Schlam 2016.
Methods | Setting: Winsconsin, USA; primary care clinics Recruitment: Recruited during primary care visits (11 primary care clinics in 2 healthcare systems). Existing clinical care staff (i.e. medical assistants), prompted by electronic health record technology, invited identified smokers during clinic visits to participate in a research programme to help them quit smoking |
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Participants | 544 smokers, 41% M, av. age 46.2, av. cigs/day 18.6, motivated to quit | |
Interventions | 1. No maintenance (phone) counselling ± extended medication ± (on site) medication adherence counselling ± automated adherence calls ± helping hand (HH) with feedback and counselling 2. No automated adherence calls ± extended medication ± (on site) medication adherence counselling ± maintenance (phone) counselling ± helping hand (HH) with feedback and counselling (not used in analysis) 3. Automated adherence calls ± extended medication ± (on site) medication adherence counselling ± maintenance (phone) counselling ± helping hand (HH) with feedback and counselling (not used in analysis) 4. Maintenance (phone) counselling ± extended medication ± (on site) medication adherence counselling ± automated adherence calls ± helping hand (HH) with feedback and counselling ‐ 8 x 15‐min calls at weeks 3, 4, 6, 8, 10, 14, 18 and 22 Quote: "All participants received a standard cessation intervention: 8 weeks of nicotine patch+nicotine gum and 50 minutes of counseling delivered over four sessions [in visits 1 week before and 1 week after the target quit day (TQD), and in calls on the TQD and at week 2]." |
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Outcomes | Self‐reported abstinence at 52 weeks (7‐day PP) Validation: none |
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Notes | New for 2018 update Funding: "This research was supported by grants 9P50CA143188 and 1K05CA139871 from the National Cancer Institute to the University ofWisconsin Center for Tobacco Research and Intervention and by theWisconsin Partnership Program. L.M. C. is also supported by NIH grants P50DA10075 and R01DK097364. This work was carried out in part while T.R.S. was a Primary Care Research Fellow supported by a National Research Service Award (T32HP10010) from the Health Resources and Services Administration to the University of Wisconsin Department of Family Medicine. J.W.C. is also supported by Merit Review Award 101CX00056 from the US Department of Veterans Affairs. W.‐Y.L. is also supported by NSF grant DMS‐1305725." Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Participants were randomized to one of 32 unique experimental conditions… via a database that used stratified, computer‐generated, permuted block randomization…” |
Allocation concealment (selection bias) | Low risk | Quote: “Staff could not view the allocation sequence. The database did not reveal participants’ treatment condition to staff until participants’ eligibility was confirmed; participants were blinded to treatment condition until they provided consent.” |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Abstinence not biochemically validated. Level of personal contact differed between arms |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition is much larger in Maintenance Counselling arm (51%) than in No Maintenance Counselling arm (44%) |