Randomized controlled trial comparing health-related quality of life in patients undergoing vertical scar versus inverted T-shaped reduction mammaplasty.

BACKGROUND: There is controversy regarding the superiority of the vertical scar reduction technique versus the inverted T-shaped reduction technique for breast reduction surgery. METHODS: Two hundred fifty-five patients were randomized to either the vertical scar reduction or inverted T-shaped reduction technique immediately before surgery over a 5-year period. Patients completed the Health Utilities Index Mark 3, Short Form-36, Breast-Related Symptoms Questionnaire, and Multidimensional Body-Self Relations Questionnaire at 1 week preoperatively and 1, 6, and 12 months postoperatively. Data were treated according to intention-to-treat principles. The primary outcome was the difference in the change in Health Utilities Index Mark 3 score from baseline to 12 months postoperatively between the two techniques. RESULTS: Patients undergoing either technique gained a statistically significant and clinically important improvement from baseline to 1 year postoperatively in the Health Utilities Index Mark 3 (vertical scar reduction, 0.81, 0.16 to 0.87, 0.19; inverted T-shaped reduction, 0.79, 0.20 to 0.89, 0.15) and the Breast-Related Symptoms Questionnaire (vertical scar reduction, 50.26, 12.98 to 95.59, 9.36; inverted T-shaped reduction, 50.06, 12.50 to 94.09, 9.86). No difference in mean change in scores from baseline to 12 months postoperatively was seen in any of the quality of life questionnaires between the techniques. CONCLUSIONS: There was a clinically important improvement between baseline and 1 year postoperatively in both groups in the Health Utilities Index Mark 3 and the Breast-Related Symptoms Questionnaire. The authors conclude that the techniques are similar when quality of life is the outcome of interest. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

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.

Pyrocarbon versus silicone proximal interphalangeal joint arthroplasty: a systematic review.

BACKGROUND: Arthritis at the proximal interphalangeal joint can be a disabling chronic condition. Silicone arthroplasty is a common surgical treatment option to provide pain relief and maintain joint mobility. Pyrocarbon implants are gaining popularity as an alternative to silicone prostheses. The purpose of this systematic review is to compare the outcomes of silicone and pyrocarbon arthroplasties for patients with proximal interphalangeal joint arthritis. METHODS: A computerized search was conducted to identify studies evaluating outcomes of silicone and pyrocarbon arthroplasties. The data extracted were patient demographics, pain relief, range of motion, grip and pinch strength, costs, quality of life, and complications. RESULTS: Thirty-five relevant citations were identified. Available data showed that both arthroplasties offered satisfactory pain relief. The implants also provided similar postoperative weighted mean arcs of motion, with a value of 37.4 ± 13.6 degrees for silicone and 44.8 ± 16.8 degrees for pyrocarbon. There were comparable results in grip and pinch strengths as well. No studies were identified that performed an economic analysis of arthroplasty. Six studies assessed quality-of-life outcomes after pyrocarbon surgery, and results were mixed. The rates of revision and salvage procedures performed secondary to complications were higher after pyrocarbon arthroplasty. CONCLUSIONS: Based on the available low level of evidence, pyrocarbon arthroplasty does not demonstrate clear superiority over silicone implants. In fact, there is concern about the complication rates of these implants. Future studies should focus on more rigorous study designs using validated quality-of-life scales and economic evaluations before widespread adoption of this new implant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

A systematic review of power and sample size reporting in randomized controlled trials within plastic surgery.

BACKGROUND: The randomized controlled trial is a reliable study design for assessing the effectiveness of a surgical intervention, provided it is adequately powered. This systematic review examines the appropriateness of reporting of power and sample size in randomized controlled trials within the plastic surgery literature. METHODS: Original randomized controlled trials published from January of 1990 to December of 2010 in nine high-impact plastic surgery journals were appraised. The data extracted from each study included calculation of power and sample size, number of patients, and effect size. A Jadad score was calculated, providing a quality assessment of the randomized controlled trial. RESULTS: : Of the 736 original articles, 463 met the inclusion criteria; 88 (19.0 percent) of these 463 reported performing a priori power analysis or sample size calculation. Of these 88 studies, 68 (77.3 percent) had an adequate sample size. In most studies, a standard of 0.05 for the type I error and 0.20 for type II error was used. There has been some improvement in the reporting of power and sample size in the decades from 1990 to 2010. CONCLUSIONS: Nineteen percent of 463 randomized controlled trials in the plastic surgery literature reported performing an a priori power analysis or sample size calculation. The implication is that when we read the results of a published randomized controlled trial in plastic surgery, in 81 percent of cases we cannot trust the findings. Although the reporting of power and sample size has improved in the last decade, it is still inadequate. Lack of such reporting casts doubt on the validity (truthfulness) of the study's findings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

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.

De nombreuses revues et sociétés de chirurgie utilisent de plus en plus le tableau de la qualité des preuves (QdP) pour souligner l'importance d'une bonne méthodologie d'étude. Depuis sa création, la QdP a évolué pour tenir compte de multiples méthodologies d'étude, de la rigueur du type d'étude ainsi que de la rigueur de multiples aspects de la méthodologie. L'utilisation de la QdP aide le lecteur à évaluer les publications tout en encourageant les chercheurs cliniques à produire des données probantes de qualité. Le présent article traite des avantages et des limites de la QdP, ainsi que de la QdP d'articles publiés dans le Journal canadien de chirurgie plastique (JCCP). En plus d'évaluer la QdP dans le JCCP, les auteurs font des recommandations pour améliorer la qualité et la lisibilité des articles publiés dans le JCCP.

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.

L'augmentation des dépenses et la réduction du financement dans le milieu de la santé forcent les décideurs à prioriser les interventions et à redistribuer les fonds. La prise de décision se fonde sur des données fiables au sujet des coûts et des avantages des interventions médicales et chirurgicales. Une telle méthodologie d'étude est une évaluation économique. La communauté de la chirurgie plastique a la responsabilité de produire des évaluations économiques de qualité qui appuient le rapport coût-efficacité des interventions exécutées. La présente analyse s'attarde sur l'analyse coût-utilité et son rôle dans la décision d'accepter une nouvelle technique, intervention ou technologie par rapport à une autre déjà prévalente. De plus, les cinq étapes pour entreprendre une analyse coût-utilité (efficacité) sont exposées.

Designing and reporting case series in plastic surgery.

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.

Comparison of trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition: a systematic literature review.

BACKGROUND: Trapeziectomy with ligament reconstruction and tendon interposition is currently the most popular technique for operative treatment of trapeziometacarpal osteoarthritis. Based on the evidence, however, it is uncertain whether the addition of ligament reconstruction and tendon interposition to trapeziectomy confers any advantage. The aim of this study was to systematically review the literature and determine which procedure, trapeziectomy or trapeziectomy with ligament reconstruction and tendon interposition, offers the best results to patients. METHODS: A literature search was undertaken of the following electronic databases: Cochrane, AMED, EMBASE, HaPI, HealthSTAR, MEDLINE, TRIP, and Proceedings First (2002 to 2009). Studies were selected by two independent assessors if (1) the study population included patients with trapeziometacarpal osteoarthritis and (2) the study was a randomized controlled trial or systematic review comparing the two procedures. Objective (i.e., range of motion, grip strength, pinch strength, health cost, and postoperative complications) and subjective (i.e., pain relief, hand function, overall satisfaction, and quality of life) outcomes were extracted. Statistical pooling and power analyses were performed with available data. RESULTS: Two systematic reviews and four randomized controlled trials were identified and included. There were no statistically significant differences in postoperative grip strength (p = 0.77); tip pinch strength (p = 0.72); key pinch strength (p = 0.90); pain visual analogue scale score (p = 0.34); Disabilities of the Arm, Shoulder and Hand score (p = 0.75); and number of adverse events (p = 0.13). No studies reported health costs or quality of life. CONCLUSION: Neither procedure produced greater benefit in terms of outcomes investigated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.(Figure is included in full-text article.).