Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

Fecal Immunochemical Test (FIT) for colorectal cancer screening compared to CRC screening with Guaiac –based fecal occult blood test (gFOBT) in the screening of Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC). in healthy and/or asymptomatic adults and elderly Any adult over 50 years old, both men and women, with average risk of CRC.

(See detailed scope below)

HTA Core Model Application for Screening Technologies 1.0
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Mirjana Huic (AAZ), Agnes Männik (UTA - Estonia), Jesus Gonzalez (ISCIII - Spain), Ingrid Rosian (GÖG - Austria), Gottfried Endel (HVB - Austria), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), AETSA (Spain), A. Gemelli (Italy), Avalia-t (Spain), CEIS (Italy), CEM (Luxembourg), GÖG (Austria), HAS (France), HVB (Austria), IER (Slovenia), ISCIII (Spain), Laziosanità (Italy), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), Osteba (Spain), Regione Veneto (Italy), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
5.4.2013 13.07.00
31.7.2014 9.21.00
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 2 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=206

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

<< Organisational aspectsLegal aspects >>

Social aspects

Authors: Pseudo275 Pseudo275, Pseudo108 Pseudo108

Summary

The two systematic reviews, both published in 2012 (Vart et al. 2012 and Hassan et al. 2012) found that overall participation rate/rate of adherence resulting from their meta-analysis is significantly higher with FIT than with g-FOBT. All other socio-economical association, but not gender, and reasons for a better compliance need to be better investigated. Contextual socio-cultural variables seem to affect compliance, but ad hoc comparative cross national studies should be performed.

Introduction

The social domain deals with the impact the two tests can have on patients. The patient is considered both as an “individual” with his/her own psychology, emotion, perceptions, skills and capacities  and as a “social subject”,  an individual who is part of a community or/and a group - characterized by e.g. geographical location, religion, ethnicity, socio-economic status, age, gender etc. - with which he/she shares values, believes, experiences and culture. From an individual point of view barriers to compliance can be inconvenience of the process, embarrassment, repugnance to manipulating stool, discomfort with the procedure of the test, lack of perceived risk to develop a cancer,  fear of diagnosis, but also an individual lack of understanding and a need of information/communication provided by health providers on the technology. A specific economic status, age, ethnic group etc. can also be independent variables  for compliance with one test or another, this suggesting different screening paths for different groups or/and different ad hoc educational program. Patterns of adherence by age or sex or both, ethnicity or socioeconomic status were reported in many programs that used these tests (Vernon S. W, et al. 1997).

Social, cultural and psychological variables could affect satisfaction with and acceptance of gFOBT and FIT and thus the compliance with the tests and with their procedure (uptake, use, return). It is important to consider these aspects when designing a screening program as a higher or lower compliance in a first round population screening can affect the overall participation in the program and also the  effectiveness of the screening program.  In this context willingness of individuals to perform the screening test has as equal importance as the diagnostic accuracy  of the test, because without participation no detection is possible (Hassan et al. 2012).

Methodology

Frame

The collection scope is used in this domain.

TechnologyFecal Immunochemical Test (FIT) for colorectal cancer screening
Description

FITs use an antibody (immunoglobulin) specific to human globin, the protein component of haemoglobin, to detect fecal occult blood. Immunochemical tests have improved test characteristics compared to conventional guaiac-based tests for fecal occult blood. FIT should not be subject to interference from dietary blood and it is more specific to bleeding from the distal gastrointestinal tract. They could be analytically and clinically more sensitive and specific, Their measurement can be automated and the user can adjust the concentration at which a positive result is reported. A wide range of qualitative and quantitative tests is presently available, with varying levels of sensitivity and specificity (like Hem-SP/MagStream H, Fujirebio Inc. Japan ; OC-Sensor, Eiken Chemical Co., Tokyo, Japan;    FOB Gold, Medinostics Products Supplier; Sentinel Diagnostics SpA, Milan, Italy).

Intended use of the technologyScreening

CRC screening with faecal inmunochemical test (FIT) for detection of occult blood in the stool associated with colorectal lesions (adenomas and CRC).

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Early detection and treatment of colorectal lesions before they become symptomatic has the potential to improve control of the disease, reducing morbidity and mortality associated to CRC. Early treatment of invasive lesions can be generally less detrimental for quality of life. The endoscopic removal of pre-malignant lesions also reduces the incidence of CRC by stopping the progression to cancer. Colorectal cancers and adenomatous polyps bleed has providing fecal blood haemoglobin as the biomarker of choice for current screening programmes. Stool samples could be periodically taken and analyzed for the presence of occult blood, as an early sign of colorectal lesions (adenoma or CRC).

Target condition
Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC).
Target condition description

CRC is the third most common in incidence and the fourth most common cause of cancer death worldwide. CRC is particularly suitable for screening. The disease is believed to develop in a vast majority of cases from non-malignant precursor lesions called adenomas. Adenomas can occur anywhere in the colorectum after a series of mutations that cause neoplasia of the epithelium. At some time , the adenoma may invade the submucosa and become malignant. Initially, this malignant cancer is not diagnosed and does not give symptoms  (preclinical phase). It can progress from localised (stage I) to metastasised (stage IV) cancer, until it causes symptoms and is diagnosed. Only 5–6% of the population actually develop CRC. The average duration of the development of an adenoma to CRC is estimated to be  at least 10 years. This long latent phase provides a window of opportunity for early detection of the disease.

Target population

Target population sex: Any. Target population age: adults and elderly. Target population group: Healthy and/or asymptomatic people.

Target population description

Adults, average risk of CRC, aged 50 years or over.

The best age range for offering gFOBT or FIT screening has not been investigated in trials. Circumstantial evidence suggests that mortality reduction from gFOBT is similar in different age ranges between 45 and 80 years .The age range for a national screening programme should at least include people aged 60 to 64 years in which CRC incidence and mortality are high and life-expectancy is still considerable. Only the FOBT for men and women aged 50–74 years has been recommended todate by the EU (Council Recommendation and the European guidelines for quality assurance in CRC screening and diagnosis).

Members of families with hereditary syndromes, previous diagnosis of CRC or pre-malignant lesions should follow specific surveillance protocols and are not included in the target population

ComparisonCRC screening with Guaiac –based fecal occult blood test (gFOBT)
Description

CRC screening with Guaiac–based fecal occult blood test (gFOBT)

The guaiac-based FOBT is still a commonly used method for detecting blood in faeces. To detect hemoglobin the test uses guaiac gum and its efficacy as a colorectal cancer screening test has been analyzed in several randomised controlled trials. The test detects the haem component of haemoglobin, which is identical across human and animal species and is chemically robust and only partially degraded during its passage through the gastrointestinal tract. gFOBTs cannot distinguish between human blood and blood residues from the diet.

Many guaiac-based tests are currently on the market (like Coloscreen, Helena Laboratories,Texas,USA; Hema-screen Immunostics Inc.; Hemoccult, Beckman Coulter Inc.; Hemoccult SENSA, Beckman Coulter Inc.; MonoHaem, Chemicon Europe Ltd; Hema-Check, Siemens PLC; HemaWipe, Medtek Diagnostics LLC)

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Population-based programmes have been rolled out nationwide in several European countries. Many member states  haveestablished nationwide non-population-based programmes. Some states are planning or piloting a nationwide population-based programme. These have  adopted only FOBT, some only FIT, some a mix between FOBT and endoscopy, or only colonoscopy.

Outcomes

CUR and TEC

  • Health problems (target condition)
  • Epidemiology
  • Burden of disease
  • Target population
  • Current management of the condition
  • Features of the technology
  • Life-Cycle
  • Regulatory status
  • Utilization
  • Investments and tools required to use the technology
  • Training and information needed to use the technology

SAF

  • Colonoscopy probability of perforation
  • Colonoscopy with polypectomy probability of perforation
  • Colonoscopy probability of death following perforation
  • Probability of bleeding following colonoscopy
  • Psychological harms from false-negatives and false-positives (and generally from participating in screening program)

EFF

  • Test (FIT and gFOBT) sensitivity for adenomas
  • Test (FIT and gFOBT) sensitivity for cancer
  • Test (FIT and gFOBT) specificity for adenomas
  • Test (FIT and gFOBT) specificity for cancer 
  • Adenoma incidence (detection rates)
  • Rectal cancer incidence (detection rates)
  • Colon cancer incidence (detection rates)
  • CRC incidence (detection rates)
  • Stage distribution of detected cancers
  • Rectal cancer specific mortality
  • CRC specific mortality
  • Overall mortality
  • Life years saved

ECO:

  • Model/template for  national pilots  to assess the costs and benefits of the two alternative  technologies FIT and gFOBT  and also no-programmed-screening
  • Systematic literature search of   available models and/or economic  evaluation for screening colorectal cancer with FIT and gFOBT and no screening programme
  • Resource Utilization: Publicly funded health care payer costs (screening tests, further examinations e.g. labor, colonoscopy  and treatments and administration and organisation costs of screening programme) for FIT and gFOBT (in cooperation with ORG)
  • Cost per Case detected (average, marginal, incremental) =  intermediate outcome – optional, not decided yet (relevant for deciding how often a test should be carried out and what are the incremental costs for a “new” detected case
  • Indirect Costs: not for the Core modell (should be decided later on)
  • Test accuracy: from SAF
  • Cost effectiveness analysis: HRQoL measures (both generic and context specific) (EFF and SAF for help, own Lit.research), ICER

 ORG:

  • Responsiveness of target population to invitation
  • Invitation-reminder system
  • Competence of human resources – health professionals
  • Investments needed (material,equipment)
  • Costs of using both tests (FIT, gFOBT)
  • Timeliness of results and future phases
  • Use of tools for process monitoring (completed check lists)
  • Model for Budget Impact Analysis from perspective of the payer

SOC

  • Compliance with the tests (FIT, gFOBT)
  • Anxiety and any psychological effects of using  one test or another
  • Information, counseling, communication (quality of) for the use of tests
  • Satisfaction  
  • Quality of life
  • Equity of access

LEG

  • Information as baseline for an informed consent
  • Harms or inequities that can be taken to court

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
H0001Major life areasWhich social areas does the use of the technology influence?yesWhich social areas does the use of FIT and gFOBT influence?
H0002Major life areasWho are the important others that may be affected, in addition to the individual using the technology?yesWho are the important others that may be affected, in addition to the individual using gFOBT and FIT?
H0004Major life areasWhat kind of changes may the use of the technology generate in the individual's role in the major life areas?noWe do not think that the screening of crc will provide major role-changes. This could be relevant with a positive screening result, but not for the screening participation.
H0003Major life areasWhat kind of support and resources are needed for the patient or citizen as the technology is introduced?noThis part is better treated in Organisational and costs domains.
H0010Major life areasWhat kind of social support and resources are needed for the providers as the technology is introduced?noBetter to be trated in the organisational domain.
H0011Major life areasWhat kinds of reactions and consequences can the introduction of the technology cause at the overall societal level?noIn many countries the FOBT or FIT tests are already used as screening. There are no experiences about any reactions or consequences on the overall societal level.
H0012IndividualAre there factors that could prevent a group or persons to participate?yesAre there factors that could prevent a group or persons to participate?
H0006IndividualHow do patients, citizens and the important others using the technology react and act upon the technology?yesHow do patients, citizens and the important others using FIT or gFOBT react and act upon them?
H0005IndividualWhat kind of physical and psychological changes does the implementation and use of the technology bring about and what kind of changes do patients or citizens expect?noRelevant if we had to focus on the whole screening process. Further gFOBT and FIT do not cause harms.
H0007CommunicationWhat is the knowledge and understanding of the technology in patients and citizens?yesWhat is the knowledge and understanding of FIT or gFOBT in patients and citizens?
H0008CommunicationHow do patients and citizens perceive the information they receive or require about the technology?yesHow do patients and citizens perceive the information they receive or require about FIT and gFOBT?
H0009CommunicationWhat influences patients’ or citizens’ decisions to use the technology?yesWhat influences patients’ or citizens’ decisions to use FIT or gFOBT?
H0013CommunicationWhat are the social obstacles or prospects in the communication about the technology?yesWhat are the social obstacles or prospects in the communication about gFOBT and FIT?

Methodology description

Domain frame

We will focus on the social, cultural and psychological variables that can affect the uptake – use and return of gFOBT and FIT - and will look for studies aimed at collecting evidence that tried to verify those associations or at collecting more in depth information on psychological barriers to the use of the two tests.

For some research questions we could not find any evidence, and this is highlighted in each related result card. For other research questions we detected an intra-domain overlap, so we chose to subsume evidence in only one of the two research questions and result cards that we had judged to overlap (see each single result cards for more information on intra-domain overlapping).

We could find evidence for 4 research questions/assessment elements out of the 8 we initially had selected. Result cards we filled are described below.

The first is SOC7 - AE H0001 (Which social areas does the use of FIT and gFOBT influence?). In this Result card we included evidence on how characteristics of the tests and their procedure are perceived by individual in his/her daily life (e.g. more or less burdensome according to impact on individual’s major life areas such as lifestyle and daily activities).

SOC14 - AE H0009 (What influences patients or citizens decisions to use FIT or gFOBT?) is a question that points out how societal influences can affect compliance and participation. In this result card we summarized evidence about influence of social identity (e.g. ethnicity) and of the group to which individual belongs (defnied by age, or socio-economic status, gender etc.) on compliance and participation.

The SOC10 – AE H0006 (How do patients, citizens and the important others using FIT or gFOBT react and act upon them?)  contains the evidence on different compliance and participation rates with one test or the other as it is also about satisfaction (thus compliance and participation) of  citizens using the technology.

SOC11- AE H0007 (What is the knowledge and understanding of FIT or gFOBT in patients and citizens?) is a result card were we report studies that provide information on understanding of the technology by patients related to communication or information provided by health care providers (information leaflets, invitation letters). This research question (and result card) overlaps with ORG domain, where – at least in the case of a screening program - more information can probably be found.

 

Information sources

A specific search for the social domain was conducted in the traditional databases. No mix with the literature of other domains was done. For the Search Strategy see Appendix 1.

Inclusion criteria:

We included all secondary and primary studies that where about target population (50-64 years and 65+ years; male and female; healthy/asymptomatic population; compared FIT vs gFOBT and measured/dealt with outcomes related to the social domain (e.g. compliance , participation rates associated with socio-demographical variables etc.). We included RCTs and observational studies and qualitative social studies, also if related to just one of the two technologies at stake.

A list of all the studies we selected for the full text reading is provided in the Appendix 2, with reasons for exclusion.

Quality assessment tools or criteria

As a measurement tool to assess the methodological quality of systematic reviews we used AMSTAR (at least 6 score). For primary studies we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS). See appendix 4 and 5 for both instruments applied to selected primary and secondary studies.

 

Analysis and synthesis

All abstracts from the domain specific literature search were screened by both ALS and IW, on the basis of the previously agreed inclusion criteria. Disagreement on inclusions were discussed. We read in double full articles of all the selected records, and extracted information/data from them on the basis of each single assessment elements using ad hoc extraction sheets. After this we refined which study had to be included and, for each of them, and independent data extraction was performed.

 

When a systematic review was relevant for answering  a specific result card’s question and was judged of good quality, this was our main source of information. To this we added information and data from the studies we had selected that were not included in the systematic review itself. Not all the studies and systematic reviews had relevant information and data for each single result card/assessment element. When studies were relevant, data and information from each of them where extracted and reported in the relevant result card.

 

Overall results

 

Included studies

 

Elevent 11records (Birkenfeld et al. 2011, Cole et al. 2003, Federici et al. 2005, Hassan et al. 2012, Hawley et al. 2008, Hol 2010a and Hol 2010b, Hughes et al. 2005, Levi et al. 2011, van Rossum et al. 2010, Vart et al. 2012) were included in the analysis of the social domain. Nine (9) primary studies (8 RCTs and one prospective observational study) and 2 systematic reviews (Hassan et al. 2012, Vart 2012). The complete list of all included studies and extraction of their characteristics can be found in Appendix 3. No qualitative social studies were included.

 

The two studies by Hol published in 2010 refer to the same population based trial, but describe results of different “line of research” made on the same cohort.  Both were included as they provided evidence for different result cards (compliance and socio-economic factors affecting it).

The two Israeli studies published in 2011 (Birkenfeld et al. and Levi et al) are based on the same population, but as  above, the Birkenfeld at al. article aimed at verifying if socio economic status impacted on compliance within the same population-based study described in Levi et al.). We included both Hol’s and both Levi’s and Birkenfeld as, although based on same population, they reported results on different social outcomes we included in our focus.

 

 

 

 

 

Year of publication

The studies were published in 2003 (Cole et al., 2003), 2005 (Federici et al 2005, Hughes et al 2005), 2008 (Hawley et al 2008), 2010 (Hol et al 2010a and Hol et al. 2010b, van Rossum 2010), 2011 (Birkenfeld et al. 2011, Levi et al. 2011), and 2012 (Hassan et al. 2012, Vart et al. 2012). None of the studies had a huge gap between study conduction and study publication.

 

Country

Three of the primary studies were from the Netherlands (Hol et al. 2010a and Hol et al. 2010b, van Rossum et al. 2010) two of the studies were from Israel (Birkenfeld 2011, Levi 2011 but same population from which they published two articles on different outcomes), 1 from the USA (Hawley 2008,), two from Australia (Cole  2003, Hughes 2005) and one from Italy (Federici 2005). The two systematic reviews (Hassan 2012, Vart 2012) were included studies from Australia, Italy, Netherlands, USA, Israel. Hassan 2012 included 14 studies in their meta-analysis, 4double with our search results (Federici 2005, van Rossum 2008, Hoffmann 2010, Hol 2010, Levi 2011,), whereas two included in Hassan were excluded by us (Segnan 2007 and Quintero 2012 due to no comparison of FIT versus gFOBT). Vart included 7 studies in their metanalysis, among them we did not include just Hoffman due to target population (male and veterans), while Hol 2009 was not retrieved with our search strategy, which on the other hand included two other Hol’s studies both published in 2010, which are based on the same cohort of healthy Dutch people.

 

Funding

Ten studies provided information about funding of the research, in two studies the funding was unclear or not mentioned (Hawley 2008, Federici 2005). Three studies reported a funding from companies (Birkenfeld 2011, Cole 2003, Levi 2011), four studies reported a funding by official organisations (Hassan 2012, Hol 2010a, van Rossum 2008, Vart 2012) and two studies (Hol 2010b, Hughes 2005) reported mixed official and company funding.

 

 

Official funding

Funding from companies

Birkenfeld, et al. 2011

 

Eiken Japan provided the OC-MICROTM instrument, reagents and partial financial support for administration.

Cole, et al. 2003

 

Grant support: Hemoccult SENSA and FlexSure OBT cards

were purchased from Beckman Coulter Inc. (Palo Alto CA,

USA). Enterix Inc. (Portland ME, USA) provided InSure test

kits. Grants from the Bushell Foundation and Enterix Inc.

provided part support for salaries (SC, BC).

Federici et al. 2005

Not applicable

Not applicable

Hawley et al. 2008

Unclear

Unclear

Hol 2010a (44)

This trial was funded by the Dutch Cancer Society (EMCR

2006-3673), and the Dutch Ministry of Health, Health Care Prevention

Program–Implementation (ZonMw 2006-5877).

 

Hol 2010b (46)

This trial was funded by the Dutch Cancer Society (EMCR 2006-3673), the

Dutch Ministry of Health, Health Care Prevention Program–Implementation (ZonMw

2006-5877),

Olympus Medical Systems Europe GmbH, Hamburg, Germany and Eiken

Chemical Co., Tokyo, Japan.

Hughes et al.  2005

This research was funded by Queensland Health. The pathology laboratory at Townsville General Hospital, which provided analysis of Hemoccult-II kits at a greatly reduced fee.

In addition, funding was subsidised by Enterix (Inc), which made the !nform FOBT kit and its analysis available at a highly discounted rate.

Levi et al. 2011

 

Eiken Japan provided the OC-MICROTM instrument, reagents and partial financial support for administration.

Van Rossum et al. 2008

Netherlands organization for Health Research and Development (ZonMW: number 50-50115-98-060, project 63000004)

 

Hassan et al.  2012

This study was partially funded by the Italy Ministry of Health, through a project coordinated by the Agenzia Nazionale per i Servizi Sanitari and conducted

by Laziosanità: ‘Strumenti e metodi per il governo dei processi di innovazione tecnologica, clinica ed organizzativa nel SSN – Un sistema integrato di ricerca’,

 sub-project ‘Analysis of the impact of professional involvement in evidence generation for the HTA process’ grant no. I85J07000080001.

 

Vart et al. , 2012

This research was funded via studentship provided by The Guildford Tumour Screening (G.U.T.S) charity for part fulfilment of the degree PhD Health Psychology at the University of Surrey

 

 

 

Trial registration (RCTs)

One study provided a trial registration number (van Rossum 2008).

 

Basic population data

 

SYSTEMATIC REVIEWS

Vart 2012

 

Number of included studies was 7;

(Cohorts ranged from 1818 (Cole 2003) to 20623 (van Rossum 2008).

50+

n.a.

screening population

n.a.

n.a.

population based program setting

FIT

gFOBT

Hassan 2012

Five studies compared g-FOBT with FIT, including 59 729 randomised subjects

 

Number of included studies was 5

50-74 (4x), 50-75 (4x); 55-64 (3x); 50-54/65-69 (1x); 50-80 (1x); 50-69 (1x)

male 49.5%; female 50.5% (own calculation of all studies included in the meta analysis)

no exclusions

n.a.

n.a.

population screening

FIT/gFOBT/endoscopy

FIT/gFOBT/endoscopy

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PRIMARY STUDIES

Birkenfeld 2011

16132 [10668 (gFOBT) + 5464 (FIT)]

60-74

43,1% male; 56,9% female

asymptomatic

10,8% immigrants

34% high SES, 36,6% medium SES, 29,4% low SES

Israel

primary care clinic registrees, setting population-based like

FIT

gFOBT

Cole 2003

1818 (3 groups of each 606)

 

 

 

 

 

 

 

 

 

50-69

 

 

 

 

 

 

 

 

 

 

 

49,5% male, 50,5% female (own calculation of table 1)

no exclusions

Exposure of this population to screening was low by US standards and prior participation in screening had been less than 20%.

Exposure of this population to screening was low by US standards and prior participation in screening had been less than 20%.

Australia

population screening

FIT

 

 

 

 

 

 

 

 

 

 

gFOBT

 

 

 

 

 

 

 

 

 

 

Federici 2005

7320

50-74

Guaiac 46.9% men  FIT 45.8% men

average risk

no

no

Italy

population screening

FIT

gFOBT

Hawley 2008

220

50-80

not specified, proportion controlled in the analysis

asymptomatic

74 white, 60 Africans, 78 Hispanic

 

USA, Michigan

None. Diverse hypothetical scenarios. Southern urban

FOBT, COL, SIG, FIT, V-COL

 

Hol 2010a

852

50–74

45.3% male (FOBT), 50.6% male (FIT), 50.7% (FS)

asymptomatic

5% non Cuacasian

no

NL

population screening

FIT

FOBT, FS

Hol2010b

15111

50-74

participation OR for Women 1.1 (0.9 to 1.4) (FOBT)  1.3 (1.1 to 1.4)(FIT) 0.9 (0.8 to 1.0)(FS)

asymptomatic

n.a.

n.a.

NL

population screening

FIT

FOBT, FS

Hughes 2005

3358

50-74

51.2% female

asymptomatic

no

no

Australia

population screening

FIT

FOBT, FS

Levi 2011

12,539 (4,657 FIT; 7,880 G-FOBT)

mean age FIT: 60.4, mean age FOBT 61.3

45.4% male for FIT, 42.6% male for FOBT

asymptomatic

n.a.

SES controlled

Israel

population screening

FIT

FOBT

van Rossum 2008

Out of 20.623 people the test was sent to 10.993 tests were returned

50-75 years (50.4% with GFOBT and 51.7% with IFOBT aged < 60)

47.8% (GFOBT) and 48.8% (IFOBT) male

asymptomatic

n.a.

n.a.

Netherlands

population based program setting

FIT

gFOBT

 

 

Result cards

Major life areas

Result card for SOC7: "Which social areas does the use of FIT and gFOBT influence?"

View full card
SOC7: Which social areas does the use of FIT and gFOBT influence?
Method
Result

Importance: Important

Transferability: Partially

Result card for SOC8: "Who are the important others that may be affected, in addition to the individual using gFOBT and FIT?"

View full card
SOC8: Who are the important others that may be affected, in addition to the individual using gFOBT and FIT?
Method
Frame
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Communication

Result card for SOC11: "What is the knowledge and understanding of FIT or gFOBT in patients and citizens?"

View full card
SOC11: What is the knowledge and understanding of FIT or gFOBT in patients and citizens?
Method
Result
Comment

Importance: Important

Transferability: Partially

Result card for SOC12: "How do patients and citizens perceive the information they receive or require about FIT and gFOBT?"

View full card
SOC12: How do patients and citizens perceive the information they receive or require about FIT and gFOBT?
Method
Frame
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Result card for SOC14: "What influences patients’ or citizens’ decisions to use FIT or gFOBT?"

View full card
SOC14: What influences patients’ or citizens’ decisions to use FIT or gFOBT?
Method
Result
Comment

Importance: Important

Transferability: Partially

Result card for SOC15: "What are the social obstacles or prospects in the communication about gFOBT and FIT?"

View full card
SOC15: What are the social obstacles or prospects in the communication about gFOBT and FIT?
Method
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Individual

Result card for SOC6: "Are there factors that could prevent a group or persons to participate?"

View full card
SOC6: Are there factors that could prevent a group or persons to participate?
Method
Frame
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Result card for SOC10: "How do patients, citizens and the important others using FIT or gFOBT react and act upon them?"

View full card
SOC10: How do patients, citizens and the important others using FIT or gFOBT react and act upon them?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Discussion

The two systematic reviews, both published in 2012 (Vart et al. 2012 and Hassan et al. 2012) found that overall participation rate/rate of adherence resulting from their meta-analysis is significantly higher with FIT than with g-FOBT.  Hassan et al. included two more studies (Cole et al 2003 and Hughes et al. 2005), this may be due to different search strategy, but this does not change final result.

Both studies’ authors highlight that inter-study heterogeneity in their meta-analysis is higher, but is related only to one included study, Levi et al (2011). The exclusion of Levi et al resulted in a reduction in the  I2 e  from 96% to to 0% (Hassan et al.2012). Result of the Israeli population based study show that contextual socio-cultural and/or geographical variables might affect compliance.

Reasons for FIT outperforming gFOBT (or the opposite, in the case of Isreali studies) in compliance rate needs to be better investigated via qualitative studies and quantitative designs that confirm any interpretative hypothesis. For the moment all we found in the literature are conjectures and authors’ opinions.  Socio-demographical and ethnicity variables seem to have a part in affecting compliance with one test or another, but more research seem to be needed to confirm this.

In some cases, such as socio economic status, studies give, , conflicting results. In the Australian study by Cole et al, socioeconomic status showed not to be a confounding factor, while in Birkenfeld this association was verified. More evidence is also needed to evaluate the importance of age as studies gave inconsistent result, both in term of overall compliance to screening and in terms of compliance broken down by age groups when comparing FIT and gFOBT.  On the other side, as regard to gender, results of quite all studies that focused on this variable  (Hughes, 2005; Hol, van Leerdam M.E 201; Birkenfeld 2011) showed that female gender were independent predictors of increased attendance/compliance in both arms. The study by Hughes et al. 2005, which is about the “intention to participate” (scenarios) seem to show differences among different ethnic group in preferring FIT versus gFOBT and other CRC screening methods, but yet this association should need further evidence.

References

Birkenfeld, S., et al. (2011). "Factors affecting compliance in faecal occult blood testing: a cluster randomized study of the faecal immunochemical test versus the guaiac faecal occult test." J Med Screen 18(3): 135-141.

Cole, S. R., et al. (2003). "A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer." J Med Screen 10(3): 117-122.

Federici, A., et al. (2005). "The immunochemical faecal occult blood test leads to higher compliance than the guaiac for colorectal cancer screening programmes: a cluster randomized controlled trial." J Med Screen 12(2): 83-88.

Hassan, C., et al. (2012). "Meta-analysis: adherence to colorectal cancer screening and the detection rate for advanced neoplasia, according to the type of screening test." Aliment Pharmacol Ther 36(10): 929-940.

Hawley, S. T., et al. (2008). "Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients." Med Care 46(9 Suppl 1): S10-16.

Hol, L., et al. (2010). "Screening for colorectal cancer: comparison of perceived test burden of guaiac-based faecal occult blood test, faecal immunochemical test and flexible sigmoidoscopy." Eur J Cancer 46(11): 2059-2066.

Hol, L., et al. (2010). "Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy." Gut 59(1): 62-68.

Hughes, K., et al. (2005). "Guaiac versus immunochemical tests: faecal occult blood test screening for colorectal cancer in a rural community." Aust N Z J Public Health 29(4): 358-364.

Levi, Z., et al. (2011). "A higher detection rate for colorectal cancer and advanced adenomatous polyp for  screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study." Int J Cancer 128(10): 2415-244.

Vernon, S.W. Participation in Colorectal Cancer Screening: a review , Journal of the National Cancer Institute , Vol. 89, No. 19, 1997.

 

Appendices

Domain appendices
APPENDIX 1

SERACH STRATEGY

SOC domain: compliance, acceptability, satisfaction

MEDLINE

 

Colorectal neoplasms (MESH term)

All terms

Neoplasms, Colorectal

Colorectal Neoplasm

Neoplasm, Colorectal

Colorectal Tumors

Colorectal Tumor

Tumor, Colorectal

Tumors, Colorectal

Colorectal Carcinoma

Carcinoma, Colorectal

Carcinomas, Colorectal

Colorectal Carcinomas

Colorectal Cancer

Cancer, Colorectal

Cancers, Colorectal

Colorectal Cancers

OR

(Colorect*  OR Colon * OR rect* or anal* or anus* OR intestin* or bowel*)

 

AND

 

 (carcinoma* OR neoplasm* OR adenocarcinom* OR cancer* OR tumor* OR sarcom* OR polyp* OR adenoma* OR neoplasia)

AND

Test*  (All Fiedls)

OR

Screening*(All Fields)

AND

 

“Faecal immunochemical test*”

 

Or

Fit

OR

(immunohistochem* or immunochem* or immunol*)

 

AND

 

(fecal immunochemical test* or faecal immunochemical test* or fecal immunochemistry test* or faecal immunochemistrytest*

Or “Screening test*”

Or “occult blood test*”

OR

 ColoScreen*  Or  Hema-Screen* or Hemdetect* or Hemoccult* or SENSA* or  Hema-Check* or  hemoCARE*or  Peroheme* or ColoCare* or  Lifeguard* or Fecatwin* or HemaW ipe* Or Instaccult* or Monohaem* or Okokit* or Seracult* or Dencoccult* or ColoRectal* or Early detector* Or Fe Cult* or Feca EI A* or Hemo FEC* or Hexagon* or SureScreen* or Hemaprompt* or Hemdetect* or Camco PAK* or  Colocheck* or Cecogenics* or  Hemates t* or

Dencocult* or Fecatest* or Hemofecia* or Quick-CULT*

2 OR “OC-sensor test*” OR “Insure fit” OR  “HemeSelect”, “FlexSure OBT, and “OC-Sensor Micro FIT*”

AND

compliance OR adherence OR acceptance OR acceptability OR participation OR preference OR preferences OR invitation OR 'perception  OR perceptions

OR Non-Adherence

OR attitude*

OR Satisfaction

OR

Patient compliance MESH term

Adults, ENGLISH, All fields, Article, e review

 

EMBASE

 

Colorectal Carcinoma

 (EMTREE TERM)

 

OR

“Colorectal Carcinoma”.exp

 

OR

(Colorect*  OR Colon * OR rect* or anal* or anus* OR intestin* or bowel*) .exp

 

AND

 

 (carcinoma* OR neoplasm* OR adenocarcinom* OR cancer* OR tumor* OR sarcom* OR polyp* OR adenoma* OR neoplasia).exp

AND

Test*  (Exp)

OR

Screening*(Exp)

AND

“Faecal immunochemical test*”

 

Or

Fit

OR

(immunohistochem* or immunochem* or immunol*).exp

 

AND

 

((fecal immunochemical test* or faecal immunochemical test* or fecal immunochemistry test* or faecal immunochemistrytest*).exp

Or “Screening test*”

Or “occult blood test*”)

OR

 ColoScreen*  Or  Hema-Screen* or Hemdetect* or Hemoccult* or SENSA* or  Hema-Check* or  hemoCARE*or  Peroheme* or ColoCare* or  Lifeguard* or Fecatwin* or HemaW ipe* Or Instaccult* or Monohaem* or Okokit* or Seracult* or Dencoccult* or ColoRectal* or Early detector* Or Fe Cult* or Feca EI A* or Hemo FEC* or Hexagon* or SureScreen* or Hemaprompt* or Hemdetect* or Camco PAK* or  Colocheck* or Cecogenics* or  Hemates t* or

Dencocult* or Fecatest* or Hemofecia* or Quick-CULT*

2 OR “OC-sensor test*” OR “Insure fit” OR  “HemeSelect”, “FlexSure OBT, and “OC-Sensor Micro FIT*”

AND

compliance OR adherence OR acceptance OR acceptability OR participation OR preference OR preferences OR invitation OR 'perception  OR perceptions OR satisfaction

OR Non-Adherence

OR

Patient compliance EMTREE term

OR

Patient attitude EMTREE

(“article” OR “review” OR “short survey”) Limits: Humans

Cochrane Library: CDSR, DARE, HTA database, CENTRAL search strategy

 

Colorectal neoplasms (MESH term)

All terms

 

OR

(Colorect*  OR Colon * OR rect* or anal* or anus* OR intestin* or bowel*) ti,ab,kw

 

AND

 

 (carcinoma* OR neoplasm* OR adenocarcinom* OR cancer* OR tumor* OR sarcom* OR polyp* OR adenoma* OR neoplasia). ti,ab,kw

AND

Test* ti,ab,kw

OR

Screening* ti,ab,kw

AND

“Faecal immunochemical test*”.ti,ab,kw

 

Or

Fit

OR

(immunohistochem* or immunochem* or immunol*).ti,ab,kw

 

AND

 

(fecal immunochemical test* or faecal immunochemical test* or fecal immunochemistry test* or faecal immunochemistrytest*).ti,ab,kw

Or

 “Screening test*”.ti,ab,kw

Or

 “occult blood test*”.ti,ab,kw

OR

 (ColoScreen*  Or  Hema-Screen* or Hemdetect* or Hemoccult* or SENSA* or  Hema-Check* or  hemoCARE*or  Peroheme* or ColoCare* or  Lifeguard* or Fecatwin* or HemaW ipe* Or Instaccult* or Monohaem* or Okokit* or Seracult* or Dencoccult* or ColoRectal* or Early detector* Or Fe Cult* or Feca EI A* or Hemo FEC* or Hexagon* or SureScreen* or Hemaprompt* or Hemdetect* or Camco PAK* or  Colocheck* or Cecogenics* or  Hemates t* or

Dencocult* or Fecatest* or Hemofecia* or Quick-CULT*

2 OR “OC-sensor test*” OR “Insure fit” OR  “HemeSelect”, “FlexSure OBT, and “OC-Sensor Micro FIT*”).ti,ab,kw

AND

compliance OR adherence OR acceptance OR acceptability OR participation OR preference OR preferences OR invitation OR 'perception  OR perceptions OR Non-Adherence OR Attitude OR attitudes OR satisfaction

 

(“article” OR “review” OR “short survey”) Limits: Humans

 

Other consulted databases (free terms research)

 

DARE all databases; Agency for Healthcare Research and Quality (AHRQ); Australian Safety and Efficacy Register of New Interventional Procedures  (ASERNIP-S) , Health Canada; International Network of Agencies for Health Technology Assessment (INAHTA); Medical Services Advisory Committee (MSAC); National Coordinating Centre for Health Technology Assessment (NCCHTA);  National Horizon Scanning Centre; National Institute for Health and Clinical Excellence (NICE); NHS Quality Improvement Scotland (NHS QIS); Clinicaltrials.gov, Cancer.gov, Trip Database.

 

 
 
 
 
 
APPENDIX 2

List of included and excluded studies and reasons for exclusions due to the inclusion-exclusion criteria

Reference fit compliance

Target population (adults_19-64 years and elderly _65+ years;  male and female. Healthy and/or asymptomatic people),

It is about FIT or/and gFOBT

Measure/deal with outcomes that are related to the social domain (e.g. compliance with one test or the other, capacity to understand information on the two tests, etc.)

Type of study: quantitative studies_experimental or observational AND qualitative studies

1.       Akram, S., et al. (2012). "Yield of fecal immunochemical test in detection of colorectal cancer and advanced neoplasia in veteran population at dayton va medical center." Am. J. Gastroenterol. 107: S810.

 

 

NO

 

2.       Aschele, C., et al. (2009). "Chemotherapy for operable and advanced colorectal cancer." Cancer Treat Rev 35(6): 509-516.

NO

 

 

 

3.       Bampton, P. A., et al. (2005). "Interval faecal occult blood testing in a colonoscopy based screening programme detects additional pathology." Gut 54(6): 803-806.

NO

 

 

 

4.       Bhattacharya, R., et al. (2010). "Comparison of advanced noninvasive techniques to screen colorectal cancer: Fecal immunochemical test vs. fecal DNA; A cos-effectiveness study." Value Health 13(7): A265.

 

NO

 

 

5.       Birkenfeld, S., et al. (2011). "Factors affecting compliance in faecal occult blood testing: a cluster randomized study of the faecal immunochemical test versus the guaiac faecal occult test." J Med Screen 18(3): 135-141.

 

 

 

 

6.       Boemo, C., et al. (2012). "Short-term outcomes and cost evaluation of the first two rounds of a colorectal cancer screening programme based on immunochemical faecal occult blood test in a northern italian province." Endoscopy 44(4): 441.

 

NO

 

 

7.       Browne, S., et al. (2011). "Patients' needs following colorectal cancer diagnosis: where does primary care fit in?" Br J Gen Pract 61(592): e692-699.

NO

 

 

 

8.       Byers, T. (2011). "Examining stools for colon cancer prevention: what are we really looking for?" Cancer Prev Res (Phila) 4(10): 1531-1533.

 

 

 

NO

9.       Calvet, X., et al. (2002). "Evaluation of Helicobacter pylori diagnostic methods in patients with liver cirrhosis." Aliment Pharmacol Ther 16(7): 1283-1289.

NO

 

 

 

10.    Castiglione, G., et al. (1996). "Immunochemical vs guaiac faecal occult blood tests in a population-based screening programme for colorectal cancer." Br J Cancer 74(1): 141-144.

 

 

NO

 

11.    Cavallaro, L. G., et al. (2011). "Screening for colorectal cancer (CRC) from the first three rounds (2005-2011) in an Italian north-eastern district (ULSS-1) with a high adherence rate: Preliminary results." Dig. Liver Dis. 43: S185-S186.

 

NO

 

 

12.    Cha, J. M., et al. (2011). "Telephone reminder call in addition to mailing notification improved the acceptance rate of colonoscopy in patients with a positive fecal immunochemical test." Dig Dis Sci 56(11): 3137-3142.

NO

 

 

 

13.    Ching, J. Y. L., et al. (2012). "Mailing invitations for colorectal cancer (CRC) screening programme in Hong Kong: A comparison between private and public estates." J. Gastroenterol. Hepatol. 27: 200.

 

NO

 

 

14.    Ching, J. Y. L., et al. (2012). "Compliance with fecal immunochemical tests for colorectal cancer screening: A prospective cohort study." J. Gastroenterol. Hepatol. 27: 197.

The fulltext was not available

15.    Cole, S. R., et al. (2007). "An advance notification letter increases participation in colorectal cancer screening." J Med Screen 14(2): 73-75.

 

NO

 

 

16.    Cole, S. R., et al. (2009). "A faecal immunochemical test for haemoglobin using a single stool sample is effective for detecting significant colorectal neoplasia." J. Gastroenterol. Hepatol. 24: A239.

 

 

NO

 

17.    Cole, S. R., et al. (2003). "A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer." J Med Screen 10(3): 117-122.

 

 

 

 

18.    Crotta, S., et al. (2012). "High rate of advanced adenoma detection in 4 rounds of colorectal cancer screening with the fecal immunochemical test." Clin Gastroenterol Hepatol 10(6): 633-638.

 

NO

 

 

19.    Crotta, S., et al. (2012). "Interval cancers in a colorectal cancer population screening fit-based: Preliminary result of two rounds." Dig. Liver Dis. 44: S198-S199.

NO

 

 

 

20.    Daly, J. M., et al. (2010). "Mailed fecal-immunochemical test for colon cancer screening." J Community Health 35(3): 235-239.

 

NO

 

 

21.    De Haan, M. C., et al. (2012). "Does CT colonography have a role for population-based colorectal cancer screening?" Eur Radiol 22(7): 1495-1503.

 

NO

 

 

22.    Denis, B., et al. (2007). "Short term outcomes of the first round of a pilot colorectal cancer screening programme with guaiac based faecal occult blood test." Gut 56(11): 1579-1584.

 

NO

 

 

23.    Denters, M., et al. (2010). "Equal advanced neoplasia detection rates in first and second round of an fecal immunochemical test based colorectal cancer screening program." Gastroenterology 138(5): S186.

 

 

NO

 

24.    Denters, M., et al. (2010). "Participation rate in a second round of fecal immunochemical test based screening decreases due to low response rates among previous non-responders and first-time invitees." Gastroenterology 138(5): S186.

NO

 

 

 

25.    Denters, M. J., et al. (2012). "A feces collection paper does not enhance participation in a fecal immunochemical test-based colorectal cancer screening program: Randomized clinical trial." Eur.J. Cancer Prev.

 

NO

 

 

26.    Denters, M. J., et al. (2013). "Involvement of previous non-participants cannot fully compensate for lower participation in a second round of FIT-screening." Cancer Epidemiol.

 

NO

 

 

27.    Desoubeaux, N., et al. (1997). "[Mass screening of colorectal cancer by general practitioners in France: what is  the real target population?]." Gastroenterol Clin Biol 21(10): 760-763.

NO

 

 

 

28.    Ealey, J., et al. (2011). "Patients' perspectives on immunochemical fecal occult blood test (I-FOBT or FIT): Not your father's FOBT." Cancer Epidemiol. Biomarkers Prev. 20(10).

 

 

 

 

29.    Eisinger, F., et al. (2011). "Cancer survivors: familial risk perception and management advice given to their relatives." Fam Cancer 10(1): 147-155.

NO

 

 

 

30.    Federici, A., et al. (2005). "The immunochemical faecal occult blood test leads to higher compliance than the guaiac for colorectal cancer screening programmes: a cluster randomized controlled trial." J Med Screen 12(2): 83-88.

 

 

 

 

31.    Fenocchi, E., et al. (2006). "Screening for colorectal cancer in Uruguay with an immunochemical faecal occult blood test." Eur J Cancer Prev 15(5): 384-390.

 

NO

 

 

32.    Fraser, C. G., et al. (2007). "Evaluation of a card collection-based faecal immunochemical test in screening for colorectal cancer using a two-tier reflex apprTan, Woach." Gut 56(10): 1415-1418.

 

 

NO

 

33.    Graser, A., et al. (2009). "Comparison of CT colonography, colonoscopy, sigmoidoscopy and faecal occult blood tests for the detection of advanced adenoma in an average risk population." Gut 58(2): 241-248.

 

 

NO

 

34.    Grazzini, G., et al. (2000). "Colorectal cancer screening by fecal occult blood testing: results of a population-based experience." Tumori 86(5): 384-388.

 

 

NO

 

35.    Greenwald, B. (2005). "A comparison of three stool tests for colorectal cancer screening." Medsurg Nurs 14(5): 292-299; quiz 300.

 

 

 

NO

36.    Hall, M. J., et al. (2011). "Effects of a decision support intervention on decisional conflict associated with microsatellite instability testing." Cancer Epidemiol Biomarkers Prev 20(2): 249-254.

 

NO

 

 

37.    Harden, E., et al. (2011). "Exploring perceptions of colorectal cancer and fecal immunochemical testing among African Americans in a North Carolina community." Prev Chronic Dis 8(6): A134.

no

 

 

 

38.    Hassan, C., et al. (2011). "Cost effectiveness and projected national impact of colorectal cancer screening in France." Endoscopy 43(9): 780-793.

 

 

NO

 

39.    Hassan, C., et al. (2012). "Meta-analysis: adherence to colorectal cancer screening and the detection rate for advanced neoplasia, according to the type of screening test." Aliment Pharmacol Ther 36(10): 929-940.

 

 

 

 

40.    Hawley, S. T., et al. (2008). "Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients." Med Care 46(9 Suppl 1): S10-16.

 

 

 

 

41.    Heitman, S. J., et al. (2010). "Colorectal cancer screening for average-risk North Americans: an economic evaluation." PLoS Med 7(11): e1000370.

 

 

NO

 

42.    Hillyer, G. C., et al. (2011). "Feasibility and efficacy of pairing fecal immunochemical testing with mammography for increasing colorectal cancer screening among uninsured Latinas in northern Manhattan." Prev Med 53(3): 194-198.

NO

 

 

 

43.    Hoffman, R. M., et al. (2010). "Colorectal cancer screening adherence is higher with fecal immunochemical tests than guaiac-based fecal occult blood tests: a randomized, controlled trial." Prev Med 50(5-6): 297-299.

NO

 

 

 

44.    Hol, L., et al. (2010). "Screening for colorectal cancer: comparison of perceived test burden of guaiac-based faecal occult blood test, faecal immunochemical test and flexible sigmoidoscopy." Eur J Cancer 46(11): 2059-2066.

 

 

 

 

45.    Hol, L., et al. (2012). "Uptake of faecal immunochemical test screening among nonparticipants in a flexible sigmoidoscopy screening programme." Int J Cancer 130(9): 2096-2102.

NO

 

 

 

46.    Hol, L., et al. (2010). "Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy." Gut 59(1): 62-68.

 

 

 

 

47.    Hol, L., et al. (2009). "Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels." Br J Cancer 100(7): 1103-1110.

 

 

NO

 

48.    Honda, K. (2004). "A model of perceived risk for colorectal cancer among Japanese Americans." J Cancer Educ 19(4): 251-257.

 

NO

 

 

49.    Hou, W. K. (2010). "Intrapersonal and interpersonal dimensions of cancer perception: a confirmatory factor analysis of the cancer experience and efficacy scale (CEES)." Support Care Cancer 18(5): 561-571.

 

NO

 

 

50.    Hughes, K., et al. (2005). "Guaiac versus immunochemical tests: faecal occult blood test screening for colorectal cancer in a rural community." Aust N Z J Public Health 29(4): 358-364.

 

 

 

 

51.    Kapidzic, A., et al. (2012). "Quality of life in participants of a CRC screening program." Br J Cancer 107(8): 1295-1301.

 

NO

 

 

52.    Kemeny, M. M. (2004). "Surgery in older patients." Semin Oncol 31(2): 175-184.

 

NO

 

 

53.    Kempe, K. L., et al. (2012). "Automated phone and mail population outreach to promote colorectal cancer screening." Am J Manag Care 18(7): 370-378.

 

 

NO

 

54.    Khalid-de Bakker, C., et al. (2011). "Participation in colorectal cancer screening trials after first-time invitation:  a systematic review." Endoscopy 43(12): 1059-1086.

 

NO

 

 

55.    Klaver, Y. L., et al. (2012). "Outcomes of elderly patients undergoing cytoreductive surgery and perioperative intraperitoneal chemotherapy for colorectal cancer peritoneal carcinomatosis." J Surg Oncol 105(2): 113-118.

NO

 

 

 

56.    Kluhsman, B. C., et al. (2012). "A pilot study for using fecal immunochemical testing to increase colorectal cancer screening in Appalachia, 2008-2009." Prev Chronic Dis 9: E77.

 

NO

 

 

57.    Ko, C. W., et al. (2003). "Fecal occult blood testing in a general medical clinic: comparison between guaiac-based and immunochemical-based tests." Am J Med 115(2): 111-114.

NO

 

 

 

58.    Labianca, R. and B. Merelli (2010). "Screening and diagnosis for colorectal cancer: present and future." Tumori 96(6): 889-901.

 

 

 

NO

59.    Ladabaum, U., et al. (2011). "Screening for colorectal cancer with a blood test: Projected effectiveness and cost-effectiveness of a novel plasma methylated septin-9 DNA (mSEPT9) assay." Gastroenterology 140(5): S50-S51.

 

 

 

NO

60.    Laiyemo, A., et al. (2012). "DC screen for life program: Taking colon cancer screening to the uninsured." Am. J. Gastroenterol. 107: S569-S570.

 

 

NO

 

61.    Lam, T. Y. T., et al. (2011). "Three-year follow up on a colorectal cancer screening program in Hong Kong: A prospective cohort study." J. Gastroenterol. Hepatol. 26: 6-7.

 

NO

 

 

62.    Lane, J. M., et al. (2010). "Can quantitative immunochemical fecal occult blood tests be used in single sample format without compromising colorectal neoplasia yield?" Gastroenterology 138(5): S184.

 

 

NO

 

63.    Launoy, G. (2009). "[Improvement in screening for colorectal cancer associated with the use of immunochemical faecal occult blood test]." Pathol Biol (Paris) 57(6): 488-492.

 

 

 

NO

64.    Lee, V., et al. (2006). "Meaning-making and psychological adjustment to cancer: development of an intervention and pilot results." Oncol Nurs Forum 33(2): 291-302.

 

NO

 

 

65.    Levi, Z., et al. (2011). "A higher detection rate for colorectal cancer and advanced adenomatous polyp for  screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study." Int J Cancer 128(10): 2415-244.

 

 

 

 

66.    Levy, B. T., et al. (2012). "Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices." J Am Board Fam Med 25(1): 73-82.

 

 

NO

 

67.    Li, C. M., et al. (2007). "Factors associated with referral compliance of abnormal immunochemical faecal occult blood test." J Med Screen 14(4): 186-190.

NO

 

 

 

68.    Manne, S., et al. (2003). "Understanding intention to undergo colonoscopy among intermediate-risk siblings of colorectal cancer patients: a test of a mediational model." Prev Med 36(1): 71-84.

 

NO

 

 

69.    Mantyh, C. R., et al. (2001). "Coloplasty in low colorectal anastomosis: manometric and functional comparison with straight and colonic J-pouch anastomosis." Dis Colon Rectum 44(1): 37-42.

 

NO

 

 

70.    Masya, L. M., et al. (2009). "Preferences for outcomes of treatment for rectal cancer: patient and clinician utilities and their application in an interactive computer-based decision aid." Dis Colon Rectum 52(12): 1994-2002.

 

NO

 

 

71.    McQueen, A., et al. (2008). "Construct validity and invariance of four factors associated with colorectal cancer screening across gender, race, and prior screening." Cancer Epidemiol Biomarkers Prev 17(9): 2231-2237.

 

NO

 

 

72.    Nadel, M. R., et al. (2010). "Fecal occult blood testing beliefs and practices of U.S. primary care physicians: serious deviations from evidence-based recommendations." J Gen Intern Med 25(8): 833-839.

 

 

NO

 

73.    Osborne, J. M., et al. (2012). "Patterns of participation over multiple rounds of faecal immunochemical test-based screening for colorectal cancer." J. Gastroenterol. Hepatol. 27: 27.

 

NO

NO

 

74.    Park, D. I., et al. (2010). "Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening." Am J Gastroenterol 105(9): 2017-2025.

NO

 

 

 

75.    Park, M. J., et al. (2011). "Trends in the National Cancer Screening Program for colorectal cancer in the Republic of Korea, 2004-2009." Asian Pac J Cancer Prev 12(12): 3489-3493.

 

NO

 

 

76.    Potter, M. B., et al. (2010). "Comparative effectiveness of two pharmacy-based colorectal cancer screening interventions during an annual influenza vaccination campaign." J Am Pharm Assoc (2003) 50(2): 181-187.

NO

 

 

 

77.    Quintero, E., et al. (2012). "Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening." N Engl J Med 366(8): 697-706.

 

NO

 

 

78.    Rabeneck, L., et al. (2012). "Fecal immunochemical tests compared with guaiac fecal occult blood tests for population-based colorectal cancer screening." Can J Gastroenterol 26(3): 131-147.

 

 

 

 

79.    Rao, R. S., et al. (2004). "Understanding the factors underlying disparities in cancer screening rates using  the Peters-Belson approach: results from the 1998 National Health Interview Survey." Med Care 42(8): 789-800.

 

 

NO

 

80.    Ritvo, P., et al. (2008). "Factorial validity and invariance of a survey measuring psychosocial correlates of colorectal cancer screening in Ontario, Canada--a replication study." Cancer Epidemiol Biomarkers Prev 17(11): 3279-3283.

 

NO

 

 

81.    Roslani, A. C., et al. (2012). "Screening for colorectal neoplasias with fecal occult blood tests: false-positive impact of non-dietary restriction." Asian Pac J Cancer Prev 13(1): 237-241.

 

 

NO

 

82.    Rozen, P. et al. (2000). "Comparative screening with a sensitive guaiac and specific immunochemical occult  blood test in an endoscopic study." Cancer 89(1): 46-52.

 

NO

 

 

83.    Rustagi, T. and V. R. Konjeti (2012). "Survey of primary care residents to assess awareness of updated 2008 ACG guidelines for colorectal cancer screening." Am. J. Gastroenterol. 107: S809.

 

 

 

NO

84.    Sastre, J., et al. (2011). "First-line single-agent cetuximab in elderly patients with metastatic colorectal  cancer. A phase II clinical and molecular study of the Spanish group for digestive tumor therapy (TTD)." Crit Rev Oncol Hematol 77(1): 78-84.

 

NO

 

 

85.    Schiff, L., et al. (2009). "Development of serum tests for colorectal cancer screening." Value Health 12(7): A257.

 

 

NO

 

86.    Segnan, N., et al. (2007). "Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening." Gastroenterology 132(7): 2304-2312.

 

NO

 

 

87.    Senore, C., et al. (2010). "The added value of immunochemical FOBT following a negative screening sigmoidoscopy." Gastroenterology 138(5): S186-S187.

NO

 

 

 

88.    Senore, C., et al. (2012). "Offering people a choice for colorectal cancer screening." Gut.

NO

 

 

 

89.    Senore, C., et al. (2011). "Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting." J Med Screen 18(3): 128-134.

 

NO

 

 

90.    Senore, C., et al. (2009). "Comparing diagnostic yield and interval cancer rates of different strategies of colorectal cancer screening." Gastroenterology 136(5): A53.

 

 

NO

 

91.    Sharaf, R. N. and U. Ladabaum (2013). "Comparative effectiveness and cost-effectiveness of screening colonoscopy vs. sigmoidoscopy and alternative strategies." Am J Gastroenterol 108(1): 120-132.

 

 

NO

 

92.    Shuhaibar, M., et al. (2011). "A comparative study of faecal occult blood kits in a colorectal cancer screening  program in a cohort of healthy construction workers." Ir J Med Sci 180(1): 103-108.

NO

 

 

 

93.    Simonds, V. W., et al. (2011). "Cancer screening among Native Americans in California." Ethn Dis 21(2): 202-209.

 

NO

 

 

94.    SR, C., et al. "An advance notification letter increases participation in colorectal cancer screening." Journal of medical screening.

 

NO

 

 

95.    SR, C., et al. "A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer." Journal of medical screening.

 

 

 

 

96.    Stare, J., et al. (2005). "Goodness of fit of relative survival models." Stat Med 24(24): 3911-3925.

 

NO

 

 

97.    Stegeman, I., et al. (2012). "Implementation of population screening for colorectal cancer by repeated Fecal Immunochemical Test (FIT): Third round." BMC Gastroenterol. 12.

NO

 

 

 

98.    Sule, A. Z., et al. (2007). "One stage procedure in the management of acute sigmoid volvulus without colonic lavage." Surgeon 5(5): 268-270.

 

NO

 

 

99.    Sung, J. J., et al. (2011). "Three years follow-up on a colorectal cancer screening program: A prospective cohort of 4,961 asymptomatic subjects." Gastroenterology 140(5): S182-S183.

 

NO

 

 

100. Svensson, E., et al. (2006). "Frailty modelling of colorectal cancer incidence in Norway: indications that individual heterogeneity in risk is related to birth cohort." Eur J Epidemiol 21(8): 587-593.

 

NO

 

 

101.Tan, W. S., et al. (2012). "Opportunistic screening for colorectal neoplasia in singapore using an immunochemical faecal occult blood test (FIT) by the Singapore Cancer Society." Colorectal Dis. 14: 3.

 

NO

 

 

102.Terhaar sive Droste, J. S., et al. (2011). "Higher fecal immunochemical test cutoff levels: lower positivity rates but still  acceptable detection rates for early-stage colorectal cancers." Cancer Epidemiol Biomarkers Prev 20(2): 272-280.

 

 

NO

 

103.Tiro, J. A., et al. (2005). "Factorial validity and invariance of a survey measuring psychosocial correlates of colorectal cancer screening among African Americans and Caucasians." Cancer Epidemiol Biomarkers Prev 14(12): 2855-2861.

 

NO

 

 

104.Van Dam, L., et al. (2010). "Comparing participants and non-participants of a randomized colorectal cancer screening program using guaiac-based and immunochemical fecal occult blood test and flexible sigmoidoscopy." Gastroenterology 138(5): S191.

 

NO

 

 

105.Van Dam, L., et al. (2010). "Experiences of general practitioners regarding their role in the referral process for colonoscopy after a positive colorectal cancer screening test." Gastroenterology 138(5): S191.

NO

 

 

 

106.VanDam, L., et al. (2010). "Comparison of participants and non-participants in a flexible sigmoidoscopy screening program, with an alternative invitation for fecal immunochemical testing." Gastroenterology 138(5): S351.

 

NO

 

 

107.Van Roon, A. H., et al. (2011). "Attendance and diagnostic yield of repeated fecal immunochemical test screening with intervals of 1, 2, or 3 years: A comparative population-based colorectal cancer screening trial." Gastroenterology 140(5): S405.

 

NO

 

 

108.Van Roon, A. H., et al. (2010). "Fecal immunochemical test (FIT) characteristics by sample return time in a population-based colorectal cancer screening trial." Gastroenterology 138(5): S133.

 

 

NO

 

109.Van Roon, A. H., et al. (2010). "Attendance and diagnostic yield of one versus two-sample fecal immunochemical test (FIT) screening; a comparative population-based colorectal cancer trial." Gastroenterology 138(5): S134.

 

 

NO

 

110.Van Roon, A. H. C., et al. (2013). "Random comparison of repeated faecal immunochemical testing at different intervals for population-based colorectal cancer screening." Gut 62(3): 409-415.

 

 

NO

 

111.Van Roosbroeck, S., et al. (2012). "Population-based screening for colorectal cancer using an immunochemical faecal occult blood test: a comparison of two invitation strategies." Cancer Epidemiol 36(5): e317-324.

 

NO

 

 

112. Van Rossum, L. G., et al. (2009). "Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme." Br J Cancer 101(8): 1274-1281.

 

 

NO

 

113. Van Rossum, L. G., et al. (2008). "Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population." Gastroenterology 135(1): 82-90.

 

 

 NO

 

114. Van Turenhout, S. T., et al. (2012). "Anticipating implementation of colorectal cancer screening in The Netherlands: a  nation wide survey on endoscopic supply and demand." BMC Cancer 12: 46.

 

 

NO

 

115. Vanness, D. J., et al. (2011). "Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations." Radiology 261(2): 487-498.

 

NO

 

 

116. Vart, G., et al. (2012). "Comparing participation rates between immunochemical and guaiac faecal occult blood tests: a systematic review and meta-analysis." Prev Med 55(2): 87-92.

 

 

 

 

117.Watts, B. G., et al. (2003). "Intention to be screened over time for colorectal cancer in male automotive workers." Cancer Epidemiol Biomarkers Prev 12(4): 339-349.

NO

 

 

 

118.Weiss, J. M. and P. R. Pfau (2012). "New era for stool screening tests: Fecal immunochemical tests, DNA, and beyond." Curr. Colorectal Cancer Rep. 8(1): 1-5.

 

 

 

NO

119.Williams, J. A., et al. (1987). "Evaluation of an immunochemical test for faecal occult blood in screening for colorectal neoplasia in a high risk group." Aust N Z J Surg 57(12): 951-957.

NO

 

 

 

120.Wilschut, J., et al. (2010). "Quantitative immunochemical fecal occult blood screening under a colonoscopy constraint: A Higher cut-off level, a smaller age range or a longer screening interval? A cost-effectiveness analysis." Gastroenterology 138(5): S183.

 

 

NO

 

121.Wilschut, J., et al. (2010). "Should we offer individuals two samples of a fecal immunochemical test for colorectal cancer screening instead of one? A cost-effectiveness analyis." Gastroenterology 138(5): S183-S184.

 

 

NO

 

122.Wong, C. K., et al. (2011). "Efficacy of a single day fecal immunochemical occult blood testing (FIT) collection strategy for screening relevant colorectal neoplasias." Gastroenterology 140(5): S410.

 

 

NO

 

123.Wong, C. K. W., et al. (2012). "The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer." Int. J. Colorectal Dis. 27(12): 1657-1664.

 

 

NO

 

124. Wong, M. C., et al. (2012). "Changes in the choice of colorectal cancer screening tests in primary care settings from 7,845 prospectively collected surveys." Cancer Causes Control 23(9): 1541-1548.

 

NO

 

 

126. Wong, M. C. S., et al. (2010). "A comparison of the acceptance of immunochemical faecal occult blood test and colonoscopy in colorectal cancer screening: A prospective study among Chinese." Aliment. Pharmacol. Ther. 32(1): 74-82.

 

NO

 

 

127.Young, C. W., et al. (1988). "Phase I trial and clinical pharmacological evaluation of hexamethylene bisacetamide administration by ten-day continuous intravenous infusion at twenty-eight-day intervals." Cancer Res 48(24 Pt 1): 7304-7309.

 

NO

 

 

128.Young, G. P. (2009). "Population-based screening for colorectal cancer: Australian research and implementation." J Gastroenterol Hepatol 24 Suppl 3: S33-42.

 

 

 

NO

129.Young, G. P. (2012). "New Developments in Screening for Colorectal Cancer: Report on the World Endoscopy Organization Workshop Chicago, May 2011." Pract. Gastroenterol. 36(12): 32-36.

 

 

 

NO

130.Young, G. P. and S. Cole (2007). "New stool screening tests for colorectal cancer." Digestion 76(1): 26-33.

 

 

 

NO

131.Young, G. P. and S. R. Cole (2009). "Which fecal occult blood test is best to screen for colorectal cancer?" Nat. Clin. Pract. Gastroenterol. Hepatol. 6(3): 140-141.

 

 

 

NO

132.Young, G. P., et al. (2003). "Prescreening evaluation of a brush-based faecal immunochemical test for haemoglobin." J Med Screen 10(3): 123-128.

 

NO

 

 

133.Zajac, I. T., et al. (2010). "Endorsement by the primary care practitioner consistently improves participation  in screening for colorectal cancer: a longitudinal analysis." J Med Screen 17(1): 19-24.

 

NO

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX 3

 

 

 

published

2011

2003

2005

2012

2008

2010

2010

2005

2010

2012

period study conducted

unclear

April-August 2001

June 2002

studies from 1999-2012

not found

November 2006 to May 2008

between November 2006 and November 2007

The initial mail-out was conducted in November 2000.

2008

2000-2011

country(ies) of study

Israel

Australia

Italy, Lazio region

Italy

USA

NL

NL

Australien, Queensland

Israel

Australia, Italy, Netherlands, USA, Israel

n of studies included (systematic review)

primary study

primary study

primary study

14 in the meta-analysis, 7 double with our search results (Segnan, Ferderici, van Rossum 2008, Hoffmann, Hol 2010 (RCT comparing…), Levi, Quintero 2012

primary study

primary study

primary study

primary study

primary study

7 (6 are also included in our search)

sponsoring

Eiken Japan provided the OC-MICROTM instrument, reagents and partial financial support for administration.

Hemoccult SENSA and FlexSure OBT cards were purchased from Beckman Coulter Inc. (Palo Alto CA, USA). Enterix Inc. (Portland ME, USA) provided InSure test kits. Grants from Bushell Foundation and Enterix Inc. provided part support for salaries (SC, BC).

n.a.

partially funded by the Italy Ministry of Health, through a project coordinated by the Agenzia Nazionale per i Servizi Sanitari and conducted by Laziosanità: ‘Strumenti e metodi per il governo dei processi di innovazione tecnologica, clinica ed organizzativa nel SSN – Un sistema integrato di ricerca’,  sub-project ‘Analysis of the impact of professional involvement in evidence generation for the HTA process’ grant no. I85J07000080001.

unclear

This trial was funded by the Dutch Cancer Society (EMCR 2006-3673), and the Dutch Ministry of Health, Health Care Prevention Program–Implementation (ZonMw 2006-5877).

This trial was funded by the Dutch Cancer Society (EMCR 2006-3673), the Dutch Ministry of Health, Health Care Prevention Program–Implementation (ZonMw 2006-5877), Olympus Medical Systems Europe GmbH, Hamburg, Germany and Eiken Chemical Co., Tokyo, Japan.

This research was funded by Queensland Health. In addition, funding was subsidised by Enterix (Inc), which made the !nform FOBT kit and its analysis available at a highly discounted rate, and the pathology laboratory at Townsville General Hospital, which provided analysis of Hemoccult-II kits at a greatly reduced fee.

Eiken Japan provided the OC-MICROTM instrument, reagents and partial financial support for administration.

This research was funded via studentship provided by The Guildford Tumour Screening (G.U.T.S) charity for part fulfilment of the degree PhD Health Psychology at the University of Surrey

Quantitative-Experimental

Quantitative-Experimental/ RCT

Quantitative-Experimental/ RCT

Quantitative-Experimental/ RCT

meta-analysis

Quantitative- Observational

Quantitative-Experimental/ RCT

Quantitative-Experimental/ RCT

Quantitative-Experimental/ RCT

Quantitative-Experimental/ RCT

systematic review

Trial registration number (for RCTs only)

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

n.a.

Methods

target population and the primary area clinics were clustered according to socioeconomic status (SES). into three SES classes (high, medium, low) using software based on postal code and estimated income. Clinics were then randomly allocated into either the FIT or gFOBT arm.

randomly selected from the electoral roll of the Australian Electoral Commission

 13 selected hospitals to accurately represent gastroenterology units and geographic areas. All GPs (more than 100 patients in the target population (age 50–74) included in the survey

Relevant publications were identified by MEDLINE/EMBASE and other databases for the period 1999–2012. A previous systematic review was used for the period before 1966–1999. RCTs and controlled studies including a direct comparison of the uptake rates among different options for CRC screening were included.

Purposive sampling from waiting areas of 3 community health centres. Patients aged 50-80 recruited. They were asked to rate 8 hypothetical CRC screening tests scenarios

A representative sample of the Dutch population (aged 50–74 years) was randomised to be invited for gFOBT, FIT and FS screening. participants were asked to complete a questionnaire in the waiting area of the endoscopy unit

From a representative sample of the Dutch population aged 50–74 years, a random sample of 15 011 individuals was taken by computer generated algorithm and 1:1:1 randomised

The two groups were randomly allocated to kit type by flipping a coin. Patients from the largest and smallest practices received the immunochemical kit, and patients from the other two practices received the guaiac test..

Nine medium-sized primary care clinics (1,000–2,000 patients) were included, three clinics from each SES.

search in Pubmed and Cochrane Db, includion of RCTs comparing FIT versus gFOBT, exclusion of studies comparing with invasive methods,

Outcomes measured

Primary outcomes 1) To compare the ‘kit compliance’ 2) To compare the compliance for ‘kit return’ 3) To compare the overall compliance for test uptake

Secondary outcome

1) to assess the effect of the sociodemographic factors on the compliance for test uptake.

Primary outcomes

1) Participation rate Secondary outcome

1) demographic variables' impact on participation

Primary outcomes

1) percentage of compliance

Primary outcomes

1) Adherence

2) detection rates for advanced neoplasia and cancer

Primary outcomes

1) screening preferences 2) variation in crc among racially ethnically diverse primary care patients

Primary outcomes

1) To assess differences in perceived burden and willingness to return for a second screening round among participants

Primary outcomes

1) participation rate to each of the three screening strategies

Primary outcomes

1) screening participation in a rural community, comparing guaiac and immunochemical tests

Primary outcomes

1) to compare FIT with G-FOBT in screening 2) to assess the feasibility of this approach in the urban population in Israel, with special relation to different socioeconomic classes

Primary outcomes

1) to compare participation rates of gFOBT and FIT

Secondary outome

2 to assess which characteristics of the test acted as barriers or facilitators to participation

participants

Eligible participants aged 50–74 years were linked to the nine selected primary care clinics. Patients who had an established CRC or inflammatory bowel disease were excluded.

A pool of 4000 potential invitees

CRC screening target population (i.e. people aged 50–74) is 1.5 million

Population sample

75 participants per racial/ethnic group

In total 402/481 (84%) gFOBT and 530/659 (80%) FIT screenees returned their questionnaire

Population sample

A rural Queensland community was selected, with a population of approximately 15,000 people (approximately 4,200 were aged 50 years or older)

A total of 12,539 patients were included in the study: 4,657 patients of Group A had FIT and 7,880 patients of Group B had G-FOBT.

The cohorts invited ranged from 1818 (Cole 2003) to 20623 (van Rossum 2008).

n of participants

16132 [10668 (gFOBT) + 5464 (FIT)]

1818 (3 groups of each 606)

n =7320

197910; Five studies compared g-FOBT with FIT, including 59 729 randomised subjects

220

852

15011

3358; Of the 3,861 individuals contacted by the study, 503 (13.0%) received both immunochemical and guaiac kits.

12,539 (4,657 FIT; 7,880 G-FOBT)

the cohorts invited ranged from 1818 (Cole 2003) to 20623 (van Rossum 2008).

age range

60-74

50-69

50-74

50-74 (4x), 50-75 (4x); 55-64 (3x); 50-54/65-69 (1x); 50-80 (1x); 50-69 (1x)

50-80 (mean 59)

50–74

50-74

50-74

mean age FIT: 60.4, mean age FOBT 61.3

50+

gender proportion m to f

43,1% male; 56,9% female

49,5% male, 50,5% female (own calculation of table 1)

Guaiac 46.9% men  FIT 45.8% men

male 49.5%; female 50.5% (own calculation of all studies included in the meta analysis)

not specified. Analysis was controlled by age and gender for all groups

45.3% male (FOBT), 50.6% male (FIT), 50.7% (FS)

participation OR for Women 1.1 (0.9 to 1.4) (FOBT)  1.3 (1.1 to 1.4)(FIT) 0.9 (0.8 to 1.0)(FS)

51.2% female

45.4% male for FIT, 42.6% male for FOBT

n.a.

health status

screening population

screening population

screening population

screening population

screening population

screening population

screening population

screening population

screening population

screening population

ethnic minority

10,8% immigrants

Exposure of this population to screening was low by US standards and prior participation in screening had been less than 20%.

no

n.a.

74 white, 60 Africans, 78 Hispanic

5% non Cuacasian

n.a.

no

n.a.

n.a.

specific population group (i.e. economic situation, uninsured, speicif workers,…)

34% high SES, 36,6% medium SES, 29,4% low SES

 

no

n.a.

racically and ethnically diverse

no

n.a.

no

SES controlled

n.a.

Setting (e.g. population screening program – rounds - opportunistic screening etc.)

primary care clinic registrees, setting population-based like

Typical urban setting that is relatively naïve to the value and practice of screening

population screening

population screening

population screening

population screening

population screening

population screening

population screening

population based program setting

intervention

FIT

FIT

FIT

FIT/gFOBT/endoscopy

all possible screening tests

FIT

FIT

FIT

FIT

FIT

comparator

gFOBT

gFOBT

gFOBT

FIT/gFOBT/endoscopy

using white people as referrence for the regression model

FOBT, FS

FOBT, FS

FOBT, FS

FOBT

gFOBT

 
 

 

 

APPENDIX 4 Quality Assessment of selected primary studies QUORUM – 2
 
 

 

 

 

 

 

 

5.       Birkenfeld, S., et al. (2011).

17.    Cole, S. R., et al. (2003).

30.    Federici, A., et al. (2005).

40.    Hawley, S. T., et al. (2008).

44.    Hol, L., et al. (2010).

46.    Hol, L., et al. (2010). 59(1): 62-68.

50.    Hughes, K., et al. (2005).

65.    Levi, Z., et al. (2011).

116. Vart, G., et al. (2012).

 

Internal validity

Select: + , - , ? or NR “Not relevant or of minor relevance in this study”

 

 

 

 

 

 

 

 

 

Add free text to explain

 

 

 

 

 

 

 

 

 

Selection

Was the sequence generation adequate?

+ - ? NR

+

+

+

NR

?

+

+

+

75%+

Was allocation concealment adequate?

+ - ? NR

NR

NR

NR

NR

NR

+

+

+

60%+

Was a consecutive or random sample of patients enrolled? (applies to non randomized studies)

+ - ? NR

NR

NR

NR

+

 

 

 

 

 

Did the study avoid inappropriate exclusions?

+ - ? NR

+

+

+

+

NR

+

+

+

nr

Were the baseline characteristics similar? (applies to non randomized studies)

+ - ? NR

+

+

+

+

+

+

+

+

nr

Could the selection of patients have introduced bias?

YES  NO

NO

NO

no

no

NO

NO

NO

+

75%-

Conduct

Were participants and personnel blinded?

+ - ? NR

-

-

-

-

NR

+

-

nr

nr

Were the  co-interventions identical?

+ - ? NR

+

-

-

NR

+

+

+

+

nr

Was the number of withdrawals or uncompleted measurements appropriately low?

+ - ? NR

+

+

+

+

+

+

+

+

nr

Could the conduct of the intervention have introduced bias?

YES  NO

NO

YES

no

NR

no

no

yes (by the information given to the test)

yes (by the information given to the test)

nr

Interpretation

Were outcome assessors  blinded?

+ - ? NR

-

-

-

NR

NR

+

+

nr

nr

Could the interpretation of the intervention have introduced bias?

YES  NO

NO

NO

NO

NR

NO

no

no

no

nr

Analysis and reporting

Was data analyzed appropriately?

+ - ? NR

+

+

+

+

+

+

+

+

nr

Was incomplete outcome data addressed?

+ - ? NR

+

+

+

+

+

+

+

+

nr

Was the study free from selective reporting?

+ - ? NR

?

+

+

+

+

+

+

+

nr

Other

Was the study funding independent from  manufacturer?

+ - ? NR

-

-

+

+

+

-

?

-

nr

Free of other bias? Which?

+ - ? NR

 

+

+

+

+

+

+

+

nr

 

 

 

 

 

 

 

 

 

 

 

 

 

External validity

 

 

 

 

 

 

 

 

 

 

 

Relevant patient group

+ - ?

+

+

+

+

+

+

+

+

+

 

Relevant intervention

+ - ?

+

+

+

+

+

+

+

+

+

 

Relevant comparator

+ - ?

+

+

+

+

+

+

+

+

+

 

Relevant endpoint measures

+ - ?

+

+

+

+

+

+

+

+

+

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX 5

 

Quality Assessment of selected systematic reviews  AMSTAR (http://amstar.ca/Amstar_Checklist.php)

 

 

 

 

 

Hassan et al., 2012

 

Vart et al. 2012

 

For each question, select:

 

  • Yes
  • No
  • Can’t  answer
  • Not applicable

 

  1. Was the sequence generation adequate?

 NA

NA

  1. Was there duplicate study selection and data extraction?

Yes

Yes

  1. Was a comprehensive literature search performed?

Yes

Yes

  1. Was the status of the publication used as an inclusion criterion?

Yes

No

  1. Was a list of studies (included and excluded) provided?

Yes (in the on line version of the article)

No

  1. Were the characteristics of the included studies provided?

 

 

Yes

Yes

  1. Was the scientific quality of the included studies assessed and documented?

 

Yes

Yes

  1. Was the scientific quality of the included studies assessed used appropriately in formulating conclusions?

Yes

No

  1. Were the methods used to combine the findings of studies appropriate?

Yes

Yes

  1. Was the likelihood of publication bias assessed?

No

No

  1. Was the conflict of interest included?

Yes

Yes

 

9/11 (minimum 6 score)

6/11 (minimum 6 score)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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