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Poor Reporting of Outcomes Beyond Accuracy in Point-of-Care Tests for Syphilis: A Call for a Framework

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      Abstract

      Background. Point-of-care (POC) diagnostics for syphilis can contribute to epidemic control by offering a timely knowledge of serostatus. Although accuracy data on POC syphilis tests have been widely published, few studies have evaluated broader outcomes beyond accuracy that impact patients and health systems. We comprehensively reviewed evidence and reporting of these implementation research outcomes (IROs), and proposed a framework to improve their quality. Methods. Three reviewers systematically searched 6 electronic databases from 1980 to 2014 for syphilis POC studies reporting IROs. Data were abstracted and findings synthesised narratively. Results. Of 71 studies identified, 38 documented IROs. IROs were subclassified into preference (7), acceptability (15), feasibility (15), barriers and challenges (15), impact (13), and prevalence (23). Using our framework and definitions, a pattern of incomplete documentation, inconsistent definitions, and lack of clarity was identified across all IROs. Conclusion. Although POC screening tests for syphilis were generally favourably evaluated across a range of outcomes, the quality of evidence was compromised by inconsistent definitions, poor methodology, and documentation of outcomes. A framework for standardized reporting of outcomes beyond accuracy was proposed and considered a necessary first step towards an effective implementation of these metrics in POC diagnostics research.

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      Modern epidemiology

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        A tutorial on pilot studies: the what, why and how

        Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.
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          Modern Epidemiology

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            Author and article information

            Affiliations
            1Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada H3A 1A2
            2Department of Health Administration, Université de Montréal, Montreal, QC, Canada H3C 3J7
            3Unité de Santé Internationale (USI), Centre de Recherche Hospitalièr de l'Université de Montréal (CRCHUM), Montreal, QC, Canada H2X 0A9
            4Division of Clinical Epidemiology, Department of Medicine, Royal Victoria Hospital, McGill University Health Centre, V Building (V2.19), 687 Pine Avenue West, Montreal, QC, Canada H3A 1A1
            5Department of Medicine, McGill University, Montreal, QC, Canada H3A 1A1
            Author notes

            Academic Editor: David Dowdy

            Journal
            AIDS Res Treat
            AIDS Res Treat
            ART
            AIDS Research and Treatment
            Hindawi Publishing Corporation
            2090-1240
            2090-1259
            2014
            27 March 2014
            : 2014
            24795821
            3985157
            10.1155/2014/465932
            Copyright © 2014 Yalda Jafari et al.

            This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

            Funding
            Funded by: http://dx.doi.org/10.13039/501100000024 Canadian Institutes of Health Research
            Award ID: KRS 102067
            Funded by: http://dx.doi.org/10.13039/501100000024 Canadian Institutes of Health Research
            Award ID: HBF 103210
            Categories
            Review Article

            Infectious disease & Microbiology

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