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. 2024 Aug 2;7(8):e2279.
doi: 10.1002/hsr2.2279. eCollection 2024 Aug.

Surrogate endpoints for neonatal outcome: A rapid review

Shiraz El Adam  1 , Karissa Johnston  1 , Maanasa Venkataraman  1 , Vanessa Perez Patel  2
Affiliations

Surrogate endpoints for neonatal outcome: A rapid review

Shiraz El Adam et al. Health Sci Rep. .
No abstract available

Keywords: preterm birth; review; strength of association; surrogate endpoints; time to delivery.

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Conflict of interest statement

Shiraz El Adam, Karissa Johnston, and Maanasa Venkataraman are employees of Broadstreet HEOR and received consultancy fees from Organon. Vanessa Perez Patel is an employee of Organon.

Figures

Figure 1
Figure 1
Randomized controlled trials evaluating treatment effects on the occurrence of preterm birth and, separately, neonatal morbidity/mortality outcomes (n = 4 studies). The O'Brien et al. study reported odds ratios; all other studies reported relative risks. Abbreviations: 17‐OHPC, 17‐hydroxyprogesterone caproate, PBO, Placebo, PTB, preterm birth. Interpretation: Area < 1 on the x‐axis favors the intervention, while the area > 1 favors placebo. Most trials reported no statistically significant differences between study groups across surrogate and neonatal clinical endpoints; although Meis et al. reported a statistically significant reduction attributed to the intervention for the surrogate endpoint (i.e., preterm birth), significant reductions were not reported for the neonatal clinical endpoints evaluated. The strength of surrogacy was not evaluated in any study.
Figure 2
Figure 2
AMSTAR‐2 quality assessment of systematic literature reviews (n = 25 studies). Interpretation: Overall confidence rating: High, no or one noncritical weakness; Moderate, more than one noncritical weakness; Low, one critical flaw with or without noncritical weaknesses; Critically Low, more than one critical flaw with or without noncritical weaknesses. Abbreviations: AMSTAR, Assessing the Methodological Quality of Systematic Reviews; PICO, Population Intervention Comparator Outcomes.
Figure A1
Figure A1
Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) Flow Diagram. From: Page MJ, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71. Notes: *Articles did not report treatment effect simultaneously in surrogate endpoint(s) and morbidity/mortality outcomes.
See this image and copyright information in PMC

References

    1. Ciani O, Manyara AM, Davies P, et al. A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. EClinicalMedicine. 2023;65:102283. - PMC - PubMed
    1. Kraus VB, Simon LS, Katz JN, et al. Proposed study designs for approval based on a surrogate endpoint and a post‐marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs. Osteoarth Cartil. 2019;27(4):571‐579. - PMC - PubMed
    1. U.S. Food and Drug Administration . Table of surrogate endpoints that were the basis of drug approval or licensure. 2022. https://www.fda.gov/drugs/development-resources/table-surrogate-endpoint...
    1. Garritty C, Gartlehner G, Nussbaumer‐Streit B, et al. Cochrane rapid reviews methods group offers evidence‐informed guidance to conduct rapid reviews. J Clin Epidemiol. 2021;130:13‐22. - PMC - PubMed
    1. Saade GR, Shennan A, Beach KJ, et al. Randomized trials of retosiban versus placebo or atosiban in spontaneous preterm labor. Am J Perinatol. 2021;38(S 01):e309‐e317. - PubMed

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