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Brief ReportBrief Report

Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion

Caitlin K. Moynihan, Panne A. Burke, Sarah A. Evans, Amie C. O'Donoghue and Helen W. Sullivan
The Journal of the American Board of Family Medicine July 2018, 31 (4) 645-649; DOI: https://doi.org/10.3122/jabfm.2018.04.170242
Caitlin K. Moynihan
Fors Marsh Group, Arlington, VA (CKM, PAB, SAE); and US Food and Drug Administration, Silver Spring, MD (ACO, HWS).
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Panne A. Burke
Fors Marsh Group, Arlington, VA (CKM, PAB, SAE); and US Food and Drug Administration, Silver Spring, MD (ACO, HWS).
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Sarah A. Evans
Fors Marsh Group, Arlington, VA (CKM, PAB, SAE); and US Food and Drug Administration, Silver Spring, MD (ACO, HWS).
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Amie C. O'Donoghue
Fors Marsh Group, Arlington, VA (CKM, PAB, SAE); and US Food and Drug Administration, Silver Spring, MD (ACO, HWS).
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Helen W. Sullivan
Fors Marsh Group, Arlington, VA (CKM, PAB, SAE); and US Food and Drug Administration, Silver Spring, MD (ACO, HWS).
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Article Figures & Data

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    Table 1.

    Final Participant Demographics

    CategoryClassificationCompleted Counts
    Total72
    Physician typePrimary care physician50
    Endocrinologist22
    SexMale45
    Female27
    Race/ethnicityAfrican American or black4
    Asian15
    Hispanic4
    White49
    Age44 or Under29
    45 to 6437
    65 or Older6
    UrbanicityLarge urban (eg, Washington, DC)46
    Small urban (eg, St. Louis, MO)19
    Suburban/rural (eg, Cortez, CO)7
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    Table 2.

    Comprehension of Terms Related to Clinical Trial Data

    Terms*Codebook DefinitionAccurateNot AccurateDid Not Know
    Overall no. (%)Physician typeOverall no. (%)Physician typeOverall No. (%)Physician type
    Endo. no. (%)PCP no. (%)Endo. no. (%)PCP no. (%)Endo. no. (%)PCP no. (%)
    N†72 (100.0)22 (100.0)50 (100.0)
    Randomized controlled trial (RCT)Participants are randomly assigned to treatment groups: control (placebo or standard treatment), experimental (receives treatment being assessed).45 (62.5)15 (68.2)30 (60.0)24 (33.3)7 (31.8)17 (34.0)2 (2.8)0 (0.0)2 (4.0)
    Noninferiority RCTConducted to demonstrate that the new treatment is not inferior/clinically worse than standard treatment20 (27.8)5 (22.7)15 (30.0)33 (45.8)15 (68.2)18 (36.0)16 (22.2)2 (9.1)14 (28.0)
    Noninferiority margin of 10%Must explain one of the following:6 (8.3)2 (9.1)4 (8.0)31 (43.1)12 (54.6)19 (38.0)17 (23.6)5 (22.7)12 (24.0)
    –If the difference in the assessed endpoint between the new treatment and the standard treatment is 10% or less, the treatments are considered equal (or the new treatment is non-inferior to, not any worse than the standard treatment).
    –If the difference is more than 10%, the treatments are not equal/the new treatment is inferior.
    Adjusted meanThe averages/means have been corrected to account for data imbalances (or covariates/confounding factors) that may have inherently occurred between the two groups.2 (2.8)0 (0.0)2 (4.0)24 (33.3)8 (36.4)16 (32.0)46 (63.9)14 (63.6)32 (64.0)
    RerandomizationPart way through the study, some, or all of the participants are randomly assigned again, to either their original group or the other group, for the completion of the study.25 (34.7)11 (50.0)14 (28.0)25 (34.7)5 (22.7)20 (40.0)22 (30.6)6 (27.3)16 (32.0)
    Intent-to-treat analysisResults are based on the participants' original random assignment, regardless of whether they completed the protocol or actually received the treatment (all patients enrolled are analyzed at the end of the study).10 (13.9)7 (31.8)3 (6.0)33 (45.8)11 (50.0)22 (44.0)28 (38.9)4 (18.2)24 (48.0)
    Per-protocol analysisOnly those patients who completed/adhered to the study are included in the analysis.0 (0.0)0 (0.0)0 (0.0)34 (47.2)10 (45.5)24 (48.0)37 (51.4)12 (54.6)25 (50.0)
    Modified intent to treatParticipants were excluded from the analysis if they did not receive a specified minimum amount of the intended intervention.0 (0.0)0 (0.0)0 (0.0)26 (36.1)9 (40.9)17 (34.0)44 (61.1)12 (54.6)32 (64.0)
    Last observation carried dorwardThe last data point/outcome measurement available for that particular participant is carried forward as the end point, regardless of when the measurement occurred.9 (12.5)6 (27.3)3 (6.0)19 (26.4)6 (27.3)13 (26.0)44 (61.1)10 (45.5)34 (68.0)
    • ↵* Terms were presented to participants as follow-up probes to the actual promotional materials aimed at health care providers. Responses were coded by two researchers who categorized responses as accurate, not accurate (including incomplete and partially or completely inaccurate responses), or did not know.

    • ↵† Numbers and percentages may not add to total N or 100% due to skip patterns, rounding, and missing values. Missing values occurred due to qualitative nature of study as moderator skipped questions due to time.

    • Endo, endocrinologist; PCP, primary care physician

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The Journal of the American Board of Family     Medicine: 31 (4)
The Journal of the American Board of Family Medicine
Vol. 31, Issue 4
July-August 2018
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Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion
Caitlin K. Moynihan, Panne A. Burke, Sarah A. Evans, Amie C. O'Donoghue, Helen W. Sullivan
The Journal of the American Board of Family Medicine Jul 2018, 31 (4) 645-649; DOI: 10.3122/jabfm.2018.04.170242

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Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion
Caitlin K. Moynihan, Panne A. Burke, Sarah A. Evans, Amie C. O'Donoghue, Helen W. Sullivan
The Journal of the American Board of Family Medicine Jul 2018, 31 (4) 645-649; DOI: 10.3122/jabfm.2018.04.170242
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