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Abstract：
BACKGROUND: Symptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients\' perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI.
METHODS: Concept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants\' understanding of the instructions, items, response scales, and recall periods of the instrument.
RESULTS: During Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.
CONCLUSIONS: The qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.
METHODS: Concept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants\' understanding of the instructions, items, response scales, and recall periods of the instrument.
RESULTS: During Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.
CONCLUSIONS: The qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.
摘要：
背景：症状评估是确定胰腺外分泌功能不全（EPI）的疾病状态和最佳管理的关键因素。需要标准化的患者报告结果（PRO）问卷来评估诊断为EPI的患者的症状。这项定性研究的目的是从患者的角度增加对EPI症状体验的理解，并制定和评估美国EPI患者EPI症状问卷（EPI-SQ）的内容效度。
方法：进行概念启发访谈（第一阶段），以了解临床诊断为EPI的患者的症状体验（即，根据最新值，粪便胰腺弹性蛋白酶值≤200mcg/g）归因于慢性胰腺炎或胰腺切除术。EPI-SQ是基于从第一阶段访谈中提取的数据和临床专家的反馈而开发的。接下来,进行单独的认知访谈(第二阶段)，以评估参与者对说明的理解，items,反应量表，和仪器的召回期。
结果：在第一阶段访谈中（n=21），19名参与者（90％）报告腹痛是最常见的EPI症状，生活方式改变是最常见的影响（n=18；86％）。第二阶段结果表明，所有参与者（n=7）认为12项EPI-SQ与他们的症状体验相关，并且他们理解这些项目，说明,和预期的响应选项。
结论：本研究的定性数据支持EPI-SQ在美国诊断为EPI患者人群中测量EPI症状严重程度的内容有效性。
方法：进行概念启发访谈（第一阶段），以了解临床诊断为EPI的患者的症状体验（即，根据最新值，粪便胰腺弹性蛋白酶值≤200mcg/g）归因于慢性胰腺炎或胰腺切除术。EPI-SQ是基于从第一阶段访谈中提取的数据和临床专家的反馈而开发的。接下来,进行单独的认知访谈(第二阶段)，以评估参与者对说明的理解，items,反应量表，和仪器的召回期。
结果：在第一阶段访谈中（n=21），19名参与者（90％）报告腹痛是最常见的EPI症状，生活方式改变是最常见的影响（n=18；86％）。第二阶段结果表明，所有参与者（n=7）认为12项EPI-SQ与他们的症状体验相关，并且他们理解这些项目，说明,和预期的响应选项。
结论：本研究的定性数据支持EPI-SQ在美国诊断为EPI患者人群中测量EPI症状严重程度的内容有效性。
