Chapter 10 348 Recruitment Recruitment takes place at participating health care institutions, starting with Erasmus MC. Potential participants are informed about the group-based smoking cessation training sessions through internal websites, flyers, information sessions provided by SineFuma or by referral through their company doctor. Potential participants receive a letter explaining the different incentive schemes and the research procedures. Upon enrolment, informed consent is required. Allocation Within participating institutions, participants will be individually randomised 1:1 to either the control or intervention arm. Permuted block randomisation with varying block sizes of four and six is used. There are two stratification factors: participating institution and readiness-to-quit (preparation or contemplation stage). A computer-generated allocation sequence was provided by ALEA randomisation service, in collaboration with the Erasmus MC Clinical Trial Centre. The block sizes will not be disclosed so as to ensure allocation concealment. ALEA will not release the randomisation result until the patient has been recruited into the trial and all baseline questionnaires have been completed. Participants are informed about their allocation by email. Inherent to the intervention and study design, participants and outcome assessors will not be blinded to allocation. Group session trainers will be blinded to allocation and data will be anonymised before analysis. Collection methods As described in the section ‘Outcomes’, self-reported abstinence will be validated using expired air CO concentration readings obtained via a handheld monitor. Participants will be invited to complete web-based questionnaires assessing selfreported quality of life (EQ-5DF),25 smoking abstinence self-efficacy (SASEQ),26 perceived stress (Perceived Stress Scale)27 and self-reported smoking abstinence (point prevalence and continuous abstinence)23 at each time point during followup. At baseline the following items will be collected: educational level following the International Standard Classification of Education (ISCED),28 0 (early childhood education) to 8 (doctoral or equivalent level), individual gross monthly income (<€1500, €1500-1900, €1900-2600, >€2600), age, Body Mass Index (BMI), gender and smoking behaviour (pack years, history of quit attempts, and smoking history). In order to provide a personalised advise the following
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