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.

Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598].

OBJECTIVES: To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. DESIGN: Randomised controlled trial. SETTING: Tertiary obstetric hospitals offering external cephalic version (ECV). POPULATION: Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. METHODS: Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. MAIN OUTCOME MEASURES: Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. RESULTS: Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference -8.92; 95% CI -13.18, -4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14, 1.47), had no increase in anxiety and reported greater satisfaction with decision making and overall experience of pregnancy and childbirth. In contrast, 19% of women in the usual care group reported they would have made a different decision about their care. CONCLUSIONS: A decision aid is an effective and acceptable tool for pregnant women that provides an important adjunct to standard counselling for the management of breech presentation.

Development of a communication aid to facilitate risk communication in consultations with unaffected women from high risk breast cancer families: a pilot study.

UNLABELLED: The literature on risk perception in women from high-risk breast cancer families reveals persistent over-estimation of risk, even after counseling. In this study, a communication aid was designed to facilitate discussion of risk between clinical geneticists and genetic counselors and women from this high-risk population. METHOD: Stage 1. The aid was developed by an expert panel of clinical geneticists, genetic counselors, psychologists, an epidemiologist, an oncologist, linguists and a consumer. It was guided by the international literature on risk communication and a large multi-centre Australian study of risk communication. The 13 page full-color communication aid used varying formats of words, numbers, graphs and pie-charts to address (a) the woman's subjective risk; (b) the population risk of breast cancer; c) the risk of inherited breast cancer; (d) the cumulative risk for women with BRCA1 and BRCA2 mutations; (e) family risk factors; (f) the woman's suitability for genetic testing; (h) screening and management recommendations, and (i) a re-assessment of the woman's subjective risk. Stage 2: A before-after pilot study of 38 women who were unaffected with breast cancer and were attending four Australian familial cancer clinics was undertaken. Baseline and follow-up questionnaires were completed by 27 women. Outcomes were compared to those observed in 107 similar women undergoing genetic counseling without the communication aid in 2001. RESULTS: The risk communication aid appears to be beneficial; breast cancer genetics knowledge improved in some areas and importantly, risk perceptions improved in the cohort receiving the communication aid. Psychological measures showed no difference in anxiety or depression between the group receiving the communication aid and the comparison cohort. Women and clinicians were very positive about the usefulness of the communication aid as an adjunct to the genetic counseling consultation.

Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial.

BACKGROUND: Privacy laws have recently created restrictions on how researchers can approach study participants. METHOD: In a randomised trial of 152 patients, 50-74 years old, in a family practice, 60 were randomly selected to opt-out and 92 to opt-in methods. Patients were sent an introductory letter by their doctor in two phases, opt-out before and opt-in after introduction of the new Privacy Legislation in December 2001. Opt-out patients were contacted by researchers. Opt-in patients were contacted if patients responded by email, free telephone number or a reply-paid card. RESULTS: Opt-in recruited fewer patients (47%; 43/92) after invitation compared with opt-out (67%; 40/60); (-20%; [-4% to -36%]). No proportional difference in recruitment was found between opt-in and opt-out groups varied by age, sex or socioeconomic status. The opt-in group had significantly more people in active decision-making roles (+30%; [10% to 50%]; p = 0.003). Non-significant trends were observed towards opt-in being less likely to include people with lower education (-11.8%; [-30% to 6.4%]; p = 0.13) and people who were not screened (-19.1%; [-40.1% to 1.9%]; p = 0.08). Opt-in was more likely to recruit people with a family history of colorectal cancer (+12.7%; [-2.8%, 28.2%]; p = 0.12). CONCLUSIONS: The number of participants required to be approached was markedly increased in opt-in recruitment. Existing participants (eg, screening attendees) with a vested interest such as increased risk, and those preferring an active role in health decision making and with less education were likely to be recruited in opt-in. Research costs and generalisability are affected by implementing privacy legislation.

A glossary for evidence based public health

It defines and explains some of the main concepts underpinning evidence based public health, and it draws on the published literature, experience gained over several years analysis of the topic, and discussions with public health colleagues, including researchers, practitioners, policy makers, and students

Communication and information-giving in high-risk breast cancer consultations: influence on patient outcomes.

This longitudinal study aimed to document (i) the information-giving and patient-communication styles of clinical geneticists and genetic counsellors (consultants) in familial breast cancer clinics and (ii) assess the effect of these styles on women's knowledge, whether their expectations were met, satisfaction, risk perception and psychological status. A total of 158 women from high-risk breast cancer families completed self-report questionnaires at 2 weeks preconsultation and 4 weeks postconsultation. The consultations were audiotaped, transcribed and coded. Multivariate logistic regressions showed that discussing prophylactic mastectomy (P=0.00) and oophorectomy (P=0.01) led to women having significantly more expectations met; discussing genetic testing significantly decreased anxiety (P=0.03) and facilitating understanding significantly decreased depression (P=0.05). Receiving a summary letter of the consultation significantly lowered anxiety (P=0.01) and significantly increased the accuracy of perceived risk (P=0.02). Women whose consultant used more supportive communications experienced significantly more anxiety about breast cancer at the 4 weeks follow-up (P=0.00). These women were not significantly more anxious before genetic counselling. In conclusion, this study found that consultants vary in the amount of information they give and the way they communicate; and this variation can result in better or worse psychosocial outcomes. Greater use of supportive and counselling communications appeared to increase anxiety about breast cancer. Identifying methods to assist consultants to address emotional issues effectively may be helpful.

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."

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.

Tailoring communication in consultations with women from high risk breast cancer families.

This multicentre study examined the influence of patient demographic, disease status and psychological variables on clinical geneticists/genetic counsellors (consultants) behaviours in initial consultations with women from high-risk breast cancer families. One hundred and fifty-eight women completed a pre-clinic self-report questionnaire. The consultations were audiotaped, transcribed verbatim and coded. Consultants did not vary their behaviour according to women's expectations. However, significantly more aspects of genetic testing were discussed with women who were affected with breast cancer (P<0.001), screening and management with unaffected women (P=0.01) and breast cancer prevention with younger women (P=0.01). Prophylactic mastectomy was discussed more frequently with women with medical and allied health training (P=0.02), and prophylactic oophorectomy with women affected with breast cancer (P=0.03), those in non-professional occupations (P=0.04) and with a family history of breast and ovarian cancer (P<0.001). Consultants used significantly more behaviours to facilitate understanding with women who were in non-professional occupations (P=0.04); facilitated active patient involvement more with women affected with breast cancer (P<0.001) and used more supportive and counselling behaviours with affected women (P=0.02). This study showed that patient demographics were more likely to predict consultants' communication behaviours than the woman's psychological status. Methods to facilitate assessment of psychological morbidity are needed to allow more tailored communication.

Feasibility study of the early detection and treatment of renal disease by mass screening.

AIM: To determine whether mass screening for proteinuria may be worthwhile in the detection of early renal disease in Australians. METHODS: A feasibility study was conducted using systematic review, meta-analysis and cost-effectiveness methods. RESULTS: End-stage renal disease (ESRD) develops in about 1500 Australians each year. Of these, about 1000 are over 50 years of age (an incidence of about 200 per million, per year). Proteinuria, which is present in about 5% of the general population, confers an approximately 15-fold increased risk for ESRD. Twelve randomized trials of angiotensin-converting enzyme inhibitors (ACEi), in 1943 patients with varying degrees of renal impairment, hypertension and proteinuria, showed that the risk of developing ESRD can be reduced by about 30% over a 2- to 3-year period. In a general-practice-based screening model involving: (i) an opportunistic single dipstick test for protein, (ii) a confirming 24-h urine test for protein and (iii) commencement of ACEi in appropriate individuals, 20 000 people over 50 years of age would need to be screened to prevent one case of ESRD. To achieve this, approximately 100 people would need to be treated with ACEi for 2 to 3 years, and 1,000 would need to have a 24-h urine protein test (and of these, 700 would be false positives). Such a strategy may save health dollars but some critical research questions are still unanswered. What is an individual's risk of developing ESRD, given values for proteinuria, blood pressure and renal function? What is the benefit of ACEi in screen-detected cases, which are at low risk of ESRD? What psychological and physical harm is caused by screening, including the specific renal investigations and treatments that follow on from proteinuria detection? CONCLUSIONS: Given available data, screening middle-aged and older Australians for proteinuria and treating some with ACEi is, at best, a promising primary prevention strategy for preventing ESRD. However, a large population-based cohort study, with nested trial of ACEi, is still required to evaluate whether this model of screening for renal disease does more harm than good.

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.

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.

Breast cancer screening uptake in women at increased risk of developing hereditary breast cancer.

This multicenter study assessed breast cancer screening uptake in 461 unaffected women at increased risk of developing breast cancer on the basis of family history who approached familial cancer clinics for advice about surveillance options. At the time of attending the clinic, 89% and 90% of participants were vigilant with respect to age- and risk-specific recommendations for mammography and clinical breast examination, respectively, and 51% reported practicing breast self-examination monthly or more frequently. The degree to which health outcomes are perceived to be under one's personal control (chi2 = -2.09, p = 0.0037) and breast cancer anxiety (chi2 = 8.11, p = 0.044) were both associated with monthly or more frequent breast self-examination, while there were no associations with sociodemographic characteristics. A significantly lower percentage (56%) of women aged <30 were vigilant with respect to mammography recommendations, compared to 77%, 96% and 98% of women aged 30-39, 40-49 and >50, respectively (chi2 = 37.2, p < 0.0001). These relatively low rates of mammographic screening in young women may reflect concerns about increased cancer risk associated with early and repeated radiation exposure or lack of sensitivity in young women with radiographically dense breasts. If mammographic screening is ultimately shown to lower mortality in women at high risk, there will be a strong case to promote screening in young women. The need for regular mammographic screening would then need to be highlighted and reinforced amongst young women and their referring physicians. Awareness amongst general practitioners, who are largely responsible for referral to screening services, would also need to be increased.