Country x National HES manual Contents Aims and purpose of the survey ........................................................................................................................ 1 Organization and management of the national HES ......................................................................................... 1 Timing of the survey .......................................................................................................................................... 1 Target population and sample size.................................................................................................................... 1 Target population .......................................................................................................................................... 1 Sample size .................................................................................................................................................... 1 Sampling procedures ......................................................................................................................................... 1 Sampling frame.............................................................................................................................................. 1 Sampling procedure ...................................................................................................................................... 2 Legal, ethical and data confidentiality issues .................................................................................................... 2 National legislation and regulations .............................................................................................................. 2 Process for ethical approval .......................................................................................................................... 2 Informed consent form ................................................................................................................................. 2 Obtaining informed consent ......................................................................................................................... 2 Recruitment, scheduling appointments and motivating participants............................................................... 2 Quality assurance .............................................................................................................................................. 3 Training programme ...................................................................................................................................... 3 Pilot survey .................................................................................................................................................... 3 Quality control ............................................................................................................................................... 3 Data management ............................................................................................................................................. 3 Selected measurements .................................................................................................................................... 3 Non-participant information ............................................................................................................................. 4 Selected examination site ................................................................................................................................. 4 Questionnaire and its administration and validation ........................................................................................ 4 Questionnaire ................................................................................................................................................ 4 Administration mode..................................................................................................................................... 4 Checking questionnaires and interviewing ................................................................................................... 4 Measurement procedures in the examinations ................................................................................................ 5 Blood pressure ........................................................................................................................................... 5 Height ........................................................................................................................................................ 5 Weight ....................................................................................................................................................... 5 Waist circumference.................................................................................................................................. 5 Additional measurements ......................................................................................................................... 5 Feedback to the participants ..................................................................................................................... 5 Analytic laboratory, blood sample collection and storage of the samples ....................................................... 5 Selection of the analytic laboratory .............................................................................................................. 5 Blood sample collection ................................................................................................................................ 5 Sample logistics ............................................................................................................................................. 6 Long term storage of the samples ................................................................................................................. 6 Fieldwork staff ................................................................................................................................................... 6 Coordination of the fieldwork ....................................................................................................................... 6 Safety issues .................................................................................................................................................. 6 Fieldwork logistics ......................................................................................................................................... 6 Dissemination, publicity and reporting ............................................................................................................. 6 Reporting ....................................................................................................................................................... 6 Budget and funding ........................................................................................................................................... 7 Risk assessment ................................................................................................................................................. 7 Evaluation .......................................................................................................................................................... 7 3 Aims and purpose of the survey Describe here the specific aims of the survey in your country. List the key public health issues to be described, evaluated and monitored using the data from this survey. Organization and management of the national HES See EHES guidelines in the EHES Manual, Part A, Chapter 1. Describe here who has commissioned the survey and who will conduct the survey. Describe here the organization and management structure of the survey. Timing of the survey See EHES guidelines in the EHES Manual, Part A, Chapter 6. Specify here the year and months when the survey is expected to be carried out. Estimate also the length of the fieldwork period. If your country has previous national HESs, specify also their periods and describe how the previous survey(s) and other national surveys affect the timing of this survey. Provide also information on which days of the week and which times of the day the survey is planned to be conducted. Target population and sample size See EHES guidelines in the EHES Manual, Part A, Chapter 2. Target population Provide here a detailed description of the target population. Define here also if institutionalized persons can be included to the target population and specify what kind of institutes can be included and which cannot. Specify also any other population groups that would be excluded from the survey. Sample size Provide here the sample size or the survey and how it was determined. Sampling procedures See EHES guidelines in the EHES Manual, Part A, Chapter 3. Sampling frame Specify here the sampling frame(s) to be used in different stages of sampling. Provide further information about the sampling frames (when last updated, how is it updated, frequency of updating, what information relevant to the survey can be obtained from the sampling frame). 1 Sampling procedure Describe here in detail how the sampling goes. How many stages are used, what are the Primary Sampling Units (PSU), what are the Secondary Sampling Units (SSU), what stratification is used and what is the sample size in each stage, etc. Legal, ethical and data confidentiality issues See EHES guidelines in the EHES Manual, Part A, Chapter 4. National legislation and regulations Specify here the national legislation and regulations (ethical, medical research and data protection) which have an effect on conducting the HES. Describe also the implications of these laws and regulations on the survey. Process for ethical approval Describe here which authority provides the ethical approval for the national survey. Describe the process of obtaining the ethical approval and the documents needed for that. Provide also an estimate of the time how long it takes to prepare the needed material and obtain the approval. Informed consent form If your country will start the HES soon, provide the informed consent form with all the supporting documents (information leaflet, etc.) approved by ethics committee. If you will start the HES later, provide a draft informed consent form with supporting documents. Take the national legislation is taken into account in drafting these. Obtaining informed consent See EHES guideline in the EHES Manual, Part B, Chapter 3. Describe here how the informed consent is obtained from the participants. Recruitment, scheduling appointments and motivating participants See EHES guidelines in the EHES Manual, Part A, Chapter 1 for recruitment process,s and material and Part B, Chapter 2 for scheduling appointments and motivating participants. Describe here the recruitment process: o How selected persons are contacted? o What kind of recruitment material is used? o How many contact attempts are made before deciding that the person is a non-participant or not possible to contact. Describe here how the appointment scheduling for interviews and examinations are done. Describe what methods are used to increase the overall interest of participation. Describe here what kinds of methods are used to motivate reluctant persons to get them to participate. 2 Quality assurance See EHES guidelines in the EHES Manual, Part A, Chapter 11 for components of the quality assurance and Part B, Chapter 7 for fieldwork specific quality control measures. Training programme See EHES guidelines in the EHES Manual, Part A, Chapter 15. Describe here the plans for the national training programme. o Which personnel groups need training and what kind of? o Who are the trainers and what are their qualification, professions and how many there are? o How long the training will take, what issues are covered during the training and which are the training methods? o When the training is planned to be organized in relation to the fieldwork? If you have already organized the training or will do so in near future, provide training materials used. If you don’t have your HES in near future, list to potential training materials which should be prepared . Pilot survey Describe here when the pilot survey will be conducted in relation to the full-size HES, where the pilot will be conducted and how. Quality control Describe the internal quality control measures and external quality assessment planned for the survey. Also measurement specific quality control procedures should be included. Data management See EHES guidelines in the EHES Manual, Part A, Chapter 12 for the data management structures and Part B, Chapter 6 for issues on data management during the fieldwork. Describe here what kind of data management system is planned for the survey and how the data security is ensured. Describe also the data back-up procedures. Describe here how the subject identification is defined for the survey and how data confidentiality is ensured. Describe here how the data are transferred from the field to the central office and to the database. Are the data entered directly to a computer or first recorded on paper forms and entered to a computer later? What kind of program is used for data entry? Selected measurements See EHES guidelines in the EHES Manual, Part A, Chapter 5. 3 List here the selected measurements and questionnaire items for the survey and provide a rational behind their selection. Non-participant information See EHES guidelines in the EHES Manual, Part A, Chapter 13. Describe here what kind of information can and will be collected from the non-participants. From which data sources non-participant information will be collected. If you use a specific questionnaire to collect information from the non-participants, attach the questionnaire to this manual. Selected examination site See EHES guidelines in the EHES Manual, Part A, Chapter 7. Describe here the type(s) of examination site(s) planned for the survey and the rationale behind their selection. If there were any national legislation or cultural norms affecting on decision, describe these as well. Questionnaire and its administration and validation Questionnaire See EHES guidelines in the EHES Manual, Part B, Chapter 5. Provide here selected questionnaire and rationale behind the questions. Where the selected questions and their translations validated? Where any of the selected questions part of some international or national set of questions? If the national HES is conducted soon, provide as an attachment a copy of the questionnaire. If the national HES is not conducted soon, provide topic which most likely would be included to the questionnaire. Administration mode See EHES guidelines in the EHES Manual, Part A, Chapter 8. Describe here which questionnaire administration modes are planned to be used in the survey and why they were chosen. Describe also in which languages used questionnaire(s) are available/will be made available. How long is the questionnaire and how long does it take to complete it? Describe here the procedures used to pre-test the questionnaire. Checking questionnaires and interviewing See EHES guidelines in the EHES Manual, Part B, Chapter 4. 4 Describe here how the completed questionnaires are checked on the field. If some of the questionnaires are filled-in during the interview, describe also the instructions provided for the interviewers. Measurement procedures in the examinations See EHES guidelines in the EHES Manual, Part B, Chapter 5. Blood pressure Describe equipment planned to be used for the blood pressure measurement. Describe the detailed measurement protocol. Height Describe equipment planned to be used for the height measurement. Describe the detailed measurement protocol. Weight Describe equipment planned to be used for the weight measurement. Describe the detailed measurement protocol. Waist circumference Describe equipment planned to be used for the waist circumference measurement. Describe the detailed measurement protocol. Additional measurements List the additional measurements which are planned to be included to the HES. For each additional measurement, describe equipment planned to be used for the measurement. For each additional measurement, describe in detail the measurement protocol. Feedback to the participants Describe the feedback that is planned to be provided to the participants on the results of the measurements before they leave the examination site. Describe also the feedback they get later. Also describe how and by whom the feedback is provided. Analytic laboratory, blood sample collection and storage of the samples See EHES guidelines in the EHES Manual, Part A, Chapter 10 and Part B, Chapter 5.5. Selection of the analytic laboratory Describe here which laboratory will analyse the blood samples. Provide justification why this specific laboratory was chosen. Is the laboratory accredited and if yes, specify the accreditation authority. Blood sample collection Describe equipment planned to be used for blood sample collection. Describe the detailed blood sample collection protocol. 5 Describe the sample handling protocol. Sample logistics Describe here how the samples are planned to be stored on the field. Describe the transfer of the sampled from the examination site to the laboratory for analysis. Long term storage of the samples Describe here the plans for the long term storage of the collected samples. What samples will be stored for future use, how and where? Fieldwork staff See EHES guidelines in the EHES Manual, Part A, Chapter 9 and Part B, Chapter 1. Describe here the possible legal requirements and cultural norms which may affect the selection of the survey staff in your country. Describe the composition of the fieldwork team and the number of teams needed for the survey. Coordination of the fieldwork See EHES guidelines in the EHES Manual, Part B, Chapter 1. Describe here the division of tasks between team members. Describe how the fieldwork is supervised. Describe how the communication within team and to the central coordinating office is organized. Safety issues See EHES guidelines in the EHES Manual, Part B, Chapter 1. Describe here how the safety of the fieldwork team members is ensured. What safety training and instructions are provided? Fieldwork logistics See EHES guidelines in the EHES Manual, Part B, Chapter 1. Describe here how the fieldwork teams, equipment and materials are moved from an examination site to another. Dissemination, publicity and reporting See EHES guidelines in the EHES Manual, Part A, Chapter 14. Provide here the national dissemination and publicity plans for the survey. Reporting Describe here the national reports. 6 Budget and funding See EHES guidelines in the EHES Manual, Part A, Chapter 16. Calculate the survey budget for full-size HES (including also costs of the planning and preparation, and a fieldwork pilot, as well as the basic reporting). What are the potential sources of funding for the national HES? Risk assessment See EHES guidelines in the EHES Manual, Part A, Chapter 1. Prepare a risk assessment for the survey. What are the expected risks, their implications and how these could be solved? Evaluation See EHES guidelines in the EHES Manual, Part A, Chapter 1. Prepare a plan how the survey would be evaluated at the end. List indicators for the evaluation of the survey? 7