Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews.

INTRODUCTION: To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment. METHODS: Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. The PTV interviews focused on patients' DGP symptoms and the impact of DGP on their lives, and the EOTV interviews focused on any symptom changes patients experienced during the trial. RESULTS: Of 90 enrolled trial participants, 78 (86.7%) opted to participate in the interview study. Bloating, stomach fullness, upper abdominal pain, vomiting, constipation, and heartburn or reflux were each reported spontaneously by a majority of the 73 PTV interview participants with evaluable data. These patients commonly reported bloating (n = 20), upper abdominal pain (n = 12), and nausea (n = 11) as their most bothersome DGP symptom. Of 51 EOTV interview participants, 44 (86.3%) reported improvement in at least one DGP symptom either spontaneously or when asked about specific symptoms reported during their PTV interview. CONCLUSION: Bloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening. FUNDING: Ironwood Pharmaceuticals. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02289846.

Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children.

BACKGROUND: A validated questionnaire is needed to monitor respiratory control in preschool-aged children. OBJECTIVE: We sought to develop and validate a caregiver-completed questionnaire that measures respiratory control in young children. METHODS: A 33-item questionnaire that included asthma impairment and risk items was administered to 486 caregivers of children aged younger than 5 years with a current, recent, or past history of respiratory symptoms. Stepwise regression was used to select a subset of items with the greatest discriminant validity in relation to guidelines-defined asthma control in a random two-thirds development sample. Reliability, validity, and ability to screen for respiratory control problems were tested in development and validation samples (remaining one-third sample). RESULTS: The content of the 5 items selected, the Test for Respiratory and Asthma Control in Kids (TRACK), included frequency of respiratory symptoms (wheeze, cough, shortness of breath), activity limitation, and nighttime awakenings in the past 4 weeks; rescue medication use in the past 3 months; and oral corticosteroid use in the previous year. Reliability was greater than 0.70 in both samples. ANOVA showed that mean scores differed significantly (P < .001) in the expected direction across both samples for 3 levels of guidelines-based respiratory control, physician-recommended change in therapy, and symptom status. In the development and validation samples, screening analyses revealed areas under the receiver operating characteristic curve of 0.88 and 0.82, respectively; control status was correctly classified in 81% and 78% of cases. CONCLUSION: TRACK is a valid, easy-to-administer, caregiver-completed questionnaire of respiratory control in preschool-aged children with symptoms consistent with asthma.