Kramer 2001.

Methods	Double‐blinded RCT.
Participants	A total of 281 healthy breastfeeding women who were motivated to breastfeed and their healthy term singleton infants recruited in the immediate postpartum period prior to hospital discharge.
Interventions	Participants were randomly allocated to 1 of 2 counselling interventions provided by a research nurse trained in lactation counselling. A basic breastfeeding promotion package was included in both the intervention and control groups. The intervention group (n = 140) were "asked to avoid pacifiers when the infant cried or fussed" and suggested alternative ways to provide comfort. The control group (n = 141) "all options were discussed for calming an infant" including pacifier use.
Outcomes	Mothers were asked to complete a validated behaviour diary on 3 consecutive days, at 4, 6 and 9 weeks of age. Study mothers were interviewed at 3 months. Primary outcome measures: rate of early weaning at 3 months, 72‐hour infant behaviour logs detailing frequency and duration of crying and fussing and pacifier use at 4, 6, 9 weeks.
Notes	The trial was carried out from January 1998 to August 1999 on women giving birth at the Royal Victoria Hospital, a McGill University‐affiliatted maternity hospital in Montreal, Quebec.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomisation within each stratum was accomplished using computer‐generated random numbers in blocks of 4." "Women were stratified by parity and if multiparous according to whether they had breastfed previously."
Allocation concealment (selection bias)	Low risk	"The assigned allocation was contained in an opaque envelope opened by a research nurse after the consent was obtained."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not reported. Comment: blinding of the participants is not feasible.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Study mothers were interviewed at 3 months by a research assistant who was blinded to the intervention status of the mother."
Incomplete outcome data (attrition bias) All outcomes	Low risk	8.2% (23/281) participants, i.e. 13/140 from pacifier‐avoidance group, 10/141 from pacifier‐advised group lost to follow‐up and did not complete the trial.
Selective reporting (reporting bias)	Low risk	None detected.
Other bias	Low risk	None detected.