|Number of pages||2|
|Journal||Controlled clinical trials|
|State||Published - Oct 1992|
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In: Controlled clinical trials, Vol. 13, No. 5, 10.1992, p. 392-393.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - A low cost screening survey to assess sample yield and refine study entry criteria
AU - Gordon, Mae O.
AU - Zadnik, Karia
AU - Barr, Joseph T.
AU - Edrington, Timothy B.
AU - Morgan, Derek
N1 - Funding Information: Shrinkage in the expected number of protocol eligible subjects can dramatically lengthen the recruitment period and increase the cost of a study. To obtain realistic estimates of the availability of eligible subjects for a clinical trial comparing the safety and efficacy of two contact lens fitting methods in the management of keratoconus, we conducted a national, voluntary survey of 37 private practices and academic institutions. The survey consisted of a one page form which collected data on disease sevedty, as well as 5 key inclusion and exclusion criteria specific to the proposed study. The survey data (n = 1266 subjects) not only permitted accurate estimates of the available pool of eligible patients at each clinic, but also the probable rate of recruitment. An unanticipated benefit was that the screening data permitted an assessment of proposed entry criteria. The survey disclosed that proposed entry cdteria excluded a substantial proportion of the "target" sample. Adjusting entry criteda to improve representation of the target sample increased the rate of eligibility from 23% to 37% with no change in the disease sevedty of eligible study patients. This reduced the needed number of participating clinics from 16 to 10 resulting in a substantial cost savings for the proposed tdal. This survey screening method has broad applicability and offers investigators an opportunity to assess study eligibility prior to randomization. Supported by NEI Grant #EY-02687, EY-08652.
PY - 1992/10
Y1 - 1992/10
UR - http://www.scopus.com/inward/record.url?scp=44049110167&partnerID=8YFLogxK
U2 - 10.1016/0197-2456(92)90079-F
DO - 10.1016/0197-2456(92)90079-F
M3 - Article
AN - SCOPUS:44049110167
SN - 0197-2456
VL - 13
SP - 392
EP - 393
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
IS - 5