Defining definitions: a Delphi study to develop a core outcome set for conditions of severe maternal morbidity

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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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 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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Development of a Core Outcome Set for Fetal MyelomenIngoCele (COSMiC): study protocol

10.21203/rs.2.21011/v2 ◽

2020 ◽

Author(s):

Samar Altoukhi ◽

Clare L Whitehead ◽

Greg Ryan ◽

Jan Deprest ◽

Luc Joyeux ◽

...

Keyword(s):

Clinical Practice ◽

Systematic Reviews ◽

Maternal Morbidity ◽

Core Outcome Set ◽

Significant Risk ◽

Second Phase ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set

Abstract Background: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, but is associated with a significant risk of prematurity and maternal morbidity. Fetoscopic surgery comes with less maternal morbidity yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify outcomes previously reported for prenatally diagnosed OSB. We will assess will maternal (primary and subsequent pregnancies), fetal, neonatal and childhood outcomes until adolescence. In a second phase, we will conduct semi-structured interviews with stakeholders, to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians, and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential online rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a face-to-face consensus meeting with all stakeholder groups. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews, and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long term childhood outcomes.Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): 1187. International Prospective Register of Systematic Reviews (PROSPERO): CRD42018104880.

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A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA)

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03603-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Bertrand Gachon ◽

◽

Thomas Schmitz ◽

France Artzner ◽

Olivier Parant ◽

...

Keyword(s):

Anal Sphincter ◽

Maternal Morbidity ◽

Core Outcome Set ◽

Core Outcome ◽

Operative Delivery ◽

Sphincter Injury ◽

Mediolateral Episiotomy ◽

Anal Sphincter Injury ◽

Outcome Set ◽

One Year

Abstract Background We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA). Methods A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman’s history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as “not important”. In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as “not important” or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study. Results Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women. Conclusion We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery. Trial registration The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 (NCT04446780).

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