急性胰腺炎患者报告结局测量量表的设计与验证：PAN-PROMISE研究
Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study.
作者信息
de-Madaria Enrique, Sánchez-Marin Claudia, Carrillo Irene, Vege Santhi Swaroop, Chooklin Serge, Bilyak Andriy, Mejuto Rafael, Mauriz Violeta, Hegyi Peter, Márta Katalin, Kamal Ayesha, Lauret-Braña Eugenia, Barbu Sorin T, Nunes Vitor, Ruiz-Rebollo M Lourdes, García-Rayado Guillermo, Lozada-Hernandez Edgard E, Pereira Jorge, Negoi Ionut, Espina Silvia, Hollenbach Marcus, Litvin Andrey, Bolado-Concejo Federico, Vargas Rómulo D, Pascual-Moreno Isabel, Singh Vikesh K, Mira José J
机构信息
Pancreatic Unit, Gastroenterology Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain
Pancreatic Unit, Gastroenterology Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain.
出版信息
Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
OBJECTIVE
This study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient.
DESIGN
A PROM instrument (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, PAN-PROMISE scale) was designed based on the opinion of patients, professionals and an expert panel. The scale was validated in an international multicentre prospective cohort study, describing the severity of AP and quality of life at 15 days after discharge as the main variables for validation. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) methodology was applied. Both the design and validation stages considered the content and face validity of this new instrument; the metric properties of the different items, reliability (reproducibility and internal consistence), the construct, structural and criterion validity, responsiveness and interpretability of this scale.
RESULTS
PAN-PROMISE consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. The validation cohort involved 15 countries, 524 patients. The intensity of symptoms changed from higher values during the first 24 hours to lower values at discharge and 15 days thereafter. Items converged into a unidimensional ordinal scale with good fit indices. Internal consistency and split-half reliability at discharge were adequate. Reproducibility was confirmed using test-retest reliability and comparing the PAN-PROMISE score at discharge and 15 days after discharge. Evidence is also provided for the convergent-discriminant and empirical validity of the scale.
CONCLUSION
The PAN-PROMISE scale is a useful tool to be used as an endpoint in clinical trials, and to quantify patient well-being during the hospital admission and follow-up.
TRIAL REGISTRATION NUMBER
NCT03650062.
目的
本研究旨在开发并验证一种以患者为中心的急性胰腺炎（AP）患者报告结局指标（PROM）作为终点指标。
设计
基于患者、专业人员和专家小组的意见设计了一种PROM工具（急性胰腺炎患者报告结局量表，一项国际前瞻性队列研究，PAN - PROMISE量表）。该量表在一项国际多中心前瞻性队列研究中进行了验证，将AP的严重程度和出院后15天的生活质量作为主要验证变量。应用了COSMIN（基于共识的健康状况测量工具选择标准）方法。设计和验证阶段均考虑了这一新工具的内容和表面效度；不同条目的计量学特性、信度（可重复性和内部一致性）、结构效度、结构和标准效度、反应度及可解释性。
结果
PAN - PROMISE由一个基于引起AP患者最不适和最担忧症状的七项量表组成。验证队列涉及15个国家的524名患者。症状强度在最初24小时内较高，出院时及此后15天降低。条目汇聚成一个单维有序量表，拟合指数良好。出院时的内部一致性和分半信度足够。通过重测信度以及比较出院时和出院后15天的PAN - PROMISE评分来确认可重复性。还提供了该量表的聚合区分效度和实证效度的证据。
结论
PAN - PROMISE量表是一种有用的工具，可作为临床试验的终点指标，并用于量化住院期间和随访期间患者的健康状况。
试验注册号
NCT03650062。
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