Fields 2008.

Methods	Study design: Parallel‐group RCT Location: Akron Ohio, USA Number of centres: 1 Study period: October 2005 to March 2006 Funding source: Internal hospital funding
Participants	Setting: 24‐bed stroke, neurological and medical ICU Inclusion criteria: Any mechanically‐ventilated patient on the stroke/medical ICU intubated in the hospital for < 24 hours , no previous diagnosis of pneumonia Exclusion criteria: Patients with prior tracheotomies, younger than 18 years, AIDS secondary to immunocompromised systems, edentulous patients Number randomised: Not stated Number evaluated: Not stated Baseline characteristics: Not reported
Interventions	Comparison: Toothbrushing 8‐hourly versus usual care Experimental group: Nurse brushed patient's teeth, tongue and hard palate for > 1 minute, then used toothette swab to swab patient's teeth, tongue and hard palate for > 1 minute, then apply moisturiser to lips. Mouth and pharynx were suctioned as needed using catheter which was replaced every 24 hours. Oral assessment every 12 hours. Oral care kit #2 provided for each participant, with worksheet #2 Control group: Usual care (unspecified) which could include up to 2 toothbrushings daily and toothette mouthcare as needed. Nurses used oral care kit #1 and worksheet #1
Outcomes	1. Incidence of VAP
Notes	Sample size calculation: "Desired sample size was 200 ventilator dependent patients or 2000 ventilator days" Email sent to authors 3 September 2012 requesting numbers of patients treated. No reply received. Trial included in text as narrative only
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"..a plastic bin labelled 1‐350, containing sealed envelopes which each had either worksheet #1 or #2, plus information about the trial to give to families". No mention of whether envelopes were sequentially numbered. Method of sequence generation not described
Allocation concealment (selection bias)	Low risk	Allocation contained in sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible, both nurses and participants would have known allocated treatment
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Outcome of VAP assessed by infection control nurse. Unclear whether this person was blinded to allocated treatment
Incomplete outcome data (attrition bias) All outcomes	High risk	The study neither reports the number of participants randomised nor the number analysed
Selective reporting (reporting bias)	High risk	No numerical data were reported in this paper. VAP incidence was not reported by treatment group or with any measure of variance
Other bias	Unclear risk	Insufficient information in the trial report to produce confidence in the methodology of this trial