Cost-effectiveness of point-of-care devices for detection of anemia in community settings in India

Anemia is a public health problem affecting 46.3% of the population in India.1Didzun O. De Neve J.-W. Awasthi A. et al.Anaemia among men India: nationally representative cross-sectional study.Lancet Global Health. 2019; 7: e1685-e1694Google Scholar It affects 58% children under five years age, 54% adolescent girls 15–19 53% women reproductive 50% pregnant mothers, and 29% boys country.2IIPS: National Family Health Survey 4. in: India Fact Sheet. Sciences IIoP. Mumbai, India2015-16Google Detection anemia important for institution appropriate management. Several methods are available diagnosis especially outreach field settings where well-equipped laboratories unavailable. The devices have been tested diverse yielded varied levels accuracy.3Chaudhary R. Dubey Sonker Techniques used screening hemoglobin blood donors: current insights future directions.Hematol Res Rev. 2017; 8: 75-88Google Scholar, 4Dubey Murti S. Validation hemoglobinometer use outdoor donation camps.Asian J Transfus Sci. 2016; 10Google 5Gamal M. Abdelhamid B. Zakaria D. al.Evaluation noninvasive monitoring trauma patients with low levels.Shock: Inj Inflamm Sepsis: Lab Clin Approaches. 2018; 49: 150-153Google 6Neogi S.B. Negandhi H. Kar al.Diagnostic accuracy haemoglobin colour strip (HCS-HLL), digital haemoglobinometer (TrueHb) non-invasive device (TouchHb) anaemia.J clin Pathol. 69: 164-170Google 7Parker Han Z. Abu-Haydar E. al.An evaluation measurement tools their reliability when child Rwanda: randomized study.PLoS One. 13 (e0187663-e0187663)Google In absence concrete evidence, there need to examine that potential be included programs. Given fact most happens community provision laboratory support seems difficult, ought workers (Auxillary Nurse Midwives or ANMs) as end users. Currently four such identified settings, namely, hemoglobinometers (True Hb Hemocue), devices, i.e. Masimo Pulse Oximetry test Spectroscopic spectroscopic test.8Neogi Sharma J. Ray Saxena Diagnostic efficacy (TrueHb), HemoCue non invasive settings-a proposal.Indian Community 30 (Supp): 86-88Google Identification suitable services warrants analysis parameters other than diagnostic accuracy. Some include cost effectiveness, user-friendliness operational factors. There evaluate them order identify effective Indian similar settings. A multicentric study across sites was undertaken assess (effectiveness) these (described elsewhere).9Neogi Pandey point-of-care detection India.BMC Serv Res. 2020; 20: 468Google objective estimate effectiveness by evaluating incremental each case detected from systems perspective. secondary user friendliness issues India. An performance some recently. Four (index tests) True Digital Hemoglobinometer, HemoCue, Masimo's were examined on an adequate sample adult attending practice areas Medical colleges Jawaharlal Institute Postgraduate Education Research (JIPMER), Puducherry, Calcutta College, Kolkata, West Bengal. To different weather conditions, additionally at All (AIIMS) Jodhpur Rural hospital, Reckong Peo (Himachal Pradesh). index tests compared against autoanalyzer (gold standard). Accuracy expressed sensitivity, specificity, likelihood ratios, predictive values area curve (AUC) agreement. According this study, TrueHb performed better Massimo devices. technicians between (AUC 0.92 v/s 0.90, p > 0.05). Hemocue detecting < For severe anemia, significantly 0.91 0.70; 0.05) 0.73; showed bias mean difference (95%CI) 0.47 g/dl (0.42, 0.52), (0.82, 1.03) anemia. TrueHb, it −0.28 (−0.37, −0.20) all readings, 0.06 (−0.52, 0.63) anemia.9Neogi This alongside design. data collection conducted August 2018 March 2019. protocol cost-effectiveness approach has published elsewhere.10Neogi John al.Cost-effectiveness versus [version 1; peer review: 1 not approved].F1000Research. 8Google costs captured through primary using micro-costing (bottom up) methodology sites. At first step, every input consumed individual identified. Secondly, quantity resource item, human (ANM time test), equipment (device, charger, adapter), accessories (micro cuvettes/strips), consumables (used non-medical (items facility rooms), capital space (i.e. conducting third unit calculated items. Inputs manufacturers accessories, while procurement considered no-medical Unit ANM dividing total salary per month divided taken 26 working days 7 h day receiving full salary). Other multiplying units consumed. Rental value testing reference rental prevalent area. Since government hospitals, shared costs, administrative administration requirement time-consuming, hence analysis. Data sensitivity collected simultaneously site. Effectiveness defined here rate detect details Cost relative efficiency workers. Incremental Ratios (ICERs) (reported study) ICER as: [(Mean test) - (Mean B]/[(Detection rate) – (Detection B]. standard) main study. However, utility point care very comparison difficult. comparator, purpose calculations, we which compared. both annual year, discounted standard guidelines economic evaluations.11Husereau Drummond Petrou al.Consolidated reporting standards (CHEERS) statement.BMJ Br Med (Clin Ed). 2013; 346: f1049Google Sensitivity lower upper bounds medical Scenario year also assumption can screen 2 days/week (approximately 50 weeks), assuming 10 min test, will able 6 42 (assuming work day). scenario assumes ANMs no outside work. done quasi-health system perspective horizon one year. outcome measure ‘correct diagnosis’ referred ability true positives. priority national program, separately Reporting findings followed CHEERS guidelines.11Husereau Although would estimate, deemed Hence, included. Operational aid taking decision feasibility its We therefore explored aspects like ease use, portability, objectivity average perform expertise required strip/cuvette wastage. These gathered specifications mentioned product inserts, research staff involved None had any immediate complications following needle pricks although could record long term effects due logistic reasons. Laboratory independently asked criteria: daylight, scope subjective errors, convenience patient, interpretation (Hb) results, power/battery, performing required, scale (very poor) 5 (excellent) method. score method (maximum method). assessments understand perspectives users (4 site, 16 total). shown Table 1. minimum (INR 104.8) rural 140.0) urban maximum 137.0 177.4 areas). Costs more areas. Additional found INR 24.4 38.7 TrueHb. (Table 1).Table 1Costs resources measuring Hemoglobin (in INR).ComponentData sourcesHemocueTrue HbSpectroscopic deviceMasimoRuralUrbanRuralUrbanRuralUrbanRuralUrbanHuman (ANM)Health data16.7 (13.9%)17.7 (10.7%)17.1 (12.5%)17.5 (9.9%)18.1 (16.5%)18.1 (12.9%)16.6 (15.8%)18.3 (12.6%)Equipment adapter)Device manufacturers0.2 (0.1%)0.2 (0.1%)0.004 (0%)0.004 (0%)0.05 (0.04%)0.05 (0.04%)3.4 (3.2%)3.4 (2.3%)Accessories (Micro cuvettes/strips)Device manufacturers11.9 (9.9%)11.9 (7.2%)26.4 (19.3%)26.4 (14.9%)0.0 (0%)0.0 (0%)Consumables test)Collected hospital records12.3 (10.2%)19.7 (12.0%)12.3 (9.0%)19.7 (11.1%)6.1 (5.6%)4.3 (3.1%)6.1 (5.8%)4.3 (3.0%)Non-medical rooms)Collected records78.8 (65.5%)113.4 (69.0%)80.8 (59.0%)112.3 (63.3%)85.4 (77.6%)116.4 (82.9%)78.3 (74.7%)117.2 (81.0%)Capital (rental)Collected records0.4 (0.3%)1.6 (0.9%)0.4 (0.3%)1.5 (0.9%)0.5 (0.4%)1.6 (1.1%)0.4 (1.1%)Total cost/test (INR)120.3164.3137.0177.4110.1140.4104.8144.7 Open table new tab contributed highest (12.1% cost), (11.5% total) items examination room (such furniture-examination chairs, cupboards, curtains, wash basins, soaps, buckets, light, fan etc) majority device. results (case sensitivity) compute primarily looking utilized, present 2). bound higher rate.Table 2Incremental ratios (ICER) (costs INR).ComponentsHemoCueTrueHbSpectroscopic deviceMassimoAnemia Base caseReference−464.330.465.1 Lower sensitivityReference−407.728.060.0 Upper sensitivityReference−557.134.073.3Severe caseReference41.554.152.2 sensitivityReference46.246.458.9 sensitivityReference45.896.853.4 3 provides 1869 cases 224840 wastage 27789.30, 1806 247422 402278. With regards 73 11508 While only 39 10105 year.Table 3Scenario devices.Haemo CueTrue deviceMasimoDetection anemiaTotal Per Test (INR)120.3137110.1104.8Total number (approx)aThe numbers estimated 7000–8000 she cater to. approximate women/@ crude birth 20/1000 150–180 estimation visit makes (1000 tests/yr) plus non-pregnant (1000/yr); Adolescents @15% (1100/yr) Assuming 15–20 tests/days 5–6 week thoughout assumed 4200.4200420042004200Expected @50% prevalence2100210021002100Total (true positives based data) test0.890.860.560.66Total year1869180611761386Cost (INR)224840.7247422129477.6145252.8Total (INR)252630287700231210220080Wastage (INR)27789.340278101732.474827.2Detection ANM4200420042004200Expected @2% prevalence (based estimates eg NFHS)84848484Total test0.470.870.280.17Total year39.4873.0823.5214.28Cost (INR)4749.4410011.962589.551496.54Wastage (INR)5355.751496.046658.847306.65Total (INR)10105.2115089248.48803.2a 4200. choosing programmatic several into consideration. spectrum condition (anemia our case) gains weightage, factors influence decision. Of rated best 4). fared terms friendliness, shelf life fully charged batteries. On hand, outweighed portability device, range temperature storage, without having batteries 5). Besides, Overestimation nearly gm% may change category subsequent management.Table 4An assessment workersParametersHemoCueTrueHbSpectroscopic deviceMassimo deviceEase Use4434Efficiency daylight4534Portability5524Convenience Patient5425Need Power/Battery5524Average test5334Expertise required5424Total Score (out 35)33301729 5Features (HemoCue TrueHb).ParametersHemocueTrue HbAccuracy (all categories; Case sensitivity+++ (90%)+++ (86%)Mean diff Gold categories+++ (0.18)+++ (−0.22)Accuracy (Severe Anemia).. sensitivity- (47%)+++ (87%)Mean anemia- (0.84)+++ (−0.06)Accuracy conditions±+Data storage- (no data)+ (only values)Portability (weight device)+ (500 gms)+++(60 gms)Portability (dimensions) inches)+ (5.5 × 2.7 X6.2)+++ (4.7 2.3 x 0.3)Ease (user friendliness)+++++Ease duration training+++ (4–5 h)+++(4–5 h)Objectivity readings++++++Patient convenience++++++Need recalibration (NR- Not required)+++ (NR)+++ (NR)Strip/cuvette (Number test)++(1.2)+ (1.35)Operating temperature+ (10- 40O C)++ (5-45O C)Strip/Cuvettes Storage conditions+ C)Shelf equipment+++ (7 years)++ (5 years)Shelf strips/microcuvettes++(2 years)+ (1 year)Source power facility++ (AC adapter)++ (Charger)Source community+(4 AA batteries)++ (device should charged, needed))Number (fully charged/batteries)++ (510)+ (200)Biomedical waste managementLancet microcuvettesLancet stripsApprovalsFDA approved, CLIA compliantCLIA compliant, ISO FDA process+++ Very good, ++ Good, +Average, Poor, ± Equivocal. +++ shows whereas friendly issues, Clinical benefit quality but yield. 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