Surgical complication outcome (SCOUT) score: A new method to evaluate quality of care in vascular surgery

Purpose: Surgical outcome data are generally reported as raw morbidity and mortality rates, which do not necessarily reflect quality of surgical care. The Society for Vascular Surgery has led this area with recommendations by the Ad Hoc Committee on Reporting Standards to establish standardized methods of outcome assessment in vascular surgery. The purpose of this study was to evaluate a new method for evaluating the overall quality of surgical care, which includes surgeon, nursing, and hospital system performance. The goal of the method is to identify problem areas in surgical practice that can be targeted for focused improvement to improve outcome.Methods: A database of more than 9000 general and vascular surgical cases was compiled over a 3-year period. Every postoperative complication was tabulated prospectively by a surgical nurse on a daily basis. Fifty clinically significant complication types specific for vascular surgery patients were identified from a list of 151 postoperative events by a panel of vascular surgeons and were grouped into nine broad categories (vascular, cardiac, pulmonary, etc.). These complications reflect the entire continuum of postoperative care, including surgeon, nursing, and hospital system performance. Each complication type was further stratified into four grades (mild, moderate, severe, death) and assigned a SCOUT severity score from 0 to 100 (0, no complication; 100, death) by the panel of surgeons. For ease of data collection and monitoring of outcome, a software program was developed to run on a laptop computer and includes medical history, risk factors, pertinent laboratory data, and the preassigned SCOUT severity scores for measuring outcome. In this study, 170 major vascular procedures performed over the previous 12-month period were prospectively evaluated using the SCOUT method in an attempt to more easily identify problem areas of practice. In-hospital morbidity and 30-day mortality results were examined.Results: One hundred sixteen postoperative complications were identified in the 170 patients, with an overall morbidity rate of 51% and a 30-day mortality rate of 1.8%. Fifty-three percent of the complications were “mild” and required minimal intervention or observation only. Abdominal aortic aneurysm repair was associated with the highest morbidity rate (mean SCOUT score, 384.35), whereas distal extremity bypass grafting had the lowest morbidity rate (mean SCOUT score, 114.4). However, subgroup analysis demonstrated that cardiac events accounted for 52% of the morbidity associated with distal extremity bypass but only 34.7% of the morbidity associated with abdominal aortic aneurysm repair (p < 0.05).Conclusions: The SCOUT score is a new technical quality of care measure that can objectively quantify surgeon and other hospital system–related performance. The SCOUT score allows the surgeon to identify problem areas that can then be targeted for improvement to positively affect outcome. (J Vasc Surg 1997;25:1007-15.)     

Safety and efficacy of the combination of nivolumab plus ipilimumab in patients with melanoma and asymptomatic or symptomatic brain metastases (CheckMate 204)

BackgroundIn patients with melanoma and asymptomatic brain metastases (MBM), nivolumab plus ipilimumab provided an intracranial response rate of 55%. Here, we present the first report for patients who were symptomatic and/or required corticosteroids and updated data for asymptomatic patients.MethodsPatients with measurable MBM, 0.5-3.0 cm, were enrolled into Cohort A (asymptomatic) or Cohort B (stable neurologic symptoms and/or receiving corticosteroids). Nivolumab, 1 mg/kg, and ipilimumab, 3 mg/kg, were given intravenously every 3 weeks ×4, followed by nivolumab, 3 mg/kg, every 2 weeks until progression, unacceptable toxicity, or 24 months. The primary endpoint was intracranial clinical benefit rate (CBR; complete response [CR], partial response [PR], or stable disease ≥6 months).ResultsSymptomatic patients (N = 18) received a median of one nivolumab and ipilimumab combination dose and had an intracranial CBR of 22.2%. Two of 12 patients on corticosteroids had CR; 2 responded among the 6 not on corticosteroids. Median intracranial progression-free survival (PFS) and overall survival (OS) were 1.2 and 8.7 months, respectively. In contrast, with 20.6 months of follow-up, we confirmed an intracranial CBR of 58.4% in asymptomatic patients (N = 101); median duration of response, PFS, and OS were not reached. No new safety signals were observed.ConclusionsNivolumab plus ipilimumab provides durable clinical benefit for asymptomatic patients with MBM and should be considered for first-line therapy. This regimen has limited activity in MBM patients with neurologic symptoms and/or requiring corticosteroids, supporting the need for alternative approaches and methods to reduce the dependency on corticosteroids. Clinical trial registration. ClinicalTrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT02320058","term_id":"NCT02320058"}}NCT02320058.     

Leptin in relation to carcinoma In situ of the breast: A study of pre‐menopausal cases and controls

Leptin reflects the amount of energy stores, regulates energy balance and is associated with circulating levels of reproductive hormones and insulin‐like growth factor‐I (IGF‐I). Breast cancer has also been associated with obesity, reproductive hormones and circulating IGF‐I levels. To determine whether leptin is involved in the etiology of breast cancer, we compared serum leptin levels in 83 cases of pre‐menopausal carcinoma in situ of the breast and 69 healthy controls recruited in Massachusetts. Serum leptin levels were 13.69 + 1.3 ng/ml in cases and 16.03 + 1.7 ng/ml in controls. Data were also analyzed using multiple logistic regression with adjustment for known risk factors for the development of breast cancer as well as anthropometric, demographic and hormonal variables, including estradiol, prolactin, IGF‐I and IGF‐binding protein‐3. Odds ratios were 1.75 (95% CI, 0.73–4.21) for the second control‐defined tertile and 1.54 (0.46–5.16 ) for the third control‐defined tertile relative to the first. Thus, leptin does not appear to increase the risk of pre‐menopausal breast cancer in situ substantially. Int. J. Cancer 80:523–526, 1999. © 1999 Wiley‐Liss, Inc.     

Different effects of chronic THC on the neuroadaptive response of dopamine D2/3 receptor‐mediated signaling in roman high‐ and roman low‐avoidance rats

The Roman high (RHA)‐ and low (RLA)‐avoidance rat sublines have been identified as an addiction‐prone and addiction‐resistant phenotype based on their high vs. low locomotor responsiveness to novelty and high vs. low ability to develop neurochemical and behavioral sensitization to psychostimulants, respectively. Most studies though have focused on psychostimulants and little is known about the neuroadaptive response of these two lines to cannabinoids. This study investigated the effects of chronic exposure to Δ⁹‐tetrahydrocannabinol (THC) on dopamine D_2/3 receptor (D_2/3R) availabilities and functional sensitivity in the mesostriatal system of RHA and RLA rats. At baseline, RLA rats exhibited higher densities of mesostriatal D2/3R but lower levels of striatal CB₁R mRNA and displayed a lower locomotor response to acute THC as compared to RHAs. Following chronic THC treatment, striking changes in D_2/3R signaling were observed in RLA but not in RHA rats, namely an increased availability and functional supersensitivity of striatal D_2/3R, as evidenced by a supersensitive psychomotor response to the D_2/3R agonist quinpirole. Moreover, in RLA rats, the lower was the locomotor response to acute THC, the higher was the psychomotor response to quinpirole following chronic THC. These results showing a greater neuroadaptive response of RLA vs. RHA rats to chronic THC thus contrast with previous studies showing a resistance to neuroadaptive response of RLAs to psychostimulants, This suggests that, contrasting with their low proneness to psychostimulant drug‐seeking, RLAs may exhibit a heightened proneness to cannabinoid drug‐seeking as compared to RHA rats.     

Low to moderate lifetime alcohol consumption is associated with less advanced stages of fibrosis in non-alcoholic fatty liver disease

Background and aim: Moderate alcohol consumption has been associated with a lower risk of disease severity in non-alcoholic fatty liver disease (NAFLD). It is unclear if this reflects current or lifetime drinking, or can be attributed to confounders such as diet and exercise. We evaluated the impact of lifetime alcohol consumption on fibrosis severity in NAFLD.

Methods: We prospectively enrolled 120 subjects with biopsy-proven NAFLD and through detailed questionnaires examined lifetime alcohol consumption, diet and physical activity. Main outcome measures were odds ratios (OR) for fibrosis stage, calculated through ordinal regression after adjustment for body mass index, diabetes mellitus type 2, smoking and age at biopsy. A biomarker for recent alcohol consumption, phosphatidyl ethanol (PEth) was sampled.

Results: An increase in median weekly alcohol consumption to a maximum of 13 drinks per week was associated with lower fibrosis stage (adjusted OR for each incremental unit, 0.86; 95% CI, 0.76–0.97; p?=?.017). The lowest risk for fibrosis was found with the lowes`t odds seen in the top quartile of alcohol consumption (aOR 0.23; 95% CI 0.08–0.66; p?=?.006). Adding soft drink and coffee consumptions, and physical activity to the model did not change the estimates. Subjects with PEth ≥0.3?μmol/L had higher ORs for a higher fibrosis stage (aOR 2.77; 95% CI 1.01–7.59; p?=?.047).

Conclusion: Lifetime alcohol consumption with up to 13 units per week is associated with lower fibrosis stage in NAFLD. Elevated PEth is associated with higher stages of fibrosis.     

Prolonged anti-resorptive activity of zoledronic acid: evidence from postmenopausal osteopenic women and patients with Paget’s disease of bone

Clinical Rheumatology -     

Serum total adiponectin in nonalcoholic fatty liver disease: a systematic review and meta-analysis

Hypoadiponectinemia might represent a risk factor for nonalcoholic fatty liver disease (NAFLD). We performed a systematic review and meta-analysis to evaluate the serum total adiponectin levels in patients with simple nonalcoholic fatty liver (NAFL), those with nonalcoholic steatohepatitis (NASH), and controls. Data were extracted from PubMed, EMBASE, and Cochrane Central Register of Controlled Trials electronic databases (up to December 2009). The main outcome was the weighted mean differences (WMDs) in adiponectin between comparison groups. Twenty-eight studies were included in the systematic review. A meta-analysis of 27 studies that reported data on 2243 subjects (698 controls and 1545 patients with NAFLD) was performed. Controls had higher serum adiponectin compared with NAFL patients (12 studies, random-effects WMD [95% confidence interval {CI}] = 3.00 [1.57-4.43], I² = 80.4%) or NASH patients (19 studies, random-effects WMD [95% CI] = 4.75 [3.71-5.78], I² = 84.1%). The NASH patients demonstrated lower adiponectin compared with NAFL patients (19 studies, random-effects WMD [95% CI] = 1.81 [1.09-2.53], I² = 71.7%). By performing a meta-regression analysis, body mass index, age, sex, and type 2 diabetes mellitus failed to account for heterogeneity. However, the performance of liver biopsy on controls had significant effect on the outcome and accounted for 76.7%, 85.5%, and 22.8% of the between-study variance for comparisons between controls vs NAFLD, NAFL, and NASH patients, respectively. Based on liver histology, serum adiponectin levels are similar in NAFL patients and controls, but hypoadiponectinemia may play an important pathophysiological role in the progression from NAFL to NASH.