Research

JAMA | Original Investigation

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

A Randomized Clinical Trial
Harbinder K. Sandhu, DHealthPsy; Katie Booth, MSc; Andrea D. Furlan, MD, PhD; Jane Shaw, BSc;
Dawn Carnes, PhD; Stephanie J. C. Taylor, MD; Charles Abraham, PhD; Sharisse Alleyne, BSc;
Shyam Balasubramanian, MD; Lauren Betteley, BA; Kirstie L. Haywood, PhD; Cynthia P. Iglesias-Urrutia, PhD;
Sheeja Krishnan, PhD; Ranjit Lall, PhD; Andrea Manca, PhD; Dipesh Mistry, PhD; Sian Newton, MSc;
Jennifer Noyes, MD; Vivien Nichols, MSc; Emma Padfield, HnD; Anisur Rahman, PhD; Kate Seers, DSc;
Nicole K. Y. Tang, PhD; Colin Tysall, ONC; Sam Eldabe, MD; Martin Underwood, MD

Visual Abstract
IMPORTANCE Opioid use for chronic nonmalignant pain can be harmful. Viewpoint page 1738
OBJECTIVE To test whether a multicomponent, group-based, self-management intervention Related article page 1789
reduced opioid use and improved pain-related disability compared with usual care.
Supplemental content
DESIGN, SETTING, AND PARTICIPANTS Multicentered, randomized clinical trial of 608 adults
taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl,
hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol,
and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary
care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred
March 18, 2020.

INTERVENTION Participants were randomized 1:1 to either usual care or 3-day–long group
sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support
delivered by a nurse and lay person for 12 months.

MAIN OUTCOMES AND MEASURES The 2 primary outcomes were Patient-Reported Outcomes
Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score
(T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important
difference, 3.5) and the proportion of participants who discontinued opioids at 12 months,
measured by self-report.

RESULTS Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median
daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month
follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores
between the 2 groups at 12-month follow-up (−4.1 in the intervention and −3.17 in the usual
care groups; between-group difference: mean difference, −0.52 [95% CI, −1.94 to 0.89];
P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the
intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55
[95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001).
Serious adverse events occurred in 8% (25/305) of the participants in the intervention group
and 5% (16/303) of the participants in the usual care group. The most common serious
adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care
group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care
group). Four people (1%) in the intervention group received additional medical care for
possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever
and pain, small intestinal bleed, and an overdose suicide attempt).

CONCLUSIONS AND RELEVANCE In people with chronic pain due to nonmalignant causes,
compared with usual care, a group-based educational intervention that included group and
individual support and skill-based learning significantly reduced patient-reported use of
opioids, but had no effect on perceived pain interference with daily life activities. Author Affiliations: Author
affiliations are listed at the end of this
TRIAL REGISTRATION isrctn.org Identifier: ISRCTN49470934 article.
Corresponding Author: Harbinder K.
Sandhu, DHealthPsy, Warwick Clinical
Trials Unit, Warwick Medical School,
University of Warwick, Gibbet Hill,
Coventry, CV4 7AL, UK (harbinder.k.
JAMA. 2023;329(20):1745-1756. doi:10.1001/jama.2023.6454 [email protected]).

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 Research Original Investigation Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

O
pioids are widely used to treat chronic nonmalig-
nant pain.1 In 2022, an Agency for Healthcare Re- Key Points
search and Quality report concluded that opioids
Question Among patients with chronic pain, does a
may have small beneficial effects for chronic nonmalignant multicomponent intervention consisting of group meetings,
causes of pain, but are not superior to nonopioid therapy education, individual support, and skill-based learning reduce
and are associated with increased risk of short- and long- opioid use and improve pain interference with daily activities
term harms.2 In 2020, more than 142 million opioid pre- compared with usual care?
scriptions were dispensed in the US.3 Findings In this multicentered, randomized clinical trial that
Optimal methods for reducing opioid use remain unclear. included 608 participants with chronic pain due to nonmalignant
Tapering opioids quickly without providing alternatives for causes from primary care settings in the UK, at 12-month
pain management has potential to cause harm, including sui- follow-up, 29% of people in the intervention group, compared
cide, or mental health crisis.4,5 However, prior studies that with 7% in the usual care group, discontinued opioids, but there
were no statistically significant differences in pain interference
used pain self-management, complementary medicine, phar-
with daily life activities between the 2 groups at 12 months.
macological and biomedical intervention, and opioid replace-
ment to reduce chronic opioid use were limited by poor study Meaning Among patients with chronic pain due to nonmalignant
methodology or lack of evidence of safety.6 causes, a group-based educational intervention significantly
reduced opioid use had no effect on perceived pain compared
Multimodal treatment approaches that include nonphar-
with usual care.
macologic strategies may prevent harm due to rapid tapering
while facilitating effective treatment of chronic pain.7 The
I-WOTCH (Improving the Wellbeing of People With Opioid from fixed UK Census categories. Data on race and ethnicity
Treated Chronic Pain) randomized clinical trial (RCT) was were collected to evaluate the generalizability of results in
conducted within the UK National Health Service to test the UK.
whether a multimodal approach that facilitated opioid taper- Potential participants with multiple prior prescriptions of
ing in people with chronic nonmalignant pain could reduce strong opioids were identified from the electronic records of
opioid use and improve pain control among people using general (family) practices in the midlands and northeast geo-
opioids to treat chronic pain from nonmalignant causes. graphic areas of England (Figure 1). People living in chronic care
facilities (care homes) or unable to leave their home without
assistance and those using methadone that was not pre-
scribed for chronic pain were excluded. Posters advertising the
Methods study were placed in clinics to identify potential volunteers.
Trial Design and Oversight Eligibility was determined by telephone.
The trial protocol was approved by the Yorkshire & The Participants completed baseline questionnaires by mail
Humber–South Yorkshire Research Ethics Committee and (Table 1). Medication use at baseline and informed consent were
was overseen by an independent trial steering committee, confirmed by telephone.
with an independent data monitoring and ethics commit-
tee. Written informed consent was obtained from partici- Randomization
pants by mail. Participants were randomized in a 1:1 ratio using a minimiza-
The trial protocol is available in Supplement 1. The initial tion program stratified by geographic locality (midlands/
protocol was developed on September 9, 2016, and finalized on northeast of England), baseline score for pain intensity (low
February 10, 2021, before any data were evaluated. The initial intensity ≤8 and high intensity ≥9), and baseline morphine
statistical analysis plan was completed on May 8, 2018, and fi- equivalent dose of opioids (0-29, 30-59, 60-89, 90-119, 120-
nalized on January 29, 2019, before any data were analyzed. 149, and ≥150 mg).
The clinical trial was designed as a pragmatic, multi- Randomization was performed by the Warwick Clinical
center, 1:1 RCT to test the superiority of an intervention, com- Trials Unit programming team using Structured Query
pared with usual care, for improving outcomes in people with Language. Randomization was performed when at least 16
chronic nonmalignant pain. Enrollment began May 17, 2017, participants had completed baseline testing because 16 par-
and ended January 30, 2019. Final follow-up occurred March ticipants was sufficient to begin an intervention group.
18, 2020. Participants were not blind to group assignment.

Participants Interventions
Participants were 18 years or older and using strong opioids Both groups received enhanced usual care, consisting of
as defined by the British National Formulary (buprenorphine, My Opioid Manager based on the 2010 Canadian Opioid
dipipanone, morphine, diamorphine, fentanyl, hydromor- Guideline,10 a self-help booklet containing information about
phone, methadone, oxycodone, papaveretum, pentazocine, pain, opioids, and opioid tapering, as well as a relaxation CD.
pethidine, tapentadol, and tramadol) for at least 3 months on In addition, the intervention group was offered a group-
most days in the preceding month for chronic nonmalignant based educational intervention designed to encourage opioid
pain8 (eTable 2 in Supplement 2). Race and ethnicity data cessation with a mutually agreeable decision plan between
were collected using self-report, and participants selected the participant and nurse. The intervention also increased

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 Reducing Opioid Use for Chronic Pain With a Group-Based Intervention Original Investigation Research

Figure 1. Participant Selection, Randomization, and Follow-up in the I-WOTCH Trial

21 353 Adults not receiving palliative care and with ≥2 prescriptions for
strong opioids in 6 mo identified from 191 clinics (computer search)a

19 133 Excluded
18 680 Did not respond to invitation
453 Not invitedb

2220 Replied to invitation

133 Replied and not interested

2087 Interested and approached

for eligibility assessment

546 Did not respond

1541 Assessed for eligibility

491 Ineligible
264 Unable to attend group sessionc
115 Did not use opioids for last 3 mo
26 Younger than 18 y
25 Unknown
22 Did not use opioids for chronic
nonmalignant pain
14 Not fluent in written and spoken English
8 Serious mental health problemsc
8 Participated in a clinical trial in the last 90 d
6 Reported chronic headache as dominant pain
3 Did not want to inform GP of participation
GP indicates general practitioner;
I-WOTCH, Improving the Wellbeing of
1050 Eligible People With Opioid Treated Chronic
Pain; and PROMIS-PI-SF-8a,
442 Eligible but not randomized Patient-Reported Outcomes
293 Consent not received Measurement Information System
102 Not interested Pain Interference Short Form 8a.
19 Unknown a
Nine self-referrals and 5 secondary
12 Unable to contact
8 Consent received too late care referrals.
5 Too late to contact b
General practitioner practice felt it
2 Ineligible inappropriate to approach. Reasons
1 Waiting list included malignant pain, short life
expectancy, care home
resident/housebound, severe
608 Randomizedd
mental illness, and active cancer
causing pain.
c
305 Randomized to receive education 303 Randomized to receive usual care One person listed both reasons.
and support intervention d
Randomization stratified by
geographic locality, baseline pain
76 Without follow-up at 12 moe 92 Without follow-up at 12 moe severity (low/high), and baseline
43 Withdrew completely 46 Lost to follow-up morphine equivalent dose of
29 Lost to follow-up 45 Withdrew completely
opioids. Two self-referrals and 2
4 Died 1 Died
secondary care referrals.
e
See eTable 11 in Supplement 2 for
229 Included in the primary analysis for 210 Included in the primary analysis for
pain interference (PROMIS-PI-SF-8a) pain interference (PROMIS-PI-SF-8a) follow-up rates and availability of
76 Without follow-up 92 Without follow-up secondary outcomes at 4 and 8
225 Included in the primary analysis for 1 Missing primary outcome months. See eTables 10 and 12
opioid usef 208 Included in the primary analysis for through 14 in Supplement 2 for
76 Without follow-up opioid usef information on withdrawals.
4 Missing primary outcome 92 Without follow-up f
Opioid use calculated as morphine
3 Missing primary outcome
equivalent dose per day in the four
weeks prior to 12-month follow-up.

participants’ self-efficacy (confidence), implemented self- experience with opioid tapering. Group topics for discussion
management strategies for pain, and improved well-being.11 included education about opioids and withdrawal and skills-
The intervention included 3-day–long group meetings based learning for self-management of pain. Case studies
held once weekly and led by a trained intervention nurse illustrating successful opioid tapering and challenges were
and by a lay person with chronic nonmalignant pain and discussed. Participants also received an educational DVD,

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 Research Original Investigation Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

Table 1. Baseline Demographic Characteristics and Outcome Measures of All Randomized Participants by Treatment Group

No. (%)
Education and support intervention Usual care
Characteristic (n = 305) (n = 303)
Age, mean (SD), y 62.1 (11.9) 60.4 (13.8)
Gendera
No. 304 301
Male 125 (41) 117 (39)
Female 178 (59) 184 (61)
Other 1 (<1) 0
Race and ethnicity/ancestryb
No. 304 301
Black African 1 (<1) 0
Black Caribbean 3 (1) 3 (1)
Black Other 1 (<1) 0
Indian 2 (1) 4 (1)
Pakistani 1 (<1) 0
White 295 (97) 290 (96)
Other 1 (<1) 3 (1)
Prefer not to say 0 1 (<1)
Employment status
No. 304 301
Employed 67 (22) 65 (22)
Unable to work due to long-term sickness 78 (26) 76 (25)
Retired from paid work 134 (44) 136 (45)
Otherc 25 (8) 24 (8)
Age at time of leaving full-time education, yd
No. 304 301
≤16 174 (57) 172 (57)
≥17 125 (41) 123 (41)
Other 5 (2) 6 (2)
Length of time experiencing pain, y
No. 304 301
≤5 52 (17) 53 (18)
>5 252 (83) 248 (82)
Time taking opioids, y
No. 304 301
≤5 115 (38) 125 (42)
>5 189 (62) 176 (58)
Type of pain disordere
No. 299 300
Multisite pain 277 (93) 264 (88)
Lower back pain 241 (81) 249 (83)
Chronic widespread pain 154 (52) 137 (46)
Daily opioid use, morphine equivalent dose/df
0-29.9 103 (34) 98 (32)
30-59.9 95 (31) 103 (34)
60-89.9 42 (14) 44 (15)
90-119.9 18 (6) 17 (6)
120-149.9 10 (3) 12 (4)
≥150 37 (12) 29 (10)
Median (IQR), mg 49 (25-81) [n = 305] 44 (25-75) [n = 303]

(continued)

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 Reducing Opioid Use for Chronic Pain With a Group-Based Intervention Original Investigation Research

Table 1. Baseline Demographic Characteristics and Outcome Measures of All Randomized Participants by Treatment Group (continued)

No. (%)
Education and support intervention Usual care
Characteristic (n = 305) (n = 303)
Baseline scale scores, mean (SD)
Pain interference (PROMIS-PI-SF-8a)g 68.5 (6.0) [n = 304] 68.2 (6.2) [n = 301]
Pain intensity (PROMIS-PI-SF-3a)h 69.3 (6.8) [n = 305] 68.8 (7.1) [n = 303]
SF-12i
Mental component score 41 (10.8) [n = 304] 41 (11.4) [n = 301]
Physical component score 32 (8.1) [n = 304] 32 (8.1) [n = 301]
Pittsburgh Sleep Quality Indexj 12 (4.3) [n = 278] 12 (4.1) [n = 285]
HADSk
Anxiety 9 (5.1) [n = 303] 9 (5.1) [n = 298]
Depression 9 (4.6) [n = 304] 9 (4.6) [n = 298]
Pain Self-Efficacy Questionnairel 24 (12.7) [n = 301] 25 (13.6) [n = 300]
EQ-5D-5Lm
Utility 0.3 (0.3) [n = 304] 0.4 (0.3) [n = 301]
VAS 47 (21.4) [n = 304] 49 (21.3) [n = 301]
n
SHOWS 11 (5.5) [n = 303] 11 (5.0) [n = 301]
Abbreviations: EQ-5D-5L, EuroQol 5-dimension 5-level; HADS, Hospital Anxiety considered average, while scores 60 to 81.8 indicate high pain intensity.9
and Depression Scale; PROMIS-PI-SF-3a, PROMIS Scale v1.0–Pain Intensity MCID, 3.5 (eTable 37 in Supplement 2).
Short Form 3a; PROMIS-PI-SF-8a, Patient-Reported Outcomes Measurement i
The 12-item Short Form Health Survey compiles 8 domains of daily living to
Information System Pain Interference Short Form 8a; SF, Short Form; assess quality of life. Scores range from 0 to 100, with higher scores reflecting
SHOWS, Short Opiate Withdrawal Scale; VAS, visual analog scale. better physical and mental functioning. Mental MCID, 3.3; physical MCID, 3.8
a
Categories from which participants could choose included male, female, prefer (eTable 34 in Supplement 2).
not to answer, and other. j
Pittsburgh Sleep Quality Index scores range from 0 to 21, with higher scores
b
Ethnicity was self-reported using the listed options, with participants only able indicating worse sleep quality. The 19 self-reported questions are combined to
to select 1 option. There were no participants who reported Chinese or create 7 component scores. The score is calculated by summing the 7
Bangladeshi ethnicity. “Other” was included as a category from which component scores (range, 0-3) to create a global score ranging from 0 to 21.
participants could choose. This global score has been reported. MCID, 3.0 (eTable 37 in Supplement 2).
c k
Other employment status includes participants who were still receiving HADS anxiety and depression scores range from 0 to 21, with higher scores
part-time or full-time education, caring for home/family, unemployed, indicating worse anxiety and depression. Each of the 7 questions measuring
or other. anxiety has a score ranging from 0 to 3. These 7 scores are summated to
d
Leaving education at age 17 years or older includes participants who left create the reported anxiety score. The same method applies to depression
education aged 17 to 19 years, 20 years or older, or participants still in score. Anxiety MCID, 1.7; depression MCID, 1.7 (eTable 35 in Supplement 2).
l
education. “Other” most often referred to those who returned to education Pain Self-Efficacy Questionnaire scores range from 0 to 60, with higher scores
later in life. indicating stronger self-efficacy beliefs. The questionnaire consists of 10
e
Participants self-reported sources of pain and were able to report more than 1. questions, each having a score ranging from 0 to 6. The score is calculated by
f
summing these 10 scores to create the reported score. MCID, 7.0 (eTable 37 in
For opioid types by region, see eTable 2 in Supplement 2.
Supplement 2).
g
PROMIS-PI-SF-8a uses 8 self-reported items from the prior 7 days to m
EQ-5D-5L utility score ranges from less than 0 to 1, with higher scores
determine how much pain interferes with daily life. Reported as standardized
indicating better quality of life. EQ-5D-5L VAS score ranges from 0 to 100, with
T scores and calculated using the recommended HealthMeasures Scoring
scores of 100 indicating “best health you can imagine” and 0 indicating “worst
Service, higher scores indicate greater interference. Scores 40.7 to 60 are
health you can imagine.” These scores ranging from 0 to 100 were
considered average, while scores 60 to 77 indicate high interference.9
self-reported by participants and that self-reported score is reported. Utility
Indicative minimal clinically important difference (MCID), 3.5 (eTable 33 in
MCID, 0.07; VAS MCID, 7.0 (eTable 36 in Supplement 2).
Supplement 2).
n
h
SHOWS score ranges from 0 to 30, with higher scores indicating more severe
PROMIS-PI-SF-3a uses 3 self-reported items from the prior 7 days to
symptoms. The scale consists of 10 questions, each with a score of 0 to 3,
determine how much pain interferes with daily life. Reported as standardized
which are summed to give the reported score. MCID, 3 (eTable 37 in
T scores and calculated using the recommended HealthMeasures Scoring
Supplement 2).
Service, higher scores indicate greater pain intensity. Scores 36.3 to 60 are

relaxation CD, mindfulness CD, and distraction techniques. week (eTable 3 in Supplement 2). The tapering program was
Additionally, participants had an individual, 1-hour consulta- individualized according to opioid preparation and indi-
tion (based on motivational interviewing) with a nurse, 2 vidual circumstances. Audio recordings of a 10% subset of
monitoring telephone calls (30 minutes each), and a face-to- intervention activities were analyzed by the process evalua-
face consultation (1 hour).12 Nurses used a tapering app spe- tion team (C.A., V.N., K.S.) to assess intervention fidelity and
cifically designed for this trial that computed a standard opi- the extent to which the intervention was delivered according
oid tapering plan consisting of a reduction of 10% of the to the manual of procedures.13,14 The total time required for
baseline dose each week until 30% of the baseline dose was each group and individual session was 17 hours over an 8- to
reached, then a reduction of 10% of the remaining dose per 10-week period.

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 Research Original Investigation Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

Primary Outcomes the proportion of participants reporting no opioid use over the
There were 2 primary outcomes measured at 12-month previous 4 weeks, measured at 4 and 8 months. Follow-up
follow-up: the Patient-Reported Outcomes Measurement questionnaires were mailed at 4, 8, and 12 months. When ques-
Information System (PROMIS) Pain Interference Short Form tionnaires were not returned by mail, participants were called
8a (PROMIS-PI-SF-8A) score (T-score range, 40.7-77; 77 indi- by telephone to collect PROMIS-PI-SF-8a, opioid use, and
cates worst pain interference; minimal clinically important EQ-5D-5L.21 Prescribed opioid medication from clinician rec-
difference [MCID], 3.5; eTable 33 in Supplement 2) and the ords and use of health care resources were not reported. While
proportion of participants reporting no opioid use over the the intent was to blind outcome assessors, some participants
previous 4 weeks at 12-month follow-up 15 (eTable 2 in revealed treatment allocation during these calls, thus com-
Supplement 2). Results for both primary outcomes were from plete blinding was not achieved.
patient report, obtained by mailed questionnaire. Patients
who did not return a mailed questionnaire for the primary Adverse Events
outcomes were telephoned. In addition, self-reported opioid Participants were asked if they experienced any adverse events
use data were confirmed in a subsequent telephone call. (AEs) during their taper of opioids in each individual session
Validated MCID values specific to this intervention by the nurse. The principal investigator and clinical members
were not available for any outcome measures. MCID values of the study team assessed and confirmed each adverse event.
were, therefore, based on existing literature (eTables 33-37 All AEs and serious adverse events (SAEs) were reported to the
in Supplement 2). trial management group for review and oversight.
Investigators originally planned to report opioid use as
daily morphine equivalent dose (MED) during the 4 weeks prior Statistical Analysis
to 12-month follow-up.16 However, the final opioid use data The original sample size calculation used the PROMIS-PI-
did not satisfy the normality assumption of the linear regres- SF-8a as the primary outcome.15 To attain a meaningful dif-
sion, due to a large number of zero values and data were posi- ference of 3.5 points on PROMIS-PI-SF-8a, equivalent to a stan-
tively skewed (eTables 30-32 and eFigures 1-2 in Supple- dardized mean difference of 0.35, assuming a usual care group
ment 2). Therefore, the primary outcome for opioid use was mean of 50, an SD of 10, at 5% significance with 90% power
changed to the proportion of participants reporting no opioid (intraclass correlation coefficient of 0.01, mean group size of
use. This decision was made after looking at the blind distri- 10 participants), and allowing for 20% attrition required 468
bution of data. randomized participants. Adjusting the significance level to
2.5% for 2 primary outcomes and adjusting the design effect
Secondary Outcomes for clustering to reflect actual group sizes gave a revised sample
Secondary outcomes were pain intensity (PROMIS Scale v1.0– size of 542.
Pain Intensity Short Form 3a; T-score range, 36.3-81.8; 81.8 The original protocol, dated September 9, 2016, had a single
indicates worst pain intensity; MCID, 3.5 [eTable 37 in primary outcome of pain interference. The target sample size
Supplement 2])17,18; severity of opioid withdrawal symptoms of 468 was achieved on October 24, 2018, and on this date ad-
(Short Opiate Withdrawal Scale [SHOWS]; score range, 0-30; ditional potential participants had provided informed con-
30 indicates worst symptoms; MCID, 3.0 [eTable 37 in sent and were available for randomization. Therefore, the
Supplement 2]) 19 ; health-related quality of life (SF-12v2 protocol was revised on December 19, 2018, to increase
health survey and EuroQol 5-dimension 5-level [EQ-5D-5L]; the sample size to 542 and add the primary outcome of opi-
SF-12 mental and physical component scores range, 0-100, oid use. The independent trial steering committee, data moni-
100 indicates best functioning; mental MCID, 3.3; physical toring committee, funders, and ethics committee all sup-
MCID, 3.8 [eTable 34 in Supplement 2] and EQ-5D-5L utility ported a decision to continue recruitment and include a
score range: <0-1, 1 indicates best quality of life; EQ-5D-5L secondary primary outcome. Independent trial steering com-
visual analog scale range, 0-100, 100 indicates best health; mittee approval was given on October 12, 2018 (section 1 of
utility MCID, 0.07; visual analog scale MCID, 7.0 [eTable 36 Supplement 2). Neither the study team nor the independent
in Supplement 2]) 20, 21 ; sleep quality (Pittsburgh Sleep trial steering committee reviewed any data prior to this deci-
Quality Index; score range, 0-21, 21 indicates worst sleep sion. The analysis plan and protocol were finalized before data
quality; MCID, 3.0 [Supplement 2])22; emotional well-being collection was complete. No decisions on outcome selection
(Hospital Anxiety and Depression Scale; score range, 0-21, 21 were made after data were available.
indicates worst anxiety or depression; anxiety MCID, 1.7; The main analyses were according to treatment allocation
depression MCID, 1.7 [eTable 35 in Supplement 2])23; self- at the time of randomization. Primary outcomes used 2-sided
efficacy (Pain Self-Efficacy Questionnaire; score range, 0-60, tests at the 2.5% significance level. All other statistical tests were
60 indicates strongest self-belief; MCID, 7.0 [eTable 37 in 2-sided at the 5% significance level. The estimates, 95% CIs, and
Supplement 2])24; and the proportion of participants who P values were reported for each statistical test.
reduced opioids by 50% from baseline. Secondary outcomes Partially nested mixed-effects regression (linear and logis-
were measured at baseline and 4, 8, and 12 months. tic) models to estimate the treatment effects for both primary
Additional secondary measures were the proportion of par- and secondary outcomes were used (Tables 2 and 3). Age,
ticipants who reduced opioids by 50% from baseline, mea- gender, site location, baseline pain intensity, baseline opioid
sured at 4, 8, and 12 months, and PROMIS-PI-SF-8a scores and band (for linear model only), and the baseline value of the

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 Reducing Opioid Use for Chronic Pain With a Group-Based Intervention Original Investigation Research

Table 2. Daily Opioid Use and PROMIS-PI-SF-8a Scores at 12 Months (Primary Outcome) and 4 Months and 8 Months (Secondary Outcomes)

No./total (%)
Education and support Absolute difference, % Adjusted effect estimate
intervention Usual care (95% CI) (95% CI) P value
Primary outcomea
Fully tapered off opioids 65/225 (29) 15/208 (7) 21.7 (14.8 to 28.6) OR, 5.55 (2.80 to 10.99)c <.001
at 12 mo (MED = 0)b
e
PROMIS-PI-SF-8a at 12 mo, 64.2 (7.7) [n = 229] 64.7 (7.3) [n = 210] MD, −0.52 (−1.94 to 0.89) −0.89 (−2.12 to 0.33) .15
mean (SD)d
Secondary outcomes
Fully tapered off opioids
(MED = 0)b
At 4 mo 58/224 (26) 7/201 (3) 22.4 (16.1 to 28.7) OR, 11.61 (5.06 to 26.63)c <.001
At 8 mo 57/193 (30) 11/163 (7) 22.8 (15.3 to 30.3) OR, 7.25 (3.46 to 15.18)c <.001
≥50% MED reduction
from baseline
At 4 mo 112/224 (50) 31/201 (15) 34.6 (26.3 to 42.8) OR, 6.12 (3.77 to 9.92)f <.001
At 8 mo 110/193 (57) 38/163 (23) 33.7 (24.1 to 43.2) OR, 4.94 (3.04 to 8.03)f <.001
At 12 mo 129/225 (57) 57/208 (27) 29.9 (21.1 to 38.8) OR, 3.76 (2.47 to 5.71)f <.001
PROMIS-PI-SF-8a score,
mean (SD)d
At 4 mo 64.5 (7.5) [n = 227] 64.6 (7.2) [n = 202] MD, −0.09 (−1.48 to 1.31) −0.73 (−1.93 to 0.48)e .24
At 8 mo 64.5 (7.3) [n = 199] 64.9 (7.5) [n = 166] MD, −0.39 (−1.93 to 1.14) −0.75 (−2.10 to 0.59)e .27
d
Abbreviations: OR, odds ratio; MD, mean difference; MED, morphine equivalent PROMIS-PI-SF-8a T score reported. Refer to footnote a of Table 1 on
dose; PROMIS-PI-SF-8a, Patient-Reported Outcomes Measurement Information PROMIS-PI-SF-8a scoring and calculation. Indicative minimal clinically
System Pain Interference Short Form 8a. important difference (MCID), 3.5 (eTable 33 in Supplement 2).
a e
A total of 433 (71.2%) of the 608 randomized participants had opioid use Based on a heteroscedastic partially nested mixed-effect model with
primary outcome data reported. A total of 439 (72.2%) of the 608 corrected degrees of freedom, adjusted for age, gender, baseline pain
randomized participants had pain interference (PROMIS-PI-SF-8a) primary intensity, geographic location, baseline opioid band, and baseline
outcome data reported. PROMIS-PI-SF-8a T score. The education support group was used as the
b
Daily MED over previous 4 weeks. Reported are those who fully tapered off cluster variable for the intervention group, with individual clusters of size 1
opioids (MED = 0 mg). See eTable 1 in Supplement 2 for equivalences used. used for each participant in usual care.
f
See eTable 18 in Supplement 2 for opioid tapering by baseline MED band. Based on partially nested mixed-effect logistic model adjusted for age, gender,
c
Based on partially nested mixed-effect logistic model adjusted for age, gender, baseline pain intensity, geographic location, and baseline opioid band. The
baseline pain intensity, geographic location, and baseline MED. The education education support group was used as the cluster variable for the intervention
support group was used as the cluster variable for the intervention group, with group, with individual clusters of size 1 used for each participant in usual care.
individual clusters of size 1 used for each participant in usual care. ORs and ORs and 95% CIs are reported.
95% CIs reported.

dependent variable were covariates in the fixed-effects model. type I error due to multiple comparisons, findings for analy-
The education support group was the cluster variable for the in- ses of secondary end points should be interpreted as explor-
tervention group, with individual clusters of size 1 used for each atory. Statistical analyses were conducted using Stata version
participant in usual care, to account for the partial clustering.25,26 16.1 (StataCorp).29
Model assumptions were assessed as appropriate.
In a sensitivity analysis, an instrumental variable analy-
sis to adjust for nonadherence was performed on 2 levels of
adherence: (1) minimal adherence (attending day 1 of the in-
Results
tervention plus the first 1-on-1 session) and (2) full adherence Recruitment
(attending 3 days, the first 1-on-1 session, and ≥1 telephone Of 20 900 people approached in 191 general practices, 2220
calls).27 In addition to the usual assumptions for this analy- potential participants expressed interest in study participa-
sis, monotonicity was required. An inverse probability weight- tion and 9 people self-referred (eTables 5-6 in Supplement 2).
ing analysis was conducted as a sensitivity analysis to assess Of these, 1541 (69%) were reached by telephone and assessed
whether the missing data affected conclusions.28 for eligibility. Of these, 608 people (39%) were randomized
A prespecified subgroup analysis for the primary out- (mean [SD] age, 61 [12.9] years; 362 [60%] were female; and
comes, testing for an interaction for baseline anxiety, depres- 585 [96%] reported their ethnicity as White British and 8 as
sion, and opioid use, defined using their median values was Black [1.3%]) (Figure 1; Table 1; eTables 7-9 in Supplement 2).
completed. Prespecified sensitivity analyses for the primary At baseline, 34% (103/305) in the intervention group and 32%
outcome, excluding participants included in process eval- (98/303) in the usual care group were in the lowest opioid
uation interviews, adjusting for the imbalance of death, category (0-29.9 MED per day), with 12% (37/305) and 10%
and split by baseline pain disorders were also completed (29/303) in the highest opioid category (≥150 MED per day) in
(eTables 23-25 in Supplement 2). Because of the potential for the intervention and usual care groups, respectively (Table 1).

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 Research Original Investigation Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

Table 3. Secondary Outcomes

Mean (SD)
Education and support Mean difference Adjusted effect estimate
intervention Usual care (95% CI) (95% CI)a P valuea
a
Pain intensity (PROMIS-PI-SF-3a)
4 mo 65.0 (8.1) [n = 189] 65.9 (7.7) [n = 151] −0.96 (−2.66 to 0.75) −1.42 (−3.08 to 0.23) .09
8 mo 65.0 (8.7) [n = 182] 65.9 (7.3) [n = 147] −0.92 (−2.69 to 0.85) −1.47 (−3.03 to 0.09) .06
12 mo 64.7 (8.6) [n = 187] 65.6 (7.7) [n = 159] −0.91 (−2.64 to 0.83) −1.31 (−2.88 to 0.26) .10
SF-12 mental component scoreb
4 mo 45.8 (11.6) [n = 189] 44.4 (12.1) [n = 151] 1.38 (−1.16 to 3.92) 2.29 (0.30 to 4.27) .02
8 mo 43.9 (11.7) [n = 181] 44.3 (12.0) [n = 146] −0.39 (−2.98 to 2.20) 0.28 (−1.79 to 2.35) .79
12 mo 43.4 (11.8) [n = 185] 44.1 (11.2) [n = 160] −0.67 (−3.12 to 1.77) 0.41 (−1.59 to 2.42) .68
SF-12 physical component scoreb
4 mo 33.9 (10.0) [n = 189] 33.2 (9.3) [n = 151] 0.67 (−1.41 to 2.75) 0.87 (−0.62 to 2.36) .25
8 mo 34.2 (9.2) [n = 181] 33.2 (9.4) [n = 146] 0.97 (−1.07 to 3.01) 1.06 (−0.52 to 2.65) .19
12 mo 33.6 (8.8) [n = 185] 33.8 (9.3) [n = 160] −0.24 (−2.15 to 1.66) −0.02 (−1.49 to 1.44) .98
Pittsburgh Sleep Quality Indexb
4 mo 11.2 (4.4) [n = 177] 12.1 (4.2) [n = 141] −0.94 (−1.90 to 0.01) −0.65 (−1.38 to 0.08) .08
8 mo 10.8 (4.5) [n = 170] 11.8 (4.2) [n = 140] −0.97 (−1.96 to 0.02) −0.72 (−1.46 to 0.02) .06
12 mo 11.3 (4.3) [n = 175] 11.6 (4.4) [n = 150] −0.33 (−1.29 to 0.62) −0.10 (−0.82 to 0.63) .80
HADS anxiety scoreb
4 mo 8.1 (4.8) [n = 187] 8.3 (5.3) [n = 149] −0.16 (−1.25 to 0.93) −0.59 (−1.30 to 0.12) .10
8 mo 8.3 (5.0) [n = 176] 7.7 (5.0) [n = 146] 0.59 (−0.51 to 1.69) 0.27 (−0.44 to 0.99) .44
12 mo 8.3 (5.0) [n = 182] 7.8 (5.3) [n = 157] 0.49 (−0.61 to 1.59) 0.11 (−0.67 to 0.89) .78
HADS depression scoreb
4 mo 7.6 (4.4) [n = 190] 8.1 (4.6) [n = 150] −0.55 (−1.53 to 0.42) −0.94 (−1.63 to −0.25) .01
8 mo 7.9 (4.7) [n = 181] 8.1 (4.5) [n = 147] −0.17 (−1.18 to 0.83) −0.35 (−1.04 to 0.34) .31
12 mo 8.3 (4.8) [n = 182] 7.7 (4.7) [n = 156] 0.58 (−0.45 to 1.60) −0.02 (−0.77 to 0.73) .95
Pain Self-Efficacy Questionnaireb
4 mo 31.2 (14.6) [n = 189] 28.8 (14.7) [n = 147] 2.39 (−0.78 to 5.56) 4.19 (1.97 to 6.41) <.001
8 mo 30.4 (14.8) [n = 180] 29.0 (14.4) [n = 146] 1.37 (−1.84 to 4.59) 2.05 (−0.18 to 4.28) .07
12 mo 29.1 (15.2) [n = 185] 29.1 (13.5) [n = 159] −0.01 (−3.08 to 3.06) 1.43 (−0.87 to 3.73) .22
EQ-5D-5L utilityb
4 mo 0.43 (0.28) [n = 228] 0.40 (0.30) [n = 199] 0.03 (−0.03 to 0.08) 0.57 (0.01 to 0.10) .02
8 mo 0.39 (0.28) [n = 197] 0.41 (0.29) [n = 166] −0.02 (−0.08 to 0.04) −0.001 (−0.05 to 0.05) .96
12 mo 0.42 (0.28) [n = 227] 0.41 (0.29) [n = 209] 0.01 (−0.05 to 0.06) 0.02 (−0.02 to 0.06) .32
EQ-5D-5L VASb
4 mo 53.3 (22.6) [n = 227] 51.6 (23.3) [n = 199] 1.66 (−2.72 to 6.04) 4.43 (0.70 to 8.16) .02
8 mo 53.1 (23.2) [n = 197] 51.5 (23.7) [n = 165] 1.58 (−3.28 to 6.44) 3.88 (−0.24 to 7.99) .06
12 mo 52.0 (24.0) [n = 228] 51.3 (23.7) [n = 209] 0.68 (−3.81 to 5.17) 2.35 (−1.62 to 6.32) .24
Short Opiate Withdrawal Scaleb
4 mo 9.2 (5.1) [n = 190] 9.6 (6.0) [n = 150] −0.4 (−1.59 to 0.79) −0.65 (−1.61 to 0.31) .18
8 mo 9.3 (5.4) [n = 181] 9.5 (5.2) [n = 146] −0.20 (−1.36 to 0.97) −0.29 (−1.20 to 0.61) .52
12 mo 9.3 (5.4) [n = 183] 9.4 (5.5) [n = 156] −0.11 (−1.27 to 1.06) −0.35 (−1.34 to 0.65) .49
Abbreviations: EQ-5D-5L, EuroQol 5-dimension 5-level; HADS, Hospital Anxiety score. The education support group was used as the cluster variable for the
and Depression Scale; PROMIS-PI-SF-3a, PROMIS Scale v1.0–Pain Intensity intervention group, with clusters of size 1 used for each participant in usual
Short Form 3a; SF, Short Form; VAS, visual analog scale. care.
a b
Based on a heteroscedastic partially nested mixed-effect model with See footnotes g through n in Table 1 for information on scoring, minimal
corrected degrees of freedom, adjusted for age, gender, baseline pain clinically important differences, and calculations of each secondary outcome.
intensity, geographic location, baseline opioid band, and baseline outcome

Thirty-five group interventions were delivered at 25 nurse, and 144 (47%) achieved full adherence to the program.
community locations (median group size, 9 [IQR, 5-11]); 206 The median time from randomization to the first group ses-
of 305 participants (68%) attended the first session, 190 sion was 12 days (IQR, 6-23) (eTable 15 in Supplement 2).
(62%) achieved minimum adherence of attending at least Final follow-up was March 18, 2020, and the trial ended on
day 1 of the group sessions and a 1-on-1 session with the November 11, 2021.

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 Reducing Opioid Use for Chronic Pain With a Group-Based Intervention Original Investigation Research

Figure 2. Pain Interference and Morphine Equivalent Dose Opioid Use Scores at Baseline and 12 Months

A Daily morphine equivalent doses by participant B Daily morphine equivalent doses by group
Education and support intervention Usual care
800 800 800

Baseline 12 mo
Daily morphine equivalent dose, mg

Daily morphine equivalent dose, mg

Daily morphine equivalent dose, mg

600 600 600

400 400 400

200 200 200

0 0 0
1 225 1 208 Usual Education and
Participants, No. Participants, No. care support intervention
Group

C PROMIS-PI-SF-8a T scores by participant D PROMIS-PI-SF-8a T scores by group

Education and support intervention Usual care
80 80 80 Baseline 12 mo

70 70 70
PROMIS-PI-SF-8a T score

PROMIS-PI-SF-8a T score

PROMIS-PI-SF-8a T score
60 60 60

50 50 50

40 40 40
1 228 1 208 Usual Education and
Participants, No. Participants, No. care support intervention
Group

The parallel line plots (A and C) contain a line for each participant in the study life (see footnote g in Table 1 for information on PROMIS-PI-SF-8A scoring and
with baseline and 12-month data available. Each line starts at the baseline value ranges). Panel A shows the daily morphine equivalent dose (continuous value)
(circle) and extends along the line to the 12-month value. Panel C shows the used in the previous 4 weeks from the time point. Panels B and D show the
Patient-Reported Outcomes Measurement Information System Pain corresponding box and whisker plots, with lines and boxes indicating medians
Interference Short Form 8a (PROMIS-PI-SF-8a) standardized T score and IQRs, whiskers indicating 1.5 × the IQR, and dots representing more
(range, 40.7-77), with higher scores signifying higher pain interference in daily extreme data.

Mean adherence (fidelity) to the course manual, defined There was no statistically significant between-group differ-
as intervention delivery and adhering to the steps outlined in ence in PROMIS-PI-SF-8a scores (mean difference, −0.52
the manual, was 83% (range, 25%-100%, with a median of 88%) [95% CI, −1.94 to 0.89]; P = .15; Table 2). At 12 months, 65 of
and competence of delivery as taught in the intervention train- 225 participants (29%) in the intervention group and 15 of 208
ing had a mean of 79% (range, 0%-100%, with a median of (7%) in the usual care group had discontinued opioids (abso-
86%). The 1-on-1 nurse consultation sample (n = 27) had an ad- lute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001; odds
herence to manual mean of 91% (range, 61%-100%) and com- ratio, 5.55 [95% CI, 2.80 to 10.99]; Table 2).
petence mean of 93% (range, 50%-100%) (eTables 16-17 in
Supplement 2). Secondary Outcomes
Of 10 secondary outcomes, collected over 3 points (ie, total of
Primary Outcomes 30 secondary outcome measurements), 5 were statistically sig-
PROMIS-PI-SF-8a data were available for 439 of 608 partici- nificant, favoring the intervention. At 12-month follow-up, the
pants (72%) and opioid use data were available for 433 of 608 proportion of participants who reduced daily MED by 50% or
participants (71%) at 12-month follow-up. PROMIS-PI-SF-8a more from baseline was 57% in the intervention group and 27%
scores improved in both groups over the 12-month trial: −4.1 in the usual care group (absolute difference, 29.9% [95% CI,
(95% CI, −4.98 to −3.22) in the intervention group and −3.17 21.1% to 38.8%]; odds ratio, 3.76 [95% CI, 2.47 to 5.71]; P < .001).
(95% CI, −4.10 to −2.24) in the usual care group (Figure 2).9 The proportion of participants who reduced daily MED by 50%

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 Research Original Investigation Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

or more at 4- and 8-month follow-up was also statistically sig- individual support as well as skill-based learning sig-
nificant (Table 2). At 4-month follow-up, participants random- nificantly reduced patient-reported use of opioids com-
ized to the intervention had statistically significant improve- pared with usual care. However, there was no effect on per-
ment in mental health (SF-12 mental component score and ceived pain interference with daily life activities at 12-month
Hospital Anxiety and Depression Scale depression subscale), follow-up.
pain self-efficacy (Pain Self-Efficacy Questionnaire), and health- Of 10 secondary outcome measures, collected over 3
related quality of life (EQ-5D-5L utility and visual analog scale points (a total of 30 secondary outcome measurements),
scores) but not at any other points (Table 3). There were no sta- only 5 of the measurements were statistically significant
tistically significant between-group differences in pain inten- and improved in the intervention group compared with
sity (PROMIS Scale v1.0–Pain Intensity Short Form 3a), opioid usual care. Tapering of opioids was achieved through health
withdrawal symptoms (SHOWS), or sleep quality measured by care professional and peer group support rather than pre-
the Pittsburgh Sleep Quality Index at any point (Table 3). scribing additional medications. The intervention consisted
of establishing a therapeutic alliance with the patient and
Sensitivity Analyses gradual opioid tapering to reduce adverse effects including
The instrumental variable analyses were not meaningfully dif- withdrawal symptoms.
ferent from the primary analysis (eTables 19-20 in Supple- A 2022 systematic review of opioid reduction interventions
ment 2). However, the analyses were limited by model as- in primary care identified 4 RCTs (N = 231) of patient-centered
sumptions, and the fact that the clinical trial was not blinded. interventions to reduce opioid use for chronic nonmalignant
The findings from the inverse probability weighting analysis pain.30 The interventions included mindfulness-oriented and
showed no meaningful differences from the primary analysis meditation-cognitive behavioral approaches, but opioid ta-
(eTable 4 in Supplement 2). The tests for interaction in pre- pering was not an explicit goal in these RCTs. None of these
specified subgroup analyses were not statistically significant found a statistically significant between-group difference in
(eTables 21-22 in Supplement 2). Additional prespecified analy- opioid use.
ses also showed no change in conclusions (eTables 23-25 in In another 2022 systematic review that identified 2 RCTs
Supplement 2). (N = 238) of pain management programs not based in pri-
mary care reporting on opioid cessation, 30% of those in the
Adverse Events intervention group and 12% in the usual care group stopped
There were 52 serious adverse events (32 in the intervention and taking opioids (risk ratio, 2.15 [95% CI, 1.02 to 4.53]).6 Similar
20 in the usual care group) reported by 41 participants (25 in the to the current trial, the interventions included specific aims
intervention and 16 in the usual care group), including 5 deaths to reduce reliance on opioid through behavior change and
(4 in the intervention and 1 in the usual care group), metastatic incorporated a biopsychosocial framework.
prostate cancer, aortic dissection, lymphoma complication, sub- A subsequent RCT of 250 participants published in 2022
dural empyema secondary to otitis media, and unknown cause reported that 16% of people receiving supportive group therapy
of death. In the usual care group, 1 SAE (arthritis flare-up, which and 35% of people offered mindfulness-oriented recovery en-
resulted in a hospital admission) was possibly study related. hancement reduced opioid use by 50% or more (P = .009) at
In this participant, pain temporarily worsened by opioid with- 9 months, and no adverse events related to the intervention
drawal required hospital admission for pain control. In the were reported.31
intervention group, there was 1 expected SAE of moderate
severity that was probably related to the study (hot flushes/ Limitations
shooting pains in limbs after tapering) and 3 possibly related This study had several limitations. First, opioid use among
SAEs (1 expected [hospitalization from joint/back pain] and 2 participants was measured using self-report on a mailed
unexpected [surges in pain and hot sensations after tapering and questionnaire, with participant-report verified in a telephone
small intestinal bleed, and an overdose suicide attempt]). Ad- call from a member of the study team. Results for this pri-
verse events were reported by 22 of 305 participants (7%) and mary outcome were not validated with blood or urine
8 of 303 participants (3%) in the intervention and usual care samples. Second, participants were not blind to group assign-
groups, respectively (eTables 26-29 in Supplement 2). The most ment. Third, study coordinators were regularly unblinded by
common adverse events were psychological (eg, sleep distur- study participants.
bance, panic attack, suicidal thoughts, and low mood and sui- Fourth, individuals in this trial volunteered to participate
cidal ideation; 2% in the intervention group and 1% in the usual and, therefore, were likely more committed to reduce use of
care group) and nervous system (eg, headache, muscle spasms, opioid medications than people who did not participate.
withdrawal symptoms, and vertigo; 2% in the intervention group Fifth, only 47% of participants randomized to the interven-
and less than 1% in the usual care group). tion fully adhered to the intervention, defined as attending
days 1 to 3 (group sessions), the first individual session with
the nurse, and at least 1 further follow-up session. Sixth, the
12-month follow-up rate was 72%. Seventh, 33% of partici-
Discussion pants used an MED of less than 30 mg per day at baseline.
In this multicentered, randomized clinical trial, a group- Results may not be generalizable to people using higher
based educational intervention that consisted of group and doses of morphine at baseline.

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 Reducing Opioid Use for Chronic Pain With a Group-Based Intervention Original Investigation Research

Eighth, participants were recruited from a community set-

ting. Results may not be applicable to other settings. Ninth, re- Conclusions
sults may not be applicable to health care systems where opi-
oid tapering requires shared prescribing between primary and A group-based educational intervention that included group
secondary care. Tenth, the length of time needed to deliver the and individual support and skill-based learning significantly
intervention and intensity may limit the generalizability in reduced patient-reported use of opioids compared with usual
clinical practice. Eleventh, some AEs may have been missed care, but there was no effect on perceived pain interference
if participants did not recall or report these. with daily life activities.

ARTICLE INFORMATION Iglesias-Urrutia, Krishnan, Lall, Mistry, Newton, member of a different NIHR funding board
Accepted for Publication: March 31, 2023. Noyes, Nichols, Padfield, Seers, Tang, Eldabe, (HS&DR). Prof Tang reported receiving grants from
Underwood. NIHR Health Technology Assessment and UK
Author Affiliations: Warwick Clinical Trials Unit, Drafting of the manuscript: Sandhu, Booth, Furlan, Research and Innovation Medical Research Council
Warwick Medical School, University of Warwick, Shaw, Alleyne, Balasubramanian, Betteley, Lall, and being chief investigator or coinvestigator of
Coventry, United Kingdom (Sandhu, Booth, Manca, Mistry, Newton, Noyes, Rahman, Seers, other chronic pain–related projects funded by the
Alleyne, Betteley, Lall, Mistry, Nichols, Padfield, Tang, Eldabe, Underwood. NIHR, Medical Research Council, and
Underwood); Toronto Rehabilitation Institute, Critical revision of the manuscript for important Warwick-Wellcome Translational Partnership. Prof
University Health Network, Toronto, Ontario, intellectual content: Furlan, Carnes, Taylor, Eldabe reported receiving grants from the NIHR
Canada (Furlan); Department of Medicine, Abraham, Haywood, Iglesias-Urrutia, Krishnan, Lall, (project No. 14/224/04) during the conduct of the
University of Toronto, Toronto, Ontario, Canada Manca, Noyes, Nichols, Padfield, Rahman, Seers, study and personal fees from Medtronic, Boston
(Furlan); Institute for Work & Health, Toronto, Tang, Tysall, Eldabe, Underwood. Scientific, Mainstay Medical, and Saluda Medical
Ontario, Canada (Furlan); Department of Pain Statistical analysis: Booth, Krishnan, Lall, Mistry, and grants from Medtronic and NIHR outside the
Medicine, James Cook University Hospital, Noyes, Underwood. submitted work; and being chair of the NHS
Middlesbrough, United Kingdom (Shaw, Noyes, Obtained funding: Sandhu, Furlan, Taylor, Abraham, England Clinical Reference Group for Specialised
Eldabe); now with Boston Scientific, Hemel Haywood, Iglesias-Urrutia, Lall, Manca, Padfield, Pain. Prof Underwood reported being chief
Hempstead, United Kingdom (Shaw); Wolfson Rahman, Seers, Tang, Eldabe, Underwood. investigator or coinvestigator on multiple previous
Institute of Population Health, Barts and The Administrative, technical, or material support: and current research grants from the NIHR,
London School of Medicine and Dentistry, Queen Sandhu, Furlan, Shaw, Taylor, Alleyne, Betteley, Arthritis Research UK, and coinvestigator on grants
Mary University of London, London, United Newton, Noyes, Padfield, Tysall, Eldabe. funded by the Australian National Health and
Kingdom (Carnes, Taylor, Newton); School of Supervision: Sandhu, Furlan, Alleyne, Medical Research Council; being an NIHR senior
Psychology, Deakin University, Geelong, Victoria, Balasubramanian, Lall, Newton, Noyes, Rahman, investigator until March 2021; receiving travel
Australia (Abraham); Department of Anaesthesia Seers, Eldabe. expenses for speaking at conferences from the
and Pain Medicine, University Hospital Coventry Other - health economics: Manca. professional organizations hosting the conferences;
and Warwickshire NHS Trust, Coventry, United Other: Carnes. serving as director and shareholder of Clinvivo Ltd;
Kingdom (Balasubramanian); Division of Health Other - trial management: Tang. being part of an academic partnership with Serco
Sciences, Warwick Medical School, University of Other - lead health economist: Iglesias-Urrutia. Ltd, funded by the European Social Fund, related to
Warwick, Coventry, United Kingdom (Haywood, return-to-work initiatives; receiving some salary
Seers); Department of Health Sciences, University Conflict of Interest Disclosures: Prof Sandhu
reported receiving grants from the National support from University Hospitals Coventry and
of York, York, United Kingdom (Iglesias-Urrutia, Warwickshire; being a coinvestigator on 3
Krishnan); Danish Centre for Healthcare Institute for Health and Care Research (NIHR) and
serving as director of Health Psychology Services NIHR-funded studies receiving additional support
Improvements, Aalborg University, Aalborg, from Stryker Ltd; receiving honoraria for teaching/
Denmark (Iglesias-Urrutia); Centre for Health Ltd, providing psychological services for a range of
health-related conditions. Dr Furlan is author of My lecturing from the Consortium for Advanced
Economics, University of York, York, United Research Training in Africa; and receiving grants
Kingdom (Manca); now with Statistics and Decision Opioid Manager book and app, distributed in iTunes
and Google Play for health care professionals and from the Research Council of Norway. Until March
Sciences, Janssen Pharmaceuticals Research & 2020, he was an editor of the NIHR journal series
Development, High Wycombe, United Kingdom owned by University Health Network, the hospital
where she works. Both book and app are free of and a member of the NIHR Journal Editors Group,
(Mistry); now with IQVIA, Reading, Berkshire, for which he received a fee. No other disclosures
United Kingdom (Padfield); Centre for charge. Dr Furlan has a monetized YouTube channel
since January 2021 that contains some videos were reported.
Rheumatology Research, University College
London, London, United Kingdom (Rahman); about opioids and opioid tapering. Since April 2021, Funding/Support: The study was funded by the
Department of Psychology, University of Warwick, Dr Furlan has an unrestricted educational grant to National Institute for Health and Care Research.
Coventry, United Kingdom (Tang); University/User maintain an online self-assessment opioid course Role of the Funder/Sponsor: The funder had no
Teaching and Research Action Partnership, for health care professionals in Canada. The funding role in the design and conduct of the study;
University of Warwick, Coventry, United Kingdom is provided by the Canadian Generics collection, management, analysis, and
(Tysall); Service User and Carer Engagement, Pharmaceutical Association. Prof Taylor reported interpretation of the data; preparation, review, or
Coventry University, Coventry, United Kingdom being chief investigator or coinvestigator on approval of the manuscript; and decision to submit
(Tysall); Hôpital de Morges, Morges, Switzerland multiple previous and current research grants from the manuscript for publication.
(Eldabe); University Hospitals Coventry and the NIHR. Dr Iglesias-Urrutia reported receiving
grants from the NIHR during the conduct of the Disclaimer: The findings and conclusions in this
Warwickshire NHS Trust, Coventry, United Kingdom article are those of the authors and do not
(Underwood). study; and for the past 10 years, she was a member
of the Medical Technologies Advisory Committee at necessarily reflect the views of the National
Author Contributions: Dr Lall and Ms Booth had the National Institute for Health and Care Institute of Health and Care Research.
full access to all of the data in the study and take Excellence. Prof Manca reported receiving Additional Contributions: We thank all
responsibility for the integrity of the data and the nonfinancial support from the National Institute for participants who took part in the study for their
accuracy of the data analysis. Health and Care Excellence (having been a member time and willingness to engage with the study. We
Concept and design: Sandhu, Furlan, Shaw, Carnes, of the institute’s technology appraisal committee), also thank the programming team: Henry Adjei,
Taylor, Abraham, Alleyne, Balasubramanian, personal fees from Pfizer, and grants from the NIHR MSc, Chockalingam Muthiah, BSc, and Adrian Willis,
Haywood, Iglesias-Urrutia, Lall, Manca, Noyes, outside the submitted work. Prof Rahman reported BA, all with Warwick Clinical Trials Unit, University
Rahman, Seers, Tang, Tysall, Eldabe, Underwood. receiving grants from NIHR during the conduct of of Warwick, Coventry, UK, for their support in the
Acquisition, analysis, or interpretation of data: the study. Prof Seers reported receiving grants from development and running of the opioid tapering
Sandhu, Booth, Furlan, Taylor, Abraham, Betteley, NIHR during the conduct of the study and being a app. They did not receive compensation. We also

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 Research Original Investigation Reducing Opioid Use for Chronic Pain With a Group-Based Intervention

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