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

A. Health Problem and Current Use of the Technology

Target Condition

  • CUR1 [from A0001]: Which disease/health problem/potential health problem will FIT be used for?
  • CUR2 [from A0002]: What, if any, is the precise definition/ characterization of adenomas and/or colorectal carcinoma (CRC)? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?
  • CUR4 [from A0003]: Which are the known risk factors for acquiring adenomas and/or CRC?
  • CUR6 [from A0004]: What is the natural course of CRC?
  • CUR8 [from A0005]: What are the symptoms at different stages of adenomas and/or CRC?
  • CUR9 [from A0006]: What is the burden of CRC?
  • CUR11 [from A0009]: What aspects of the burden of CRC are targeted by CRC screening with FIT?

Target Population

  • CUR10 [from A0007]: What is the target population for colorectal carcinoma screening with FIT?
  • CUR26 [from A0023]: How many people belong to the target population in Europe?

Utilisation

  • CUR12 [from A0011]: Which countries use FIT for CRC screening?
  • CUR13 [from A0011]: Which percentage of target population is accually screened in countries with CRC screening program with FIT?
  • CUR14 [from A0012]: What kind of variations in use of CRC screening methods are there across countries/regions/settings?

Current Management of the Condition

  • CUR15 [from A0013]: How are adenomas/CRC currently diagnosed?
  • CUR16 [from A0013]: How are adenomas/CRC currently screened?
  • CUR17 [from A0014]: How should adenomas/CRC be diagnosed or screened according to published algorithms/guidelines?
  • CUR20 [from A0016]: How should adenomas/CRC be managed according to published algorithms/guidelines?
  • CUR21 [from A0017]: What are the differences in the management for different stages of CRC?
  • CUR22 [from A0018]: What are the other evidence-based alternatives to CRC screening with FIT?
  • CUR27 [from A0018]: What are the technical characteristics and analytical validity of guaiac-based fecal occult blood test (FOBT), as main CRC screening comparator in this assessment?
  • CUR18 [from A0015]: How are adenomas/CRC currently managed?

Life-Cycle

  • CUR23 [from A0019]: In which phase is the development of FIT?

Regulatory Status

  • CUR24 [from A0020]: Which market authorization status (CE mark) has FIT in other countries, or international authorities?
  • CUR25 [from A0021]: What is the reimbursement status of CRC screening with FIT across countries?

B. Description and technical characteristics of technology

Features of the technology

  • TEC1 [from B0001]: What is FIT?
  • TEC2 [from B0002]: Why is FIT used?
  • TEC3 [from B0003]: What is the phase of FIT?
  • TEC4 [from B0004]: Who will apply FIT?
  • TEC5 [from B0005]: In what place and context is FIT intended to be used?
  • TEC6 [from B0006]: Are there any special features relevant to FIT?
  • TEC16 [from B0016]: To what population(s) will FIT be used on?
  • TEC17 [from B0017]: Is FIT field changing rapidly?
  • TEC18 [from B0018]: Are the reference values or cut-off points clearly established?

Investments and tools required to use the technology

  • TEC7 [from B0007]: What material investments are needed to use FIT?
  • TEC8 [from B0008]: What kind of special premises are needed to use FIT?
  • TEC9 [from B0009]: What equipment and supplies are needed to use FIT?
  • TEC10 [from B0010]: What kind of data and records are needed to monitor the use FIT?
  • TEC11 [from B0011]: What kind of registers are needed to monitor the use FIT?

Training and information needed to use the technology

  • TEC12 [from B0012]: What kind of qualification, training and quality assurance processes are needed for the use or maintenance of FIT?
  • TEC14 [from B0014]: What kind of training and information should be provided for the patient who uses FIT, or for his family/carer?
  • TEC15 [from B0015]: What information of FIT should be provided for patients outside the target group and the general public?
  • TEC13 [from B0013]: What kind of training is needed for the personnel treating or investigating patients using FIT?

C. Safety

Patient safety

  • SAF1 [from C0001]: What kind of harms can use of FIT cause to the patient; what are the incidence, severity and duration of harms?
  • SAF2 [from C0002]: What is the dose relatedness of the harms to patients?
  • SAF3 [from C0003]: What is the timing of onset of harms to patients: immediate, early or late?
  • SAF4 [from C0004]: Is the incidence of the harms to patients likely to change over time?
  • SAF5 [from C0005]: Are there susceptible patient groups that are more likely to be harmed through use of FIT?
  • SAF6 [from C0006]: What are the consequences of false positive, false negative and incidental findings brought about using FIT to the patients from the viewpoint of patient safety?
  • SAF7 [from C0007]: What are the special features in using (applying/interpreting/maintaining) FIT that may increase the risk of harmful events?
  • SAF8 [from C0008]: What is the safety of FIT in comparison to alternative technologies used for the same purpose?
  • SAF10 [from C0029]: Does the existence of harms influence tolerability or acceptability of FIT?

Occupational safety

  • SAF9 [from C0020]: What kind of occupational harms can occur when using FIT?

Environmental safety

  • SAF11 [from C0040]: What kind of risks for public and environment may occur when using FIT?

Safety risk management

  • SAF12 [from C0061]: Is there evidence that harms increase or decrease in different organizational settings?
  • SAF13 [from C0062]: How can one reduce safety risks for patients (including technology-, user-, and patient-dependent aspects)?
  • SAF14 [from C0063]: How can one reduce safety risks for professionals (including technology-, user-, and patient-dependent aspects)?

D. Clinical Effectiveness

Mortality

  • EFF2 [from D0001]: What is the effect of FIT versus gFOBT for CRC screening on overall mortality?
  • EFF4 [from D0002]: What is the effect of FIT versus gFOBT for CRC screening on the mortality caused by CRC?
  • EFF6 [from D0003]: What is the effect of FIT versus gFOBT for CRC screening on the mortality due to other causes than CRC?

Morbidity

  • EFF8 [from D0005]: How does the use of FIT for CRC screening modify the symptoms and findings of adenomas and CRC?
  • EFF10 [from D0006]: How does FIT for CRC screening modify the progression of adenomas and CRC?
  • EFF18 [from D0026]: How does the use of FIT versus gFOBT for CRC screening technology modify the effectiveness of subsequent interventions?

Change-in management

  • EFF12 [from D0020]: Does use of FIT versus FOBT for CRC screening lead to improved detection of adenomas and CRC?
  • EFF14 [from D0022]: Does FIT for CRC screening detect other potential health conditions that can impact the subsequent management decisions?
  • EFF16 [from D0023]: How does FIT versus FOBT for CRC screening modify the need for other technologies and use of resources?

Test accuracy

  • EFF20 [from D1001]: What is the accuracy of FIT for CRC screening against reference standard?
  • EFF22 [from D1002]: How does FIT compare to gFOBT for CRC screening in terms of accuracy measures?
  • EFF24 [from D1003]: What is the reference standard and how likely does it classify adenoma and CRC correctly?
  • EFF26 [from D1005]: What is the optimal threshold value of FIT for CRC screening?
  • EFF31 [from D1006]: Does FIT for CRC screening reliably rule in or rule out adenomas and CRC?
  • EFF28 [from D1007]: How does FIT accuracy vary in different settings?
  • EFF30 [from D1008]: What is known about the intra- and inter-observer variation in FIT interpretation?

E. Costs and economic evaluation

Resource utilization

  • ECO1 [from E0001]: What types of resources are used when delivering FIT and its comparators gFOBT and no screening(resource use identification)?
  • ECO2 [from E0002]: What amounts of resources are used when delivering FIT and its comparators gFOBT and no screening (resource use measurement)?

Unit costs

  • ECO3 [from E0003]: What are the unit costs of the resources used when delivering FIT and its comparators gFOBT and no screening?

Outcomes

  • ECO4 [from E0005]: What are the incremental effects of FIT relative to its comparator(s)gFOBT and no screening?

Cost-effectiveness

  • ECO5 [from E0006]: What is the incremental cost-effectiveness ratio (FIT versus gFOBT; FIT versus no screening; gFOBT versus no screening)?
  • ECO6 [from E0007]: What is the appropriate time horizon?
  • ECO7 [from E0008]: What is the method of analysis?

F. Ethical analysis

Principal questions about the ethical aspects of technology

  • ETH1 [from F0001]: Is FIT a new, innovative mode of care, an add-on to or modification of a standard mode of care or a replacement of a standard?

Autonomy

  • ETH2 [from F0006]: Can FIT entail special challenges/risk that the patient/person needs to be informed of?

Beneficence/nonmaleficence

  • ETH3 [from F0010]: What are the benefits and harms for patients, and what is the balance between the benefits and harms when implementing and when not implementing FIT? Who will balance the risks and benefits in practice and how?

Justice and Equity

  • ETH4 [from F0012]: What are the consequences of implementing / not implementing FIT on justice in the health care system? Are principles of fairness, justness and solidarity respected?
  • ETH5 [from F0013]: How are technologies presenting with relevantly similar (ethical) problems treated in health care system?

Questions about effectiveness and accuracy

  • ETH6 [from F0017]: What are the proper end-points for assessment and how should they be investigated?
  • ETH7 [from F0018]: Are the accuracy measures decided and balanced on a transparent and acceptable way?

G. Organisational aspects

Process

  • ORG1 [from G0001]: What kind of work flow, participant flow and other processes are needed?
  • ORG2 [from G0002]: What kind of involvement has to be mobilized for participants and important others?
  • ORG3 [from G0003]: What kind of staff, training and other human resources are required?
  • ORG4 [from G0004]: What kind of co-operation and communication of activities have to be mobilised?
  • ORG11 [from G0012]: What kind of quality assurance is needed and how should it be organised?

Structure

  • ORG5 [from G0005]: How does de-centralisation or centralization requirements influence the implementation of FIT?
  • ORG6 [from G0006]: What kinds of investments are needed (material or premises) and who are responsible for those?
  • ORG7 [from G0007]: What is the likely budget impact of the implementation of FIT for the payers (e.g. government)?

Management

  • ORG8 [from G0008]: What management problems and opportunities are attached to FIT?
  • ORG12 [from G0013]: What kind of monitoring requirements and opportunities are there for FIT?

Culture

  • ORG9 [from G0010]: How is FIT accepted?
  • ORG10 [from G0011]: How are the other interest groups taken into account in the planning / implementation of FIT?

H. Social aspects

Major life areas

  • SOC7 [from H0001]: Which social areas does the use of FIT and gFOBT influence?
  • SOC8 [from H0002]: Who are the important others that may be affected, in addition to the individual using gFOBT and FIT?

Individual

  • SOC10 [from H0006]: How do patients, citizens and the important others using FIT or gFOBT react and act upon them?
  • SOC6 [from H0012]: Are there factors that could prevent a group or persons to participate?

Communication

  • SOC11 [from H0007]: What is the knowledge and understanding of FIT or gFOBT in patients and citizens?
  • SOC12 [from H0008]: How do patients and citizens perceive the information they receive or require about FIT and gFOBT?
  • SOC14 [from H0009]: What influences patients’ or citizens’ decisions to use FIT or gFOBT?
  • SOC15 [from H0013]: What are the social obstacles or prospects in the communication about gFOBT and FIT?

I. Legal aspects

Autonomy of the patient

  • LEG1 [from I0002]: Is the voluntary participation of patients guaranteed properly?
  • LEG7 [from I0034]: Who is allowed to give consent for minors and incompetent persons?
  • LEG9 [from I0036]: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?

Privacy of the patient

  • LEG2 [from I0008]: Do laws/ binding rules require informing relatives about the results?
  • LEG3 [from I0009]: Do laws/ binding rules require appropriate measures for securing patient data?

Equality in health care

  • LEG4 [from I0011]: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to FIT?
  • LEG5 [from I0012]: Is FIT subsidized by the society?
  • LEG8 [from I0035]: Do laws/ binding rules require appropriate preventive or treatment measures available for all?

Authorisation and safety

  • LEG10 [from I0015]: Has the technology marketing authorisation?