Patient-reported Outcome Scale in Acute Pancreatitis

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).