Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

BACKGROUND: Cancer patients want access to reliable information about currently recruiting clinical trials. PATIENTS AND METHODS: Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. RESULTS: Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). CONCLUSIONS: Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Issues faced by unaffected men with a family history of prostate cancer: a multidisciplinary overview.

PURPOSE: Despite the established importance of the role of family history in prostate cancer, relatively little research encompasses the psychosocial issues relevant to unaffected men with a family history of prostate cancer. To determine the completeness and quality of available literature on the issues faced by men with a high risk of prostate cancer, we conducted a multidisciplinary review of the literature to provide some guidance on the information that clinicians might provide to men who are concerned about family history. MATERIALS AND METHODS: A structured literature search was conducted by a multidisciplinary team of clinicians and researchers who reviewed the medical and psychosocial literature, and identified 21 relevant studies. RESULTS: Research suggests that many high risk patients are concerned about the risk of prostate cancer, and some may significantly overestimate that risk. Several studies have shown high screening rates among high risk patients and high levels of interest in genetic testing for prostate cancer risk should it become available, yet many men also report a desire for more information about their personal risk and risk management options. CONCLUSIONS: Given the lack of clear data on the efficacy of prostate cancer screening among high risk patients, clinicians could consider providing men who are concerned about family history with information on their personal risk, help them to clarify the potential benefits, limitations and harms of prostate cancer screening in their situation, and then support their choice regarding the management of prostate cancer risk.

Psychological impact of genetic testing in women from high-risk breast cancer families.

Psychological adjustment in 90 women (30 carriers and 60 non-carriers) who had undergone genetic testing for mutations in BRCA1 and BRCA2 breast/ovarian cancer susceptibility genes was compared with that of 53 women who were not offered genetic testing. Women were assessed prior to genetic testing and 7-10 days, 4 and 12 months after carrier status disclosure using self-administered questionnaires. Compared with women not offered testing, mutation carriers had significantly higher breast cancer distress 7-10 days (t=2.80, P=0.005) and 12 months (t=2.01, P=0.045) post-notification. Non-carriers showed a significant decrease in state anxiety 7-10 days post-notification (t=2.27, P=0.024) and in depression 4 months post-notification (t=2.26, P=0.024), compared with women not offered testing. These data show that non-carriers derive psychological benefits from genetic testing. Women testing positive may anticipate a sustained increase in breast cancer distress following disclosure, although no other adverse psychological outcomes were observed in this group.

Comparison of conventional and single bottle system for blood cultures.

A single bottle blood culture system (Oxoid Signal system) was compared with a conventional two bottle subculturing system. A total of 2016 routine blood samples yielded 186 (9%) clinically important isolates. Of these, 40 (21%) were isolated only in the Oxoid system and 30 (17%) only in the conventional system. One hundred and sixteen (62%) were isolated from both systems. Volume of blood was not significantly associated with the rate of detection but was significantly associated with the speed of detection. A continuation of the study with a Signal bottle and single conventional bottle confirmed initial results of the increased isolation rate using two systems. The Oxoid single bottle blood culture system was at least comparable with a conventional system in terms of rate of detection of organisms and was superior in terms of speed of detection.

Perceived sensitivity of mammographic screening: women's views on test accuracy and financial compensation for missed cancers.

OBJECTIVES: To estimate women's expectations of the accuracy of screening mammography and to explore attitudes towards compensation for missed cancers. DESIGN: Cross sectional survey (by telephone). SETTING: Australia; population-based survey conducted in April 1996. PARTICIPANTS: Random sample of women aged 30-69 years. A total of 2935 women completed the Breast Health Survey (adjusted response rate 65%). A random sample of 115 completed this sub-survey on perceived sensitivity of mammographic screening and compensation for missed cancers. RESULTS: About one third of women (32.2%, 95% CI 23.7, 40.7) had an unrealistically high expectation of the sensitivity of screening mammography, reporting it to be 95% or higher. Approximately 40% of the women (43.5%, 95% CI 34.4, 52.6) thought that screening mammography should pick up all cancers (should have a sensitivity of 100%). Just under half the women (45.2%, 95% CI 36.1, 54.3) said financial compensation should be awarded for a cancer missed by screening mammography even if the cancer was missed as a consequence of the small failure rate of the test. Younger women living in metropolitan areas and women who had realistic expectations of the accuracy of the tests were more likely to favour financial compensation. CONCLUSION: Unrealistically high expectations of the sensitivity of screening mammography were common in this group of women. Many women favoured financial compensation for missed cancers even if the cancer was missed solely because of the failure rate of the test. Public education is required to inform women of the limited sensitivity of breast cancer tests but this may not reduce claims for financial compensation when cancers are missed.

Cancer screening.

"Screening is the systematic application of a test or inquiry, to identify individuals at sufficient risk of a specific disorder to benefit from further investigation or direct preventive action, among persons who have not sought medical attention on account of symptoms of that disorder."

Effects of hypoxia on renal hormonal balance in normal subjects and in patients with COPD.

There is a complex interaction between pulmonary haemodynamics, hormonal, and salt and water balance in patients with chronic obstructive pulmonary disease (COPD) and in normal subjects exposed to hypoxia or high altitude. This study aims to investigate the effects of hypoxia on renal hormonal balance in normal subjects and patients with COPD, particularly the role of urinary dopamine and atrial natriuretic peptide (ANP). Urinary dopamine output, ANP, and plasma renin activity (PRA) were measured in 12 normal subjects exposed to hypoxia (12% O2) and hyperoxia (40% O2) for 1 h and in 15 patients with exacerbations of COPD while breathing air or O2. These measurements were repeated in six of the patients with exacerbations of COPD when they were clinically stable. Hypoxia caused an increase in ANP levels (49 +/- 6-62 +/- 6 pg ml-1, P < 0.05) and a fall in urinary dopamine output (277 +/- 39-205 +/- 33 ng h-1, P < 0.002) in normal subjects. Hyperoxia was associated with a return of plasma ANP to the baseline values. In patients with exacerbations of COPD plasma ANP levels were higher (181 +/- 36 pg ml-1) than in normal subjects (49.5 +/- 6.5 pg ml-1, P < 0.001). Urinary dopamine output breathing air (175 +/- 34 ng h-1) was similar to the levels when normal subjects were made hypoxaemic and PRA was elevated in comparison to normal values. There was no change in their levels following the acute administration of oxygen in patients presenting with exacerbations of COPD, but oxygen improved urinary sodium excretion (P < 0.05). In six patients re-studied when clinically stable there was a fall in urinary dopamine output, plasma ANP and PRA when breathing air in comparison to the acute stage of the disease (P < 0.05). These data suggest presence of renal hormonal imbalance including endogenous urinary dopamine output during hypoxic exacerbation of COPD and in normal subjects exposed to hypoxia.

The use of probenecid to increase the serum amoxycillin levels in patients with bronchiectasis.

Amoxycillin 3 g twice daily is effective in treating patients with bronchiectasis who have daily purulent sputum. However, it is a relatively expensive treatment if used for prolonged periods. This pilot study in six patients with bronchiectasis showed that the concurrent administration of probenecid with a smaller dose of amoxycillin produced similar clinical responses and pharmacokinetic profiles to those found with high dose amoxycillin alone. The amount of amoxycillin used was reduced by two thirds, producing a potential saving of approximately pound 1000 per patient per annum in those taking long term treatment.

Telling people about screening programmes and screening test results: how can we do it better?

To make an informed choice about whether to be screened, people need information that allows them to weigh up the benefits and harms of screening. To understand their screening test results they require even more information. Yet currently, people attending a screening programme or considering a screening test may only be told that the test can detect disease or risk factors for disease, and that early intervention improves outcomes. When given their test results, people are generally only told the test was abnormal ("positive") or normal ("negative"). We believe that information given before and after the screening test can, and should, be improved. This will probably require information that includes both the benefits and harms of screening and is probabilistic. Indeed, we believe the traditional dichotomisation of screening test results into positive and negative is problematic, and could be replaced by standard use of risks or probabilistic data before and after screening. The relevant risk data could be explained in a range of ways, for example, quantitatively, qualitatively, and/or by "anchoring" to everyday experiences. In this paper we explore why dichotomisation of screening test results is problematic and look at the adverse consequences of presenting test results in terms of true and false, positive and negative. We present some ideas on alternative ways of providing information on screening programmes and screening test results. Our aim is to stimulate debate about these issues and to provide some starting points which could be further developed and evaluated in a wide range of screening programmes.

Long-term outcomes of genetic counseling in women at increased risk of developing hereditary breast cancer.

This multicenter study evaluated the impact of genetic counseling in 218 women at risk of developing hereditary breast cancer. Women were assessed prior to counseling and 12-month post-counseling using self-administered, mailed questionnaires. Compared to baseline, breast cancer genetics knowledge was increased significantly at follow-up, and greater increases in knowledge were associated with educational level. Breast cancer anxiety decreased significantly from baseline to follow-up, and these decreases were associated with improvements in perceived risk. A significant decrease in clinical breast examination was observed at the 12-month follow-up. Findings suggest that women with a family history of breast cancer benefit from attending familial cancer clinics as it leads to increases in breast cancer genetics knowledge and decreases in breast cancer anxiety. The lowered rates of clinical breast examination indicate that the content of genetic counseling may need to be reviewed to ensure that women receive and take away the right message.

Reliability and validity of women's recall of mammographic screening.

OBJECTIVE: To assess the reliability and validity of self-reported attendance for mammographic screening. METHODS: To assess reliability of recall of attendance for a screening mammogram, 100 women selected at random were interviewed twice (approximately one week apart). To assess validity, 127 women who reported having a mammogram within the national breast screening program (BreastScreen Australia) consented to having their reports verified by the national program. RESULTS: Test-retest reliability for the question "Have you ever had a mammogram?" was perfect (agreement 100%, kappa 1). Validity was also high. About one-quarter of women (24.4%) recalled the exact date of their last mammogram and a further third (39.4%) correctly reported the month in which the mammogram was done. Almost all (91.3%) women reported the mammogram date accurately to within 12 months of the recorded date. CONCLUSIONS: These data suggest that Australian women provide reliable and valid information in relation to mammographic screening attendance. IMPLICATIONS: Self-reported data about attendance for mammographic screening are likely to provide reliable and valid estimates for research and health services evaluation purposes.

Knowledge and perceptions about breast cancer incidence, fatality and risk among Australian women.

OBJECTIVE: Breast cancer is the most common fatal cancer among Australian women. This study aimed to provide an accurate national picture of women's understanding of breast cancer incidence, fatality and risk. METHOD: A telephone survey explored the knowledge and perceptions of a sample of 2,935 Australian women in relation to breast cancer incidence, fatality, risk factors, risk perception and level of concern. RESULTS: Australian women were well aware of breast cancer in general terms, however, there were major aspects of incidence and risk which were poorly understood. Only 5% of women nominated age as a risk factor, and only one-third were able to make an approximately correct estimate of the incidence of breast cancer in Australia. CONCLUSIONS AND IMPLICATIONS: Recommendations for future information campaigns include targeting understanding of lifetime risk of developing breast cancer, age as a risk factor, survival from breast cancer and the need to separately address the perceptions of older versus younger women.