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Program for the epidemiological evaluation of stroke in Tandil, Argentina

(PREVISTA) study: rationale and design
Luciano A. Sposato1,2*, Mariano L. Coppola3,4,5, Juan Altamirano3,4,5,
Brenda Borrego Guerrero5, Jorge Casanova14, Maximiliano De Martino3, Alejandro Díaz3,
Valery L. Feigin6, Fernando Funaro4, María E. Gradillone3, María L. Lewin3,
Renato D. Lopes7,8,9, Daniel H. López4,5, Mariel Louge4, Patricia Maccarone4, Cecilia Martens3,
Marcelo Miguel4, Alejandro Rabinstein10, Hernán Morasso14, Patricia M. Riccio2,
Gustavo Saposnik11, Damián Silva3, Ramón Suasnabar4, Thomas Truelsen12, Araceli Uzcudun3,
Carlos A. Viviani13, and M. Cecilia Bahit1

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. All causes of death will be adjudicated by an ad-hoc
Twitter: @SposatoL committee.
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-
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
Hospital Ramón Santamarina, Tandil, Province of Buenos Aires, decision-making in the region.
Argentina Key words: developing countries, epidemiology, hispanic, incidence,
Nueva Clínica Chacabuco, Tandil, Province of Buenos Aires, Argentina mortality, stroke
Sanatorio Tandil, Tandil, Province of Buenos Aires, Argentina
National Institute for Stroke and Applied Neurosciences, School of Reha-
bilitation and Occupation Studies, AUT University, Auckland, Northcote, Introduction and rationale
New Zealand
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
Duke Clinical Research Institute, Durham, NC, USA adult disability worldwide (1,2). Although the incidence of cere-
Brazilian Clinical Research Institute (BCRI), Sao Paulo, SP, Brazil
Neuroscience Intensive Care Unit, Mayo Clinic, Rochester, MN, USA
brovascular disease has increased by over 100% between 1970 and
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
Department of Neurology, Copenhagen University Hospital, Herlev,
interventions are implemented (4,5). The scarce availability of
Círculo Médico de Tandil, Buenos Aires, Argentina high-quality epidemiological data on cerebrovascular disease in
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

© 2013 The Authors. Vol 8, October 2013, 591–597 591

International Journal of Stroke © 2013 World Stroke Organization
Protocols L. A. Sposato et al.

countries is crucial for developing health policies aimed at dis- Methods

tributing resources more efficiently.
There are only a few well-designed, population-based, stroke PREVISTA was developed according to the criteria for studies of
incidence studies in Latin America (7). Since year 2000, only four stroke incidence, proposed by Sudlow and Warlow (20), and by
population-based stroke incidence studies were conducted in using the World Health Organization (WHO)’s Standardized
Latin America (8): Iquique (Chile, 2000–2002) (9), Matao (Brazil, Tools for Stroke Surveillance manual (21,22).
2003–2004) (10), Joinville (Brazil 2005–2006) (11), and Durango
Tandil City
(Mexico, 2007–2008) (12). Extrapolation of the findings of these
The city of Tandil is located in the province of Buenos Aires,
studies to other Latin-American countries is methodologically
360 km south from Buenos Aires City and more than 100 km
problematic as they included different race-ethnic communities
from the nearest stroke center. It is considered a referral city for
and socio-demographically diverse populations, where data were
hospitalization and clinic consultations.
collected at least more than five-years ago. Also, socioeconomic
The Tandilean population is originated from few local inhab-
indicators, which are important determinants of stroke incidence
itants and a large immigration influx from Italy, Spain, France
and mortality (9), were not completely assessed. In addition, no
(Basques), and Denmark.
stroke incidence studies have ever been conducted in Argentina.
The population is distributed along an urbanized area of
The population of Tandil is representative of most of Latin-
22·07 km2 (13·7 mi2) surrounded by a suburban area of 30·3 km2
American populations with low- and middle-income economies
(18·8 mi2). There are seven nearby cities at a mean distance of
(Table 1). Thus, the findings and conclusions of the program for
103 ± 32 km (64 ± 20 mi). The nearest cities are Ayacucho and
the epidemiological evaluation of stroke in Tandil, Argentina
Benito Juárez (both at 80 km/50 mi).
(PREVISTA) could provide data that may guide future health
Owing to these unique features, it is unlikely for Tandilean
policy initiatives in the region.
patients with acute stroke or TIA to seek medical attention else-
Objectives where. According to the 2010 National Census, the population of
PREVISTA is an investigator-initiated population-based study Tandil was of 123 871 inhabitants. There is one public hospital
aimed at assessing the incidence and the incidence of first-ever with 101 beds, two private hospitals with a total 134 beds, and 10
and recurrent stroke/transient ischemic attack (TIA), and death at outpatient clinics. Four neurologists work in these outpatient
different points of time (28 days, six-months, and 12 months) in clinics, and approximately 350 physicians work in the city. There
the city of Tandil, Buenos Aires, Argentina. are no stroke units in Tandil. In terms of availability of neuroim-

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)

Tandil (19) 13 51·6 99 12 11·0 7·4

Argentina 11 51·1 98 13 9·1 7·8
Bolivia 5 50·1 91 41 2·0 NA
Brazil 7 50·8 90 15 11·0 6·1
Chile 9 50·6 99 8 12·6 7·2
Colombia 6 50·8 93 16 6·2 9·1
Ecuador 6 49·9 92 20 4·0 5·2
Paraguay 5 49·5 94 20 2·8 4·4
Peru 6 49·9 NA 15 5·3 4·4
Uruguay 14 51·7 98 9 11·7 NA
Venezuela 6 49·8 96 13 13·7 7·2

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.

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International Journal of Stroke © 2013 World Stroke Organization
L. A. Sposato et al. Protocols
aging studies, two 8-Slice General Electric Lightspeed® computed stroke care or those without a permanent address in Tandil (less
tomography (CT) scanners (General Electric Medical Systems, than 12 months of residency in the city) during the study period
Milwaukee, WI, USA) are located at one of the private hospitals will not be included in the study.
and at a facility separated by less than 1 km from the three hospitals
(‘Resonancia del Centro’). A third CT scanner is available at the Case ascertainment
public hospital (Elscint CT-Twin flash, Philips, Amsterdam, the The three Tandilean hospitals will be enrolling incident and
Netherlands). For the purpose of the study, we will be using a 1·5-T recurrent stroke/TIA patients. Also, general practitioners were
General Electric Horizon magnetic resonance imaging (MRI) contacted for participating in the study. To ensure inclusion of all
scanner (General Electric Medical Systems, Milwaukee, WI, USA), events during the recruitment period of two-years, we will estab-
which is located in Resonancia del Centro. A second MRI scanner lish an ‘intensive stroke/TIA-screening program’ (ISP) (hot
(0·23-T General Electric Profile scanner, General Electric Medical pursuit), which consists of a comprehensive daily tracking
Systems, Milwaukee, WI, USA), which is set at one of the private program of every potential vascular event including stroke/TIA at
hospitals, will be used only if the first one is out of order. three levels (Fig. 1): (1) events admitted to three Tandilean hos-
More details about Tandil and PREVISTA study can be found at pitals: admissions and discharges to/from every service in the
the study website ( three hospitals (emergency room, general ward, intensive care
unit, coronary care unit, and cath. Lab); (2) nonfatal community
Patients events: (a) consultations in the 10 available ambulatory care
The study will enroll all new (incident) and recurrent consecutive centers; (b) list of patients undergoing ambulatory brain CT or
events of stroke or TIA in the City of Tandil, Argentina using MRI scanning; (c) lists of patients scheduled for echocardiogra-
overlapping data sources between May 1, 2013 and April 30, 2015. phy and carotid Doppler ultrasound; and (d) admissions to reha-
The study population will comprise the following categories of bilitation or tertiary care centers; and (3) fatal community events:
incident and recurrent cerebrovascular events: (1) ischemic daily search for any suspected stroke-related death through revi-
strokes (IS), (2) nontraumatic primary intracerebral haemor- sion of death certificates at funeral homes and local offices of vital
rhages (PICH), (3) subarachnoid haemorrhages (SAH), and statistics.
(4) TIAs. All new events will be initially assessed and classified by For enhancing recruitment of patients at the ambulatory level,
a field neurologist as: (1) probable, (2) possible, and (3) unlikely. we have encouraged general practitioners and cardiologists to
Two board-certified neurologists will adjudicate the events as: refer any patient with symptoms potentially associated with
(1) confirmed IS, (2) confirmed PICH, (3) confirmed SAH, stroke or TIA to the neurologists at each outpatient clinic. The
(4) confirmed TIA, (5) stroke of unknown pathological subtype, study coordinator will also visit the 10 outpatient clinics in the
and (6) nonstroke. Patients referred from another city seeking city on a weekly basis with the aim of sustaining awareness along

Fig. 1 Case ascertainment and follow-up. ER, emergency room; GW, general ward; CCU, coronary care unit; ICU, intensive care unit; cath lab, catheter

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International Journal of Stroke © 2013 World Stroke Organization
Protocols L. A. Sposato et al.

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

Fig. 2 Estimated recruitment rate.

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International Journal of Stroke © 2013 World Stroke Organization
L. A. Sposato et al. Protocols
different pathophysiological subtypes: (1) large vessel atheroscle- be evaluated by two certified neurologists and will be stored for
rosis, (2) cardioembolism, (3) small vessel occlusion, (4) stroke of further analyses.
other determined etiology, and (5) stroke of undetermined etiol- The CRF will comprise data on: (1) anonymized administrative
ogy (two or more causes identified, negative evaluation or incom- information, (2) time of stroke/TIA onset, (3) socioeconomic
plete assessment). Oxfordshire Classification will be used for status, (4) presenting signs and symptoms, (5) vascular risk
categorizing strokes into: (1) total anterior circulation infarction, factors, (6) previous use of antithrombotic drugs, and (7) modi-
(2) partial anterior circulation infarction, (3) lacunar infarction, fied Rankin Scale at 28 days, 6, and 12 months.
and (4) posterior circulation infarction.
Death will be categorized as: (1) neurological (herniation, Statistical analysis
edema, hydrocephalus, raised intracranial pressure, and recurrent For enabling future comparisons, PREVISTA will use a similar
stroke); (2) pneumonia (or any other chest infection); (3) other statistical approach as that of Proyecto Investigación de Stroke en
infections leading to death (urinary tract infection, infective Chile: Iquique Stroke Study (PISCIS) Project (9). We will calculate
endocarditis, sepsis of any other cause); (4) cardio-respiratory incidence rates using the population of the city of Tandil as de-
(myocardial infarction, congestive heart failure, sudden death, nominator based on the 2010 Census (123 871 inhabitants) (19).
acute respiratory distress syndrome, and pulmonary embolism); Incidence rates of first-ever strokes will be adjusted to Argen-
(5) other causes (accident, cancer, and acquired immunodefi- tine population by the direct method (19) and by using the WHO
ciency syndrome); and (6) unknown. Deaths will be also classified World population by the direct method (31). Data will also be
as vascular (consequences of qualifying or recurrent stroke, myo- stratified by age (decades of life), gender, subtypes of stroke,
cardial infarction, congestive heart failure, sudden death, and pul- TOAST classification, and socioeconomic status. Data will be
monary embolism) or nonvascular (any other cause). Causes of stratified according to gender and decades of life.
death will be adjudicated by an ad hoc committee comprised by We will calculate confidence intervals for crude rates and for
two certified neurologists and two certified cardiologists. specific rates for age and gender on the assumption of a normal
distribution for counts greater than 100 and Poisson distribution
Data collection for counts less than 100. Confidence intervals for age-adjusted
Patients will be assessed upon enrollment (day 0 after stroke/ rates will be calculated according to the formula proposed by
TIA), at day 28, and at 6 and 12 months. Data will be collected in Keyfitz (32). The χ2 and Fisher’s exact tests will be used to
a printed case report form (CRF, supplementary file in Spanish). compare categorical variables, and the Mann–Whitney U-test and
This information will be subsequently recorded in an electronic, Student’s t-test will be used to compare continuous variables. All
web-based, anonymized, and encrypted database developed by tests will be two tailed.
Kinetica Solutions® (Buenos Aires, Argentina), which will be Ethical considerations
stored in Windows Azure®, Microsoft’s cloud platform The study will be conducted in accordance with good clinical
(Redmond, WA, USA). The investigator’s manual with definitions practice (GCP), all applicable subject privacy and confidentiality
for every variable and few operational hints (Supplementary file, requirements, and the guiding principles of the declaration of
in Spanish) is included in the printed CRF. Helsinki. All subject’s data will be confidential and only autho-
Data will be initially collected during hospital stay. Written rized individuals will have access to study-related documents.
informed consent will be obtained from the patient or the closest Written informed consent will be obtained from each subject
family member or legal guardian. prior to participation in the study. The closest family member or
Follow-up will be undertaken at 28 days, 6, and 12 months by legal guardian will be asked to consent on behalf of the patient if
using prescheduled telephone interviews. In order to minimize he/she is unable to do it.
delays in case of off days, vacations, or pregnancy, three physicians An independent Ethics Committee has approved the study and
will be responsible for doing these interviews. For those cases in the informed consent form. The database will be registered at the
which patients are not able to speak on the phone (i.e. aphasia, Argentinean National Office for the Protection of Personal Data
tracheostomy, death), a family member will be asked to respond (Ministry of Justice and Human Rights).
to the questions.
As not all participating neurologists are certified or familiar Organizational structure
with the administration of the national institutes of Health Stroke PREVISTA study is led by an academic steering committee com-
Scale (NIHSS), stroke severity will be determined by quantifying posed of two cochairs and local and international experts in
the number of neurological deficits (28,29) by using the 6S Score stroke and epidemiology. This committee will provide scientific
(30), as done in other stroke registries. The 6S score has good direction and input, will address policy issues regarding the pro-
correlation with the NIHSS, in-hospital mortality, and neurologi- tocol, and will meet periodically to assess the trial progress. PRE-
cal worsening during hospital stay (30). VISTA study has an advisory board comprised by two
As mentioned, before, every patient will undergo brain CT or international stroke experts who will provide input and guidance
MRI scanning. Participants will be assessed according to the usual with respect to specific scientific issues (e.g. publication strategy
protocol for stroke patients when possible (e.g. carotid Doppler and quality). A subset of the Steering Committee has overseen the
ultrasound, magnetic resonance angiography, transthoracic, or study protocol and has decided on the final approval of the
transesophageal echocardiography). Neuroimaging studies will primary manuscript. This committee will assess enrolment and

© 2013 The Authors. Vol 8, October 2013, 591–597 595

International Journal of Stroke © 2013 World Stroke Organization
Protocols L. A. Sposato et al.

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
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PREVISTA could provide a useful model for stroke studies in 2013.

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International Journal of Stroke © 2013 World Stroke Organization
L. A. Sposato et al. Protocols
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