Systematic review and meta-analysis of prognostic characteristics for breast cancers in populations with digital vs film mammography indicate the transition may have increased both early detection and overdiagnosis.

OBJECTIVES: Film mammography has been replaced by digital mammography in breast screening programs globally. This led to a small increase in the rate of detection, but whether the detection of clinically important cancers increased is uncertain. We aimed to assess the impact on tumor characteristics of screen-detected and interval breast cancers. STUDY DESIGN AND SETTING: We searched seven databases from inception to October 08, 2023, for publications comparing film and digital mammography within the same population of asymptomatic women at population (average) risk of breast cancer. We recorded reported tumor characteristics and assessed risk of bias using the Risk Of Bias In Non-randomised Studies - of Interventions tool. We synthesized results using meta-analyses of random effects. RESULTS: Eighteen studies were included in the analysis from 8 countries, including 11,592,225 screening examinations (8,117,781 film; 3,474,444 digital). There were no differences in tumor size, morphology, grade, node status, receptor status, or stage in the pooled differences for screen-detected and interval invasive cancer tumor characteristics. There were statistically significant increases in screen-detected ductal carcinoma in situ (DCIS) across all grades: 0.05 (0.00-0.11), 0.14 (0.05-0.22), and 0.19 (0.05-0.33) per 1000 screens for low, intermediate, and high-grade DCIS, respectively. There were similar (non-statistically significant) increases in screen-detected invasive cancer across all grades. CONCLUSION: The increased detection of all grades of DCIS and invasive cancer may indicate both increased early detection of more aggressive disease and increased overdiagnosis.

Breast Cancer Stage and Size Detected with Film versus Digital Mammography in New South Wales, Australia: A Population-Based Study Using Routinely Collected Data.

BACKGROUND: Digital mammography has replaced film mammography in breast-screening programs globally, including Australia. This led to an increase in the rate of detection, but whether there was increased detection of clinically important cancers is uncertain. METHODS: In this population-wide retrospective cohort study in New South Wales, Australia spanning 2004 to 2016 and including 4,631,656 screens, there were 22,965 cancers in women screened with film (n = 11,040) or digital mammography (n = 11,925). We examined the change in tumor characteristics overall and how these rates changed over time, accounting for changes in background rates using an interrupted time-series. Comparisons were made with unscreened women (n = 26,326) during this time. RESULTS: We found increased detection of in situ cancer (3.36 per 10,000 screens), localized invasive, and smaller-sized breast cancers attributable to the change in mammography technology, whereas screen-detected intermediate-sized and metastatic breast cancers decreased. Rates of early-stage and intermediate-sized interval cancers increased, and late-stage (-1.62 per 10,000 screens) and large interval cancers decreased. In unscreened women, there were small increases in the temporal trends of cancers across all stages. CONCLUSIONS: At least some of the increased detection of smaller early-stage cancers may have translated into a reduction in larger and late-stage cancers, indicating beneficial detection of cancers that would have otherwise progressed. However, the increased detection of smaller early-stage and small cancers may also have increased over-diagnosis of lesions that would otherwise have not caused harm. IMPACT: Robust evaluation of potential benefits and harms is needed after changes to screening programs. See related In the Spotlight, p. 638.

Hypertensive retinopathy and cardiovascular disease risk: 6 population-based cohorts meta-analysis.

Background: The cardiovascular risk associated with different levels of hypertensive retinopathy, including mild, remains unclear. We performed an individual participant meta-analysis from 6 population-based cohort studies to determine the relationship of hypertensive retinopathy with incident cardiovascular outcomes. Methods: We identified cohort studies that objectively assessed hypertensive retinopathy from photographs, documented incident cardiovascular outcomes, and were population-based. Six studies contributed data from 11,013 individuals at baseline with 5-13 years follow-up. Participants were recruited if they had hypertension and did not have confounding conditions such as diabetic retinopathy. Main outcome measures were incident coronary heart disease (CHD), stroke and a composite endpoint of cardiovascular disease (CHD or stroke). Pooled estimates of incident risk ratios (IRR) were obtained after adjusting for age, gender, systolic blood pressure, serum total cholesterol, high density lipoprotein and smoking. Results: Among eligible participants with hypertension and without diabetes, there were 1018/9662 (10.5%) incident CHD events, 708/11,013 (6.4%) incident stroke events and 1317/9378 (14.0%) incident CVD events. Mild hypertensive retinopathy was associated with increased risk of CVD (IRR 1.13, 95% CI 1.00 to 1.27) and CHD (IRR 1.17, 95% CI 1.02 to 1.34) but not stroke; moderate hypertensive retinopathy was associated with increased risk of CVD (IRR 1.25 95% CI 1.02 to 1.53) but not stroke or CHD individually. Conclusions: In persons with hypertension, both mild and moderate hypertensive retinopathy were associated with higher CVD risk.

Carer preparedness improved by providing a supportive educational intervention for carers of patients with high-grade glioma: RCT results.

BACKGROUND: High-grade glioma (HGG) is a rapidly progressing and debilitating disease. Family carers take on multiple responsibilities and experience high levels of distress. We aimed to deliver a nurse-led intervention (Care-IS) to carers to improve their preparedness to care and reduce distress. METHODS: We conducted a randomised controlled trial (ACTRN:12612001147875). Carers of HGG patients were recruited during patients' combined chemoradiation treatment. The complex intervention comprised four components: (1) initial telephone assessment of carer unmet needs; (2) tailored hard-copy resource folder; (3) home visit; and, (4) monthly telephone support for up to 12 months. Primary outcomes included preparedness for caregiving and distress at 2, 4, 6 and 12 months. Intervention effects were estimated using linear mixed models which included a time by group interaction. Secondary outcomes included anxiety, depression, quality of life, carer competence and strain. RESULTS: We randomised 188 carers (n = 98 intervention, n = 90 control). The intervention group reported significantly higher preparedness for caregiving at 4 months (model ß = 2.85, 95% CI 0.76-4.93) and all follow-up timepoints including 12 months (model ß = 4.35, 95% CI 2.08-6.62), compared to the control group. However, there was no difference between groups in carer distress or any secondary outcomes. CONCLUSIONS: This intervention was effective in improving carer preparedness. However, carer distress was not reduced, potentially due to the debilitating/progressive nature of HGG and ongoing caring responsibilities. Future research must explore whether carer interventions can improve carer adjustment, self-efficacy and coping and how we support carers after bereavement. Additionally, research is needed to determine how to implement carer support into practice.

Considerations for Evaluating the Introduction of New Cancer Screening Technology: Use of Interval Cancers to Assess Potential Benefits and Harms.

This framework focuses on the importance of the consideration of the downstream intermediate and long-term health outcomes when a change to a screening program is introduced. The authors present a methodology for utilising the relationship between screen-detected and interval cancer rates to infer the benefits and harms associated with a change to the program. A review of the previous use of these measures in the literature is presented. The framework presents other aspects to consider when utilizing this methodology, and builds upon an existing framework that helps researchers, clinicians, and policy makers to consider the impacts of changes to screening programs on health outcomes. It is hoped that this research will inform future evaluative studies to assess the benefits and harms of changes to screening programs.

Effect of a School-Based Educational Intervention About the Human Papillomavirus Vaccine on Psychosocial Outcomes Among Adolescents: Analysis of Secondary Outcomes of a Cluster Randomized Trial.

Importance: Delivery of vaccination to adolescents via a school-based program provides an opportunity to promote their involvement in health decision-making, service provision, and self-efficacy (belief in one's ability to perform a certain behavior). Objective: To examine the effect of a human papillomavirus (HPV) vaccination education and logistical intervention on adolescent psychosocial outcomes. Design, Setting, and Participants: In this cluster randomized trial and process and qualitative evaluation, adolescents aged 12 to 13 years (first year of high school) were recruited at high schools in Western Australia (WA) and South Australia (SA) in 2013 and 2014. Statistical analysis was performed from January 2016 to December 2020. Interventions: The complex intervention consisted of an adolescent intervention to promote knowledge and psychosocial outcomes, shared decisional support tool, and logistical strategies. Main Outcomes and Measures: Prespecified secondary outcomes were assessed. The HPV Adolescent Vaccination Intervention Questionnaire (HAVIQ) was used to measure changes in adolescent knowledge (6-item subscale), fear and anxiety (6-item subscale), self-efficacy (5-item subscale), and decision-making (8-item subscale). The hypothesis was that the intervention would improve adolescent involvement in vaccine decision-making (measured before dose 1 only), improve vaccine-related self-efficacy, and reduce vaccine-related fear and anxiety (measured before doses 1, 2, and 3). Mean (SD) scores for each subscale were compared between intervention and control students. In the process evaluation, focus groups were conducted. Analyses of the HAVIQ data were conducted from 2016 to 2020. Qualitative analyses of the focus groups were undertaken from 2017 to 2020. Results: The trial included 40 schools (21 intervention and 19 control) across sectors with 6967 adolescents (mean [SD] age, 13.70 [0.45] years). There were 3805 students (1689 girls and 2116 boys) in the intervention group and 3162 students (1471 girls and 1691 boys) in the control group. The overall response rate for the HAVIQ was 55%. In WA, where parental consent was required, the response rate was 35% (1676 of 4751 students); in SA, where parental consent was not required, it was 97% (2166 of 2216 students). The mean (SD) score for decision-making in the intervention group before dose 1 was 3.50 (0.42) of 5 points and 3.40 (0.40) in the control group, a small but significant difference of 0.11 point (95% CI, 0.06 to 0.16 point; P < .001). There was a small difference in favor of the intervention group in reduced vaccination-related anxiety (pre-dose 1 difference, -0.11 point [95% CI, -0.19 to -0.02 point]; pre-dose 2 difference, -0.18 point [95% CI, -0.26 to -0.10 point]; pre-dose 3 difference, -0.18 [95% CI, -0.24 to -0.11]) and increased vaccination self-efficacy (pre-dose 1 difference, 4.0 points; [95% CI, 1.0 to 7.0 points]; pre-dose 2 difference, 4.0 points [95% CI, 2.0 to 6.0 points]; pre-dose 3 difference, 3.0 points [95% CI, 1.0 to 5.0 points]). Focus group data from 111 adolescents in 6 intervention and 5 control schools revealed more confidence and less anxiety with each vaccine dose. Conclusions and Relevance: In this cluster randomized trial, there was a small difference in adolescent decisional involvement and vaccine-related confidence and reduced vaccination-related fear and anxiety that was maintained throughout the vaccine course in the intervention vs control groups. Guidelines for vaccination at school should incorporate advice regarding how this outcome can be achieved. Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12614000404628.

The management of women with ductal carcinoma in situ of the breast in Australia and New Zealand between 2007 and 2016.

BACKGROUND: The incidence of detected ductal carcinoma in situ (DCIS) continues to increase and now accounts for 14% of all breast cancer, and 20%-25% of screen-detected cases. Treatment trends of DCIS are important in order to inform the ongoing debate about possible overdiagnosis and overtreatment, but have not been investigated for over a decade in Australia and New Zealand. Against this background, we aimed to describe the temporal trends in management of DCIS in Australian and New Zealander women. METHODS: Using the BreastSurgANZ Quality Audit (BQA) database, we conducted a descriptive study of the trends of management of DCIS in Australia and New Zealand from 2007 to 2016. We assessed the frequency of surgical treatments, adjuvant therapies, and axillary surgery conducted in women with pure DCIS. RESULTS: There were 17 883 cases of pure DCIS in 2007-2016 in Australia and New Zealand recorded in the BQA database. The treatment patterns were consistent with no changes over time. The most common surgical treatment was breast-conserving surgery (66%), followed by mastectomy (37%), and 36% of women with DCIS received sentinel node biopsy (SNB). CONCLUSION: The clinical management of women diagnosed with DCIS in Australia and New Zealand, appears stable over time. A substantial proportion of women with DCIS receive SNB and this aspect of surgical care warrants further exploration to determine whether it represents appropriate care. These results, alongside the outcomes of the ongoing clinical trials on the management of DCIS, will help inform if any changes to best practice treatment are required.

Informing Women About Overdetection in Breast Cancer Screening: Two-Year Outcomes From a Randomized Trial.

BACKGROUND: Supporting well-informed decisions about breast cancer screening requires communicating that inconsequential disease may be detected, leading to overdiagnosis and overtreatment. Having previously shown that telling women about overdetection improved informed choice, we investigated effects on screening knowledge and participation over 2 years. METHODS: We conducted a community-based, parallel-group, randomized controlled trial in Australia. Participants were women aged 48-50 years, without personal or strong family history of breast cancer, who had not undergone mammography in the past 2 years. We randomly assigned 879 women to receive the intervention decision aid (evidence-based information on overdetection, breast cancer mortality reduction, and false-positives) or control decision aid (identical but without overdetection information). We interviewed 838 women postintervention and recontacted them for follow-up at 6 months and 1 and 2 years. Main outcomes for this report are screening knowledge and participation. RESULTS: We interviewed 790, 746, and 712 participants at 6 months, 1, and 2 years, respectively. The intervention group demonstrated superior knowledge throughout follow-up. After 2 years, conceptual knowledge was adequate in 123 (34.4%) of 358 women in the intervention group compared with 71 (20.1%) of 354 control participants(odds ratio = 2.04, 95% confidence interval = 1.46 to 2.85). Groups were similar in total screening participation (200 [55.1%] vs 204 [56.0%]; = 0.97, 95% confidence interval = 0.73 to 1.29). CONCLUSIONS: A brief decision aid produced lasting improvement in women's understanding of potential consequences of screening, including overdetection, without changing participation rates. These findings support the use of decision aids for breast cancer screening.

Unwanted Sex Due to Intoxication among Australians Aged 16-69 Years.

Intoxication can be a factor in unwanted sex, but research on the extent of the issue in both women and men is limited. We assessed the prevalence, correlates, and 10-year time-trends of unwanted sex due to intoxication among a representative sample of 4,279 women and 3,875 men aged 16-69 years in Australia and considered how these vary by gender. In 2012-13, 16% of women and 10% of men reported ever having had a sexual experience when they "did not want to because they were too drunk or high at the time." For both women and men, this was associated with younger age, bisexual activity, and reports of lifetime injection drug use, sexually transmitted infections, and forced sex. Among women only, it was associated with drinking above guideline levels and ever having terminated a pregnancy. Among men only, it was associated with current tobacco smoking, elevated psychosocial distress, and poor general health. Compared with 2001-02 data, fewer men reported unwanted intoxicated sex, while there were no changes for women as a whole. Interpreting these findings through an intersectional assemblage framework supports stronger understanding of the multiple factors influencing sexuality and substance use with implications for promoting equity, safety, and sexual health.

Impact of Full-Field Digital Mammography Versus Film-Screen Mammography in Population Screening: A Meta-Analysis.

BACKGROUND: Breast screening programs replaced film mammography with digital mammography, and the effects of this practice shift in population screening on health outcomes can be measured through examination of cancer detection and interval cancer rates. METHODS: A systematic review and random effects meta-analysis were undertaken. Seven databases were searched for publications that compared film with digital mammography within the same population of asymptomatic women and reported cancer detection and/or interval cancer rates. RESULTS: The analysis included 24 studies with 16 583 743 screening examinations (10 968 843 film and 5 614 900 digital). The pooled difference in the cancer detection rate showed an increase of 0.51 per 1000 screens (95% confidence interval [CI] = 0.19 to 0.83), greater relative increase for ductal carcinoma in situ (25.2%, 95% CI = 17.4% to 33.5%) than invasive (4%, 95% CI = -3% to 13%), and a recall rate increase of 6.95 (95% CI = 3.47 to 10.42) per 1000 screens after the transition from film to digital mammography. Seven studies (80.8% of screens) reported interval cancers: the pooled difference showed no change in the interval cancer rate with -0.02 per 1000 screens (95% CI = -0.06 to 0.03). Restricting analysis to studies at low risk of bias resulted in findings consistent with the overall pooled results for all outcomes. CONCLUSIONS: The increase in cancer detection following the practice shift to digital mammography did not translate into a reduction in the interval cancer rate. Recall rates were increased. These results suggest the transition from film to digital mammography did not result in health benefits for screened women. This analysis reinforces the need to carefully evaluate effects of future changes in technology, such as tomosynthesis, to ensure new technology leads to improved health outcomes and beyond technical gains.

Cesarean delivery: Trend in indications over three decades within a major city hospital network.

INTRODUCTION: The cesarean delivery rate has been increasing globally in recent decades. The reasons for this are complex and subject to ongoing debate. Investigation of the indications for cesarean delivery and how these have changed over an extended period of time could provide insight into the reasons for changing obstetric practice. Our objective was to explore contributing factors to the increasing rate of cesarean delivery by examining the incidence of and indications for cesarean delivery over the past three decades at our institutions. MATERIAL AND METHODS: We conducted a retrospective observational study of all cesarean deliveries, from 24 weeks' gestational age onwards, within an inner-city hospital network in Sydney, Australia, between August 1989 and December 2016. The primary outcome measures were the rates of and indications for emergency and planned cesarean delivery. We also examined our data within the Robson 10-Group Classification system. RESULTS: There were 147 722 births over the study period, with 37 309 cesarean deliveries for an overall rate of 25.3%. The rate of cesarean delivery increased from 18.7% in 1989-1994 (8.7% emergency, 10% planned) to 30.4% in 2010-2016 (11.4% emergency, 19% planned). Emergency cesarean delivery for slow progress increased from 3.4% to 5.5% of all births (a relative increase of 62%) and other emergency cesareans mainly performed for suspected intrapartum fetal compromise increased from 5.2% to 5.6% (a relative increase of 8%). Previous uterine surgery (predominantly cesarean section) was the largest contributor to the increase in planned procedures from 3.8% to 9.0% of all births, and 29% of all cesarean deliveries. Primary cesarean delivery for planned antenatal fetal indications, previous pregnancy problems, multiple gestation and maternal choice all increased substantially in combined rate from 0.7% to 4.9%. Cesarean rates in Robson groups 6, 7 and 8 (term breech and multiple gestations) increased most over time. CONCLUSIONS: The increased rate of cesarean delivery is mainly attributable to a greater number of procedures performed for slow progress in labor, breech presentation or repeat cesarean section.

Evaluating two decision aids for Australian men supporting informed decisions about prostate cancer screening: A randomised controlled trial.

BACKGROUND: Australian clinicians are advised to 'offer evidence-based decisional support to men considering whether or not to have a PSA test'. This randomised trial compared the performance and acceptability of two new decision aids (DAs) to aid men in making informed choices about PSA screening. METHODS: ~3000 Australian men 45-60 years with varying educational attainment were recruited via an online panel and randomised to view one of two online decision aids (one full length, one abbreviated) and completed a questionnaire. The primary outcome was informed choice about PSA screening. FINDINGS: Significantly more men in the long DA group (38%) made an informed choice than men who received the shorter DA (33%) (95% CI 1.1% to 8.2%; p = 0.008). On knowledge, the long DA group scored, on average, 0.45 points higher than the short DA group (95% CI 0.14 to 0.76; p = 0.004) and 5% more of the participants achieved an adequate knowledge score (95% CI 1.9% to 8.8%; p = 0.002). Men allocated the long DA were less likely to intend to have a PSA test in the future (53%) than men in the short DA group (59%). Both DAs rated highly on acceptability. CONCLUSIONS: Both DAs were useful and acceptable to men regardless of education level and both supported informed decision making. The long version resulted in higher knowledge, and a higher proportion of men able to make an informed choice, but the differences were small. Long DAs may be useful for men whose informational needs are not satisfied by a short DA.

Personalized melanoma risk assessments and tailored prevention advice: a pragmatic randomized controlled trial in Australian general practice.

BACKGROUND: Personalized risk assessments using prediction models that incorporate several melanoma risk factors may promote melanoma-prevention behaviours. OBJECTIVES: To evaluate the effect on short-term melanoma-prevention behaviours of web-based, real-time, model-generated personalized melanoma risk information and tailored prevention advice, and its feasibility and clinician acceptability. METHODS: Between February and April 2016, in an open randomized controlled trial across four general medical practices in New South Wales, Australia, 272 patients were randomly allocated to receive (i) real-time model-generated personalized melanoma risk assessment and tailored melanoma-prevention advice or (ii) generic melanoma-prevention advice. We measured self-reported melanoma-prevention behaviours at baseline and 6 weeks and the intervention's feasibility and acceptability. RESULTS: Follow-up questionnaires were completed by 185 patients at 6 weeks: 174 assessed as average risk and 11 as high or very high risk. There were no statistically significant differences between intervention and control patients in sun protection, sun exposure or early diagnosis behaviours. When stratified by melanoma risk, average risk patients in the intervention group appeared to show greater sun protection at 6 weeks (mean difference = 0.23, on a scale of 1-5; 95% confidence interval: 0.01 to 0.45; P = 0.04) than patients in the control group; the P value for interaction between intervention and risk category was 0.10. There was favourable feedback from patients and general practitioners. CONCLUSIONS: Web-based delivery in general practice of real-time, model-generated personalized melanoma risk prediction and tailored melanoma-prevention advice is feasible and acceptable. An apparent increase in sun protection behaviour in average risk patients warrants further evaluation in different risk groups.

Could disease labelling have positive effects? An experimental study exploring the effect of the chronic fatigue syndrome label on intended social support.

Objective Chronic fatigue syndrome (CFS) patients report limited social support, which can affect symptom severity. Friends are a key source of social support for young adults with CFS, but there is limited research on friends' responses to the CFS label. We explored the potential benefits or harms of the CFS label for shaping the potential for social support from a friend's perspective. Method 207 university students responded to hypothetical scenarios about a close friend experiencing CFS. Participants were randomly allocated to either the CFS-label or no-label conditions. The potential for social support was operationalised as attitude (sympathetic or hostile), intended treatment support and intended behavioural support. Results The CFS label elicited a greater potential for social support, with significantly higher sympathetic responses, lower rejecting responses and greater support for active treatment. These effects were significantly greater in men compared to women. There was no effect on intended behavioural support. Conclusion This study suggests the CFS label may increase the potential for social support. Young adults, particularly men, held more supportive attitudes towards their friend when the CFS label was used. Practical Implications The effects of labels on the potential for social support need to be considered when evaluating the usefulness of a disease label.

Effect of a Change in Papillary Thyroid Cancer Terminology on Anxiety Levels and Treatment Preferences: A Randomized Crossover Trial.

Importance: Given evidence of overdiagnosis and overtreatment of small papillary thyroid cancers (PTCs), strategies are needed to promote the consideration of less invasive treatment options for patients with low-risk PTC. Objective: To determine the association of treatment preferences and anxiety levels for PTC with the terminology used to describe the condition. Design, Setting, and Participants: This randomized crossover study involved a community sample of 550 Australian men and women 18 years or older without a history of thyroid cancer. Between March 16, 2016, and July 26, 2016, participants accessed an online study that presented 3 hypothetical but clinically realistic scenarios, each of which described PTC as papillary thyroid cancer, papillary lesion, or abnormal cells. Participants were exposed to all 3 scenarios with the different terminologies, and participants were randomized by the order (first, second, or third) in which they viewed the terminologies. Data analysis was conducted from September 1, 2016, to May 15, 2017. Main Outcomes and Measures: Treatment choice (total thyroidectomy, hemithyroidectomy, or active surveillance), diagnosis anxiety, and treatment choice anxiety. Results: Of the 550 participants who completed the online study and were included in the analysis, 279 (50.7%) were female and the mean (SD) age was 49.9 (15.2) years. A higher proportion of participants (108 [19.6%]) chose total thyroidectomy when papillary thyroid cancer was used to describe the condition compared with the percentage of participants who chose total thyroidectomy when papillary lesion (58 [10.5%]) or abnormal cells (60 [10.9%]) terminology was used. At first exposure, the papillary thyroid cancer terminology led 60 of 186 participants (32.3%) to choose surgery compared with 46 of 191 participants (24.1%) who chose surgery after being exposed to papillary lesion terminology first (risk ratio [RR], 0.73; 95% CI, 0.53-1.02) and 47 of 173 participants (27.2%) after being exposed to abnormal cells (RR, 0.82; 95% CI, 0.60-1.14) terminology first. After the first exposure, participants who viewed papillary thyroid cancer terminology reported significantly higher levels of anxiety (mean, 7.8 of 11 points) compared with those who viewed the papillary lesion (mean, 7.0 of 11 points; mean difference, -0.8; 95% CI, -1.3 to -0.3) or abnormal cells (mean, 7.3 of 11 points; mean difference, -0.5; 95% CI, -1.0 to 0.01). Overall, interest in active surveillance was high and higher levels of anxiety were reported by those who chose surgery, regardless of which terminology was viewed first (mean difference, 1.5; 95% CI, 1.0-1.9). Conclusions and Relevance: Changing the terminology of small PTCs may be one strategy to reduce patients' anxiety levels and help them consider less invasive management options. To curtail overdiagnosis and overtreatment in PTC, other strategies may include providing balanced information about the risks and advantages of alternative treatments. Trial Registration: anzctr.org.au Identifier: ACTRN12616000271404.

Smartphone Smoking Cessation Application (SSC App) trial: a multicountry double-blind automated randomised controlled trial of a smoking cessation decision-aid 'app'.

OBJECTIVE: To assess the efficacy of an interactive smoking cessation decision-aid application (pp) compared with a smoking cessation static information app on continuous abstinence. DESIGN: Automated double-blind randomised controlled trial with 6 months follow-up (2014-2015). SETTING: Smartphone-based. PARTICIPANTS: 684 participants (daily smokers of cigarettes, 18 years old or over) recruited passively from app stores in the USA, Australia, UK and Singapore, and randomised to one of two sub-apps. INTERVENTIONS: Behavioural, decision-aid, smartphone application. MAIN OUTCOMES: Continuous abstinence at 10 days, 1 month, 3 months and 6 months. RESULTS: Smokers who received the decision-aid app were more likely to be continuously abstinent at 1 month compared with the information-only app (28.5% vs 16.9%; relative risk (RR) 1.68; 95% CI 1.25 to 2.28). The effect was sustained at 3 months (23.8% vs 10.2%; RR 2.08; 95% CI 1.38 to 3.18) and 6 months (10.2% vs 4.8%; RR 2.02; 95% CI 1.08 to 3.81). Participants receiving the decision-aid app were also more likely to have made an informed choice (31.9% vs 19.6%) and have lower decisional conflict (19.5% vs 3.9%). CONCLUSION: A smartphone decision-aid app with support features significantly increased smoking cessation and informed choice. With an increasing number of smokers attempting to quit, unassisted evidence-based decision-aid apps can provide an effective and user-friendly option to many who are making quit decisions without healthcare professionals. TRIAL REGISTRATION NUMBER: ACTRN12613000833763.

Carcinoma in situ of the breast in New South Wales, Australia: Current status and trends over the last 40 year.

BACKGROUND: The incidence of non-invasive breast cancer has increased substantially over time. We aim to describe temporal trends in the incidence of carcinoma in situ of the breast in New South Wales (NSW), Australia. METHODS: Descriptive study of trends in the incidence of ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS) in women who received a diagnosis from 1972 to 2012, recorded in the NSW Cancer Registry. RESULTS: Carcinoma in situ as a proportion of all breast cancer was 0.4% during the prescreening period 1972 to 1987 and is currently 14.1% (2006 to 2012). Among 10,810 women diagnosed with DCIS, incidence across all ages rose from 0.15 per 100,000 during 1972 to 1983 to 16.81 per 100,000 over 2006 to 2012, representing a 100-fold increase (IRR 113.10; 95% CI 81.94 to 156.08). Among women in the target age group for screening (50-69 years) incidence rose from 0.27 per 100,000 to 51.96 over the same period (IRR 195.50; 95% CI 117.26 to 325.89). DCIS incidence peaks in women aged 60-69 years. DCIS incidence has not stabilized despite screening being well established for over 20 years, and participation rates in the target age range remaining stable. CONCLUSIONS: Our findings raise questions about the value of the increasing detection of DCIS and aggressive treatment of these lesions, especially among older women, and support trials of de-escalated treatment.

How information about overdetection changes breast cancer screening decisions: a mediation analysis within a randomised controlled trial.

OBJECTIVES: In a randomised controlled trial, we found that informing women about overdetection changed their breast screening decisions. We now present a mediation analysis exploring the psychological pathways through which study participants who received the intervention processed information about overdetection and how this influenced their decision-making. We examined a series of potential mediators in the causal chain between exposure to overdetection information and women's subsequently reported breast screening intentions. DESIGN: Serial multiple mediation analysis within a randomised controlled trial. SETTING: New South Wales, Australia. PARTICIPANTS: 811 women aged 48-50 years with no personal history of breast cancer. INTERVENTIONS: Two versions of a decision aid giving women information about breast cancer deaths averted and false positives from mammography screening, either with (intervention) or without (control) information on overdetection. MAIN OUTCOME: Intentions to undergo breast cancer screening in the next 2-3 years. MEDIATORS: Knowledge about overdetection, worry about breast cancer, attitudes towards breast screening and anticipated regret. RESULTS: The effect of information about overdetection on women's breast screening intentions was mediated through multiple cognitive and affective processes. In particular, the information led to substantial improvements in women's understanding of overdetection, and it influenced-both directly and indirectly via its effect on knowledge-their attitudes towards having screening. Mediation analysis showed that the mechanisms involving knowledge and attitudes were particularly important in determining women's intentions about screening participation. CONCLUSIONS: Even in this emotive context, new information influenced women's decision-making by changing their understanding of possible consequences of screening and their attitudes towards undergoing it. These findings emphasise the need to provide good-quality information on screening outcomes and to communicate this information effectively, so that women can make well-informed decisions. TRIAL REGISTRATION NUMBER: This study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001035718) on 17 September 2013.

"Standard Care" in Cancer Clinical Trials: An Analysis of Care Provided to Women in the Control Arms of Breast Cancer Clinical Trials.

Background: For trials to validly evaluate new treatments, comparison against the best existing alternative treatment is essential. We reviewed the care provided to women in control arms of breast cancer clinical trials to estimate the proportion consistent with the standard of care as defined in clinical guidelines. Methods: We analyzed phase III randomized controlled breast cancer trials comparing drug treatments with "standard care," enrolling between 2004 and 2014, and registered on ClinicalTrials.gov Our primary outcome was the proportion of trials in which treatment in the control arm was consistent with concurrent NCCN Guidelines. A secondary analysis assessed trials recruiting outside the United States that provided control group therapy not consistent with NCCN Guidelines, comparing them with the German Gynecological Oncology Group (AGO) guidelines. We assessed associations between the primary outcome and a priori selected trial characteristics. Results: This study included 210 trials that recruited 229,182 women worldwide; 29% of trials (60/210) did not provide control group treatment that was consistent with NCCN Guidelines. For trials not recruiting in the United States, results were similar; in 21% of trials, control arm treatment was inconsistent with both AGO and NCCN Guidelines. Factors significantly associated with offering control arm treatment that were inconsistent with guidelines were time period (later trials were less likely to be consistent), breast cancer stage and type (trials in early-stage breast cancer and estrogen receptor-negative disease were less likely consistent), and recruitment in ≥4 countries and recruitment outside the United States. Conclusions: To ensure that clinical trials achieve their goal of obtaining the best information to guide patient treatment, the question of how investigators chose and describe "standard care" for control arm participants warrants further investigation.

Trends in stage-specific breast cancer incidence in New South Wales, Australia: insights into the effects of 25 years of screening mammography.

PURPOSE: Screening mammography aims to improve breast cancer (BC) prognosis by increasing the incidence of early-stage tumours in order to decrease the incidence of late-stage cancer, but no reports have investigated these potential effects in an Australian population. Therefore we aimed to identify temporal trends in stage-specific BC in New South Wales (NSW), Australia, between 1972 and 2012. METHODS: An observational study of women who received a diagnosis of BC from 1972-2012 as recorded in the NSW Cancer Registry, a population-based registry with almost complete coverage and high rates of histological verification. We analysed trends in stage-specific incidence before screening and compared them to periods after screening began. Our primary group of interest was women in the target age range of 50-69 years, though trends in women outside the target age were also assessed. RESULTS: Screening was not associated with lower incidence of late-stage BC at diagnosis. Incidence for all stages remained higher than prescreening levels. In women aged 50-69 years, the incidence of carcinoma in situ (CIS), localised and regional BC has more than doubled compared to the prescreening era, with incidence rate ratios ranging from 2.0 for regional (95% CI 1.95-2.13) to 121.8 for CIS (95% CI 82.58-179.72). Before the introduction of screening, there was a downward trend in distant metastatic BC incidence, and after the introduction of screening there was an increase (IRR 1.8; 95% CI 1.62-2.00). In women too young to screen the incidence of late-stage BC at diagnosis also increased, whereas localised disease was stable. CONCLUSIONS: The incidence of all stages of BC has increased over the past 40 years, with the greatest rise seen during the established screening period for women aged 50-69 years. Our findings suggest that some of the expected benefits of screening may not have been realised and are consistent with overdiagnosis.