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Background: Chronic pain is a leading cause of disability. Radiofrequency denervation (RFD) is effective when performed according to guidelines for patients with correctly diagnosed zygapophyseal joint pain (ZJP). However, the cost-effectiveness of this method has not been fully explored., Objective: The aim of this study was to analyze whether RFD is cost-effective for ZJP from a societal perspective., Study Design: Cost effectiveness study based on an observational study., Setting: An interventional pain management clinic in central Sweden., Methods: Patients - This cost-effectiveness study was performed for all patients (n = 873) assessed between 2010 and 2016 at a specialized interventional pain clinic in Sweden. Those diagnosed with ZJP (n = 331, 37.9%) were treated with RFD and followed up for 1 year after the RFD. Using data collected from national registers, we determined the health care costs, medication costs, the patients' time and travel costs, and the patients' ability to work. The effects of RFD on quality-adjusted life years (QALY) and cost/QALY gained were calculated., Results: On average, patients reported very low health-related quality of life (HRQoL; EQ-5D index: 0.212). After RFD, HRQoL increased significantly to 0.530 (P < 0.0001). Drug consumption and specialized health care consumption were reduced by 54% and 81%, respectively, and the cost/QALY gained from a societal perspective was 221,324 Swedish krona (USD ~26,008). The sensitivity analysis showed that the treatment was cost-effective in all scenarios evaluated, using the patients as their own controls. The cost/QALY gained from a health care perspective was 72,749 Swedish krona (USD ~8,548)., Limitations: The results are based on data collected at one center. The results need to be compared with those from pain rehabilitation programs and should be confirmed using data from other centers., Conclusions: Patients referred for RFD in Sweden report extremely low HRQoL. HRQoL significantly increased following RFD in patients with ZJP. Medications and health care consumption decreased after RFD. RFD was cost-effective, and the sensitivity analysis yielded stable results in different scenarios. Therefore, RFD is a cost-effective treatment that meets the Swedish National Board of Health and Welfare criteria for a high priority treatment., Trial Registration: The study was registered at ClinicalTrials.gov (NCT01835704) with Protocol ID SE-Dnr-2012-446-31M-1.  https://clinicaltrials.gov/ct2/show/NCT01835704.

The increasing availability and capabilities of mobile phones make them a feasible means of data collection. Electronic Data Capture (EDC) systems have been used widely for public health monitoring and surveillance activities, but documentation of their use in complicated research studies requiring multiple systems is limited. This paper shares our experiences of designing and implementing a complex multi-component EDC system for a community-based four-armed cluster-Randomised Controlled Trial in the rural plains of Nepal, to help other researchers planning to use EDC for complex studies in low-income settings. We designed and implemented three interrelated mobile phone data collection systems to enrol and follow-up pregnant women (trial participants), and to support the implementation of trial interventions (women's groups, food and cash transfers). 720 field staff used basic phones to send simple coded text messages, 539 women's group facilitators used Android smartphones with Open Data Kit Collect, and 112 Interviewers, Coordinators and Supervisors used smartphones with CommCare. Barcoded photo ID cards encoded with participant information were generated for each enrolled woman. Automated systems were developed to download, recode and merge data for nearly real-time access by researchers. The systems were successfully rolled out and used by 1371 staff. A total of 25,089 pregnant women were enrolled, and 17,839 follow-up forms completed. Women's group facilitators recorded 5717 women's groups and the distribution of 14,647 food and 13,482 cash transfers. Using EDC sped up data collection and processing, although time needed for programming and set-up delayed the study inception. EDC using three interlinked mobile data management systems (FrontlineSMS, ODK and CommCare) was a feasible and effective method of data capture in a complex large-scale trial in the plains of Nepal. Despite challenges including prolonged set-up times, the systems met multiple data collection needs for users with varying levels of literacy and experience.

Background: Low birth weight (LBW, < 2500 g) affects one third of newborn infants in rural south Asia and compromises child survival, infant growth, educational performance and economic prospects. We aimed to assess the impact on birth weight and weight-for-age Z-score in children aged 0-16 months of a nutrition Participatory Learning and Action behaviour change strategy (PLA) for pregnant women through women's groups, with or without unconditional transfers of food or cash to pregnant women in two districts of southern Nepal., Methods: The study is a cluster randomised controlled trial (non-blinded). PLA comprises women's groups that discuss, and form strategies about, nutrition in pregnancy, low birth weight and hygiene. Women receive up to 7 monthly transfers per pregnancy: cash is NPR 750 (~US$7) and food is 10 kg of fortified sweetened wheat-soya Super Cereal per month. The unit of randomisation is a rural village development committee (VDC) cluster (population 4000-9200, mean 6150) in southern Dhanusha or Mahottari districts. 80 VDCs are randomised to four arms using a participatory 'tombola' method. Twenty clusters each receive: PLA; PLA plus food; PLA plus cash; and standard care (control). Participants are (mostly Maithili-speaking) pregnant women identified from 8 weeks' gestation onwards, and their infants (target sample size 8880 birth weights). After pregnancy verification, mothers may be followed up in early and late pregnancy, within 72 h, after 42 days and within 22 months of birth. Outcomes pertain to the individual level. Primary outcomes include birth weight within 72 h of birth and infant weight-for-age Z-score measured cross-sectionally on children born of the study. Secondary outcomes include prevalence of LBW, eating behaviour and weight during pregnancy, maternal and newborn illness, preterm delivery, miscarriage, stillbirth or neonatal mortality, infant Z-scores for length-for-age and weight-for-length, head circumference, and postnatal maternal BMI and mid-upper arm circumference. Exposure to women's groups, food or cash transfers, home visits, and group interventions are measured., Discussion: Determining the relative importance to birth weight and early childhood nutrition of adding food or cash transfers to PLA women's groups will inform design of nutrition interventions in pregnancy., Trial Registration: ISRCTN75964374 , 12 Jul 2013.

There is growing evidence of the effectiveness of early childhood interventions to improve the growth and development of children. Although, historically, nutrition and stimulation interventions may have been delivered separately, they are increasingly being tested as a package of early childhood interventions that synergistically improve outcomes over the life course. However, implementation at scale is seldom possible without first considering the relative cost and cost-effectiveness of these interventions. An evidence gap in this area may deter large-scale implementation, particularly in low- and middle-income countries. We conduct a literature review to establish what is known about the cost-effectiveness of early childhood nutrition and development interventions. A set of predefined search terms and exclusion criteria standardized the search across five databases. The search identified 15 relevant articles. Of these, nine were from studies set in high-income countries and six in low- and middle-income countries. The articles either calculated the cost-effectiveness of nutrition-specific interventions (n = 8) aimed at improving child growth, or parenting interventions (stimulation) to improve early childhood development (n = 7). No articles estimated the cost-effectiveness of combined interventions. Comparing results within nutrition or stimulation interventions, or between nutrition and stimulation interventions was largely prevented by the variety of outcome measures used in these analyses. This article highlights the need for further evidence relevant to low- and middle-income countries. To facilitate comparison of cost-effectiveness between studies, and between contexts where appropriate, a move towards a common outcome measure such as the cost per disability-adjusted life years averted is advocated. Finally, given the increasing number of combined nutrition and stimulation interventions being tested, there is a significant need for evidence of cost-effectiveness for combined programmes. This too would be facilitated by the use of a common outcome measure able to pool the impact of both nutrition and stimulation activities., (Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2014; all rights reserved.)

Background: Harm reduction strategies commonly include needle and syringe programmes (NSP), opioid substitution therapy (OST) and interventions combining these two strategies. Despite the proven effectiveness of harm-reduction strategies in reducing human immunodeficiency virus (HIV) infection among injecting drug users (IDUs), no study has compared the cost-effectiveness of these interventions, nor the incremental cost effectiveness of combined therapy. Using data from the Global Fund, this study compares the cost-effectiveness of harm reduction strategies in Eastern Europe and Central Asia, using the Ukraine as a case study., Methods: A Markov Monte Carlo simulation is carried out using parameters from the literature and cost data from the Global Fund. Effectiveness is presented as both QALYs and infections averted. Costs are measured in 2011 US dollars., Results: The Markov Monte Carlo simulation estimates the cost-effectiveness ratio per infection averted as $487.4 [95% CI: 488.47-486.35] in NSP and $1145.9 [95% CI: 1143.39-1148.43] in OST. Combined intervention is more costly but more effective than the alternative strategies with a cost effectiveness ratio of $851.6[95% CI: 849.82-853.55]. The ICER of the combined strategy is $1086.9/QALY [95% CI: 1077.76:1096.24] compared with NSP, and $461.0/infection averted [95% CI: 452.98:469.04] compared with OST. These results are consistent with previous studies., Conclusions: Despite the inherent limitations of retrospective data, this study provides evidence that harm-reduction interventions are a cost-effective way to reduce HIV prevalence. More research on into cost effectiveness in different settings, and the availability of fiscal space for government uptake of programmes, is required.

Importance: Community-based interventions can reduce neonatal mortality when health systems are weak. Population coverage of target groups may be an important determinant of their effect on behavior and mortality. A women's group trial at coverage of 1 group per 1414 population in rural Bangladesh showed no effect on neonatal mortality, despite a similar intervention having a significant effect on neonatal and maternal death in comparable settings., Objective: To assess the effect of a participatory women's group intervention with higher population coverage on neonatal mortality in Bangladesh., Design: A cluster randomized controlled trial in 9 intervention and 9 control clusters., Setting: Rural Bangladesh., Participants: Women permanently residing in 18 unions in 3 districts and accounting for 19 301 births during the final 24 months of the intervention., Interventions: Women's groups at a coverage of 1 per 309 population that proceed through a participatory learning and action cycle in which they prioritize issues that affected maternal and neonatal health and design and implement strategies to address these issues., Main Outcomes and Measures: Neonatal mortality rate., Results: Analysis included 19 301 births during the final 24 months of the intervention. More than one-third of newly pregnant women joined the groups. The neonatal mortality rate was significantly lower in the intervention arm (21.3 neonatal deaths per 1000 live births vs 30.1 per 1000 in control areas), a reduction in neonatal mortality of 38% (risk ratio, 0.62 [95% CI, 0.43-0.89]) when adjusted for socioeconomic factors. The cost-effectiveness was US $220 to $393 per year of life lost averted. Cause-specific mortality rates suggest reduced deaths due to infections and those associated with prematurity/low birth weight. Improvements were seen in hygienic home delivery practices, newborn thermal care, and breastfeeding practices., Conclusions and Relevance: Women's group community mobilization, delivered at adequate population coverage, is a highly cost-effective approach to improve newborn survival and health behavior indicators in rural Bangladesh., Trial Registration: isrctn.org Identifier: ISRCTN01805825., Competing Interests: Disclosures: None reported.

Background: The cost of maternity care can be a barrier to access that may increase maternal and neonatal mortality risk. We analyzed spending on maternity care in urban slum communities in Mumbai to better understand the equity of spending and the impact of spending on household poverty., Methods: We used expenditure data for maternal and neonatal care, collected during post-partum interviews. Interviews were conducted in 2005-2006, with a sample of 1200 slum residents in Mumbai (India). We analysed expenditure by socio-economic status (SES), calculating a Kakwani Index for a range of spending categories. We also calculated catastrophic health spending both with and without adjustment for coping strategies. This identified the level of catastrophic payments incurred by a household and the prevalence of catastrophic payments in this population. The analysis also gave an understanding of the protection from medical poverty afforded by coping strategies (for example saving and borrowing)., Results: A high proportion of respondents spent catastrophically on care. Lower SES was associated with a higher proportion of informal payments. Indirect health expenditure was found to be (weakly) regressive as the poorest were more likely to use wage income to meet health expenses, while the less poor were more likely to use savings. Overall, the incidence of catastrophic maternity expenditure was 41%, or 15% when controlling for coping strategies. We found no significant difference in the incidence of catastrophic spending across wealth quintiles, nor could we conclude that total expenditure is regressive., Conclusions: High expenditure as a proportion of household resources should alert policymakers to the burden of maternal spending in this context. Differences in informal payments, significantly regressive indirect spending and the use of savings versus wages to finance spending, all highlight the heavier burden borne by the most poor. If a policy objective is to increase institutional deliveries without forcing households deeper into poverty, these inequities will need to be addressed. Reducing out-of-pocket payments and better regulating informal payments should have direct benefits for the most poor. Alternatively, targeted schemes aimed at assisting the most poor in coping with maternal spending (including indirect spending) could reduce the household impact of high costs.