Development of postpartum-specific extensions to the PROMIS sleep disturbance and sleep-related impairment item banks

Abstract Background Postpartum sleep is a unique construct, and existing sleep patient-reported outcome measures (PROMs) do not adequately address some of its fundamental domains. We aimed to develop postpartum-specific extension items to the PROMIS Sleep Disturbance (SD) and Sleep Related Impairment (SRI) item banks. Methodology The postpartum-specific SD and SRI items were developed to add to the existing PROMIS SD and SRI item banks. Postpartum-specific PROMIS items were generated based on findings from literature characterizing postpartum sleep, including systematic reviews and qualitative interviews with patients and experts from diverse specialties. The candidate items were subsequently iteratively adapted and selected through a modified Delphi process involving a panel of 21 stakeholders including experts in obstetrics, sleep, psychiatry, patients and partner representatives. Items achieving consensus with ≥ 70% stakeholder agreement were subsequently piloted and refined through recorded cognitive debriefing interviews with postpartum individuals until no further suggestions were generated in 5 consecutive interviews. Results Nine new postpartum SD items, and four new SRI items were developed to extend the existing PROMIS SD (27 items) and SRI item banks (16 items). The new items covered six concepts (psychological factors, infant-related sleep disruption, pain, social support, feeding of infant, and sleep interference with self-care, maternal-neonatal bonding, and energy), and ten underlying dimensions (worry, post-traumatic stress symptoms, maternal-neonatal bonding, activities of daily living, pain, neonatal awakenings, maternal awakenings, latency, social support, infant feeding) of postpartum sleep. Conclusions We developed postpartum-specific extensions to the existing PROMIS SD and SRI item banks using the National Institute of Health PROMIS framework. Next steps include evaluation of their psychometric properties, clinical validation, and studies to establish clinically important differences in scores for clinical application.