Patient-reported Outcome Scale in Acute Pancreatitis
Patient-reported Outcome Scale in Acute Pancreatitis
The PAN-PROMISE study (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis-an international
 proSpEctive cohort study) aims to measure an outcome variable in acute pancreatitis (AP)
 based in the patient´s experience. PAN-PROMISE is a cohort study involving patients with AP.
 The patient´s symptom perception will be compared with the opinion of the clinicians and with
 clinical outcomes.
Currently, the most important outcome variables in Acute Pancreatitis (AP) are persistent
 organ failure (POF) and mortality, according to the physician point of view. These variables
 occur infrequently (<10 and <5% respectively) (Sternby et all, see "References"), therefore,
 studies designed to assess the effectiveness of new treatments for AP to decrease POF or
 mortality require a very large sample of patients, which is unfeasible. Currently, clinical
 trials addressing the management of AP do not take into account Patient Reported Outcome
 Measures.

 PROMS (Patient Reported Outcome Measures) have been defined as any report of the status of a
 patient's health condition that comes directly from the patient, without interpretation of
 the patient's response by a clinician or anyone else (first link in "References"). PROMS are
 gaining importance as a tool to design outcome variables. This kind of measurement has been
 recently included in the quality assesment approaches (Crossing the Quality Chasm: A New
 Health System for the 21st Century, see "References"), being PROMS a useful tool to improve
 the triple aim framework of better quality, appropriate utilization, and enhanced patient
 experience (second link in "References"). The aim of PAN-PROMISE is to incorporate an outcome
 variable in AP based in the patient´s experience. For this purpose the investigators involved
 in this project have developed a new instrument based on symptoms found to be important for
 the patient. This new instrument is intended to be a simple quantitative variable, relevant
 for the patient, that can be useful to test new treatments for AP without the need for a very
 large sample size, fulfilling the requirements of the triple aim framework by incorporating
 an outcome measurement defined by the patient.

 Hypothesis:

 -  PROMS must be incorporated to patient care and research in AP to improve the triple aim
 framework of better quality, appropriate utilization, and enhanced patient experience

 -  A PROMS scale is a useful outcome variable to investigate new treatments in AP

 -  The different severity categories of the revision of the Atlanta Classification (RAC)
 have different scores on the PROMS scale in acute pancreatitis: severe greater than
 moderate and mild, moderate greater than mild.

 -  Increasing scores on the PROMS scale are associated to increased morbidity

 Aims:

 -  Main aim 1: to measure patient´s symptoms during an episode of AP and to correlate the
 intensity of these symptoms to clinical outcomes

 -  Main aim 2: to design and validate a PROMS scale in AP intended to be an suitable
 outcome variable in future trials addressing the management of AP

 Methods

 Part 1: development of the PAN-PROMISE instrument The PAN-PROMISE research team developed a
 qualitative study in which three nominal groups were conducted, two with patients who had
 suffered an acute pancreatitis (AP) in hospitals in Alicante (Universitarian General
 Hospital)), and Valencia (Clinic Hospital), Spain and another with clinicians from the
 Alicante region with experience in treating patients with AP. Participants were asked about
 the symptoms that cause the most discomfort and concern to patients at three specific times:
 before receiving treatment for AP, during hospital admission and after discharge. The
 perspectives of patients and professionals were compared. From the information gathered in
 the nominal groups, a first version of a PROMS questionnaire was elaborated and shared with
 an international group of gastroenterologists, experienced in the management of pancreatitis,
 from 4 countries (Germany, Spain, USA, India and Turkey) through an online application to
 determine to what extent these experiences were shared in frequency and intensity by patients
 in these different countries. With all this information, a PROMS instrument was generated.

 Part 2: measurement of patient´s symptoms in an international cohort study

 2.1 Design. The PAN-PROMISE instrument is being measured in patients participating in a
 multicenter international prospective cohort study. Consecutive adult patients with AP are
 eligible after signed informed consent.

 2.2 Center recruitment The PAN-PROMISE study has been endorsed by the Spanish Association of
 Pancreatology (AESPANC), the Spanish Association of Gastroenterology (AEG) and the
 International Association of Pancreatology (IAP); these associations shared the project with
 their members and through their social networks, calling for researchers and centers to join
 this initiative. PAN-PROMISE has also a webpage www.promisepancreatitis.com to promote center
 recruitment.

 2.3 Patient registry PAN-PROMISE measurement will rely on a patient registry hosted in the
 Spanish Association of Gastroenterology (AEG) REDCap node. AEG offered this REDCap web-based
 online patient registry tool at no cost. Claudia Sánchez-Marin, a gastroenterologist, is on
 charge of quality control (data validation, data checks, contact with researchers to solve
 issues). The REDCap online registry was designed with logical rules to ensure good quality
 data entry, including mandatory fields to enter, logical ranges for quantitative variables,
 alarms if logical rules are not coherent (for example to have persistent organ failure but to
 classify the episode as mild or moderate), expanding fields only available in the presence of
 certain circumstances (for example, detailed organ failure description is only available if
 the patient had organ failure).
Inclusion Criteria:

 -  Patients ≥18 and <80 years.

 -  Karnofsky performance status previous to AP 100 (normal, no complaints, no evidence of
 disease), 90 (able to carry on normal activity; minor signs or symptoms of disease) or
 80 (normal activity with effort; some signs or symptoms of disease).

 -  Acute pancreatitis defined as at least 2 of the following 3 criteria: A) Typical
 abdominal pain, B) Elevation of amylase and/or lipase more than 3 times the upper
 limit of normality, and C) Imaging (preferably CT and/or MR) compatible with AP.

 -  Written informed consent.

 Exclusion Criteria:

 -  Time between onset of symptoms and presentation in the emergency room (ER) greater
 than 48 hours (we do not consider as onset of symptoms previous self-limited heraldic
 biliary pain)

 -  Recruitment >24h after presentation in the ER

 -  Karnofsky performance status previous to AP 70 (Cares for self; unable to carry on
 normal activity or to do active work) or less

 -  Inability to express or understand the instructions of the study (severe congenital or
 acquired intellectual deficit).

 -  More than 1 previous episode of AP.

 -  Chronic pancreatitis.

 -  Presence of diseases or conditions different from AP that may interfere with the
 scale: other causes of abdominal pain (especially acute cholecystitis; Note:
 choledocholithiasis-acute cholangitis is not an exclusion criteria), obstruction of
 the digestive tract (peptic pyloric stenosis, gastrointestinal anastomotic stenosis,
 diabetic gastroparesis, gastrointestinal neoplasia...), nausea-vomiting (brain tumor,
 chemotherapy...) or weakness (pre-existing anemia with Hb <9 mg/dL, heart failure or
 respiratory insufficiency associated with minimal effort dyspnea, or domiciliary
 treatment with O2, advanced neoplasms or other debilitating diseases).