Critical appraisal:Garvelink MM, Ter Kuile MM, Louwé LA, Hilders CGJM, Stiggelbout AM 2017

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Critical Appraisal

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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.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Study aims:

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

Number of Patients:

36

62 women were eligible, of which 42 were invited by their specialized gynaecologist or fertility specialist (74%) to participate in the study soon after diagnosis but before they were referred for counselling about FP. A total of 36 women signed up for participation and 26 (72%) were randomized to brochures (n=13) or the DA (n=13). stratified by medical centre
Oncology departments of 26 medical centres had agreed to participate in the study, of which 13 actually recruited women.
Reported outcome(s):

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

Results of outcome(s):

-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.

Comments on results:

Other 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

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
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.


Size of effect
2 Reason for decision: Did not report 95%CIs but no meanifully significant differences.
Relevance of evidence
1 Additional comments: RCT (but small sample - underpowered)

Asked the main primary outcomes for DA evaluation.

Result of appraisal

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Completed by

Dr Jessica Harris

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Article
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
User:Michelle.peate
Topic area
Guidelines:COSA:Cancer fertility preservation guidelines/Oncofertility service development
Clinical question
Form
Form:Critical appraisal


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