The learning curve to achieve satisfactory completion rates in upper GI endoscopy: an analysis of a national training database.

OBJECTIVE: The aim of this study was to determine the number of OGDs (oesophago-gastro-duodenoscopies) trainees need to perform to acquire competency in terms of successful unassisted completion to the second part of the duodenum 95% of the time. DESIGN: OGD data were retrieved from the trainee e-portfolio developed by the Joint Advisory Group on GI Endoscopy (JAG) in the UK. All trainees were included unless they were known to have a baseline experience of >20 procedures or had submitted data for <20 procedures. The primary outcome measure was OGD completion, defined as passage of the endoscope to the second part of the duodenum without physical assistance. The number of OGDs required to achieve a 95% completion rate was calculated by the moving average method and learning curve cumulative summation (LC-Cusum) analysis. To determine which factors were independently associated with OGD completion, a mixed effects logistic regression model was constructed with OGD completion as the outcome variable. RESULTS: Data were analysed for 1255 trainees over 288 centres, representing 243 555 OGDs. By moving average method, trainees attained a 95% completion rate at 187 procedures. By LC-Cusum analysis, after 200 procedures, >90% trainees had attained a 95% completion rate. Total number of OGDs performed, trainee age and experience in lower GI endoscopy were factors independently associated with OGD completion. CONCLUSIONS: There are limited published data on the OGD learning curve. This is the largest study to date analysing the learning curve for competency acquisition. The JAG competency requirement for 200 procedures appears appropriate.

Definition and taxonomy of interval colorectal cancers: a proposal for standardising nomenclature.

OBJECTIVE: Interval colorectal cancers (interval CRCs), that is, cancers occurring after a negative screening test or examination, are an important indicator of the quality and effectiveness of CRC screening and surveillance. In order to compare incidence rates of interval CRCs across screening programmes, a standardised definition is required. Our goal was to develop an internationally applicable definition and taxonomy for reporting on interval CRCs. DESIGN: Using a modified Delphi process to achieve consensus, the Expert Working Group on interval CRC of the Colorectal Cancer Screening Committee of the World Endoscopy Organization developed a nomenclature for defining and characterising interval CRCs. RESULTS: We define an interval CRC as a "colorectal cancer diagnosed after a screening or surveillance exam in which no cancer is detected, and before the date of the next recommended exam". Guidelines and principles for describing and reporting on interval CRCs are provided, and clinical scenarios to demonstrate the practical application of the nomenclature are presented. CONCLUSIONS: The Working Group on interval CRC of the World Endoscopy Organization endorses adoption of this standardised nomenclature. A standardised nomenclature will facilitate benchmarking and comparison of interval CRC rates across programmes and regions.

Developing a strategy for accreditation of clinical services.

Accreditation is one method of assuring quality. Accreditation requires the setting of standards and the creation of a robust and reliable process for assessing them. Accreditation offers different advantages to different groups, eg quality assurance to commissioners and the boards of provider organisations, confidence and choice for patients, and a quality improvement pathway for services to follow. This paper is focused on service accreditation and it proposes that service accreditation be professionally led.

A novel method for determining the difficulty of colonoscopic polypectomy.

INTRODUCTION: Endoscopists are now expected to perform polypectomy routinely. Colonic polypectomy varies in difficulty, depending on polyp morphology, size, location and access. The measurement of the degree of difficulty of polypectomy, based on polyp characteristics, has not previously been described. OBJECTIVE: To define the level of difficulty of polypectomy. METHODS: Consensus by nine endoscopists regarding parameters that determine the complexity of a polyp was achieved through the Delphi method. The endoscopists then assigned a polyp complexity level to each possible combination of parameters. A scoring system to measure the difficulty level of a polyp was developed and validated by two different expert endoscopists. RESULTS: Through two Delphi rounds, four factors for determining the complexity of a polypectomy were identified: size (S), morphology (M), site (S) and access (A). A scoring system was established, based on size (1-9 points), morphology (1-3 points), site (1-2 points) and access (1-3 points). Four polyp levels (with increasing level of complexity) were identified based on the range of scores obtained: level I (4-5), level II (6-9), level III (10-12) and level IV (>12). There was a high degree of interrater reliability for the polyp scores (interclass correlation coefficient of 0.93) and levels (κ=0.888). CONCLUSIONS: The scoring system is feasible and reliable. Defining polyp complexity levels may be useful for planning training, competency assessment and certification in colonoscopic polypectomy. This may allow for more efficient service delivery and referral pathways.

European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Colonoscopic surveillance following adenoma removal.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on colonoscopic surveillance following adenoma removal includes 24 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of surveillance and other elements in the screening process, including multi-disciplinary diagnosis and management of the disease.

European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Quality assurance in endoscopy in colorectal cancer screening and diagnosis.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on quality assurance in endoscopy includes 50 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of endoscopy and other elements in the screening process, including multidisciplinary diagnosis and management of the disease.

Development and roll out of the JETS e-portfolio: a web based electronic portfolio for endoscopists.

The JAG Endoscopy Training System (JETS) e-portfolio was designed to provide an electronic log of endoscopic experience, improve the effectiveness of training, streamline the JAG certification process and support the quality assurance of trainers, units and regional training programmes. It was piloted in 2008 with an 82.6% uptake in trainees offered the system. The system was released in the UK in September 2009. Steady adoption across the UK demonstrates the service finds it a valuable tool. In time it will be the only vehicle through which a trainee can achieve certification through JAG to practise independently.

Control of downy mildew on grapes in organic viticulture.

Few active substances with fungicide activity can be used in organic farming, above all copper and sulphur. The copper is the only substance that can be used against downy mildew; however, since it causes problems of environmental impact, incompatible with organic farming's objective of environmentally friendly farming, the Commission of the European Communities has fixed a ceiling on use expressed in terms of kilograms of copper per hectare per year (Regulation EC n. 473/2002). In order to identify natural products that are able to carry out an anti-downy mildew activity, and to evaluate the effectiveness of low rate copper formulations that can reduce the quantities of copper compound, four-year experimental trials were carried out in organic vineyards. The trials have been carried out according to the Guidelines EPPO/OEPP PP 1/31 (3). Among the low rate copper formulations, copper hydroxide and copper sulphate have been tested. Among the natural substances alternative to copper formulations we have tested: phytostimulant, homeopathic products, acid clay-based products (bentotamnio), resistance promoters (chitosan and lignosulfonate), plant extracts (orange extract, propolis and equisetum) and potassium bicarbonate. All natural substances, with the exception of plant extracts and potassium bicarbonate, were tested in association with low rate copper formulations. In the trials it has been possible to test the effectiveness of different formulations in condition of high, medium and low pressure of Plasmopara viticola (Berk. et Curt.) Berl. et De Toni. Both the copper compounds and the natural products were able to guarantee a satisfactory protection in condition of low and medium pressure of downy mildew. The trial carried out in 2004 was characterized by high pressure of P. viticola; under this condition only the copper formulations produced a satisfactory protection against downy mildew. However, in 2004, we tested only two products alternative to copper compounds. Further studies are needed to verify if the formulations alternative to copper, that gave good results in condition of low and medium pressure of P. viticola, are able to guarantee a satisfactory protection even in condition of high pressure of downy mildew. We would like to highlight that in the four-years of trials the copper formulations tested always guaranteed a metallic copper quantity under 6 kg/ha that is the maximum limit of use/year imposed by Regulation EC n. 473/2002.

Reducing community dyspepsia drug costs: a controlled trial.

BACKGROUND: Dyspepsia drug costs account for nearly 0.5% of the National Health Service budget. We hypothesised that improved management of dyspepsia would lead to reduced drug costs. AIM: To determine whether a multifaceted educational strategy for general practitioners aimed at improving quality of dyspepsia management can control dyspepsia costs without increasing demand for endoscopy. METHODS: A multifaceted educational intervention was delivered to general practitioners in West Gloucestershire but not to those in the east of the county. Dyspepsia drug costs, the primary outcome measure, were obtained from the Prescription Pricing Authority and compared between the two sides of the county. Referral rates for endoscopy, admission to the gastrointestinal bleed unit, and delayed diagnosis of gastric cancer were secondary measures recorded in West Gloucestershire only. RESULTS: Following the intervention, drug costs declined and then stabilised in West Gloucestershire. Drug costs peaked in the control group 15 months after those in the intervention group. Using an autoregressive integrated moving average model it was estimated the overall costs in the intervention group reduced by 57.9 pence per head of population per half year (95% confidence interval 45.8-69.9 pence/half year; p<0.0001) in comparison with the control group. This difference was maintained for three consecutive years resulting in a cumulative saving of pound1.13 million. Referral rates for upper gastrointestinal endoscopy remained stable during the study period. CONCLUSION: A multifaceted educational intervention for general practitioners designed to improve the quality of care of patients with dyspepsia is an effective means of controlling dyspepsia drug costs without increasing demand for endoscopy.

The significance of cagA(+) Helicobacter pylori in reflux oesophagitis.

BACKGROUND: Helicobacter pylori is a gastroduodenal pathogen associated with ulceration, dyspepsia, and adenocarcinoma. Recent preliminary studies have suggested that H pylori may be protective for oesophageal adenocarcinoma. In addition, strains of H pylori identified by the presence of the cytotoxin associated gene A (cagA) are shown to have a significant inverse association with oesophageal adenocarcinoma. Given that cagA(+) H pylori may protect against oesophageal carcinoma, these strains may be protective for oesophagitis, a precursor of oesophageal carcinoma. AIMS: The aim of this study was to investigate the association between cagA(+) H pylori and endoscopically proved oesophagitis. PATIENTS: The study group included 1486 patients attending for routine upper gastrointestinal tract endoscopy. METHODS: At endoscopy the oesophagus was assessed for evidence of reflux disease and graded according to standard protocols. Culture and histology of gastric biopsy specimens determined H pylori status. The prevalence of cagA was identified by an antibody specific ELISA (Viva Diagnostika, Germany). RESULTS: H pylori was present in 663/1485 (45%) patients and in 120/312 (38%) patients with oesophagitis. Anti-CagA antibody was found in 499/640 (78%) H pylori positive patients. Similarly, anti-CagA antibody was found in 422/521 (81%) patients with a normal oesophagus and in 42/60 (70%) with mild, 24/35 (69%) with moderate, and 11/24 (46%) with severe oesophagitis. The risk of severe oesophagitis was significantly decreased for patients infected with cagA(+) H pylori after correction for confounding variables (odds ratio 0.57, 95% confidence interval 0.41-0.80; p=0.001). CONCLUSIONS: These results suggest that infection by cagA(+) H pylori may be protective for oesophageal disease.

A comparison of six commercial kits for Helicobacter pylori detection.

The British Society of Gastroenterologists suggests that dyspeptic patients under 45 years of age should be screened serologically for Helicobacter pylori infection, to reduce endoscopy workload. We have compared the sensitivity, specificity, and predictive value of six commercial serological kits intended for pre-endoscopy screening for H. pylori with histopathology and culture in 82 dyspeptic patients, 35 of whom were H. pylori positive. The kits' sensitivities were as follows: Bio-Rad GAP 100%, Helico-G 100%, Premier 97%, and Pyloriset EIA-G 94%. Poor specificity of the ELISA kits--Bio-Rad GAP 67%, Helico-G 67%, Premier 85%, and Pyloriset EIA-G 76%--was due to previous treated or cleared H. pylori infection. Allowing for previously documented H. pylori infection or peptic ulcer improved specificity--Bio-Rad GAP 84%, Helico-G 84%, Premier 100%, and Pyloriset EIA-G 90%. The Pyloriset Dry latex kit had a higher specificity (86%) but a lower sensitivity (75%) than the Oxoid latex kit (specificity 70%, sensitivity 94%). The qualitative Premier Launch kit had the best overall results (and was the easiest ELISA to perform). Reliable serological diagnosis of H. pylori is now suitable for screening dyspeptic patients.

General practice patients' beliefs about their symptoms.

BACKGROUND: Patients' beliefs about symptoms are major influences on consultation and its consequences. However, little information is available about the beliefs of patients when they consult their general practitioner (GP). AIM: To describe and quantify the range of beliefs of patients about their symptoms before consultation, and to test the hypothesis that patients who attribute symptoms to stress or lifestyle would expect less benefit than others from physical medicine but more from lifestyle change and emotional support. METHOD: Interviews with 100 patients attending one of two general practices were used to form a questionnaire, which was completed by 406 patients attending one of three general practices in contrasting areas of Greater London. This measured the frequency of specific beliefs about the causes of their symptoms and about effective forms of help. Patients were seen before their consultation. RESULTS: The most common aetiological beliefs concerned stress and lifestyle. In general, the mechanisms underlying symptoms were thought to be disturbances in bodily functioning rather than pathological processes. The most valued form of help was explanation and discussion of symptoms. Nevertheless, about half the patients expected benefit from medication and only slightly fewer from hospital investigation or treatment. Patients who attributed symptoms to stress or lifestyle were no less likely to expect help from medication or specialist referral, but they were more likely to see benefit in explanation and counselling or lifestyle change. CONCLUSIONS: These findings suggest hypotheses for future research into the effects that patients' attributions of their symptoms to stress and lifestyle have on their health care demands, emphasize the importance of routinely assessing patients' beliefs on consulting the GP, and provide information that can help to direct this assessment in the individual case.

Gastric cancer below the age of 55: implications for screening patients with uncomplicated dyspepsia.

AIMS: To test the hypothesis that gastric cancer presenting with uncomplicated dyspepsia is rare below the age of 55. PATIENTS AND METHODS: The area studied was the postcode defined catchment area of a district general hospital (Gloucestershire Royal) serving a population of 280,500. An open access endoscopy service has been available in this district for more than 17 years. All cases of gastric cancer during a seven year period (1986-92) were drawn from the local pathology database. The database of the neighbouring hospital and the South West Cancer Registry were searched for missed cases from the postcoded area. Hospital and general practitioner records were retrospectively reviewed with respect to duration of symptoms, and previous consultation and investigation for dyspepsia; and alarming symptoms and signs suggestive of underlying malignancy (unexplained recent weight loss, dysphagia, haematemesis or melaena, anaemia, previous gastric surgery, palpable mass, and perforation). RESULTS: Twenty five of 319 cases of gastric cancer detected during the seven year period were aged less than 55. Twenty four of these 25 patients presented with one or more suspicious symptoms or signs. Only one patient (4%) aged less than 55 presented with uncomplicated dyspepsia. In two patients there was a delay in diagnosis of more than six months after first presenting to the general practitioner. Both these patients had significant symptoms at presentation. CONCLUSION: Gastric cancer is rare below the of 55 (7.8% of all cases) and, even in the presence of established open access endoscopy, presents with suspicious symptoms or signs in 96% of cases. The age limit for screening uncomplicated dyspepsia can be raised safely to 55.

Is saliva serology useful for the diagnosis of Helicobacter pylori?

BACKGROUND: The Cortecs Diagnostics Helisal Assay test is a quantitative immunoassay for salivary IgG antibodies against Helicobacter pylori. Saliva can be obtained simply with the kit in the general practitioners surgery. AIMS: To compare the new saliva serological test for H pylori with 'gold standard' evidence of H pylori infection (antral biopsy specimens for histology, culture, and urease test) and a new serum serological test. PATIENTS: Eighty six unselected dyspeptic patients undergoing endoscopy. METHODS: Each patient provided saliva and serum before endoscopy for H pylori serology, which was compared against 'gold standard' evidence of infection. RESULTS: Thirty two patients were H pylori positive by the 'gold standard' tests. At a cut off value of 0.15 EU/ml the saliva test had a sensitivity of 88% and a specificity of 71%, with a negative predictive value of 90%. If patients who were taking omeprazole or had recent antibiotics are excluded, the sensitivity is unchanged but the specificity increases to 79%. The serum test had a similar sensitivity of 85% but better specificity of 78%. CONCLUSION: Serum testing remains the best serological test for H pylori in the hospital setting. Saliva testing may have a role in epidemiological studies and in screening dyspeptic patients in general practice, especially in children in whom venesection is more difficult.

The measurement of beliefs about physical symptoms in English general practice patients.

A way of measuring patients' beliefs about the origin of their symptoms would allow the investigation of important questions concerning the consultation process and its outcome. The purpose of this study was to develop an instrument that could measure the beliefs about symptoms of patients attending their general practitioner and to demonstrate its utility by comparing beliefs about three types of symptom (respiratory, musculoskeletal and gastrointestinal). Interviews of 150 patients generated items for the belief questionnaire which was then completed by a second sample of 406 general practice patients. Principal components analysis of the responses identified eight readily interpretable belief dimensions: stress; lifestyle; wearing out; environment; internal-structural; internal-functional; weak constitution; concern. Scales were constructed to measure each dimension and the symptom groups were compared. Gastrointestinal symptoms were the most likely to be attributed to internal malfunction and to lifestyle or weak constitution. Musculoskeletal symptoms were more likely to be attributed to structural problems caused by the body wearing out and respiratory symptoms, in contrast, to the influence of the environment. Contrary to prediction, attribution to stress was made equally for the different types of symptom. We have devised a questionnaire, valid specifically for general practice patients, which permits the quantification of beliefs in this setting. The questionnaire could be used in future to track how beliefs respond to medical intervention and how, in turn, beliefs influence illness behaviour.

Measuring the meaning of life for patients with incurable cancer: the life evaluation questionnaire (LEQ).

Clinical observation, systematic research and popular anecdote indicate that, when confronted by death, people change the criteria by which they evaluate their lives. Questionnaires used routinely to assess quality of life in people with poor-prognosis cancer tend to be symptom-based and do not assess factors which become important when confronted by fatal illness, such as the meaning of life and the degree to which life has been enriched by the illness. To develop a questionnaire which would be sensitive to these areas, patients with incurable cancer and carers of such patients were interviewed in depth. Responses were reviewed by a panel of patients, clinicians and carers and formed into an inventory which was completed by 200 similar patients. Principal components analysis identified five dimensions: clearer perception of the meaning of life; freedom versus restriction of life; resentment of the illness; contentment with past and present life; past and present social integration. Only the most symptom-oriented scales (freedom, resentment) correlated with the Rotterdam Symptom Checklist. Scale scores showed that younger patients were more resentful of their illness, but also gained a clearer perception of the meaning of life. This questionnaire can evaluate psychological needs of people with incurable cancer which are neglected by existing instruments.