Ronaldson 2018.
| Study characteristics | ||
| Methods | Design: Randomized controlled trial Setting: Primary care practice, UK Recruitment: QUOTE: "patients at participating practices who met eligibility criteria were sent a recruitment pack through the post), and opportunistic recruitment by general practitioners (GPs) and nurses at face‐to‐face consultations" |
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| Participants | 674 adults older than 35 years; 49% F; mean age 53 years; 16 cpd on average | |
| Interventions | The smoking cessation advice for both groups typically involved participants being offered a stop smoking program lasting 6 to 8 weeks, either on a one‐to‐one basis or with group support, with or without medication, which could have comprised nicotine or non‐nicotine products. Intervention: participants received lung function tests (spirometry, microspirometry, peak flow meter measurement, and a WheezoMeter) and case finding questionnaires Control: participants were on waiting list for the intervention, as well as receiving usual care (above). Participants received the spirometry intervention after the final trial follow‐up |
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| Outcomes | Self‐reported PPA at 6m Validation: None |
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| Funding Source | Department of Health Respiratory Programme | |
| Author's declarations of interest | Authors declared that they had no conflict of interest | |
| Notes | Strategy: Spirometry 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: "the sequence generated by an independent data manager" |
| Allocation concealment | Low risk | QUOTE: "The randomisation sequence was concealed using York Trials Unit's secure randomised system, which was accessed by computer" |
| Blinding of outcome assessors All outcomes | High risk | Abstinence was self‐reported and there was different contact between trial arms |
| Incomplete outcome data All outcomes | Low risk | 32/387 (8.3%) in the usual care arm and 53/767 (6.9%) in the intervention arm were lost to follow‐up |
| Other bias | High risk | Waitlist control study. It appears that participants knew they were on a waiting list, based on the following statement: QUOTE: "Participants, clinicians, investigators, and evaluators were not blind to the participants' group allocation because of the nature of the trial design and analysis". This means participants in the control arm may have postponed their quit attempt until after the trial, when they received treatment |