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Henderson JT, Webber EM, Weyrich M, et al. Screening for Breast Cancer: A Comparative Effectiveness Review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2024 Apr. (Evidence Synthesis, No. 231.)
Screening for Breast Cancer: A Comparative Effectiveness Review for the U.S. Preventive Services Task Force [Internet].
Show detailsAppendix E Table 1Additional Details on Included Trials and NRSIs
| Intervention Category | Study Design |
Author, Year Study/Trial Name | Country | Comparison (IG vs. CG) | Number of Readers | Reader Experience/Training | Type of Reading | Consensus Method | Case and Mortality Ascertainment Method |
|---|---|---|---|---|---|---|---|---|---|
| Age to Stop | NRSI | Garcia-Albeniz, 2020 | US | Continuing annual DM beyond 70 years of age vs. Stopping annual DM at 70 years of age | NR | NR | NR | NR | Medicare data and National Death Index |
| Screening Frequency | RCT |
Blamey, 2002 UKCCCR | UK | Annual DM vs. Triennial DM | NR | NR | NR | NR | Local hospital data and regional cancer registries |
| NRSI |
Ho, 2022 BCSC | US | Annual DBT/DM or DM vs. Biennial DBT/DM or DM | NR | NR | NR | NR | BCSC registry data, pathology databases, stage/regional tumor registries, state death records | |
|
McGuinness, 2018 KYRAS | US | Annual DM vs. Biennial DM | NR | NR | NR | NR | Electronic health record | ||
|
Miglioretti, 2015 BCSC | US | Annual DM vs. Biennial DM | NR | NR | NR | NR | BCSC registry data, pathology databases, stage/regional tumor registries | ||
| Parvinen, 2011 | Finland | Annual DM vs. Biennial DM | 8 | NR | Dual | NR | National cancer and mortality databases | ||
| Digital Breast Tomosynthesis | RCT |
Armaroli, 2022 Proteus Donna Fair | Italy | DBT/DM (round 1), DM (round 2) vs. DM | 38 | Radiologists received basic training in integrated DM and DBT and pass a trial evaluation with the interpretation of 40 DBT cases. Readers met regional quality assurance of 5,000+ mammograms per year with periodic audits of performance. | Dual independent | If either radiologist gave a score of 3 (probably benign) or higher the case was considered positive and recalled for investigation without consensus or arbitration | Population screening database, histology reports, hospital and population cancer registry |
|
Heindel, 2022 TOSYMA Good | Germany | DBT/sDM vs. DM | NR | Participated in all regular teaching courses for mammography screening program and having passed the yearly test of 50 screening case studies, a volume of at least 5,000 screening mammograms the year before participating in the study, readers regularly assessed with an emphasis on a comparable number of sets for DBT/sDM and DM images | Dual independent | In case of any suspicious abnormality, reading results were clarified with an arbitrator to decide whether women had to be recalled for further diagnostic tests | Cancer registries | ||
|
Pattacini, 2022 RETomo Good | Italy | DBT/DM (round 1), DM (round 2) vs. DM | 10 | 4 to 20 years. Regional quality assurance criterion of at least 5,000 mammograms per year and period audits of individual performance indications and interval cancer imagining review | Dual independent | Arbitration by third reviewer | Screening database and cancer registry | ||
|
Hofvind, 2021 To-Be Good | Norway | DBT/sDM vs. DM (round 1), DBT/sDM (round 2) | 8 | Their experience in screen reading (screen film and digital mammography) before start-up of the trial varied from zero to approximately 110,000 examinations | Dual independent | Consensus was done by pairs of radiologists, and a third radiologist was consulted if the pair could not agree | National cancer registry | ||
| NRSI |
Sprague, 2023 BCSC | US | DBT vs. DM | NR | NR | NR | NR | BCSC registry data, pathology databases, stage/regional tumor registries | |
|
Ho, 2022 BCSC-2022a | US | DBT vs. DM | 699 | NR | NR | NR | BCSC registry data, pathology databases, stage/regional tumor registries, state death records | ||
|
Kerlikowske, 2022 BCSC-2022b | US | DBT vs. DM | NR | NR | NR | NR | BCSC registry data, pathology databases, regional/state tumor registries, SEER programs | ||
|
Johnson, 2021 MBTST | Sweden | DBT/DM vs. DM | 7 | 2 to 41 years. Previous experience with DBT from clinical work or studies of previous DBT | Dual independent | Examinations that scored as suspicious based on any modality were evaluated at a consensus meeting | National cancer registry | ||
| Richman, 2021 | US | DBT/DM vs. DM | NR | NR | NR | NR | Commercial insurance claims | ||
|
Hovda, 2020 OVVV | Sweden | DBT/sDM (round 1), DM (round 2) vs. DM | NR | 0 to 14 (using DM), 0 to 3 (using DBT) | Dual independent | Readings given a score of 1-5. If at least one radiologist gave score of 2 (probably benign) or greater a consensus meeting was held to determine recall Consensus with random pairs of radiologists | National cancer registry | ||
|
Conant, 2016 PROSPR | US | DBT/DM vs. DM | NR | NR | NR | NR | Electronic health records, pathology databases, institutional and state cancer registries | ||
| Supplemental MRI | RCT |
Veenhuizen, 2021 DENSE | The Netherlands | DM plus MRI vs. DM | NR | 5 to 23 years | Single reader | For those with a BI-RADS 3 score, double reading was performed, consensus on level 3 lead to repeat MRI within 6 months | National cancer registry |
| NRSI | Ganguli, 2022 | US | MRI vs. DM | NR | NR | NR | NR | Medical claims database | |
| Supplemental Ultrasound | RCT |
Ohuchi, 2016 J-START | Japan | DM plus US vs. DM | NR | <1 for ultrasound training. Ultrasonography is performed by qualified physicians, laboratory technologists, clinical radiological technologists, or nurses having experience with breast ultrasonography and completed the breast ultrasonography training program. The technologists and the physicians involved in this trial are asked to finish 2-day, 16-hour education program for the standardization of ultrasound screening for breast cancer | Dual independent | Results of ultrasound were reassessed by physicians at the study sites, including radiologists and breast surgeons | Study database, postal survey, vital registry |
| NRSI |
Lee, 2019 BCSC | US | DM plus US vs. DM | NR | NR | NR | NR | BCSC registry data, pathology databases, stage/regional tumor registries, state death records |
Abbreviations: BCSC=Breast Cancer Surveillance Consortium; BI-RADS=Breast Imaging Reporting and Data System; DBT=digital breast tomosynthesis; DENSE=Dense Tissue and Early Breast Neoplasm Screening; DM=digital mammography; J-START=Japan Strategic Anti-cancer Randomized Trial; MBTST=Malmo Breast Tomosynthesis Screening Trial; NR=not reported; NRSI=nonrandomized study of intervention; RCT=randomized controlled trial; RETomo=Reggio Emilia Tomosynthesis Trial; sDM=synthetic mammography; PROSPR=Population-based Research Optimizing Screening through Personalized Regimens; To-Be=Tomosynthesis Trial in Bergen; TOSYMA=TOmosynthesis plus SYnthesized MAmmography study; OVVV=Oslo-Vestfold-Vestre Viken; UKCCR=United Kingdom Coordinating Committee on Cancer Research trial; US=ultrasound
- Appendix E Table 1, Additional Details on Included Trials and NRSIs - Screening ...Appendix E Table 1, Additional Details on Included Trials and NRSIs - Screening for Breast Cancer: A Comparative Effectiveness Review for the U.S. Preventive Services Task Force
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