ABSTRACT
INTRODUCTION: The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial. METHODS AND ANALYSIS: A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost-utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis. ETHICS AND DISSEMINATION: Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers. REGISTRATION: The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019. TRIAL REGISTRATION NUMBER: CTRI/2019/05/019197; Clinical Trial Registry.
Subject(s)
Neonatal Sepsis , Probiotics , Infant, Newborn , Humans , Infant , Neonatal Sepsis/prevention & control , Cost-Benefit Analysis , Birth Weight , India , Probiotics/therapeutic use , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Cancer has become one of the ten leading causes of death in India. Breast cancer is the most common diagnosed malignancy in India, it ranks second to cervical cancer. An increasing trend in incidence is reported from various registries of national cancer registry project and now India is a country with largest estimated number of breast cancer deaths worldwide. AIM: To study the factors associated with breast cancer. OBJECTIVES: To study the association between breast cancer and selected exposure variables and to identify risk factors for breast cancer. MATERIALS AND METHODS: A hospital based Case control study was conducted at Shirdi Sai Baba Cancer Hospital and Research Center, Manipal, Udupi District. RESULTS: Total 188 participants were included in the study, 94 cases and 94 controls. All the study participants were between 25 to 69 years of age group. The cases and controls were matched by ± 2 years age range. Non vegetarian diet was one of the important risk factors (OR 2.80, CI 1.15-6.81). More than 7 to 12 years of education (OR 4.84 CI 1.51-15.46) had 4.84 times risk of breast cancer as compared with illiterate women. CONCLUSION: The study suggests that non vegetarian diet is the important risk factor for Breast Cancer and the risk of Breast Cancer is more in educated women as compared with the illiterate women. LIMITATION: This is a Hospital based study so generalisability of the findings could be limited.
