The Inclusion of Patients’ Reported Outcomes to Inform Treatment Effectiveness Measures in Opioid Use Disorder. A Systematic Review

Figures & data

Figure 1 PRISMA Flow Diagram for Study Selection Process.

Notes: PRISMA figure adapted from Page M, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71. Common Creative.⁶⁹

Table 1 Summary of Included Study Characteristics

Author, Year	Study Design	Participant Demographics (Sample Size, Sex, Ethnicity)	Country	Type of MOUD	Inclusion Criteria	Measurement of Patient-Reported Goal	Patient-Reported Goals
Dale-Perera, 2015^Citation38	Cross Sectional	N=248 Male=179 Female=69 Ethnicity=NR	United Kingdom	Methadone, buprenorphine, and buprenorphine-naloxone	Participants currently receiving MOUD	Patients of MOUD were asked about “goals of therapy”.	Presented most reported response. Treatment goal was to become drug-free (56%).
Gelpi-Acosta, 2014^Citation39	Qualitative	Specific population: heroin street users n=28 but only 15 were enrolled in methadone treatment 23 males 16 Hispanic 3 African American 9 Caucasian Mean age=38	United States	Methadone	Participants were 18 years of age or older, able to communicate in English and/or Spanish, currently used heroin, enrolled in methadone treatment, and provided proof of enrollment.	Participants went through a detailed semi-structured interview which was analyzed into themes	Goals were to avoid the “morning sickness”, desire to quit heroin and observe social norms (licit work and family)
Groshkova, 2013^Citation33	Secondary analyses of a trial	N=127 Mean age=37.2 Male=93 Female=34 Ethnicity: Caucasian= 122 African-American=4 Mixed=1	United Kingdom	Optimized oral methadone, supervised injectable heroin, and supervised injectable methadone	Participants were chronic heroin users who were on MOUD for at least 6 months but continued to use heroin for 50% of the time in the past 3 months	Asked the open-ended question at baseline: what areas of your life would you most like help with?	Deduce substance misuse (80.5%) achieve stability, normality, routine, and structure (15.9%) improve education and work opportunities (15.0%) improve housing situation (12.4%) improve physical health (11.5%) improve psychological wellbeing (11.5%) improve finances (11.5%) improve relationships with family and friends (7.1%) increase non-drug scene socialization (6.2%) reduce criminal activity (2.7%)
Marchand, 2020^Citation35	Qualitative	N=30 Mean age=44.7 Female=14 Male=16 Indigenous=7 Non-Indigenous=23	Canada	Injectable diacetylmorphine and hydromorphone treatments	Participants receiving injectable opioid agonist treatment	In-depth interviews that used open-ended questions relating to various domains of patient-centred care	Theme of self-reported outcomes emerged (outcomes that participants prioritized). Outcomes were reduced street opioid use, reduced involvement in illegal activities, reduced worry and stress related to street opioid use and illegal activities, increased sense of stability and routine, and improved health
Mitchell, 2011^Citation34	Qualitative	N=6 Mean age=37 Male=5 Female=1 Mean age=37 Ethnicity Caucasian=6 African American=3	United States	Methadone	Participants who were discharged from initial methadone program but re-entered a new one within 12 months	Semi-structured interview with questions relating to treatment attitude and experiences	Theme of initial goals of treatment emerged which included getting a decent place to live, having a job, going back to school raising children, forging meaningful relationships with others, staying off illicit drugs and being abstinent.
O’Reilly, 2011^Citation37	Mixed Methods	N=41 Mean age=34.5 Male=30 Female=11 Ethnicity = not reported	Ireland	Methadone	Patients receiving methadone treatment	Questionnaire with open and closed-ended questions including long-term treatment goals	Continue methadone treatment into the future (17%) stop methadone treatment in the immediate future (59%) stop taking methadone eventually (22%)
Sanger, 2020^Citation32	Mixed methods	n=2031 mean age=39.1 males=1135 females=896 intersex=1 ethnicity: European n=1154 Indigenous n=367 Other= 437	Canada	Methadone and buprenorphine-naloxone	Participants diagnosed with OUD, receiving MOUD, 16 years of age or older and provided written consent	Asked the open-ended question: What are your goals from treatment?	Themes emerged from the responses which were: stop MOUD, avoid illicit drugs, live a “normal” life, manage pain, avoid OUD symptoms, taper off MOUD, and no changes in treatment wanted.
Stover, 2010^Citation36	Cross-sectional	n=200 males=132 females=68	Germany	Methadone, buprenorphine, and buprenorphine-naloxone	For patients, it was people who are opioid dependent and currently receiving treatment)	Participants were asked a questionnaire on various domains related to their treatment including reasons for starting treatment	Desire to improve their health (71%) change social networks (61%) cease committing crimes, (57%) reduce illicit drug use (52%) improve employment status (51%)

Table 2 Critical Appraisal Skills Program of Included Qualitative Studies

	Was There a Clear Statement of the Aims of Research	Is a Qualitative Methodology Appropriate	Was the Recruitment Strategy Appropriate to the Aims of the Research	Was Data Collected in a Way That Addresses the Research Issue	Has the Relationship Between Researcher and Participant Been Adequately Considered	Have Ethical Issues Been Taken into Considerations	Was the Data Analysis Sufficiently Rigorous	Is There a Clear Statement of Findings	How Valuable is the Research
Marchand 2020	Yes	Yes	Yes	Yes	no	yes	yes	yes	yes
Sanger 2021	Yes	Yes	Yes	Yes	no	yes	yes	yes	yes
Mitchell 2011	Yes	Yes	Yes	Yes	yes	no	yes	yes	yes
Gelpi-Acosta 2015	Yes	Yes	Yes	Yes	yes	no	yes	yes	yes
O’Reilly 2011	Yes	Yes	Yes	Yes	no	no	yes	yes	yes

Table 3 Newcastle-Ottawa Scale Risk of Bias of Included Observational Studies

	Representativeness of the Sample	Sample Size	Non-Respondents	Ascertainment of the Exposure (Risk Factor)	Comparability:	Assessment of the Outcome	Statistical Test		Total
Dale-Perera 2015	*	0	*	0	*	*	*		5
Stover 2010	*	0	0	**	*	*	*		6
	Representativeness of the exposed cohort	Selection of the non-exposed cohort	Ascertainment of the exposure (risk factor)	Demonstration that the outcome of interest was not present at beginning of study	Comparability:	Assessment of the outcome	Was the follow-up long enough for outcomes to occur	Adequacy of follow-up of cohorts	Total
Groshkova 2013	*	*	*	*	*	0	*	0	6

Notes: *Indicates one star in the NOS scale. **Indicates two stars in the NOS.

Table 4 Themes Generated from Patient Reported Outcomes of MOUD

THEME GENERATED	REPORTED OUTCOME 1	REPORTED OUTCOME 2	REPORTED OUTCOME 3	REPORTED OUTCOME 4	REPORTED OUTCOME 5	REPORTED OUTCOME 6	REPORTED OUTCOME 7
TREATMENT RETENTION	No change from current treatment	Continue methadone treatment into the future
AVOID ILLICIT DRUGS	Reduced street opioid use	Become drug-free	Avoid illicit drugs	Staying off illicit drugs	Desire to quit heroin	Reduce substance misuse	Reduce illicit drug use
AVOID WITHDRAWAL	Prevent OUD symptoms	Avoid the “morning sickness”
REDUCE CRIMINAL ACTIVITY	Reduced involvement in illegal activities	Reduce criminal activity	Cease committing crimes to support their opioid dependence
MENTAL HEALTH IMPROVEMENT	Reduced worry and stress related to street opioid use and illegal activities	Improve psychological wellbeing	Good mental health
STABILITY AND NORMALCY	Increased sense of stability and routine	Normal life	Achieve stability, normality, routine, and structure
PHYSICAL HEALTH IMPROVEMENT	Improved health	Improve physical health	Desire to improve their health	Pain Management
STOP MOUD	Stop treatment	Stop taking methadone, either in the immediate future
TAPER OFF MOUD	Taper off treatment	Stop taking methadone, eventually
IMPROVE HOUSING	Getting a decent place to live	Improve housing situation
EDUCATION AND EMPLOYMENT	Having a job	Going back to school	Have licit work	Improve education and work opportunities	Improve finances	Improve employment status	Get education, job, and wanting to support their family
IMPROVED FAMILIAL/SOCIAL RELATIONSHIPS	Raising children	Family	Improve relationships with family and friends	Forging meaningful relationships with others.	Increase non-drug scene socialisation	Change social networks

Page M, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71. doi:10.1136/bmj.n71

 Web of Science ®Google Scholar

Dale-Perera A, Alam F, Barker P. Opioid-dependence treatment in the era of recovery: insights from a UK survey of physicians, patients and out-of-treatment opioid users. J Subst Use. 2015;20(5):354–362. doi:10.3109/14659891.2014.923532

 Web of Science ®Google Scholar

Gelpi-Acosta C. Challenging biopower:“Liquid cuffs” and the “Junkie” habitus. Drugs. 2015;22(3):248–254.

 Web of Science ®Google Scholar

Groshkova T, Metrebian N, Hallam C, et al. Treatment expectations and satisfaction of treatment‐refractory opioid‐dependent patients in RIOTT, the R andomised I njectable O piate T reatment T rial, the UK’s first supervised injectable maintenance clinics. Drug Alcohol Rev. 2013;32(6):566–573. doi:10.1111/dar.12062

 PubMed Web of Science ®Google Scholar

Marchand K, Foreman J, MacDonald S, Harrison S, Schechter MT, Oviedo-Joekes E. Building healthcare provider relationships for patient-centered care: a qualitative study of the experiences of people receiving injectable opioid agonist treatment. Subst Abuse Treat Prev Policy. 2020;15(1):1–9. doi:10.1186/s13011-020-0253-y

 PubMed Web of Science ®Google Scholar

Mitchell SG, Morioka R, Reisinger HS, et al. Redefining retention: recovery from the patient’s perspective. J Psychoactive Drugs. 2011;43(2):99–107. doi:10.1080/02791072.2011.587392

 PubMed Web of Science ®Google Scholar

O’Reilly F, O’Connell D, O’Carroll A, Whitford DL, Long J. Sharing control: user involvement in general practice based methadone maintenance. Ir J Psychol Med. 2011;28(3):129–133. doi:10.1017/S079096670001209X

 PubMedGoogle Scholar

Sanger N, Panesar B, Rosic T, et al. The future of precision medicine in opioid use disorder: inclusion of patient-important outcomes in clinical trials. Braz J Psychiatry. 2020;43:138–146.

 Google Scholar

Stöver H. Barriers to opioid substitution treatment access, entry and retention: a survey of opioid users, patients in treatment, and treating and non-treating physicians. Eur Addict Res. 2011;17(1):44–54. doi:10.1159/000320576

 PubMed Web of Science ®Google Scholar