Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial

David R. Karp, Benjamin F. Chong, Judith A. James, Cristina Arriens, Mariko Ishimori, Daniel J. Wallace, Duanping Liao, Nancy J. Olsen

Research output: Contribution to journalArticle

Abstract

Objective: Recruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment. Methods: After obtaining institutional review board approval, study coordinators approached individuals who generally fit proposed criteria for the trial. A standardized script was followed in a structured interview. Levels of interest were determined and any reasons for concerns were collected with an open-ended format. Results: A total of 45 subjects were interviewed, of which 73% expressed an interest in the trial, and 64% said they were likely to enroll. Concerns of those who were not interested included risk of hydroxychloroquine, desire not to receive placebo, and lack of time for participation. Conclusion: The mock recruitment suggests that the trial will be attractive to suitable patients. The concerns raised support other data indicating that provision of information is crucial to achieving enrollment goals. Mock recruitment of potential investigators should be considered also to address referral concerns.

Original languageEnglish (US)
Pages (from-to)1425-1429
Number of pages5
JournalArthritis Care and Research
Volume71
Issue number11
DOIs
StatePublished - Nov 1 2019

Fingerprint

Antimalarials
Hydroxychloroquine
Research Ethics Committees
Referral and Consultation
Randomized Controlled Trials
Placebos
Research Personnel
Interviews

All Science Journal Classification (ASJC) codes

  • Rheumatology

Cite this

Karp, D. R., Chong, B. F., James, J. A., Arriens, C., Ishimori, M., Wallace, D. J., ... Olsen, N. J. (2019). Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care and Research, 71(11), 1425-1429. https://doi.org/10.1002/acr.23802
Karp, David R. ; Chong, Benjamin F. ; James, Judith A. ; Arriens, Cristina ; Ishimori, Mariko ; Wallace, Daniel J. ; Liao, Duanping ; Olsen, Nancy J. / Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. In: Arthritis Care and Research. 2019 ; Vol. 71, No. 11. pp. 1425-1429.
@article{6a11484f708b4d69b315350030f4d7ca,
title = "Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial",
abstract = "Objective: Recruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment. Methods: After obtaining institutional review board approval, study coordinators approached individuals who generally fit proposed criteria for the trial. A standardized script was followed in a structured interview. Levels of interest were determined and any reasons for concerns were collected with an open-ended format. Results: A total of 45 subjects were interviewed, of which 73{\%} expressed an interest in the trial, and 64{\%} said they were likely to enroll. Concerns of those who were not interested included risk of hydroxychloroquine, desire not to receive placebo, and lack of time for participation. Conclusion: The mock recruitment suggests that the trial will be attractive to suitable patients. The concerns raised support other data indicating that provision of information is crucial to achieving enrollment goals. Mock recruitment of potential investigators should be considered also to address referral concerns.",
author = "Karp, {David R.} and Chong, {Benjamin F.} and James, {Judith A.} and Cristina Arriens and Mariko Ishimori and Wallace, {Daniel J.} and Duanping Liao and Olsen, {Nancy J.}",
year = "2019",
month = "11",
day = "1",
doi = "10.1002/acr.23802",
language = "English (US)",
volume = "71",
pages = "1425--1429",
journal = "Arthritis Care and Research",
issn = "2151-464X",
publisher = "John Wiley and Sons Inc.",
number = "11",

}

Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. / Karp, David R.; Chong, Benjamin F.; James, Judith A.; Arriens, Cristina; Ishimori, Mariko; Wallace, Daniel J.; Liao, Duanping; Olsen, Nancy J.

In: Arthritis Care and Research, Vol. 71, No. 11, 01.11.2019, p. 1425-1429.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial

AU - Karp, David R.

AU - Chong, Benjamin F.

AU - James, Judith A.

AU - Arriens, Cristina

AU - Ishimori, Mariko

AU - Wallace, Daniel J.

AU - Liao, Duanping

AU - Olsen, Nancy J.

PY - 2019/11/1

Y1 - 2019/11/1

N2 - Objective: Recruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment. Methods: After obtaining institutional review board approval, study coordinators approached individuals who generally fit proposed criteria for the trial. A standardized script was followed in a structured interview. Levels of interest were determined and any reasons for concerns were collected with an open-ended format. Results: A total of 45 subjects were interviewed, of which 73% expressed an interest in the trial, and 64% said they were likely to enroll. Concerns of those who were not interested included risk of hydroxychloroquine, desire not to receive placebo, and lack of time for participation. Conclusion: The mock recruitment suggests that the trial will be attractive to suitable patients. The concerns raised support other data indicating that provision of information is crucial to achieving enrollment goals. Mock recruitment of potential investigators should be considered also to address referral concerns.

AB - Objective: Recruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment. Methods: After obtaining institutional review board approval, study coordinators approached individuals who generally fit proposed criteria for the trial. A standardized script was followed in a structured interview. Levels of interest were determined and any reasons for concerns were collected with an open-ended format. Results: A total of 45 subjects were interviewed, of which 73% expressed an interest in the trial, and 64% said they were likely to enroll. Concerns of those who were not interested included risk of hydroxychloroquine, desire not to receive placebo, and lack of time for participation. Conclusion: The mock recruitment suggests that the trial will be attractive to suitable patients. The concerns raised support other data indicating that provision of information is crucial to achieving enrollment goals. Mock recruitment of potential investigators should be considered also to address referral concerns.

UR - http://www.scopus.com/inward/record.url?scp=85074191230&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85074191230&partnerID=8YFLogxK

U2 - 10.1002/acr.23802

DO - 10.1002/acr.23802

M3 - Article

C2 - 30369087

AN - SCOPUS:85074191230

VL - 71

SP - 1425

EP - 1429

JO - Arthritis Care and Research

JF - Arthritis Care and Research

SN - 2151-464X

IS - 11

ER -

Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ et al. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care and Research. 2019 Nov 1;71(11):1425-1429. https://doi.org/10.1002/acr.23802