Sherman 2016.
Methods | Study design: RCT Location: USA Setting: hospital Recruitment: "Using the electronic medical record, a daily list was generated of inpatients documented as current smokers on admission screening. Research assistants (RAs) reviewed the list twice daily and went to the bedside of every patient on the list. In addition to the inpatient units, RAs approached admitted patients who remained in the emergency department and patients in the intensive care units." |
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Participants | Defining eligibility criteria?: admitted to hospital for various healthcare problems Participant characteristics: 1619 adult smokers; 346/1619 (21.4%) female; mean age: control: 48, intervention: 49; mean cpd: control: 12.5, intervention: 12.3; nicotine dependence: level of nicotine addiction, first cigarette within: 5 minutes: 685/1619 (42.3%), 6 to 30 minutes: 321/1619 (19.8%), 31 to 60 minutes: 180/1619 (11.1%), > 60 minutes: 422/1619 (26.1%). Motivation to quit?: not selected on motivation |
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Interventions | Control: referral to quit‐line based on MI: participants referred to a quit‐line and offered NRT. Participants received one 15 to 20‐minute counselling session with a follow‐up call to assess quit status and assure any requested NRT was received. Most participants were referred to the New York state quit‐line where the counsellors are trained in MI. Intervention: MI intensive counselling plus 8 weeks of NRT if they had not received an NRT prescription at discharge. "The structured counselling protocol was based on Motivational Interviewing and Problem Solving Therapy". Provider: counsellors Intensity: single 15 to 20‐minute initial call, followed by six 10 to 15‐minute calls over 42 weeks Was MI fidelity monitored?: "The program staff members use a structured protocol to maintain a record of each of the counselling calls for internal quality assurance. To ensure intervention standardization and fidelity after study implementation, a random sample of the counsellors' phone calls will be audio taped and reviewed by a clinical psychologist and the study’s counsellor supervisor". |
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Outcomes | Definition of cessation used: 30‐day point prevalence Length of longest follow‐up: 6 months Validation: "Where possible salivary cotinine was used: several sites (including New York) made exhaustive efforts to obtain saliva from a consecutive subsample of participants reporting abstinence and no NRT or e‐cigarette use in the past 7 days at 6‐month follow‐up." Was mental health and/or well‐being measured at follow‐up?: no Was quality of life measured at follow‐up?: no |
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Funding source | "This work was supported by a grant from the National Heart, Lung and Blood Institute (NHLBI) of NIH (#1U01HL105229) and a Hurricane Sandy Supplement (#3U01HL105229‐04S1), and also in part by the New York University CTSA grant UL1TR000038 from the National Center for Advancing Translational Sciences, NIH." | |
Author conflicts of interest | "None of the authors have any conflicts of interest to report". | |
Notes | Both intervention groups received counselling based on MI albeit from different providers. This study was included in our comparison investigating the intensity of MI; however, it was removed in a sensitivity analysis due to the difference in providers between arms, which made it different to other studies included in the same comparison. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study database generated random assignments. QUOTE: "The randomisation scheme, designed by the biostatistician, employed a computerized random number generator and stratified participants on hospital site." |
Allocation concealment (selection bias) | Low risk | The study database generated random assignments. QUOTE: "The randomisation scheme, designed by the biostatistician, employed a computerized random number generator and stratified participants on hospital site." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Biochemical verification did not occur in full sample and intervention contact was not matched across study arms. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 247/804 (30.7%) lost to follow‐up in the hospital intervention arm, and 278/814 (34.2%) lost to follow‐up in the quit‐line arm. Less than 50% overall and similar rates between groups |