Siddesh Sitaram Shetty

Introduction: High-Flow Nasal Therapy (HFNT) is an innovative non-invasive form of respiratory support. Compared to standard oxygen therapy (SOT), there is an equipoise regarding the effect of HFNT on patient-centred outcomes among those at high risk of developing postoperative pulmonary complications after undergoing cardiac surgery. The NOTACS trial aims to determine the clinical and cost-effectiveness of HFNT compared to SOT within 90 days of surgery in the United Kingdom, Australia, and New Zealand. This protocol describes the methods and analyses planned for economic evaluation embedded within the ongoing NOTACS trial. Methods and analysis: The economic evaluation will identify, measure and value resources and health outcomes in both trial arms and compare changes in costs with ‘days alive and at home’ and EQ-5D-5L quality adjusted life years (QALYs) from the perspective most relevant to the decision-making country. Results from pooling data across the trial will use health and social care sector perspective. All patient-specific data including hospital/community care and health outcomes will be collected prospectively. Unit costs will be sourced from national, published or local data. Missing data will be assessed, with values replaced depending on assumed mechanism of missingness, and impact of replacement on cost-effectiveness assessed. Costs and outcomes by trial arm will be presented as components and totals per patient using a range of descriptive statistics. Regression models for costs and effects will account for patient characteristics, quality of life and health service utilization at baseline. Uncertainty in parameters, sampling and heterogeneity will be addressed through deterministic, probabilistic and subgroup analyses to assess the impact of varying methods and assumptions for costs, outcomes and approaches used in base-case analysis. Results will be interpreted using recommended national cost-effectiveness thresholds. Registration details: The study is registered with ISRCTN (ISRCTN14092678) on 13/05/2020. ISRCTN is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set.

Introduction: High-Flow Nasal Therapy (HFNT) is an innovative non-invasive form of respiratory support. Compared to standard oxygen therapy (SOT), there is an equipoise regarding the effect of HFNT on patient-centred outcomes among those at high risk of developing postoperative pulmonary complications after undergoing cardiac surgery. The NOTACS trial aims to determine the clinical and cost-effectiveness of HFNT compared to SOT within 90 days of surgery in the United Kingdom, Australia, and New Zealand. This protocol describes the methods and analyses planned for economic evaluation embedded within the ongoing NOTACS trial. Methods and analysis: The economic evaluation will identify, measure and value resources and health outcomes in both trial arms and compare changes in costs with ‘days alive and at home’ and EQ-5D-5L quality adjusted life years (QALYs) from the perspective most relevant to the decision-making country. Results from pooling data across the trial will use health and social care sector perspective. All patient-specific data including hospital/community care and health outcomes will be collected prospectively. Unit costs will be sourced interpreted using recommended national cost-effectiveness thresholds. Registration details: The study is registered with ISRCTN ( ISRCTN14092678 ) on 13/05/2020. ISRCTN is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set.

Background: Postpartum hemorrhage (PPH) is the global leading cause of maternal mortality, affecting nearly 3 to 6 percent of all women giving birth in India. The World Health Organization (WHO) has updated its guidelines to recommend the early use of intravenous (IV) tranexamic acid (TXA) in addition to standard care for all diagnosed PPH cases. This study aimed to assess the cost-effectiveness of introducing TXA for PPH management in the Indian public health system. Methods: A decision analytic model was built using a decision tree to determine the cost-effectiveness of administering IV TXA to women experiencing PPH within 3 h of birth to existing management with uterotonics and supportive care. Using a disaggregated societal perspective, the costs and consequences for a hypothetical cohort of women experiencing PPH in public health facilities was estimated. The model was populated using probabilities, clinical parameters, and utilities from published literature, while cost parameters were largely derived from a primary economic costing study. The primary outcome of interest was the incremental cost-utility ratio (ICUR). Associated clinical events and net benefits were estimated. One-way and probabilistic sensitivity analysis (PSA) was undertaken. The budget impact was estimated for a national-level introduction. Results: For an estimated annual cohort of 510,915 PPH cases in India, the addition of IV TXA would result in a per-patient disaggregated societal cost of INR 6607 (USD 95.15) with a discounted gain of 20.25 QALYs, as compared to a cost of INR 6486 (USD 93.41) with a discounted gain of 20.17 QALYs with standard care PPH management. At an ICUR value of INR 1470 per QALY gained (USD 21), the addition of IV TXA is cost-effective in Indian public health settings. The intervention is likely to prevent 389 maternal deaths, 177 surgeries, and 128 ICU admissions per 100,000 PPH cases. The findings are robust under uncertainty, with 94.5% of PSA simulations remaining cost-effective. A cumulative increase of 2.3% financial allocation for PPH management over five years will be incurred for TXA introduction. Conclusions: Addition of tranexamic acid for primary PPH management, as recommended by WHO, is cost-effective in Indian public health settings. Policy guidelines, training manuals, and facility checklists should be updated to reflect this recommendation.

Background: World Health Organisation recommends using Uterine Balloon Tamponade (UBT) for refractory atonic postpartum haemorrhage (PPH) management provided treatment protocols and surgical recourse is possible. Methods: This review collated literature from three electronic databases between January 2010 to December 2019 to compare clinical effectiveness, safety and use related parameters for condom-UBT, Bakri balloon and Every Second Matters (ESM) UBT devices used in India. Results: Thirty-three eligible studies reported effectiveness in managing all PPH causes ranging from 84.2% to 98.3% for condom-UBT and from 65.3% to 94.8% for Bakri-UBT. Three ESM-UBT studies reported PPH survival rates of 94% to 97.4%. Mean UBT effectiveness in controlling atonic PPH was 92.3% for condom-UBT, 84.3% for Bakri-UBT and 97.3% for ESM-UBT. Condom-UBT and Bakri-UBT were comparable across parameters whereas limited ESM-UBT evidence reported success in preventing maternal deaths. Conclusions: For limitations and heterogeneity in methodology and outcome parameters with existing evidence, a robust comparative RCT between UBT devices in India is recommended.

Objective: Post-partum hemorrhage (PPH) is the leading direct cause of maternal mortality in India. Uterine balloon tamponade (UBT) is recommended for atonic PPH cases not responding to uterotonics. This study assessed cost-effectiveness of three UBT devices used in Indian public health settings.Methods: A decision tree model was built to assess cost-effectiveness of Bakri-UBT and low-cost ESM-UBT alternatives as compared to the recommended standard of care i.e. condom-UBT intervention. A hypothetical annual cohort of women eligible for UBT intervention after experiencing atonic PPH in Indian public health facilities were evaluated for associated costs and outcomes over life-time horizon using a disaggregated societal perspective. Costs by undertaking primary costing and clinical parameters from published literature were used. Incremental cost per Disability Adjusted Life Years (DALY) averted, number of surgeries and maternal deaths with the interventions were estimated. An India specific willingness to pay threshold of INR 24,211 (USD 375) was used to evaluate cost-effectiveness. Detailed sensitivity analysis and expected value of information analysis was undertaken.Results: ESM-UBT at base-case Incremental Cost-Effectiveness Ratio (ICER) of INR -2,412 (USD 37) per DALY averted is a cost-saving intervention i.e. is less expensive and more effective as compared to condom-UBT. Probabilistic sensitivity analysis however shows an error probability of 0.36, indicating a degree of uncertainty around model results. Bakri-UBT at an ICER value of INR -126,219 (USD -1,957) per DALY averted incurs higher incremental societal costs and is less effective as compared to condom-UBT. Hence, Bakri-UBT is not cost-effective.Conclusion: For atonic PPH management in India, condom-UBT offers better value as compared to Bakri-UBT. Given the limited clinical effectiveness evidence and uncertainty in sensitivity analysis, cost-saving result for ESM-UBT must be considered with caution. Future research may focus on generating high quality comparative clinical evidence for UBT devices to facilitate policy decision making.

Objective Postpartum haemorrhage (PPH) is the worldwide leading cause of preventable maternal mortality. India offers free treatment for pregnancy and related complications in its public health facilities. Management with uterine balloon tamponade (UBT) is recommended for refractory atonic PPH cases. As part of health technology assessment to determine the most cost-effective UBT device, this study estimated costs of atonic PPH management with condom-UBT, Every Second Matters (ESM) UBT and Bakri balloon UBT in public health system of Maharashtra, India. Design Health system cost was estimated using primary economic microcosting, data from Health Management Information System and published literature for event probabilities. Settings Four public health facilities from the state of Maharashtra, India representing primary, secondary and tertiary level care were chosen for primary costing. Outcome measures Unit, package and annual cost of atonic PPH management with three UBT devices were measured. This included cost of medical treatment, UBT intervention and PPH related surgeries undertaken in public health system of Maharashtra for year 2017–2018. Results Medical management of atonic PPH cost the health system US$37 (95% CI 29 to 45) per case, increasing to US$44 (95% CI 36 to 53) with condom-UBT and surgical interventions for uncontrolled cases. Similar cost was estimated for ESM-UBT. Bakri-UBT reported a higher cost of US$59 (95% CI 46 to 73) per case. Overall annual cost of managing 27 915 atonic PPH cases with condom-UBT intervention in Maharashtra was US$1 226 610 (95% CI 870 250 to 1 581 596). Conclusions Atonic PPH management in public health facilities of Maharashtra with condom-UBT, ESM-UBT or Bakri-UBT accounts to 3.8%, 3.8% or 5.2% of the state’s annual spending on reproductive and child health services. These findings can guide policy-makers to include PPH complication management in publicly financed health schemes. Economic evaluation studies can use this evidence to determine cost effectiveness of UBT in Indian settings.