Christopher J. Coroneos

Designing and reporting case series in plastic surgery.

Summary: The case series is the most prevalent type of clinical research in the plastic surgery literature. However, this is a lower level study design in the hierarchy of evidence. The case series is nevertheless a useful hypothesis generator for future studies. These in turn can be tested with more robust study designs such as the randomized controlled trial. Because the case series remains the most common study design used to communicate our new innovations, there is a need to improve its reporting so that readers will know why the study was undertaken, what the results were, and how the results affect patient care. The authors provide a guide to help future investigators improve the conduct and the reporting of their case series.

A Systematic Review of Surgical Randomized Controlled Trials: Part I. Risk of Bias and Outcomes: Common Pitfalls Plastic Surgeons Can Overcome

Background: The authors investigated the methodological validity of plastic surgery randomized controlled trials that compared surgical interventions. Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Reviewers, independently and in duplicate, assessed manuscripts and performed data extraction. Methodological safeguards (randomization, allocation concealment, blinding, and incomplete outcome data) were examined using the Cochrane risk of bias tool. Regression analysis was used to identify trial characteristics associated with risk of bias. Results: Of 1664 potentially eligible studies, 173 randomized controlled trials were included. Proper randomization and allocation concealment methods were described in 61 of 173 (35 percent) and 21 of 173 (12 percent), respectively. Outcome assessors were blinded in 58 of 173 (34 percent) trials, and patients were blinded in 45 of 173 (26 percent). Follow-up rates were high, with 99 of 173 (57 percent) randomized controlled trials appearing to have complete follow-up. An intention-to-treat analysis was used in 19 of 173 (11 percent) trials. One-third (58 of 173, 34 percent) did not state their primary outcomes. The most common type of primary outcome used was a symptom/quality of life, class III, outcome (73 of 173, 42 percent). Multinomial regression demonstrated trials reporting an a priori sample size as more likely to have a low risk of bias (p = 0.001). Conclusions: This article highlights methodological safeguards that plastic surgeons should consider when interpreting results of a surgical randomized controlled trial. Allocation concealment, outcome assessor blinding, and patient blinding were identified as areas of concern. Valid and reliable outcome measures are being used in plastic surgery. This analysis provides strong rationale for continued focus on the performance and reporting of clinical trials within our specialty.

Reporting the level of evidence in the Canadian Journal of Plastic Surgery: Why is it important?

The levels of evidence (LOE) table has been increasingly used by many surgical journals and societies to emphasize the importance of proper study design. Since their origin, LOE have evolved to consider multiple study designs and also the rigour of not only the study type but multiple aspects of its design. The use of LOE aids readers in appraising the literature while encouraging clinical researchers to produce high-quality evidence. The current article discusses the benefits and limitations of the LOE, as well as the LOE of articles published in the Canadian Journal of Plastic Surgery (CJPS). Along with an assessment of the LOE in the CJPS, the authors have provided recommendations to improve the quality and readability of articles published in the CJPS.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

Background: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. Results: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Conclusions: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

Perioperative Corticosteroids Reduce Short-Term Edema and Ecchymosis in Rhinoplasty: A Meta-Analysis.

BACKGROUND A number of randomized controlled trials (RCTs) have investigated the role of perioperative corticosteroids in rhinoplasty. Each of these trials however has an insufficient sample sizes to reach definitive conclusions and detect harms. Three recent reviews have analyzed edema and ecchymosis outcomes following rhinoplasty; each arrived at a different conclusion and recommendation. OBJECTIVE To estimate the effectiveness of systemic perioperative corticosteroid treatment compared to placebo for clinical outcomes in rhinoplasty using a methodologically rigorous meta-analysis. METHODS Electronic databases were searched without language restriction. Included trials were randomized controlled trials of systemic perioperative corticosteroid treatment vs placebo in rhinoplasty evaluating at least one of: edema, ecchymosis, bleeding, cosmetic outcome, and patient satisfaction. The Cochrane risk of bias tool was applied to included trials, and the quality of evidence for each outcome was assessed using the GRADE approach. RESULTS Analyses included 336 patients from eight trials. Perioperative corticosteroids reduced the worst edema (SMD: -1.03, 95%CI -1.30 to -0.76, P < .001) and ecchymosis (SMD: -0.78, 95%CI -1.09 to 0.47, P < .001) after rhinoplasty. At one day postoperative, a single dose of perioperative corticosteroid reduced edema (SMD -1.15, 95%CI -1.42 to -0.87, P < .001) and ecchymosis (SMD -0.79, 95%CI -1.05 to -0.52, P < .001). No clinical benefit in edema or ecchymosis was found seven days postoperatively, nor did intraoperative bleeding increase. CONCLUSIONS There is high quality evidence to support perioperative systemic corticosteroid treatment in rhinoplasty to reduce short-term edema and ecchymosis without increased intraoperative bleeding. These findings are not present at seven days. For future trials, we suggest evaluation of patient satisfaction, and correlation with long-term cosmetic outcome. LEVEL OF EVIDENCE 2: Therapeutic.

Obstetrical brachial plexus injury (OBPI): Canada's national clinical practice guideline.

Objective The objective of this study was to establish an evidence-based clinical practice guideline for the primary management of obstetrical brachial plexus injury (OBPI). This clinical practice guideline addresses 4 existing gaps: (1) historic poor use of evidence, (2) timing of referral to multidisciplinary care, (3) Indications and timing of operative nerve repair and (4) distribution of expertise. Setting The guideline is intended for all healthcare providers treating infants and children, and all specialists treating upper extremity injuries. Participants The evidence interpretation and recommendation consensus team (Canadian OBPI Working Group) was composed of clinicians representing each of Canadas 10 multidisciplinary centres. Outcome measures An electronic modified Delphi approach was used for consensus, with agreement criteria defined a priori. Quality indicators for referral to a multidisciplinary centre were established by consensus. An original meta-analysis of primary nerve repair and review of Canadian epidemiology and burden were previously completed. Results 7 recommendations address clinical gaps and guide identification, referral, treatment and outcome assessment: (1) physically examine for OBPI in newborns with arm asymmetry or risk factors; (2) refer newborns with OBPI to a multidisciplinary centre by 1 month; (3) provide pregnancy/birth history and physical examination findings at birth; (4) multidisciplinary centres should include a therapist and peripheral nerve surgeon experienced with OBPI; (5) physical therapy should be advised by a multidisciplinary team; (6) microsurgical nerve repair is indicated in root avulsion and other OBPI meeting centre operative criteria; (7) the common data set includes the Narakas classification, limb length, Active Movement Scale (AMS) and Brachial Plexus Outcome Measure (BPOM) 2 years after birth/surgery. Conclusions The process established a new network of opinion leaders and researchers for further guideline development and multicentre research. A structured referral form is available for primary care, including referral recommendations.

Primary Nerve Repair for Obstetrical Brachial Plexus Injury: A Meta-Analysis.

Background: Nerve repair may be effective in improving function following obstetrical brachial plexus injury. No previous review has directly compared nerve repair to nonoperative management for similar patients, and no previous analysis has been adequately powered to determine whether nerve repair reduces impairment. Methods: Electronic databases were searched (MEDLINE, Embase, CINAHL, and Cochrane Central). Eligible studies were randomized controlled trials, observational studies, and case series (n > 9); included patients younger than 2 years undergoing nerve repair or nonoperative management of obstetrical brachial plexus injury; and reported functional impairment. Two reviewers independently screened articles using objective a priori criteria. Bias was assessed for each study. Overall quality of evidence was evaluated for each outcome. Results: Among nine cohort studies including 222 patients, nerve repair significantly reduced functional impairment compared with nonoperative management (relative risk, 0.58; 95 percent CI, 0.43 to 0.79; p < 0.001; I2 = 0 percent; absolute risk reduction, 19 percent; number needed to treat, six). Findings are consistent with comparison of similar patients from case series. With operative management, no deaths were reported; major adverse events were reported in 1.5 percent, and minor adverse events were reported in 5.0 percent of cases. Among demographic (all severities) samples managed nonoperatively, residual impairment remains in 27 percent (19 to 36 percent). Conclusions: Nerve repair reduces functional impairment in obstetrical brachial plexus injury. Nonoperative management in patients with a deficit at 3 months of age leads to a high proportion of functional impairment. Mortality is not a common risk of modern pediatric microsurgical nerve repair. Residual impairment with nonoperative management is underestimated in the reported literature. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Ulnar hammer syndrome: a systematic review of the literature.

Background: Ulnar hammer syndrome is an uncommon form of arterial insufficiency. Many treatments have been described, and debate continues about the best option. The goal of this systematic review was to determine whether ulnar hammer syndrome has an occupational association, to identify the most reliable diagnostic test, and to determine the best treatment modality. Methods: A comprehensive literature search was conducted using the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL, and EMBASE. Data from articles meeting inclusion criteria were collected in duplicate. Methodological quality of studies was assessed using the Methodological Index for Nonrandomized Studies scale. Results: Thirty studies were included in the systematic review. No randomized controlled trials were identified. There is low-quality evidence suggestive of an association between exposure to repetitive hand trauma and vibration and ulnar hammer syndrome. Various diagnostic investigations were used, but few were compared, making it difficult to determine the most reliable diagnostic test. Numerous nonoperative and operative treatments were reported. With nonoperative treatment, 12 percent had complete resolution and 70 percent had partial resolution of their symptoms. Of patients treated operatively, 42.5 percent had complete resolution and 42.5 percent had partial resolution of their symptoms. Conclusions: The heterogeneity in study design and outcome measures limits definitive conclusions about occupational association, best diagnostic test, and treatment for ulnar hammer syndrome. However, there is low-quality evidence that suggests that most patients with ulnar hammer syndrome will have partial relief of symptoms with nonoperative treatment, and operative treatment results in complete or partial resolution of symptoms in the majority of cases. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Measuring and Understanding Treatment Effectiveness in Hand Surgery

Incorporating evidence-based medicine into practice is now an expectation for hand surgeons. Hand surgeons need to be able to assess associated benefits, risks, cost, and applicability of a treatment option when providing care to their patients. Using a clinical example, this article takes the reader through the three-step approach when using a publication from the medical literature on therapy. The focus of this article is primarily the second and third steps, which involve measuring and understanding treatment effectiveness.

Reduced venous thrombosis and re-exploration time with anastomotic coupling device: A cohort study

In the anastomotic coupling device literature, no comparative study has reported operative times, included consecutive patients, or used a matched comparison group. Our objective was to analyze patency and operative time in free flaps with venous anastomoses performed with ACD versus hand‐sewn. Methods: For consecutive free flaps, re‐explorations and complications were reviewed in duplicate. Operative times for ACD versus hand‐sewn were compared for: (1) matched unilateral DIEPs, and (2) re‐explorations. Results: Overall, 147 ACD and 144 hand‐sewn flaps were included. Venous thrombosis was significantly lower with ACD (1/147[1%] vs.9/144[6%], P < 0.01). There was no difference in re‐exploration for venous insufficiency, or overall re‐exploration. Re‐exploration time was significantly shorter with ACD (69mins vs.205mins, P = 0.009). Conclusions: ACD significantly decreases venous thrombosis compared to hand‐sewn veins, and significantly shortens re‐exploration time. Outcomes allow an estimate of cost utility for the ACD in decreasing venous thromboses and shortening re‐exploration time.