Study reference

(first author, publication year)

Was the allocation sequence adequately generated? ^a

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?^b

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?^c

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?^d

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?^e

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?^f

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure^g

LOW (green)

Some concerns (orange)

HIGH (red)

Hopkins, 2020

Definitely yes;

Reason: computer-supported randomization (cluster RCT)

Probably yes;

Reason: computer-supported randomization (cluster RCT)

Probably no;

Reason: Patients NA, clinicians were blinded  and outcome assessors were not blinded (blinding of data collectors and analysts not reported)

Definitely no;

Reason: There was no loss of follow-up (applicable)

Definitely yes;

Reason: All relevant outcomes were reported

Probably no;

Reason: Cross-contamination could not be ruled out entirely.

Implementation was not fully, about 50% of all junior doctors attended the education sessions.

No other problems noted.

HIGH

Possible cross-contamination and the low implementation grade favors the control group, however other potential biases such as lack of blinding may be in favor of the intervention group.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated? ^a

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?^b

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?^c

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?^d

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?^e

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?^f

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure^g

LOW (green)

Some concerns (orange)

HIGH (red)

Plewniak, 2021

Definitely yes

Reason: computerized algorithm

Definitely yes

Reason: undisclosed randomly varying block sizes. Randomization assignments were kept in a separate location by a research coordinator, and other staff were blinded to the scheme.

Probably no

Reason: Patients and clinicians were not blinded. Data collectors  and outcome assessors were blinded (nurses the phoned for follow-up) (blinding of analysts not reported)

Probably no

Reason: Loss of follow-up in both groups, almost equal.

Definitely yes

Reason: All relevant outcomes were reported

Probably no

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding

Davidson 2020

Definitely yes

Reason: random

number sequence generator

Definitely yes

Reason: Patients were assigned randomly at

their preoperative visit with the use of a sequentially numbered, opaque,

sealed envelopes by either a research

nurse or the primary investigator.

Definitely  no

Reason: Unmasked study for all people involved

Probably yes

Reason: 3% los to follow-up in intervention group and 0% in control group

Definitely yes

Reason: All relevant outcomes were reported

Probably no

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding

Gold 2020

Definitely yes

Reason: computer-based random number generator

Definitely yes

Reason: Patients were sequentially slotted at the time of discharge by study personnel, following discharge assessment by the responsible clinical team. Each patient slot corresponded to a numbered, opaque, sealed envelope containing the randomization outcome, which was

opened at the time of discharge.

Definitely  no

Reason: non-blinded study for all people involved

Probably no

Reason: loss of follow-up, all in control group (n=3 (15%)

Definitely yes

Reason: All relevant outcomes were reported

Probably no

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding and loss of follow-up

Selley 2020

Probably no

Reason: block randomization by the research staff

Not reported

Definitely  no

Reason: patients were not blinded, surgeons were blinded, other people involved unlcear

Probably no

Reason: Loss of follow-up in both groups, almost equal; 10% in intervention group and 9.6% in control group.

Definitely yes

Reason: All relevant outcomes were reported

Probably no

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

HIGH

Due to blinding and inadequate randomization and loss of follow-up

Gaddis, 2019

Definitely yes

Reason: computer generation of a random allocation sequence

Definitely yes

Reason: sealed enrollment

packets, followed by enrollment of patients using consecutively

numbered packets at each of 3 surgical sites.

Probably no

Reason: Patients were not given information regarding prescription

size of other patients in the study, and were therefore blinded as to

whether their prescription size represented the larger or smaller group.

Blinding of healthcare providers, data collectors outcome assessors and data analysts is unknown.

Probably yes

Reason: Loss of follow-up in both groups, not equal; 8% in intervention group and 13% in control group.

No intention to treat analysis.

Definitely yes

Reason: All relevant outcomes were reported

Probably no

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding and loss of follow-up

Osmundson, 2019

Definitely yes

Reason: Randomization was performed centrally using RedCap and occurred prior to discharge using random, permuted blocks of 4–8.

Unclear

Reason: not reported

Probably no

Reason: No information was provided

Probably yes

Reason: Loss of follow-up in both groups, not equal; 11.5% in intervention group and 7.4% in control group.

No intention to treat analysis.

Definitely yes

Reason: All relevant outcomes were reported

Probably no

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding and loss of follow-up

Hannon, 2018

Definitely yes

Reason: A blocked randomization was performed within Stata/IC 14.2

(StataCorp, College Station, TX) and was stratified by operative

joint.

Unclear

Reason: not reported

Probably no

Reason: Patients were not blnded.

Clinical staff who measured objective outcomes and

prescribed refills were blinded to the patients’ treatment group. Blinding of outcome assessors and data analysts is unknown.

Definitely yes

Reason: Large lost to follow-up in both groups, infrequent (38% in intervention group and 21% in control group)

Both intention to treat and per protocol analysis were performed (29 cross-overs)

Definitely yes

Reason: All relevant outcomes were reported

Probably yes

Reason: 29 cross-overs by mistake of personnel.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

HIGH

Due to blinding and large loss to follow-up and cross-overs.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated? ^a

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?^b

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?^c

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?^d

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?^e

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?^f

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure^g

LOW (green)

Some concerns (orange)

HIGH (red)

Ilyas, 2021

Definitely no

Reason: Randomization was based on birth year

Definitely no

Reason: Randomization was based on birth year

Definitely no

Reason:

Surgeons prescribed opioids for postoperative

pain were blinded to the results of the randomization. Unclear if patients were blinded, however, control intervention was no preoperative education, so they can probably deduce in which group they were in. Randomization, data collection, and education were

performed by trained research fellows. But not clear if the data collectors were blinded (blinding of outcome assessors and analysts not reported)

Definitely no

Reason: In total, after excluding patients because they did not meet the inclusion criteria, 44 (15.7%) patients did not complete their pain diaries. So 237 were available for analysis. Authors of the study did not count these patients as loss to follow-up or as incomplete outcome data and did not report how many of these patients were randomised in the intervention or control group.

Probably yes

Reason: Adverse events were not reported, while the method section stated that they would.

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

HIGH

Due to inadequate randomization, blinding,  and loss to follow-up.

Stepan, 2021

Definitely yes

Reason: Patients were randomised using a stratified computer-generated block randomization schedule created by a hospital statistician.

Definitely yes

Reason: The research assistant recruiting

patients and overseeing the study allocated patients preoperatively using the randomization

schedule. Neither surgeon nor patient had access to the schedule.

Probably no

Reason: Neither surgeon nor patient had access to the schedule, and both were blinded to

the allocation group during the study period (blinding of data collectors, outcome assessors and data analysts is not reported)

Definitely no

Reason: 24.6% lost to follow-up in control group (n=31 incomplete data and n=1 excluded for chronic opioid use) and 32,1% in intervention group (n=42 incomplete data and n=2 chronic opioid use).

Definitely yes

Reason: All predefined outcomes were reported

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to large loss to follow-up and blinding

Syed, 2018

Definitely yes

Reason: Patients were randomised with a computer-generated scheme to the study group or the control group

Definitely yes

Reason: Patients were randomised with a computer-generated scheme to the study group or the control group

Probably no

Reason: Patients and healthcare providers were blinded (blinding of data collectors, outcome assessors and analysts not reported)

Probably yes

Reason: Intervention, 2 (2.9%) and control:

4 (5.7%). Reasons:

Did not respond to follow up request

Definitely yes

Reason: All primary and secondary outcomes were reported

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding

Cheesman, 2020 (2-year follow-up study of Syed, 2018)

‘’ ‘’

‘’ ‘’

‘’ ‘’

Definitely no

Reason: In total, 25% did not complete the questionnaire at 2-year follow-up. Authors did not report if these patients were randomised in the intervention or control group.

Definitely yes

Reason: All primary and secondary outcomes were reported

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding and loss to follow-up

Egan, 2020

Definitely yes

Reason: A random number generator was used to develop a

random allocation sequence prior to beginning enrollment.

Randomization to the intervention or control group was completed prior to obtaining consent for the study based on sequential numbering of study folders. Study folders were identical externally, and the code for the randomization

was stored separately and accessible only for data analysis.

Definitely yes

Reason: A random number generator was used to develop a

random allocation sequence prior to beginning enrollment.

Randomization to the intervention or control group was completed prior to obtaining consent for the study based on sequential numbering of study folders. Study folders were identical externally, and the code for the randomization

was stored separately and accessible only for data analysis.

Probably yes

Reason: Study participants were not informed of the arms of the study, and providers involved in patient care, consent, and postoperative questionnaire administration were blinded. Only data analysts had access to the randomization code.

Definitely no

Reason: Loss-to-follow-up:

Intervention:

8 (16%)

Reasons: Did not undergo the planned procedure (n=1), underwent another surgery prior to completing the postoperative questionnaire (n=7).

Control:

3 (6%)

Reasons: Did not undergo the planned procedure at the study institution (n=2), underwent another surgery prior to completing the postoperative questionnaire (n=1).

Incomplete outcome data:

Intervention:

3 (6%)

Reasons: Did not complete questionnaire

Control:

1 (2%)

Reasons: Did not complete questionnaire

Definitely yes

Reason: All primary and secondary outcomes were reported

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to loss to follow-up differences in both groups and a violation of the randomization procedure by excluding patients who underwent another surgery prior to completing the postoperative questionnaire.

Vincent, 2020

Unclear

Reason: Not reported

Unclear

Reason: Not reported

Definitely no

Reason: Patients were not blinded to their

treatment arm, but their treating surgeons were (blinding of data collectors, outcome assessors and data analysts is not reported).

Definitely no

Reason: Not reported how many patients from the intervention or control group were lost to follow-up. The authors stated: 156 patients were enrolled and randomised, however 25 (16%) were lost to follow-up or subsequently excluded based on the above criteria.

It was not clear how many patients were lost to follow-up or excluded based on the exclusion criteria.

Probably yes

Reason: nonopioid

medication consumption and any adverse effects related to pain management experience was not reported, while the method section stated that they would.

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

HIGH

Due to inadequate randomization, blinding and loss to follow-up.

Alter, 2017

Definitely no

Reason: Patients were randomised using a

simple randomization scheme by birth year. Patients born with an odd birth year were assigned to the

counseling (study) group, and those born with an even birth year were assigned to the no counseling (control)

group.

Definitely no

Reason: Patients were randomised using a

simple randomization scheme by birth year. Patients born with an odd birth year were assigned to the

counseling (study) group, and those born with an even birth year were assigned to the no counseling (control)

group.

Unclear

Reason: Not reported

Definitely yes

Reason: 0% loss to follow-up.

Definitely yes

Reason: All predefined  outcomes were reported

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to inadequate randomization and blinding

Moyano, 2011

Definitely yes

Reason: Patients were assigned to either the experimental or control group using a random numbers

table generated by computer.

Definitely yes

Reason: Patients were assigned to either the experimental or control group using a random numbers

table generated by computer.

Probably no

Reason: data collectors  and data analysts were blinded (blinding of patients, healthcare providers and outcome assessors was not reported).

Probably no

Reason: in the intervention group: 7.0% (4/57) loss to follow-up. Control group: 11.6% (5/43). Reasons for loss to follow-up were not reported.

Definitely yes

Reason: All predefined  outcomes were reported

Probably yes

Reason: No relevant problems observed.

However, the patient reported outcome measures are subjective and prone to error or socially acceptable answers.

Some concerns

Due to blinding,  and loss to follow-up.

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Ilyas (2021), USA

Type of study:

RCT

Setting and country:

Outpatient orthopedic surgeries, USA

Funding and conflicts of interest:

The authors have no relevant financial relationships

to disclose.

Inclusion criteria:

Patients undergoing

shoulder, elbow, wrist, knee, foot, and/or ankle surgery

Exclusion criteria:

Age younger than 18 years, inpatient procedures, surgeries distal to the wrist, and surgeries under local anesthesia

only.

N total at baseline:

Intervention: 107

Control: 130

Important prognostic factors²:

Sex:

I: 38% M

C: 51% M

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

Patients receiving preoperative education from trained research fellows. Education:

A brief multimedia presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative education consisted of (1) background on the opioid epidemic, including basic facts and consequences; (2) description of risk factors for opioid abuse and how to consume opioids safely; (3) information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively; (4) encouraging the use of nonopioid therapy prior to taking the prescribed opioids or quickly transitioning to nonopioid medications postoperatively; and (5) contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication was needed.

Describe  control (treatment/procedure/test):

Patients not receiving preoperative education

Length of follow-up:

Not reported

Loss-to-follow-up:

None

Incomplete outcome data:

In total, after excluding patients because they did not meet the inclusion criteria, 44 (15.7%) patients did not complete their pain diaries. So 237 were available for analysis. Authors of the study did not count these patients as loss to follow-up or as incomplete outcome data.

Intervention:

N (%): not reported

Control:

N (%): Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pill count (n) mean (range)

I: 6 pills; range, 2-16.5 pills

C: mean, 12 pills; range, 4-24.8 pills) (P<.05)

MEQ mean (range)

I: 45 MEQ; range, 15-120
C: 83.8 MEQ; range, 30.0-178 (P<.05)

VAS (0-100) recorded on the day of surgery through postoperative day 5, mean (range)

I: 25.5 (14.0-36.0)

C: 26.0 (17.0-40.0)

p: 0.166

Refill, no (%)

Four (3.7%) patients in the intervention group requested a refill of their opioid prescription vs. 10 (7.7%) patients in the control group; (p=.31)

Satisfaction adequate, n (%):

Agree or strongly agree:

I: 72 (73.5%)

C: 98 (76.6%) p=0.705

Satisfaction strong enough, n (%):

Agree or strongly agree:

I: 71 (75.5%)

C: 100 (82.6%)

p=0.479

Stepan, 2021

Type of study:

RCT

Setting and country:

Outpatient elective ‘nonminor’ hand surgery, USA

Funding and conflicts of interest:
Each author certifies that he or she has no commercial associations that might pose a conflict of interest in connection with the submitted article.

Inclusion criteria:

English-speaking patients older than 18 years undergoing outpatient elective “nonminor” hand surgery procedures at an academic tertiary care center.

Patients

undergoing cubital tunnel release, basal joint

arthroplasty, palmar fasciectomy, tendon repair or

transfers, nerve repair or transfer, ligament repair or reconstruction, radius and ulnar osteotomies, and arthrodesis or arthroplasty of the wrist/hand/fingers

Exclusion criteria:

patients with fractures (because of the variability in fracture severity, type, and inability

to distinguish between pain associated with the

injury versus surgery), preoperative pain in the ipsilateral

upper extremity from a secondary condition not related to the study procedure, or allergies or

inability to consume opioid medications. Patients with current substance abuse and chronic use of pain medication (daily use of pain medication for

any disease)

N total at baseline:

Intervention: 137

Control: 130

Important prognostic factors²:

Sex:

I: 55.9% M

C: 44.1% M

Groups comparable at baseline?

No, patients in the

control group were significantly older (median, 62.5 years) than those in the education (median, 58 years; p = 0.045) group.

Describe intervention (treatment/procedure/test):

Standardized pain management education.

Standard presurgical counseling and 7 minutes of standardized perioperative pain management education. This webinar and educational content discussed expected pain after surgery, described the opioid epidemic and side effects of opioids, and emphasized a tiered system of pain management. Patients were instructed to first use nonpharmaceutical modalities of pain relief (e.g., rest, ice, elevation), then nonopioid pain medications, and finally opioid medications if necessary.

After surgery patients received routine postoperative instructions; however, in addition, they received a laminated card with a summary of the preoperative pain education.

Describe  control (treatment/procedure/test):

Routine perioperative counseling surrounding surgery and pain management according to their individual surgeon’s standard of care.

After surgery, patients received routine postoperative instructions from nursing and their surgeon’s practice.

Length of follow-up:

14 days

Loss-to-follow-up:

Intervention:

44 (32.1%)

Reasons:

n=31 incomplete data and n=1 excluded for chronic opioid use.

Control:

32 (24.6)

Reasons:

n=42 incomplete data and n=2 chronic opioid use.

Outcome measures and effect size (include 95%CI and p-value if available):

Opioids pills consumed, median (range)

I: 2 (0 – 56)

C: 5 (0 – 49) p<0.001

OME consumed, median (range)

I: 7.8 (0–405)

C: 40.0 (0 – 323) p<0.001

Average wk-1 pain

(Highest pain level for the day on a scale ranging from 0 to 10.)

I: 3.3 (0 – 9.3)

C: 3.6 (0–9.1), p=0.27

Refill, n (%)

I: 2 (2.6%)

C: 9 (10.5%) p = 0.046

Satisfaction survey, n (%)

Satisfied

I: 73 (94.8)

C: 78 (91.8)

Neutral

I: 3 (3.9)

C: 0 (0.0)

Dissatisfied

I: 1 (1.3)

C: 7 (8.2)

P = 0.03

Syed (2018)

2-year follow-up Cheesman (2020)

Type of study:

RCT

Setting and country:

Arthroscopic rotator cuff repair

USA

Funding and conflicts of interest:

The Authors, their immediate families, and any research

foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.

Inclusion criteria:

All patients older than 18 years and clinically indicated for an ARCR.

Exclusion criteria:

Patients with irreparable rotator cuff tears, allergic or sensitivity to the study medication, history of gastrointestinal

issues, or any evidence of glenohumeral arthritis were

excluded.

N total at baseline:

Intervention: 70

Control: 70

Important prognostic factors²:

Sex:

I: 67.6 % M

C: 68.2% M

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

Formal preoperative opioid education involving recommended postoperative opioid use, side effects, dependence, and addiction. They also watched a 2-minute computer-based presentation concerning opioid abuse and its consequences. In addition, they were provided with a paper outline for review highlighting the most important points of the presentation.

Describe  control (treatment/procedure/test):

Standard preoperative education followed by a discussion of risks and benefits. No formal education on opioid use, dependence, and addiction was provided.

Length of follow-up:

3 months (Syed, 2018)

2 years (Cheesman, 2020)

Loss-to-follow-up (Syed, 2018):

Intervention:

2 (2.9%)

Reasons:

Did not respond to follow up request

Control:

4 (5.7%)

Reasons:

Did not respond to follow up request

Loss-to-follow-up (Cheesman, 2020):

75.0% (105 of 140) completed the questionnaire at a minimum of 2 years following ARCR

Outcome measures and effect size (include 95%CI and p-value if available):

Total number of narcotics consumed, mean ± SD

At 2 weeks p=0.1

I: 25.5 ± 19.5 

C: 35.1 ± 31.6

At 6 weeks p=.02

I: 40.4 ± 39.1

C: 60.6 ± 61.2

At 3 mo  p=0.01

I: 51.2 ± 57.7

C: 87.2 ± 98.3

VAS, mean ± SD

At 2 weeks p=0.008

I: 3.3 ± 2.2

C: 4.4 ± 2.5

At 6 weeks p=0.001

I: 2.4 ± 2.0

C: 3.7 ± 2.4

At 3 mo  p=0.2

I: 2.2 ± 2.4

C: 2.2 ± 2.2

No. of pills consumed, median (IQ range) (2 year follow-up)

I: 60 [30, 132)

C: 120 [30, 340]

p=0.10

MME median (IQ range)

I: 375 [199, 1496]

C: 725 [ 150,2190]

VAS, mean

I: 1.53

C: 1.70

p=0.94

Egan, 2020

Type of study:

RCT

Setting and country:

Breast surgery, USA

Funding and conflicts of interest:

The authors have nothing to disclose. No funding was received for this study.

Inclusion criteria:

Female gender, age 18 or greater, and no previous mastectomy

on either breast

Exclusion criteria:

Did not undergo the planned

procedure at the study institution, (underwent another surgery prior to completing the postoperative questionnaire, violates randomization procedure by excluding these patients).

N total at baseline:

Intervention: 50

Control: 50

Important prognostic factors²:

Sex:

Only woman

Groups comparable at baseline?

Yes, however, participants in

the control group were statistically more likely to be a

current tobacco user

Describe intervention (treatment/procedure/test):

An instrument was developed to be provided as a single-paged paper handout to the intervention group. The instrument was designed to be consumed in 5 min or less preoperatively. The instrument was divided into three sections. The first section contained information about pain expectations and goals, including working towards a goal of tolerable pain. The second section included examples of opioid and adjunct medications which may be used perioperatively. Risks associated with opioid use were included in this section. The final section included examples of non-medication pain control methods and statements to normalize the pain experience for the patient.

Describe  control (treatment/procedure/test):

Standard of care, including standard patient counseling from the surgical and perioperative teams

Length of follow-up:

Postoperative questionnaires were completed a median of 13.0 days after surgery in both groups

Loss-to-follow-up:

Intervention:

8 (16%)

Reasons: Did not undergo the planned procedure (n=1) (consultants of the Knowledge Institute do not think this is a loss to follow-up, but an exclusion criterium), underwent another surgery prior to completing the postoperative questionnaire (n=7).

Control:

3 (6%)

Reasons: Did not undergo the planned procedure at the study institution (n=2) (consultants of the Knowledge Institute do not think this is a loss to follow-up, but an exclusion criterium), underwent another surgery prior to completing the postoperative questionnaire (n=1).

Incomplete outcome data:

Intervention:

3 (6%)

Reasons: Did not complete questionnaire

Control:

1 (2%)

Reasons: Did not complete questionnaire

Outcome measures and effect size (include 95%CI and p-value if available):

Number of opioid tablets consumed, mean (SD)

I: 16.2 (16.4)

C: 24.3 (21.8)

p=0.05

Postoperative pain scores (scale 0-10)
I: 3.0 (1.8);

C 3.6 (1.6);

p = 0.06

Refill, n, (%)

I: 6/39 (15%);

C: 10/46 (22%)

p=0.3

Vincent, 2020

Type of study:

RCT

Setting and country:

Outpatient upper extremity surgery,

USA

Funding and conflicts of interest:

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The author(s) received no financial support for the research,

authorship, and/or publication of this article.

Inclusion criteria:

Patients aged between 18 and 89, English speaking,

and indicated to undergo elective outpatient upper

extremity surgery by 1 of 5 board certified and fellowship trained

orthopedic surgeons.

Exclusion criteria:

Surgeries performed under only local anesthesia, preoperative

opioid use, and inpatient surgery.

N total at baseline:

156 were enrolled and randomized, however 25 were lost to follow-up or subsequently

excluded based on the above criteria. It was not clear how many patients were lost to follow-up.

Intervention: 62

Control: 69

Important prognostic factors²:

Sex:

I: 58% M

C: 61% M

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

Pretaped standardized 5-minute video (https://youtu.be/3wnF4JlFNBc) played on a digital tablet in the preoperative area that educated the patient as to the nature of opioids, statistics on the “Opioid Epidemic” in America, how to safely consume opioids, nonopioid pain management strategies, and how to avoid opioid dependence.

Describe  control (treatment/procedure/test):

No preoperative opioid counseling.

Length of follow-up:

14 days

Loss-to-follow-up:

Not reported how many patients from the intervention or control group were lost to follow-up. The authors stated: 156 patients were enrolled and randomized, however 25 were lost to follow-up or subsequently excluded based on the above criteria.

It was not clear how many patients were lost to follow-up or excluded based on the exclusion criteria.

Outcome measures and effect size (include 95%CI and p-value if available):

Number of opioid tablets consumed, mean (SD)

I: 11.77 (10.2)

C: 17.4 (12.6) p=0.007

MEU = morphine equivalent units, mean (SD)

I: 93.7 (97.6)

C: 143.2 (123.0) p=0.013

VAS pain score, mean

Surgery day

I: 3.75

C: 4.29  p=0.371

Day 1

I: 5.66

C: 5.63 p=0.958

Day 2

I: 5.39

C: 5.45 p=0.909

Day 3

I: 4.73

C: 4.80 p=0.881

Day 4

I: 4.22

C: 4.26 p=0.934

Day 5

I: 3.81

C: 3.98 p=0.721

Refill rates, %

I: 4.8%

C: 13% p=0.104

Patient satisfaction

In total 77% of the patients felt that they received an adequate number of opioids and 73% found their opioids to be strong enough to relieve their pain. These findings were consistent between the intervention and control groups, regarding quantity (p=0.752) or strength (p=0.647).

Alter, 2017

Type of study:

RCT

Setting and country:

Carpal Tunnel Release Surgery, USA

Funding and conflicts of interest:

All authors of this journal-based CME activity have no relevant conflicts of interest to

disclose.

No external source of funding was used for this

study.

Inclusion criteria:

CTR surgery performed

under local anesthesia only, on an outpatient basis

Exclusion criteria:

Any CTR surgery

performed with sedation, or performed with any additional concomitant procedures, or if the patient had

any history of preoperative opioid consumption or

an opioid allergy

N total at baseline:

Intervention: 20

Control: 20

Important prognostic factors²:

Sex:

I: 45 % M

C: 30% M

Groups comparable at baseline?

Yes, however only age and sex were reported.

Describe intervention (treatment/procedure/test):

Preoperative opioid counseling consisted of reviewing the same 1-page informational form with the surgeon immediately prior to the procedure on the day of surgery. The counseling consisted of explaining the significance and problems associated with the opioid epidemic. The counseling also consisted of making 5 formal preoperative recommendations for the patient to consider including (1) determining if the patient has any risk factors for  opioid abuse; (2) to take nonopioid therapy prior to utilizing the prescribed opioids; (3) to understand the anticipated duration of typical opioid consumption surgery after CTR surgery; (4) to understand that the lowest dose opioid will be prescribed; and (5) to declare if any opioid painkillers are also being prescribed by other providers.

Describe  control (treatment/procedure/test):

No formal counseling

Length of follow-up:

3 days

Loss-to-follow-up:

0% loss to follow-up

Incomplete outcome data:

No incomplete outcome data

Outcome measures and effect size (include 95%CI and p-value if available):

Number of pills consumed, mean

Day of surgery

I: 0.65

C: 1.90 p<0.05

Day 1

I: 0.45

C: 1.50 p<0.05

Day 2

I: 0.18

C: 0.65 p=0.07

Day 3

I: 0.13

C: 0.15 p=0.87

Total

I: 1.40

C: 4.20 p<0.05

Pain level 0-10 (mean)

Day of surgery

I: 4.25

C: 4.75 p=0.56

Day 1

I: 3.85

C: 4.20 p=0.62

Day 2

I: 2.40

C: 2.65 p=0.64

Day 3

I: 1.90

C: 1.80 p=0.82

Moyano, 2011

Type of study:

RCT

Setting and country:

Major orthopedic, gynecological or plastic surgical procedures, Colombia

Funding and conflicts of interest:

The authors report no conflict of interest.

Inclusion criteria:

patients scheduled for major orthopedic, thoracic, gynecological, or plastic surgical procedures suitable for postoperative intravenous morphine patient controlled analgesia (PCA)

Exclusion criteria:

1. Patients with previous administration of morphine or a previous experience with PCA.

2.Contraindications to the use of morphine.

3. The presence of cognitive disorders or their appearance

during the postoperative period.

4. Prior record of substance addiction.

5. Postoperative surgical complications.

N total at baseline:

Intervention: 57

Control: 43

Important prognostic factors²:

age ± SD:

Not reported

Sex:

Not reported

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

After the initial intravenous morphine titration in the recovery room and once a pain intensity of 3 to 4 (on a 10-point visual analog scale) had been reached, a leaflet was given to the patient within the first 3 postoperative hours. The patient was then invited to ask questions on its content.

The leaflet specifically described the advantages of morphine use during the postoperative period, including analgesic efficacy, the most frequent side effects, and their treatment. It also included detailed explanations on questions regarding addiction, nausea and vomiting, respiratory depression, and tolerance (postoperative).

Describe  control (treatment/procedure/test):

General information leaflet on the advantages of proper post-operative pain management without emphasizing any specific medication (postoperative).

Length of follow-up:

24 hours

Loss-to-follow-up:

Intervention:

4 (7.0%)

Control:

5 (11.6%)

Reasons for loss to follow-up were not reported.

Outcome measures and effect size (include 95%CI and p-value if available):

Morphine consumption (mg), mean (SD)

I: 19.60 (1.65)

C: 19.03 (2.39) p=0.4324

10-point VAS pain, mean (SD)

I: 2.34 (0.224)

C: 2.1 (0.235) p=0.48

Level of satisfaction (scale 0-7)

I: 6.28

C: 6.31 p=0.8208

Providing the leaflet in

the postoperative period could be less suitable than in

the preoperative period. Also during this time, patients already received IV PCA.