RESUMO
Purpose: Although the frequency of noninferiority trials is increasing, the consistency of the reporting of these trials can vary. The aim of this systematic review was to assess the reporting quality of radiation therapy noninferiority trials. Methods and Materials: The PubMed, Embase, and Cochrane databases were queried for randomized controlled radiation therapy trials with noninferiority hypotheses published in English between January 2000 and July 2022, and this was performed by an information scientist. Descriptive statistics were used to summarize data. Results: Of 423 records screened, 59 (14%) were included after full-text review. All were published after 2003 and open label. The most common primary cancer type was breast (n = 15, 25%). Altered radiation fractionation (n = 26, 45%) and radiation de-escalation (n = 11, 19%) were the most common types of interventions. The most common primary endpoints were locoregional control (n = 17, 29%) and progression-free survival (n = 14, 24%). Fifty-three (90%) reported the noninferiority margin, and only 9 (17%) provided statistical justification for the margin. The median absolute noninferiority margin was 9% (interquartile range, 5%-10%), and the median relative margin was 1.51 (interquartile range, 1.33-2.04). Sample size calculations and confidence intervals were reported in 54 studies (92%). Both intention-to-treat and per-protocol analyses were reported in 27 studies (46%). In 31 trials (53%), noninferiority of the primary endpoint was reached. Conclusions: There was variability in the reporting of key components of noninferiority trials. We encourage consideration of additional statistical reasoning such as guidelines or previous trials in the selection of the noninferiority margin, reporting both absolute and relative margins, and the avoidance of statistically vague or misleading language in the reporting of future noninferiority trials.
RESUMO
Background: Because continued cigarette smoking after a cancer diagnosis is associated with detrimental outcomes, supporting cancer patients with smoking cessation is imperative. We evaluated the effect of the Smoking Cessation Program at the London Regional Cancer Program (lrcp) over a 2-year period. Methods: The Smoking Cessation Program at the lrcp began in March 2014. New patients are screened for tobacco use. Tobacco users are counselled about the benefits of cessation and are offered referral to the program. If a patient accepts, a smoking cessation champion offers additional counselling. Follow-up is provided by interactive voice response (ivr) telephone system. Accrual data were collected monthly from January 2015 to December 2016 and were evaluated. Results: During 2015-2016, 10,341 patients were screened for tobacco use, and 18% identified themselves as current or recent tobacco users. In 2015, 84% of tobacco users were offered referral, but only 13% accepted, and 3% enrolled in ivr follow-up. At the lrcp in 2016, 77% of tobacco users were offered referral to the program, but only 9% of smokers accepted, and only 2% enrolled in ivr follow-up. Conclusions: The Smoking Cessation Program at the lrcp has had modest success, because multiple factors influence a patient's success with cessation. Limitations of the program include challenges in referral and counselling, limited access to nicotine replacement therapy (nrt), and minimal follow-up. To mitigate some of those challenges, a pilot project was launched in January 2017 in which patients receive free nrt and referral to the local health unit.
