Patient-reported Outcome Scale in Acute pancreatitis-an International Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 525
- 试验地点
- 26
- 主要终点
- Severity of acute pancreatitis according to the revised Atlanta classification [incidence of local and/or systemic complications]
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Severity of acute pancreatitis according to the revised Atlanta classification [incidence of local and/or systemic complications]
时间窗: Up to 15 days after hospital discharge from index hospital admission
Mild acute pancreatitis (no complications), moderately severe acute pancreatitis (local complications and/or transient (≤48h) organ failure and/or exacerbation of previous comorbidity), severe acute pancreatitis (persistent (\>48h) organ failure) (see revised Atlanta classification, Banks et al, Gut 2013)
PAN-PROMISE patient reported outcome measurement instrument
时间窗: From within 24h after admission to 15 days after discharge
PROMISE SCALE (Patient-reported Outcome Scale in Acute pancreatitis) Each item is scored from 0 to 10 ( worst score in the last 24h): 0 none, 10: the highest possible intensity according to the patient 1. Pain, especially in the abdomen, chest or back 2. Abdominal distention (bloating, sensation of excess gas) 3. Difficulty eating, sensation of food being stuck in the stomach 4. Difficulty with bowel movements (constipation or straining on bowel movements) 5. Nausea and/or vomiting 6. Thirst 7. Weakness, lack of energy, fatigue, difficulty moving
次要结局
- Systemic Inflammatory Response Syndrome (SIRS)(Up to 15 days after hospital discharge from index hospital admission)
- C-reactive protein(48 and 72h after recruitment)
- EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30) Version 3.0(15 days after hospital discharge)
- Need for invasive treatment(Up to 15 days after hospital discharge from index hospital admission)
- Admission in the Intensive Care Unit(Up to 15 days after hospital discharge from index hospital admission)
- Mortality(Up to 15 days after hospital discharge from index hospital admission)
- Local complications (incidence of pancreatic/peripancreatic necrosis and acute peripancreatic fluid collections)(Up to 15 days after hospital discharge from index hospital admission)
- Need for nutritional support(Up to 15 days after hospital discharge from index hospital admission)
- Organ failure(Up to 15 days after hospital discharge from index hospital admission)
- Hospital readmission(Up to 15 days after hospital discharge from index hospital admission)
- Hospital stay(Up to 15 days after hospital discharge from index hospital admission)
研究者
Enrique de-Madaria
Principal Investigator
Hospital General Universitario de Alicante