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  1. Article: Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID).

    Jin, Xinyao / Pang, Bo / Zhang, Junhua / Liu, Qingquan / Yang, Zhongqi / Feng, Jihong / Liu, Xuezheng / Zhang, Lei / Wang, Baohe / Huang, Yuhong / Josephine Fauci, Alice / Ma, Yuling / Soo Lee, Myeong / Yuan, Wei'an / Xie, Yanming / Tang, Jianyuan / Gao, Rui / Du, Liang / Zhang, Shuo /
    Qi, Hanmei / Sun, Yu / Zheng, Wenke / Yang, Fengwen / Chua, Huizi / Wang, Keyi / Ou, Yi / Huang, Ming / Zhu, Yan / Yu, Jiajie / Tian, Jinhui / Zhao, Min / Hu, Jingqing / Yao, Chen / Li, Youping / Zhang, Boli

    Engineering (Beijing, China)

    2020  Volume 6, Issue 10, Page(s) 1147–1152

    Abstract: Since its outbreak in December 2019, a series of clinical trials on coronavirus disease 2019 (COVID ... outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was ... identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID ...

    Abstract Since its outbreak in December 2019, a series of clinical trials on coronavirus disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) Handbook: Version 1.0, a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine (TCM), evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (www.chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019 novel coronavirus (2019-nCoV) reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO
    Keywords covid19
    Language English
    Publishing date 2020-03-18
    Publishing country China
    Document type Journal Article
    ZDB-ID 2886869-9
    ISSN 2095-8099
    ISSN 2095-8099
    DOI 10.1016/j.eng.2020.03.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)

    Jin, Xinyao / Pang, Bo / Zhang, Junhua / Liu, Qingquan / Yang, Zhongqi / Feng, Jihong / Liu, Xuezheng / Zhang, Lei / Wang, Baohe / Huang, Yuhong / Josephine Fauci, Alice / Ma, Yuling / Soo Lee, Myeong / Yuan, Wei'an / Xie, Yanming / Tang, Jianyuan / Gao, Rui / Du, Liang / Zhang, Shuo /
    Qi, Hanmei / Sun, Yu / Zheng, Wenke / Yang, Fengwen / Chua, Huizi / Wang, Keyi / Ou, Yi / Huang, Ming / Zhu, Yan / Yu, Jiajie / Tian, Jinhui / Zhao, Min / Hu, Jingqing / Yao, Chen / Li, Youping / Zhang, Boli

    Engineering, In Press

    2020  

    Abstract: Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID ... outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was ... determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one ...

    Abstract Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.
    Keywords Core outcome set ; COVID-19 ; Clinical trials ; 2019-nCoV ; Coronavirus disease ; covid19
    Language English
    Publishing country de
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article: Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)

    Jin, Xinyao / Pang, Bo / Zhang, Junhua / Liu, Qingquan / Yang, Zhongqi / Feng, Jihong / Liu, Xuezheng / Zhang, Lei / Wang, Baohe / Huang, Yuhong / Josephine Fauci, Alice / Ma, Yuling / Soo Lee, Myeong / Yuan, Wei039 / an, / Xie, Yanming / Tang, Jianyuan / Gao, Rui / Du, Liang /
    Zhang, Shuo / Qi, Hanmei / Sun, Yu / Zheng, Wenke / Yang, Fengwen / Chua, Huizi / Wang, Keyi / Ou, Yi / Huang, Ming / Zhu, Yan / Yu, Jiajie / Tian, Jinhui / Zhao, Min / Hu, Jingqing / Yao, Chen / Li, Youping / Zhang, Boli

    Abstract: Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID ... outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was ... determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one ...

    Abstract Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #9250
    Database COVID19

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  4. Article ; Online: Core outcomes sets for studies evaluating critical illness and patient recovery.

    Dinglas, Victor D / Cherukuri, Sai P S / Needham, Dale M

    Current opinion in critical care

    2020  Volume 26, Issue 5, Page(s) 489–499

    Abstract: ... outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19 ... with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19 ... Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve ...

    Abstract Purpose of review: Given the growing body of critical care clinical research publications, core outcome sets (COSs) are important to help mitigate heterogeneity in outcomes assessed and measurement instruments used, and have potential to reduce research waste. This article provides an update on COS projects in critical care medicine, and related resources and tools for COS developers.
    Recent findings: We identified 28 unique COS projects, of which 15 have published results as of May 2020. COS topics relevant to critical care medicine include mechanical ventilation, cardiology, stroke, rehabilitation, and long-term outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19), with a 'meta-COS' summarizing common outcomes across these projects. To help facilitate COS development, there are existing resources, standards, guidelines, and tools available from the Core Outcome Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve LTO project (www.improvelto.com/).
    Summary: Many COS projects have been completed in critical care, with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19, critical care rehabilitation, and patient recovery and LTOs. Extensive resources are accessible to help facilitate rigorous COS development.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Cardiology ; Coronavirus Infections ; Critical Illness ; Delphi Technique ; Humans ; Pandemics ; Pneumonia, Viral ; Research Design ; Respiration, Artificial ; SARS-CoV-2 ; Stroke Rehabilitation
    Keywords covid19
    Language English
    Publishing date 2020-08-06
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 1235629-3
    ISSN 1531-7072 ; 1070-5295
    ISSN (online) 1531-7072
    ISSN 1070-5295
    DOI 10.1097/MCC.0000000000000750
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Core outcomes sets for studies evaluating critical illness and patient recovery

    Dinglas, Victor D / Cherukuri, Sai P S / Needham, Dale M

    Curr Opin Crit Care

    Abstract: ... outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19 ... with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19 ... Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve ...

    Abstract PURPOSE OF REVIEW: Given the growing body of critical care clinical research publications, core outcome sets (COSs) are important to help mitigate heterogeneity in outcomes assessed and measurement instruments used, and have potential to reduce research waste. This article provides an update on COS projects in critical care medicine, and related resources and tools for COS developers. RECENT FINDINGS: We identified 28 unique COS projects, of which 15 have published results as of May 2020. COS topics relevant to critical care medicine include mechanical ventilation, cardiology, stroke, rehabilitation, and long-term outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19), with a 'meta-COS' summarizing common outcomes across these projects. To help facilitate COS development, there are existing resources, standards, guidelines, and tools available from the Core Outcome Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve LTO project (www.improvelto.com/). SUMMARY: Many COS projects have been completed in critical care, with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19, critical care rehabilitation, and patient recovery and LTOs. Extensive resources are accessible to help facilitate rigorous COS development.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #708833
    Database COVID19

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  6. Article ; Online: Core Outcomes Set for Trials in People With Coronavirus Disease 2019.

    Tong, Allison / Elliott, Julian H / Azevedo, Luciano Cesar / Baumgart, Amanda / Bersten, Andrew / Cervantes, Lilia / Chew, Derek P / Cho, Yeoungjee / Cooper, Tess / Crowe, Sally / Douglas, Ivor S / Evangelidis, Nicole / Flemyng, Ella / Hannan, Elyssa / Horby, Peter / Howell, Martin / Lee, Jaehee / Liu, Emma / Lorca, Eduardo /
    Lynch, Deena / Marshall, John C / Gonzalez, Andrea Matus / McKenzie, Anne / Manera, Karine E / McLeod, Charlie / Mehta, Sangeeta / Mer, Mervyn / Morris, Andrew Conway / Nseir, Saad / Povoa, Pedro / Reid, Mark / Sakr, Yasser / Shen, Ning / Smyth, Alan R / Snelling, Tom / Strippoli, Giovanni Fm / Teixeira-Pinto, Armando / Torres, Antoni / Turner, Tari / Viecelli, Andrea K / Webb, Steve / Williamson, Paula R / Woc-Colburn, Laila / Zhang, Junhua / Craig, Jonathan C / COVID-19-Core Outcomes Set (COS) Workshop Investigators

    2020  

    Abstract: ... to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019 ... OBJECTIVES: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous ... critically important outcomes to be consistently reported in coronavirus disease 2019 trials. ...

    Abstract OBJECTIVES: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. DESIGN: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. SETTING: International. SUBJECTS: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019. CONCLUSIONS: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.
    Keywords COVID-19-Core Outcomes Set (COS) Workshop Investigators ; Humans ; Pneumonia ; Viral ; Coronavirus Infections ; Research Design ; Adult ; Aged ; Middle Aged ; Health Services Accessibility ; Female ; Male ; Randomized Controlled Trials as Topic ; Pandemics ; Symptom Assessment ; Betacoronavirus ; Outcome Assessment ; Health Care ; covid19
    Language English
    Publisher Critical care medicine
    Publishing country uk
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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  7. Article ; Online: Core Outcomes Set for Trials in People With Coronavirus Disease 2019

    Tong, Allison / Elliott, Julian H. / Azevedo, Luciano Cesar / Baumgart, Amanda / Bersten, Andrew / Cervantes, Lilia / Chew, Derek P. / Cho, Yeoungjee / Cooper, Tess / Crowe, Sally / Douglas, Ivor S. / Evangelidis, Nicole / Flemyng, Ella / Hannan, Elyssa / Horby, Peter / Howell, Martin / Lee, Jaehee / Liu, Emma / Lorca, Eduardo /
    Lynch, Deena / Marshall, John C. / Matus Gonzalez, Andrea / McKenzie, Anne / Manera, Karine E. / McLeod, Charlie / Mehta, Sangeeta / Mer, Mervyn / Conway Morris, Andrew / Nseir, Saad / Povoa, Pedro / Reid, Mark / Sakr, Yasser / Shen, Ning / Smyth, Alan R. / Snelling, Tom / Strippoli, Giovanni FM / Teixeira-Pinto, Armando / Torres, Antoni / Turner, Tari / Viecelli, Andrea K. / Webb, Steve / Williamson, Paula R. / Woc-Colburn, Laila / Zhang, Junhua / Craig, Jonathan C. / COVID-19-Core Outcomes Set (COS) Workshop Investigators

    2020  

    Abstract: ... to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019 ... Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous ... critically important outcomes to be consistently reported in coronavirus disease 2019 trials. ...

    Abstract Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019.Design: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set.Setting: International.Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers).Interventions: None.Measurements: None.Main Results: Six themes were identified. “Responding to the critical and acute health crisis” reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. “Capturing different settings of care” highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. “Encompassing the full trajectory and severity of disease” was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). “Distinguishing overlap, correlation and collinearity” meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). “Recognizing adverse events” refers to the potential harms of new and evolving interventions. “Being cognizant of family and psychosocial wellbeing” reflected the pervasive impacts of coronavirus disease 2019.Conclusions: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.
    Keywords Critical Care and Intensive Care Medicine ; covid19
    Subject code 610
    Publishing date 2020-08-17
    Publisher Lippincott, Williams & Wilkins
    Publishing country uk
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article: Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)

    In Press

    2020  

    Abstract: Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID ... outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was ... determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one ...

    Abstract Since its outbreak in December 2019, a series of clinical trials on Coronavirus Disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) handbook (version 1.0), a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine, evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019-nCoV reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.
    Keywords COVID-19 ; 2019-nCoV ; Core outcome set ; Coronavirus disease ; Clinical trials
    Language English
    Document type Article
    Database Repository for Life Sciences

    Full text online

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