Data collection and management

Data are collected at the individual level (demographic data, data collected using standardized tools/questionnaires), household level (information on the head of the family, structured questionnaires, daily records of use of the CSF) and village (community) level. Field-based data collection will be paper-based and will be done by trained data collectors. Prior to starting data collection, all research staff will be trained in protection of human subjects, good clinical practice guidelines and administration, data entry and analysis of study-specific data collection tools. All the data collectors, trainers and research officers will receive refresher training at regular intervals to ensure data quality and adherence to intervention protocol. The YAM follow-up data collection schedule will be explained to the parents of child participants at the time of the informed consent/assent procedure. Quarterly review and facilitation meetings will be organised at the village level for retaining the participants in the CSF and mhGAP intervention. Three follow-up visits will be conducted if participants are absent for whatever reason when the data collection is due. Written Informed consent will be sought from all participants. Consent of an illiterate participant will be obtained in the presence of a literate impartial witness according to the guidelines of the Indian Council of Medical Research [39]. In intervention 1, consent of one of the parents and assent of the adolescent will be obtained. For intervention 2, consent of the head of the household (one who manages the use of pesticides at home) will be sought. Similarly, consent of the head of the household will be sought for collecting data on use of community storage boxes. For intervention 3, consent of all the CHWs will be obtained only for data collection. For surveillance data collection consent of all the key informants will be obtained. Each study participant will receive a 5-digit alphanumeric unique study ID. The collected data will be de-identified prior to entry into the electronic database.

SPIRIT will develop and implement a comprehensive data management system allowing for collecting high-quality data by maintaining ongoing on-site and off-site quality assurance and quality control checks. Research staff handling study data will receive extensive training in procedures for handling sensitive information, accurate data entry, surveillance and intervention-specific data storage and data archive. All completed forms will be checked for completeness and accuracy, first by data collectors and later by a research associate responsible for data management. During monthly monitoring visits, the data manager will audit hard copies of the completed CRFs to check for completeness and accuracy. Prior to entering the data into an electronic data capture interface, all study data will be anonymized. A separate record will be maintained linking identifiable information and unique study IDs. Participant-specific data will be entered into the electronic data capture interface using only study IDs. Data entered will be cross-checked and an audit trail will be maintained if corrections in the data are warranted. Raw data will not be uploaded onto the Internet; instead an electronic data capture interface will function offline, and data will be transferred from Mehsana to Pune (where the project coordination office is) from the site on a monthly basis using encrypted and protected hard drives. The data manager will maintain the database with cleaned data, which will be used by the statistician based in Pune for data analysis.

All consent and assent forms and records of personally identifiable information will be kept confidential and protected from unauthorized access. Hard copies of the CRFs obtained from the surveillance system will be stored by month of surveillance, whereas hard copies of the interventions-specific data will be stored by village where the data were collected. All data will be kept in locked cupboards, accessible by key only by the data management staff and the principal investigators only.

The trial is monitored by an independent DSMB. The DSMB is made up of five members and consists of independent experts in biostatistics, health services research, medical ethics, public health, social science research and clinical trials within the Indian context; it will meet twice a year to oversee the trial. The trial is also subject to quarterly independent quality assurance audit of the performance of the site as per the guidelines of the funding agency.