scholarly journals Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
V. Shepherd ◽  
F. Wood ◽  
M. Robling ◽  
E. Randell ◽  
K. Hood
Keyword(s):  
Decision Making ◽  
Outcome Measures ◽  
Scoping Review ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Additional Patient ◽  
Trial Participation ◽  
Core Outcome ◽  
Outcome Set

Abstract Background Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation. Methods We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020. Results A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting. Conclusions The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies’ experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement. Trial registration The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

scholarly journals Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

2021 ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Michael Robling ◽  
Elizabeth Randell ◽  
Kerenza Hood
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Additional Patient ◽  
Trial Participation ◽  
Core Outcome ◽  
Capacity To Consent ◽  
Outcome Set ◽  
Participation Decisions

Abstract BackgroundTrials involving adults who lack capacity to provide consent for themselves rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Following decades of innovations to improve informed consent in trials, the first interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measurement in the evaluation of these novel interventions will impede comparisons between their effectiveness. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation on behalf of adults who lack capacity to consent.MethodsWe used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.ResultsA total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items. Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group. We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.ConclusionsThe study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. Further work is required to identify appropriate measures and timing of outcome measurement. Enhancing the quality of proxy decisions will help improve trial participation decisions for these vulnerable groups. Trial registration: The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

scholarly journals The outcomes of Perthes’ disease

2020 ◽  
Vol 102-B (5) ◽  
pp. 611-617
Author(s):  
Donato G. Leo ◽  
Helen Jones ◽  
Rebecca Murphy ◽  
Justin Wei Leong ◽  
Tina Gambling ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Research ◽  
Qualitative Interviews ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Perthes Disease ◽  
Core Outcome ◽  
Outcome Set ◽  
Life Impact

Aims To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. Methods The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents. Results In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). Conclusion Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes’ disease. Cite this article: Bone Joint J 2020;102-B(5):611–617.

scholarly journals Developing a core outcome set for children with protracted bacterial bronchitis

2020 ◽  
Vol 6 (1) ◽  
pp. 00344-2019
Author(s):  
Francis J. Gilchrist ◽  
Imran Ali ◽  
Malcolm Brodlie ◽  
Will D. Carroll ◽  
Bridget Kemball ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Respiratory Pathogen ◽  
Core Outcome ◽  
Potential Core ◽  
Outcome Set ◽  
Protracted Bacterial Bronchitis ◽  
Wet Cough

BackgroundProtracted bacterial bronchitis (PBB) is a chronic endobrochial infection and a leading cause of chronic wet cough in children. There is an urgent need for a randomised controlled trial to investigate the optimal treatment but there is no core outcome set (COS) to inform choice of outcomes. A COS is a standardised set of outcomes representing the minimum that should be measured and reported in clinical trials of a specific condition. We have developed a COS for PBB.MethodsPotential core outcomes were collated from a systematic review, interviews with parents and a clinician survey. A two-round Delphi survey of healthcare professionals identified which outcomes had consensus for inclusion. The final COS was agreed at a consensus meeting of parent representatives and clinicians.Results20 outcomes were identified for the Delphi survey. After two rounds, 10 reached consensus. These were combined and edited at the consensus meeting into the final six: 1) Resolution of cough assessed using a cough score/diary recorded daily by parent(s) during treatment; 2) relapse of chronic wet cough and/or cumulative antibiotic treatment during ≥12 months follow-up; 3) change in child's quality of life (parent-proxy reporting for young children); 4) emergence of antibiotic resistance; 5) development of bronchiectasis diagnosed on clinically indicated computed tomography scans; and 6) microbiological clearance of identified respiratory pathogen if samples readily available.ConclusionsWe have developed a COS for PBB which will reduce the outcome heterogeneity and bias of future clinical trials, as well as promoting comparison between studies.

scholarly journals A Core Outcome Set to Evaluate Physical Activity Interventions for People Living With Dementia

2019 ◽  
Author(s):  
Ana-Carolina Gonçalves ◽  
Dinesh Samuel ◽  
Mary Ramsay ◽  
Sara Demain ◽  
Alda Marques
Keyword(s):  
Physical Activity ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Core Outcome ◽  
Card Sorting ◽  
Modified Delphi ◽  
Outcome Set ◽  
Group 2 ◽  
The Moment

Abstract Background and Objectives A core outcome set (COS) to evaluate physical activity (PA) interventions for people living with dementia is needed, as the development of guidelines is currently limited by important heterogeneity in this field of research. Development of COS often includes Delphi surveys, but people living with dementia are often excluded. This study aimed to reach consensus on this COS using a modified Delphi survey to enable the participation of people living with dementia. Research Design and Methods Two stakeholders groups took part in a Delphi survey (Group 1: people living with dementia and family caregivers; Group 2: professionals from different backgrounds, including physiotherapists, occupational therapists, and researchers). Caregivers and professionals completed the survey remotely. Participants living with dementia took part face-to-face, using a card sorting strategy. The consensus process was finalized with a consensus meeting. Results Ninety-five participants of both groups completed the modified Delphi. Of those, 11 attended the consensus meeting. The card sorting strategy was successful at including people living with dementia. Seven outcomes reached consensus: preventing falls; doing what you can do; staying healthy and fit; walking better, being able to stand up and climb stairs; feeling brighter; enjoying the moment; and, feeling useful and having a purpose. Discussion and Implications Robust and innovative methodological strategies were used to reach a consensus on a COS (what to measure) to evaluate PA for people living with dementia. Future work will focus on the selection of the most appropriate tools to measure these outcomes (how to measure).

scholarly journals Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcus Bateman ◽  
Jonathan P. Evans ◽  
Viana Vuvan ◽  
Val Jones ◽  
Adam C. Watts ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Health Care Professionals ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Outcome Evaluation ◽  
Core Outcome ◽  
Outcome Set ◽  
Lateral Elbow ◽  
Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

scholarly journals Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need

2021 ◽  
Vol 8 (1) ◽  
pp. e000529
Author(s):  
Lisa N Guo ◽  
Lourdes M Perez-Chada ◽  
Robert Borucki ◽  
Vinod E Nambudiri ◽  
Victoria P Werth ◽  
...  
Keyword(s):  
Disease Activity ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Core Outcome Set ◽  
Cutaneous Lupus Erythematosus ◽  
Core Outcome ◽  
Outcome Set ◽  
Starting Point ◽  
Cutaneous Lupus

ObjectiveThe lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies.MethodsWe conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined.ResultsProposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument.ConclusionThis work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.

scholarly journals How to evaluate the clinical outcome of joint-preserving treatment for osteonecrosis of the femoral head: development of a core outcome set

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Zhipeng Xue ◽  
Jigao Sun ◽  
Taixian Li ◽  
Zeqing Huang ◽  
Weiheng Chen
Keyword(s):  
Femoral Head ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Walking Distance ◽  
Core Outcome ◽  
Outcome Indicators ◽  
X Ray ◽  
Outcome Set ◽  
Core Outcomes ◽  
Hip Flexion

Abstract Background This study aimed to develop a core outcome set (COS) for clinical trials of joint-preserving treatment for osteonecrosis of the femoral head (ONFH), that is, to define a minimal set of outcomes that should be reported in such trials. Methods A mixed research method was adopted in this study. First, clinical trials of hip preservation therapy were systematically researched and analyzed. Second, a three-round Delphi survey involving both doctors and patients was carried out to obtain the core outcome indicators. Round 1 was a modified Delphi questionnaire for doctors and patients to determine which outcomes are important to these stakeholders, round 2 determined what clinical evaluation core outcomes should be included for the joint-preserving treatment of ONFH, and round 3 determined how core outcomes should be measured. Finally, a consensus meeting was held to discuss and vote on the established COS. Results The results of the systematic review showed that 42 outcome indicators were classified according to common signs and symptoms, quality of life, long-term outcomes, radiological evaluation, blood biochemistry, and indexes of safety. The three rounds of Delphi surveys completed the selection of indicators for the COS and the determination of the corresponding measurements. A total of 73 orthopedic doctors and 103 patients participated in round 1, and the top 10 indicators selected were basically the same. In round 2, 32 experts identified the following indicators: pain, range of motion (ROM) of hip flexion, walking distance, and stable rating of X-ray images. In round 3, 35 experts defined the measurement of each indicator. Finally, the consensus meeting identified the four indicators aforementioned that constituted the COS. The scores for pain, ROM of hip flexion, and walking distance are from 0 to 10; 0 represents the best scores, while 10 represents the most serious impairment. The stable rating of X-ray images is determined by the morphology of the femoral head and the change in the density of the necrotic area. Conclusions We established a COS for hip-preserving treatment of ONFH that includes four indicators: pain, ROM of hip flexion, walking distance, and stable rating of X-ray images.

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.

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