Heterogeneity in the measurement and reporting of outcomes in studies of electronic cigarette use in adolescents: a systematic analysis of observational studies
Abstract:There are substantial differences in measurement and reporting of parameters across observational studies of electronic and conventional cigarette use in adolescents. These studies are at risk of reporting bias, and results are difficult to interpret. A core outcome set that should be measured and reported in all observational studies is required, using structured consensus techniques.
“…Selecting the most appropriate outcome category in which to place each reported outcome presented a challenge which is consistent with other data in the oral health field [ 23 ]. Often, this was because the outcomes were poorly defined or were closely or inter-related [ 31 ]. Instances of overlap of outcome domains also resulted from composite outcome measurement tools.…”
BackgroundInconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations.MethodsPubMed, Embase, Web of Knowledge and Cochrane CENTRAL were systematically searched (1 January 1968 to 25 August 2015). Inclusion criteria: RCTs comparing any technique for prevention or management of caries with another or placebo and RCTs comparing interventions to support patients undergoing treatment of caries (without setting, dentition or age restrictions). Categories were developed through piloting and group consensus and outcomes grouped accordingly.ResultsOf 4773 search results, 764 were potentially relevant, full text was available for 731 papers and 605 publications met the inclusion criteria and were included. For all outcomes across the time periods 1968–1980 and 2001–2010, reporting of outcome ‘caries experience’ reduced from 39% to 18%; ‘clinical performance of the restoration’ reporting increased from 33% to 42% although there was a reduction to 22% in 2011–2015. Emerging outcome domains include ‘lesion activity’ and ‘pulp health-related outcomes’, accounting for 1% and 0%, respectively, during 1968–1980 and 10% and 4% for 2011–2015. Reporting ‘resource efficiency’ and ‘quality of life measures’ have remained at a low level. No publications reported tooth survival independent of an index such as DMFT or equivalent. Primary outcomes were only identified as such in 414 (68%) of the reports.ConclusionsOver the past 50 years, outcome reporting for trials on prevention and management of carious lesions have tended to focus on outcomes measuring caries experience and restoration material clinical performance with lesion activity and cost-effectiveness increasingly being reported. Patient-reported and patient-focused outcomes are becoming more common (although as secondary outcomes) but remain low in use. The challenge with developing a COS will be balancing commonly previously reported outcomes against those more relevant for the future.Trial registrationPROSPERO, CRD42015025310. Registered on 14 August 2015, Trials (Schwendicke et al., Trials 16:397, 2015) and COMET initiative online (COMET, 2017).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2256-1) contains supplementary material, which is available to authorized users.
“…Selecting the most appropriate outcome category in which to place each reported outcome presented a challenge which is consistent with other data in the oral health field [ 23 ]. Often, this was because the outcomes were poorly defined or were closely or inter-related [ 31 ]. Instances of overlap of outcome domains also resulted from composite outcome measurement tools.…”
BackgroundInconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations.MethodsPubMed, Embase, Web of Knowledge and Cochrane CENTRAL were systematically searched (1 January 1968 to 25 August 2015). Inclusion criteria: RCTs comparing any technique for prevention or management of caries with another or placebo and RCTs comparing interventions to support patients undergoing treatment of caries (without setting, dentition or age restrictions). Categories were developed through piloting and group consensus and outcomes grouped accordingly.ResultsOf 4773 search results, 764 were potentially relevant, full text was available for 731 papers and 605 publications met the inclusion criteria and were included. For all outcomes across the time periods 1968–1980 and 2001–2010, reporting of outcome ‘caries experience’ reduced from 39% to 18%; ‘clinical performance of the restoration’ reporting increased from 33% to 42% although there was a reduction to 22% in 2011–2015. Emerging outcome domains include ‘lesion activity’ and ‘pulp health-related outcomes’, accounting for 1% and 0%, respectively, during 1968–1980 and 10% and 4% for 2011–2015. Reporting ‘resource efficiency’ and ‘quality of life measures’ have remained at a low level. No publications reported tooth survival independent of an index such as DMFT or equivalent. Primary outcomes were only identified as such in 414 (68%) of the reports.ConclusionsOver the past 50 years, outcome reporting for trials on prevention and management of carious lesions have tended to focus on outcomes measuring caries experience and restoration material clinical performance with lesion activity and cost-effectiveness increasingly being reported. Patient-reported and patient-focused outcomes are becoming more common (although as secondary outcomes) but remain low in use. The challenge with developing a COS will be balancing commonly previously reported outcomes against those more relevant for the future.Trial registrationPROSPERO, CRD42015025310. Registered on 14 August 2015, Trials (Schwendicke et al., Trials 16:397, 2015) and COMET initiative online (COMET, 2017).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2256-1) contains supplementary material, which is available to authorized users.
“…The definitions of quit intentions and attempts also vary across studies. Marked variation across studies in the measurement of adolescent e-cigarette use makes results difficult to interpret ( 26 ). Future research needs to use consistent and validated measures to assess quit intentions and attempts and to examine reasons for using e-cigarette by e-cigarette use frequency.…”
IntroductionAlthough adolescent cigarette use continues to decline in the United States, electronic cigarette (e‑cigarette) use among adolescents has escalated rapidly. This study assessed trends and patterns of e‑cigarette use and concurrent cigarette smoking and the relationships between e-cigarette use and smoking cessation intentions and behaviors among high school students in North Carolina.MethodsData came from high school students who completed the school-based, cross-sectional North Carolina Youth Tobacco Survey in 2011 (n = 4,791) and 2013 (n = 4,092). This study assessed changes in prevalence of e-cigarette and cigarette use from 2011 through 2013, and cessation-related factors associated with those students’ current and past use of e‑cigarettes in 2013.ResultsThe prevalence of current e-cigarette use (use in the past 30 days) significantly increased from 1.7% (95% CI, 1.3%–2.2%) in 2011 to 7.7% (95% CI, 5.9%–10.0%) in 2013. Among dual users, current e-cigarette use was negatively associated with intention to quit cigarette smoking for good (relative risk ratio [RRR] = 0.51; 95% CI, 0.29–0.87) and with attempts to quit cigarette smoking in the past 12 months (RRR = 0.69; 95% CI, 0.49–0.97). Current e-cigarette smokers were less likely than those who only smoked cigarettes to have ever abstained from cigarette smoking for 6 months (RRR = 0.42; 95% CI, 0.21–0.82) or 1 year (RRR = 0.21; 95% CI, 0.09–0.51) and to have used any kind of aids for smoking cessation (RRR = 0.46; 95% CI, 0.29–0.74).ConclusionPublic health practitioners and cessation clinic service providers should educate adolescents about the risks of using any nicotine-containing products, including e-cigarettes, and provide adequate tobacco cessation resources and counseling to adolescent tobacco users.
“…A study in mice has shown that inhalation of cartridge nicotine in e‐cigarette results in allergen‐induced airway inflammation and hyperresponsiveness caused by infiltration of inflammatory cells, including eosinophils, into the airway 14 . Patients who presented with respiratory complications following e‐cigarette use were found to have evidence of increased inflammation 37 . The damage and irritation caused by the contents of e‐cigarettes to the respiratory system of users, as well as the increased susceptibility to infections, provides a biologically plausible mechanism for why e‐cigarette use causes coughing in users.…”
Background
The use of electronic cigarettes (e‐cigarettes) among adolescents is increasing worldwide. E‐cigarettes are marketed as a safe alternative to other tobacco products. The aim of this systematic review is to evaluate whether e‐cigarette use in children and adolescents is associated with coughing.
Method
Studies were identified through systematic searches of Excerpta Medica Database, Medline, Cumulative Index to Nursing and Allied Health Literature, British Nursing Index, OVID Emcare, Health Management Information Consortium, PsycINFO, and Allied and Complementary Medicine. The Grey Literature was also searched. Selected studies either contained only children and adolescents as study participants or if adults were included, the data for adolescents and children must be presented separately.
Results
Seven studies were selected from 104. Three studies compared e‐cigarette users with nonusers; two studies found a significant association between coughing and e‐cigarette use in adolescence. Two studies investigated whether adolescents attributed their symptoms to their e‐cigarette use. One study reported that coughing was the most likely negative symptom reported by adolescents on initiation of e‐cigarette use; the other study found that adolescents, on initiation of e‐cigarette use, reported coughing. Two studies looked at the cases of children and adolescents who had presented to the hospital after e‐cigarette use and found coughing was a common presenting symptom.
Conclusion
This systematic review shows that adolescent use of e‐cigarettes is associated with increased coughing and e‐cigarette users are more likely to report coughing compared to non‐users.
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