Page 64 - ESHRE2019

6. Selective reporting
1 “All measured outcomes were reported” +-
Patient satisfaction was measured using four different scales at 1 day and 2
weeks post surgery. Only one scale was reported in the paper at 1 day post
surgery. +
The study protocol stated that the primary outcome was ongoing pregnancy. The
3 paper reported live birth as the primary outcome and ongoing pregnancy as a -
secondary outcome
The study protocol stated that live birth was the primary outcome, but live birth was not reported in the paper. Ongoing pregnancy and clinical pregnancy were reported.
“Adverse events were uncommon and did not differ significantly between the ? two groups”
The study reported clinical and ongoing pregnancy. No study protocol or trial ? registration was available.
7. Other bias
Cochrane Handbook
• The conduct of the study is affected by interim results (e.g. recruiting additional participants from a subgroup showing more benefit).
• There is deviation from the study protocol in a way that does not reflect clinical practice (e.g. post hoc stepping-up of doses to exaggerated levels).
• There is pre-randomization administration of an intervention that could enhance or diminish the effect of a subsequent, randomized, intervention.
• Inappropriate administration of an intervention (or co-intervention).
• Contamination (e.g. participants pooling drugs).
• Occurrence of ‘null bias’ due to interventions being insufficiently well delivered or overly wide inclusion criteria for participants (Woods 1995).
• An insensitive instrument is used to measure outcomes (which can lead to under-estimation of both beneficial and harmful effects).
• Fraud
• Baseline imbalance - prognostic factors only (but should this be in there?)
Default is low risk
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