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                                          • Lung cancer screening in risk groups Systematic review(s) of effectiveness and utility (part 1) Costs and budgetary consequences (part 2)

                                          Lung cancer screening in risk groups Systematic review(s) of effectiveness and utility (part 1) Costs and budgetary consequences (part 2)

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                                          Research areas: Oncology, Prevention and screening, Health economics

                                          Project leaders: Claudia Wild (part 1), Ingrid Zechmeister-Koss (part 2)
                                          Project team:
                                          - Thomas Semlitsch (IAVEM) & EUnetHTA partners (IQWIG, potentially others) (part 1)
                                          - Christan Böhler, Sarah Wolf (part 2)
                                          Duration: May 2020 – November 2020
                                          Language: English with German summary

                                          Publications: 
                                          HTA Project report No. 132a: http://eprints.aihta.at/1282/ (part 1)
                                          HTA Projektbericht Nro 132b: https://eprints.aihta.at/1283 (part 2)

                                           

                                          Background:

                                          Lung cancer is one of the most common cancers in Austria, as well as the most frequent cancer-related cause of death in men and the second most frequent in women [1]. The risk factors for lung cancer include smoking in particular, but also (occupational) exposure to pollutants (e.g. radon, asbestos or particulate matter), as well as pre-existing diseases of the lung or bronchial system (e.g. chronic obstructive pulmonary disease [COPD] or fibrosis). A rough differentiation is made between small cell lung cancer and non-small cell lung cancer, whereby the small cell form usually has a significantly worse course.

                                          Since a large prospective study on the screening of high-risk individuals for lung cancer (NELSON study [2]) concluded that cancer mortality could be reduced by 20% through low-dose computer tomography (LDCT), which is now also recommended in the USA, an intensive debate on the conditions under which screening with LDCT could be useful also started in Europe. Even before the results of the NELSON study were published, the establishment of lung cancer screening in risk groups was discussed nationally in expert circles, such as the Oncology Advisory Board, and the Austrian Society of Pneumology (ÖGP) together with the Austrian Society of Radiology (ÖRG) have set up a special task force for this purpose. However, others argue against the interpretation of the NELSON study that, although fewer people in the screening group died with a lung cancer diagnosis, there were more people with a different cancer diagnosis and there was no difference in overall mortality [3].

                                          Aside from the interpretation of the available evidence, other factors are important in the implementation of risk group screening, such as screening intervals (1, 2 years); the way screening is organised (opportunistic vs. organised); information strategies to reach the target group; and an analysis of costs and budget implications, taking into account not only the resource consumption of the screening programme but also subsequent clinical treatments.

                                          Project objective and research questions:

                                          The aim of the project is to summarise the clinical evidence on lung cancer screening for risk groups and to obtain an overview of the elements of relevant costs as reported in publications on health economic evaluations and therefore to develop decision support for/against lung cancer screening in Austria.

                                          The following research questions are to be answered in Part 1:

                                          • RQ1: What is the benefit/risk of screening for lung cancer using low-dose chest computer tomography (LDCT) compared to no screening in individuals at elevated risk of lung cancer?
                                          • RQ2: What is the benefit/risk of screening for lung cancer using biomarkers in addition to low-dose chest computer tomography (LDCT) compared to screening using LDCT alone in individuals at elevated risk of lung cancer?
                                          • RQ3: What is the benefit/risk of annual screening/systematic screening for lung cancer compared to screening with longer intervals (2 years or longer) / opportunistic screening in individuals at elevated risk of lung cancer?
                                          • RQ4: What is the best strategy to inform individuals in the target group about and/or to maximise participation in the screening for lung cancer?

                                          The following research questions will be answered in Part 2:

                                          • FF5: What are the relevant cost-components of lung cancer screening that have been considered in published health economic evaluations?
                                          • FF6: Which methods have been used in the literature to estimate the cost of lung cancer screening and how should they be critically appraised?
                                          • FF7: What are the results of existing economic evaluations of lung cancer screening in terms of cost-effectiveness and budget impact?

                                          Method (Part 1):

                                          Systematic review: Systematic literature search (in several databases), critical evaluation and synthesis

                                          • RQ1: Further processing/editing of the IQWIG report (completion June 2020).
                                          • RQ2 + RQ3: Overview of additional information on persons at risk, on screening intervals, type of organisation of screening from additionally searched sources and from the randomised controlled trials (RCTs) on which the IQWIG report is based.
                                          • RQ4: Overview of information strategies for reaching the target groups.

                                          Method (Part 2):

                                          Systematic review of published international economic evaluations on lung cancer screening: systematic literature search and synthesis:

                                          • FF5: Data extraction and overview of relevant cost-components as reported in health economic evaluations of lung cancer screening.
                                          • FF6: Data extraction and critical appraisal of key methods used in available studies to estimate the cost of lung cancer screening.
                                          • FF7: Data extraction and tabulation of cost-effectiveness and budget-impact estimates from international studies as well as a brief discussion of results, without transferring these results to the Austrian context.

                                          Considering the geographic transferability of results from international cost-effectiveness and budget-impact analyses to the Austrian context does not form part of this study, as this is not considered feasible for the Austrian healthcare setting. Rather, this exercise may form the basis of an Austria-specific cost-effectiveness and/or budget-impact analysis that may be conducted as a follow-up study to this project.

                                          Search strategies:

                                          • Medline via Ovid, Embase, Cochrane (CENTRAL), INAHTA-Database, Centre for Research and Dissemination (CRD), EconLit, NHS Economic Evaluation Database
                                          • Period of publication: Part 1: no limitation, Part 2: starting from 2005
                                          • Hand search in references (if necessary using Scopus), Internet research

                                          All process steps (literature selection, quality assessment, extraction) are performed independently by at least two scientists.

                                          Inclusion criteria (PICO scheme) Part 1:

                                          RQ1: What is the benefit/risk of screening for lung cancer using low-dose chest computer tomography (LDCT) compared to no screening in individuals at elevated risk of lung cancer?

                                          Description

                                          Project scope

                                          Population

                                          Adult persons (age 18 and older) without lung cancer (confirmed or suspected) at elevated risk of lung cancer

                                          1. Risk factors: current or previous tobacco smoking
                                          2. Potential risk factors: occupational toxins (e.g. radon, asbestos or fine particle exposure), COPD, lung fibrosis
                                          3. Clinical phenotypes: age, comorbidities, sex, ethnicity

                                          Intervention

                                          Screening for lung cancer using low-dose chest computer tomography (LDCT)

                                          Comparison

                                          No screening (usual care) or screening for lung cancer using other imaging technologies, especially chest x-ray

                                          Outcomes

                                          • Overall mortality
                                          • Lung cancer mortality
                                          • Occurrence of lung cancer
                                          • Stage distributions of lung cancers
                                          • Number and type of follow-up investigations
                                          • Health-related quality of life
                                          • Overdiagnosis
                                          • Overtreatment
                                          • Serious adverse events
                                          • Radiation dose of screening
                                          • Radiation-related patient outcomes

                                          Timeframe: no limitation

                                          Study design: Limited only to RCTs (except radiation exposure)

                                          RQ2: What is the benefit/risk of screening for lung cancer using biomarkers in addition to low-dose chest computer tomography (LDCT) compared to screening using LDCT alone in individuals at elevated risk of lung cancer?

                                          Description

                                          Project scope

                                          Population

                                          Adult persons (age 18 and older) without lung cancer (confirmed or suspected) at elevated risk of lung cancer

                                          Risk factors: current or previous tobacco smoking, occupational toxins (e.g. radon, asbestos or fine particle exposure), COPD, lung fibrosis

                                          Intervention

                                          Screening for lung cancer using biomarkers in addition to low-dose chest computer tomography (LDCT)

                                          Comparison

                                          Screening for lung cancer using LDCT alone

                                          Outcomes

                                          • Overall mortality
                                          • Lung cancer mortality
                                          • Occurrence of lung cancer
                                          • Stage distributions of lung cancers
                                          • Number and type of follow-up investigations
                                          • Health-related quality of life
                                          • Overdiagnosis
                                          • Overtreatment
                                          • Serious adverse events
                                          • Radiation dose of screening
                                          • Radiation-related patient outcomes

                                          Timeframe: no limitation

                                          Study design: Limited only to RCTs (except radiation exposure)

                                          RQ3: What is the benefit/risk of annual screening/systematic screening for lung cancer compared to screening with longer intervals (2 years or longer) / opportunistic screening in individuals at elevated risk of lung cancer?

                                          Description

                                          Project scope

                                          Population

                                          Adult persons (age 18 and older) without lung cancer (confirmed or suspected) at elevated risk of lung cancer

                                          Risk factors: current or previous tobacco smoking, occupational toxins (e.g. radon, asbestos or fine particle exposure), COPD, lung fibrosis

                                          Intervention

                                          1. Annual screening for lung cancer as recommended in guidelines
                                          2. Organised/systematic screening for lung cancer

                                          Comparison

                                          a.1) Screening for lung cancer as recommended in guidelines with longer screening intervals (2 years or longer) in organised/systematic screening

                                          a.2) Screening for lung cancer as recommended in guidelines with longer screening intervals (2 years or longer) in opportunistic/unsystematic screening

                                          b.1) Annual screening for lung cancer as recommended in guidelines in organised/systematic screening

                                          b.2) Annual screening for lung cancer as recommended in guidelines in opportunistic/unsystematic screening

                                          Outcomes

                                          • Overall mortality
                                          • Lung cancer mortality
                                          • Occurrence of lung cancer
                                          • Stage distributions of lung cancers
                                          • Number and type of follow-up investigations
                                          • Health-related quality of life
                                          • Overdiagnosis
                                          • Overtreatment
                                          • Serious adverse events
                                          • Radiation dose of screening
                                          • Radiation-related patient outcomes

                                          Study design: Limited only to RCTs (except radiation exposure)

                                          RQ4: What is the best strategy to inform individuals in the target group about and/or to maximise participation in the screening for lung cancer?

                                          Description

                                          Project scope

                                          Population

                                          Adult persons (age 18 and older) without lung cancer (confirmed or suspected) at elevated risk of lung cancer

                                          Risk factors: current or previous tobacco smoking, occupational toxins (e.g. radon, asbestos or fine particle exposure), COPD, lung fibrosis

                                          Intervention

                                          Specific information strategy for lung cancer screening (e.g. patient leaflets, TV/Radio commercials)

                                          Comparison

                                          Another specific information strategy for lung cancer screening or no specific information strategy for lung cancer screening

                                          Outcomes

                                          • Adherence rate to screening
                                          • Patient satisfaction
                                          • Increased knowledge
                                          • Overall mortality
                                          • Lung cancer mortality
                                          • Occurrence of lung cancer
                                          • Stage distributions of lung cancers
                                          • Number and type of follow-up investigations
                                          • Health-related quality of life
                                          • Overdiagnosis
                                          • Overtreatment
                                          • Serious adverse events

                                          Timeframe: no limitation

                                          Study design: Limited only to RCTs

                                          Inclusion criteria (PICO scheme) Part 2:

                                          Population

                                          • Adult persons (age 18 and older) without lung cancer (confirmed or suspected) at elevated risk of lung cancer
                                          • Risk factors: current or previous tobacco smoking, occupational toxins (e.g. radon, asbestos or fine particle exposure), COPD, lung fibrosis

                                          Intervention

                                          • Various forms of lung cancer screening (such as organised /systematic screening, opportunistic screening, screening at various intervals)
                                            • Low-dose chest computer tomography (LDCT)
                                            • LDCT + biomarkers

                                          Comparison

                                          • No screening
                                          • Screening for lung cancer using other imaging technologies, in particular, chest x-ray

                                          Outcomes

                                          • Components of direct and indirect cost of lung cancer screening, including treatment cost after a positive screening-test result as well as the cost of false-positive results
                                          • Methods of cost-estimation used in published studies
                                          • Cost-effectiveness estimates
                                            • Incremental cost-effectiveness ratios (ICERs)
                                            • Incremental net monetary benefit (INMBs)
                                          • Budget-impact estimates

                                          Study types

                                          Health economic evaluations (CMA, CEA, CUA, CBA) and budget impact analyses

                                          Publication period

                                          From 2005 onwards

                                          Language

                                          German/ English

                                          Abbreviations: CBA – Cost-benefit analysis, CEA – Cost-effectiveness analysis, CMA – Cost-minimisation analysis, CUA – Cost-utility analysis, HTA – Health Technology Assessment

                                          Timetable/ Milestones:

                                          Timetable (Part 1)

                                          Activities

                                          April 2020

                                          Call for Collaboration in EUnetHTA,

                                          Scoping, precision of the research question (PICO), preparation of the project protocol

                                          May 2020

                                          Formation of the EUnetHTA team, precision of the research question (PICO), preparation of the EUnetHTA project protocol

                                          June 2020

                                          Systematic literature research, selection and procurement of relevant literature

                                          July-August 2020

                                          Preparation of extraction tables, synthesis and evaluation of evidence

                                          September 2020

                                          Writing the report

                                          October-November 2020

                                          Internal and external review, layout & finalisation, report publication

                                          Timetable (Part 2)

                                          Activities

                                          May 2020

                                          Scoping, precision of the research question (PICO), preparation of the project protocol

                                          June 2020

                                          Systematic literature research, selection and procurement of relevant literature

                                          June-August 2020

                                          Preparation of extraction tables, synthesis and evaluation of evidence

                                          September 2020

                                          Writing the report

                                          October-November 2020

                                          Internal and external review, layout & finalisation, report publication

                                          References:

                                          [1]       Statistik Austria (2020). Österreichisches Krebsregister (Cited:09/12/2019) und Todesursachenstatistik. Online available (accessed 25/04/2020): https://www.statistik.at/web_de/statistiken/menschen_und_gesellschaft/gesundheit/krebserkrankungen/index.html

                                          [2]        De Koning et al., Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial, N Engl J Med 2020; 382:503-513

                                          [3]        Gigerenzer, G. http://www.rwi-essen.de/unstatistik/100/, Harding Center for Risk Literacy

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