A core outcome set for damage control laparotomy via modified Delphi method

ObjectivesDamage control laparotomy (DCL) remains an important tool in the trauma surgeon’s armamentarium. Inconsistency in reporting standards have hindered careful scrutiny of DCL outcomes. We sought to develop a core outcome set (COS) for DCL clinical studies to facilitate future pooling of data via meta-analysis and Bayesian statistics while minimizing reporting bias.MethodsA modified Delphi study was performed using DCL content experts identified through Eastern Association for the Surgery of Trauma (EAST) ‘landmark’ DCL papers and EAST ad hoc COS task force consensus.ResultsOf 28 content experts identified, 20 (71%) participated in round 1, 20/20 (100%) in round 2, and 19/20 (95%) in round 3. Round 1 identified 36 potential COS. Round 2 achieved consensus on 10 core outcomes: mortality, 30-day mortality, fascial closure, days to fascial closure, abdominal complications, major complications requiring reoperation or unplanned re-exploration following closure, gastrointestinal anastomotic leak, secondary intra-abdominal sepsis (including anastomotic leak), enterocutaneous fistula, and 12-month functional outcome. Despite feedback provided between rounds, round 3 achieved no further consensus.ConclusionsThrough an electronic survey-based consensus method, content experts agreed on a core outcome set for damage control laparotomy, which is recommended for future trials in DCL clinical research. Further work is necessary to delineate specific tools and methods for measuring specific outcomes.Level of evidenceV, criteria

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A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review

Trials ◽

10.1186/s13063-017-1805-y ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 3

Author(s):

Johanna Taylor ◽

Jan R. Böhnke ◽

Judy Wright ◽

Ian Kellar ◽

Sarah L. Alderson ◽

...

Keyword(s):

Systematic Review ◽

Mental Illness ◽

Delphi Study ◽

Core Outcome Set ◽

Self Management ◽

Core Outcome ◽

Modified Delphi ◽

Management Interventions ◽

Outcome Set ◽

Illness Study

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

Trials ◽

10.1186/s13063-021-05291-9 ◽

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.

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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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