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Review
. 2024 May 10;5(5):CD013822.
doi: 10.1002/14651858.CD013822.pub2.

Shared decision-making for supporting women's decisions about breast cancer screening

Affiliations
Review

Shared decision-making for supporting women's decisions about breast cancer screening

Paula Riganti et al. Cochrane Database Syst Rev. .

Abstract

Background: In breast cancer screening programmes, women may have discussions with a healthcare provider to help them decide whether or not they wish to join the breast cancer screening programme. This process is called shared decision-making (SDM) and involves discussions and decisions based on the evidence and the person's values and preferences. SDM is becoming a recommended approach in clinical guidelines, extending beyond decision aids. However, the overall effect of SDM in women deciding to participate in breast cancer screening remains uncertain.

Objectives: To assess the effect of SDM on women's satisfaction, confidence, and knowledge when deciding whether to participate in breast cancer screening.

Search methods: We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 8 August 2023. We also screened abstracts from two relevant conferences from 2020 to 2023.

Selection criteria: We included parallel randomised controlled trials (RCTs) and cluster-RCTs assessing interventions targeting various components of SDM. The focus was on supporting women aged 40 to 75 at average or above-average risk of breast cancer in their decision to participate in breast cancer screening.

Data collection and analysis: Two review authors independently assessed studies for inclusion and conducted data extraction, risk of bias assessment, and GRADE assessment of the certainty of the evidence. Review outcomes included satisfaction with the decision-making process, confidence in the decision made, knowledge of all options, adherence to the chosen option, women's involvement in SDM, woman-clinician communication, and mental health.

Main results: We identified 19 studies with 64,215 randomised women, mostly with an average to moderate risk of breast cancer. Two studies covered all aspects of SDM; six examined shortened forms of SDM involving communication on risks and personal values; and 11 focused on enhanced communication of risk without other SDM aspects. SDM involving all components compared to control The two eligible studies did not assess satisfaction with the SDM process or confidence in the decision. Based on a single study, SDM showed uncertain effects on participant knowledge regarding the age to start screening (risk ratio (RR) 1.18, 95% confidence interval (CI) 0.61 to 2.28; 133 women; very low certainty evidence) and frequency of testing (RR 0.84, 95% CI 0.68 to 1.04; 133 women; very low certainty evidence). Other review outcomes were not measured. Abbreviated forms of SDM with clarification of values and preferences compared to control Of the six included studies, none evaluated satisfaction with the SDM process. These interventions may reduce conflict in the decision made, based on two measures, Decisional Conflict Scale scores (mean difference (MD) -1.60, 95% CI -4.21 to 0.87; conflict scale from 0 to 100; 4 studies; 1714 women; very low certainty evidence) and the proportion of women with residual conflict compared to control at one to three months' follow-up (rate of women with a conflicted decision, RR 0.75, 95% CI 0.56 to 0.99; 1 study; 1001 women, very low certainty evidence). Knowledge of all options was assessed through knowledge scores and informed choice. The effect of SDM may enhance knowledge (MDs ranged from 0.47 to 1.44 higher scores on a scale from 0 to 10; 5 studies; 2114 women; low certainty evidence) and may lead to higher rates of informed choice (RR 1.24, 95% CI 0.95 to 1.63; 4 studies; 2449 women; low certainty evidence) compared to control at one to three months' follow-up. These interventions may result in little to no difference in anxiety (MD 0.54, 95% -0.96 to 2.14; scale from 20 to 80; 2 studies; 749 women; low certainty evidence) and the number of women with worries about cancer compared to control at four to six weeks' follow-up (RR 0.88, 95% CI 0.73 to 1.06; 1 study, 639 women; low certainty evidence). Other review outcomes were not measured. Enhanced communication about risks without other SDM aspects compared to control Of 11 studies, three did not report relevant outcomes for this review, and none assessed satisfaction with the SDM process. Confidence in the decision made was measured by decisional conflict and anticipated regret of participating in screening or not. These interventions, without addressing values and preferences, may result in lower confidence in the decision compared to regular communication strategies at two weeks' follow-up (MD 2.89, 95% CI -2.35 to 8.14; Decisional Conflict Scale from 0 to 100; 2 studies; 1191 women; low certainty evidence). They may result in higher anticipated regret if participating in screening (MD 0.28, 95% CI 0.15 to 0.41) and lower anticipated regret if not participating in screening (MD -0.28, 95% CI -0.42 to -0.14). These interventions increase knowledge (MD 1.14, 95% CI 0.61 to 1.62; scale from 0 to 10; 4 studies; 2510 women; high certainty evidence), while it is unclear if there is a higher rate of informed choice compared to regular communication strategies at two to four weeks' follow-up (RR 1.27, 95% CI 0.83 to 1.92; 2 studies; 1805 women; low certainty evidence). These interventions result in little to no difference in anxiety (MD 0.33, 95% CI -1.55 to 0.99; scale from 20 to 80) and depression (MD 0.02, 95% CI -0.41 to 0.45; scale from 0 to 21; 2 studies; 1193 women; high certainty evidence) and lower cancer worry compared to control (MD -0.17, 95% CI -0.26 to -0.08; scale from 1 to 4; 1 study; 838 women; high certainty evidence). Other review outcomes were not measured.

Authors' conclusions: Studies using abbreviated forms of SDM and other forms of enhanced communications indicated improvements in knowledge and reduced decisional conflict. However, uncertainty remains about the effect of SDM on supporting women's decisions. Most studies did not evaluate outcomes considered important for this review topic, and those that did measured different concepts. High-quality randomised trials are needed to evaluate SDM in diverse cultural settings with a focus on outcomes such as women's satisfaction with choices aligned to their values.

Trial registration: ClinicalTrials.gov NCT00247442 NCT04741503 NCT01361035 NCT04948983.

PubMed Disclaimer

Conflict of interest statement

PR, MVRY, KSK, and JVAF have published commentaries, taught, and conducted research related to shared‐decision making. With a grant from the Hospital Italiano de Buenos Aires, we developed a decision aid for breast cancer screening: decidirmamografia.com.ar/. The development paper and alpha testing of this tool (acceptability and usability, not an implementation study) was submitted for publication and is under review. We have no commercial interest or revenue from this decision aid.

CMEL: none known.

NJS: none known.

CAR: EviSalud ‐ Evidencias en Salud (other business ownership). This online platform provides courses related to evidence‐based medicine and research methods. There are no direct or indirect relationships with the review topic.

JVAF is Managing Editor for the Cochrane Metabolic and Endocrine Disorders Group, Clinical Editor for the Cochrane Urology Group, and Cochrane's Governing Board member. He was not involved in the editorial process of this review. The views of this manuscript do not represent the views of the Cochrane Governing Board, as JVAF has an authoring role in this manuscript.

Figures

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Study flow diagram.
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1.1
1.1. Analysis
Comparison 1: Shared decision‐making (all components) versus control, Outcome 1: Knowledge
2.1
2.1. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 1: Confidence ‐ decisional conflict ‐ continuous
2.2
2.2. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 2: Confidence ‐ decisional conflict ‐ dichotomous
2.3
2.3. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 3: Confidence ‐ regret/anticipated regret
2.4
2.4. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 4: Knowledge ‐ continuous
2.5
2.5. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 5: Knowledge ‐ informed choice (composite of knowledge, attitudes and intentions)
2.6
2.6. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 6: Knowledge ‐ dichotomous (correct answers)
2.7
2.7. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 7: Anxiety ‐ continuous
2.8
2.8. Analysis
Comparison 2: Some components of shared decision‐making, including clarification of values and preferences, versus control, Outcome 8: Anxiety ‐ dichotomous
3.1
3.1. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 1: Confidence
3.2
3.2. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 2: Confidence ‐ long‐term follow‐up
3.3
3.3. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 3: Knowledge ‐ continuous
3.4
3.4. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 4: Knowledge ‐ continuous ‐ long term
3.5
3.5. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 5: Knowledge ‐ informed choice (composite of knowledge, attitudes and intentions)
3.6
3.6. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 6: Knowledge ‐ dichotomous (correct answers)
3.7
3.7. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 7: Anxiety and depression
3.8
3.8. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 8: Anxiety and depression ‐ long term
3.9
3.9. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 9: Cancer worry
3.10
3.10. Analysis
Comparison 3: Studies focused only on enhanced communication, without clarification of values and preferences, versus control, Outcome 10: Cancer worry ‐ long term

Update of

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Lippey 2022 {published data only}
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Lo 2018 {published data only}
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Molina 2018 {published data only}
    1. Molina Y, Kim SJ, Berrios N, Glassgow AE, San Miguel Y, Darnell JS, et al. Patient navigation improves subsequent breast cancer screening after a noncancerous result: evidence from the patient navigation in medically underserved areas study. Journal of Women's Health (2002) 2018;27(3):317‐23. [PMID: ] - PMC - PubMed
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Narasimmaraj 2016 {published data only}
    1. Narasimmaraj PR, Stover Fiscalini A, Kaplan CP, Van't Veer LJ, Hallada AM, Thompson CK, et al. A pilot feasibility study of the WISDOM study, a preference-tolerant randomized controlled trial evaluating a risk-based breast cancer screening strategy. Cancer Research 2016;76(4):P3-10-01.
NCT00150917 {published data only}
    1. NCT00150917. RCT of a group intervention for women with a family history of breast cancer. clinicaltrials.gov/ct2/show/NCT00150917 (first received 8 September 2005).
NCT00247442 {published data only}
    1. NCT00247442. Australian screening mammography decision aid trial (ASMDAT). clinicaltrials.gov/ct2/show/NCT00247442 (first received 1 November 2005). [ACTRN: 12605000695606]
NCT01336257 {published data only}
    1. NCT01336257. Effectiveness of a decision support system in improving the diagnosis and screening rate of breast cancer. clinicaltrials.gov/ct2/show/NCT01336257 (first received 15 April 2011).
NCT02964234 {published data only}
    1. NCT02964234. Empowering Latinas to obtain breast cancer screenings. clinicaltrials.gov/ct2/show/NCT02964234 (first received 16 November 2016).
NCT02986230 {published data only}
    1. NCT02986230. Cancer prevention clinical decision support. clinicaltrials.gov/ct2/show/NCT02986230 (first received 8 December 2016).
NCT04601272 {published data only}
    1. NCT04601272. Evaluating the shared decision making process scale in cancer screening decisions. clinicaltrials.gov/ct2/show/NCT04601272 (first received 23 October 2020).
Orlando 2018 {published data only}
    1. Orlando LA, Wu RR, Buchanan A, Myers RA, Ginsburg GS. The intersection of population health and precision medicine: employing technology to optimize risk assessment in primary care. BMC Health Services Research 2018;33(2):367. [PMID: ]
Percefull 2020 {published data only}
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Petrova 2015 {published data only}
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Phillips 2018 {published data only}
    1. Phillips K-A, Lo L, Bressel M, Collins IM, Emery J, Weideman P, et al. Acceptability and usability of iPrevent, a web-based decision support tool for assessment and management of breast cancer risk. Cancer Research 2018;78(4):P4-11-02.
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Ruffin 2004 {published data only}
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    1. Russell KM, Champion VL, Monahan PO, Millon-Underwood S, Zhao Q, Spacey N, et al. Randomized trial of a lay health advisor and computer intervention to increase mammography screening in African American women. Cancer Epidemiology, Biomarkers & Prevention 2010;19(1):201-10. - PMC - PubMed
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    1. Saywell RM, Champion VL, Zollinger TW, Maraj M, Skinner CS, Zoppi KA, et al. The cost effectiveness of 5 interventions to increase mammography adherence in a managed care population. American Journal of Managed Care 2003;9(1):33‐44. - PubMed
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    1. NCT02273206. Collaborative care to reduce depression and increase cancer screening among low-income urban women project (Prevention Care Manager 3 Project). clinicaltrials.gov/ct2/show/NCT02273206 (first received 23 October 2014).
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References to studies awaiting assessment

NCT02914197 {published data only}
    1. NCT02914197. Giving information on the risks and limitations of mammography screening (GIRLS). clinicaltrials.gov/ct2/show/NCT02914197 (first received 26 September 2016).
NCT03631758 {published data only}
    1. NCT03631758. Evaluating the impact of evidence-based information about mammography on breast cancer screening decisions. clinicaltrials.gov/ct2/show/NCT03631758 (first received 15 August 2018).

References to ongoing studies

NCT04948983 {published data only}
    1. NCT04948983. The effect of a patient decision aids for breast cancer screening. clinicaltrials.gov/ct2/show/NCT04948983 (first received 2 July 2021).

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