European Society of Coloproctology Core Outcome Set for haemorrhoidal disease: an international Delphi study among healthcare professionals

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.

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The development of a faecal incontinence core outcome set: an international Delphi study protocol

International Journal of Colorectal Disease ◽

10.1007/s00384-021-03865-2 ◽

2021 ◽

Vol 36 (3) ◽

pp. 617-622

Author(s):

Sadé Assmann ◽

Daniel Keszthelyi ◽

Jos Kleijnen ◽

Merel Kimman ◽

Foteini Anastasiou ◽

...

Keyword(s):

Systematic Review ◽

Study Protocol ◽

Faecal Incontinence ◽

Delphi Study ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Link Type ◽

Outcome Set

Abstract Purpose Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. Trial registration This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554. The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336.

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Mental wellbeing in doctors: the measure matters! development of a core outcome set for measuring wellbeing in doctors

BJPsych Open ◽

10.1192/bjo.2021.630 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S235-S236

Author(s):

David Baldwin ◽

Aimee O'Neill ◽

Julia Sinclair ◽

Gemma Simons

Keyword(s):

Health Education ◽

Delphi Study ◽

Research Policy ◽

Core Outcome Set ◽

Care Quality ◽

Mental Wellbeing ◽

Medical Council ◽

Core Outcome ◽

Outcome Set ◽

Health And Social Care

AimsTo achieve a consensus Core Outcome Set for measuring mental wellbeing in doctors.Hypothesis: A minimum set of valid, reliable and practical wellbeing measures is needed for doctors.BackgroundThe importance of doctors’ mental wellbeing to everyone using Health Care is highlighted by the levels of burnout reported in doctors around the world. In 2019 a number of UK policy documents made recommendations for the wellbeing of doctors, but how those wellbeing interventions are evaluated needs to be defined. Core Outcome Sets are increasingly being used in medicine to prevent waste in research, by recommending the inclusion of a minimum set of valid, reliable and practical measures. An operational definition and Core Outcome Set for wellbeing in doctors is needed to meaningfully progress the work in this field.MethodThe Centre for Workforce Wellbeing (C4WW), a collaboration between the University of Southampton and Health Education England, was created to support research into the nature, assessment and enhancement of wellbeing in physicians. A Systematic Review of wellbeing measures used in doctors and the robustness of those measures, along with surveys of 250 UK doctors of all grades and specialities and patient and public involvement is informing what a core outcome set could be. A Delphi Study among 37 UK experts has been initiated to establish the consensus Core Outcome Set.ResultPublication of research into doctors’ wellbeing is growing internationally. In the UK alone data are being captured by multiple national organisations including: the Care Quality Commission, General Medical Council, British Medical Association and the Royal Colleges. Health and Social Care Organisations are, therefore, keen to “do something” and are spending money on wellbeing interventions with little, or no, evidence base and a lack of appropriate, comparable evaluation. A Core Outcome Set for measuring wellbeing in doctors is ethically required to reduce waste, to replace burnout measures and to refine wellbeing interventions.ConclusionWellbeing measures that actually measure wellbeing, and not burnout, which are validated, reliable and practical, are needed to inform local organisational, national government and international research policy. An absence of burnout does not equate to wellbeing. The focus of measurement needs to shift to capture in what contexts we thrive, not just survive. If everyone used the same Core Outcome Set to measure mental wellbeing, direct comparisons could be made, and money invested, in creating infrastructure, processes and cultures that really work.Health Education England funded PhD.

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Development of a core outcome set for myelodysplastic syndromes – a Delphi study from the EUMDS Registry Group

British Journal of Haematology ◽

10.1111/bjh.16654 ◽

2020 ◽

Vol 191 (3) ◽

pp. 405-417 ◽

Cited By ~ 2

Author(s):

Ursula Rochau ◽

Igor Stojkov ◽

Annette Conrads‐Frank ◽

Helena H. Borba ◽

Karin A. Koinig ◽

...

Keyword(s):

Myelodysplastic Syndromes ◽

Delphi Study ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set

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Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type 2 diabetes

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000700 ◽

2019 ◽

Vol 7 (1) ◽

pp. e000700 ◽

Cited By ~ 3

Author(s):

Nicola L Harman ◽

John P H Wilding ◽

Dave Curry ◽

James Harris ◽

Jennifer Logue ◽

...

Keyword(s):

Type 2 Diabetes ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Consensus Meeting ◽

Core Outcome ◽

Outcome Set ◽

Core Outcomes ◽

Effectiveness Trials

ObjectivesHeterogeneity in outcomes measured across trials of glucose-lowering interventions for people with type 2 diabetes impacts on the ability to compare findings and may mean that the results have little importance to healthcare professionals and the patients that they care for. The SCORE-IT study (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes) has addressed this issue by establishing consensus on the most important outcomes for non-surgical interventions for hyperglycemia in type 2 diabetes.Research design and methodsA comprehensive list of outcomes was developed from registered clinical trials, online patient resources, qualitative literature and long-term studies in the field. This list was then scored in a two-round online Delphi survey completed by healthcare professionals, people with type 2 diabetes, researchers in the field and healthcare policymakers. The results of this online Delphi were discussed and ratified at a face-to-face consensus meeting.Results173 people completed both rounds of the online survey (116 people with type 2 diabetes, 37 healthcare professionals, 14 researchers and 6 policymakers), 20 of these attended the consensus meeting (13 people with type 2 diabetes and 7 healthcare professionals). Consensus was reached on 18 core outcomes across five domains, which include outcomes related to diabetes care, quality of life and long-term diabetes-related complications.ConclusionsImplementation of the core outcome set in future trials will ensure that outcomes of importance to all stakeholders are measured and reported, enhancing the relevance of trial findings and facilitating the comparison of results across trials.

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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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Gathering Global Perspectives to Establish the Research Priorities and Minimum Data Sets for Degenerative Cervical Myelopathy: Sampling Strategy of the First Round Consensus Surveys of AO Spine RECODE-DCM

Global Spine Journal ◽

10.1177/21925682211047546 ◽

2021 ◽

pp. 219256822110475

Author(s):

Oliver D. Mowforth ◽

Danyal Z Khan ◽

Mei Yin Wong ◽

George A. E. Pickering ◽

Lydia Dean ◽

...

Keyword(s):

Cervical Myelopathy ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Research Priorities ◽

Core Outcome ◽

Core Data ◽

Minimum Data ◽

Outcome Set ◽

Data Elements ◽

Degenerative Cervical Myelopathy

Study Design Survey. Introduction AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) is an international initiative that aims to accelerate knowledge discovery and improve outcomes by developing a consensus framework for research. This includes defining the top research priorities, an index term and a minimum data set (core outcome set and core data elements set – core outcome set (COS)/core data elements (CDE)). Objective To describe how perspectives were gathered and report the detailed sampling characteristics. Methods A two-stage, electronic survey was used to gather and seek initial consensus. Perspectives were sought from spinal surgeons, other healthcare professionals and people with degenerative cervical myelopathy (DCM). Participants were allocated to one of two parallel streams: (1) priority setting or (2) minimum dataset. An email campaign was developed to advertise the survey to relevant global stakeholder individuals and organisations. People with DCM were recruited using the international DCM charity Myelopathy.org and its social media channels. A network of global partners was recruited to act as project ambassadors. Data from Google Analytics, MailChimp and Calibrum helped optimise survey dissemination. Results Survey engagement was high amongst the three stakeholder groups: 208 people with DCM, 389 spinal surgeons and 157 other healthcare professionals. Individuals from 76 different countries participated; the United States, United Kingdom and Canada were the most common countries of participants. Conclusion AO Spine RECODE-DCM recruited a diverse and sufficient number of participants for an international PSP and COS/CDE process. Whilst PSP and COS/CDE have been undertaken in other fields, to our knowledge, this is the first time they have been combined in one process.

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Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.15397 ◽

2018 ◽

Vol 125 (13) ◽

pp. 1673-1680 ◽

Cited By ~ 11

Author(s):

F Dos Santos ◽

S Drymiotou ◽

A Antequera Martin ◽

BW Mol ◽

C Gale ◽

...

Keyword(s):

Delphi Study ◽

Core Outcome Set ◽

Induction Of Labour ◽

Core Outcome ◽

Outcome Set

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Developing a core outcome set for interventions to improve discharge from mental health inpatient services: a survey, Delphi and consensus meeting with key stakeholder groups

BMJ Open ◽

10.1136/bmjopen-2019-034215 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034215

Author(s):

Natasha Tyler ◽

Nicola Wright ◽

Andrew Grundy ◽

Justin Waring

Keyword(s):

Mental Health ◽

Health Services ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Consensus Meeting ◽

Service Users ◽

Core Outcome ◽

Stakeholder Groups ◽

The Core ◽

Outcome Set

ObjectiveTo develop a core set of outcomes to be used in all future studies into discharge from acute mental health services to increase homogeneity of outcome reporting.DesignWe used a cross-sectional online survey with qualitative responses to derive a comprehensive list of outcomes, followed by two online Delphi rounds and a face-to-face consensus meeting.SettingThe setting the core outcome set applies to is acute adult mental health.ParticipantsParticipants were recruited from five stakeholder groups: service users, families and carers, researchers, healthcare professionals and policymakers.InterventionsThe core outcome set is intended for all interventions that aim to improve discharge from acute mental health services to the community.ResultsNinety-three participants in total completed the questionnaire, 69 in Delphi round 1 and 68 in round 2, with relatively even representation of groups. Eleven participants attended the consensus meeting. Service users, healthcare professionals, researchers, carers/families and end-users of research agreed on a four-item core outcome set: readmission, suicide completed, service user-reported psychological distress and quality of life.ConclusionImplementation of the core outcome set in future trials research will provide a framework to achieve standardisation, facilitate selection of outcome measures, allow between-study comparisons and ultimately enhance the relevance of trial or research findings to healthcare professionals, researchers, policymakers and service users.

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Measuring the outcomes of volunteering for education: development and pilot of a tool to assess healthcare professionals’ personal and professional development from international volunteering

BMJ Open ◽

10.1136/bmjopen-2018-028206 ◽

2019 ◽

Vol 9 (7) ◽

pp. e028206 ◽

Cited By ~ 1

Author(s):

Natasha Tyler ◽

Carlos Collares ◽

Ged Byrne ◽

Lucie Byrne-Davis

Keyword(s):

Professional Development ◽

Healthcare Professional ◽

Item Response ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Principal Component ◽

Self Report ◽

Core Outcome ◽

Item Questionnaire ◽

Outcome Set

ObjectiveThe development and pilot of a self-report questionnaire, to assess personal and professional development of healthcare professionals gained through experiences in low-income and middle-income countries.DesignThe instrument was developed from a core set of the outcomes of international placements for UK healthcare professionals. Principal component analysis and multidimensional item response theory were conducted using results of a cross-sectional pilot study to highlight items with the best psychometric properties.SettingQuestionnaires were completed both online and in multiple UK healthcare professional events face-to-face.Participants436 healthcare professional participants from the UK (with and without international experience) completed a 110-item questionnaire in which they assessed their knowledge, skills and attitudes.MeasuresThe 110-item questionnaire included self-report questions on a 7-point Likert scale of agreement, developed from the core outcome set, including items on satisfaction, clinical skills, communication and other important healthcare professional knowledge, skills, attitudes and behaviours. Item reduction led to development of the 40-item Measuring the Outcomes of Volunteering for Education-Tool. Internal consistency was evaluated by the Cronbach’s α coefficient. Exploratory analysis investigated the structure of the data using principal component analysis and multivariate item response theory.ResultsExploratory analysis found 10 principal components that explained 71.80% of the variance. Components were labelled ‘attitude to work, adaptability, adapting communication, cultural sensitivity, difficult communication, confidence, teaching, management, behaviour change and life satisfaction’. Internal consistency was acceptable for the identified components (α=0.72–0.86).ConclusionsA 40-item self-report questionnaire developed from a core outcome set for personal and professional development from international placements was developed, with evidence of good reliability and validity. This questionnaire will increase understanding of impact of international placements, facilitating comparisons of different types of experience. This will aid decision making about whether UK healthcare professionals should be encouraged to volunteer internationally and in what capacity.

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