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Nicotine Replacement Therapy for Smoking Cessation or Reduction: A Review of the Clinical Evidence [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan 16.

APPENDIX 3Summary of Study Strengths and Limitations

First Author,
Publication
Year
StrengthsLimitations
Systematic review / meta-analysis assessed with AMSTAR check list
Stead LF15 2012, UK, New Zealand
  • Research questions and selection criteria were defined and presented
  • Comprehensive literature search based on pre-defined criteria
  • Two independent investigators performed data extraction
  • List of included and excluded studies provided
  • Quality assessment of the included studies was described
  • Methods used to combine the findings were clearly reported
  • Conflict of interests declared
  • One investigator performed study selection
  • Whether the quality of included studies was considered in the analysis and conclusion was not clearly indicated
Mills EJ13 2012, Multi-nations (Canada, UK and USA)
  • Research questions and selection criteria were defined and presented
  • Comprehensive literature search based on pre-defined criteria
  • Two independent investigators performed study selection, and data extraction
  • List of included studies provided29,30
  • Quality assessment of the included studies was described
  • Methods used to combine the findings were clearly reported
  • Conflict of interests declared
  • List of excluded studies not provided
  • Whether the quality of included studies was considered in the analysis and conclusion was not clearly indicated
Moore D25 2009, UK
  • Research questions and selection criteria were defined and presented
  • Comprehensive literature search based on pre-defined criteria
  • Two independent investigators performed study selection
  • One investigator performed data extraction and the second investigator checked the data
  • List of included studies provided
  • Quality assessment of the included studies was described
  • Methods used to combine the findings were clearly reported
  • Conflict of interests declared
  • List of excluded studies not provided
  • Whether the quality of included studies was considered in the analysis and conclusion was not clearly indicated
  • Publication bias was not assessed
Randomized controlled trials assessed with SIGN 50 Check list 2
Chen HK22 2013, Taiwan
  • Research question was clearly defined
  • Double blinding process was described
  • Key patient characteristics at baseline were comparable in the treatment and control groups
  • Only difference between groups was treatment under investigation
  • Key outcome measurement was standard, valid and reliable
  • ITT analysis performed
  • Randomization method was not clearly described
  • Allocation concealment was not reported
  • Drop-out rates were high in both arms (19.6% vs. 22.8%)
  • Whether the results across all centers were comparable were not addressed
Schnoll RA27 2013, USA and Canada
  • Research question was clearly defined
  • Key patient characteristics at baseline were comparable in the treatment and control groups
  • Only difference between groups was treatment under investigation
  • Key outcome measurement was standard, valid and reliable
  • ITT analysis performed
  • Drop-out rate comparable in both arms
  • Randomization method was not clearly described
  • Allocation concealment was not reported
  • Blinding process was not clearly described
  • Whether the results across all centers were comparable were not addressed
Tonnesen P26 2012, Denmark. and Germany
  • Research question was clearly defined
  • Randomization method was clearly described
  • Allocation concealment was reported
  • Double blind was described
  • Key patient characteristics at baseline were comparable in the treatment and control groups
  • Only difference between groups was treatment under investigation
  • Key outcome measurement was standard, valid and reliable
  • ITT analysis performed
  • Drop-out rate were high in both arms (NRT vs. placebo: 47.5%% vs. 53.4% )
  • Whether the results across all centers were comparable were not addressed
Lam TH23 2012 P.R. China, USA
  • Research question was clearly defined
  • Key patient characteristics at baseline are comparable in the treatment and control groups
  • Only difference between groups was treatment under investigation
  • Key outcome measurement was standard, valid and reliable
  • ITT analysis performed
  • Drop-out rate were low and comparable in both arms (5.8% vs. 4.4%)
  • Randomization method was not clearly described
  • Allocation concealment was not reported
  • Single blind process
  • Whether the results across all centers were comparable were not addressed
Kralikova E24 2009 Czech Republic, UK and France
  • Research question was clearly defined
  • Double blinding process
  • Key patient characteristics at baseline were comparable in the treatment and control groups
  • Only difference between groups was treatment under investigation
  • ITT analysis performed
  • Randomization method was not clearly described
  • Allocation concealment was not reported
  • Drop-out not reported
  • Whether the results across all centers were comparable were not addressed
Shiffman S28 2009, USA
  • Research question was clearly defined
  • Randomization method was clearly described
  • Double blinding process
  • Key patient characteristics at baseline were comparable in the treatment and control groups
  • Only difference between groups was treatment under investigation
  • Key outcome measurement was standard, valid and reliable
  • ITT analysis performed
  • Allocation concealment was not clearly reported
  • High drop-out rate ( NRT vs. placebo: 95% vs. 91% for 2mg, 98% vs. 91% for 4mg)
  • Whether the results across all centers were comparable were not addressed

AMSTAR=A Measurement Tool to Assess the Methodological Quality of Systematic Reviews; ITT=intention to treat; NRT=nicotine replacement therapy; SIGN=Scottish Intercollegiate Guidelines Network.

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Nicotine Replacement Therapy for Smoking Cessation or Reduction: A Review of the Clinical Evidence [Internet].

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