INSTRUCTIONS FOR VITAL SIGNS SCREENING FORM
VSS, VERSION A (QXQ)
I. GENERAL INSTRUCTIONS
The Vital Signs Screening form is a form that collects weight, height, blood pressure, heart rate and
waist circumference at the screening visit. BMI (Body Mass Index) is computed by the data
management system to determine eligibility for the study. The Vital Signs Screening form must be
filled out by trained personnel, in most cases the Study Coordinator, at the Screening Visit. This
person should be familiar with and understand the document titled "General Instructions For
Completing Paper Forms” prior to completing this form.
Header Information: The header information consists of key fields which uniquely identify each
recorded instance of a form.
PATIENT ID NUMBER: Affix the pre-printed label to the form. This is a unique 8-character code
assigned at the DCC for each study patient. Labels are provided.
FORM CODE: This is a three-letter mnemonic code for the form, which is pre-assigned as “VSS”.
VERSION: This is a one-letter version assigned to the form, which is pre-assigned as “A”.
VISIT: Visit is pre-assigned as the screening visit (01).
SEQ #: Sequence number is pre-assigned as 001 (the first and only instance of this form at visit
01).
PATIENT INITIALS: Enter the first, middle, and last initial of the patient. For those with no middle
name, use a ‘⎯‘ (dash). For example:
A ⎯ Z
VISIT DATE: Enter the date on which the data was collected. Code in numbers using leading
zeroes where necessary to fill all boxes. For example, September 6, 2008, would be entered as:
0 9 / 0 6 / 2 0 0 8
M M
D
D
Y
Y Y Y
Please Note for RE-SCREENING VISITS: If this is a re-screening visit, please refer to Section 6.5
of the Study Reference Manual for more instruction on how to update paper forms for rescreening visits. Updated information is keyed into the DMS on the existing Visit
01/Sequence 001 record.
COATS Vital Signs Screening Form Version A (VSSA) QxQ, 07/01/08
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II. DETAILED INSTRUCTIONS FOR EACH ITEM
A. WEIGHT
Item 1. Have the patient remove shoes and overgarments, and empty their pockets. Have the
patient stand on the scale and look straight ahead. Wait 5 seconds for the scale to come
to rest before taking the measurement. Weight is measured in pounds, round up or down
to the nearest whole pound. For example, 157.2 rounded down to 157, 157.8 is rounded
up to 158, and 157.5 is rounded up to 158. Record weight (in pounds) on the form...
B. HEIGHT
Item 2a. Standing Height. Height is measured twice using a stadiometer.
To assemble the stadiometer:
•
•
•
Remove stadiometer parts from box.
Place the large, gray base (with feet imprints facing up) on the floor.
Assemble the stadiometer shaft by connecting the four rectangular shaft parts. Each
part has shapes on either end. You connect one part with the next by “matching up
the shapes” from the top end of one part with the bottom end of the next part, and so
on. Insert the first rectangular part into the back of the stadiometer base with the
arrow facing down towards the base. Then, match up the shapes and insert the next
part. Continue this process until all four parts are assembled into the shaft. Note:
shapes are different on either side of the shaft parts. Once the shaft is assembled,
place the measuring device on the shaft by sliding it down from the top of the shaft
(flat end first).
To perform the measurements:
Have patient remove his/her shoes, as well as hats and any other head gear. In addition, make
sure that the patient is not wearing a hairstyle that may affect the height measurement (e.g., hair
pulled back on top of head, hair clip on top of head). With the patient’s shoes still removed, ask
the patient to stand with his/her back to the stadiometer shaft. Ask the patient to look straight
ahead and assume a normal, upright posture. Gently bring the measuring device down, toward
the patient’s head, until it is resting firmly on the crown of the head. Record the first height
measurement to the nearest half of an inch. For example, for a person who is somewhere
between 68 and 69 inches tall, round up or down as follows:
68 1/8
68 ¼
68 3/8
68 ½
68 5/8
68 ¾
68 7/8
=
=
=
=
=
=
=
68.0
68.5
68.5
68.5
68.5
69.0
69.0
As another example, the reading illustrated below is between 64 and 65 inches. The patient
is just over 64 ¼ inches tall, so record 64.5 on the form.
COATS Vital Signs Screening Form Version A (VSSA) QxQ, 07/01/08
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Ask the patient to step off the stadiometer before repeating the measurement.
Item 2b. Ask the patient to return to the stadiometer for a second measurement. Repeat the height
measurement, and again record the height to the nearest half of an inch, rounding either
up or down.
Next, compute the difference of the two height measurements. If the difference between
the two height measurements is one inch or more, repeat both height measurements until
the difference between the two measurements is less than one inch. Line through the first
measurements, write in the new measurements directly to the left of the first
measurements, and initial and date the changes.
If | HEIGHT2a – HEIGHT2b | ≥ 1 inch then repeat both measurements.
Item 2c. You may want to calculate the mean height so that you can compute BMI. You can record
it on the form, but the Data Management System will do this computation when the
information is entered into the system. Mean height is computed as follows:
meanHEIGHT = [ HEIGHT2a + HEIGHT2b ] / 2
C. BODY MASS INDEX (BMI)
You may also want to compute BMI, but again, the DMS will do this computation when the
information is entered into the system.
Item 3. BMI is computed as follows:
BMI = [ WEIGHTpounds * 704.5 ] / [meanHEIGHTinches * meanHEIGHTinches]
If BMI is greater than 35 or less than 18, the patient is ineligible for the study.
D. BLOOD PRESSURE AND HEART RATE
With patient seated and arm supported, take the blood pressure measurement.
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Item 4. Systolic. Record the systolic blood pressure on the form in mm Hg.
Item 5. Diastolic. Record the diastolic blood pressure on the form in mm Hg.
Item 6. Heart rate. Take the patient’s radial pulse for 30 seconds. Multiply the pulse rate by 2 and
record the beats per minute on the form.
E. WAIST
The waist measurement is performed twice with a Gulick II measuring device. The Gulick II
provides accurate measurements by applying a constant amount of tension with every
measurement, however, it is recommended that the same trained personnel perform the waist
measurement for a specific individual at every patient visit.
Guidelines:
Waist measurements can be taken over light weight clothes.
Have the subject remove any coats or sweaters.
Procedure:
To take a measurement, pull an appropriate amount of tape out of the white plastic housing.
Next, wrap the tape once around the patient’s body, then have the patient find the top of his/her
iliac crest (you may have to help guide the patient in finding the top of the iliac crest). The top of
the patient’s thumbs should then be in line with the top of the iliac crest. The subject can now
remove their hands. Pull the tape measure taunt to the point between the two red balls while
aligning the tapes “zero line” along side of the tape graduations. (Note: you have pulled the
proper amount when you see one red ball and the edge of the silver disk, if you see both
red balls and the silver disk in between them, then you have pulled too far.) The correct
measurement is the measurement where the “0” lines up (i.e., record the measurement next to
the tape’s “zero line”). Use inches.
Item 7a. Waist. Measure at the top of the iliac crest. Round up or down to the nearest half-inch.
For example, for a person whose waist is somewhere between 36 and 37 inches, round up
or down as follows:
36 1/8
36 ¼
36 3/8
36 ½
36 5/8
36 ¾
36 7/8
=
=
=
=
=
=
=
36.0
36.5
36.5
36.5
36.5
37.0
37.0
Item 7b. Repeat the waist measurement, and again record to the nearest half of an inch, rounding
either up or down. Record the waist measurement in inches on the form.
Next, compute the difference of the two waist measurements. If the difference between
the two height measurements is more than one inch, repeat both waist measurements until
the difference between the two measurements is one inch or less. Line through the first
measurements, write in the new measurements directly to the left of the first
measurements, and initial and date the changes.
If | WAIST7a – WAIST7b | > 1 inch then repeat both measurements.
COATS Vital Signs Screening Form Version A (VSSA) QxQ, 07/01/08
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ADMINISTRATIVE INFORMATION
Item 8. Comments. Record brief, pertinent comments related to the overall collection of the data on
this form. In the data management system, there are 3 lines, 70 characters per line, to
record these comments.
Item 9. Staff Code Number. The person at the clinic who collected the data on this form enters
his/her code number in the boxes provided. This code is on every form. The DCC assigns
a code to each study member based upon his/her certification for specific areas of data
collection within the COATS study. Please ask the study coordinator if you are unsure of
your code.
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