title: The Burden of Opioid-Induced Constipation: Discordance Between Patient and Health Care Provider Reports.
abstract: BACKGROUND
  Opioid-induced constipation (OIC), a common side effect of opioid treatment for chronic pain, affects patient health-related quality of life (HRQL) and may prompt some patients to lower the dose or alter adherence to their opioid medication, compromising pain relief. Although health care providers (HCPs) are aware of the potential for OIC, patients may not inform their HCPs of their OIC symptoms, and HCPs may not initiate conversation regarding OIC if their patients' pain is controlled. Patients often try to address OIC symptoms on their own by using natural approaches or over-the-counter options. When OIC is discussed in an office visit, HCPs typically recommend conventional laxatives to relieve symptoms, but the efficacy of this approach is unproven and often suboptimal. In many areas of medicine, HCP perceptions of the impact of adverse effects of treatment on a patient's HRQL do not align with the patient's experience.
  
  
  OBJECTIVE
  To (a) describe HCP-reported understanding of his or her patients' experiences with OIC and (b) evaluate the level of agreement or discordance in perception between patients and their HCPs of OIC's impact on clinical outcomes.
  
  
  METHODS
  This was a prospective, longitudinal, observational cohort study conducted in the United States, Canada, Germany, and the United Kingdom (NCT01928953) in patients aged 18 to 85 years who had been receiving daily opioid therapy for ≥ 4 weeks for chronic noncancer pain with presence of OIC in the past 2 weeks. Data were collected from retrospective chart reviews, HCP questionnaires, and web-based patient surveys. Eligible patients enrolled online and completed the Patient Assessment of Constipation-Symptoms, the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem, the EuroQOL 5 Dimensions, and the Global Assessment of Treatment Benefit, Satisfaction, and Willingness to Continue standardized questionnaires. The patient-reported component included 1 baseline survey and 8 follow-up surveys over 24 weeks. HCPs completed a web-based survey at baseline and at week 24 to assess their perceptions of OIC burden, treatment patterns, laxative use, and overall treatment satisfaction. The correspondence of patient- and HCP-reported data was evaluated for all similar outcomes from these 2 databases.
  
  
  RESULTS
  Patients (N = 489) reported a mean (SD) number of bowel movements (BMs) per week and spontaneous BMs per week of 3.7 (2.9) and 1.4 (2.3), respectively, at baseline. Most (87%) reported chronic pain of ≥ 2 years duration; 65% had used opioids for ≥ 2 years; and the mean pain score at baseline was 6.3, consistent with a moderate-to-severe pain population. Most (97%) patients at baseline reported any gastrointestinal-related symptom of at least moderate intensity, with 82% reporting the same intensity of any symptom at week 24. Of the 405 patients who had seen their HCPs in the past month, 63% reported that they had spoken to their HCPs about constipation, and 62% reported that their HCPs had asked them if they had constipation in the past month. The proportion of agreement between HCPs and their patients on the presence of constipation at baseline was 61%. Similar average pain ratings between HCPs and patients (5.9 vs. 6.0) at week 24 suggested clear communication regarding the level of pain experienced by the patient; however, OIC symptoms, laxative use and effectiveness, and impact of OIC on pain management and HRQL were not fully appreciated by HCPs.
  
  
  CONCLUSIONS
  The importance and severity of OIC are perceived differently by patients and their HCPs, a discordance that complicates pain management and demonstrates a need for greater communication. These disparate perceptions indicate a need for clinical education and coordination of care by HCPs to improve understanding and proactively manage OIC in patients with chronic noncancer pain.
authors.affiliation: 1 Group Director of Quality, Design & Analytics, Global Medicines Development, Payer & Real World Evidence, AstraZeneca Pharmaceuticals, Gaithersburg, Maryland.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: LoCasale
authors.affiliation: 2 U.S. Medical Affairs Medical Lead, AstraZeneca Pharmaceuticals, Wilmington, Delaware.
authors.forename: Catherine
authors.initials: C
authors.lastname: Datto
authors.affiliation: 3 Research Scientist, Research, Evidera, Bethesda, Maryland.
authors.forename: Hilary
authors.initials: H
authors.lastname: Wilson
authors.affiliation: 4 Senior Manager and Senior Research Scientist, United BioSource Corporation, Montreal, QC, Canada.
authors.forename: Karen
authors.initials: K
authors.lastname: Yeomans
authors.affiliation: 5 Vice President, Research, Evidera, Bethesda, Maryland.
authors.forename: Karin S
authors.initials: KS
authors.lastname: Coyne
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects* / Q000627:therapeutic use; D059350:Chronic Pain / Q000188:drug therapy; D003248:Constipation / Q000139:chemically induced*; D005260:Female; D006282:Health Personnel; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D000701:Analgesics, Opioid