432 results found
Borsci S, Uchegbu I, Buckle P, et al., 2018, Designing medical technology for resilience: integrating health economics and human factors approaches., Expert Rev Med Devices, Vol: 15, Pages: 15-26
INTRODUCTION: The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthcare system and a failure to recognise the need to generate resilient products. Areas covered: Recognising a cross-disciplinary need to enhance evidence generation early in a technology's life cycle, the present paper proposes a new approach that integrates human factors and health economic evaluation as part of a wider systems approach to the design of technology. This approach (Human and Economic Resilience Design for Medical Technology or HERD MedTech) supports early stages of product development and is based on the recent experiences of the National Institute for Health Research London Diagnostic Evidence Co-operative in the UK. Expert commentary: HERD MedTech i) proposes a shift from design for usability to design for resilience, ii) aspires to reduce the need for service adaptation to technological constraints iii) ensures value of innovation at the time of product development, and iv) aims to stimulate discussion around the integration of pre- and post-market methods of assessment of medical technology.
Boshier PR, Fehervari M, Markar SR, et al., 2018, Variation in Exhaled Acetone and Other Ketones in Patients Undergoing Bariatric Surgery: a Prospective Cross-sectional Study., Obes Surg
BACKGROUND: Dietary restriction together with alteration of the gastrointestinal tract results in major metabolic changes and significant weight loss in patients undergoing bariatric surgery. Current methods of measuring these changes are often inaccurate and lack a molecular basis. The objective of this study was to determine the role of exhaled ketones as non-invasive markers of nutritional status in patients undergoing surgical treatment of obesity. METHODS: Patients at different stages of treatment for obesity were recruited to this single-centre cross-sectional study. The sample time points were as follows: (i) at the time of initial attendance prior to dietary or surgical interventions, (ii) on the day of surgery following a low carbohydrate diet, and (iii) > 3 months after either Roux-en-Y gastric bypass or sleeve gastrectomy. The concentrations of ketones within breath samples were analysed by selected ion flow tube mass spectrometry. RESULTS: Forty patients were recruited into each of the three study groups. Exhaled acetone concentrations increased significantly following pre-operative diet (1396 ppb) and bariatric surgery (1693 ppb) compared to the start of treatment (410 ppb, P < 0.0001). In comparison, concentrations of heptanone (6.5 vs. 4.1 vs. 1.4 ppb, P = 0.021) and octanone (3.0 vs. 1.4 vs. 0.7 ppb, P = 0.021) decreased significantly after dieting and surgical intervention. Exhaled acetone (ρ - 0.264, P = 0.005) and octanone (ρ 0.215, P = 0.022) concentrations were observed to correlate with excess body weight at the time of sampling. Acetone and octanone also correlated with neutrophil and triglyceride levels (P < 0.05). CONCLUSION: Findings confirm breath ketones, particularly acetone, to be a potentially clinically useful method of non-invasive nutritional assessment in obese patients.
Doran SLF, Romano A, Hanna GB, 2018, Optimisation of sampling parameters for standardised exhaled breath sampling, JOURNAL OF BREATH RESEARCH, Vol: 12, ISSN: 1752-7155
Garas G, Markar SR, Malietzis G, et al., 2018, Induced Bias Due to Crossover Within Randomized Controlled Trials in Surgical Oncology: A Meta-regression Analysis of Minimally Invasive versus Open Surgery for the Treatment of Gastrointestinal Cancer, ANNALS OF SURGICAL ONCOLOGY, Vol: 25, Pages: 221-230, ISSN: 1068-9265
Jamel S, Markar SR, Malietzis G, et al., 2018, Prognostic significance of peritoneal lavage cytology in staging gastric cancer: systematic review and meta-analysis, GASTRIC CANCER, Vol: 21, Pages: 10-18, ISSN: 1436-3291
Markar SR, Mackenzie H, Jemal S, et al., 2018, Emergency Presentation of Esophagogastric Cancer: Predictors and Long-term Prognosis., Ann Surg, Vol: 267, Pages: 711-715
OBJECTIVE: To identify patient factors that are associated with emergency presentation of esophageal and gastric cancer, and further to evaluate long-term prognosis in this cohort. BACKGROUND: The incidence of emergency presentation is variable, with the prognosis of patients stabilized and discharged to return for elective surgery unknown. METHODS: The primary admission of patients with esophageal or gastric cancer within the Hospital Episode Statistics database (1997-2012) was used to classify as emergency or elective diagnosis. Multivariate regression analyses were used to identify patient factors associated with emergency diagnosis and prognosis. RESULTS: A total of 35,807 (29.4%) and 45,866 (39.6%) patients with esophageal and gastric cancer presented as an emergency over the study period. Age ≥70, female sex, non-white ethnicity, Charlson comorbidity index score ≥3 and more deprived Townsend index were independent predictors of emergency cancer diagnosis. Emergency diagnosis was an independent predictor of increased 5-year mortality for all patients with esophageal cancer [hazard ratio (HR) = 1.63, 95% confidence interval (CI) 1.61-1.65] and gastric cancer (HR = 1.20, 95% CI 1.16-1.23). Specifically patients receiving surgery on an elective follow-up admission with an initial emergency diagnosis had a poorer prognosis (esophageal cancer: HR = 1.35, 95% CI 1.27-1.44, gastric cancer: HR = 1.13. 95% CI 1.04-1.22), with a significant increase in liver recurrence (esophageal cancer: 7.1% vs 4.9%; P < 0.001, gastric cancer: 7.0% vs 4.8%; P < 0.001) compared to patients referred electively. CONCLUSIONS: Emergency presentation of esophageal and gastric cancer is associated with a poor prognosis, due to the increased incidence of metastatic disease at diagnosis and a higher recurrence rate after surgery.
Markar SR, Mackenzie H, Ni M, et al., 2018, The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection, GUT, Vol: 67, Pages: 79-85, ISSN: 0017-5749
Markar SR, Mackenzie H, Wiggins T, et al., 2018, Influence of national centralization of oesophagogastric cancer on management and clinical outcome from emergency upper gastrointestinal conditions, BRITISH JOURNAL OF SURGERY, Vol: 105, Pages: 113-120, ISSN: 0007-1323
Murray AC, Markar S, Mackenzie H, et al., 2018, An observational study of the timing of surgery, use of laparoscopy and outcomes for acute cholecystitis in the USA and UK., Surg Endosc
BACKGROUND: Evidence supports early laparoscopic cholecystectomy for acute cholecystitis. Differences in treatment patterns between the USA and UK, associated outcomes and resource utilization are not well understood. METHODS: In this retrospective, observational study using national administrative data, emergency patients admitted with acute cholecystitis were identified in England (Hospital Episode Statistics 1998-2012) and USA (National Inpatient Sample 1998-2011). Proportions of patients who underwent emergency cholecystectomy, utilization of laparoscopy and associated outcomes including length of stay (LOS) and complications were compared. The effect of delayed treatment on subsequent readmissions was evaluated for England. RESULTS: Patients with a diagnosis of acute cholecystitis totaled 1,191,331 in the USA vs. 288 907 in England. Emergency cholecystectomy was performed in 628,395 (52.7% USA) and 45,299 (15.7% England) over the time period. Laparoscopy was more common in the USA (82.8 vs. 37.9%; p < 0.001). Pre-treatment (1 vs. 2 days; p < 0.001) and total ( 4 vs. 7 days; p < 0.001) LOS was lower in the USA. Overall incidence of bile duct injury was higher in England than the USA (0.83 vs. 0.43%; p < 0.001), but was no different following laparoscopic surgery (0.1%). In England, 40.5% of patients without an immediate cholecystectomy were subsequently readmitted with cholecystitis. An additional 14.5% were admitted for other biliary complications, amounting to 2.7 readmissions per patient in the year following primary admission. CONCLUSION: This study highlights management practices for acute cholecystitis in the USA and England. Despite best evidence, index admission laparoscopic cholecystectomy is performed less in England, which significantly impacts subsequent healthcare utilization.
Penna M, Hompes R, Arnold S, et al., 2018, Incidence and Risk Factors for Anastomotic Failure in 1594 Patients Treated by Transanal Total Mesorectal Excision: Results From the International TaTME Registry., Ann Surg
OBJECTIVE: To determine the incidence of anastomotic-related morbidity following Transanal Total Mesorectal Excision (TaTME) and identify independent risk factors for failure. BACKGROUND: Anastomotic leak and its sequelae are dreaded complications following gastrointestinal surgery. TaTME is a recent technique for rectal resection, which includes novel anastomotic techniques. METHODS: Prospective study of consecutive reconstructed TaTME cases recorded over 30 months in 107 surgical centers across 29 countries. Primary endpoint was "anastomotic failure," defined as a composite endpoint of early or delayed leak, pelvic abscess, anastomotic fistula, chronic sinus, or anastomotic stricture. Multivariate regression analysis performed identifying independent risk factors of anastomotic failure and an observed risk score developed. RESULTS: One thousand five hundred ninety-four cases with anastomotic reconstruction were analyzed; 96.6% performed for cancer. Median anastomotic height from anal verge was 3.0 ± 2.0 cm with stapled techniques accounting for 66.0%. The overall anastomotic failure rate was 15.7%. This included early (7.8%) and delayed leak (2.0%), pelvic abscess (4.7%), anastomotic fistula (0.8%), chronic sinus (0.9%), and anastomotic stricture in 3.6% of cases. Independent risk factors of anastomotic failure were: male sex, obesity, smoking, diabetes mellitus, tumors >25 mm, excessive intraoperative blood loss, manual anastomosis, and prolonged perineal operative time. A scoring system for preoperative risk factors was associated with observed rates of anastomotic failure between 6.3% to 50% based on the cumulative score. CONCLUSIONS: Large tumors in obese, diabetic male patients who smoke have the highest risk of anastomotic failure. Acknowledging such risk factors can guide appropriate consent and clinical decision-making that may reduce anastomotic-related morbidity.
Romano A, Hanna GB, 2018, Identification and quantification of VOCs by Proton Transfer Reaction Time of Flight Mass Spectrometry: an experimental workflow for the optimization of specificity, sensitivity and accuracy., J Mass Spectrom
Proton Transfer Reaction Time of Flight Mass Spectrometry (PTR-ToF-MS) is a direct injection MS technique, allowing for the sensitive and real-time detection, identification and quantification of volatile organic compounds (VOCs). When aiming to employ PTR-ToF-MS for targeted VOC analysis some methodological questions must be addressed, such as the need to correctly identify product ions, or evaluating the quantitation accuracy. This work proposes a workflow for PTR-ToF-MS method development, addressing the main issues affecting the reliable identification and quantification of target compounds. We determined the fragmentation patterns of 13 selected compounds (aldehydes, fatty acids, phenols). Experiments were conducted under breath-relevant conditions (100% humid air), and within an extended range of reduced electric field values (E/N = 48-144 Td), obtained by changing drift tube voltage. Reactivity was inspected using H3O+, NO+and O2+as primary ions. The results show that a relatively low (< 90 Td) E/N often permits to reduce fragmentation enhancing sensitivity and identification capabilities, particularly in the case of aldehydes using NO+, where a 4-fold increase in sensitivity is obtained by means of drift voltage reduction. We developed a novel calibration methodology, relying on diffusion tubes used as gravimetric standards. For each of the tested compounds, it was possible to define suitable conditions whereby experimental error, defined as difference between gravimetric measurements and calculated concentrations, was 8% or lower.
Acharya A, Markar SR, Ni M, et al., 2017, Biomarkers of acute appendicitis: systematic review and cost-benefit trade-off analysis, SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, Vol: 31, Pages: 1022-1031, ISSN: 0930-2794
Antonowicz S, Bodai Z, Wiggins T, et al., 2017, Detoxification loss drives aldehydemetabolic reprogramming and contributes to genotoxicity in oesophageal adenocarcinoma, BRITISH JOURNAL OF SURGERY, Vol: 104, Pages: 46-46, ISSN: 0007-1323
Borsci S, Buckle P, Huddy J, et al., 2017, Usability study of pH strips for nasogastric tube placement, PLOS ONE, Vol: 12, ISSN: 1932-6203
Borsci S, Buckle P, Uchegbu I, et al., 2017, Integrating human factors and health economics to inform the design of medical device: A conceptual framework, Pages: 49-52, ISSN: 1680-0737
© Springer Nature Singapore Pte Ltd. 2018. The reliability and clinical utility of a medical device are required to demonstrate its impact and to enhance its success in the market. To fully establish these attributes it is necessary to investigate the context of use and the needs of the users. In healthcare, there is a growing use of human factors and health economics methods to generate evidence of the potential success of a new device. This requires investigating not only the device itself but also the elements surrounding the technology - e.g., end-users, environment of use, other operators and technologies, etc. Acquiring this information in the early stages of device development is essential. This enables designers to appreciate the operational challenges and barriers that the device will face in real life settings and may enable improved design to better fit with the environment in terms of ease of use, safety and cost effectiveness. Human factors and health economics experts have not traditionally worked together to achieve this. However, both health economists and human factors experts need to understand and map the context of use to develop realistic scenarios for the cost-effectiveness analysis and for usability testing of a new device. This paper presents a new conceptual framework for the integration of human factors and health economics to evaluate new diagnostics devices. The framework is currently under test, and its full implementation represents an ongoing aim of the National Institute for Health Research Diagnostic Evidence Co-operative of London.
Boshier PR, Huddy JR, Zaninotto G, et al., 2017, Dumping syndrome after esophagectomy: a systematic review of the literature, DISEASES OF THE ESOPHAGUS, Vol: 30, ISSN: 1442-2050
Boshier PR, Knaggs AL, Hanna GB, et al., 2017, Perioperative changes in exhaled nitric oxide during oesophagectomy, JOURNAL OF BREATH RESEARCH, Vol: 11, ISSN: 1752-7155
Boshier PR, Ziff C, Adam ME, et al., 2017, Effect of perioperative blood transfusion on the long-term survival of patients undergoing esophagectomy for esophageal cancer: a systematic review and meta-analysis., Dis Esophagus
Perioperative blood transfusion has been linked to poorer long-term survival in patients undergoing esophagectomy, presumably due to its potential immunomodulatory effects. This review aims to summarize existing evidence relating to the influence of blood transfusion on long-term survival following esophagectomy for esophageal cancer. A systematic literature search (up to February 2017) was conducted for studies reporting the effects of perioperative blood transfusion on survival following esophagectomy for esophageal cancer. Meta-analysis was used to summate survival outcomes. Twenty observational studies met the criteria for inclusion. Eighteen of these studies compared the outcomes of patients who received allogenic blood transfusion to patients who did not receive this intervention. Meta-analysis of outcomes revealed that allogenic blood transfusion significantly reduced long-term survival (HR = 1.49; 95% CI 1.26 to 1.76; P < 0.001). There appeared to be a dose-related response with patients who received ≥3 units of blood having lower long-term survival compared to patient who received between 0 and 2 units (HR = 1.59; 95% CI 1.31 to 1.93; P < 0.001). Two studies comparing patients who received allogenic versus autologous blood transfusion showed superior survival in the latter group. Factors associated with the requirement for perioperative blood transfusion included: intraoperative blood loss; preoperative hemoglobin; operative approach; operative time, and; presences of advanced disease. These findings indicate that perioperative blood transfusion is associated with significantly worse long-term survival in patients undergoing esophagectomy for esophageal cancer. Autologous donation of blood, meticulous intraoperative hemostasis, and avoidance of unnecessary transfusions may prevent additional deaths attributed to this intervention.
Bouras G, Markar SR, Burns EM, et al., 2017, The psychological impact of symptoms related to esophagogastric cancer resection presenting in primary care: A national linked database study, EJSO, Vol: 43, Pages: 454-460, ISSN: 0748-7983
Brodie BA, Marker SR, Romano A, et al., 2017, Non-invasive exhaled breath volatile organic compound analysis for the diagnosis of pancreatic cancer, BRITISH JOURNAL OF SURGERY, Vol: 104, Pages: 37-37, ISSN: 0007-1323
El-Osta A, Woringer M, Pizzo E, et al., 2017, Does use of point-of-care testing improve cost-effectiveness of the NHS Health Check programme in the primary care setting? A cost-minimisation analysis, BMJ OPEN, Vol: 7, ISSN: 2044-6055
Faiz O, Hanna GB, 2017, Understanding Administrative Data, ANNALS OF SURGERY, Vol: 265, Pages: E29-E29, ISSN: 0003-4932
Faiz O, Hanna GB, 2017, Understanding Administrative Data., Ann Surg, Vol: 265
Frampton AE, Miller HC, Malczewska A, et al., 2017, MicroRNAs Associated with Small Bowel Neuroendocrine Tumours and Their Metastases, 14th Annual ENETS Conference for the Diagnosis and Treatment of Neuroendocrine Tumor Disease, Publisher: KARGER, Pages: 22-22, ISSN: 0028-3835
Harris-Birtill D, Singh M, Zhou Y, et al., 2017, Gold nanorod reshaping in vitro and in vivo using a continuous wave laser, PLOS ONE, Vol: 12, ISSN: 1932-6203
Markar S, Wiggins T, Antonowicz S, et al., 2017, Breath volatile organic compound analysis for the diagnosis of oesophago-gastric cancer; multi-centre blinded validation clinical trial, ECCO European Cancer Congress, Publisher: ELSEVIER SCI LTD, Pages: S3-S4, ISSN: 0959-8049
Markar SR, Chin S-T, Romano A, et al., 2017, Breath Volatile Organic Compound Profiling of Colorectal Cancer Using Selected Ion Flow-Tube Mass Spectrometry., Ann Surg
OBJECTIVE: BACKGROUND:: Breath VOCs have the potential to noninvasively diagnose cancer. METHODS: Exhaled breath samples were collected using 2-L double-layered Nalophan bags, and were analyzed using selected-ion-flow-tube mass-spectrometry. Gold-standard test for comparison was endoscopy for luminal inspection and computed tomography (CT) to confirm cancer recurrence. Three studies were conducted: RESULTS:: CONCLUSION:: This study suggests the association of a single breath biomarker with the primary presence and recurrence of CRCa. Further multicenter validation studies are required to validate these findings.
Markar SR, Mackenzie H, Askari A, et al., 2017, Effect of Esophageal Cancer Surgeon Volume on Management and Mortality From Emergency Upper Gastrointestinal Conditions Population-based Cohort Study, ANNALS OF SURGERY, Vol: 266, Pages: 847-853, ISSN: 0003-4932
Markar SR, Mackenzie H, Mikhail S, et al., 2017, Surgical resection of hepatic metastases from gastric cancer: outcomes from national series in England, GASTRIC CANCER, Vol: 20, Pages: 379-386, ISSN: 1436-3291
Markar SR, Noordman BJ, Mackenzie H, et al., 2017, Multimodality treatment for esophageal adenocarcinoma: multi-center propensity-score matched study, ANNALS OF ONCOLOGY, Vol: 28, Pages: 519-527, ISSN: 0923-7534
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