Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Hersch J

PROVIDER: S-EPMC8562961 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Hersch Jolyn J Barratt Alexandra A McGeechan Kevin K Jansen Jesse J Houssami Nehmat N Dhillon Haryana H Jacklyn Gemma G Irwig Les L McCaffery Kirsten K

Journal of the National Cancer Institute 20211101 11

<h4>Background</h4>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.<h4>Methods</h4>We conducted a community-based, parallel-group, randomized controlled trial in Australia. Participants were women aged 4 ...[more]

PMID: 33871631

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Project description:ObjectivesIn 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.DesignSerial multiple mediation analysis within a randomised controlled trial.SettingNew South Wales, Australia.Participants811 women aged 48-50 years with no personal history of breast cancer.InterventionsTwo 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 outcomeIntentions to undergo breast cancer screening in the next 2-3 years.MediatorsKnowledge about overdetection, worry about breast cancer, attitudes towards breast screening and anticipated regret.ResultsThe 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.ConclusionsEven 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 numberThis study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001035718) on 17 September 2013.

Project description:ObjectiveTo develop, pilot and refine a decision aid (ahead of a randomised trial evaluation) for women around age 50 facing their initial decision about whether to undergo mammography screening.DesignTwo-stage mixed-method pilot study including qualitative interviews (n=15) and a randomised comparison using a quantitative survey (n=34).SettingNew South Wales, Australia.ParticipantsWomen aged 43-59 years with no personal history of breast cancer.InterventionsThe decision aid provides evidence-based information about important outcomes of mammography screening over 20 years (breast cancer mortality reduction, overdetection and false positives) compared with no screening. The information is presented in a short booklet for women, combining text and visual formats. A control version produced for the purposes of comparison omits the overdetection-related content.OutcomesComprehension of key decision aid content and acceptability of the materials.ResultsMost women considered the decision aid clear and helpful and would recommend it to others. Nonetheless, the piloting process raised important issues that we tried to address in iterative revisions. Some participants found it hard to understand overdetection and why it is of concern, while there was often confusion about the distinction between overdetection and false positives. In a screening context, encountering balanced information rather than persuasion appears to be contrary to people's expectations, but women appreciated the opportunity to become better informed.ConclusionsThe concept of overdetection is complex and new to the public. This study highlights some key challenges for communicating about this issue. It is important to clarify that overdetection differs from false positives in terms of its more serious consequences (overtreatment and associated harms). Screening decision aids also must clearly explain their purpose of facilitating informed choice. A staged approach to development and piloting of decision aids is recommended to further improve understanding of overdetection and support informed decision-making about screening.

Project description:Background. Breast cancer screening has been presented to women as mostly positive for decades, despite voices raising issues related to harms since its introduction. Public communications about breast cancer screening tended to use persuasive techniques aimed at maximizing uptake. Concern about the harm of overdetection is more recent, and awareness of overdetection among the public is limited. We aimed to assess the impact of extensive information on treatment following overdetection in breast screening on women's acceptance of screening, and to assess correlates of acceptance. Methods. We performed an online survey among women aged 45-75 from the general public in the Netherlands and Australia, asking women their maximum acceptable ratio of overdetection, per breast cancer death avoided, for four treatment scenarios (randomized order): mastectomy; lumpectomy; lumpectomy plus radiotherapy; lumpectomy plus radiotherapy and hormone therapy. The effect of treatment was assessed using General Linear Models, controlling for socio-demographics, experience, and psychological characteristics. Results. Four-hundred Australian and 403 Dutch women responded. Around half of the women would always screen, even at a 6:1 overdetection-to-death-avoided ratio. Acceptance was highest for the lumpectomy scenario, decreasing with more invasive treatment. In multivariate analyses the effect of treatment remained (p<0.001). Higher acceptance was seen for women with children (p=0.04), screening experience (p<0.001), and less understanding of overdetection (p<0.001). A learning effect was seen: acceptance was highest for the first scenario shown. Conclusions. Acceptance of overdetection was high, but decreased after the first scenario and with invasiveness of treatment. This provides a first indication that with more knowledge and understanding, women may move from uncritical acceptance of screening towards a more informed decision that involves a trade-off of the benefits and harms.

Project description:ObjectiveThe Veterans Health Administration (VHA) conducted a randomized quality improvement evaluation to determine whether augmenting patient-centered medical homes with Primary care Intensive Management (PIM) decreased utilization of acute care and health care costs among patients at high risk for hospitalization. PIM was cost-neutral in the first year; we analyzed changes in utilization and costs in the second year.Data sourcesVHA administrative data for five demonstration sites from August 2013 to March 2019.Data sourcesAdministrative data extracted from VHA's Corporate Data Warehouse.Study designVeterans with a risk of 90-day hospitalization in the top 10th percentile and recent hospitalization or emergency department (ED) visit were randomly assigned to usual primary care vs primary care augmented by PIM. PIM included interdisciplinary teams, comprehensive patient assessment, intensive case management, and care coordination services. We compared the change in mean VHA inpatient and outpatient utilization and costs (including PIM expenses) per patient for the 12-month period before randomization and 13-24 months after randomization for PIM vs usual care using difference-in-differences.Principal findingsBoth PIM patients (n = 1902) and usual care patients (n = 1882) had a mean of 5.6 chronic conditions. PIM patients had a greater number of primary care visits compared to those in usual care (mean 4.6 visits/patient/year vs 3.7 visits/patient/year, p < 0.05), but ED visits (p = 0.45) and hospitalizations (p = 0.95) were not significantly different. We found a small relative increase in outpatient costs among PIM patients compared to those in usual care (mean difference + $928/patient/year, p = 0.053), but no significant differences in mean inpatient costs (+$245/patient/year, p = 0.97). Total mean health care costs were similar between the two groups during the second year (mean difference + $1479/patient/year, p = 0.73).ConclusionsApproaches that target patients solely based on the high risk of hospitalization are unlikely to reduce acute care use or total costs in VHA, which already offers patient-centered medical homes.

Project description:ObjectiveTo evaluate differences in short-term perinatal outcomes between the two prominent screening strategies for gestational diabetes mellitus, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and Carpenter-Coustan.MethodsIn this single-site, blinded, randomized, comparative effectiveness trial, participants received a nonfasting 50-g oral glucose tolerance test and, if less than 200 mg/dL (less than 11.1 mmol/L), were randomized to further screening with either IADPSG or Carpenter-Coustan criteria. Gestational diabetes treatment occurred per routine clinical care. The primary outcome was incidence of large-for-gestational-age (LGA) neonates. Prespecified secondary outcomes included small-for-gestational-age (SGA) neonates, cesarean birth, and neonatal and maternal composites of adverse perinatal outcomes. Assuming a 15% incidence of LGA neonates in the Carpenter-Coustan group, 782 participants provided more than 80% power to detect a 7% absolute risk reduction with the use of IADPSG; planned recruitment was 920 for anticipated attrition.ResultsFrom June 2015 to February 2019, 1,016 participants were enrolled and 921 were randomized to IADPSG (n=461) or Carpenter-Coustan (n=460) groups. Gestational diabetes incidence (14.4% vs 4.5%, P<.001) and diabetes medication use (9.3% vs 2.4%; P<.001) were more common in the IADPSG group; there were no differences in LGA neonates, either overall (risk reduction 0.90, 97.5% CI 0.53-1.52) or among women without gestational diabetes (risk reduction 0.85, 97.5% CI 0.49-1.48). Those screened with IADPSG had higher rates of neonatal morbidity but fewer study-related adverse events. Rates of SGA neonates, cesarean birth, and maternal morbidity composite did not differ significantly between study groups.ConclusionsThe IADPSG screening criteria resulted in more women diagnosed and treated for gestational diabetes than Carpenter-Coustan without reducing the incidence of LGA birth weight or maternal or neonatal morbidity.Clinical trial registrationClinicalTrials.gov, NCT02309138.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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