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Table 2 Smoking Treatment Optimisation in Pharmacies (STOP) trial data collection

From: Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial

Outcome/type of tissue sample Description/process of data collection Time of collection/follow-up point Source of data
STOP trial—outcome data collection
 Throughput From service commissioners Received quarterly after STOP training intervention and study recruitment of service users Routinely collected data under gatekeeper agreement (includes 12 months of historical pharmacy outcome data prior to randomisation date)
 4-week retention rate From service commissioners Received quarterly after STOP training intervention and study recruitment of service users Routinely collected data under gatekeeper agreement (includes 12 months of historical pharmacy outcome data prior to randomisation date)
 4-week quit rate From service commissioners Received quarterly after STOP training intervention and study recruitment of service users Routinely collected data under gatekeeper agreement (includes 12 months of historical pharmacy outcome data prior to randomisation date)
 Continuous abstinence rate at 6 months Consented participants who quit at 4 weeks are contacted at 6 months by a study researcher to ask:
(i) their quit status—if response is yes (abstinent), a cotinine saliva collection kit is sent by post with instructions to give sample and return kit to ABS Laboratories in freepost envelope provided
(ii) if participants completed the NCSCT questionnaire that was given to them at end of NHS SSP week 4—if response is no, the questionnaire is completed with researcher by telephone or sent by post with instructions to complete and return to study team in freepost envelope provideda
At 6 months if participant had quit at 4 weeks Directly from individually consented service users for additional data collection
 Detailed analysis on the effectiveness of the STOP training intervention Data collected from STOP study participants comprise record number, exempt from prescription charge, gender, pregnant, age, occupation, ethnicity, national ethnicity, source of referral, referral by, patient practice, first session date, advisor name and nicotine replacement therapy products used. Data collected are anonymised. No personal details are recorded or used by the study team At end of study From individually consented service users for additional data collection (i.e. collected as routine data)
STOP trial—process data collection
 Satisfaction about the NHS SSP NCSCT (short) satisfaction survey Post 4 weeks of the NHS SSP Directly from smoker service users (individually consented)
 Self-efficacy in smoking cessation delivery Assessing self-efficacy in delivery of smoking cessation using previously developed Likert scale [27] At baseline and at 5 months from date of written consent Directly from pharmacy staff
 Study recruitment and retention rates. Reasons for non-participation and dropout (i) Estimate study participation rate of (a) pharmacies (i.e. number of pharmacies recruited/total number approached to participate) and (b) pharmacy staff (i.e. number of pharmacy staff recruited/total number present in participating pharmacy and approached to participate)
(ii) Estimate study retention rate of (a) pharmacies (i.e. number of pharmacies who dropped out/number recruited) and (b) pharmacy staff (i.e. number of pharmacy staff who dropped out/number recruited)
(iii) Reasons for study non-participation and withdrawal among pharmacy staff
  Recorded by study team
 Intervention attendance and completion rates. Reasons for non-attendance and dropout (i) Estimate STOP training intervention (a) attendance (i.e. number of staff who attended training/number assigned/who agreed to receive the intervention) and (b) dropout rates among pharmacy staff (i.e. number who dropped out of training/number attended)
(ii) Reasons for non-attendance and non-completion
  To be recorded by study team
 Acceptability of intervention training and delivery in practice Questionnaire using previously developed Likert scale [27] At 5 months post written consent date Directly from intervention pharmacy staff
 Fidelity assessment at the pharmacy counter Assessment of delivery of skills in practice at the pharmacy counter (in all 60 pharmacies) around engagement of service users into the NHS SSP via simulated clients using checklist developed for study 4–6 weeks post training Directly from pharmacy staff
 Fidelity assessment in pharmacy consultation room Assessment of skills (from 33% of 30 intervention pharmacies, n = 10) around retention and quit success via audio-recording consultations 4–6 weeks post training Directly from intervention audio-recordings of pharmacy staff
 Views and experiences about the STOP training and its delivery in practice. Interview data about views of the STOP training intervention and delivery of learnt skills in practice, reasons for non-attendance and non-completion 4 weeks post training Directly from intervention pharmacy staff
 Study recruitment and retention rates for additional data collection (i) Estimate participation rate of smoker service users in the STOP study for additional data collection (i.e. total number of smokers who joined the NHS SSP and gave individual written consent/total number who joined the NHS SSP)
(ii) Estimate service user retention rate in STOP study (i.e. number of consented service users who dropped out or are lost to follow up/total number of consented service users)
  To be recorded by study team
 Views and experiences about the NHS SSP with a focus on engagement and retention, reasons for completion and non-completion of the NHS SSP Interview data about experience of the NHS SPP focusing on engagement and retention into the programme, reasons for non-completion of the programme Post 4 weeks of the NHS SSP Directly from service users
STOP trial—tissue sample data collection
 Saliva sample and DNA Biochemical assessment of nicotine and DNA extraction and storage At the end of the first session of the NHS SSP Directly from individually consented smoker service users
 Saliva sample Cotinine assessment for continued abstinence At 6 months among those who quit at 4 weeks of the NHS SSP Directly from individually consented smoker service users
  1. The focus of this study is only to collect the tissue samples and extract and store the DNA and assess salivary cotinine at 6 months to confirm cessation—critical to report for this study outcome
  2. NCSCT National Centre for Smoking Cessation and Training, NHS SSP National Health Service Stop Smoking Programme
  3. aA £10 voucher is sent in the same post to incentivise return of the questionnaire and saliva kit. Those not returning the questionnaire or kit are contacted a maximum of three times by the study team by telephone [26]