Core outcome measurement instruments for use in clinical and research settings for adults with post-COVID-19 condition: an international Delphi consensus study.

Post-COVID-19 condition (also known as long COVID) is a new, complex, and poorly understood disorder. A core outcome set (COS) for post-COVID-19 condition in adults has been developed and agreement is now required on the most appropriate measurement instruments for these core outcomes. We conducted an international consensus study involving multidisciplinary experts and people with lived experience of long COVID.

Patient participation impacts outcome domain selection in core outcome sets for research: an updated systematic review.

Objectives: The importance of including patients, carers, and the public in health research is well recognized, including the need to consider outcomes in health care research that reflect the priorities of patients. Core outcome sets (COS) define the minimum set of outcomes that should be measured and reported in research of a given condition, determined through consensus among key stakeholders. The Core Outcome Measures in Effectiveness Trials Initiative undertakes an annual systematic review (SR) to identify newly published COS to update its online database of COS for research.

Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis.

Objective: To compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition.

Design: Cross sectional analysis.

Setting: US and Europe.

Identifying a core outcome set for pulmonary sarcoidosis research - the Foundation for Sarcoidosis Research - Sarcoidosis Clinical OUtcomes Taskforce (SCOUT).

Background: Pulmonary sarcoidosis is a rare granulomatous disease of unknown aetiology. Heterogeneity in the outcomes measured in trials of treatment for pulmonary sarcoidosis has impacted on the ability to systematically compare findings, contributing to research inefficiency. The FSR-SCOUT study has aimed to address this heterogeneity by developing a core outcome set that represents a patient and health professional consensus on the most important outcomes to measure in future research for the treatment of pulmonary sarcoidosis.

A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study.

Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS).

Studying the post-COVID-19 condition: research challenges, strategies, and importance of Core Outcome Set development.

Background: A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden.

Main Text: While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure.

Scout - sarcoidosis outcomes taskforce. A systematic review of outcomes to inform the development of a core outcome set for pulmonary sarcoidosis.

Background: Clinical trials evaluating different management strategies for pulmonary sarcoidosis may measure different outcomes. This heterogeneity in outcomes can lead to waste in research due to the inability to compare and combine data. Core outcome sets (COS) have the potential to address this issue and here we describe a systematic review of outcomes as the first step in the development of a COS for pulmonary sarcoidosis research.

Inclusion of participants from low-income and middle-income countries in core outcome sets development: a systematic review.

Objective: Our study aims to describe differences or similarities in the scope, participant characteristics and methods used in core outcome sets (COS) development when only participants from high-income countries (HICs) were involved compared with when participants from low-income and middle-income countries (LMICs) were also involved.

Design: Systematic review.

Data Sources: Annual Core Outcome Measures in Effectiveness Trials systematic reviews of COS which are updated based on SCOPUS and MEDLINE, searches.

More than half of systematic reviews have relevant core outcome sets.

Objectives: Using recent systematic reviews (SRs), our objectives were to: (1) develop a framework to assess whether a given COS is relevant to the scope of a SR; (2) examine the proportion of SRs for which relevant COS exist; and (3) for SRs for which COS exist, examine the extent to which outcomes in the COS and outcomes in the SR match.

Study Design And Setting: We included a sample of SRs published by the Agency for Healthcare Research and Quality Evidence-based Practice Center Program between January 1, 2018 and October 12, 2020. We searched for potentially relevant COS from the Core Outcome Measures for Effectiveness Trials (COMET) database.

Patient-reported outcome measures in core outcome sets targeted overlapping domains but through different instruments.

Objective: There is no comprehensive assessment of which patient-reported outcomes (PROs) are recommended in core outcome sets (COS), and how they should be measured. The aims of this study are to review COS that include patient-reported outcomes measures (PROMs), identify their target health domains, main characteristics, and their overlap within and across different disease areas.

Study Design And Setting: We selected COS studies collected in a publicly available database that included at least one recommended PROM.

'It is good to have a target in mind': qualitative views of patients and parents informing a treat to target clinical trial in juvenile-onset systemic lupus erythematosus.

Objective: We sought to explore patient and parental views on treatment targets, outcome measures and study designs being considered for a future JSLE treat-to-target (T2T) study.

Methods: We conducted topic-guided, semistructured interviews with JSLE patients and parents and analysed the audio recorded interviews using thematic approaches.

Results: Patients and parents differed regarding symptoms they felt would be tolerable, representing 'low disease activity'.

Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research.

Background: An annual update to a systematic review of core outcome sets (COS) for research ensures that the COMET database is up-to-date. The aims of this study were to: (i) identify COS that were published or indexed in 2019 and to describe the methodological approaches used in these studies; (ii) investigate whether children have been included as participants in published COS development studies, and which methods have been used to facilitate their participation; iii) update a previous exercise to identify COS relevant to the most burdensome global diseases and injuries.

Methods: MEDLINE and SCOPUS were searched to identify studies published or indexed between (and inclusive of) January 2019 and December 2019.

Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review.

Objectives: A core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews ('reviews') are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to inform the choice of outcomes in Cochrane systematic reviews ('reviews') and investigates the views of the coordinating editors of Cochrane Review Groups (CRGs) on this topic.

Methods used in the selection of instruments for outcomes included in core outcome sets have improved since the publication of the COSMIN/COMET guideline.

Objectives: Once a core outcome set (COS) has been defined, it is important to achieve consensus on how these outcomes should be measured. The aims of this systematic review were to gain insight into the methods used to select outcome measurement instruments and to determine whether methods have improved following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)/Core Outcome Measures in Effectiveness Trials (COMET) guideline publication.

Study Design And Setting: Eligible articles, which were identified from the annual COMET systematic review, concerned any COS development studies that provided a recommendation on how to measure the outcomes included in the COS.

Ensuring young voices are heard in core outcome set development: international workshops with 70 children and young people.

Plain English Summary: Researchers test treatments to ensure these work and are safe. They do this by studying the effects that treatments have on patients by measuring outcomes, such as pain and quality of life. Often research teams measure different outcomes even though each team is studying the same condition.

Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research.

Background: A systematic review of core outcome sets (COS) for research is updated annually to populate an online database. It is a resource intensive review to do annually but automation techniques have potential to aid the process. The production of guidance and standards in COS development means that there is now an expectation that COS are being developed and reported to a higher standard.

Incorporating patients' perspectives into the initial stages of core outcome set development: a rapid review of qualitative studies of type 2 diabetes.

Conducting systematic reviews of qualitative studies to incorporate patient perspectives within the early stages of core outcome set (COS) development can be resource intensive. We aimed to identify an expedited approach to be used as part of the wider COS development process. Specifically, we undertook a rapid review of qualitative studies of patients' views and experiences of type 2 diabetes.

Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research.

Background: The Core Outcome Measures in Effectiveness Trials (COMET) database is a publically available, searchable repository of published and ongoing core outcome set (COS) studies. An annual systematic review update is carried out to maintain the currency of database content.

Methods: The methods used in the fourth update of the systematic review followed the same approach used in the original review and previous updates.

Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries.

Background: Core outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process.

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps.

Background: The COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further studies where a COS has been developed.

Improving the relevance and consistency of outcomes in comparative effectiveness research.

Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition.

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey.

Background: A COS represents an agreed minimum set of outcomes that should be measured and reported in all trials of a specific condition. The COMET (Core Outcome Measures in Effectiveness Trials) initiative aims to collate and stimulate the development and application of COS, by including data on relevant studies within a publically available internet-based resource. In recent years, there has been an interest in increasing the development of COS.

"It's sort of a lifeline": Chronic obstructive pulmonary disease patients' experiences of home telehealth.

Objective: Home telehealth can provide considerable benefits to people diagnosed with chronic obstructive pulmonary disease, yet 20% of patients abandon telehealth. Identifying the factors that affect whether or not a patient decides to continue using telehealth is therefore crucial to the goal of mainstreaming telehealth. However, studies to date have only assessed the perceptions of patients who are not currently using telehealth, have used telehealth in experimental sessions, or are enrolled in a trial.