Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Medical Informatics and Decision Making
Published in: BMC Medical Informatics and Decision Making 1/2023

Open Access 01-12-2023 | Ovarian Cancer | Research

Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial

Authors: Sibylle Kautz-Freimuth, Marcus Redaèlli, Arim Shukri, Hannah Kentenich, Dusan Simic, Vanessa Mildenberger, Rita Schmutzler, Kerstin Rhiem, Stephanie Stock

Published in: BMC Medical Informatics and Decision Making | Issue 1/2023

Login to get access

Abstract

Background

Women with pathogenic BRCA1 or BRCA2 variants are at high risk for breast and ovarian cancer. Preventive options include risk-reducing breast and ovarian surgeries and intensified breast surveillance. However, individual decision-making is often associated with decisional conflicts. Two evidence-based decision aids have recently been developed for these women (healthy or with unilateral breast cancer) for the German context to support them in their decision-making process. This study evaluated their effectiveness.

Methods

In a randomized controlled study, women (aged 18–70 years) with pathogenic BRCA1 or BRCA2 variants were randomly assigned 1:1 to the intervention (IG, n = 230) or control (CG, n = 220) group. All participants received usual care. After baseline survey (t0), IG participants additionally received the DAs. Follow-up surveys were at three (t1) and six (t2) months. Primary outcome was decisional conflict at t1. Secondary analyses included decision status, decision regret, knowledge on risks and preventive options, self-reported psychological symptoms, acceptability of DAs, and preparation for decision-making.

Results

Of 450 women recruited, 417 completed t0, 398 completed t1 and 386 completed t2. Compared to CG, IG participants had lower decisional conflict scores at t1 (p = 0.049) and t2 (p = 0.006) and higher scores for knowledge (p = 0.004), acceptability (p = 0.000), and preparation for decision-making (p < 0.01).

Conclusions

These DAs can help improve key parameters of decision-making in women with pathogenic BRCA1 and BRCA2 variants and, thus, provide a useful add-on to the current counseling and care concept for these women in Germany.

Trial registration

German Clinical Trials Register, DRKS-ID: DRKS00015823, retrospectively registered 14/06/2019.
Literature
1.
Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips K-A, Mooij TM, Roos-Blom M-J, et al. Risks of breast, ovarian, and contralateral breast Cancer for BRCA1 and BRCA2 mutation carriers. JAMA. 2017;317:2402–16.CrossRefPubMed
2.
Robert Koch-Institut, Herausgeber und die Gesellschaft der epidemiologischen Krebsregister Deutschland e.V., Herausgeber. Krebs in Deutschland für 2017/2018. 13. Auflage. Berlin; 2021.
3.
Rhiem K, Engel C, Graeser M, Zachariae S, Kast K, Kiechle M, et al. The risk of contralateral breast cancer in patients from BRCA1/2 negative high risk families as compared to patients from BRCA1 or BRCA2 positive families: a retrospective cohort study. Breast Cancer Res. 2012;14:R156.CrossRefPubMedPubMedCentral
4.
the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC), Bick U, Engel C, Krug B, Heindel W, Fallenberg EM, et al. High-risk breast cancer surveillance with MRI: 10-year experience from the german consortium for hereditary breast and ovarian cancer. Breast Cancer Res Treat. 2019;175:217–28.CrossRef
5.
De Felice F, Marchetti C, Musella A, Palaia I, Perniola G, Musio D, et al. Bilateral risk-reduction mastectomy in BRCA1 and BRCA2 mutation carriers: a Meta-analysis. Ann Surg Oncol. 2015;22:2876–80.CrossRefPubMed
6.
Heemskerk-Gerritsen BAM, Jager A, Koppert LB, Obdeijn AI-M, Collée M, Meijers-Heijboer HEJ, et al. Survival after bilateral risk-reducing mastectomy in healthy BRCA1 and BRCA2 mutation carriers. Breast Cancer Res Treat. 2019;177:723–33.CrossRefPubMedPubMedCentral
7.
Li X, You R, Wang X, Liu C, Xu Z, Zhou J, et al. Effectiveness of prophylactic Surgeries in BRCA1 or BRCA2 mutation carriers: a Meta-analysis and systematic review. Clin Cancer Res. 2016;22:3971–81.CrossRefPubMed
8.
9.
Rebbeck TR, Kauff ND, Domchek SM. Meta-analysis of risk reduction estimates Associated with risk-reducing salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers. JNCI J Natl Cancer Inst. 2009;101:80–7.CrossRefPubMed
10.
Domchek SM, Friebel TM, Singer CF, Evans DG, Lynch HT, Isaacs C, et al. Association of Risk-Reducing surgery in BRCA1 or BRCA2 mutation carriers with Cancer Risk and Mortality. JAMA. 2010;304:967–75.CrossRefPubMedPubMedCentral
11.
De Felice F, Marchetti C, Boccia SM, Romito A, Sassu CM, Porpora MG, et al. Risk-reducing salpingo-oophorectomy in BRCA1 and BRCA2 mutated patients: an evidence-based approach on what women should know. Cancer Treat Rev. 2017;61:1–5.CrossRefPubMed
12.
O’Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA, Moulton BW, Sepucha KR, et al. Toward the ‘Tipping Point’: decision aids and informed patient choice. Health Aff (Millwood). 2007;26:716–25.CrossRefPubMed
13.
14.
Brehaut JC, O’Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a decision regret scale. Med Decis Making. 2003;23:281–92.CrossRefPubMed
15.
16.
Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;2017.
17.
Kautz-Freimuth S, Redaèlli M, Rhiem K, Vodermaier A, Krassuski L, Nicolai K, et al. Development of decision aids for female BRCA1 and BRCA2 mutation carriers in Germany to support preference-sensitive decision-making. BMC Med Inform Decis Mak. 2021;21:180.CrossRefPubMedPubMedCentral
18.
Kautz-Freimuth S, Redaèlli M, Isselhard A, Shukri A, Vodermaier A, Rhiem K, et al. Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial. Trials. 2022;23:157.CrossRefPubMedPubMedCentral
19.
Rhiem K, Bücker-Nott H, Hellmich M, Fischer H, Ataseven B, Dittmer‐Grabowski C, et al. Benchmarking of a checklist for the identification of familial risk for breast and ovarian cancers in a prospective cohort. Breast J. 2019;25:455–60.CrossRefPubMed
20.
21.
O’Connor A. User manual - decisional conflict scale. Ottawa, Canada: Ottawa Hospital Research Institute; 1993.
22.
Buchholz A, Hölzel L, Kriston L, Simon D, Härter M. Die Decisional Conflict Scale in deutscher Sprache (DCS-D) – Dimensionale Struktur in einer Stichprobe von Hausarztpatienten. Klin Diagn Eval. 2011;4:15–30.
23.
24.
25.
26.
Herrmann-Lingen C, Buss U, Snaith R. HADS-D. Hospital anxiety and Depression Scale - Deutsche Version. Deutsche Adaptation der Hospital anxiety and Depression Scale (HADS) von R.P. Snaith und A.S. Zigmond. 3rd ed. Bern: Huber; 2011.
27.
Zigmond AS, Snaith RP. The Hospital anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
28.
Weiss D, Marmar C. The impact of event scale - revised. In: Wilson JP, Keane TM, editors. Assessing psychological trauma and PTSD. New York: Guilford Press; 1996. pp. 399–411.
29.
Maercker A, Schützwohl M. Erfassung von psychischen Belastungsfolgen: die impact of event Skala-revidierte Version. Diagnostica. 1998;44:130–41.
30.
Hinz A, Brähler E. Normative values for the hospital anxiety and Depression Scale (HADS) in the general german population. J Psychosom Res. 2011;71:74–8.CrossRefPubMed
31.
32.
Metcalfe K, Poll A, O’Connor A, Gershman S, Armel S, Finch A, et al. Development and testing of a decision aid for breast cancer prevention for women with a BRCA1 or BRCA2 mutation. Clin Genet. 2007;72:208–17.CrossRefPubMed
33.
Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O’Connor AM. Validation of a Preparation for decision making scale. Patient Educ Couns. 2010;78:130–3.CrossRefPubMed
34.
Buchholz A, Simon D, Härter M. Die Preparation for decision-making scale in deutscher sprache (PDMS-D) – Faktorielle und konkurrente Validität in einer Onlinestich­ probe von Personen mit Kreuzschmerz oder Depression. Klin Diagn Eval. 2011;4:31–45.
35.
Peate M, Meiser B, Cheah BC, Saunders C, Butow P, Thewes B, et al. Making hard choices easier: a prospective, multicentre study to assess the efficacy of a fertility-related decision aid in young women with early-stage breast cancer. Br J Cancer. 2012;106:1053–61.CrossRefPubMedPubMedCentral
36.
Goel V, Sawka CA, Thiel EC, Gort EH, O’Connor AM. Randomized Trial of a patient decision aid for choice of Surgical treatment for breast Cancer. Med Decis Making. 2001;21:1–6.CrossRefPubMed
37.
Schwartz MD, Valdimarsdottir HB, DeMarco TA, Peshkin BN, Lawrence W, Rispoli J, et al. Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction. Health Psychol. 2009;28:11–9.CrossRefPubMedPubMedCentral
38.
Metcalfe KA, Dennis C-L, Poll A, Armel S, Demsky R, Carlsson L, et al. Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial. Genet Med. 2017;19:330–6.CrossRefPubMed
39.
Armstrong K, Weber B, Ubel PA, Peters N, Holmes J, Schwartz JS. Individualized survival curves improve satisfaction with Cancer Risk Management decisions in women with BRCA1/2 mutations. J Clin Oncol. 2005;23:9319–28.CrossRefPubMed
40.
41.
42.
Krassuski L, Vennedey V, Stock S, Kautz-Freimuth S. Effectiveness of decision aids for female BRCA1 and BRCA2 mutation carriers: a systematic review. BMC Med Inform Decis Mak. 2019;19:154.CrossRefPubMedPubMedCentral
43.
Mathieu E, Barratt A, Davey HM, McGeechan K, Howard K, Houssami N. Informed choice in Mammography Screening: a Randomized Trial of a decision aid for 70-Year-old women. Arch Intern Med. 2007;167:2039–46.CrossRefPubMed
44.
Keller K, Meisel C, Grübling N, Petzold A, Wimberger P, Kast K. Patient-reported satisfaction after Prophylactic Operations of the breast. Breast Care. 2019;14:217–23.CrossRefPubMedPubMedCentral
45.
D’Alonzo M, Piva E, Pecchio S, Liberale V, Modaffari P, Ponzone R, et al. Satisfaction and impact on quality of life of clinical and instrumental surveillance and prophylactic surgery in BRCA-mutation carriers. Clin Breast Cancer. 2018;18:e1361–6.CrossRefPubMed
46.
Braude L, Kirsten L, Gilchrist J, Juraskova I. A systematic review of women’s satisfaction and regret following risk-reducing mastectomy. Patient Educ Couns. 2017;100:2182–9.CrossRefPubMed
47.
Zdenkowski N, Butow P, Tesson S, Boyle F. A systematic review of decision aids for patients making a decision about treatment for early breast cancer. The Breast. 2016;26:31–45.CrossRef
48.
Berlin NL, Tandon VJ, Hawley ST, Hamill JB, MacEachern MP, Lee CN, et al. Feasibility and efficacy of decision aids to improve decision making for postmastectomy breast Reconstruction: a systematic review and Meta-analysis. Med Decis Making. 2019;39:5–20.CrossRefPubMed
49.
Autorengruppe Bildungsberichterstattung, Maaz K, Artelt C, Buchholz S. Bildung in Deutschland 2020. wbv Media; 2020.
50.
Fleary SA, Ettienne R. Social Disparities in Health literacy in the United States. HLRP Health Lit Res Pract. 2019;3.
51.
Hooker GW, Leventhal K-G, DeMarco T, Peshkin BN, Finch C, Wahl E, et al. Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a Randomized Trial. Med Decis Making. 2011;31:412–21.CrossRefPubMed
Metadata
Title
Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial
Authors
Sibylle Kautz-Freimuth
Marcus Redaèlli
Arim Shukri
Hannah Kentenich
Dusan Simic
Vanessa Mildenberger
Rita Schmutzler
Kerstin Rhiem
Stephanie Stock
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2023
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-023-02327-9

Other articles of this Issue 1/2023

BMC Medical Informatics and Decision Making 1/2023 Go to the issue

Research

Development and validation of a nomogram for blood transfusion during intracranial aneurysm clamping surgery: a retrospective analysis

Research

Perturbing BEAMs: EEG adversarial attack to deep learning models for epilepsy diagnosing

Research

The accuracy of artificial intelligence in predicting COVID-19 patient mortality: a systematic review and meta-analysis

Research

The coming Omicron waves and factors affecting its spread after China reopening borders

Research

Research on outpatient capacity planning combining lean thinking and integer linear programming

Research

An intelligent decision support system for acute postoperative endophthalmitis: design, development and evaluation of a smartphone application