| Methods |
Randomised controlled trial |
| Participants |
Married couples who were commencing an infertility medical investigation. Inclusion criteria were: females had to experience primary subfertility and had to be unaware of the reason for their failure to get pregnant. 39 couples were randomised into the Emotional and Sexual Information Group (IG) (n = 13), the Emotional IG (n = 13), and the Procedural IG (n = 13). Mean (SD) age of the males was 32.3 (5.2) years and mean (SD) age of the females was 29.8 (4.1) years. Duration of subfertility was 2.3 (1.7) years for all couples |
| Interventions |
The Emotional and Sexual IG received information about how to cope better with medical investigations. Each couple then viewed a 15‐min videotape and read a 15‐page sex information booklet.
The Emotional IG (attentional control) received the information and viewed the videotape.
The Procedural IG (attentional control) received the information and viewed a 12‐min videotape that described only procedural aspects.
The intervention took 1 day (pre‐fertility treatment, face to face), and couples received a phone call every month |
| Outcomes |
Pregnancy, anxiety (measured by STAI‐state). Pregnancy was measured 6 months post‐testing. Anxiety was measured pre‐ and post‐testing |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
“each couple was then randomly assigned to one of three groups” |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment not reported |
| Blinding of participants and personnel (performance bias)
Subjective outcomes |
Low risk |
Participants were blinded: “in order to equate for expectations of benefit across groups”. Personnel not stated |
| Blinding of participants and personnel (performance bias)
Objective outcomes |
Low risk |
Participants were blinded: “in order to equate for expectations of benefit across groups”. Personnel not stated |
| Blinding of outcome assessment (detection bias)
Subjective outcomes |
Low risk |
Participants were blinded and were the outcome assessors |
| Blinding of outcome assessment (detection bias)
Objective outcomes |
Low risk |
No blinding, but the follow‐up appears to be complete. Greater attempts of intervention group follow‐up than of control group follow up, which could lead to bias, will be unlikely in this case |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
High bias due to removal of 4 couples from pre‐post analyses owing to the fact that that they fell pregnant, i.e. the participants with the desired outcome were removed. It is unclear which intervention group these participants came from. Given that there were 9 pregnancies in total, it is also unclear why only 4 excluded |
| Selective reporting (reporting bias) |
High risk |
Numerous questionnaires administered. Of those assessing psychological adjustment, only STAI‐state reported as the measurements “were highly correlated” and STAI‐state “was selected for analysis because it was considered the best measure of an individual’s current stress level.” Other measurements were selected for inclusion in the analysis on the basis of model selection procedures, which were not described and must be to some extent arbitrary. No primary outcome is named. Only the values of those measurements for which significant change was observed are reported in Table 2. There is great scope for ‘researcher degrees of freedom’ as a result of these features ‐ arbitrary decisions which may affect the inference of the study |
| Other bias |
High risk |
Baseline imbalances between the groups in education and body image. A validated questionnaire was used for the primary outcome |
