Van Rossem 2017.
| Study characteristics | ||
| Methods | Design: Randomized controlled trial Setting: Primary healthcare center in The Netherlands Recruitment: Participants were recruited by practice assistants, general practitioners (GPs) and practice nurses (PNs) and via a brief and easily written leaflet displayed in the waiting room |
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| Participants | 295 participants, 19 cpd, av.age 48, 53% F | |
| Interventions | PN Group: Participants were offered 3 face‐to‐face and 7 telephone sessions, starting 1 week prior to the quit attempt until 1 year after the quit attempt. Participants also received a prescription for varenicline GP Group: Participants received a minimum of 1 visit in which they received a prescription for varenicline. Participants were free to contact their GP in case of questions or side‐effects | |
| Outcomes | Prolonged abstinence from 9w to 26w Validation: Expired CO < 10 ppm |
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| Funding Source | This was an investigator‐initiated trial, funded by a collaboration of Eindhoven Corporation of Primary Health Care Centres (SGE), Pfizer (grant number GPIHP_RG_2010014T1330) and Research School CAPHRI | |
| Author's declarations of interest | QUOTE: "D.K. received an unrestricted grant from Pfizer Inc. and The Eindhoven Corporation of Primary Health Care Centers for this investigator‐initiated smoking cessation trial. C.S. received funding for research proposals from GlaxoSmithKline and Pfizer. A.L. was a general practitioner at The Eindhoven Corporation of Primary Health Care Centers during the research. All other authors declare that they have no competing interests in relation to this paper" | |
| Notes | Strategy: Adjunctive counseling Level: Patient Comparison type: Single component vs. standard care |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Low risk | Computer‐generated random‐number sequence |
| Allocation concealment | Low risk | Computer‐generated random‐number sequence, allocation disclosed by phone |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status biochemically validated |
| Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 18.0% (n = 53/295); 14.8% (n = 22/149) in the PN group and 20.0% (n = 31/146) in the GP group were lost to follow‐up at 6 months |