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

ABSTRACT: 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.

SUBMITTER: Wright N

PROVIDER: S-EPMC6456836 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Wright Naomi N Abantanga Francis F Amoah Michael M Appeadu-Mensah William W Bokhary Zaitun Z Bvulani Bruce B Davies Justine J Miti Sam S Nandi Bip B Nimako Boateng B Poenaru Dan D Tabiri Stephen S Yifieyeh Abiboye A Ade-Ajayi Niyi N Sevdalis Nick N Leather Andy A

Wellcome open research 20190308

<b>Background:</b> 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. <b>Methods:</b> A hybrid type-2 effectiveness-implementation, pre-post study design will be utilised. Usi ...[more]

PMID: 30984879

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Project description:Heat-stable carbetocin (HSC), a long-acting oxytocin analogue that does not require cold-chain transportation and storage, is effective in preventing postpartum haemorrhage (PPH) in vaginal and caesarean deliveries in tertiary-care settings. We aimed to identify literature documenting how it is implemented in resource-limited and lower-level maternity care settings to inform policies and practices that enable its introduction in these contexts. A rapid scoping review was conducted with an 8-week timeframe by two reviewers. MEDLINE, EMBASE, Emcare, the Joanna Briggs Institute Evidence-Based Practice Database, the Maternity and Infant Care Database, and the Cochrane Library were searched for publications in English, French, and Spanish from January 2011 to September 2021. Randomized and non-randomized studies examining the feasibility, acceptability, and health system considerations in low-income and lower-middle-income countries were included. Relevant data were extracted using pretested forms, and results were synthesized descriptively. The search identified 62 citations, of which 12 met the eligibility criteria. The review did not retrieve studies focusing on acceptability and health system considerations to inform HSC implementation in low-resource settings. There were no studies located in rural or lower-level maternity settings. Two economic evaluations concluded that HSC is not feasible in terms of cost-effectiveness in lower-middle-income economies with private sector pricing, and a third one found superior care costs in births with PPH than without. The other nine studies focused on demonstrating HSC effectiveness for PPH prevention in tertiary hospital settings. There is a lack of evidence on the feasibility (beyond cost-effectiveness), acceptability, and health system considerations related to implementing HSC in resource-constrained and lower-level maternity facilities. Further implementation research is needed to help decision-makers and practitioners offer an HSC-inclusive intervention package to prevent excessive bleeding among pregnant women living in settings where oxytocin is not available or of dubious quality.

Project description:BackgroundIn many low- and middle-income countries, where vaccinations will be delayed and healthcare systems are underdeveloped, the COVID-19 pandemic will continue for the foreseeable future. Mortality scales can aid frontline providers in low-resource settings (LRS) in identifying those at greatest risk of death so that limited resources can be directed towards those in greatest need and unnecessary loss of life is prevented. While many prognostication tools have been developed for, or applied to, COVID-19 patients, no tools to date have been purpose-designed for, and validated in, LRS.ObjectivesThis study aimed to develop a pragmatic tool to assist LRS frontline providers in evaluating in-hospital mortality risk using only easy-to-obtain demographic and clinical inputs.MethodsMachine learning was used on data from a retrospective cohort of Sudanese COVID-19 patients at two government referral hospitals to derive contextually appropriate mortality indices for COVID-19, which were then assessed by C-indices.FindingsData from 467 patients were used to derive two versions of the AFEM COVID-19 Mortality Scale (AFEM-CMS), which evaluates in-hospital mortality risk using demographic and clinical inputs that are readily obtainable in hospital receiving areas. Both versions of the tool include age, sex, number of comorbidities, Glasgow Coma Scale, respiratory rate, and systolic blood pressure; in settings with pulse oximetry, oxygen saturation is included and in settings without access, heart rate is included. The AFEM-CMS showed good discrimination: the model including pulse oximetry had a C-statistic of 0.775 (95% CI: 0.737-0.813) and the model excluding it had a C-statistic of 0.719 (95% CI: 0.678-0.760).ConclusionsIn the face of an enduring pandemic in many LRS, the AFEM-CMS serves as a practical solution to aid frontline providers in effectively allocating healthcare resources. The tool's generalisability is likely narrow outside of similar extremely LRS settings, and further validation studies are essential prior to broader use.

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

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

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