ACRIN 6654 ACRIN Study 6654 PLACE LABEL HERE Pulmonary Function Test Institution Institution No. Participant Initials Instructions: This form documents the spirometry performed at the enrollment visit. Responses to Parts A and B will be retained at the site. The RA is to submit only part C of this form via the ACRIN website. Submit part C via paper only in the event of a revised or corrected form via fax to ACRIN Data Management. A. Preliminary Questions to Ask Participant Prior to Testing. A “yes” answer will require that spirometry be postponed. Note: Postpone spirometry for the time(s) indicated. Have you had a respiratory infection in the past 3 weeks (including today)? 1
If yes, reschedule tests for 3 weeks from time of resolution of symptoms. In the past 6 hours, have you used a short-acting inhaled bronchodilator, such as Albuterol® (brand names Proventil® or Ventolin®) or Ipratropium (brand name Atrovent®)? 1
If yes, postpone tests for 6 hours or more from the last time of inhalant usage. In the past 24 hours, have you used a long-acting inhaled bronchodilator, such as Salmeterol (brand name Serevent®), or a long-acting oral bronchodilator, such as Proventil Repetabs® or a twice-daily Theophylline (brand name Theodur® or Theobid®). 1
If yes, postpone test 24 hours or more. In the past 6 hours, have you used a short-acting oral bronchodilator (such as Proventil® 2 mg or 4 mg) or an over-the-counter preparation for chest congestion, wheezing or asthma? 1 No 2 Yes* If yes, postpone test for 6 hours or more from the time the medication was taken. B. Participant data Age of participant Gender (sex) of participant 1 cm Height of participant (with shoes removed) 6654 PA 3-07-03 1 of 2
If this is a revised or correctedform, please check box and fax
ACRIN Study 6654 PLACE LABEL HERE Institution Institution No. Participant Initials C. Spirometry: Perform the spirometry per the recommendations of the American Thoracic Society (ATS)
utilizing the SpiroPro device provided to each study site. 8a. Date of spirometry Date reflects postponed spirometry date: 1 No Verify that flow-volume measurements were performed as per ATS criteria: 1 No FVC (L-BTPS) From the best trial FVC% predicted FEV % predicted
FEV % predicted = 100 x (observed FEV /predicted FEV )
Calculated using the best FEV and best FVC
Comments (may include comments on effort, etc.):_________________________________________________________
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Signature of person responsible for data Date form completed (mm-dd-yyyy) __________________________________________________ Signature of person entering data onto web 6654 PA 3-07-03 2 of 2
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