Participant-level information | |||
Elements | Importance | Definition | |
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 | 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 min and elevates heart rate to 35%–60% of maximum heart rate (eg, housework, gardening, slow walking); moderate exercise is 20–60 min and elevates heart rate to 35%–60% of maximum heart rate (eg, basketball, single tennis, brisk walking); strenuous exercise elevates heart rate to over 60% of maximum heart rate (eg, 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). | ||
Anthropometrics | 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 three measurements. |
Average weight | E | The measurement of mass or quantity of heaviness of an individual (in kg). Averaged over three 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 (ie, 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 mm Hg). |
Average diastolic blood pressure | The average pressure exerted into the systemic arterial circulation during cardiac ventricular relaxation and filling (in mm Hg). | ||
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. | ||
Urine and Serum Test Index | Urinary albumin | E | 24 hours measurement of urine concentration of albumin (in mg/L). |
Urinary creatinine | E | 24 hours measurement of urine concentration of creatinine (in mmol/L). | |
Urinary total protein | E | 24 hours measurement of urine concentration of total protein (in mg/L). | |
Serum albumin | O | A quantitative spot-measurement of the amount of albumin present in a sample of serum (in µmol/L). | |
Serum creatinine | O | A quantitative spot-measurement of the amount of creatinine present in a sample of serum (in µmol/L). | |
Serum urea | O | A quantitative spot-measurement of the amount of creatinine present in a sample of serum. (in µmol/L). | |
Estimated glomerular filtration rate | E | Measurement of the flow rate of filtered fluid through the kidney, calculated using the chronic kidney disease (CKD)-Epidemiology Collaboration (CKD-EPI) equation. | |
Kidney disease history | Personal history of kidney failure | ||
Has a doctor or healthcare worker ever told you that you had kidney failure? | E | Participant’s history of impaired kidney function, including kidney impairment, early-stage and advanced-stage kidney disease. | |
How old were you when you were first told by a medical person that you had kidney failure? | |||
If Yes, are one or both working well now? | |||
Are you currently on renal dialysis? | |||
Have you ever had a kidney transplant? | |||
Family history of kidney failure | |||
Has anyone in your family either had kidney disease or died from it? | E | Participant’s background regarding impaired kidney function of blood relatives (persons related by descent). | |
Do you know what type of kidney disease? | |||
If Yes, please specify:’ | |||
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. | |
Kidney disease-related information | Hospital | E | The name and address of the institution that provides medical, surgical or psychiatric care and treatment for the sick or the injured |
Clinical diagnosis | E | The diagnosis made from the study of the signs and symptoms of a disease. | |
Date of diagnosis | E | The calendar date on which a clinical diagnosis is made. | |
Instrumentation | E | Specialised objects, or items of electrical or electronic equipment, employed to perform diagnosis (with versions). | |
Clinical signs and symptoms | E | The objective evidence of disease perceptible to the examining healthcare worker (sign) and subjective evidence of disease perceived by the patient (symptom). | |
Congenital conditions | O | The objective evidence of perceptible by the examining healthcare worker of defects that are present at birth. | |
Histopathology | O | The visual examination of cells or tissue (or images of them) with an assessment regarding the quality of the cells or tissue. | |
Comorbidities (systemic) | E | The presence of co-existing or additional systemic diseases with reference to an initial diagnosis or with reference to the index condition that is the subject of study. | |
Comorbidities (pathogenic) | 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. | ||
Therapy | Therapy | E | Therapeutic intervention for kidney disease, excluding, drug therapy, diet therapy, radiotherapy and surgery. |
30-day frequency | The number of occurrences of kidney therapy per unit time (30 days). | ||
Start date | The calendar date on which treatment was initiated. | ||
End date | The calendar date on which treatment is to be or was terminated. | ||
End 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). |
E, essential; O, optional.