Smoking cessation for peripheral arterial disease: systematic review protocol.

Background: peripheral arterial disease has smoking as its main avoidable vascular risk factor. However, most studies do not focus on smoking as the main exposure variable.

Objectives: to assess the impact of smoking cessation interventions versus active comparator, placebo or no intervention, on peripheral arterial disease outcomes.

Methods: we will use the Cochrane Handbook for Systematic Reviews of Interventions to guide whole this review process. We will consider parallel or cluster-randomised controlled trials (RCTs), quasi-RCTs, and cohort studies. We will search CENTRAL, MEDLINE, Embase, PsycINFO, LILACS and IBECS. We will also conduct a search of ClinicalTrials.gov and the ICTRP for ongoing or unpublished trials. Each research step will involve at least two independent reviewers. We will create a table, using GRADE pro GDT software, reporting the pooled effect estimates for the following outcomes: all-cause mortality, lower limb amputation, adverse events, walking distance, clinical severity, vessel or graft secondary patency, and QoL.

Conclusions: we will assess these outcomes according to the five GRADE considerations to assess the certainty of the body of evidence for these outcomes, and to draw conclusions about the certainty of the evidence within the review.