scholarly journals ERS Statement: A core outcome set for clinical trials evaluating the management of chronic obstructive pulmonary disease (COPD) exacerbations

2021 ◽  
pp. 2102006
Author(s):  
Alexander G. Mathioudakis ◽  
Fekri Abroug ◽  
Alvar Agusti ◽  
Sachin Ananth ◽  
Per Bakke ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Health Professionals ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Copd Exacerbations ◽  
The Core ◽  
Arterial Blood ◽  
Outcome Set

Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritized for inclusion in the core outcome set through a two-round Delphi survey that was completed by 1,063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in 5 continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to (i) finalize the core outcome set and (ii) prioritize a single measurement instrument to be used for evaluating each of the prioritized outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for in all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, need for higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimize some of the selected measurement instruments. The panel did not consider the prioritized set of outcomes and associated measurement instruments burdensome for patients and health professionals to use.

scholarly journals Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

2019 ◽  
Vol 5 (2) ◽  
pp. 00072-2019 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Mia Moberg ◽  
Julie Janner ◽  
Pablo Alonso-Coello ◽  
Jørgen Vestbo
Keyword(s):  
Outcome Measures ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Core Outcome ◽  
Copd Exacerbations ◽  
Outcome Set ◽  
Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

scholarly journals Core Outcome Set for Clinical Trials of COVID-19 based on Traditional Chinese and Western Medicine

2020 ◽  
Author(s):  
Ruijin Qiu ◽  
Chen Zhao ◽  
Tengxiao Liang ◽  
Xuezeng Hao ◽  
Ya Huang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Western Medicine ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Oxygen Intake ◽  
Inflammatory Factor ◽  
Core Outcome ◽  
Arterial Blood ◽  
Outcome Set ◽  
Factor C

AbstractBackgroundDevelopment of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials.MethodsA preliminary list of outcomes were developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Frontline clinicians, as well as nurse, methodologist, evidence based-medicine researcher, and staff from the Chinese Clinical Trials Registry participated by video conference to vote.ResultsNinety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS include clinical outcomes (recovery/improvement/progression/death), etiology (SARS-CoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (Pulmonary imaging, blood oxygen saturation, PaO2/FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instrument/definition were also recommended.ConclusionA COS for COVID-19 may improve consistency of outcome reporting in clinical trials.

scholarly journals Health Literacy and Health Outcomes in Patients with Low Back Pain – A Scoping Review

2021 ◽  
Author(s):  
Clarence Ye King See ◽  
Helen Elizabeth Smith ◽  
Lorainne Tudor Car ◽  
Joanne Protheroe ◽  
Wei Cong Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Back Pain ◽  
Back Pain ◽  
Health Literacy ◽  
Health Outcomes ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Low Back ◽  
The Core ◽  
Outcome Set

Abstract BACKGROUND: The World Health Organisation highlights low back pain as a leading and growing cause of disability worldwide. In the field of chronic pain, higher health literacy is linked to lower pain intensity and better pain control. However, there remains a paucity of evidence, with a recent systematic review finding only three studies meeting its inclusion criteria. OBJECTIVES: This scoping review had two objectives in exploring research in chronic back pain, which were to identify:1) The health literacy measures currently employed for back pain and the aspects of health literacy they include.2) The back-pain health outcomes included in such work and the extent to which these reflect the core outcome set for clinical trials in non-specific low back pain.METHODS: The search broadened the search strategy used in the systematic review, with the eligibility criteria defined by the Joanna Briggs Institute PCC mnemonic, namely: · Population – Patients with LBP (≥ 10% of study population), of any age, gender, or race· Concept – Relationship of LBP health outcomes to HL· Context – Any healthcare setting, in any geographical settingIt was conducted using thirteen bibliographic databases, employing medical subject heading (MeSH) terms for low back pain and health literacy, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A thematic framework approach was used for analysis.RESULTS: The search yielded ten relevant studies for inclusion, amongst which a total of nine health literacy measures and 50 health outcome measures were used. The health outcomes assessed by the included studies could be broadly categorised into: Pain, Disability, Behaviour, Knowledge and Beliefs, and Resource Utilisation. Most outcome measures employed (36 out of 50) were not directly relevant to addressing the core outcome set for clinical trials in non-specific low back pain.CONCLUSIONS: A dearth of studies in this field of research was noted, especially in Asia and low-middle income countries. Methodological limitations were identified, including in study design and outcome measures. To allow for comparison across findings and the development of a rigorous evidence base, future work should include the core outcome set for clinical trials in non-specific low back pain. Furthermore, research thus far has focused on a narrow range of populations and there is an urgent need to broaden the evidence-base to include those with characteristics known to be moderators in health outcomes. Such work demands the incorporation of comprehensive measures of health literacy that have both generic and culturally sensitive components.

scholarly journals Health Literacy and Health Outcomes in Patients with Back Pain – A Scoping Review

2020 ◽  
Author(s):  
Clarence Ye King See ◽  
Helen Elizabeth Smith ◽  
Lorainne Tudor Car ◽  
Joanne Protheroe ◽  
Wei Cong Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Back Pain ◽  
Back Pain ◽  
Health Literacy ◽  
Health Outcomes ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Low Back ◽  
The Core ◽  
Outcome Set

Abstract BACKGROUND: The World Health Organisation highlights back pain as a leading and growing cause of disability worldwide. In the field of chronic pain, higher health literacy is linked to lower pain intensity and better pain control. However, there remains a paucity of evidence, with a recent systematic review finding only three studies meeting its inclusion criteria. OBJECTIVES: This scoping review had two objectives in exploring research in chronic pain, which were to identify:1) The health literacy measures currently employed. 2) The back-pain health outcomes included in such work and the extent to which these reflect the core outcome set for clinical trials in non-specific low back pain.METHODS: The search broadened the search strategy used in the systematic review. It was conducted using thirteen bibliographic databases, employing medical subject heading (MeSH) terms for back pain and health literacy, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A thematic framework approach was used for analysis.RESULTS: The search yielded ten relevant studies for inclusion, amongst which a total of nine health literacy measures and 50 health outcome measures were used. The health outcomes assessed by the included studies could be broadly categorised into: Pain, Disability, Behaviour, Knowledge and Beliefs, and Resource Utilisation. Most outcome measures employed (36 out of 50) were not directly relevant to addressing the core outcome set for clinical trials in non-specific low back pain.CONCLUSIONS: A dearth of studies in this field of research was noted, especially in Asia and low-middle income countries. Methodological limitations were identified, including in study design and outcome measures. To allow for comparison across findings and the development of a rigorous evidence base, future work should include the core outcome set for clinical trials in non-specific low back pain. Furthermore, research thus far has focused on a narrow range of populations and there is an urgent need to broaden the evidence-base to include those with characteristics known to be moderators in health outcomes. Such work demands the incorporation of comprehensive measures of health literacy that have both generic and culturally sensitive components.

scholarly journals Developing a core outcome set for future infertility research: an international consensus development study†‡

2020 ◽  
Vol 35 (12) ◽  
pp. 2725-2734 ◽  
Author(s):  
J M N Duffy ◽  
H AlAhwany ◽  
S Bhattacharya ◽  
B Collura ◽  
C Curtis ◽  
...  
Keyword(s):  
Medical Research ◽  
Live Birth ◽  
Systematic Reviews ◽  
Core Outcome Set ◽  
Human Reproduction ◽  
Core Outcome ◽  
Consensus Development ◽  
The Core ◽  
Outcome Set ◽  
Fertility Problems

Abstract STUDY QUESTION Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S) This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER Core Outcome Measures in Effectiveness Trials Initiative: 1023.

scholarly journals Development of a Core Outcome Set for Clinical Trials of Traditional Chinese Medicine in Lung Cancer: a Study Protocol

2021 ◽  
Author(s):  
Mingyan Zhang ◽  
Hui Zi Chua ◽  
Bohan Niu ◽  
Kai Li ◽  
Junhua Zhang
Keyword(s):  
Lung Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Stakeholder Groups ◽  
The Core ◽  
Outcome Set

Abstract Background: Lung cancer (LC) is currently the leading cause of cancer death globally. LC accounts for a high mortality and incidence rate of cancer in both men and women. Radiotherapy and chemotherapy, though effective for some patients, have strong side effects and most of them only have palliative effect. Though many studies reported the effectiveness of traditional Chinese medicine (TCM) treatment on LC, the lack of methodological quality in clinical trials resulted in heterogeneous reporting of outcomes, making it difficult to compare and combine in different trials, limiting the validity of meta-analysis and reducing the value of clinical studies. A core outcome set (COS) could reduce outcome reporting bias and heterogeneity across studies of LC using TCM-related interventions. The aim of this study is to develop a standardized COS for LC in TCM clinical trials (COS-TCM-LC) to improve the methodological quality of TCM clinical studies to serve as a guidance in healthcare decision making for LC.Methods: The study has been developed according to the Core Outcome Set-STAandards for Development standards for the design of a COS study. The study process consisted 4 stages as follows: (1) Identifying a list of potential outcomes through systematic reviews of TCM RCTs and 2 clinical registry databases, qualitative surveys on patients and healthcare professionals to form an outcome pool and finally establishing a preliminary checklist of outcomes. (2) Selection of stakeholder groups. (3) Representatives of stakeholder groups will be invited to participate in a two-round Delphi survey. (4) A face-to-face consensus meeting will be held to determine the final COS-TCM-LC.Discussion: In this study protocol, we have followed the guidelines of COS-STAndardized Protocol (STAP) statement and checked the items in COS-STAndards for Developement (STAD). Developing a COS-TCM-LC will improve the quality of future RCTs on LC with the TCM interventions and promote better evidence-based clinical decision-making.Trial registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1483 (http://www.comet-initiative.org/studies/details/1483).

scholarly journals Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

2021 ◽  
Vol 8 ◽  
Author(s):  
Ruijin Qiu ◽  
Songjie Han ◽  
Xuxu Wei ◽  
Changming Zhong ◽  
Min Li ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Adverse Events ◽  
Health Professionals ◽  
Core Outcome Set ◽  
Essential Medicines ◽  
Core Outcome ◽  
Outcome Set

Aims: To identify a minimum set of efficacy and adverse events for patients with acute heart failure (AHF) among different stakeholders in clinical trials of traditional Chinese medicine and Western medicine.Methods and Analysis: First, we will develop a preliminary long list of outcomes that includes efficacy and adverse events/reactions via three steps: (i) systematic reviews of efficacy and safety outcomes for clinical trials of AHF; (ii) drugs included in the National Medical Insurance Catalog, the National Essential Medicines Catalog, and the WHO Essential Medicines List will be collected and safety outcomes extracted from the package inserts; and (iii) patients' or caregivers' semi-structured interviews will be carried out to add new viewpoints to the list. Second, after merging outcomes and grouping them under different outcome domains, questionnaires for health professionals and patients will be separately developed. Further, two rounds of Delphi survey for health professionals and a survey for patients and the public will be carried out. Third, different stakeholders will discuss and determine the final core outcome set (COS) for AHF in a consensus meeting.Ethics and Dissemination: The entire project has been approved by the Ethics Committee of the main institution. After the final COS is developed, it will be published and discussed widely in conferences.Clinical Trial Registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1566 (available at: https://www.cometinitiative.org/Studies/Details/1566).

scholarly journals Health literacy and health outcomes in patients with low back pain: a scoping review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ye King Clarence See ◽  
Helen Elizabeth Smith ◽  
Lorainne Tudor Car ◽  
Joanne Protheroe ◽  
Wei Cong Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Back Pain ◽  
Back Pain ◽  
Health Literacy ◽  
Health Outcomes ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Low Back ◽  
The Core ◽  
Outcome Set

Abstract Background Low back pain is a leading cause of disability worldwide. Health literacy has been associated with pain intensity and pain control. However, there is a paucity of evidence regarding this association. In the field of low back pain research, inconsistent reporting of outcomes has been highlighted. To address this issue a Core Outcome Set has been developed. Objectives The objectives of this scoping review were: (1) The health literacy measures currently employed for low back pain and the aspects of health literacy they include. (2) The low back pain health outcomes included in such work. (3) The extent to which these health outcomes reflect the Core Outcome Set for Clinical Trials in Non-Specific Low Back Pain. Methods The search included thirteen bibliographic databases, using medical subject heading terms for low back pain and health literacy, and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. The eligibility criteria were defined by the Joanna Briggs Institute PCC mnemonic. A thematic framework approach was used for analysis. Results The search yielded ten relevant studies for inclusion, amongst which a total of nine health literacy measures and 50 health outcome measures were used. Most health literacy measures focused on functional health literacy, with few assessing communicative and critical health literacy. The health outcomes assessed by the included studies could be broadly categorised into: Pain, Disability, Behaviour, Knowledge and Beliefs, and Resource Utilisation. Most of these outcome measures studied (36 out of 50) did not directly reflect the Core Outcome Set for Clinical Trials in Non-Specific Low Back Pain. Conclusions To allow for comparison across findings and the development of a rigorous evidence base, future work should include the Core Outcome Set for Clinical Trials in Non-Specific Low Back Pain. There is an urgent need to broaden the evidence-base to include regions where low back pain morbidity is high, but data is lacking. Such work demands the incorporation of comprehensive measures of health literacy that have both generic and culturally sensitive components.

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