13. Peer-Review of the Surgical Literature: A Double-Blinded Randomized Controlled Trial

13. Peer-Review of the Surgical Literature: A Double-Blinded Randomized Controlled Trial

ASSOCIATION FOR ACADEMIC SURGERY AND SOCIETY OF UNIVERSITY SURGEONS—ABSTRACTS per 100 mL of study volume was administered to both groups on completion...

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ASSOCIATION FOR ACADEMIC SURGERY AND SOCIETY OF UNIVERSITY SURGEONS—ABSTRACTS per 100 mL of study volume was administered to both groups on completion of the study volume transfusion. The ICU team, patients, and assessors were blinded to treatment assignment. A transfusion protocol was followed within the ICU. The baseline characteristics between the groups were similar. The processed study bag was of a smaller volume (280 mL [0 mL, 550 mL] versus 590 mL [215 mL, 726 mL], p⫽0.0004) but a higher hematocrit (29% [0%, 34%] versus 23% [20%, 25%], p⫽0.001). No difference was observed in the primary outcome of proportion of patients transfused with homologous RBC’s (39% in both groups). Likewise, no difference existed in proportion of patients transfused with any blood product (44%). Finally, the volume of chest tube output was no different (600 mL [500 mL, 940 mL] versus 670 mL [490 mL, 932 mL], p⫽0.62) nor was the discharge hemoglobin (98.8 ⫾ 12.8 g/L versus 98.2 ⫾ 11.6 g/L), p⫽0.73). Predictors of transfusion included Gender (p⫽0.003), Body Surface Area (P⬍0.0001), Preoperative Hemoglobin (P⫽0.036), and Time on CPB (P⫽0.02). Study patients were transfused less than patients who met the inclusion criteria but did not participate in the study (39.6% versus 63.4%, p⬍0.0001). Conclusion: There is no benefit to processing residual CPB volume with ultrafiltration in isolated, first time adult CABG patients on transfusion or bleeding. However, ensuring that the residual CPB blood is retransfused into the patient with adequate flush may reduce exposure to homologous transfusion. Smaller female patients with low preoperative hemoglobin level and long CPB times were at highest risk for transfusion. 11. PROSPECTIVE VALIDATION OF A SIMPLE SCORING MODEL TO PREDICT SINGLE GLAND DISEASE IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM (PHPT). D. M. Elaraj1, R. S. Sippel2, S. Lindsay3, I. Sansano3, Q. Y. Duh3, O. H. Clark3, E. Kebebew3; 1Northwestern University Feinberg School of Medicine, Chicago, IL; 2University of Wisconsin School of Medicine, Madison, WI; 3University of California San Francisco, San Francisco, CA Background: Primary hyperparathyroidism (PHPT) is caused by a single gland adenoma in the great majority (80-87%) of cases. Many surgeons now use a focused or limited approach parathyroidectomy rather than the traditional bilateral neck exploration to treat PHPT. In select patients, this focused approach will result in biochemical cure without subjecting the patient to the risks associated with a bilateral neck exploration. In order to determine those patients best suited for focused approach parathyroidectomy, a scoring model predictive of patients with single gland PHPT has been developed based on retrospective analysis. It assigns a score of 1 to each of the following preoperative variables: calcium ⱖ12 mg/dL, intact parathyroid hormone (PTH) ⱖ2 times the upper limit of normal, positive ultrasound and positive sestamibi scan for 1 enlarged gland, and concordant imaging findings (maximum score ⫽5). A score ⱖ3 was found to predict single gland PHPT with a positive predictive value of 100%. The objective of this study was to prospectively validate this scoring model. Methods: 487 patients (mean age 59.2⫾13.4 years, F:382, M:105) underwent 492 parathyroidectomies for PHPT from May 2005 to May 2007. All underwent preoperative biochemical testing as well as neck ultrasound and sestamibi scan. Postoperative calcium and PTH within the normal range were used to confirm biochemical cure. Results: Of 492 parathyroidectomies, 88% were initial and 12% were reoperations. The overall cure rate was 96%, with 85% of cases due to a single gland adenoma. The mean preoperative calcium was 11.1⫾0.8 mg/dL and mean PTH 128⫾89 pg/mL. Ultrasound was positive for a single gland in 66%, sestamibi positive in 79%, with concordant imaging results in 54%. 278 patients (56%) had scores ⱖ3 and 214 (44%) scores of 0-2. Patients with scores ⱖ3 were more likely to have a single gland adenoma (97% vs 68%, p⬍0.0001), and underwent more focused approach parathyroidectomies (55% vs 17%, p⬍0.0001) than those with scores of 0-2. The rate of single gland PHPT increased with increasing score: 96% (170/177)

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for a score⫽3, 98% (82/84) for a score⫽4, and 100% (17/17) for a score⫽5. The cure rate after a focused approach parathyroidectomy in patients with scores ⱖ3 was 99%. Conclusions: This study validates the previously published scoring model for predicting single gland PHPT based on preoperative biochemical and imaging data. Patients with scores ⱖ3 have high rates of single gland PHPT and can expect cure rates of 99% after focused approach parathyroidectomy. 12. VALIDATION OF A PHYSICAL ACTIVITY QUESTIONNAIRE (CHAMPS) AS AN INDICATOR OF POSTOPERATIVE RECOVERY AFTER LAPAROSCOPIC CHOLECYSTECTOMY. L. Feldman, P. Kaneva, S. Demyttenaere, F. Carli, G. Fried, N. Mayo; McGill University, Montreal, QC, Canada Introduction: While many surgical innovations (eg., minimally invasive surgery, “fast-track” surgery) are advocated on the basis that they “shorten recovery”, recovery has neither been consistently defined nor measured. During recovery, patients report fatigue and lack of energy, resulting in reduced participation in a variety of activities. The goal of this study was to contribute evidence for validity of a physical activity questionnaire (CHAMPS) as an indicator of post surgical recovery. Methods: CHAMPS consists of 41 questions asking the subject to estimate the length of time spent on a broad range of physical activities in the previous week; responses are converted into kcal/kg/week, an estimate of energy expended on the listed activities in a typical week. Patients scheduled for laparoscopic cholecystectomy were assessed preoperatively, then 1 week and 1 month postop (sensitivity to change). To assess construct validity of CHAMPS, results were compared with other measures used to estimate recovery, including pain and fatigue (visual analog scale), health-related quality of life (SF-36), complications, and patient’s self-reported “percent recovery compared to normal”. In addition, CHAMPS was compared with a simple measure of exercise capacity, the 6-minute walk test (6MWT). Data expressed as mean (SD). P⬍0.05 was considered statistically significant. Results: 50 patients, 72% female, age 51⫾17 years, participated. 86% had ambulatory surgery, and 75% had some comorbidity (ASA ⬎1). CHAMPS-estimated energy expenditure decreased significantly from 49(37) kcal/kg/wk preop to 23(19) kcal/kg/wk (p⬍0.0001) at one-week post op. It was still below baseline at 40 (31) kcal/kg/wk one month postop (p⫽0.047), with 54% of patients still below baseline. At all time points, there were significant correlations with CHAMPS and the SF-36 Physical Function and Vitality subscales, pain with movement, fatigue and 6MWT distance. At one month, there was a significant difference in physical activity levels between patients who reported complications and patients who did not (22.4(19)vs 47.8(33), p⫽0.001). Conclusion: This study provides evidence for construct validity and sensitivity to change for a physical activity questionnaire (CHAMPS) as a measure of surgical recovery. 13. PEER-REVIEW OF THE SURGICAL LITERATURE: A DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL. P. Mehta, S. A. Roman, D. C. Thomas, J. A. Sosa; Yale University School of Medicine, New Haven, CT Introduction: Evidence-based surgery is predicated on the quality of published literature. We measured the quality of surgical manuscripts selected by peer-review and identify predictors of excellence. Methods: A random sample of 120 manuscripts about clinical therapeutics in surgery were taken from 1998 in five eminent peerreviewed surgical and medical journals. Manuscripts were blinded for author, institution, and journal of origin. Four surgeons and four methodologists evaluated their quality using two novel, validated instruments based on subject selection, study protocol (i.e. “blinding”, inclusion criteria, use of control groups), statistical analysis and inference, intervention description, outcome assessments, presentation of results, and perceived impact a decade after publication via citation index. They generated separate clinical and methodological quality scores for each manuscript. Predictors of quality were iden-

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ASSOCIATION FOR ACADEMIC SURGERY AND SOCIETY OF UNIVERSITY SURGEONS—ABSTRACTS

tified based on univariate and multivariate regression analyses. Results: Among our sample of manuscripts, oncology was the most common study subject (26%), followed by general surgery/GI (24%), and vascular, transplant, and/or cardiothoracic surgery (23%). The average number of study subjects was 417; the majority of manuscripts were from the U.S. (53%) and from a single institution (59%). Just 18% had a statistician-author. The mean number of citations was 128. Surgical manuscripts submitted to medical journals, as compared to surgical journals, had on average significantly better clinical (1.7 vs. 2.5, p⬍0.001), methodologic (2.1 vs. 2.7, p⬍0.001) and total quality scores (3.8 vs. 5.2, p⬍0.001). They had more subjects (mean ⫽ 891 vs. 259, p⬍.001) and were more likely to have a statistician as a co-author (43 vs.10%, p⬍0.001), a multiinstitutional, international collaboration (30 vs.8%, p⬍.001), and a high citation index (70 vs.10%, p⬍.001). They were more often from outside the U.S. (70% vs. 40%, p⬍0.001). Manuscripts stemming from direct journal submission had better methodologic scores than those submitted for publication after presentation at surgical society meetings (2.5 vs 2.7, p⬍.0.05), but were comparable in clinical and total quality scores. The best scores by subject were in vascular, transplant, and/or cardiothoracic surgery (p⬍0.01) Overall, significant independent predictors of surgical manuscript quality were having a statistician as a co-author, number of times the manuscript has been cited, and a larger number of study subjects. For all surgical manuscripts, quality assessment using our novel instrument predicted the number of citations ten years later (p⬍0.001). Conclusion: The quality of surgical manuscripts can be improved by including a statistician as a co-author. Efforts should be directed to implementing multi-institutional and interdisciplinary trials. Peerreview across journals can be standardized through the use of a validated instrument such as this one to measure the methodologic and clinical quality of manuscripts submitted for publication. 14. PTSD: INCIDENCE AND IMPACT ON QUALITY OF LIFE AFTER TRAUMATIC INJURY. J. L. Anderson, K. Brasel; Medical College of Wisconsin, Milwaukee, WI Introduction: PTSD is a strong correlate of post-injury quality of life. It occurs in 9-42% of patients after traumatic injury, with the variability partially driven by the method of diagnosis. There is also variable association with post-injury quality of life. We hypothesized that PTSD was related both to injury mechanism and quality of life. Methods: A screening program was implemented at a Level I trauma center on October 1, 2007. Patients were given the SF-36 and the 17-item PTSD checklist prior to discharge. Both surveys were self-administered, although patients were giving the option of completing them with trauma program personnel. A score ⱖ 44 categorized a patient as having PTSD on the 17-item PTSD civilian checklist. Individual SF-36 domain scores as well as the physical (PCS) and mental component scores (MCS) were calculated. Incidence of PTSD by injury mechanism was analyzed using the Chi-square Test. PCS and MCS in patients with and without PTSD were analyzed using the Student’s T-Test. Results: Between program implementation and July 10, 2008, 321 patients were given both surveys. 236 (73.5%) completed the surveys. PTSD was present in 21%. Patients with intentional injury had a significantly higher rate of PTSD than those with unintentional injury (43% vs 13%, p⬍0.0001). MCS was significantly lower in patients with PTSD (20.62 vs 22.44, p⬍0.005). There was no difference in PCS. Injured patients had lower MCS and PCS than population norms, regardless of the presence of PTSD, indicating poorer quality of life (both p⬍0.0001). Conclusion: The self-administered PTSD checklist is an efficient tool, saving inperson resources for those needing treatment or intervention. The incidence of PTSD varies significantly by injury mechanism. Understanding which patients are more likely to develop PTSD can help to triage and deploy appropriate patient care. The significant association of PTSD with quality of life suggests that early intervention for PTSD may impact the quality of life in this patient population.

Mechanism Unintentional injury MVC Fall Pedestrian struck MCC Recreational injury Intentional injury GSW SW Assault

PTSD present (n)

PTSD absent (n)

11 7 3 2 0

71 26 10 24 11

16 9 2

25 8 3

15. BEHAVIORAL AND SOCIAL-EMOTIONAL OUTCOMES IN MORBIDLY OBESE ADOLESCENTS AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING. A. Vazzana, H. Youn, C. Ren Fielding, G. Fielding, E. P. Nadler; NYU School of Medicine, New York, NY Background: As increasing data suggest that laparoscopic adjustable gastric banding (LAGB) represents a safe and effective treatment for morbidly obese adolescents, attention can begin to focus on secondary outcomes, including weight-related behavioral and socialemotional functioning. We hypothesized that LAGB would improve eating and exercise habits, interpersonal and psychological functioning, and self-esteem. Methods: Patients ages 14-17 who have undergone LAGB at our institution since 2005 were asked to complete the Revised Children’s Manifest Anxiety Scale, the Beck Depression Inventory-Short Form, the Harter Self-Esteem global self-worth subscale, and the SHAPEDOWN Habit Inventory. Patients completed the scale pre-operatively and one year after surgery. Twenty-one patients (15 females, 6 males) had at least one year of follow-up after surgery and completed the questionnaires at both time points. Repeated-measures analyses of variances (ANOVAs) were performed to compare pre- and post-surgical differences (Time). Statistical significance was assigned for p-values ⬍.05. Results: There were several significant main effects of Time that consistently indicated improvements across variables. Post-surgically, patients reported exercising more (F ⫽ 14.31, p ⬍ .01) and being generally more active throughout the day (F ⫽ 13.26, p ⬍ .05). Eating was characterized as slower paced (F ⫽ 17.85, p ⬍ .05), less frequent (F ⫽ 4.54, p ⬍ .05), and smaller portioned (F ⫽ 19.92, ⬍ .01) following surgery. Banded patients were more likely to eat in response to hunger cues (F ⫽ 7.01, p ⬍ .05), and less in response to environmental (F ⫽ 21.89, p ⬍ .01) or emotional (F ⫽ 5.23, p ⬍ .05) cues. They binged less often (F ⫽ 10.58, p ⬍ .01). No significant differences were found in either the types of food consumed (F ⫽ .83, ns) or the foods available in the home (F ⫽ .07, ns). Interpersonally, banded patients were more likely to disclose their feelings (F ⫽ 12.55, p ⬍ .01) and perceived greater peer support (F ⫽ 7.67, p ⬍ .01). There was a trend for greater familial support post-surgically (F ⫽ 3.13, p ⬍ .09). Patients who were banded had higher overall self-esteem (F ⫽ 18.18, p ⬍ .01), were less depressed (F ⫽ 8.48, p ⬍ .01) and anxious (F ⫽ 12.70, p ⬍ .01), and had a better body image (F ⫽ 29.28, p ⬍ .01). Weightrelated feelings of self-worth (F ⫽ 13.94, p ⬍ .01) and depression (F ⫽ 24.78, p ⬍ .01) also improved post-surgically. Conclusions: LAGB represents a life-altering procedure that extends beyond weight loss to enhance adolescent patients’ lifestyles and social-emotional functioning. Patients lead more active lifestyles, have better relationship dynamics, and feel good about themselves. Post-surgical eating patterns indicate compliance with the dietary protocol. Increased attention should be directed at improving the availability and selection of healthy food choices. Future studies should investigate whether the positive behavioral and social-emotional attributes associated with banding are sustainable and are related to weight maintenance.