Training and assessment in flexible sigmoidoscopy: using a novel direct observation of procedural skills (DOPS) assessment tool.

BACKGROUND AND AIMS: Data supporting milestone development during flexible sigmoidoscopy (FS) training are lacking. We aimed to present validity evidence for our formative direct observation of procedural skills (DOPS) assessment in FS, and use DOPS to establish competency benchmarks and define learning curves for a national training cohort. METHODS: This prospective UK-wide (211 centres) study included all FS formative DOPS assessments submitted to the national e-portfolio. Reliability was estimated from generalisability theory analysis. Item and global DOPS scores were correlated with lifetime procedure count to study learning curves, with competency benchmarks defined using contrasting groups analysis. Multivariable binary logistic regression was performed to identify independent predictors of DOPS competence. RESULTS: This analysis included 3,616 DOPS submitted for 468 trainees. From generalisability analysis, sources of overall competency score variance included: trainee ability (27%), assessor stringency (15%), assessor subjectivity attributable to the trainee (18%) and case-to-case variation (40%), which enabled the modelling of reliability estimates. The competency benchmark (mean DOPS score: 3.84) was achieved after 150-174 procedures. Across the cohort, competency development occurred in the order of: pre-procedural (50-74), non-technical (75-149), technical (125-174) and post-procedural (175-199) skills. Lifetime procedural count (p<0.001), case difficulty (p<0.001), and lifetime formative DOPS count (p=0.001) were independently associated with DOPS competence, but not trainee or assessor specialty. CONCLUSION: Sigmoidoscopy DOPS can provide valid and reliable assessments of competency during training and can be used to chart competency development. Contrary to earlier studies, based on destination-orientated endpoints, overall competency in sigmoidoscopy was attained after 150 lifetime procedures.

Barriers to colorectal cancer screening among Medicare consumers.

BACKGROUND: Few studies have examined lack of physician recommendation and other reasons for under-utilization of colorectal cancer (CRC) screening in the Medicare population. METHODS: Data from a telephone survey conducted in 2001 in a random sample of Medicare consumers residing in North and South Carolina were used to examine barriers to CRC screening, focusing on consumers' reports of receiving a physician's recommendation to obtain CRC screening and reasons for not being screened. Analyses were restricted to respondents with no history of CRC (n = 1901). Descriptive statistics were used to characterize respondents' CRC screening status, receipt of a physician's recommendation for screening, and reasons for not being screened. Logistic regression modeling was used to examine factors associated with receiving a physician recommendation for fecal occult blood test, sigmoidoscopy, colonoscopy, any endoscopy, and any CRC test. RESULTS: Thirty-one percent of Medicare consumers had never been tested for CRC, and 18% had been tested but were not current with Medicare-covered intervals. Overall, 28% reported not receiving a physician recommendation for screening. Predictors of receiving a physician recommendation included sociodemographic (younger age, white race, more education), health status (increased CRC risk, comorbidity), and healthcare access (had a routine/preventive care visit in the past 12 months) factors. Lack of knowledge/awareness and the physician not ordering the test were commonly cited reasons for not having CRC tests. CONCLUSIONS: Colorectal cancer screening was under-utilized by Medicare consumers in two states, and lack of physician recommendation was an important contributing factor. Providing a benefit under the Medicare program does not ensure its widespread use by consumers or their physicians.

Open-access versus hospital-initiated flexible sigmoidoscopy: a comparative audit of efficacy.

BACKGROUND AND AIMS: There is a continuing demand for the provision of open-access endoscopy services. While open-access gastroscopy is now a well-established practice in most hospitals, open-access flexible sigmoidoscopy (OAS) is not yet available to the same extent. We present our early experience with OAS, a new service provided by our unit. PATIENTS, METHODS AND RESULTS: Over a 12-month period, 255 flexible sigmoidoscopies were carried out (139 OAS and 116 hospital-initiated sigmoidoscopies, HIS). Referral criteria for sigmoidoscopy were similar in both groups, with rectal bleeding and change in bowel habit being the most frequent. RESULTS: The two groups were comparable with regards to age and gender, but patients referred for OAS had symptoms for shorter duration than those referred for HIS (30 +/- 5.6 months v. 101 +/- 28 months, P < 0.00001). The diagnostic yield for OAS was 44% and for HIS 29% (P= 0.01). Significant pathology (colorectal cancer, polyps and newly diagnosed inflammatory bowel disease, colonic strictures) was detected in 31 patients (22%) in the OAS group and 12 patients (10%) in the HIS group (P = 0.02). Six cancers were diagnosed (5 OAS, 1 HIS), all staged Duke A. The waiting times for OAS and HIS were 3.1 +/- 0.3 weeks and 11.4 +/- 1.2 weeks, respectively (P = 0.0001). The diagnostic yield of fibre-optic endoscopy was independent of duration of symptoms, although patients referred for OAS with rectal bleeding and/or diarrhoea had a higher diagnostic yield (55/125, 44%). CONCLUSION: OAS is feasible and effective, with a high diagnostic yield. Such service can usually be provided with minimal added resources.

Prospective, randomized, single-blind comparison of two preparations for screening flexible sigmoidoscopy.

BACKGROUND: The best and most cost-effective bowel cleansing regimen for patients undergoing flexible sigmoidoscopy is not known. The aim of this study was to compare patient tolerance, quality of preparation, and cost of 2 bowel cleansing regimens for flexible sigmoidoscopy. METHODS: Two hundred fifty consecutive patients referred for screening flexible sigmoidoscopy were randomized to receive an oral preparation (45 mL oral sodium phosphate and 10 mg bisacodyl) or an enema preparation (2 Fleet enemas and 10 mg bisacodyl). Tolerance of the preparation was graded as easy, tolerable, slightly difficult, extremely difficult, or intolerable. The endoscopist was blinded to which preparation the patient received and graded the quality of the preparation as poor, fair, good, or excellent. Cost was calculated by adding the cost of the medications and the cost for the nursing time required to prepare the patient for endoscopy. RESULTS: Patients in the oral preparation group were more likely to grade the preparation as easy or tolerable when compared with the enema group (96.8% vs. 56.4%, p < 0.001). The endoscopist graded the quality of the preparation as good or excellent in 86.5% of the patients in the oral preparation group compared with 57.3% in the enema group (p < 0.001). In the oral preparation group, the mean nursing time (34.6 vs. 65.3 minutes, p < 0.001) and cost ($16.39 vs. $31.13, p < 0.001) were significantly less than in the enema group. CONCLUSIONS: An oral sodium phosphate preparation results in a superior quality endoscopic examination that is better tolerated and more cost-effective than enemas in patients undergoing screening flexible sigmoidoscopy.

EndoSheath endoscopic system.

To address the problems inherent in reprocessing endoscopes--the time required (about an hour per use), the difficulty of the process, and the adverse consequences of endoscope contamination--Vision Sciences Inc. introduced the EndoSheath endoscopic system. It consists of a disposable sheath that fits over a specially designed reusable fiberoptic endoscope. When an endoscopic procedure is completed, the sheath is discarded, and the endoscope is wiped with alcohol and reused. We evaluated one of the EndoSheath products--a sheathed sigmoidoscope--for its suitability in an endoscopy suite. We examined the unit and surveyed a number of users. We found that, although it would considerably shorten the time between endoscopic procedures, the unit was not well suited for an endoscopy suite because it provided no more protection than would be afforded by a carefully followed reprocessing protocol. However, users informed us that the sigmoidoscope and one other product--a nasopharyngo-laryngoscope--would likely be useful in a doctor's office or a hospital clinic.

Barriers to office-based screening sigmoidoscopy: does reimbursement cover costs?

Screening with flexible sigmoidoscopy may reduce mortality rates from colorectal cancer. Primary care physicians are able to provide this screening procedure, but many have been reluctant to do so, partly because of the impression that reimbursement rates are inadequate to cover physician costs. This study examines the cost of performing flexible sigmoidoscopy in a primary care practice and compares this cost with the new Medicare reimbursement rate for flexible sigmoidoscopy. Fixed and variable costs associated with the performance of office-based flexible sigmoidoscopy were derived from the published literature. The principal assumption in the analyses is that the time required to perform flexible sigmoidoscopy represents an opportunity cost because the physician could use that time to see additional patients during routine office hours. Sensitivity analyses were done across a range of estimates for the cost variables. When Medicare reimbursement rates were used, the physician's total cost for flexible sigmoidoscopy without biopsy was $86.86, which is similar to the Medicare reimbursement rate for screening flexible sigmoidoscopy (code 45330, $87.84). The calculations were most sensitive to estimates of equipment cost, procedure time, number of procedures performed per year, additional malpractice coverage, and revenue generated per hour of outpatient care. The estimated cost per procedure in a screening program that includes the ability to perform biopsy is $152.93, which exceeds Medicare reimbursement rates across the range of all variables included in the sensitivity analyses. Thus, low reimbursement may limit the adoption of screening flexible sigmoidoscopy with or without biopsy in primary care practices.

Flexible sigmoidoscopy as a mass screening tool.

Endoscopic removal of premalignant adenomas from the distal bowels of the entire population, 3 to 5-yearly from age 50, is advocated in the US as a feasible method of reducing colorectal cancer mortality rates. In the UK, a single flexible sigmoidoscopy (FS) is regarded as a more cost-effective option. Although more acceptable than colonoscopy, FS and polypectomy are expensive and invasive procedures carrying a small risk of serious harm. We believe that, before implementing mass screening, precise estimates are required of the magnitude of the reduction in mortality and costs (financial, physical and emotional). Several randomized trials, including a large British study, are currently evaluating these aspects.

Feasibility of high-volume screening sigmoidoscopy using a flexible fiberoptic endoscope and a disposable sheath system.

OBJECTIVES: Sigmoidoscopy is an effective screening test for colorectal cancer but has yet to have a major impact on mortality because, in part, of inadequate utilization by physicians. To address concerns of inefficient use of time and resources, we examined the feasibility of high volume, single-day flexible sigmoidoscopy (FS) screening sessions using an innovative fiberoptic sigmoidoscope with a disposable sheath system. METHODS: All City of Boston employees over the age of 50 yr (n = 6137) were invited by mail to undergo a screening FS at Boston City Hospital (BCH). Respondents (n = 564) were contacted by phone by the program coordinator on receipt of a prepaid postcard and were scheduled (n = 227) consecutively into 15-min slots on 1 of 6 1/2-day (3-h) weekend sessions. Preregistration was completed at BCH during the week before each session and included enrollment, completion of a brief risk questionnaire, documentation of informed consent, and bowel prep instructions. Procedures were performed by three physician endoscopists rotating among four endoscopy rooms per session. Each room was staffed with a nurse to aid in patient care and a technician to set up equipment. RESULTS: A total of 198 of the 227 (87%) scheduled patients underwent screening FS during the three sessions. Physicians performed a mean of 3.5 procedures per room per hour, or 4.7 procedures per hour overall, with a mean depth of scope insertion of 51 +/- 10 cm and a mean procedure time of 4.7 +/- 3.3 min. Equipment set-up time and patient turnaround time averaged 4.6 +/- 1.7 min and 11.0 +/- 6.0 min, respectively. Polyps were detected in 29 (14.6%) patients, and a Dukes' A cancer was detected in one (0.5%). The only complication was a cardiac arrhythmia. A crude estimate of direct costs approximated $ 75 per examination. CONCLUSION: High volume, single-day FS using the fiberoptic sigmoidoscope with a disposable sheath system offers an effective strategy for enhancing physicians compliance, and possibly patient compliance, with screening sigmoidoscopy through more efficient use of time and resources.

Demographic differences in African-American patients with neoplastic lesions detected by flexible sigmoidoscopy.

There is a higher incidence of colorectal cancer in young African-American patients compared with white Americans. This study examines the incidence, demographic pattern, and distribution of neoplastic lesions identified by flexible sigmoidoscopy in an African-American population. A sample of charts was reviewed from an urban gastroenterology practice that serves predominantly African Americans. A total of 455 patients were found who underwent flexible sigmoidoscopy. The sample included 391 symptomatic patients and 64 asymptomatic patients. Two hundred fifty-five patients were < 50 years old and 200 patients were > or = 50 years. More neoplastic lesions were found among older patients (21 patients: 14 with polyps and 7 cancers) than among younger patients (7 patients: 3 with polyps and 4 cancers); the difference of all positive findings between the two groups was significant. However, the cancerous rate for younger patients was not statistically different from that for older patients. These findings suggest that young African-American patients with colorectal symptoms should undergo aggressive approaches to detect cancer early.

Cost analysis for procedure comparisons.

Using the methodology of activity-based costing as a conceptual framework, the authors present the potential cost reduction of a new office routine and a medical procedure. The costs of a new instrument for colorectal cancer screening and a new surveying and follow-up of at-risk patients show that time and relevant costs in the G.I Clinic and G.I Endoscopy Lab were significantly reduced.

Fluorescein endoscopy. A technique for noninvasive assessment of intestinal ischemia.

Late diagnosis contributes significantly to the mortality and morbidity of mesenteric ischemia. Although flexible endoscopy permits noninvasive assessment of the colon, ischemic colitis is often difficult to differentiate from nonspecific proctitis/colitis or mucosal changes seen in inflammatory bowel diseases. Intravenously administered fluorescein sodium (FSC) has long been used intraoperatively to assess bowel viability because its uptake is inversely proportional to the degree of intestinal ischemia. The authors wished to determine if FSC could be used to augment conventional endoscopy in an attempt to identify and monitor ischemic areas of the bowel within reach of the endoscope. Segmental mesenteric ligation of canine rectum was performed, and serial transanal biopsies obtained. Endoscopy was performed after intravenous FSC administration, using a rigid proctoscope, with a long-wave ultraviolet light source inserted into the lumen of the scope. Areas of nonspecific-appearing proctitis did not take up FSC and were easily differentiated from well-perfused areas by their failure to fluoresce. Ischemic areas were monitored in this manner over a 28-day period. Complete resolution of ischemic mucosal changes occurred with late stricture formation. In humans, the sigmoid and left colon are the areas most frequently affected by ischemic colitis. Because long-wave ultraviolet light is not transmitted through glass fibers, a different light source was needed for potential clinical application. To this end, a single fiber of an argon laser was inserted through the instrument channel of a colonoscope, resulting in greater fluorescence than seen with the ultraviolet light. FSC endoscopy appears to be a sensitive and accurate method of detecting and monitoring ischemic colitis and has many potential clinical applications.

Screening of colorectal cancer.

Colorectal cancer (CRC) remains a cancer in a disappointing location. However, its location clearly has an advantage that could theoretically permit efficient secondary prevention: the preceding of the cancer by a benign lesion, ie, the adenoma. Complete colonoscopy and its substitute, the double-contrast barium enema, and their specific limitations, must be reserved for high-risk patients: hereditary cancers and ulcerative colitis. For all the others, ie, adults of 45 years of age and with standard risks, the proposal is either to select the patients to be colonoscoped through occult blood testing of the stools or to perform a fiber sigmoidoscopy or a combination of both. Although imperfect, both methods allow the detection of polyps and cancers at a presymptomatic stage, when they are either benign or malignant, but localized and with a better prognosis. However, the absolute proof of the benefits of this strategy of screening would be the demonstration by controlled studies of a prolonged survival rate or a decrease in morbidity. Until now, this proof is not fully available.

The long and short of flexible sigmoidoscopy: does it matter?

Physicians performing fiberoptic sigmoidoscopy may choose between a 35 and 60 cm instrument. Confusion and dispute exist concerning the advantages of one over the other. In an effort to resolve this question, 100 consecutive symptomatic patients were examined in an outpatient sigmoidoscopy clinic. Both the Olympus OSF-30 and Olympus OSF-60 flexible sigmoidoscopes were used on each patient alternately. Mean examination time, patient tolerance, diagnostic findings, instrument cost, physician training time, and insertion length were recorded and compared. The longer scope detected five more polyps and 25 additional cases of diverticulosis which were located beyond the reach of the shorter scope. The increased number of findings with the longer scope was expected; however, the increased number of polyps was not statistically significant. The additional number of findings with the longer scope was expected and with increased number of examinations the increased number of polyps may prove to be statistically significant. Neither instrument can substitute for colonoscopy in the overall management of colorectal neoplasms. We conclude that with adequate training and cost control, either instrument can be used for screening proctosigmoidoscopy; but the trend suggests a greater number of polyps are detected with the longer instrument.

Why flexible sigmoidoscopy instead of rigid sigmoidoscopy?

Representative outcome studies describing the procedures of rigid sigmoidoscopy and use of the 60-cm flexible sigmoidoscope are summarized. Subspecialist outcomes are compared with those obtained by family physicians. Family physicians consistently obtain similar insertion depths and diagnostic yields, although comparison is difficult because of referral bias and inconsistency regarding the reporting of hyperplastic polyps. No complications have been reported to date. Low physician and patient compliance with suggested guidelines for sigmoidoscopic examination may be partially responsible for unchanged five-year survival rates for colorectal cancer over the last 30 years. Preliminary studies indicate that the 60-cm flexible sigmoidoscope has improved compliance in at least one setting. Longitudinal cost-benefit studies should be performed in primary care settings.