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Evidence-based medicine has attracted huge interest over the last eleven years in the UK. Various groups within the health care 'industry' have taken it up with great enthusiasm, often because they see in it a means of furthering a personal, political or factional agenda. It has been seized by health care purchasers and hospital management as a means of resisting pressure for expenditure, some groups of doctors in competition with others for patients or resources and enthusiasts for particular treatments. Conversely, there are many who have dismissed it as a fad, or a 'rebranding' of established principles of medical education and professional development, and who claim that they have been practising it all their working lives. Because of the number of different agendas for which it has proved a useful slogan, it is common to find doctors who are confused as to what evidence-based medicine is, or sceptical as to whether the phrase has real meaning. \u00a9 2006 Elsevier Ltd. All rights reserved.
\n \n\n \n \nSurgery remains the mainstay of treatment with curative intent for established gastric cancer. Patient selection is critical to achieving satisfactory outcomes, and involves careful assessment of both patient fitness and disease stage. Staging techniques have multiplied and become much more sensitive in recent years. Current best practice involves a combination of spiral CT scan, Endoscopic ultrasound, PET scanning and laparoscopy. Only a minority of patients progress to potentially curative surgery after staging and fitness assessment in Western centres. Conventional treatment involves a distal subtotal gastrectomy or total gastrectomy depending on the site of the lesion. Innovative techniques include the Merendino operation, and pylorus and nerve sparing gastrectomies for earlier stage disease in the proximal and distal stomach, respectively. There is evidence of nutritional and quality of life benefit in the first 2 years after surgery from formation of a gastric substitute reservoir. Laparoscopic resection is well established in Japan and is developing rapidly elsewhere but its role and outcomes are not yet well defined. Radical lymph node dissection remains controversial: randomised trial evidence of overall benefit is lacking, but expert series have produced excellent results, and there are indications of a sub-group benefit for patients with stage II and III disease. The increased morbidity and mortality associated with radical dissection appear to be largely attributable to pancreatic and splenic resection together with limitations in Unit expertise. Surgical palliation has become less important in recent years as interventional radiology and endoscopy techniques have been developed for the same purposes. Overall mortality and survival results have improved dramatically over the last 20 years, but interpretation of these figures is made difficult by major changes in staging and case selection. The chances of long-term survival are, however, clearly much greater, and those of peri-operative death much less for an individual patient accepted for surgery in 2006 than they would have been in 1986.
\n \n\n \n \nPURPOSE OF REVIEW: Improvements in safety and quality benefit from a systems approach. Human factors is the study and practice of the relationship between humans and systems. This review examines recent advances in human factors in healthcare. RECENT FINDINGS: Early studies focused on understanding incidents, and on the translation of principles from aviation to healthcare, which demonstrated a useful but limited application of the human factors approach. More recent studies have begun to address the complexity of the relationship between human behaviour and technology, tasks, environment and organization. Human factors frameworks have been usefully applied that aid in these complex considerations, providing a better understanding of the healthcare system, and a much broader range of solutions to problems than checklists, protocols or training. In particular, in improving equipment design and procurement; improving job design by understanding the demands and tasks of individual healthcare practitioners; in improving what and when training is delivered; and the integration of these complex system components into a coherent whole. SUMMARY: The human factors approach is not yet mature in healthcare, but the importance is being increasingly recognized, and the breadth of application continually expanded.
\n \n\n \n \nOBJECTIVE: To evaluate patient safety in an emergency surgical unit using process and outcome measures in parallel. BACKGROUND: Patient harm from errors in care is common in modern surgical practice. Measurement of the problem is essential to any solution, but current methods of evaluating patient harm are either impractical or inadequate. We have therefore analyzed compliance with safety-relevant care processes, with the aim of developing a process-based system for evaluating ward safety. METHODS: Adverse events (AE), potential adverse events (PAE), and 7 safety-relevant processes were measured on a 38-bed surgical emergency unit over a 16-week period. AE, PAE, and process measures were studied by prospective direct observation in large convenience samples, using objective measures. Possible influences on AE and PAE risk were analyzed. RESULTS: Compliance with the 7 processes studied ranged from 23% to 89%. The AE and PAE rates were 11.9% and 13.8% in a 63% sample of admissions (n = 607). Length of stay was significantly associated with both AE (P < 0.001) and PAE (P < 0.001). Having an operation was also associated with AE (P = 0.001) but not with PAE. No other factors appeared to influence AE/PAE rates. Delays were the commonest causes of both AE and PAE. CONCLUSIONS: Compliance with individual care processes on a ward with average levels of patient harm is poor. Length of hospital stay increases the risk of both AE and PAE, suggesting a system defect. A bundle of care processes may be useful for monitoring safety improvement.
\n \n\n \n \nBACKGROUND: This article reviews the evidence on the safety and efficacy of minimally invasive surgery for gastric and oesophageal cancer. METHODS: An electronic search of the literature between 1997 and 2007 was undertaken to identify primary studies and systematic reviews; studies were retrieved and analysed using predetermined criteria. Information on the safety and efficacy of minimally invasive surgery for gastric and oesophageal cancer was recorded and analysed. RESULTS: From 188 abstracts reviewed, 46 eligible studies were identified, 23 on oesophagectomy and 23 on gastrectomy. There were 35 case series, eight case-matched studies and three randomized controlled trials. Compared with the contemporary results of open surgery, reports on minimally invasive surgery indicate potentially favourable outcomes in terms of operative blood loss, recovery of gastrointestinal function and hospital stay. However, the quality of the data was generally poor, with many potential sources of bias. CONCLUSION: Minimally invasive surgery is feasible but evidence of benefit is currently weak.
\n \n\n \n \nBACKGROUND: Surgeons have a reputation for decisiveness and self-confidence, which suggests that they may tolerate uncertainty poorly and therefore be less capable than other doctors of experiencing clinical equipoise. Their 'typical' behaviour is characteristic of the stable extrovert personality and so they may prefer spontaneous clinical judgement over randomized trials. The aim of this study was to compare personality dimensions and tolerance of uncertainty among surgeons and hospital physicians, to determine whether differences in either property might help to explain the apparently poor performance of surgeons in conducting randomized controlled trials. METHODS: This was a postal questionnaire study of 1000 consultant general surgeons and 1000 consultant physicians. Respondents completed a short self-assessment of Eysenck personality dimensions, Budner's Intolerance of Ambiguity scale and a short questionnaire about attitudes to randomized trials. Correlation and multiple regression analyses were performed. RESULTS: The response rate was 36.5 per cent. Physicians were more likely to be women (P < 0.001) and had spent 1 more year in academic posts than surgeons (P < 0.030). Surgeons were significantly more extrovert (P < 0.001) and less neurotic (P < 0.001) than physicians. Surgeons were significantly more intolerant of uncertainty than physicians (P = 0.007). Multivariate analysis identified age (P < 0.030) and sex (P = 0.015) as independent predictors of intolerance of uncertainty. The attitudes of surgeons and physicians to randomized trials were no different. CONCLUSION: Surgeons are not prejudiced against randomized trials, but their intolerance of uncertainty may inhibit them from deciding that an individual patient is suitable for trial entry. If more surgeons were female, this difference between surgeons and physicians might disappear.
\n \n\n \n \nINTRODUCTION: This paper expands the analogy between motor racing team pit stops and patient handovers. Previous studies demonstrated how the handover of patients following surgery could be improved by learning from a motor racing team. This has been extended to include contributions from several motor racing teams, and by examining transfers at several different interfaces at a non-specialist UK teaching hospital. METHODS: Letters of invitation were sent to the technical managers of nine Formula 1 motor racing teams. Semistructured interviews were carried out at a UK teaching hospital with 10 clinical staff involved in the handover of patients from surgery to recovery and intensive care. RESULTS: Three themes emerged from the motor racing responses; (1) proactive learning with briefings and checklists to prevent errors; (2) active management using technology to transfer information, and (3) post hoc learning from the storage and analysis of electronic data records. The eight healthcare themes were: historical working practice; problems during transfer; poor awareness of handover protocols; poor team coordination; time pressure; lack of consistency in handover practice; poor communication of important information; and awareness that handover was a potential threat to patient safety. CONCLUSIONS: The lessons from motor racing can be applied to healthcare for proactive planning, active management and post hoc learning. Other high-risk industries see standardisation of working practices, interpersonal communication, consistency and continuous development as fundamental for success. The application of these concepts would result in improvements in the quality and safety of the patient handover process.
\n \n\n \n \nBACKGROUND: Mortality after oesophagectomy is lower in high-volume than in low-volume surgical units. Case series from cardiothoracic surgeons report lower mortality rates than those from general surgeons. We therefore used a national data set to investigate the effects of surgical specialty and volume on mortality after oesophagectomy. METHODS: We analysed Hospital Episode Statistics for oesophagectomy for cancer (n=9034 cases), linked to data from death certificates, in England from 1998 to 2003. RESULTS: After adjustment for patients' age, sex and deprivation score, the odds ratio (OR) for death of general surgeons' (GS) patients, compared with cardiothoracic surgeons' (CTS) patients, was significantly high: 1.62 [95% CI 1.34-1.96] at 30 days and 1.38 [1.18-1.61] at 90 days. The odds ratio for high-volume GS patients was not significantly different from that for high-volume CTS patients. However, the odds ratio for low-volume GS patients compared with high-volume CTS patients was significantly high: 1.72 (1.40-2.11) at 30 days and 1.48 (1.26-1.74) at 90 days. CONCLUSION: Patients treated by general surgeons in low-volume hospitals had worse mortality outcomes than those treated by general surgeons in high-volume hospitals or by cardiothoracic surgeons. This is important because a majority of patients who underwent oesophagectomy for cancer were in this high-mortality risk group.
\n \n\n \n \nGraphical methods are becoming increasingly used to monitor adverse outcomes from surgical interventions. However, uptake of such methods has largely been in the area of cardiothoracic surgery or in transplants with relatively little impact made in surgical oncology. A number of the more commonly used graphical methods including the Cumulative Mortality plot, Variable Life-Adjusted Display, Cumulative Sum (CUSUM) and funnel plots will be described. Accounting for heterogeneity in case-mix will be discussed and how ignoring case-mix can have considerable consequences. All methods will be illustrated using data from the Scottish Audit of Gastro-Oesophageal Cancer services (SAGOCS) data set.
\n \n\n \n \nPURPOSE: Like other branches of surgery, Urology has encountered major challenges in aligning the research processes by which new interventions are assessed with the principles of Evidence-Based Medicine. This article explains the IDEAL framework and recommendations and illustrates how they might affect the evaluation of current controversial urological procedures. METHODS: From an inside perspective, we provide an overview of the efforts of the IDEAL Working Group to date with special emphasis on the field of Urology. RESULTS: There are clear differences between drugs and interventions in the natural history of innovations. Since the conventional framework for conducting trials of new treatments is largely based on the former, the evaluation of surgical innovations using the same template can encounter significant problems. Difficulties in performing randomized controlled trials of surgical techniques and the persistence of the case series as an important feature of the scientific literature have been the two most controversial aspects of this mismatch between the subject of research and the methodology used. The IDEAL framework provides a description of the process of innovation and development for surgical trials, and the associated recommendations provide a suggested alternative approach to developing study designs, which are appropriate for the specific problems of new techniques. CONCLUSIONS: IDEAL provides a new framework for surgical innovation that was developed with broad stakeholder input from the surgical community and is expected to have a transformative impact on the way that urologists perform clinical research.
\n \n\n \n \nBACKGROUND: Concern over the frequency of unintended harm to patients has focused attention on the importance of teamwork and communication in avoiding errors. This has led to experiments with teamwork training programmes for clinical staff, mostly based on aviation models. These are widely assumed to be effective in improving patient safety, but the extent to which this assumption is justified by evidence remains unclear. METHODS: A systematic literature review on the effects of teamwork training for clinical staff was performed. Information was sought on outcomes including staff attitudes, teamwork skills, technical performance, efficiency and clinical outcomes. RESULTS: Of 1036 relevant abstracts identified, 14 articles were analysed in detail: four randomized trials and ten non-randomized studies. Overall study quality was poor, with particular problems over blinding, subjective measures and Hawthorne effects. Few studies reported on every outcome category. Most reported improved staff attitudes, and six of eight reported significantly better teamwork after training. Five of eight studies reported improved technical performance, improved efficiency or reduced errors. Three studies reported evidence of clinical benefit, but this was modest or of borderline significance in each case. Studies with a stronger intervention were more likely to report benefits than those providing less training. None of the randomized trials found evidence of technical or clinical benefit. CONCLUSION: The evidence for technical or clinical benefit from teamwork training in medicine is weak. There is some evidence of benefit from studies with more intensive training programmes, but better quality research and cost-benefit analysis are needed.
\n \n\n \n \nOBJECTIVES: To evaluate the process of incident reporting in a surgical setting. In particular: the influence of event outcome on reporting behaviour; staff perception of surgical complications as reportable events. DESIGN: Anonymous web-based questionnaire survey. SETTING: General Surgical Department in a UK teaching hospital. POPULATION: Of 203 eligible staff, 55 (76.4%) doctors and 82 (62.6%) nurses participated. MAIN OUTCOME MEASURES: Knowledge and use of local reporting system; propensity to report incidents which vary by outcome (harm, no harm, harm prevented); propensity to report surgical complications; practical and psychological barriers to reporting. RESULTS: Nurses were significantly more likely to know of the local reporting system and to have recently completed a report than doctors. The level of harm (F(1.8,246) = 254.2, p<0.001), incident type (F(1.9,258) = 64.4, p<0.001) and profession (F(1,135) = 20.7, p<0.001) all significantly affected the likelihood of reporting. Staff were most likely to report an incident when harm occurred. Doctors were significantly less likely to report surgical complications than other types of incident (15% vs 53%, z = 4.633, p<0.001). Fear was a significantly less important barrier to reporting than other reasons (z = -3.49, p<0.0002). CONCLUSION: An incident is more likely to be reported if harm results. Surgical complications are not generally perceived to be \"reportable incidents,\" but they are addressed in Mortality and Morbidity meetings (M&M). Integrating M&M and incident reporting data will result in more comprehensive healthcare safety systems.
\n \n\n \n \nUnintended harm to patients in operating theatres is common. Correlations have been demonstrated between teamwork skills and error rates in theatres. This was a single-institution uncontrolled before-after study of the effects of \"non-technical\" skills training on attitudes, teamwork, technical performance and clinical outcome in laparoscopic cholecystectomy (LC) and carotid endarterectomy (CEA) operations. The setting was the theatre suite of a UK teaching hospital. Attitudes were measured using the Safety Attitudes Questionnaire (SAQ). Teamwork was scored using the Oxford Non-Technical Skills (NOTECHS) method. Operative technical errors (OTEs), non-operative procedural errors (NOPEs), complications, operating time and length of hospital stay (LOS) were recorded. A 9 h classroom non-technical skills course based on aviation \"Crew Resource Management\" (CRM) was offered to all staff, followed by 3 months of twice-weekly coaching from CRM experts. Forty-eight procedures (26 LC and 22 CEA) were studied before intervention, and 55 (32 and 23) afterwards. Non-technical skills and attitudes improved after training (NOTECHS increase 37.0 to 38.7, t = -2.35, p = 0.021, SAQ teamwork climate increase 64.1 to 69.2, t = -2.95, p = 0.007). OTEs declined from 1.73 to 0.98 (u = 1071, p = 0.009), and NOPEs from 8.48 to 5.16 per operation (t = 4.383, p<0.001). These effects were stronger in the LC group than in CEA procedures. The operating time was unchanged, and a non-significant reduction in LOS was observed. Non-technical skills training improved technical performance in theatre, but the effects varied between teams. Considerable cultural resistance to adoption was encountered, particularly among medical staff. Debriefing and challenging authority seemed more difficult to introduce than other parts of the training. Further studies are needed to define the optimal training package, explain variable responses and confirm clinical benefit.
\n \n\n \n \nINTRODUCTION: The frequency of adverse events in the operating theatre has been linked to the quality of teamwork and communication. Developing suitable measures of teamwork may play a role in reducing errors in surgery. This study reports on the development and evaluation of a method for measuring operating-theatre teamwork quality. METHODS: The Oxford Non-Technical Skills (NOTECHS) scale was developed from an aviation instrument for assessment of non-technical skills. Consultation with experts and task analysis led to modifications reflecting the complexities of the theatre teamwork, particularly the coexistence of three subteams (surgeons, anaesthetists and nurses). The scale was then evaluated using teams performing laparoscopic cholecystectomy (n = 65) before and after teamwork training. Attitudes to teamwork and surgical error rates were assessed by questionnaire and direct observation methods, and used to assess the reliability and validity of the Oxford NOTECHS scale. RESULTS: The interobserver reliability was excellent in 24 operations independently assessed by two observers (R(wg) = 0.99), confirmed by a third observer in 11 cases (R(wg) = 0.99). Validity was demonstrated through improved scores after teamwork training (t = -3.019, p = 0.005), concurrent with improved attitudes to teamwork after training; inverse correlation between NOTECHS scores and surgical errors (rho = -0.267, p = 0.046); strong inverse correlation between surgical subteam score and surgical errors (rho = -0.412, n = 65, p = 0.001); and strong correlation with teamwork scores from an alternative system (n = 5, r = 0.886, p = 0.046). CONCLUSION: The Oxford NOTECHS scale appears to be a reliable and valid instrument for assessing teamwork in the operating theatre, and is ready for further application.
\n \n\n \n \nBACKGROUND: The data are scarce on the outcome for elderly patients presenting with resectable gastric cancer in the West who have been treated with minimally invasive surgery. This report presents the authors' early experience with totally laparoscopic gastric resections for cancer in elderly patients. METHODS: A total of 20 patients underwent laparoscopic gastrectomy procedures: 14 distal, 5 subtotal, and 1 total gastrectomy. The male-to-female ratio was 15 to 5. The ages ranged from 75 to 88 years (mean, 80 years). RESULTS: All cases were managed laparoscopically with R0 resection. Four patients needed high-dependency unit care postoperatively. There were no perioperative deaths. The median time required for the procedure was 212 min, and time to diet was 4 days. The hospital stay was 8 days. Four patients experienced significant complications, with two patients requiring reoperation. The pathology was adenocarcinoma for 17 patients and high-grade dysplasia for 3 patients. CONCLUSION: Among elderly patients for whom conventional gastric surgery carries a high morbidity and mortality risk, minimal access surgery may offer equivalent oncologic integrity but with superior safety and economy. The primary aim is to remove the tumor with at least a D1 lymphadenectomy.
\n \n\n \n \nOBJECTIVE: To analyze the effects of surgical, anesthetic, and nursing teamwork skills on technical outcomes. SUMMARY BACKGROUND DATA: The value of team skills in reducing adverse events in the operating room is presently receiving considerable attention. Current work has not yet identified in detail how the teamwork and communication skills of surgeons, anesthetists, and nurses affect the course of an operation. METHODS: Twenty-six laparoscopic cholecystectomies and 22 carotid endarterectomies were studied using direct observation methods. For each operation, teams' skills were scored for the whole team, and for nursing, surgical, and anesthetic subteams on 4 dimensions (leadership and management [LM]; teamwork and cooperation; problem solving and decision making; and situation awareness). Operating time, errors in surgical technique, and other procedural problems and errors were measured as outcome parameters for each operation. The relationships between teamwork scores and these outcome parameters within each operation were examined using analysis of variance and linear regression. RESULTS: Surgical (F(2,42) = 3.32, P = 0.046) and anesthetic (F(2,42) = 3.26, P = 0.048) LM had significant but opposite relationships with operating time in each operation: operating time increased significantly with higher anesthetic but decreased with higher surgical LM scores. Errors in surgical technique had a strong association with surgical situation awareness (F(2,42) = 7.93, P < 0.001) in each operation. Other procedural problems and errors were related to the intraoperative LM skills of the nurses (F(5,1) = 3.96, P = 0.027). CONCLUSIONS: Detailed analysis of team interactions and dimensions is feasible and valuable, yielding important insights into relationships between nontechnical skills, technical performance, and operative duration. These results support the concept that interventions designed to improve teamwork and communication may have beneficial effects on technical performance and patient outcome.
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