Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial.
Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2022.22092
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发表时间：
2022-07-01
影响因子：
13.8
通讯作者：
Crew, Katherine D.
中科院分区：
文献类型：
--
作者：
Kukafka, Rita;Pan, Samuel;Silverman, Thomas;Zhang, Tianmai;Chung, Wendy K.;Terry, Mary Beth;Fleck, Elaine;Younge, Richard G.;Trivedi, Meghna S.;McGuinness, Julia E.;He, Ting;Dimond, Jill;Crew, Katherine D.
患者和临床医生的决策支持对在初级保健机构中接受遗传性乳腺癌和卵巢癌综合征基因检测资格筛查的女性接受遗传咨询有何影响？在这项由 187 名女性和 67 名临床医生参与的随机临床试验中，接受决策援助的患者接受遗传咨询的比例为 19.8%，未接受决策援助的患者接受遗传咨询的比例为 11.6%，尽管这在统计上并不显着。在这项随机临床试验中，尽管参与干预的多种族女性中有超过三分之一接受了遗传咨询，但遗传咨询的接受率并未显着增加。这项整群随机临床试验研究了与单独的标准教育相比，患者和临床医生决策支持对 BRCA1/2 基因检测的影响。为了促进识别携带 BRCA1/2 变异的女性，美国预防服务工作组建议初级保健临床医生对无症状女性进行筛查，以了解携带 BRCA1/2 变异风险是否增加。与单独的标准教育相比，检查患者和临床医生关于 BRCA1/2 基因检测的决策支持的效果。这项整群随机临床试验在一个学术医疗中心进行，包括 67 名临床医生（随机化单位）和 187 名患者。患者资格标准包括年龄在 21 至 75 岁之间、无乳腺癌或卵巢癌病史、既往未接受遗传性乳腺癌和卵巢癌综合征 (HBOC) 遗传咨询或检测、且符合 BRCA1/2 基因检测家族史标准的女性。 RealRisks 为患者提供决策帮助，乳腺癌风险导航工具为临床医生提供决策支持。患者在入组后 6 个月内安排与临床医生就诊。主要终点是 6 个月时接受遗传咨询。次要结局是 6 个月和 24 个月时的基因检测采用率、基于基线、1 个月、临床后访视和 6 个月时进行的患者调查的决策措施（感知的乳腺癌风险、乳腺癌担忧、基因检测知识、决策冲突）。从2018年12月至2020年2月，纳入了187名可评估患者（干预组101名，对照组86名）（平均[SD]年龄：40.7[13.2]岁；88名西班牙裔患者[46.6%]；15名非西班牙裔黑人患者[8.1%]；72名非西班牙裔白人患者[38.9%]；35名164 名患者 (87.8%) 完成了试验。干预组（20 名患者[19.8%]）和对照组（10 名患者[11.6%]）在 6 个月时的遗传咨询接受率没有显着差异；差异，8.2 个百分点；OR，1.88 [95% CI，0.82-4.30]；P = .14）。 6 个月内基因检测的采用率也没有统计学意义（干预组有 13 名患者 [12.9%]，对照组有 7 名患者 [8.1%]；P = .31）。 24 个月时，干预组有 31 名患者 (30.7%) 接受基因检测，而对照组为 18 名患者 (20.9%) (P = .14)。比较基线至 6 个月时各组之间的决策措施，感知的乳腺癌风险和乳腺癌担忧显着下降（标准平均差分别 = −0.48 和 -0.40）。这项随机临床试验没有发现接受患者和临床医生决策支持的患者与接受标准教育的患者相比，遗传咨询的接受率显着增加，尽管参与干预的多种族女性中超过三分之一接受了遗传咨询。这些发现表明，这些高危女性的主要优势是能够选择筛查和预防服务来降低癌症风险。 ClinicalTrials.gov 标识符：NCT03470402
What is the effect of patient and clinician decision support on genetic counseling uptake among women screened in the primary care setting for hereditary breast and ovarian cancer syndrome genetic testing eligibility? In this randomized clinical trial of 187 women and 67 clinicians, genetic counseling uptake was 19.8% for patients who received the decision aid vs 11.6% patients who did not, although this was not a statistically significant difference. In this randomized clinical trial, there was not a significant increase in genetic counseling uptake, although more than one-third of the ethnically diverse women enrolled to the intervention underwent genetic counseling. This cluster randomized clinical trial investigates the effects of patient and clinician decision support for BRCA1/2 genetic testing compared with standard education alone. To promote the identification of women carrying BRCA1/2 variants, the US Preventive Services Task Force recommends that primary care clinicians screen asymptomatic women for an increased risk of carrying a BRCA1/2 variant risk. To examine the effects of patient and clinician decision support about BRCA1/2 genetic testing compared with standard education alone. This clustered randomized clinical trial was conducted at an academic medical center including 67 clinicians (unit of randomization) and 187 patients. Patient eligibility criteria included women aged 21 to 75 years with no history of breast or ovarian cancer, no prior genetic counseling or testing for hereditary breast and ovarian cancer syndrome (HBOC), and meeting family history criteria for BRCA1/2 genetic testing. RealRisks decision aid for patients and the Breast Cancer Risk Navigation Tool decision support for clinicians. Patients scheduled a visit with their clinician within 6 months of enrollment. The primary end point was genetic counseling uptake at 6 months. Secondary outcomes were genetic testing uptake at 6 and 24 months, decision-making measures (perceived breast cancer risk, breast cancer worry, genetic testing knowledge, decision conflict) based upon patient surveys administered at baseline, 1 month, postclinic visit, and 6 months. From December 2018 to February 2020, 187 evaluable patients (101 in the intervention group, 86 in the control group) were enrolled (mean [SD] age: 40.7 [13.2] years; 88 Hispanic patients [46.6%]; 15 non-Hispanic Black patients [8.1%]; 72 non-Hispanic White patients [38.9%]; 35 patients [18.9%] with high school education or less) and 164 (87.8%) completed the trial. There was no significant difference in genetic counseling uptake at 6 months between the intervention group (20 patients [19.8%]) and control group (10 patients [11.6%]; difference, 8.2 percentage points; OR, 1.88 [95% CI, 0.82-4.30]; P = .14). Genetic testing uptake within 6 months was also statistically nonsignificant (13 patients [12.9%] in the intervention group vs 7 patients [8.1%] in the control group; P = .31). At 24 months, genetic testing uptake was 31 patients (30.7%) in intervention vs 18 patients (20.9%) in control (P = .14). Comparing decision-making measures between groups at baseline to 6 months, there were significant decreases in perceived breast cancer risk and in breast cancer worry (standard mean differences = −0.48 and −0.40, respectively). This randomized clinical trial did not find a significant increase in genetic counseling uptake among patients who received patient and clinician decision support vs those who received standard education, although more than one-third of the ethnically diverse women enrolled in the intervention underwent genetic counseling. These findings suggest that the main advantage for these high-risk women is the ability to opt for screening and preventive services to decrease their cancer risk. ClinicalTrials.gov Identifier: NCT03470402
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DOI：
10.1158/1055-9965.epi-15-0293
发表时间：
2015-11
期刊：
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
影响因子：
--
作者：
Chen L;Li CI
通讯作者：
Li CI
DOI：
10.1093/jamia/ocaa273
发表时间：
2021-02-15
期刊：
Journal of the American Medical Informatics Association : JAMIA
影响因子：
--
作者：
Goedhart NS;Zuiderent-Jerak T;Woudstra J;Broerse JEW;Betten AW;Dedding C
通讯作者：
Dedding C
影响因子：
254.7
作者：
DeSantis, Carol E.;Fedewa, Stacey A.;Jemal, Ahmedin
通讯作者：
Jemal, Ahmedin
影响因子：
5.5
作者：
Bellcross, Cecelia A.;Kolor, Katherine;Khoury, Muin J.
通讯作者：
Khoury, Muin J.
影响因子：
1.7
作者：
Joseph, G.;Kaplan, C.;Pasick, R.
通讯作者：
Pasick, R.