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. 2010 Jan 20;2010(1):CD003974. doi: 10.1002/14651858.CD003974.pub3

Malcolm 1980.

Methods Design: three group parallel trial 
 Purpose: examine the effect of nicotine chewing gum treatment on smoking
Participants Patients: smokers 
 Baseline comparability: yes
Interventions Placebo: chewing gum without nicotine 
 Untreated: no chewing gum 
 Experimental: chewing gum with nicotine 
 (Co‐intervention: NS)
Outcomes Number of abstinent smokers (based on carboxyhaemoglobin levels) 
 Number of abstinent smokers (based on self report)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk NS
Allocation concealment? Unclear risk NS
Blinding? 
 Treatment provider Low risk 'The trial was double blind between the gum groups'
Blinding? 
 Outcome assessor Unclear risk NS
Incomplete outcome data addressed? 
 All outcomes High risk Drop‐out > 15% or NS
Free of selective reporting? Unclear risk No protocol available
Free of other bias? Low risk  
No signs of variance inequality or skewness? Unclear risk Not relevant (binary outcome)
Trial size > 49? Low risk N = 121
Clearly concealed allocation + trial size > 49 + drop‐out max 15% High risk Drop‐out > 15% or NS