Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study)

Abstract BackgroundInternational stakeholder participation is important in the development of core outcome sets (COS). Stakeholders, however, may value health outcomes differently when regional differences are considered. Here, we explore how region, health income and participant characteristics influence prioritisation of outcomes during development of a COS for gastric cancer surgery trials (the GASTROS study).Methods952 participants from 55 countries participating in a Delphi survey during COS development were eligible for inclusion. Recruits were grouped according to region (East or West), country income classification (high and low-to-middle income) and other characteristics (e.g. patients; age, sex, time since surgery, mode of treatment, surgical approach and healthcare professionals; clinical experience). Groups were compared with respect to how they categorised outcomes (‘consensus in’, ‘consensus out’, ‘no consensus’). Outcomes categorised as ‘consensus in’ or ‘consensus out’ by all 3 stakeholder groups would be automatically included in or excluded from the COS respectively.ResultsIn total, 13 outcomes were categorised ‘consensus in’, 13 ‘consensus out’ and 31 ‘no consensus’. There was little variation in prioritisation of outcomes by stakeholders from Eastern or Western countries and high or low-to-middle income countries. There was little variation in outcome prioritisation within either health professional or patient groups.ConclusionOur study suggests that there is little variation in opinion within stakeholder groups when participant region and other characteristics are considered. This finding may help COS developers when designing their Delphi surveys and recruitment strategies. Further work across other clinical fields is needed before broad recommendations can be made.

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How are trial outcomes prioritised by stakeholders from different regions? Analysis of an international Delphi survey to develop a core outcome set in gastric cancer surgery

PLoS ONE ◽

10.1371/journal.pone.0261937 ◽

2021 ◽

Vol 16 (12) ◽

pp. e0261937

Author(s):

Bilal Alkhaffaf ◽

Aleksandra Metryka ◽

Jane M. Blazeby ◽

Anne-Marie Glenny ◽

Paula R. Williamson ◽

...

Keyword(s):

Gastric Cancer ◽

Intraoperative Complications ◽

Core Outcome Set ◽

Disease Free Survival ◽

Cancer Surgery ◽

Delphi Survey ◽

Core Outcome ◽

Middle Income ◽

Gastric Cancer Surgery ◽

Stakeholder Groups

Background International stakeholder participation is important in the development of core outcome sets (COS). Stakeholders from varying regions may value health outcomes differently. Here, we explore how region, health income and participant characteristics influence prioritisation of outcomes during development of a COS for gastric cancer surgery trials (the GASTROS study). Methods 952 participants from 55 countries participating in a Delphi survey during COS development were eligible for inclusion. Recruits were grouped according to region (East or West), country income classification (high and low-to-middle income) and other characteristics (e.g. patients; age, sex, time since surgery, mode of treatment, surgical approach and healthcare professionals; clinical experience). Groups were compared with respect to how they categorised 56 outcomes identified as potentially important to include in the final COS (‘consensus in’, ‘consensus out’, ‘no consensus’). Outcomes categorised as ‘consensus in’ or ‘consensus out’ by all 3 stakeholder groups would be automatically included in or excluded from the COS respectively. Results In total, 13 outcomes were categorised ‘consensus in’ (disease-free survival, disease-specific survival, surgery-related death, recurrence of cancer, completeness of tumour removal, overall quality of life, nutritional effects, all-cause complications, intraoperative complications, anaesthetic complications, anastomotic complications, multiple organ failure, and bleeding), 13 ‘consensus out’ and 31 ‘no consensus’. There was little variation in prioritisation of outcomes by stakeholders from Eastern or Western countries and high or low-to-middle income countries. There was little variation in outcome prioritisation within either health professional or patient groups. Conclusion Our study suggests that there is little variation in opinion within stakeholder groups when participant region and other characteristics are considered. This finding may help COS developers when designing their Delphi surveys and recruitment strategies. Further work across other clinical fields is needed before broad recommendations can be made.

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STANDARDIZING AND HARMONIZING OUTCOME MEASUREMENT IN MULTIMODAL PAIN THERAPY- VAPAIN CORE OUTCOME SET RECOMMENDATION

10.26226/morressier.598b05d8d462b80290b5360e ◽

2017 ◽

Author(s):

Ulrike Kaiser

Keyword(s):

Pain Therapy ◽

Outcome Measurement ◽

Core Outcome Set ◽

Core Outcome ◽

Multimodal Pain Therapy ◽

Outcome Set

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Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’

Trials ◽

10.1186/1745-6215-15-247 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 142

Author(s):

Cecilia A C Prinsen ◽

Sunita Vohra ◽

Michael R Rose ◽

Susanne King-Jones ◽

Sana Ishaque ◽

...

Keyword(s):

Outcome Measures ◽

Delphi Study ◽

Outcome Measurement ◽

Core Outcome Set ◽

Core Outcome ◽

Measurement Instruments ◽

Outcome Set ◽

Core Outcome Measures ◽

Effectiveness Trials

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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)

10.21203/rs.3.rs-226692/v1 ◽

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)

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Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol

ERJ Open Research ◽

10.1183/23120541.00193-2020 ◽

2020 ◽

Vol 6 (3) ◽

pp. 00193-2020

Author(s):

Alexander G. Mathioudakis ◽

Fekri Abroug ◽

Alvar Agusti ◽

Per Bakke ◽

Konstantinos Bartziokas ◽

...

Keyword(s):

Study Protocol ◽

Task Force ◽

Core Outcome Set ◽

Measurement Instrument ◽

Chronic Obstructive ◽

Core Outcome ◽

European Respiratory Society ◽

Copd Exacerbations ◽

Outcome Set ◽

Multi Stakeholder

Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations.For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus.Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.

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Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol

Trials ◽

10.1186/s13063-018-2904-0 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 7

Author(s):

Ruijin Qiu ◽

Min Li ◽

Xiaoyu Zhang ◽

Shiqi Chen ◽

Chengyu Li ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Study Protocol ◽

Outcome Measurement ◽

Core Outcome Set ◽

Core Outcome ◽

Measurement Instruments ◽

Outcome Set

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A Core Outcome Set for Nonpharmacological Community-Based Interventions for People Living With Dementia at Home: A Systematic Review of Outcome Measurement Instruments

The Gerontologist ◽

10.1093/geront/gnaa071 ◽

2020 ◽

Cited By ~ 1

Author(s):

Andrew J E Harding ◽

Hazel Morbey ◽

Faraz Ahmed ◽

Carol Opdebeeck ◽

Ruth Elvish ◽

...

Keyword(s):

Outcome Measurement ◽

Core Outcome Set ◽

Face Validity ◽

Core Outcome ◽

Measurement Instruments ◽

Community Based Interventions ◽

Community Based ◽

Key Stakeholders ◽

Outcome Set ◽

Dementia Research

Abstract Background and Objectives It is questionable whether existing outcome measurement instruments (OMIs) in dementia research reflect what key stakeholders’ value. We attained consensus from more than 300 key stakeholders, including people living with dementia, and identified 13 core outcome items for use in nonpharmacological and community-based interventions for people with dementia living at home. In this systematic review, we review OMIs that have previously been used in dementia care research to determine how, or even if, the 13 core outcome items can be measured. Research Design and Methods We extracted self-reported OMIs from trials, reviews, and reports of instrument development. Searches were undertaken in the ALOIS database, MEDLINE, PsycINFO, CINAHL, SocINDEX, and COSMIN databases. We aimed to assess the psychometric properties of OMI items for face validity with the core outcome items, content validity, internal consistency, and responsiveness. We held a coresearch workshop involving people living with dementia and care partners in order to ratify the findings. Results In total 347 OMIs were located from 354 sources. Of these, 76 OMIs met the inclusion criteria. No OMIs were deemed to have sufficient face validity for the core outcome set (COS) items, and no OMIs proceeded to further assessment. The “best” available OMI is the Engagement and Independence in Dementia Questionnaire. Discussion and Implications This study provides a practical resource for those designing dementia research trials. Being able to measure the COS items would herald a paradigm shift for dementia research, be responsive to what key stakeholders value and enhance the ability to make comparisons.

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OMERACT Filter 2.1: Elaboration of the Conceptual Framework for Outcome Measurement in Health Intervention Studies

The Journal of Rheumatology ◽

10.3899/jrheum.181096 ◽

2019 ◽

Vol 46 (8) ◽

pp. 1021-1027 ◽

Cited By ~ 19

Author(s):

Maarten Boers ◽

Dorcas E. Beaton ◽

Beverley J. Shea ◽

Lara J. Maxwell ◽

Susan J. Bartlett ◽

...

Keyword(s):

Conceptual Framework ◽

Outcome Measures ◽

Intervention Studies ◽

Outcome Measurement ◽

Core Outcome Set ◽

Health Intervention ◽

Health Conditions ◽

Core Outcome ◽

Outcome Set ◽

Core Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of “measurable aspects of health conditions” from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).Methods.At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.Results.The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.Conclusion.We expect that the Filter 2.1 framework will improve the process of core set development.

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