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Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making.
MyLungHealth is a multi-site pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centered design process, informed by patient and provider focus groups and interviews. The intervention's effectiveness will be evaluated through a patient-randomized trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused clinical decision support and shared decision-making intervention) against DecisionPrecision+ alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1 (Study of Patients with Uncertain LCS Eligibility) Control Arm | No Intervention | In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2. | |
| Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention Arm | Experimental | Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2. |
|
| Study 2 (Study of Patients with Documented LCS Eligibility) Control Arm | Active Comparator | In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyLungHealth | Behavioral | MyLungHealth is a patient-centered, EHR-integrated smoking data-quality improvement and education intervention. A key component of the MyLungHealth intervention is a pre-visit LCS eligibility questionnaire asked through the Epic EHR patient portal for individuals with unclear LCS eligibility due to missing or potentially inaccurate data in the EHR. Another key component of the MyLungHealth intervention is an interoperable, patient-centered educational app delivered through the EHR patient portal. |
| Measure | Description | Time Frame |
|---|---|---|
| Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening | In Study 1, the primary outcome was the number of patients newly identified as eligible for lung cancer screening during the 12-month follow-up period, defined as having a smoking history of at least 20 pack-years and being a current smoker or having quit within the past 15 years, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal. | 1 year trial period |
| Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered. | In Study 2, which enrolled participants with documented lung cancer screening eligibility at baseline, the primary outcome was the count of participants for whom a low-dose computed tomography (LDCT) lung cancer screening order was placed during the 12-month follow-up period, as identified from structured electronic health record order data. | 1 year trial period |
| Measure | Description | Time Frame |
|---|---|---|
| Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known. | In Study 1, which enrolled participants with uncertain lung cancer screening eligibility at baseline, a secondary outcome was the count of participants for whom lung cancer screening eligibility status became known during the 12-month follow-up period, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal. |
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Inclusion criteria for both study 1 and study 2:
Exclusion criteria for both study 1 and study 2:
Inclusion criteria for study 1:
Inclusion criteria for study 2:
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| Name | Affiliation | Role |
|---|---|---|
| Kensaku Kawamoto, MD, PhD, MHS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States | ||
| University of Utah Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142092 | Background | Kukhareva PV, Li H, Caverly TJ, Del Fiol G, Fagerlin A, Butler JM, Hess R, Zhang Y, Taft T, Flynn MC, Reddy C, Martin DK, Warner IA, Rodriguez-Loya S, Warner PB, Kawamoto K. Implementation of Lung Cancer Screening in Primary Care and Pulmonary Clinics: Pragmatic Clinical Trial of Electronic Health Record-Integrated Everyday Shared Decision-Making Tool and Clinician-Facing Prompts. Chest. 2023 Nov;164(5):1325-1338. doi: 10.1016/j.chest.2023.04.040. Epub 2023 May 3. | |
| 41452617 |
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On completion, study data will be made available in compliance with institutional and sponsor data sharing policies.
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This was a pragmatic, minimal-risk trial conducted under a waiver of informed consent. Eligibility was determined using pretrial structured EHR data. No in-person screening or consent procedures were performed. Participants were not contacted prior to randomization. No participants were excluded after randomization.
Participants were identified using electronic health record (EHR) data from primary care clinics at University of Utah Health and New York University Langone Health. Eligible patients were adults aged 50-79 years with a documented smoking history, an active patient portal account, and a primary care visit in the prior 12 months. Recruitment and randomization were fully automated and embedded within the EHR as part of a pragmatic clinical trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm | In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2. |
| FG001 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2. |
| FG002 | Study 2 (Study of Patients With Documented LCS Eligibility) Control Arm | In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders. |
| FG003 | Study 2 (Study of Patients With Documented LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were assessed for all randomized participants in the intention-to-treat population using pre-randomization electronic health record data. Because baseline data were obtained from routinely collected clinical records, some baseline variables had missing or incomplete values. No participants were excluded from the baseline analysis, and the baseline analysis population is identical to the randomized population described in the Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm | In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at baseline, obtained from structured electronic health record demographic data prior to randomization. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening | In Study 1, the primary outcome was the number of patients newly identified as eligible for lung cancer screening during the 12-month follow-up period, defined as having a smoking history of at least 20 pack-years and being a current smoker or having quit within the past 15 years, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal. | This is study 1 primary outcomes, not applicable for study 2 participants. | Posted | Count of Participants | Participants | 1 year trial period |
|
1 year
Adverse events were monitored throughout the study period through passive clinician self-report. Participating clinicians were instructed that they could notify the study team of adverse events potentially related to the intervention via email. No such notifications were received. No study-specific active surveillance or adjudication of adverse events was performed, consistent with the minimal-risk, pragmatic design of this EHR-integrated decision support trial. No adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm | In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2. |
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This was a pragmatic, EHR-embedded clinical trial conducted under a waiver of informed consent, and outcomes were ascertained using routinely collected electronic health record data rather than study-specific assessments. Intervention exposure varied, as not all participants randomized to the intervention arm had the opportunity to engage with the patient-facing tool or chose to do so. Adverse event monitoring relied on passive clinician self-report rather than active surveillance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kensaku Kawamoto | University of Utah | 801-587-8076 | kensaku.kawamoto@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2025 | Mar 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2025 | Mar 24, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a patient randomized trial that includes two sub-studies, with 2 arms each.
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|
| Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm | Experimental | Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR. |
|
|
| DecisionPrecision+ | Behavioral | DecisionPrecision+ is a multi-faceted intervention which includes provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders. |
|
| 1 year trial period |
| Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered. | Secondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial. | 1 year trial period |
| Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed. | Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was completed during the 1-year trial. | 1 year trial period |
| Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed. | A secondary outcome for Study 2 will be the percentage of participants for whom LDCT was completed during the 1-year trial. | 1 year trial period |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| Derived |
| Kukhareva PV, Li H, Balbin C, Stevens ER, Mann DM, Butler JM, Caverly TJ, Del Fiol G, Kaphingst KA, Schlechter CR, Tiase VL, Fagerlin A, Zhang Y, Hess R, Flynn MC, Reddy C, Martin D, Warner PB, Nanjo C, Choi J, Ngo-Metzger Q, Kawamoto K. Enhancement of Patient-Centered Lung Cancer Screening: The MyLungHealth Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):167-176. doi: 10.1001/jamaoncol.2025.5672. |
| 39806641 | Derived | Kukhareva P, Balbin C, Stevens E, Mann D, Tiase V, Butler J, Del Fiol G, Caverly T, Kaphingst K, Schlechter CR, Fagerlin A, Li H, Zhang Y, Hess R, Flynn M, Reddy C, Warner P, Choi J, Martin D, Nanjo C, Metzger Q, Kawamoto K. The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care. BMJ Open. 2024 Dec 22;14(12):e087056. doi: 10.1136/bmjopen-2024-087056. |
| BG001 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2. |
| BG002 | Study 2 (Study of Patients With Documented LCS Eligibility) Control Arm | In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders. |
| BG003 | Study 2 (Study of Patients With Documented LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR. |
| BG004 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| Years |
|
| Sex: Female, Male | Sex as recorded in structured electronic health record demographic fields prior to randomization. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race and ethnicity were derived from patient self-report as recorded in structured electronic health record fields during routine clinical care. Categories were harmonized across participating health systems and reported as Hispanic/Latinx (any race), non-Hispanic African American/Black, non-Hispanic White, and Other, which included non-Hispanic American Indian or Alaska Native, non-Hispanic Asian, non-Hispanic Native Hawaiian or Pacific Islander, non-Hispanic multiracial, and missing or unspecified race and/or ethnicity. | Number | Participants |
|
| OG001 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2. |
|
|
| Primary | Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered. | In Study 2, which enrolled participants with documented lung cancer screening eligibility at baseline, the primary outcome was the count of participants for whom a low-dose computed tomography (LDCT) lung cancer screening order was placed during the 12-month follow-up period, as identified from structured electronic health record order data. | Posted | Count of Participants | Participants | 1 year trial period |
|
|
|
| Secondary | Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known. | In Study 1, which enrolled participants with uncertain lung cancer screening eligibility at baseline, a secondary outcome was the count of participants for whom lung cancer screening eligibility status became known during the 12-month follow-up period, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal. | Posted | Count of Participants | Participants | 1 year trial period |
|
|
|
| Secondary | Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered. | Secondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial. | Posted | Count of Participants | Participants | 1 year trial period |
|
|
|
| Secondary | Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed. | Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was completed during the 1-year trial. | Posted | Count of Participants | Participants | 1 year trial period |
|
|
|
| Secondary | Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed. | A secondary outcome for Study 2 will be the percentage of participants for whom LDCT was completed during the 1-year trial. | Posted | Count of Participants | Participants | 1 year trial period |
|
|
|
| 0 |
| 13,317 |
| 0 |
| 13,317 |
| 0 |
| 13,317 |
| EG001 | Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2. | 0 | 13,412 | 0 | 13,412 | 0 | 13,412 |
| EG002 | Study 2 (Study of Patients With Documented LCS Eligibility) Control Arm | In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders. | 0 | 2,262 | 0 | 2,262 | 0 | 2,262 |
| EG003 | Study 2 (Study of Patients With Documented LCS Eligibility) Intervention Arm | Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR. | 0 | 2,312 | 0 | 2,312 | 0 | 2,312 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |