STUDY PARTICIPANT INFORMATION SHEET STUDY TITLE: A Multicentre Prospective Observational Study on Cardiovascular Risk Factors to build a Standardized Predictive Risk Score for Indian Population INSTRUCTIONS: Please read and understand the information given below. While reading the document and during the course of the study, you are free to ask any study related question. Your question will be answered and required study related clarification will also be provided. A signed Xerox copy of this document will be provided to you. I.Introduction: You are being invited to take part in the research study which is done as a part of identifying risk factors for Cardiovascular Diseases in Indian Population. The details of the study are described below for your understanding. If you have any queries/clarifications feel free to ask me. II.Background: Overview: Cardiovascular diseases account for 30% deaths in India. There is a need to conduct a study project on patient data to determine, & interpret risk factors associated with Cardiovascular Diseases(CVDs) in Indian Population. Goal: The goal of the study is to determine relevant Risk Factors associated with Cardiac Disease, develop CVD risk score prediction model and integrate this in Healthcare Organizations’ Electronic Medical Record. Methodology: The retrospective data analysis arm of the study included 31,599 participants aged between 18 to 91 between year from 2010 to 2017 from Apollo Hospitals. A multi-step risk factors selection process was used to build the prediction model. The model was built with clinical and life style related risk factors including Hypertension, Diabetes, Blood Pressure, BMI, Diet, Physical Activity, Smoking and Tobacco preferences. Inferences: Study was consistent with International Studies on higher significance for risk factors like Diabetes, Hypertension, Diastolic Blood Pressure & Chewing Tobacco on Indian Population. Conclusion: This is the first Electronic Medical Record Integrated Heart Risk related project and risk model on Indian population using retrospective & prospective data which can be helpful in better prevention of Cardiovascular diseases. The tool also integrates a Clinical Decision Support System following the Risk Score generation which would provide appropriate online guideline to the physician to stratify the modifiable risk and take a proper approach for further management. To determine a Standardized Risk Score for Indian Population 2. Who can take part in the study? Any individual Aged between 18-79 years Willing to provide informed consent and comply with study procedure Presenting for Routine Health Check (Asymptomatic) Presenting with Cardiovascular, Respiratory, General Weakness, Abnormal Lab Values or Imaging Tests (Symptomatic) 3. Duration of Your participation You will be followed up for a period of 5 years. 4. Total No. of study participants: The total number of study participants are 6100 5. Possible benefits of taking part in this study: Understand the different Cardiovascular Risk Factors Determine your current and prospective scores (during follow up and / or annual visits) Determine your modifiable risk factors and a guidance how this can be reduced through therapeutic intervention and lifestyle management 6. Possible disadvantage or risks of taking part in this study: Long term – 5 years follow up Annual or repeat visits for Health Check or Outpatient Consultation 7. Study procedure: During the visit for the Health Check Up or Outpatient Consultation, your Investigator (doctor) shall review the following information – Age: Your Age in years. Gender: Your Gender - Male/Female. Systolic Blood Pressure: The blood pressure when the heart is contracting. It is specifically the maximum arterial pressure during contraction of the left ventricle of the heart. Diastolic Blood Pressure: The diastolic pressure is specifically the minimum arterial pressure during relaxation and dilatation of the ventricles of the heart when the ventricles fill with blood. BMI: Body mass Index, calculated based on Height and Weight. (Weight in Kgs)/(Height in Mtr)^2 Diet: To determine, if you eat Vegetarian, Non Vegetarian, Mixed (both vegetarian and non-vegetarian). Alcohol: To determine, if you are currently drinking Alcohol or in past or do not drink. Smoking: To determine, if you are smoking currently or in past or do not smoke. Tobacco: To determine, if you are chewing tobacco currently or in past or do not chew. Physical Activity: To determine, if you are Physically Active in following categories: Mild, Moderate, Active, Not active. FH of Heart Disease: To determine, if your parents or siblings had cardiovascular disease or not. History of Heart Disease: To determine, if you had a heart disease previously or not. Hypertension Medication: To determine, if you are taking medication for hypertension or not. Diabetes : To determine, if you have controlled, uncontrol or no diabetes. Dyslipidaemia: Dyslipidaemia, defined as elevated total or low-density lipoprotein (LDL) cholesterol levels, or low levels of high-density lipoprotein (HDL) cholesterol. Currently capture if a person has dyslipidaemia or not. Heart Rate: Number of Heart Beats per minute. Heart Rhythm: Heart Rhythm if it is Regularly Regular, Regularly Irregular, Irregularly Regular or Irregularly Irregular. Rate of Respiration: Number of Breaths per Minute. Chronic Heart Symptom: If you have recurring Heart Disease related symptom like: Chest Pain, Breathlessness etc. Weight: Your Weight in Kg. Height: Your Height in cm. Psychological Stress - To determine, if you have any of the following - No Stress Negative Thought Patterns and Emotions Depressive Syndromes Anxiety Syndromes Chronic Stress 8. Collection of data: Your data shall be collected in a standardized electronic format 9. Confidentiality of data : Confidentiality The organization and the Investigator shall maintain the confidentiality of data, especially with respect to the information about the patient or any other individual sharing their health information, which would otherwise be known only to the physician or care givers. The data shall be secured & stored in the Electronic and Manual Medical Records. Data Content Your data shall include the demographic & registration details, clinical data – personal & family history, assessment details, treatment and medication details, investigations like lab diagnosis, diagnostic imaging and other invasive procedures. Source of Data The source of your data shall include the previous records, results of the assessment and diagnostic & treatment procedures. The source may be from the organization, yourself, your family & friends (e.g. next of kin) and other external sources like lab, diagnostic or treatment facilities. The data are generated and shared with the organization during the processes of registration, consultation and ongoing treatment at the different locations in the organization. Data sharing for research purposes The organization and the Investigator shall use your data, following anonymization and de – identification of the individual for research purposes for retrospective and prospective studies. Conformation to Laws & Regulation The organization and the Investigator shall conform to the national laws and internal guidelines on collection, security & storage and sharing of the data – Indian Council of Medical Research & Drug Controller General of India guidelines, General Data Protection Regulation 2016 (European Union), World Health Organization and Food and Drug Administration (United States). The Institutional Ethics Committee of respective research sites, where data are used and analysed for research purpose, are accredited by National Accreditation Board for Hospitals and Healthcare Providers (India). Data Sharing with other Organizations Data Sharing with other Organizations - The organization and the Investigator shall not share data with other organizations unless required under law and following appropriate contract to institutions, where the data isn’t stored in facilities or servers outside the country abiding by the national laws. All data are appropriately encrypted meeting necessary specification and shared with anonymity Withdrawal of Consent for Sharing Data You may choose to withdraw your consent to share your data for research purposes which would be respected by the Organization and the Investigator 10. Signing of the consent form and keeping a copy of the Patient Information Sheet: On agreeing to participate in the study, you may sign the consent form with your legally accepted representative. The investigators shall provide a copy of Patient Information in Informed Consent Form to Study Subjects and Versions of the Informed Consent Form 11. What will happen to the results of the research/trial study? The results of the study shall be published and shall be available for public use as Standardized Cardiovascular Risk Score for Indian Population. You will not be identified in any report/publication. 12. Who is organizing the study? Are there any compensation for participation? The study is organized by Microsoft and Apollo Hospitals As this study is an observational, prospective data collection study, there are no allocated compensation. You would have to pay for the visit to the investigator, including your tests and investigations, travel to the hospital or clinic, any further medication or intervention required for your treatment. 13. Who has reviewed the study? The Institutional Ethics Committee has reviewed and approved the study Privacy Policy For the Users / Users under Vendors, Importers and all entities using the Clinical API. DO NOT - Access or use the Clinical AI APIs, Documentation, or associated cloud services except as expressly permitted by the Clinical AI subscription and distribution agreement. 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