Marley 2014.
| Study characteristics | ||
| Methods | Design: Randomized controlled trial Setting: 2 Aboriginal Controlled Community Health Services, Australia Recruitment: Passive recruitment through visits to primary care clinics and active recruitment by researchers through community and family links |
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| Participants | 163 Aboriginal and/or Torres Strait Islanders, ≥ 16 years of age, reporting current smoking or quitting within 2 weeks of recruitment, thinking about cutting down or quitting smoking, regular client of 1 of 2 Aboriginal Health Services. av. age 39, 54% F, av. cpd 15 | |
| Interventions | Intervention: in addition to usual care, participants received in‐person smoking cessation counseling scheduled weekly for the first 4 weeks, monthly to 6 months and 2‐monthly to 12 months (12 sessions). Delivered by Aboriginal researchers Control: participants received usual care ‐ smoking cessation support at their local primary health care service, including advice regarding quitting, pharmacotherapy, and self‐initiated follow‐up |
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| Outcomes | 7‐day PPA at 12m Validation: Urinary cotinine < 50 ng/mL |
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| Funding Source | National Health and Medical Research Council of Australia (NHMRC, project grant number 513818) | |
| Author's declarations of interest | Authors declared that they had no competing interest. | |
| 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 | QUOTE: "A computer generated random allocation sequence was used" |
| Allocation concealment | Low risk | QUOTE: "Sealed envelopes containing the allocation were kept at the centralised coordinating site. Allocation occurred via telephone with envelopes being opened in sequential order" |
| 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 14.3% (n = 24/168); 15.5% (n = 9/58) in the intervention group and 13.6% (n = 15/110) in the control group were lost to follow‐up at 12 months |