title: Pain severity reduces life quality in chronic pancreatitis: Implications for design of future outcome trials.
abstract: OBJECTIVE
  Chronic pancreatitis (CP) is a disabling disease characterised by abdominal pain, and various pancreatic and extra-pancreatic complications. We investigated the interactions between pain characteristics (i.e. pain severity and its pattern in time), complications, and quality of life (QOL) in patients with CP.
  
  
  METHODS
  This was a cross-sectional study of 106 patients with CP conducted at two North European tertiary medical centres. Detailed information on clinical patient characteristics was obtained from interviews and through review of the individual patient records. Pain severity scores and pain pattern time profiles were extracted from the modified brief pain inventory short form and correlated to QOL as assessed by the EORTC QLQ-C30 questionnaire. Interactions with exocrine and endocrine pancreatic insufficiency, as well as pancreatic and extra-pancreatic complications were analysed using regression models.
  
  
  RESULTS
  Pain was the most prominent symptom in our cohort and its severity was significantly correlated with EORTC global health status (r = -0.46; P < 0.001) and most functional and symptom subscales. In contrast the patterns of pain in time were not associated with any of the life quality subscales. When controlling for interactions from exocrine and endocrine pancreatic insufficiency no effect modifications were evident (P = 0.72 and P = 0.85 respectively), while the presence of pancreatic and extra-pancreatic complications was associated with an almost 15% decrease in life quality (P = 0.004).
  
  
  CONCLUSIONS
  Pain severity and disease related complications significantly reduce life quality in patients with CP. This information is important in order to design more accurate and clinical meaningful endpoints in future outcome trials.
authors.affiliation: Mech-Sense, Department of Gastroenterology & Hepatology, Aalborg University Hospital, Denmark. Electronic address: soren.s.olesen@gmail.com.
authors.forename: Søren Schou
authors.initials: SS
authors.lastname: Olesen
authors.affiliation: Mech-Sense, Department of Gastroenterology & Hepatology, Aalborg University Hospital, Denmark.
authors.forename: Jacob
authors.initials: J
authors.lastname: Juel
authors.affiliation: Mech-Sense, Department of Radiology, Aalborg University Hospital, Denmark.
authors.forename: Anders Klitgaard
authors.initials: AK
authors.lastname: Nielsen
authors.affiliation: Mech-Sense, Department of Radiology, Aalborg University Hospital, Denmark.
authors.forename: Jens Brøndum
authors.initials: JB
authors.lastname: Frøkjær
authors.affiliation: Pain and Nociception Neuroscience Research Group, Department of Anaesthesiology, Pain and Palliative Care, Radboud University Medical Centre, The Netherlands; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Denmark.
authors.forename: Oliver H G
authors.initials: OH
authors.lastname: Wilder-Smith
authors.affiliation: Mech-Sense, Department of Gastroenterology & Hepatology, Aalborg University Hospital, Denmark; Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Denmark.
authors.forename: Asbjørn Mohr
authors.initials: AM
authors.lastname: Drewes
mesh_terms: D000328:Adult; D000368:Aged; D000428:Alcohol Drinking / Q000009:adverse effects; D000701:Analgesics, Opioid / Q000627:therapeutic use; D002760:Cholangiopancreatography, Endoscopic Retrograde; D003430:Cross-Sectional Studies; D003718:Denmark; D010188:Exocrine Pancreatic Insufficiency / Q000150:complications / Q000473:pathology; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010146:Pain / Q000188:drug therapy / Q000209:etiology* / Q000523:psychology*; D010147:Pain Measurement; D050500:Pancreatitis, Chronic / Q000150:complications* / Q000523:psychology*; D011788:Quality of Life; D012107:Research Design; D012907:Smoking / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid
keywords: Chronic pancreatitis; Complications; Pain severity; Pain time pattern; Quality of life; Symptoms