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Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. This article is the reprint with Russian translation edited by Dr. Ruslan Saygitov. The original that can be observed here: Cohen JF, Korevaar DA, Altman DG, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: Explanation and elaboration. BMJ Open 2016;6:e012799. doi: 10.1136/bmjopen-2016-012799.

This is the second article of a series on how to use diagnostic test accuracy evidence. In this article, we explain how diagnostic test accuracy estimates may be applied in clinical practice, using the example of coronavirus disease 2019 (COVID-19). Using clinical scenarios, we guide the reader through the process of applying estimates of diagnostic accuracy to change the pre-test probability of disease, and make clinical decisions about their patient.

Using all-cause mortality data in England and Wales over the peak of the COVID-19 outbreak in March and April, we directly estimated the number of excess deaths that may have occurred if the outbreak in Australia had been of a similar extent to that in England and Wales.

Recovery after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection remains uncertain. A considerable proportion of patients experience persistent symptoms after SARS-CoV-2 infection which impacts health-related quality of life and physical function.

Characteristics of people treated for localised melanoma who had all follow-up at MIA compared with some follow-up outside MIA (with a specialist or GP). Same as file title. (DOCX 19 kb)

© 2018 Bell et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Objective Blood pressure variability (BPV) has been associated with risk of cardiovascular events in observational studies, independently of mean BP levels. In states with higher autonomic imbalance, such as in diabetes, the importance of BP variability may theoretically be even greater. We aimed to investigate the incremental value of BPV for prediction of cardiovascular and all-cause mortality in patients with type 2 diabetes. Methods We identified 9,855 patients without pre-existing cardiovascular disease who did not change BP-lowering treatment during the observation period from a Swedish primary health care cohort of patients with type 2 diabetes. BPV was summarized as the standard deviation (SD), coefficient of variation (CV), or variation independent of mean (VIM). Patients were followed for a median of 4 years and associations with cardiovascular and all-cause mortality were investigated using Cox proportional hazards models. Results BPV was not associated with cardiovascular specific or all-cause mortality in the total sample. In patients who were not on BP-lowering drugs during the observation period (n = 2,949), variability measures were associated with all-cause mortality: hazard ratios were 1.05, 1.04 and 1.05 for 50% increases in SD, CV and VIM, respectively, adjusted for Framingham risk score risk factors, including mean BP. However, the addition of the variability measures in this subgroup only led to very minimal improvement in discrimination, indicating they may have limited clinical usefulness (change in C-statistic ranged from 0.000–0.003 in all models). Conclusions Although BPV was independently associated with all-cause mortality in diabetes patients in primary care who did not have pre-existing cardiovascular disease or BP-lowering drugs, it may be of minimal clinical usefulness above and beyond that of other routinely measured predictors, including mean BP.

15-item survey questionnaire. Survey questionnaire developed by the investigators, containing 15 questions about shared care and routine test use. (DOCX 15 kb)

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. This work was supported by the National Health and Medical Research Council of Australia through project grant number 1062389.

The Appendix provides a more detailed outline of the derivations of the test statistics and variances associated with estimates of selection and preference effects described in this paper. (DOCX 64Â kb)

From 2013 through 2017, the Australian national breast cancer screening programme is gradually inviting women aged 70–74 years to attend screening, following a policy decision to extend invitations to older women. We estimate the benefits and harms of the new package of biennial screening from age 50–74 compared with the previous programme of screening from age 50–69. Using a Markov model, we applied estimates of the relative risk reduction for breast cancer mortality and the risk of overdiagnosis from the Independent UK Panel on Breast Cancer Screening review to Australian breast cancer incidence and mortality data. We estimated screening specific outcomes (recalls for further imaging, biopsies, false positives, and interval cancer rates) from data published by BreastScreen Australia. When compared with stopping at age 69, screening 1,000 women to age 74 is likely to avert one more breast cancer death, with an additional 78 women receiving a false positive result and another 28 women diagnosed with breast cancer, of whom eight will be overdiagnosed and overtreated. The extra 5 years of screening results in approximately 7 more overdiagnosed cancers to avert one more breast cancer death. Thus extending screening mammography in Australia to older women results in a less favourable harm to benefit ratio than stopping at age 69. Supporting informed decision making for this age group should be a public health priority.

Our primary purpose was to assess the clinical (predictive) validity of central retinal thickness (CRT) and best corrected visual acuity (BCVA) at 1 week and 1 month after starting treatment with ranibizumab for central retinal vein occlusion. The authors also assessed detectability of response to treatment.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalizability of its results. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

First online questionnaire. (PDF 502 kb)

Feedback from editorial board members and reviewers from Radiology. (DOCX 28 kb)

The STARD 2015 Group. (DOCX 38 kb)

One-page explanation of STARD 2015. (DOCX 32 kb)

Questionnaire for piloting among experts in the field of imaging. (PDF 83 kb)

Rationale for STARD 2015 items. (DOCX 45 kb)

Summary of responses to the online surveys. (DOCX 31 kb)

Literature review: results. (DOCX 141 kb)

Second online questionnaire. (PDF 208 kb)

Appendix 1. Methodological comparison of IPD meta-analysis and previous study-level analysis of agreement between MRI and pathologic tumor measurements post-NAC. Appendix 2. PRISMA flowchart. Appendix 3. Research protocol and data collection template. Appendix 4. MRI technical characteristics of studies included in the IPD analysis. Appendix 5. Bland Altman Plots for MRI (absolute and log transformed values). Appendix 6. Bland Altman Plots for US (absolute and log transformed values). Appendix 7. Bland Altman Plots for mammography (absolute and log transformed values). Appendix 8. Bland Altman Plots for clinical examination (absolute and log transformed values). Appendix 9. Pooled relative differences (%) (fixed effect unless noted) and limits of agreement for studies and patients comparing the respective tests. Appendix 10. Forest plots of MRI and comparator tests (relative mean differences with pathology). Appendix 11. Forest plots of MRI and comparator tests (absolute mean differences with pathology). Appendix 12. Forest plots of MRI by chemotherapy agent and HER2 status (absolute mean differences with pathology). (DOC 796 kb)

Background: Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical examination is to identify patients with a higher likelihood of underlying serious pathology, such as vertebral fracture, who may require additional investigation and specific treatment. All 'evidence-based' clinical practice guidelines recommend the use of red flags to screen for serious causes of back pain. However, it remains unclear if the diagnostic accuracy of red flags is sufficient to support this recommendation. Objectives: To assess the diagnostic accuracy of red flags obtained in a clinical history or physical examination to screen for vertebral fracture in patients presenting with LBP. Search methods: Electronic databases were searched for primary studies between the earliest date and 7 March 2012. Forward and backward citation searching of eligible studies was also conducted. Selection criteria: Studies were considered if they compared the results of any aspect of the history or test conducted in the physical examination of patients presenting for LBP or examination of the lumbar spine, with a reference standard (diagnostic imaging). The selection criteria were independently applied by two review authors. Data collection and analysis: Three review authors independently conducted 'Risk of bias' assessment and data extraction. Risk of bias was assessed using the 11-item QUADAS tool. Characteristics of studies, patients, index tests and reference standards were extracted. Where available, raw data were used to calculate sensitivity and specificity with 95% confidence intervals (CI). Due to the heterogeneity of studies and tests, statistical pooling was not appropriate and the analysis for the review was descriptive only. Likelihood ratios for each test were calculated and used as an indication of clinical usefulness. Main results: Eight studies set in primary (four), secondary (one) and tertiary care (accident and emergency = three) were included in the review. Overall, the risk of bias of studies was moderate with high risk of selection and verification bias the predominant flaws. Reporting of index and reference tests was poor. The prevalence of vertebral fracture in accident and emergency settings ranged from 6.5% to 11% and in primary care from 0.7% to 4.5%. There were 29 groups of index tests investigated however, only two featured in more than two studies. Descriptive analyses revealed that three red flags in primary care were potentially useful with meaningful positive likelihood ratios (LR+) but mostly imprecise estimates (significant trauma, older age, corticosteroid use; LR+ point estimate ranging 3.42 to 12.85, 3.69 to 9.39, 3.97 to 48.50 respectively). One red flag in tertiary care appeared informative (contusion/abrasion; LR+ 31.09, 95% CI 18.25 to 52.96). The results of combined tests appeared more informative than individual red flags with LR+ estimates generally greater in magnitude and precision. Authors' conclusions: The available evidence does not support the use of many red flags to specifically screen for vertebral fracture in patients presenting for LBP. Based on evidence from single studies, few individual red flags appear informative as most have poor diagnostic accuracy as indicated by imprecise estimates of likelihood ratios. When combinations of red flags were used the performance appeared to improve. From the limited evidence, the findings give rise to a weak recommendation that a combination of a small subset of red flags may be useful to screen for vertebral fracture. It should also be noted that many red flags have high false positive rates; and if acted upon uncritically there would be consequences for the cost of management and outcomes of patients with LBP. Further research should focus on appropriate sets of red flags and adequate reporting of both index and reference tests.

BACKGROUND: There is limited evidence on the relative effectiveness of different follow-up schedules for patients with AJCC stage I or II melanoma, but less frequent follow-up than is currently recommended has been proposed. OBJECTIVES: To describe melanoma clinicians' perspectives on the functions of follow-up, factors that influence follow-up intervals, and important considerations for extending intervals. METHODS: Qualitative interviews with 16 clinicians (surgical oncologists, dermatologists, melanoma unit physicians) who conduct follow-up at two of Australia's largest specialist centers. RESULTS: Follow-up is conducted for early detection of recurrences or new primary melanomas, to manage patient anxiety, support patient self-care, and as part of shared care. Recommended intervals are based on guidelines but account for each patient's clinical risk profile, level of anxiety, patient education requirements, capacity to engage in skin self-examination, and how the clinician prefers to manage any suspicious lesions. CONCLUSIONS: To revise guidelines and implement change it is important to understand the rationale underpinning existing practice. Extended follow-up intervals for early stage melanoma are more likely to be adopted after the first year when patients are less anxious and sufficiently prepared to conduct self-examination. Clinicians may retain existing schedules for highly anxious patients or those unable to examine themselves.

BACKGROUND: Patients treated for melanoma are advised to have lifelong full body skin examinations. Extended intervals between examinations have been proposed, but although this may be clinically effective, psychosocial aspects of follow-up are not well understood. This systematic review summarised patient and clinician preferences, experiences and adherence with recommended follow-up of stage I/II melanoma. METHODS: Medline, PsycINFO, CINAHL, Embase, Cochrane Library, ACP Journal Club and NHS Economic Evaluation Database were searched from database inception to week 3 April 2010, to identify original studies of psychosocial outcomes of follow-up after treatment of stage I/II primary cutaneous melanoma, as reported by patients or clinicians. The results were synthesised, and characteristics likely to maximise patients' well-being and adherence to follow-up schedules were proposed. RESULTS: We found 15 studies that met the inclusion criteria. Anxiety with melanoma follow-up was common; patients valued reassurance, information and psychosocial support, but long-term adherence to schedules was variable. Some wanted more emotional support from their clinician than was provided. Clinicians sometimes ordered additional blood and imaging tests to reassure patients. GPs were hesitant to conduct melanoma follow-up, but a trial providing technical training and protocols reported positive outcomes. Both patients and GPs wanted prompt access to melanoma specialists when suspicious lesions were found. CONCLUSION: Psychosocial aspects of follow-up impact on patient well-being and potential adherence to schedules, and may influence clinician practice. If follow-up schedules or personnel are to be revised, psychosocial impacts on patients must be explicitly addressed, as well as guidance and specialist support for clinicians.

Response rules are increasingly used by the Pharmaceuticals Benefits Scheme (PBS) in Australia and the National Institute of Clinical Excellence (NICE) in the U.K. to limit continued subsidy of very expensive drugs to patients who demonstrate an ‘adequate’ response. By targeting therapy to patients who appear to benefit most, policy makers aim to increase the cost‐effectiveness of therapy. However, the value of response rules in fulfilling this aim is unproven. We present a four‐item checklist that may be used to help decision makers identify when a response rule is appropriate. As an example, we apply our checklist to the response rules used for tumour necrosis factor (TNF) inhibitors in rheumatoid arthritis. On the basis of the checklist we find that the response rules in both countries are inadequate and may cause therapy to be inappropriately ceased in some and continued in others. Careful assessment is needed before decision makers adopt a response rule as a way of increasing the cost effectiveness of therapy. Copyright © 2009 John Wiley & Sons, Ltd.

Retinal vessel caliber may be a novel marker of coronary heart disease (CHD) risk. However, the sex-specific effect, magnitude of association, and effect independent of traditional CHD disease risk factors remain unclear.To determine the association between retinal vessel caliber and risk for CHD.Relevant studies in any language identified through MEDLINE (1950 to June 2009) and EMBASE (1950 to June 2009) databases.Studies were included if they examined a general population, measured retinal vessel caliber from retinal photographs, and documented CHD risk factors and incident CHD events.6 population-based prospective cohort studies provided data for individual participant meta-analysis.Proportional hazards models, adjusted for traditional CHD risk factors, were constructed for retinal vessel caliber and incident CHD in women and men. Among 22,159 participants who were free of CHD and followed for 5 to 14 years, 2219 (10.0%) incident CHD events occurred. Retinal vessel caliber changes (wider venules and narrower arterioles) were each associated with an increased risk for CHD in women (pooled multivariable-adjusted hazard ratios, 1.16 [95% CI, 1.06 to 1.26] per 20-microm increase in venular caliber and 1.17 [CI, 1.07 to 1.28] per 20-microm decrease in arteriolar caliber) but not in men (1.02 [CI, 0.94 to 1.10] per 20-microm increase in venular caliber and 1.02 [CI, 0.95 to 1.10] per 20-microm decrease in arteriolar caliber). Women without hypertension or diabetes had higher hazard ratios.Error in the measurement of retinal vessel caliber and Framingham variables was not taken into account.Retinal vessel caliber changes were independently associated with an increased risk for CHD events in women.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in a study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve the reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in a study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve the reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

Overview CPG recommendations older people (n=47), organised by medical condition then by year of publication (reverse chronological) (PDF 354 kb)

Examples of brief and more extensive guideline recommendations for older people according to the three criteria for CPG recommendations older people. (PDF 525 kb)

Overview CPG recommendations older people (n=47), organised by medical condition then by year of publication (reverse chronological) (PDF 354 kb)

Study 2 qualitative interview questions about how GPs reassess primary CVD risk. (DOCX 14Â kb)

Study 2 qualitative interview questions about how GPs reassess primary CVD risk. (DOCX 14Â kb)

Supporting Quotes from the CPGs (PDF 436 kb)

Factors associated with routine investigations used during follow-up. Same as file title. (DOCX 17 kb)

Examples of brief and more extensive guideline recommendations for older people according to the three criteria for CPG recommendations older people. (PDF 525 kb)

Factors associated with routine investigations used during follow-up. Same as file title. (DOCX 17 kb)

Introduction: Women are largely unaware that mammography screening can cause overdetection of inconsequential disease, leading to overdiagnosis and overtreatment of breast cancer. Evidence is lacking about how information on overdetection affects women’s breast screening decisions and experiences. This study investigates the consequences of providing information about overdetection of breast cancer to women approaching the age of invitation to mammography screening. Methods and analysis: This is a randomised controlled trial with an embedded longitudinal qualitative substudy. Participants are a community sample of women aged 48–50 in New South Wales, Australia, recruited in 2014. Women are randomly allocated to either quantitative only follow-up (n=904) or additional qualitative follow-up (n=66). Women in each stream are then randomised to receive either the intervention (evidence-based information booklet including overdetection, breast cancer mortality reduction and false positives) or a control information booklet (including mortality reduction and false positives only). The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions) assessed via telephone interview at 2 weeks postintervention. Secondary outcomes measured at this time include decision process (decisional conflict and confidence) and psychosocial outcomes (anticipated regret, anxiety, breast cancer worry and perceived risk). Women are further followed up at 6 months, 1 and 2 years to assess self-reported screening behaviour and long-term psychosocial outcomes (decision regret, quality of life). Participants in the qualitative stream undergo additional in-depth interviews at each time point to explore the views and experiences of women who do and do not choose to have screening. Ethics and dissemination: The study has ethical approval, and results will be published in peer-reviewed journals. This research will help ensure that information about overdetection may be communicated clearly and effectively, using an evidence-based approach, to women considering breast cancer screening. Trial registration number: Australian New Zealand Clinical Trials Registry ACTRN12613001035718. National Health and Medical Research Council

Objective: To elicit women's responses to information about the nature and extent of overdiagnosis in mammography screening (detecting disease that would not present clinically during the woman's lifetime) and explore how awareness of overdiagnosis might influence attitudes and intentions about screening. Design: Qualitative study using focus groups that included a presentation explaining overdiagnosis, incorporating different published estimates of its rate (1-10%, 30%, 50%) and information on the mortality benefit of screening, with guided group discussions Setting: Sydney, Australia Participants: Fifty women aged 40-79 years with no personal history of breast cancer and with varying levels of education and participation in screening. Results: Prior awareness of breast cancer overdiagnosis was minimal. Women generally reacted with surprise, but most came to understand the issue. Responses to overdiagnosis and the different estimates of its magnitude were diverse. The highest estimate (50%) made some women perceive a need for more careful personal decision making about screening. In contrast, the lower and intermediate estimates (1-10% and 30%) had limited impact on attitudes and intentions, with many women remaining committed to screening. For some women, the information raised concerns, not about whether to screen but whether to treat a screen detected cancer or consider alternative approaches (such as watchful waiting). Information preferences varied: many women considered it important to take overdiagnosis into account and make informed choices about whether to have screening, but many wanted to be encouraged to be screened. Conclusions: Women from a range of socioeconomic backgrounds could comprehend the issue of overdiagnosis in mammography screening, and they generally valued information about it. Effects on screening intentions may depend heavily on the rate of overdiagnosis. Overdiagnosis will be new and counterintuitive for many people and may influence screening and treatment decisions in unintended ways, underscoring the need for careful communication. Refereed/Peer-reviewed

Purpose To develop more evidence-based guidelines for the frequency of patient follow-up after treatment of localized (American Joint Committee on Cancer [AJCC] stage I or II) melanoma. Methods We used data from Melanoma Institute Australia on an inception cohort of 3,081 consecutive patients first diagnosed with stage I or II melanoma between January 1985 and December 2009. Kaplan-Meier curves and Cox models were used to characterize the time course and predictors for recurrence and new primaries. We modeled the delay in diagnosis of recurrence or new primary as well as the number of monitoring visits required using two monitoring schedules: first, according to 2008 Australian and New Zealand guidelines and, second, with fewer visits, especially for those at lowest risk of recurrence. Results For every 1,000 patients beginning follow-up, 229 developed recurrence and 61 developed new primary within 10 years. There was only a small difference in modeled delay in diagnosis (extra 44.9 and 9.6 patients per 1,000 for recurrence and new primary, respectively, with delay greater than 2 months) using a schedule that requires far fewer visits (3,000 fewer visits per 1,000 patients) than recommended by current guidelines. AJCC substage was the most important predictor of recurrence, whereas age and date of primary diagnosis were important predictors of developing new primary. Conclusion By providing less intensive monitoring, more efficient follow-up strategies are possible. Fewer visits with a more focused approach may address the needs of patients and clinicians to detect recurrent or new melanoma.

Objective. In current medical literature, mammography and other cancer screening programs are subject to controversy because of debate about the magnitude and nature of the benefits and harms. This paper discusses the issues around informed choice for women considering breast screening. Method. We discuss qualitative and quantitative studies of women’s attitudes to breast screening and informed choice. Results. Women view breast screening as a way of avoiding potential regret, and reassurance from normal results is highly valued. Screening participants acknowledge anxiety about false positives but awareness regarding potential over detection of indolent breast cancer is minimal, and research is needed to assess how better understanding of screening downsides may affect women’s views. In any case, weighing up screening advantages and disadvantages is sensitive to personal preferences. Conclusions. Communicators have an ethical obligation to make balanced information available to women,which is flexible enough to respond to the level of detail and involvement desired by each individual. Many women want to know more and to participate more actively in screening decisions. Techniques have been developed to present balanced information and support individual decision making in ways that are accessible and empowering for the wider community. Evaluations of breast cancer screening must integrate clinical data with evidence on the perspectives of women themselves. Refereed/Peer-reviewed