Economic evaluation
psychosis
The objective of the economic evaluation will be to inform decision-makers in India and Pakistan about the incremental cost and associated health outcomes of using DIALOG+ in the routine management of psychosis relative to the active control and from the perspective of the healthcare system. The supplementary objective of the economic evaluation will be to generate evidence on the costs of including DIALOG+ in the existing healthcare delivery systems in public and not-for-profit private sectors in India and in Pakistan.The economic component will collect data on costs and health outcomes associated with the intervention and control arms. Costs will cover health sector costs and resources associated with providing the intervention as well as cost to the patient and their families for seeking care. Methods of micro costing will be used to determine the monetary value of the resources used for the management of psychosis with DIALOG+ and the active control. Healthcare cost will include time cost of healthcare providers, cost of capital resources and their maintenance and cost of supplies. A time and motion study will be conducted to estimate the resources use of the health facilities [Health outcomes will be measured in quality-adjusted life years (QALYs). The European quality of life instrument EQ5D-5L will be used to capture health effects on patients, alongside the MANSA. Urdu and Tamil translation of EQ5D-5L will be obtained from the EUROQOL group. The EQ5D-5L tool will be administered at baseline, 6 months and 12 months follow-up. The valuation set of preference of the general population required to convert the EQ5D-5L to QALYs will be obtained from studies conducted in India [Incremental cost effectiveness ratios (ICERs) will be calculated as the ratio of difference in costs over difference in outcomes.Uncertainty will arise in the estimates of cost, QALYs and ICERs from two sources (1) sampling and (2) methodological assumptions. Methods similar to those for the RCT will be used in the economic evaluation to deal with missing data or censored data. Skewness and correlation in cost and outcomes data will be treated with Bayesian or frequentist techniques. For Pakistani results, ICERS will be adjusted for clustering effect at facility level. Probabilistic one-way or two-way sensitivity analysis will be carried out as a robustness check for the uncertainty surrounding the estimated ICERs due to assumptions used while estimating costs and outcomes.A health economic analysis plan will be developed and agreed with the local research team and signed off by the International Steering Committee (ISC) prior to data analysis.