Measuring utilities of severe facial disfigurement and composite tissue allotransplantation of the face in patients with severe face and neck burns from the perspectives of the general public, medical experts and patients.

PURPOSE: In an otherwise healthy patient with severe facial disfigurement secondary to burns, composite tissue allotransplantation (CTA) results in life-long immunosuppressive therapy and its associated risk. In this study, we assess the net gain of CTA of face (in terms of utilities) from the perspectives of patient, general public and medical expert, in comparison to the risks. METHODS: Using the standard gamble (SG) and time-trade off (TTO) techniques, utilities were obtained from members of general public, patients with facial burns, and medical experts (n=25 for each group). The gain (or loss) in utility and quality adjusted life years (QALY) were estimated using face-to-face interviews. A sensitivity analysis using variable life expectancy was conducted. RESULTS: From the patient perspective, severe facial burn was associated with a health utility value of 0.53, and 27.1 QALYs as calculated by SG, and a health utility value of 0.57, and 28.9 QALYs as calculated by TTO. In comparison, CTA of the face was associated with a health utility value of 0.64, and 32.3 QALYs (or 18.2 QALYs years per sensitivity analysis) as calculated by SG, and a health utility value of 0.67, and 34.1 QALYs (or 19.2QALYs per sensitivity analysis) as calculated by TTO. However, a loss of 8.9 QALYs (by SG method) to 9.5 QALYs (by TTO method) was observed when the life expectancy was decreased in the sensitivity analysis. Similar results were obtained from the general population and medical experts perspectives. CONCLUSION: We found that severe facial disfigurement is associated with a significant reduction in the health-related quality of life, and CTA has the potential to improve this. Further, we found that a trade-off exists between the life expectancy and gain in the QALYs, i.e. if life expectancy following CTA of face is reduced, the gain in QALY is also diminished. This trade-off needs to be validated in future studies.

Levels of evidence: a comparison between top medical journals and general pediatric journals.

BACKGROUND: Given the large number of publications in all fields of practice, it is essential that clinicians focus on the resources that provide the highest level of evidence (LOE). We sought to determine the LOE that exists in the field of pediatrics, present in the general pediatric as well as high impact clinical literature. METHODS: Clinical pediatric literature, published between April 2011 and March 2012 inclusive in high-impact clinical journals (HICJ) (New England Journal of Medicine, Journal of the American Medical Association, & The Lancet) and the highest-impact general pediatric journals (GPJ) (Pediatrics, Journal of Pediatrics, & Archives of Pediatrics & Adolescent Medicine), was assessed. In addition to the LOE, articles were evaluated on criteria including subspecialty within pediatrics, number of authors, number of centers, and other parameters. Eligible level I randomized control trials were appraised using the Consolidated Standards of Reporting Trials (CONSORT) guidelines. RESULTS: Of 6511 articles screened, 804 met inclusion criteria (68 in HICJ and 736 in GPJ). On average, LOE in pediatrics-focused articles within The Lancet were significantly higher than all GPJ (p < 0.05). Average CONSORT scores were significantly higher in HICJ vs. GPJ (15.2 vs. 13.6, respectively, p < 0.001). CONCLUSIONS: LOE and quality of randomized control trials within the pediatric field is highest within HICJ, however, only represent a small proportion of data published. Following CONSORT criteria, and promoting studies of high LOE may allow authors and readers to turn to journals and articles of greater clinical impact.

The utility of hand transplantation in hand amputee patients.

PURPOSE: To measure the desirable health outcome, termed utility, and the expected quality-adjusted life years (QALYs) gained with hand composite tissue allotransplantation (CTA) using hand amputee patients and the general public. METHODS: Using the standard gamble (SG) and time trade-off (TTO) techniques, utilities were obtained from 30 general public participants and 12 amputee patients. The health utility and net QALYs gained or lost with transplantation were computed. A sensitivity analysis was conducted to account for the effects of lifelong immunosuppression on the life expectancy of transplant recipients. Higher scores represent greater utility. RESULTS: Hand amputation mean health utility as measured by the SG and TTO methods, respectively, was 0.72 and 0.80 for the general public and 0.69 and 0.70 for hand amputees. In comparison, hand CTA mean health utility was 0.74 and 0.82 for the general public and 0.83 and 0.86 for amputees. Hand CTA imparted an expected gain of 0.9 QALYs (SG and TTO) in the general public and 7.0 (TTO) and 7.8 (SG) QALYs in hand amputees. A loss of at least 1.7 QALYs was demonstrated when decreasing the life expectancy in the sensitivity analysis in the hand amputee group. CONCLUSIONS: Hand amputee patients did not show a preference toward hand CTA with its inherent risks. With this procedure being increasingly adopted worldwide, the benefits must be carefully weighed against the risks of lifelong immunosuppressive therapy. This study does not show clear benefit to advocate hand CTA.

The level of evidence presented at plastic surgery meetings: what do we have to learn?

BACKGROUND: Internationally, plastic surgery societies have placed an increasing emphasis on the importance of evidence-based medicine. The authors aimed to categorize levels of evidence of podium presentations at three major North American plastic surgical meetings, and to assess the factors associated with a higher level evidence. METHODS: Presentations at the 2010/2011 meetings of three of the largest societies of plastic surgeons in North America were evaluated for the area of research, number and origin of authors, subdomain of plastic surgery, number of centers of collaboration, number of subjects, study subtype, and level of evidence. RESULTS: One hundred eighty-eight presentations were screened, and 126 met eligibility criteria. The American Society of Plastic Surgeons was the largest meeting with 74 presentations (58.7 percent). Breast (23.8 percent) and craniofacial (21.4 percent) topics were most frequently covered. Most studies had five or fewer authors (76.4 percent), were conducted at a single center (84.3 percent), were therapeutic (89.7 percent), and had 50 or fewer subjects (36.8 percent). Two studies (1.6 percent) were level I, 11 (8.7 percent) were level II, 54 (42.9 percent) were level III, 46 (36.5 percent) were level IV, and 13 (10.3 percent) were level V. Overall, the mean level of evidence was 3.45, and one of every 10 presentations was of higher level of evidence (level I or II). Higher level evidence presentations were found to be associated with multicenter studies. CONCLUSIONS: Evidence presented at major plastic surgical meetings is rarely level I and infrequently level II. Opportunities to create greater awareness of the need for prospective high-level studies are needed.

Levels of evidence in the neurosurgical literature: more tribulations than trials.

BACKGROUND: The importance of evidence-based medicine has been well documented and supported across various surgical subspecialties. OBJECTIVE: To quantify the levels of evidence across publications in the neurosurgical literature, to assess the change in evidence over time, and to indicate predictive factors of higher-level evidence. METHODS: We reviewed the levels of evidence across published clinical studies in 3 neurosurgical journals from 2009 to 2010. Randomized trials were evaluated by use of the Detsky quality of reporting scale. Levels-of-evidence data for the same journals in 1999 were obtained from the literature, and regression analysis was performed to identify predictive factors for higher-level evidence. RESULTS: Of 660 eligible articles, 14 (2.1%) were Level I, 54 (8.2%) were level II, 73 (11.1%) were Level III, 287 (43.5%) were level IV, and 232 (35.2%) were level V. The number of level I studies decreased significantly between 1999 and 2010 (3.4% vs. 2.1%, respectively; P = .01). Seven randomized clinical trials were identified, and 1 trial had significant methodological limitations (mean Detsky index = 16.3; SD = 1.8). Publications with larger sample size were significantly associated with higher levels of evidence (levels I and II; odds ratio, 1.7; 95% confidence interval, 1.45-2.05; P = .001). The ratio of higher levels of evidence to lower levels was 0.11. CONCLUSION: Higher levels of evidence (levels I and II) represent only 1 in 10 neurosurgical clinical papers in the top neurosurgical journals. Increased awareness of the need for better evidence in the field through education and adoption of the levels of evidence may improve the conduct and publication of prospective studies.

Evidence in the aesthetic surgical literature over the past decade: how far have we come?

BACKGROUND: Over the past decade, the concepts of evidence-based medicine have become commonplace in surgery. The authors aimed to categorize level of evidence in the aesthetic surgical literature over three intervals during a 10-year period, and to compare this to other surgical specialties. The authors also aimed to assess the quality and predictor factors of higher level evidence. METHODS: Clinical aesthetic surgical literature published in the highest impact journals in 2000, 2005, and 2009/2010 was reviewed. Articles were evaluated for journal, date of publication, number and origin of authors, area, centers of collaboration, number of subjects, study subtype, and level of evidence. Eligible level I studies were evaluated using the Detsky Quality Scale. RESULTS: Five thousand eighty-eight articles were screened, and 526 met eligibility criteria. Thirteen studies (2.5 percent) were level I, 72 (13.7 percent) were level II, 57 (10.8 percent) were level III, 263 (50 percent) were level IV, and 121 (23 percent) were level V. Detsky Quality Scale scores averaged 68.4 percent (minimum, 40 percent; maximum 85 percent). Publications of larger sample size (p = 0.01) and published in Plastic and Reconstructive Surgery (p = 0.02) were significantly associated with higher levels of evidence (levels I/II). The ratio of level I evidence to other levels (levels II to V) in aesthetic surgery compared favorably with oral and plastic surgery; however, ratios were eightfold, sixfold, and fivefold less than those reported in ophthalmology, otolaryngology, and orthopedic surgery, respectively. CONCLUSIONS: Over the past decade, the mean level of evidence in the aesthetic literature has improved. However, level I evidence is the least represented, and these studies have methodologic limitations.