title: Poor Reporting of Outcomes Beyond Accuracy in Point-of-Care Tests for Syphilis: A Call for a Framework.
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.
authors.affiliation: Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada H3A 1A2.
authors.forename: Yalda
authors.initials: Y
authors.lastname: Jafari
authors.affiliation: Department of Health Administration, Université de Montréal, Montreal, QC, Canada H3C 3J7 ; Unité de Santé Internationale (USI), Centre de Recherche Hospitalièr de l'Université de Montréal (CRCHUM), Montreal, QC, Canada H2X 0A9.
authors.forename: Mira
authors.identifier: 0000-0001-5642-787X
authors.initials: M
authors.lastname: Johri
authors.affiliation: Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada H3A 1A2.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Joseph
authors.affiliation: Division 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.
authors.forename: Caroline
authors.initials: C
authors.lastname: Vadnais
authors.affiliation: Division 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 ; Department of Medicine, McGill University, Montreal, QC, Canada H3A 1A1.
authors.forename: Nitika
authors.initials: N
authors.lastname: Pant Pai