Dr. Usha Menon currently serves as Professor at the Department of Endocrinology, School of Medicine, Kochi.

Qualification: MRCP


Publication Type: Journal Article

Year of Publication Title


K. Singh, Ali, M. K., Devarajan, R., Shivashankar, R., Kondal, D., Ajay, V. S., Usha Menon, Varthakavi, P. K., Viswanathan, V., Dharmalingam, M., Bantwal, G., Sahay, R. Kumar, Masood, M. Qamar, Khadgawat, R., Desai, A., Prabhakaran, D., Narayan, K. M. Venkat, Phillips, V. L., and Tandon, N., “Rationale and Protocol for Estimating the Economic Value of a Multicomponent Quality Improvement Strategy for Diabetes Care in South Asia”, Glob Health Res Policy, vol. 4, p. 7, 2019.[Abstract]

Background: Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide. We describe the economic evaluation protocol within a randomised controlled trial that tested a multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia.

Methods/design: This economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and Pakistan. The economic evaluation comprises both a within-trial cost-effectiveness analysis (mean 2.5 years follow up) and a microsimulation model-based cost-utility analysis (life-time horizon). Effectiveness measures include multiple risk factor control (achieving HbA1c < 7% and blood pressure < 130/80 mmHg and/or LDL-cholesterol< 100 mg/dl), and patient reported outcomes including quality adjusted life years (QALYs) measured by EQ-5D-3 L, hospitalizations, and diabetes related complications at the trial end. Cost measures include direct medical and non-medical costs relevant to outpatient care (consultation fee, medicines, laboratory tests, supplies, food, and escort/accompanying person costs, transport) and inpatient care (hospitalization, transport, and accompanying person costs) of the intervention compared to usual diabetes care. Patient, healthcare system, and societal perspectives will be applied for costing. Both cost and health effects will be discounted at 3% per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime horizon. Outcomes will be reported as the incremental cost-effectiveness ratios (ICER) to achieve multiple risk factor control, avoid diabetes-related complications, or QALYs gained against varying levels of willingness to pay threshold values. Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs (95% CIs) across public vs. private settings and using conservative estimates of effect size (95% CIs) for multiple risk factor control. Costs will be reported in US$ 2018.

Discussion: We hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes, thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings.

Trial registration: ClinicalTrials.gov: NCT01212328.

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A. R. Asirvatham, Usha Menon, Pavithran, P. V., Vasukutty, J. R., Kumar, H., Bhavani, N., Menon, A., Nair, V., Lakshmanan, V., Varma, A. K., Sukumaran, M. T., and Bal, A., “Role of Procalcitonin as a Predictor of Clinical Outcome in Acute Diabetic Foot Infections: A Prospective Study”, Indian J Endocrinol Metab, vol. 23, no. 1, pp. 122-127, 2019.[Abstract]

Background: Prediction of outcome in diabetic foot infection (DFI) remains difficult due to lack of active signs of infection, and apparently normal white blood cell (WBC) count. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) have been studied previously in this regard and were not useful. Hence, we evaluated procalcitonin (PCT) as a prognostic marker in this study.

Objectives: We aimed to study the role of PCT, CRP, and ESR levels in predicting clinical outcome of acute DFI.

Materials and Methods: A total of 250 subjects (197 men, 53 women) with acute DFI were enrolled. WBC count, ESR, CRP, and PCT were done for all subjects at admission after obtaining informed consent. Subjects were managed according to hospital protocol and followed up for 1 month. Clinical outcome was assessed based on mobility and morbidity status of the subject.

Results: Old age, anemia, hyponatremia, hypoalbuminemia, and elevated serum creatinine were risk factors for poor outcome. Presence of cardiac failure, diabetic retinopathy, peripheral vascular disease, previous amputations, and positive bone culture had negative influence on clinical outcome. Elevated WBC count, ESR, CRP, and serum PCT were significantly associated with bad outcome. Elevated PCT (>2 ng/ml) [odds ratio (OR) (95% confidence interval (CI)), 2.03 (1.13-5.19), < 0.001], gangrene [OR (95% CI), 2.2 (1.02-4.73), = 0.04], and sepsis [OR (95% CI), 10.101 (4.34-23.25), < 0.001] were good predictors of clinical outcome in acute DFI.

Conclusion: PCT proved to be a reliable marker of acute DFI and good predictor of clinical outcome than existing markers WBC count, ESR, and CRP. Hence it should be useful for clinicians while managing acute DFI.

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