Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland

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Despite advancements in diagnostics and treatment, significant challenges persist throughout the diagnostic pathway, including nonspecific symptoms, patient-related delays, and inefficiencies within the healthcare system. The establishment of Rapid Access Lung Clinics (RALCs) in 2009 has improved referral processes, yet only half of lung cancer cases are currently diagnosed via this route, indicating a need to better understand alternative diagnostic pathways. Aim This study aims to map diagnostic pathways for lung cancer in Ireland and evaluate their impact on clinical outcomes, including time to diagnosis, treatment initiation, and survival. Methods This retrospective cohort study will include all patients whose lung cancer care commenced at the Beaumont RCSI Cancer Centre between 2012 and 2023. We will undertake a comprehensive analysis of diagnostic pathways, examining associations with (1) sociodemographic factors, (2) presenting symptoms, (3) time to diagnosis, (4) treatment approaches, and (5) survival outcomes. The study will employ descriptive statistics, multivariate logistic and linear regression models, and survival analysis to characterise and compare pathways. Implications This protocol outlines a methodological approach to utilising routine healthcare data to map lung cancer diagnostic pathways in Ireland. The findings will provide critical evidence for the HSE National Cancer Control Programme and policymakers to improve health system processes and enhance early detection. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://hrbopenresearch.org/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://hrbopenresearch.org/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://hrbopenresearch.org/articles/8-91", "name": "Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and..." } } ] } Home Browse Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Harris Á, Buckley S, Jacob B et al. Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :91 ( https://doi.org/10.12688/hrbopenres.14127.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] Áine Harris 1 , Stephen Buckley 1 , Benjamin Jacob https://orcid.org/0000-0003-1119-064X 1 , Joshua A Olaniyi 2 , Emmet O'Brien 2 , Patrick Redmond 1 Áine Harris 1 , Stephen Buckley 1 , [...] Benjamin Jacob https://orcid.org/0000-0003-1119-064X 1 , Joshua A Olaniyi 2 , Emmet O'Brien 2 , Patrick Redmond 1 PUBLISHED 18 Aug 2025 Author details Author details 1 Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland 2 Beaumont Cancer Centre, Beaumont Hospital, Dublin, Ireland Áine Harris Roles: Conceptualization, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Stephen Buckley Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Benjamin Jacob Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Validation, Writing – Review & Editing Joshua A Olaniyi Roles: Conceptualization, Data Curation, Funding Acquisition, Resources, Writing – Review & Editing Emmet O'Brien Roles: Conceptualization, Data Curation, Funding Acquisition, Resources, Supervision, Writing – Review & Editing Patrick Redmond Roles: Conceptualization, Data Curation, Funding Acquisition, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Lung cancer is a leading cause of cancer-related mortality in Ireland, with survival outcomes closely linked to the timeliness of diagnosis. Despite advancements in diagnostics and treatment, significant challenges persist throughout the diagnostic pathway, including nonspecific symptoms, patient-related delays, and inefficiencies within the healthcare system. The establishment of Rapid Access Lung Clinics (RALCs) in 2009 has improved referral processes, yet only half of lung cancer cases are currently diagnosed via this route, indicating a need to better understand alternative diagnostic pathways. Aim This study aims to map diagnostic pathways for lung cancer in Ireland and evaluate their impact on clinical outcomes, including time to diagnosis, treatment initiation, and survival. Methods This retrospective cohort study will include all patients whose lung cancer care commenced at the Beaumont RCSI Cancer Centre between 2012 and 2023. We will undertake a comprehensive analysis of diagnostic pathways, examining associations with (1) sociodemographic factors, (2) presenting symptoms, (3) time to diagnosis, (4) treatment approaches, and (5) survival outcomes. The study will employ descriptive statistics, multivariate logistic and linear regression models, and survival analysis to characterise and compare pathways. Implications This protocol outlines a methodological approach to utilising routine healthcare data to map lung cancer diagnostic pathways in Ireland. The findings will provide critical evidence for the HSE National Cancer Control Programme and policymakers to improve health system processes and enhance early detection. READ ALL READ LESS Keywords Cohort study, Lung cancer, Diagnostic pathways, Early Detection of Cancer, Referrals, Ireland Corresponding Author(s) Áine Harris ( [email protected] ) Close Corresponding author: Áine Harris Competing interests: No competing interests were disclosed. Grant information: Áine Harris’s involvement was funded by ‘HSE National Doctors Training and Planning’ via the Academic Track Internship Training Programme. Copyright: © 2025 Harris Á et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Harris Á, Buckley S, Jacob B et al. Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :91 ( https://doi.org/10.12688/hrbopenres.14127.1 ) First published: 18 Aug 2025, 8 :91 ( https://doi.org/10.12688/hrbopenres.14127.1 ) Latest published: 18 Aug 2025, 8 :91 ( https://doi.org/10.12688/hrbopenres.14127.1 ) Introduction Lung cancer is the leading cause of cancer-related mortality globally, accounting for a higher number of deaths than breast, prostate, and colorectal cancers combined 1 – 3 . In Ireland, it remains the most common cause of cancer death for both women and men, contributing to 20.2% of cancer mortality 1 , 2 . Despite advances in medical science and cancer treatments, the survival rates for lung cancer remain low, with a 5-year survival of 24% 2 , 4 , 5 . This low survival rate is primarily due to the late-stage presentation of the disease: while patients diagnosed at Stages I and II have a 5-year survival of 57% and 35%, respectively, over a third of cases are identified at Stage IV, where survival drops to just 4% 2 . Despite advances in medical science and cancer treatments, the survival rates for lung cancer remain low, with a 5-year survival of 24% 2 , 4 , 5 . This low survival rate is primarily due to the late-stage presentation of the disease: while patients diagnosed at Stages I and II have a 5-year survival of 57% and 35%, respectively, over a third of cases are identified at Stage IV, where survival drops to just 4% 2 . Challenges in timely diagnosis Early diagnosis is critical for improving survival, as lung cancer detected in its initial stages is more amenable to treatment 4 , 6 , 7 . However, early-stage lung cancer often presents asymptomatically or with nonspecific symptoms, leading to diagnostic delays 4 , 8 , 9 . In Ireland, approximately 26.1% of lung cancer cases are diagnosed following emergency presentation 2 . While emergency diagnosis shortens the time from referral to diagnosis, it is also linked to a 9-fold increased risk of 1-month mortality compared to non-emergency diagnostic pathways 10 . In Ireland, approximately 26.1% of lung cancer cases are diagnosed following presentation to the emergency department 2 . While emergency diagnosis shortens the time from referral to diagnosis, it is also linked to a 9-fold increased risk of 1-month mortality compared to non-emergency diagnostic pathways 10 . Several factors impede early diagnosis, including patient-related delays in seeking care and difficulties faced by general practitioners (GPs) in differentiating lung cancer symptoms from more common conditions 4 , 8 , 9 . Such challenges highlight the need to understand how diagnostic pathways function within the Irish healthcare context. Existing knowledge The diagnosis of lung cancer in Ireland involves multiple steps across primary, secondary, and tertiary care. The introduction of Rapid Access Lung Cancer Clinics (RALCCs) in 2009, as part of the National Cancer Control Programme (NCCP), aimed to streamline diagnosis and improve timely access to care 11 , 12 . Approximately 50% of lung cancer cases in Ireland are diagnosed through RALCCs, but over 60% of these cases are already at an advanced stage (Stages III and IV), indicating a need for earlier detection 12 , 13 . Lung cancer also has the fifth highest proportion of cases presenting as emergencies among all cancers in Ireland 2 . Approximately 50% of lung cancer cases in Ireland are diagnosed through RALCCs, but over 60% of these cases are already at an advanced stage (Stages III and IV), indicating a need for earlier detection 12 , 13 . Lung cancer also has the fifth highest proportion of cases presenting as emergencies among all cancers in Ireland 2 RALCCs typically provide an appointment within 10 days of referral, with 99% occurring within 15 days 11 – 13 . In contrast, the National Optimal Lung Cancer Pathway in England aims for CT thorax within 72 hours of referral for patients with suspected lung cancer and completion of diagnostic investigations, staging and treatment plan within 28 days of referral 14 . Patients referred to RALCCs undergo a non-contrast chest CT, followed by further investigations as necessary. Although survival rates have improved for patients managed within the RALCC framework, its utilisation remains suboptimal, partly due to GPs limiting referrals to cases with definitive signs of lung cancer 13 . However, surveyed healthcare professionals perceived the RALCC’s as underused with many GP’s referring patients only when there is definitive signs of lung cancer 11 . Consequently, patients diagnosed outside of RALCCs often face poorer outcomes 11 , 15 . A UK study by the National Cancer Intelligence Network found that approximately one-third of patients diagnosed via emergency pathways had presented to their GP before their diagnosis, often requiring multiple visits 15 . Given the similarities between the role of GPs within the respective healthcare systems, understanding these diagnostic patterns in Ireland is critical for enhancing diagnostic interventions and reducing system inefficiencies. Unmet needs Despite the importance of early diagnosis, there is a limited understanding of lung cancer diagnostic pathways in Ireland. Barriers to timely diagnosis include geographical access, socioeconomic factors, lack of awareness, and misinterpretation of symptoms 16 . Additionally, financial constraints, particularly for patients without government subsided primary care, may lead to delayed GP consultations when symptoms are attributed to comorbidities or smoking history. A comprehensive evaluation of diagnostic pathways, patient characteristics, and system-level factors is essential to identify and address obstacles to timely lung cancer diagnosis. Aim and objectives This study aims to characterise diagnostic pathways for lung cancer at the Beaumont RCSI Cancer Centre and assess their impact on diagnosis timeliness and clinical outcomes. The specific objectives are: 1. Characterise Diagnostic Pathways: To map the routes to lung cancer diagnosis within a single centre, detailing the sequence of care from the initial presentation in primary care to confirmation of diagnosis in secondary or tertiary care. 2. Identify Presentation and Referral Patterns: To evaluate the symptom profiles and referral processes, including the nature, duration, and frequency of symptoms leading to medical consultation, and the subsequent referral patterns to the cancer centre. 3. Examine Diagnostic Timelines and Contributing Factors: To analyse the intervals between key milestones in the diagnostic process and identify factors influencing the speed of diagnosis, such as patient demographics, symptomatology, healthcare access, and referral pathways. Methods Study design and setting This is a single-centre, retrospective cohort study aiming to investigate the diagnostic pathways of patients with lung cancer at Beaumont Hospital, Dublin, over an 11-year period (1st January 2012 to 31st December 2023). Beaumont Hospital serves as a tertiary referral centre and is part of the Beaumont RCSI Cancer Centre (BRCC), providing a comprehensive setting to capture data on lung cancer diagnosis and management. Participants and eligibility criteria The study cohort is drawn from the BRCC Lung Cancer Registry, which prospectively collects data on all lung cancer patients diagnosed and treated at Beaumont Hospital. Eligible participants include patients with a primary diagnosis of lung cancer during the study timeframe. Exclusion criteria are: 1. Patients not discussed at a multidisciplinary meeting (MDM). 2. Patients referred from private hospitals or outside the RCSI Hospital Group. 3. Patients treated for lung metastases originating from other primary cancers. Focusing on newly diagnosed primary lung cancer cases ensures analysis of initial diagnostic pathways, avoiding confounding by recurrent or metastatic disease Data source and variable definitions Data will be sourced from the BRCC Lung Cancer Registry, which integrates information from medical records. Key variables include: Demographics: Age, gender, and smoking status. Clinical and diagnostic details: Referral type (e.g., GP, emergency department, RALCC), diagnostic tests performed (e.g., CT, biopsy), and associated timelines. Pulmonary function and cancer characteristics: FEV1 (Forced Expiratory Volume in 1 second), FEV1% (predicted), cancer type, stage, histological subtype, and date of diagnosis. Treatment and outcomes: Initial treatment type (e.g., surgery, chemotherapy), date of treatment initiation, and survival outcomes (current status or date of death). Appendix 1 provides a detailed list of variables and definitions. Data quality and bias minimisation To mitigate selection bias, all eligible patients from the registry during the specified period will be included, ensuring a complete case capture. Recall bias is minimised through the use of prospectively collected registry data. Additionally, the registry data undergoes regular validation and cleaning processes, ensuring reliability. Temporal delays in data collection (>1 year from event) will be reported, and any potential impact on analyses will be discussed. Data access and management The BRCC Lung Cancer Registry data is accessed via the Beaumont Cancer Clinical Trials and Research Unit, with approval from the Clinical Governance Department of Beaumont Hospital. All identifiable patient data is anonymised prior to analysis, in compliance with data protection policies. Data extraction and management processes will be systematically documented to ensure reproducibility. Statistical analysis plan Analysis will address the study objectives in five phases: 1. Descriptive analysis: Sociodemographic and clinical characteristics will be summarised, including smoking status and pulmonary function test data, to provide an overview of the cohort. 2. Pathway categorisation: Diagnostic pathways will be mapped, analysing the sequence of care and timelines from presentation to diagnosis. The distribution of referral types and pathway characteristics will be assessed by patient demographics. 3. Relationship with disease stage: Associations between diagnostic pathways and cancer stage at diagnosis will be examined using frequency analysis and Kaplan-Meier survival curves to illustrate diagnostic milestones. 4. Treatment decisions: Multivariate logistic regression will identify factors influencing initial treatment modalities, incorporating demographics, clinical features, and referral pathways. 5. Survival outcomes: Kaplan-Meier survival curves and Cox proportional hazards models will evaluate the impact of diagnostic pathways on survival, adjusting for confounders. Sensitivity analyses will test the robustness of findings. Statistical analyses will be performed using software such as R or Stata, with appropriate coding for regression analyses, survival modelling, and variable transformations. Ethical considerations and reporting This study utilises data collected as part of a clinical audit approved by Beaumont Hospital’s Clinical Governance Department (Registration number CA2024/136). Data access for anonymised lung cancer records (2012–2023) was granted by the Cancer Clinical Trials and Research Unit (Registration number CDR 115). As no identifiable data is used, individual patient consent was not required. The study will follow the RECORD reporting guidelines for transparent reporting of observational research using routinely collected health data. Discussion Key results and anticipated contribution This study aims to provide a comprehensive analysis of the diagnostic pathways for lung cancer within a major Irish healthcare setting, with the goal of identifying critical delays and contributing factors in the diagnosis process. By delineating these pathways and understanding their variability, the findings are expected to identify bottlenecks in care, evaluate the impact of different referral sources, and provide insights into how early diagnosis can be facilitated. Moreover, this analysis will contribute to a more nuanced understanding of the Irish lung cancer diagnostic landscape, highlighting areas for potential intervention and improvement. Comparison with existing literature The study’s context-specific focus on the Irish healthcare system will enable a comparison with similar cohorts and pathways internationally, offering valuable insights into diagnostic disparities. Prior research from other healthcare systems, such as the UK, has identified key challenges in emergency presentations and delayed diagnoses in primary care (Swann et al. , 2024). This study will further our understanding of whether these patterns are consistent or divergent in Ireland, particularly in light of the implementation of Rapid Access Lung Cancer Clinics (RALCCs). Such a comparison will allow for the identification of system-level facilitators and barriers that are unique to the Irish context while exploring potential parallels with other countries. Strengths and limitations This study benefits from its cohort design within a single tertiary care centre, which allows for detailed examination of diagnostic pathways from initial symptoms to confirmed diagnosis and treatment. By incorporating data from both primary and secondary care, it provides a comprehensive view of patient pathways, including referral patterns, presenting symptoms, and diagnostic timelines. There are, however, some limitations. The single-centre focus at Beaumont Hospital may limit the applicability of findings to other regions in Ireland, particularly as diagnostic pathways may vary between urban and rural settings or across different healthcare systems. Additionally, the study is reliant on registry data from patients managed within Beaumont Hospital, which may not fully represent the experiences of individuals diagnosed or treated in other settings. This could lead to underrepresentation of patients with atypical presentations or delays in care-seeking. This will be mitigated with transparency in reporting, strategies for imputation where appropriate and sensitivity analysis. The reliance on routinely collected data also poses challenges, including potential gaps or inconsistencies in documentation, particularly for events that occurred over a year prior to data entry. Variations in clinical recording practices over time may influence the completeness and accuracy of the dataset Implications for practice, research & policy The insights gained from this study could significantly impact clinical practice. By highlighting the common symptoms and demographic factors associated with delayed diagnosis, primary care physicians and specialists can be more vigilant in identifying potential lung cancer cases. This could lead to more prompt referrals and diagnostic testing, ultimately reducing the time to diagnosis and improving patient outcomes. Our findings will have important implications for healthcare policy in Ireland. Identifying inefficiencies and disparities in the diagnostic process can inform the development of targeted policies aimed at improving access to diagnostic services and reducing waiting times. Policy changes guided by this research could lead to more efficient use of healthcare resources and better allocation of funding towards areas in need of improvement. This study opens several avenues for future research. Longitudinal studies could provide further insight into the progression of lung cancer symptoms and the long-term outcomes of patients based on their diagnostic journey. Additionally, research focusing on interventions aimed at reducing diagnostic delays could be highly beneficial. Conclusions In conclusion, this study has the potential to significantly advance our understanding of lung cancer diagnostic pathways in Ireland. By systematically analysing the timelines, referral patterns, and factors influencing the diagnosis of lung cancer, it aims to identify actionable opportunities for improving early detection and streamlining care. The findings are expected to inform clinical practice, guide healthcare policy reforms, and lay the groundwork for future research aimed at enhancing early diagnosis and improving lung cancer outcomes. Through this comprehensive examination, the study aspires to support the development of evidence-based strategies that will contribute to more timely and equitable cancer care delivery in Ireland. Data availability Zenodo: Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland: Appendix 1 and 2; https://doi.org/10.5281/zenodo.15083933 17 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Faculty Opinions recommended References 1. Department of Health (DoH): Health in Ireland key trends 2023. [cited 2024 Jul 17]. Reference Source 2. Registry NC: Annual statistical report of the national cancer registry. Ireland, 2023; [cited 2024 Jul 17]. Reference Source 3. Bray F, Laversanne M, Sung H, et al. : Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024; 74 (3): 229–63. PubMed Abstract | Publisher Full Text 4. Balata H, Quaife SL, Craig C, et al. : Early diagnosis and lung cancer screening. Clin Oncol (R Coll Radiol). 2022; 34 (11): 708–15. PubMed Abstract | Publisher Full Text 5. Ibodeng GO, Uche IN, Mokua R, et al. : A snapshot of lung cancer: where are we now?-a narrative review. Ann Transl Med. 2023; 11 (6): 261. PubMed Abstract | Publisher Full Text | Free Full Text 6. Goldstraw P, Chansky K, Crowley J, et al. : The IASLC lung cancer staging project: proposals for revision of the TNM stage groupings in the forthcoming (Eighth) edition of the TNM classification for lung cancer. J Thorac Oncol. 2016; 11 (1): 39–51. PubMed Abstract | Publisher Full Text 7. Knight SB, Crosbie PA, Balata H, et al. : Progress and prospects of early detection in lung cancer. Open Biol. 2017; 7 (9): 170070. PubMed Abstract | Publisher Full Text | Free Full Text 8. Polanco D, Pinilla L, Gracia-Lavedan E, et al. : Prognostic value of symptoms at lung cancer diagnosis: a three-year observational study. J Thorac Dis. 2021; 13 (3): 1485–1494. PubMed Abstract | Publisher Full Text | Free Full Text 9. Bradley SH, Kennedy MPT, Neal RD: Recognising lung cancer in primary care. Adv Ther. 2019; 36 (1): 19–30. PubMed Abstract | Publisher Full Text | Free Full Text 10. Swann R, Lyratzopoulos G, Rubin G, et al. : Predictors and consequences of different pathways to emergency diagnosis of cancer in England: evidence from linked national audit and cancer registration data. Cancer Epidemiol. 2024; 92 : 102607. PubMed Abstract | Publisher Full Text 11. Saab MM, O’Driscoll M, FitzGerald S, et al. : Referring patients with suspected lung cancer: a qualitative study with primary healthcare professionals in Ireland. Health Promot Int. 2022; 37 (3): daac088. PubMed Abstract | Publisher Full Text | Free Full Text 12. Keogh RJ, Barr MP, Keogh A, et al. : Lung cancer in the Republic of Ireland. J Thorac Oncol. 2023; 18 (7): 851–7. PubMed Abstract | Publisher Full Text 13. Hennessy M, Ryan D, Clarke S, et al. : Optimal timing of CT scanning in the rapid access lung cancer clinic. September 5, 2022; [cited 2024 Jul 17]. 14. NHS England: National Optimal Lung Cancer Pathway (NOLCP) for suspected and confirmed lung cancer: referral to treatment UPDATE 2024 Version 4.0. NHS, London, 2024; [cited 2024 Dec 9]. Reference Source 15. Diagnosing cancer in an emergency: patterns of emergency presentation of cancer in Ireland 2002-2015. [cited 2024 Jul 17]. Reference Source 16. Saab MM, Noonan B, Kilty C, et al. : Awareness and help-seeking for early signs and symptoms of lung cancer: a qualitative study with high-risk individuals. Eur J Oncol Nurs. 2021; 50 : 101880. PubMed Abstract | Publisher Full Text 17. Harris A, Buckley S, Jacob B, et al. : Protocol for a cohort study on lung cancer diagnostic pathways and outcomes in Ireland: appendix 1 and 2. 2025. Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 18 Aug 2025 ADD YOUR COMMENT Comment Author details Author details 1 Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland 2 Beaumont Cancer Centre, Beaumont Hospital, Dublin, Ireland Áine Harris Roles: Conceptualization, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Stephen Buckley Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Benjamin Jacob Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Validation, Writing – Review & Editing Joshua A Olaniyi Roles: Conceptualization, Data Curation, Funding Acquisition, Resources, Writing – Review & Editing Emmet O'Brien Roles: Conceptualization, Data Curation, Funding Acquisition, Resources, Supervision, Writing – Review & Editing Patrick Redmond Roles: Conceptualization, Data Curation, Funding Acquisition, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information Áine Harris’s involvement was funded by ‘HSE National Doctors Training and Planning’ via the Academic Track Internship Training Programme. Article Versions (1) version 1 Published: 18 Aug 2025, 8:91 https://doi.org/10.12688/hrbopenres.14127.1 Copyright © 2025 Harris Á et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Harris Á, Buckley S, Jacob B et al. Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :91 ( https://doi.org/10.12688/hrbopenres.14127.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 18 Aug 2025 Views 0 Cite How to cite this report: Deppen S. Reviewer Report For: Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :91 ( https://doi.org/10.21956/hrbopenres.15526.r49304 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-91/v1#referee-response-49304 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 16 Sep 2025 Stephen Deppen , Vanderbilt University Medical Center, Nashville, USA Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15526.r49304 Harris and colleagues propose a retrospective review of their institution's care delivery in the diagnosis and treatment of lung cancer. By performing this review, they hope to discover bottlenecks and system failures that may be improved upon and possibly inform ... Continue reading READ ALL Harris and colleagues propose a retrospective review of their institution's care delivery in the diagnosis and treatment of lung cancer. By performing this review, they hope to discover bottlenecks and system failures that may be improved upon and possibly inform how those pathways of care are reflected across Ireland and may be improved. Repetitive language in 1 st paragraph. Paragraph needs to end with goal of study. “Therefore, implementing clinical care that maximizes early stage diagnosis and minimizes time to diagnosis and treatment are paramount in improving lung cancer survival. 2 nd paragraph another repetition, edit: In Ireland, approximately 26.1% of lung cancer cases are diagnosed following presentation to the emergency department (2). While emergency diagnosis shortens the time from referral to diagnosis, it is also linked to a 9-fold increased risk of 1-month mortality compared to non-emergency diagnostic pathways (10). 3 rd paragraph another repetition, edit/remove: Approximately 50% of lung cancer cases in Ireland are diagnosed through RALCCs, but over 60% of these cases are already at an advanced stage (Stages III and IV), indicating a need for earlier detection(12,13). 12 year time range, ending in 2023. Is that criteria based upon patients diagnosed or treated at that time and will you perform follow-up outcomes in those patients diagnosed or treated thorough Dec. 2025? Given technological changes in methods of diagnosis (navigational bronchoscopy, robotic bronchoscopy, CT guided and robotic TBNA) and treatment like types of resection (VATS, robotic, SBRT segmentectomy/wedge vs Lobe), chemotherapy/immunotherapy, etc. and workup (pre-op PET, PFTs, ect.) are the planned endpoints sufficient over this time frame to best capture the intended impact (diagnostic planning) and not changes in the pulmonary disease field. Are you also excluding those diagnosed outside Beaufort (outside bronch biopsy) but treated at your location? Specify. Invasive diagnostic types (i.e. pathology proven) or performance of NGS with targeted genetic variations performed are not well described as captured results? Screening, incidental and symptomatic presentation are radically different from the diagnostic – prognostic stand point with symptomatic being the most likely late stage and poor outcomes. You need to consider the time to start measuring your outcomes (nodule discovery, nodule assessment at your institution, presentation to your institution, etc.) , and then capturing the population characteristics (w/imaging, w/o a diagnosis, etc.) with a focus on the information set at presentation, associations with patient characteristics and treatment (or diagnosis). Method of discovery as screening discovered nodule have longest follow-up time. Are you trying to develop and implement an intervention within your system or outside or both? Guideline based care is not addressed. Assuming everyone is getting the right treatment is fine, but then you need to make sure you focus on when they hit your system, who is hitting your system, and then how your system is tackling the disease. Follow-up of nodules incidentally discovered in the ED is a different intervention from getting your system to (potentially, discover and track nodules), diagnose the nodule, get PET imaging, do PFT/DLCO test and schedule surgery (ideally in under 30 days from diagnosis to surgery for clinical stage 1 or 2. When you talk about emergency presentations, are those individuals with symptomatic disease or having a large, scary lesion that needs to get pathology yesterday? Or is this the population of incidentally discovered nodules that need tracking over time (Fleichner guideline delivered care?) This issue may be more of a language issue but clarity would help. Scary and symptomatic lesions are different from one that has 3 sequential CT scans and has been tracked for 2 years. Questions of capacity (bottlenecks from interventional pulmonary schedule) vs system failures (patient loss, delay in GP orders) are different but both are necessary for your question. Population and outcome need to be better defined. Timeliness of care is a proposed outcome metric. Definition of when the clock starts and when it stops is needed. Early vs late stage are different diseases and need different outcome definitions for outcome (prognosis, treatment initiation, etc.) and thus disease specific considerations for delay/failure measurement need to be made (NGS based targeted care vs not). Date of multidisciplinary review is missing in meta-data list. Does time to diagnosis clock start at time of nodule discovery, presentation to system, or ??? Screening discovered nodules may have an order of magnitude higher time to diagnosis (300+days vs <60 for incidental) from time of nodule discovery yet get guideline LUNGRads appropriate care and early stage disease treatment (best outcome). Quite a bit is missing in the data collection. Data at presentation, discovery methods, referral method, etc. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Lung cancer diagnosis and treatment, health services research, quality improvement and implementation science. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Deppen S. Reviewer Report For: Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :91 ( https://doi.org/10.21956/hrbopenres.15526.r49304 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-91/v1#referee-response-49304 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 18 Aug 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 18 Aug 25 read Stephen Deppen , Vanderbilt University Medical Center, Nashville, USA Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Deppen S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 16 Sep 2025 | for Version 1 Stephen Deppen , Vanderbilt University Medical Center, Nashville, USA 0 Views copyright © 2025 Deppen S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Harris and colleagues propose a retrospective review of their institution's care delivery in the diagnosis and treatment of lung cancer. By performing this review, they hope to discover bottlenecks and system failures that may be improved upon and possibly inform how those pathways of care are reflected across Ireland and may be improved. Repetitive language in 1 st paragraph. Paragraph needs to end with goal of study. “Therefore, implementing clinical care that maximizes early stage diagnosis and minimizes time to diagnosis and treatment are paramount in improving lung cancer survival. 2 nd paragraph another repetition, edit: In Ireland, approximately 26.1% of lung cancer cases are diagnosed following presentation to the emergency department (2). While emergency diagnosis shortens the time from referral to diagnosis, it is also linked to a 9-fold increased risk of 1-month mortality compared to non-emergency diagnostic pathways (10). 3 rd paragraph another repetition, edit/remove: Approximately 50% of lung cancer cases in Ireland are diagnosed through RALCCs, but over 60% of these cases are already at an advanced stage (Stages III and IV), indicating a need for earlier detection(12,13). 12 year time range, ending in 2023. Is that criteria based upon patients diagnosed or treated at that time and will you perform follow-up outcomes in those patients diagnosed or treated thorough Dec. 2025? Given technological changes in methods of diagnosis (navigational bronchoscopy, robotic bronchoscopy, CT guided and robotic TBNA) and treatment like types of resection (VATS, robotic, SBRT segmentectomy/wedge vs Lobe), chemotherapy/immunotherapy, etc. and workup (pre-op PET, PFTs, ect.) are the planned endpoints sufficient over this time frame to best capture the intended impact (diagnostic planning) and not changes in the pulmonary disease field. Are you also excluding those diagnosed outside Beaufort (outside bronch biopsy) but treated at your location? Specify. Invasive diagnostic types (i.e. pathology proven) or performance of NGS with targeted genetic variations performed are not well described as captured results? Screening, incidental and symptomatic presentation are radically different from the diagnostic – prognostic stand point with symptomatic being the most likely late stage and poor outcomes. You need to consider the time to start measuring your outcomes (nodule discovery, nodule assessment at your institution, presentation to your institution, etc.) , and then capturing the population characteristics (w/imaging, w/o a diagnosis, etc.) with a focus on the information set at presentation, associations with patient characteristics and treatment (or diagnosis). Method of discovery as screening discovered nodule have longest follow-up time. Are you trying to develop and implement an intervention within your system or outside or both? Guideline based care is not addressed. Assuming everyone is getting the right treatment is fine, but then you need to make sure you focus on when they hit your system, who is hitting your system, and then how your system is tackling the disease. Follow-up of nodules incidentally discovered in the ED is a different intervention from getting your system to (potentially, discover and track nodules), diagnose the nodule, get PET imaging, do PFT/DLCO test and schedule surgery (ideally in under 30 days from diagnosis to surgery for clinical stage 1 or 2. When you talk about emergency presentations, are those individuals with symptomatic disease or having a large, scary lesion that needs to get pathology yesterday? Or is this the population of incidentally discovered nodules that need tracking over time (Fleichner guideline delivered care?) This issue may be more of a language issue but clarity would help. Scary and symptomatic lesions are different from one that has 3 sequential CT scans and has been tracked for 2 years. Questions of capacity (bottlenecks from interventional pulmonary schedule) vs system failures (patient loss, delay in GP orders) are different but both are necessary for your question. Population and outcome need to be better defined. Timeliness of care is a proposed outcome metric. Definition of when the clock starts and when it stops is needed. Early vs late stage are different diseases and need different outcome definitions for outcome (prognosis, treatment initiation, etc.) and thus disease specific considerations for delay/failure measurement need to be made (NGS based targeted care vs not). Date of multidisciplinary review is missing in meta-data list. Does time to diagnosis clock start at time of nodule discovery, presentation to system, or ??? Screening discovered nodules may have an order of magnitude higher time to diagnosis (300+days vs <60 for incidental) from time of nodule discovery yet get guideline LUNGRads appropriate care and early stage disease treatment (best outcome). Quite a bit is missing in the data collection. Data at presentation, discovery methods, referral method, etc. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Lung cancer diagnosis and treatment, health services research, quality improvement and implementation science. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Deppen S. Peer Review Report For: Protocol for a Cohort Study on Lung Cancer Diagnostic Pathways and Outcomes in Ireland [version 1; peer review: 1 approved with reservations] . HRB Open Res 2025, 8 :91 ( https://doi.org/10.21956/hrbopenres.15526.r49304) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-91/v1#referee-response-49304 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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