods used in analyses. Recommendations were developed on the basis of theory where possible, but tempered by ethical and pragmatic considerations, as well as the needs of users. The panel developed recommendations through 2 1/2 years of discussions. Comments on preliminary drafts prepared by panel working groups were solicited from federal government methodologists, health agency officials, and academic methodologists. The panel's methodological recommendations address (1) components belonging in the numerator and denominator of a cost-effectiveness (C/E) ratio; (2) measuring resource use in the numerator of a C/E ratio; (3) valuing health consequences in the denominator of a C/E ratio; (4) estimating effectiveness of interventions; (5) incorporating time preference and discounting; and (6) handling uncertainty. Recommendations are subject to the ¿rule of reason,¿ balancing the burden engendered by a practice with its importance to a study. If researchers follow a standard set of methods in CEA, the quality and comparability of studies, and their ultimate utility, can be much improved.
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            Women's groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis

            Maternal and neonatal mortality rates remain high in many low-income and middle-income countries. Different approaches for the improvement of birth outcomes have been used in community-based interventions, with heterogeneous effects on survival. We assessed the effects of women's groups practising participatory learning and action, compared with usual care, on birth outcomes in low-resource settings. We did a systematic review and meta-analysis of randomised controlled trials undertaken in Bangladesh, India, Malawi, and Nepal in which the effects of women's groups practising participatory learning and action were assessed to identify population-level predictors of effect on maternal mortality, neonatal mortality, and stillbirths. We also reviewed the cost-effectiveness of the women's group intervention and estimated its potential effect at scale in Countdown countries. Seven trials (119,428 births) met the inclusion criteria. Meta-analyses of all trials showed that exposure to women's groups was associated with a 37% reduction in maternal mortality (odds ratio 0.63, 95% CI 0.32-0.94), a 23% reduction in neonatal mortality (0.77, 0.65-0.90), and a 9% non-significant reduction in stillbirths (0.91, 0.79-1.03), with high heterogeneity for maternal (I(2)=58.8%, p=0.024) and neonatal results (I(2)=64.7%, p=0.009). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0.026 and p=0.011, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 55% reduction in maternal mortality (0.45, 0.17-0.73) and a 33% reduction in neonatal mortality (0.67, 0.59-0.74). The intervention was cost effective by WHO standards and could save an estimated 283,000 newborn infants and 41,100 mothers per year if implemented in rural areas of 74 Countdown countries. With the participation of at least a third of pregnant women and adequate population coverage, women's groups practising participatory learning and action are a cost-effective strategy to improve maternal and neonatal survival in low-resource settings. Wellcome Trust, Ammalife, and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Birmingham and the Black Country programme. Copyright © 2013 Elsevier Ltd. All rights reserved.
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              Programme costs in the economic evaluation of health interventions

              Estimating the costs of health interventions is important to policy-makers for a number of reasons including the fact that the results can be used as a component in the assessment and improvement of their health system performance. Costs can, for example, be used to assess if scarce resources are being used efficiently or whether there is scope to reallocate them in a way that would lead to improvements in population health. As part of its WHO-CHOICE project, WHO has been developing a database on the overall costs of health interventions in different parts of the world as an input to discussions about priority setting. Programme costs, defined as costs incurred at the administrative levels outside the point of delivery of health care to beneficiaries, may comprise an important component of total costs. Cost-effectiveness analysis has sometimes omitted them if the main focus has been on personal curative interventions or on the costs of making small changes within the existing administrative set-up. However, this is not appropriate for non-personal interventions where programme costs are likely to comprise a substantial proportion of total costs, or for sectoral analysis where questions of how best to reallocate all existing health resources, including administrative resources, are being considered. This paper presents a first effort to systematically estimate programme costs for many health interventions in different regions of the world. The approach includes the quantification of resource inputs, choice of resource prices, and accounts for different levels of population coverage. By using an ingredients approach, and making tools available on the World Wide Web, analysts can adapt the programme costs reported here to their local settings. We report results for a selected number of health interventions and show that programme costs vary considerably across interventions and across regions, and that they can contribute substantially to the overall costs of interventions.
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                Author and article information

                Journal
                Glob Health Action
                Glob Health Action
                GHA
                Global Health Action
                Co-Action Publishing
                1654-9716
                1654-9880
                18 February 2014
                2014
                : 7
                : 10.3402/gha.v7.23257
                Affiliations
                [1 ]Institute for Global Health, University College London, London, UK
                [2 ]SNEHA, Mumbai, India
                [3 ]Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK
                [4 ]Health Economics and Systems Group, London School of Hygiene and Tropical Medicine, London, UK
                [5 ]BADAS, Dhaka, Bangladesh
                [6 ]Ekjut, Ranchi, India
                [7 ]MIRA, Kathmandu, Nepal
                Author notes
                [* ]Correspondence to: Neha Batura, Institute for Global Health, University College London, 30 Guilford Street, London WC1N 1EH, UK, Email: n.batura@ 123456ucl.ac.uk
                Article
                23257
                10.3402/gha.v7.23257
                3929994
                24565214
                8f400118-bf0d-4941-9ae5-083eded1266e
                © 2014 Neha Batura et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 08 November 2013
                : 14 January 2014
                : 20 January 2014
                Categories
                Original Article

                Health & Social care
                cost-effectiveness analysis,randomised control trials,cost data,multisite,lmic

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