There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review.

Background This systematic review of prospective longitudinal primary studies sought to determine whether electronic cigarette (e-cigarette) use by teenagers who had never smoked conventional tobacco cigarettes (tobacco cigarettes) at baseline was associated with subsequently commencing tobacco cigarette smoking. Methods The review followed the principles of a systematic review and meta-analysis. A key word search identified peer-reviewed articles published between 1 January 2005 and 2 October 2019 from seven bibliographic databases and one search engine. Using pre-prepared inclusion/exclusion criteria two researchers independently screened abstracts, and subsequently, full text papers. Selected articles were quality assessed in duplicate. Data on study participants characteristics, exposure and outcome measures were recorded in an adapted Cochrane Data Extraction Form. Feasibility assessment was done to detect clinical heterogeneity and choose an approach to meta-analysis. Analysis comprised pairwise random effects meta-analyses, and sensitivity and subgroup analyses. Results From the 6619 studies identified, 14 one-off primary studies in 21 articles were suitable for inclusion. The participants ages ranged from 13 to 19 years and comprised teenagers based in Europe and North America. Nine of the 14 one-off studies, with follow-up periods between 4 and 24 months, met the criteria for inclusion in a meta-analysis of the association between ever use of e-cigarettes and subsequent initiation of tobacco cigarette use. Based on primary study adjusted odds ratios, our meta-analysis calculated a 4.06 (95% confidence interval (CI): 3.00–5.48, I2 68%, 9 primary studies) times higher odds of commencing tobacco cigarette smoking for teenagers who had ever used e-cigarettes at baseline, though the odds ratio were marginally lower (to 3.71 times odds, 95%CI: 2.83–4. 86, I2 35%, 4 primary studies) when only the four high-quality studies were analysed. Conclusion The systematic review found that e-cigarette use was associated with commencement of tobacco cigarette smoking among teenagers in Europe and North America, identifying an important health-related harm. Given the availability and usage of e-cigarettes, this study provides added support for urgent response by policymakers to stop their use by teenagers to decrease direct harms in this susceptible population group, as well as to conserve achievements in diminishing tobacco cigarette initiation.

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Introduction : Clinical guideline development often involves a rigorous synthesis of evidence involving multidisciplinary stakeholders with different priorities and knowledge of evidence synthesis; this makes communicating findings complex. Summary formats are typically used to communicate the results of evidence syntheses, however, there is little consensus on which formats are most effective and acceptable for different stakeholders. Methods This mixed-methods systematic review (MMSR) aimed to evaluate the effectiveness and acceptability (e.g., usability preferences, and attitudes and preferences towards) of evidence synthesis summary formats for GDG members. We followed the PRISMA 2020 guideline and Joanna Briggs Institute Manual for Evidence Synthesis for MMSRs. We searched six databases (inception to April 20, 2021) for randomised controlled trials (RCTs), RCTs with a qualitative component, and qualitative studies. Screening, data extraction, and quality appraisal was performed in duplicate. Qualitative findings were synthesised using meta-aggregation and quantitative findings are described narratively. Results We identified 17,240 citations and screened 54 full-text articles, resulting in 22 eligible articles (20 unique studies): 4 articles reported the results of 5 RCTs, one of which also had a qualitative component. The other 18 articles discussed the results of 16 qualitative studies. Therefore we had 5 trials and 17 qualitative studies to extract data from. Studies were geographically heterogeneous and included a variety of stakeholders and summary formats. All 5 RCTs assessed knowledge or understanding with 3 reporting improvement with newer formats. The qualitative analysis identified 6 themes: ‘presenting information’, ‘tailoring content for end users’, ‘trust in synthesis producers’, ‘knowledge requirements’, ‘quality of included studies’, and ‘properly contextualising findings’. Across these themes, the synthesis resulted in 130 recommendations for practice. Nine recommendations were supported by both quantitative and qualitative evidence and 121 by only qualitative. A majority focused on how to present information (n = 68) and tailor content for different end users (n = 24). Conclusions This MMSR provides guidance on how to improve evidence summary structure and layout. This can be used by synthesis producers to better communicate to GDGs. Study findings will inform the co-creation of evidence summary format prototypes based on GDG member’s needs. Word Count: 345 Registration: The protocol for this project was previously published and the project was pre-registered on Open Science Framework. [1, 2]

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Peer-reviewed publications and conference proceedings are the mainstay of data sources for systematic reviews and network meta-analyses (NMA), but access to informative unpublished data is now becoming commonplace. To explore the usefulness of three types of 'grey' literature-clinical trials registries, clinical study reports and data from regulatory authorities-we conducted four case studies. The reporting of outcome data in peer-reviewed publications, the clinical trials registries and the clinical study reports for two clinical trials-one in melanoma, one in juvenile idiopathic arthritis (JIA)-was examined. In addition, we assessed the value of including unpublished data from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in evidence syntheses of hepatitis C virus (HCV) and chronic obstructive pulmonary disease (COPD), respectively. For the clinical trials in melanoma and JIA, we identified outcome parameters on ClinicalTrials.gov additional to those reported in the peer-reviewed publications: subgroup data and additional efficacy end points/extended follow-up, respectively. The clinical study report also provided results for several subgroups unavailable elsewhere. For HCV and COPD, additional outcome data were obtained from the EMA European Public Assessment Report (EPAR) and the FDA, respectively, including data on subgroups and mortality. We conclude that data from these grey literature sources have the potential to influence results of systematic reviews and NMAs, and may thus have implications for healthcare decisions. However, it is important to consider carefully the availability, reliability and consequent usability of these data sources in systematic reviews and NMAs.

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In an attempt to keep pace with the increasing number of trials being conducted each year, journals make articles available as E-publications ahead of print. E-publications are not available to search through the conventional databases (MEDLINE, EMBASE, CENTRAL) used in systematic reviews, but are searchable using PubMed. We used a search syntax designed to exclusively identify E-publications in PubMed to assess the importance of searching for E-publications in systematic reviews. Two case studies were conducted: updating de novo systematic reviews in particularly active areas of current research, type 2 diabetes mellitus and advanced melanoma. A search for E-publications was conducted concurrently to the conventional systematic reviews. Network diagrams were constructed with and without the results of the E-publications search to demonstrate the potential impact E-publications could have on any evidence synthesis. The advanced melanoma systematic review conducted in conventional databases identified nine studies. The E-publication search identified three additional studies reporting information for three new interventions and additional information for five interventions. Critically, if an evidence synthesis were to be conducted the identification of one of the pivotal nivolumab trials, CheckMate 067, (ipilimumab, nivolumab and ipilimumab+nivolumab) allows the connection of an otherwise disconnected evidence network. The diabetes systematic review conducted in conventional databases identified 28 studies. The E-publication search identified one additional study including an extra intervention; if evidence synthesis were feasible, the E-publication would add a loop to the evidence network which could influence analysis results. Failure to search for E-publications ahead of print may mean that evidence syntheses do not take into account all the data publicly available at the time of review.