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Baseline Clinical Characteristics
This form captures information about baseline signs and symptoms surrounding the patient’s kidney disease.
Unless a study protocol explicitly specifies this timeframe, the baseline timeframe for data in this form is 90 days before and up to 7 days after the index diagnosis date.
For example, if a patient was diagnosed on April 1, 2023, only enter information about the patient’s signs and symptoms from January 1, 2023, through April 8, 2023.
For each sign or symptom, first select the level of documentation found in the patient’s chart. There are three options: documented as present, documented as not present, or not documented.
Documented as Present = If you find mention of the sign or symptom BEING present, select the first option.
Documented as Not Present = Select the second option iIf you find mention of the sign or symptom NOT being present.
Not Documented = If you DO NOT SEE ANY MENTION do not see any mention of the sign or symptom in the patient’s chart.
The date field will be disabled until you select the first option, indicating that positive documentation of the sign or symptom was seen.
Enter only the date of the most recent finding of each sign or symptom.
For example: If a patient experienced a headache due to hypertension both 30 days before the index diagnosis and three days before the index diagnosis, select the date that corresponds to 3 days before the index diagnosis
In the setting of repeated findings, the finding closest to the index diagnosis date should be selected as the baseline finding.
Leave the date field blank if a sign or symptom is not seen.
Guidelines:
If an exact date is not available, but it is known that the finding was present at the time of the diagnosis (e.g., hematuria), then select the date of the diagnosis.
If an exact year is not available, an approximation is acceptable. If any approximations are used, please make a note in the comments section at the end of this form.
If the options provided do not capture some important information about the patient’s baseline clinical characteristics, please use the table at the bottom of the form by adding a new row for each other sign or symptom.
If the date of any baseline signs and symptoms is unavailable, use July 1 with the approximate year of diagnosis. If an exact year is not available, an approximation is acceptable. If any approximations are used, please make a note in the comments section.
Once the date is entered, please click on the calculator to calculate the age at the time of the INDEX diagnosis date.