bluuebunny/crossref_metadata_2025_split huggingface dataset:
Use of Research Biopsies in Clinical Trials: Are Risks and Benefits Adequately Discussed?
Authors: Overman Michael J. , Modak Janhavi , Kopetz Scott , Murthy Ravi , Yao James C. , Hicks Marshall E. , Abbruzzese James L. , Tam Alda L. 
Published: November 2012

Purpose Although the incorporation of research biopsies into clinical trials is increasing, limited information is available about how study protocols and informed consents integrate and describe their use. Methods All therapeutic clinical trials in which image-guided research biopsies were performed from January 1, 2005, to October 1, 2010, were identified from an interventional radiology database. Data from study protocols and informed consents were extracted and analyzed. Procedural complications were recorded. Results A total of 57 clinical trials were identified, of which 38 (67%) contained at least one mandatory biopsy. The analysis of the research biopsy tumor tissue was a study end point in 95% of trials. The primary indication for a research biopsy was for integral biomarker analysis in 32% and for correlative science in 68% of trials. A statistical analytic plan for the correlative science research biopsy tumor tissue was mentioned in 26%, described as exploratory in 51%, and not mentioned in 23% of trials. For studies with mandatory biopsies, biopsy was an eligibility criterion in 71% of trials, and a statistical justification for the research biopsy sample size was present in 50% of trials. A total of 745 research biopsies were performed on 576 patients. Overall and major complication rates were 5.2% (39 of 745 biopsies) and 0.8% (six of 745 biopsies), respectively. Complication rates for intrathoracic and abdominal/pelvic solid organ biopsies were 17.1% (36 of 211 biopsies) and 1.6% (three of 189 biopsies), respectively. Site-stratified research biopsy–related risks were discussed in five consents. Conclusion A better representation of the risks and benefits of research biopsies in study protocols and informed consents is needed.
Low Hepatitis C Viral Load Predicts Better Long-Term Outcomes in Patients Undergoing Resection of Hepatocellular Carcinoma Irrespective of Serologic Eradication of Hepatitis C Virus
Authors: Shindoh Junichi , Hasegawa Kiyoshi , Matsuyama Yutaka , Inoue Yosuke , Ishizawa Takeaki , Aoki Taku , Sakamoto Yoshihiro , Sugawara Yasuhiko , Makuuchi Masatoshi , Kokudo Norihiro 
Published: November 2012

Purpose Hepatitis C virus (HCV) infection has been recognized as a potent risk factor for the postoperative recurrence of hepatocellular carcinoma (HCC). However, little is known about the impact of HCV viral load on surgical outcomes. The study objective was to investigate clinical significance of HCV viral load on long-term outcomes of HCC. Patients and Methods Three hundred seventy patients who were classified as Child-Pugh class A and underwent curative liver resections for HCV-related HCC were divided into low and high viral load groups (≤ or > 5.3 log10IU/mL) based on the results of a minimum P value approach to predict moderate to severe activity of hepatitis; the clinical outcomes were then compared. Results The 5-year recurrence-free survival rate was 36.1% in the low viral load group and 12.4% in the high viral load group (P < .001). The 5-year overall survival rate was 76.6% in the low viral load group and 57.7% in the high viral load group (P < .001). Multivariate analysis confirmed significant correlation between high viral load and tumor recurrence with a hazard ratio of 1.87 (95% CI, 1.41 to 2.48; P < .001). Subanalysis revealed that the favorable results in the low viral load group were not attributed to whether or not serologic eradication of HCV was obtained both in primary and recurrent lesions. Conclusion Low HCV viral load predicts better long-term surgical outcomes in patients with HCC regardless of the serologic eradication of HCV.
Bortezomib Added to Daunorubicin and Cytarabine During Induction Therapy and to Intermediate-Dose Cytarabine for Consolidation in Patients With Previously Untreated Acute Myeloid Leukemia Age 60 to 75 Years: CALGB (Alliance) Study 10502
Authors: Attar Eyal C. , Johnson Jeffrey L. , Amrein Philip C. , Lozanski Gerard , Wadleigh Martha , DeAngelo Daniel J. , Kolitz Jonathan E. , Powell Bayard L. , Voorhees Peter , Wang Eunice S. , Blum William , Stone Richard M. , Marcucci Guido , Bloomfield Clara D. , Moser Barry , Larson Richard A. 
Published: November 2012

Purpose The purpose of this study was to determine remission induction frequency when bortezomib was combined with daunorubicin and cytarabine in previously untreated older adults with acute myeloid leukemia (AML) and safety of bortezomib in combination with consolidation chemotherapy consisting of intermediate-dose cytarabine (Int-DAC). Patients and Methods Ninety-five adults (age 60 to 75 years; median, 67 years) with previously untreated AML (including therapy-related and previous myelodysplastic syndrome) received bortezomib 1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11 with daunorubicin 60 mg/m2 on days 1 through 3 and cytarabine 100 mg/m2 by continuous IV infusion on days 1 through 7. Patients who achieved complete remission (CR) received up to two courses of consolidation chemotherapy with cytarabine 2 gm/m2 on days 1 through 5 with bortezomib. Three cohorts with escalating dose levels of bortezomib were tested (0.7, 1.0, and 1.3 mg/m2). Dose-limiting toxicities were assessed during the first cycle of consolidation. The relationship between cell surface expression of CD74 and clinical outcome was assessed. Results Frequency of CR was 65% (62 of 95), and 4% of patients (four of 95) achieved CR with incomplete platelet recovery (CRp). Eleven patients developed grade 3 sensory neuropathy. Bortezomib plus Int-DAC proved tolerable at the highest dose tested. Lower CD74 expression was associated with CR/CRp (P = .04) but not with disease-free or overall survival. Conclusion The addition of bortezomib to standard 3 + 7 daunorubicin and cytarabine induction chemotherapy for AML resulted in an encouraging remission rate. The maximum tested dose of bortezomib administered in combination with Int-DAC for remission consolidation was 1.3 mg/m2 and proved tolerable. Further testing of this regimen is planned.
The relative effects of fat versus muscle mass on cystatin C and estimates of renal function in healthy young men
Authors: Chew-Harris Janice S C , Florkowski Christopher M , George Peter M , Elmslie Jane L , Endre Zoltan H 
Published: November 2012

Background It is well known that plasma creatinine concentration is affected by muscle mass, while some studies have suggested cystatin C is affected by body mass index (BMI). Our aim was to assess the effects of lean versus fat mass on cystatin C and creatinine derivative equations in estimating glomerular filtration rate (GFR) in healthy young men. Methods Three groups of participants were studied: those classified as normal (BMI 18-25 kg/m 2 with body fat, 30%); muscular subjects (BMI .30 kg/m 2 and body fat, 20%); and obese subjects (BMI .30 kg/m 2 and body fat .30%). All underwent diethylenetriamine pentaacetic acid GFR, bio-electrical impedance and dual-energy X-ray absorptiometry body composition analysis, measurement of plasma cystatin C, creatinine and high-sensitivity C-reactive protein and completed a diet record. Results Cystatin C was highest in the obese group (0.77 mg/L; 95% confidence intervals [CI] 0.69-0.77) and creatinine was highest in the muscular group (90.1 μmol/L; 95% CI 84.3-96.0). On multivariate analysis, body fat and GFR (P = 0.003) were significant determinants of cystatin C; muscle mass and age affected creatinine significantly (P = 0.02). Using cystatin C equations, Le Bricon and Hoek showed significantly lower estimated GFR in the obese group but performed reasonably well within 50%, 30% and 20% of GFR. Creatinine equations showed significant underestimations of GFR for the muscular group. Conclusions Body fat is a significant determinant of cystatin C while creatinine concentration is highly affected by muscle mass and age. Body composition plays an important role in the interpretation of renal function. Cystatin C equations are still accurate in predicting GFR in our healthy male group without chronic kidney disease.
Between-assay variability of faecal calprotectin enzyme-linked immunosorbent assay kits
Authors: Whitehead S J , French J , Brookes M J , Ford C , Gama R 
Published: November 2012

Background Faecal calprotectin (f-Cp), a marker of intestinal inflammation, can be used to distinguish between functional and organic bowel disease. F-Cp, following extraction, is commonly quantified using enzyme-linked immunosorbent assays (ELISAs) but there are no data comparing the different f-Cp assays or sample extraction devices. We, therefore, evaluated and compared the performance of the Immunodiagnostik, Bühlmann and Eurospital f-Cp ELISA assays as well as the Roche, Immunodiagnostik and ScheBo Biotech commercial faecal extraction devices. We also briefly report results from a pilot f-Cp external quality assurance (EQA) scheme. Methods Imprecision, linearity, recovery, drift and limit of quantitation of the f-Cp assays were evaluated and between-assay variability assessed. The three commercial sample extraction devices were compared with the manual weighing method. Four faecal samples were distributed as part of a pilot EQA scheme to 15 laboratories using quantitative ELISA f-Cp assays. Results The three f-Cp assays demonstrated adequate intra-/interbatch imprecision, linearity and recovery. The crosscomparison study and EQA data demonstrated that, for the same sample, the Bühlmann assay reports up to 3.8 times higher f-Cp concentrations than the Immunodiagnostik and Eurospital assays. On average, the commercial extraction devices led to a 7.8-28.1% under-recovery of f-Cp in comparison to the manual weighing method. Conclusions Laboratories should be aware of the lack of the assay standardization, as demonstrated by the between-assay variability. A comparison between f-Cp concentrations reported by these assays and clinical markers of disease severity is required in order to determine their diagnostic accuracy. The EQA scheme represents the first available programme for f-Cp.
Crowdsourcing New Product Ideas over Time: An Analysis of the Dell IdeaStorm Community
Authors: Bayus Barry L. 
Published: November 2012

Several organizations have developed ongoing crowdsourcing communities that repeatedly collect ideas for new products and services from a large, dispersed “crowd” of nonexperts (consumers) over time. Despite its promises, little is known about the nature of an individual's ideation efforts in such an online community. Studying Dell's IdeaStorm community, serial ideators are found to be more likely than consumers with only one idea to generate an idea the organization finds valuable enough to implement, but they are unlikely to repeat their early success once their ideas are implemented. As ideators with past success attempt to again come up with ideas that will excite the organization, they instead end up proposing ideas similar to their ideas that were already implemented (i.e., they generate less diverse ideas). The negative effects of past success are somewhat mitigated for ideators with diverse commenting activity on others' ideas. These findings highlight some of the challenges in maintaining an ongoing supply of quality ideas from the crowd over time. This paper was accepted by Kamalini Ramdas, entrepreneurship and innovation.
Tiers in One-Sided Matching Markets: Theory and Experimental Investigation
Authors: Wang Yu , Haruvy Ernan 
Published: November 2012

The design of a matching market may affect behavior in prematch stages. In some settings, forward-looking agents might purchase low-priced properties with the intention of trading up. From a design standpoint, such behavior is undesirable. We investigate a tiered structure as a potential solution. Using a model that endogenizes prematch acquisition decisions, we show that tiers promote exchange while protecting the primary market. In the laboratory, we find that both firm revenue and total social surplus are improved by tiered matching, and the amount of improvement depends on the exchange mechanism the firm uses. We focus on two popular mechanisms—deposit first and request first. We find that subjects are less likely to take advantage of the match under tier-free deposit first mechanism, possibly because of risk aversion. Thus, a tiered approach is more critical under the request first mechanism. We confirm that risk aversion partly explains deviations from theory. This paper was accepted by Uri Gneezy, behavioral economics.
Questionable safety of thyroid surgery with same day discharge
Authors: Doran HE , England J , Palazzo F 
Published: November 2012

INTRODUCTION Over the last two decades increasing numbers of surgical procedures have been performed on an outpatient basis. In 2000 the National Health Service in England set the target of performing 75% or more of all elective surgical procedures as day cases and in 2001 the British Association of Day Surgery added thyroidectomy to the list of day case procedures. However, same day discharge following thyroidectomies has been adopted by only a very small number of UK centres. The aim of this review was to establish the evidence base surrounding same day discharge thyroid surgery. METHODS The British Association of Endocrine and Thyroid Surgeons commissioned the authors to perform a review of the best available evidence regarding day case thyroid surgery as a part of a consensus position to be adopted by the organisation. A MEDLINE® review of the English medical literature was performed and the relevant articles were collated and reviewed. RESULTS There are limited comparative data on day case thyroid surgery. It is feasible and may save individual hospitals the cost of inpatient stay. However, the risk of airway compromising and life threatening post-operative bleeding remains a major concern since it is not possible to positively identify those patients most and least at risk of bleeding after thyroidectomy. It is estimated that half of all post-thyroidectomy bleeds would occur outside of the hospital environment if patients were discharged six hours after surgery. CONCLUSIONS Same day discharge in a UK setting cannot be endorsed. Any financial benefits may be outweighed by the exposure of patients to an increased risk of an adverse outcome. Consequently, 23-hour surgery is recommended.
Safe percutaneous suprapubic catheterisation
Authors: Goyal NK , Goel A , Sankhwar SN 
Published: November 2012

INTRODUCTION We describe our technique of percutaneous suprapubic catheter insertion with special reference to steps that help to avoid common complications of haematuria and catheter misplacement. METHODS The procedure is performed using a stainless steel reusable trocar under local infiltrative anaesthesia, usually at the bedside. After clinical confirmation of a full bladder, the trocar is advanced into the bladder through a skin incision. Once the bladder is entered, the obturator is removed and the assistant inserts a Foley catheter followed by rapid balloon inflation. Slight traction is applied to the catheter for about five minutes. Patients with previous lower abdominal surgery, an inadequately distended bladder or acute pelvic trauma do not undergo suprapubic catheterisation using this method. RESULTS The procedure was performed in 72 men (mean age: 42.4 years, range: 18–78 years) with urinary retention with a palpable bladder. The average duration of the procedure was less than five minutes. No complications were noted in any of the patients. CONCLUSIONS Trocar suprapubic catheter insertion is a safe and effective bedside procedure for emergency bladder drainage and can be performed by resident surgeons. The common complications associated with the procedure can be avoided with a few careful steps.
Abdominal compartment syndrome caused by tension pneumoperitoneum in a scuba diver
Authors: Bunni J , Bryson PJ , Higgs SM 
Published: November 2012

Abdominal compartment syndrome is a surgical emergency caused by a raised intra-abdominal pressure, which may lead to respiratory, cardiovascular and renal compromise. It is most commonly seen in post-operative and trauma patients and it has a variety of causes. Tension pneumoperitoneum (TP) is a rare cause of abdominal compartment syndrome most often seen after gastrointestinal endoscopy with perforation. We present the case of a fit 52-year-old experienced female diver who developed TP and shock following a routine training dive to 27m. Following accidental inhalation of water, she had an unstaged ascent and, on reaching the surface, developed severe acute abdominal pain and distension. She was brought to our emergency department by air ambulance for assessment. Clinical and radiological examination revealed a shocked patient with dramatic free intra-abdominal gas and signs of abdominal compartment syndrome, which was treated with needle decompression. Symptoms and signs resolved quickly with no need for further surgical intervention. TP is a surgical emergency where surgery can be avoided with prompt diagnosis and treatment.
How safe is diathermy in patients with cochlear implants?
Authors: Frampton SJ , Ismail-Koch H , Mitchell TE 
Published: November 2012

INTRODUCTION Cochlear implants are surgically inserted electrical devices that enable severely or profoundly deaf individuals to interpret sounds from their environment and communicate more effectively. As a result of their electrical nature, they are susceptible to electromagnetic interference and can be damaged by excessive electrical energy. Surgical diathermy is one source of such potentially damaging energy. The British Cochlear Implant Group guidelines advise that monopolar diathermy should not be used in the head and neck region in patients with cochlear implants and that bipolar diathermy should not be used within 2cm of the implant ( http://www.bcig.org.uk/site/public/current/safety.htm ). METHODS A questionnaire was provided to 36 surgeons working in different specialties in the head and neck region, inquiring as to their knowledge of the safety considerations when using diathermy in cochlear implant patients. Thirty-five surgeons provided responses. RESULTS Overall, 77% of the respondents were unaware of the existence of published guidelines. Even when given an option to seek advice, 11% erroneously felt it was safe to use monopolar diathermy above the clavicles with a cochlear implant in situ and 49% felt that there was no restriction on the use of bipolar diathermy. CONCLUSIONS There is a significant deficit in the knowledge of safe operating practice in the rapidly expanding population of patients with cochlear implants which threatens patient safety. Through this publication we aim to increase awareness of these guidelines among members of the surgical community and this paper is intended to act as a point of reference to link through to the published safety guidelines.
Safety and efficacy of percutaneous nephrolithotomy for the treatment of paediatric urolithiasis
Authors: Veeratterapillay R , Shaw MBK , Williams R , Haslam P , Lall A , De la Hunt M , Hasan ST , Thomas DJ 
Published: November 2012

INTRODUCTION Paediatric percutaneous nephrolithotomy (PCNL) has revolutionised the treatment of paediatric nephrolithiasis. Paediatric PCNL has been performed using both adult and paediatric instruments. Stone clearance rates and complications vary according to the technique used and surgeon experience. We present our experience with PCNL using adult instruments and a 28Fr access tract for large renal calculi in children under 18 years. METHODS All patients undergoing PCNL at our institution between 2000 and 2009 were reviewed. Demographics, surgical details and post-operative follow-up information were obtained to identify stone clearance rates and complications. RESULTS PCNL was performed in 32 renal units in 31 patients (mean age: 10.8 years). The mean stone diameter was 19mm (range: 5–40mm). Twenty-six cases required single puncture and six required multiple tracts. Overall, 11 staghorn stones, 10 multiple calyceal stones and 11 single stones were treated. Twenty-seven patients (84%) were completely stone free following initial PCNL. Two cases had extracorporeal shock wave lithotripsy for residual fragments, giving an overall stone free rate of 91% following treatment. There was no significant bleeding or sepsis encountered either during the operation or in the post-operative setting. No patient required or received a blood transfusion. CONCLUSIONS Paediatric PCNL can be performed safely with minimal morbidity using adult instruments for large stone burden, enabling rapid and complete stone clearance.
Ectopic Cushing’s syndrome due to a mesenteric neuroendocrine tumour
Authors: Mashoori N , Rabani AH , Kazemeini AR 
Published: November 2012

INTRODUCTION Neuroendocrine tumours (NETs) are tumours that commonly involve the gastrointestinal system. Common primary sites in the gastrointestinal system include the small intestine, appendix, rectum and pancreas. Mesenteric NETs are extremely rare entities and are sparsely reported in the literature. CASE HISTORY We report the case of a 62-year-old woman with ectopic Cushing’s syndrome due to excessive adrenocorticotropic hormone secretion by a primary mesenteric tumour in the small intestine and its liver metastases. CONCLUSIONS Although rare, the mesentery can be a primary site for NETs. It can cause similar symptoms and require similar treatment options. Tumour resection and debulking are acceptable ways to improve both the survival and symptoms.
Management of colorectal polyp cancers
Authors: Naqvi S , Burroughs S , Chave HS , Branagan G 
Published: November 2012

INTRODUCTION Management of malignant colorectal polyps is controversial. The options are resection or surveillance. Resection margin status is accepted as an independent predictor of adverse outcome. However, the rate of adverse outcome in polyps with a resection margin of <1mm has not been investigated. METHODS A retrospective search of the pathology database was undertaken. All polyp cancers were included. A single histopathologist reviewed all of the included polyp cancers. Polyps were divided into three groups: clear resection margin, involved resection margin and unknown resection margin. Polyps were also analysed for tumour grade, morphology, Haggitt/Kikuchi level and lymphovascular invasion. Adverse outcome was defined as residual tumour at the polypectomy site and/or lymph node metastases in the surgical group and local or distant recurrence in the surveillance group. RESULTS Sixty-five polyps (34 male patients, mean age: 73 years, range: 50–94 years) were included. Forty-six had clear polyp resection margins; none had any adverse outcomes. Sixteen patients had involved polyp resection margins and twelve of these underwent surgery: seven had residual tumour and two of these patients had lymph node metastases. Four underwent surveillance, of whom two developed local recurrence. Three patients had resection margins on which the histopathologist was unable to comment. All patients with a clear resection margin had no adverse outcome regardless of other predictive factors. CONCLUSIONS Polyp cancers with clear resection margins, even those with <1mm clearance, can be treated safely with surveillance in our experience. Polyp cancers with unknown or involved resection margins should be treated surgically.