Browsing by Author "Bacha, Tigist"

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    Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study
    (Frontiers Media, 2024-11-05) Lopez-Baron, Eliana; Abbas, Qalab; Caporal, Paula; Agulnik, Asya; Attebery, Jonah E.; Holloway, Adrian; Kissoon, Niranjan Tex; Mulgado-Aguas, Celia Isabel; Amegan-Aho, Kokou; Majdalani, Marianne; Ocampo, Carmen; Pascal, Havugarurema; Miller, Erika; Kanyamuhunga, Aimable; Tekleab, Atnafu Mekonnen; Bacha, Tigist; González-Dambrauskas, Sebastian; Bhutta, Adnan T.; Kortz, Teresa B.; Murthy, Srinivas; Remy, Kenneth E.; Global Health Subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; Pediatrics, School of Medicine
    Background: One of the greatest challenges to conducting multicenter research studies in low and middle-income countries (LMICs) is the heterogeneity in regulatory processes across sites. Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research. Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in LMICs during the IRB process of an international multicenter observational point prevalence study (Global PARITY). Design: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study participating centers to explore characteristics of the IRB process, costs, and barriers to research approval. A shorter survey was employed for sites that expressed interest in participating in Global PARITY and started the approval process, but ultimately did not participate in data collection (non-participating sites) to assess IRB characteristics. Results: Of the 91 sites that sought IRB approval, 46 were successful in obtaining approval and finishing the data collection process. The survey was completed by 46 (100%) participating centers and 21 (47%) non-participating centers. There was a significant difference between participating and non-participating sites in IRB approval of a waiver consent and in the requirement for a legal review of the protocol. The greatest challenge to research identified by non-participating sites was a lack of research time and the lack of institutional support. Conclusions: Global collaborative research is crucial to increase our understanding of pediatric critical care conditions in hospitals of all resource-levels and IRBs are required to ensure that this research complies with ethical standards. Critical barriers restrict research activities in some resource limiting countries. Increasing the efficiency and accessibility of local IRB review could greatly impact participation of resource limited sites and enrollment of vulnerable populations.
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    Etiology of hospital mortality in children living in low- and middle-income countries: a systematic review and meta-analysis
    (Frontiers Media, 2024-06-07) Kortz, Teresa B.; Mediratta, Rishi P.; Smith, Audrey M.; Nielsen, Katie R.; Agulnik, Asya; Gordon Rivera, Stephanie; Reeves, Hailey; O'Brien, Nicole F.; Hau Lee, Jan; Abbas, Qalab; Attebery, Jonah E.; Bacha, Tigist; Bhutta, Emaan G.; Biewen, Carter J.; Camacho-Cruz, Jhon; Coronado Muñoz, Alvaro; deAlmeida, Mary L.; Owusu, Larko Domeryo; Fonseca, Yudy; Hooli, Shubhada; Wynkoop, Hunter; Leimanis-Laurens, Mara; Mally, Deogratius Nicholaus; McCarthy, Amanda M.; Mutekanga, Andrew; Pineda, Carol; Remy, Kenneth E.; Sanders, Sara C.; Tabor, Erica; Teixeira Rodrigues, Adriana; Yuee Wang, Justin Qi; Kissoon, Niranjan; Takwoingi, Yemisi; Wiens, Matthew O.; Bhutta, Adnan; Pediatrics, School of Medicine
    In 2019, 80% of the 7.4 million global child deaths occurred in low- and middle-income countries (LMICs). Global and regional estimates of cause of hospital death and admission in LMIC children are needed to guide global and local priority setting and resource allocation but are currently lacking. The study objective was to estimate global and regional prevalence for common causes of pediatric hospital mortality and admission in LMICs. We performed a systematic review and meta-analysis to identify LMIC observational studies published January 1, 2005-February 26, 2021. Eligible studies included: a general pediatric admission population, a cause of admission or death, and total admissions. We excluded studies with data before 2,000 or without a full text. Two authors independently screened and extracted data. We performed methodological assessment using domains adapted from the Quality in Prognosis Studies tool. Data were pooled using random-effects models where possible. We reported prevalence as a proportion of cause of death or admission per 1,000 admissions with 95% confidence intervals (95% CI). Our search identified 29,637 texts. After duplicate removal and screening, we analyzed 253 studies representing 21.8 million pediatric hospitalizations in 59 LMICs. All-cause pediatric hospital mortality was 4.1% [95% CI 3.4%–4.7%]. The most common causes of mortality (deaths/1,000 admissions) were infectious [12 (95% CI 9–14)]; respiratory [9 (95% CI 5–13)]; and gastrointestinal [9 (95% CI 6–11)]. Common causes of admission (cases/1,000 admissions) were respiratory [255 (95% CI 231–280)]; infectious [214 (95% CI 193–234)]; and gastrointestinal [166 (95% CI 143–190)]. We observed regional variation in estimates. Pediatric hospital mortality remains high in LMICs. Global child health efforts must include measures to reduce hospital mortality including basic emergency and critical care services tailored to the local disease burden. Resources are urgently needed to promote equity in child health research, support researchers, and collect high-quality data in LMICs to further guide priority setting and resource allocation.