Result card

  • ECO4: What are the incremental effects of FIT relative to its comparator(s)gFOBT and no screening?
English

What are the incremental effects of FIT relative to its comparator(s)gFOBT and no screening?

Authors: Principal Investigators: Anna-Theresa Renner, Ingrid Rosian-Schikuta, Investigators: Nika Berlic, Neill Booth, Valentina Prevolnik Rupel

Internal reviewers: Pseudo178 Pseudo178, Pseudo283 Pseudo283, Pseudo291 Pseudo291, Pseudo293 Pseudo293, Pseudo294 Pseudo294, Pseudo297 Pseudo297, Pseudo298 Pseudo298

The effectiveness of the screening methods for CRC is elaborated in the Clinical Effectiveness domain. The incremental effectiveness of FIT versus gFOBT presented here is based on the results of the systematic literature review of cost-effectiveness studies using decision analytic modelling. 

There are differences in the output measures used by the included cost-effectiveness studies. Eight studies are using life-years gained as the measure of effectiveness {10, 12, 13, 16-19, 25}, six are using Quality adjusted life years (QALY) {14, 15, 20-24} and one is using the intermediate outcome “detected advanced tumours” {11}. Since there are different study designs (type of model, perspective, time horizon, population, etc.) and input parameters (sensitivity, specificity, compliance rate, etc.) the results of the models are not necessarily comparable.

Life-years gained when using FIT instead of gFOBT:

 

  • In general the results of the cost-effectiveness modelling show that using FIT instead of gFOBT increases the life-years per person. The incremental effects range from 0.041 life-years gained per person over a lifetime if annual screening is performed from age 65 – 79 {10}, to 0.003 life-years-gained after 10 years if only one round of screening is performed in a cohort of 50-75 year-olds {19}.
  • There are two different types of guaiac-based tests, which are frequently used as comparators in cost-effectiveness studies: Hemoccult II and Hemoccult SENSA. The effect on life-years gained of the latter, Heoccult SENSA, is estimated to be similar to that of the immunochemical tests {10, 25}.
  • Most studies using life-years gained as the measure for effectiveness are based on data from the USA and France {10, 12, 13, 16-18, 25}. Only one study is based on data from the Netherlands {19}.

 

Table 5: Incremental effects of FIT vs. gFOBT in life-years gained (LYG):

Author (year)

Life-years gained (1)

Comparators

Screening age

Participation rate

Discount rate

Country

van Ballegooijen et al. (2003) {10}

0.041

FIT 98%-specificity vs. gFOBT (Hemoccult II); annual

65-79

100%

3%

USA

0.04

FIT 95% specificity vs. gFOBT (Hemoccult II); annual

0.0008

FIT 98% specificity vs. gFOBT (Hemoccult Sensa); annual

0.00003

FIT 95% specificity vs. gFOBT (Hemocult Sensa); annual

Berchi et al. (2004) {12}

0.0198

FIT vs. gFOBT; after 20 years; biennial

50-74

43.7%

5%

France

Hassan et al. (2011) {13}

0.01707

Annual FIT vs. biennial gFOBT

50-74

Adherence(2): 40%; compliance(3): 100%

3%

France

0.01337

FIT vs. gFOBT; biennial

Heresbach et al. (2010) {16}

0.02744

FIT vs. gFOBT; after 30 years; biennial

50-74

42%

3%

France

Lejeune et al. (2010) {17}

0.01329

FIT vs. gFOBT; after 20 years; biennial

50-74

55%

3%

France

Parekh et al. (2008) {18}

0.00919

FIT vs. gFOBT; annual;

50-80

100%

3%

USA

van Rossum et al. (2011) {19}

0.003

FIT vs. gFOBT; after 10 years; 1 round of screening

50-75

gFOBT: 47%

FIT: 60%

3%

Netherlands

Zauber (2010) {25}

0.0144

FIT vs. gFOBT (Hemoccult II); annual

50-80

100%

3%

USA

-0.00005

FIT vs. gFOBt (Hemoccult Sensa); annual

 

(1) Per person when using FIT instead of gFOBT (over a lifetime if not stated otherwise)

(2) Attending initial screening

(3) Attending subsequent rescreening

QALYs gained when using FIT instead of gFOBT:

All included cost-effectiveness studies that used QALYs as effectiveness measure support the results of the studies using life-years gained as the endpoint. The results of the comparison between FIT and gFOBT range from 0.036 QALYs gained per person over a lifetime by screening a cohort of 50-75 year-olds annually with FIT instead of gFOBT {22}, to 0.01 QALYs gained over a lifetime when annually screening a population of the same age with a low performance FIT instead of a gFOBT {14}. The study with the highest QALY gain also assumes the highest compliance with the screening strategies (75%). The smallest differences between the effectiveness of FIT and gFOBT occur when the test performance (sensitivity) is assumed to be low. The studies using QALYs as effectiveness measure are based on data from Canada {14, 15, 22}, England {23}, France {21} and Ireland {20}. Wilschut et al. (2011) {24} does not give the estimated effects of FIT and gFOBT and hence does not allow an estimation of the incremental effects.

 

Table 6: Incremental effects of FIT vs. gFOBT in Quality Adjusted Life-years (QALYs):

Author (year)

QALYs gained (1)

Comparators

Screening age

Participation rate

Discount rate

Country

Heitman et al. (2009) (2) {14}

 

0.020

FITmid vs. gFOBT; annual;

50-74

adherence: 68%; compliance: 63%

5%

Canada

0.020

FIThigh vs. gFOBT; annual;

0.010

FITlow vs. gFOBT; annual;

Heitman et al. (2010) {15}

0.035

FIThigh vs. gFOBThigh; annual;

50-75

Adherence(3): 68%; compliance(4): 63%

5%

Canada

0.011

FITlow vs. gFOBTlow; annual;

Sharp et al. (2012) {20}

0.016

FIT vs. gFOBT; biennial;

55-74

53%

4%

Ireland

Sobhani et al. (2011) {21}

0.013

FIT vs. gFOBT; biennial;

50-75

57.3%

3%

France

Telford et al. (2010) {22}

0.036

FIT vs. gFOBT; annual;

50-75

73%

5%

Canada

Whyte et al. (2012) {23}

0.016

FIT vs. gFOBT; biennial;

60-74

adherence: 54%; compliance: 85%

3.5%

England

 

(1) Per person when using FIT instead of gFOBT (over a lifetime).

(2) The time horizon is not clearly stated in the published article but it seems likely to be over a lifetime.

(3) Attending initial screening

(4) Attending subsequent rescreening

 

Increase in detected advanced tumours when using FIT instead of gFOBT:

 

One cost-effectiveness study uses detected advanced tumours as effectiveness measure {11}. This is an intermediate outcome that is used in clinical studies, and can only be assumed to be correlated with the final outcomes, life-years and QALYs gained. The results of this study show that the higher the cut-off level of the FIT (ranging from 20 – 148 ng/ml) the less effective FIT becomes compared to gFOBT (incremental effects ranging from 188 more detected tumours by FIT compared to gFOBT to 99 less detected by FIT). The reason for this is that the positive predictive value increases with the cut-off level, which means that a higher cut-off level reduces unnecessary follow-up colonoscopies but it also reduces the chance that a tumour is found if the level of blood in the stools is low (e.g. 20ng/ml).

 

Overall, the FIT seems to be more effective than gFOBT irrespective of the outcome measure used. The only exception is Zauber (2010) who compared FIT with a specific gFOBT (Hemoccult SENSA) and estimated that this specific gFOBT is marginally more effective (at the 5th decimal place) than FIT {25}. 

The transferability of a model´s results depends on similarities and dissimilarities of the relevant settings. Important model parameters that should be comparable are the age range, the rate of compliance and the discount rate. Furthermore, the basic demography of the model country and the country-specific epidemiology should be considered when transferring results from one setting to another. 

Critical
Partially
Renner P et al. Result Card ECO4 In: Renner P et al. Costs and economic evaluation In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

References