Gastrointestinal Endoscopy Competency Assessment Tool: reliability and validity evidence.

BACKGROUND: Rigorously developed and validated direct observational assessment tools are required to support competency-based colonoscopy training to facilitate skill acquisition, optimize learning, and ensure readiness for unsupervised practice. OBJECTIVE: To examine reliability and validity evidence of the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT) for colonoscopy for use within the clinical setting. DESIGN: Prospective, observational, multicenter validation study. Sixty-one endoscopists performing 116 colonoscopies were assessed using the GiECAT, which consists of a 7-item global rating scale (GRS) and 19-item checklist (CL). A second rater assessed procedures to determine interrater reliability by using intraclass correlation coefficients (ICCs). Endoscopists' first and second procedure scores were compared to determine test-retest reliability by using ICCs. Discriminative validity was examined by comparing novice, intermediate, and experienced endoscopists' scores. Concurrent validity was measured by correlating scores with colonoscopy experience, cecal and terminal ileal intubation rates, and physician global assessment. SETTING: A total of 116 colonoscopies performed by 33 novice (<50 previous procedures), 18 intermediate (50-500 previous procedures), and 10 experienced (>1000 previous procedures) endoscopists from 6 Canadian hospitals. MAIN OUTCOME MEASUREMENTS: Interrater and test-retest reliability, discriminative, and concurrent validity. RESULTS: Interrater reliability was high (total: ICC=0.85; GRS: ICC=0.85; CL: ICC=0.81). Test-retest reliability was excellent (total: ICC=0.91; GRS: ICC=0.93; CL: ICC=0.80). Significant differences in GiECAT scores among novice, intermediate, and experienced endoscopists were noted (P<.001). There was a significant positive correlation (P<.001) between scores and number of previous colonoscopies (total: ρ=0.78, GRS: ρ=0.80, CL: Spearman's ρ=0.71); cecal intubation rate (total: ρ=0.81, GRS: Spearman's ρ=0.82, CL: Spearman's ρ=0.75); ileal intubation rate (total: Spearman's ρ=0.82, GRS: Spearman's ρ=0.82, CL: Spearman's ρ=0.77); and physician global assessment (total: Spearman's ρ=0.90, GRS: Spearman's ρ=0.94, CL: Spearman's ρ=0.77). LIMITATIONS: Nonblinded assessments. CONCLUSION: This study provides evidence supporting the reliability and validity of the GiECAT for use in assessing the performance of live colonoscopies in the clinical setting.

Gastrointestinal Endoscopy Competency Assessment Tool: development of a procedure-specific assessment tool for colonoscopy.

BACKGROUND: Ensuring competence remains a seminal objective of endoscopy training programs, professional organizations, and accreditation bodies; however, no widely accepted measure of endoscopic competence currently exists. OBJECTIVE: By using Delphi methodology, we aimed to develop and establish the content validity of the Gastrointestinal Endoscopy Competency Assessment Tool for colonoscopy. DESIGN: An international panel of endoscopy experts rated potential checklist and global rating items for their importance as indicators of the competence of trainees learning to perform colonoscopy. After each round, responses were analyzed and sent back to the experts for further ratings until consensus was reached. MAIN OUTCOME MEASUREMENTS: Consensus was defined a priori as ≥80% of experts, in a given round, scoring ≥4 of 5 on all remaining items. RESULTS: Fifty-five experts agreed to be part of the Delphi panel: 43 gastroenterologists, 10 surgeons, and 2 endoscopy managers. Seventy-three checklist and 34 global rating items were generated through a systematic literature review and survey of committee members. An additional 2 checklist and 4 global rating items were added by Delphi panelists. Five rounds of surveys were completed before consensus was achieved, with response rates ranging from 67% to 100%. Seven global ratings and 19 checklist items reached consensus as good indicators of the competence of clinicians performing colonoscopy. LIMITATIONS: Further validation required. CONCLUSION: Delphi methodology allowed for the rigorous development and content validation of a new measure of endoscopic competence, reflective of practice across institutions. Although further evaluation is required, it is a promising step toward the objective assessment of competency for use in colonoscopy training, practice, and research.

Qualitative study of physician perspectives on classifying screening and nonscreening colonoscopy using administrative health data: adding practice does not make perfect.

BACKGROUND: Previously developed screening colonoscopy algorithms based on diagnostic and endoscopy procedural variables have not been sufficiently accurate for use in epidemiological and health services research. OBJECTIVE: To increase understanding of the administrative health database variables that could help to discern screening and nonscreening colonoscopy. METHODS: A qualitative study using physician focus groups was conducted in Montreal (Quebec), Calgary (Alberta) and Toronto (Ontario). Specialty-specific focus group sessions were held among family physicians and gastroenterologists - the physicians responsible for referring patients to and performing screening colonoscopy, respectively. Interview guides were developed to better understand physician clinical and billing practices. Discussions were audiotaped, transcribed verbatim and analyzed using the constant comparative approach. RESULTS: Forty family physicians and seven gastroenterologists participated in five focus group sessions. Patient variables included demographics (age) and medical history (colorectal cancer risk factors/symptoms, medication for colorectal cancer risk factors/symptoms, gastrointestinal disorders, severe disease). Clinical practice variables included timing of the colonoscopy (evenings, weekends, holidays, during hospitalization; same-day endoscopist consultation and colonoscopy), use of services (hospitalization, annual examination, transfer from other facility) and procedure use patterns (large bowel or other medical/surgical procedure before and subsequent to colonoscopy). However, wide variability in clinical and billing practices will likely preclude the development of a reasonably accurate screening colonoscopy algorithm. Physicians suggested adding a screening colonoscopy code to the administrative health data. CONCLUSIONS: Failure to acknowledge the limitations of the provincial administrative health databases to identify screening colonoscopy may lead to incorrect conclusions and the establishment of inappropriate health care policies.

How well is Helicobacter pylori treated in usual practice?

BACKGROUND: Helicobacter pylori is a WHO class I carcinogen also associated with nonmalignant gastrointestinal diseases. Effective treatment exists, and all persons infected with H pylori should receive treatment. However, data regarding the rates of treatment prescription in clinical practice are lacking. OBJECTIVE: To determine the rates of H pylori treatment in usual practice. METHODS: Patients with histological evidence of H pylori infection between January 1, 2007, and December 31, 2007, at Sunnybrook Health Sciences Centre (Toronto, Ontario) were identified. Charts were reviewed to determine the rates of H pylori treatment and confirmation of eradication, when indicated. Questionnaires were subsequently sent to endoscopists of patients identified as not having received treatment to determine the reasons for lack of treatment. RESULTS: A total of 102 patients were H pylori positive and were appropriate candidates for treatment, of whom 58 (57%) were male and 78 (76%) were outpatients, with 92 (90%) receiving eradication therapy. When indicated, 15 of 22 (68%) patients received confirmation of eradication, 13 of 18 (72%) patients underwent repeat endoscopy and 86% received complete therapy. Outpatients were more likely to receive eradication therapy (OR 10.3 [95% CI 2.6 to 40.4]; P=0.001) and complete therapy (OR 13.2 [95% CI 3.8 to 45.7]; P=0.0001) compared with inpatients. Having a follow-up appointment resulted in higher treatment rates (OR 12.0 [95% CI 3.0 to 47.5]; P=0.001). CONCLUSION: During the time period studied, adequate rates of H pylori treatment were achieved in outpatients and patients who had formal follow-up at Sunnybrook Health Sciences Centre. However, some aspects of care remain suboptimal including treatment of inpatients and care following treatment. Additional studies are required to identify strategies to improve the care of patients infected with H pylori.

Comparing patient and endoscopist perceptions of the colonoscopy indication.

BACKGROUND: determining whether a colonoscopy is performed for screening or nonscreening purposes can facilitate clinical practice and research. However, there is no simple method to determine the colonoscopy indication using patient medical files or health administrative databases. OBJECTIVE: to determine patient-endoscopist agreement on the colonoscopy indication. METHODS: a cross-sectional study was conducted among staff endoscopists and their patients at seven university-affiliated hospitals in Montreal, Quebec. The study participants were 50 to 75 years of age, they were able to understand English or French, and were about to undergo colonoscopy. Self- (endoscopist) and interviewer-administered (patient) questionnaires ascertained information that permitted classification of the colonoscopy indication. Patient colonoscopy indication was defined as the following: perceived screening (routine screening, family history, age); perceived nonscreening (follow-up); medical history that implied nonscreening; and a combination of the three preceding indications. Agreement between patient and endoscopist indications was measured using concordance and Kappa statistic. RESULTS: in total, 702 patients and 38 endoscopists participated. The three most common reasons for undergoing colonoscopy were routine screening/regular check-up (33.8%), follow-up to a previous problem (30.2%) and other problem (24.6%). Concordance (range 0.79 to 0.85) and Kappa (range 0.58 to 0.70) were highest for perceived nonscreening colonoscopy. Recent large bowel symptoms accounted for 120 occurrences of disagreement in which the patient perceived a nonscreening colonoscopy while the endoscopist perceived a screening colonoscopy. CONCLUSIONS: patient self-report may be an acceptable means for rapidly assessing whether a colonoscopy is performed for screening or nonscreening purposes. Delivery of patient-centred care may help patients and endoscopists reach a shared understanding of the reason for colonoscopy.

Referring patients to nurses: outcomes and evaluation of a nurse flexible sigmoidoscopy training program for colorectal cancer screening.

Colorectal cancer is a significant health burden. Several screening options exist that can detect colorectal cancer at an early stage, leading to a more favourable prognosis. However, despite years of knowledge on best practice, screening rates are still very low in Canada, particularly in Ontario. The present paper reports on efforts to increase the flexible sigmoidoscopy screening capacity in Ontario by training nurses to perform this traditionally physician-performed procedure. Drawing on American, British and local experience, a professional regulatory framework was established, and training curriculum and assessment criteria were developed. Training was initiated at Princess Margaret Hospital and Sunnybrook and Women's College Health Sciences Centre in Toronto, Ontario. (During the study, Sunnybrook and Women's College Health Sciences Centre was deamalgamated into two separate hospitals: Women's College Hospital and Sunnybrook Health Sciences Centre.) Six registered nurses participated in didactic, simulator and practical training. These nurses performed a total of 77 procedures in patients, 23 of whom had polyps detected and biopsied. Eight patients were advised to undergo colonoscopy because they had one or more neoplastic polyps. To date, six of these eight patients have undergone colonoscopy, one patient has moved out of the province and another patient is awaiting the procedure. Classifying the six patients according to the most advanced polyp histology, one patient had a negative colonoscopy (no polyps found), one patient's polyps were hyperplastic, one had a tubular adenoma, two had advanced neoplasia (tubulovillous adenomas) and one had adenocarcinoma. All these lesions were excised completely at colonoscopy. Overall, many difficulties were anticipated and addressed in the development of the training program; ultimately, the project was affected most directly by challenges in encouraging family physicians to refer patients to the program. As health human resource strategies continue to evolve, it is believed that lessons learned from experience make an important contribution to the knowledge of how nontraditional health services can be organized and delivered.

Clinical recommendations for the use of recombinant human erythropoietin in patients with hepatitis C virus being treated with ribavirin.

Today, combination antiviral therapy with pegylated interferon-alpha and ribavirin (RBV) allows many patients infected with hepatitis C virus (HCV) to achieve a sustained virological response, which is equivalent to cure. Data also support the clinical benefit of combination antiviral therapy in patients coinfected with HCV and HIV, and in patients who have received a liver transplant. Antiviral therapy with pegylated interferon-alpha and RBV is, however, associated with a high incidence and significant magnitude of anemia. This anemia may have several mechanisms, including bone marrow suppression and hemolysis. In addition, patients coinfected with HIV may have both pre-existing and RBV-associated anemia. Management of anemia in patients with HCV through RBV dose reduction or treatment discontinuation may compromise the effectiveness of treatment, because studies have demonstrated that treatment adherence or maintenance of antiviral therapy dose is an important predictor of sustained virological response. Anemia associated with combination antiviral therapy in patients with HCV is frequently associated with an inadequate or blunted endogenous erythropoietin response. Accumulating evidence now supports the use of recombinant human erythropoietin (rHuEpo) to manage anemia in these patients, with the objective of maintaining the RBV dose, but clinical standards are lacking. The present article reviews the data relevant to the use of rHuEpo in this patient population and proposes a set of clinical practice standards to assist clinicians in selecting patients for rHuEpo and in implementing rHuEpo therapy effectively.

Clinical pharmacology consultations: consultation requests may be misleading -- an organized approach to drug-induced hepatitis.

The present case report describes a consultation with the Clinical Pharmacology Consultation Service at the Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario, for drug-induced hepatitis in a patient with multiple drug exposures. The original question to be addressed was whether dalteparin was responsible for an acute rise in liver transaminases. The approach involved establishing a best possible diagnosis of the adverse event, obtaining a comprehensive history of drug exposure and evaluating the possible contributory role of alternate etiologies supported by a literature search. On balance, based on temporal relationships and previous case reports, ranitidine was considered to be the most likely causal agent. The initial consultation request was to investigate the likelihood that daltaperin caused hepatitis; however, a systematic and comprehensive approach led to the conclusion that it was more likely to be ranitidine-induced hepatitis.

Lower gastrointestinal bleeding and ischemic colitis.

OBJECTIVE: To compare the incidence and clinical characteristics of lower gastrointestinal (LGI) bleeding due to ischemic colitis with those with LGI bleeding of other causes. METHODS: A chart review was performed of patients admitted with LGI bleeding to Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, between July 1, 1997 and January 31, 2000. RESULTS: Of 124 patients with LGI bleeding, 24 cases were due to ischemic colitis, 62 to diverticulosis, 11 to inflammatory bowel disease (IBD) and 27 to all other causes ('others'). The average ages of patients in each group were 66.5, 76.5, 40.5 and 77.5 years, respectively. Patients with ischemic colitis were statistically younger than those with diverticular bleeding and 'others'. Patients with IBD were younger than those in the other three groups. The only statistical difference for vascular disease risks was hypertension, because of its absence from the IBD group. Three patients with ischemic colitis underwent blood transfusions, while 23 with diverticulosis, 15 'others' and none with IBD received blood. Three patients with ischemic colitis and one patient from the 'others' group died. More women (75) than men (49) had LGI bleeding - in total and within each subgroup. Of women with LGI bleeding, many more with ischemic colitis (44.4%) than with diverticulosis (3.0%), IBD (0%) or 'others' (5.6%) were taking estrogen. CONCLUSIONS: Ischemic colitis was the second most common cause of LGI bleeding. LGI bleeding from all causes was more common in women than in men. Many more women in the ischemic colitis group than in the other groups were using estrogen therapy.

Registered nurse-performed flexible sigmoidoscopy in Ontario: development and implementaton of the curriculum and program.

Although colorectal cancer is a leading cause of death in Canada, it is curable if detected in the early stages. Flexible sigmoidoscopy has been shown to reduce the incidence and mortality of colorectal cancer in patients who are at average risk for this disease and, therefore, is an appropriate screening intervention. Moreover, it may be performed by nonphysicians. A program to enable registered nurses to perform flexible sigmoidoscopy to increase colorectal cancer screening capacity in Ontario was developed. This program incorporated practical elements learned from other jurisdictions as well as specific regional considerations to fit within the health care system of Ontario. The nurses received structured didactic and simulation training before performing sigmoidoscopies on patients under physician supervision. After training, nurses were evaluated by two assessors for their ability to perform complete sigmoidoscopies safely and independently. To date, 17 nurses have achieved independence in performing flexible sigmoidoscopy at 14 sites. In total, nurses have screened >7000 Ontarians, with a cancer detection rate of 5.1 per 1000 screened, which is comparable with rates in other jurisdictions and with sigmoidoscopy performed by gastroenterologists, surgeons and other trained nonphysicians. We have shown, therefore, that with proper training and program structure, registered nurses are able to perform flexible sigmoidoscopy in a safe and thorough manner resulting in a significant increase in access to colorectal cancer screening.

Surgical residents' perceptions on learning gastrointestinal endoscopy: more hours and more standardization wanted.

OBJECTIVE: Gastrointestinal endoscopy is a complex task that involves an interaction of cognitive and manual skills. There is no consensus on the optimal way to teach endoscopy. We sought to evaluate our formal endoscopy curriculum for general surgery trainees to improve the effectiveness and quality of the endoscopy teaching in this program. DESIGN: We conducted focus group sessions over a 2-year period. Participants were general surgery residents, who are at the end of their endoscopy training rotation. The goal was to obtain the opinions and perceptions of trainees actively involved in learning endoscopy. SETTING: University-based general surgery residency. PARTICIPANTS: Second-year general surgery residents. RESULTS: A total of 24 residents participated in 7 focus group sessions over 2 years. Four central themes emerged that included training structure and expectations, development of endoscopy competence, teaching approaches and teaching tools, and recommendations for improvement of the training experience. CONCLUSIONS: An assessment of the themes led to the following concrete suggestions for improvement: the development of an algorithmic approach to endoscopy for the novice learner, consideration to introduce additional experience in endoscopy later in the 5-year surgery program, and consideration to incorporate a train-the-trainer curriculum for faculty that teach endoscopy.