Rationale and design of the Oxycodone Users Registry: A prospective, multicenter registry of patients with nonmalignant pain

Authors

  • Myoung Kim, PhD Ortho McNeil Janssen Scientific Affairs, LLC 1000 Route 202 Room 3204 Raritan, NJ 08869 (908) 218-6419 (908) 218-1286 (fax)
  • Wing Chow, PharmD, MPH Janssen Scientific Affairs, LLC Health Economics and Outcomes Research 1000 Route 202, Room 3255 Raritan, New Jersey 08869 908/927-5102 908/218-1286 (fax)
  • Carmela Benson, MS Ortho McNeil Janssen Scientific Affairs, LLC 1000 Route 202 Raritan, NJ 08869 (908) 927-5102 (908) 218-1286 (fax)

DOI:

https://doi.org/10.5055/jom.2013.0160

Abstract

Objective: This article describes the rationale and design of the Oxycodone Users Registry (OUR) study and lessons learned during study development and data collection.

Design: The OUR study used a prospective registry design.

Setting: Sixty-five academic and private medical practices across the United States, including both specialists and primary care settings.

Participants: A total of 814 patients with 1) injury or trauma of the head, neck, back, chest, or extremities; 2) fibromyalgia; 3) arthritis; 4) neuropathic pain; 5) other back or neck pain; or 6) postoperative pain following outpatient orthopedic surgery.

Interventions: Patients received immediate-release oxycodone either as monotherapy or as combination therapy, starting within 3 days following the baseline visit and continuing as needed for at least 5 days.

Main outcome measures: Patient demographics and disease information were recorded at baseline. Follow-up assessments at days 3, 7, 14, 21, and 28 included pain intensity, pain relief, opioid-related symptoms, a sleep scale, the Brief Pain Inventory-Short Form, and the Work Limitations Questionnaire-Short Form. Adverse events, medical resource utilization, and changes to the oxycodone prescription were recorded during the study. At the end of study treatment, patients rated global treatment satisfaction, how bothersome side effects were, and the most important factor that would discourage them from future oxycodone therapy.

Results: This report describes the study design, rationale, and lessons learned.

Conclusions: Understanding the rationale, design, and lessons learned from the conduct of the OUR study provides insight that can used in future registry studies.

Keywords: oxycodone, opioid, registry, design, rationale

DOI:10.5055/jom.2013.0160

References

Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. 2nd ed. AHRQ Publication No.10-EHC049. Rockville, MD: Agency for Healthcare Research and Quality, 2010.

Lapane KL, Quilliam BJ, Benson C, et al.: Gastrointestinal events after opioid treatment in non-malignant pain: Correlates of occurrence and impact on health related quality of life. J Opioid Manag. 2013; 9: 205-216.

Caudill-Slosberg MA, Schwartz LM, Woloshin S: Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004; 109: 514-519.

Manchikanti L, Singh A: Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Phys. 2008; 11: S63-88.

Katz WA, Barkin RL: Dilemmas in chronic/persistent pain management. Am J Ther. 2008; 15: 256-264.

Harris JD: Management of expected and unexpected opioid-related side effects. Clin J Pain. 2008; 24 (Suppl 10): S8-S13.

Swegle JM, Logemann C: Management of common opioid-induced adverse effects. Am Fam Phys. 2006; 74: 1347-1354.

Oderda GM, Evans RS, Lloyd J, et al.: Cost of opioid-related adverse drug events in surgical patients. J Pain Symptom Manage. 2003; 25: 276-283.

Bell T, Milanova T, Grove G, et al.: OBD symptoms impair quality of life and daily activities, regardless of frequency and duration of opioid treatment: Results of a US patient survey (PROBE survey). J Pain. 2007; 8(Suppl 1): S71.

VanDenKerkhof EG, Hopman WM, Towheed T, et al.: Pain, health-related quality of life and health care utilization after inpatient surgery: A pilot study. Pain Res Manag. 2006; 11: 41-47.

Aparasu R, McCoy RA, Weber C, et al.: Opioid-induced emesis among hospitalized nonsurgical patients: Effect on pain and quality of life. J Pain Symptom Manage. 1999; 18: 280-288.

Kwong W, Gasik A, Voeller S, et al.: Importance of opioid side effects in pain management from patient perspective. J Pain. 2009; 10(Suppl 1): S51.

White PF: Management of postoperative pain and emesis. Can J Anaesth. 1995; 42: 1053-1055.

Burke JP, Pestotnik SL, Classen DC, et al.: Evaluation of the financial impact of ketorolac tromethamine therapy in hospitalized patients. Clin Ther. 1996; 18: 197-211.

Stephens J, Laskin B, Pashos C, et al.: The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors. Rheumatology (Oxford). 2003; 42 Suppl 3: iii40-52.

Stewart WF, Ricci JA, Chee E, et al.: Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003; 290: 2443-2454.

Ricci JA, Stewart WF, Chee E, et al.: Pain exacerbation as a major source of lost productive time in US workers with arthritis. Arthritis Rheum. 2005; 53: 673-681.

Beauregard L, Pomp A, Choiniere M: Severity and impact of pain after day-surgery. Can J Anaesth. 1998; 45: 304-311.

Katz JN: Lumbar disc disorders and low-back pain: Socioeconomic factors and consequences. J Bone Joint Surg Am. 2006; 88 (Suppl 2): 21-24.

Henschke N, Maher CG, Refshauge KM, et al.: Prognosis in patients with recent onset low back pain in Australian primary care: Inception cohort study. BMJ. 2008; 337: a171.

Manchikanti L, Singh V, Smith HS, et al.: Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 4: Observational studies. Pain Phys. 2009; 12: 73-108.

Vogt MT, Kwoh CK, Cope DK, et al.: Analgesic usage for low back pain: Impact on health care costs and service use. Spine. 2005; 30: 1075-1081.

Webster BS, Verma SK, Gatchel RJ: Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine. 2007; 32: 2127-2132.

Franklin GM, Stover BD, Turner JA, et al.: Early opioid prescription and subsequent disability among workers with back injuries: The Disability Risk Identification Study Cohort. Spine. 2008; 33: 199-204.

Gross DP, Stephens B, Bhambhani Y, et al.: Opioid prescriptions in canadian workers’ compensation claimants: Prescription trends and associations between early prescription and future recovery. Spine. 2009; 34: 525-531.

Sadowski CA, Carrie AG, Grymonpre RE, et al.: Access and intensity of use of prescription analgesics among older Manitobans. Can J Clin Pharmacol. 2009; 16: e322-330.

Peacock WF, Hollander JE, Diercks DB, et al.: Morphine and outcomes in acute decompensated heart failure: An ADHERE analysis. Emerg Med J. 2008; 25: 205-209.

Engeland A, Skurtveit S, Morland J: Risk of road traffic accidents associated with the prescription of drugs: A registry-based cohort study. Ann Epidemiol. 2007; 17: 597-602.

Dowling K, Storr CL, Chilcoat HD: Potential influences on initiation and persistence of extramedical prescription pain reliever use in the US population. Clin J Pain. 2006; 22: 776-783.

Chinellato A, Terrazzani G, Debetto P, et al.: Retrospective analysis of opioid prescriptions in cancer patients in a northern Italian region. Br J Clin Pharmacol. 2006; 62: 130-133.

Jauncey ME, Taylor LK, Degenhardt LJ: The definition of opioid-related deaths in Australia: Implications for surveillance and policy. Drug Alcohol Rev. 2005; 24: 401-409.

Meine TJ, Roe MT, Chen AY, et al.: Association of intravenous morphine use and outcomes in acute coronary syndromes: Results from the CRUSADE Quality Improvement Initiative. Am Heart J. 2005; 149: 1043-1049.

Jarlbaek L, Andersen M, Hallas J, et al.: Use of opioids in a Danish population-based cohort of cancer patients. J Pain Symptom Manage. 2005; 29: 336-343.

Herrera E, Rocafort J, De Lima L, et al.: Regional palliative care program in Extremadura: An effective public health care model in a sparsely populated region. J Pain Symptom Manage. 2007; 33: 591-598.

Zorowitz RD, Smout RJ, Gassaway JA, et al.: Usage of pain medications during stroke rehabilitation: the Post-Stroke Rehabilitation Outcomes Project (PSROP). Top Stroke Rehabil. 2005; 12: 37-49.

Murphy BA, Chen A, Curran WJ Jr, et al.: Longitudinal oncology registry of head and neck carcinoma (LORHAN((R))): Initial supportive care findings. Support Care Cancer. 2009; 17(11): 1393-1401.

Jarlbaek L, Andersen M, Kragstrup J, et al.: Cancer patients’ share in a population’s use of opioids. A linkage study between a prescription database and the Danish Cancer Registry. J Pain Symptom Manage. 2004; 27: 36-43.

Kashiwagi M, Arlettaz R, Lauper U, et al.: Methadone maintenance program in a Swiss perinatal center: (I): Management and outcome of 89 pregnancies. Acta Obstet Gynecol Scand. 2005; 84: 140-144.

Arlettaz R, Kashiwagi M, Das-Kundu S, et al.: Methadone maintenance program in pregnancy in a Swiss perinatal center (II): Neonatal outcome and social resources. Acta Obstet Gynecol Scand. 2005; 84: 145-150.

Strike CJ, Gnam W, Urbanoski K, et al.: Factors predicting 2-year retention in methadone maintenance treatment for opioid dependence. Addict Behav. 2005; 30: 1025-1028.

Rehm J, Frick U, Hartwig C, et al.: Mortality in heroin-assisted treatment in Switzerland 1994-2000. Drug Alcohol Depend. 2005; 79: 137-143.

Gibson AE, Degenhardt LJ: Mortality related to pharmacotherapies for opioid dependence: A comparative analysis of coronial records. Drug Alcohol Rev. 2007; 26: 405-410.

Sims SA, Snow LA, Porucznik CA: Surveillance of methadone-related adverse drug events using multiple public health data sources. J Biomed Inform. 2007; 40: 382-389.

Clausen T, Anchersen K, Waal H: Mortality prior to, during and after opioid maintenance treatment (OMT): A national prospective cross-registry study. Drug Alcohol Depend. 2008; 94: 151-157.

Nordt C, Stohler R: Estimating heroin epidemics with data of patients in methadone maintenance treatment, collected during a single treatment day. Addiction. 2008; 103: 591-597.

Davstad I, Stenbacka M, Leifman A, et al.: An 18-year follow-up of patients admitted to methadone treatment for the first time. J Addict Dis. 2009; 28: 39-52.

Deer T, Chapple I, Classen A, et al.: Intrathecal drug delivery for treatment of chronic low back pain: Report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004; 5: 6-13.

Ilias W, le Polain B, Buchser E, et al.: Patient-controlled analgesia in chronic pain patients: Experience with a new device designed to be used with implanted programmable pumps. Pain Pract. 2008; 8: 164-170.

Portenoy RK, Farrar JT, Backonja MM, et al.: Long-term use of controlled-release oxycodone for noncancer pain: Results of a 3-year registry study. Clin J Pain. 2007; 23: 287-299.

Anastassopoulos KP, Chow W, Ackerman SJ, et al.: Oxycodone-related side effects: Impact on degree of bother, adherence, pain relief, satisfaction, and quality of life. J Opioid Manag. 2011; 7: 203-215.

Hale M, Upmalis D, Okamoto A, et al.: Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: A randomized, double-blind study. Curr Med Res Opin. 2009; 25: 1095-1104.

Farrar JT, Young JP, Jr., LaMoreaux L, et al.: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001; 94: 149-158.

Farrar JT, Berlin JA, Strom BL: Clinically important changes in acute pain outcome measures: A validation study. J Pain Symptom Manage. 2003; 25: 406-411.

Farrar JT, Portenoy RK, Berlin JA, et al.: Defining the clinically important difference in pain outcome measures. Pain. 2000; 88: 287-294.

Portenoy RK, Thaler HT, Kornblith AB, et al.: The Memorial Symptom Assessment Scale: An instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994; 30A: 1326-1336.

Apfelbaum JL, Gan TJ, Zhao S, et al.: Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004; 99: 699-709.

Casarett D, Karlawish J, Sankar P, et al.: Designing pain research from the patient’s perspective: What trial end points are important to patients with chronic pain? Pain Med. 2001; 2: 309-316.

Hays R, Stewart A. Sleep measures. In: Stewart A, Ware J, eds. Measuring Functioning and Well-Being: the Medical Outcomes Study Approach. Durham, NC: Duke University Press, 1992: 235-259.

Keller S, Bann CM, Dodd SL, et al.: Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004; 20: 309-318.

Ware J, Jr., Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. Med Care. 1996; 34: 220-233.

Lerner D, Amick BC III, Rogers WH, et al.: The Work Limitations Questionnaire. Med Care. 2001; 39: 72-85.

Poole HM, Murphy P, Nurmikko TJ: Development and preliminary validation of the NePIQoL: A quality-of-life measure for neuropathic pain. J Pain Symptom Manage. 2009; 37: 233-245.

Douglas C, Windsor C, Wollin J: Understanding chronic pain complicating disability: Finding meaning through focus group methodology. J Neurosci Nurs. 2008; 40: 158-168.

Jacobson AF, Myerscough RP, Delambo K, et al.: Patients’ perspectives on total knee replacement. Am J Nurs. 2008; 108: 54-63; quiz 63-54.

Published

05/01/2013

How to Cite

Kim, PhD, M., W. Chow, PharmD, MPH, and C. Benson, MS. “Rationale and Design of the Oxycodone Users Registry: A Prospective, Multicenter Registry of Patients With Nonmalignant Pain”. Journal of Opioid Management, vol. 9, no. 3, May 2013, p. 189—196, doi:10.5055/jom.2013.0160.

Issue

Section

Articles