Content Validation of the Prenatal Evaluation and Referral for Lactation (PEARL) Tool Using a Delphi Method

Abstract

Abstract Background Delayed onset of lactogenesis II or delayed secretory activation defined as > 72 hours postpartum, is a recognized barrier to successful breastfeeding initiation and duration. Prenatal identification and screening for risk factors associated with delayed secretory activation remains underutilized in maternal-child health services. This project aimed to develop and validate the Prenatal Evaluation and Referral for Lactation (PEARL) tool, a prenatal screening and referral tool, to screen for potential lactation risks and provide prompt anticipatory counseling and early referral to an IBCLC lactation consultant or breastfeeding medicine physician. Methods Tool development was informed by a systematic literature review conducted on October 2, 2024, across four databases (CINAHL, PubMed, Scopus, and Embase), identifying clinical and other health factors associated with delayed lactogenesis II. Based on the evidence, preliminary tool items were generated and refined. Content validity and usability were evaluated using a three-round Delphi method with a panel of lactation experts. The iterative survey process assessed item relevance, clarity, and clinical utility, with interrater reliability and item-level content validity thresholds established a priori. Results A panel of twelve lactation professionals participated across three Delphi rounds. In Round 1, the average measures Intraclass Correlation Coefficient (ICC) was 0.769 (95% CI: 0.425–0.953), with a statistically significant F-test result of F(6, 150) = 4.336, p < .001, indicating moderate interrater reliability below the predefined 0.80 threshold. After revisions and expert feedback, Round 2 achieved an ICC of 0.911 (95% CI: 0.787–0.979), reflecting excellent interrater reliability. The F-test for Round 2, F(7, 112) = 11.284, p < .001, further confirmed statistically significant agreement. The final tool includes indicators linked to referral prompts grounded in evidence-based maternal-child health policies. Tool testing included a provider-facing training module to ensure appropriate tool implementation. Conclusions The validated PEARL tool offers a feasible and efficient method to screen for lactation risk factors during prenatal care, facilitating timely referrals and enhancing care coordination. The PEARL tool has the potential to improve breastfeeding outcomes through preventative prenatal interventions.