|Title||STANDARIZATION OF CLINICAL TECHNIQUES|
|Author, Co-Author||Karla Zadnik, Joseph Barr, Mae Gordon, Timothy Edrington, The Study Group|
Grand Ballroom A
|Abstract|| PURPOSE. The issue of standardization of clinical measurement techniques in clinical research studies is an important one affecting reliability and validity of results and statistical power. How can investigators ensure proper standardization of measures when more than one person takes measures and more than one clinic is involved?
METHODS. The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study, a 14-site observational study of up to 1,000 keratoconus patients began in April 1995 with a centralized Training Meeting. Prior to this meeting, participants completed written examinations on the standard CLEK Study measures. Participants were trained and certified on standard clinical measures: visual acuity, keratometry, refraction, and slit lamp examination, and on clinical measures developed specifically for the CLEK Study: fluorescein photography, first definite apical clearance lens (FDACL) application, and corneal photography.
RESULTS. Considerable variability was observed among attending optometric clinicians and technicians. For example, Bailey-Lovie acuity charts are not routinely used for clinical care, and participants needed training and rehearsal in using the charts with the ETDRS testing protocol. Difference in the specific details of clinical techniques became evident; practitioners were hesitant to adhere to a standard refraction protocol (figuring 'my way is best') and were not in the habit of occluding the fellow eye during keratometry. After receiving the centralized training, both photography techniques were ultimately certified via actual photographs interpreted by the CLEK Photography Reading Center.
CONCLUSIONS. In order to collect reliable and valid data, whether in a single-center study with multiple investigators or in a multi-center study, participants must be trained using standardized techniques and certified in the study's measurement protocols-even those that involve everyday optometric techniques. The CLEK Study will utilize s
|Affiliation of Co-Authors|