Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies
Objectives To document and share the process of establishing the nationally representative multisite surveillance network for intussusception in India, coordination, data management and lessons learnt from the implementation.Design This study combined both retrospective and prospective surveillance...
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BMJ Publishing Group
2021-05-01
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| author | Rakesh Kumar Ashish Wakhlu Manoja Kumar Das Narendra Kumar Arora Atul Gupta John Mathai Bhadresh R Vyas Pavai Arunachalam Cenita J Sam Arindam Ray Javeed Iqbal Bhat Jayanta K Goswami K Kameswari Lalit Bharadia Lalit Sankhe Neelam Mohan Pradeep K Jena Rachita Sarangi Rashmi Shad Sanjib K Debbarma J Shyamala Simmi K Ratan Suman Sarkar Vijayendra Kumar Anand P Dubey Gowhar Nazir Mufti Harsh Trivedi Jimmy Shad Kaushik Lahiri Meera Luthra P Padmalatha Ruchirendu Sarkar A Santosh Kumar Subrat Kumar Sahoo Sunil K Ghosh Sushant Mane Bashir Ahmad Charoo Bikasha Bihary Tripathy G Rajendra Prasad S Harish Kumar K Jothilakshmi Nihar Ranjan Sarkar Saurabh Garge MK Ajaya Kumar Satya SG Mohapatra |
| author_facet | Rakesh Kumar Ashish Wakhlu Manoja Kumar Das Narendra Kumar Arora Atul Gupta John Mathai Bhadresh R Vyas Pavai Arunachalam Cenita J Sam Arindam Ray Javeed Iqbal Bhat Jayanta K Goswami K Kameswari Lalit Bharadia Lalit Sankhe Neelam Mohan Pradeep K Jena Rachita Sarangi Rashmi Shad Sanjib K Debbarma J Shyamala Simmi K Ratan Suman Sarkar Vijayendra Kumar Anand P Dubey Gowhar Nazir Mufti Harsh Trivedi Jimmy Shad Kaushik Lahiri Meera Luthra P Padmalatha Ruchirendu Sarkar A Santosh Kumar Subrat Kumar Sahoo Sunil K Ghosh Sushant Mane Bashir Ahmad Charoo Bikasha Bihary Tripathy G Rajendra Prasad S Harish Kumar K Jothilakshmi Nihar Ranjan Sarkar Saurabh Garge MK Ajaya Kumar Satya SG Mohapatra |
| author_sort | Rakesh Kumar |
| collection | DOAJ |
| description | Objectives To document and share the process of establishing the nationally representative multisite surveillance network for intussusception in India, coordination, data management and lessons learnt from the implementation.Design This study combined both retrospective and prospective surveillance approaches.Setting 19 tertiary care institutions were selected in India considering the geographic representation and public and private mixParticipants All children under-2 years of age with intussusceptionPrimary and secondary outcome measures The experience of site selection, regulatory approvals, data collection, quality assurance and network coordination were documented.Results The site selection process involved systematic and objective four steps including shortlisting of potential institutions, information seeking and telephonic interaction, site visits and site selection using objective criteria. Out of over 400 hospitals screened across India, 40 potential institutions were shortlisted and information was sought by questionnaire and interaction with investigators. Out of these, 25 institutes were visited and 19 sites were finally selected to participate in the study. The multistep selection process allowed filtering and identification of sites with adequate capacity and motivated investigators. The retrospective surveillance documented 1588 cases (range: 14–652 cases/site) and prospective surveillance recruited 621 cases (range: 5–191 cases/site). The multilayer quality assurance measures monitored and ensured protocol adherence, complete record retrieval and data completeness. The key challenges experienced included time taken for obtaining regulatory and ethical approvals, which delayed completion of the study. Ten sites continued with another multisite vaccine safety surveillance study.Conclusion The experience and results of this systematic and objective site selection method in India are promising. The systematic multistep site selection and data quality assurance methods presented here are feasible and practical. The lessons from the establishment and coordination of this surveillance network can be useful in planning, selecting the sites and conducting multisite and surveillance studies in India and developing countries. |
| format | Article |
| id | doaj-art-ee86157ef039427f8eab8e0adeaf4e13 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ee86157ef039427f8eab8e0adeaf4e132025-08-20T01:47:22ZengBMJ Publishing GroupBMJ Open2044-60552021-05-0111510.1136/bmjopen-2020-046827Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studiesRakesh Kumar0Ashish WakhluManoja Kumar Das1Narendra Kumar AroraAtul Gupta2John MathaiBhadresh R VyasPavai ArunachalamCenita J SamArindam Ray3Javeed Iqbal Bhat4Jayanta K GoswamiK KameswariLalit BharadiaLalit Sankhe5Neelam MohanPradeep K JenaRachita SarangiRashmi ShadSanjib K DebbarmaJ ShyamalaSimmi K RatanSuman SarkarVijayendra KumarAnand P DubeyGowhar Nazir MuftiHarsh TrivediJimmy ShadKaushik LahiriMeera Luthra6P PadmalathaRuchirendu SarkarA Santosh KumarSubrat Kumar SahooSunil K GhoshSushant Mane7Bashir Ahmad Charoo8Bikasha Bihary Tripathy9G Rajendra PrasadS Harish KumarK JothilakshmiNihar Ranjan SarkarSaurabh GargeMK Ajaya KumarSatya SG MohapatraOtorhinolaryngology and Head & Neck Surgery, All India Institute of Medical Sciences, New Delhi, IndiaThe INCLEN Trust International, New Delhi, IndiaKing’s College Hospital Foundation Trust, London, UKVaccine Delivery, Bill & Melinda Gates Foundation India, New Delhi, Delhi, India1 Pediatrics, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, IndiaDepartment of Community Medicine, JJ Hospital, Mumbai, IndiaDepartment of Pediatric Surgery, Holy Family Hospital Delhi, New Delhi, Delhi, IndiaDepartment of Pediatrics, Grant Government Medical College and Sir JJ Group of Hospitals, Byculla, Mumbai, Maharashtra, India1 Pediatrics, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, IndiaPediatric Surgery, AIIMS Bhubaneswar, Bhubaneswar, Odisha, IndiaObjectives To document and share the process of establishing the nationally representative multisite surveillance network for intussusception in India, coordination, data management and lessons learnt from the implementation.Design This study combined both retrospective and prospective surveillance approaches.Setting 19 tertiary care institutions were selected in India considering the geographic representation and public and private mixParticipants All children under-2 years of age with intussusceptionPrimary and secondary outcome measures The experience of site selection, regulatory approvals, data collection, quality assurance and network coordination were documented.Results The site selection process involved systematic and objective four steps including shortlisting of potential institutions, information seeking and telephonic interaction, site visits and site selection using objective criteria. Out of over 400 hospitals screened across India, 40 potential institutions were shortlisted and information was sought by questionnaire and interaction with investigators. Out of these, 25 institutes were visited and 19 sites were finally selected to participate in the study. The multistep selection process allowed filtering and identification of sites with adequate capacity and motivated investigators. The retrospective surveillance documented 1588 cases (range: 14–652 cases/site) and prospective surveillance recruited 621 cases (range: 5–191 cases/site). The multilayer quality assurance measures monitored and ensured protocol adherence, complete record retrieval and data completeness. The key challenges experienced included time taken for obtaining regulatory and ethical approvals, which delayed completion of the study. Ten sites continued with another multisite vaccine safety surveillance study.Conclusion The experience and results of this systematic and objective site selection method in India are promising. The systematic multistep site selection and data quality assurance methods presented here are feasible and practical. The lessons from the establishment and coordination of this surveillance network can be useful in planning, selecting the sites and conducting multisite and surveillance studies in India and developing countries.https://bmjopen.bmj.com/content/11/5/e046827.full |
| spellingShingle | Rakesh Kumar Ashish Wakhlu Manoja Kumar Das Narendra Kumar Arora Atul Gupta John Mathai Bhadresh R Vyas Pavai Arunachalam Cenita J Sam Arindam Ray Javeed Iqbal Bhat Jayanta K Goswami K Kameswari Lalit Bharadia Lalit Sankhe Neelam Mohan Pradeep K Jena Rachita Sarangi Rashmi Shad Sanjib K Debbarma J Shyamala Simmi K Ratan Suman Sarkar Vijayendra Kumar Anand P Dubey Gowhar Nazir Mufti Harsh Trivedi Jimmy Shad Kaushik Lahiri Meera Luthra P Padmalatha Ruchirendu Sarkar A Santosh Kumar Subrat Kumar Sahoo Sunil K Ghosh Sushant Mane Bashir Ahmad Charoo Bikasha Bihary Tripathy G Rajendra Prasad S Harish Kumar K Jothilakshmi Nihar Ranjan Sarkar Saurabh Garge MK Ajaya Kumar Satya SG Mohapatra Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies BMJ Open |
| title | Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies |
| title_full | Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies |
| title_fullStr | Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies |
| title_full_unstemmed | Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies |
| title_short | Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies |
| title_sort | experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in india lessons for multisite research studies |
| url | https://bmjopen.bmj.com/content/11/5/e046827.full |
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