Yingst 2020.
| Study characteristics | ||
| Methods | Design: Cross‐over study Recruitment: Participants were recruited from people living with HIV/AIDS (PLWHA) (who smoked) seeking care at the Penn State Health HIV Comprehensive Care Program Setting: USA Study start date:Not reported |
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| Participants | Total N: 17; 41.2% female; mean age 49.1 (SD 8.8); mean cpd 16.9 (SD 7.9); mean CO 22.4 (13.1) E‐cigarettes use at baseline: not reported Motivated to quit: No Inclusion criteria:
Exclusion criteria: not reported |
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| Interventions |
EC: Cig‐a‐like; Refillable Cig‐a‐like device (Blu), nicotine concentration 24 mg/ml. Propylene glycol/ vegetable glycerin ratio 70/30. Nicotine delivery 4.56 ng/ml after 20 puffs in 10 minutes Button‐operated device (eGO), nicotine concentration 36 mg/ml. Propylene glycol/ vegetable glycerin ratio 70/30. Nicotine delivery 6.9 ng/ml after 10 puffs in 5 minutes (refillable) |
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| Outcomes | Visits: baseline, day 7, day 14, day 21 CO measured (day 0, 7, 14, 21); adverse events (nausea, dizziness) Also: Number of tobacco cigarettes smoked per day (self‐report); EC puffs per day (self‐report) |
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| Study funding | This study was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number P50DA036107 and the Center for Tobacco Products of the U.S. Food and Drug Administration. JY is also funded by the Penn State Cancer Institute (PSCI) and TE is also supported by U54DA036105. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration | |
| Author declarations | JF has done paid consulting for pharmaceutical companies involved in producing smoking cessation medications, including GSK, Pfizer, Novartis, J&J, and Cypress Bioscience. TE is a paid consultant in litigation against the tobacco industry and the electronic cigarette industry and is named on a patent application for a device that measures the puffing behavior of electronic cigarette users | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Used 2 ENDS in a random order – not enough information |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Unable to blind, but interventions judged equally intensive |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Objective outcome‐ CO monitoring (CO < 10 ppm) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Unclear what outcomes were prespecified |
AE: adverse event; BMI: body mass index; CO: carbon monoxide; COT: cotinine; cpd: cigarettes per day; EC: electronic cigarette; ENDS: electronic nicotine delivery system; FTND: Fagerström Test for Nicotine Dependence; HRQoL: health‐related quality of life; IQR: interquartile range; ITT: intention‐to‐treat; LTFU: lost to follow‐up; MMT: methadone maintenance treatment; NEC: nicotine electronic cigarette; NRT: nicotine replacement therapy; PEC: placebo electronic cigarette; PP(A): point prevalence (abstinence); ppm: parts per million; SAE: serious adverse event; SD: standard deviation; SMI: serious mental illness; TQD: target quit date; UC: usual care