Figure 1
Survey response to proposed participant-level information.
Figure 2
Survey response to proposed study- and experiment-level information.
Table 1
The Minimum Information Required Guideline: Stroke Research and Clinical Data Reporting.
| Elements | Importance | Definition | ||
|---|---|---|---|---|
| Participant-level information | ||||
| Demographics | Date of Birth | E | The calendar date on which a participant was born. | |
| Sex | E | The classification of the participant’s sex. | ||
| Self-reported Race/Ethnicity | E | Membership to social group based on a common heritage. | ||
| Country of Birth (COB) | E | The country that the participant was born in. | ||
| Country of Residence | O | The country that the participant resides in. | ||
| Native Language(s) | E | The primary systematic means of communication used in the participant’s household. | ||
| Tribal Affiliation | O | The tribe which the participant is affiliated to. | ||
| Father’s Country of Birth | O | The country in which the participant’s biological father was born. | ||
| Mother’s Country of Birth | O | The country in which the participant’s biological mother was born. | ||
| Lifestyle Factors | History of Hypertension | Has a healthcare worker ever said that you have high blood pressure or hypertension? | E | Participant’s background regarding high blood pressure or hypertension. |
| If yes, then at what age were you first told this? | ||||
| FOR WOMEN ONLY: Was this during pregnancy? | ||||
| Have you ever taken medication for hypertension/high blood pressure? | ||||
| If yes, then at what age did you begin taking medicine for this? | ||||
| Physical Activity | 7-Day Frequency | E | The number of occurrences of physical activity per unit time (7 days). | |
| Time | The average time spent per physical activity (in min). | |||
| Intensity | The average energy expended per physical activity. Light exercise is 20–60 minutes and elevates heart rate to 35–60% of maximum heart rate (e.g. housework, gardening, slow walking); moderate exercise is 20–60 minutes and elevates heart rate to 35–60% of maximum heart rate (e.g. basketball, single tennis, brisk walking); strenuous exercise elevates heart rate to over 60% of maximum heart rate (e.g. jogging, swimming, bicycling). | |||
| Alcohol Use | Lifetime Use | E | A description of an individual’s current and past experience with alcoholic beverage consumption. | |
| Age of Initiation | The age of initiation of alcoholic beverage consumption. | |||
| 30-Day Frequency | The number of occurrences of alcoholic beverage consumption per unit time (past 30 days). | |||
| 30-Day Quantity | A record of the quantity of alcohol consumption (in standard drinks) (past 30 days). | |||
| Tobacco Use | Lifetime Use | E | Record of whether the participant has ever used any tobacco product during his or her entire life. | |
| Lifetime Frequency | ||||
| Age of Initiation | The age of initiation of tobacco use. | |||
| Recreational Drug Use | Lifetime Use | E | Record of whether the participant has ever used a drug during his or her entire life. | |
| Age of Initiation | The age of initiation of drug use. | |||
| 30-Day Type | A record of the participant’s type of drug use within the past 30 days. | |||
| 30-Day Frequency | The number of occurrences of drug use per unit time (past 30 days). | |||
| Diet | E | The customary allowance of food and drink taken by a person from day to day. | ||
| Anthropo-metrics | Average Height | E | The vertical measurement of distance from the sole to the crown of the head with body standing on a flat surface and fully extended (in cm). Averaged over 3 measurements. | |
| Average Weight | E | The measurement of mass or quantity of heaviness of an individual (in kg). Averaged over 3 measurements. | ||
| Waist Circumference | O | The abdominal circumference at the navel (in cm). | ||
| Head Circumference | O | A circumferential measurement of the head at the widest point (in cm). | ||
| Body Surface Area | O | A measure of the 2-dimensional extent of the body surface (i.e. the skin) (in m2). | ||
| Prosthesis (if applicable) | E | Location of a device which is an artificial substitute for a missing body part or function. | ||
| Blood Pressure | Average Systolic Blood Pressure | E | The average pressure exerted into the systemic arterial circulation during the contraction of the left ventricle of the heart. (in mmHg). | |
| Average Diastolic Blood Pressure | The average pressure exerted into the systemic arterial circulation during cardiac ventricular relaxation and filling (in mmHg). | |||
| Adverse Drug Reactions | Medication | O | The drug product which caused a detrimental or unintended response associated with the use of a medication. | |
| Type | The type of detrimental or unintended response associated with the use of a medication. | |||
| Date | The calendar date on which the ADR occurred. | |||
| Dyslipidaemia | High-Density Lipoprotein (HDL) Low-Density Lipoprotein (LDL) | E | A lipoprotein metabolism disorder characterized by decreased levels of high-density lipoproteins, or elevated levels of plasma cholesterol, low-density lipoproteins and/or triglycerides. | |
| Triglycerides | ||||
| Stroke History | History of Stroke | Were you ever told by a doctor or healthcare worker that you had a stroke, TIA, mini-stroke, transient-ischemic attack? | E | A question to determine if the respondent has had a stroke and/or any symptoms related to this event. |
| Have you ever had a sudden painless weakness or numbness on one side of the body, suddenly lost one half of your vision, lost the ability to understand what people are saying or lost the ability to express yourself verbally or in writing? | ||||
| Family History of Stroke | Has anyone in your family had a stroke? | E | A record of a patient’s background regarding stroke and stroke-related events of blood relatives. | |
| Primary Prevention | E | Primary prevention involves prevention of disease in susceptible individuals or populations through promotion of health and specific protection as distinguished from the prevention of complications or after-effects of existing disease. | ||
| Secondary Prevention | E | Secondary prevention involves procedures or treatment processes designed to prevent further complications. | ||
| Consanguinity | Any cases of consanguineous mating in the family? | O | Reproduction between genetically related individuals. | |
| ‘If Yes, please specify:’ | ||||
| Sample-specific Information | Sample Identifier | E | Name or other identifier of an entry from a biosample database. | |
| Sample’s Case or Control Status | O | An indication of a subject’s status as a case or a control for a given study. | ||
| Consent | E | The planned process that an individual agrees to participate in. | ||
| Stroke-related Information | Differential Diagnosis | E | Differential diagnosis refers to the process of differentiating one diagnosis from another, and in turn, providing the most fitting diagnosis based on an individual’s presentation. | |
| Date of Diagnosis | O | The calendar date of confirmatory diagnostic testing. | ||
| Stroke Scale | O | Classification systems employed for clinical and research purposes which to improve diagnostic accuracy, determine the suitability of specific treatments, monitor change in neurologic impairments, and predict and measure outcomes. | ||
| Instrumentation | O | The specialized objects, or items of electrical or electronic equipment, employed to perform diagnosis (with versions). | ||
| Clinical Signs | E | The objective evidence of disease perceptible to the examining healthcare worker. | ||
| Stroke Outcome | E | The result of an action (stroke). | ||
| Stroke Impact | E | Disabilities and impairments due to a stroke. | ||
| Histopathology | E | The visual examination of cells or tissue (or images of them) with an assessment regarding the quality of the cells or tissue. | ||
| Pre-Stroke Co-morbidities (Systemic) | E | The presence of co-existing or additional medical conditions pre-stroke. | ||
| Post-Stroke Co-morbidities (Systemic) | E | The presence of co-existing or additional medical conditions post-stroke. | ||
| Pathogenic Co-morbidities | E | The presence of co-existing or additional pathogenic diseases with reference to an initial diagnosis or with reference to the index condition that is the subject of study. | ||
| Allergies | O | An immune response or reaction to substances that are usually not harmful. | ||
| Prescribed Medication | Medication | E | A record of the prescribed drug product currently in use. | |
| Dosage | The size or frequency of a dose of a medicine or drug. | |||
| Strength | The amount of the medicine or drug that provides its particular effect. | |||
| Reason | The cause of the prescription. | |||
| Start Date | The calendar date on which treatment was initiated. | |||
| Stop Date | The calendar date on which treatment is to be or was terminated. | |||
| Non-Prescribed Medication | Medication | E | A record of the non-prescribed drug product use in the past 2 weeks. | |
| Dosage | The size or frequency of a dose of a medicine or drug. | |||
| Reason | The cause of the prescription. | |||
| Start Date | The calendar date on which treatment was initiated. | |||
| Stop Date | The calendar date on which treatment is to be or was terminated. | |||
| Study-level information | ||||
| Study-specific information | Research Institute | E | The name of the organisation affiliated with a specific study. | |
| Study Duration | O | The duration of any specifically defined piece of work that is undertaken or attempted to meet requirements (in years). | ||
| Study Start Date | O | The calendar date on which the project is initiated. | ||
| Study ID | E | The unique identifier of the project. | ||
| Disease | E | Clinical entity defined by a set of phenotypic abnormalities resulting from a common physiopathological mechanism with a homogeneous evolution and homogeneous therapeutic possibilities. | ||
| Clinical Subtype | O | The subdivision of a disease, malformation syndrome, morphological anomaly, biological anomaly, clinical syndrome or particular clinical situation in a disease or a syndrome further defined by its particular clinical presentation. | ||
| Study Design | E | The nature of the investigation or the investigational use for which clinical study is being done. | ||
| Study Aim | E | A textual entity describing the study aim. | ||
| Sample Size | E | The subset number of a larger population, selected for investigation to draw conclusions or make estimates about the larger population. | ||
| PMID | O | PubMed unique identifier of an article. | ||
| DOI | O | Digital Object Identifier (DOI) of a published article. | ||
| Experiment-level information | ||||
| General | Biospecimen Type | E | The type of a material sample taken from a biological entity for research purposes. | |
| Sample Management Protocol | E | The specifications employed for the management of samples. | ||
| Quality Control Protocol | E | The specifications employed to ensure a certain level of quality of biospecimens. | ||
| Experimental Aim | E | A textual entity describing the experimental aim. | ||
| Experimental Protocol | E | The specifications with respect to the design and implementation of an experiment or set of experiments. | ||
| Instrumentation | E | Specialised equipment, tools, appliances, and(or) apparatus employed in the experiment(s). | ||
| Data Analysis | E | The data transformation techniques used to analyse and interpret the data to gain a better understanding of it. | ||
| Experimental Result | E | The outcome of the experiment or set of experiments. | ||
| Output Location | O | Full name and location of output (raw or analysed data). | ||
[i] Footnote: E – Essential; O – Optional.