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Research ArticleOriginal Research

“Finding the Right FIT”: Rural Patient Preferences for Fecal Immunochemical Test (FIT) Characteristics

Robyn Pham, Suzanne Cross, Bianca Fernandez, Kathryn Corson, Kristen Dillon, Coco Yackley and Melinda M. Davis
The Journal of the American Board of Family Medicine September 2017, 30 (5) 632-644; DOI: https://doi.org/10.3122/jabfm.2017.05.170151
Robyn Pham
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
BS
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Suzanne Cross
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
MPH, CHW
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Bianca Fernandez
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
BA
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Kathryn Corson
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
PhD
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Kristen Dillon
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
MD
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Coco Yackley
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
BS
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Melinda M. Davis
From Oregon Rural Practice-based Research Network, Portland, OR (RP, MMD); Community Health Advocacy and Research Alliance, Hood River (RP, SC, BF, KC, KD, CY, MMD); Columbia Gorge Health Council, The Dalles (SC, CY); The Next Door, Inc., Hood River (BF); PacificSource Columbia Gorge CCO, Hood River (KD); Department of Family Medicine & School of Public Health, Oregon Health & Science University, Portland (MMD).
PhD
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  • Article
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Article Figures & Data

Figures

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  • Appendix 1.
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    Appendix 1.

    Images and Materials Associated with Each FIT Kit Tested (N = 6 FITs)

Tables

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    • View popup
    Table 1.

    Characteristics of FITs Identified for User Testing (Selection Date: Summer/Fall 2015)

    FIT Kit Name (Manufacturer)Test InstructionsMaterials Included in KitSamples, No.Cards, No.Other Kit Characteristics
    Collection/ Storage MethodInstructions ProvidedOther MaterialsPositivity Rate*Sensitivity for CRC†
    OC-Light® (Polymedco)Place paper in toilet, deposit stool onto paper, use grooved probe to collect sample before stool touches water, store sample inside liquid vial. Fill out the label on the tube, wrap tube in absorbent pad, insert into specimen bag.Grooved probe/vialEnglish—YSpecimen bag, biodegradable paper, absorbent pad, CRC fact sheet1N/A8.4 to 14.2%52,5388% to 96%52,53
    Spanish—Online only
    Color pictures—N
    Hemosure® iFOB Test (Hemosure, Inc.)Affix adhesive paper on toilet, deposit stool on paper, poke grooved probe in stool at 6 different sites, screw applicator back into vial, place into specimen bag.Grooved probe/vialEnglish—YSpecimen bag, adhesive flushable tissue1N/ANo studies available
    Spanish—Y88%54 (per company website)
    Color Pictures—Y
    QuickVue® (Quidel)Fill out label on collection vial. Affix paper on toilet and deposit stool on paper. Poke grooved probe in stool at 5 different sites, screw probe into vial, shake. Insert vial into absorbent pad and specimen bag, seal.Grooved probe/vialEnglish—YSpecimen bag, absorbent pad, adhesive flushable tissue1N/ANo studies availableNo studies available
    Spanish—Y
    Color Pictures—Y
    InSure® FIT™ (Enterix Inc.)Brush stool in toilet water, brush sample on card A. Complete label and affix onto flap to reseal. Repeat process with a different bowel for card B.Brush (2)/ cardEnglish—YN/A214.6 to 5.6%5587%55
    Spanish—Online only
    Color pictures—English only
    OneStep+ (Henry Schein)Affix paper on toilet, deposit stool on paper, collect sample from 4 different sites of stool using wooden stick. Open flap on sample card, apply sample to window 1, spread evenly to cover, close flap. Repeat to complete window 2 with next bowel movement.Wooden Stick (2)/ CardEnglish—YAdhesive flushable tissue1 to 21No studies availableNo studies available
    Spanish—Y
    Color Pictures—N
    Hemoccult® ICT (Beckman Coulter)Place plastic wrap or newspaper over toilet, place provided tissue on top of wrap/newspaper to catch stool over water. Deposit stool, collect two samples with wooden stick, open flap on card, spread samples on flap, close, and dry overnight. Repeat with additional card(s) on a new day.Wooden stick (2 to 3)/cardsEnglish—YFlushable tissue2 or 3 days2 to 33.2% to 9%56,5798%53
    Spanish—Online only
    Color Pictures—N
    • ↵* Positivity rate is the proportion of test that have a positive result.

    • ↵† Sensitivity is the proportion of actual positives which are correctly identified as such (eg, the percentage of patients with CRC who are correctly identified as having the condition).

    • Note: All 6 FIT kits are Clinical Laboratory Improvement Amendments (CLIA) waived and can be used at the point of care. We could not locate clinical effectiveness data for 2 of the tests. Many of the 132 tests listed by the Federal Drug Administration for detection of fecal occult blood lack publicly available data on clinical effectiveness.

    • View popup
    Table 2.

    Demographic Characteristics of Participants Engaged in FIT Testing and Focus Groups

    CharacteristicsCompleted FIT Kits and Questionnaires (N = 18)Participated in Focus Group (N = 13)
    Female9 (50)8 (62)
    Age, mean (SD)55.6 (4.3)55.5 (7.4)
    Hispanic10 (55.6)7 (53.8)
    Primary language
        English9 (50.0)7 (53.8)
        Spanish9 (50.0)6 (46.2)
    Insurance
        Medicaid9 (50.0)6 (46.2)
        Medicare2 (11.1)0 (0)
        Uninsured3 (16.7)5 (38.4)
        Private3 (16.7)2 (15.4)
        Unknown1 (5.5)0 (0)
    County of residence
        Wasco10 (55.6)9 (69.2)
        Hood river5 (27.8)2 (15.4)
        Multnomah2 (11.0)1 (7.7)
        Klickitat1 (5.6)1 (7.7)
    FIT or gFOBT in prior 3 years5 (29)*1 (7.7)†
    • ↵* N = 17.

    • ↵† N = 12.

    • View popup
    Table 3.

    Participant Agreement with Statements about the FIT Kits on the Study Questionnaires

    OC-Light®, % (N = 12)Hemosure® iFOB Test, % (N = 13)InSure® FIT™, % (N = 14)QuickVue®, % (N = 12)OneStep+, % (N = 11)Hemoccult® ICT, % (N = 11)
    % Responses Agree/Strongly Agree
        After reading the directions, I felt sure I knew how to use the kit correctly.836279757345
        The kit package was easy to open.10092100100100100
        The collection tool (tube, brush or stick) was easy for me to use.10010093759164
        Collecting the sample was quick.928586839160
        I feel confident I did everything correctly.837786758264
        Most people I know would be willing to complete a kit like this.835067555027
        Using this kit was no big deal.837577588236
    % Responses Disagree/Strongly Disagree
        I had problems collecting the stool sample.828579837360
        Collecting the sample was disgusting.554646501836
        [It was] embarrassing to store the sample.N/AN/A55N/A5025
    • View popup
    Table 4.

    Descriptive Findings from the FIT Kit Specimen Adequacy Analysis (N = 66)

    OC-Light® (N = 12)Hemosure® iFOB Test (N = 13)InSure® FIT™ (N = 7)QuickVue® (N = 11)OneStep+ (N = 12)Hemoccult® ICT (N = 11)
    Packaged correctly7 (58)8 (62)7 (100)8 (73)12 (100)10 (91)
        In mailer (Y)11 (92)11 (85)7 (100)10 (91)12 (100)10 (91)
        In bio bag (Y)8 (67)11 (85)N/A11 (100)N/AN/A
        With pad (C)7 (58)8 (62)N/A9 (82)N/AN/A
    Labeled correctly8 (67)5 (38)6 (86)5 (45)8 (67)7 (64)
        Label (Y)7 (58)5 (38)5 (71)5 (45)7 (58)7 (64)
        Different days (Y)N/AN/A4 (57)N/A4 (33)5 (45)
        Collection date (Y)8 (67)5 (38)6 (86)4 (36)7 (58)7 (64)
    Sampled correctly10 (83)12 (92)6 (86)11 (100)11 (92)7 (64)
        Color of liquid (T/B)10 (83)12 (92)N/A11 (100)N/AN/A
        Returned all cardsN/AN/A7 (100)*N/A12 (100)*9 (82)†
        Sample on all cardsN/AN/A7 (100)N/A11 (92)8 (73)†
        Specimen appearanceN/AN/A7 (100)N/A12 (100)10 (91)
        Coverage (>50%)N/AN/A6 (86)N/A11 (92)7 (64)
        ClosedN/AN/A7 (100)N/A12 (100)10 (91)
    • B, brown; C, correct; T, tan; Y, yes.

    • ↵* 1 card total.

    • ↵† 3 cards total.

    • View popup
    Table 5.

    FIT Kit Rankings from Most to Least Preferred by Questionnaire and Focus Group Data

    A. Combined Rankings for FIT Kit User Testing Data Sets

    FIT NameData SourceOverall
    Questionnaire (N = 79)English Focus Group (N = 6)Spanish Focus Group (N = 8)
    OC-Light®112/3*1
    Hemosure® iFOB Test2/3*312
    InSure® FIT™2/3*22/3*3
    QuickVue®4444
    OneStep+5555
    Hemoccult® ICT6666
    • ↵* 2/3 signifies a tie for second place.

  • B. Test Characteristics for Overall FIT Kit Ranking

    Kit RankingCollection ToolInstructionsNo. Sampling DaysNo. Cards
    ProbeStickBrushColored PicturesLarge Font123123
    1. OC-Light®XXX
    2. Hemosure® iFOB TestXXXX
    3. InSure® FIT™XXXX
    4. QuickVue®XXX
    5. OneStep+XXXX
    6. Hemoccult® ICTXXXXX
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The Journal of the American Board of Family     Medicine: 30 (5)
The Journal of the American Board of Family Medicine
Vol. 30, Issue 5
September-October 2017
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“Finding the Right FIT”: Rural Patient Preferences for Fecal Immunochemical Test (FIT) Characteristics
Robyn Pham, Suzanne Cross, Bianca Fernandez, Kathryn Corson, Kristen Dillon, Coco Yackley, Melinda M. Davis
The Journal of the American Board of Family Medicine Sep 2017, 30 (5) 632-644; DOI: 10.3122/jabfm.2017.05.170151

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“Finding the Right FIT”: Rural Patient Preferences for Fecal Immunochemical Test (FIT) Characteristics
Robyn Pham, Suzanne Cross, Bianca Fernandez, Kathryn Corson, Kristen Dillon, Coco Yackley, Melinda M. Davis
The Journal of the American Board of Family Medicine Sep 2017, 30 (5) 632-644; DOI: 10.3122/jabfm.2017.05.170151
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