Developing and implementing an interventional bundle to reduce mortality from gastroschisis in low-resource settings

Wellcome Open Research

article

Naomi Wright¹  Francis Abantanga²  Michael Amoah³  William Appeadu-Mensah⁴  Zaitun Bokhary⁵  Bruce Bvulani⁶  Justine Davies⁷  Sam Miti⁸  Bip Nandi⁹  Boateng Nimako³  Dan Poenaru^1,10  Stephen Tabiri²  Abiboye Yifieyeh³  Niyi Ade-Ajayi^1,11  Nick Sevdalis^1,12  Andy Leather¹ 

[1] King's Centre for Global Health and Health Partnerships, School of Population Health and Environmental Sciences, King's College London;Department of Surgery, Tamale Teaching Hospital;Department of Surgery, Komfo Anokye Teaching Hospital;Department of Paediatric Surgery, Korle-Bu Teaching Hospital;Department of Paediatric Surgery, Muhimbili National Hospital;Department of Paediatric Surgery, University Teaching Hospital of Lusaka;Global Health and Education Department, University of Birmingham;Department of Paediatrics, Arthur Davison Children's Hospital;Department of Paediatric Surgery, Kamuzu Central Hospital;McGill University;Department of Paediatric Surgery, King's College Hospital;Centre for Implementation Science, King's College London

关键词: Gastroschisis;    Intervention;    Mortality;    Low-Resource Setting;    LMIC;    Implementation;    Congenital Anomaly;    Neonatal Surgical Care;   

DOI  :  10.12688/wellcomeopenres.15113.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: Gastroschisis is associated with less than 4% mortality in high-income countries and over 90% mortality in many tertiary paediatric surgery centres across sub-Saharan Africa (SSA). The aim of this trial is to develop, implement and prospectively evaluate an interventional bundle to reduce mortality from gastroschisis in seven tertiary paediatric surgery centres across SSA.Methods: A hybrid type-2 effectiveness-implementation, pre-post study design will be utilised. Using current literature an evidence-based, low-technology interventional bundle has been developed. A systematic review, qualitative study and Delphi process will provide further evidence to optimise the interventional bundle and implementation strategy. The interventional bundle has core components, which will remain consistent across all sites, and adaptable components, which will be determined through in-country co-development meetings. Pre- and post-intervention data will be collected on clinical, service delivery and implementation outcomes for 2-years at each site. The primary clinical outcome will be all-cause, in-hospital mortality. Secondary outcomes include the occurrence of a major complication, length of hospital stay and time to full enteral feeds. Service delivery outcomes include time to hospital and primary intervention, and adherence to the pre-hospital and in-hospital protocols.  Implementation outcomes are acceptability, adoption, appropriateness, feasibility, fidelity, coverage, cost and sustainability. Pre- and post-intervention clinical outcomes will be compared using Chi-squared analysis, unpaired t-test and/or Mann-WhitneyU test. Time-series analysis will be undertaken using Statistical Process Control to identify significant trends and shifts in outcome overtime. Multivariate logistic regression analysis will be used to identify clinical and implementation factors affecting outcome with adjustment for confounders.Outcome: This will be the first multi-centre interventional study to our knowledge aimed at reducing mortality from gastroschisis in low-resource settings. If successful, detailed evaluation of both the clinical and implementation components of the study will allow sustainability in the study sites and further scale-up.Registration: ClinicalTrials.gov Identifier{"type":"clinical-trial","attrs":{"text":"NCT03724214","term_id":"NCT03724214"}}NCT03724214.

【 授权许可】

CC BY