Developing and implementing an interventional bundle to reduce mortality from gastroschisis in low-resource settings
| Autor: | Abiboye C Yifieyeh, Andrew J M Leather, Niyi Ade-Ajayi, Justine Davies, Sam Miti, Nick Sevdalis, Bruce Bvulani, Dan Poenaru, Boateng Nimako, Bip Nandi, William Appeadu-Mensah, Francis Atindaana Abantanga, Zaitun Bokhary, Michael Amoah, Stephen Tabiri, Naomi J. Wright |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Service delivery framework media_common.quotation_subject Delphi method Medicine (miscellaneous) Fidelity Intervention Logistic regression Outcome (game theory) General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Study Protocol LMIC 0302 clinical medicine 030225 pediatrics medicine 030212 general & internal medicine Mortality Low-Resource Setting Intensive care medicine media_common Gastroschisis business.industry Articles medicine.disease Statistical process control Neonatal Surgical Care 3. Good health Congenital Anomaly Implementation business Qualitative research |
| Zdroj: | Wellcome Open Research |
| ISSN: | 2398-502X |
| Popis: | 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-Whitney U 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 NCT03724214. |
| Databáze: | OpenAIRE |
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