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Research ArticleOriginal Research

Barriers to Follow-Up Colonoscopy After Positive FIT or Multitarget Stool DNA Testing

Gregory S. Cooper, Ashley Grimes, James Werner, Shufen Cao, Pingfu Fu and Kurt C. Stange
The Journal of the American Board of Family Medicine January 2021, 34 (1) 61-69; DOI: https://doi.org/10.3122/jabfm.2021.01.200345
Gregory S. Cooper
From the Division of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland OH (GSC, AG); Center for Community Health Integration and Department of Family Medicine, Case Western Reserve University, Cleveland OH (JW, KCS); Department of Population and Quantitative Health, Case Western Reserve University, Cleveland OH (SC, PF); and the Case Comprehensive Cancer Center, Cleveland OH (GSC, JW, PF, KCS).
MD
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Ashley Grimes
From the Division of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland OH (GSC, AG); Center for Community Health Integration and Department of Family Medicine, Case Western Reserve University, Cleveland OH (JW, KCS); Department of Population and Quantitative Health, Case Western Reserve University, Cleveland OH (SC, PF); and the Case Comprehensive Cancer Center, Cleveland OH (GSC, JW, PF, KCS).
MS
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James Werner
From the Division of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland OH (GSC, AG); Center for Community Health Integration and Department of Family Medicine, Case Western Reserve University, Cleveland OH (JW, KCS); Department of Population and Quantitative Health, Case Western Reserve University, Cleveland OH (SC, PF); and the Case Comprehensive Cancer Center, Cleveland OH (GSC, JW, PF, KCS).
PhD
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Shufen Cao
From the Division of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland OH (GSC, AG); Center for Community Health Integration and Department of Family Medicine, Case Western Reserve University, Cleveland OH (JW, KCS); Department of Population and Quantitative Health, Case Western Reserve University, Cleveland OH (SC, PF); and the Case Comprehensive Cancer Center, Cleveland OH (GSC, JW, PF, KCS).
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Pingfu Fu
From the Division of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland OH (GSC, AG); Center for Community Health Integration and Department of Family Medicine, Case Western Reserve University, Cleveland OH (JW, KCS); Department of Population and Quantitative Health, Case Western Reserve University, Cleveland OH (SC, PF); and the Case Comprehensive Cancer Center, Cleveland OH (GSC, JW, PF, KCS).
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Kurt C. Stange
From the Division of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland OH (GSC, AG); Center for Community Health Integration and Department of Family Medicine, Case Western Reserve University, Cleveland OH (JW, KCS); Department of Population and Quantitative Health, Case Western Reserve University, Cleveland OH (SC, PF); and the Case Comprehensive Cancer Center, Cleveland OH (GSC, JW, PF, KCS).
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    Figure 1.

    Kaplan-Meier estimation of time-to-colonoscopy of patients who had FIT test and who had mt-sDNA. The median time-to-colonoscopy for patients FIT was N/A (50% rate was not reached for this group). The median (95% CI) time-to-colonoscopy for patients who had mt-sDNA was 2.16 (95% CI, 1.80-2.52) months. Abbreviation: FIT, fecal immunochemical testing.

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    Table 1.

    Characteristics of FIT and mt-sDNA Tests

    CharacteristicFITMt-sDNA
    Measures stool hemoglobinYesYes
    Measures genomic markersNoYes
    Approved as screening testYesYes
    Labeling restricted to average risk patientsNoYes
    Recommended interval1 year3 years
    Kit distributionIn-person or mail from local labMail from external site
    Kit returnIn person or mail to local labMail to external site
    Reminder calls to returnNoYes
    Medicare out-of-pocket cost$0$0
    Medicare reimbursement$22$483
    • FIT, fecal immunochemical testing.

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    Table 2.

    Patient Characteristics of Cohort of 631 Patients

    VariablesAll Patients (n = 631), Mean (STD)/Frequency (%)Mt-sDNA (n = 323)FIT (n = 308)P Value*
    Age (years)69.19 (10.57)69.55 (7.95)68.82 (12.76).39
    Sex
     Female349 (55.3)205 (63.47)144 (46.75)<.0001
     Male282 (44.7)118 (41.84)164 (53.25)
    Hispanic
     No573 (99.13))285 (99.30)288 (98.97).66
     Yes5 (0.87)2 (0.70)3 (1.03)
    Race
     Asian3 (0.49)0 (0.00)3 (0.99)
     Black48 (7.77)17 (5.41)31 (10.20)
     Other1 (0.16)0 (0.00)1 (0.33).064
     White563 (91.10)296 (94.27)267 (87.83)
     Hispanic2 (0.32)1 (0.32)1 (0.33)
     Native1 (0.16)0 (0.00)1 (0.33)
    Insurance
     Commercial301 (47.7)151 (46.7)150 (48.7)
     Medicaid11 (1.7)5 (1.6)6 (1.9)
     Medicare290 (46)158 (48.9)132 (42.9).18
     Self-pay9 (1.4)3 (0.9)6 (1.9)
     Unknown20 (3.2)6 (1.9)14 (4.6)
    Specialty
     Family Medicine368 (58.3)143 (44.3)225 (73)
     Internal Medicine242 (38.3)163 (50.5)79 (25.7)
     GI20 (3.2)16 (4.9)4 (1.3)<.0001
     Gynecology1 (0.2)1 (0.3)0 (0)
    Provider Gender
     Female317 (50.2)175 (54.2)142 (26.1).43
     Male314 (49.8)148 (45.8)166 (53.9)
    Mid-Level Provider
     Yes37 (5.9)22 (6.8)15 (4.9).3
     No (physician)594 (94.1)301 (93.2)293 (95.1)
    • ↵*P value was based on the comparison between two cohorts (FIT, mt-sDNA) of patients.

    • GI, gastroenterology; FIT, fecal immunochemical testin; STD, standard deviation.

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    Table 3.

    Reasons for Lack of Follow-up after Positive mt-sDNA or FIT*

    FIT (n = 164) Frequency (%)Mt-sDNA (n = 92) Frequency (%)
    System
     GI clinic referral48 (29.3)11 (12.0)
     Colonoscopy not scheduled5 (3.0)17 (18.5)
     Total53 (32.3)28 (30.4)
    Provider level
     Attributed to false positive3 (1.8)0 (0.0)
     Failure to inform patient0 (0.0)7 (7.6)
     Attributed to other reasons39 (23.8)1 (1.1)
     Recent colonoscopy done24 (14.6)1 (1.1)
     Other health issue to prioritize 8 (4.9)11 (12.0)
     Unknown21 (12.8)20 (21.7)
     Total95 (57.9)40 (43.5)
    Patient level
     Patient refused (before ordered)8 (4.9)8 (8.7)
     Patient refused (after ordered)4 (2.5)15 (16.3)
     No show/cancellation42 (25.6)26 (28.3)
     Did not complete bowel prep0 (0)1 (1.1)
     Other reason6 (3.7)3 (3.3)
     Total60 (36.6)53 (57.6)
    • ↵*Determined by medical record review.

    • FIT, fecal immunochemical testing; GI, gastroenterology.

    • View popup
    Table 4.

    Cox Regression Analysis on Time-to-Colonoscopy

    VariablesUnivariate Cox RegressionMultivariable Cox Regression
    HR95% CI of HRP valueHR95% CI of HRP Value
    Age (per year increase)0.990.98, 1.00.130.990.98, 1.00.181
    Sex (female vs male)1.170.95, 1.43.141.090.83, 1.32.717
    Race (Black vs White)1.300.91, 1.85.161.380.95, 2.00.089
    Insurance (commercial vs Medicare)1.120.91, 1.38.291.100.87, 1.39.411
    Screening test method (mt-sDNA vs FIT)1.831.48, 2.25< .00011.751.40, 2.19< .0001
    Specialty (FM vs IM)0.870.71, 1.08.202
    Provider gender (female vs male)1.301.06, 1.60.011.190.95, 1.50.125
    Mid-level provider (yes vs no)1.160.77, 1.75.483
    • FIT, fecal immunochemical testing; FM, family medicine; HR, hazard ratio; IM, internal medicine; CI, confidence interval.

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The Journal of the American Board of Family     Medicine: 34 (1)
The Journal of the American Board of Family Medicine
Vol. 34, Issue 1
January/February 2021
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Barriers to Follow-Up Colonoscopy After Positive FIT or Multitarget Stool DNA Testing
Gregory S. Cooper, Ashley Grimes, James Werner, Shufen Cao, Pingfu Fu, Kurt C. Stange
The Journal of the American Board of Family Medicine Jan 2021, 34 (1) 61-69; DOI: 10.3122/jabfm.2021.01.200345

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Barriers to Follow-Up Colonoscopy After Positive FIT or Multitarget Stool DNA Testing
Gregory S. Cooper, Ashley Grimes, James Werner, Shufen Cao, Pingfu Fu, Kurt C. Stange
The Journal of the American Board of Family Medicine Jan 2021, 34 (1) 61-69; DOI: 10.3122/jabfm.2021.01.200345
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