2.10. Data collection plan
pain, illness, anxiety/depression, Comorbidity
Patients’ data will be gathered through clinical interview, clinical examination, and by reviewing the electronic medical records and the Participant Diary (provided to each participant after randomization).We will gather information on:Baseline characteristics: age, sex, recruiting hospital, body mass index, and the ASA score (American Society of Anesthesiologists’ classification scale of overall physical health).AP etiology.Symptoms presented and their onset date.ER discharge date (Home Monitoring Group).Hospital admission and discharge dates (In-Hospital Group).BISAP score and Charlson Comorbidity Index at diagnosis.Clinical data: Vital signs; VAS score; oral feeding tolerance.Laboratory and Imaging data.ER attendance and/or hospital readmission during the first 30 days after diagnosis.Mortality at 30 days after the diagnosis and new AP episode during the 30-day follow-up.EuroQoL in the outpatient clinic visit.Adverse EventsThe BISAP score is a prognostic scoring system for early identification of patients at risk for in-hospital mortality.The Charlson Comorbidity Index consists of 19 items displaying different clinical weights on the basis of the adjusted risk of one-year mortality, controlling for severity of illness and age. It has been shown to accurately relate with the 10-year life expectancy.The pain VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 centimeters long (100 mm) anchored at the extremes by 2 verbal descriptors referring to the pain status. An introductory question (with or without a time recall period) asks the patient to tick the line on the point that best refers to his/her pain.The EuroQoL questionnaire is a widely used instrument to measure health-related QoL. We will use the EQ-5D-3L version, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale (EQ-VAS). The EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems (labeled 1–3). The EQ-VAS records the respondent’s self-rated health on a vertical VAS where the endpoints are labeled “The best health you can imagine” and “The worst health you can imagine.”