Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+)
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 Suicid...
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| Format: | Article |
| Language: | English |
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Elsevier
2016-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865416300382 |
| _version_ | 1818007147159486464 |
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| author | Kelly M. Harrington Matthew H. Liang Keri Hannagan Soe Soe Thwin Ryan E. Ferguson Natalie Morgenstern Erick Flores Ira R. Katz |
| author_facet | Kelly M. Harrington Matthew H. Liang Keri Hannagan Soe Soe Thwin Ryan E. Ferguson Natalie Morgenstern Erick Flores Ira R. Katz |
| author_sort | Kelly M. Harrington |
| collection | DOAJ |
| description | 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© and VA psychiatrists were individually emailed an invitation to complete an anonymous online survey. Three email waves were sent over three weeks.
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. |
| first_indexed | 2024-04-14T05:11:52Z |
| format | Article |
| id | doaj.art-abb60b29ba7640768245296dda0149f6 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-14T05:11:52Z |
| publishDate | 2016-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-abb60b29ba7640768245296dda0149f62022-12-22T02:10:32ZengElsevierContemporary Clinical Trials Communications2451-86542016-12-014C14915410.1016/j.conctc.2016.08.004Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+)Kelly M. Harrington0Matthew H. Liang1Keri Hannagan2Soe Soe Thwin3Ryan E. Ferguson4Natalie Morgenstern5Erick Flores6Ira R. Katz7Massachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USAMassachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USAMassachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USAMassachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USAMassachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USAMassachusetts Veterans Epidemiology and Research Information Center (MAVERIC), Cooperative Studies Program Coordinating Center (CSPCC), Boston, MA, USAVA Boston Healthcare System, Department of Rheumatology, Boston, MA, USAVeterans Affairs Office of Mental Health Operations, Washington, DC, USABackground: 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© and VA psychiatrists were individually emailed an invitation to complete an anonymous online survey. Three email waves were sent over three weeks. 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.http://www.sciencedirect.com/science/article/pii/S2451865416300382Controlled clinical trialEffect sizeClinical surveyClinicians' opinionsSample size estimation |
| spellingShingle | Kelly M. Harrington Matthew H. Liang Keri Hannagan Soe Soe Thwin Ryan E. Ferguson Natalie Morgenstern Erick Flores Ira R. Katz 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 Controlled clinical trial Effect size Clinical survey Clinicians' opinions Sample size estimation |
| title | Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+) |
| title_full | Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+) |
| title_fullStr | Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+) |
| title_full_unstemmed | Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+) |
| title_short | Design and conduct of a provider survey to determine a clinically persuasive effect size in planning VA Cooperative Study #590 (Li+) |
| title_sort | design and conduct of a provider survey to determine a clinically persuasive effect size in planning va cooperative study 590 li |
| topic | Controlled clinical trial Effect size Clinical survey Clinicians' opinions Sample size estimation |
| url | http://www.sciencedirect.com/science/article/pii/S2451865416300382 |
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