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The availability of population-based epidemiological data on will enroll all new (incident) and recurrent consecutive cases of
the incident risk of stroke is very scarce in Argentina and other stroke and transient ischemic attack in the City of Tandil
Latin American countries. In response to the priorities estab- between May 1st, 2013 and April 30, 2015. The study will
lished by the World Health Organization and the United include patients with ischemic stroke, non-traumatic primary
Nations, PREVISTA was envisaged as a population-based intracerebral hemorrhage, subarachnoid hemorrhage, and
program to determine the risk of first-ever and recurrent transient ischemic attack. To ensure the inclusion of every
stroke and transient ischemic attack incidence and mortality in cerebrovascular event during an observation period of two
Tandil, Buenos Aires, Argentina. years, we will instrument an ‘intensive screening program’,
The study will be conducted according to Standardized consisting of a comprehensive daily tracking of every potential
Tools for Stroke Surveillance (STEPS Stroke) methodology and event of stroke or transient ischemic attack using multiple
Correspondence: Luciano A. Sposato*, Department of Clinical overlapping sources. Mortality would be determined during
Neurological Sciences, London Health Sciences Centre, Western follow-up for every enrolled patient. Also, fatal community
University, 339 Windermere Rd, Room C7-123. P.O. Box 5339, London, events would be screened daily through revision of death
ON, Canada N6A 5A5. certificates at funeral homes and local offices of vital statistics.
E-mail. lsposato@uwo.ca All causes of death will be adjudicated by an ad-hoc
Twitter: @SposatoL committee.
1
Vascular Research Institute at INECO Foundation, Buenos Aires, The close population of Tandil is representative of a large
Argentina proportion of Latin-American countries with low- and middle-
2
Department of Clinical Neurological Sciences, London Health Sciences income economies. The findings and conclusions of PREVISTA
Centre, Western University, London, ON, Canada may provide data that could support future health policy
3
Hospital Ramón Santamarina, Tandil, Province of Buenos Aires, decision-making in the region.
Argentina Key words: developing countries, epidemiology, hispanic, incidence,
4
Nueva Clínica Chacabuco, Tandil, Province of Buenos Aires, Argentina mortality, stroke
5
Sanatorio Tandil, Tandil, Province of Buenos Aires, Argentina
6
National Institute for Stroke and Applied Neurosciences, School of Reha-
bilitation and Occupation Studies, AUT University, Auckland, Northcote, Introduction and rationale
New Zealand
7
Paulista School of Medicine, Federal University of São Paulo, São Paulo, Rationale
SP, Brazil Stroke is the second cause of death and a leading cause of acquired
8
Duke Clinical Research Institute, Durham, NC, USA adult disability worldwide (1,2). Although the incidence of cere-
9
Brazilian Clinical Research Institute (BCRI), Sao Paulo, SP, Brazil
10
Neuroscience Intensive Care Unit, Mayo Clinic, Rochester, MN, USA
brovascular disease has increased by over 100% between 1970 and
11
Stroke Outcomes Research Center, Li Ka Shing Knowledge Institute, 2008 in low- and middle-income countries, there has been a 42%
Departments of Medicine and Health Policy Management and Evaluation decrease in high-income nations (3). Low- and middle-income
(HPME) and Institute for Clinical Evaluative Sciences (ICES), St. countries have the largest burden of cerebrovascular disease, and
Michael’s Hospital, University of Toronto, Toronto, ON, Canada this burden will increase in the future unless effective preventive
12
Department of Neurology, Copenhagen University Hospital, Herlev,
Denmark
interventions are implemented (4,5). The scarce availability of
13
Círculo Médico de Tandil, Buenos Aires, Argentina high-quality epidemiological data on cerebrovascular disease in
14
Neuroimaging Studies, Resonancia del Centro, Tandil, Argentina many of these countries, particularly in Latin America, is a limi-
Search Terms: Stroke, Transient Ischemic Attack, Epidemiology, Inci-
tation for health authorities’ awareness of the stroke burden and
dence, Mortality, Population based. for identification of priority areas for preventive interventions.
The United Nations (UN) has stated that it is crucial that Latin-
Conflict of interest: Dr Gustavo Saposnik is supported by the Distinguished
Clinician Scientist Award from Heart and stroke Foundation of Canada.
American countries improve their data collection systems for
None of the remaining authors have conflicts of interest to disclose. assessing health indicators at the population level and for
measuring the impact of public health policies and resources
Funding: None.
utilization (6). The availability of high-quality data on the
DOI: 10.1111/ijs.12171 epidemiological burden of cerebrovascular disease in these
Table 1 Socioeconomic indicators of Tandil City and Latin-American countries (year 2010)
Population Population, Literacy rate, adult Mortality rate, GDP per capita Unemployment,
aged ≥65 (% female (% of total (% of people infant (per 1000 (current US$) male (% of male
City/country of total) (13) total) (14) ≥15 years) (15) live births) (16) (17) labor force) (18)
Population aged ≥65 (% of total): population ages 65 and above as a percentage of the total population. Population is based on the de facto definition
of population, which counts all residents regardless of legal status or citizenship – except for refugees not permanently settled in the country of
asylum, who are generally considered part of the population of the country of origin.
Population, female (% of total): percentage of the population that is female.
Literacy rate, adult total (% of people ≥15 years): percentage of the population aged 15 and above who can, with understanding, read and write a
short, simple statement on their everyday life. Generally, ‘literacy’ also encompasses ‘numeracy’, the ability to make simple arithmetic calculations. This
indicator is calculated by dividing the number of literates aged 15 years and over by the corresponding age group population and multiplying the result
by 100.
Mortality rate, infant (per 1000 live births): number of infants dying before reaching one-year of age, per 1000 live births in a given year.
GDP per capita (current US$): GDP per capita is gross domestic product divided by midyear population. GDP is the sum of gross value added by all
resident producers in the economy plus any product taxes and minus any subsidies not included in the value of the products. It is calculated without
making deductions for depreciation of fabricated assets or for depletion and degradation of natural resources. Data are in current US dollars.
Unemployment, male (% of male labor force): share of the labor force that is without work but available for and seeking employment.
NA, data not available; GDP, gross domestic product.
Fig. 1 Case ascertainment and follow-up. ER, emergency room; GW, general ward; CCU, coronary care unit; ICU, intensive care unit; cath lab, catheter
laboratory.
time. Furthermore, an awareness campaign on stroke signs and scan will be done within the first 72 hours. MRI will be also done
symptoms will be simultaneously starting with the ISP program whenever possible. Strokes of patients not being able to undergo
beginning in April 2013. This campaign will comprise the distri- neuroimaging studies will be classified as of ‘unknown type’.
bution of flyers and posters in public areas and interviews in local Cerebrovascular events will be defined according to the standard
newspapers, magazines, television, and radio. WHO definition (21,24). IS will be defined as a focal neurological
With regard to fatal community events, there are two funeral impairment of sudden onset, and lasting more than 24 hours (or
homes and two local offices of vital statistics in Tandil that have leading to death), and of presumed vascular origin (21,24). TIA
agreed to make their data readily available for the investigators. will be defined as a focal (or at times global) neurological or
The study coordinator will retrieve death certificates weekly and retinal impairment of sudden onset, and lasting less than 24 hours,
will record every death and its cause in the study database. Two and of presumed vascular origin (21,24). PICH will be defined as
certified neurologists will assess the cause of death in every case in a permanent episode of neurological dysfunction caused by a
order to identify potential cerebrovascular events, and verbal parenchymal brain haemorrhage evidenced on neuroimaging
autopsies will be used to investigate every case of suspected stroke studies, regardless of duration of symptoms (21,24). Cerebrovas-
(21). A prespecified verbal autopsy form will be used for deter- cular events will be classified as SAH in the presence of typical
mining if the cause of death was a stroke. For those cases in which symptoms (e.g. headache, nausea, vomiting, decreased alertness)
a stroke is suspected as the cause of death, medical records will we with evidence of blood in the subarachnoid space as noted
reviewed if available (23). by neuroimaging studies (CT/MRI), cerebrospinal fluid (CSF)
examination or autopsy, irrespective of symptoms duration.
Estimated study population
Subjects with stroke or TIA will be considered as incident (first
On the basis of a previous two-month pilot study performed by
ever in a lifetime stroke or TIA) in the absence of a clinical history
our team in Tandil and based on the analysis of 30 population-
of stroke independent of CT/MRI findings. Stroke patients with a
based stroke incidence studies from other countries performed in
history of TIA who develop subsequent stroke will be regarded as
the last decade, the estimated number of patients to be included
incident strokes. After the exclusion of other potential causes of
during the two-year recruitment period is 730, being 504 incident
neurological deterioration, we will define a stroke or a TIA as
strokes, 154 recurrent strokes and TIAs (137 strokes and 17 TIAs),
recurrent if a period of neurological stability of ≥24 hours is
and 72 incident TIAs (8) (Fig. 2).
demonstrated between the index stroke and the subsequent cere-
Definitions and classification of cerebrovascular brovascular event (25). IS and TIAs will be further classified
events and mortality according to Trial of ORG 10172 in Acute Stroke Treatment
Every patient will undergo neuroimaging studies with the aim of (TOAST) criteria (26) and according to Oxfordshire Classifica-
classifying stroke types (ischemia vs. haemorrhage). A head CT tion (27). TOAST criteria will be used for stratifying IS into five
conduction of the study, and will supervise the publication of other low- and middle-income countries within and beyond
subgroup analyses as ‘threaded publications’ (33). A certified neu- Latin America.
rologist in Tandil City will be responsible for leading the opera-
tional aspects of the study, functioning as a chief operational References
officer or general local coordinator. Every participating center will 1 Lozano R, Naghavi M, Foreman K et al. Global and regional mortality
have a team of field investigators led by a principal investigator. from 235 causes of death for 20 age groups in 1990 and 2010: a
Every investigator was trained in GCP, in stroke diagnosis and systematic analysis for the Global Burden of Disease Study 2010.
treatment, in the use of modified Rankin Scale, and in the inter- Lancet 2012; 380:2095–128.
2 Murray CJ, Vos T, Lozano R et al. Disability-adjusted life years
pretation of each of the study variables prior to the initiation of (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a
the study. The local study coordinator will be responsible for systematic analysis for the Global Burden of Disease Study 2010.
administrative assignments of the study. Lancet 2012; 380:2197–223.
3 Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. World-
Data quality control wide stroke incidence and early case fatality reported in 56 population-
A certified neurologist will be in charge of data quality control based studies: a systematic review. Lancet Neurol 2009; 8:355–69.
with the purpose of ensuring consistency and completeness of 4 Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and
every case (Fig. 1). A case will be closed and restricted for further regional burden of disease and risk factors, 2001: systematic analysis of
population health data. Lancet 2006; 367:1747–57.
changes if CRF is consistent and complete. By contrast, if incon- 5 Feigin VL. Stroke in developing countries: can the epidemic be
sistencies or missing data are detected, a query will be sent to the stopped and outcomes improved? Lancet Neurol 2007; 6:94–7.
study coordinator who will be responsible of contacting the cor- 6 Political declaration of the High-level Meeting of the General Assem-
responding investigator for solving the data quality issue. The bly on the Prevention and Control of Non-communicable Diseases.
database will be closed after the last patient undergoes quality Draft resolution submitted by the President of the General Assembly.
Available at: http://www.previstastudy.org/PDHLM.pdf Accessed on
control. July 12, 2013.
Trial administration 7 Lavados PM, Hennis AJ, Fernandes JG et al. Stroke epidemiology,
prevention, and management strategies at a regional level: Latin
The trial will be administered by the INECO Foundation, an America and the Caribbean. Lancet Neurol 2007; 6:362–72.
Argentinean nonprofit organization that promotes research, 8 Sposato LA, Saposnik G. Gross domestic product and health expendi-
scientific training of professionals in the field of neuro- ture associated with incidence, 30-day fatality, and age at stroke onset:
sciences, and community education on the prevention, the early a systematic review. Stroke 2012; 43:170–7.
detection, and the treatment of neurological and psychiatric 9 Lavados PM, Sacks C, Prina L et al. Incidence, case-fatality rate, and
prognosis of ischaemic stroke subtypes in a predominantly Hispanic-
diseases. Mestizo population in Iquique, Chile (PISCIS project): a community-
Results and conclusions reported in this manuscript are those based incidence study. Lancet Neurol 2007; 6:140–8.
of the authors and are independent from any funding source or 10 Minelli C, Fen LF, Minelli DP. Stroke incidence, prognosis, 30-day, and
trial administrator. 1-year case fatality rates in Matão, Brazil: a population-based prospec-
tive study. Stroke 2007; 38:2906–11.
11 Cabral NL, Gonçalves AR, Longo AL et al. Incidence of stroke sub-
types, prognosis and prevalence of risk factors in Joinville, Brazil: a 2
Summary and conclusions year community based study. J Neurol Neurosurg Psychiatry 2009;
80:755–61.
The WHO and the UN have made their formal statements on the 12 Cantu-Brito C, Majersik JJ, Sánchez BN et al. Door-to-door capture of
need of high quality data on noncommunicable diseases from incident and prevalent stroke cases in Durango, Mexico: the Brain
Attack Surveillance in Durango Study. Stroke 2011; 42:601–6.
low- and middle-income countries. PREVISTA is one of the first 13 The World Bank. Population ages 65 and above (% of total). Avail-
results of this call to action. Our study will provide information able at: http://data.worldbank.org/indicator/SP.POP.65UP.TO.ZS/
on stroke epidemiology within the population of Tandil, which is countries Accessed on July 12, 2013.
representative of a large proportion of Latin-American countries 14 The World Bank. Population, female (% of total). Available at: http://
with low- and middle-income economies. Thus, PREVISTA may data.worldbank.org/indicator/SP.POP.65UP.TO.ZS/countries
Accessed on July 12, 2013.
contribute to reduce this gap in knowledge. Providing actual and 15 The World Bank. Literacy rate, adult total (% of people ≥ 15 years).
current stroke incidence data will serve as the substrate for devel- Available at: http://data.worldbank.org/indicator/SE.ADT.LITR.ZS
oping of more accurate and efficient health care policies. These Accessed on July 12, 2013.
data could help to generate higher stroke awareness among policy 16 The World Bank. Mortality rate, infant (per 1,000 live births).
makers, professionals, and the general population. The results of Available at: http://data.worldbank.org/indicator/SP.DYN.IMRT.IN/
countries Accessed on July 12, 2013.
the Argentinean National Stroke Registry (ReNACer) served as a 17 The World Bank. GDP per capita (current US$). Available at: http://
source for drafting the first National Stroke ACT by the Argen- data.worldbank.org/indicator/SE.ADT.LITR.ZS Accessed on July 12,
tinean Neurological Society, and the results of PREVISTA could 2013.
help to reinforce the enactment of this law, as well to promote of 18 The World Bank. Unemployment, male (% of male labor force). Avail-
new provincial initiatives. Additionally, by gathering data on spe- able at: http://data.worldbank.org/indicator/SL.UEM.TOTL.MA.ZS/
countries Accessed on July 12, 2013.
cific risk factors profiles in a Latin-American population, it will be 19 Annual Census 2010. Final results. Available at: http://www.censo
possible to develop more efficient prevention strategies. Finally, 2010.indec.gov.ar/resultadosdefinitivos.asp Accessed on July 12,
PREVISTA could provide a useful model for stroke studies in 2013.