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Glargaard S, Thomsen JH, Tuxen C, Lindholm MG, Bang CA, Schou M, Iversen K, Rasmussen RV, Løgstrup BB, Vraa S, Stride N, Seven E, Barasa A, Tofterup M, Høfsten DE, Rossing K, Køber L, Gustafsson F, Thune JJ. A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure. Circulation 2025; 151:1150-1161. [PMID: 40166829 PMCID: PMC12011436 DOI: 10.1161/circulationaha.124.073521] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2024] [Accepted: 03/05/2025] [Indexed: 04/02/2025]
Abstract
BACKGROUND TAP-IT (Thoracentesis to Alleviate Cardiac Pleural Effusion-Interventional Trial) investigated the effect of therapeutic thoracentesis in addition to standard medical therapy in patients with acute heart failure and sizeable pleural effusion. METHODS This multicenter, unblinded, randomized controlled trial, conducted between August 31, 2021, and March 22, 2024, included patients with acute heart failure, left ventricular ejection fraction ≤45%, and non-negligible pleural effusion. Patients with very large effusions (more than two-thirds of the hemithorax) were excluded. Participants were randomly assigned 1:1 to upfront ultrasound-guided pleural pigtail catheter thoracentesis in addition to standard medical therapy or standard medical therapy alone. The primary outcome was days alive out of the hospital over the following 90 days; key secondary outcomes included length of admission and 90-day all-cause mortality. All outcomes were analyzed according to the intention-to-treat principle. RESULTS A total of 135 patients (median age, 81 years [25th; 75th percentile, 75; 83]; 33% female; median left ventricular ejection fraction, 25% [25th; 75th percentile, 20%; 35%]) were randomized to either thoracentesis (n=68) or standard medical therapy (n=67). The thoracentesis group had a median of 84 days (77; 86) alive out of the hospital over the following 90 days compared with 82 days (73; 86) in the control group (P=0.42). The mortality rate was 13% in both groups, with no difference in survival probability (P=0.90). There were no differences in the duration of the index admission (control group median, 5 days [3; 8]; thoracentesis group median, 5 days [3; 7], P=0.69). Major complications occurred in 1% of thoracenteses performed during the study period. CONCLUSIONS For patients with acute heart failure and pleural effusion, a strategy of upfront routine thoracentesis in addition to standard medical therapy did not increase days alive out of the hospital for 90 days, all-cause mortality, or duration of index admission. The current findings lay the groundwork for future research to confirm the results. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT05017753.
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Affiliation(s)
- Signe Glargaard
- Department of Cardiology, Copenhagen University Hospital–Bispebjerg and Frederiksberg, Denmark (S.G., J.H.T., C.T., J.J.T.)
| | - Jakob Hartvig Thomsen
- Department of Cardiology, Copenhagen University Hospital–Bispebjerg and Frederiksberg, Denmark (S.G., J.H.T., C.T., J.J.T.)
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
| | - Christian Tuxen
- Department of Cardiology, Copenhagen University Hospital–Bispebjerg and Frederiksberg, Denmark (S.G., J.H.T., C.T., J.J.T.)
| | - Matias Greve Lindholm
- Department of Cardiology, Copenhagen University Hospital–Zealand University Hospital Roskilde, Denmark (M.G.L., C.A.B.)
| | - Christian Axel Bang
- Department of Cardiology, Copenhagen University Hospital–Zealand University Hospital Roskilde, Denmark (M.G.L., C.A.B.)
| | - Morten Schou
- Departments of Cardiology (M.S., K.I., R.V.R.), Copenhagen University Hospital–Herlev and Gentofte, Herlev, Denmark
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
| | - Kasper Iversen
- Departments of Cardiology (M.S., K.I., R.V.R.), Copenhagen University Hospital–Herlev and Gentofte, Herlev, Denmark
- Emergency Medicine and Internal Medicine (K.I.), Copenhagen University Hospital–Herlev and Gentofte, Herlev, Denmark
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
| | - Rasmus Vedby Rasmussen
- Departments of Cardiology (M.S., K.I., R.V.R.), Copenhagen University Hospital–Herlev and Gentofte, Herlev, Denmark
| | - Brian Bridal Løgstrup
- Department of Cardiology, Aarhus University Hospital, Denmark (B.B.L.)
- Institute of Clinical Medicine, Aarhus University, Denmark (B.B.L.)
| | - Søren Vraa
- Department of Cardiology, Aalborg University Hospital, Denmark (S.V.)
| | - Nis Stride
- Department of Cardiology, Copenhagen University Hospital–North Zealand, Hilleroed, Denmark (N.S.)
| | - Ekim Seven
- Department of Cardiology, Copenhagen University Hospital–Amager and Hvidovre, Hvidovre, Denmark (E.S., A.B.)
| | - Anders Barasa
- Department of Cardiology, Copenhagen University Hospital–Amager and Hvidovre, Hvidovre, Denmark (E.S., A.B.)
- Department of Cardiology, Copenhagen University Hospital–Glostrup, Denmark (A.B.)
| | - Marlene Tofterup
- Department of Cardiology, Odense University Hospital, Denmark (M.T.)
| | - Dan Eik Høfsten
- Department of Cardiology, Heart Centre, Copenhagen University Hospital–Rigshospitalet, Denmark (D.E.H., K.R., L.K., F.G.)
| | - Kasper Rossing
- Department of Cardiology, Heart Centre, Copenhagen University Hospital–Rigshospitalet, Denmark (D.E.H., K.R., L.K., F.G.)
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
| | - Lars Køber
- Department of Cardiology, Heart Centre, Copenhagen University Hospital–Rigshospitalet, Denmark (D.E.H., K.R., L.K., F.G.)
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
| | - Finn Gustafsson
- Department of Cardiology, Heart Centre, Copenhagen University Hospital–Rigshospitalet, Denmark (D.E.H., K.R., L.K., F.G.)
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
| | - Jens Jakob Thune
- Department of Cardiology, Copenhagen University Hospital–Bispebjerg and Frederiksberg, Denmark (S.G., J.H.T., C.T., J.J.T.)
- Department of Clinical Medicine, University of Copenhagen, Denmark (J.H.T., M.S., K.I., K.R., L.K., F.G., J.J.T.)
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Pete R, Pinard C, Sirodot F, Molnar I, Dressaire M, Ginzac A, Abrial C, Durando X, Tekath M. Patient satisfaction with radio-frequency identification (RFID) tag localization compared with wire localization for nonpalpable breast lesions: the RFID trial. BMC Cancer 2025; 25:123. [PMID: 39844175 PMCID: PMC11753160 DOI: 10.1186/s12885-025-13453-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/09/2024] [Accepted: 01/03/2025] [Indexed: 01/24/2025] Open
Abstract
BACKGROUND Most breast cancers are detected at an early stage in which case conservative surgery is indicated. An accurate preoperative localization technique is essential for conservative surgery of non-palpable breast lesions. Currently, the gold standard technique is wire localization (WL). However, this technique has well-known drawbacks. Several wire-free techniques have been developed to overcome these drawbacks; one technique is localisation by Radiofrequency Identification (RFID). The purpose of this clinical trial was to assess the superiority of RFID tags (HOLOGIC) in terms of patient satisfaction, over wire localization of non-palpable breast lesions. METHODS This was a single-centre, prospective, controlled and non-interventional trial. Patients were followed from their inclusion at the time of the preoperative consultation to the postoperative consultation, one month after surgery. Data on anxiety and satisfaction was collected from patients and clinicians using questionnaires, and clinical data was collected from the medical files. The primary outcome was the patients' satisfaction scores, assessed using a visual analogue scale. RESULTS Eighty patients were sequentially enrolled in two groups: the wire group (n = 40) and the RFID group (n = 40). One patient from the RFID group was excluded from the analysis because of a substantial migration during deployment. On a 10-point Visual Analogue Scale, the patients' median satisfaction score was 9.8 (IQR = 1.32) for the wire group and 10 (IQR = 0.07) for the RFID group (p < 0.001). A reduction in pain between device insertion and surgery was observed in the RFID group (p = 0.009). The median placement time was shorter in the RFID group (15 min, IQR = 6) than in the wire group (20 min, IQR = 30) (p = 0.01). CONCLUSION Our results show a statistically significant difference in median patient satisfaction score with the localization of non-palpable breast cancer lesions using RFID tags compared to the use of the WL. Although our results did not show clinically significant outcomes in terms of satisfaction, RFID tags are a reliable alternative to WL and simplify the organization of patients' healthcare trajectories. TRIAL REGISTRATION ClinicalTrials.gov ID; NCT04750889 registered on February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT04750889?term=rfid&draw=2&rank=1.
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Affiliation(s)
- Raphaël Pete
- Unité de Sénologie, Centre Jean PERRIN, Clermont-Ferrand, France
- Service de Radiologie, Centre Hospitalier Universitaire, Clermont-Ferrand, France
| | - Céleste Pinard
- Division de Recherche Clinique, Délégation Recherche Clinique & Innovation, Centre Jean PERRIN Division de Recherche Clinique, 58, rue Montalembert, Clermont-Ferrand, 63011, France.
- Université Clermont Auvergne, INSERM UMR 1240 « Imagerie Moléculaire et Stratégies Théranostiques », Centre Jean PERRIN, Clermont-Ferrand, France.
- Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France.
| | - Fanny Sirodot
- Service de chirurgie oncologique, Centre Jean PERRIN, Clermont-Ferrand, France
| | - Ioana Molnar
- Division de Recherche Clinique, Délégation Recherche Clinique & Innovation, Centre Jean PERRIN Division de Recherche Clinique, 58, rue Montalembert, Clermont-Ferrand, 63011, France
- Université Clermont Auvergne, INSERM UMR 1240 « Imagerie Moléculaire et Stratégies Théranostiques », Centre Jean PERRIN, Clermont-Ferrand, France
- Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France
| | - Margot Dressaire
- Service de Radiologie, Centre Hospitalier Universitaire, Clermont-Ferrand, France
| | - Angeline Ginzac
- Division de Recherche Clinique, Délégation Recherche Clinique & Innovation, Centre Jean PERRIN Division de Recherche Clinique, 58, rue Montalembert, Clermont-Ferrand, 63011, France
- Université Clermont Auvergne, INSERM UMR 1240 « Imagerie Moléculaire et Stratégies Théranostiques », Centre Jean PERRIN, Clermont-Ferrand, France
- Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France
| | - Catherine Abrial
- Division de Recherche Clinique, Délégation Recherche Clinique & Innovation, Centre Jean PERRIN Division de Recherche Clinique, 58, rue Montalembert, Clermont-Ferrand, 63011, France
- Université Clermont Auvergne, INSERM UMR 1240 « Imagerie Moléculaire et Stratégies Théranostiques », Centre Jean PERRIN, Clermont-Ferrand, France
- Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France
| | - Xavier Durando
- Division de Recherche Clinique, Délégation Recherche Clinique & Innovation, Centre Jean PERRIN Division de Recherche Clinique, 58, rue Montalembert, Clermont-Ferrand, 63011, France
- Université Clermont Auvergne, INSERM UMR 1240 « Imagerie Moléculaire et Stratégies Théranostiques », Centre Jean PERRIN, Clermont-Ferrand, France
- Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France
- Département d'oncologie médicale, Centre Jean PERRIN, Clermont-Ferrand, France
| | - Marielle Tekath
- Unité de Sénologie, Centre Jean PERRIN, Clermont-Ferrand, France
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Peipert JD, Roydhouse J, Tighiouart M, Henry NL, Kim S, Hays RD, Rogatko A, Yothers G, Ganz PA. Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04. Qual Life Res 2024; 33:3069-3079. [PMID: 39080091 PMCID: PMC11541265 DOI: 10.1007/s11136-024-03746-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/19/2024] [Indexed: 11/07/2024]
Abstract
PURPOSE Regulatory guidance suggests capturing patient-reported overall side effect impact in cancer trials. We examined whether the Functional Assessment of Cancer Therapy (FACT) GP5 item ("I am bothered by side effects of treatment") post-neoadjuvant chemotherapy/radiotherapy differed between oxaliplatin vs. non- oxaliplatin arms in the National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 trial of stage II-III rectal cancer patients. METHODS The R-04 neoadjuvant trial compared local-regional tumor control between patients randomized to receive 5-fluorouracil or capecitabine with radiation, with or without oxaliplatin (4 treatment arms). Participants completed surveys at baseline and immediately after chemoradiotherapy. GP5 has a 5-point response scale: "Not at all" (0), "A little bit" (1), "Somewhat" (2), "Quite a bit" (3), and "Very much" (4). Logistic regression compared the odds of reporting moderate-high side effect impact (GP5 2-4) between patients receiving oxaliplatin or not after chemoradiotherapy, controlling for relevant patient characteristics. We examined associations between GP5 and other patient-reported outcomes reflecting side effects. RESULTS Analyses were performed among 1132 study participants. Participants receiving oxaliplatin were 1.58 times (95% CI: 1.22-2.05) more likely to report moderate-high side effect bother at post-chemotherapy/radiation. In both arms, worse overall side effect impact was associated with patient-reported diarrhea, nausea, vomiting, and peripheral sensory neuropathy (p < 0.01 for all). CONCLUSION This secondary analysis of R-04 found that GP5 distinguished between patients receiving oxaliplatin or not as part of their post-neoadjuvant chemoradiotherapy, adding patient-centric evidence on the reduced tolerability of oxaliplatin and demonstrating that GP5 is sensitive to known toxicity differences between treatments. CLINICALTRIALS GOV: NCT00058474.
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Affiliation(s)
- John Devin Peipert
- Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 Michigan Ave, 22nd Floor, Chicago, IL, 60611, USA.
| | - Jessica Roydhouse
- Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia
| | - Mourad Tighiouart
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | | | - Sungjin Kim
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Ron D Hays
- Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA, USA
| | - Andre Rogatko
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Greg Yothers
- University of Pittsburgh and NRG Oncology, Pittsburgh, PA, USA
| | - Patricia A Ganz
- Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA, USA
- Department of Medicine (Hematology/Oncology), David Geffen School of Medicine at University of California, Los Angeles, CA, USA
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Hu Y, Ai J. Development and Validation of Radiomics-Based Models for Predicting the Parametrial Invasion in Stage IB1 to IIA2 Cervical Cancer. Int J Gen Med 2024; 17:3813-3824. [PMID: 39246805 PMCID: PMC11380489 DOI: 10.2147/ijgm.s478842] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2024] [Accepted: 08/24/2024] [Indexed: 09/10/2024] Open
Abstract
Objective To develop an early warning system that enables accurate parametrial invasion (PMI) risk prediction in cervical cancer patients with early-stage. Methods We retrospectively collected 218 early-stage cervical cancer patients who were treated in Jingzhou Central Hospital from January 31, 2015, to January 31, 2023, and diagnosed with early stage cervical cancer by pathology. The prediction model training is achieved by randomly dividing 70% of the training queue population, with the remaining 30% used as the testing queue. Then, a prediction model based on machine learning algorithms (including random forest, generalized linear regression, decision tree, support vector machine, and artificial neural network) is constructed to predict the risk of PMI occurrence. Ultimately, the analysis of receiver operating characteristic curve (ROC) and decision curve analysis (DCA) is used to evaluate the predictive ability of various prediction models. Results We finally included radiomics-based candidate variables that can be used for PMI model. Multivariate logistic regression analysis showed that energy, correlation, sum entropy (SUE), entropy, mean sum (MES), variance of differences (DIV), and inverse difference (IND) were independent risk factors for PMI occurrence. The predictive performance AUC of five types of machine learning ranges from 0.747 to 0.895 in the training set and can also reach a high accuracy of 0.905 in the testing set, indicating that the predictive model has ideal robustness. Conclusion Our ML-based model incorporating GLCM parameters can predict PMI in cervical cancer patients with stage IB1 to IIA2, particularly the RFM, which could contribute to distinguishing PMI before surgery, especially in assisting decision-making on surgical scope.
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Affiliation(s)
- Yao Hu
- Department of Obstetrics and Gynecology, Jingzhou Hospital Affiliated to Yangtze University,Jingzhou Central Hospital, Jingzhou, Hubei, People's Republic of China
| | - Jiao Ai
- Department of Urology, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou Central Hospital, Jingzhou, Hubei, People's Republic of China
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Zheng Y, Cai Y, Yan Y, Chen S, Gong K. Novel Approach to Personalized Physician Recommendations Using Semantic Features and Response Metrics: Model Evaluation Study. JMIR Hum Factors 2024; 11:e57670. [PMID: 39146009 PMCID: PMC11362707 DOI: 10.2196/57670] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2024] [Revised: 06/02/2024] [Accepted: 06/22/2024] [Indexed: 08/16/2024] Open
Abstract
BACKGROUND The rapid growth of web-based medical services has highlighted the significance of smart triage systems in helping patients find the most appropriate physicians. However, traditional triage methods often rely on department recommendations and are insufficient to accurately match patients' textual questions with physicians' specialties. Therefore, there is an urgent need to develop algorithms for recommending physicians. OBJECTIVE This study aims to develop and validate a patient-physician hybrid recommendation (PPHR) model with response metrics for better triage performance. METHODS A total of 646,383 web-based medical consultation records from the Internet Hospital of the First Affiliated Hospital of Xiamen University were collected. Semantic features representing patients and physicians were developed to identify the set of most similar questions and semantically expand the pool of recommended physician candidates, respectively. The physicians' response rate feature was designed to improve candidate rankings. These 3 characteristics combine to create the PPHR model. Overall, 5 physicians participated in the evaluation of the efficiency of the PPHR model through multiple metrics and questionnaires as well as the performance of Sentence Bidirectional Encoder Representations from Transformers and Doc2Vec in text embedding. RESULTS The PPHR model reaches the best recommendation performance when the number of recommended physicians is 14. At this point, the model has an F1-score of 76.25%, a proportion of high-quality services of 41.05%, and a rating of 3.90. After removing physicians' characteristics and response rates from the PPHR model, the F1-score decreased by 12.05%, the proportion of high-quality services fell by 10.87%, the average hit ratio dropped by 1.06%, and the rating declined by 11.43%. According to whether those 5 physicians were recommended by the PPHR model, Sentence Bidirectional Encoder Representations from Transformers achieved an average hit ratio of 88.6%, while Doc2Vec achieved an average hit ratio of 53.4%. CONCLUSIONS The PPHR model uses semantic features and response metrics to enable patients to accurately find the physician who best suits their needs.
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Affiliation(s)
- Yingbin Zheng
- Biomedical Big Data Center, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen City, China
| | - Yunping Cai
- Meteorological Disaster Prevention Technology Center, Xiamen Meteorological Bureau, Xiamen City, China
| | - Yiwei Yan
- Biomedical Big Data Center, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen City, China
| | - Sai Chen
- Meteorological Disaster Prevention Technology Center, Xiamen Meteorological Bureau, Xiamen City, China
| | - Kai Gong
- Biomedical Big Data Center, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen City, China
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Sides T, Kbaier D. Investigating How the Use of Technology Can Reduce Missed Appointments: Quantitative Case Study at a General Practitioner Surgery. J Med Internet Res 2024; 26:e43894. [PMID: 39073855 PMCID: PMC11319880 DOI: 10.2196/43894] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2022] [Revised: 06/23/2023] [Accepted: 05/30/2024] [Indexed: 07/30/2024] Open
Abstract
BACKGROUND SMS texting systems have been considered a potential solution to reduce missed appointments in primary care. Existing research in this area focuses on qualitative studies investigating the attitudes of SMS text users and receivers. OBJECTIVE This study aimed to examine appointment data from an independent general practitioner (GP) surgery in Wrexham, United Kingdom, with approximately 15,000 patients, to determine the impact of text messaging systems on reducing missed appointments. The objective of this study was to investigate whether the use of text messages can effectively reduce missed appointments. METHODS To collect data for the study, SQL reports were run on EMIS Web, the United Kingdom's most widely used clinical system. The data spanned 10 years, from September 1, 2010, to March 31, 2020. Data accuracy was verified by cross-referencing with appointment diary records. Mann-Whitney and Kruskal-Wallis tests, chosen for their suitability in comparing groups in nonparametric settings, were conducted in Microsoft Excel due to its accessibility. RESULTS Statistical analyses were conducted to compare data before and after implementation of the text messaging system. The results revealed a significant 42.8% reduction in missed appointments (before: 5848; after: 3343; P<.001). Further analysis of demographic characteristics revealed interesting trends, with no significant difference in missed appointments between genders, and variations observed across different age groups. The median number of missed appointments was not significantly different between genders (women: 1.55, IQR 1.11-2.16; men: 1.61, IQR 1.08-2.12; P=.73). Despite the prevalence of mobile phone use among young adults aged 20-25 years, the highest rates of missed appointments (848/7256, 11.7%) were noted in this group, whereas the lowest rates were noted in the 75-80 years age group (377/7256; 5.2%; P<.001). Analysis by age and gender indicated inconsistencies: women aged 20-25 years (571/4216) and men aged 35-40 years (306/3040) had the highest rates of missed appointments, whereas women aged 70-75 years (177/4216) and men aged 75-80 years (129/3040) had the lowest rates (P<.001 for both). CONCLUSIONS This study demonstrates that SMS text messaging in primary care can significantly reduce missed appointments. Implementing technology such as SMS text messaging systems enables patients to cancel appointments on time, leading to improved efficiency in primary care settings.
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Affiliation(s)
- Teresa Sides
- The Open University, Milton Keynes, United Kingdom
- Glyndwr University, Wrexham, United Kingdom
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Yang KF, Li SJ, Xu J, Zheng YB. Machine learning prediction model for gray-level co-occurrence matrix features of synchronous liver metastasis in colorectal cancer. World J Gastrointest Surg 2024; 16:1571-1581. [PMID: 38983351 PMCID: PMC11229995 DOI: 10.4240/wjgs.v16.i6.1571] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2024] [Revised: 03/16/2024] [Accepted: 04/25/2024] [Indexed: 06/27/2024] Open
Abstract
BACKGROUND Synchronous liver metastasis (SLM) is a significant contributor to morbidity in colorectal cancer (CRC). There are no effective predictive device integration algorithms to predict adverse SLM events during the diagnosis of CRC. AIM To explore the risk factors for SLM in CRC and construct a visual prediction model based on gray-level co-occurrence matrix (GLCM) features collected from magnetic resonance imaging (MRI). METHODS Our study retrospectively enrolled 392 patients with CRC from Yichang Central People's Hospital from January 2015 to May 2023. Patients were randomly divided into a training and validation group (3:7). The clinical parameters and GLCM features extracted from MRI were included as candidate variables. The prediction model was constructed using a generalized linear regression model, random forest model (RFM), and artificial neural network model. Receiver operating characteristic curves and decision curves were used to evaluate the prediction model. RESULTS Among the 392 patients, 48 had SLM (12.24%). We obtained fourteen GLCM imaging data for variable screening of SLM prediction models. Inverse difference, mean sum, sum entropy, sum variance, sum of squares, energy, and difference variance were listed as candidate variables, and the prediction efficiency (area under the curve) of the subsequent RFM in the training set and internal validation set was 0.917 [95% confidence interval (95%CI): 0.866-0.968] and 0.09 (95%CI: 0.858-0.960), respectively. CONCLUSION A predictive model combining GLCM image features with machine learning can predict SLM in CRC. This model can assist clinicians in making timely and personalized clinical decisions.
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Affiliation(s)
- Kai-Feng Yang
- Department of Gastrointestinal Surgery, Renmin Hospital of Wuhan University, Wuhan 430030, Hubei Province, China
| | - Sheng-Jie Li
- Department of Gastrointestinal Surgery, The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People’s Hospital, Yichang 443008, Hubei Province, China
| | - Jun Xu
- Department of Gastrointestinal Surgery, The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People’s Hospital, Yichang 443008, Hubei Province, China
| | - Yong-Bin Zheng
- Department of Gastrointestinal Surgery, Renmin Hospital of Wuhan University, Wuhan 430030, Hubei Province, China
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Husby AE, Simpson MR, Dalbye R, Larsen M, Vanky E, Løvvik TS. Childbirth experiences in women with polycystic ovary syndrome: A cohort study. Acta Obstet Gynecol Scand 2024; 103:1092-1100. [PMID: 38366810 PMCID: PMC11103144 DOI: 10.1111/aogs.14800] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2023] [Revised: 01/11/2024] [Accepted: 01/24/2024] [Indexed: 02/18/2024]
Abstract
INTRODUCTION Women with polycystic ovary syndrome (PCOS) have more pregnancy complications like gestational diabetes, hypertension, and preterm labor than other women. Metformin has been used in an attempt to improve pregnancy outcomes. Our study aims to explore childbirth experiences in women with PCOS compared with a reference population. It also explores the potential influence of metformin, obesity, pregnancy complications, and the duration and mode of birth on childbirth experiences. MATERIAL AND METHODS This study is a cohort study combining data from two randomized trials conducted in Norway, Sweden and Iceland. The PregMet2 study (ClinicalTrials.gov, NCT01587378) investigated the use of metformin vs. placebo in pregnant women with PCOS. The Labour Progression Study (ClinicalTrials.gov, NCT02221427) compared the WHO partograph to Zhang's guidelines for progression of labor and were used as the reference population. A total of 365 women with PCOS and 3604 reference women were included. Both studies used the Childbirth Experience Questionnaire (CEQ). Main outcome measures were total CEQ score and four domain scores. The CEQ scores were compared using Mann-Whitney U test for women in Robson group 1 with PCOS (n = 131) and reference women (n = 3604). CEQ scores were also compared between metformin-treated (n = 180) and placebo-treated (n = 185) women with PCOS, and for different subgroups of women with PCOS. RESULTS There was no difference in total CEQ score between women with PCOS and reference women-Wilcoxon-Mann-Whitney (WMW)-odds 0.96 (95% confidence interval [CI] 0.78-1.17). We detected no difference in CEQ scores between the metformin- and placebo-treated women with PCOS (WMW-odds 1.13, 95% CI 0.89-1.43). Complications in pregnancy did not affect CEQ (WMW-odds 1, 95% CI 0.76-1.31). Higher body mass index (WMW-odds 0.75, 95% CI 0.58-0.96), longer duration of labor (WMW-odds 0.69, 95% CI 0.49-0.96), and cesarean section (WMW-odds 0.29, 95% CI 0.2-0.42) were associated with lower CEQ scores in women with PCOS. CONCLUSIONS Women with PCOS experience childbirth similarly to the reference women. Metformin did not influence childbirth experience in women with PCOS, neither did pregnancy complications. Obesity, long duration of labor or cesarean section had a negative impact on childbirth experience.
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Affiliation(s)
- Anne Engtrø Husby
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Obstetrics and GynecologySt Olav's University HospitalTrondheimNorway
| | - Melanie Rae Simpson
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
| | - Rebecka Dalbye
- Department of Obstetrics and GynecologyØstfold Hospital TrustGrålumNorway
- Department of Nursing and Health Promotion, Faculty of Health SciencesOslo Metropolitan UniversityOsloNorway
| | - Marit Larsen
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Obstetrics and GynecologySt Olav's University HospitalTrondheimNorway
| | - Eszter Vanky
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Obstetrics and GynecologySt Olav's University HospitalTrondheimNorway
| | - Tone Shetelig Løvvik
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Obstetrics and GynecologySt Olav's University HospitalTrondheimNorway
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9
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Glargaard S, Thomsen JH, Løgstrup BB, Schou M, Iversen KK, Tuxen C, Nielsen OW, Bang CA, Lindholm MG, Seven E, Barasa A, Stride N, Vraa S, Tofterup M, Rasmussen RV, Høfsten DE, Rossing K, Køber L, Gustafsson F, Thune JJ. Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial. BMJ Open 2024; 14:e078155. [PMID: 38245015 PMCID: PMC10806591 DOI: 10.1136/bmjopen-2023-078155] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2023] [Accepted: 12/21/2023] [Indexed: 01/22/2024] Open
Abstract
INTRODUCTION Pleural effusion is present in half of the patients hospitalised with acute heart failure. The condition is treated with diuretics and/or therapeutic thoracentesis for larger effusions. No evidence from randomised trials or guidelines supports thoracentesis to alleviate pleural effusion due to acute heart failure. The Thoracentesis to Alleviate cardiac Pleural effusion Interventional Trial (TAP-IT) will investigate if a strategy of referring patients with acute heart failure and pleural effusion to up-front thoracentesis by pleural pigtail catheter insertion in addition to pharmacological therapy compared with pharmacological therapy alone can increase the number of days the participants are alive and not hospitalised during the 90 days following randomisation. METHODS AND ANALYSIS TAP-IT is a pragmatic, multicentre, open-label, randomised controlled trial aiming to include 126 adult patients with left ventricular ejection fraction ≤45% and a non-negligible pleural effusion due to heart failure. Participants will be randomised 1:1, stratified according to site and anticoagulant treatment, and assigned to referral to up-front ultrasound-guided pleural pigtail catheter thoracentesis in addition to standard pharmacological therapy or to standard pharmacological therapy only. Thoracentesis is performed according to local guidelines and can be performed in participants in the pharmacological treatment arm if their condition deteriorates or if no significant improvement is observed within 5 days. The primary endpoint is how many days participants are alive and not hospitalised within 90 days from randomisation and will be analysed in the intention-to-treat population. Key secondary outcomes include 90-day mortality, complications, readmissions, and quality of life. ETHICS AND DISSEMINATION The study has been approved by the Capital Region of Denmark Scientific Ethical Committee (H-20060817) and Knowledge Center for Data Reviews (P-2021-149). All participants will sign an informed consent form. Enrolment began in August 2021. Regardless of the nature, results will be published in a peer-reviewed medical journal. TRIAL REGISTRATION NUMBER NCT05017753.
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Affiliation(s)
- Signe Glargaard
- Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark
| | - Jakob Hartvig Thomsen
- Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark
| | - Brian Bridal Løgstrup
- Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Morten Schou
- Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Herlev, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Kasper Karmark Iversen
- Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Herlev, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Christian Tuxen
- Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark
| | - Olav W Nielsen
- Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Christian Axel Bang
- Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark
| | | | - Ekim Seven
- Department of Cardiology, Copenhagen University Hospital-Amager and Hvidovre, Copenhagen, Denmark
| | - Anders Barasa
- Department of Cardiology, Copenhagen University Hospital-Glostrup, Glostrup, Denmark
| | - Nis Stride
- Department of Cardiology, Copenhagen University Hospital-North Zealand, Hilleroed, Denmark
| | - Søren Vraa
- Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
| | - Marlene Tofterup
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | - Rasmus Vedby Rasmussen
- Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Herlev, Denmark
| | - Dan Eik Høfsten
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
| | - Kasper Rossing
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
| | - Lars Køber
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
| | - Finn Gustafsson
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
| | - Jens Jakob Thune
- Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
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10
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Viegas ÂA, Santos T, Nobre JNP, Santos JMD, Silva Lage VKD, Fernandes AC, Peixoto MFD, Morais RLDS, Sartorio A, Mendonça VA, Lacerda ACR. Association between biomarkers of redox status and cytokines with different patterns of habitual physical activity in eutrophic and overweight/obese preschoolers: multivariate analysis of a cross-sectional study. BMC Public Health 2023; 23:2353. [PMID: 38017390 PMCID: PMC10683275 DOI: 10.1186/s12889-023-17295-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2023] [Accepted: 11/22/2023] [Indexed: 11/30/2023] Open
Abstract
BACKGROUND Although it is well known that obesity is frequently associated with reduced levels of habitual physical activity (HPA), which contributes to determining severe oxidative stress and inflammatory state, this association is however unknown in preschoolers so far. This study aimed to investigate the association between biomarkers of redox status and cytokines with different patterns of HPA according to the adiposity of preschoolers. METHODS A cross-sectional study was conducted in 50 preschoolers (25 overweight/obese, OW/OB and 25 eutrophic, EU), matched for age, sex, economic level, and maternal education. Total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase (CAT) activities, substances reactive to thiobarbituric acid (TBARS), soluble tumor necrosis factor receptors (sTNFRs), and leptin levels were evaluated. HPA levels were evaluated by accelerometry (ActiGraph GT9X accelerometer). Correlation, multiple linear regression, and partial least squares regression analysis were used to determine the association between redox status biomarkers and cytokines with different patterns of HPA (HPA level, bouts of moderate to vigorous physical activity [MVPA], and multivariate pattern of HPA) in EU and OW/OB preschoolers. RESULTS OW/OB preschoolers had lower CAT activity, higher levels of TAC, TBARS, and cytokines, and similar levels of HPA to EU preschoolers. In EU preschoolers, SOD activity exhibited a stronger negative association with moderate intensity ranges of HPA (R2 = 0.18), and negative correlation with sTNFRs (r = -0.40 to -0.46). TBARS had a stronger positive association with ranges of light intensity in the multivariate pattern of HPA (R2 = 0.10). In OW/OB preschoolers, the HPA multivariate associative pattern was predominantly from vigorous intensity ranges. Thus, SOD activity had a positive association with the multivariate pattern of HPA (R2 = 0.38) and MVPA bouts (β [95% CI] = 0.457 [0.0026. 0.0576]). TAC had a negative association with the multivariate pattern of HPA (R2 = 0.38) and MVPA bouts (β [95% CI] = -0.718 [-0.0025. -0.0003]). Additionally, leptin levels were lower in OW/OB preschoolers engaged in vigorous physical activity (VPA) (8000-9999 counts/min) for longer periods of time. CONCLUSION The results of this study indicate that OW/OB preschoolers have higher levels of oxidative stress biomarkers and pro-inflammatory cytokines compared to EU preschoolers. Moreover, VPA may exert antioxidative and anti-inflammatory effects in OW/OB preschoolers.
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Affiliation(s)
- Ângela Alves Viegas
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Thiago Santos
- Postgraduate Program in Animal Biology (PPGBA), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Juliana Nogueira Pontes Nobre
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Jousielle Márcia Dos Santos
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Vanessa Kelly da Silva Lage
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Amanda Cristina Fernandes
- Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Marco Fabrício Dias Peixoto
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Rosane Luzia De Souza Morais
- Postgraduate Program Health, Society and Environment (PPGSaSA), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Alessandro Sartorio
- Division of Auxology and Metabolic Diseases & Experimental Laboratory for Auxo-endocrinological Research, Istituto Auxologico Italiano, IRCCS, Piancavallo-Verbania, Italy
| | - Vanessa Amaral Mendonça
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
- Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil
| | - Ana Cristina Rodrigues Lacerda
- Multicenter Postgraduate Program in Physiological Sciences (PPGMCF), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.
- Integrated Center for Research and Postgraduate Studies in Health (CIPq Saúde), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.
- Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.
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11
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van der Veen A, Ramaekers M, Marsman M, Brenkman HJF, Seesing MFJ, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, de Steur WO, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R. Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial). J Gastrointest Surg 2023; 27:2057-2067. [PMID: 37464143 PMCID: PMC10579125 DOI: 10.1007/s11605-023-05728-3] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2022] [Accepted: 05/01/2023] [Indexed: 07/20/2023]
Abstract
BACKGROUND Laparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the clinical relevance of this reduction, since these outcomes are reported in few randomized trials and in limited detail. METHODS This secondary analysis of a multicenter randomized trial compared laparoscopic versus open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). Postoperative pain was analyzed by opioid consumption in oral morphine equivalents (OME, mg/day) at postoperative day (POD) 1-5, WHO analgesic steps, and Numeric Rating Scales (NRS, 0-10) at POD 1-10 and discharge. Regression and mixed model analyses were performed, with and without correction for epidural analgesia. RESULTS Between 2015 and 2018, 115 patients in the laparoscopic group and 110 in the open group underwent surgery. Some 16 patients (14%) in the laparoscopic group and 73 patients (66%) in the open group received epidural analgesia. At POD 1-3, mean opioid consumption was 131, 118, and 53 mg OME lower in the laparoscopic group, compared to the open group, respectively (all p < 0.001). After correcting for epidural analgesia, these differences remained significant at POD 1-2 (47 mg OME, p = 0.002 and 69 mg OME, p < 0.001, respectively). At discharge, 27% of patients in the laparoscopic group and 43% patients in the open group used oral opioids (p = 0.006). Mean highest daily pain scores were between 2 and 4 at all PODs, < 2 at discharge, and did not relevantly differ between treatment arms. CONCLUSION In this multicenter randomized trial, postoperative pain was comparable between laparoscopic and open gastrectomy. After laparoscopic gastrectomy, this was generally achieved without epidural analgesia and with fewer opioids. TRIAL REGISTRATION NCT02248519.
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Affiliation(s)
- Arjen van der Veen
- Department of Surgery, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100 G04.228, 3508 GA, Utrecht, Netherlands.
| | - Mark Ramaekers
- Department of Surgery, Catharina Hospital, Eindhoven, Netherlands
| | - Marije Marsman
- Department of Anesthesiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Hylke J F Brenkman
- Department of Surgery, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100 G04.228, 3508 GA, Utrecht, Netherlands
| | - Maarten F J Seesing
- Department of Surgery, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100 G04.228, 3508 GA, Utrecht, Netherlands
| | - Misha D P Luyer
- Department of Surgery, Catharina Hospital, Eindhoven, Netherlands
| | | | - Jan H M B Stoot
- Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, Netherlands
| | - Juul J W Tegels
- Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, Netherlands
| | - Bas P L Wijnhoven
- Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands
| | - Wobbe O de Steur
- Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
| | | | | | - Werner A Draaisma
- Department of Surgery, Meander Medical Center, Amersfoort, Netherlands
| | - Suzanne S Gisbertz
- Department of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands
| | - Donald L van der Peet
- Department of Surgery, Amsterdam UMC, Location VUmc, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands
| | - Anne M May
- University Medical Center Utrecht, Utrecht University, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands
| | - Jelle P Ruurda
- Department of Surgery, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100 G04.228, 3508 GA, Utrecht, Netherlands
| | - Richard van Hillegersberg
- Department of Surgery, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100 G04.228, 3508 GA, Utrecht, Netherlands.
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12
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Lu C, Xing ZX, Xia XG, Long ZD, Chen B, Zhou P, Wang R. Development and validation of a postoperative pulmonary infection prediction model for patients with primary hepatic carcinoma. World J Gastrointest Oncol 2023; 15:1241-1252. [PMID: 37546550 PMCID: PMC10401473 DOI: 10.4251/wjgo.v15.i7.1241] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/01/2023] [Revised: 05/14/2023] [Accepted: 06/12/2023] [Indexed: 07/12/2023] Open
Abstract
BACKGROUND There are factors that significantly increase the risk of postoperative pulmonary infections in patients with primary hepatic carcinoma (PHC). Previous reports have shown that over 10% of patients with PHC experience postoperative pulmonary infections. Thus, it is crucial to prioritize the prevention and treatment of postoperative pulmonary infections in patients with PHC.
AIM To identify the risk factors for postoperative pulmonary infection in patients with PHC and develop a prediction model to aid in postoperative management.
METHODS We retrospectively collected data from 505 patients who underwent hepatobiliary surgery between January 2015 and February 2023 in the Department of Hepatobiliary and Pancreaticospleen Surgery. Radiomics data were selected for statistical analysis, and clinical pathological parameters and imaging data were included in the screening database as candidate predictive variables. We then developed a pulmonary infection prediction model using three different models: An artificial neural network model; a random forest model; and a generalized linear regression model. Finally, we evaluated the accuracy and robustness of the prediction model using the receiver operating characteristic curve and decision curve analyses.
RESULTS Among the 505 patients, 86 developed a postoperative pulmonary infection, resulting in an incidence rate of 17.03%. Based on the gray-level co-occurrence matrix, we identified 14 categories of radiomic data for variable screening of pulmonary infection prediction models. Among these, energy, contrast, the sum of squares (SOS), the inverse difference (IND), mean sum (MES), sum variance (SUV), sum entropy (SUE), and entropy were independent risk factors for pulmonary infection after hepatectomy and were listed as candidate variables of machine learning prediction models. The random forest model algorithm, in combination with IND, SOS, MES, SUE, SUV, and entropy, demonstrated the highest prediction efficiency in both the training and internal verification sets, with areas under the curve of 0.823 and 0.801 and a 95% confidence interval of 0.766-0.880 and 0.744-0.858, respectively. The other two types of prediction models had prediction efficiencies between areas under the curve of 0.734 and 0.815 and 95% confidence intervals of 0.677-0.791 and 0.766-0.864, respectively.
CONCLUSION Postoperative pulmonary infection in patients undergoing hepatectomy may be related to risk factors such as IND, SOS, MES, SUE, SUV, energy, and entropy. The prediction model in this study based on diffusion-weighted images, especially the random forest model algorithm, can better predict and estimate the risk of pulmonary infection in patients undergoing hepatectomy, providing valuable guidance for postoperative management.
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Affiliation(s)
- Chao Lu
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
| | - Zhi-Xiang Xing
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
| | - Xi-Gang Xia
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
| | - Zhi-Da Long
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
| | - Bo Chen
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
| | - Peng Zhou
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
| | - Rui Wang
- Department of Hepatobiliary & Pancreaticospleen Surgery, Yangtze University, Jing Zhou hospital, Jingzhou 434020, Hubei Province, China
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Chen IR, Huang CC, Tu SJ, Wang GJ, Lai PC, Lee YT, Yen JC, Chang YS, Chang JG. Dysregulation of Immune Cell Subpopulations in Atypical Hemolytic Uremic Syndrome. Int J Mol Sci 2023; 24:10007. [PMID: 37373158 DOI: 10.3390/ijms241210007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2023] [Revised: 05/30/2023] [Accepted: 06/07/2023] [Indexed: 06/29/2023] Open
Abstract
Atypical hemolytic uremic syndrome (aHUS) is a rare, life-threatening thrombotic microangiopathy. Definitive biomarkers for disease diagnosis and activity remain elusive, making the exploration of molecular markers paramount. We conducted single-cell sequencing on peripheral blood mononuclear cells from 13 aHUS patients, 3 unaffected family members of aHUS patients, and 4 healthy controls. We identified 32 distinct subpopulations encompassing 5 B-cell types, 16 T- and natural killer (NK) cell types, 7 monocyte types, and 4 other cell types. Notably, we observed a significant increase in intermediate monocytes in unstable aHUS patients. Subclustering analysis revealed seven elevated expression genes, including NEAT1, MT-ATP6, MT-CYB, VIM, ACTG1, RPL13, and KLRB1, in unstable aHUS patients, and four heightened expression genes, including RPS27, RPS4X, RPL23, and GZMH genes, in stable aHUS patients. Additionally, an increase in the expression of mitochondria-related genes suggested a potential influence of cell metabolism on the clinical progression of the disease. Pseudotime trajectory analysis revealed a unique immune cell differentiation pattern, while cell-cell interaction profiling highlighted distinctive signaling pathways among patients, family members, and controls. This single-cell sequencing study is the first to confirm immune cell dysregulation in aHUS pathogenesis, offering valuable insights into molecular mechanisms and potential new diagnostic and disease activity markers.
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Affiliation(s)
- I-Ru Chen
- Graduate Institute of Clinical Medical Science, College of Medicine, China Medical University, Taichung 40402, Taiwan
- Division of Nephrology and the Kidney Institute, Department of Internal Medicine, China Medical University and Hospitals, Taichung 404332, Taiwan
| | - Chiu-Ching Huang
- Graduate Institute of Clinical Medical Science, College of Medicine, China Medical University, Taichung 40402, Taiwan
- Division of Nephrology and the Kidney Institute, Department of Internal Medicine, China Medical University and Hospitals, Taichung 404332, Taiwan
| | - Siang-Jyun Tu
- Center for Precision Medicine, China Medical University Hospital, Taichung 404332, Taiwan
| | - Guei-Jane Wang
- Graduate Institute of Clinical Medical Science, College of Medicine, China Medical University, Taichung 40402, Taiwan
- Department of Medical Research, China Medical University Hospital, Taichung 404332, Taiwan
| | - Ping-Chin Lai
- Division of Nephrology and the Kidney Institute, Department of Internal Medicine, China Medical University and Hospitals, Taichung 404332, Taiwan
| | - Ya-Ting Lee
- Center for Precision Medicine, China Medical University Hospital, Taichung 404332, Taiwan
- Department of Medical Research, China Medical University Hospital, Taichung 404332, Taiwan
- Epigenome Research Center, China Medical University Hospital, Taichung 404332, Taiwan
| | - Ju-Chen Yen
- Center for Precision Medicine, China Medical University Hospital, Taichung 404332, Taiwan
- Department of Medical Research, China Medical University Hospital, Taichung 404332, Taiwan
- Epigenome Research Center, China Medical University Hospital, Taichung 404332, Taiwan
| | - Ya-Sian Chang
- Center for Precision Medicine, China Medical University Hospital, Taichung 404332, Taiwan
- Department of Medical Research, China Medical University Hospital, Taichung 404332, Taiwan
- Epigenome Research Center, China Medical University Hospital, Taichung 404332, Taiwan
| | - Jan-Gowth Chang
- Graduate Institute of Clinical Medical Science, College of Medicine, China Medical University, Taichung 40402, Taiwan
- Center for Precision Medicine, China Medical University Hospital, Taichung 404332, Taiwan
- Department of Medical Research, China Medical University Hospital, Taichung 404332, Taiwan
- Epigenome Research Center, China Medical University Hospital, Taichung 404332, Taiwan
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Cuneo A, Yang R, Zhou H, Wang K, Goh S, Wang Y, Raiti J, Krashin D, Murinova N. The Utility of a Novel, Combined Biofeedback-Virtual Reality Device as Add-on Treatment for Chronic Migraine: A Randomized Pilot Study. Clin J Pain 2023; 39:286-296. [PMID: 37026763 DOI: 10.1097/ajp.0000000000001114] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2022] [Accepted: 03/23/2023] [Indexed: 04/08/2023]
Abstract
OBJECTIVES To determine if the frequent use of a combined biofeedback-virtual reality device improves headache-related outcomes in chronic migraine. MATERIALS AND METHODS In this randomized, controlled pilot study, 50 adults with chronic migraine were randomized to the experimental group (frequent use of a heart rate variability biofeedback-virtual reality device plus standard medical care; n=25) or wait-list control group (standard medical care alone; n=25). The primary outcome was a reduction in mean monthly headache days between groups at 12 weeks. Secondary outcomes included mean change in acute analgesic use frequency, depression, migraine-related disability, stress, insomnia, and catastrophizing between groups at 12 weeks. Tertiary outcomes included change in heart rate variability and device-related user experience measures. RESULTS A statistically significant reduction in mean monthly headache days between groups was not demonstrated at 12 weeks. However, statistically significant decreases in the mean frequency of total acute analgesic use per month (65% decrease in the experimental group versus 35% decrease in the control group, P <0.01) and depression score (35% decrease in the experimental group versus 0.5% increase in the control group; P <0.05) were shown at 12 weeks. At study completion, more than 50% of participants reported device satisfaction on a 5-level Likert scale. DISCUSSION Frequent use of a portable biofeedback-virtual reality device was associated with decreases in the frequency of acute analgesic use and in depression in individuals with chronic migraine. This platform holds promise as an add-on treatment for chronic migraine, especially for individuals aiming to decrease acute analgesic use or interested in nonmedication approaches.
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15
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Bavaro DA, Fanizzi A, Iacovelli S, Bove S, Comes MC, Cristofaro C, Cutrignelli D, De Santis V, Nardone A, Lagattolla F, Rizzo A, Ressa CM, Massafra R. A Machine Learning Approach for Predicting Capsular Contracture after Postmastectomy Radiotherapy in Breast Cancer Patients. Healthcare (Basel) 2023; 11:healthcare11071042. [PMID: 37046969 PMCID: PMC10094026 DOI: 10.3390/healthcare11071042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2023] [Revised: 03/14/2023] [Accepted: 04/03/2023] [Indexed: 04/14/2023] Open
Abstract
In recent years, immediate breast reconstruction after mastectomy surgery has steadily increased in the treatment pathway of breast cancer (BC) patients due to its potential impact on both the morpho-functional and aesthetic type of the breast and the quality of life. Although recent studies have demonstrated how recent radiotherapy techniques have allowed a reduction of adverse events related to breast reconstruction, capsular contracture (CC) remains the main complication after post-mastectomy radio-therapy (PMRT). In this study, we evaluated the association of the occurrence of CC with some clinical, histological and therapeutic parameters related to BC patients. We firstly performed bivariate statistical tests and we then evaluated the prognostic predictive power of the collected data by using machine learning techniques. Out of a sample of 59 patients referred to our institute, 28 patients (i.e., 47%) showed contracture after PMRT. As a result, only estrogen receptor status (ER) and molecular subtypes were significantly associated with the occurrence of CC after PMRT. Different machine learning models were trained on a subset of clinical features selected by a feature importance approach. Experimental results have shown that collected features have a non-negligible predictive power. The extreme gradient boosting classifier achieved an area under the curve (AUC) value of 68% and accuracy, sensitivity, and specificity values of 68%, 64%, and 74%, respectively. Such a support tool, after further suitable optimization and validation, would allow clinicians to identify the best therapeutic strategy and reconstructive timing.
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Affiliation(s)
| | - Annarita Fanizzi
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Serena Iacovelli
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Samantha Bove
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Maria Colomba Comes
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Cristian Cristofaro
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Daniela Cutrignelli
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Valerio De Santis
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Annalisa Nardone
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Fulvia Lagattolla
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Alessandro Rizzo
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Cosmo Maurizio Ressa
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
| | - Raffaella Massafra
- I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124 Bari, Italy
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16
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Song J, Verbeeck J, Huang B, Hoaglin DC, Gamalo-Siebers M, Seifu Y, Wang D, Cooner F, Dong G. The win odds: statistical inference and regression. J Biopharm Stat 2023; 33:140-150. [PMID: 35946932 DOI: 10.1080/10543406.2022.2089156] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/15/2022]
Abstract
Generalized pairwise comparisons and win statistics (i.e., win ratio, win odds and net benefit) are advantageous in analyzing and interpreting a composite of multiple outcomes in clinical trials. An important limitation of these statistics is their inability to adjust for covariates other than by stratified analysis. Because the win ratio does not account for ties, the win odds, a modification that includes ties, has attracted attention. We review and combine information on the win odds to articulate the statistical inferences for the win odds. We also show alternative variance estimators based on the exact permutation and bootstrap as well as statistical inference via the probabilistic index. Finally, we extend multiple-covariate regression probabilistic index models to the win odds with a univariate outcome. As an illustration we apply the regression models to the data in the CHARM trial.
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Affiliation(s)
- James Song
- BeiGene, Ridgefield Park, New Jersey, USA
| | | | - Bo Huang
- Pfizer Inc, Groton, Connecticut, USA
| | - David C Hoaglin
- Department of Population and Quantitative Health Sciences, UMass Chan Medical School, Worcester, Massachusetts, USA
| | | | - Yodit Seifu
- Bristol Myers Squibb, Berkeley Heights, New Jersey, USA
| | - Duolao Wang
- Liverpool School of Tropical Medicine, Liverpool, UK
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17
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Calsavara VF, Diniz MA, Tighiouart M, Ganz PA, Henry NL, Hays RD, Yothers G, Rogatko A. Simulation study comparing analytical methods for single-item longitudinal patient-reported outcomes data. Qual Life Res 2023; 32:827-839. [PMID: 36245019 PMCID: PMC9992042 DOI: 10.1007/s11136-022-03267-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/29/2022] [Indexed: 01/16/2023]
Abstract
PURPOSE Efficient analytical methods are necessary to make reproducible inferences on single-item longitudinal ordinal patient-reported outcome (PRO) data. A thorough simulation study was performed to compare the performance of the semiparametric probabilistic index models (PIM) with a longitudinal analysis using parametric cumulative logit mixed models (CLMM). METHODS In the setting of a control and intervention arm, we compared the power of the PIM and CLMM to detect differences in PRO adverse event (AE) between these groups using several existing and novel summary scores of PROs. For each scenario, PRO data were simulated using copula multinomial models. Comparisons were also exemplified using clinical trial data. RESULTS On average, CLMM provided substantially greater power than the PIM to detect differences in PRO-AEs between the groups when the baseline-adjusted method was used, and a small advantage in power when using the baseline symptom as a covariate. CONCLUSION Although the CLMM showed the best performance among analytical methods, it relies on assumptions difficult to verify and that might not be fulfilled in the real world, therefore our recommendation is the use of PIM models with baseline symptom as a covariate.
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Affiliation(s)
- Vinicius F Calsavara
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA.
| | - Márcio A Diniz
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA
| | - Mourad Tighiouart
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA
| | - Patricia A Ganz
- University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA
| | - N Lynn Henry
- University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA
| | - Ron D Hays
- Department of Medicine, University of California Los Angeles, Los Angeles, CA, USA
| | | | - André Rogatko
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA
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18
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Knoerl R, Mazzola E, Woods H, Buchbinder E, Frazier L, LaCasce A, Luskin MR, Phillips CS, Thornton K, Berry DL, Ligibel J. Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer. J Music Ther 2023:7036622. [PMID: 36787235 DOI: 10.1093/jmt/thac017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/15/2023]
Abstract
The purpose of this secondary analysis was to explore physiological, psychological, and situational influencing factors that may affect the impact of a mindfulness-music therapy intervention on anxiety severity in young adults receiving cancer treatment. Young adults receiving cancer treatment for ≥ eight weeks were recruited from adult and pediatric oncology outpatient centers at Dana-Farber Cancer Institute. Participants were asked to attend up to four, in-person (offered virtually via Zoom video conference after the onset of the COVID-19 pandemic) 45-min mindfulness-based music therapy sessions over twelve weeks with a board-certified music therapist. Participants completed questionnaires about anxiety, stress, and other cancer treatment-related outcomes before and after participating in the intervention. Changes in anxiety (i.e., PROMIS Anxiety 4a) over time were compared among baseline physiological (e.g., age or sex), psychological (e.g., stress), and situational influencing (i.e., intervention delivery format) factors using Wilcoxon-rank sum tests. Thirty-one of the 37 enrolled participants completed the baseline and post-intervention measures and were eligible for inclusion in the secondary analysis. Results revealed that higher baseline physical functioning (median change = -6.65), anxiety (median change=-5.65), fatigue (median change = -5.6), sleep disturbance (median change = -5.6), female sex (median change = -5.15), or virtual intervention delivery (median change = -4.65) were potential physiological, psychological, or situational influencing factors associated with anxiety improvement following mindfulness-based music therapy. Additional investigation into physiological, psychological, or situational influencing factors associated with anxiety response will help to tailor the design of future mindfulness-music therapy interventions to decrease psychological distress and address the unique psychosocial concerns among young adults receiving cancer treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT03709225.
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Affiliation(s)
- Robert Knoerl
- Phyllis F. Cantor Center for Research in Nursing and Patient Care Services, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Emanuele Mazzola
- Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Heather Woods
- The Leonard P. Zakim Center for Integrative Therapies and Healthy Living, Dana-Farber Cancer Institute, Boston, MA, USA
| | | | - Lindsay Frazier
- Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Ann LaCasce
- Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Marlise R Luskin
- Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Carolyn S Phillips
- Phyllis F. Cantor Center for Research in Nursing and Patient Care Services, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Katherine Thornton
- Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Donna L Berry
- Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, USA
| | - Jennifer Ligibel
- Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
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19
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Jin J, Zhou H, Sun S, Tian Z, Ren H, Feng J, Jiang X. Machine learning based gray-level co-occurrence matrix early warning system enables accurate detection of colorectal cancer pelvic bone metastases on MRI. Front Oncol 2023; 13:1121594. [PMID: 37035167 PMCID: PMC10073745 DOI: 10.3389/fonc.2023.1121594] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2022] [Accepted: 03/02/2023] [Indexed: 04/11/2023] Open
Abstract
Objective The mortality of colorectal cancer patients with pelvic bone metastasis is imminent, and timely diagnosis and intervention to improve the prognosis is particularly important. Therefore, this study aimed to build a bone metastasis prediction model based on Gray level Co-occurrence Matrix (GLCM) - based Score to guide clinical diagnosis and treatment. Methods We retrospectively included 614 patients with colorectal cancer who underwent pelvic multiparameter magnetic resonance image(MRI) from January 2015 to January 2022 in the gastrointestinal surgery department of Gezhouba Central Hospital of Sinopharm. GLCM-based Score and Machine learning algorithm, that is,artificial neural net7work model(ANNM), random forest model(RFM), decision tree model(DTM) and support vector machine model(SVMM) were used to build prediction model of bone metastasis in colorectal cancer patients. The effectiveness evaluation of each model mainly included decision curve analysis(DCA), area under the receiver operating characteristic (AUROC) curve and clinical influence curve(CIC). Results We captured fourteen categories of radiomics data based on GLCM for variable screening of bone metastasis prediction models. Among them, Haralick_90, IV_0, IG_90, Haralick_30, CSV, Entropy and Haralick_45 were significantly related to the risk of bone metastasis, and were listed as candidate variables of machine learning prediction models. Among them, the prediction efficiency of RFM in combination with Haralick_90, Haralick_all, IV_0, IG_90, IG_0, Haralick_30, CSV, Entropy and Haralick_45 in training set and internal verification set was [AUC: 0.926,95% CI: 0.873-0.979] and [AUC: 0.919,95% CI: 0.868-0.970] respectively. The prediction efficiency of the other four types of prediction models was between [AUC: 0.716,95% CI: 0.663-0.769] and [AUC: 0.912,95% CI: 0.859-0.965]. Conclusion The automatic segmentation model based on diffusion-weighted imaging(DWI) using depth learning method can accurately segment the pelvic bone structure, and the subsequently established radiomics model can effectively detect bone metastases within the pelvic scope, especially the RFM algorithm, which can provide a new method for automatically evaluating the pelvic bone turnover of colorectal cancer patients.
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20
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Sapienza LG, Maia MAC, Gomes MJL, Mattar A, Baiocchi G, Calsavara VF. Randomized clinical trial of tissue equivalent bolus prescription in postmastectomy radiotherapy stratified by skin involvement status. Clin Transl Radiat Oncol 2022; 39:100570. [PMID: 36594077 PMCID: PMC9803916 DOI: 10.1016/j.ctro.2022.100570] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2022] [Revised: 12/15/2022] [Accepted: 12/19/2022] [Indexed: 12/24/2022] Open
Abstract
Purpose To assess the impact and optimize the prescription of tissue-equivalent bolus in postmastectomy radiotherapy (PMRT), we compared the use of different bolus regimens tailored by skin involvement status. Methods Patients with breast cancer who required PMRT were recruited (NCT01925651) and classified into two groups: standard-risk (SR, without skin involvement) and high-risk (HR, with skin involvement). SR was randomized between no bolus or 5 mm-bolus on alternate days and HR between 5 mm-bolus on alternate days or daily. Conventional fractionation (50.4 Gy; 1.8 Gy/daily) was used. Acute skin toxicity was evaluated blindly and the radiodermatitis-specific toxicity index [rads-TI] calculated. Subsequently, patients were followed up to assess oncologic outcomes, focusing on chest wall (CW) local control. Results Fifty-eight patients were enrolled (34 SR and 24 HR). Baseline characteristics were similar between arms within the same risk group. Overall, maximal radiodermatitis rates were 29.4 % (G2) and 15.7 % (G3). In the SR group, no difference existed in G2 radiodermatitis incidence between the subgroups (p = 0.70) and no G3 events occurred. In the HR group, incidences of G2 (100 % vs 44.5 %, p = 0.01) and G3 radiodermatitis (70 % vs 11.1 %, p = 0.02) were higher with daily bolus. After adjusting for confounders, the daily bolus had a higher incidence of G2 (p = 0.03), G3 radiodermatitis (p = 0.04), and worse rads-TI (p < 0.01). After a median follow-up of 6.2 years, the 5-year local control was 95.8 % (95 %CI: 88.2 %-100 %) in the SR and 91.7 % (95 %CI: 77.3 %-100 %) in the HR groups. Per risk group, there was no difference in local control between the SR (p = 0.90) or the HR bolus regimens (p = 0.70). Conclusion Daily 5 mm bolus prescription significantly increased the overall toxicity burden. In this preliminary study, within the same risk group, no detriment in CW local control was detected with less intense bolus regimens (SR: no bolus; HR: alternate-days bolus). Additionally, the rads-TI was able to distinguish overall radiodermatitis burden.
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Affiliation(s)
- Lucas Gomes Sapienza
- Department of Radiation Oncology, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA,Corresponding author at: 5925 Almeda Rd #11609, Houston, TX 77004, USA.
| | | | - Maria José Leite Gomes
- Department of Radiation Oncology, Hospital Federal dos Servidores do Estado (HFSE-RJ), Rio de Janeiro, RJ, Brazil
| | - André Mattar
- Department of Mastology, Hospital Pérola Byington, São Paulo, SP, Brazil
| | - Glauco Baiocchi
- Department of Gynecologic Oncology, A.C. Camargo Cancer Center, São Paulo, SP, Brazil
| | - Vinicius Fernando Calsavara
- Department of Biostatistics and Bioinformatics, Samuel Oschin Cancer Center, Cedars-Sinai, Los Angeles, CA, USA
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21
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Chirinos JA, Lopez-Jaramillo P, Giamarellos-Bourboulis EJ, Dávila-Del-Carpio GH, Bizri AR, Andrade-Villanueva JF, Salman O, Cure-Cure C, Rosado-Santander NR, Cornejo Giraldo MP, González-Hernández LA, Moghnieh R, Angeliki R, Cruz Saldarriaga ME, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori JE, Gomez-Laiton E, Cotrina Pereyra R, Ravelo Hernández JL, Arbañil H, Accini-Mendoza J, Pérez-Mayorga M, Milionis C, Poulakou G, Sánchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-García RJ, Castro-Callirgos CA, Alfaro Carrasco RM, Garrido Lecca Danos W, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Ortega-Legaspi J, Jacoby D, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer NK, Putt M, Cohen JB. A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019. Nat Metab 2022; 4:1847-1857. [PMID: 36344766 PMCID: PMC9640855 DOI: 10.1038/s42255-022-00698-3] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2022] [Accepted: 10/21/2022] [Indexed: 11/09/2022]
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cytotoxicity may involve inhibition of peroxisome proliferator-activated receptor alpha. Fenofibrate activates peroxisome proliferator-activated receptor alpha and inhibits SARS-CoV-2 replication in vitro. Whether fenofibrate can be used to treat coronavirus disease 2019 (COVID-19) infection in humans remains unknown. Here, we randomly assigned inpatients and outpatients with COVID-19 within 14 d of symptom onset to 145 mg of oral fenofibrate nanocrystal formulation versus placebo for 10 d, in a double-blinded fashion. The primary endpoint was a severity score whereby participants were ranked across hierarchical tiers incorporating time to death, mechanical ventilation duration, oxygenation, hospitalization and symptom severity and duration. In total, 701 participants were randomized to fenofibrate (n = 351) or placebo (n = 350). The mean age of participants was 49 ± 16 years, 330 (47%) were female, mean body mass index was 28 ± 6 kg/m2 and 102 (15%) had diabetes. Death occurred in 41 participants. Compared with placebo, fenofibrate had no effect on the primary endpoint. The median (interquartile range) rank in the placebo arm was 347 (172, 453) versus 345 (175, 453) in the fenofibrate arm (P = 0.819). There was no difference in secondary and exploratory endpoints, including all-cause death, across arms. There were 61 (17%) adverse events in the placebo arm compared with 46 (13%) in the fenofibrate arm, with slightly higher incidence of gastrointestinal side effects in the fenofibrate group. Overall, among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes ( NCT04517396 ).
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Affiliation(s)
- Julio A Chirinos
- Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
| | - Patricio Lopez-Jaramillo
- Instituto de Investigación MASIRA, Facultad de Ciencias de la Salud, Universidad de Santander, Bucaramanga, Colombia
| | - Evangelos J Giamarellos-Bourboulis
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | | | | | | | - Oday Salman
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
- Department of Medicine, American University of Beirut, Beirut, Lebanon
| | | | | | | | - Luz A González-Hernández
- Unidad de VIH, Hospital Civil de Guadalajara and Universidad de Guadalajara, Guadalajara, Mexico
| | - Rima Moghnieh
- Department of Medicine, Makassed General Hospital, Beirut, Lebanon
| | - Rapti Angeliki
- 6th Department of Pulmonary Medicine, SOTIRIA Athens General Hospital of Chest Disease, Athens, Greece
| | - María E Cruz Saldarriaga
- Centro de Investigación de Enfermedades Infecciosas y Tropicales, Hospital Nacional Adolfo Guevara Velasco, Cuzco, Peru
| | - Marcos Pariona
- Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru
| | - Carola Medina
- Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru
| | - Ioannis Dimitroulis
- 6th Department of Pulmonary Medicine, SOTIRIA Athens General Hospital of Chest Disease, Athens, Greece
| | - Charalambos Vlachopoulos
- 1st Department of Cardiology, National and Kapodistrian University of Athens, Medical School,, Athens, Greece
| | | | - Juan E Rodriguez-Mori
- Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Peru
| | | | | | | | | | | | | | - Charalampos Milionis
- Department of Internal Medicine, Ioannina University General Hospital, Ioannina, Greece
| | - Garyfallia Poulakou
- 3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece
| | | | | | | | | | | | | | | | - Tiffany Sharkoski
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | - Katherine Greene
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | - Bianca Pourmussa
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | - Candy Greczylo
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | - Juan Ortega-Legaspi
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | - Douglas Jacoby
- 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece
| | - Jesse Chittams
- Biostatistics Analysis Core, Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA, USA
| | - Paraskevi Katsaounou
- Section of Pneumonology and Respiratory Failure, 1st Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece
| | - Zoi Alexiou
- 2nd Department of Internal Medicine, THRIASIO Eleusis General Hospital, Eleusis, Greece
| | - Styliani Sympardi
- 1st Department of Internal Medicine, THRIASIO Eleusis General Hospital, Eleusis, Greece
| | - Nancy K Sweitzer
- Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA
- Division of Cardiology, University of Arizona, Tucson, AZ, USA
| | - Mary Putt
- Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Jordana B Cohen
- Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
- Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
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22
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Henry NL, Kim S, Hays RD, Diniz MA, Tighiouart M, Gresham G, Luu M, Cecchini RS, Yothers G, Rogatko A, Ganz PA. Toxicity Index, patient-reported outcomes, and persistence of breast cancer chemotherapy-associated side effects in NRG Oncology/NSABP B-30. NPJ Breast Cancer 2022; 8:123. [DOI: 10.1038/s41523-022-00489-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2022] [Accepted: 10/21/2022] [Indexed: 11/21/2022] Open
Abstract
AbstractAdjuvant chemotherapy improves breast cancer survival but is associated with bothersome short- and long-term toxicity. Factors associated with toxicity, especially subacute toxicity up to 2 years following chemotherapy, have not been fully elucidated. The NRG Oncology/NSABP B-30 clinical trial compared 3 different doxorubicin-, cyclophosphamide-, and docetaxel-based chemotherapy regimens given over 3–6 months. Patients with hormone receptor-positive breast cancer received subsequent adjuvant endocrine therapy. From baseline through 24 months, 2156 patients completed questionnaires serially. We used multivariable probabilistic index models to identify factors associated with acute (>0–12 months) and subacute (>12–24 months) difficulties with pain, cognition, vasomotor symptoms, and vaginal symptoms. For all symptom domains, presence of symptoms prior to chemotherapy initiation were associated with symptoms in the subacute period (all p < 0.001). In addition, different combinations of patient factors and breast cancer treatments were associated with increased likelihood of pain, vasomotor, and vaginal symptoms in the subacute period. Consideration of pre-treatment symptoms and patient factors, as well as treatments for breast cancer, can facilitate identification of groups of patients that may experience symptoms following completion of chemotherapy. This information may be important for treatment-decision-making when alternative regimens are equivalent in benefit.
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Chirinos J, Lopez-Jaramillo P, Giamarellos-Bourboulis E, Dávila-Del-Carpio G, Bizri A, Andrade-Villanueva J, Salman O, Cure-Cure C, Rosado-Santander N, Giraldo MC, González-Hernández L, Moghnieh R, Angeliki R, Saldarriaga MC, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori J, Gomez-Laiton E, Pereyra R, Hernández JR, Arbañil H, Accini-Mendoza J, Pérez-Mayorga M, Milionis H, Poulakou G, Sánchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia R, Castro-Callirgos C, Carrasco RA, Danos WL, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer N, Putt M, Cohen J. A Randomized Trial of Lipid Metabolism Modulation with Fenofibrate for Acute Coronavirus Disease 2019. RESEARCH SQUARE 2022:rs.3.rs-1933913. [PMID: 35982675 PMCID: PMC9387540 DOI: 10.21203/rs.3.rs-1933913/v1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Indexed: 06/15/2023]
Abstract
Background Abnormal cellular lipid metabolism appears to underlie SARS-CoV-2 cytotoxicity and may involve inhibition of peroxisome proliferator activated receptor alpha (PPARα). Fenofibrate, a PPAR-α activator, modulates cellular lipid metabolism. Fenofibric acid has also been shown to affect the dimerization of angiotensin-converting enzyme 2, the cellular receptor for SARS-CoV-2. Fenofibrate and fenofibric acid have been shown to inhibit SARS-CoV-2 replication in cell culture systems in vitro . Methods We randomly assigned 701 participants with COVID-19 within 14 days of symptom onset to 145 mg of fenofibrate (nanocrystal formulation with dose adjustment for renal function or dose-equivalent preparations of micronized fenofibrate or fenofibric acid) vs. placebo for 10 days, in a double-blinded fashion. The primary endpoint was a ranked severity score in which participants were ranked across hierarchical tiers incorporating time to death, duration of mechanical ventilation, oxygenation parameters, subsequent hospitalizations and symptom severity and duration. ClinicalTrials.gov registration: NCT04517396. Findings: Mean age of participants was 49 ± 16 years, 330 (47%) were female, mean BMI was 28 ± 6 kg/m 2 , and 102 (15%) had diabetes mellitus. A total of 41 deaths occurred. Compared with placebo, fenofibrate administration had no effect on the primary endpoint. The median (interquartile range [IQR]) rank in the placebo arm was 347 (172, 453) vs. 345 (175, 453) in the fenofibrate arm (P = 0.819). There was no difference in various secondary and exploratory endpoints, including all-cause death, across randomization arms. These results were highly consistent across pre-specified sensitivity and subgroup analyses. Conclusion Among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes.
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Affiliation(s)
| | | | | | | | | | | | - Oday Salman
- Hospital of the University of Pennsylvania and Perelman School of Medicine, American University of Beirut
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | - Tiffany Sharkoski
- Hospital of the University of Pennsylvania and Perelman School of Medicine
| | - Katherine Greene
- Hospital of the University of Pennsylvania and Perelman School of Medicine
| | - Bianca Pourmussa
- Hospital of the University of Pennsylvania and Perelman School of Medicine
| | - Candy Greczylo
- Hospital of the University of Pennsylvania and Perelman School of Medicine
| | | | | | | | | | | | - Mary Putt
- Perelman School of Medicine. University of Pennsylvania
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Fintzi J, Bonnett T, Tebas P, Marconi VC, Levine CB, El Sahly HM, McLellan SLF, Benson CA, Rostad CA, Ganesan A, Huprikar N, Frank MG, Mularski RA, Atmar RL, Park PK, Short WR, Beigel JH, Mehta AK, Sweeney DA. Unraveling the Treatment Effect of Baricitinib on Clinical Progression and Resource Utilization in Hospitalized COVID-19 Patients: Secondary Analysis of the Adaptive COVID-19 Treatment Randomized Trial-2. Open Forum Infect Dis 2022; 9:ofac219. [PMID: 35818363 PMCID: PMC9129131 DOI: 10.1093/ofid/ofac219] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2022] [Accepted: 04/22/2022] [Indexed: 11/12/2022] Open
Abstract
Background The Adaptive COVID Treatment Trial-2 (ACTT-2) found that baricitinib in combination with remdesivir therapy (BCT) sped recovery in hospitalized coronavirus disease 2019 (COVID-19) patients vs remdesivir monotherapy (RMT). We examined how BCT affected progression throughout hospitalization and utilization of intensive respiratory therapies. Methods We characterized the clinical trajectories of 891 ACTT-2 participants requiring supplemental oxygen or higher levels of respiratory support at enrollment. We estimated the effect of BCT on cumulative incidence of clinical improvement and deterioration using competing risks models. We developed multistate models to estimate the effect of BCT on clinical improvement and deterioration and on utilization of respiratory therapies. Results BCT resulted in more linear improvement and lower incidence of clinical deterioration compared with RMT (hazard ratio [HR], 0.74; 95% CI, 0.58 to 0.95). The benefit was pronounced among participants enrolled on high-flow oxygen or noninvasive positive-pressure ventilation. In this group, BCT sped clinical improvement (HR, 1.21; 95% CI, 0.99 to 1.51) while slowing clinical deterioration (HR, 0.71; 95% CI, 0.48 to 1.02), which reduced the expected days in ordinal score (OS) 6 per 100 patients by 74 days (95% CI, -8 to 154 days) and the expected days in OS 7 per 100 patients by 161 days (95% CI, 46 to 291 days) compared with RMT. BCT did not benefit participants who were mechanically ventilated at enrollment. Conclusions Compared with RMT, BCT reduces the clinical burden and utilization of intensive respiratory therapies for patients requiring low-flow oxygen or noninvasive positive-pressure ventilation compared with RMT and may thereby improve care for this patient population.
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Affiliation(s)
- Jonathan Fintzi
- Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA
| | - Tyler Bonnett
- Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
| | - Pablo Tebas
- Division of Infectious Diseases/Clinical Trials Unit, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Vincent C Marconi
- Emory University School of Medicine and Rollins School of Public Health, Emory Vaccine Center, Atlanta Veterans Affairs Medical Center, Atlanta, Georgia, USA
| | - Corri B Levine
- Division of Infectious Disease, Department of Medicine, University of Texas Medical Branch, Galveston, Texas, USA
| | - Hana M El Sahly
- Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA
| | - Susan L F McLellan
- Division of Infectious Disease, Department of Medicine, University of Texas Medical Branch, Galveston, Texas, USA
| | - Constance A Benson
- Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California, San Diego, La Jolla, California, USA
| | - Christina A Rostad
- Division of Infectious Diseases, Department of Pediatrics, Emory University School of Medicine and Children’s Healthcare of Atlanta, Atlanta, Georgia, USA
| | - Anuradha Ganesan
- Division of Infectious Disease, Walter Reed National Military Medical Center, Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland, USA
| | - Nikhil Huprikar
- Division of Pulmonary/Critical Care Medicine, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA
| | - Maria G Frank
- Department of Medicine, Denver Health Hospital Authority, Associate Professor of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Richard A Mularski
- The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
| | - Robert L Atmar
- Department of Medicine, Baylor College of Medicine, Houston, Texas, USA
| | - Pauline K Park
- Division of Acute Care Surgery, Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA
| | - William R Short
- Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - John H Beigel
- Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA
| | - Aneesh K Mehta
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA
| | - Daniel A Sweeney
- Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of California, San Diego, La Jolla, California, USA
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Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops. Qual Life Res 2022; 31:2901-2916. [PMID: 35553325 PMCID: PMC9470723 DOI: 10.1007/s11136-022-03127-w] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/16/2022] [Indexed: 11/12/2022]
Abstract
Introduction Failure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018. Method Annual workshops were conducted 2011–2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann–Whitney U tests assessed whether workshop protocols scored higher than controls by item and overall. Results Participants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 13, median = 3.81/10, interquartile range = 3.24) and control protocols (n = 9, 3.51/10 (2.14)), (p = 0.35). Workshop protocols scored higher than controls on two items: ‘specify PRO concepts/domains’ (p = 0.05); ‘methods for handling missing data’ (p = 0.044). Conclusion Although participants were highly satisfied with these workshops, the completeness of PRO protocol content generally did not improve. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content. Supplementary Information The online version contains supplementary material available at 10.1007/s11136-022-03127-w.
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Roan VD, Sun KJ, Valentim CCS, Bheemidi AR, Iyer A, Singh RP, Talcott KE. Patient Satisfaction in the Era of COVID-19: Virtual Visit versus In-person Visit Satisfaction. Optom Vis Sci 2022; 99:190-194. [PMID: 34889857 DOI: 10.1097/opx.0000000000001843] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
Abstract
SIGNIFICANCE Teleophthalmology became widely used during the coronavirus 2019 pandemic; however, the quality of this care remains to be understood. PURPOSE This study aimed to compare patient satisfaction levels from virtual and in-person visits based on post-visit surveys, as well as investigate demographic characteristics that may predict patient satisfaction with virtual visits. METHODS Virtual (n = 2943) and in-person (n = 56,175) visits from March 19, 2020, to July 31, 2020, were identified using the electronic health record system. For in-person visits, a random subset of 3000 visits was acquired using a random number generator. Of these, 2266 virtual and 2590 in-person visits met the inclusion criteria. Patients who completed the Telemedicine for Medical Practice Survey and Medical Practice Survey were analyzed in this report. Nonparametric Mann-Whitney test was used to compare scores between groups. RESULTS Two hundred eleven virtual patients (9.31%; 82 phone, 115 video, 14 hybrid) and 307 in-person patients (11.85%) completed the Telemedicine for Medical Practice Survey and Medical Practice Survey, respectively. Satisfaction scores were similar and high in both groups-virtual visit satisfaction scores averaged 4.82, whereas in-person visit satisfaction averaged 4.85 (P = .80, θ = 0.501 [0.493 to 0.509]). Only one question yielded significantly different satisfaction scores, and no demographic variables were significant predictors of satisfaction scores. CONCLUSIONS Patient satisfaction is comparable between virtual and in-person visits, validating the continued usage of telemedicine for eye care visits.
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Affiliation(s)
- Vivian D Roan
- Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Kristie J Sun
- Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Carolina C S Valentim
- Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
| | | | - Amogh Iyer
- Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
| | - Rishi P Singh
- Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
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Estimation and Testing of Wilcoxon–Mann–Whitney Effects in Factorial Clustered Data Designs. Symmetry (Basel) 2022. [DOI: 10.3390/sym14020244] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
Clustered data arise frequently in many practical applications whenever units are repeatedly observed under a certain condition. One typical example for clustered data are animal experiments, where several animals share the same cage and should not be assumed to be completely independent. Standard methods for the analysis of such data are Linear Mixed Models and Generalized Estimating Equations—however, checking their assumptions is not easy, especially in scenarios with small sample sizes, highly skewed, count, and ordinal or binary data. In such situations, Wilcoxon–Mann–Whitney type effects are suitable alternatives to mean-based or other distributional approaches. Hence, no specific data distribution, symmetric or asymmetric, is required. Within this work, we will present different estimation techniques of such effects in clustered factorial designs and discuss quadratic- and multiple contrast type-testing procedures for hypotheses formulated in terms of Wilcoxon–Mann–Whitney effects. Additionally, the framework allows for the occurrence of missing data: estimation and testing hypotheses are based on all-available data instead of complete-cases. An extensive simulation study investigates the precision of the estimators and the behavior of the test procedures in terms of their type-I error control. One real world dataset exemplifies the applicability of the newly proposed procedures.
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Larsen SV, Ozenne B, Köhler-Forsberg K, Poulsen AS, Dam VH, Svarer C, Knudsen GM, Jørgensen MB, Frokjaer VG. The Impact of Hormonal Contraceptive Use on Serotonergic Neurotransmission and Antidepressant Treatment Response: Results From the NeuroPharm 1 Study. Front Endocrinol (Lausanne) 2022; 13:799675. [PMID: 35360055 PMCID: PMC8962375 DOI: 10.3389/fendo.2022.799675] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/21/2021] [Accepted: 01/31/2022] [Indexed: 11/21/2022] Open
Abstract
BACKGROUND Hormonal contraceptive (HC) use has been associated with an increased risk of developing a depressive episode. This might be related to HC's effect on the serotonergic brain system as suggested by recent cross-sectional data from our group, which show that healthy oral contraceptive (OC) users relative to non-users have lower cerebral serotonin 4 receptor (5-HT4R) levels. Here, we determine if cerebral 5-HT4R binding differs between HC non-users, OC users, and hormonal intrauterine device (HIUD) users among women with an untreated depressive episode. Also, we test if antidepressant drug treatment response and its association with pre-treatment 5-HT4R binding depends on HC status. METHODS [11C]-SB207145 Positron Emission Tomography imaging data from the NeuroPharm-NP1 Study (NCT02869035) were available from 59 depressed premenopausal women, of which 26 used OCs and 10 used HIUDs. The participants were treated with escitalopram. Treatment response was measured as the relative change in the Hamilton Depression Rating Scale 6 items (rΔHAMD6) from baseline to week eight. Latent variable models were used to evaluate the association between global 5-HT4R binding and OC and HIUD use as well as rΔHAMD6. RESULTS We found no evidence of a difference in global 5-HT4R binding between depressed HC users and non-users (p≥0.51). A significant crossover interaction (p=0.02) was observed between non-users and OC users in the association between baseline global 5-HT4R binding and week eight rΔHAMD6; OC users had 3-4% lower binding compared to non-users for every 10% percent less improvement in HAMD6. Within the groups, we observed a trend towards a positive association in non-users (padj=0.10) and a negative association in OC users (padj=0.07). We found no strong evidence of a difference in treatment response between the groups (p=0.13). CONCLUSIONS We found no difference in 5-HT4R binding between HC users vs. non-users in depressed women, however, it seemed that 5-HT4R settings differed qualitatively in their relation to antidepressant drug treatment response between OC users and non-users. From this we speculate that depressed OC users constitutes a special serotonin subtype of depression, which might have implications for antidepressant drug treatment response.
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Affiliation(s)
- Søren Vinther Larsen
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
| | - Brice Ozenne
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark
| | - Kristin Köhler-Forsberg
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- Psychiatric Center Copenhagen, Mental Health Services in the Capital Region of Denmark, Copenhagen, Denmark
| | | | - Vibeke Høyrup Dam
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
| | - Claus Svarer
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
| | - Gitte Moos Knudsen
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
| | - Martin Balslev Jørgensen
- Psychiatric Center Copenhagen, Mental Health Services in the Capital Region of Denmark, Copenhagen, Denmark
| | - Vibe Gedso Frokjaer
- Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- Psychiatric Center Copenhagen, Mental Health Services in the Capital Region of Denmark, Copenhagen, Denmark
- *Correspondence: Vibe Gedso Frokjaer,
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TSUSHIMA E. Interpreting Results from Statistical Hypothesis Testing: Understanding the Appropriate P-value. Phys Ther Res 2022; 25:49-55. [DOI: 10.1298/ptr.r0019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/16/2022] [Accepted: 03/02/2022] [Indexed: 11/23/2022]
Affiliation(s)
- Eiki TSUSHIMA
- Graduate School of Health Sciences, Hirosaki University, Japan
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Chen J, Kwan LC, Ma LY, Choi HY, Lo YC, Au SY, Tsang CH, Cheng BL, Feldman G. Retrospective and prospective hindsight bias: Replications and extensions of Fischhoff (1975) and Slovic and Fischhoff (1977). JOURNAL OF EXPERIMENTAL SOCIAL PSYCHOLOGY 2021. [DOI: 10.1016/j.jesp.2021.104154] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
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Brodeur J, Ley AF, Bonnet M. A survey of Midwest physicians' experiences with patients in psychiatric distress in the emergency department. J Osteopath Med 2021; 121:773-778. [PMID: 34315193 DOI: 10.1515/jom-2021-0052] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2021] [Accepted: 06/08/2021] [Indexed: 11/15/2022]
Abstract
CONTEXT Emergency medicine (EM) physicians commonly stabilize patients with acute psychiatric distress, such as suicidal ideation. Research has shown that suicidal ideation is difficult to manage in emergency department (ED) settings and that patients in psychiatric distress are often "boarded" in the ED while awaiting more definitive care. OBJECTIVES To examine the attitudes and experiences of emergency physicians regarding the care of patients in psychiatric distress. Special attention is given to suicidal ideation due to its prevalence in the United States. METHODS A 19 question anonymous survey was sent via email to 55 emergency medicine residency directors throughout Michigan, Ohio, Indiana, and Illinois, who were identified using an Internet search of residency programs in the region. The program directors were asked to distribute the survey to their colleagues and residents. The intent of this procedure was to generate as many survey responses as possible, while obscuring the identities of the respondents. Responses were gathered from October 29, 2019 until January 16, 2020. The survey was designed to assess respondents' self-reported demographic data as well as their experiences with the boarding process, initial examination, final disposition, reevaluation of the patient, physician training and resources, and follow up care. Statistical analysis was performed using a Mann-Whitney U test, significance was set at p<0.01. RESULTS In total, 47 EM physicians responded to the survey; however, not all of the respondents completed all 19 questions. Ten of 44 respondents (22.7%) reported that they do not perform the initial psychiatric examination themselves and instead defer to a nurse or social worker. Twenty-two of 44 respondents (50.0%) reported that they defer to a social worker when determining the final disposition of psychiatric patients. Respondents reevaluated patients in psychiatric distress statistically significantly less often (p=0.01) compared with patients with cardiac pathology. Additionally, 15 of 38 respondents (39.5%) reported that they did not feel adequately trained to handle psychiatric emergencies, and 36 of 39 respondents (92.3%) of physicians felt that their facility would benefit from additional mental health resources. Thirty five of 39 respondents (89.7%) reported that their facility did not have a system in place to follow up with suicidal patients upon discharge. CONCLUSIONS Caring for patients who are acutely suicidal or in psychiatric distress is complex and more research is needed to optimize treatment strategies. The results of this study indicate that EM physicians may regularly defer to nonphysician providers when evaluating and treating patients in psychiatric distress. A perceived lack of training in psychiatry may contribute to this practice. The results of this study are in accord with previous research that indicated a need for additional psychiatry training in EM residencies.
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Affiliation(s)
- Jack Brodeur
- Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA
| | - Alyse Folino Ley
- Psychiatry Residency Program, Department of Psychiatry, Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA.,Child and Adolescent Psychiatry Fellowship, Department of Psychiatry, Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA
| | - Michelle Bonnet
- PGY IV, Psychiatry Residency Program, Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA
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Cheng H, Zeng R, Kong L, Ding C, He Y, Zhuang W, Sun Y. Establishment of predicting equation for individual sufentanil dosage postoperatively based on gene polymorphisms. Pain Pract 2021; 22:39-46. [PMID: 33977649 DOI: 10.1111/papr.13030] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2020] [Revised: 04/21/2021] [Accepted: 04/27/2021] [Indexed: 11/29/2022]
Abstract
BACKGROUND Postoperative analgesia is widely used for patients undergoing major surgeries. Individual differences in genetic polymorphisms may be obstructive factors for accurately anesthetics using. However, the equation for predicting sufentanil dosage postoperatively based on genetic design has been established yet. Our aim was to establish sufentanil dosage postoperatively prediction equation based on patients' genetic polymorphisms. METHODS One hundred forty patients with total gastrectomy and radical resection of pulmonary carcinoma were included. To establish sufentanil dosage postoperatively for patients with gastric cancer, we collected patients' basic information and CYP3A4*1G, COMTVal158Met, OPRM1A118G, and ABCB1C3435T gene sequencing results. To verify this equation, we put patients' with lung cancer surgeries information into it. RESULTS The sufentanil dosage prediction equation postoperatively was y = 4.104 - 0.222 × (gender) + 0.021 × (OPRM1A118G) + 0.249 × (ABCB1C3435T). Patients' with lung cancer surgeries information were substituted into it. The results showed no significant differences between predicted and actual sufentanil dosage (p > 0.05). CONCLUSION We established the prediction equation for individual sufentanil dosage postoperatively based on gene polymorphisms. The results showed this prediction equation was valid, which might be used for different types of surgeries. We established an equation for individual dosage of sufentanil for postoperative analgesia based on gene polymorphisms. The results show that the prediction equation is valid, the information might be used for different types of postoperative analgesia, and the painful patients will have great potential safe and personalized pain control after analgesic therapy. It might also have potential as a clinical tool.
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Affiliation(s)
- Huawei Cheng
- Division of Life Sciences and Medicine, Department of Pharmacy, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
| | - Rong Zeng
- Division of Life Sciences and Medicine, Department of Anesthesiology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
| | - Lingsuo Kong
- Division of Life Sciences and Medicine, Department of Anesthesiology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
| | - Conglan Ding
- Division of Life Sciences and Medicine, Department of Medical Oncology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
| | - Yifu He
- Division of Life Sciences and Medicine, Department of Medical Oncology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
| | - Wei Zhuang
- Division of Life Sciences and Medicine, Department of Pharmacy, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
| | - Yancai Sun
- Division of Life Sciences and Medicine, Department of Pharmacy, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China
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Zou G. Confidence interval estimation for treatment effects in cluster randomization trials based on ranks. Stat Med 2021; 40:3227-3250. [PMID: 33942338 DOI: 10.1002/sim.8918] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2020] [Revised: 01/25/2021] [Accepted: 02/03/2021] [Indexed: 11/08/2022]
Abstract
A cluster randomization trial is one in which clusters of individuals are randomly allocated to different intervention arms. This design has become the standard for the evaluation of health care and educational strategies. To assess treatment effect, many cluster randomization trials involve outcomes that are lack meaningful units, making interpretation difficult. This difficulty may be dealt with by estimating the Mann-Whitney probability, which quantifies the probability that a typical response from one treatment arm is larger (or smaller) than a typical response from the other arm. In this work, we propose procedures for estimating this probability in cluster randomization trials. Primary emphasis is given to confidence interval estimation in trials with a small number of large clusters. The essence of the procedures is to obtain placement values based on overall ranks and arm-specific ranks prior to application of the ratio estimator, cluster-size-weighted means and mixed models for adjusting clustering effects. Nine confidence intervals were developed by applying three interval methods each based on the three variance estimators. The proposed methods can be applied to studies with binary, ordinal or continuous outcomes without making parametric assumptions. Simulation results demonstrated that the three variance estimators performed equally well, with the confidence interval procedures based on logit and inverse hyperbolic sine transformations performing better in terms of coverage and average interval width, even when the numbers of clusters are as small as 3 to 5 clusters per arm. The methods are illustrated using data from three published cluster randomization trials with SAS code provided.
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Affiliation(s)
- Guangyong Zou
- Department of Epidemiology & Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada.,Robarts Research Institute, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada.,Alimentiv Inc., London, Ontario, Canada
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Gresham G, Diniz MA, Razaee ZS, Luu M, Kim S, Hays RD, Piantadosi S, Tighiouart M, Yothers G, Ganz PA, Rogatko A. Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index. J Natl Cancer Inst 2021; 112:1266-1274. [PMID: 32091598 PMCID: PMC7735773 DOI: 10.1093/jnci/djaa028] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2019] [Revised: 12/24/2019] [Accepted: 02/17/2020] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND The National Cancer Institute Moonshot research initiative calls for improvements in the analysis and reporting of treatment toxicity to advise key stakeholders on treatment tolerability and inform regulatory and clinical decision making. This study illustrates alternative approaches to toxicity evaluation using the National Surgical Adjuvant Breast and Bowel Project R-04 clinical trial as an example. METHODS National Surgical Adjuvant Breast and Bowel Project R-04 was a neoadjuvant chemoradiation trial in stage II-III rectal cancer patients. A 2 x 2 factorial design was used to evaluate whether the addition of oxaliplatin (Oxa) to 5-fluorouracil (5FU) or capecitabine (Cape) with radiation therapy improved local-regional tumor control. The toxicity index (TI), which accounts for the frequency and severity of toxicities, was compared across treatments using multivariable probabilistic index models, where Pr A < B indicates the probability that higher values of TI were observed for A when compared with B. Baseline age, sex, performance status, body mass index, surgery type, and stage were evaluated as independent risk factors. RESULTS A total of 4560 toxicities from 1558 patients were analyzed. Results from adjusted probabilistic index models indicate that oxaliplatin-containing regimens had statistically significant (P < .001) probability (Pr) for higher TI compared with regimens without oxaliplatin (Pr 5FU < 5FU + Oxa = 0.619, 95% confidence interval [CI] = 0.560 to 0.674; Pr 5FU < Cape + Oxa = 0.627, 95% CI = 0.568 to 0.682; Pr Cape < 5FU + Oxa = 0.587, 95% 0.527 to 0.644; and Pr Cape < Cape + Oxa = 0.596, 95% 0.536 to 0.653). When compared with other existing toxicity analysis methods, TI provided greater power to detect differences between treatments. CONCLUSIONS This article uses standard data collected in a cancer clinical trial to introduce descriptive and analytic methods that account for the additional burden of multiple toxicities. These methods may provide a more accurate description of a patient's treatment experience that could lead to individualized dosing for better toxicity control. Future research will evaluate the generalizability of these findings in trials with similar drugs.
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Affiliation(s)
- Gillian Gresham
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.,Brigham and Women's Hospital, Harvard University, Boston, MA, USA
| | - Márcio A Diniz
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Zahra S Razaee
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Michael Luu
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Sungjin Kim
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Ron D Hays
- Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA, USA.,Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA, USA.,RAND Corporation, Santa Monica, CA, USA
| | | | - Mourad Tighiouart
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Greg Yothers
- University of Pittsburgh and NRG Oncology, Pittsburgh, PA, USA
| | - Patricia A Ganz
- Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA, USA.,Center for Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA, USA.,Department of Medicine (Hematology/Oncology), David Geffen School of Medicine at University of California, Los Angeles, CA, USA
| | - André Rogatko
- Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
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de Ree R, Willemsen J, Te Grotenhuis G, de Ree R, Kolkert J, Peppelman M. Continuous monitoring in COVID-19 care: a retrospective study in time of crisis. JAMIA Open 2021; 4:ooab030. [PMID: 34136756 PMCID: PMC8083333 DOI: 10.1093/jamiaopen/ooab030] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2020] [Revised: 03/11/2021] [Accepted: 04/09/2021] [Indexed: 11/13/2022] Open
Abstract
Background A new monitoring system was implemented to support nursing staff and physicians on the COVID-19 ward. This system was designed to remotely monitor vital signs, to calculate an automated Early Warning Score, and to help identify patients at risk of deterioration. Methods Hospitalized patients who tested positive for SARS-CoV-2 were connected to 2 wireless sensors measuring vital signs. Patients were divided into 2 groups based on the occurrence of adverse events during hospitalization. Heart and respiratory rate were monitored continuously and an automated EWS was calculated every 5 minutes. Data were compared between groups. Results Prior to the occurrence of adverse events, significantly higher median heart and respiration rate and significantly lower median SPO2 values were observed. Mean and median automated EWS were significantly higher in patients with an adverse event. Conclusion Continuous monitoring systems might help to detect clinical deterioration in COVID-19 patients at an earlier stage.
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Affiliation(s)
- Roy de Ree
- Department of Health Innovation, Slingeland Hospital, Doetinchem, Gelderland, The Netherlands
| | - Jorn Willemsen
- Department of Health Innovation, Slingeland Hospital, Doetinchem, Gelderland, The Netherlands
| | - Gilbert Te Grotenhuis
- Department of Health Innovation, Slingeland Hospital, Doetinchem, Gelderland, The Netherlands
| | - Rick de Ree
- Department of Health Innovation, Slingeland Hospital, Doetinchem, Gelderland, The Netherlands
| | - Joé Kolkert
- Department of Surgery, Slingeland Hospital, Doetinchem, Gelderland, The Netherlands
| | - Malou Peppelman
- Department of Health Innovation, Slingeland Hospital, Doetinchem, Gelderland, The Netherlands
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Stress-related emotional and behavioural impact following the first COVID-19 outbreak peak. Mol Psychiatry 2021; 26:6149-6158. [PMID: 34349224 PMCID: PMC8335462 DOI: 10.1038/s41380-021-01219-6] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/10/2020] [Revised: 06/21/2021] [Accepted: 06/29/2021] [Indexed: 12/15/2022]
Abstract
The COVID-19 pandemic poses multiple psychologically stressful challenges and is associated with an increased risk for mental illness. Previous studies have focused on the psychopathological symptoms associated with the outbreak peak. Here, we examined the behavioural and mental-health impact of the pandemic in Israel using an online survey, during the six weeks encompassing the end of the first outbreak and the beginning of the second. We used clinically validated instruments to assess anxiety- and depression-related emotional distress, symptoms, and coping strategies, as well as questions designed to specifically assess COVID-19-related concerns. Higher emotional burden was associated with being female, younger, unemployed, living in high socioeconomic status localities, having prior medical conditions, encountering more people, and experiencing physiological symptoms. Our findings highlight the environmental context and its importance in understanding individual ability to cope with the long-term stressful challenges of the pandemic.
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Tverring J, Åkesson A, Nielsen N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 2020; 21:994. [PMID: 33272319 PMCID: PMC7711053 DOI: 10.1186/s13063-020-04863-5] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2020] [Accepted: 11/03/2020] [Indexed: 02/08/2023] Open
Abstract
BACKGROUND Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. METHODS We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021. DISCUSSION We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. TRIAL REGISTRATION ClinicalTrials.gov NCT04395807 . Registered on 20 May 2020.
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Affiliation(s)
| | - Anna Åkesson
- Lunds universitet Medicinska fakulteten, Lund, Sweden
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Pizzo F, Roehri N, Giusiano B, Lagarde S, Carron R, Scavarda D, McGonigal A, Filipescu C, Lambert I, Bonini F, Trebuchon A, Bénar CG, Bartolomei F. The Ictal Signature of Thalamus and Basal Ganglia in Focal Epilepsy: A SEEG Study. Neurology 2020; 96:e280-e293. [PMID: 33024023 DOI: 10.1212/wnl.0000000000011003] [Citation(s) in RCA: 68] [Impact Index Per Article: 13.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2020] [Accepted: 08/26/2020] [Indexed: 11/15/2022] Open
Abstract
OBJECTIVE To determine the involvement of subcortical regions in human epilepsy by analyzing direct recordings from these regions during epileptic seizures using stereo-EEG (SEEG). METHODS We studied the SEEG recordings of a large series of patients (74 patients, 157 seizures) with an electrode sampling the thalamus and in some cases also the basal ganglia (caudate nucleus, 22 patients; and putamen, 4 patients). We applied visual analysis and signal quantification methods (Epileptogenicity Index [EI]) to their ictal recordings and compared electrophysiologic with clinical data. RESULTS We found that in 86% of patients, thalamus was involved during seizures (visual analysis) and 20% showed high values of epileptogenicity (EI >0.3). Basal ganglia may also disclose high values of epileptogenicity (9% in caudate nucleus) but to a lesser degree than thalamus (p < 0.01). We observed different seizure onset patterns including low voltage high frequency activities. We found high values of thalamic epileptogenicity in different epilepsy localizations, including opercular and motor epilepsies. We found no difference between epilepsy etiologies (cryptogenic vs malformation of cortical development, p = 0.77). Thalamic epileptogenicity was correlated with the extension of epileptogenic networks (p = 0.02, ρ 0.32). We found a significant effect (p < 0.05) of thalamic epileptogenicity regarding the postsurgical outcome (higher thalamic EI corresponding to higher probability of surgical failure). CONCLUSIONS Thalamic involvement during seizures is common in different seizure types. The degree of thalamic epileptogenicity is a possible marker of the epileptogenic network extension and of postsurgical prognosis.
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Affiliation(s)
- Francesca Pizzo
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris.
| | - Nicolas Roehri
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Bernard Giusiano
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Stanislas Lagarde
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Romain Carron
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Didier Scavarda
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Aileen McGonigal
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Cristina Filipescu
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Isabelle Lambert
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Francesca Bonini
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Agnes Trebuchon
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Christian-George Bénar
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris
| | - Fabrice Bartolomei
- From the Epileptology Department (F.P., S.L., A.M., I.L., F. Bonini, A.T., F. Bartolomei), Functional and Stereotactic Neurosurgery (R.C.), and Pediatric Neurosurgery (D.S.), APHM, Timone Hospital, Institut de Neurosciences des Systèmes (F.P., N.R., B.G., S.L., R.C., D.S., A.M., I.L., F. Bonini, A.T., C.-G.B, F. Bartolomei), INSERM, Aix Marseille Universite; and Psychiatrie et Neurosciences (C.F.), GHU Paris, St Anne, Paris.
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Buri M, Curt A, Steeves J, Hothorn T. Baseline-adjusted proportional odds models for the quantification of treatment effects in trials with ordinal sum score outcomes. BMC Med Res Methodol 2020; 20:104. [PMID: 32375705 PMCID: PMC7204322 DOI: 10.1186/s12874-020-00984-2] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2019] [Accepted: 04/20/2020] [Indexed: 11/10/2022] Open
Abstract
Background Sum scores of ordinal outcomes are common in randomized clinical trials. The approaches routinely employed for assessing treatment effects, such as t-tests or Wilcoxon tests, are not particularly powerful in detecting changes in relevant parameters or lack the ability to incorporate baseline information. Hence, tailored statistical methods are needed for the analysis of ordinal outcomes in clinical research. Methods We propose baseline-adjusted proportional odds logistic regression models to overcome previous limitations in the analysis of ordinal outcomes in randomized clinical trials. For the validation of our method, we focus on common ordinal sum score outcomes of neurological clinical trials such as the upper extremity motor score, the spinal cord independence measure, and the self-care subscore of the latter. We compare the statistical power of our models to other conventional approaches in a large simulation study of two-arm randomized clinical trials based on data from the European Multicenter Study about Spinal Cord Injury (EMSCI, ClinicalTrials.gov Identifier: NCT01571531). We also use the new method as an alternative analysis of the historical Sygen®clinical trial. Results The simulation study of all postulated trial settings demonstrated that the statistical power of the novel method was greater than that of conventional methods. Baseline adjustments were more suited for the analysis of the upper extremity motor score compared to the spinal cord independence measure and its self-care subscore. Conclusions The proposed baseline-adjusted proportional odds models allow the global treatment effect to be directly interpreted. This clear interpretation, the superior statistical power compared to the conventional analysis approaches, and the availability of open-source software support the application of this novel method for the analysis of ordinal outcomes of future clinical trials.
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Affiliation(s)
- Muriel Buri
- Department of Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, CH-8001, Switzerland
| | - Armin Curt
- University Hospital Balgrist, Spinal Cord Injury Center, Forchstrasse 340, Zurich, CH-8008, Switzerland
| | - John Steeves
- International Collaboration On Repair Discoveries (ICORD), University of British Columbia, Vancouver/Kelowna, Canada
| | - Torsten Hothorn
- Department of Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, CH-8001, Switzerland.
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Lu J, Zhang Y, Ding P. Sharp bounds on the relative treatment effect for ordinal outcomes. Biometrics 2019; 76:664-669. [PMID: 31742664 DOI: 10.1111/biom.13148] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2019] [Accepted: 09/04/2019] [Indexed: 11/29/2022]
Abstract
For ordinal outcomes, the average treatment effect is often ill-defined and hard to interpret. Echoing Agresti and Kateri, we argue that the relative treatment effect can be a useful measure, especially for ordinal outcomes, which is defined as γ = pr { Y i ( 1 ) > Y i ( 0 ) } - pr { Y i ( 1 ) < Y i ( 0 ) } , with Y i ( 1 ) and Y i ( 0 ) being the potential outcomes of unit i under treatment and control, respectively. Given the marginal distributions of the potential outcomes, we derive the sharp bounds on γ , which are identifiable parameters based on the observed data. Agresti and Kateri focused on modeling strategies under the assumption of independent potential outcomes, but we allow for arbitrary dependence.
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Affiliation(s)
- Jiannan Lu
- Analysis and Experimentation, Microsoft Corporation, Redmond, Washington
| | - Yunshu Zhang
- Department of Statistics, North Carolina State University, Raleigh, North Carolina
| | - Peng Ding
- Department of Statistics, University of California, Berkeley, California
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Kössler W, Mukherjee A. Distribution-free simultaneous tests for location-scale and Lehmann alternative in two-sample problem. Biom J 2019; 62:99-123. [PMID: 31631379 DOI: 10.1002/bimj.201900057] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2019] [Revised: 05/03/2019] [Accepted: 06/10/2019] [Indexed: 11/11/2022]
Abstract
The paper deals with the classical two-sample testing problem for the equality of two populations, one of the most fundamental problems in biomedical experiments and case-control studies. The most familiar alternatives are the difference in location parameters or the difference in scale parameters or in both the parameters of the population density. All the tests designed for classical location or scale or location-scale alternatives assume that there is no change in the shape of the distribution. Some authors also consider the Lehmann-type alternative that addresses the change in shape. Two-sample tests under Lehmann alternative assume that the location and scale parameters are invariant. In real life, when a shift in the distribution occurs, one or more of the location, scale, and shape parameters may change simultaneously. We refer to change of one or more of the three parameters as a versatile alternative. Noting the dearth of literature for the equality two populations against such versatile alternative, we introduce two distribution-free tests based on the Euclidean and Mahalanobis distance. We obtain the asymptotic distributions of the two test statistics and study asymptotic power. We also discuss approximating p-values of the proposed tests in real applications with small samples. We compare the power performance of the two tests with several popular existing distribution-free tests against various fixed alternatives using Monte Carlo. We provide two illustrations based on biomedical experiments. Unlike existing tests which are suitable only in certain situations, proposed tests offer very good power in almost all types of shifts.
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Affiliation(s)
- Wolfgang Kössler
- Department of Computer Science, Humboldt University of Berlin, Berlin, Germany
| | - Amitava Mukherjee
- Production, Operations and Decision Sciences Area, XLRI - Xavier School of Management, XLRI Jamshedpur, Jharkhand, India
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Król M, Król ME. Autism limits strategic thinking after all: A process tracing study of the beauty contest game. THINKING & REASONING 2019. [DOI: 10.1080/13546783.2019.1679256] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Affiliation(s)
- Michał Król
- Department of Economics, School of Social Sciences, University of Manchester, Manchester, UK
| | - Magdalena Ewa Król
- Wrocław Faculty of Psychology, SWPS University of Social Sciences and Humanities in Wrocław, Warsaw, Poland
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Fay MP, Brittain EH, Shih JH, Follmann DA, Gabriel EE. Causal estimands and confidence intervals associated with Wilcoxon-Mann-Whitney tests in randomized experiments. Stat Med 2018; 37:2923-2937. [PMID: 29774591 PMCID: PMC6373726 DOI: 10.1002/sim.7799] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2017] [Revised: 03/05/2018] [Accepted: 04/03/2018] [Indexed: 11/10/2022]
Abstract
Although the P value from a Wilcoxon-Mann-Whitney test is used often with randomized experiments, it is rarely accompanied with a causal effect estimate and its confidence interval. The natural parameter for the Wilcoxon-Mann-Whitney test is the Mann-Whitney parameter, ϕ, which measures the probability that a randomly selected individual in the treatment arm will have a larger response than a randomly selected individual in the control arm (plus an adjustment for ties). We show that the Mann-Whitney parameter may be framed as a causal parameter and show that it is not equal to a closely related and nonidentifiable causal effect, ψ, the probability that a randomly selected individual will have a larger response under treatment than under control (plus an adjustment for ties). We review the paradox, first expressed by Hand, that the ψ parameter may imply that the treatment is worse (or better) than control, while the Mann-Whitney parameter shows the opposite. Unlike the Mann-Whitney parameter, ψ is nonidentifiable from a randomized experiment. We review some nonparametric assumptions that rule out Hand's paradox through bounds on ψ and use bootstrap methods to make inferences on those bounds. We explore the relationship of the proportional odds parameter to Hand's paradox, showing that the paradox may occur for proportional odds parameters between 1/9 and 9. Thus, large effects are needed to ensure that if treatment appears better by the Mann-Whitney parameter, then treatment improves responses in most individuals. We demonstrate these issues using a vaccine trial.
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Affiliation(s)
- Michael P Fay
- Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
| | - Erica H Brittain
- Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
| | - Joanna H Shih
- Biometric Research Branch, DCTD, National Cancer Institute, Rockville, MD, USA
| | - Dean A Follmann
- Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
| | - Erin E Gabriel
- Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden
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