目标:为考虑选择性卵子冷冻(EEF)的女性设计的决策援助是否会影响决策冲突和其他与决策相关的结果?
结论:决策援助减少了决策冲突,让女性做好决策准备,不会造成痛苦。
背景:选择性卵子冷冻决定很复杂,78%的女性报告了高度的决策冲突。决策辅助用于支持复杂的健康决策。我们为考虑EEF的女性开发了一个在线决策辅助工具,并证明它在第一阶段测试中是可以接受和有用的。
方法:单盲,进行双臂平行组随机对照试验.目标样本量为286名参与者。对照(现有网站信息)或干预(决策援助加现有网站信息)组为1:1,并按澳大利亚州/地区和先前的IVF专家咨询进行分层。参与者在2020年9月至2021年3月之间招募,结果记录在12个月内。数据使用在线调查收集,数据收集于2022年3月完成。
方法:年龄≥18岁的女性,生活在澳大利亚,考虑到EEF,精通英语,并且使用包括社交媒体帖子在内的多种方法招募互联网访问,谷歌广告,时事通讯/布告板帖子,和生育诊所推广。完成基线调查后,参与者通过电子邮件发送了他们分配的网站链接。随访调查在6个月和12个月进行。主要结果是决策冲突(决策冲突量表)。其他结果包括痛苦(抑郁焦虑和压力量表),有关卵子冷冻和女性年龄相关不孕的知识(研究特定的措施),是否做出了决定,准备决定卵子冷冻(准备决策量表),知情选择(知情选择的多维度量),和决策后悔(决策后悔量表)。
结果:总体而言,306名参与者(平均年龄30岁;SD:5.2)被随机分配(干预n=150,对照组n=156)。在12个月时,决策冲突量表得分显着降低(平均得分差异:-6.99[95%CI:-12.96,-1.02],调整基线决策冲突后,干预组和对照组的P=0.022)。6个月时,干预组比对照组更愿意决定EEF(平均得分差异:9.22[95%CI:2.35,16.08],P=0.009)。12个月时,在痛苦中没有观察到组差异(平均得分差异:0.61[95%CI:-3.72,4.93],P=0.783),知识(平均得分差异:0.23[95%CI:-0.21,0.66],P=0.309),或是否做出决定(相对风险:1.21[95%CI:0.90,1.64],P=0.212)。在知情选择中没有发现组差异(相对风险:1.00[95%CI:0.81,1.25],P=0.983)或决策后悔(中位数得分差异:-5.00[95%CI:-15.30,5.30],P=0.337)在12个月内决定EEF的参与者中(干预n=48,对照n=45)。
结论:由于使用的招募方法和2019年冠状病毒大流行引起的限制,未知的参与者摄取和潜在的抽样偏差。一些结果的样本量很小,限制了所做的推论。使用特定研究或经过调整的验证措施可能会影响某些结果的可靠性。
结论:这是第一个评估EEF决策援助的随机对照试验。决策援助减少了决策冲突,改善了妇女的决策准备。该工具将公开提供,可以为国际使用量身定制。
背景:决策援助是在皇家妇女医院基金会和McBainFamilyTrust的资助下开发的。该研究由国家健康与医学研究委员会(NHMRC)项目赠款APP1163202资助,授予M.Hickey,M.Peate,R.J.诺曼,和R·哈特(2019-2021年)。S.S.,M.P.,D.K.,和S.B.得到了NHMRC项目赠款APP1163202的支持,以执行这项工作。R.H.是西澳大利亚州生育专家的医学主任和城市生育国家医学主任。他收到了MSD的资助,默克-塞罗诺,和Ferring制药与本研究无关,是CHA-SMG的股东。R.L.是墨尔本妇女健康总监(医疗实践),ANZSREI执行秘书(荣誉),RANZCOGCREI子专业委员会成员(荣誉),以及墨尔本生活生育诊所和皇家妇女医院公共生育服务的生育专家。R.A.A.已获得与本研究无关的FerringPharmaceuticals的资助。M.H.,K.H.,和R.J.N.没有冲突要声明。
背景:ACTRN12620001032943。
■2020年8月11日。
■2020年9月29日。
OBJECTIVE: Does a purpose-designed Decision Aid for women considering elective egg freezing (EEF) impact decisional conflict and other decision-related outcomes?
CONCLUSIONS: The Decision Aid reduces decisional conflict, prepares women for decision-making, and does not cause distress.
BACKGROUND: Elective egg-freezing decisions are complex, with 78% of women reporting high decisional conflict. Decision Aids are used to support complex health decisions. We developed an online Decision Aid for women considering EEF and demonstrated that it was acceptable and useful in Phase 1 testing.
METHODS: A single-blind, two-arm parallel group randomized controlled
trial was carried out. Target sample size was 286 participants. Randomization was 1:1 to the control (existing website
information) or intervention (Decision Aid plus existing website
information) group and stratified by Australian state/territory and prior IVF specialist consultation. Participants were recruited between September 2020 and March 2021 with outcomes recorded over 12 months. Data were collected using online surveys and data collection was completed in March 2022.
METHODS: Females aged ≥18 years, living in Australia, considering EEF, proficient in English, and with internet access were recruited using multiple methods including social media posts, Google advertising, newsletter/noticeboard posts, and fertility clinic promotion. After completing the baseline survey, participants were emailed their allocated website link(s). Follow-up surveys were sent at 6 and 12 months. Primary outcome was decisional conflict (Decisional Conflict Scale). Other outcomes included distress (Depression Anxiety and Stress Scale), knowledge about egg freezing and female age-related infertility (study-specific measure), whether a decision was made, preparedness to decide about egg freezing (Preparation for Decision-Making Scale), informed choice (Multi-Dimensional Measure of Informed Choice), and decision regret (Decision Regret Scale).
RESULTS: Overall, 306 participants (mean age 30 years; SD: 5.2) were randomized (intervention n = 150, control n = 156). Decisional Conflict Scale scores were significantly lower at 12 months (mean score difference: -6.99 [95% CI: -12.96, -1.02], P = 0.022) for the intervention versus control group after adjusting for baseline decisional conflict. At 6 months, the intervention group felt significantly more prepared to decide about EEF than the control (mean score difference: 9.22 [95% CI: 2.35, 16.08], P = 0.009). At 12 months, no group differences were observed in distress (mean score difference: 0.61 [95% CI: -3.72, 4.93], P = 0.783), knowledge (mean score difference: 0.23 [95% CI: -0.21, 0.66], P = 0.309), or whether a decision was made (relative risk: 1.21 [95% CI: 0.90, 1.64], P = 0.212). No group differences were found in informed choice (relative risk: 1.00 [95% CI: 0.81, 1.25], P = 0.983) or decision regret (median score difference: -5.00 [95% CI: -15.30, 5.30], P = 0.337) amongst participants who had decided about EEF by 12 months (intervention n = 48, control n = 45).
CONCLUSIONS: Unknown participant uptake and potential sampling bias due to the recruitment methods used and restrictions caused by the coronavirus disease 2019 pandemic. Some outcomes had small sample sizes limiting the inferences made. The use of study-specific or adapted validated measures may impact the reliability of some results.
CONCLUSIONS: This is the first randomized controlled
trial to evaluate a Decision Aid for EEF. The Decision Aid reduced decisional conflict and improved women\'s preparation for decision making. The tool will be made publicly available and can be tailored for international use.
BACKGROUND: The Decision Aid was developed with funding from the Royal Women\'s Hospital Foundation and McBain Family Trust. The study was funded by a National Health and Medical Research Council (NHMRC) Project Grant APP1163202, awarded to M. Hickey, M. Peate, R.J. Norman, and R. Hart (2019-2021). S.S., M.P., D.K., and S.B. were supported by the NHMRC Project Grant APP1163202 to perform this work. R.H. is Medical Director of Fertility Specialists of Western Australia and National Medical Director of City Fertility. He has received grants from MSD, Merck-Serono, and Ferring Pharmaceuticals unrelated to this study and is a shareholder of CHA-SMG. R.L. is Director of Women\'s Health Melbourne (Medical Practice), ANZSREI Executive Secretary (Honorary), RANZCOG CREI Subspecialty Committee Member (Honorary), and a Fertility Specialist at Life Fertility Clinic Melbourne and Royal Women\'s Hospital Public Fertility Service. R.A.A. has received grants from Ferring Pharmaceuticals unrelated to this
study. M.H., K.H., and R.J.N. have no conflicts to declare.
BACKGROUND: ACTRN12620001032943.
UNASSIGNED: 11 August 2020.
UNASSIGNED: 29 September 2020.