Developing a core outcome set for a congenital abnormalities surveillance programme in Rwanda – a Delphi consensus study

Background: In 2015 it was reported that approximately 300,000 newborns die within four weeks of birth every year, worldwide, due to congenital anomalies. This represents approximately 11% of neonatal deaths. This has led scientists, clinicians and public health authorities to establish congenital abnormality registries (CARs). There is currently no CAR in Rwanda. In establishing such a registry, it was determined that the first step was to identify the core outcome set (COS) (or minimal data-set) of variables and outcomes for the registry to ensure that the final results are meaningful and employable. This study aimed to use Delphi consensus methods to identify a methodologically robust COS for a congenital abnormalities surveillance programme in Rwanda. Methods: A three-round, modified Delphi study was undertaken between April and June 2017. Round 1 was a literature and internet search followed by an open and closed question round with experts in Rounds 2 and 3, respectively. Results: An initial draft COS of 136 outcomes was created from a review of 15 African studies and 14 international repository tools including the European Surveillance of Congenital Anomalies and the World Health Organization surveillance guidance. In total, 36 and 34 participants took part in Rounds 2 and 3, respectively. A total of 32 new outcomes were added by participants in Round 2. 103 outcomes met the pre-defined consensus criteria and made up the final COS in Round 3. Conclusions: This is the first core outcome set for a congenital abnormality surveillance programme in an African nation identified in the literature. The next stage is to field-test the surveillance programme using passive case-finding in teaching hospitals in Rwanda.

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Developing a Minimum Data Set for a congenital abnormalities surveillance programme in Rwanda – a modified e-Delphi consensus study

F1000Research ◽

10.12688/f1000research.19762.2 ◽

2021 ◽

Vol 8 ◽

pp. 1037

Author(s):

Annette Uwineza ◽

Aline Muhorakeye ◽

Janvier Hitayezu ◽

Peter Thomas Cartledge

Keyword(s):

Delphi Study ◽

Congenital Anomalies ◽

Congenital Abnormality ◽

World Health ◽

Minimum Data Set ◽

Consensus Methods ◽

Delphi Consensus ◽

Data Set ◽

Surveillance Programme ◽

Minimum Data

Background: In 2015 it was reported that approximately 300,000 newborns die within four weeks of birth every year, worldwide, due to congenital anomalies. This represents approximately 11% of neonatal deaths. This has led scientists, clinicians and public health authorities to establish congenital abnormality registries (CARs). There is currently no CAR in Rwanda. In establishing such a registry, it was determined that the first step was to identify the Minimum Data Set (MDS) of items/variables and outcomes for the registry to ensure that the final results are meaningful and employable. This study aimed to use Delphi consensus methods to identify a methodologically robust MDS for a congenital abnormality surveillance programme in Rwanda. Methods: A three-round, modified Delphi study was undertaken between April and June 2017. Round 1 was a literature and internet search followed by an open and closed question round with experts in Rounds 2 and 3, respectively. Results: An initial draft MDS of 134 items was created from a review of 15 African studies and 14 international repository tools including the European Surveillance of Congenital Anomalies and the World Health Organization surveillance guidance. In total, 36 and 34 eligible participants were included in Rounds 2 and 3, respectively. A total of 32 new items were added by participants in Round 2. 103 items met the pre-defined consensus criteria and made up the final MDS in Round 3. Conclusions: This is the first Minimum Data Set for a congenital abnormality surveillance programme in an African nation identified in the literature. The next stage is to field-test the surveillance programme using passive case-finding in teaching hospitals in Rwanda.

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G273(P) Developing a core outcome set for a congenital abnormalities surveillance program in rwanda – a delphi consensus study

10.1136/archdischild-2019-rcpch.265 ◽

2019 ◽

Author(s):

PT Cartledge ◽

A Muhorakeye ◽

A Uwineza ◽

J Hitayezu

Keyword(s):

Congenital Abnormalities ◽

Core Outcome Set ◽

Surveillance Program ◽

Core Outcome ◽

Delphi Consensus ◽

Outcome Set

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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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A multi-stakeholder Delphi consensus core outcome set for clinical trials in moderate-to-severe asthma (coreASTHMA)

Annals of Allergy Asthma & Immunology ◽

10.1016/j.anai.2021.03.022 ◽

2021 ◽

Author(s):

Vickram Tejwani ◽

Hsing-Yuan Chang ◽

Annie P. Tran ◽

Jennifer Al Naber ◽

Florian S. Gutzwiller ◽

...

Keyword(s):

Clinical Trials ◽

Severe Asthma ◽

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Outcome Set ◽

Multi Stakeholder

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Core Outcome Set for Reporting Outcomes of Interventions for Velopharyngeal Dysfunction: Final Results of the COS-VPD Initiative

The Cleft Palate-Craniofacial Journal ◽

10.1177/10556656211035026 ◽

2021 ◽

pp. 105566562110350

Author(s):

Catherine de Blacam ◽

Adriane L. Baylis ◽

Richard E. Kirschner ◽

Susan Smith ◽

Debbie Sell ◽

...

Keyword(s):

Core Outcome Set ◽

A Priori ◽

Delphi Panel ◽

Core Outcome ◽

Delphi Consensus ◽

Assessment Development ◽

Comparison Of Results ◽

Outcome Set ◽

Patient Reported ◽

Panel Rating

Objective To date, the recording of outcomes of interventions for velopharyngeal dysfunction (VPD) has not been standardized. This makes a comparison of results between studies challenging. The aim of this study was to develop a core outcome set (COS) for reporting outcomes in studies examining the management of VPD. Design A two-round Delphi consensus process was used to develop the COS. Patients, Participants The expert Delphi panel comprised patients and caregivers of patients with VPD, surgeons and speech and language therapists specializing in cleft palate, and researchers with expertise in VPD. Interventions A long list of outcomes was derived from the published literature. In each round of a Delphi survey, participants were asked to score outcomes using the Grading of Recommendations, Assessment, Development, and Evaluations scale of 1 to 9, with 1 to 3 labeled “not important,” 4 to 6 labeled “important but not critical,” and 7 to 9 labeled “critical.” Main outcome measure Consensus criteria were specified a priori. Outcomes with a rating of 75% or more of the panel rating 7 to 9 and 25% or fewer rating 1 to 3 were included in the COS. Results A total of 31 core outcomes were identified from the Delphi process. This list was condensed to combine topic areas to produce a final COS of 10 outcomes, including both processes of care and patient-reported outcomes that should be considered for reporting in future studies of VPD. Conclusions Implementation of the COS-VPD will facilitate consistency of outcomes data collection and comparison of results across studies.

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Consensus Building in OMERACT: Recommendations for Use of the Delphi for Core Outcome Set Development

The Journal of Rheumatology ◽

10.3899/jrheum.181094 ◽

2019 ◽

Vol 46 (8) ◽

pp. 1041-1046 ◽

Cited By ~ 3

Author(s):

Susan Humphrey-Murto ◽

Richard Crew ◽

Beverley Shea ◽

Susan J. Bartlett ◽

Lyn March ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Core Outcome Set ◽

Delphi Process ◽

Consensus Building ◽

Core Outcome ◽

Delphi Consensus ◽

International Consensus ◽

Work In Progress ◽

Outcome Set

Objective.Developing international consensus on outcome measures for clinical trials is challenging. The following paper will review consensus building in Outcome Measures in Rheumatology (OMERACT), with a focus on the Delphi.Methods.Based on the literature and feedback from delegates at OMERACT 2018, a set of recommendations is provided in the form of the OMERACT Delphi Consensus Checklist.Results.The OMERACT delegates generally supported the use of the checklist as a guide. The checklist provides guidance for clearly outlining the multiple aspects of the Delphi process.Conclusion.OMERACT is deeply committed to consensus building and these recommendations should be considered a work in progress.

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Development of a core outcome set (COS) for studies relating to awareness and clinical management of reduced fetal movement: study protocol

Trials ◽

10.1186/s13063-021-05839-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Dexter J. L. Hayes ◽

Declan Devane ◽

Jo C. Dumville ◽

Valerie Smith ◽

Tanya Walsh ◽

...

Keyword(s):

Systematic Review ◽

Pregnancy Outcomes ◽

Clinical Management ◽

Core Outcome Set ◽

Fetal Movement ◽

Core Outcome ◽

Delphi Consensus ◽

Outcome Set ◽

Fetal Movements ◽

Adverse Pregnancy

Abstract Background Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy outcomes by evaluating interventions to raise awareness of RFM in pregnancy, such as kick counting, evaluating interventions for the clinical management of RFM, or both. However, there is not currently a core outcome set (COS) for studies of RFM. This study aims to create a COS for use in research studies that aim to raise awareness of RFM and/or evaluate interventions for the clinical management of RFM. Methods A systematic review will be conducted, to identify outcomes used in randomised and non-randomised studies with control groups that aimed to raise awareness of RFM (for example by using mindfulness techniques, fetal movement counting, or other tools such as leaflets or mobile phone applications) and/or that evaluated the clinical management of RFM. An international Delphi consensus will then be used whereby stakeholders will rate the importance of the outcomes identified in the systematic review in (i) awareness and (ii) clinical management studies. The preliminary lists of outcomes will be discussed at a consensus meeting where one final COS for awareness and management, or two discrete COS (one for awareness and one for management), will be agreed upon. Discussion A well-developed COS will provide researchers with the minimum set of outcomes that should be measured and reported in studies that aim to quantify the effects of interventions.

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Development of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.14430 ◽

2016 ◽

Vol 124 (4) ◽

pp. 661-667 ◽

Cited By ~ 25

Author(s):

BH Al Wattar ◽

K Tamilselvan ◽

R Khan ◽

A Kelso ◽

A Sinha ◽

...

Keyword(s):

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Modified Delphi ◽

Outcome Set ◽

Multi Stakeholder ◽

In Pregnancy

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Development of a Core Outcome Set for clinical trials aimed at improving antimicrobial stewardship in care homes

International Journal of Pharmacy Practice ◽

10.1093/ijpp/riab016.019 ◽

2021 ◽

Vol 29 (Supplement_1) ◽

pp. i15-i16

Author(s):

H Q Nguyen ◽

D T Bradley ◽

M M Tunney ◽

C M Hughes

Keyword(s):

Clinical Trials ◽

Older People ◽

Antimicrobial Stewardship ◽

Healthcare Professionals ◽

Care Home ◽

Core Outcome Set ◽

Care Homes ◽

Core Outcome ◽

Delphi Consensus ◽

Outcome Set

Abstract Introduction Diverse outcomes reported in clinical trials to improve antimicrobial stewardship (AMS) in care homes has hindered evidence synthesis [1]. We previously reported that a number of outcomes for care home AMS which may be important to healthcare professionals and relatives of care home residents had not been measured in previous trials [2]. It is essential to generate a set of important outcomes (a core outcome set – COS) for future studies of AMS interventions in care homes. Aim To develop a COS for use in clinical trials aimed at improving AMS in care homes. Methods A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study [2], was presented in a three-round international Delphi consensus survey, followed by an online consensus exercise. Stakeholders engaged in AMS in care homes (e.g. healthcare professionals, representatives of care home residents) were invited to participate, having been identified through the research team’s contacts and knowledge of relevant organisations. A 9-point Likert scale was used during the consensus procedures and an outcome was included in the COS if 80% or more of participants scored between 7 and 9, and 15% or less scored between 1 and 3. Less stringent criteria for inclusion were also applied if the final COS comprised fewer than three outcomes. Subsequently, a suitable outcome measurement instrument (OMI) was selected for each outcome in the COS using the following steps: finding existing OMIs in the literature and consulting with experts, assessing the quality of OMIs, and selecting one OMI for each core outcome via a two-round international Delphi consensus exercise. Consent was obtained from all participants taking part in all consensus procedures. Results The initial inventory of 14 outcomes was presented to 82 international Delphi panellists from 17 countries in the first round who also suggested three additional outcomes. These 17 outcomes were rated again in two further rounds, with consensus achieved for ten outcomes. A subsequent online consensus exercise with twelve participants from Northern Ireland, including the research team, reached consensus to include five outcomes in the COS (Table 1). Regarding selection of OMIs for the COS, 17 OMIs were identified through literature searches and experts’ suggestions. Based on quality assessment, three OMIs - ‘Number of antimicrobial courses started per 1000 resident-days’, ‘Rate of antimicrobial days of therapy per 1000 resident-days’, and ‘Van Buul algorithms to evaluate appropriateness of initiating or withholding antibiotics’ - were selected for a two-round Delphi exercise with 59 participants from 16 countries. Consensus was reached to select two OMIs for the COS, as presented in Table 1. Conclusion This is the first study to develop a COS for use in clinical trials aimed at improving AMS in care homes. Although we recruited few representatives from advocacy groups for older people, care home staff and managers, there was common agreement for inclusion of a number of outcomes. This COS represents the minimum that should be used in research and trialists may consider exploring other outcomes as reported in previous studies. References 1. Nguyen HQ, Tunney MM, Hughes CM. Interventions to Improve Antimicrobial Stewardship for Older People in Care Homes: A Systematic Review. Drugs and Aging. 2019;36(4):355–69. 2. Nguyen HQ, Bradley DT, Tunney MM, Hughes CM. Antimicrobial Stewardship in Care Homes: Outcomes of Importance to Stakeholders. J Hosp Infect. 2020 Jan 27;104(4):582–91.

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