Methods |
Randomised controlled trial |
Participants |
Female fertility patients from 3 fertility centers in west and mid USA who were both primary and secondary subfertile, had access to a computer with Internet, were married or in cohabitation, and were not currently involved in a professionally led informative support group or workshop. The mean age was 34 years |
Interventions |
Solomon four group design: group 1 and 3 viewed an Internet program that seeks to expand the positive potential of individuals toward health. Group 2 and 4 did not view the program. Group 1 was the intervention group, and group 2 was control group.
Women viewed 63 minutes (mean), during fertility treatment and individually |
Outcomes |
Infertility distress (measured by Fertility Problem Inventory), adjustment in relationships (measured by Revised Dyadic Adjustment Scale), negative support (measured by Perceived Negative Support Scale). All measured at pre‐ and post assessment |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
“were randomised”, ”randomly permutated blocks of size four were used within 2 strata” |
Allocation concealment (selection bias) |
Low risk |
“Study research coordinator did allocation, but did not decide which participants were included” |
Blinding of participants and personnel (performance bias)
Subjective outcomes |
Low risk |
“participants were not aware of...” Solomon four group design used |
Blinding of participants and personnel (performance bias)
Objective outcomes |
Unclear risk |
Not applicable |
Blinding of outcome assessment (detection bias)
Subjective outcomes |
Low risk |
Women filled in the questionnaires and were blinded |
Blinding of outcome assessment (detection bias)
Objective outcomes |
Unclear risk |
Not applicable |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Intention‐to‐treat analysis not performed, and withdrawals were all from the intervention groups, none from the control groups |
Selective reporting (reporting bias) |
Unclear risk |
Unclear without access to the protocol |
Other bias |
Low risk |
No other obvious sources of bias. Validated questionnaires were used |