Cochrane guidance on conducting a systematic review (13) and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis - Protocols (PRISMA-P 2015) (14) were used to inform the preparation of this protocol and the Cochrane guidance and main PRISMA statement (15) will inform the conduct and reporting of the review (PRISMA-P checklist - Additional file 1). This systematic review protocol will be registered in the international prospective register of systematic reviews, PROSPERO (Registration number - submitted).
Objective
Our main objective is to review published studies to determine whether any aspect of vision, and particularly interventions to improve vision function, are associated with traffic safety outcomes in LMICs.
Criteria for considering studies for this review
Type of studies
We will include any study (interventional or observational) which aimed to assess whether vision is associated with traffic safety outcomes in LMICs. Motor vehicle collisions or motor vehicle crash or road traffic injuries are rarely reported in LMICs and reliable data on crashes are rare. Therefore, we aim to include studies that report poor vision among drivers and any measure of traffic safety or surrogate outcomes.
Type of participants
Eligible participants for these studies will be any person driving a vehicle (e.g., motorcycle, car, bus, truck or other commercial vehicle) with special attention on persons whose income derives in whole or in part from driving a vehicle in a LMIC, where this information is available.
Type of outcome measures
The primary outcome of this review is any measure of traffic safety or a surrogate outcome (e.g., hard braking, accelerometer-measured events, etc.) proven or expected to be associated with traffic safety. We will also collect data on the quality of the vision of drivers as a secondary outcome measure.
Search methods
A comprehensive search strategy has been developed in consultation with an information specialist. We will search MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), CINAHL (EBSCO host), Web of Science, Cochrane Database of Systematic Reviews (CDSR) and The Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library. These sources will be searched from the year of inception to April 2020. A list of search terms for LMICs (as recommended by the Cochrane Library) will be applied in each strategy to identify studies from LMICs.(16) The search strategy is shown in Additional file 2. We will also check the reference lists of eligible studies, to identify additional studies for the review and efforts will be made to translate publications not in English.(17)
Data collection and analysis
Selection of studies
We will include eligible studies of any design which either attempt to access traffic safety outcomes of any kind among persons with any vision deficit or examine vision among persons who use roads. Two reviewers (PP, VO) will use the eligibility criteria to independently check the titles and abstracts retrieved by the searches to identify potentially eligible articles. Any disagreements will be adjudicated by a third reviewer (NC). The full text of the potentially eligible articles will be retrieved, and their eligibility confirmed. Data extraction will be done for the eligible articles by the co-reviewers. The study authors will be contacted for any relevant data that are not in their article. The extracted data and data collected from authors will be used in data synthesis of the review.
Assessment of methodological quality
The risk of bias and quality of the included studies will be assessed according to the guidelines of the critical appraisal of skills program (CASP) tool and National Institute of Health (USA) quality assessment tool (NIH-QAT) for the relevant study design. Study characteristics will be tabulated according to the domains described in these tools. We will assess risk of bias of each included study using a tool appropriate to the study design.
Data items and extraction
We will extract data from each study into a specially prepared MS Excel spreadsheet. This will include country, year, study design, setting, sample size, participant characteristics, type of vehicle / driver, measure of visual acuity/other vision related domains and reported outcomes. One reviewer will extract the data and a second reviewer will verify it.
Data synthesis
We will first describe the study characteristics, such as study design, country and setting, type of driver, category of vehicle. In the next stage, we will provide quantitative synthesis of the findings for the reported outcomes. We will use odds ratio for binary outcomes and mean differences for continuous variables.
Heterogeneity will be assessed across the studies. If meta-analyses are appropriate, we will use a random effect model, with a fixed effect model used in a sensitivity analysis. We will also conduct sensitivity analyses to assess the impact of unmeasured confounding and study assumptions, such as experience of the driver, underlying other visual pathologies other than primary cause measured, different driving environments that will affect the primary outcome, time to event data, different exposure definitions and different outcome definitions.
Where the necessary data are available, we will conduct subgroup analysis for persons whose income derives in whole or in part from driving a vehicle in a LMIC and other drivers who drives commercial vehicles. We will also conduct subgroup analyses based on the type of vehicle, and demographic characteristics of the driver (sex and age). We also hope to conduct a subgroup analysis of adherence to vision related licensure requirements and rates of compliance.