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A prenatal trisomy 21 screening program using alpha-fetoprotein, human chorionic gonadotropin, and free estriol assays on maternal dried blood.

OBJECTIVE: The feasibility of large-scale Down syndrome maternal screening with dried blood samples and nonradioactive methods was examined. STUDY DESIGN: A prospective observation study was performed on a nonselected population of 11,241 pregnant women sampled between January 1991 and September 1992, between 14 and 24 weeks' gestation (ultrasonographic scanning available for 91.6%), through a multicenter collaborative network. Enzyme-linked immunosorbent assays for alpha-fetoprotein, human chorionic gonadotropin, and free estriol were performed on dried blood samples. Risk determination was made with an in-house software implementing the multivariate gaussian log likelihood method. RESULTS: A total of 10,450 samples were eligible for the study. Mean age at term was 27.9 years. A total of 6.84% of the patients were > or = 35 years old with a prior risk of trisomy 21 > 1:350. The general positive rate of our sample was 8.15%. After calculation 31.7% with prior risk > 1:350 were still in the high-risk group; 6.36% of the low-risk group were found to be at high risk for Down syndrome. Fifteen trisomic pregnancies were observed, of which 11 had a calculated risk higher than the selected cutoff value (1:350). The overall detection rate was 73%, specificity was 92%, and positive predictive power was 1.2%. CONCLUSION: Our pilot study has shown performances within the range of conventional serum screening programs. Dried blood assays are a handy alternative to serum assays. Blot paper cards represent a simple method of sampling, well fitted for large population screening. Combined with nonradioactive methods, this method appears to be both low cost and effective. The current work apparently is the first large-scale Down screening program performed with dried blood.

Adult↗

Bladder cancer screening program for a petrochemical cohort with potential exposure to beta-napthylamine.

Approximately 1800 workers in pipe manufacturing plants in the United States may have been exposed to beta-napthlyamnine between 1970 and 1996. Once the chemical was detected, the contaminated additive in the resin was identified and discontinued. A bladder cancer-screening program was initiated in 1999. An annual two-stage screening program was developed to test for microscopic hematuria (stage one) and cytology (stage two), with a urology referral of positive or suspicious cytology. This paper presents the program methodology, cohort enumeration, recruitment, and enrollment strategies, and screening protocol. Enrollment data from the first 3 years are presented. Annual screening of a cohort of current and former employees is feasible. Original personnel records are often incomplete, making cohort identification important. Personal contact and follow-up are key elements of successful recruitment and retention.

2-Naphthylamine↗

Implementation of a screening program for chlamydial infection in incarcerated adolescents.

BACKGROUND: In collaboration with the Houston Department of Health and Human Services, the authors implemented and evaluated a urine-based chlamydia screening program in incarcerated youth in Harris County, Texas, and assessed predictor variables for infection. GOAL: To implement and evaluate chlamydia screening in incarcerated youth. STUDY DESIGN: The authors determined prevalence of chlamydial infection, treatment rates, and predictor variables in 589 youth and repeated the measures 6 months later in 975 additional youth. RESULTS: Initially, the prevalence of infection was 9.6% in males and 28.1% in females; 88% of infected youth were treated while incarcerated. White males had a significantly lower prevalence of chlamydial infection; however, consistent condom use was not associated with a lower prevalence of chlamydia. In the 6-month assessment of chlamydia prevalence in 975 youth, prevalence and treatment rates remained high and predictor variables were similar. CONCLUSION: The authors instituted a screening program for chlamydial infection in incarcerated youth that was performing well at reassessment 6 months later.

Adolescent↗

Culturally sensitive breast cancer screening programs for older black women.

Breast cancer is the leading cause of cancer mortality among black women. Elderly black women are particularly vulnerable and suffer the "double jeopardy" effect of older age and minority status. Older black women are not benefiting from the early detection provided through breast cancer screening. Factors that prevent this population from using breast cancer screening include cost, accessibility, availability, lack of knowledge, health care provider variables, and lack of community involvement. Breast cancer screening programs are needed that address cultural diversity to screen women who presently are not seen according to established guidelines. This article focuses on the need for primary care providers to offer culturally sensitive breast cancer screening programs designed for the older black woman. A model is presented based on Leininger's Culture Care Theory and the Health Belief Model. Specific strategies to increase the older black woman's participation in breast cancer screening practices are described.

Black or African American↗

The potential role of serum CA 125 in an ultrasound-based screening program for familial ovarian cancer.

We have assessed the potential role of a test based upon the measurement of serum CA 125 in an ultrasound-based screening program for familial ovarian cancer. A sample of peripheral blood was taken from 1502 self-referred, asymptomatic women whose pedigree showed that at least one close relative had developed the disease. All women in the study underwent one screening by transvaginal ultrasonography (consisting of one or more scans) to detect any persistent lesion and a change in ovarian volume. Women with a positive result were referred for surgery. The concentration of serum CA 125 was measured in all samples at the end of the study. Seven ovarian cancers (4 invasive and 3 of borderline malignancy; 5 FIGO stage Ia, 1 stage IIa, 1 stage III) and 55 benign lesions were detected. We calculated the effect that a prescreening test (based on different threshold values for serum CA 125) would have had on the number of women entering the ultrasound-based screening program, and on the detection rate and false-positive rate of the overall procedure. There was a direct relationship between the number of women referred for ultrasound screening and the detection rate. The use of a threshold value for serum CA 125 > or = 20 U/ml would have meant that 380 women (25.3%) were referred for ultrasonography and 5 out of 7 cancers (71%) would have been detected with a false-positive rate of 1.1%. The odds of a woman with a positive screening result having cancer at surgery would have been about 1:3 (which would improve to about 1:1 if observational indices of color Doppler imaging and a morphological score had been used throughout). We concluded that a prescreening immunochemical test based on the measurement of serum CA 125 (with a threshold value of > or = 20 U/ml) would increase the prior odds for familial ovarian cancer by 2.8, but would lower the overall detection rate by 29% at the prevalence screening.

Adolescent↗

[Mass screening programs for breast cancer in France. Comparative evaluation].

OBJECTIVE: The purpose of this work was to comparatively assess the results of mass screening programs for breast cancer implemented in six French departments in 1986, within the scope of the National Fund for Health Prevention, Education and Information of the National Health Insurance Office of Salaried Workers. MATERIAL AND METHODS: The data collected by the screening centres were analyzed by ten assessment teams that were independent from the program promotion staff, all using the same evaluation form. A complementary population study performed in eight French districts then, allowed assessing the frequency of self-referred screening (mammography performed out of program). RESULTS: The rate of participation in screening programs, in relation to the invited population, ranged from 21 to 48%, according to the district (36% in average). This low participation was probably related to the extent of self-referred screening. In fact, 19 to 40% of women, according to the district, had previously had a screening mammographic coverage: rate was around 68% in women aged 50 to 69 years. Positive findings with mammography ranged from 4.5 to 15.8% (10.1% in average), while intervention rates ranged from 0.7 to 1.6% and detection rates from 3.8 to 6.2%. The ratio between benign tumors and cancers ranged from 0.7 to 2.1 according to the district. In order to enlighten the judgement on French results, we propose a comparison with the international standards in force. CONCLUSION: The various experiences with breast cancer screening in France show that this screening is technically feasible on the basis of existing medical structures. However, some criteria are still below the expected values, especially if compared with international standards. This result is probably accounted for by the high rate self-referred screening before age 40 in France. In these conditions, the question is whether extending breast cancer screening programs in France is an appropriate course of action.

Breast Neoplasms↗

Pitfalls in screening for neonatal hypothyroidism. Report of the New England Regional Screening Program and the New England Congenital Hypothyroidism Collaborative.

This report reviews problems encountered during the first five years of operation of the New England Regional Screening Program. Human error was responsible for either overlooked or delayed diagnosis and treatment in 14/159 infants with hypothyroidism. This group consisted of three infants who were never tested, six infants whose diagnosis was missed because of errors during the processing of the blood specimens, and five additional children in whom the diagnosis of hypothyroidism could not be made at birth because the concentrations of thyroid-stimulating hormone were not elevated. Many of the problems, most of which occurred during the first two years of the study, have been eliminated by improved communication and monitoring. This study emphasizes the potential vulnerability of all screening programs and underscores the need for physicians to continue to exercise their best clinical judgement regardless of the circumstances.

Congenital Hypothyroidism↗

Ontario Maternal Serum Screening Program: practices, knowledge and opinions of health care providers.

OBJECTIVE: To determine the practices, knowledge and opinions of health care providers regarding a prenatal genetic screening program in Ontario. DESIGN: Cross-sectional self-reported survey. SETTING: Ontario. PARTICIPANTS: Random sample of 2000 family physicians, all 565 obstetricians and all 62 registered midwives in the province. Among subjects who were eligible (those providing antenatal care or attending births) the response rates were 91% (778/851), 76% (273/359) and 78% (46/59) respectively. MAIN OUTCOME MEASURES: Which patients were offered maternal serum screening (MSS), how results were being communicated, knowledge of the test's sensitivity, likes and dislikes about MSS and recommendations regarding the program. RESULTS: Most (97%) of respondents stated that they were offering MSS to the pregnant women in their practices; 88% were offering it routinely to all pregnant women (87% of the family physicians, 90% of the obstetricians and 100% of the midwives). Most (92%) of the respondents stated that they communicate positive results to their patients personally as soon as they are received; 23% did so for negative results. The respondents correctly identified the initial positive rate but underestimated the false-positive rate. About one-third did not respond to these knowledge questions. Of those who gave feedback on the screening program, 50% recommended that it not be changed, 29% suggested that it be changed, and 22% recommended that it be scrapped. CONCLUSIONS: Participation in the Ontario Maternal Serum Screening Program by health care providers has been good, although knowledge about MSS is far from ideal. Many providers have reservations about the program. In light of concerns raised about the high false-positive rate and the anxiety such results generate in pregnant women, there is a need for more education of providers and patients and a better understanding of women's experiences with genetic screening.

Abnormalities, Multiple↗

Estimating lead time and sensitivity in a screening program without estimating the incidence in the screened group.

Early indicators of the effectiveness of a screening test for chronic diseases such as breast cancer are the length of time the diagnosis is advanced by screening, the lead time, and the sensitivity of the screening test. This paper describes a model for simultaneously estimating the mean lead time and the sensitivity when only the number of cancers detected at the successive screenings and the number of cancers occurring in the time interval between the screening examinations are known. This model is particularly useful in assessing the effect of screening when the underlying cancer incidence in the screened group is unknown. The model is fitted to the data of 235 screen-detected breast cancer cases and 146 interval cancers diagnosed across 6 screening rounds of the program in Nijmegen. The maximum likelihood estimate for the mean lead time ranges from 1.3 years in the under age 50 group to 2.2 years in the age 50-65 group, both estimates having large confidence intervals. The corresponding sensitivity estimates are 0.92 and 1.00.

Adult↗

The use of a cancer registry in a mass screening program for colorectal cancer.

This paper presents the results of our experiences in utilizing a population-based registry in the follow-up of individuals screened for colorectal cancer. The colorectal screening program under study was conducted in the Western New York area in 1984. A total of 58,934 stool guaiac slide kits were distributed and 11,497 persons returned them for testing. Of these, one or more slides were positive in 264 persons. The names of all persons returning kits for testing were subsequently matched against the names of all individuals reported to the Western New York Tumor Registry as having been diagnosed with colorectal cancer in 1984. Through this mechanism, 18-positive matches were uncovered; 16 were found in the screening registry as having had a positive guaiac test; the remaining 2 were found to have had negative guaiac test results. The results of this screening program and the methods of follow-up employed are discussed.

Colonic Neoplasms↗

[Familial incidence of colorectal carcinoma and its significance for a screening program (the example of Upper Basel area)].

Primary prevention of colorectal carcinoma aims at interruption of the adenoma-carcinoma sequence. Colonoscopy is the most reliable screening method, but up to now has only been recommended for persons at high risk. The ongoing 10-year study defines a possible risk group and determines the efficacy of a preventive screening program based on family history. This paper reports on the descriptive statistics of the first five years. All patients with colonic carcinoma diagnosed between 1987 and 1991 living in the upper part of Canton Basel-Land were registered. According to the family history, patients with at least one first degree relative with colonic carcinoma were defined as index patients. Their first degree relatives entered a prospective screening program which includes colonoscopy. 230 colonic carcinomas were diagnosed in the upper part of Basel-Land, representing an incidence of 48/year/100,000 persons. They included 3 (1.3%) hereditary and 227 (98.7%) sporadic carcinomas. 23 (10%) patients had a positive family history. These patients defined 94 relatives at risk. The incidence of colonic carcinoma in the Canton studied does not differ from that reported in Switzerland. Therefore, this part of Basel-Land can be considered representative. The 1.3% hereditary carcinomas are in contrast to the published data of 6%.

Adenomatous Polyposis Coli↗

A universal newborn hearing screening program in Taiwan.

OBJECTIVE: Mackay Memorial Hospital and the Children's Hearing Foundation established a pilot universal newborn hearing screening program in November 1998. Our objective was to assess the feasibility, accuracy and cost effectiveness of implementing universal newborn hearing screening in Taiwan. METHOD: Between November 1998 and October 2000 a total of 6765 newborns were screened for hearing loss prior to discharge from the wellborn nursery at Mackay Memorial Hospital. The average age of the subjects at the initial screening test was 52 h. The program employed a three stage hearing screening protocol using transient evoked otoacoustic emmisions (TEOAE) screening with referral for diagnostic auditory brainstem response assessment. RESULTS: The mean TEOAE screening time per ear was 41.43 s. The overall pass rate at the time of hospital discharge was 93.6%. Thus achieving an acceptable referral rate of 6.4% for diagnostic audiological assessments. Nine newborns were identified with permanent bilateral hearing impairment. 26 newborns were identified with permanent unilateral hearing impairment. Infants identified with bilateral hearing loss were immediately referred to the Children's Hearing Foundation for hearing aid assessment and fitting. Infants as young as 5 weeks of age were successfully fitted with hearing instruments and enrolled in the family centered early intervention program at the Children's Hearing Foundation. CONCLUSION: The frequency of bilateral congenital hearing loss requiring amplification in this population is shown to be approximately 1 in 752 newborns. This finding is consistent with previous research, which has indicated hearing loss to be the most frequently occurring birth defect. Universal newborn hearing screening using TEOAEs proved to be a cost effective and feasible method of identifying congenital hearing loss in Taiwan. The existence of many successful screening programs worldwide and the availability of fast, objective, reliable and inexpensive hearing screening procedures means that universal newborn hearing screening is becoming the standard of care.

Acoustic Stimulation↗

Incidental findings in a federally-sponsored cancer screening program.

The volume of non-cancer related clinical services and referrals for medical care of women as a consequence of their enrollment in a federally-sponsored breast and cervical cancer screening program was examined. We randomly sampled 100 medical records from among 389 individuals who received cancer screening services through the Connecticut Breast and Cervical Cancer Early Detection Program. Medical record audits tabulated occasions when women were offered or received diagnostic or therapeutic procedures as a by product of their program participation. Breast screening was provided to 100 women and 49 individuals received cervical cancer screening. In addition, 87 percent of the sample were offered or received one or more non-cancer related health services. Physical exams were provided to 86 women, laboratory tests were ordered for 11 individuals and 55 referrals were made to address a myriad of specific medical needs that were uncovered incidental to breast and cervical cancer screening. Among 26 women who did not heed recommendations for follow-up care, cost, inconvenience and beliefs that medical problems were not immediate concerns were cited. Local screening program sponsors should be cognizant that the health care needs and limited resources of some target populations may be substantial. Mechanisms to assure that needed health care is available to individuals should be built and into all categorical health service programs.

Attitude to Health↗

Addressing unanswered questions about population cholesterol screenings: the Model Systems for Blood Cholesterol Screening Program.

Elevated blood cholesterol is one of the three major modifiable risk factors for heart disease. Almost 60% of adults in the United States have an elevated blood cholesterol level, yet most adults are unaware of their level. The National Heart, Lung and Blood Institute (NHLBI) and other organizations have now recommended that all adults be tested to assess their blood cholesterol level. New portable blood cholesterol analyzers have recently been designed and are being promoted widely for cholesterol screening. However, there are many unanswered questions about the reliability of these devices and about the usefulness of mass cholesterol screening programs. The Model Systems for Blood Cholesterol Screening Program, an NHLBI-funded effort consisting of three research projects designed to provide a systematic evaluation of these devices and of mass cholesterol screening, is described. This research will contribute to a data base from which recommendations regarding public cholesterol screening will be made.

Adult↗

Considering school health program screening services as a cost offset: a comparison of existing reimbursements in one state.

This paper reports results of an analysis of the approximate costs of Colorado school health program screening activities during the 1993/94 school year had they been conducted elsewhere in the public or private sectors. School nurses and health aides performed 1,161,779 screening procedures during the year, an average of 1.93 per child enrolled in school districts throughout the state. Charges for Current Procedures Terminology (CPT) codes, which correspond to school health program screening activities, were used to approximate market value. Conservative assumptions were made regarding provider skill and time requirements as well as student service utilization profiles. The general dimension of the contribution of school health screening activities was found to be impressive.

Colorado↗

A pilot community-based screening program for gestational diabetes.

A pilot community-based screening program for gestational diabetes has been in operation in Cleveland, Ohio, since April 1, 1977. A socioeconomic and racially heterogeneous group of pregnant women are being routinely tested at approximately 24-28 wk of gestation by a capillary whole blood glucose determination, 2-h after a 75-g oral challenge. The results of the first 2225 screenings are analyzed in terms of the variables of maternal race, age, and stage of gestation. The overall incidence of positive screenings (greater than or equal to 120 mg/dl) is shown to be 11.5%, with significantly more positive tests among the whites than the nonwhites. Follow-up oral glucose tolerance testing results in an overall detection rate for abnormal carbohydrate metabolism of 3.1%. The data suggest that a 2-h screening procedure is more efficient than a 1-h procedure in that fewer confirmatory glucose tolerance tests need to be performed in order to yield this rate of detection. It may soon be feasible to introduce such a program on a wider community basis in concert with regionalized perinatal care.

Black People↗

Radiologic aspects of breast cancers detected through a breast cancer screening program.

Early detection of breast cancer and reduced mortality in women with this disease is today attributed to the widespread use of mammography. High-quality performance is essential in every step of breast cancer screening programs in order to avoid unnecessary anxiety and surgery in the women concerned. This report presents the radiologic aspects of screening cancers. A total of 8370 asymptomatic women aged between 50-69 years were screened with 2-view mammography, of which only 70 (0.84%) were selected for surgery after a thorough work-up. Cancers were verified histologically in 61 women and 9 showed non-malignant histology, giving a cancer detection rate of 7.3 cancers per thousand screened asymptomatic woman. The benign/malignant ratio in the operated cases is thus approximately 1:7. The cancers detected showed all existing types of mammographic features where 77% (47 cases) showed rather typical findings, such as spiculated densities both with and without microcalcifications and with microcalcifications only. The remaining 23% (14 cases) showed parenchymal distortions, asymmetric and well-defined densities, both with and without calcifications. Our results indicate that surgery can be minimized without impairing the breast cancer detection rate. Radiologists in screening programs should be aware that a large proportion of non-palpable breast cancers present in rather unconventional forms. This point is important in order to maintain a high cancer detection rate and thereby justify the widespread use of mammography as a screening tool for breast cancer in asymptomatic women.

Aged↗

[Screening program for alpha-1 antitrypsin deficiency in patients with chronic obstructive pulmonary disease, using dried blood spots on filter paper].

Alpha-1 antitrypsin (AAT) deficiency is an under-diagnosed disease and screening programs have therefore been recommended for patients with chronic obstructive pulmonary disease (COPD). We present the results of the pilot phase of a screening program for AAT deficiency in order to evaluate the technique used, the procedures for transporting samples and the results obtained. Over a period of one month, five centers collected samples from all COPD patients for whom plasma concentrations of AAT or Pi phenotype had not yet been determined. Capillary blood spots were dried on filter paper and then sent by surface mail to a central laboratory for study. An immunonephelometric assay was used to determine AAT and DNA phenotyping was done by use of a Light Cycler. Samples were analyzed from 86 COPD patients (76 men, 10 women) with a mean age of 68.2 years. AAT deficiency was ruled out for 74 patients (86%) who had concentrations above the cutoff established, although one of them was MZ heterozygote by genotype. Among the 12 remaining patients (13.9%), only two also had a Z allele. The rest were individuals with concentrations below the established threshold and no evidence of a Z allele (10 patients, 11.6%). The Z allele frequency observed (3/172; 1.74%) was very similar to that found in the general population. The results of this pilot study allowed us to confirm that the method used to collect samples worked well. The sampling method is applicable, easy and well-accepted by participating physicians. It allowed AAT concentrations and Z allele deficiency to be determined. The method correlates well with standard techniques used for samples in whole blood.

Aged↗