{
  "abstract": "Introduction Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.Methods and analysis PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.Ethics and dissemination This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.",
  "authors": [
    {
      "affiliations": [
        "Department of Surgery, University of Florida, Gainesville, Florida, USA",
        "Department of Cancer Centre, UF Health, Gainesville, Florida, USA",
        "Department of Epidemiology, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Dejana Braithwaite"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Florida, Gainesville, Florida, USA",
        "Department of Cancer Centre, UF Health, Gainesville, Florida, USA"
      ],
      "name": "Shama D Karanth"
    },
    {
      "affiliations": [
        "Regenstrief Institute Inc, Indianapolis, Indiana, USA",
        "Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana, USA"
      ],
      "name": "Jiang Bian"
    },
    {
      "affiliations": [
        "University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Rafael Meza"
    },
    {
      "affiliations": [
        "Department of Epidemiology, University of Michigan, Ann Arbor, Michigan, USA"
      ],
      "name": "Jihyoun Jeon"
    },
    {
      "affiliations": [
        "Ontario Health, Toronto, Ontario, Canada",
        "Department of Health Sciences, Brock University, St. Catharines, Ontario, Canada"
      ],
      "name": "Martin Tammemagi"
    },
    {
      "affiliations": [
        "Department of Epidemiology, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Meghann Wheeler"
    },
    {
      "affiliations": [
        "Department of Public Health, Purdue University College of Health and Human Services, West Lafayette, Indiana, USA"
      ],
      "name": "Pianpian Cao"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Florida College of Medicine, Gainesville, Florida, USA"
      ],
      "name": "Mindaugas Rackauskas"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Pratibha Shrestha"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Florida, Gainesville, Florida, USA",
        "Department of Cancer Centre, UF Health, Gainesville, Florida, USA"
      ],
      "name": "Hyung-Suk (Alex) Yoon"
    },
    {
      "affiliations": [
        "Rescue Lung Society, Jupiter, Florida, USA"
      ],
      "name": "Andrea Borondy Kitts"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Himanshi Verma"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Marissa Carmella Blair"
    },
    {
      "affiliations": [
        "Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Aokun Chen"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Florida College of Medicine, Gainesville, Florida, USA"
      ],
      "name": "Devika Das"
    },
    {
      "affiliations": [
        "Department of Biostatistics, University of Florida College of Medicine and College of Public Health and Health Professions, Gainesville, Florida, USA"
      ],
      "name": "Xiangyang Lou"
    },
    {
      "affiliations": [
        "Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Yonghui Wu"
    },
    {
      "affiliations": [
        "Stanford University School of Medicine, Stanford, California, USA"
      ],
      "name": "Summer Han"
    },
    {
      "affiliations": [
        "Department of Radiology, University of Florida College of Medicine, Gainesville, Florida, USA"
      ],
      "name": "Bruno Hochhegger"
    },
    {
      "affiliations": [
        "Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Yi Guo"
    },
    {
      "affiliations": [
        "Department of Health Systems Science, Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, California, USA"
      ],
      "name": "MK Gould"
    }
  ],
  "title": "Protocol for an observational cohort study integrating real-world data and microsimulation to assess imaging surveillance strategies in stage I–IIIA NSCLC patients in OneFlorida+",
  "uid": "93586a71-079c-5ab3-8a61-110a8169902a"
}