A low cost screening survey to assess sample yield and refine study entry criteria

Mae O. Gordon; Karia Zadnik; Joseph T. Barr; Timothy B. Edrington; Derek Morgan

doi:10.1016/0197-2456(92)90079-F

A low cost screening survey to assess sample yield and refine study entry criteria

Mae O. Gordon, Karia Zadnik, Joseph T. Barr, Timothy B. Edrington, Derek Morgan

Research output: Contribution to journal › Article › peer-review

Original language	English
Pages (from-to)	392-393
Number of pages	2
Journal	Controlled clinical trials
Volume	13
Issue number	5
DOIs	https://doi.org/10.1016/0197-2456(92)90079-F
State	Published - Oct 1992

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10.1016/0197-2456(92)90079-F

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@article{f455ddec386d4f2f869e1ecc50d865db,

title = "A low cost screening survey to assess sample yield and refine study entry criteria",

author = "Gordon, {Mae O.} and Karia Zadnik and Barr, {Joseph T.} and Edrington, {Timothy B.} and Derek Morgan",

note = "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.",

year = "1992",

month = oct,

doi = "10.1016/0197-2456(92)90079-F",

language = "English",

volume = "13",

pages = "392--393",

journal = "Controlled clinical trials",

issn = "0197-2456",

number = "5",

}

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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

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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

ER -

A low cost screening survey to assess sample yield and refine study entry criteria

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