Sophocles H. Voineskos

Systematic review of skin graft donor-site dressings.

Background: Debate continues about what split-thickness skin graft donor-site dressing provides the best outcomes for patients at the lowest cost. The goal of this systematic review was to determine which donor-site dressings are associated with the best outcomes for the following: pain, infection rate, healing quality, healing rate, quality of life, and cost. Methods: A comprehensive literature review and assessment was undertaken by two independent reviewers. Articles were selected using specific inclusion criteria. Split-thickness skin graft donor-site dressings were classified as either moist or nonmoist based on the state of the dressing upon initial application. Methodological quality of randomized controlled trials was assessed using the Jadad scale. Results: Seventy-five relevant articles were included in the final analysis, three of which were review articles. The most commonly measured outcome was healing rate (64 of 72), followed by pain (58 of 72), infection rate (40 of 72), healing quality (40 of 72), and cost (15 of 72). No studies measured quality of life. The majority of articles were randomized controlled trials (35 of 75), followed by observational studies (22 of 75), unsystematic clinical observations (15 of 75), and review articles (three of 75). It was difficult to compare moist and nonmoist dressings in this review because of the methodological heterogeneity of the included articles. The available evidence suggests, however, that moist dressings are superior in terms of pain. Conclusions: Some weak evidence exists that supports “wet dressings.” To determine the best split-thickness skin graft donor-site dressing, more methodologically sound randomized controlled trials are needed. Trials with parallel economic evaluations should be undertaken to answer this question.

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.

Systematic review of economic evaluations in plastic surgery.

Background: Economic evaluations are quantitative methods comparing alternative interventions using cost data and expected outcomes. They are used to recommend/dissuade adoption of new surgical interventions and compare different clinical pathways, settings (inpatient/outpatient), or time horizons to determine which procedure may be more cost-effective. The objective of this systematic review was to describe all published English economic evaluations related to a plastic surgery domain. Methods: A comprehensive English literature review of the MEDLINE, EMBASE, The Cochrane Library, Health Economic Evaluations Database, Ovid Health Star, and Business Source Complete databases was conducted (January 1, 1986, to June 15, 2012). Articles were assessed by two independent reviewers using predefined data fields and selected using specific inclusion criteria. Extracted information included country of origin, journal, and date of publication. Domain of plastic surgery and type of economic evaluation were ascertained. Results: Ninety-five articles were included in the final analysis, with cost analysis being the most common economic evaluation (82 percent). Full economic evaluations represented 18 percent. General cutaneous disorders/burns (24 percent), breast surgery (20 percent), and “multiple” (15 percent) were the top domains studied. Authors were predominantly based in the United States (56 percent) and published in the journal Plastic and Reconstructive Surgery (22 percent), with a significant proportion (40 percent) published in the last 5 years. Conclusions: Partial economic assessments (cost analyses) with limited benefit represent the majority of economic evaluations in plastic surgery. This suggests an urgent need to alert plastic surgeons to the advantages of full economic evaluations (cost-effectiveness and cost utility analyses) and the need to perform such rigorous analyses.

The performance and publication of cost-utility analyses in plastic surgery: Making our specialty relevant.

Increased spending and reduced funding for health care is forcing decision makers to prioritize procedures and redistribute funds. Decision making is based on reliable data regarding the costs and benefits of medical and surgical procedures; such a study design is known as an economic evaluation. The onus is on the plastic surgery community to produce high-quality economic evaluations that support the cost effectiveness of the procedures that are performed. The present review focuses on the cost-utility analysis and its role in deciding whether a novel technique/procedure/technology should be accepted over one that is prevalent. Additionally, the five steps in undertaking a cost-utility (effectiveness) analysis are outlined.

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.

A Systematic Review of the Endoscopic Management of Orbital Floor Fractures

OBJECTIVE To determine the safety and efficacy of the endoscopic management of isolated orbital floor fractures. METHODS A systematic review was performed using electronic databases. Studies investigating the reconstruction of isolated orbital floor fractures using an endoscopic approach were considered for inclusion. Two investigators independently reviewed all results. Study quality was assessed using the Methodological Index for Nonrandomized Studies scale. Primary outcomes were the resolution of diplopia and enophthalmos. Secondary outcomes were postoperative complications, including blindness, paresthesias, sinusitis, infection, conversion to external approach, and need for revision surgery. RESULTS Nine studies capturing 172 patients met the inclusion criteria for systematic review. Two studies were comparative and 7 were case series. Study quality was poor, lacking prospective data and reliable assessment of outcomes. Strong reviewer agreement was observed (intraclass correlation, 84%; 95% CI, 35%-96%). Diplopia resolved in 102 of 118 patients (86%) and enophthalmos resolved in 41 of 43 (95%). No complications of blindness, sinusitis, or conversion to external approach were reported. Thirteen patients (8%) had transient cheek numbness. Two patients (1%) required revision surgery. CONCLUSIONS Reconstruction of isolated orbital floor fractures through an endoscopic approach appears to be safe and effective. High-level evidence prospectively comparing endoscopic and external approaches, however, is lacking.

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.

Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery

Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.