Effect of Lower Extremity Nerve Decompression in Patients with Painful Diabetic Peripheral Neuropathy: The DNND Randomized, Observation Group- and Placebo Surgery-controlled Clinical Trial.

OBJECTIVE: Evaluate the effect of nerve decompression on pain in patients with lower extremity painful Diabetic Peripheral Neuropathy (DPN). SUMMARY BACKGROUND DATA: Currently, no treatment provides lasting relief for patients with DPN. Benefits of nerve decompression remain inconclusive. METHODS: This double-blinded, observation- and same-patient sham surgery-controlled randomized trial enrolled patients aged 18-80 years with lower extremity painful DPN who failed one-year of medical treatment. Patients were randomized to nerve decompression- or observation-group (2:1). Decompression-group patients were further randomized and blinded to nerve decompression in either right or left leg and sham surgery in the opposite leg. Pain (11-point Likert score) was compared between decompression and observation groups and between decompressed versus sham legs at 12 and 56 months. RESULTS: Of 2987 screened patients, 78 were randomized. At 12 months, compared with controls (n=37), both right-decompression-group (n=22) and left-decompression-group (n=18) reported lower pain (mean difference for both, -4.46; [95% CI, -6.34 to -2.58 and -6.48 to -2.45 respectively]; P<0.0001). Decompressed and sham legs equally improved. At 56 months, compared with controls (n=14), pain was lower in both the right-decompression-group (n=20) (mean difference, -7.65; [95% CI, -9.87 to -5.44]; P<0.0001) and left-decompression-group (n=16) (mean difference, -7.26; [95% CI, -9.60 to -4.91]; P<0.0001). Mean pain score was lower in decompressed versus sham legs (mean difference, 1.57 [95% CI, 0.46 to 2.67]; P=0.0002). CONCLUSION: Although nerve decompression was associated with reduced pain, the benefit of surgical decompression needs further investigation since a placebo effect may be responsible for part or all of these effects.

Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair.

OBJECTIVE: To identify clinical and demographic characteristics associated with prolapse recurrence by 12 months after native tissue transvaginal repair. METHODS: This was a planned secondary analysis of a randomized trial including postmenopausal participants with stage 2 or greater apical or anterior vaginal prolapse scheduled for surgical repair at three U.S. sites. Participants underwent vaginal hysterectomy (if uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The intervention was perioperative (5 weeks or more preoperatively and 12 months postoperatively) vaginal estrogen compared with placebo cream. The primary outcome was time to failure by 12 months after surgery, defined by objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, symptomatic vaginal bulge, or retreatment. For this analysis, participants were grouped according to failure compared with success, and multiple factors were compared, including age, time since menopause, race and ethnicity, parity, body mass index (BMI), baseline genital hiatus measurement, prolapse stage and point of maximal prolapse, surgery type (uterosacral or sacrospinous ligament suspension), and concomitant procedures. Factors were assessed for association with the hazard of surgical failure using Cox proportional hazards models, adjusted for site and treatment group. Factors with P <.50 from this analysis were considered for inclusion in the final multivariable model; site and treatment group were kept in this model. RESULTS: One hundred eighty-six participants underwent surgery; 183 provided complete data. There were 30 failures (16.4%) and 153 successes (83.4%) at 12 months. On bivariate analysis, failure was associated with decreasing age, shorter duration since menopause, Latina ethnicity, and greater baseline genital hiatus. In the final multivariable model, which included age, BMI, and point of maximal prolapse, only age remained significantly associated with surgical failure (adjusted hazard ratio [per year] 0.92, 95% CI, 0.86-0.98, P =.016). CONCLUSION: Among postmenopausal women, younger age was associated with increased frequency of prolapse recurrence by 12 months after native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02431897.

Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial.

Importance: Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain. Objective: To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair. Design, Setting, and Participants: This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020. Interventions: The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation). Main Outcomes and Measures: The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events. Results: Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen. Conclusions and Relevance: Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair. Trial Registration: ClinicalTrials.gov Identifier: NCT02431897.

Burnout in Surgical Residents of Underrepresented in Medicine Backgrounds: Key Influencing Factors and Possible Solutions.

INTRODUCTION: Alarming rates of burnout in surgical training pose a concern due to its deleterious effects on both patients and providers. Datum remains lacking on rates of burnout in surgical residents based on race and ethnicity. This study aims to document the frequency of burnout in surgical residents of racially underrepresented backgrounds and elucidate contributing factors. METHODS: A 35-question anonymized survey was distributed to general surgery residents from 23 programs between August 2018 and May 2019. This survey was designed from the validated Maslach Burnout Inventory, and included additional questions assessing participant demographics, educational, and social backgrounds. Responses were analyzed utilizing chi-square tests and Wilcoxon rank sum tests. There was also a free response portion of the survey which was evaluated using thematic analysis. RESULTS: We received 243 responses from 23 general surgery programs yielding a 9% (23/246) program response rate and 26% (243/935) response rate by surgical residents. One hundred and eighty-five participants (76%) identified as nonunderrepresented in medicine and 58 (24%) of participants identified as underrepresented in medicine. Fifty-three percent were male and 47% female. Overall, sixty-six percent of all surgical residents (n = 161) endorsed burnout with racially underrepresented residents reporting higher rates of burnout at 76% compared to 63% in their nonunderrepresented counterparts (P = 0.07). CONCLUSIONS: Although the generalizability of these results is limited, higher rates of reported burnout in racially underrepresented trainees noted in our study illuminates the need for continual dialogue on potential influencing factors and mitigation strategies.

Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse.

BACKGROUND: Menopause and the decline in systemic estrogen are associated with the development of pelvic floor disorders, such as prolapse, urinary incontinence, overactive bladder, and vulvovaginal atrophy symptoms. Past evidence suggests that postmenopausal women with symptomatic prolapse gain benefit from the preoperative application of intravaginal estrogen, but it is unknown whether they would experience improvement in other pelvic floor symptoms when treated with intravaginal estrogen. OBJECTIVE: This study aimed to determine the effects of intravaginal estrogen (compared with placebo) on stress and urgency urinary incontinence, urinary frequency, sexual function and dyspareunia, and vaginal atrophy symptoms and signs in postmenopausal women with symptomatic prolapse. STUDY DESIGN: This was a planned ancillary analysis of a randomized, double-blind trial, "Investigation to Minimize Prolapse Recurrence Of the Vagina using Estrogen," which included participants with ≥stage 2 apical and/or anterior prolapse scheduled for transvaginal native tissue apical repair at 3 US sites. The intervention was 1 g conjugated estrogen intravaginal cream (0.625 mg/g) or identical placebo (1:1), inserted nightly for 2 weeks and then twice weekly for ≥5 weeks total before surgery and continued twice weekly for 1 year postoperatively. For this analysis, question responses were compared from participants' baseline and preoperative visits: lower urinary tract symptoms (Urogenital Distress Inventory-6 Questionnaire); sexual health questions, including dyspareunia (Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA-Revised); and atrophy-related symptoms (dryness, soreness, dyspareunia, discharge, and itching; each scored 1-4, 4 being quite a bit bothersome). Masked examiners assessed vaginal color, dryness, and petechiae (each scored 1-3, total range 3-9, with 9 being the most estrogenized appearing). Data were analyzed by intent to treat and "per protocol" (ie, those adherent with ≥50% of expected intravaginal cream use, per objective tube before and after weights). RESULTS: Of 199 participants randomized (mean age of 65 years) and contributing baseline data, 191 had preoperative data. The characteristics were similar between groups. Total Urogenital Distress Inventory-6 Questionnaire scores showed minimal change during this median time of 7 weeks between baseline and preoperative visits, but for those with at least moderately bothersome baseline stress urinary incontinence (32 in the estrogen group and 21 in the placebo group), 16 (50%) in the estrogen group and 9 (43%) in the placebo group showed improvement (P=.78). In addition, 43% of participants in the estrogen group and 31% of participants in the placebo group showed improvement in urgency urinary incontinence (P=.41), and 41% of participants in the estrogen group and 26% of participants in the placebo group showed improvement in urinary frequency (P=.18). There was minimal change in the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA-Revised scores among sexually active women; dyspareunia rates did not differ between intravaginal estrogen and placebo at the preoperative assessment: 42% and 48%, respectively (P=.49). The maximum score for most bothersome atrophy symptom (among those with baseline symptoms and adherent to study cream) improved slightly more with intravaginal estrogen (adjusted mean difference, -0.33 points; 95% confidence interval, -0.98 to 0.31), but this was not statistically significant (P=.19). However, on examination, among adherent participants, objective signs of atrophy were more improved with intravaginal estrogen treatment (+1.54 vs +0.69; mean difference, 0.85; 95% confidence interval, 0.05-1.65; P=.01). CONCLUSION: Despite objective changes in the vaginal epithelium consistent with increased estrogenization among drug-adherent participants, the results were inconclusive regarding whether 7 weeks of preoperative intravaginal estrogen cream in postmenopausal women with symptomatic pelvic organ prolapse was associated with improved urinary function, sexual function, dyspareunia symptoms, and other symptoms commonly attributed to atrophy. Additional study is needed.

Patients with Limited Life Expectancy Are Biopsied for Keratinocyte Cancers at Similar Frequency to Healthy Patients.

BACKGROUND: In many fields of medicine, guidelines recommend reduced cancer screening in patients of advanced age with limited life expectancy (LLE). In dermatology, there are currently no guidelines for adjusted evaluation and management practices of keratinocyte cancer (KC) in patients with LLE. Little is known regarding evaluation and management patterns and frequency of biopsies in these patients. OBJECTIVE: We sought to determine if dermatology providers biopsy LLE patients with similar frequency to their age-matched peers and quantify frequency of associated complications. METHODS: This was a retrospective cohort study of evaluations for skin cancer quantified by skin biopsy frequency at the North Texas Veterans Affairs Health System dermatology clinic for 3,062 patients between 2005 and 2009, including a 5-year follow-up period. Life expectancy was quantified by the validated Charlson Comorbidity Index (CCI) with a Deyo adaptation. RESULTS: There was no significant difference in biopsy frequency of KC in LLE versus non-LLE patients in most age-controlled groups, with increased biopsy frequency in LLE patients in the 65-74 age category (p = 0.02). There was also an increased risk of complications from biopsy in the 75-84 (many comorbidities subgroup: RR = 3.27, p = 0.002; some comorbidities subgroup: RR = 2.26, p = 0.048) and 65-74 (many comorbidities subgroup: RR = 1.52, p = 0.004) age groups when compared to age-matched healthy controls. CONCLUSION: Biopsy frequency is similar or increased in patients with LLE compared with age-matched controls, with increased frequency of complications. Further studies are needed to understand the underlying factors driving these practice patterns.

Palliative care consultation and end-of-life outcomes in hospitalized COVID-19 patients.

RATIONALE: The impact of palliative care consultation on end-of-life care has not previously been evaluated in a multi-center study. OBJECTIVES: To evaluate the impact of palliative care consultation on the incidence of cardiopulmonary resuscitation (CPR) performed and comfort care received at the end-of-life in hospitalized patients with COVID-19. METHODS: We used the Society of Critical Care Medicine's COVID-19 registry to extract clinical data on patients hospitalized with COVID-19 between March 31st, 2020 to March 17th, 2021 and died during their hospitalization. The proportion of patients who received palliative care consultation was assessed in patients who did and did not receive CPR (primary outcome) and comfort care (secondary outcome). Propensity matching was used to account for potential confounding variables. MEASUREMENTS AND MAIN RESULTS: 3,227 patients were included in the analysis. There was no significant difference in the incidence of palliative care consultation between the CPR and no-CPR groups (19.9% vs. 19.4%, p = 0.8334). Patients who received comfort care at the end-of-life were significantly more likely to have received palliative care consultation (43.3% vs. 7.7%, p < 0.0001). After propensity matching for comfort care on demographic characteristics and comorbidities, this relationship was still significant (43.2% vs. 8.5%; p < 0.0001). CONCLUSION: Palliative care consultation was not associated with CPR performed at the end-of-life but was associated with increased incidence of comfort care being utilized. These results suggest that utilizing palliative care consultation at the end-of-life may better align the needs and values of patients with the care they receive.

Utility of Brief Psychological Measures for Prediction of Prolonged Symptom Clearance in Concussed Student Athletes.

OBJECTIVE: Variability in recovery time following sport-related concussion (SRC) is poorly understood. We explored the utility of brief mood, anxiety, and sleep questionnaires as postinjury predictors of SRC symptom clearance in adolescents. METHOD: At initial visit 0-2 weeks postinjury, concussed athletes aged 12-18 years self-reported injury/medical factors (prior concussion, loss of consciousness, amnesia, and concussion symptom severity) and were administered psychological symptom measures. At 3 months, medical record review determined return-to-play (RTP) date. Subjects were divided into two datasets, with the first utilized for developing cutoff scores and then validated with the second dataset. RESULTS: A total of 64% of the 141 participants had early RTP (within 21 days postinjury), and 23% had late RTP (postinjury day 30 or later). The Generalized Anxiety Disorder Screener (GAD-7, M = 2.1, SD = 3.1) was the only significant predictor (p = .001), with a 1.4-fold [95% CI 1.2-1.8] increased risk for every point. No other factors in the full model discriminated recovery groups (ps > .05). Receiver operating characteristic curve analysis derived a GAD-7 cut score ≥3 (sensitivity= 56.7%, specificity = 74.2%, AUCs = 0.63-0.79, ps < .001). CONCLUSIONS: Postconcussion anxiety symptoms may help identify individuals at increased risk for prolonged recovery.

Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Recurrence of the Vagina using Estrogen: IMPROVE).

OBJECTIVES: To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair. METHODS: Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence. RESULTS: Recruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit. CONCLUSIONS: This trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.

Baseline Prevalence of Polypharmacy in Older Hypertensive Study Subjects with Elevated Dementia Risk: Findings from the Risk Reduction for Alzheimer's Disease Study (rrAD).

BACKGROUND: Little is known about the prevalence of polypharmacy, the taking of five or more medications a day, in older adults with specific dementia risk factors. OBJECTIVE: To examine the prevalence of polypharmacy in participants at baseline in a vascular risk reduction focused Alzheimer's disease (rrAD) trial targeting older patients with hypertension and elevated dementia risk. METHODS: We conducted a detailed review of medications in a cross-sectional study of community-dwelling older adults with hypertension and elevated dementia risk. Medications were identified in a structured interview process with an onsite pharmacist or qualified designee. Polypharmacy was defined as use of five or more medications on a regular basis. Descriptive analyses were conducted on the sample as well as direct comparisons of subgroups of individuals with hypertension, diabetes, and hyperlipidemia. RESULTS: The 514 rrAD participants, mean age 68.8 (standard deviation [sd] 6), reported taking different combinations of 472 unique medications at their baseline visit. The median number of medications taken by participants was eight [Range 0-21], with 79.2% exhibiting polypharmacy (n = 407). Sites differed in their prevalence of polypharmacy, χ2(3) = 56.0, p < 0.001. A nearly identical percentage of the 2,077 prescribed (51.8%) and over the counter (48.2%) medications were present in the overall medication profile. The presence of diabetes (87.5%), hyperlipidemia (88.2%), or both (97.7%) was associated with a higher prevalence of polypharmacy than participants who exhibited hypertension in the absence of either of these conditions (63.2%), χ2(3) = 35.8, p < 0.001. CONCLUSION: Participants in a dementia risk study had high levels of polypharmacy, with the co-existence of diabetes or hyperlipidemia associated with a greater prevalence of polypharmacy as compared to having hypertension alone.

Comparison of 1-field, 2-fields, and 3-fields fundus photography for detection and grading of diabetic retinopathy.

AIM: To evaluate the sensitivity and specificity of 1-, 2-, and 3-fields, nonmydriatic (NM), 45° color photography compared with mydriatic ophthalmoscopy for detection of diabetic retinopathy (DR). METHODS: Masked, comparative case series was performed utilizing a group of 128 diabetic patients (256 eyes) with various stages of DR who underwent both 3-fields NM color photography and ophthalmologic examination. In a blinded manner, the same optometrist who read the original 3-fields images for a patient read the 1- and 2-fields photographs on separate dates later. RESULTS: The sensitivity and specificity of digital retinal photography compared with dilated ophthalmoscopy were, respectively: 88% and 76% for 1-field; 94% and 69% for 2-fields; and 100% and 79% for 3-fields. The proportion of agreement between fundus photography reading and exam DR diagnosis were 58% for 1-field, 58% for 2-fields, and 77% for 3-fields. Kappa and Cramer's V statistics for 1-, 2-, and 3-fields were 0.55 and 0.60, 0.52 and 0.57, and 0.72 and 0.74, respectively. Three-fields measurement of DR was most similar to the dilated ophthalmological exam overall and across all DR severity levels. CONCLUSIONS: Compared to 1- and 2-fields fundus photography, 3-fields is superior for detecting vision-threatening DR. One- and 2-fields have reasonable sensitivity for DR screening.

Changes in alpha-foetoprotein and Gc-globulin in relation to outcomes in non-acetaminophen acute liver failure.

BACKGROUND: Changes in Gc-globulin (Gc) and in alpha-foetoprotein (AFP) have been shown to be related to outcome in patients with acute liver failure (ALF). Gc is a serum protein that complexes with intravascular actin released during cellular necrosis. AFP, also made by hepatocytes, is associated with hepatocellular growth and regeneration. Previously, low absolute levels or decreases over time in either AFP or Gc portended to be a poor outcome. METHODS: In a retrospective analysis of the double-blind trial of intravenous N-acetylcysteine (NAC) for ALF not because of acetaminophen, sera on days 1 and 3 or days 2 and 4 following admission were available to measure AFP in 70 patients and Gc in 66 patients. Mann-Whitney U tests were performed on the admission values, the absolute change and the fractional change of AFP and Gc to compare TFS (transplant-free survival) and non-TFS (death or transplantation). Logistic regression and receiver operating characteristic (ROC) analyses were performed to evaluate the markers in comparison and in addition to King's College Criteria (KCC). RESULTS: Transplant-free survival patients were characterized by increases in AFP, whereas non-TFS had significantly different (negative) absolute and fractional changes (P < .01). The addition of declining AFP levels to KCC improved the area under the curve in predicting non-TFS (AUC >70%). Gc globulin values did not differ between TFS and non-TFS in the 2-day intervals studied (P> .2). CONCLUSION: In this comparison of two prognostic markers in patients with non-acetaminophen-induced ALF, rising AFP but not rising Gc levels was associated with TFS. TRIAL REGISTRATION: ClinicalTrials.gov number NCT00004467.

Frequency of psychological distress in gynecologic cancer patients seen in a large urban medical center.

Psychological distress in cancer is a well-documented phenomenon, but additional information is needed about demographic and disease correlates in diverse populations with different forms of cancer. This study focused on gynecologic cancers. Using the Distress Thermometer and the Hospital Anxiety and Depression Scale, this study examined distress levels in 94 women with gynecologic cancer who were being treated as outpatients at a large urban medical center. The distress levels in this sample were lower than in comparable studies, raising questions about openness to reporting distress. Those who reported higher levels of distress were more likely to also report a mental health diagnosis or psychiatric medication. This suggests that an alternate form for distress screening may involve inquiring about mental health treatment. In this sample, younger women and those with higher educational achievement or private health insurance had higher levels of distress. Conversely, there were no relations between distress levels and disease characteristics, indicating that, for example, women with early stage disease have just as much risk of distress as those with later-stage disease.

Association of Adjuvant Therapy with Improved Survival in Ampullary Cancer: A National Cohort Study.

BACKGROUND: There are limited data on the efficacy of adjuvant therapy in ampullary cancer. The aim of this study was to determine whether adjuvant therapy was associated with improved survival for patients with ampullary cancer. METHODS: From the National Cancer Database, we identified ampullary cancer patients who underwent resection between 2004 and 2013. We performed 1:1 propensity score matching, comparing patients who had postoperative observation to patients who received adjuvant chemotherapy (ACT) or adjuvant chemoradiotherapy (ACRT). RESULTS: We identified 4190 patients who fit our inclusion criteria; 63% had postoperative observation, 21% received ACT, and 16% underwent ACRT. In the matched cohorts, the use of ACT was associated with improved overall survival (HR = 0.82, 95% CI = 0.71 to 0.95). The median overall survival was 47.2 months for the ACT group and 35.5 months for the observation group. In a separate matched analysis, ACRT was also associated with improved survival (HR = 0.84, 95% CI = 0.72 to 0.98) as compared to observation. The median overall survival was 38.1 months for the ACRT group and 31.0 months for the observation group. The benefit was more pronounced in high-risk patients, such as ones with higher T and N categories. CONCLUSIONS: In this retrospective study, the use of adjuvant therapy in ampullary cancer was associated with significantly improved overall survival. The benefit of adjuvant therapy for this disease should be confirmed in a more rigorous fashion via randomized controlled trials.

The surgeon-performed ultrasound: a curriculum to improve residents' basic ultrasound knowledge.

BACKGROUND: Despite the development of ultrasound courses by the American College of Surgeons two decades ago, many residencies lack formal ultrasound training. The aim of this study was to assess the previous ultrasound experience of residents and the efficacy of a new ultrasound curriculum by comparing pre- and post-course tests. METHODS: A pre-course survey and test were sent to all residents at the University of Texas Southwestern Medical Center. Pre-interns and junior residents received a didactic lecture on ultrasound basics and the extended focused assessment with sonography for trauma and were given hands-on practice. Finally, a post-course test and survey were sent to the pre-interns and junior residents. RESULTS: Only 11.3% of the residents reported having previous exposure to a formal ultrasound curriculum, and only 12.7% were taught by faculty. On the pre-course test, there was no difference in performance among senior residents, junior residents, and pre-interns (P = 0.114). After taking the course, the pre-interns improved their performance, and their average increased from 44.3% (standard deviation = 12.4%) to 66.1% (standard deviation = 12.2%; P < 0.001). The junior residents also had an improvement in their performance on the test after the course (P < 0.001). Junior residents performed better than pre-interns on the post-course test (P = 0.001). CONCLUSIONS: The knowledge of surgical residents in ultrasound basics and extended focused assessment with sonography for trauma can be improved with the establishment of an ultrasound curriculum. We believe that such an educational endeavor should be encouraged by all surgical residencies.

Transcriptional and Cytokine Profiles Identify CXCL9 as a Biomarker of Disease Activity in Morphea.

IFN-related pathways have not been studied in morphea, and biomarkers are needed. We sought to characterize morphea serum cytokine imbalance and IFN-related gene expression in blood and skin to address this gap by performing a case-control study of 87 participants with morphea and 26 healthy control subjects. We used multiplexed immunoassays to determine serum cytokine concentrations, performed transcriptional profiling of whole blood and lesional morphea skin, and used double-staining immunohistochemistry to determine the cutaneous cellular source of CXCL9. We found that CXCL9 was present at increased concentrations in morphea serum (P < 0.0001), as were other T helper type 1 cytokines. CXCL9 serum concentration correlated with the modified Localized Scleroderma Skin Severity Index (r = 0.44, P = 0.0001), a validated measure of disease activity. CXCL9 gene expression was also increased in inflammatory lesional morphea skin (fold change = 30.6, P = 0.006), and preliminary transcriptional profiling showed little evidence for IFN signature in whole blood. Double-staining immunohistochemistry showed CXCL9 co-localized with CD68+ dermal macrophages. In summary, inflammatory morphea is characterized by T helper type 1 cytokine imbalance in serum, particularly CXCL9, which is associated with disease activity. CXCL9 expression in lesional macrophages implicates the skin as the source of circulating cytokines. CXCL9 is a promising biomarker of disease activity in morphea.