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Harrington KM, Liang MH, Hannagan K, et al. Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+). Contemp Clin Trials Commun. 2016;4:149-154doi: 10.1016/j.conctc.2016.08.004.
Harrington, K. M., Liang, M. H., Hannagan, K., Thwin, S. S., Ferguson, R. E., Morgenstern, N., Flores, E., & Katz, I. R. (2016). Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+). Contemporary clinical trials communications, 4149-154. https://doi.org/10.1016/j.conctc.2016.08.004
Harrington, Kelly M, et al. "Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+)." Contemporary clinical trials communications vol. 4 (2016): 149-154. doi: https://doi.org/10.1016/j.conctc.2016.08.004
Harrington KM, Liang MH, Hannagan K, Thwin SS, Ferguson RE, Morgenstern N, Flores E, Katz IR. Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+). Contemp Clin Trials Commun. 2016 Aug 31;4:149-154. doi: 10.1016/j.conctc.2016.08.004. eCollection 2016 Dec 15. PMID: 29736478; PMCID: PMC5935897.
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Contemp Clin Trials Commun. 2016 Aug 31;4:149-154. doi: 10.1016/j.conctc.2016.08.004. eCollection 2016 Dec 15.

Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+).

Contemporary clinical trials communications

Kelly M Harrington, Matthew H Liang, Keri Hannagan, Soe Soe Thwin, Ryan E Ferguson, Natalie Morgenstern, Erick Flores, Ira R Katz

Affiliations

  1. Massachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USA.
  2. VA Boston Healthcare System, Department of Rheumatology, Boston, MA, USA.
  3. Veterans Affairs Office of Mental Health Operations, Washington, DC, USA.

PMID: 29736478 PMCID: PMC5935897 DOI: 10.1016/j.conctc.2016.08.004

Abstract

BACKGROUND: The estimation of an effect size is an important step in designing an adequately powered, feasible clinical trial intended to change clinical practice. During the planning phase of VA Cooperative Study #590, "Double-Blind Placebo-Controlled Study of Lithium for Preventing Repeated Suicidal Self-Directed Violence in Patients with Depression or Bipolar Disorder (Li+)," it was not clear what effect size would be considered large enough to influence prescribing behavior among practicing clinicians.

METHODS: We conducted an online survey of VA psychiatrists to assess their interest in the study question, their clinical experience with lithium, and their opinion about what suicide reduction rate would change their prescribing habits. The 9-item survey was hosted on SurveyMonkey

RESULTS: Overall, 862 of 2713 VA psychiatrists (response rate = 31.8%) responded to the anonymous survey. 74% of the respondents would refer a patient to the proposed trial, 9% would not, and 17% were unsure. Presented with suicide reduction rates in 10% increments ranging from 10 to 100%, 61% of respondents indicated that they would use lithium if suicide attempts were reduced by at least 40%; 83% would use lithium if it reduced attempts by at least 50%.

CONCLUSIONS: Even with the limitations of response bias and the reliability of responses on future prescribing behavior, a survey of potential users of a clinical trial's results offers a convenient, empirical method for determining and justifying clinically relevant effect sizes.

Keywords: Clinical survey; Clinicians' opinions; Controlled clinical trial; Effect size; Sample size estimation

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