Publications by authors named "Paula Williamson"

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.

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  • There is a lack of standard outcomes being measured in studies for adult epilepsy treatments, making it hard to assess their effectiveness.
  • As part of a project to create a Core Outcome Set, researchers analyzed 104 trials and found 374 unique outcome terms that fit into 45 different concepts, covering multiple areas like seizures and emotional functioning.
  • Most studies only measured 10 out of the 45 concepts frequently, reflecting a significant inconsistency in how outcomes are reported, which emphasizes the need for standardized outcomes in future epilepsy clinical trials.
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  • The study aimed to identify and prioritize the professional development needs of research methodologists in the UK, highlighting their significant role in health and care research.
  • An electronic Delphi survey, involving multiple rounds and input from stakeholders, revealed a total of 56 development aspects, leading to 25 prioritized areas after consensus meetings.
  • Key priorities include having supportive line managers, defined career pathways, recognition of their role, and sufficient time for training, which can guide individuals and employers in enhancing professional development strategies.
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  • Clinical trials, essential for healthcare, also significantly contribute to climate change; researchers have developed a method to calculate their carbon footprint and applied it to 10 UK and international trials.
  • Data on trial activities was collected from 10 trial units, evaluated for emission sources, and feedback was gathered on the carbon footprint calculation process.
  • The carbon footprints of the trials varied widely, highlighting key areas for emissions reduction, with suggestions to incorporate carbon footprint considerations during the trial design phase.
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: 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.

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  • The WHO's 2019 strategy focuses on enhancing research for snakebite treatments, particularly in South Asia, where the issue is most severe.
  • A Core Outcome Set (COS) was developed through a systematic review and Delphi surveys, involving healthcare providers, patients, and the public, to identify essential outcomes for snakebite research across five intervention groups.
  • The consensus achieved includes specific outcomes for managing reactions to antivenom and various manifestations caused by snake venom, which will help standardize research and improve efficiency in future studies.
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Findings 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.

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Background: 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.

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Objectives: 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.

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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.

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The 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).

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  • A systematic review was conducted to analyze how outcomes of meningioma clinical trials are measured and reported, addressing the lack of agreement on these measures.
  • The study reviewed 30 published articles and 18 ongoing trials, resulting in 47 clinical trials and 659 reported outcomes, which were grouped into unique terms using a standardized classification system.
  • The findings highlight the need for a more consistent approach to outcome measurement, leading to plans for a consensus meeting to create a core outcome set to guide future trials.
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  • A systematic review was conducted to analyze how outcomes are measured in studies of patients with incidental intracranial meningioma, as inconsistent practices have hindered comparative research.
  • The review included 33 published articles, resulting in 268 reported outcomes, which were refined to 178 unique outcomes categorized into 53 standardized terms and classified into 9 outcome domains.
  • The goal is to create a Core Outcome Set through stakeholder consensus, improving the consistency of outcome measurements in future studies.
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  • - The study investigates the availability and use of core outcome sets (COS) in relation to the top diseases affecting China, focusing on identifying whether existing COS align with ongoing clinical trials in the country.
  • - Methods include analyzing the COMET database for relevant COS, examining data from the Chinese Clinical Trial Registry for overlaps, and conducting surveys and interviews with clinical trial investigators to gauge their understanding and perceptions of COS.
  • - Findings aim to address knowledge gaps regarding COS and their relevance to prevalent diseases in China, ultimately enhancing the application of COS in future clinical research.
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  • The manuscript emphasizes the significance of increasing the adoption of Core Outcome Sets (COS) through collaboration and understanding the needs of various stakeholders.
  • A simulation format was used to engage eight Collaborator groups, highlighting the importance of COS and identifying barriers like lack of recommendations, inadequate patient involvement, and low awareness.
  • The findings advocate for COS development that includes patients and collaborators at all levels, calling for future research to investigate effective implementation and the role of validated instruments in improving COS uptake.
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Objectives: 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.

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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.

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Background: 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.

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Objectives: 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.

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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.

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Background: 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.

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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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  • The climate crisis has prompted the Low Carbon Clinical Trials Working Group to create a strategy aimed at reducing greenhouse gas emissions from clinical trials by measuring their carbon footprint.
  • They developed a process map to identify core activities in clinical trials and sourced emission factors to convert data into greenhouse gas emissions.
  • By applying this method to two clinical trials, they estimated their carbon footprints and provided guidance for future trials to identify areas for reducing emissions and improving methodology.
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