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      Process Evaluation of a Medical Student–Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster Randomized Trial

      research-article
      , MD 1 , 2 , , 1 , 3 , , MD 4 , 5 , 5 , 6 , 7 , 8 , 8 , 9 , , MD 10 , 11 , 12 , 12 , , MD 13 , 13 , , MD 14 , , MD 13 , , MD 15 , , PhD 16 , 7 , 6 , 6 , 6 , 6 , 17 , 8 , , MD 18 , , MD 7 , 6 , , MD 7 , , MD 7 , , MD 19 , , PhD 20 , , MD 2 , , MD 6 , , MD 1 , , MD 21 , , MD 21 , , MD 22
      (Reviewer), (Reviewer), (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      schools, tobacco prevention, smoking prevention, medical students, medical school

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          Abstract

          Background

          Most smokers start smoking during their early adolescence under the impression that smoking entails positive attributes. Given the addictive nature of cigarettes, however, many of them might end up as long-term smokers and suffering from tobacco-related diseases. To prevent tobacco use among adolescents, the large international medical students’ network Education Against Tobacco (EAT) educates more than 40,000 secondary school students per year in the classroom setting, using evidence-based self-developed apps and strategies.

          Objective

          This study aimed to evaluate the long-term effectiveness of the school-based EAT intervention in reducing smoking prevalence among seventh-grade students in Germany. Additionally, we aimed to improve the intervention by drawing conclusions from our process evaluation.

          Methods

          We conduct a cluster-randomized controlled trial with measurements at baseline and 9, 16, and 24 months postintervention via paper-and-pencil questionnaires administered by teachers. The study groups consist of randomized schools receiving the 2016 EAT curriculum and control schools with comparable baseline data (no intervention). The primary outcome is the difference of change in smoking prevalence between the intervention and control groups at the 24-month follow-up. Secondary outcomes are between-group differences of changes in smoking-related attitudes and the number of new smokers, quitters, and never-smokers.

          Results

          A total of 11,268 students of both sexes, with an average age of 12.32 years, in seventh grade of 144 secondary schools in Germany were included at baseline. The prevalence of cigarette smoking in our sample was 2.6%. The process evaluation surveys were filled out by 324 medical student volunteers, 63 medical student supervisors, 4896 students, and 141 teachers.

          Conclusions

          The EAT cluster randomized trial is the largest school-based tobacco-prevention study in Germany conducted to date. Its results will provide important insights with regards to the effectiveness of medical student–delivered smoking prevention programs at school.

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/13508

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          Most cited references43

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          Effectiveness of school-based smoking prevention curricula: systematic review and meta-analysis

          Objective To assess effectiveness of school-based smoking prevention curricula keeping children never-smokers. Design Systematic review, meta-analysis. Data: MEDLINE (1966+), EMBASE (1974+), Cinahl, PsycINFO (1967+), ERIC (1982+), Cochrane CENTRAL, Health Star, Dissertation Abstracts, conference proceedings. Data synthesis: pooled analyses, fixed-effects models, adjusted ORs. Risk of bias assessed with Cochrane Risk of Bias tool. Setting 50 randomised controlled trials (RCTs) of school-based smoking curricula. Participants Never-smokers age 5–18 (n=143 495); follow-up ≥6 months; all countries; no date/language limitations. Interventions Information, social influences, social competence, combined social influences/competence and multimodal curricula. Outcome measure Remaining a never-smoker at follow-up. Results Pooling all curricula, trials with follow-up ≤1 year showed no statistically significant differences compared with controls (OR 0.91 (0.82 to 1.01)), though trials of combined social competence/social influences curricula had a significant effect on smoking prevention (7 trials, OR 0.59 (95% CI 0.41 to 0.85)). Pooling all trials with longest follow-up showed an overall significant effect in favour of the interventions (OR 0.88 (0.82 to 0.95)), as did the social competence (OR 0.65 (0.43 to 0.96)) and combined social competence/social influences curricula (OR 0.60 (0.43 to 0.83)). No effect for information, social influences or multimodal curricula. Principal findings were not sensitive to inclusion of booster sessions in curricula or to whether they were peer-led or adult-led. Differentiation into tobacco-only or multifocal curricula had a similar effect on the primary findings. Few trials assessed outcomes by gender: there were significant effects for females at both follow-up periods, but not for males. Conclusions RCTs of baseline never-smokers at longest follow-up found an overall significant effect with average 12% reduction in starting smoking compared with controls, but no effect for all trials pooled at ≤1 year. However, combined social competence/social influences curricula showed a significant effect at both follow-up periods. Systematic review registration Cochrane Tobacco Review Group CD001293.
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            Prevalence of acne vulgaris in Chinese adolescents and adults: a community-based study of 17,345 subjects in six cities.

            Acne vulgaris is a common skin condition in adolescents. The prevalence of acne is thought to vary between ethnic groups and countries. A large-scale community-based study was performed in six cities in China to determine the prevalence and possible risk factors for acne in the Chinese population. A total of 17,345 inhabitants were included in this study. Of these, 1,399 were found to have acne. No acne was found in subjects under 10 years of age, and only 1.6% in the 10-year-old group had acne. Prevalence then increased rapidly with age, up to 46.8% in the 19-year-old group. After that, it declined gradually with age. Acne was rare in people over 50 years of age. In subjects in their late teens and 20s, acne was more prevalent in males, while in those over 30 years of age it was more prevalent in females. In subjects with acne, 68.4% had mild; 26.0% had moderate and 5.6% had severe acne. In adult acne, persistent acne was much more common (83.3%) than late-onset acne (16.7%). Smoking and drinking were found to be associated with adolescent acne, while no association was found between diet and acne. These results suggest that the prevalence of acne in the Chinese population is lower than that in Caucasian populations, and that adult acne is not uncommon in Chinese subjects.
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              It's time to change the default for tobacco treatment.

              The World Health Organization estimates that 1 billion people will die from tobacco-related illnesses this century. Most health-care providers, however, fail to treat tobacco dependence. This may be due in part to the treatment 'default'. Guidelines in many countries recommend that health-care providers: (i) ask patients if they are 'ready' to quit using tobacco; and (ii) provide treatment only to those who state they are ready to quit. For other health conditions--diabetes, hypertension, asthma and even substance abuse--treatment guidelines direct health-care providers to identify the health condition and initiate evidence-based treatment. As with any medical care, patients are free to decline--they can 'opt out' from care. If patients do nothing, they will receive care. For tobacco users, however, the treatment default is often that they have to 'opt in' to treatment. This drastically limits the reach of tobacco treatment because, at any given encounter, a minority of tobacco users will say they are ready to quit. As a result, few are offered treatment. It is time to change the treatment default for tobacco dependence. All tobacco users should be offered evidence-based care, without being screened for readiness as a precondition for receiving treatment. Opt-out care for tobacco dependence is warranted because changing defaults has been shown to change choices and outcomes for numerous health behaviors, and most tobacco users want to quit; there is little to no evidence supporting the utility of assessing readiness to quit, and an opt-out default is more ethical.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                April 2019
                11 April 2019
                : 8
                : 4
                : e13508
                Affiliations
                [1 ] Department of Translational Oncology National Center for Tumor Diseases, German Cancer Research Center (DKFZ) University of Heidelberg Heidelberg Germany
                [2 ] Department of Dermatology University Hospital Heidelberg Heidelberg Germany
                [3 ] Faculty of Medicine University of Bonn Bonn Germany
                [4 ] Faculty of Medicine University of Hannover Hannover Germany
                [5 ] Faculty of Medicine University of Düsseldorf Düsseldorf Germany
                [6 ] National Center for Tumor Diseases German Cancer Research Center (DKFZ) University of Heidelberg Heidelberg Germany
                [7 ] Faculty of Medicine Justus-Liebig-University of Gießen Gießen Germany
                [8 ] Faculty of Medicine University of Regensburg Regensburg Germany
                [9 ] Faculty of Medicine University of Bochum Bochum Germany
                [10 ] Institute for Prevention and Occupational Medicine of the German Social Accident Insurance Institute of the Ruhr-University Bochum (IPA) Bochum Germany
                [11 ] Faculty of Medicine University of Essen Essen Germany
                [12 ] Faculty of Medicine University of Freiburg Freiburg im Breisgau Germany
                [13 ] Department of Psychiatry and Psychotherapy University Hospital of Tuebingen Tübingen Germany
                [14 ] Department of Anaesthesiology and Intensive Care Medicine University Hospital of Cologne Cologne Germany
                [15 ] Department of Otorhinolaryngology Head and Neck Surgery University Hospital of Erlangen Erlangen Germany
                [16 ] Cancer Prevention Unit German Cancer Research Center (DKFZ) Heidelberg Germany
                [17 ] Faculty of Medicine University of Göttingen Göttingen Germany
                [18 ] Institute of Occupational Medicine, Social Medicine and Environmental Medicine Goethe-University of Frankfurt am Main Frankfurt am Main Germany
                [19 ] Division of General Internal Medicine Massachusetts General Hospital Harvard Medical School Boston, MA United States
                [20 ] Cognitive Science and Assessment Institute University of Luxembourg Luxembourg Luxembourg
                [21 ] School of Medicine Federal University of Ouro Preto Ouro Preto Brazil
                [22 ] Health Sciences Centre University of Calgary Calgary, AB Canada
                Author notes
                Corresponding Author: Titus Josef Brinker titus.brinker@ 123456dkfz.de
                Author information
                http://orcid.org/0000-0002-3620-5919
                http://orcid.org/0000-0003-3621-4396
                http://orcid.org/0000-0001-9154-2646
                http://orcid.org/0000-0002-6033-7276
                http://orcid.org/0000-0001-9798-7275
                http://orcid.org/0000-0001-6490-1551
                http://orcid.org/0000-0002-9594-8974
                http://orcid.org/0000-0001-5967-1683
                http://orcid.org/0000-0003-4841-3843
                http://orcid.org/0000-0001-7498-0329
                http://orcid.org/0000-0001-6553-7536
                http://orcid.org/0000-0001-7749-0958
                http://orcid.org/0000-0002-8528-6022
                http://orcid.org/0000-0001-9428-0274
                http://orcid.org/0000-0002-6756-448X
                http://orcid.org/0000-0002-5441-081X
                http://orcid.org/0000-0001-7769-4731
                http://orcid.org/0000-0003-3477-4082
                http://orcid.org/0000-0001-7470-9037
                http://orcid.org/0000-0001-8059-8986
                http://orcid.org/0000-0003-1764-6783
                http://orcid.org/0000-0002-5395-3652
                http://orcid.org/0000-0002-4236-3438
                http://orcid.org/0000-0002-3933-5487
                http://orcid.org/0000-0002-0940-498X
                http://orcid.org/0000-0003-2718-0358
                http://orcid.org/0000-0002-2468-6452
                http://orcid.org/0000-0002-3163-5776
                http://orcid.org/0000-0001-8551-6556
                http://orcid.org/0000-0003-1946-0894
                http://orcid.org/0000-0003-0281-7172
                http://orcid.org/0000-0001-7016-7373
                http://orcid.org/0000-0002-2716-3702
                http://orcid.org/0000-0002-2223-1657
                http://orcid.org/0000-0002-4425-6513
                http://orcid.org/0000-0002-7358-185X
                http://orcid.org/0000-0001-6169-0808
                http://orcid.org/0000-0001-9221-3297
                http://orcid.org/0000-0003-1806-2501
                http://orcid.org/0000-0002-2720-6514
                http://orcid.org/0000-0002-0535-4663
                Article
                v8i4e13508
                10.2196/13508
                6482400
                30973348
                05fa71f3-2ac8-467a-a2af-1603acd952e4
                ©Titus Josef Brinker, Fabian Buslaff, Janina Leonie Suhre, Marc Philipp Silchmüller, Evgenia Divizieva, Jilada Wilhelm, Gabriel Hillebrand, Dominik Penka, Benedikt Gaim, Susanne Swoboda, Sonja Baumermann, Jörg Werner Walther, Christian Martin Brieske, Lena Jakob, Hannah Maria Baumert, Ole Anhuef, Selina Marisa Schmidt, Jonas Alfitian, Anil Batra, Lava Taha, Ute Mons, Felix Johannes Hofmann, Ailís Ceara Haney, Caelán Max Haney, Samuel Schaible, Thien-An Tran, Hanna Beißwenger, Tobias Stark, David A Groneberg, Werner Seeger, Aayushi Srivastava, Henning Gall, Julia Holzapfel, Nancy A Rigotti, Tanja Gabriele Baudson, Alexander H Enk, Stefan Fröhling, Christof von Kalle, Breno Bernardes-Souza, Rayanna Mara de Oliveira Santos Pereira, Roger Thomas. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.04.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                History
                : 26 January 2019
                : 20 February 2019
                : 22 March 2019
                : 23 March 2019
                Categories
                Protocol
                Protocol

                schools,tobacco prevention,smoking prevention,medical students,medical school

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