The development and phase 1 evaluation of a Decision Aid for elective egg freezing.

BACKGROUND: Elective egg freezing decisions are complex. We developed a Decision Aid for elective egg freezing and conducted a phase 1 study to evaluate its acceptability and utility for decision-making. METHODS: The online Decision Aid was developed according to International Patient Decision Aid Standards and evaluated using a pre/post survey design. Twenty-six Australian women aged 18-45 years, interested in receiving elective egg freezing information, proficient in English, and with access to the internet were recruited using social media and university newsletters. Main outcomes were: acceptability of the Decision Aid; feedback on the Decision Aid design and content; concern raised by the Decision Aid, and; utility of the Decision Aid as measured by scores on the Decisional Conflict Scale and on a study-specific scale assessing knowledge about egg freezing and age-related infertility. RESULTS: Most participants found the Decision Aid acceptable (23/25), balanced (21/26), useful for explaining their options (23/26), and for reaching a decision (18/26). Almost all reported satisfaction with the Decision Aid (25/26) and the level of guidance  it provided (25/26). No participant reported serious concerns about the Decision Aid, and most would recommend it to other women considering elective egg freezing (22/26). Median Decisional Conflict Scale score decreased from 65/100 (Interquartile range: 45-80) pre-Decision Aid to 7.5/100 (Interquartile range: 0-37.5) post-Decision Aid review (p < 0.001). Median knowledge score increased from 8.5/14 (Interquartile range: 7-11) pre-Decision Aid to 11/14 (Interquartile range: 10-12) post-Decision Aid review (p = 0.01). CONCLUSION: This elective egg freezing Decision Aid appears acceptable and useful for decision-making. It improved knowledge, reduced decisional conflict and did not raise serious concerns. The Decision Aid will be further evaluated using a prospective randomised control trial. STUDY REGISTRATION: ACTRN12618001685202 (retrospectively registered: 12 October 2018).

Randomized control trial of a decision aid for women considering elective egg freezing: The Eggsurance study protocol.

BACKGROUND: Uptake of elective egg freezing has increased globally. The decision to freeze eggs is complex, and detailed, unbiased information is needed. To address this, we developed an online Decision Aid for women considering elective egg freezing. Decision Aids are the standard of care to support complex health decisions. OBJECTIVES: This study will measure the impact of the Decision Aid on decision-making (e.g. decisional conflict, engagement in decision-making, distress, and decision delay) and decision quality (e.g. knowledge, level of informed choice, and regret). METHODS AND ANALYSIS: A single-blinded two-arm parallel-group randomized controlled trial. Women considering elective egg freezing will be recruited using social media, newsletters, and fertility clinics. Data will be collected at baseline (recruitment), 6-month, and 12-month post-randomization. The primary hypothesis is that the intervention (Decision Aid plus Victorian Assisted Reproductive Technology Authority website) will reduce decisional conflict (measured using the Decisional Conflict Scale) at 12 months more than control (Victorian Assisted Reproductive Technology Authority website only). Secondary outcomes include engagement in decision-making (Perceived Involvement in Care Scale), distress (Depression, Anxiety, and Stress Scale), decision delay, knowledge, informed choice (Multi-dimensional Measure of Informed Choice), and decisional regret (Decisional Regret Scale). ETHICS: The study was approved by the University of Melbourne Human Research Ethics Committee (Ethics ID: 2056457). Informed consent will be obtained from all participants prior to enrolment. DISCUSSION: This is the first international randomized controlled trial that aims to investigate the effect of an elective egg freezing Decision Aid on decision-related outcomes (e.g. decisional conflict, informed choice, and regret). It is anticipated that participants who receive the Decision Aid will have better decision and health outcomes. REGISTRATION DETAILS: ACTRN12620001032943: Comparing different information resources on the process and quality of decision-making in women considering elective egg freezing.