Ockhuijsen 2014.
Methods | Randomised controlled trial | |
Participants | Women undergoing a stimulated or cryopreserved IVF/ICSI treatment cycle at a university hospital in the Netherlands. Women were excluded if they could not speak Dutch. 377 women were randomised into the PRCI group (n = 127), the monitoring group (n = 117), and the control group (n = 124). Mean (SD) age was 34.9 (4.7) years in PRCI group, 34.6 (4.7) in monitoring group, and 34.8 (5.0) in control group. They were both primary and secondary subfertile. Duration of subfertility was 3.4 (2.2) years in PRCI group, 3.1 (2.2) in monitoring group, and 3.1 (2.3) in control group |
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Interventions | The PRCI group received a small card with 10 positive reappraisal statements and a leaflet with explanation as a self administered coping intervention. They read the card twice a day for 14 days during fertility treatment and filled in the DRK for 14 days. The monitoring group only filled in the DRK for 14 days. The control group received routine care | |
Outcomes | Anxiety and depression (measured by HADS), positive and negative emotions daily (measured 14 days by DRK), clinical pregnancy (with foetal heartbeat) (measured 6 weeks post ET) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “A computer‐generated table of random numbers was used to achieve the stratified randomization of the 372 women who met the eligibility criteria” |
Allocation concealment (selection bias) | Low risk | Patient records were concealed to the independent researcher who performed allocation |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Although the women did not know what the intervention was, those in the PRCI group had "something extra" given to them, probably resulting in non‐specific placebo effects. Personnel appear to be adequately blinded. Those performing embryo transfer blind to allocation |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Although the women did not know what the intervention was, those in the PRCI group had "something extra" given to them. The premise of this review is that psychological states may influence pregnancy/birth outcomes |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Self reported questionnaires are used. Women were not adequately blinded |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | “An independent research assistant verified random data input for accuracy of the database.” Pregnancy outcome was ascertained for all randomised women |
Incomplete outcome data (attrition bias) All outcomes | High risk | High levels (> 20%) of drop‐out in all groups. Mixed‐effects models used to include women with incomplete sets of observations, but no imputation of missing data |
Selective reporting (reporting bias) | Unclear risk | Protocol: quality of life and coping will be measured. Not reported. Primary outcome was stated |
Other bias | High risk | As noted by authors, possible effects in 2 of the arms due to daily monitoring by DRK. A validated questionnaire was used for the primary outcomes |