Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study
Introduction Lung cancer is the leading cause of cancer death in the USA and worldwide, and lung cancer screening (LCS) with low-dose CT (LDCT) has the potential to improve lung cancer outcomes. A critical question is whether the ratio of potential benefits to harms found in prior LCS trials applies...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e064142.full |
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| author | Yi Guo Dongyu Zhang Rafael Meza Jihyoun Jeon Dejana Braithwaite Gerard A Silvestri Michael K Gould Jiang Bian Bruno Hochhegger Shama D Karanth Christopher G Slatore Martin Tammemagi Mattthew Schabath Meghann Wheeler Frederic J Kaye |
| author_facet | Yi Guo Dongyu Zhang Rafael Meza Jihyoun Jeon Dejana Braithwaite Gerard A Silvestri Michael K Gould Jiang Bian Bruno Hochhegger Shama D Karanth Christopher G Slatore Martin Tammemagi Mattthew Schabath Meghann Wheeler Frederic J Kaye |
| author_sort | Yi Guo |
| collection | DOAJ |
| description | Introduction Lung cancer is the leading cause of cancer death in the USA and worldwide, and lung cancer screening (LCS) with low-dose CT (LDCT) has the potential to improve lung cancer outcomes. A critical question is whether the ratio of potential benefits to harms found in prior LCS trials applies to an older and potentially sicker population. The Personalised Lung Cancer Screening (PLuS) study will help close this knowledge gap by leveraging real-world data to fully characterise LCS recipients. The principal goal of the PLuS study is to characterise the comorbidity burden of individuals undergoing LCS and quantify the benefits and harms of LCS to enable informed decision-making.Methods and analysis PLuS is a multicentre observational study designed to assemble an LCS cohort from the electronic health records of ~40 000 individuals undergoing annual LCS with LDCT from 2016 to 2022. Data will be integrated into a unified repository to (1) examine the burden of multimorbidity by race/ethnicity, socioeconomic status and age; (2) quantify potential benefits and harms; and (3) use the observational data with validated simulation models in the Cancer Intervention and Surveillance Modeling Network (CISNET) to provide LCS outcomes in the real-world US population. We will fit a multivariable logistic regression model to estimate the adjusted ORs of comorbidity, functional limitations and impaired pulmonary function adjusted for relevant covariates. We will also estimate the cumulative risk of LCS outcomes using discrete-time survival models. To our knowledge, this is the first study to combine observational data and simulation models to estimate the long-term impact of LCS with LDCT.Ethics and dissemination The study was approved by the Kaiser Permanente Southern California Institutional Review Board and VA Portland Health Care System. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations include protection of patient confidentiality. |
| format | Article |
| id | doaj-art-8b1d12152354454c910d4ed2e84a4ec4 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8b1d12152354454c910d4ed2e84a4ec42025-02-01T14:50:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-064142Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational studyYi Guo0Dongyu Zhang1Rafael Meza2Jihyoun Jeon3Dejana Braithwaite4Gerard A Silvestri5Michael K Gould6Jiang Bian7Bruno Hochhegger8Shama D Karanth9Christopher G Slatore10Martin Tammemagi11Mattthew Schabath12Meghann Wheeler13Frederic J Kaye14Shanghai Pudong New Area Mental Health Center, Shanghai, China1 Department of Oncology, Georgetown University School of Medicine, Washington, District of Columbia, USADepartment of Epidemiology, University of Michigan, Ann Arbor, Michigan, USA2 Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan, USACancer Center, UF Health, Gainesville, Florida, USADivision of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina, USADepartment of Health Systems Science, Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, California, USA5 Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USADepartment of Radiology, University of Florida, Gainesville, Florida, USACancer Center, UF Health, Gainesville, Florida, USACenter to Improve Veteran Involvement in Care, Portland VA Medical Center, Portland, Oregon, USADepartment of Health Sciences, Brock University, St. Catharines, Ontario, CanadaDepartment of Cancer Epidemiology, H Lee Moffitt Cancer Center and Research Center Inc, Tampa, Florida, USADepartment of Epidemiology, University of Florida, Gainesville, Florida, USADivision of Hematology and Oncology, Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida, USAIntroduction Lung cancer is the leading cause of cancer death in the USA and worldwide, and lung cancer screening (LCS) with low-dose CT (LDCT) has the potential to improve lung cancer outcomes. A critical question is whether the ratio of potential benefits to harms found in prior LCS trials applies to an older and potentially sicker population. The Personalised Lung Cancer Screening (PLuS) study will help close this knowledge gap by leveraging real-world data to fully characterise LCS recipients. The principal goal of the PLuS study is to characterise the comorbidity burden of individuals undergoing LCS and quantify the benefits and harms of LCS to enable informed decision-making.Methods and analysis PLuS is a multicentre observational study designed to assemble an LCS cohort from the electronic health records of ~40 000 individuals undergoing annual LCS with LDCT from 2016 to 2022. Data will be integrated into a unified repository to (1) examine the burden of multimorbidity by race/ethnicity, socioeconomic status and age; (2) quantify potential benefits and harms; and (3) use the observational data with validated simulation models in the Cancer Intervention and Surveillance Modeling Network (CISNET) to provide LCS outcomes in the real-world US population. We will fit a multivariable logistic regression model to estimate the adjusted ORs of comorbidity, functional limitations and impaired pulmonary function adjusted for relevant covariates. We will also estimate the cumulative risk of LCS outcomes using discrete-time survival models. To our knowledge, this is the first study to combine observational data and simulation models to estimate the long-term impact of LCS with LDCT.Ethics and dissemination The study was approved by the Kaiser Permanente Southern California Institutional Review Board and VA Portland Health Care System. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations include protection of patient confidentiality.https://bmjopen.bmj.com/content/12/6/e064142.full |
| spellingShingle | Yi Guo Dongyu Zhang Rafael Meza Jihyoun Jeon Dejana Braithwaite Gerard A Silvestri Michael K Gould Jiang Bian Bruno Hochhegger Shama D Karanth Christopher G Slatore Martin Tammemagi Mattthew Schabath Meghann Wheeler Frederic J Kaye Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study BMJ Open |
| title | Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study |
| title_full | Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study |
| title_fullStr | Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study |
| title_full_unstemmed | Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study |
| title_short | Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study |
| title_sort | personalised lung cancer screening plus study to assess the importance of coexisting chronic conditions to clinical practice and policy protocol for a multicentre observational study |
| url | https://bmjopen.bmj.com/content/12/6/e064142.full |
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