Table 2.
Studies addressing decisional regret in context of decision aids validation.
| Study | Origin | Type | Aims | Sample | Study Design | Decisional Regret Measures | Relevant Findings about Decisional Regret |
|---|---|---|---|---|---|---|---|
| Peate et al. [30] | Australia | Quantitative | - To evaluate the efficacy of a DA compared with usual care among young women diagnosed with early breast cancer. - Specific aims: (i) Compare changes in decision-related outcomes, including decisional conflict about fertility treatment decisions and knowledge, over time. (ii) Compare decision-related outcomes, including decisional regret about treatment decisions, and informed choice at 1- and 12-months post diagnosis. (iii) Examine potential changes in anxiety and depression as a result of the use of the DA compared to usual care. |
- N = 120 (Intervention group: 48; Control group: 72) - Newly diagnosed early-stage breast cancer patients - Mean age control group: 33.8 - Mean age intervention group: 32.3 - 71.6% (control group) and 76.6% (intervention group) had - 36.1% (control group) and 25% (intervention group) had children |
Prospective study Non-randomized trial design Control group: consumer guide; Intervention group: received the DA Baseline (1st consultation, T1 (1 month after), T2 (at 12 months) |
DRS- to measure regret related to FP treatment decisions (measured T1 e T2) | -At 1 month, regret scores regarding fertility-related decisions were not significantly different between the control and intervention groups. -After adjusting for education, the intervention group had significantly lower decisional regret at 12 months. |
| Garvelink et al. [31] | The Netherlands | Quantitative | -To test the feasibility and effects of the detailed DA compared to brochures about FP on decisional conflict, knowledge, regret, and reproductive concerns. |
- N = 36 (Intervention group: 13; Control group: 13) - Newly diagnosed breast cancer patients - Mean age control group: 32.9 - Mean age intervention group: 35.8 - 92% (in control and (intervention group) had male partner - 46% (in control and (intervention group) had children |
RCT Control group: Informational brochures Intervention group: received the DA Baseline (T0), T1 (6 weeks after T0), T2 (6 months after T0) |
At T1 and T2: DRS- measure regret related to FP (measured T1 e T2) | - Both groups showed a trend for a minor increase in regret between T1 and T2. |
| Ehrbar et al. [32] | Switzerland | Quantitative | - Secondary analysis of the results of an RCT evaluating a DA for female patients with different cancer diagnoses: - To address the long-term impact of DA on knowledge and attitude - To explore its long-term effectiveness regarding decisional regret - To investigate the association between decisional conflict and decisional regret over time. |
- N = 51 (Intervention group: 27; Control group: 24) - Different diagnosis, majority breast cancer - Mean age control group: 28.78 - Mean age intervention group: 29.92 - 85.2% (control group) and 75% (intervention group) had - 14.8% (control group) and 12.5% (intervention group) had children |
RCT Control group: usual care Intervention group: received the DA T1: directly after fertility counseling; T2: 1 month later; T3: 12 months later. |
DRS- to measure regret related to FP treatment decisions (measured T2 e T3) | - Decisional regret low and stable in all participants. - Decisional regret was lower in the intervention group when compared to the control group, but the difference was not significant. - Positive association between decisional conflict and decisional regret at T3 (12 months). |
Abbreviations: TX, cancer treatment; DX, cancer diagnosis; GYN, gynecologic cancer; FP, fertility preservation; FSS, fertility-sparing surgery; QoL, quality of life; DRS, decisional regret scale; DA, decision aid; RCT, randomized controlled trial.