Cost-effectiveness of invasive devices versus non-invasive devices for screening of anemia in field settings in India: A study protocol

Abstract

In India, an estimated 53% of women and 58% of children are anemic.  The accuracy of Sahli’s hemoglobinometer, commonly used for detecting anemia in public health settings, is questionable. This study presents the protocol for assessment of cost and cost effectiveness of devices for screening of anemia using invasive devices (HemoCue 301 and True Hb), and non-invasive devices (AJO Spectroscopic Test and Masimo Pulse Oximetery test) compared to automated auto-analyser (reference test). The study population will include all adult patients attending the outpatient department in urban/rural health centres for routine investigations. Each included patient will undergo either one or two index tests apart from the reference test, on a predefined weekly schedule to avoid bias. The total and incremental costs of the intervention will be measured prospectively by measuring both screening and provider costs.  Since the priority of the national program is detection of severe anemia, detection rates of anemia and severe anemia will be considered to calculate effectiveness. Cost comparisons of median, average and range of costs across the invasive and non-invasive devices will be calculated. Cost-effectiveness analysis will be compared for four devices within time horizon of 1 year. Ethics approval for the study has been obtained from the institutional ethics committees of the hospitals. The study protocol will generate evidence on the use of cost effectiveness of medical devices to influence policy decisions.