BACKGROUND: Cognitive interviewing is a technique that can be used to improve and refine questionnaire items. We describe the basic methodology of cognitive interviewing and illustrate its utility through our experience using cognitive interviews to refine a questionnaire assessing parental understanding of concepts related to preterm birth. METHODS: Cognitive interviews were conducted using current best practices. Results were analyzed by the multidisciplinary research team and questionnaire items that were revealed to be problematic were revised. RESULTS: Revisions to the questionnaire items were made to improve clarity and to elicit responses that truly reflected the participants understanding of the concept. CONCLUSION: Cognitive interviewing is a useful methodology for improving validity of questionnaire items, we recommend researchers developing new questionnaire items design and complete cognitive interviews to improve their items and increase confidence in study conclusions.

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ImportancePreterm birth is a leading cause of infant mortality and child morbidity. Preterm birth is not always unexpected, yet standard prenatal care does not offer anticipatory education to parents at risk of delivering preterm, which leaves parents unprepared to make health care choices during the pregnancy that can improve survival and decrease morbidity in case of preterm birth.ObjectiveTo evaluate the effect of the Preemie Prep for Parents (P3) program on maternal knowledge of preterm birth, preparation for decision-making, and anxiety.Design, Setting, and ParticipantsRecruitment for this randomized clinical trial conducted at a US academic medical center took place from February 3, 2020, to April 12, 2021. A total of 120 pregnant persons with a risk factor for preterm birth were enrolled between 16 and 21 weeks’ gestational age and followed up through pregnancy completion.InterventionStarting at 18 weeks’ gestational age, P3 program participants received links delivered via text message to 51 gestational age–specific short animated videos. Control participants received links to patient education webpages from the American College of Obstetricians and Gynecologists.Main Outcomes and MeasuresAt 25 weeks’ gestation, scores on the Parent Prematurity Knowledge Questionnaire (scored as percent correct), Preparation for Decision Making Scale (scored 0-100), and Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety computerized adaptive test. Analysis was based on an intention to treat.ResultsA total of 120 pregnant participants (mean [SD] age, 32.5 [4.9] years) were included in the study; 60 participants were randomized to each group. Participants in the P3 group scored higher than those in the control group on knowledge of long-term outcomes at 25 weeks (88.5% vs 73.2%; estimated difference, 15.3 percentage points; 95% CI, 8.3-22.5 percentage points; P < .001). Participants in the P3 group reported being significantly more prepared than did participants in the control group for neonatal resuscitation decision-making at 25 weeks (Preparation for Decision Making Scale score, 76.0 vs 52.3; difference, 23.7; 95% CI, 14.1-33.2). There was no difference between the P3 group and the control group in anxiety at 25 weeks (mean [SE] PROMIS Anxiety scores, 53.8 [1.1] vs 54.0 [1.1]; difference, −0.1; 95% CI, −3.2 to 2.9).Conclusions and RelevanceIn this randomized clinical trial, pregnant persons randomly assigned to the P3 program had more knowledge of core competencies and were more prepared to make decisions that affect maternal and infant health, without experiencing worse anxiety. Mobile antenatal preterm birth education may provide a unique benefit to parents with preterm birth risk factors.Trial RegistrationClinicalTrials.gov Identifier: NCT04093492

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