Genevieve Gore

Regulation profiles of e-cigarettes in the United States: a critical review with qualitative synthesis

BackgroundElectronic cigarettes (e-cigarettes) have been steadily increasing in popularity since their introduction to US markets in 2007. Debates surrounding the proper regulatory mechanisms needed to mitigate potential harms associated with their use have focused on youth access, their potential for nicotine addiction, and the renormalization of a smoking culture. The objective of this study was to describe the enacted and planned regulations addressing this novel public health concern in the US.MethodsWe searched LexisNexis Academic under Federal Regulations and Registers, as well as State Administrative Codes and Registers. This same database was also used to find information about planned regulations in secondary sources. The search was restricted to US documents produced between January 1st, 2004, and July 14th, 2014.ResultsWe found two planned regulations at the federal level, and 74 enacted and planned regulations in 44 states. We identified six state-based regulation types, including i) access, ii) usage, iii) marketing and advertisement, iv) packaging, v) taxation, and vi) licensure. These were further classified into 10 restriction subtypes: sales, sale to minors, use in indoor public places, use in limited venues, use by minors, licensure, marketing and advertising, packaging, and taxation. Most enacted restrictions aimed primarily to limit youth access, while few regulations enforced comprehensive restrictions on product use and availability.ConclusionsCurrent regulations targeting e-cigarettes in the US are varied in nature and scope. There is greater consensus surrounding youth protection (access by minors and/or use by minors, and/or use in limited venues), with little consensus on multi-level regulations, including comprehensive use bans in public spaces.

Impact of Molecular Diagnostics for Tuberculosis on Patient-Important Outcomes: A Systematic Review of Study Methodologies

Background Several reviews on the accuracy of Tuberculosis (TB) Nucleic Acid Amplification Tests (NAATs) have been performed but the evidence on their impact on patient-important outcomes has not been systematically reviewed. Given the recent increase in research evaluating such outcomes and the growing list of TB NAATs that will reach the market over the coming years, there is a need to bring together the existing evidence on impact, rather than accuracy. We aimed to assess the approaches that have been employed to measure the impact of TB NAATs on patient-important outcomes in adults with possible pulmonary TB and/or drug-resistant TB. Methods We first develop a conceptual framework to clarify through which mechanisms the improved technical performance of a novel TB test may lead to improved patient outcomes and outline which designs may be used to measure them. We then systematically review the literature on studies attempting to assess the impact of molecular TB diagnostics on such outcomes and provide a narrative synthesis of designs used, outcomes assessed and risk of bias across different study designs. Results We found 25 eligible studies that assessed a wide range of outcomes and utilized a variety of experimental and observational study designs. Many potentially strong design options have never been used. We found that much of the available evidence on patient-important outcomes comes from a small number of settings with particular epidemiological and operational context and that confounding, time trends and incomplete outcome data receive insufficient attention. Conclusions A broader range of designs should be considered when designing studies to assess the impact of TB diagnostics on patient outcomes and more attention needs to be paid to the analysis as concerns about confounding and selection bias become relevant in addition to those on measurement that are of greatest concern in accuracy studies.

Efficacy and Safety of Smoking Cessation Interventions in Patients With Cardiovascular Disease: A Network Meta-Analysis of Randomized Controlled Trials.

Background— Although the efficacy and safety of smoking cessation interventions are well established, their efficacy and safety in patients with cardiovascular disease (CVD) remain unclear. The objective of this study was to evaluate the efficacy and safety of pharmacological and behavioral smoking cessation interventions in CVD patients via a meta-analysis of randomized controlled trials. Methods and Results— EMBASE, PsycINFO, MEDLINE, PubMed, and the Cochrane Tobacco Addiction Specialized Register were searched for randomized controlled trials evaluating the efficacy of smoking cessation pharmacotherapies and behavioral therapies in CVD patients. Outcomes of interest were smoking abstinence at 6 and 12 months, defined using the most rigorous criteria reported. Data were pooled across studies for direct comparisons using random-effects models. Network meta-analysis using a graph-theoretical approach was used to generate the indirect comparisons. Seven pharmacotherapy randomized controlled trials (n=2809) and 17 behavioral intervention randomized controlled trials (n=4666) met our inclusion criteria. Our network meta-analysis revealed that varenicline (relative risk [RR]: 2.64; 95% confidence interval [CI], 1.34–5.21) and bupropion (RR: 1.42; 95% CI, 1.01–2.01) were associated with greater abstinence than placebo. The evidence about nicotine replacement therapies was inconclusive (RR: 1.22; 95% CI, 0.72–2.06). Telephone therapy (RR: 1.47; 95% CI: 1.15–1.88) and individual counseling (RR: 1.64, 95% CI: 1.17–2.28) were both more efficacious than usual care, whereas in-hospital behavioral interventions were not (RR: 1.05; 95% CI, 0.78–1.43). Conclusions— Our meta-analysis suggests varenicline and bupropion, as well as individual and telephone counseling, are efficacious for smoking cessation in CVD patients.

Scoping reviews: establishing the role of the librarian

Health librarians have made a significant and enduring contribution to knowledge syntheses through our work on systematic reviews as expert searchers [1], methodologists [2], and information managers [3]. The scoping review is now emerging as an alternative and increasingly popular method to synthesize the literature on a given topic. Many librarians have noticed this trend and (1) may be considering getting involved or (2) may wish to learn more but may not know where to start with the growing body of literature on this type of review.

Combination Therapies for Smoking Cessation: A Hierarchical Bayesian Meta-Analysis

CONTEXT Treatment guidelines recommend the use of combination therapies for smoking cessation, particularly behavioral therapy (BT) as an adjunct to pharmacotherapy. However, these guidelines rely on previous reviews with important limitations. This studys objective was to evaluate the efficacy of combination therapies compared with monotherapies, using the most rigorous data available. EVIDENCE ACQUISITION A systematic review and meta-analysis of RCTs of pharmacotherapies, BTs, or both were conducted. The Cochrane Library, Embase, PsycINFO, and PubMed databases were systematically searched from inception to July 2015. Inclusion was restricted to RCTs reporting biochemically validated abstinence at 12 months. Direct and indirect comparisons were made in 2015 between therapies using hierarchical Bayesian models. EVIDENCE SYNTHESIS The search identified 123 RCTs meeting inclusion criteria (60,774 participants), and data from 115 (57,851 participants) were meta-analyzed. Varenicline with BT increased abstinence more than other combinations of a pharmacotherapy with BT (varenicline versus bupropion: OR=1.56, 95% credible interval [CrI]=1.07, 2.34; varenicline versus nicotine patch: OR=1.65, 95% CrI=1.10, 2.51; varenicline versus short-acting nicotine-replacement therapies: OR=1.68, 95% CrI=1.15, 2.53). Adding BT to any pharmacotherapy compared with pharmacotherapy alone was inconclusive, owing to wide CrIs (OR=1.17, CrI=0.60, 2.12). Nicotine patch with short-acting nicotine-replacement therapy appears safe and increases abstinence versus nicotine-replacement monotherapy (OR=1.63, CrI=1.06, 3.03). Data are limited concerning other pharmacotherapy combinations and their safety and tolerability. CONCLUSIONS Evidence suggests that combination therapy benefits may be less than previously thought. Combined with BT, varenicline increases abstinence more than other pharmacotherapy with BT combinations.

Safety and effectiveness of neuraminidase inhibitors for influenza treatment, prophylaxis, and outbreak control: a systematic review of systematic reviews and/or meta-analyses

Objectives To review evidence from systematic reviews and/or meta-analyses (SR/MAs) regarding neuraminidase inhibitor (NI) safety and effectiveness. Methods We conducted an SR of SR/MAs of randomized control and/or observational studies. We searched eight electronic databases for SR/MAs that examined the effectiveness or safety of NIs administered for influenza (i.e. influenza-like illness or lab-confirmed) treatment or prophylaxis. Results We identified 27 (0.7%) eligible SR/MAs of 3723 articles reviewed. NI (n = 2) or oseltamivir (n = 1) versus no treatment were consistently associated with a decrease in mortality odds among the hospitalized, general population (OR range 0.2 - 0.8). Oseltamivir versus no treatment was associated with a decrease in hospitalization and pneumonia risk/odds in 2/4 SR/MAs. Oseltamivir (n = 4) and zanamivir (n = 3) were consistently associated with a 0.5 - 1 day decrease in symptom duration. Oseltamivir (n = 4) or zanamivir (n = 4) versus no prophylaxis were consistently associated with a decrease in the odds/risk of symptomatic secondary transmission (OR/RR range 0.1 - 0.5). Oseltamivir versus no treatment was consistently associated with a 1.5- to 2.5-fold increase in the odds/risk of nausea (n = 4) and vomiting (n = 5). Conclusions NI treatment is likely to be effective at reducing mortality among hospitalized patients, and symptom duration by up to 1 day in the general population. Oseltamivir or zanamivir prophylaxis are likely to be effective at reducing secondary symptomatic influenza transmission. Increased nausea and vomiting are likely associated with oseltamivir use. We recommend that decisions regarding NI use are made in consideration of potential adverse events, particularly for the general population at low risk of complications. Among hospitalized patients, NI administration seems warranted to reduce mortality risk.

Undergraduates Prefer Federated Searching to Searching Databases Individually

A Review of: Belliston, C. Jeffrey, Jared L. Howland, & Brian C. Roberts. “Undergraduate Use of Federated Searching: A Survey of Preferences and Perceptions of Value-Added Functionality.” College & Research Libraries 68.6 (Nov. 2007): 472-86. Objective – To determine whether use of federated searching by undergraduates saves time, meets their information needs, is preferred over searching databases individually, and provides results of higher quality. Design – Crossover study. Setting – Three American universities, all members of the Consortium of Church Libraries & Archives (CCLA): BYU (Brigham Young University, a large research university); BYUH (Brigham Young University – Hawaii, a small baccalaureate college); and BYUI (Brigham Young University – Idaho, a large baccalaureate college) Subjects – Ninety-five participants recruited via e-mail invitations sent to a random sample of currently enrolled undergraduates at BYU, BYUH, and BYUI. Methods – Participants were given written directions to complete a literature search for journal articles on two biology-related topics using two search methods: 1. federated searching with WebFeat® (implemented in the same way for this study at the three universities) and 2. a hyperlinked list of databases to search individually. Both methods used the same set of seven databases. Each topic was assigned in random order to one of the two search methods, also assigned in random order, for a total of two searches per participant. The time to complete the searches was recorded. Students compiled their list of citations, which were later normalized and graded. To analyze the quality of the citations, one quantitative rubric was created by librarians and one qualitative rubric was approved by a faculty member at BYU. The librarian-created rubric included the journal impact factor (from ISI’s Journal Citation Reports®), the proportion of citations from peer-reviewed journals (determined from Ulrichsweb.com™) to total citations, and the timeliness of the articles. The faculty-approved rubric included three criteria: relevance to the topic, quality of the individual citations (good quality: primary research results, peer-reviewed sources), and number of citations. Data were then analysed using ANOVA and MANOVA. Finally, librarians at the ACRL 13th National Conference Presentation were polled about their perceptions of the time savings of federated searching, whether the method meets undergraduates’ information needs, undergraduate preference for searching, and the quality of citations found. Main Results – Seventy percent of all participants preferred federated searching. For all schools combined, there was no statistically significant difference between the average time taken using federated searching (20.34 minutes) vs. non-federated searching (22.72 minutes). For all schools combined, there was a statistically significant difference in satisfaction of results favouring federated searching (5.59/7 vs. 4.80/7 for non-federated searching, α = .05). According to the librarian-created rubric, citations retrieved from federated searching were a statistically significant 6% lower in quality than citations retrieved from non-federated searching (α = .05). The faculty-approved rubric did not detect a difference in the quality of the citations retrieved using the 2 methods. Librarians’ perceptions as assessed at the ACRL 13th National Conference Presentation generally matched the authors’ findings. Conclusion – Overall, students in this study preferred federated searching, were more satisfied with the results of federated searching, and saved time (although the savings were not statistically significant). The quality of citations retrieved via both methods was judged to be similar. The study provides useful information for librarians interested in users’ experiences and perceptions of federated searching, and indicates future studies worth conducting.

Impact of fluoroquinolone treatment on delay of tuberculosis diagnosis: A systematic review and meta-analysis

Background Fluoroquinolones are among the most commonly used antibiotics for the treatment of respiratory infections. Because fluoroquinolones show bactericidal activity against Mycobacterium tuberculosis, there is concern that their use can delay the diagnosis of tuberculosis. We conducted a systematic review and meta-analysis to assess whether empiric treatment with fluoroquinolones delays the diagnosis and treatment of tuberculosis in patients with respiratory tract infections. Objectives The primary objective was to assess the delay in days in the diagnosis and treatment of tuberculosis, among patients who received quinolones, compared to those who received non-fluoroquinolone antibiotics. Methods We included studies of adult patients treated with fluoroquinolones prior to a confirmed diagnosis of tuberculosis. We performed a literature search of 7 databases (including PubMed, Embase and Cochrane Library) with no language restrictions. We calculated an unweighted mean of estimate of difference in delay across all studies. For the studies for which the estimate was available as a mean with standard deviation, a weighted average using a random effects meta-analysis model was estimated. Results A total of 3983 citations were identified from the literature search; of these, 17 articles were selected for full-text review. A total of 10 studies were retained for the synthesis. These included 7 retrospective cohort studies and 3 case-control studies. Only one of these studies was from a high TB burden country, South Africa. The most commonly used fluoroquinolones were levofloxacin, gemifloxacin and moxifloxacin. The unweighted average of difference in delay between the fluoroquinolone group and non-fluoroquinolone group was 12.9 days (95% CI 6.1–19.7). When these differences were pooled using a random effects model, the weighted estimate was 10.9 days (95% CI 4.2–17.6). When stratified by acid-fast smear status, the delay was consistently greater in the smear-negative group. Conclusion Although results are variable, the use of fluoroquinolones in patients with respiratory infections seems to delay the diagnosis of TB by nearly two weeks. Consistent with the International Standards for TB Care, their use should be avoided when tuberculosis is suspected.

Safety and effectiveness of neuraminidase inhibitors in situations of pandemic and/or novel/variant influenza: a systematic review of the literature, 2009–15

&NA; Objectives: To review systematically the published literature evaluating neuraminidase inhibitor (NI) safety and effectiveness in situations of pandemic and novel/variant influenza. Methods: We searched six online databases using comprehensive search criteria for observational studies and randomized controlled trials investigating the effects of NI treatment, prophylaxis or outbreak control in patients of all ages. Results: Overall, 165 studies were included (95% observational), which were generally of low methodological quality due to lack of adjustment for confounding variables. In studies reporting adjusted estimates in general populations, NI treatment appeared likely to be effective against mortality (primarily if administered within 48 h of symptom onset) and potentially effective in reducing pneumonia. NIs appeared effective in reducing secondary transmission when indicated for prophylaxis. Limited, low-quality data suggest NIs are likely safe in general populations and may be safe in pregnant women and children. Data are scarce regarding safety of NIs in adults and high-risk individuals. Conclusions: Most included studies were observational, statistically underpowered and at high risk of reporting biased and/or confounded effect estimates. NI treatment appeared likely effective in reducing mortality (cause unspecified) and pneumonia in general populations, with increasing benefit when administered with 48 h of symptom onset. NI pre- or post-exposure prophylaxis is likely effective in reducing secondary transmission of influenza in a general population. Our evidence suggests NIs are likely safe to use in the general population; however, data for children and pregnant women are limited. Knowledge gaps persist in specific populations such as Aboriginals, high-risk individuals and the elderly.

A Systematic Review of Combination Therapies for Smoking Cessation

Introduction: The use of pharmacological and behavioural therapies has been shown to help smokers quit. However, the efficacy of combining smoking cessation therapies remains poorly understood. We conducted a systematic review of randomized controlled trials (RCTs) with factorial designs to assess the efficacy of combination smoking cessation therapies. Methods: We performed a systematic search of the Cochrane Library, EMBASE, PsycINFO, and PubMed databases for RCTs of combination therapies for smoking cessation. We included RCTs with factorial designs,reporting biochemically validated point prevalence or continuous abstinence outcomes at 6 or 12 months. Combination therapies were either two pharmacotherapies or apharmacotherapy with behavioural therapy. Pharmacotherapies included nicotine replacement therapies (NRTs), bupropion, and varenicline. Behavioural therapies included counselling and minimal intervention. Results: A total of 11 RCTs met our inclusion criteria: 4 combinations of pharmacotherapies and 7 combinations of a pharmacotherapy with behavioural intervention. Combinations were two NRTs (2 RCTs), bupropion with NRT (3 RCTs), bupropion with behavioural intervention (4 RCTs), and NRT with behavioural intervention (3 RCTs). No identified trials combined varenicline with other included pharmacotherapies. Combining pharmacotherapies did not increase smoking abstinence at 6 or 12 months, compared with pharmacological monotherapies. Evidence suggests a modest yet inconsistent benefit from combining pharmacotherapy with behavioural therapy. Conclusion: Evidence from RCTs with factorial designs does not conclusively show combination smoking cessation therapies to be superior to monotherapies. Pharmacotherapies could be prescribed without behavioural therapy, with minimal loss of treatment efficacy. Key words: Smoking cessation, combination therapy, systematic review