1 Health Examination Survey (INSEF) - National component This manual has been prepared by national experts from Portugal. Carlos Matias Dias with his team from the Instituto Nacional de Saúde Dr. Ricardo Jorge, IP (http://www.insa.pt ) wrote this manual based on their experience from the EHES Pilot Survey conducted in 2010-2011. The EHES Pilot Project has received funding from the European Commission / DG Sanco. The views expressed here are those of the authors and they do not represent the Commission’s official position. More information about the EHES Pilot Project: http://www.ehes.info
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1
Health Examination Survey (INSEF) - National component
This manual has been prepared by national experts from Portugal. Carlos Matias Dias with his team from the Instituto Nacional de Saúde Dr. Ricardo Jorge, IP (http://www.insa.pt) wrote this manual based on their experience from the EHES Pilot Survey conducted in 2010-2011.
The EHES Pilot Project has received funding from the European Commission / DG Sanco. The views expressed here are those of the authors and they do not represent the Commission’s official position.
More information about the EHES Pilot Project: http://www.ehes.info
4.1 FINISH NATIONAL INSTITUTE OF HEALTH AND WELFARE (THL) .............................................. 7 4.2 NATIONAL HEALTH INSTITUTE - DOUTOR RICARDO JORGE (INSA) ......................................... 8 4.3 REGIONAL HEALTH ADMINISTRATIONS AND REGIONAL HEALTH SECRETARIATS OF THE AUTONOMOUS REGIONS ......................................................................................................................... 9
5 MATERIAL AND METHODS ..................................................................................................... 9
5.1 GENERAL STUDY DESIGN / TYPE OF STUDY................................................................................... 9 5.2 TARGET POPULATION.................................................................................................................... 9 5.3 DRAWING AND CHOICE OF THE SAMPLE ....................................................................................... 9
5.3.1 Dimension of the sample..................................................................................................... 10 5.4 VARIABLES UNDER STUDY ........................................................................................................... 11
5.4.1 Dimensions and variables under study ............................................................................... 12 5.5 RECRUITMENT OF PARTICIPANTS ............................................................................................... 15
5.5.1 Selection of participants ..................................................................................................... 15 5.6 COLLECTION OF DATA ................................................................................................................ 16
5.6.1 Places of data collection..................................................................................................... 16 5.6.2 Maximizing participation ................................................................................................... 16 5.6.3 Maximizing answers ........................................................................................................... 17
5.7 PREPARATION OF THE FIELD WORK ........................................................................................... 17 5.7.1 Preparation of the support materials.................................................................................. 17
5.8 DATA PROCESSING AND TRANSFER ............................................................................................. 18 5.9 DATA ANALYSIS ........................................................................................................................... 19
6 QUALITY CONTROL ................................................................................................................ 19
7 PILOT STUDY ............................................................................................................................ 19
8 ACTIVITIES SCHEDULE IN EACH REGION ......................................................................... 21
9 REGIONAL RESOURCES NEEDED FOR THE PILOT STUDY............................................. 22
10 ETHICAL AND LEGAL ASPECTS ........................................................................................... 23
10.1 ETHICS COMMITTEE .............................................................................................................. 23 10.2 INFORMED CONSENT .............................................................................................................. 23 10.3 PROTECTION AGAINST THE RESEARCH INHERENT RISKS...................................................... 23 10.4 SHARING BENEFITS ................................................................................................................. 24 10.5 . SHARING AND ACCESS TO DATA AND BIOLOGICAL SAMPLES .............................................. 24
EHES – European Health Examination Survey (European inquiry of health with physical examination)
FEHES - Feasibility of the European Health Examination Survey
INSA - National Institute of Health, Doutor Ricardo Jorge
INSEF - Health Survey with Physical Examination
PREHES - Preparing the European Health Examination Survey
THL - Finnish Institute of Public Health
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Summary The aim of the portuguese Health Examination Survey (INSEF - Portuguese acronym
for the Health Examination Survey) is the completion of an epidemiological diagnosis
of the health situation of the population residing in Portugal, through a description of its
health status, health determinants (using clinical, biochemical and genetic data) and use
of health care, contributing for health planning and health research in Portugal. The
relevance of INSEF mainly resides in collecting data on the dimensions described above
in the same individuals, using standardized instruments and methods, including
biological and antropometric measurements whic validate interview data. An additional
advantage is the creation of a bank of biological materials and interview data, available
to additional research. A representative sample of the resident population with approximately 8,000 individuals
will be studied, stratified by health region, using methods of general health interview
surveys, and including an additional physical examination component collection of
biological materials. Data will be collected in a random sample of health centres in each
health region. The Regional Health Administrations of Health will be invited to
participate in the whole process as partners, including planning phase, implementation
and data collection and reporting. This project will be developed in an optic of sharing
resources between the National Health Institute (INSA) and the Regional Health
Administrations (RHA). INSEF is an observational study with a cross-sectional design, which follows the
international recommendations for the first European Health Examination Survey
(EHES), currently in preparation and in which the INSA participates.. A joint
operational action between INSEF and EHES is advantageous as it allows the collection
of data for both purposes, maintaining high data comparability and validity between the
national regions and with European countries involved. The duration of the project is 3 years and includes the preparation, field work, data
analysis, elaboration and dissemination of the reports. The developed resources will
have a time of longer life, since the biological samples and the database can be used in
additional studies, relevant from the standpoint of public health.
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The knowledge, materials and procedures developed will be shared between the
institutions involved, especially with the teams of the Regional Departments of Public
Health through their participation in all steps of the study, increasing their capital for
future use.
1 Interest and relevance of the Health Examination Survey (INSEF)
The National Health Plan - Priorities - (DGS, 2004), in its aims, proposes “obtain gains
in health, increasing the level of health in different stages of life and reducing the
burden of disease”. In proposing strategic guidelines for health and to the National
Health System, the National Health Plan adopts a perspective towards disease
prevention and health promotion throughout the life cycle and result in health gains. To reduce the risk factors of illness, especially chronic conditions (cancer,
cardiovascular diseases, respiratory diseases, diabetes, depression), implies to know and
to adopt a multidimensional and prospective approach on its prevalence in the
Portuguese Population. This knowledge constitutes a fundamental base for the reflection on the programs and
policies to promote, in a health promotion perspective, towards the prevention of
disease an access to primary and long-term health care. The National Health Interview Survey, regularly carried through in Portugal, is a useful
instrument for politic health decision and for the evaluation of the interventions,
generating estimates on the states of health and illness of the Portuguese population, as
well as the determinant factors and the use of health services. However, some aspects of
population health can only be assessed in a reliable and valid way, through studies in
which to the interview component, a physical examination of those selected is
performed. Examples of these characteristics are: blood pressure, body mass index, lipid
and genetic profiles, functional and cognitive abilities, among others. In Portugal, previous studies have already been carried out, which included physical
examination, namely studies of the prevalence of obesity (Carmo et. Al., 2006), diabetes
1) Provides partial funding, tools and standard procedures, training and monitoring
throughout the project EHES;
2) Supports the implementation of a central data management system for pooling the
data for quality assessment, basic reporting and evaluation;
3) Supports the planning, methodology, data analysis and the project evaluation, and
supports the preparation of final reports. 4.2 National Health Institute - Doutor Ricardo Jorge (INSA) This is the promoter of EHES in Portugal. It is responsible, also, for the preparation,
implementation, analysis and dissemination of the INSEF results, in collaboration with
the participating entities. The INSA has the following responsibilities:
1) Planning the study together with the participant entities;
2) Setting up the necessary national infrastructure for field work;
3) Plan, organize and conduct the pilot study;
4) Obtain the Portuguese Health Ministry cooperation and funding for the study in
collaboration with the participating entities;
5) Produce, adapt, test and provide standardized instruments, guidelines, training and
support to the regions (procedures manuals), plan and prepare the sampling
procedures;
6) Define and set up a central data management system for pooling the data for quality
assessment, basic reporting and evaluation;
7) Produce a progress and final report and promote results dissemination;
8) Evaluate the study. The preparation of the INSA participation includes these activities in the national
component of the European Survey with physical Examination (EHES) (2012/2013).
INSA, in collaboration with the participating entities, will carry out the data analysis,
laboratory measurements, preparation of progress and final reports, as well as the
publicity and dissemination of results. Departments involved in INSEF:
DEP - Department of Epidemiology: coordinate and implement the INSEF;
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DPS - Department of Health Promotion and Chronic Diseases: supports the DEP in
all phases of the study.
4.3 Regional Health Administrations and Regional Health Secretariats of the Autonomous Regions
The five Regional Health Administrations (North, Central, Lisbon, Alentejo, Algarve) and the two Regional Secretariats of Health (Madeira and Azores) participate in all phases of INSEF and are partners in the national component of EHES.
The Regional Health Administrations have the following responsibilities:
1) To indicate the key professionals who will implement the study in the region.
Contact each survey site through the regional coordinator to assure the necessary
human and material resources for the data collection; 2) To supply the necessary data for sample design;
3) To co-ordinate and guarantee the implementation of the field work through the
material allocation , logistic and human resources adjusted to the recruitment of the
people composing the sample and the data collection;
4) To assure the rigorous fulfilment of the defined quality standards in the study under
the supervision INSA/THL. 5 Material and methods
5.1 General study design / type of study
This is an observational, cross-sectional, descriptive epidemiological study with data
collection through a questionnaire, physical examination and laboratory analysis of
biological materials. 5.2 Target population
The target population comprises mainland Portugal and Autonomous Regions (Azores
and Madeira) residents included on the National Health System (NHS) and aged 25 to
75 years old.
5.3 Drawing and choice of the sample A random sample stratified by Health Region will have a two stages selection of
sampling units:
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a) Random health centres selection with proportional probability to population
dimension;
b) Random sample selection to meet the objectives established by the stratification
variables (age group and sex). This choice will be made through the lists of NHS users. In the beginning, an oversized
list of individuals to convoke will be considered, to compensate the non-responses. As the male participation rate is expected to be lower than the female participation rate,
a higher sample size for males will be proposed (three times more). Alternate lists of
recruitment will also be set up if the first draft does not meet the set sampling
objectives. 5.3.1 Dimension of the sample
The sample size determination considers three assumptions:
It studies any dichotomous characteristic;
It starts with a prevalence of 50% representing a worst case scenario;
It requires a precision of at least 5% for each Health Region.
These assumptions imply the need for a larger size sample for any numerical
characteristic and that the sample size will consider the prevalence that is really of
interest. Table 1, below, shows that a sample size between 384 and 600 individuals, for
each health region, is necessary to meet the assumptions. Choosing an intermediate number of 450 individuals, the minimum precision for the
prevalence of any characteristic is 4,6%. This number generates, in the whole of the 7
Health Regions, a sample of 3150 individuals that will allow a minimum precision of
1,7% for the prevalence of any health characteristic of the target population.
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Table 1 - Sample sizes for a significance level of 5%, a prevalence of 50% and various levels of
5.4 Variables under study The main INSEF areas follow national and international guidelines, such as those
outlined for EHES, proposed by the project FEHES, those used by the 4th National
Health Survey (2005/2006) and other instruments selected by INSA. The INSEF
includes a set of tests and anthropometric measures (weight, height), clinical (blood
pressure, heart rate), biochemical (cholesterol, glucose) and an interview questionnaire.
The questions posed by FEHES for the European Survey are structured in four thematic
areas (Table 3).
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Table 3 – Indicators of health inquiry with physical examination
Indicators Demographic and socio-economic factors
Age Sex Occupation Education
State of health/ disease
General health perception Limitations of physical functions in the AVD Psychological Stress Muscle and joint pain Specific conditions of the disease: CVD, diabetes, mental health, respiratory diseases (asthma, COOPD), occurrence of other chronic diseases
Determinants of health
Tobacco consumption Alcohol consumption Eating habits Physical activity Social support
Health Care Use of health services (for specific and general health conditions) Use of medication (for specific and general health conditions)
Source: KTL, “Recommendations will be the health examination surveys in Europe” (2008), Feasibility
of European Health Examination Survey (FEHES), P. 14
5.4.1 Dimensions and variables under study With all the contributions the questionnaire will cover the following dimensions and
variables under study.
Demographic and socio-economic factors
Socio-demographic characterization of the inquired/respondent: sex, age, date of
birth, family information, nationality, place of birth, places of residence,
qualifications, number of years of school attendance, occupation, employment status,
nature of contract, working arrangements, sector of activity, household income
(global and individual).
Characterization of the household - Number of people living in the household,
household composition, number of people under 18 years old.
State of health
Characterization of health state / chronic and acute disease:
The respondent: self-perception of health status; chronic diseases should be considered
for longer than 6 months and 12 months and diagnosed by a doctor. Consider the
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following diseases: hypertension, asthma, emphysema, chronic bronchitis, cancer,
Complete blood count CRP (C reactive protein) Glucose Creatinine Total cholesterol High density lipoprotein (HDL) Low density lipoprotein (LDL) Triglycerides Gamma glutamyl transferase (GGT) Alanine aminotransferase (ALT) Aspartate aminotransferase (AST)
Genetic parameters: Allele frequencies of genes that encode proteins The selected variants will be in genes that encode proteins involved in six major cellular and physiologic pathways: 1) nutrient metabolism (e.g. homocysteine, lipids, glucose and alcohol); 2) immune and inflammatory responses; 3) xenobiotic metabolism (e.g. drugs, carcinogens or environmental contaminants); 4) DNA repair; 5) haemostasis and the rennin –angiotensin-aldosterone system; and 6) oxidative stress.
5.5 Recruitment of participants
5.5.1 Selection of participants Each region will select the respondents and contact them, twice, individuals by letter
(invitation):
1) A first postal contact, two weeks before the expected week for the collection of data,
explaining the study and requesting participation (letter of invitation with an insert);
2) A second postal delivery within a week, indicating the location and day for the
interview and physical examination, explaining as well the duration. In the same
week the participants will receive a telephone call, in order to ensure maximum
participation and to plan possible changes of dates. This telephone contact will also
serve to collect minimal information about the reasons for possible non-participation,
their health status and determinants.
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5.6 Collection of data 5.6.1 Places of data collection Depending on the region availability, two strategies for action may be used, concerning
the definition of the data collection location: 1) Decentralized units, previously defined in each region, localised in the health centres,
or their extensions when appropriate (core strategy); 2) A fixed location, situated in each region, to where the individuals will dislocate
themselves, after the participation invitation (alternative strategy). 5.6.2 Maximizing participation
One of the foreseen obstacles in the survey process is the percentage of NHS users
interest. The participation level will be monitored during recruitment, in order to detect
early deviations from planned sampling distributions. The sampling and recruitment
strategies will be modified, if necessary, to correct the discrepancies.
There should be made efforts to maximize the participation rate. According to FEHES
(2008), the response rate in some countries (Finland, Germany, Poland, United
Kingdom and United States of America), using health surveys with physical
examination on representative samples, is about 70%. This value does not differ much
from a study conducted, very recently, by INSA (ECOS project, 2009) about the level
of participation in Portuguese population in a study of genetic research. This study
revealed that 64.1% of the Portuguese would be available to participate through the
donation of blood, enabling it to be stored in a bio bank designed for this purpose
(INSA, 2009). However, it is considered that the effective participation rate can be below this value,
particularly in certain population strata. Factors for non-participation include functional
limitations due to health problems, lack of interest or work / school obligations. To address the non-participation, in exceptional cases there may exist different ways to
conduct the survey, extended hours on weekdays or in the weekend, if possible, and
various forms of questionnaire administration (directly or indirectly) to cover the largest
number of participants. These problems require a careful and strategically planned
reflection, because there is the risk of not covering all population groups in the chosen
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sample. For this reason, it will be necessary to contact a greater number of individuals
in certain subgroups, in order to achieve a higher number of participants. 5.6.3 Maximizing answers
One of the advantages of questionnaires administered directly by an interviewer – face
to face - is the lowest risk of non-responses due to problems of illiteracy, visual
impairments or comprehension difficulties, despite the additional costs associated with a
longer time to obtain the answers. In these cases, the entire questionnaire can be
administered by a health professional. In the case of lack of time, participants can send the questionnaire by post (addressed to
INSA) or fill it through the internet, after assigning an access code (secondary strategy
to avoid). Self-administration of the questionnaire has the advantage of greater privacy, flexibility
and speed. The main disadvantage is the increased risk of non-response due to lack of
understanding of an issue and of not returning the questionnaire, when delivered to fill
at home and send later to the core team. These drawbacks can be overcome with the
provision of a free telephone number that allows central questions or even collect the
missing data, or by creating a website (secondary strategy). 5.7 Preparation of the field work
5.7.1 Preparation of the support materials
5.7.1.1 Questionnaire The questionnaire design is a DEP / INSA responsibility. The questionnaire will have a
previous test in order to validate the understanding of the questions, the average
duration of its fulfilling (interview or self-administration) and identify potential errors in
its formulation.
There are two forms of questionnaire administration: (a) the main areas of INSEF, including questions relating to chronic and acute disease
existence (respondent and family), functional capacity, mental health, medication use,
physical activity and health service use, will be administered by a health professional;
(b) the remaining questions should be completed by the participant after conclusion of
the physical exam or while he / she waits for it. The self - administered questionnaire
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includes socio-demographic and economic variables (income and expenditure), various
lifestyle aspects and environmental factors (consumption of alcohol, tobacco, food, sun
exposure), quality of life, social support and evaluation of health services.
5.7.1.2 Procedures for measuring
The anthropometric (weight, height, blood pressure) and biochemical measurements
will be made in accordance with the recommendations proposed by FEHES. The
regional teams will be trained in these procedures by the INSA core team who will be
trained by the team of the Finish National Institute of Health and Welfare.
5.7.1.3 Training support materials
Materials to support training will be produced by the core team at INSA following the
guidelines of the Finnish partner and using appropriate materials available from the
National Health Surveys carried out on Portugal. 5.7.1.4 Constitution and training of the field teams
All parts of the field team will be trained in interview techniques and general physical
examination, based on a questionnaire constructed for this purpose (questionnaire 1 and
2), basic procedures for physical examination and blood collection. All training sessions
will be of INSA’s responsibility through a field manual to support training, covering the
three phases: collection of blood, anthropometry and the questionnaire. The training
sessions are, essentially, practical. The training process will be carried out in teams composed by the responsible for the
communications with the ARS and the field teams, taking place in the health centres
previously selected, in cooperation with a INSA core team, so that it is possible to
address potential problems that may arise along the data collection process. 5.8 Data processing and transfer
After the collection and record of biological samples, anthropometric data and
questionnaires, each material collected will have a bar code. Biological samples should
be stored and transferred to the Public Health Laboratory Regional within two hours
after collection. The remaining material collected (registration of anthropometric data
and questionnaires) should have a first validation by a field team and then be
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transported to the INSA facilities. All samples will be transported to the National
Institute of Health laboratory where they will be centrally processed and stored.
5.9 Data analysis The data analysis will be planned according to the regions, INSA and international
commitments information needs. As so, the analysis plan is discussed in advance
between the DEP / INSA and each ARS. Data analysis includes a weighting of sample
data and the use of sample design variables to obtain estimates of the proportions
variance and variables means.
6 Quality control A set of procedures for the INSEF quality control mechanisms will be established, such
as the interlocutors and / or INSA team presence during the process of data collection or
periodically checking the equipment and compliance with standard laboratorial
procedures. 7 Pilot study The pilot study was designed to test the logistics and get information prior to
performing the large-scale study and so, to improve the latter quality and efficiency.
This pilot study completion can identify deficiencies in design or procedures that can be
corrected before more resources are invested in a large-scale study. The completion of the pilot study should allow assessment of the human resources
needs, logistics of the fieldwork, sampling population, ethical and legal aspects,
laboratory testing, potential difficulties in translating the instruments and measurement
protocols, adapt the training of field teams, data management and quality control. The pilot study covers 200 people (50 per region) obtained by sampling. The pilot study
takes place in one location, centrally located in each region, or possibly in two or more
sites in each region. The pilot phase (previous test and pilot study) will be held in the
1st half of 2010 (see schedule). The pilot study is strongly recommended by THL and, although their objectives and
methods depend on previous regional experience, should consider the following aspects:
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1) To reveal critical aspects that require standardization, such as training needs and key
aspects of the procedures manual, which will be necessary to adjust the training of
interviewers and finalize the survey manuals;
2) To test the participants’ availability and document their reactions to the study,
developing additional methods that motivate people to participate;
3) To calculate the average length of interviews and physical examination, per
participant, as it is essential to estimate the resources required and the time that users
must spend. It is recommended that participants are informed about the average /
maximum time for the survey and that waiting times are the minimum possible
(maximum 1 hour). The whole procedure must be tested during the pilot, so that
waiting times are minimized. If it becomes necessary to stay longer, and if fasting is
required, should be taken into consideration the comfort of participants offering a
small meal;
4) To test, during the pilot, difficulties in the understanding or the administration of the
questionnaire, replacing or reformulating questions when necessary;
5) To test the equipment in use, including the required for physical examination,
software and data management, essential to avoid problems in collecting and
managing information, and to obtain more precise estimates of space requirements,
equipment and the global logistic process;
6) To test the logistics related to the transport of biological materials, from the places of
interview to the laboratory and subsequent analysis;
7) To identify practical problems that may arise during the pilot study in order to
anticipate solutions to any problems that may arise during the fieldwork. After the pilot study there will be a meeting with the participating entities in order to
discuss the gained experience during the pilot phase and proposed possible protocol
improvements for the main study.
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8 Activities schedule in each region
Plan, prepare the definition of the pilot study
To supervise the accomplishment and to evaluate the study pilot
Develop a strategic plan for the implementation of the 1st National Health Survey of Physical Examination (INSEF1) Implement the operations system of data collection
Evaluate results
YEAR 2009 2010 2011
MONTHS Sep. Oct. Nov. Dec. Jan. Feb Mar Apr Mai. Jun. Jul. Aug. Set. Oct. Nov. Dec. Jan. Feb Mar Apr Mai. Jun. Jul. Aug. Set. Oct. Nov. Dec.
Activities to carry through / products To elaborate the scientific protocol for the study (product 1) To elaborate a preparatory and operational document for the study pilot (product 2)
Data collection
Evaluation document of the study pilot (product 3)
Plan of improvement (product 4) Data collection Report of results (product 5) Report of evaluation (product 6)
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9 Regional resources needed for the pilot study
Physicists Materials Transport Human beings Others Rooms Furniture Equipment Material Procedures
E registers
PHYSICAL EXAMINATION
A room for physical examination and blood collection.
A table to measure the arterial tension and weight/height; Two chairs; An screen.
One balance; Sphygmomanometers; Body meter.
Measurement protocols (F1).
1 health professional.
Light meal: milk yoghurt cookies coffee or tea
BLOOD HARVEST A table to support blood collection; Two chairs; Examination table.
Refrigerated centrifuge.
Tubes for collection of venous blood.
Measurement protocols (F1).
Transport of blood samples to the regional laboratory.
1 health professional.
APLIC. OF THE QUESTIONNAIRE
A second room for the completion of the questionnaire (applied directly and indirectly).
2 tables for interviews; 1 table for a breakfast; 3 chairs.
A computer with internet connection; A printer; A telephone.
Paper or computer.
Registration of participants and non participants (questionnaire) - (F2) e (F3).
1 health professional (or social sciences, or administrative); Functions: Management of the participants list; Attendance schedules; Clarification of doubts about the administration of the questionnaire survey and exceptional cases.
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10 Ethical and legal aspects The collection, storage and use of data and / or biological samples will be made in
respect for the individuals involved maintaining their privacy and confidentiality, and so
responding to ethical and legal questions. Internationally, the collection and use of these materials is regulated by a large number
of different laws, often contradictory. In Portugal, any study involving human subjects
should be conducted in accordance with the Law No. 12/2005 of 26 January. In this
context, the INSEF meets the following key principles: 10.1 Ethics Committee
As early as possible, there will be a Monitoring Committee formally established for the
purpose of approving and regularly monitor the study development. Whenever possible,
the protocols and procedures will be reviewed and approved by this committee to ensure
the safety and protection of individuals. 10.2 Informed Consent
The participants will give their informed consent voluntarily before any inquiry.
Participants will have the right to withdraw from the study at any time, if they wish.
This possibility is formally described in the consent form that people will sign (included
in field manual). 10.3 Protection against the research inherent risks In the measurement protocols measures are provided to minimize the physical and
psychological risks associated with blood collection and ensuring that care is provided
to patients if necessary. All procedures for this project are regulated under the law governing the protection of
personal data. These include the reversible anonymisation of data (provided by a
numerical code known only by the regional team that links data from a regional list of
users to the materials deposited at INSA), secure storage of data and biological products
at INSA and access to these data restricted to a limited number of researchers.
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10.4 Sharing benefits The results obtained will be shared with professionals and decision makers in health and
is a useful reference for informed health policy-making, both in prevention, and a
diagnosis and treatment of diseases perspective. The results of laboratory exams will be returned to participants, through their general
practitioner. 10.5 . Sharing and access to data and biological samples
The use of the biological samples and associated data must be consistent with the
information contained in the declaration of informed consent. The INSA Ethics Committee will properly authorize and make available the data and /
or biological samples for research purposes that can contribute to relevant scientific
discoveries, according to the best scientific knowledge and best practice. The request for access must be based on considerations such as the scientific merit and
potential impact of the proposed research, benefits to public health, ethical
considerations and legal qualifications of the research team. The availability of data and
/ or biological samples can only be made after approval by the Ethics Committee of
INSA.
11 Expected results 11.1 Generated information and knowledge
After the conclusion of the INSEF we will be able to estimate the national and regional
population frequency and distribution of: 1) Chronic cardiovascular, respiratory, endocrine (diabetes), blood (anaemia), pain
(acute and chronic) and mental health problems (depression, anxiety, psychological
distress), among others;
2) Main health determinant factors, including alcohol consumption, consumption and
exposure to tobacco smoke, drug use, physical activity, among others;
3) The medical, pharmacological or behavioural interventions in order to treat or
alleviate the effects of major diseases identified;
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In addition, we will obtain national standards for measures such as body mass index,
blood pressure, total cholesterol, triglycerides, blood glucose, haemoglobin and we will
create a bio bank with biological samples from a representative number of Portuguese. 11.2 Expected impacts
The data obtained from the INSEF will allow having epidemiological information
needed to plan interventions on major health problems (cardiovascular disease, diabetes,
obesity, among others). The data will contribute to monitor the growth of emerging
problems, and adjustment of interventions and health policies.
This set of information will certainly be a useful reference for informed health policy-
making both from prevention and health promotion perspectives, at national and
regional levels. Obtaining data in a systematic and integrated European Survey will be beneficial not
only because of the opportunity to compare data between European countries, but also
because of the knowledge and skills transfer gained through experience accumulated by
the Finish Public Health Institute. 11.3 Expected products
The production of knowledge will be underpinned by the development of a set of
products, temporally planned: 1) National Report of results and a final national database;
2) Regional Report and a regional database that will be available to each ARS,
according to the protocol to establish;
3) As secondary products, stand out thematic reports, technical manuals (procedures -
physical examination, laboratory, questionnaire administration, training materials,
ethic and legal procedures, data management and quality assessment), progress and
final reports, in order to make an assessment when necessary. It should be noted that all end products from the project will state explicitly all entities
involved.
The information generated by INSEF will be available through a series of publications
and articles in scientific and technical journals. For health professionals and researchers,
the data will be facilitated through the Internet or on CD-ROMs.
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Research institutions, care providers and health educators will significantly benefit from
the information generated by INSEF. The main data users will be the INSA partners
who cooperated in the planning and development of the study, as this information is
essential to implement and evaluate the region plans. Regional Health Administrations
and Regional Health Secretariats of the Autonomous Regions will appear as co-authors. Ultimately, this study results will benefit the Portuguese population in very important
ways. The facts about the distribution of health problems and risk factors in the
population give researchers important clues about the diseases causes. In this context,
this resource will tend to become continuous, with the aim of providing health
information about the Portuguese population along time and which will be integrated
with data from other European countries. The results will allow also a comprehensive
assessment of the health state evolution of our population, which will become
fundamental to the development and implementation of a set of guidelines and
initiatives to renew the health policies.
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12 Bibliography AMARAL, O.; Pereira, C.; Escoval. A. (2007), “Prevalência de obesidade em
adolescentes do distrito de Viseu”, Revista Portuguesa de Saúde Pública. 24:1, p. 47-