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On the catch-up time method for analyzing cancer screening trials.

In randomized cancer screening trials, the ratio of the mortality rate for the screened group to that for the control group is typically not constant as a function of years from randomization. This is due to an initial lag effect, but also to a dilution effect that results from the accrual of comparable cases in both groups after the end of the screening period. In order to combat the potential loss of power when applying conventional analysis tools, specifically the logrank test, Aron and Prorok (International Journal of Epidemiology 15, 36-43), have advocated analyzing the mortality experience using only the subcohort of cases ascertained within a given time period. However, it is not clear how to select an appropriate case ascertainment point, since this will depend on aspects of the natural history of the disease process which are poorly identified. Aron and Prorok suggest choosing the case ascertainment point to be the point at which the cumulative number of cases in the control group first becomes equal to that in the intervention group, that is, the "catch-up time." In this paper, we undertake a thorough evaluation of the bias and power properties of the catch-up time method. We base our study on simulated data resembling the Health Insurance Plan of Greater New York study cohort. We consider several models for postdiagnosis survival under the null hypothesis of no screening effect on mortality, and under the alternative hypothesis of an effect of screening. We show that the catch-up method can yield tests with sizeable bias. In the absence of detailed knowledge about the underlying disease process, we suggest some adaptive tests that maintain nominal size but have more attractive power properties than the standard logrank test.

Adult↗

Organization and results of cervical cancer screening in the German Democratic Republic.

This paper describes the introduction of a cervical cancer screening programme in the German Democratic Republic after conclusions were drawn from two pilot studies. The pilot studies were carried out to decide between two organizational structures: computerized monitoring, such as invitations to participate, versus full integration of the programme into the basic gynaecological health care system. Since similarly high attendance rates were obtained in the two systems, the recommendation for the GDR as a whole was to conform with the noncomputerized system. This programme has been implemented in Berlin, capital of the GDR, for ten years. Incidence decreased rapidly among women of all ages (33% lower than at the beginning) and for women aged 40-49 (58% lower). Mortality rates for women of all ages are now 37% lower, and for women of ages 50-59, 57% lower. A comparison of incidence in the screened and unscreened population shows that nonparticipants have a relative risk of 3.0 for developing the disease and of 11.3 for dying from the disease. In an analysis of the failures of screening, the cervical smears of 184 previously screened cancer cases were re-examined. In 48% no reason for failure was found. Possibilities for improving the results further, including a screening registry, are discussed.

Adult↗

Patient education for informed decision making about prostate cancer screening: a randomized controlled trial with 1-year follow-up.

PURPOSE: The efficacy of prostate cancer screening is uncertain, and professional organizations recommend educating patients about potential harms and benefits. We evaluated the effect of a videotape decision aid on promoting informed decision making about prostate cancer screening among primary care patients. METHODS: A group of 160 men, 45 to 70 years of age, with no history of prostate cancer, were randomized to view or not to view a 20-minute educational videotape before a routine office visit at a university-based family medicine clinic. The subjects were contacted again 1 year after their visit to assess their receipt of prostate cancer screening (digital rectal examination [DRE] or prostate-specific antigen [PSA] testing), their satisfaction with their screening decision, and knowledge retention since the baseline assessment. RESULTS: Follow-up assessments were completed for 87.5% of the intervention subjects and 83.8% of the control subjects. The rate of DRE did not differ between the 2 groups. Prostate-specific antigen testing was reported by 24 of 70 (34.3%) intervention subjects and 37 of 67 (55.2%) control subjects (P = .01). African American men were more likely to have had PSA testing (9 of 16, 56.3%) than were white men (13 of 46, 28.3%) (P = .044). Satisfaction with the screening decision did not differ between the study groups. Intervention subjects were more knowledgeable of prostate cancer screening than were control subjects, although these differences declined within 1 year (P < .001). CONCLUSIONS: Decision aids for prostate cancer screening can have a long-term effect on screening behavior and appear to promote informed decision making.

Aged↗

Breast cancer screening.

PURPOSE AND DESIGN: Three breast cancer screening methods are commonly employed: mammography, breast self examination (BSE), and physical examination by trained personnel (PE). Case-control, retrospective, and prospective studies have examined the efficacy of these screening modalities in reducing breast cancer mortality. However, there are three biases pertinent to many of these studies: lead-time, length, and selection biases. The best way to exclude these biases is to compare screened and unscreened women in a randomized controlled trial with breast cancer mortality as the end point. Eight trials have examined the effect of mammographic screening on breast cancer mortality and two have examined the impact of screening with BSE. In addition, a large trial will soon be initiated in India to assess the impact of screening by PE on breast cancer mortality. This article reviews these trials and discusses the implications of the studies. RESULTS: The overall results of the randomized controlled trials indicate that mammographic screening in women over age 50 can reduce breast cancer mortality by about 25%. However, its efficacy in women between the ages of 40 and 49 is disputed, and another large trial has been initiated in the United Kingdom to resolve this controversy. Preliminary results of two trials indicate that BSE has no impact on breast cancer mortality. However, longer follow-up of these trials is necessary before drawing any conclusions regarding BSE. CONCLUSIONS: Mammographic screening in postmenopausal women is an effective means of reducing breast cancer mortality. However, the impact of mammographic screening on breast cancer mortality in premenopausal women is disputed. At least four potentially harmful consequences of mammographic screening merit consideration: lead time effect, radiation exposure, false-positives, and overdiagnosis. Thus, women between the ages of 40 and 49, in particular, should be informed of the potential for benefit and harm prior to mammographic screening.

Adult↗

Ovarian cancer screening.

BACKGROUND: The three most extensively evaluated screening methods for ovarian cancer are pelvic examination, serum CA 125, and transvaginal sonography (TVS). The lack of sensitivity of pelvic examination and serum CA 125 has limited their use in ovarian cancer screening. Currently, the most effective screening method for ovarian cancer is TVS. METHODS: Transvaginal sonography was performed with a standard ultrasound unit and a 5.0 MHz vaginal transducer. Each ovary was measured in three dimensions and ovarian volume was calculated using the prolate ellipsoid formula (L x H x W x 0.523). An ovarian volume greater than or equal to 20 cm3 in premenopausal women and greater than or equal to 10 cm3 in postmenopausal women was considered abnormal. Also, any internal papillary projection from the tumor wall was considered abnormal. A patient with an abnormal screen had a repeat TVS in 4-6 weeks. Women with a persisting abnormality on TVS underwent pelvic examination, serum CA 125 determination, Doppler flow sonography, and tumor morphologic indexing before operative tumor removal. RESULTS: Eighty-five hundred asymptomatic women underwent TVS screening. One hundred twenty-one of these women had a persisting abnormality and underwent tumor removal. Fifty-seven patients had serous cystadenomas and eight had primary ovarian cancers. Six patients had Stage IA ovarian cancer, one had Stage IIC ovarian cancer, and one had Stage IIIB ovarian cancer. Only one of these patients had palpable ovarian enlargement on clinical examination and one had an elevated serum CA 125. All patients are alive and well 4-61 months after conventional therapy. The direct cost of TVS screening was highest during the initial years of the program and fell progressively to $30/screen during the 4th year of the study. Worldwide, more than 14,000 women have been screened using ultrasonography, and 19 ovarian cancers have been detected. More than 20,000 patient-screening-years have been accrued, and there have been no deaths from primary ovarian cancer in the screened population. CONCLUSIONS: Transvaginal sonography screening causes a decrease in stage at detection and a decrease in case-specific mortality. Further study is needed to determine if annual TVS screening will significantly reduce ovarian cancer mortality. The cost for TVS screening is reasonable and is well within the range of that reported for other screening tests.

Biomarkers, Tumor↗

Development of a brief survey on colon cancer screening knowledge and attitudes among veterans.

INTRODUCTION: Poor knowledge of and negative attitudes toward available screening tests may account in part for colorectal cancer screening rates being the lowest among 17 quality measures reported for the Department of Veterans Affairs health care system, the largest integrated health system in the United States. The purpose of this study was to develop a brief assessment tool to evaluate knowledge and attitudes among veterans toward colorectal cancer screening options. METHODS: A 44-item questionnaire was developed to assess knowledge, attitudes, and beliefs about colorectal cancer and screening and was then administered as part of an ongoing randomized controlled trial among 388 veterans receiving care in a general medicine clinic. Sixteen candidate items on colorectal cancer knowledge, attitudes, and beliefs were selected for further evaluation using principal components analysis. Two sets of items were then further analyzed. RESULTS: Because the Cronbach alpha for beliefs was low (alpha = 0.06), the beliefs subscale was deleted from further consideration. The final scale consisted of seven items: a four-item attitude subscale (alpha = 0.73) and a three-item knowledge subscale (alpha = 0.59). Twelve-month follow-up data were used to evaluate predictive validity; improved knowledge and attitudes were significantly associated with completion of flexible sigmoidoscopy (P = .004) and completion of either flexible sigmoidoscopy or colonoscopy (P = .02). CONCLUSION: The two-factor scale offers a parsimonious and reliable measure of colorectal cancer screening knowledge and attitudes among veterans. This colorectal Cancer Screening Survey (CSS) may especially be useful as an evaluative tool in developing and testing of interventions designed to improve screening rates within this population.

Aged↗

Barriers to cancer screening amongst women with mental health problems.

The involvement of women with mental health problems in cancer screening was examined in order to explore service delivery options among this particular group. Structured interviews were used to identify the utilization of cancer screening and barriers experienced in accessing such screening among this group. The sample of women reported similar utilization rates of cancer screening as the general female population of the same Australian state. However, they identified a number of barriers to effective access to cancer screening. In response to the interview finding that consumers valued screening services from a well-known provider in a familiar environment, a series of women's health clinics were offered within a mental health service. This experience is described and was used to try to better understand barriers to cancer screening experienced by women with mental health problems. The women's health clinics were most efficiently offered in conjunction with hospital-based psychiatric services.

Australia↗

Cervical cancer screening: state of the art.

PURPOSE OF REVIEW: The objective of cervical cancer screening is to prevent the occurrence of and death from cervical cancer by detecting and treating high-grade squamous intraepithelial lesions. A significant decline in occurrence and mortality from cervical cancer in developed countries has been associated with the application of organized cervical screening programs. The use of the available local health methods in cervical cancer screening can be adjusted in different countries. This review discusses the recent results in traditional and alternative cervical cancer screening. RECENT FINDINGS: The current recommendations of both the American Cancer Society and the American College of Obstetricians and Gynecologists concerning clinical practice guidelines for cervical cancer screening are commented upon. New methods and new technology for cervical cancer screening are described. Attributable failure factors in the screening process, particularly in the coverage, are analyzed. A critical assessment of the suitability of local cervical cancer screening resources is discussed. SUMMARY: Screening is clearly a complex multifactorial process, not a test. Nowadays, with the human papillomavirus vaccine on the horizon, screening is the best strategy for cervical cancer control. Good screening programs, with high coverage, quality control and follow-up included, are the basis of obtaining better results. The Papanicolaou test and its variants are the best methods of cervical cancer screening in high-resource settings. Alternative visual inspection using cervical dyes could be the most useful method in low-resource settings. The challenge for the future may be less of a technical nature and more dependent on local finances and screening policies.

Female↗

An investigation into why two-view mammography is better than one-view in breast cancer screening.

AIM: To determine why two-view mammography in screening for breast cancer is more effective than using a single medio-lateral oblique view. MATERIALS AND METHODS: In the United Kingdom Coordinating Committee on Cancer Research randomized trial of one- vs two-view mammography in breast cancer screening the oblique view was assessed by one radiologist and two views (oblique and cranio-caudal) assessed by another. For the present study the mammographic films were retrieved from the screening centres and assessed by three consultant radiologists. Mammographic films were available from 110 women; 87 had their breast cancer detected by both one and two views and in 23 it was missed by one view but detected using two views. Outcome measures were breast size, location and size of the cancer, mammographic features, presence of microcalcification and overall radiological assessment. RESULTS: Although 23 cancers were missed in the original trial when one view was used, only two were not visible on the oblique view. Cancers missed using a single oblique view (and only detected if the cranio-caudal view was available with the oblique) tended to be smaller by about 4 mm (P = 0.05), centrally located in the breast (P = 0.16), not spiculated or round, (P </= 0. 001) and lacked microcalcification (P = 0.15). Breast size and breast radiographic density were not significantly associated with breast cancer detection. CONCLUSIONS: The results provide the basis for the observation that two-view mammographic screening is more effective than one-view mammographic screening.Hackshaw, A. (2000). Clinical Radiology55, 454-458.

Breast Neoplasms↗

Breast cancer screening in rural populations: a pilot study.

This report describes the development and implementation of a pilot intervention project designed to determine the economic, logistic, behavioral, and attitudinal variables that influence rural women's participation in a community-based breast cancer screening program. This paper reports on survey responses of women who registered for this pilot breast cancer screening program. It includes information on all women who registered for the project--both those who received breast cancer screening and those who did not. The study is a pilot intervention project, the overall goal of which was to develop a network of community providers, organizations, and volunteers to facilitate breast cancer screening among rural women. Of the 159 women registered for this pilot program, 101 (63.5%) were screened (receiving both a clinical breast examination and mammogram). The attitudes of women surveyed through the project confirm the importance of a physician recommendation for breast cancer screening. More than 90 percent of both the screened and unscreened groups of women stated that a doctor's recommendation to have breast cancer screening is important. Further, nearly 42 percent of the unscreened group had never had a physician recommend breast cancer screening. Despite existing barriers to screening, this pilot study demonstrated that health care professionals and regional organizations that have not traditionally been associated with delivering health care in this particular community setting can successfully work together to implement breast cancer screening programs.

Adult↗

Using nurse practitioners for skin cancer screening: a pilot study.

BACKGROUND: Skin cancer screening has the potential to detect early precancerous lesions and may ultimately be important in reducing melanoma mortality. The purpose of this study was to evaluate the ability of trained nurse practitioners to accurately identify suspicious lesions in a clinical setting. METHODS: We identified five nurse practitioners who had no previous experience in evaluating skin lesions. Each nurse practitioner participated in a training program for skin cancer detection consisting of a workshop, clinical apprenticeship, and didactic lectures. RESULTS: Evaluation of nurse practitioner competency involved three assessments. First, the nurse practitioner's ability to distinguish benign and malignant lesions was assessed using clinical color slides. The sensitivity of all five nurse practitioners to refer benign and malignant lesions for dermatologic follow-up based on the slides was 100%, whereas the specificity ranged from 53% to 100%. Second, each nurse practitioner evaluated approximately 25 different patients along with a single dermatologist. The nurse practitioner's ability to correctly refer patients with suspicious lesions for dermatologic follow-up was determined based on the dermatologist's assessment of need for referral. Results suggested a referral sensitivity and specificity ranging from 67% to 100% and 62% to 100%, respectively. In the final clinical assessment, 30 patients were independently examined by two dermatologists and four nurse practitioners. Using the consensus clinical diagnosis of the dermatologists as the gold standard, the nurse practitioner's sensitivity for detecting significant skin cancer lesions ranged from 50% to 100% and the detection specificity was 99% to 100%. CONCLUSIONS: These preliminary results have important implications for skin cancer screening efforts and suggest that nurse practitioners can be trained to accurately identify and triage suspicious lesions.

Clinical Competence↗

A model-based analysis of the HIP project for breast cancer screening.

A computer simulation approach is used to test assumptions about sensitivity of mammography and physical examination, and about the duration of preclinical screen-detectable breast cancer. Values between 50% and 80% for the combined sensitivity of the 2 tests give a good explanation of the results of the HIP randomized trial of breast cancer screening. The mean duration of the preclinical stage can vary from 1.6 years for high sensitivity values to 2.7 years for low values. In comparison with previous analyses of the HIP data our estimate for the sensitivity is lower, and the mean duration of the preclinical stage is longer. This is a consequence of the use of a more detailed model in our analysis, allowing for a more complete use of the HIP data in testing model assumptions. Similar analyses of data from recent screening projects in The Netherlands resulted in compatible estimates for the duration of preclinical breast cancer.

Age Factors↗

Issues in determining cancer screening recommendations: who, what, and when.

PURPOSE/OBJECTIVES: To provide an overview of the issues involved in evaluating and choosing cancer screening guidelines. DATA SOURCES: Current epidemiologic literature. DATA SYNTHESIS: Screening is universally accepted as being important for cancer control. A number of organizations have developed cancer screening guidelines. However, agreement on who should be screened, with what tests, and at what ages and intervals is far from universal. Choice of screening guidelines may be influenced by differences in populations of interest and considerations of screening effectiveness. CONCLUSION: Directing patients toward appropriate screening tests and intervals requires attention to information about screening tests and to individual and institutional characteristics. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses should be aware of the various issues that influence cancer screening recommendations. Nurses advising patients about or developing cancer screening services must consider identifying both the patient population to be screened and factors influencing screening test effectiveness. This information then can be used to choose the most appropriate guidelines from those available. Consideration of the issues also can be applied as advances in screening evolve.

Guidelines as Topic↗

Progress in cancer screening practices in the United States: results from the 2000 National Health Interview Survey.

BACKGROUND: Understanding differences in cancer screening among population groups in 2000 and successes or failures in reducing disparities over time among groups is important for planning a public health strategy to reduce or eliminate health disparities, a major goal of Healthy People 2010 national cancer screening objectives. In 2000, the new cancer control module added to the National Health Interview Survey (NHIS) collected more detailed information on cancer screening compared with previous surveys. METHODS: Data from the 2000 NHIS and earlier surveys were analyzed to discern patterns and trends in cancer screening practices, including Pap tests, mammography, prostate specific antigen (PSA) screening, and colorectal screening. The data are reported for population subgroups that were defined by a number of demographic and socioeconomic characteristics. RESULTS: Women who were least likely to have had a mammogram within the last 2 years were those with no usual source of health care (61%), women with no health insurance (67%), and women who immigrated to the United States within the last 10 years (61%). Results for Pap tests within the last 3 years were similar. Among both men and women, those least likely to have had a fecal occult blood test or endoscopy within the recommended screening interval had no usual source of care (14% for men and 18% for women), no health insurance (20% for men and 18% for women), or were recent immigrants (20% for men and 18% for women). An analysis of changes in test use since the 1987 survey indicates that the disparities are widening among groups with no usual source of care. CONCLUSIONS: No striking improvements have been observed for the groups with greatest need. Although screening use for most groups has increased since 1987, major disparities remain. Some groups, notably individuals with no usual source of care and the uninsured are falling further behind; and, according to the 2000 data, recent immigrants also experience a significant gap in screening utilization. More attention is needed to overcome screening barriers for these groups if the population benefits of cancer screening are to be achieved.

Adult↗

A case-control evaluation of the effect of breast cancer screening in the United Kingdom trial of early detection of breast cancer.

OBJECTIVE: The aim was to assess the extent to which selection bias affects a case-control study of breast cancer screening in which attenders and non-attenders for screening are compared. DESIGN: There were two retrospective case-control studies, one estimating the risk of death from breast cancer in women in the screening district relative to those in the comparison district (study A), the second estimating the relative risk for women who had ever been screened compared with women who had never been screened in the screening district alone (study B). For cases and controls in study B, the women's screening history was summarised for the time period from date of entry to diagnosis of the case, or the equivalent time from date of entry for the matched controls. For cases detected by screening, the screen at which cancer was detected was included in the screening history. SUBJECTS: Cases were deaths from breast cancer in women with disease diagnosed after entry to the trial, up to 31 December 1986 or a maximum of seven years from date of entry, in one of the screening districts (Guildford) and one of the comparison districts (Stoke) participating in the UK Trial of Early Detection of Breast Cancer: study A: 198 deaths in Guildford and Stoke; study B: 51 deaths in Guildford only. There were five age matched controls for each case, with length of follow up at least as great as the time from entry to death of the case. MAIN RESULTS: The estimate of the risk of death from breast cancer in the screening district relative to the comparison district from study A was 0.76, thus implying a reduction of 24% in the screening district, similar to that obtained from a cohort analysis of data from the two districts. In contrast, the relative risk in study B for ever v never screened women was 0.51, which, taking the 72% compliance into account, would result in a relative risk of 0.65 for the screening district if there were no selection bias. The risk of breast cancer mortality in the never screened relative to the comparison district was 1.13, despite the fact that incidence rates in the two populations were similar. This suggested that cancers in the never screened group had a particularly poor prognosis, contributing to selection bias. CONCLUSIONS: The possible existence of selection bias should lead to caution in interpretation of the results of case-control studies of the effect of breast cancer screening on mortality.

Breast Neoplasms↗

[Stages and barriers in cancer screening behaviour of 45 to 60-year old men--results of an empirical study].

UNLABELLED: Between 2002 and 2004 the Centre of Applied Health Sciences of the University of Lüneburg carried out a research project concerning the cancer screening behaviour of men. Within a standardised survey all men aged 45 - 60 years of a local health insurance company were interviewed by a postal questionnaire about their cancer screening behaviour including their main reasons to engage or not to engage in the (insurance financed) cancer screening tests. 337 questionnaires could be analysed. As a theoretical framework, the "transtheoretical model" of Prochaska et al. was used to characterise the men according to their degree of readiness to engage in cancer screening tests. RESULTS: 25% of the men were regularly engaged in cancer screening tests. 40% have been engaged at least once or were in the stage of "preparation" to do so in the near future. 35% were resistant to undergo cancer screening tests. Anxiety concerning the check-up itself or the possibility to have a positive result were the main barriers for men not to engage in cancer screening. As an important factor to overcome such barriers, these men mentioned the need for better communication between doctors and patients. To improve cancer screening behaviour, this was considered more important than general information campaigns or organisational changes concerning the check-ups.

Adult↗

Health beliefs, locus of control, emotional control and women's cancer screening behaviour.

Improvements in women's cancer-screening behaviours can lead to a reduction in the incidence of breast and cervical cancer. This paper considers the utility of three social psychological models as predictors of such behaviours. Almost 400 women throughout Northern Ireland completed a questionnaire designed to measure the extent of their cancer-screening behaviour, their health beliefs about cancer, their health locus of control and their emotional control. It was found that several components of the health belief model and of locus of control were predictors of the behaviours. The most important predictor of breast self-examination was confidence in how to practise BSE while the most important predictor of attendance for cervical smears was lack of fear of the consequences of the investigation. The findings are discussed with reference to attempts to promote these practices.

Adolescent↗

Survey of the opinions, knowledge, and practices of gastroenterologists regarding colorectal cancer screening and use of the fecal occult blood test.

OBJECTIVES: Primary care physicians and internal medicine residents have poor understanding of colorectal cancer screening and the use of fecal occult blood tests. If acceptance and implementation of colorectal cancer screening is to improve, gastroenterologists may have to take a more leading role in the education of their primary care colleagues, physicians in training, and the general public. However, before this can be recommended, it is necessary to determine how closely gastroenterologists follow currently recommended guidelines and how they use fecal occult blood tests. METHODS: We mailed a two-page, structured questionnaire about colorectal cancer screening and use of fecal occult blood tests to 8000 randomly selected gastroenterologists in the United States. RESULTS: We received responses from 24% of the gastroenterologists. Almost all used fecal occult blood tests in the office setting, 86% on stool obtained at rectal examination. The test was frequently used for reasons other than colorectal cancer screening, and often without adequate patient instruction on dietary and medication restrictions. Of the respondents, 98% commenced screening at age < or = 50 yr, whereas 37% either continued screening into advanced age or never stopped. Annual fecal occult blood testing with flexible sigmoidoscopy every 5 yr was the screening strategy recommended by 71% of the respondents, whereas 25% recommended colonoscopy every 10 yr. However, 77% of the gastroenterologists chose colonoscopy for personal colorectal cancer screening. CONCLUSIONS: Gastroenterologists usually give appropriate advice on colorectal cancer screening but often misuse fecal occult blood tests. This may produce excessively high false-positive screening rates, leading to unnecessary diagnostic testing without apparent benefit.

Attitude of Health Personnel↗