Background: Outcome measurement is essential to progress clinical practice and improve patient care.
Aim: To develop a Core Outcome Set for best care for the dying person.
Design: We followed the Core Outcome Measures in Effectiveness Trials (COMET) Initiative guidelines, which involved identifying potential outcomes via a systematic literature review (n = 619 papers) and from participants in the "iLIVE" project (10 countries: 101 patients, 37 family members, 63 clinicians), followed by a two-round Delphi study, and a consensus meeting.
: Core outcome sets (COS) represent agreed-upon minimum outcomes that should be reported in all studies in a given topic area. Cochrane reviews are considered among the most rigorously conducted systematic reviews (SRs). In 2019, seven of the first 100 published Cochrane SRs (7%) cited a COS in relation to choosing outcomes.
View Article and Find Full Text PDFFindings from individual trials of physical rehabilitation interventions in critically ill adults have limited potential for meta-analysis and informing clinical decision-making because of the heterogeneity in selection and reporting of outcomes used for evaluation. The objective of this study was to determine a core outcome set (COS) for use in all future trials evaluating physical rehabilitation interventions delivered across the critical illness continuum of recovery. An international, two-round, online, modified Delphi consensus process, following recommended standards, was conducted.
View Article and Find Full Text PDFBackground: Digital technologies, such as wearable devices and smartphone applications (apps), can enable the decentralisation of clinical trials by measuring endpoints in people's chosen locations rather than in traditional clinical settings. Digital endpoints can allow high-frequency and sensitive measurements of health outcomes compared to visit-based endpoints which provide an episodic snapshot of a person's health. However, there are underexplored challenges in this emerging space that require interdisciplinary and cross-sector collaboration.
View Article and Find Full Text PDFObjectives: To compare the outcomes selected for the same condition in core outcome sets (COSs) for research with those in COS for the routine care setting.
Methods: A sample of COS was created from the most frequent five health areas within previous systematic reviews of COS for research and COS for routine care. Outcomes were extracted and categorized using an outcome taxonomy.
Core outcome set (COS) development and use enhances comparability of research findings. It may also enhance the translation of research into practice and reduce research waste. However, there is limited involvement of stakeholders from low- and middle-income countries (LMICs) in COS development and use.
View Article and Find Full Text PDFThe primary objective of this systematic review was to describe the number and type of heading descriptors used in all published studies which report on heading incidence in football. The secondary objective was to detail the data collection and reporting methods used in the included studies to present heading incidence data. Eligible studies were identified through searches of five electronic databases: Ovid MEDLINE, CINAHL, EMBASE, SPORTDiscus, and Web of Science, using a combination of free-text keywords (inception to 12th September 2023).
View Article and Find Full Text PDFObjectives: In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS.
Study Design And Setting: We examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS.
Objectives: A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in specific areas of health or health care. A COS is developed through a consensus process to ensure health care outcomes to be measured are relevant to decision-makers, including patients and health-care professionals. Use of COS in guideline development is likely to increase the relevance of the guideline to those decision-makers.
View Article and Find Full Text PDFBackground: Trial method research produces recommendations on how to best conduct trials. However, findings are not routinely implemented into practice. To better understand why, we conducted a mixed method study on the challenges of implementing trial method research findings into UK-based clinical trial units.
View Article and Find Full Text PDFObjectives: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials.
View Article and Find Full Text PDFEur Respir J
March 2024
The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition.
View Article and Find Full Text PDFBackground: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community.
Methods: The PRIMORANT study had three phases.
Background: Healthcare systems data (HSD) has the potential to optimise the efficiency of randomised controlled trials (RCTs), by decreasing trial-specific data demands. Therefore, the use of HSD in trials is expected to increase. In 2019, it was estimated that 47% of NIHR-funded trials were planning to use HSD.
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