Marta M. Gilson

Management of patients with pancreatic adenocarcinoma: National trends in patient selection, operative management, and use of adjuvant therapy

BACKGROUND Surgical resection remains the only potentially curative option for patients with pancreatic adenocarcinoma (PAC). Advances in surgical technique and perioperative care have reduced perioperative mortality; however, temporal trends in perioperative morbidity and the use of adjuvant therapy on a population basis remain ill-defined. STUDY DESIGN Using Surveillance, Epidemiology, and End Results-Medicare data, 2,461 patients with resected PAC were identified from 1991 to 2005. We examined trends in preoperative comorbidity indices, adjuvant treatment, type of pancreatic resection, and changes in morbidity and mortality during 4 time intervals (ie, 1991-1996, 1997-2000, 2001-2003, and 2003-2005). RESULTS The majority of patients underwent pancreaticoduodenectomy (n = 1,945; 79%). There was a temporal increase in mean patient age (p < 0.05) and the number of patients with multiple preoperative comorbidities (Elixhauser comorbidities ≥3: 1991-1996, 10% vs 2003-2005, 26%; p < 0.001). Perioperative morbidity (53%) did not, however, change over time (p = 0.97) and 30-day mortality decreased by half (1991-1996: 6% vs 2003-2005: 3%; p = 0.04). Overall, 51% (n = 1,243) of patients received adjuvant therapy, with the majority receiving chemoradiation (n = 817; 33%). Among patients who received adjuvant therapy, factors associated with receipt of adjuvant chemotherapy alone relative to chemoradiation included older patient age (odds ratio = 1.75; p < 0.001) and ≥3 medical comorbidities (odds ratio = 1.57; p = 0.007). Receipt of adjuvant chemotherapy alone also increased over time (2003-2005 vs 1991-1996, odds ratio = 2.21; p < 0.001). CONCLUSIONS Perioperative 30-day mortality associated with resection for PAC decreased by one-half from 1991 to 2005. Although patients undergoing resection for PAC were older and had more preoperative comorbidities, the incidence of perioperative complications remained stable. The relative use of adjuvant chemotherapy alone vs chemoradiation therapy for PAC has increased in the United States during the 15 years examined.

Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ) SST report number 19

Purpose: To evaluate responsiveness of the National Eye Institute Visual Function Questionnaire (NEI-VFQ) to changes in visual acuity and to provide estimates of minimum clinically meaningful changes in NEI-VFQ scores. Methods: Data were combined from three clinical trials of submacular surgery for subfoveal choroidal neovascularization. Patients who completed NEI-VFQ interviews and visual acuity measurements at baseline and 2 years later contributed data for analysis. Data were analyzed using anchor-based (relating 2-year change in NEI-VFQ to 2-year change in visual acuity using correlation and linear regression) and distribution-based (standardized response mean) methods. Results: Of 1,015 patients enrolled, 828 patients completed NEI-VFQ interviews and had visual acuity measurements at baseline and 2 years later. Median age of patients was 75 years (range 18 to 94); all patients had subfoveal choroidal neovascularization in at least one eye. Median overall NEI-VFQ score at baseline was 69.9 (mean, 66.5). Based on anchor-based methods, a 2-line change in visual acuity of the better-seeing eye translated to a 3.4-point change in the overall NEI-VFQ score and from 2.4-point to 7.0-point changes in most subscale scores. The NEI-VFQ was sensitive to both gains and losses in visual acuity; the standardized response mean for the overall NEI-VFQ score in patients with a 2-line gain was 0.6 and for patients with 2-line loss was −0.3. In the subgroup of patients with a 2-line loss of visual acuity in the better-seeing eye, patients who had overall NEI-VFQ scores at baseline greater than the median (59.8) had an standardized response mean of −0.9 for the overall NEI-VFQ score and patients who had overall NEI-VFQ scores at baseline at or below the median had a standardized response mean of 0.2 for the overall NEI-VFQ score. A 4-point change in the overall NEI-VFQ and a 5-point change in individual subscale scores corresponded to a small clinically meaningful change. Conclusions: The NEI-VFQ was responsive to 2-year changes in visual acuity but was less responsive to changes among patients with poorer NEI-VFQ scores at baseline. Based on this analysis, a 4-point change in the overall NEI-VFQ and a 5-point change in individual subscale scores may be considered minimum clinically meaningful within-person changes in NEI-VFQ scores.

Needlestick Injuries Among Medical Students: Incidence and Implications

Purpose To determine the incidence of needlestick injuries in medical school and to examine the behaviors associated with reporting injuries to an occupational health office. Medical students have underdeveloped surgical skills and are at high risk of needlestick injuries. Method Recent medical school graduates enrolled in a surgery residency at 17 medical centers were surveyed regarding needlestick injuries that they sustained during medical school. The survey asked about the circumstances and cause of injury and postinjury reporting. Results Of 699 respondents, 415 (59%) reported having sustained a needlestick injury as a medical student; the median number of injuries per injured respondent was 2 (interquartile range: 1-2). Respondents who sustained a needlestick injury in medical school were more likely to sustain a needlestick injury during residency than those who did not experience a needlestick injury in medical school (odds ratio [OR]: 2.57; 95% CI: 1.84, 3.58). Of 89 residents who sustained their most recent needlestick injury during medical school, 42 (47%) did not report their injury to an employee health office. Conclusions Needlestick injuries and underreporting of these injuries are common among medical students and place them at risk for hepatitis and human immunodeficiency virus. Strategies aimed at improving reporting systems and creating a culture of reporting should be implemented by medical centers.

Three-dimensional computed tomographic angiography to predict weight and volume of deep inferior epigastric artery perforator flap for breast reconstruction†

Background: Three‐dimensional computed tomographic angiography (3D CTA) can be used preoperatively to evaluate the course and caliber of perforating blood vessels for abdominal free‐flap breast reconstruction. For postmastectomy breast reconstruction, many women inquire whether the abdominal tissue volume will match that of the breast to be removed. Therefore, our goal was to estimate preoperative volume and weight of the proposed flap and compare them with the actual volume and weight to determine if diagnostic imaging can accurately identify the amount of tissue that could potentially to be harvested. Methods: Preoperative 3D CTA was performed in 15 patients, who underwent breast reconstruction using the deep inferior epigastric artery perforator flap. Before each angiogram, stereotactic fiducials were placed on the planned flap outline. The radiologist reviewed each preoperative angiogram to estimate the volume, and thus, weight of the flap. These estimated weights were compared with the actual intraoperative weights. Results: The average estimated weight was 99.7% of the actual weight. The interquartile range (25th to 75th percentile), which represents the “middle half” of the patients, was 91–109%, indicating that half of the patients had an estimated weight within 9% of the actual weight; however, there was a large range (70–133%). Conclusion: 3D CTA with stereotactic fiducials allows surgeons to adequately estimate abdominal flap volume before surgery, potentially giving guidance in the amount of tissue that can be harvested from a patients lower abdomen.

Management of unresolved, recurrent, and/or contralateral neurogenic symptoms in patients following first rib resection and scalenectomy

BACKGROUND Surgical treatment for neurogenic thoracic outlet syndrome does not always yield successful outcomes. The purpose of this study was to describe patients with unresolved, recurrent, and/or contralateral symptoms following first rib resection and scalenectomy (FRRS) and to determine therapies for improving their outcomes. METHODS Data on 161 neurogenic thoracic outlet syndrome patients (182 FRRS procedures) were prospectively collected from 2003 to 2011 and retrospectively reviewed for evidence of unresolved, recurrent, and/or contralateral neurogenic symptoms following FRRS. Demographic and clinical characteristics, interventions, and outcomes were compared between these patients and those with a successful result. RESULTS Twenty-three patients (24 FRRS) had unresolved symptoms at a mean of 16.1 ± 14.7 postoperative months. Compared with successes, these patients were older (mean age, 45 vs 38 years; P = .002) and active smokers (33% vs 13%; P = .031), with a longer duration of symptoms (90 vs 48 months; P = .005). They had higher rates of chronic pain syndromes (67% vs 14%; P < .001), neck and/or shoulder comorbidities (58% vs 22%; P < .001), preoperative opioid use (67% vs 31%; P = .001), and preoperative Botox injections (46% vs 20%; P = .009) with less relief (18% vs 64%; P = .014). Sixteen patients had recurrent symptoms at a mean of 12.1 ± 9.7 postoperative months. These patients had more chronic pain syndromes (38%; P = .028) and neck and/or shoulder comorbidities (50%; P = .027), with recurrence secondary to scar tissue (69%; P < .001) and reinjury (31%; P = .002). Postoperative treatments for both groups included physical therapy and local injections, where six unresolved (26%) and 13 recurrent (81%) patients achieved freedom from opioids at the end of the follow-up period. Twenty-one patients had contralateral symptoms and underwent secondary FRRS at a mean of 15.0 months (range, 7-30 months) following primary FRRS. The first operation was successful in 90% of cases. CONCLUSIONS Patients with unresolved symptoms are older, active smokers with more comorbid pain syndromes, neck and/or shoulder disease, and a longer symptom duration. These patients face a more difficult recovery, whereas patients with recurrent symptoms are well managed with physical therapy and Botox injections. Patients with contralateral symptoms at >1 year are effectively treated with secondary FRRS. Patients must be followed closely after FRRS to determine if additional interventions are necessary to ensure successful results.

ACGME Core Competency Training, Mentorship, and Research in Surgical Subspecialty Fellowship Programs

OBJECTIVE To determine the perceived effectiveness of surgical subspecialty training programs in teaching and assessing the 6 ACGME core competencies including research. DESIGN Cross-sectional survey. SETTING ACGME approved training programs in pediatric urology and colorectal surgery. PARTICIPANTS Program Directors and recent trainees (2007-2009). RESULTS A total of 39 program directors (60%) and 57 trainees (64%) responded. Both program directors and recent trainees reported a higher degree of training and mentorship (75%) in patient care and medical knowledge than the other core competencies (p<0.0001). Practice based learning and improvement, interpersonal and communication, and professionalism training were perceived effective to a lesser degree. Specifically, in the areas of teaching residents and medical students and team building, program directors, compared with recent trainees, perceived training to be more effective, (p = 0.004, p = 0.04). Responses to questions assessing training in systems based practice ubiquitously identified a lack of training, particularly in financial matters of running a practice. Although effective training in research was perceived as lacking by recent trainees, 81% reported mentorship in this area. According to program directors and recent trainees, the most effective method of teaching was faculty supervision and feedback. Only 50% or less of the recent trainees reported mentorship in career planning, work-life balance, and job satisfaction. CONCLUSIONS Not all 6 core competencies and research are effectively being taught in surgery subspecialty training programs and mentorship in areas outside of patient care and research is lacking. Emphasis should be placed on faculty supervision and feedback when designing methods to better incorporate all 6 core competencies, research, and mentorship.

Blunt-Mechanism Facial Fracture Patterns Associated With Internal Carotid Artery Injuries: Recommendations for Additional Screening Criteria Based on Analysis of 4,398 Patients

PURPOSE Blunt internal carotid artery injuries (BCAIs) can result from craniofacial trauma, yet the association between craniofacial fractures and BCAIs is poorly understood. MATERIALS AND METHODS A retrospective cohort study of patients with blunt-mechanism facial fracture(s) presenting to a large trauma center was undertaken to identify facial fracture patterns predictive of BCAIs. Predictor variables included specific facial fracture patterns. Additional variables included demographic, injury mechanism, and associated injury classifications. Outcome variables included the presence or absence of BCAIs. All radiographic fracture patterns were confirmed by author review of computed tomographic imaging. BCAIs were confirmed and graded using the Biffl system. Differences in fracture patterns and demographic parameters in patients who presented with versus without concomitant BCAIs were compared, and relative risks for BCAI were calculated. Existing Eastern Association for the Surgery of Trauma Level III Blunt Cerebrovascular Injury (BCVI) screening criteria then were applied to the dataset to determine if additional fracture patterns would be useful in BCAI screening as determined by alterations in screening sensitivity and specificity. RESULTS Seventy BCAIs were identified in 54 of 4,398 patients with facial fractures (1.2%). Bilateral fractures in each facial third, complex midface, Le Fort, and subcondylar fractures, fractures in association with the cervical spine, and basilar skull fractures were high risk for concomitant BCAI. Twenty percent of BCAIs would not have been captured by existing Eastern Association for the Surgery of Trauma Level III BCVI screening criteria. When patients meeting these screening criteria were removed from the study population, Le Fort I and subcondylar fractures were the only fracture patterns conferring increased risk for BCAI. Addition of these criteria to existing criteria improved the screening negative predictive value. CONCLUSION Specific facial fracture patterns, including bilateral fractures in any facial third and complex midface, Le Fort I, and subcondylar fractures, confer increased risk of BCAI, especially in association with basilar skull fractures. Suspicion for BCAI in these patients may improve diagnosis and enable prompt therapeutic intervention. Addition of Le Fort I fractures to existing BCAI screening criteria improves sensitivity and may be of clinical utility in ruling out BCAIs.

Risk factors for rhegmatogenous retinal detachment in the submacular surgery trials: SST report No. 22.

Objective: To identify risk factors associated with the development of rhegmatogenous retinal detachment (RRD) in patients enrolled in the Submacular Surgery Trials. Methods: One thousand fifteen patients with eligible subfoveal neovascular lesions in the study eye were assigned randomly to observation or to surgery. Eyes were examined at 3 months, 6 months, 12 months, and 24 months after enrollment to assess study outcomes and adverse events, including RRDs. Adverse events also were reported at other times as clinical personnel became aware of them. Potential risk factors for the development of RRD in study eyes were evaluated using recursive partitioning and logistic regression analysis. Results: Among 506 eyes assigned to surgery, RRD developed in 44 (8.7%) compared with 4 (0.8%) of 509 eyes assigned to observation. Of the 44 eyes in which RRD developed, 27 had age-related macular degeneration (AMD) and large (>3.5 MPS disk areas) hemorrhagic subfoveal neovascular lesions at baseline and represented 16.1% of all eyes with such lesions assigned to surgery. Eyes with AMD and larger hemorrhagic lesions (>16 MPS disk areas) together with relatively poor visual acuity (best-corrected visual acuity ≤20/1280) had a higher risk of RRD (odds ratio = 6.2, 95% confidence interval: 2.2–16.7) compared with those with smaller lesions and better visual acuity at baseline. Conclusion: Poor visual acuity and very large, predominantly hemorrhagic subfoveal neovascular AMD lesion type were the greatest risk factors for RRD after submacular surgery. Submacular surgery should be undertaken in such eyes with full awareness of the risk of RRD during subsequent follow-up.

Comparison of Survival Among Eligible Patients not Enrolled Versus Enrolled in the Collaborative Ocular Melanoma Study (COMS) Randomized Trial of Pre-Enucleation Radiation of Large Choroidal Melanoma

Purpose: To compare survival between patients enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation therapy (PERT) for large choroidal melanoma and eligible patients who did not enroll. Methods: COMS clinical center personnel prospectively reported to the COMS Coordinating Center all patients with choroidal melanoma examined between November 1986 and December 1994. Deaths of enrolled patients were reported prospectively by clinical center personnel. In a COMS ancillary study, we retrospectively searched medical records of participating clinical centers, the Social Security Death Index, and the National Death Index to determine vital status of eligible patients not enrolled. Cox proportional hazards analysis was used to compare survival within 10 years of baseline reporting and before July 31, 2000, of enrolled patients versus eligible patients not enrolled. Results: Clinical centers that received local institutional review board approval to participate in this ancillary study prospectively reported on 129 of 299 eligible patients not enrolled in the COMS PERT trial. The baseline characteristics of the 129 patients included in this ancillary study were similar to those of the 170 patients not included; 73 patients were reported as deceased. Previously identified prognostic covariates, i.e., age and longest tumor diameter, were confirmed to predict survival in both enrolled patients and eligible patients not enrolled; trial enrollment was not predictive. After adjusting for prognostic covariates and stratifying by clinical center, the estimated hazard ratio (enrolled vs. not-enrolled) was 1.12 (95% confidence interval: 0.83 to 1.51). Conclusions: The results of the COMS PERT trial should be generalizable to all patients with choroidal melanoma meeting the eligibility criteria for that trial. While the methods we used may not be generalizable to all clinical trials because of unique features of the COMS, other researchers may be able to use similar methods to determine the generalizability of their trial results.

Surgical removal vs observation for idiopathic or ocular histoplasmosis syndrome-associated subfoveal choroidal neovascularization: Vision Preference Value Scale findings from the randomized SST Group H Trial: SST Report No. 17.

OBJECTIVE To determine whether patients receiving observation vs surgery for subfoveal choroidal neovascularization that was idiopathic or associated with histoplasmosis differed in preference values assigned to their health and vision status. METHODS Before and after enrollment, patients rated their current vision on a scale from 0 (blind) to 100 (perfect vision) and rated blindness and perfect vision on a scale from 0 (dead) to 100 (perfect health and vision). Scores for current vision were converted to a preference value scale (0 represents death; 100, perfect health and vision). RESULTS In 170 patients, no significant difference existed between the observation and surgery arms in median vision preference values at baseline (74 vs 70) or at the 12- (74 vs 78) or 24-month follow-up (77 vs 73) (P > .05). Preference values did not differ between arms for subgroups defined by age, unilateral vs bilateral choroidal neovascularization, or good vs poor baseline visual acuity. CONCLUSIONS Submacular surgery was no better than observation in the preference values patients assigned to their health status, despite previously reported improvements in vision-specific quality of life. TRIAL REGISTRATION (clinicaltrials.gov) Identifier: NCT00000150. CLINICAL RELEVANCE Ophthalmologists should consider the effects on different measures of quality of life when determining treatment for patients similar to those in the Submacular Surgery Trials Group H Trial.