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      Cleaning up China’s Medical Cabinet—An Antibiotic Take-Back Programme to Reduce Household Antibiotic Storage for Unsupervised Use in Rural China: A Mixed-Methods Feasibility Study

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          Abstract

          Background: Antibiotic misuse and unsafe disposal harm the environment and human health and contribute to the global threat of antimicrobial resistance. Household storage of antibiotics for unsupervised use and careless disposal of medications is a common practice in China and most low- and middle-income countries. Currently, few interventions are available to address this challenge. Objective: This study assesses the feasibility and acceptability of an evidence-based, theory-informed, community-based take-back programme for disposing household’s expired, unwanted, or unused antibiotics in rural China. Methods: We adopted the RE-AIM framework and the community-based participatory research principles in the development, implementation, and evaluation of the intervention. The RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) and Medical Research Council’s frameworks were employed in analysing and reporting evaluation results. A mixed-methods, controlled pre-and post-test design was used for (1) quantitative surveying of a representative community panel of 50 households, and (2) qualitative semi-structured stakeholders’ interviews to explore intervention and study design feasibility and acceptability at three phases: pre-intervention, intervention, and post-intervention. Quantitative and qualitative data from a similar village—serving as a control—were also collected. Results: All a priori feasibility objectives were met: Conversion to consent was 100.0% (100 screened, approached, recruited, and consented). All participants completed the pre-intervention assessment, and 44/50 households in the intervention village completed the post-intervention assessment. The programme, embedded in existing social and physical infrastructure for dissemination, directly reached over 68.2% (30/44) of its target audience. Stakeholders reported the intervention and study design as feasible and acceptable. Conclusions: This study illustrates the feasibility, acceptability, and potential efficacy of community-based antibiotic take-back programmes in China to encourage safe disposal and decrease the availability of expired, unwanted, or unused antibiotics in the household for unsupervised use.

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          The RE-AIM framework: a systematic review of use over time.

          We provided a synthesis of use, summarized key issues in applying, and highlighted exemplary applications in the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. We articulated key RE-AIM criteria by reviewing the published literature from 1999 to 2010 in several databases to describe the application and reporting on various RE-AIM dimensions. After excluding nonempirical articles, case studies, and commentaries, 71 articles were identified. The most frequent publications were on physical activity, obesity, and disease management. Four articles reported solely on 1 dimension compared with 44 articles that reported on all 5 dimensions of the framework. RE-AIM was broadly applied, but several criteria were not reported consistently.
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            An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

            Background There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size justification should give the minimum number of participants needed in order to meet the objectives of the trial. This paper seeks to describe the target sample sizes set for pilot and feasibility randomised controlled trials, currently running within the United Kingdom. Methods Data were gathered from the United Kingdom Clinical Research Network (UKCRN) database using the search terms ‘pilot’ and ‘feasibility’. From this search 513 studies were assessed for eligibility of which 79 met the inclusion criteria. Where the data summary on the UKCRN Database was incomplete, data were also gathered from: the International Standardised Randomised Controlled Trial Number (ISRCTN) register; the clinicaltrials.gov website and the website of the funders. For 62 of the trials, it was necessary to contact members of the research team by email to ensure completeness. Results Of the 79 trials analysed, 50 (63.3%) were labelled as pilot trials, 25 (31.6%) feasibility and 14 were described as both pilot and feasibility trials. The majority had two arms (n = 68, 86.1%) and the two most common endpoints were continuous (n = 45, 57.0%) and dichotomous (n = 31, 39.2%). Pilot trials were found to have a smaller sample size per arm (median = 30, range = 8 to 114 participants) than feasibility trials (median = 36, range = 10 to 300 participants). By type of endpoint, across feasibility and pilot trials, the median sample size per arm was 36 (range = 10 to 300 participants) for trials with a dichotomous endpoint and 30 (range = 8 to 114 participants) for trials with a continuous endpoint. Publicly funded pilot trials appear to be larger than industry funded pilot trials: median sample sizes of 33 (range = 15 to 114 participants) and 25 (range = 8 to 100 participants) respectively. Conclusion All studies should have a sample size justification. Not all studies however need to have a sample size calculation. For pilot and feasibility trials, while a sample size justification is important, a formal sample size calculation may not be appropriate. The results in this paper describe the observed sample sizes in feasibility and pilot randomised controlled trials on the UKCRN Database.
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              Review of antibiotic resistance in China and its environment

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                Author and article information

                Journal
                Antibiotics (Basel)
                Antibiotics (Basel)
                antibiotics
                Antibiotics
                MDPI
                2079-6382
                27 April 2020
                May 2020
                : 9
                : 5
                : 212
                Affiliations
                [1 ]London School of Hygiene & Tropical Medicine, London WC1H 9SH, UK; leesa.lin@ 123456lshtm.ac.uk (L.L.); James.Hargreaves@ 123456lshtm.ac.uk (J.R.H.)
                [2 ]The Institute of Social and Family Medicine, School of Medicine, Zhejiang University, 866 Yuhangtang Rd., Hangzhou 310058, China; xiaominwang2018@ 123456zju.edu.cn (X.W.); weiyiwang@ 123456zju.edu.cn (W.W.)
                Author notes
                [* ]Correspondence: zhouxudong@ 123456zju.edu.cn ; Tel.: +86-571-88208221
                Author information
                https://orcid.org/0000-0003-4123-4762
                https://orcid.org/0000-0002-0784-5343
                Article
                antibiotics-09-00212
                10.3390/antibiotics9050212
                7277206
                32349422
                69f85cf2-83ad-4064-9433-f2d934537d2b
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 02 April 2020
                : 24 April 2020
                Categories
                Article

                drug take-back,environment,community health,drug abuse,prescription drugs,antimicrobial resistance (amr),re-aim,community-based participatory research (cbpr),feasibility,pilot

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