Shifting quality chronic pain treatment measures from processes to outcomes

Christa Coleman; Robert P. Lennon; Rose Hennessy Garza; Christin Veasley; Jay Kuchera; Robert Edwards; Aleksandra E. Zgierska

doi:10.5055/jom.2023.0802

Authors

Christa Coleman, PsyD, MSCP https://orcid.org/0000-0003-4255-5592
Robert P. Lennon, MD, JD
Rose Hennessy Garza, PhD, MPH
Christin Veasley, BS
Jay Kuchera, MD
Robert Edwards, PhD
Aleksandra E. Zgierska, MD, PhD

DOI:

https://doi.org/10.5055/jom.2023.0802

Keywords:

opioids, treatment, monitoring, chronic pain

Abstract

Objective: Misapplication of the 2016 Centers for Disease Control (CDC) opioid prescribing guidelines has led to overemphasis of morphine-equivalent daily dose (MEDD) as a “metric of success” in chronic noncancer pain (CNCP), resulting in unintentional harms to patients. This article reviews CNCP-related guidelines and patient preferences in order to identify pragmatic, patient-centered metrics to assess treatment response and safety in opioid-treated CNCP.

Methods: We reviewed the clinical (CDC), research (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials), and implementability-related guidelines (GuideLine Implementability Appraisal), along with relevant patient-identified treatment goals. From these, we summarize a guideline-concordant, patient-centered, implementable set of measures to aid the clinical management of opioid-treated CNCP.

Results: We identify metrics across three domains of care: (1) treatment response metrics, which align with the CNCP care goals (pain intensity, pain interference including function and quality of life, and global impression of change); (2) risk assessment (“safety”) metrics, eg, MEDD, benzodiazepine-opioid or naloxone-opioid coprescribing, and severity of mental health disorders, which evaluate the risk-benefit profile of opioid therapy; and (3) adherence (“process”) metrics, which assess clinician/patient adherence to the guideline-recommended opioid therapy monitoring practices, eg, the presence of completed treatment agreement or urine toxicology testing. All metrics should be informed by implementability principles, eg, be decidable, executable, and measurable.

Conclusions: This article summarizes guideline-concordant, patient-centered, implementable metrics for assessing treatment response, safety, and adherence in opioid-treated CNCP. Regardless of which specific treatment guidelines are applied, this approach could help conceptualize and standardize the collection and reporting of CNCP-relevant metrics, compare them across health systems, and optimize care and treatment outcomes in opioid-treated CNCP.

Author Biographies

Christa Coleman, PsyD, MSCP

Assistant Professor, Departments of Psychiatry and Behavioral Health and Anesthesiology and Perioperative Medicine, Penn State College of Medicine, Hershey, Pennsylvania

Robert P. Lennon, MD, JD

Associate Professor, Department of Family and Community Medicine, Penn State College of Medicine, Hershey; Affiliate Faculty, Penn State Law, University Park, Pennsylvania

Rose Hennessy Garza, PhD, MPH

Visiting Assistant Professor, Joseph J Zilber School of Public Health, University of Wisconsin – Milwaukee, Milwaukee, Wisconsin

Christin Veasley, BS

Co-Founder & Director, Chronic Pain Research Alliance, Milwaukee, Wisconsin

Jay Kuchera, MD

Director, Specialized Opioid Support Services, Resolute Pain Solutions, Envision Physician Services, Port Saint Lucie, Florida

Robert Edwards, PhD

Associate Professor, Department of Anesthesiology, Brigham & Women’s Hospital, Harvard School of Medicine, Boston, Massachusetts

Aleksandra E. Zgierska, MD, PhD

Professor, Departments of Family and Community Medicine, Public Health Sciences, and Anesthesiology and Perioperative Medicine, Penn State College of Medicine, Hershey, Pennsylvania

References

Dowell D, Haegerich TM, Chou R: CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016; 65(1): 1-49. DOI: 10.15585/mmwr.rr6501e1.

Centers for Disease Control and Prevention, National Center for Injury Prevention and Control: Quality improvement (QI) and care coordination: Implementing the CDC guideline for prescribing opioids for chronic pain. 2021. Available at https://www.cdc.gov/opioids/healthcare-admins/pdf/Quality-Improvement-Care-Coordination-508.pdf. Accessed October 4, 2023.

Stone W, Huang P: CDC issues new opioid prescribing guidance, giving doctors more leeway to treat pain. NPR. 2022. Available at https://www.npr.org/sections/healthshots/2022/11/03/1133908157/new-opioid-prescribing-guidelines-give-doctors-more-leeway-to-treat-pain. Accessed September 11, 2023.

Busse JW, Juurlink D, Guyatt GH: Addressing the limitations of the CDC guideline for prescribing opioids for chronic noncancer pain. CMAJ. 2016; 188(17-18): 1210-1211. DOI: 10.1503/cmaj.161023.

Busse JW, Craigie S, Juurlink DN, et al.: Guideline for opioid therapy and chronic noncancer pain. CMAJ. 2017; 189(18): E659-E666. DOI: 10.1503/cmaj.170363.

Larochelle MR, Lodi S, Yan S, et al.: Comparative effectiveness of opioid tapering or abrupt discontinuation vs no dosage change for opioid overdose or suicide for patients receiving stable long-term opioid therapy. JAMA Netw Open. 2022; 5(8): e2226523. DOI: 10.1001/jamanetworkopen.2022.26523.

Agnoli A, Xing G, Tancredi DJ, et al.: Association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. JAMA. 2021; 326(5): 411-419. DOI: 10.1001/jama.2021.11013.

CMS: Note to: Medicare advantage organizations, prescription drug plan sponsors, and other interested parties. 2018. Available at https://www.cms.gov/medicare/health-plans/medicareadvtgspecratestats/downloads/announcement2018.pdf. Accessed May 19, 2021.

Dowell D, Ragen KR, Jones CM, et al.: CDC clinical practice guideline for prescribing opioids for pain—United States, 2022. MMWR Recomm Rep. 2022; 71(RR-3): 1-95. DOI: 10.15585/mmwr.rr7103a1.

Voon P, Karamouzian M, Kerr T: Chronic pain and opioid misuse: A review of reviews. Subst Abuse Treat Prev Policy. 2017; 12(1): 36. DOI: 10.1186/s13011-017-0120-7.

Knight KR, Kushel M, Chang JS, et al.: Opioid pharmacovigilance: A clinical-social history of the changes in opioid prescribing for patients with co-occurring chronic non-cancer pain and substance use. Soc Sci Med. 2017; 186: 87-95. DOI: 10.1016/j.socscimed.2017.05.043.

US Food and Drug Administration (FDA): The voice of the patient: Chronic pain. Center for Drug Evaluation and Research (CDER). FDA. Available at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/voice-patient-seriesreports-fdas-patient-focused-drug-development-initiative. Accessed February 19, 2020.

Dowell D, Haegerich T, Chou R: No shortcuts to safer opioid prescribing. N Engl J Med. 2019; 380(24): 2285-2287. DOI: 10.1056/NEJMp1904190.

Kroenke K, Alford DP, Argoff C, et al.: Challenges with implementing the centers for disease control and prevention opioid guideline: A consensus panel report. Pain Med. 2019; 20(4): 724-735. DOI: 10.1093/pm/pny307.

US Food and Drug Administration: FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. FDA Drug Safety Communication. 2019. Available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuationopioid-pain-MEDDicines-and-requires-label-changes. Accessed February 19, 2020.

Hayes CJ, Krebs EE, Hudson T, et al.: Impact of opioid dose escalation on the development of substance use disorders, accidents, self-inflicted injuries, opioid overdoses and alcohol and non-opioid drug-related overdoses: A retrospective cohort study. Addiction. 2020; 115: 1098-1112.

Shiffman RN, Dixon J, Brandt C, et al.: The GuideLine Implementability Appraisal (GLIA): Development of an instrument to identify obstacles to guideline implementation. BMC Med Inform Decis Mak. 2005; 5: 23. DOI: 10.1186/1472-6947-5-23.

Kharasch ED, Clark JD, Adams JM: Opioids and public health: The prescription opioid ecosystem and need for improved management. Anesthesiology. 2022; 136(1): 10-30. DOI: 10.1097/ALN.0000000000004065.

Dworkin RH, Turk DC, Farrar JT, et al.: Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005; 113(1-2): 9-19. DOI: 10.1016/j.pain.2004.09.012.

Bothmer J, Broatch J, Hemmenway N, et al.: Chronic pain assessment: Pain perspectives. 2019. Available at http://www.forgrace.org/grace-content/uploads/2019/11/Grunenthal-Pain-Scale-FINAL-2-11.19.pdf. Accessed May 9, 2022.

Krebs EE, Lorenz KA, Bair MJ, et al.: Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009; 24(6): 733-738. DOI: 10.1007/s11606-009-0981-1.

Kerns RD, Turk DC, Rudy TE: The West Haven-Yale multidimensional pain inventory (WHYMPI). Pain. 1985; 23(4): 345-356. DOI: 10.1016/0304-3959(85)90004-1.

Cleeland CS, Ryan KM: Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994; 23(2): 129-138.

Beck AT, Ward CH, Mendelson M, et al.: An inventory for measuring depression. Arch Gen Psychiatry. 1961; 4: 561-571. DOI: 10.1001/archpsyc.1961.01710120031004.

McNair DM, Lorr M, Droppleman LF: Profile of Mood States. San Diego, CA: Educational and Industrial Testing Service, 1971.

Guy W: ECDEU Assessment Manual for Psychopharmacology (DHEW Publication No. ADM 76–338). Washington, DC: US Government Printing Office, 1976.

Begg C, Cho M, Eastwood S, et al.: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996; 276(8): 637-639. DOI: 10.1001/jama.276.8.637.

Turk DC, Dworkin RH, Allen RR, et al.: Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003; 106(3): 337-345. DOI: 10.1016/j.pain.2003.08.001.

Turk DC, Dworkin RH, Revicki D, et al.: Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain. Pain. 2008; 137(2): 276-285. DOI: 10.1016/j.pain.2007.09.002.

Banta-Green CJ, Merrill JO, Doyle SR, et al.: Opioid use behaviors, mental health and pain—Development of a typology of chronic pain patients. Drug Alcohol Depend. 2009; 104(1-2): 34-42. DOI: 10.1016/j.drugalcdep.2009.03.021.

Smith SM, Paillard F, McKeown A, et al.: Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: An ACTTION systematic review. J Pain. 2015; 16(5): 389-411. DOI: 10.1016/j.jpain.2015.01.009.

Volkow ND, Jones EB, Einstein EB, et al.: Prevention and treatment of opioid misuse and addiction: A review. JAMA Psychiatry. 2019; 76(2): 208-216. DOI: 10.1001/jamapsychiatry.2018.3126.

Yudko E, Lozhkina O, Fouts A: A comprehensive review of the psychometric properties of the drug abuse screening test. J Subst Abuse Treat. 2007; 32(2): 189-198. DOI: 10.1016/j.jsat.2006.08.002.

Reinert DF, Allen JP: The alcohol use disorders identification test: An update of research findings. Alcoholism Clin Exp Res. 2007; 31(2): 185-199. DOI: 10.1111/j.1530-0277.2006.00295.x.

Kroenke K, Spitzer RL, Williams JB: The Patient Health Questionnaire-2: Validity of a two-item depression screener. Med Care. 2003; 41(11): 1284-1292. DOI: 10.1097/01.MLR.0000093487.78664.3C.

Kroenke K, Spitzer RL, Williams JB: The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med. 2001; 16(9): 606-613. DOI: 10.1046/j.1525-1497.2001.016009606.x.

Kroenke K, Spitzer RL, Williams JB, et al.: The patient health questionnaire somatic, anxiety, and depressive symptom scales: A systematic review. Gen Hosp Psychiatry. 2010; 32(4): 345-359. DOI: 10.1016/j.genhosppsych. 2010.03.006.

Posner K, Brown GK, Stanley B, et al.: The Columbia-suicide severity rating scale: Initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011; 168(12): 1266-1277. DOI: 10.1176/appi.ajp.2011.10111704.

Frank JW, Lovejoy TI, Becker WC, et al.: Patient outcomes in dose reduction or discontinuation of long-term opioid therapy: A systematic review. Ann Intern Med. 2017; 167(3): 181-191. DOI: 10.7326/M17-0598.

Coffin PO, Barreveld AM: Inherited patients taking opioids for chronic pain—Considerations for primary care. N Engl J Med. 2022; 386(7): 611-613. DOI: 10.1056/NEJMp2115244.

Tuan WJ, Sehgal N, Zgierska AE: Using electronic health record's data to assess daily dose of opioids prescribed for outpatients with chronic non-cancer pain. Fam Med Community Health. 2021; 9(Suppl. 1). DOI: 10.1136/fmch-2021-001277.

Agarwal AK, Lee D, Ali Z, et al.: Patient-reported opioid consumption and pain intensity after common orthopedic and urologic surgical procedures with use of an automated text messaging system. JAMA Netw Open. 2021; 4(3): e213243. DOI: 10.1001/jamanetworkopen.2021.3243.

Smith SM, Jones JK, Katz NP, et al.: Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations. J Pain. 2017; 18(11): 1287-1294. DOI: 10.1016/j.jpain.2017.03.015.

Quanbeck A, Brown RT, Zgierska AE, et al.: A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: A novel implementation strategy for adopting clinical guidelines for opioid prescribing in primary care. Implementation Sci. 2018; 13(1): 21. DOI: 10.1186/s13012-018-0713-1.

Bifulco L, Anderson DR, Blankson ML, et al.: Evaluation of a chronic pain screening program implemented in primary care. JAMA Netw Open. 2021; 4(7): e2118495. DOI: 10.1001/jamanetworkopen.2021.18495.

Coleman C, Lennon R, Robinson J, et al.: Opioid dose risk, clinician and patient characteristics and adherence to opioid prescribing recommendations in chronic noncancer pain. J Opioid Manag. 2023, in press.

Holzer KJ, Veasley C, Kerns RD, et al.: Partnering with patients in clinical trials of pain treatments: A narrative review. Pain. 2022; 163(10): 1862-1873.