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Developing a Core Outcome Set for the Evaluation of Antibiotic Use in Prelabor Rupture of Membranes: A Systematic
Dan Liu1,2,3,4, Lin Wu4,5, Jiefeng Luo1,2,3,4
1West China School of Pharmacy, Sichuan University, Chengdu, China.
Insights
This study identified 109 unique outcomes for antibiotic use in prelabor rupture of membranes (PROM), highlighting inconsistencies in research. An initial core outcome set was formed to standardize evaluation in PROM antibiotic studies.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Evidence-Based Medicine
Background:
- Prelabor rupture of membranes (PROM) increases infection risk, yet optimal prophylactic antibiotic regimens are debated.
- Existing research on antibiotics for PROM suffers from inconsistent outcome reporting, complicating data synthesis.
- A standardized core outcome set (COS) is needed to evaluate antibiotic interventions in PROM effectively.
Approach:
- Conducted a systematic review of 90 studies to identify all reported outcomes for antibiotic use in PROM.
- Performed semi-structured interviews with 30 pregnant women experiencing PROM to capture patient perspectives on outcomes.
- Grouped identified outcomes into domains and compared findings between preterm PROM (PPROM) and term PROM (TPROM).
Key Points:
- A total of 109 unique outcomes were identified across 90 studies, with significant overlap and unique reporting (35.1% in PPROM, 57.1% in TPROM).
- The physiological domain was most frequently reported for both PPROM and TPROM outcomes.
- Patient interviews yielded 10 additional outcomes, emphasizing the need to incorporate patient concerns, which are often underreported in existing literature.
Conclusions:
- Significant variability exists in outcome selection and reporting in studies evaluating antibiotics for PROM.
- An initial core outcome set for evaluating antibiotic use in PROM has been established.
- This COS aims to improve consistency and comparability in future research on PROM management.
Abstract:
Background: Prelabor rupture of membranes (PROM) is associated with maternal and neonatal infections. Although guidelines suggest prophylactic antibiotics for pregnant women with PROM, the optimal antibiotic regimen remains controversial. Synthesizing the data from different studies is challenging due to variations in reported outcomes. Objective: This study aimed to form the initial list of outcomes for the core outcome set (COS) that evaluates antibiotic use in PROM by identifying all existing outcomes and patients' views. Methods: Relevant studies were identified by searching PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang, and VIP databases. We also screened the references of the included studies as a supplementary search. We extracted basic information from the articles and the outcomes. Two reviewers independently selected the studies, extracted the data, extracted the outcomes, and grouped them into domains. Then, semi-structured interviews based on the potential factors collected by the systematic review were conducted at West China Second Hospital of Sichuan University. Pregnant women who met the diagnostic criteria for PROM were enrolled. Participants reported their concerns about the outcomes. Two researchers identified the pregnant women's concerns. Results: A total of 90 studies were enrolled in this systematic review. The median outcomes in the included studies was 7 (1-31), and 109 different unique outcomes were identified. Pre-term PROM (PPROM) had 97 outcomes, and term PROM (TPROM) had 70 outcomes. The classification and order of the core outcome domains of PPROM and TPROM were consistent. The physiological domain was the most common for PPROM and TPROM outcomes. Furthermore, 35.1 and 57.1% outcomes were only reported once in PPROM and TPROM studies, respectively. Thirty pregnant women participated in the semi-structured interviews; 10 outcomes were extracted after normalized, and the outcomes were reported in the systematic review. However, studies rarely reported pregnant women's concerns. Conclusion: There was considerable inconsistency in outcomes selection and reporting in studies about antibiotics in PROM. An initial core outcomes set for antibiotics in PROM was formed.
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