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10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities

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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Pulmonology".

Deadline for manuscript submissions: closed (20 December 2022) | Viewed by 26805

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Special Issue Editor

Dr. Sukhwinder Singh Sohal

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Respiratory Translational Research Group, Department of Laboratory Medicine, College of Health and Medicine, University of Tasmania, Launceston, TAS 7248, Australia
Interests: COPD; COVID-19; asthma; idiopathic pulmonary fibrosis (IPF); lung cancer; airway remodelling; effects and mechanisms of inhaled corticosteroids (ICS); effects of electronic nicotine delivery systems; mechanisms of respiratory infections and inflammation; smoking cessation and air pollution
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Special Issue Information

Dear Colleagues,

It gives me great pleasure to announce to our readership that the year 2021 celebrates the 10^th anniversary of the Journal of Clinical Medicine (JCM). I congratulate the journal on this important milestone. Lung health remains a priority as the COVID-19 pandemic continues to grasp our attention in 2021. As one of the major sections of JCM, we are launching a 10^th anniversary Special Issue in the Pulmonology section.

To commemorate this important landmark and encourage lung health, we are pleased to announce that we are accepting papers for the Special Issue, entitled Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities. Chronic lung disease involves multifaceted pathologies involving several mechanisms. There is an urgent need to understand these pathological mechanisms. Early disease mechanisms are even more important to change the disease trajectory in the early days. At the same time, we need novel diagnostics and tools to detect early changes. Only by understanding what is happening may new therapeutics evolve. Collectively, this will allow early interventions that will lead to better management of patients and will enormously inform clinical practice. To answer these important questions and promote further research, we sincerely welcome your submissions to this Special Issue in the JCM.

Dr. Sukhwinder Singh Sohal
Guest Editor

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Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly journal published by MDPI.

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Keywords

Pulmonology
lung Disease
COPD
Asthma
COVID-19
Tuberculosis
Lung cancer
Bronchiectasis
Cystic fibrosis
Interstitial lung disease
Pulmonary hypertension
Sleep Apnea

Published Papers (12 papers)

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Research

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15 pages, 1760 KiB

Open AccessArticle

The Landscape of Lipid Metabolism in Lung Cancer: The Role of Structural Profiling

by Chanchan Hu, Luyang Chen, Yi Fan, Zhifeng Lin, Xuwei Tang, Yuan Xu, Yiming Zeng and Zhijian Hu

J. Clin. Med. 2023, 12(5), 1736; https://doi.org/10.3390/jcm12051736 - 21 Feb 2023

Cited by 1 | Viewed by 1417

Abstract

The aim of this study was to explore the relationship between lipids with different structural features and lung cancer (LC) risk and identify prospective biomarkers of LC. Univariate and multivariate analysis methods were used to screen for differential lipids, and two machine learning methods were used to define combined lipid biomarkers. A lipid score (LS) based on lipid biomarkers was calculated, and a mediation analysis was performed. A total of 605 lipid species spanning 20 individual lipid classes were identified in the plasma lipidome. Higher carbon atoms with dihydroceramide (DCER), phosphatidylethanolamine (PE), and phosphoinositols (PI) presented a significant negative correlation with LC. Point estimates revealed the inverse associated with LC for the n-3 PUFA score. Ten lipids were identified as markers with an area under the curve (AUC) value of 0.947 (95%, CI: 0.879–0.989). In this study, we summarized the potential relationship between lipid molecules with different structural features and LC risk, identified a panel of LC biomarkers, and demonstrated that the n-3 PUFA of the acyl chain of lipids was a protective factor for LC. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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10 pages, 1386 KiB

Open AccessEditor’s ChoiceArticle

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study

by Małgorzata Ostrowska, Alicja Rzepka-Cholasińska, Łukasz Pietrzykowski, Piotr Michalski, Agata Kosobucka-Ozdoba, Małgorzata Jasiewicz, Michał Kasprzak, Jacek Kryś and Aldona Kubica

J. Clin. Med. 2023, 12(2), 420; https://doi.org/10.3390/jcm12020420 - 04 Jan 2023

Cited by 14 | Viewed by 3013

Abstract

Up to 80% of COVID-19 survivors experience prolonged symptoms known as long COVID-19. The aim of this study was to evaluate the effects of a multidisciplinary rehabilitation program in patients with long COVID-19. The rehabilitation program was composed of physical training (aerobic, resistance, and breathing exercises), education, and group psychotherapy. After 6 weeks of rehabilitation in 97 patients with long COVID-19, body composition analysis revealed a significant decrease of abdominal fatty tissue (from 2.75 kg to 2.5 kg; p = 0.0086) with concomitant increase in skeletal muscle mass (from 23.2 kg to 24.2 kg; p = 0.0104). Almost 80% of participants reported dyspnea improvement assessed with the modified Medical Research Council scale. Patients’ physical capacity assessed with the 6 Minute Walking Test increased from 320 to 382.5 m (p < 0.0001), the number of repetitions in the 30 s Chair Stand Test improved from 13 to 16 (p < 0.0001), as well as physical fitness in the Short Physical Performance Battery Test from 14 to 16 (p < 0.0001). The impact of fatigue on everyday functioning was reduced in the Modified Fatigue Impact Scale from 37 to 27 (p < 0.0001). Cardiopulmonary exercise test did not show any change. The multidisciplinary rehabilitation program has improved body composition, dyspnea, fatigue and physical capacity in long COVID-19 patients. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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14 pages, 2398 KiB

Open AccessArticle

Clinicopathological Characteristics of Primary Pulmonary Hodgkin Lymphoma (PPHL): Two Institutional Experiences with Comprehensive Literature Review of 115 PPHL Cases

by Hera Jung, Hyun-Soo Kim, Joungho Han, Young Hyeh Ko, Yoo-Duk Choi and Taebum Lee

J. Clin. Med. 2023, 12(1), 126; https://doi.org/10.3390/jcm12010126 - 23 Dec 2022

Cited by 3 | Viewed by 1741

Abstract

Primary pulmonary Hodgkin lymphoma (PPHL) is an extremely rare condition. Its clinicopathological characteristics remain unclear because of the limited number of patients with PPHL. The aim of this study was to comprehensively analyze the clinicopathological characteristics of PPHL. We reviewed the electronic medical records and pathology slides of our 10 PPHL patients. The female-to-male ratio was 6:4, and the mean age was 41 years. Although three patients had no symptoms, seven had localized or generalized symptoms, including cough, sputum, chest discomfort/pain, and weight loss. Some cases had not been diagnosed as PPHL in the initial needle biopsy. Four patients underwent surgical resection. With chemotherapy, eight patients achieved complete remission. We also conducted a thorough literature review on 105 previously reported PPHL cases. Among a total of 115 PPHL cases, the most common subtype was nodular sclerosis (37.4%). More than half of the cases (55%) were clinically suspected as infectious pneumonia. Of 61 patients whose biopsies were available, 27 (44.3%) were diagnosed correctly as Hodgkin lymphoma, whereas the misdiagnoses included tuberculosis, Langerhans cell histiocytosis, solitary fibrous tumor, and adenocarcinoma. We demonstrated that PPHL represents a diagnostic challenge on small biopsies. Recognizing that this rare tumor can mimic infectious and inflammatory diseases as well as malignancies is important because the accurate diagnosis of PPHL is essential for adequate clinical management. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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7 pages, 479 KiB

Open AccessArticle

Efficacy of Combining Multiple Electromagnetic Navigation Bronchoscopy Modalities for Diagnosing Lung Nodules

by Ju Yeun Song, Sun Hye Shin, Hongseok Yoo, Byeong-Ho Jeong, Sang-Won Um, Hojoong Kim, O Jung Kwon and Kyungjong Lee

J. Clin. Med. 2022, 11(24), 7341; https://doi.org/10.3390/jcm11247341 - 10 Dec 2022

Cited by 3 | Viewed by 1198

Abstract

Electromagnetic navigation bronchoscopy (ENB) is one of the non-invasive methods used for lung nodule biopsy. We evaluated the efficacy of combining radial endobronchial ultrasound (R-EBUS)-guided transbronchial lung biopsy (TBLB) with ENB-guided TBLB or transbronchial needle aspiration (TBNA) for diagnosing lung nodules. Forty patients with a lung nodule underwent ENB-TBLB or TBNA, followed by R-EBUS-TBLB if available. The final diagnosis was benign or malignant, depending on the surgical pathology or 24-month follow-up computed tomography (CT). We compared the sensitivity, negative predictive value, and accuracy between combinations of procedures. The mean nodule size was 21.65 mm, and 60.0% of the nodules were solid. The bronchus was within the nodule in 67.5% and 65.0% of cases examined using CT and R-EBUS, respectively. The accuracies of ENB-TBLB alone, ENB-TBLB/TBNA, and R-EBUS-TBLB plus ENB-TBLB/TBNA were 74.4%, 82.5%, and 90.0%, respectively. The sensitivity levels of the aforementioned procedures were 69.8%, 78.8%, and 87.9%, respectively. Among 21 patients who underwent both ENB-TBLB and R-EBUS-TBLB, the latter revealed malignant cells in three of nine patients (33.3%) with benign ENB-TBLB results. Combined ENB-TBLB/TBNA and R-EBUS-TBLB had increased sensitivity and diagnostic accuracy for lung nodules. ENB and R-EBUS are complementary; using both modalities improves the sensitivity and accuracy of lung nodule diagnoses. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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11 pages, 1994 KiB

Open AccessArticle

Esophageal Pressure Measurement in Acute Hypercapnic Respiratory Failure Due to Severe COPD Exacerbation Requiring NIV—A Pilot Safety Study

by Alexandru Tudor Steriade, Mihai Gologanu, Roxana Silvia Bumbacea, Stefan Nicolae Bogdan and Dragos Bumbacea

J. Clin. Med. 2022, 11(22), 6810; https://doi.org/10.3390/jcm11226810 - 17 Nov 2022

Viewed by 1012

Abstract

Esophageal pressure (Pes) measurements could optimise ventilator parameters in acute respiratory failure (ARF) patients requiring noninvasive ventilation (NIV). Consequently, the objectives of our study were to evaluate the safety and accuracy of applying a Pes measuring protocol in ARF patients with AECOPD under NIV in our respiratory intermediate care unit (RICU). An observational cohort study was undertaken. The negative inspiratory swing of Pes (ΔPes) was measured: in an upright/supine position in the presence/absence of NIV at D1 (day of admission), D3 (3rd day of NIV), and DoD (day of discharge). A digital filter for artefact removal was developed. We included 15 patients. The maximum values for ∆Pes were recorded at admission (mean ∆Pes 23.2 cm H₂O) in the supine position. ∆Pes decreased from D1 to D3 (p < 0.05), the change being BMI-dependent (p < 0.01). The addition of NIV decreased ∆Pes at D1 and D3 (p < 0.01). The reduction of ∆Pes was more significant in the supine position at D1 (8.8 cm H₂O, p < 0.01). Under NIV, ∆Pes values remained higher in the supine versus upright position. Therefore, the measurement of Pes in AECOPD patients requiring NIV can be safely done in an RICU. Under NIV, ∆Pes reduction is most significant within the first 24 h of admission. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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15 pages, 839 KiB

Open AccessArticle

Sedentary Behaviour, Physical Activity, and Their Associations with Health Outcomes at the Time of Diagnosis in People with Inoperable Lung Cancer

by Shu Ning Ch’ng, Joanne A. McVeigh, David Manners, Terry Boyle, Carolyn J. Peddle-McIntyre, Rajesh Thomas, Jeanie Leong, Samantha Bowyer, Kirsten Mooney, Leon Straker, Daniel A. Galvão and Vinicius Cavalheri

J. Clin. Med. 2022, 11(19), 5870; https://doi.org/10.3390/jcm11195870 - 04 Oct 2022

Cited by 1 | Viewed by 1528

Abstract

This study aimed to examine sedentary behaviour (SB), physical activity (PA) and their associations with health-related measures at the time of diagnosis in people with inoperable lung cancer. People newly diagnosed with inoperable lung cancer were invited to participate in the study and asked to wear an accelerometer for seven consecutive days. Variables analysed included time spent in SB, light intensity PA (LIPA) and moderate-to-vigorous intensity PA (MVPA). Daily steps were also recorded. Data on symptoms, health-related quality of life (HRQoL), hand grip force, comorbidities and lung function were collected. Of the 120 patients referred to the study, 89 (74%) consented to participate, and SB/PA data were available for 79 (age 71 ± 11 years; 29 females). Participants spent 71% of their waking time in SB, 28% in LIPA and 1% in MVPA. Regression models demonstrated that increased SB was associated with more symptoms of fatigue and dyspnoea (p ≤ 0.02 for both), poorer HRQoL (general health and physical component score; p ≤ 0.02 for all) and lower hand grip force. For PA variables, higher daily step count was associated with better scores in all health-related measures (p < 0.05 for all). LIPA was associated with more health-related outcomes than MVPA. These findings may guide future interventions in this population. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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9 pages, 1982 KiB

Open AccessCommunication

Speckled Tracking of Pleura—A Novel Tool for Lung Ultrasound; Distinguishing COVID-19 from Acute Heart Failure

by Batsheva Tzadok, Yair Blumberg, Moti Shubert, Majdi Halabi, Eran Tal-Or, Noa Bachner-Hinenzon and Shemy Carasso

J. Clin. Med. 2022, 11(16), 4846; https://doi.org/10.3390/jcm11164846 - 18 Aug 2022

Viewed by 1798

Abstract

For the acutely dyspneic patient, discerning bedside between acute decompensated heart failure (ADHF) and COVID-19 is crucial. A lung ultrasound (LUS) is sensitive for detecting these conditions, but not in distinguishing between them; both have bilateral B-lines. The Blue protocol uses pleural sliding to differentiate decreased pneumonia; however, this is not the case in ADHF. Nonetheless, this pleural sliding has never been quantified. Speckled tracking is a technology utilized in the echocardiography field that quantifies the motion of tissues by examining the movement of ultrasound speckles. We conducted a retrospective study of LUS performed in emergency room patients during the COVID-19 pandemic. Speckled tracking of the pleura by applying software to the B-mode of pleura was compared between COVID-19 patients, ADHF patients, and patients with no respiratory complaints. A significant difference was found between the patient groups on speckled tracking both in respect of displacement and velocity. ADHF had the highest displacement, followed by COVID-19, and then non-respiratory patients: 1.63 ± 1.89, 0.59 ± 0.71, and 0.24 ± 0.45, respectively (p < 0.01). A similar trend was seen in velocity with ADHF having the highest velocity 0.34 ± 0.37, followed by COVID-19 0.14 ± 0.71, and non-respiratory patients 0.02 ± 0.09 (p <0.01). Speckled tracking of the pleura is a potential tool for discerning between different causes of dyspnea. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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11 pages, 2059 KiB

Open AccessArticle

Effects of COPD on Left Ventricular and Left Atrial Deformation in Patients with Acute Myocardial Infarction: Strain Analysis Using Speckle-Tracking Echocardiography

by Julian Grebe, Tobias Müller, Ertunc Altiok, Michael Becker, András P. Keszei, Nikolaus Marx, Michael Dreher and Ayham Daher

J. Clin. Med. 2022, 11(7), 1917; https://doi.org/10.3390/jcm11071917 - 30 Mar 2022

Cited by 1 | Viewed by 1897

Abstract

Myocardial strain analysis, which describes myocardial deformation (shortening or lengthening), provides more detailed information about left ventricular (LV) and atrial (LA) functions than conventional echocardiography and delivers prognostic information. To analyze the effects of COPD on left heart function upon acute myocardial infarction (AMI), consecutive AMI patients were retrospectively screened, and patients were included if a post-AMI echocardiography and results of recent pulmonary function tests (PFTs) were available. Strain analysis was performed by a cardiologist who was blinded to clinical information. Overall, 109 AMI patients were included (STEMI: 38%, non-STEMI: 62%). COPD patients (41%) had significantly more impaired LV “global-longitudinal-strain” (LV-GLS) compared to non-COPD patients (−15 ± 4% vs. −18 ± 4%; p < 0.001, respectively), even after adjusting for LV-ejection-fraction (LVEF) and age (mean estimated difference: 1.7%, p = 0.009). Furthermore, COPD patients had more impaired LA strain (LAS) than non-COPD patients in all cardiac cycle phases (estimated mean differences after adjusting for LVEF and age: during reservoir phase: −7.5% (p < 0.001); conduit phase: 5.5% (p < 0.001); contraction phase: 1.9% (p = 0.034)). There were no correlations between PFT variables and strain values. In conclusion, the presence of COPD was associated with more impaired LV and LA functions after AMI, as detected by strain analysis, which was independent of age, LVEF, and PFT variables. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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12 pages, 6825 KiB

Open AccessArticle

Angiotensin-Converting Enzyme 2 (ACE2), Transmembrane Peptidase Serine 2 (TMPRSS2), and Furin Expression Increases in the Lungs of Patients with Idiopathic Pulmonary Fibrosis (IPF) and Lymphangioleiomyomatosis (LAM): Implications for SARS-CoV-2 (COVID-19) Infections

by Wenying Lu, Mathew Suji Eapen, Gurpreet Kaur Singhera, James Markos, Greg Haug, Collin Chia, Josie Larby, Samuel James Brake, Glen P. Westall, Jade Jaffar, Rama Satyanarayana Raju Kalidhindi, Nimesha De Fonseka, Venkatachalem Sathish, Tillie L. Hackett and Sukhwinder Singh Sohal

J. Clin. Med. 2022, 11(3), 777; https://doi.org/10.3390/jcm11030777 - 31 Jan 2022

Cited by 5 | Viewed by 3828

Abstract

We previously reported higher ACE2 levels in smokers and patients with COPD. The current study investigates if patients with interstitial lung diseases (ILDs) such as IPF and LAM have elevated ACE2, TMPRSS2, and Furin levels, increasing their risk for SARS-CoV-2 infection and development of COVID-19. Surgically resected lung tissue from IPF, LAM patients, and healthy controls (HC) was immunostained for ACE2, TMPRSS2, and Furin. Percentage ACE2, TMPRSS2, and Furin expression was measured in small airway epithelium (SAE) and alveolar areas using computer-assisted Image-Pro Plus 7.0 software. IPF and LAM tissue was also immunostained for myofibroblast marker α-smooth muscle actin (α-SMA) and growth factor transforming growth factor beta1 (TGF-β1). Compared to HC, ACE2, TMPRSS2 and Furin expression were significantly upregulated in the SAE of IPF (p < 0.01) and LAM (p < 0.001) patients, and in the alveolar areas of IPF (p < 0.001) and LAM (p < 0.01). There was a significant positive correlation between smoking history and ACE2 expression in the IPF cohort for SAE (r = 0.812, p < 0.05) and alveolar areas (r = 0.941, p < 0.01). This, to our knowledge, is the first study to compare ACE2, TMPRSS2, and Furin expression in patients with IPF and LAM compared to HC. Descriptive images show that α-SMA and TGF-β1 increase in the IPF and LAM tissue. Our data suggests that patients with ILDs are at a higher risk of developing severe COVID-19 infection and post-COVID-19 interstitial pulmonary fibrosis. Growth factors secreted by the myofibroblasts, and surrounding tissue could further affect COVID-19 adhesion proteins/cofactors and post-COVID-19 interstitial pulmonary fibrosis. Smoking seems to be the major driving factor in patients with IPF. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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Review

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18 pages, 902 KiB

Open AccessReview

The Complex Association between COPD and COVID-19

by Nikhil T. Awatade, Peter A. B. Wark, Andrew S. L. Chan, SM Abdullah Al Mamun, Nurul Yaqeen Mohd Esa, Kazuto Matsunaga, Chin Kook Rhee, Philip M. Hansbro, Sukhwinder Singh Sohal and on behalf of the Asian Pacific Society of Respirology (APSR) COPD Assembly

J. Clin. Med. 2023, 12(11), 3791; https://doi.org/10.3390/jcm12113791 - 31 May 2023

Cited by 2 | Viewed by 3040

Abstract

Chronic obstructive pulmonary disease (COPD) is significant cause of morbidity and mortality worldwide. There is mounting evidence suggesting that COPD patients are at increased risk of severe COVID-19 outcomes; however, it remains unclear whether they are more susceptible to acquiring SARS-CoV-2 infection. In this comprehensive review, we aim to provide an up-to-date perspective of the intricate relationship between COPD and COVID-19. We conducted a thorough review of the literature to examine the evidence regarding the susceptibility of COPD patients to COVID-19 infection and the severity of their disease outcomes. While most studies have found that pre-existing COPD is associated with worse COVID-19 outcomes, some have yielded conflicting results. We also discuss confounding factors such as cigarette smoking, inhaled corticosteroids, and socioeconomic and genetic factors that may influence this association. Furthermore, we review acute COVID-19 management, treatment, rehabilitation, and recovery in COPD patients and how public health measures impact their care. In conclusion, while the association between COPD and COVID-19 is complex and requires further investigation, this review highlights the need for careful management of COPD patients during the pandemic to minimize the risk of severe COVID-19 outcomes. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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Other

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15 pages, 2395 KiB

Open AccessSystematic Review

Diagnostic Accuracy of the Artificial Intelligence Methods in Medical Imaging for Pulmonary Tuberculosis: A Systematic Review and Meta-Analysis

by Yuejuan Zhan, Yuqi Wang, Wendi Zhang, Binwu Ying and Chengdi Wang

J. Clin. Med. 2023, 12(1), 303; https://doi.org/10.3390/jcm12010303 - 30 Dec 2022

Cited by 7 | Viewed by 2718

Abstract

Tuberculosis (TB) remains one of the leading causes of death among infectious diseases worldwide. Early screening and diagnosis of pulmonary tuberculosis (PTB) is crucial in TB control, and tend to benefit from artificial intelligence. Here, we aimed to evaluate the diagnostic efficacy of a variety of artificial intelligence methods in medical imaging for PTB. We searched MEDLINE and Embase with the OVID platform to identify trials published update to November 2022 that evaluated the effectiveness of artificial-intelligence-based software in medical imaging of patients with PTB. After data extraction, the quality of studies was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using a bivariate random-effects model. In total, 3987 references were initially identified and 61 studies were finally included, covering a wide range of 124,959 individuals. The pooled sensitivity and the specificity were 91% (95% confidence interval (CI), 89–93%) and 65% (54–75%), respectively, in clinical trials, and 94% (89–96%) and 95% (91–97%), respectively, in model-development studies. These findings have demonstrated that artificial-intelligence-based software could serve as an accurate tool to diagnose PTB in medical imaging. However, standardized reporting guidance regarding AI-specific trials and multicenter clinical trials is urgently needed to truly transform this cutting-edge technology into clinical practice. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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14 pages, 1275 KiB

Open AccessSystematic Review

Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review

by Dionysios Palermos, Theodoros N. Sergentanis, Maria Gavriatopoulou, Panagiotis Malandrakis, Theodora Psaltopoulou, Evangelos Terpos and Ioannis Ntanasis-Stathopoulos

J. Clin. Med. 2022, 11(23), 7176; https://doi.org/10.3390/jcm11237176 - 02 Dec 2022

Viewed by 2227

Abstract

Current lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs have gained significant ground due to their increased flexibility, compared to the conventional model of drug development from phase I to phase IV trials. One such adaptive approach is the seamless phase II/III design, which has been used to reduce the total sample size and drug development time. In this context, an algorithmic systematic search was conducted in MEDLINE (PUBMED), SCOPUS, EMBASE and Cochrane Central Register of Controlled Trials until 31 June 2022 in order to identify lung cancer trials of systematic treatments that have employed the seamless phase II/III methodology and to describe their characteristics. The search strategy yielded a total of 1420 records that were screened through their title and abstract; 28 eligible trials were included in the systematic review. Based on the study endpoints, the most common subtype included phase II/III trials with inefficacy/futility analyses (61%; 17/28), followed by dose escalation phase II/III trials (18%; 5/28), one multi-arm multi stage trial and 5 trials with other design (18%). Most eligible trials were open-label (71%; 20/27), included patients with non-small cell lung cancer (82%; 23/28), evaluated targeted therapies and/or immunotherapies (82%; 23/28) and recruited patients with advanced disease (89.3%; 25/28). In conclusion, the seamless phase II/III design is a feasible and suitable approach in lung cancer research, with distinct design subcategories according to study endpoints. Full article

(This article belongs to the Special Issue 10th Anniversary of JCM— Pathophysiological Mechanisms, Diagnostics for Lung Diseases, and Therapeutic Modalities)

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