Symptoms and Dietary Impact in Hypertriglyceridemia-Associated Pancreatitis: Development and Content Validity of Two New Measures
| العنوان: | Symptoms and Dietary Impact in Hypertriglyceridemia-Associated Pancreatitis: Development and Content Validity of Two New Measures |
|---|---|
| المؤلفون: | Karen Selk, Joshua A Strayer, Hayes Dansky, David C. Whitcomb, Cynthia J Girman, Robert J. Sanchez, Jason A. Randall, Erin E. Kershaw, Claire Burbridge, Tara Symonds |
| المصدر: | PharmacoEconomics Open |
| بيانات النشر: | Springer Science and Business Media LLC, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Pharmacology, medicine.medical_specialty, Abdominal pain, business.industry, Health Policy, Hypertriglyceridemia, MEDLINE, medicine.disease, Clinical trial, Internal medicine, Content validity, Medicine, Acute pancreatitis, Pancreatitis, Pharmacology (medical), Original Research Article, Thematic analysis, medicine.symptom, business |
| الوصف: | Background Severe hypertriglyceridemia (sHTG) is a rare condition, complicated by episodes of acute pancreatitis (AP), which can cause pain and/or life-threatening multi-organ dysfunction. Currently, there are no disease-specific patient-reported outcome (PRO) measures evaluating symptoms or dietary impact for this condition. Objective The objective of this study was to explore patient-reported symptoms and impacts of sHTG and AP and develop new measures to capture the symptoms and dietary impacts of this condition using patient language. Methods In-depth, semi-structured concept elicitation interviews were conducted with 12 US-based participants to explore their experience and identify key symptoms and impact on dietary behavior, both during and between episodes of AP. Participants had a range of AP severity with a previous triglyceride reading > 1000 mg/dL, and at least one attack of AP within the last 12 months. Transcripts were coded using thematic analysis. Results Qualitative data analysis revealed the substantial burden of AP associated with sHTG. Participants reported experiencing symptoms, especially abdominal pain, both during and between attacks of AP, and discussed considerable diet changes to prevent or minimize future attacks. A conceptual model was refined, based on patient input, and reviewed by clinical experts to determine key concepts for inclusion within two PRO measures, one evaluating symptoms and another evaluating impact on dietary behavior. Items were drafted using patient-derived language. A 19-item symptoms measure [Hypertriglyceridemia and Acute Pancreatitis Symptom Scale (HAP-SS)] and a 6-item dietary impact measure (Hypertriglyceridemia and Acute Pancreatitis Dietary Behavior (HAP-DB) measure) were developed, both with a 24-h recall period. Conclusions The qualitative analysis confirmed the substantial burden of AP associated with sHTG. This research resulted in development of two disease-specific PRO measures for use during and between attacks of AP. These measures are being utilized in a clinical trial, which will confirm content, structure, and psychometric properties. Electronic supplementary material The online version of this article (10.1007/s41669-019-0155-y) contains supplementary material, which is available to authorized users. |
| تدمد: | 2509-4254 2509-4262 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2b54152fedf0294eaf012c94d60e488c https://doi.org/10.1007/s41669-019-0155-y |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....2b54152fedf0294eaf012c94d60e488c |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 25094254 25094262 |
|---|