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Instructions for V34 PE/Lipodystrophy Form


Physical Exam

Question 3: Body Weight

The patient should be weighed in his clothing. However, heavy clothes such as coats, thick sweaters and shoes should be removed. Also ask the participant to empty his pockets of keys, wallets, loose change, etc.

A balance scale should be used. Be sure the scale is balanced so that the indicator is at zero when no weight is on the scale. The scale should be level and on a firm surface (not a carpet). The participant should be instructed to stand in the middle of the platform of the balance scale with head erect and eyes looking straight ahead. Adjust the weight on the indicator until it is balanced. Have the subject step off the scale, reset the balance to zero and repeat. If measures differ by more than 1.0 lb, repeat a third time. Use the first measurement when a third measurement is not needed. If a third measurement is done, record that measurement as long as it is within 1.0 lb of either of the two previous measurements. If the third measurement is not within 1.0 lb of either of the first two measurements, repeat measurements until you get two measurements within 1.0 lb and use the last of these two measurements.


Lipodystrophy Form

The following items refer to the lipodystrophy questionnaire. This questionnaire should be administered to ALL participants regardless of serostatus. It should be administered after the physical exam by the examiner. The examiner should first ask the participants the questions on the self-report portion of the questionnaire and then conduct the lipodystrophy physical exam. The guidelines below and the videotape provided should be used as a reference for making the measurements.

Self Report:

Question 1.b:

Severity should be assessed at the time of the visit. For circumstances where there has been a partial reversal of the condition, the severity should still be assessed at the time of the visit

Some examples of coding participant X’s response are:

  • X had some arm fat loss but later gained approximately the same amount he lost. “None” should be coded under current severity
  • At visit 33 X had “severe” facial fat loss. But, in the past 6 months, he gained about half of it back. At visit 34 the severity would be coded as “moderate.”

Question 2.b:

An example of coding participant X’s response is:

  • X increased his trouser waist size by 3 inches, but a few months later he lost 2 inches from his waist. “Increase” should be marked as well as “1-2 inch.” (3-2=1 for a net gain of 1 inch)

Exam:

Body Height

This only needs to be measured if the participant does not have a value from a previous visit as part of the Lipodystrophy exam. A clinic stadiometer is to be used whenever possible. The subject stands erect on the horizontal platform with his back parallel to the vertical mounted measure scale (but not touching the wall), looking straight ahead. The head should be in the horizontal plane defined by the lower margin of the bony socket containing the eye and the most forward point in the notch just above the anterior cartilaginous projections of the external ear. The horizontal measuring block is brought down snugly, but not tightly, on the top of the head. The subject’s height is recorded to the nearest 1.0 inch. Ask the subject to step off the platform, raise measuring block and ask subject to return to the platform. Repeat the measure. If measure differs by more than 1.0 inch, repeat a third time. The subject should be instructed to stand as straight as possible but with feet flat on the floor. (If a stadiometer is not used, a tape mounted to the wall should be used. In this case, a check should be made to be sure the floor is level, the wall is at a 90 degree angle to the floor, the wall is straight and the measuring tape is mounted perpendicular to the floor). Use the first measurement when a third measurement is not needed. If a third measurement is done, record that measurement as long as it is within 1.0 inch of either of the two previous measurements. If the third measurement is not within 1.0 inch of either of the first two measurements, repeat measurements until you get two measurements within 0.5 inches and use the last of these two measurements.

Waist Girth

The study participant is in a standing position. The participant is asked to hold up his gown. The examiner stands behind the participant and palpates the hip area for the right iliac crest. (see Exhibit A) The examiner marks a horizontal line at the high point of the iliac crest and then crosses the line to indicate the midaxillary line of the body. The pants and underclothing of the participant must be lowered slightly for the examiner to directly palpate on the hip area for the iliac crest. The examiner then stands on the participant’s right side and places the measuring tape around the trunk in a horizontal plane at this level marked on the right side of the trunk. Make sure that the tape is parallel to the floor and that the tape is snug, but does not compress the skin. The measurement is made at minimal respiration to the nearest 1.0 cm.

Hip Girth

The study participant stands erect with feet together and weight evenly distributed on both feet. The participant is holding up the examination gown. The examiner places the measuring tape around the buttocks. The tape is placed at the maximum extension of the buttocks (see Exhibit B). The examiner then adjusts the sides of the tape and checks the front and sides so that the plane of the tape is horizontal. The zero end of the tape is held under the measurement value. The tape is held snugly but not tight. The examiner takes the measurement from the right side. The measurement is taken to the nearest 1.0 cm.

Arm Girth

The study participant is standing with the right elbow relaxed so that the right arm hangs freely to the side. The examiner marks the point halfway between the lateral projection of the acromian process of the scapula (bump on backside of shoulder) and the interior part of the olecranon process (elbow). The measuring tape is placed around the upper arm at the marked point perpendicular to the long axis of the upper arm. The tape is again held so that the zero end is held below the measurement value. The tape rests on the skin surface, but is not pulled tight enough to compress the skin. The arm circumference is recorded to the nearest 0.1 cm.

Thigh Girth

The study participant is sitting as shown on the instructional video. The examiner marks the point midway between the inguinal crease and the nearest border of the patella or kneecap. The examiner stands on the participant’s right side and the measuring tape is placed around the mid-thigh at the marked point. The tape is positioned perpendicular to the long axis of the thigh with the zero end of the tape held below the measurement value. The tape rests firmly on the skin without compressing the skin. The thigh circumference is measured to the nearest 0.1 cm.