title: Challenges in Implementation of the ANISA Protocol at the Odisha Site in India.
abstract: BACKGROUND
  The Aetiology of Neonatal Infection in South Asia (ANISA) study is being carried out at 5 sites across Bangladesh, India and Pakistan, generating in-depth information on etiologic agents in the community setting. Pregnancies are identified, births are registered and young infants are followed up to 59 days old with regular assessments for possible serious bacterial infection following a generic protocol. Specimens are collected from suspected cases. This article describes the challenges in implementing the generic ANISA protocol and modifications made to accommodate the Odisha site, India.
  
  
  CONCLUSIONS
  Primary challenges in implementing the protocol are the large geographic area, with a population of over 350,000, to be covered; assessing young infants at home and arranging timely transport of sick young infants to study hospitals for physician confirmation of illness; and specimen collection and treatment. A large workforce is deployed in a 3-tier system in the field, while clinical, microbiology, laboratory and data management teams collaborate dynamically. Mobile phones with text message capability, integration with the Odisha State government's health system, involvement of local communities and strict monitoring at different levels have been critical in addressing these challenges.
  
  
  CONCLUSIONS
  This article describes the challenges and modalities adopted to collect complex and accurate data on etiology, timing of disease and associated factors for community-acquired neonatal infections. Attention to local culture and customs, training and employing community level workers and supervisors, involving existing government machinery, using technology (cell phones), and uninterrupted systematic monitoring are critical for implementing such complex protocols that aim to collect population-based data to drive policy.
authors.affiliation: From the *Asian Institute of Public Health, Bhubaneswar, Odisha, India; †Ispat General Hospital, Rourkela, Odisha, India; ‡Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska; and §Sri Ramachandra Bhanj Medical College, Cuttack, Odisha, India.
authors.forename: Radhanath
authors.initials: R
authors.lastname: Satpathy
authors.forename: Pritish
authors.initials: P
authors.lastname: Nanda
authors.forename: Nimai C
authors.initials: NC
authors.lastname: Nanda
authors.forename: Himadri B
authors.initials: HB
authors.lastname: Bal
authors.forename: Ranjita
authors.initials: R
authors.lastname: Mohanty
authors.forename: Archana
authors.initials: A
authors.lastname: Mishra
authors.forename: Tapoja
authors.initials: T
authors.lastname: Swain
authors.forename: Keshab C
authors.initials: KC
authors.lastname: Pradhan
authors.forename: Kalpana
authors.initials: K
authors.lastname: Panigrahi
authors.forename: Ambarish
authors.initials: A
authors.lastname: Dutta
authors.forename: Pravas R
authors.initials: PR
authors.lastname: Misra
authors.forename: Sailajanandan
authors.initials: S
authors.lastname: Parida
authors.forename: Pinaki
authors.initials: P
authors.lastname: Panigrahi
mesh_terms: D003625:Data Collection; D062665:Epidemiological Monitoring; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D000071074:Neonatal Sepsis / Q000453:epidemiology / Q000209:etiology*; D012307:Risk Factors; D012424:Rural Population; D013048:Specimen Handling; D014505:Urban Population