scholarly journals Developing a core outcome set for periodontal trials

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254123
Author(s):  
Thomas J. Lamont ◽  
Jan E. Clarkson ◽  
David N. J. Ricketts ◽  
Peter A. Heasman ◽  
Craig R. Ramsay ◽  
...  
Keyword(s):  
Periodontal Diseases ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Face To Face ◽  
Key Stakeholders ◽  
Delphi Round ◽  
Outcome Set ◽  
Effectiveness Trials ◽  
Dental Professional ◽  
Dental Professionals

Background There is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals. Objective Develop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases. Methods Mixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting. Participants Key stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers. Results The literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss. Conclusions Implementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions. Registration COMET Database: http://www.comet-initiative.org/studies/details/265?result=true

scholarly journals 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

2019 ◽  
Vol 7 (1) ◽  
pp. e000700 ◽  
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.

scholarly journals Generic outcome set for the international registry on Laser trEAtments in Dermatology (LEAD): a protocol for a Delphi study to achieve consensus on what to measure

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e038145
Author(s):  
Frederike Fransen ◽  
Phyllis Spuls ◽  
Murad Alam ◽  
Ashraf Badawi ◽  
Pablo Boixeda ◽  
...  
Keyword(s):  
Delphi Study ◽  
Skin Diseases ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Core Outcome ◽  
International Registry ◽  
Key Stakeholders ◽  
Delphi Round ◽  
Outcome Set ◽  
Laser Treatments

IntroductionWhile laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders.Methods and analysisBy reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry.Ethics and disseminationAn ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.

scholarly journals Using a web-based method to achieve stakeholder consensus about core outcomes for clinical trials is a viable option in the face of pandemic-related movement restrictions: Qualitative methods study (Preprint)

2021 ◽  
Author(s):  
Roulla Katiri ◽  
Deborah A. Hall ◽  
Derek J. Hoare ◽  
Kathryn Fackrell ◽  
Adele Horobin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Core Outcome ◽  
Web Based ◽  
Face To Face ◽  
Outcome Set ◽  
Study Team ◽  
The Face ◽  
Single Sided Deafness

BACKGROUND Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes makes it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK-government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study. OBJECTIVE This article describes and evaluates the modifications taken by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol. METHODS The study team worked with healthcare users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experience of the 22 participating members. Feedback covered (i) pre-meeting preparation, (ii) process of facilitated discussions and voting, (iii) ability to contribute, and (iv) perceived fairness of the outcome. RESULTS On balance, the web-based meeting achieved its original goals of open discussion, debate, and voting to agree a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and managing the unpredictability of tasks on the day. CONCLUSIONS Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximise inclusiveness, enhance geographical access, as well as to reduce research costs. CLINICALTRIAL N/A

scholarly journals The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ebony Richardson ◽  
Alison McEwen ◽  
Toby Newton-John ◽  
Karine Manera ◽  
Chris Jacobs
Keyword(s):  
Systematic Review ◽  
Genetic Testing ◽  
Core Outcome Set ◽  
Carrier Screening ◽  
Core Outcome ◽  
The Core ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Methods Of Measurement ◽  
Genetic Carrier Screening

Abstract Background Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for ‘what to measure’ in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention. Objectives The development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice. Methods In accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: (i) a systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement; (ii) a systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes; (iii) semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them; (iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps; and (v) a virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting. Discussion This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions. COMET core outcome set registration http://www.comet-initiative.org/Studies/Details/1381.

scholarly journals A protocol for developing a core outcome set for ectopic pregnancy

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Krystle Y. Chong ◽  
Sarah Solangon ◽  
James Kemper ◽  
Kurt Barnhart ◽  
Pamela Causa Andrieu ◽  
...  
Keyword(s):  
Ectopic Pregnancy ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Future Research ◽  
Controlled Trials ◽  
Core Outcome ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Core Outcomes ◽  
Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

scholarly journals Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

2020 ◽  
Author(s):  
Katharina M Lang ◽  
Kathryn L. Harrison ◽  
Paula R. Williamson ◽  
Brian J.P. Huntly ◽  
Gert Ossenkoppele ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Face To Face ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Stakeholder Consensus ◽  
Acute Myeloid

Abstract Background Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area. The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy. In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia. Methods The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings. The Delphi survey will reduce the preliminary outcome list to essential core outcomes. After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia. Discussion The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.

scholarly journals What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Dan Brunsdon ◽  
Linda Biesty ◽  
Peter Brocklehurst ◽  
Valerie Brueton ◽  
Declan Devane ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Priority Setting ◽  
Online Survey ◽  
Consensus Meeting ◽  
Randomised Trials ◽  
Face To Face ◽  
Key Stakeholders ◽  
James Lind Alliance ◽  
Research Questions ◽  
Priority Setting Partnership

Abstract Background One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders. Methods This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative, to support key stakeholders (researchers, patients, and the public) in jointly identifying and agreeing on priority research questions. There were three stages. (1) First an initial online survey was conducted consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure that they had not been answered by existing research. (2) An interim stage involved a further online survey where stakeholders were asked to select questions of key importance from the longlist. (3) A face-to-face consensus meeting was held, where key stakeholder representatives agreed on an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials. Results A total of 456 respondents yielded 2431 answers to six open-ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the Steering Group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting in which key stakeholder representatives prioritised the order. The ‘Top 10’ of these are reported in this paper. The number one ranked question was ’What motivates a participant’s decision to complete a clinical trial?’ The entire list will be available at www.priorityresearch.ie. Conclusion The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.

scholarly journals Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Anna N. Millar ◽  
◽  
Amrit Daffu-O’Reilly ◽  
Carmel M. Hughes ◽  
David P. Alldred ◽  
...  
Keyword(s):  
Older Adults ◽  
Core Outcome Set ◽  
Care Homes ◽  
Core Outcome ◽  
Outcome Set ◽  
Effectiveness Trials

scholarly journals How to evaluate the clinical outcome of joint-preserving treatment for osteonecrosis of the femoral head: development of a core outcome set

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Zhipeng Xue ◽  
Jigao Sun ◽  
Taixian Li ◽  
Zeqing Huang ◽  
Weiheng Chen
Keyword(s):  
Femoral Head ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Walking Distance ◽  
Core Outcome ◽  
Outcome Indicators ◽  
X Ray ◽  
Outcome Set ◽  
Core Outcomes ◽  
Hip Flexion

Abstract Background This study aimed to develop a core outcome set (COS) for clinical trials of joint-preserving treatment for osteonecrosis of the femoral head (ONFH), that is, to define a minimal set of outcomes that should be reported in such trials. Methods A mixed research method was adopted in this study. First, clinical trials of hip preservation therapy were systematically researched and analyzed. Second, a three-round Delphi survey involving both doctors and patients was carried out to obtain the core outcome indicators. Round 1 was a modified Delphi questionnaire for doctors and patients to determine which outcomes are important to these stakeholders, round 2 determined what clinical evaluation core outcomes should be included for the joint-preserving treatment of ONFH, and round 3 determined how core outcomes should be measured. Finally, a consensus meeting was held to discuss and vote on the established COS. Results The results of the systematic review showed that 42 outcome indicators were classified according to common signs and symptoms, quality of life, long-term outcomes, radiological evaluation, blood biochemistry, and indexes of safety. The three rounds of Delphi surveys completed the selection of indicators for the COS and the determination of the corresponding measurements. A total of 73 orthopedic doctors and 103 patients participated in round 1, and the top 10 indicators selected were basically the same. In round 2, 32 experts identified the following indicators: pain, range of motion (ROM) of hip flexion, walking distance, and stable rating of X-ray images. In round 3, 35 experts defined the measurement of each indicator. Finally, the consensus meeting identified the four indicators aforementioned that constituted the COS. The scores for pain, ROM of hip flexion, and walking distance are from 0 to 10; 0 represents the best scores, while 10 represents the most serious impairment. The stable rating of X-ray images is determined by the morphology of the femoral head and the change in the density of the necrotic area. Conclusions We established a COS for hip-preserving treatment of ONFH that includes four indicators: pain, ROM of hip flexion, walking distance, and stable rating of X-ray images.

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