Ballantyne JC Patient-centered health care: are opioids a special case? Spine J. 2009 Sep;9(9):770-2. doi: 10.1016/j.spinee.2009.06.006. Epub 2009 Jul 29.
Beaumont JL, Cella D, Phan AT, Choi S, Liu Z, Yao JC Comparison of health-related quality of life in patients with neuroendocrine tumors with quality of life in the general US population. Pancreas. 2012 Apr;41(3):461-6. doi: 10.1097/MPA.0b013e3182328045.
Bernabeo E, Holmboe ES Patients, providers, and systems need to acquire a specific set of competencies to achieve truly patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):250-8. doi: 10.1377/hlthaff.2012.1120.
Brumder T, Wood SB Strategies to improve linkages between primary care and substance abuse treatment. Treatment Research Center Conference on Clinical Innovations in Substance Abuse Treatment May 19, 2012; University of California San Francisco, CA
Centers for Disease Control and Prevention (CDC) Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
Chou R, Fanciullo GJ, Fine PG, Miaskowski C, Passik SD, Portenoy RK Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009 Feb;10(2):131-46. doi: 10.1016/j.jpain.2008.10.009. Review.
Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022. Erratum in: Am J Prev Med. 2010 Dec;39(6):613.
Cohen J Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988
Demidenko E Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46.
Deyo RA, Mirza SK, Turner JA, Martin BI Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102. Review.
Driessen E, Hollon S Motivational interviewing from a cognitive behavioral perspective. Cogn Behav Pract. 2011;18:70-73
Edlund MJ, Martin BC, Russo JE, DeVries A, Braden JB, Sullivan MD The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription. Clin J Pain. 2014 Jul;30(7):557-64. doi: 10.1097/AJP.0000000000000021.
Frantsve LM, Kerns RD Patient-provider interactions in the management of chronic pain: current findings within the context of shared medical decision making. Pain Med. 2007 Jan-Feb;8(1):25-35. Review.
Frosch DL, May SG, Rendle KA, Tietbohl C, Elwyn G Authoritarian physicians and patients' fear of being labeled 'difficult' among key obstacles to shared decision making. Health Aff (Millwood). 2012 May;31(5):1030-8. doi: 10.1377/hlthaff.2011.0576.
Grady D, Berkowitz SA, Katz MH Opioids for chronic pain. Arch Intern Med. 2011 Sep 12;171(16):1426-7. doi: 10.1001/archinternmed.2011.213. Epub 2011 Jun 13.
Greene J, Hibbard JH, Sacks R, Overton V When seeing the same physician, highly activated patients have better care experiences than less activated patients. Health Aff (Millwood). 2013 Jul;32(7):1299-305. doi: 10.1377/hlthaff.2012.1409.
Gureje O, Simon GE, Von Korff M A cross-national study of the course of persistent pain in primary care. Pain. 2001 May;92(1-2):195-200.
Hibbard JH, Greene J What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061. Review.
Hibbard JH, Stockard J, Mahoney ER, Tusler M Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26.
Hinchcliff M, Beaumont JL, Thavarajah K, Varga J, Chung A, Podlusky S, Carns M, Chang RW, Cella D Validity of two new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea short form. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1620-8. doi: 10.1002/acr.20591.
Hsieh FY, Bloch DA, Larsen MD A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34.
Katz MH Long-term opioid treatment of nonmalignant pain: a believer loses his faith. Arch Intern Med. 2010 Sep 13;170(16):1422-4. doi: 10.1001/archinternmed.2010.335. Erratum in: Arch Intern Med. 2010 Nov 8;170(20):1810. Dosage error in article text.
Kline-Simon AH, Falk DE, Litten RZ, Mertens JR, Fertig J, Ryan M, Weisner CM Posttreatment low-risk drinking as a predictor of future drinking and problem outcomes among individuals with alcohol use disorders. Alcohol Clin Exp Res. 2013 Jan;37 Suppl 1:E373-80. doi: 10.1111/j.1530-0277.2012.01908.x. Epub 2012 Jul 24.
Makoul G, Krupat E, Chang CH Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. Epub 2007 Jun 18.
Matthias MS, Krebs EE, Collins LA, Bergman AA, Coffing J, Bair MJ "I'm not abusing or anything": patient-physician communication about opioid treatment in chronic pain. Patient Educ Couns. 2013 Nov;93(2):197-202. doi: 10.1016/j.pec.2013.06.021. Epub 2013 Aug 2.
McLellan AT, Turner BJ Chronic noncancer pain management and opioid overdose: time to change prescribing practices. Ann Intern Med. 2010 Jan 19;152(2):123-4. doi: 10.7326/0003-4819-152-2-201001190-00012. Erratum in: Ann Intern Med. 2010 Mar 16;152(6):408.
Mertens JR, Flisher AJ, Satre DD, Weisner CM The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20.
Miller WR, Rollnick S, eds Motivational Interviewing : Preparing People for Change. 2nd ed. New York: Guildord Press; 2002
National Research Council Health Literacy: A Prescription to End Confusion. Washington, DC: The National Academies Press; 2004. http://www.nap.edu/catalog.php?record_id=10883. Accessed January 19, 2014
Obradovic M, Lal A, Liedgens H Validity and responsiveness of EuroQol-5 dimension (EQ-5D) versus Short Form-6 dimension (SF-6D) questionnaire in chronic pain. Health Qual Life Outcomes. 2013 Jul 1;11:110. doi: 10.1186/1477-7525-11-110. Review.
Okie S A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. Erratum in: N Engl J Med. 2011 Jan 20;364(3):290.
Pain Survey Executive Summary Massachusetts Pain Initiative. 2010. http://www.masspaininitiative.org/files/MassPI%20Pain%20Survey%20-%20Executive%20Summary%20v3.pdf. Updated August 15, 2013. Accessed January 18, 2014.
PROMIS Network Center PROMIS (Patient Reported Outcome Measurement Information System). USA.gov. http://www.nihpromis.org/?AspxAutoDetectCookieSupport=1#3. Accessed January 18, 2014
Putre L Caring for health care's costliest patients: Aligning Forces for Equality & Robert Wood Johnson Foundation. 2014. http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2014/rwjf409911. Accessed January 17, 2014
Substance Abuse and Mental Health Services Administration Table 1.1a. Admissions aged 12 and older, by primary substance of abuse: 1999-2009. Treatment Episode Dataset (TEDS) 1999-2009. National Admissions to Substance Abuse Treatment Services. 2010. http://www.samhsa.gov/data/DASIS/teds09/TEDS2k9NTbl1.1a.htm. Accessed January 19, 2014.
Sullivan MD, Ballantyne JC What are we treating with long-term opioid therapy? Arch Intern Med. 2012 Mar 12;172(5):433-4. doi: 10.1001/archinternmed.2011.2156.
Sullivan MD Limiting the potential harms of high-dose opioid therapy: comment on "Opioid dose and drug-related mortality in patients with nonmalignant pain". Arch Intern Med. 2011 Apr 11;171(7):691-3. doi: 10.1001/archinternmed.2011.101.
Towle A, Godolphin W Framework for teaching and learning informed shared decision making. BMJ. 1999 Sep 18;319(7212):766-71. Review.
Trescott CE, Beck RM, Seelig MD, Von Korff MR Group Health's initiative to avert opioid misuse and overdose among patients with chronic noncancer pain. Health Aff (Millwood). 2011 Aug;30(8):1420-4. doi: 10.1377/hlthaff.2011.0759.
U S. Food and Drug Administration. Background on opioid REMS. Drugs. 2012. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm187975.htm. Updated April 22, 2013. Accessed January 17, 2014.
U S. Food and Drug Administration. Questions and answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) opioid analgesics. Drugs. 2012. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm. Updated March 1, 2013. Accessed January 17, 2014.
Upshur CC, Bacigalupe G, Luckmann R "They don't want anything to do with you": patient views of primary care management of chronic pain. Pain Med. 2010 Dec;11(12):1791-8. doi: 10.1111/j.1526-4637.2010.00960.x. Epub 2010 Oct 1.
Volkow ND, McLellan TA Curtailing diversion and abuse of opioid analgesics without jeopardizing pain treatment. JAMA. 2011 Apr 6;305(13):1346-7. doi: 10.1001/jama.2011.369.
Von Korff M, Kolodny A, Deyo RA, Chou R Long-term opioid therapy reconsidered. Ann Intern Med. 2011 Sep 6;155(5):325-8. doi: 10.7326/0003-4819-155-5-201109060-00011.
Von Korff MR Opioids for chronic noncancer pain: as the pendulum swings, who should set prescribing standards for primary care? Ann Fam Med. 2012 Jul-Aug;10(4):302-3. doi: 10.1370/afm.1422.
Warner M, Chen LH, Makuc DM Increase in fatal poisonings involving opioid analgesics in the United States, 1999-2006. NCHS Data Brief. 2009 Sep;(22):1-8.
Weisner C, Parthasarathy S, Chi F, et al Integrating alcohol and drug treatment with primary care: a medical home model. Treatment Research Center Conference on Clinical Innovations in Substance Abuse Treatment May 19, 2012; University of California San Francisco, CA
Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
