Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study

Abstract

ObjectiveThis study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient.DesignA 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.ResultsPAN-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.ConclusionThe 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 numberNCT03650062

Dimensions Used in Instruments for QALY Calculation: A Systematic Review

“…Additionally, when available, we collected information on the sociodemographic characteristics of the participants in the different stages, and the method used to recruit them. The analysis of the quality of the studies was done with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) grid [ 11 ].…”

Early Weight-Based Aggressive vs. Non-Aggressive Goal-Directed Fluid Resuscitation in the Early Phase of Acute Pancreatitis: An Open-Label Multicenter Randomized Controlled Trial (The WATERFALL Trial), Design, and Rationale

“…One important aspect of WATERFALL will be to explore the effect of fluid resuscitation on the patient's symptoms. We may hypothesize that AFR may be associated with decreased thirst [an important symptom for patients with AP ( 14 )] but may increase abdominal distension or even decrease oral tolerance of food. For these reasons, changes in fluid policy may result in changes in patients' wellness.…”

“…For these reasons, changes in fluid policy may result in changes in patients' wellness. Our study will also focus on this frequently eluded point, using the PAN-PROMISE scale, a specific patient-reported outcome measurement for AP ( 14 ).…”

“…(A) PAN-PROMISE scale ( 14 ) ( Table 1 ) will be obtained at recruitment, and at 12 h (±4), 24 h (±4), 48 h (±4), and 72 h (±4) checkpoints…”

“…Few RCTs on AP have taken into account patient symptoms. PAN-PROMISE is a recently validated patient-reported outcome measurement scale for AP ( 14 ), thus making possible to know the impact of this disease on patients' wellness.…”