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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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Index

SUMMARY ............................................................................................................................................ 4

1 INTEREST AND RELEVANCE OF THE HEALTH EXAMINATION SURVEY (INSEF) ...... 5

2 PURPOSE AND AIMS OF THE HEALTH EXAMINATION SURVEY (INSEF) ..................... 6

2.1 PURPOSE ........................................................................................................................................ 6 2.2 GENERAL AIM ................................................................................................................................ 7 2.3 SPECIFIC OBJECTIVES................................................................................................................... 7

3 ACTION STRATEGIES................................................................................................................ 7

4 INVOLVED PARTNERS .............................................................................................................. 7

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

11 EXPECTED RESULTS ............................................................................................................... 24

11.1 GENERATED INFORMATION AND KNOWLEDGE...................................................................... 24 11.2 EXPECTED IMPACTS ............................................................................................................... 25 11.3 EXPECTED PRODUCTS............................................................................................................. 25

12 BIBLIOGRAPHY ........................................................................................................................ 27

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Acronyms and abbreviations list

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

(Cooper et. Al., 2009), hypertension (Tang Macedo et. al., 2007) and juvenile obesity

(Amaral et. al. 2007). Although important from the scientific and public health

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perspectives, many of these studies are specific to a certain type of disease, and others

lack national representativeness. The INSEF is a unique opportunity to obtain a characterization of the Portuguese

population at haematological, biochemical and genetic level, which allows multiple

research studies, especially studies of the prevalence of genetic variants of diseases

relevant from the public health perspective, such as familial hypercholesterolemia, and

studies on the interactions between genes and environment, among others. In order to

address the need for international standardization, the project FEHES – “Feasibility of a

European Health Examination Survey”; and the project “Preparing an European Health

Examination Survey” (PREHES), in which the INSA participated between 2006 - 2008,

through its Department of Epidemiology (formerly the National Observatory of Health),

both funded by the European Union and coordinated by the Finnish Public Health

Institute (THL, ex KTL). The INSEF will be developed taking into account the standardization of planning

methods and data collection and analysis necessary to the simultaneous realization of

the national component of EHES (European Inquiry with physical Examination),

making the regional and national results comparable with those of other European

countries and ensuring the quality of final products. When applied in a national and regional representative sample, INSEF thus appears as a

contribution to meet international, national and regional information needs, ensuring a

higher quality of health information created, concerning internal and external validity

and international comparability. 2 Purpose and aims of the Health Examination Survey

(INSEF) 2.1 Purpose

The main purpose of INSEF - National component of the European Survey with

physical Examination (EHES) is to build scientific knowledge about the health of the

resident Population in Portugal, providing information that supports the activities of

planning and evaluation in health and, thus, to harness the adequacy of the national

politics to the necessities of well-being and health of the population.

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2.2 General aim The general aim of INSEF is to elaborate a health diagnosis of the residing population

in Portugal, through an epidemiological description of indicators about health status,

health determinants and use of health care, using methods of health inquiry with a

component of physical examination and collection of biological materials. The

importance of this survey is to analyse how social and health determinants (tobacco and

alcohol consumption, eating habits, physical activity and various aspects of lifestyle)

and genetic factors interact to influence risk of chronic diseases in the Portuguese

population. 2.3 Specific Objectives

1) To characterize the health state of the population residing in Portugal, its

determinants and use of health care, including preventive care;

2) To characterize this population at anthropometric, haematological, biochemical and

genetic level;

3) To establish levels of reference for the main haematological and biochemical

parameters in the Portuguese population;

4) To establish a bio bank with national representation that will allow carrying out

future studies,. 3 Action strategies

1) Involvement of the Regional Health Administrations in the preparation, planning,

implementation, analysis and dissemination of INSEF;

2) Setting up the necessary national infrastructure for field work, which will be

responsible for planning, preparation and implementation of INSEF and that will

serve as well the national component of the European Survey on physical

examination (EHES), in collaboration with the 5 Regional Health Administration of

the Continent and the two Regional Secretariats from Azores and Madeira.

4 Involved partners 4.1 Finish National Institute of Health and Welfare (THL)

The THL supports all phases of the study INSEF - National Component Survey of

European Physical Examination (EHES) and has the following interventions:

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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

Effect size (difference).

Alpha Prevalence Difference Sample size 0,05 0,5 0,01 9604 0,05 0,5 0,02 2401 0,05 0,5 0,03 1067 0,05 0,5 0,04 600 0,05 0,5 0,05 384 0,05 0,5 0,046 450 0,05 0,5 0,018 3000 0,05 0,5 0,017 3150

Table 2 – Scenarios for the sample size by ACES in Algarve ARS

Sample calculation ACES Alpha Prevalence Difference Sample size Barlavento Central Sotavento 0,05 0,5 0,01 9604 3454 4969 1181

0,05 0,5 0,02 2401 864 1242 295

0,05 0,5 0,03 1067 384 552 131 0,05 0,5 0,040 600 216 311 74 0,05 0,5 0,044 496 178 257 61 0,05 0,5 0,046 450 162 233 55 0,05 0,5 0,050 384 138 199 47

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,

myocardial infarction, stroke, rheumatic disease, depression, chronic anxiety, diabetes,

osteoporosis and chronic pain.

Family history: the aim is to identify, from the ascendants of the inquired to their

children and the brothers the presence of the previously considered chronic diseases.

For Mental Health will use the Mental Health Index (MHI-5) - psychological

distress, already used in the 4th INS.

Functional evaluation will have the aim to know the incapacity degree in daily life

activities (personal and instrumental activities). Personal activities include food,

personal hygiene, mobility, medication, among others, while the instrumental refer to

domestic tasks, monitoring the queries / administrative affairs, among others.

Use of medication seeks to know the medication taken in the last two weeks, and for

what kind of disease. Medication consumption distinguishes those prescribed by a

doctor from those resulting from self-medication, which can be drugs, supplements

and / or vitamins.

Women's Health aims to know the date of first menstruation, the use of oral

contraceptives and the use of hormone replacement therapy.

Health determinatives

Tobacco consumption: refers to daily smoking, average number of smoked cigarettes

per day, number of years of consumption and exposure to tobacco smoke indoors

(home, cafes, restaurants, nightclubs, workplaces, etc.).

Consumption of alcohol: Alcoholic habits in the past 12 months (beer, wine,

liqueurs, spirits and other), number of consums/12 months, daily consumption of

these drinks in the last 7 days prior to the interview and 6 or more drinks on an

occasion/12 months.

Food habits: food frequency of meat, fish, vegetables, carbohydrates, dairy products,

fruits, pastries, snacks, sauces, salt, and consumption of stimulants (tea and coffee).

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Physical activity in individuals not confined to bed or chair, physical activity (work,

leisure) and regular physical activity. For Physical activity will use the IPAQ,

already used in 4 INS.

UV exposure: time spent in the sun between 11 am and 4 pm, sunscreen use, tanning

equipment use.

Social support: number of people who are part of the social network and the

available support elements (family, friends, etc.) in case of illness, sadness /

depression, help with housework, administrative and others.

Health care

Use of services: number of hospitalizations in the past 12 months, number of

hospitalization days (night stays and ambulatory), reasons for non-hospitalization,

regularity and number of consultations / family doctors, reasons for consultation /

general practitioner; time waiting for consultation / family doctor, local consultation,

evaluation of the quality of consultation / family doctors; regularity and number of

consultations / specialist, reasons for consulting / specialist; reasons for non-use of

consultation / specialist.

The use of services also includes, in the past 12 months, the use of laboratory / medical

exams, rehabilitation services, nutritionist, psychology and alternative medicine

(osteopathy, chiropractic, acupuncture, etc.), as well as other services within social

services (home care with nursing care, meals, housekeeping, transportation, etc.). It also

identifies the frequency of consulting a dentist or dental hygienist, the reason for

consultation and the required treatment. Finally, the biological parameters under study are the following:

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Table 4 - Physical, biochemical and genetic parameters

Anthropometric parameters Weight Height Blood Pressure

Haematological and biochemical parameters:

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-

58. CARMO, I.; Santos, O.; Camolas, J.; Vieira, J.; Carreira, M.; Medina, L.; Reis, L.;

Galvão -Teles, A. (2006), “Prevalence of obesity in Portugal”, Obesity Reviews. 7: 3, p.

233-237. ESPIGA de MACEDO M, Lima M, Silva, A. et al. (2007), “Estudo da prevalência,

tratamento e controlo da Hipertensão em Portugal”, Estuto PAP. Revista Portuguesa de

Cardiologia; 26: p. 21-39 INSTITUTO NACIONAL DE SAÚDE, Dr Ricardo Jorge, (2009) “O que pensam os

Portugueses sobre investigação genética e o estabelecimento de um biobanco em

Portugal?”, Observações, nº42, Março, INS. KTL (2008), “Recommendations for the Health Examination Surveys in Europe”,

Helsinki, FEHES. MINISTÉRIO DA SAÚDE (2004), “Plano Nacional de Saúde”, volume I –

Prioridades, Lisboa, Direcção Geral da Saúde MINISTÉRIO DA SAÚDE (2004), “Plano Nacional de Saúde”, volume II –

Orientações Estratégicas, Lisboa, Direcção Geral da Saúde SOCIEDADE PORTUGUESA DE DIABETOLOGIA, Correia, L. G. (coord), (2009),

“Estudo de prevalência da diabetes em Portugal” disponível in http://www.min-

saude.pt/portal/conteudos/a+saude+em+portugal/noticias/arquivo/2009/3/diabetes.htm