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Cluster randomization trial of sequence mass screening for colorectal cancer.

PURPOSE: Colorectal cancer is a major cause of death worldwide. To reduce the incidence and mortality from rectal cancer, an individual quantitative risk-assessment model (hereafter referred to as the Attributive Degree Value) and reverse passive hemagglutination fecal occult blood test were used in a randomized, controlled, population-based trial that was conducted in Jiashan County, People's Republic of China. METHODS: All residents of Jiashan County aged 30 years or older were enrolled in the study, and 21 townships in the county were randomized to either a screening (n = 10 townships) or control (n = 11 townships) group. Participants in the screened group submitted a one-article-per-slide stool sample and completed a structured risk-assessment questionnaire from which their attributive degree value was computed. According to study protocol, 4,299 participants were defined as high risk and underwent diagnostic evaluation with 60-cm flexible sigmoidoscopy and, in some cases, an additional screening with colonoscopy. RESULTS: From 1989 to 1996, cumulative mortality from colon cancer was 90 (95 percent confidence interval, 83-97) per 100,000 in the screened group and 83 (95 percent confidence interval, 76-90) per 100,000 in the control group (log-rank P = 1.49, P = 0.222). Mortality from rectal cancer during this time was 110 (95 percent confidence interval, 102-118) per 100,000 in the screened group, which differed significantly from the control group mortality rate of 161 (95 percent confidence interval, 152-170) per 100,000 (log-rank P = 0.003). CONCLUSION: Mass screening with a reverse passive hemagglutination fecal occult blood test along with an individual attributive degree value score was effective in reducing mortality from rectal cancer but not in reducing mortality from colon cancer or the incidence of colorectal cancer.

Adult↗

[Mass screening for breast cancer].

A CONTROVERSIAL SUBJECT: Several large randomised studies have demonstrated a reduction in mortality due to breast cancer of around 30% in women aged over 50, with the development of systematic mammography. There are data also suggesting an identical benefit in women aged 40 to 49, when screening is intensified. A recent meta-analysis has contradicted the results of randomised studies on screening, but this study is clearly debatable. THE SITUATION IN FRANCE: No randomised study has been organised. A national program is aimed at screening 7 400 000 women aged 50 to 74. THE KEY TO SUCCESS: The active participation of women, health professionals and public authorities is the fundamental condition for a well-organised mass screening.

Adult↗

[Preliminary results with the rapid fluorescence test (Weidemann) as mass screening procedure for galactosaemia in newborn infants (author transl)].

A fluorescence test was introduced in October 1974 as a screening procedure for galactosaemia in newborn infants and has been performed parallel with the Guthrie test. It is simple faster, but less sensitive (lower limit: 30 mg% galactose) than the Guthrie test. The fluorescence test provides a time saving of 1 1/2 days (3 1/2 days at weekends) which is of great importance in the diagnosis of this frequently fulminant illness. A further advantage is the high substrate specifity. One case of galactosaemia was diagnosed and only 1 false positive result was obtained amongst 50.000 screened infants, in comparison with 14 false positive results (greater than of equal to 30mg% galactose) with the Guthrie test. Of the 21 cases of galactosaemia detected to date by means of the mass screening programme 18 were due to transferase deficiency and two thirds of these cases ran a fulminant course. Initial blood galactose levels of greater than or equal to 50 mg% were registered in nearly all the cases of galactosaemia but levels of greater than or equal to 30mg% were found in 2 infants. The fluorescence test is a valuable supplementary screening test for galactosaemia but cannot replace the sensitive Guthrie test.

False Positive Reactions↗

[Economic evaluation of population-based mass screening for the early detection of cancer: a systematic review].

PURPOSE: The increasing premature mortality due to cancer has made population based screening programs for cervical,breast and colorectal cancers inevitable in Hungary. However, when confronted with limited resources, the aim is that, within the budget constrain, the greatest possible health gain should be "produced". METHODS: The authors made a systematic review of the international literature concerning the cost-effectiveness of screening programs for the above tumours. RESULTS: In case of cervical cancer the Papanicolaou test, in case of breast cancer the mammography meet the WHO criteria for population-based mass screening. The well-designed organised screening programs are more cost-effective than the opportunistic screening. Among sexually active women, according to structure the mobile screening buses, according to age group screening of the 30-39 years old women seems the most favourable. For breast cancer, screening the 60-70 years old population every second year is the reference strategy from a health economic perspective. The cost-effectiveness results of either increasing the frequency of screening, extending the program for other age groups, or selecting a high-risk population are contradictory. In case of colorectal cancer there is no screening method, which would meet the WHO criteria. The two-day FOBT seems the most favourable, followed by colonoscopy for positive results, in the 55-74 years old population every second year. CONCLUSION: In addition to fulfilling requirements for a population-based screening method, the cost-effectiveness perspective should be taken into account.

Adolescent↗

[Comparison of two types of mass screening for lung cancer in terms of cost-effectiveness: indirect chest X-ray vs LSCT].

Mass screening for lung cancer is widely performed in Japan, with the photofluoroscopic examination and sputum cytology used as the screening methods. However the clinical efficacy of these screening methods is considered to be inadequate in terms of the survival rate of the screened population. In the previous report we proposed that a specially designed CT technique, called lung cancer screening CT (LSCT), may be useful in screening for lung cancer. In this paper a preliminary comparison is made between the present and future methods of lung cancer screening in terms of cost-effectiveness. A model for cost-effectiveness analysis estimates the net life-years saved by screening and then determines the direct cost of screening including cost of therapy. Various factors are taken into account such as sensitivity of the screening methods, rate of participation in detailed examination, 5-year survival rate of the screened population, cost of the screening method, and average cost of therapy for screen-detected patients and outpatients. An example of the results is as follows: for a population with a lung cancer incidence of 200 x 10(-5) person/year and life expectancy of 30 years, the net person years saved are 672 x 10(-5) for the present screening method and 2376 x 10(-5) for LSCT screening. The cost required to save one person year are 1.46 x 10(5) yen for the present screening method and 2.03 x 10(5) yen for LSCT screening.(ABSTRACT TRUNCATED AT 250 WORDS)

Cost-Benefit Analysis↗

Colonoscopy as a mass screening tool.

There is strong evidence that population screening can reduce mortality from colorectal cancer. Screening tests such as faecal occult blood test and flexible sigmoidoscopy are used to identify patients with an increased risk of cancer who would benefit from a full colon examination. There is indirect evidence that colonoscopy may be effective as a mass screening tool. Potential benefits of colonoscopy include the ability to visualize the entire colon and to detect and remove polyps, which could prevent cancers, and identify cancers if present anywhere in the colon. Issues related to the implementation of a colonoscopy screening programme are discussed.

Colonoscopy↗

Clinical application of serum pepsinogen I and II levels for mass screening to detect gastric cancer.

A considerable number of gastric cancers derive from stomach mucosa where chronic atrophic gastritis is severe and extensive. Based on the fact that the serum pepsinogen levels provide a precise measure of the extent of chronic atrophic gastritis, we have devised a mass screening method involving serum pepsinogen measurement to identify subjects at high risk of gastric cancer. In 1991, we screened 4,647 workers (male: 4,113, female: 534, mean age: 49.0 years) at a Japanese company using this method. Out of 875 subjects (18.8%) with a serum pepsinogen I level of less than 50 micrograms/liter and a pepsinogen I/II ratio of less than 3.0, 676 subjects (14.5%) were selected for further investigation by endoscopy. This led to the detection of four subjects (0.086%) with gastric cancer (three in an early stage) and four subjects with adenoma. The cancer detection rate of this new screening method was comparable, and in some respects superior, to that of the traditional barium X-ray screening. Since the incidence of test-positive subjects was as low as 10% amongst subjects aged less than 40, this screening method appears to be especially useful for screening of younger generations. The new method is less expensive than the traditional barium X-ray and subjects experience little discomfort. Further, many serum samples can be quickly measured simultaneously. The results of this study have indicated that serum pepsinogen screening provides a valuable method for detecting gastric cancers.

Adenoma↗

[Evaluation of mass-screening for cervical cancer in Santo-Cho. Effect of repeat cytological screening].

A cytological screening program for the early detection of cervical cancer was started in the county of Santoh-Choh, north-eastern Shiga Prefecture in 1969. During the first four years between 1969 and 1972 all of the women aged more than 35 resident in this county took part in the screening program, and cervical cancer was found in 15 women out of a population of 2,960. The annual detection rate of 0.25% for the disease during this period was significantly higher than the average rate of 0.16% for the whole of Shiga Prefecture. Cervical cancer detection frequency in this county has subsequently been reduced over 7 years to about one third (0.09%) of the frequency before 1972. In this county, cervical cancer was found in three women who had received the annual repeat screenings more than three times. Re-evaluation of the previous smears in these patients revealed that two smears should have been diagnosed as positive. The present findings indicate that the effects of a mass-screening program may be improved by (1) the participation, at least once, in the screening program by all female residents, (2) annual repeat screening for more than three years and (3) adequate quality and/or accuracy control in the laboratory.

Adult↗

Follow up study on children with dyslipidaemia detected by mass screening at 18 months of age: effect of 12 months dietary treatment.

The present study was done to evaluate the effect of short-term dietary therapy on 148 dyslipidaemic children (24 familial hypercholesterolaemia, 105 non-familial hypercholesterolaemia and 19 hypertriglyceridaemia), detected by mass screening in children at 18 months of age. In the model diet used for treatment, 15% of the total calories were obtained from protein, 27% from fat and 57% from carbohydrate. Cholesterol intake was set at < 200 mg/day and the ratio of polyunsaturated to saturated fatty acid (P/S ratio) was 1.2. When compared to the composition of the diet ingested by the dyslipidaemic children, only the P/S ratio changed from 0.7 to 1.2. During 12 months treatment, levels of total cholesterol, low density lipoproteins cholesterol and apoB decreased by 10%-15% in children with familial and non-familial hypercholesterolaemia. There was no significant change in the levels of high density lipoproteins. In 19 children with hypertriglyceridaemia, the intake of carbohydrate was limited to 55% of the total calories consumed and after 12 months of treatment, triglyceride levels reverted to normal. Throughout the study period, approximately 70% of the children on this dietary therapy were seen in our clinics every 3-6 months and physical development was within normal ranges. These results, taken together, indicate that dietary therapy can be effective for correcting dyslipidaemia, even in young children.

Analysis of Variance↗

Principles in mass screening for breast cancer.

The only proven means to reduce mortality from breast cancer is detection of the disease when it is still localized to the breast. Such a cancer is usually without signs or symptoms and often not even palpable and can be detected only through mass screening. The H.I.P. study has demonstrated a 30% reduction in mortality in a randomized study group compared to a matched control. The reduction has persisted over 14 years of follow up. Questions of potential hazard from x-ray radiation, questionable significant benefit in women under 50 years, cost and motivation are discussed.

Breast Neoplasms↗

[Detection and prognosis of alimentary tract cancers--mass screening].

The limitation of detectability and curability in terms of current techniques (screening and details) were sought in otherwise healthy examinees. Not a few cancers were present in the alimentary tract, except for the stomach, in these otherwise healthy examinees who voluntarily underwent gastric cancer mass screening. The prognosis of alimentary tract cancers deteriorates in the descending, following order: colon cancer, stomach cancer, and esophageal cancer. The survival rate of primary liver cancer, cholecyst cancer, and pancreas cancer is extremely low. Unless new techniques are developed in these diagnoses, no improvement in the survival rate can be anticipated.

Digestive System Neoplasms↗

Establishment of cut off values for vanillylmandelic acid and homovanillic acid in 24-hr urine accumulation during mass screening for neuroblastoma.

The establishment of cut off values in vanillylmandelic acid (VMA) and homovanillic acid (HVA) in 24-hr urine specimens for the purpose of separating true positive cases from normal infants has been discussed. The specimens were collected at the time when thorough examinations under a mass screening programme for neuroblastoma were taking place, and data from 17 infants with neuroblastoma (patients) and 50 healthy infants (controls) have been employed. The function square root VMA2 + HVA2 = 34 (micrograms/mg of creatinine) separated the two groups with no overlapping cases. This function represents the distance from the origin of the VMA-HVA co-ordinates, and is thought to be one of the most reasonable discriminant methods when considering the distribution pattern of the data for normal cases and patients.

Chromatography, High Pressure Liquid↗

Trends in breast cancer aggressiveness before the introduction of mass screening in southeastern Netherlands 1975-1989.

OBJECTIVE: The increased incidence of breast cancer in the southeastern Netherlands was accompanied by markedly improved relative survival and stable mortality. We investigated whether the average aggressiveness of tumors changed over time in a population-based study, before the introduction of mass screening. METHODS: The mitotic activity index (MAI) was determined retrospectively for 1051 consecutive patients diagnosed with invasive, non-metastatic breast cancer in 1975, 1981, 1988, and 1989. Trends over time, and effects of age, tumor size and lymph node status were examined by univariate and multivariate regressions. RESULTS: Age-adjusted incidence of low MAI tumors changed from 35/100,000 in 1975 to 45/100,000 in 1988-89, an increase of 30% (P = 0.01), the incidence of tumors with a high MAI increased about 20% (P = 0.28), from 25 to 29/100,000. For small tumors (T1) the odds for a high MAI was lower in 1981 (OR: 0.80; 95% CI: 0.37-1.73) and 1988-89 (OR: 0.66; 95% CI: 0.35-1.23) compared to 1975. Among T3 and T4 tumors the odds increased to 2.03 (95% Cl: 0.71-5.86) in 1981 and 2.16 (0.76-6.18) in 1988-89. CONCLUSION: Although the incidence of tumors with low aggressive potential increased, the incidence of high MAI tumors also increased. Stable breast cancer mortality rates in the face of increasing incidence rates during the period 1975-89 cannot be attributed solely to changes in tumor aggressiveness; early diagnosis and better treatment may also have contributed.

Adult↗

A thin-layer, liquid-based pap test for mass screening in an area of China with a high incidence of cervical carcinoma. A cross-sectional, comparative study.

OBJECTIVE: To confirm the accuracy of the ThinPrep Pap Test (Cytyc Corp., Boxborough, Massachusetts, U.S.A.) on the basis of histologic diagnosis by biopsy and the detection of human papillomavirus (HPV) DNA in mass screening. STUDY DESIGN: A total of 1,997 women residing in Xiangyuan County, Shanxi Province, P.R.C., an area with a high incidence of cervical carcinoma, were enrolled in this study. We collected exfoliative cervical samples from all subjects into a liquid buffer (Preserv-Cyt [Cytyc]) and utilized for both cytologic screening using the ThinPrep Pap Test and HPV DNA testing. Subsequent colposcopic biopsies were taken on all subjects. All the tests were performed in an independent and blinded fashion. We compared the ThinPrep Pap test with colposcopic biopsy and HPV test. RESULTS: High grade squamous intraepithelial lesions (HSIL) (CIN 2/3) were identified in 74 (3.7%) of 1,993 women adequately assessed, and there were 12 cases of squamous cell carcinoma (SCC). The false negative rate of ThinPrep cytology was 3.2% for biopsy-confirmed CIN 3 and 9.3% for CIN 2. Twenty-seven (87%) of the 31 women with biopsy-confirmed CIN 3 and 12 (100%) of 12 with biopsy-confirmed SCC had a diagnosis of either HSIL or greater abnormalities on ThinPrep cytology. In addition, the HPV DNA detection rates offered a good correlation between cytology and biopsy. CONCLUSION: The ThinPrep Pap performed extremely well in this primary screening trial. We found a good correlation between ThinPrep cytology and colposcopic biopsy on detection of HSIL and SCC; cervical specimens collected in ThinPrep liquid buffer serve as a direct test for HPV as well.

Adult↗

Results of a repeat television-advertised mass screening program for colorectal cancer using fecal occult blood tests.

The results of a 1987 television-advertised colorectal screening program using fecal occult blood tests (FOBT) are compared with the initial 1986 program (results in parentheses). In the 1987 program, 73,508 fecal occult blood test (FOBT) kits were distributed free of charge, of which 63% were returned for analysis (57,000, 53%). Twenty-five percent of persons from the initial screening participated again in the 1987 program: 1,303 or 2.8% of persons had a positive screen (1,165, 3.9%). The predictive value of a positive screen was 23% for an adenomatous polyp and 8% for colorectal cancer (22%, 8%). Seventy-nine percent of the cancers detected were Dukes A or B or carcinoma in situ (78%). In order to promote a more thorough diagnostic work-up in positive screenes, a suggested diagnostic algorithm for the work-up of a positive FOBT was sent to participating physicians. Despite this, 35% of positive screenees had a diagnostic work-up limited to a repeat FOBT, and/or sigmoidoscopy only (32%). In conclusion, television-advertised mass screening programs consistently enroll large numbers of participants. The rate of compliance (percent of kits returned) and the limited diagnostic evaluation of persons with a positive screen appear to be the major factors limiting the success of our screening program.

Adenocarcinoma↗

[Microdetermination of TSH in dried blood spot--its use in the mass-screening for congenital or juvenile primary hypothyroidism (author's transl)].

Blood TSH (Thyroid Stimulating Hormone) was successfully measured by radioimmunoassay in a dried blood spot on filter paper which is obtained in newborn screening for metabolic disorders. By this method, the minimal detectable level of blood TSH was about 10 muU/ml, which is the approximate upper limit of normal values of blood TSH. Good correlation was found between the TSH values obtained from this specimen and from liquid serum samples from the same subjects. The duplication of assay of a single sample was not necessary. A screening program using the method described here was initiated and a 4 year old infant was found to have primary hypothyroidism, later verified by other testing methods. Since the technique is simple and adequately sensitive for the detection of hypothyroidism, it could be a valuable method for use in mass-screening of newborns for congenital hypothyroidism.

Child, Preschool↗