A Perioperative Smoking Cessation Intervention With Varenicline, Counseling, and Fax Referral to a Telephone Quitline Versus a Brief Intervention: A Randomized Controlled Trial : Anesthesia & Analgesia

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A Perioperative Smoking Cessation Intervention With Varenicline, Counseling, and Fax Referral to a Telephone Quitline Versus a Brief Intervention: A Randomized Controlled Trial

Wong, Jean MD, FRCPC*; Abrishami, Amir MD, FRCPC*; Riazi, Sheila MD, FRCPC*; Siddiqui, Naveed MD, FRCPC; You-Ten, Eric MD, FRCPC; Korman, Jennifer BScPhm, ACPR, RPh; Islam, Sazzadul BSc*; Chen, Xin Research Fellow*; Andrawes, Maged S. M. MBBS*; Selby, Peter MBBS, CCFP, FCFP§‖; Wong, David T. MD, FRCPC*; Chung, Frances MBBS, FRCPC*

Author Information
Anesthesia & Analgesia 125(2):p 571-579, August 2017. | DOI: 10.1213/ANE.0000000000001894

Smoking increases the risks for perioperative complications.1–5 Preoperative smoking cessation interventions are effective for reducing the risk for these complications6 and increasing both short-term7 and long-term abstinence.8,9 Providing perioperative smoking cessation interventions fits into the concept of the perioperative surgical home:10 a broad-based approach for surgical patients that covers the full continuum of the preoperative period, the surgical procedure, the immediate postoperative period, and extends into the postdischarge period.11 By helping patients to quit smoking before and after surgery, anesthesiologists may have a significant effect on patients’ surgical outcomes as well as their long-term health.

Intensive perioperative interventions with both behavioral and pharmacological components are effective for helping surgical patients to quit smoking.9,12 Varenicline is a highly selective α4β2 nicotinic acetylcholine receptor partial agonist and antagonist13 that partially mimics the effect of nicotine by occupying the receptor site, reducing withdrawal, and it also blocks the reinforcing effects of continued nicotine use through its antagonist action.14 Varenicline is effective for increasing abstinence in both surgical9 and nonsurgical patients.15,16

Although intensive tobacco interventions with varenicline are effective,9 they may not be feasible in busy preoperative clinics,17 and they have not been compared with brief interventions. We hypothesized that a multifaceted intervention including varenicline, intensive counseling in the preadmission clinic, and referral to Smokers’ Helpline is more effective than a brief intervention consisting of brief advice and self-referral to Smokers’ Helpline to improve short-term and long-term abstinence. The objective of this study was to determine the effectiveness of a multifaceted smoking cessation program compared with a brief intervention in the preoperative clinic to increase short-term and long-term abstinence in surgical patients.

METHODS

This multicenter, open-label randomized controlled trial was registered in the public registry ClinicalTrials.gov (number NCT01320462). Approval was obtained from the research ethics boards of the participating institutions, and written informed consent was obtained from all participants. This article adheres to the applicable Equator guidelines.

Patients in the preoperative clinics (18 years of age or older) scheduled for elective ambulatory or inpatient surgery within the next 7 to 60 days were recruited face to face by the research coordinator. The types of surgery included general surgery, orthopedics, urology, plastic surgery, vascular surgery, otolaryngology, ophthalmology, and neurosurgery. Patients who smoked at least 10 cigarettes per day during the previous year and had no period of smoking abstinence longer than 3 months in the past year were recruited.

Exclusion criteria included: current pregnancy and breastfeeding; major depression, panic disorder, psychosis, or bipolar disorder within the previous year; and use of nicotine replacement or bupropion within the previous 3 months. Also excluded were patients with cardiovascular disease (eg, coronary artery disease, unstable angina, congestive heart failure, or moderate to severe valvular disease) within the past 6 months; a serious or unstable disease within the past 6 months (eg, stroke, renal failure or insufficiency, hepatic failure, or uncontrolled hypertension); drug or alcohol abuse or dependence within the past year; and use of tobacco products other than cigarettes or marijuana use within the previous month. As well, patients with any form of cognitive impairment, participation in any other studies, inability to understand English, or lack of a telephone number to be reached for follow-up were excluded.

The demographic data and smoking habits of the patients, including the average number of cigarettes smoked per day, were recorded. The Fagerström test for nicotine dependence was administered.18 This test consists of 6 items scored from 0 to 10, with higher scores indicating greater nicotine dependence. Patients completed a questionnaire based on Prochaska and DiClemente’s “Stages of Change” model to determine their readiness to stop smoking.19 This questionnaire consists of 6 stages ranging from stage 1: precontemplation, indicating lack of readiness to quit smoking; stage 2: contemplation, considering quitting; to stage 5: maintenance of abstinence; and stage 6: termination or relapse of smoking. To determine the baseline smoking status, urinary cotinine (a metabolite of nicotine) using NicAlert urine strips (the Accutest, Jant Pharmacal Corp, Encino, CA), and expired-air carbon monoxide (COE) were measured using Smokerlyzer (the Bedfont EC50, Bedfont Scientific Ltd, Harrietsham, England) in all patients at the preoperative clinic. Patients who had COE readings of 10 parts per million or more and NicAlert levels exceeding 100 ng/mL (indicative of smoking in the previous 48 hours) were classified as smokers.

Smokers were randomized to participate in either a smoking cessation program comprised of 4 components: (1) a 10- to 15-minute structured preoperative counseling session; (2) pharmacotherapy with a free 3-month supply of varenicline; (3) an educational pamphlet; and (4) a fax referral to a quitline for proactive telephone counseling and follow-up; or to a control group that received brief advice regarding smoking cessation and quitline information for self-referral. No incentives were provided to the participants. A computer-generated randomization list for each site was generated by a research analyst who was not involved in the study. Randomization was stratified according to the intention-to-stop-smoking based on the patient’s Stage of Change (from stage 1 to 4). This approach was used because the Stage of Change may be an important predictor of abstinence from smoking. The patient assignments were placed in serially numbered, opaque-sealed envelopes according to the randomization schedule for each center. The research coordinator opened the envelope after recruitment of the patient.

One of 6 anesthesiologists or 1 pharmacist with specific training in smoking cessation delivered the counseling or brief advice for both groups in the preoperative clinic. These individuals had certified training from the TEACH certificate program in intensive smoking cessation counseling (www.teachproject.ca).20

The smoking cessation program group received counseling that included advice to quit smoking21 and information regarding smoking behavior and skill building (Supplemental Digital Content 1, Appendix 1, https://links.lww.com/AA/B656), supplemented with standard printed materials (ie, One Step at a Time: For Smokers Who Want to Quit, by Canadian Cancer Society, 2007). Patients were informed of the benefits of even short-term abstinence before surgery. The patient selected a target quit date of 24 hours before the date of surgery or any time before surgery. The varenicline was given to the patients, and they were instructed to initiate the medication exactly 1 week before the target quit date. The treatment period was 12 weeks, which included a 1-week titration as follows: days 1 to 3: 0.5 mg once daily; days 4 to 7: 0.5 mg twice daily; and days 8 to 12 weeks: 1.0 mg twice daily. If surgery was delayed or canceled, the target quit date did not change, and the patient continued the treatment according to the original schedule. Patient information was faxed to the quitline, and they received proactive telephone calls from the quitline within 48 hours after their preoperative visit.

Patients in the brief advice group received advice (approximately 3–5 minutes) regarding smoking cessation (Supplemental Digital Content 1, Appendix 1, https://links.lww.com/AA/B656). The contact information of the quitline was given to patients to call the quitline for self-referral. Patients were encouraged to receive smoking cessation medications, if desired, from other resources (eg, primary care provider).

Smokers’ Helpline is a free tobacco cessation counseling service operated by the Canadian Cancer Society offering support and information about quitting smoking and tobacco use (www.smokershelpline.ca). The follow-up schedule was determined by the Smokers’ Helpline according to its protocol (North American Quitline Consortium) and based on the patient’s Stage of Change. The details of this protocol are provided in Supplemental Digital Content 2, Appendix 2, https://links.lww.com/AA/B657. To simulate the real-life setting, there were no changes imposed by this study protocol to the Smokers’ Helpline follow-up schedule or the content of its counseling session.

The research coordinators performed all of the outcome assessments. The research coordinator visited all participants in both groups 24 hours after surgery, or at hospital discharge for ambulatory surgery, to review their smoking status. The self-reported abstinence was verified by measurement of COE and urinary cotinine in all patients.

The research coordinators contacted participants in both groups by telephone during the 1-year follow-up period to ascertain the patients’ smoking status, adverse effects, and complications. In addition, the self-reported abstinence was verified by measurement of urinary cotinine in all patients. Patients were asked to self-administer and return the urine cotinine strips (Accutest®) using prepaid return envelopes at 1, 3, 6, and 12 months after the start of treatment. The patients were contacted in the evening if the first attempt to contact patients during the day was unsuccessful. During each follow-up period, if research coordinators were unable to contact a patient after 3 attempts, the patient was considered to be still smoking at that time point.

The primary outcome measure was the 7-day point prevalence (PP) abstinence rate at 12 months after the start of treatment. The 7-day PP abstinence represents those who had not smoked cigarettes for the previous 7 days. Secondary outcome measures included 7-day PP at 1, 3, 6 months and continuous abstinence at 3, 6, and 12 months after the initial quit date. The continuous abstinence indicates abstinence over the previous 4 weeks. Other secondary outcome measures included the changes in the number of cigarettes consumed per day, Fagerström test score, and the Stage of Change at 1, 3, 6, and 12 months after the initial assigned target quit date. The incidences of perioperative complications as well as medication-related adverse events were also recorded. Abstinence was defined as a biochemically confirmed self-report of no smoking or use of any nicotine-containing products. All perioperative complications documented in the hospital charts and all adverse events at each telephone follow-up were recorded.

Statistical Analysis

The differences in the outcomes between the 2 groups at each time point were assessed by comparing abstinence rates between the groups using χ2 test or Fisher exact test (for categorical variables) and independent-sample Student t tests (for continuous variables). The demographic data are presented with descriptive statistics. Continuous data are presented as mean ± SD or median and range; categorical data are presented as frequency and percentage with 95% confidence interval (CI).

A multivariate generalized linear regression was performed to identify independent variables related to the outcome of smoking cessation. An intention-to-treat analysis was performed with missing data filled by multiple imputations. The number of imputations was 10, and each imputation generated 1 data set. The results from individual analysis of 10 data sets were pooled together as final results. The independent variables were first evaluated by univariate analysis, and the variables with P < .1 were further checked for correlation. If correlation between 2 variables existed, only 1 variable was selected for multivariate analysis, based on the clinical meaning and study design. Relative risk (RR) with 95% CI for prediction of smoking abstinence was derived from the generalized linear model with distribution = binomial and link = log. The independent variables evaluated in the analyses included age, gender, body mass index, ambulatory or inpatient surgery, type of surgery (orthopedic surgery versus other types of surgery), American Society of Anesthesiologists (ASA) classification; and baseline information (Fagerström test score, age when the patient started smoking, previous quit attempts, Stage of Change, COE level, nicotine dependence, anyone else in the home smoking, number of cigarettes per day, and any contact to Smokers’ Helpline).

All statistical tests were 2 tailed (α = .05). For all comparisons, P < .05 was considered statistically significant. Data were analyzed using SAS version 9.3 (SAS Institute Inc, Cary, NC).

Sample Size

The sample size estimate was based on the difference in the primary outcome (7-day PP abstinence at 12 month follow-up) between the 2 study groups. We used information derived from the available literature on the quit rate after routine care (eg, brief advice) in surgical patients (weighted average, 17.4%),17,22,23 and several randomized controlled trials that have shown that varenicline can increase the prevalence of abstinence at 12-month follow-up from 4% to 10% to 17% to 28%.17,24,25 Based on this information and assuming that varenicline has the same efficacy in surgical patients, we assumed the average effect size would be 15% (risk difference). Using G-Power software, the required sample size was 114 patients per group (quit rate in the smoking cessation program group, 32.4%; quit rate in the brief advice group, 17.4%; risk difference, 15%; 1-tailed, α = .05 and power = 0.8). Allowing for a 30% dropout rate in each group (34 patients), the total sample size was increased to 148 patients per group. A total of 296 patients were required to detect a difference in long-term abstinence.

RESULTS

From February 2011 to August 2013, 8570 patients were screened in the 2 preoperative clinics at Toronto Western Hospital and Mount Sinai Hospital, Toronto, Ontario, Canada. Of the 1024 (11.9%) patients who were identified to be smokers, 728 were excluded for various reasons, including not meeting the inclusion criteria (588), less than 7 days before surgery (191), smoking <10 cigarettes per day (191), use of marijuana or significant medical disease (206), and refusal to participate (140; Figure 1). A total of 296 patients were randomized to receive either the smoking cessation program (n = 151) or brief advice (n = 145). Seventeen patients in the smoking cessation program group discontinued participation, and 13 patients in the brief advice group discontinued participation during the first 3 months for various reasons (Figure 1). Follow-up occurred until September 2014. After the first 3 months, 3 patients in the smoking cessation group discontinued follow-up, and 2 patients were lost to follow-up in the brief advice group. Overall study completion rates at the 12-month follow-up for the smoking cessation program group versus the brief advice group was 131 (86.8%) vs 130 (89.7%) patients.

F1
Figure 1.:
Flow diagram of participants included in the study.

The demographic variables and baseline smoking characteristics of the 2 groups are shown in Table 1. In the smoking cessation program group and brief advice group, a majority of the patients, 33.6% and 33.8%, respectively, were in the “contemplation” Stage of Change, and at least 74% of the patients had made at least 1 quit attempt (Table 1).

T1
Table 1.:
Demographic and Baseline Characteristics

In both groups, the urinary cotinine results correlated well with self-reported abstinence. The phi correlation coefficients (indicating agreement between self-reported abstinence and the urine cotinine results) were 0.97 vs 0.98 at 3 months; 0.99 vs 0.95 at 6 months; and 0.97 vs 0.87 at 12 months for the smoking cessation program group versus the brief advice group, respectively.

Efficacy

Using an intention-to-treat analysis, the 7-day PP abstinence at 12 months was higher for the smoking cessation program group compared with the brief advice group: 42.4% vs 26.2% (RR, 1.62; 95% CI, 1.16–2.25; P = .003). The 7-day PP abstinence at 1, 3, and 6 months was also higher in the smoking cessation program group compared with the brief advice group: 45.7% vs 25.5% (RR, 1.79; 95% CI, 1.29–2.49; P < .001); 46.4% vs 26.9% (RR, 1.72; 95% CI, 1.25–2.37; P ≤ .001); and 45.0% vs 26.2% (RR, 1.72; 95% CI, 1.24–2.38; P < .001), respectively (Figure 2). The continuous abstinence was higher at 1, 3, 6, and 12 months in the smoking cessation group versus the brief advice group: 31.8% vs 16.6% (RR, 1.92; 95% CI, 1.25–2.96; P = .002); 33.8% vs 18.6% (RR, 1.72; 95% CI, 1.25–2.37; P= .003); 34.4% vs 18.6% (RR, 1.72; 95% CI, 1.24–2.38; P = .002); and 31.8% vs 16.6 (RR, 1.62; 95% CI, 1.16–2.25; P = .002), respectively (Figure 3). More patients in the smoking cessation program group were abstinent at all follow-up periods.

F2
Figure 2.:
Seven-day PP of urinary cotinine confirmed abstinence for the smoking cessation program group versus the brief advice group. The 7-day PP abstinence was higher for the smoking cessation program group versus the brief advice group at 1, 3, 6, and 12 months (P < .05). PP indicates point prevalence.
F3
Figure 3.:
The continuous abstinence was higher for the smoking cessation program group versus the brief advice group at 1, 3, 6, and 12 months (P < .05).

The nicotine dependence (as measured by the Fagerström test scores) decreased from the start of the study versus 12 months in both the smoking cessation program group and the brief advice group: 5.0 (2.0) vs 1.5 (2.2), P < .001; and 4.4 (1.8) vs 2.0 (2.2), P < .001, respectively. For patients who continued to smoke, the number of cigarettes smoked per day was also reduced for both the smoking cessation program group and the brief advice group from the start of the study versus 12 months: 17.9 (7.7) vs 11.2 (4.9) and 16.2 (7.1) vs 12.5 (6.9), P = .154, respectively; but there was no difference between the 2 groups. The Stage of Change improved in patients in the smoking cessation program versus the brief advice group at all time points after discharge from hospital, indicating an improvement in readiness to quit (P < .05)

A majority of patients in the smoking cessation program (119, 78.8%) completed at least 1 follow-up phone call for counseling with the Smokers’ Helpline versus the brief advice group, in which only 12 patients (8.3%) self-referred themselves to the Smokers’ Helpline (P < .001).

The factors associated with short-term (1 month) and long-term (12 month) smoking abstinence were evaluated by multivariate generalized linear regression analyses. The results are summarized in Table 2. For smoking abstinence at 1 month, treatment group, type of surgery, and help from Smoker’s Helpline had P < .1 on univariate generalized linear regression analysis. The help from Smoker’s Helpline was significantly correlated to treatment group (phi coefficient = .572 and P < .0001), and it was part of the smoking cessation program. Because the randomization was stratified by Stage of Change, treatment group along with type of surgery and baseline Stage of Change were chosen as independent variables for multivariate analysis. The results revealed that participating in the smoking cessation program and inpatient surgery were associated with smoking abstinence at 1 month with RR = 1.73 (95% CI, 1.26–2.39; P = .0017) and RR = 1.84 (95% CI, 1.26–2.69; P = .0027), respectively (Table 2). For smoking abstinence at 12 months, treatment group, ASA physical status, and help from Smoker’s Helpline had a P < .1 on univariate generalized linear regression analysis. Because help from Smokers’ Helpline was significantly correlated to treatment group (phi coefficient = 0.564 and P < .0001) and was part of the smoking cessation program, it was not chosen for multivariate analysis. Treatment group, along with ASA physical status and baseline Stage of Change, were chosen as independent variables for multivariate analysis. The results show that participating in the smoking cessation program was significantly associated with smoking abstinence at 12 months (RR, 1.58; 95% CI, 1.12–2.21; P = .0087). ASA physical status and Stage of Change were not significantly associated with smoking abstinence at 12 months (Table 2).

T2
Table 2.:
Factors Associated With Short-term (1-Month) and Long-term (12-Month) Smoking Abstinence: Results of Generalized Linear Regression

There was no difference in the incidence of total complications between the smoking cessation program group versus the brief advice group: 32 (22.4) vs 39 (26.2), P = .496. There was no difference in wound, pulmonary, cardiovascular, infectious, urinary tract or gastrointestinal complications between 2 groups (Table 3). There were 2 deaths within 30 days of surgery: 1 patient in the smoking cessation program group who had a craniotomy for a cerebral aneurysm died of a subarachnoid hemorrhage; and 1 patient in the brief advice group died of colon cancer.

T3
Table 3.:
Postoperative Complications for the Brief Advice Versus Smoking Cessation Program Groups

Nausea occurred more frequently in the smoking cessation program group than the brief advice group: 9.9% vs 0.7% (P < .001). In the smoking cessation program group, 10 patients had mild nausea, 4 patients had moderate nausea, and 1 patient had missing data for the severity of nausea. One patient in the brief advice group had moderate nausea. Other adverse events including edema, constipation, hypotension, pruritus, and body aches, were also reported more frequently in the smoking cessation program group versus the brief advice group: 4.6% vs 0% (P = .015; Supplemental Digital Content 3, Table, http://links.lww.com/AA/B948). There were no adverse psychiatric or cardiac events in either group.

DISCUSSION

In this study, anesthesiologists implemented a comprehensive smoking cessation program that increased both short-term and long-term abstinence compared with brief advice in patients undergoing elective noncardiac surgery. Patients in the smoking cessation program were 62% more likely to be abstinent at 12 months than the patients receiving the brief intervention. The continuous abstinence was also higher in the smoking cessation program group at all follow-up time points. Participation in the smoking cessation program was predictive of both short-term and long-term abstinence.

The result of the present study is consistent with our previous study that showed the effectiveness of pharmacotherapy with varenicline and counseling for increasing long-term abstinence in surgical patients.9 The current study highlights the importance of providing varenicline to patients as part of a multifaceted intervention.9 Moreover, many patients participating in the study desired the free 3-month supply of varenicline. The rate of abstinence is higher than the previous studies published in 2006 in the general population.16,17 The high quit rates may be attributable to a combination of several factors. First, in our current study, an anesthesiologist, or alternatively a pharmacist, provided an intensive counseling session unlike our previous study, in which 2 intensive counseling sessions were provided by a research coordinator. Advice to quit smoking from health care professionals, especially physicians, has been cited as a key motivator to quit smoking.26 Second, there has been a change in the practice of the surgeons in our hospitals. Approximately 60% of the study patients underwent general surgery, orthopedic surgery, or spine surgery; these surgeons strongly advise smokers to quit smoking and inform the patients that they may not have surgery unless he or she quits smoking. As well, we have trained the nurses, pharmacists, and anesthesiologists in our preoperative clinics to routinely provide brief advice. The high participation rate of eligible smokers may be attributed to the advice to quit smoking that is routinely provided by perioperative clinicians before the patient is approached by the research coordinator. Advice from surgeons can greatly increase abstinence from smoking, with quit rates of 89.6% at 12 months after head and neck cancer surgery.27 The current study results suggest that the follow-up counseling provided by the Smokers’ Helpline may be comparable to the brief counseling provided monthly by the research coordinator in our previous study. As well, the prevalence of smoking has continued to decline in Canada and in other developed countries during the past decade.

The quit rate of 26.2% in the brief advice group in our study is consistent with a previous Canadian study of a brief preoperative intervention consisting of brief counseling (<5 minutes) by a preadmission nurse, a free 6-week supply of nicotine replacement therapy, provision of an educational pamphlet, and a quitline referral.28 In this study, the quit rate at 12 months was 25% in the brief intervention group versus 8% in the control group, which received no intervention.28

In this study, varenicline was generally well tolerated, with the most common adverse effect being nausea. Similar to our previous study,9 there was no difference in perioperative complications between the 2 groups. Previous concerns about the safety of varenicline and adverse cardiovascular or psychiatric events29 have not been substantiated by a recent meta-analysis30 and a large retrospective cohort study that included 51,450 patients who received prescriptions for varenicline.31 This study reported that varenicline was not associated with an increased risk of cardiovascular and neuropsychiatric events, and in contrast, it was associated with a reduced risk of depression and ischemic heart disease.31

An important finding of this study is that the patients who had their telephone numbers faxed directly to the quitline were 9-fold more likely to receive proactive telephone counseling by the quitline versus the brief advice group. The Smoker’s Helpline will provide up to 6 follow-up phone calls. The combination of advice and counseling from several health care professionals, pharmacotherapy, and proactive telephone counseling provided by quitlines increases the likelihood of quitting over brief advice and self-referral.32 Our results confirm that the “Ask, Advise, and Connect” approach of directly connecting smokers to counseling resources such as quitlines, is more effective than the “Ask, Advise, Refer” approach.33 The “Ask, Advise, Connect” approach can greatly increase the reach and impact of the intervention, and shifts the burden of intensive counseling away from physicians.33 Our study confirms that patients infrequently place calls to quitlines when they are asked to self-refer.34 Fax or electronic referrals to quitlines may be a convenient and cost-effective way to overcome some of the barriers for busy clinicians, such as a lack of time, skills, or staff to provide intensive counseling and follow-up in the preadmission clinic.35,36

The present study has some limitations. The research coordinators were not blinded to the group allocation. The urine cotinine test results were mailed back to us, thus, it is possible that someone other than the patient may have performed the test. As well, we did not determine whether patients in the brief advice group sought their primary care physician or other resources for assistance in smoking cessation with pharmacotherapy. Our findings may not be applicable in countries that do not have tobacco quitlines. Although we included a variety of surgical procedures, the generalizability of our findings is limited to elective, noncardiac surgical patients without a history of cardiovascular or psychiatric illnesses.

In conclusion, a perioperative smoking cessation program with one 10- to 15-minute counseling session, pharmacotherapy with varenicline, an educational pamphlet, and a fax referral to a quitline increased long-term abstinence by 62% compared with brief counseling and self-referral to a quitline. Anesthesiologists are uniquely positioned to counsel surgical patients and work collaboratively with their surgical colleagues, pharmacists, quitlines, and other health care providers to help patients quit during the perioperative period. Further research is needed to explore the best methods for implementation of smoking cessation interventions into routine practice in preoperative settings.

ACKNOWLEDGMENTS

The authors thank Hisham Elsaid, MBBS, research fellow, Uzma Nisar, MBBS, research fellow, and Peter Liao, MD, research analyst, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada, for their assistance with the study.

DISCLOSURES

Name: Jean Wong, MD, FRCPC.

Contribution: This author helped conduct the study, interpret the results, and edit and write the manuscript.

Name: Amir Abrishami, MD, FRCPC.

Contribution: This author helped design the study, prepare protocol, and edit the manuscript.

Name: Sheila Riazi, MD, FRCPC.

Contribution: This author helped conduct the study and edit the manuscript.

Name: Naveed Siddiqui, MD, FRCPC.

Contribution: This author helped conduct the study and edit the manuscript.

Name: Eric You-Ten, MD, FRCPC.

Contribution: This author helped conduct the study and edit the manuscript.

Name: Jennifer Korman, BScPhm, ACPR, RPh.

Contribution: This author helped conduct the study.

Name: Sazzadul Islam, BSc.

Contribution: This author helped collect the data.

Name: Xin Chen, Research Fellow.

Contribution: This author helped analyze the data.

Name: Maged S. M. Andrawes, MBBS.

Contribution: This author helped collect the data.

Name: Peter Selby, MBBS, CCFP, FCFP.

Contribution: This author helped edit the manuscript.

Name: David T. Wong, MD, FRCPC.

Contribution: This author helped conduct the study and edit the manuscript.

Name: Frances Chung, MBBS, FRCPC.

Contribution: This author helped conceive and design the study, supervise the study, and edit the manuscript.

This manuscript was handled by: Nancy Borkowski, DBA, CPA, FACHE, FHFMA.

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