False-positive Screening Mammography Research Articles

Long-term psychosocial consequences of false-positive screening mammography: a cohort study with follow-up of 12–14 years in Denmark

ObjectiveTo compare the long-term psychosocial consequences of mammography screening among women with breast cancer, normal results and false-positive results.DesignA matched cohort study with follow-up of 12–14 years.SettingDenmark from 2004 to...

Abstract OT3-03-01: Diagnostic value of Three-dimensional UltRasound in women recalled from Dutch breast cancer screening with a BI-RADS 0 mammography result: The TURB0 study

Abstract Background: Three-dimensional automated whole-breast ultrasound (3D ABUS) is an emerging imaging technique that enables the standardized acquisition of volumetric images of the whole breast. Although more data become available on the added value of 3D ABUS both in the screening and diagnostic setting, to date this technique is not widely used in the Netherlands. In the Netherlands, women between the ages of 50 and 75 years are invited for breast cancer screening every two years using full-field digital mammography. Approximately 2.4% of screening participants is recalled and referred to a hospital for diagnostic work-up of inconclusive (BI-RADS 0) or suspicious findings (BI-RADS 4/5). While over half of recalls from screening results from a BI-RADS 0 screening mammography, only 11% of these women has breast cancer. However, invasive diagnostic procedures are performed in every one in five women with a false-positive BI-RADS 0 recall. False-positive screening mammography results cause anxiety in the patient, especially when a biopsy is necessary. Furthermore, the diagnostic work-up after referral is costly and exerts pressure on health care facilities. 3D ABUS may be of added diagnostic value in women recalled from screening with a BI-RADS 0 mammography result. 3D ABUS may potentially lower the number of benign biopsies in the diagnostic setting and, in a future perspective, decrease the false-positive recall rate when used as an adjunct screening tool in women with a BI-RADS 0 screening mammography result. Therefore, we aim to investigate the diagnostic accuracy and added value of 3D ABUS in women recalled from Dutch breast cancer screening with a BI-RADS 0 mammography result. Trial design: Observational multicenter prospective cohort study. The study was approved by the Medical Research Ethical Committee of the University Medical Center Utrecht. Written informed consent is obtained from all participants. In addition to screening mammography, tomosynthesis and hand-held ultrasound, bilateral, supine 3D ABUS imaging is obtained. Different imaging strategies are compared to determine the optimal combination of imaging modalities and the added value of 3D ABUS. Eligibility criteria: Women recalled from Dutch breast cancer screening with a BI-RADS 0 screening mammography result and able to give informed consent are considered eligible. Aim: To investigate the diagnostic accuracy and added value of 3D ABUS in women recalled from Dutch breast cancer screening with a BI-RADS 0 mammography result. Statistical methods: Sensitivity, specificity, negative predictive value and positive predictive value of 3D ABUS will be calculated with 95% confidence intervals, using histopathology (if available) or follow up to the next screening round approximately two years later as the reference standard. The diagnostic accuracy of different imaging strategies in the diagnostic work-up will be compared with pairwise McNemar tests and area under the receiver operating characteristic curve analyses. A p-value <0.05 will be considered statistically significant. Screening mammography will be assessed in combination with 3D ABUS imaging to calculate the number of false-positive BI-RADS 0 recalls that 3D ABUS may prevent. Subgroup analysis will be performed based on four breast density categories, measured with automated breast density software, to evaluate the added value of 3D ABUS specifically in women with dense breasts. Present accrual: 360 (April 2018 - June 2019). Target accrual: 600 (expected in April 2020) Acknowledgements: The TURB0 study is funded by General Electric. Hologic provided the breast density assessment software for the purpose of this study. Contact information: B.M.denDekker-3@umcutrecht.nl Citation Format: Bianca M den Dekker, Mireille JM Broeders, Helena M Verkooijen, Alexander Venmans, Carla Meeuwis, Wikke Setz-Pels, Ruud M Pijnappel. Diagnostic value of Three-dimensional UltRasound in women recalled from Dutch breast cancer screening with a BI-RADS 0 mammography result: The TURB0 study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-03-01.

Psychosocial consequences among women with false-positive results after mammography screening in Norway

Background: Mammography screening may cause psychosocial harm for women experiencing a false-positive screening result. Previous studies suggest long-term consequences. The aim of the present study was to assess psychosocial consequences of false-positive findings on screening mammography within a six month follow-up.Methods: A prospective matched cohort survey study using the questionnaire ‘Consequences of Screening for Breast Cancer’ (COS-BC), which was translated from Danish to Norwegian. Psychometric analyses investigated the measurement properties of the Norwegian version. Two screening clinics in Norway distributed the survey to 299 women with an abnormal mammogram and 541 women with a normal screen. Women received the questionnaire when receiving the screening result, and one and six months after screening.Results: At six months, statistically significant differences appeared in two scales: existential values and breast examination. At six-month follow-up, women with false-positive results showed no statistically significant differences from women diagnosed with breast cancer in three outcomes: sense of dejection, anxiety, and keeping my mind off things.Conclusion: Our results indicate that the psychosocial consequences from having false-positive screening mammography results diminish after six months. The results support previous research describing breast-specific outcomes. However, our results indicate that Norwegian women are less frightened than other Scandinavian mammography screening participants.

Abstract P6-02-11: When needles are needed

Abstract Background Women with positive screening mammograms but negative at assessment (false-positive) are referred back to routine screening assuming that they have an average risk of breast cancer. However in a long-term follow-up of women with false-positive screening mammography we found that these women had in fact an excess risk of breast cancer later in life; RR=1.67(von Euler-Chelpin et al, JNCI 2012). This finding has later been supported by Castells et al.(Cancer Epidemiol, 2013). Furthermore, we studied the breast cancer cases in false-positive women and found that 26% of the cases were misclassified and were in fact true positives. However, even correction for misclassification, the false-positive women in our study remained at an excess breast cancer risk. At the same time, it was clear that, in the later periods of our study, when more modern techniques were used, the rate of misclassification decreased (von Euler-Chelpin et al, Cancer Epidemiol., 2014). Over time there have been changes both in the imaging and biopsy techniques. We used data from an organised screening programme in Denmark. Since its start in 1991, needle biopsies have been performed on all palpable solid lesions and on all uncertain, suspicious or malignant findings. In the very beginning fine needle aspiration cytology (FNAC) was used, later to be replaced by needle core biopsies in the majority of cases. Since 2002, suspicious micro-calcifications and impalpable mammographic findings not found by ultrasound have been examined using stereotactic needle core biopsy and later with vacuum-assisted breast biopsy as a replacement for surgical biopsy. To have a needle breast biopsy taken is a psychological burden on the woman. To minimize the harms and maximize the benefits is at the core of developing medical care. We therefore mapped the use of needle biopsies over time in a long-standing, organised screening programme. Method: We used data from the population-based screening mammography program in Copenhagen, Denmark. The programme has a database including personal records on demographic data, date of invitation, data of screening, and test results,1998-2013. Data from the Mammography Register were linked to the Danish Pathology Register (for biopsy procedures). Results: A total of 208 500 screens were included in the study. The rate of recall for assessment ranged between 1.7-3.2% of screened women with a mean of 2.4. The false-positive rate ranged between 1.0-2.5% with a mean of 1.6%. In 1998, 56% of all recalled women had a biopsy taken, which by 2013 had risen to 74% (using two-year smoothing). In proportion of all screens, the biopsy rate was 1.9% in 1998/99 which then fell to 0.7% in 2005/06 and the rose again 2.0% in 2012/13. In 1998, 59% of the biopsies were fine-needle aspiration cytology (FNAC) which by 2013 was only used in 11% of the cases, and replaced by core biopsies, ultrasound or stereotactic guided. Conclusion While the recall rate, as well as the false-positive rate, has been fairly stable during the study period the use of needle core biopsies has had a u-shaped development and has intensified in the later years. Citation Format: von Euler-Chelpin M, Vejborg I, Lænkholm A-V, Guleria S, Peterkin A, Lynge E. When needles are needed. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P6-02-11.

Prevalence, Long-term Development, and Predictors of Psychosocial Consequences of False-Positive Mammography among Women Attending Population-Based Screening.

Cancer screening aims to detect cancer at an asymptomatic stage, although side effects from screening also occur. We investigated the prevalence, longitudinal development, and predictors of psychosocial consequences of false-positive breast cancer screening. Three hundred ninety-nine women with false-positive screening mammography responded to the Consequences of Screening-Breast Cancer (COS-BC) questionnaire immediately after a negative diagnosis (free from breast cancer) following recall examination(s) (baseline), and 6 and 12 months later. Age-matched controls (n = 499) with a negative mammogram responded to the COS-BC at the same occasions. Five COS-BC scales (Sense of dejection, Anxiety, Behavioral, Sleep, and Existential values) were used as outcome measures. Women with false-positive mammography had consistently higher prevalence of all five consequences compared with controls (P < 0.001). The prevalences decreased between baseline and 6 months (P < 0.001) but were stable between 6 and 12 months (P ≥ 0.136). Early recall profoundly predicted long-term consequences for all five outcomes (OR, 3.05-10.31), along with dissatisfaction with information at recall (OR, 2.28-2.56), being foreign-born (OR, 2.35-3.71), and lack of social support (OR, 1.13-1.25). This 1-year longitudinal study shows that women experience psychosocial consequences of false-positive screening mammography. Early recall should be performed cautiously, and provision of information as well as social support may reduce psychosocial consequences. Although delivery of population-based screening reduces breast cancer mortality, it also raises the issue of its impact on the psychosocial well-being of healthy women. Our findings identify predictors that can be targeted in future efforts to reduce the side effects of mammographic screening.

Psychometric properties of a Swedish version of the Consequences of Screening - Breast Cancer questionnaire

To evaluate the psychometric properties of a questionnaire addressing psychosocial consequences of false-positive mammographic screening. The Consequences of Screening--Breast Cancer and Lung Cancer questionnaires target psychosocial consequences of false-positive cancer screening. The Consequences of Screening--Breast Cancer questionnaire and ten items not considered lung cancer specific from the Lung Cancer questionnaire have been adapted for use in mammographic screening in Sweden, but remain psychometrically untested. Instrument development paper with psychometric cross-sectional and test-retest design. Twelve scales of a Swedish questionnaire version were tested by the Rasch model and traditional psychometric methods. Women with false-positive (Group I, n = 640) and negative (Group II, n = 802) screening mammography responded to the study questionnaire and the Nottingham Health Profile during 2009-2011. Iterative analyses resulted in nine scales demonstrating Rasch model fit, but all scales exhibited poor targeting with relatively large floor effects. Corrected item-total correlations exceeded the recommended criterion. Score differences between Groups I and II and correlations with Nottingham Health Profile sections followed an expected pattern. Cronbach's α and test-retest reliability was acceptable for group-level assessments for ten and seven scales, respectively. Five scales (Sense of dejection, Anxiety, Behavioural, Sleep and Existential values) of the Swedish questionnaire version demonstrated the best psychometric properties. Other scales should be used more cautiously. Although filling an important gap, causes of concern were identified across scales. The questionnaire should therefore be considered for group-level assessments rather than for measurement of individual degrees of psychosocial consequences.

A roller coaster of emotions and sense - coping with the perceived psychosocial consequences of a false-positive screening mammography

To explore coping with the perceived psychosocial consequences of a false-positive screening mammography. Mammographic screening has been found effective to decrease breast cancer (BC) mortality, yet there are adverse effects. Psychosocial consequences of false-positive mammographic screening have mainly been investigated from a population-based perspective. A call for qualitative studies to further explore these consequences has thus been postulated. To date, qualitative studies have elucidated women's experiences following their recall breast examinations, but their coping with perceived psychosocial consequences of a false-positive screening mammography has not yet been explored. An explorative qualitative study. Face-to-face interviews were held with a purposive heterogeneous sample of 13 Swedish-speaking women with a false-positive screening mammography. The transcripts were analysed by the use of an inductive content analysis. Coping with the perceived psychosocial consequences of a false-positive screening mammography implied a roller coaster of emotion and sense. Women described how they imagined the worst and were in a state of uncertainty feeling threatened by a fatal disease. Conversely, they felt protected, surrounded by their families and being professionally taken care of, which together with perceived sisterhood and self-empowerment evoked strength and hope. Being aware of family responsibility became a crucial matter. Experiencing false-positive screening raised thoughts of thankfulness and reappraisal of life, although an ounce of BC anxiety remained. Consequently, gained awareness about BC screening and values in life surfaced. Experiencing a false-positive screening mammography triggers agonising experiences evoking a variety of coping strategies. Provision of screening raises the issue of responsibility for an impact on psychosocial well-being among healthy women. Gained knowledge might provide a basis for interventions to prevent psychosocial consequences of false-positive mammographic screening and provide support for women with a potentially compromised ability to overcome such consequences.

Better safe than sorry: a long-term perspective on experiences with a false-positive screening mammography in Denmark

Breast screening with mammography can be contentious because of its unintended harmful repercussions. A false-positive mammography is one of the most frequent harms and can encompass both short- and long-term psychosocial implications. Based on eight qualitative in-depth interviews with women who reported negative psychosocial consequences following a false-positive mammography, this article explores how women in the study experienced having a false-positive and how these experiences manifested themselves in a long-term perspective. This article draws on data from in-depth interviews with eight women in Denmark, in 2009, who had had false positive screening results approximately 5 years before the interview. Despite all participants having a self-perception of low risk of breast cancer, they regularly participated in screening. When receiving the recall letter and in the interim, the women perceived themselves as and identified with cancer patients and feared dying. When further investigation indicated that they did not have cancer, the women in the study treated this as an acquittal and expressed gratitude for the screening programme. However, their confrontation with an initial positive breast cancer diagnosis created concerns that the women still experienced and had to manage 4 to 5 years after the initial false-positive mammography. We argue that the psychosocial consequences of having the false-positive mammography contributed to the women’s view of themselves as being subjects at constant risk. However, the women did not blame the medical technology for its inaccuracy and inflicted worries, and the false-positive mammography did not lead to them losing confidence in screening. The women in the study strove for means to control the latent anxiety that was introduced with the false-positive mammography, by continuously seeking medical confirmation of their well-being and desiring more frequent screening.

Re-attendance after false-positive screening mammography: a population-based study in the Netherlands

Background:In the current study, mammography adherence of women who had experienced a false-positive referral is evaluated, with emphasis on the probability of receiving surveillance mammography outside the national screening programme.Methods:We included 424 703 consecutive screens and collected imaging, biopsy and surgery reports of 3463 women who experienced a false-positive referral. Adherence to screening, both in and outside the screening programme, was evaluated.Results:Two years after the false-positive referral, overall screening adherence was 94.6%, with 64.7% of women returning to the national screening programme, compared with 94.9% of women re-attending the screening programme after a negative screen (P<0.0001). Four years after the false-positive screen, the overall adherence had decreased to 85.2% (P<0.0001) with a similar proportion of the women re-attending the screening programme (64.4%) and a lower proportion (20.8%) having clinical surveillance mammography. Women who had experienced a false-positive screen at their first screening round were less likely to adhere to mammography than women with an abnormal finding at one of the following screening rounds (92.4% vs 95.5%, P<0.0001).Conclusion:Overall screening adherence after previous false-positive referral was comparable to the re-attendance rate of women with a negative screen at 2-year follow-up. Overall adherence decreased 4 years after previous false-positive referral from 94.6% to 85.2%, with a relatively high estimate of women who continue with clinical surveillance mammography (20.8%). Women with false-positive screens should be made aware of the importance to re-attend future screening rounds, as a way to improve the effectiveness of the screening programme.

Adaptation to Swedish and further development of the ‘Consequences of Screening – Breast Cancer’ questionnaire: a multimethod study

Experiencing a false-positive screening mammography can cause considerable psychosocial distress. The Consequences of Screening - Breast Cancer questionnaire (COS-BC parts 1 and 2), recently developed in Denmark, is the only condition-specific questionnaire for measuring short- and long-term psychosocial consequences of false-positive mammographic screening. Additional studies are needed to further test the COS-BC before use across cultures. Furthermore, studies have suggested that the consequences of false-positive screening results are partly common across cancer screening settings, although this hypothesis remains largely untested. This study (i) assesses content validity of a Swedish version of the COS-BC, (ii) tests whether items expressing long-term consequences of false-positive lung cancer screening results are relevant in a breast cancer screening context and (iii) explores the usefulness of taking results from Rasch analyses of the source version as an aid in questionnaire translation and adaptation. Following dual-panel translation, content validity was assessed through qualitative interviews with representatives of the target population and the content validity index (CVI). Item locations and Rasch model fit of the source questionnaires were considered in the translation and assessment process. The COS-BC items were generally found relevant and provided coverage of the target construct. Content validity was supported also for nine of 10 lung cancer screening items. Scale CVI values were ≥0.81. Previous Rasch data were useful in facilitating translation and assessing item content validity. The resulting Swedish version of the COS-BC parts 1 and 2 consists of 34 and 23 items, respectively. This study illustrates the value of methodological triangulation and use of data from previous Rasch analyses in questionnaire translation and adaptation. We found support for the hypothesis that consequences of false-positive screening are common across cancer screening settings. Psychometric properties of the Swedish COS-BC remain to be established.

Consequences of Screening in Breast Cancer (COS-BC): development of a questionnaire

Objective. The aims of the study were to translate and adapt both the negative and positive items of the Psychological Consequences Questionnaire (PCQ) into Danish and to test the translated version for comprehension, suitability, and content coverage by developing new items in a setting of false-positive screening mammography. Design. The translation was carried out following an internationally accepted method involving two panels: bilingual and lay. Subjects. The suitability and the content coverage of the PCQ were tested in six group interviews. Participants in the interviews were women who had had a false-positive screening mammography. They were grouped according to additional examinations they experienced following abnormal screening mammography. The audio-recordings from the group interviews were thematically analysed to identify the key consequences of abnormal and false-positive screening mammography. Results. Fifteen new items were generated to cover the negative psychosocial consequences of abnormal and false-positive screening mammography comprehensively. Five new items were produced that concerned the consequences of screening mammography during the period after being declared “free from” suspicion of cancer. Three items from the PCQ were deleted because they were judged by interviewees to be irrelevant. Response options for the positive items were changed to allow responses in both positive and negative directions. Conclusion. Because of the major changes to both parts of the PCQ the measure derived from this study should be regarded as a new questionnaire with two parts: Consequences Of Screening in Breast Cancer (COS-BC). Part II focuses on the long-term consequences of a false-positive screening mammography.

The adequacy of measurement of short and long-term consequences of false-positive screening mammography

The adequacy of measurement of short and long-term consequences of false-positive screening mammography

The adequacy of measurement of short and long-term consequences of false-positive screening mammography.

The aim of this study is to review quantitative studies on women's experiences of consequences of false-positive screening mammography to assess the adequacy of the most frequently used instruments for measuring short-term and long-term psychological consequences. Relevant papers reporting quantitative studies on consequences of false-positive screening mammography were identified using MEDLINE, CINAHL, EMBASE and PsycInfo databases. Articles citing development and psychometric properties of the most frequently used measures were also retrieved. Finally, the review focused on studies that had used at least one of the most frequently used measures. Twenty-three relevant studies were identified. The most commonly used measures were the General Health Questionnaire (GHQ), the Hospital Anxiety and Depression Scale (HADS), the Psychological Consequences Questionnaire (PCQ) and the State-Trait Anxiety Inventory (STAI). One or more of these was used in 17 of the 23 studies. The GHQ, the HADS and the STAI have problems with language, content relevance, and content coverage in studies of false-positive screening mammography. These instruments should not be used to measure psychological consequences of any kind of cancer screening. The PCQ is an adequate questionnaire for measuring short-term consequences, and the PCQ is preferable to other measures because of its higher sensitivity. However, there is little evidence that the PCQ is able to adequately detect all long-term consequences of screening mammography. Given the inadequacy of the measurement instruments used, any current conclusions about the long-term consequences of false-positive results of screening mammography must remain tentative.

Detection of breast cancer after biopsy for false-positive screening mammography. An increased risk?

Introduction: After false-positive screening for breast cancer, women are still at risk of developing breast cancer. In this study the incidence of breast cancer in a group of women who had a false-positive outcome is compared with the expected breast cancer incidence. Methods: Follow-up data of 188 women (mean age 58 years) with a false-positive screening result were collected and analysed for breast cancer development. The mean length of follow-up in the study was 7.4 years. The occurrence of breast cancer was compared to the expected incidence of breast cancer in an age-matched control population using figures from the local cancer registration. Results: The occurrence of breast cancer in the study population (n=7) was not significantly different from the expected incidence of breast cancer in the age-matched control group (n=5). Conclusion: There is no relationship between false-positive findings during breast cancer screening and later development of breast cancer. Patients who do not have an increased risk of developing breast cancer (due to family history) should not be followed-up clinically, but should be returned to the screening programme.