Sexton 2010.
Methods | Randomised controlled trial | |
Participants | Female participants from multiple fertility clinics throughout the USA who were at least 18 years of age, who were receiving infertility‐related medical assessments or treatments or both, who had a BDI‐II score of < 20, who were not reporting any current suicidal ideation or intent, who were not receiving any psychological care, and who had Internet access. 43 women were randomised into an experimental condition (n = 21) or a control condition (n = 22). Women suffered from primary or secondary subfertility, had a mean age of 32.6 (±4.8) years and were subfertile for 2.5 (±2.1) years | |
Interventions | The experimental condition received WCWI (web‐based coping with infertility) during fertility treatment. Both CBT and psycho‐education were incorporated into the intervention. Women were allowed to devote as much time as they wanted (0 minutes, maximum 2 weeks) to the intervention. The Internet intervention was individual therapy. The control condition was placed on a waiting list | |
Outcomes | General stress (measured by Symptom Checklist‐90‐Revised) and infertility stress (measured by Fertility Problem Inventory). Measured at baseline and postintervention (2 weeks) | |
Notes | It should be noted that women in both intervention and control group became eligible for a lottery drawing for 50‐dollar gift cards as an honorarium for their assistance | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Random assignment was completed with the use of a random sequence generator computer program.” |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. The random.org website used for randomisation provides a random list but does not conceal it |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Participants and personnel were not blinded. Outcomes are likely to be influenced |
Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Not applicable |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Outcome assessor not blinded, may affect reporting of subjective outcomes |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Not applicable |
Incomplete outcome data (attrition bias) All outcomes | High risk | Many withdrawals (9 out of 43, 21%), and a further 3 did not provide measurements for the outcome assessment |
Selective reporting (reporting bias) | Unclear risk | Unclear without access to the protocol |
Other bias | High risk | Authors present 2 sets of results, which are inconsistent. Unclear which set is correct, or if inference was based on the correct set. Baseline summaries of the groups were not presented, so it is unclear if the groups were adequately balanced (confounding). Authors conducted and reported hypothesis tests of baseline demographics, but these are both uninformative and inappropriate. One woman in control group returned questionnaire 4 months after the end of the study and was excluded. Although this might be reasonable, it is not clear that any ‘cut‐off’ for receiving responses was defined in advance, and this increases researcher degrees of freedom |