Optimizing implementation of fecal immunochemical testing in Ontario: A randomized controlled trial J. Tinmouth, N.N. Baxter, L.F. Paszat, E. Randell, M. Serenity, R. Sutradhar, L. Rabeneck
Conflicts of interest None 2
Ontario s ColonCancerCheck Program Canada s first organized province-wide CRC screening program, 2008 Screening offered via family MD Ages 50-74 Average risk gfobt Increased risk Colonoscopy
Guaiac fecal occult blood test Pseudo-peroxidase of hemoglobin Done at home: 3 stools, 2 samples each FOBT+ colonoscopy 3 large RCTs meta-analysis 16% in CRC-mortality Hewitson, AJG 2008;103:1541-9
CRC screening in Canada Province Test(s) Stage of Program British Columbia (underway) FIT Province-wide Saskatchewan FIT Province-wide Manitoba gfobt Province-wide Ontario gfobt/c scopy Province-wide Prince Edward Island FIT Province-wide Nova Scotia (on hold) FIT Province-wide Alberta FIT Phased Roll Out Newfoundland & Labrador FIT Phased Roll Out Nunavut FIT Planning New Brunswick FIT Planning Quebec FIT Planning
What is FIT? Fecal immunochemical test (FIT) Specific for human hemoglobin Qualitative or quantitative Wet or Dry Potential automation in laboratory 6
FIT Much improved detection IMPROVED detection of CRC Test Sensitivity Specificity Hemoccult II 25-38% 98-99% FIT 61-91% 91 98% ALSO improved detection of POLYPS Whitlock, Annals Int Med 2008;149:638
Fecal immunochemical test (FIT) IMPROVED patient compliance Easier to collect Less stool contact One sample No diet restrictions >10% IMPROVEMENT over FOBT van Rossum LG et al., Gastro 2008;135:82 Hoffman RM et al. Prev Med 2010;5-6:297 8
FIT: Drawbacks Less stable than gfobt Hemoglobin degrades over time and at extreme temperatures Grazzini G et. al., GUT 2010;59:1511. 9
RECOMMENDATION Ontario Pilot recommended to guide implementation
Ontario FIT Pilot Study Objective: To inform the implementation of FIT in Ontario s ColonCancerCheck Program Pilot Design: Phase 1: Laboratory component Phase 2: Field component
Specific Aim To determine the impact on participation rates of: a) 2 methods of FIT distribution b) 2 methods of FIT return
FIT Kits 2 quantitative kits NS-Plus (Alfresa Pharma Corp.) OC-Diana (Eiken Chemical Company Ltd.) One sample Positive result: 15 µg Hb/g stool 13
Design: Cluster RCT 2085 MDs rostered practices invited 28 MDs randomly selected R 3865 rostered & eligible participants Mail/Mail Mail/Drop Off Pick Up/Mail Pick Up/Drop Off NS OC NS OC NS OC NS OC 14 days from sample collection to processing Results to patient and MD
Interventions Distribution methods Mailed invitation + FIT kit + instructions Mailed invitation to visit MD for screening Return methods Mail kit back (regular Canada Post) Drop kit at laboratory Patient Service Centre 15
Primary Outcomes FIT kit return w/in 6 months Secondary Positivity rates 16
Analyses Descriptive (counts, proportions) Logistic regression with Generalized Estimating Equations, adjusting for kit type, patient & physician factors 17
Baseline Patient Characteristics By Method of Distribution Characteristics Mail Out (n=1889) Pick Up (n=1967) Age (years) 50-59 60-69 70+ 62% 31% 7% 61% 30% 9% Male 52% 52% No Co-morbidity 92% 91% Prior FOBT 24% 20%
Baseline Patient Characteristics By Method of Return Characteristics Mail Back (n=1863) Drop Off (n=1993) Age (years) 50-59 60-69 70+ 64% 28% 8% 59% 32% 9% Male 51% 52% No Co-morbidity 92% 91% Prior FOBT 24% 20%
Results 18% of participants returned a kit within 6 months of invitation 20
Results By Method of Distribution Delivery method Kit returned w/in 6 months All Mail Out 24% Single mail out 16% Repeat mail out 28% Pick Up 13% 21
Results By Method of Return Delivery method Kit returned w/in 6 months Mailed back 19% Dropped off 18% 22
actors associated with FIT kit return Factor Distribution Single mail out Repeat mail out Pick up Return Mail back Drop off O.R. (95% C.I.) 2.97 (2.04 4.32) 2.75 (2.27 3.33) Ref 1.10 (0.81 1.49) Ref
Positivity Rates Overall & by method of return Cut-off 15 µg Hb/g stool 20 µg Hb/g stool Overall 13.6% 10.9% 24
Positivity Rates Over time 20.0% 18.0% 16.0% % of Kits Positive 14.0% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% 0-3 4 5 6 7 8 9 10+ # Days Between Sample Collection and Kit Processing 15 µg Hb/ 20 µg Hb/ 75 ng/ml 100 ng/ml g stool g stool
Positivity Rates Overall & by method of return Cut-off 15 µg Hb/g stool 20 µg Hb/g stool Overall 13.6% 10.9% Drop-off 14.3% 12% Mail-back 12.7% 9.6% 26
Time from collection to processing By Method of Return
Conclusions Mail-out of FIT improves participation Drop-off of FIT similar to mail-back Increased positivity rates over gfobt Positivity rates appeared to decline over time and were lower in mail back arm
Thank you 29
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Factors associated with FIT kit return Factor O.R. (95% C.I.) Participant prior gfobt 2.74 (2.25 3.33) MD prior FOBT use (ref=lowest) Highest Middle 1.56 (1.17 2.08) 1.57 (1.33 1.85)