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Screening for gastrointestinal neoplasia: efficacy and cost of two different approaches in a clinical rehabilitation centre |
Manus B, Bragelmann R, Armbrecht U, Stolte M, Stockbrugger R W |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Faecal occult blood testing (FOBT) and primary sigmoidoscopy in screening for gastrointestinal neoplasia.
Economic study type Cost-effectiveness analysis.
Study population The study population was symptomatic and asymptomatic male and female patients (mainly blue collar workers) with chronic gastrointestinal and metabolic disorders who were referred for 4-6 weeks of medical evaluation and treatment at a clinical rehabilitation centre in Germany.
Setting Hospital. The economic study was carried out inBad Kissingen, Germany.
Dates to which data relate The main effectiveness data were extracted from a clinical trial conducted between 1988 and 1991. Resource and cost data were mainly derived from 1988-91 sources. The price year was 1990.
Source of effectiveness data Effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was undertakenretrospectively on the same patient sample as that used in the effectiveness study.
Study sample A cohort of patients with chronic gastrointestinal and metabolic disorders. The study consisted of two parts.
Study A included 6,560 patients who received the FOBT "Hemofec" test. A total of 6,234 patients returned a complete FOBT, and 186 of these (2.98%) tested positive. These patients were subdivided into four categories: group I (51, 34 male, mean age 52; 17 female, mean age 45) without a history of rectal blood loss; group II (23, 17 male, mean age 45; 6 female, mean age 54) with a history of rectal blood loss within the last 12 months, group III (31, 18 male, mean age 56; 13 female, mean age 58) with a history of rectal blood loss longer than a year ago), group IV (81, 59 male, mean age 40; 22 female, mean age 37) with a known active inflammatory bowel disease such a Crohn's disease or ulcerative colitis.
Study B included 1,166 patients (691 men and 475 women) aged 50-60 years who were recommended to undergo a preventive flexible sigmoidoscopy. Of these a total of 658 patients (56%) agreed to undergo the procedure.
Power calculations to determine the sample size were not stated.
Study design This was a prospective cohort study. Study A lasted for the entire study period and study B covered the second part of the period. In study A, 95% returned a complete test. In study B, 56% agreed to undergo preventive flexible sigmoidoscopy.
Analysis of effectiveness The analysis of the clinical study was based on treatment completers only. The primary health outcomes used in the analysis in study A were: FOBT test results, number of patients who accepted further investigation, number of malignancies detected. The primary health outcomes used in the analysis in study B were: screening sigmoidoscopy results and number of patients who accepted further investigation.
Effectiveness results In study A, 186 patients (2.98%) had a positive FOBT result. 126 of these patients (68%) accepted further investigation and a total of 78 sigmoidoscopies, 78 colonoscopies and 47 gastroscopies were performed. 6 patients in whom a malignancy was detected underwent surgery. In 28 patients CRAs were identified and removed by snare excision. In study B rectosigmoid adenomas were identified in 23% of the total patients. One rectal cancer was found. Of these cases, 116 underwent an additional colonoscopy, disclosing proximal adenomas in 33.6% of the patients.
Clinical conclusions Both strategies appeared highly successful in terms of the yield of malignant and premalignant lesions.
Measure of benefits used in the economic analysis The measure of benefit was the identification of CRA and CRC.
Direct costs Costs of FOBT, sigmoidoscopy, colonoscopy, and gastroscopy tests were included. It was not reported whether quantities/costs were analysed separately or whether costs were discounted. The quantity/cost boundary adopted was the hospital. The date to which the price data refers was not stated.
Estimated benefits used in the economic analysis In study A, 26 of the 186 patients who returned a complete and positive FOBT accepted further investigation and 78 sigmoidoscopies, 78 colonoscopies and 47 gastroscopies were performed. Six patients in whom a malignancy was detected underwent surgery. In 28 patients CRAs were identified and removed by snare excision. In study B, 658/1,166 asymptomatic inrectal cancers were found. Of these cases, 116 underwent an additional colonoscopy, disclosing proximal adenomas in 39 patients (33.6%)
Cost results The total costs were $40,200 in study A and $41,454 in study B.
Synthesis of costs and benefits The cost of identifying one CRA-bearer was estimated to be $1,436 in study A and $271 in study B. The cost of identifying one patient with cancer was estimated to have been $5,435 if the cost of identifying one CRA-bearer were set to $271 as in study B. The cost of finding one patient with cancer was $5,435. The cost of finding one CRA-bearer was $235. The hypothetical cost of identifying one CRA-bearer by using colonoscopy was $581.
Authors' conclusions For the discovery of CRA, mass-screening with sigmoidoscopy of persons above the age of 50 years is advisable. For the detection of both CRA and CRC, screening with FOBT and subsequent endoscopy is an acceptable and cost-effective method.
CRD COMMENTARY - Selection of comparators The reason for the choice of comparator is clear. Both FOBT and primary sigmoidoscopyseem suitable as means of lowering morbidity and mortality from colorectal cancer but there had been little agreement as to which method should be used. You, as a user of this database, should consider whether these are widely used health technologies in your own setting.
Validity of estimate of measure of benefit The estimate of measure of benefit used in the economic analysis is likely to be internally valid.
Validity of estimate of costs Adequate details of methods of quantity/cost estimation were given. Resource and cost data were reported separately and important cost items do not appear to have been omitted.
Other issues The authors' conclusions were justified, given the uncertainties in the data. However, as no sensitivity analysis was conducted, the results need to be treated with some caution. The issue of generalisability to other settings was not addressed. However, appropriate comparisons were made with other studies in terms of pathological findings and acceptance of screening. The results were not presented selectively.
Implications of the study Further research is needed in assessing the impact of screening procedures on duration and quality of the individual life.
Bibliographic details Manus B, Bragelmann R, Armbrecht U, Stolte M, Stockbrugger R W. Screening for gastrointestinal neoplasia: efficacy and cost of two different approaches in a clinical rehabilitation centre. European Journal of Cancer Prevention 1996; 5(1): 49-55 Indexing Status Subject indexing assigned by NLM MeSH Adenoma /prevention & Adult; Colonic Neoplasms /prevention & Colonoscopy /economics; Cost-Benefit Analysis; Costs and Cost Analysis; Endoscopy; Female; Gastrointestinal Neoplasms /prevention & Gastroscopy /economics; Germany; Humans; Male; Mass Screening /economics /methods; Middle Aged; Occult Blood; Prospective Studies; Rectal Neoplasms /prevention & Rehabilitation Centers; Sigmoidoscopy /economics; Stomach Neoplasms /prevention & control; control; control /surgery; control /surgery; control /surgery AccessionNumber 21996000279 Date bibliographic record published 31/03/1999 Date abstract record published 31/03/1999 |
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