Critical appraisal:Garvelink MM, Ter Kuile MM, Louwé LA, Hilders CGJM, Stiggelbout AM 2017
Garvelink MM, Ter Kuile MM, Louwé LA, Hilders CGJM, Stiggelbout AM. Feasibility and effects of a decision aid about fertility preservation. Hum Fertil (Camb) 2017 Jun;20(2):104-112 Available from: http://www.ncbi.nlm.nih.gov/pubmed/27848252.
randomised controlled trial
feasibility and preliminary effects of a decision aid (DA) about female FP
-pilot multicentre RCT of women with BC aged 18–40 who were randomized to brochures or the DA over 18 months
Oncology departments of 26 medical centres had agreed to participate in the study, of which 13 actually recruited women.
Effectiveness of the DA and other measures - online self-report questionnaire at baseline (T0), six weeks (T1), and six months(T2): Decisional conflict; Knowledge; Reproductive concerns; Decisional regret
Recruitment timing - gynaecologist vs oncologist
-women who received brochures had a significantly lower perception (p=0.046) of their risk of losing fertility (M=6.7) compared to women who received the DA (M=8.2), but this was not correlated to other outcome measures.
-Decisional conflict - Women who received the brochures scored significantly lower on the effective DM subscale of the DCS (indicating they made an informed, values based decision that is likely to be implemented) than women who received the DA in addition to brochures. Total DC was not significantly different. At T2 there was a weak trend towards more total DC, and effective DM in the DA group.
-Knowledge - significant differences were found between baseline and T1 (DM¼1.35 out of 10), and baseline and T2 (DM¼1.25, p¼0.004; �0.56), indicating a relative increase of 22%. There were no differences between intervention and control groups
-Reproductive concerns - There were no differences between groups or measurement moments with regard to reproductive concerns
-Decisional regret -There were no statistically significant differences in anticipated regret between measurement moments, nor were there differences in regret between groups. Both groups showed a trend for a minor increase in regret between measurements made at T1 and T2 (DM=4.9; p=0.15; d=�0.29). At baseline, both groups anticipated more regret when not undergoing FP and becoming infertile, than when undergoing it and remaining fertile (indicating that it had not been necessary to pursue FP).
- Recruitment timing - Those invited through their gynaecologist, DA use was higher compared to that of women recruited via their oncologist (80.0% versus 37.5%). Additionally, they had slightly higher baseline knowledge than those recruited by their oncologist (6.4 versus 5.0 out of 10), as well as at T1 (7.8 versus 6.4 out of 10) and T2 (7.4 versus 6.2 out of 10), but the increase in knowledge was similar between the two groups (1.0 versus 1.2 out of 10). Otherwise there were no differences with regard to the outcomes.
-Feasibility outcomes - proportion of participants eligible, invited and recruited after 16 months and the proportion of completed questionnaires after 18 months
-Use of information -website statistics
Small sample - this will not underpowered.
no differences with regard to socio-demographic and medical characteristics between the two study groups
|High risk of bias||Comments: It's almost impossible to blind DA studies - as best you can try to single blind but even then it's pretty tough. COncealment unclear.|
|2||Reason for decision: Did not report 95%CIs but no meanifully significant differences.|
|1||Additional comments: RCT (but small sample - underpowered)|
Asked the main primary outcomes for DA evaluation.
- Garvelink MM, Ter Kuile MM, Louwé LA, Hilders CGJM, Stiggelbout AM. Feasibility and effects of a decision aid about fertility preservation. Hum Fertil (Camb) 2017 Jun;20(2):104-112 Available from: http://www.ncbi.nlm.nih.gov/pubmed/27848252.
- Assigned to
- Topic area
- Guidelines:COSA:Cancer fertility preservation guidelines/Oncofertility service development
- Clinical question
Section below only relevant for Cancer Council Project Officer