Publications by authors named "Jason Busse"

229 Publications

The quality of subgroup analyses in chronic pain randomized controlled trials: a methodological review.

Korean J Pain 2021 Apr;34(2):139-155

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

The quality of subgroup analyses (SGAs) in chronic non-cancer pain trials is uncertain. The purpose of this study was to address this issue. We conducted a comprehensive search in MEDLINE and EMBASE from January 2012 to September 2018 to identify eligible trials. Two pairs of reviewers assessed the quality of the SGAs and the credibility of subgroup claims using the 10 criteria developed by Sun et al. in 2012. The associations between the quality of the SGAs and the studies' characteristics including risk of bias, funding sources, sample size, and the latest impact factor, were assessed using multivariable logistic regression. Our search retrieved 3,401 articles of which 66 were eligible. The total number of SGAs was 177 of which 52 (29.4%) made a subgroup claim. Of these, only 15 (8.5%) were evaluated as being of high quality. Among the 30 SGAs that claimed subgroup effects using an appropriate method of performing interaction tests, the credibility of only 5 were assessed as high. None of the subgroup claims met all the credibility criteria. No significant association was found between the quality of SGAs and the studies' characteristics. The quality of the SGAs performed in chronic pain trials was poor. To enhance the quality of SGAs, scholars should consider the developed criteria when designing and conducting trials, particularly those which need to be specified a .
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http://dx.doi.org/10.3344/kjp.2021.34.2.139DOI Listing
April 2021

The global summit on the efficacy and effectiveness of spinal manipulative therapy for the prevention and treatment of non-musculoskeletal disorders: a systematic review of the literature.

Chiropr Man Therap 2021 Feb 17;29(1). Epub 2021 Feb 17.

Faculty of Health Sciences, Ontario Tech University, Oshawa, Canada.

Background: A small proportion of chiropractors, osteopaths, and other manual medicine providers use spinal manipulative therapy (SMT) to manage non-musculoskeletal disorders. However, the efficacy and effectiveness of these interventions to prevent or treat non-musculoskeletal disorders remain controversial.

Objectives: We convened a Global Summit of international scientists to conduct a systematic review of the literature to determine the efficacy and effectiveness of SMT for the primary, secondary and tertiary prevention of non-musculoskeletal disorders.

Global Summit: The Global Summit took place on September 14-15, 2019 in Toronto, Canada. It was attended by 50 researchers from 8 countries and 28 observers from 18 chiropractic organizations. At the summit, participants critically appraised the literature and synthesized the evidence.

Systematic Review Of The Literature: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and the Index to Chiropractic Literature from inception to May 15, 2019 using subject headings specific to each database and free text words relevant to manipulation/manual therapy, effectiveness, prevention, treatment, and non-musculoskeletal disorders. Eligible for review were randomized controlled trials published in English. The methodological quality of eligible studies was assessed independently by reviewers using the Scottish Intercollegiate Guidelines Network (SIGN) criteria for randomized controlled trials. We synthesized the evidence from articles with high or acceptable methodological quality according to the Synthesis without Meta-Analysis (SWiM) Guideline. The final risk of bias and evidence tables were reviewed by researchers who attended the Global Summit and 75% (38/50) had to approve the content to reach consensus.

Results: We retrieved 4997 citations, removed 1123 duplicates and screened 3874 citations. Of those, the eligibility of 32 articles was evaluated at the Global Summit and 16 articles were included in our systematic review. Our synthesis included six randomized controlled trials with acceptable or high methodological quality (reported in seven articles). These trials investigated the efficacy or effectiveness of SMT for the management of infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. None of the trials evaluated the effectiveness of SMT in preventing the occurrence of non-musculoskeletal disorders. Consensus was reached on the content of all risk of bias and evidence tables. All randomized controlled trials with high or acceptable quality found that SMT was not superior to sham interventions for the treatment of these non-musculoskeletal disorders. Six of 50 participants (12%) in the Global Summit did not approve the final report.

Conclusion: Our systematic review included six randomized clinical trials (534 participants) of acceptable or high quality investigating the efficacy or effectiveness of SMT for the treatment of non-musculoskeletal disorders. We found no evidence of an effect of SMT for the management of non-musculoskeletal disorders including infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. This finding challenges the validity of the theory that treating spinal dysfunctions with SMT has a physiological effect on organs and their function. Governments, payers, regulators, educators, and clinicians should consider this evidence when developing policies about the use and reimbursement of SMT for non-musculoskeletal disorders.
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http://dx.doi.org/10.1186/s12998-021-00362-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890602PMC
February 2021

Cochrane in CORR®: Oral Nonsteroidal Anti-inflammatory Drugs versus Other Oral Analgesic Agents for Acute Soft Tissue Injury.

Clin Orthop Relat Res 2021 Jan;479(1):17-23

K. Madden, Department of Surgery, McMaster University, St. Joseph's Healthcare Hamilton, and the Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

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http://dx.doi.org/10.1097/CORR.0000000000001595DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899588PMC
January 2021

Interventions to Influence Opioid Prescribing Practices for Chronic Noncancer Pain: A Systematic Review and Meta-Analysis.

Am J Prev Med 2021 01 20;60(1):e15-e26. Epub 2020 Nov 20.

Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada. Electronic address:

Context: This study is a systematic review of interventions to improve adherence to guideline recommendations for prescribing opioids for chronic noncancer pain.

Evidence Acquisition: Investigators searched CINAHL, Embase, MEDLINE, PsycINFO, the Cochrane Library, and Joanna Briggs Institute Evid Based Pract database from inception until June 3, 2019. Interventional studies to improve adherence to recommendations made by opioid guidelines for chronic noncancer pain in North America were eligible if outcomes included adherence to guideline recommendations or change in quantity of opioids prescribed. Data were extracted independently and in duplicate. Quantitative synthesis was performed using random effects meta-analysis. Confidence in evidence was determined using the Grades of Recommendation, Assessment, Development, and Evaluation.

Evidence Synthesis: A total of 20 studies (8 controlled and 12 prospective cohort) involving 1,491 providers and 72 clinics met inclusion. Interventions included education, audit and feedback, interprofessional support, shared decision making, and multifaceted strategies. Multifaceted interventions improved the use of urine drug testing (n=2, or =2.31, 95% CI=1.53, 3.49, z=3.98, p<0.01; high-certainty evidence), treatment agreements (n=2, or =1.96, 95% CI=1.47, 2.61, z=4.56, p<0.01; moderate-certainty evidence), and mental health screening (n=2, 2.57-fold, 95% CI=1.56, 4.24, z=2.32, p=0.02; low-certainty evidence) when prescribing opioids for chronic noncancer pain. Very low-certainty evidence suggests that several interventions improved the use of treatment agreements, urine drug testing, and prescription drug monitoring programs.

Conclusions: Mostly very low-certainty evidence supports a number of interventions for improving adherence to risk management strategies when prescribing opioids for chronic noncancer pain; however, the effect on patient important outcomes (e.g., overdose, addiction, death) is uncertain.
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http://dx.doi.org/10.1016/j.amepre.2020.07.012DOI Listing
January 2021

Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study.

Clin Orthop Relat Res 2021 04;479(4):805-813

F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Background: Forty percent of long bone fractures involve the tibia. These fractures are associated with prolonged recovery and may adversely affect patients' long-term physical functioning; however, there is limited evidence to inform what factors influence functional recovery in this patient population.

Question/purpose: In a secondary analysis of a previous randomized trial, we asked: What fracture-related, demographic, social, or rehabilitative factors were associated with physical function 1 year after reamed intramedullary nailing of open or closed tibial shaft fractures?

Methods: This is a secondary (retrospective) analysis of a prior randomized trial (Trial to Re-evaluate Ultrasound in the Treatment of Tibial Fractures; TRUST trial). In the TRUST trial, 501 patients with unilateral open or closed tibial shaft fractures were randomized to self-administer daily low-intensity pulsed ultrasound or use a sham device, of which 15% (73 of 501) were not followed for 1 year due to early study termination as a result of futility (no difference between active and sham interventions). Of the remaining patients, 70% (299 of 428) provided full data. All fractures were fixed using reamed (298 of 299) or unreamed (1 of 299) intramedullary nailing. Thus, we excluded the sole fracture fixed using unreamed intramedullary nailing. The co-primary study outcomes of the TRUST trial were time to radiographic healing and SF-36 physical component summary (SF-36 PCS) scores at 1-year. SF-36 PCS scores range from 0 to 100, with higher scores being better, and the minimum clinically important difference (MCID) is 5 points. In this secondary analysis, based on clinical and biological rationale, we selected factors that may be associated with physical functioning as measured by SF-36 PCS scores. All selected factors were inserted simultaneously into a multivariate linear regression analysis.

Results: After adjusting for potentially confounding factors, such as age, gender, and injury severity, we found that no factor showed an association that exceeded the MCID for physical functioning 1 year after intramedullary nailing for tibial shaft fractures. The independent variables associated with lower physical functioning were current smoking status (mean difference -3.0 [95% confidence interval -5 to -0.5]; p = 0.02), BMI > 30 kg/m2 (mean difference -3.0 [95% CI -5.0 to -0.3]; p = 0.03), and receipt of disability benefits or involvement in litigation, or plans to be (mean difference -3.0 [95% CI -5.0 to -1]; p = 0.007). Patients who were employed (mean difference 4.6 [95% CI 2.0 to 7]; p < 0.001) and those who were advised by their surgeon to partially or fully bear weight postoperatively (mean difference 2.0 [95% CI 0.1 to 4.0]; p = 0.04) were associated with higher physical functioning. Age, gender, fracture severity, and receipt of early physical therapy were not associated with physical functioning at 1-year following surgical fixation.

Conclusion: Among patients with tibial fractures, none of the factors we analyzed, including smoking status, receipt of disability benefits or involvement in litigation, or BMI, showed an association with physical functioning that exceeded the MCID.

Level Of Evidence: Level III, therapeutic study.
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http://dx.doi.org/10.1097/CORR.0000000000001573DOI Listing
April 2021

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.

Trials 2020 Oct 28;21(1):896. Epub 2020 Oct 28.

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.

Background: Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain.

Objectives And Methods: Aims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries. We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results. We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup analyses; and the use of routinely collected data for RCTs.

Discussion: The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time.
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http://dx.doi.org/10.1186/s13063-020-04808-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594472PMC
October 2020

Predictors of Long-Term Pain After Hip Arthroplasty in Patients With Femoral Neck Fractures: A Cohort Study.

J Orthop Trauma 2020 11;34 Suppl 3:S55-S63

aDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada; bThe Michael G. DeGroote National Pain Center, McMaster University, Hamilton, ON, Canada; cDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; dDepartment of Surgery, University of Western Ontario, London, ON, Canada; eDepartment of Orthopedic and Trauma Surgery, OLVG, Amsterdam and Leiden University Medical Center, Leiden, the Netherlands; fDivision of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway; gDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada; and hThe Chronic Pain Centre of Excellence for Canadian Veterans, Hamilton, ON, Canada.

Objectives: To identify factors associated with the development of prolonged pain after hip fracture surgery.

Design: Secondary analysis of a randomized controlled trial.

Setting: Eighty hospitals in 10 countries.

Patients/participants: One thousand four hundred forty-one hip fracture patients in the HEALTH trial.

Interventions: Total hip arthroplasty or hemiarthroplasty.

Main Outcome Measures: Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty.

Results: Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%).

Conclusions: Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain.

Level Of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.1097/BOT.0000000000001929DOI Listing
November 2020

A practical guide for using a survey about attitudes and behaviors to inform health care decisions.

J Clin Epidemiol 2020 12 25;128:93-100. Epub 2020 Sep 25.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.

Objectives: Surveys can provide important information about what people think or do. There is little guidance about how to use surveys in decision-making. This article provides guidance for how to appraise and use a survey to answer health care questions.

Study Design And Setting: A guidance article about the use a survey of a selected sample of people, who completed a self-report tool about their knowledge, beliefs and opinions, behaviors and experiences, or personal attributes. We use survey examples, one scenario, and a specific survey for illustration.

Results: Decision makers should consider the credibility and applicability of the results of a survey. Key threats to credibility depend on the representativeness of the population and likelihood that it provides an accurate picture of the population's knowledge, attitudes, or self-reported practices. If survey investigators do not use rigorous strategies to develop or pretest questions, there is a greater risk that results will be misleading. Decision makers may want to consider the precision of estimates and whether it would change their decisions. Finally, they need to decide how similar the surveyed population is to their specific population before applying results.

Conclusions: Decision makers can follow this guidance to critically appraise, interpret, and apply the results of surveys to health care questions.
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http://dx.doi.org/10.1016/j.jclinepi.2019.11.020DOI Listing
December 2020

Potential impact of missing outcome data on treatment effects in systematic reviews: imputation study.

BMJ 2020 08 26;370:m2898. Epub 2020 Aug 26.

Department of Internal Medicine, American University of Beirut Medical Center, PO Box 11-0236, Riad-El-Solh Beirut 1107 2020, Beirut, Lebanon

Objective: To assess the risk of bias associated with missing outcome data in systematic reviews.

Design: Imputation study.

Setting: Systematic reviews.

Population: 100 systematic reviews that included a group level meta-analysis with a statistically significant effect on a patient important dichotomous efficacy outcome.

Main Outcome Measures: Median percentage change in the relative effect estimate when applying each of the following assumption (four commonly discussed but implausible assumptions (best case scenario, none had the event, all had the event, and worst case scenario) and four plausible assumptions for missing data based on the informative missingness odds ratio (IMOR) approach (IMOR 1.5 (least stringent), IMOR 2, IMOR 3, IMOR 5 (most stringent)); percentage of meta-analyses that crossed the threshold of the null effect for each method; and percentage of meta-analyses that qualitatively changed direction of effect for each method. Sensitivity analyses based on the eight different methods of handling missing data were conducted.

Results: 100 systematic reviews with 653 randomised controlled trials were included. When applying the implausible but commonly discussed assumptions, the median change in the relative effect estimate varied from 0% to 30.4%. The percentage of meta-analyses crossing the threshold of the null effect varied from 1% (best case scenario) to 60% (worst case scenario), and 26% changed direction with the worst case scenario. When applying the plausible assumptions, the median percentage change in relative effect estimate varied from 1.4% to 7.0%. The percentage of meta-analyses crossing the threshold of the null effect varied from 6% (IMOR 1.5) to 22% (IMOR 5) of meta-analyses, and 2% changed direction with the most stringent (IMOR 5).

Conclusion: Even when applying plausible assumptions to the outcomes of participants with definite missing data, the average change in pooled relative effect estimate is substantive, and almost a quarter (22%) of meta-analyses crossed the threshold of the null effect. Systematic review authors should present the potential impact of missing outcome data on their effect estimates and use this to inform their overall GRADE (grading of recommendations assessment, development, and evaluation) ratings of risk of bias and their interpretation of the results.
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http://dx.doi.org/10.1136/bmj.m2898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448113PMC
August 2020

Predictors of Prolonged Opioid Use After Initial Prescription for Acute Musculoskeletal Injuries in Adults : A Systematic Review and Meta-analysis of Observational Studies.

Ann Intern Med 2020 11 18;173(9):721-729. Epub 2020 Aug 18.

Michael G. DeGroote National Pain Centre, McMaster University, and Chronic Pain Centre of Excellence for Canadian Veterans, Hamilton, Ontario, Canada (J.W.B.).

Background: Opioids are frequently prescribed for acute musculoskeletal injuries and may result in long-term use and consequent harms.

Purpose: To explore factors associated with persistent opioid use after its prescription for acute musculoskeletal injury.

Data Sources: Searches of multiple electronic databases, without language restrictions, from inception to 6 January 2020, and reference lists of selected articles.

Study Selection: Observational studies of adults with opioid prescriptions for outpatient acute musculoskeletal injuries, in an adjusted model, that explored risk factors for prolonged use.

Data Extraction: 6 reviewers, working in pairs, independently extracted data, rated the quality of studies, and evaluated the certainty of evidence.

Data Synthesis: 14 cohorts with 13 263 393 participants were included. The overall prevalence of prolonged opioid use after musculoskeletal injury for high-risk populations (that is, patients receiving workers' compensation benefits, Veterans Affairs claimants, or patients with high rates of concurrent substance use disorder) was 27% (95% CI, 18% to 37%). The prevalence among low-risk populations was 6% (CI, 4% to 8%; for interaction < 0.001). Moderate-certainty evidence showed increased odds of persistent opioid use with older age (absolute risk increase [ARI] for every 10-year increase, 1.1% [CI, 0.7% to 1.5%]) and physical comorbidity (ARI, 0.9% [CI, 0.1% to 1.7%]). Low-certainty evidence suggested increased risk for persistent opioid use with past or current substance use disorder (ARI, 10.5% [CI, 4.2% to 19.8%]), prescriptions lasting more than 7 days (median ARI, 4.5%), and higher morphine milligram equivalents per day.

Limitation: Sparse, heterogeneous data with suboptimal adjustment for potential confounders.

Conclusion: Avoiding prescribing opioids for acute musculoskeletal injuries to patients with past or current substance use disorder, and restricting duration to 7 days or less and using lower doses when they are prescribed, are potentially important targets to reduce rates of persistent opioid use.

Primary Funding Source: National Safety Council. (PROSPERO: CRD42018104968).
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http://dx.doi.org/10.7326/M19-3600DOI Listing
November 2020

Management of Acute Pain From Non-Low Back, Musculoskeletal Injuries : A Systematic Review and Network Meta-analysis of Randomized Trials.

Ann Intern Med 2020 11 18;173(9):730-738. Epub 2020 Aug 18.

McMaster University, Hamilton, Ontario, Canada (B.S., Y.O., E.C., S.A.R., P.E., S.T.N., W.Y., A.L., S.H.A., S.C., R.C., R.L.M., K.A., A.P., Y.S., A.D., G.H.G.).

Background: Patients and clinicians can choose from several treatment options to address acute pain from non-low back, musculoskeletal injuries.

Purpose: To assess the comparative effectiveness of outpatient treatments for acute pain from non-low back, musculoskeletal injuries by performing a network meta-analysis of randomized clinical trials (RCTs).

Data Sources: MEDLINE, EMBASE, CINAHL, PEDro (Physiotherapy Evidence Database), and Cochrane Central Register of Controlled Trials to 2 January 2020.

Study Selection: Pairs of reviewers independently identified interventional RCTs that enrolled patients presenting with pain of up to 4 weeks' duration from non-low back, musculoskeletal injuries.

Data Extraction: Pairs of reviewers independently extracted data. Certainty of evidence was evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

Data Synthesis: The 207 eligible studies included 32 959 participants and evaluated 45 therapies. Ninety-nine trials (48%) enrolled populations with diverse musculoskeletal injuries, 59 (29%) included patients with sprains, 13 (6%) with whiplash, and 11 (5%) with muscle strains; the remaining trials included various injuries ranging from nonsurgical fractures to contusions. Topical nonsteroidal anti-inflammatory agents (NSAIDs) proved to have the greatest net benefit, followed by oral NSAIDs and acetaminophen with or without diclofenac. Effects of these agents on pain were modest (around 1 cm on a 10-cm visual analogue scale, approximating the minimal important difference). Regarding opioids, compared with placebo, acetaminophen plus an opioid improved intermediate pain (1 to 7 days) but not immediate pain (≤2 hours), tramadol was ineffective, and opioids increased the risk for gastrointestinal and neurologic harms (all moderate-certainty evidence).

Limitations: Only English-language studies were included. The number of head-to-head comparisons was limited.

Conclusion: Topical NSAIDs, followed by oral NSAIDs and acetaminophen with or without diclofenac, showed the most convincing and attractive benefit-harm ratio for patients with acute pain from non-low back, musculoskeletal injuries. No opioid achieved benefit greater than that of NSAIDs, and opioids caused the most harms.

Primary Funding Source: National Safety Council. (PROSPERO: CRD42018094412).
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http://dx.doi.org/10.7326/M19-3601DOI Listing
November 2020

Addition of corticosteroids to local anaesthetics for chronic non-cancer pain injections: a systematic review and meta-analysis of randomised controlled trials.

Br J Anaesth 2020 11 12;125(5):779-801. Epub 2020 Aug 12.

Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.

Background: Despite common use, the benefit of adding steroids to local anaesthetics (SLA) for chronic non-cancer pain (CNCP) injections is uncertain. We performed a systematic review and meta-analysis of English-language RCTs to assess the benefit and safety of adding steroids to local anaesthetics (LA) for CNCP.

Methods: We searched MEDLINE, EMBASE, and CENTRAL databases from inception to May 2019. Trial selection and data extraction were performed in duplicate. Outcomes were guided by the Initiative in Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) statement with pain improvement as the primary outcome and pooled using random effects model and reported as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CIs).

Results: Among 5097 abstracts, 73 trials were eligible. Although SLA increased the rate of success (42 trials, 3592 patients; RR=1.14; 95% CI, 1.03-1.25; number needed to treat [NNT], 13), the effect size decreased by nearly 50% (NNT, 22) with the removal of two intrathecal injection studies. The differences in pain scores with SLA were not clinically meaningful (54 trials, 4416 patients, MD=0.44 units; 95% CI, 0.24-0.65). No differences were observed in other outcomes or adverse events. No subgroup effects were detected based on clinical categories. Meta-regression showed no significant association with steroid dose or length of follow-up and pain relief.

Conclusions: Addition of cortico steroids to local anaesthetic has only small benefits and a potential for harm. Injection of local anaesthetic alone could be therapeutic, beyond being diagnostic. A shared decision based on patient preferences should be considered. If used, one must avoid high doses and series of steroid injections.

Clinical Trial Registration: PROSPERO #: CRD42015020614.
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http://dx.doi.org/10.1016/j.bja.2020.06.062DOI Listing
November 2020

Delays in hospital admissions for patients with fractures - Authors' reply.

Lancet Glob Health 2020 08;8(8):e1000

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON L8L 8E7, Canada; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON L8L 8E7, Canada. Electronic address:

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http://dx.doi.org/10.1016/S2214-109X(20)30305-3DOI Listing
August 2020

Overlapping patterns of recreational and medical cannabis use in a large community sample of cannabis users.

Compr Psychiatry 2020 10 6;102:152188. Epub 2020 Jun 6.

Michael G. DeGroote Centre for Medicinal Cannabis Research, McMaster University & St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada; Peter Boris Centre for Addictions Research, McMaster University & St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada; Homewood Research Institute, Guelph, ON, Canada. Electronic address:

Background: Regulatory changes are increasing access to both medical cannabis and cannabis in general. As such, understanding patterns of recreational and medical cannabis use is a high public health priority.

Objectives: Patterns of cannabis use (recreational and medical), other substance use, and psychiatric symptoms were characterized in a large sample of community adult cannabis users in Canada, prior to federal cannabis legalization.

Methods: This was a self-report assessment of 709 cannabis users (Mean age = 30.19 (11.82) years; 55.01% female). Patterns of overall substance use and psychiatric symptomatology were compared based on recreational/medical cannabis status.

Results: Overall, 61.4% of participants endorsed exclusively recreational use, while 38.6% reported some level of medical use. Of all medical users, only 23.4% reported authorization from a health professional. Recreational cannabis users typically reported infrequent use (less than weekly), whereas medical users modally reported daily use. Compared to recreational users, medical users reported more problematic cannabis use in addition to greater psychiatric symptomatology (anxiety, depression and trauma). Interestingly, a large majority of medical users also reported using recreationally (80.6%), while exclusive medical use was less common (19.3%). This dual motives group reported more daily cannabis use and more alcohol and tobacco use. Compared to medical-only users, individuals using cannabis for both medical and recreational purposes more often used cannabis to treat psychiatric conditions.

Conclusions: These findings reveal the differences in cannabis use patterns and preferences between recreational and medical users, and even within medical users. In particular, dual motives individuals, who use cannabis for both positively and negatively reinforcing purposes, may warrant special attention as a subpopulation.
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http://dx.doi.org/10.1016/j.comppsych.2020.152188DOI Listing
October 2020

Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies.

Br J Anaesth 2020 09 28;125(3):346-357. Epub 2020 Jun 28.

Department of Anesthesia, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada; Michael G. DeGroote Centre for Medicinal Cannabis Research, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada.

Background: The prevalence and intensity of persistent post-surgical pain (PPSP) after breast cancer surgery are uncertain. We conducted a systematic review and meta-analysis to further elucidate this issue.

Methods: We searched MEDLINE, Embase, CINAHL, and PsycINFO, from inception to November 2018, for observational studies reporting persistent pain (≥3 months) after breast cancer surgery. We used random-effects meta-analysis and the Grading of Recommendations, Assessment, Development and Evaluations approach to rate quality of evidence.

Results: We included 187 observational studies with 297 612 breast cancer patients. The prevalence of PPSP ranged from 2% to 78%, median 37% (inter-quartile range: 22-48%); the pooled prevalence was 35% (95% confidence interval [CI]: 32-39%). The pooled pain intensity was 3.9 cm on a 10 cm visual analogue scale (95% CI: 3.6-4.2 cm). Moderate-quality evidence supported the subgroup effects of PPSP prevalence for localized pain vs any pain (29% vs 44%), moderate or greater vs any pain (26% vs 44%), clinician-assessed vs patient-reported pain (23% vs 36%), and whether patients underwent sentinel lymph node biopsy vs axillary lymph node dissection (26% vs 43%). The adjusted analysis found that the prevalence of patient-reported PPSP (any severity/location) was 46% (95% CI: 36-56%), and the prevalence of patient-reported moderate-to-severe PPSP at any location was 27% (95% CI: 10-43%).

Conclusions: Moderate-quality evidence suggests that almost half of all women undergoing breast cancer surgery develop persistent post-surgical pain, and about one in four develop moderate-to-severe persistent post-surgical pain; the higher prevalence was associated with axillary lymph node dissection. Future studies should explore whether nerve sparing for axillary procedures reduces persistent post-surgical pain after breast cancer surgery.
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http://dx.doi.org/10.1016/j.bja.2020.04.088DOI Listing
September 2020

Association of Three-Month Radiographic Union Score for Tibia Fractures (RUST) with Nonunion in Tibial Shaft Fracture Patients.

Cureus 2020 May 27;12(5):e8314. Epub 2020 May 27.

Orthopaedic Surgery, McMaster University, Hamilton, CAN.

Objectives Nonunions of tibial shaft fractures have profound implications on patient quality of life and are associated with physical and mental suffering. Radiographic Union Score for Tibia Fractures (RUST) may serve as an important prognostic tool for identifying patients at a high risk of nonunion. Design We used data from the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) and Fluid Lavage of Open Wounds (FLOW) trials to explore the association of three-month RUST scores with nonunion in patients with tibial shaft fractures treated with intramedullary nailing. We performed a retrospective cohort study nested within two multi-center, randomized controlled trials. Participants The patients included in the current study: (1) sustained a tibial shaft fracture and were enrolled in the SPRINT or FLOW randomized trials, (2) had initial operative management with intramedullary nailing, (3) showed radiographic evidence of an unhealed fracture at the three-month follow-up, and (4) their healing status (union or nonunion) was captured at 12-months postoperatively. Intervention Multivariable binary logistic regression was carried out to identify factors associated with nonunion, including open versus closed injury, fracture severity, fracture gap, and three-month RUST score. We determined the concordance statistic (c statistic) for our regression model both with and without the RUST score. Outcome Measurements and Results Of the 155 tibial fracture patients with complete data available for analysis, the overall rate of nonunion at 12 months was 30% (n=47). The mean three-month RUST score in patients with nonunion at 12 months was 4.8 (standard deviation (SD) 1.1) as compared to 6.3 (SD 1.7) for those healed at 12 months. In our multivariable regression analysis, open fractures conferred five-fold greater odds of nonunion at 12 months as compared to closed fractures (odds ratio (OR) 4.76, 95% confidence interval (CI):1.71-13.30). Further, three-month RUST scores of 4 and 5-6 were associated with a 47% (95% CI: 18%-73%) and 23% (4.5-51.5%) absolute risk increase of nonunion as compared to a score of ≥ 7, respectively. The addition of RUST scores to our adjusted regression model improved the c statistic from 0.70 (95%CI: 0.61-0.79) to 0.81 (95%CI: 0.74-0.88). Conclusion A third of patients with tibial shaft fractures who have failed to heal by three months will show nonunion at one year. Open fractures and lower three-month RUST scores are strongly associated with a higher risk of nonunion at one year. Further research is needed to establish whether prognosis in this high-risk group can be modified.
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http://dx.doi.org/10.7759/cureus.8314DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320642PMC
May 2020

Meta-Analyses Proved Inconsistent in How Missing Data Were Handled Across Their Included Primary Trials: A Methodological Survey.

Clin Epidemiol 2020 27;12:527-535. Epub 2020 May 27.

Clinical Research Institute, American University of Beirut, Beirut, Lebanon.

Background: How systematic review authors address missing data among eligible primary studies remains uncertain.

Objective: To assess whether systematic review authors are consistent in the way they handle missing data, both across trials included in the same meta-analysis, and with their reported methods.

Methods: We first identified 100 eligible systematic reviews that included a statistically significant meta-analysis of a patient-important dichotomous efficacy outcome. Then, we successfully retrieved 638 of the 653 trials included in these systematic reviews' meta-analyses. From each trial report, we extracted statistical data used in the analysis of the outcome of interest to compare with the data used in the meta-analysis. First, we used these comparisons to classify the "analytical method actually used" for handling missing data by the systematic review authors for each included trial. Second, we assessed whether systematic reviews explicitly reported their analytical method of handling missing data. Third, we calculated the proportion of systematic reviews that were consistent in their "analytical method actually used" across trials included in the same meta-analysis. Fourth, among systematic reviews that were consistent in the "analytical method actually used" across trials and explicitly reported on a method for handling missing data, we assessed whether the "analytical method actually used" and the reported methods were consistent.

Results: We were unable to determine the "analytical method reviews actually used" for handling missing outcome data among 397 trials. Among the remaining 241, systematic review authors most commonly conducted "complete case analysis" (n=128, 53%) or assumed "none of the participants with missing data had the event of interest" (n=58, 24%). Only eight of 100 systematic reviews were consistent in their approach to handling missing data across included trials, but none of these reported methods for handling missing data. Among seven reviews that did explicitly report their analytical method of handling missing data, only one was consistent in their approach across included trials (using complete case analysis), and their approach was inconsistent with their reported methods (assumed all participants with missing data had the event).

Conclusion: The majority of systematic review authors were inconsistent in their approach towards reporting and handling missing outcome data across eligible primary trials, and most did not explicitly report their methods to handle missing data. Systematic review authors should clearly identify missing outcome data among their eligible trials, specify an approach for handling missing data in their analyses, and apply their approach consistently across all primary trials.
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http://dx.doi.org/10.2147/CLEP.S242080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266325PMC
May 2020

Response to "understanding the behavioural determinants of opioid prescribing among family physicians: a qualitative study".

BMC Fam Pract 2020 06 13;21(1):109. Epub 2020 Jun 13.

Department of Anesthesia, Michael G. DeGroote School of Medicine, McMaster University, HSC-2V9, 1280 Main St. West, Hamilton, ON, L8S 4K1, Canada.

The 2017 Canadian opioid Guideline made both strong recommendations, indicating that all or almost all fully informed patients would choose the recommended course of action, and weak recommendations, in which different choices are appropriate for individual patients based on their values and preferences. The Guideline's recommendation to taper legacy patients prescribed high-dose opioid therapy is weak, and mandatory tapering is expressly discouraged.
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http://dx.doi.org/10.1186/s12875-020-01187-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7293785PMC
June 2020

Nonunion in Patients with Tibial Shaft Fractures: Is Early Physical Status Associated with Fracture Healing?

Cureus 2020 Apr 12;12(4):e7649. Epub 2020 Apr 12.

Orthopaedic Surgery, McMaster University, Hamilton, CAN.

Background Nonunions of tibial shaft fractures have devastating physical and psychological consequences for patients. It remains unknown if early functional status can identify patients at risk for nonunion. Questions/Purposes To determine if functional status at three months after surgery, as measured by either the short form 36 (SF-36) or the short form 12 (SF-12) health survey physical component summary (SF-12 PCS) score, can serve as a prognostic indicator for nonunion at one year in patients with fractures of the tibial shaft. Patients/Methods This study was an observational cohort study nested within two multicenter, randomized controlled trials. Patients who met the following eligibility criteria were included: (1) sustained a tibial shaft fracture that was treated with intramedullary nailing, (2) were unhealed at the three-month follow-up, (3) had a reported SF-36 or SF-12 PCS score at three months, (4) had the final 12-month follow-up with a reported radiographic healing status (bone union or nonunion), and (5) were enrolled in either the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Shaft Fractures (SPRINT) or Fluid Lavage of Open Wounds (FLOW) randomized trials. Multivariable logistic regression was performed to evaluate the association between healing status at 12 months and seven prognostic variables (open fracture, fracture pattern, nailing technique, smoking, fracture gap, three-month PCS score, and FLOW vs. SPRINT trial). Results A total of 940 patients were included in this study with an overall rate of radiographic nonunion of 13.3% (n=125) at the 12-month follow-up. Absolute nonunion risk increased with incrementally lower PCS scores (8.2%, 12.8%, 15.9%, 23.7% for scores ≥ 40, 30.0-39.99, 20.0-29.99, and < 20, respectively). In the multivariable regression analysis, PCS scores of < 20 were associated with a 2.6-times greater odds and 10% absolute risk increase of non-union, as compared to scores of ≥ 40 (OR 2.58, 95%CI: 1.02-6.53, ARI: 10.3, 95% CI: 0.1 - 28.2), whereas scores between 20 and 30 were associated with a nearly two-times greater odds of nonunion and a 6.4% absolute risk increase of nonunion (OR 1.94, 95%CI: 1.08-3.49, ARI: 6.4, 95% CI 0.6 - 15.3). Open fractures also conferred a 2.8-fold increase in odds of nonunion as compared to closed injuries (OR 2.77, 95%CI: 1.58-4.83), as did complex fractures when compared to simple fractures (OR 2.57, 95%CI: 1.64-4.02). Conclusion A considerable portion of patients with fractures of the tibial shaft treated with intramedullary nailing will experience nonunion at one-year postoperatively. Nonunion can be accurately predicted by patient functional recovery at three months as measured by the PCS of the SF-36 and SF-12 instruments.
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http://dx.doi.org/10.7759/cureus.7649DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217237PMC
April 2020

No improvement in disclosure of natural health product use to primary care medical doctors in the last 15 years: A survey of naturopathic patients.

Complement Ther Clin Pract 2020 May 23;39:101106. Epub 2020 Jan 23.

Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada; The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada; Department of Anesthesia, McMaster University, 1280, Main Street West, Hamilton, Ontario, L8S 4K1, Canada; The Michael G. DeGroote Centre for Medicinal Cannabis Research, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4K1, Canada. Electronic address:

Background: The use of natural health products (NHPs) is common in North America. In 2003, we found that 42% of NHP users had not disclosed this information to their primary care medical doctors (MDs). We repeated our survey in 2018/2019 to explore if the rate of NHP use disclosure had improved.

Methods: From November 2018-February 2019, a 21-item survey about NHP use and disclosure was administered to adult patients who visited the Robert Schad Naturopathic Clinic in Toronto, Canada.

Results: Almost all patients surveyed were using NHPs (99%), and 46% were using NHPs and prescription medication concurrently. Consistent with our 2003 findings, 42% of respondents who used NHPs did not disclose this information to their MD.

Conclusion: Disclosure of NHP use to MDs by naturopathic patients is limited and remained unchanged over the past 15 years. Future research should explore primary care MDs' hesitancy to inquire about patient NHP use.
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http://dx.doi.org/10.1016/j.ctcp.2020.101106DOI Listing
May 2020

Association between media attention and presentation of vaccination information on Canadian chiropractors' websites: a prospective mixed-methods cohort study.

CMAJ Open 2020 Apr-Jun;8(2):E338-E345. Epub 2020 May 5.

Faculty of Medicine (Kim), University of Western Ontario, London, Ont.; Departments of Medical Sciences (Kim), Health Sciences (Akhtar), Anesthesia (Busse) and Health Research Methods, Evidence & Impact (Busse), McMaster University, Hamilton, Ont.; Faculty of Medicine (Akhtar), Royal College of Surgeons in Ireland, Dublin, Ireland; Faculty of Medicine (Natalwalla), University of Toronto, Toronto, Ont.; School of Medicine (Goshua), Stanford University, Stanford, Calif.; Clinical Epidemiology Program (Wilson), Department of Medicine, Ottawa Hospital; Bruyère Research Institute (Wilson), Ottawa, Ont.

Background: Historically, some chiropractors have been critical of vaccination, and this has been the subject of recent media attention in Canada. We explored the association between media attention and public dissemination of vaccination information on Canadian chiropractors' websites.

Methods: In 2016, we identified all Canadian chiropractors' websites that provided information on vaccination by extracting details from the regulatory college website for each province using the search engine on their "find a chiropractor" page. We assessed the quality of information using the Web Resource Rating Tool (scores range from 0% [worst] to 100% [best]), determined whether vaccination was portrayed in a positive, neutral or negative manner, and conducted thematic analysis of vaccination content. We revisited all identified websites in 2019 to explore for changes to posted vaccination material.

Results: In July 2016, of 3733 chiropractic websites identified, 94 unique websites provided information on vaccination: 59 (63%) gave negative messaging, 19 (20%) were neutral and 16 (17%) were positive. The quality of vaccination content on the websites was generally poor, with a median Web Resource Rating Tool score of 19%. We identified 4 main themes: there are alternatives to vaccination, vaccines are harmful, evidence regarding vaccination and health policy regarding vaccination. From 2012 to 2016, there was 1 Canadian newspaper story concerning antivaccination statements by chiropractors, whereas 51 news articles were published on this topic between 2017 and 2019. In April 2019, 45 (48%) of the 94 websites we had identified in 2016 had removed all vaccination content or had been discontinued.

Interpretation: In 2016, a minority of Canadian chiropractors provided vaccination information on their websites, the majority of which portrayed vaccination negatively. After substantial national media attention, about half of all vaccination material on chiropractors' websites was removed within several years.
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http://dx.doi.org/10.9778/cmajo.20190204DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7207039PMC
February 2021

Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study.

Lancet Glob Health 2020 05;8(5):e711-e720

Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. Electronic address:

Background: The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission.

Methods: In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and fracture location. We further calculated adjusted relative risk (RR) from adjusted odds ratios, adjusted for the same variables. This study was registered with ClinicalTrials.gov, NCT02150980, and is ongoing.

Findings: Between April 3, 2014, and May 10, 2019, we enrolled 31 255 patients with fractures, with a median age of 45 years (IQR 31-62), of whom 19 937 (63·8%) were men, and 14 524 (46·5%) had lower limb fractures, making them the most common fractures. Of 5256 patients with open fractures, 3778 (71·9%) were not admitted to hospital within 2 h. Of 25 999 patients with closed fractures, 7141 (27·5%) were delayed by more than 24 h. Of all regions, Latin America had the greatest proportions of patients with delays (173 [88·7%] of 195 patients with open fractures; 426 [44·7%] of 952 with closed fractures). Among patients delayed by more than 24 h, the most common reason for delays were interfacility referrals (3755 [47·7%] of 7875) and Third Delays (cumulatively interfacility referral and delay in emergency department: 3974 [50·5%]), while Second Delays (delays in reaching care) were the least common (423 [5·4%]). Compared with other methods of transportation (eg, walking, rickshaw), ambulances led to delay in transporting patients with open fractures to a treating hospital (adjusted RR 0·66, 99% CI 0·46-0·93). Compared with patients with closed lower limb fractures, patients with closed spine (adjusted RR 2·47, 99% CI 2·17-2·81) and pelvic (1·35, 1·10-1·66) fractures were most likely to have delays of more than 24 h before admission to hospital.

Interpretation: In low-income and middle-income countries, timely hospital admission remains largely inaccessible, especially among patients with open fractures. Reducing hospital-based delays in receiving care, and, in particular, improving interfacility referral systems are the most substantial tools for reducing delays in admissions to hospital.

Funding: National Health and Medical Research Council of Australia, Canadian Institutes of Health Research, McMaster Surgical Associates, and Hamilton Health Sciences.
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http://dx.doi.org/10.1016/S2214-109X(20)30067-XDOI Listing
May 2020

A systematic survey showed important limitations in the methods for assessing drug safety among systematic reviews.

J Clin Epidemiol 2020 07 1;123:80-90. Epub 2020 Apr 1.

Chinese Evidence-Based Medicine Center, Cochrane China Center and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; Evidence-Based Medicine Research Center, School of Basic Science, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, Jiangxi, China. Electronic address:

Objectives: This study aimed to examine the design, conduct, and analysis of systematic reviews assessing drug safety through a cross-sectional survey.

Study Design And Setting: We searched PubMed to identity systematic reviews published in the Cochrane Database of Systematic Reviews and Core Clinical Journals indexed in 2015 and randomly sampled systematic reviews assessing drug effects at a 1:1 ratio of Cochrane and non-Cochrane reviews. Teams of two investigators independently conducted study screening and collected data, using prespecified, standardized questionnaires. In addition to general information, we collected details about the planning and analyses of safety outcomes.

Results: We included 120 systematic reviews, including 60 Cochrane and 60 non-Cochrane reviews. Most reviews searched PubMed/MEDLINE (n = 117, 97.5%), EMBASE (n = 105, 87.5%), and Cochrane CENTRAL (n = 110, 91.7%) and conducted independent and duplicate study selection (n = 98, 81.7%), risk of bias assessment (n = 105, 87.5%), and data collection (n = 105, 87.5%). Only nine (7.5%) reviews clearly defined safety outcomes, and seven (5.8%) defined a primary safety outcome; none stated whether the primary safety outcome was predefined. Among the 80 reviews that pooled the primary dichotomous safety data across studies, less than half (41%, n = 33) conducted subgroup analysis to explore for sources of heterogeneity or reported a GRADE assessment for the overall quality of evidence. Cochrane reviews were more likely to provide a study protocol (100% vs. 23.3%; P < 0.001), involve methodologists (53.3% vs. 20.0%; P < 0.001), and report a GRADE assessment for the primary safety outcome (70.6% vs. 19.6%; P < 0.001).

Conclusion: Our findings highlighted areas for improved planning and analysis in the assessment of drug safety among systematic reviews. Cochrane reviews were superior to non-Cochrane reviews; however, most reviews did not prespecify their safety outcomes or methods for analysis, explore sources of heterogeneity among pooled effects, or assess the overall quality of evidence with the GRADE approach.
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http://dx.doi.org/10.1016/j.jclinepi.2020.03.017DOI Listing
July 2020

Association of Disability Benefits and/or Litigation With Time to Return to Work After Tibia Shaft Fracture Fixation.

J Occup Environ Med 2020 05;62(5):370-374

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada (Dr Rehman, Mr Jones, Dr Madden, Ms Heels-Ansdell, Dr Busse); Canadian Academy of Osteopathy, Hamilton, Ontario, Canada (Dr Rehman); The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada (Dr Rehman, Dr Busse); Centre for Evidence-Based Orthopedics, McMaster University, Hamilton, Ontario, Canada (Dr Madden); Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada (Dr Busse) and The Michael G. DeGroote Centre for Medicinal Cannabis Research, McMaster University, Hamilton, Ontario, Canada (Dr Busse).

Objectives: We explored the association of compensation status with return to work (RTW) after tibial fracture.

Methods: Eligible patients were adults with tibial shaft fractures enrolled in the Trial to Re-evaluate Ultrasound in the Treatment of Tibial Fractures. We explored the association between disability benefits and/or litigation and RTW using multivariable discrete interval hazard analysis, adjusting for sex, age, country of residence, smoking status, body mass index, polytrauma, fracture severity, fracture gap, pain severity, and physical functioning.

Results: Of 330 eligible patients, 111 (34%) had not returned to full-time work 1-year after surgery. In our adjusted model, receipt of disability benefits and/or involvement in litigation was associated with delayed RTW (HR = 0.71, 95% CI 0.52-0.96).

Discussion: Tibial shaft fracture patients receiving disability benefits and/or involved in litigation are less likely to RTW.
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http://dx.doi.org/10.1097/JOM.0000000000001841DOI Listing
May 2020

Perceptions and Impact of the 2017 Canadian Guideline for Opioid Therapy and Chronic Noncancer Pain: A Cross-Sectional Study of Canadian Physicians.

Pain Res Manag 2020 17;2020:8380171. Epub 2020 Feb 17.

Canadian Medical Association, Ottawa, ON, Canada.

Background: Physician adherence to guideline recommendations for the use of opioids to manage chronic pain is often limited.

Objective: In February 2018, we administered a 28-item online survey to explore perceptions of the 2017 Canadian guideline for opioid therapy and chronic noncancer pain and if physicians had altered practices in response to recommendations.

Results: We invited 34,322 Canadian physicians to complete our survey, and 1,128 responded for a response rate of 3%; 687 respondents indicated they prescribed opioids for noncancer pain and answered survey questions about the guideline and their practice. Almost all were aware of the guideline, 94% had read the document, and 89% endorsed the clarity as good or excellent. The majority (86%) felt the guideline was feasible to implement, but 66% highlighted resistance by patients, and 63% the lack of access to effective nonopioid treatment as barriers. Thirty-six percent of respondents mistakenly believed the guideline recommended mandatory tapering for patients using high-dose opioid therapy (≥90 mg morphine equivalent per day), and 58% felt they would benefit from support for opioid tapering. Seventy percent of respondents had changed practices to align with guideline recommendations, with 51% engaging some high-dose patients in opioid tapering and 43% reducing the number of new opioid starts.

Conclusion: There was high awareness of the 2017 Canadian opioid guideline among respondents, and preliminary evidence that recommendations have changed practice to better align with the evidence. Ongoing education is required to avoid the misunderstanding that opioid tapering is mandatory, and research to identify effective strategies to manage chronic noncancer pain is urgently needed.
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http://dx.doi.org/10.1155/2020/8380171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048936PMC
August 2020

Attitudes Towards and Management of Opioid-induced Hyperalgesia: A Survey of Chronic Pain Practitioners.

Clin J Pain 2020 05;36(5):359-364

Departments of Anesthesia.

Objectives: Opioid-induced hyperalgesia (OIH) is a phenomenon whereby opioids increase patients' pain sensitivity, complicating their use in analgesia. We explored practitioners' attitudes towards, and knowledge concerning diagnosis, risk factors, and treatment of OIH.

Materials And Methods: We administered an 18-item cross-sectional survey to 850 clinicians that managed chronic pain with opioid therapy.

Results: The survey response rate was 37% (318/850). Most respondents (240/318, 76%) reported they had observed patients with OIH in their practice, of which 38% (84/222) reported OIH affected >5% of their chronic pain patients. The majority (133/222, 60%) indicated that OIH could result from any dose of opioid therapy. The most commonly endorsed chronic pain conditions associated with the development of OIH were fibromyalgia (109/216, 51%) and low back pain (91/216, 42%), while 42% (91/216) indicated that no individual chronic pain condition was associated with greater risk of OIH. The most commonly endorsed opioids associated with the development of OIH were oxycodone (94/216, 44%), fentanyl (86/216, 40%), and morphine (84/216, 39%); 27% (59/216) endorsed that no specific opioid was more likely to result in OIH. Respondents commonly managed OIH by opioid dose reduction (147/216, 68%), administering a nonopioid adjuvant (133/216, 62%), or discontinuing opioids (95/216, 44%).

Discussion: Most clinicians agreed that OIH is a complication of opioid therapy, but were divided regarding the prevalence of OIH, etiological factors, and optimal management.
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http://dx.doi.org/10.1097/AJP.0000000000000814DOI Listing
May 2020

Prescriber adherence to guidelines for chronic noncancer pain management with opioids: Systematic review and meta-analysis.

Health Psychol 2020 May 30;39(5):430-451. Epub 2020 Jan 30.

Department of Psychology.

Objective: This review quantified prescriber adherence to opioid prescribing guidelines for chronic noncancer pain (CNCP).

Method: We searched CINAHL, Embase, MEDLINE, PsycINFO, the Cochrane Library, and the Joanna Briggs Institute EBP Database from inception until June 3, 2019. Studies that focused on provider adherence to opioids guidelines for CNCP in North America were eligible. Four reviewers screened studies, extracted data, and assessed study quality.

Results: Thirty-eight studies were eligible, comprising 17 cross-sectional studies ( = 11,835 providers) and 22 chart reviews ( = 22,512 patients). Survey data indicated that adherence was 49% (95% CI [40, 59]) for treatment agreements, 33% (95% CI [19%, 47%]) for urine drug testing, 48% (95% CI [26%, 71%]) for consultation with drug monitoring program, 57% (95% CI [35%, 79%]) for assessing risk of aberrant medication-taking behavior, and 61% (95% CI [35%, 87%]) for mental health screening. Chart review data indicated that the proportion of patients with documentation was 40% (95% CI [29, 51]) for treatment agreements, 41% (95% CI [32%, 50%]) for urine drug testing, 40% (95% CI [2%, 78%]) for consultation with drug monitoring program, 41% (95% CI [20%, 64%]) for assessing risk of aberrant medication-taking behavior, and 22% (95% CI [9%, 33%]) for mental health screening. Year of publication, practice guideline referenced, and risk of bias explained significant heterogeneity. No study evaluated whether nonadherence to recommendations reflected well-justified deviations to care.

Conclusions: Adherence to guideline recommendations for opioids for CNCP is low. It is unclear whether nonadherence reflects thoughtful deviations in care. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/hea0000830DOI Listing
May 2020

Interventional pain management for chronic pain: a survey of physicians in Canada.

Can J Anaesth 2020 03 4;67(3):343-352. Epub 2019 Dec 4.

The Department of Anesthesia, McMaster University, Hamilton, ON, Canada.

Purpose: The use of interventional pain management (IPM) modalities to alleviate chronic pain is increasing despite the lack of high-quality evidence. We undertook this survey to explore patterns, training, and attributes of IPM practice.

Methods: We administered a 32-item survey via seven Canadian physician member organizations, whose members were engaged in the management of chronic pain.

Results: Of 777 physicians contacted, 256 (33%) responded: 45 (6%) declined to participate and 211 (27%) agreed to participate; the number of participants answering any given question varied. One hundred and sixty-nine of 194 (87%) practiced IPM and 103 of 194 (53%) managed only non-cancer pain. Pain management training of ≥ six months was associated with higher odds of IPM training (odds ratio [OR], 2.98; 95% confidence interval [CI], 1.32 to 6.7), but not necessarily ongoing IPM practice (OR, 1.97; 95% CI, 0.74 to 5.3). A substantial percentage of physicians (108 of 168 [64%]) practiced IPM based only on training received during either their base residency program or courses. Only 48 of 186 (26%) felt that there were adequate opportunities for IPM training, and 69 of 186 (37%) believed that their colleagues practiced IPM in accordance with the best current evidence.

Conclusions: Our survey indicates that IPM practice and training were not uniform, and that interventional therapies for chronic pain may not be performed in accordance with the best available evidence. Our survey highlights a lack of IPM training opportunities, which may result in substandard training. Concerted efforts involving physician organizations and regulators are needed to standardize IPM training and develop clinical guidelines to optimize evidence-based practice.
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http://dx.doi.org/10.1007/s12630-019-01547-wDOI Listing
March 2020