scholarly journals Core Outcome Sets in Miscarriage Trials (COSMisT) study: a study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018535
Author(s):  
Paul Smith ◽  
Natalie Cooper ◽  
Rima Dhillon-Smith ◽  
Emily O’Toole ◽  
T Justin Clark ◽  
...  
Keyword(s):  
Delphi Survey ◽  
Core Outcome ◽  
Potential Core ◽  
Core Outcome Sets ◽  
Face To Face ◽  
The Core ◽  
Modified Delphi ◽  
Key Stakeholders ◽  
Core Set ◽  
Core Outcomes

Introduction‘Core outcome sets’ are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations and so on) consider the important outcomes in the management or prevention of a condition. This paper describes the rationale and design for the development of Core Outcome Sets for Miscarriage Trials.Methods and analysisSystematic reviews, interviews and focus groups with patients and their partners will be conducted to identify potential core outcomes that will be introduced into a modified Delphi survey. To ensure all key stakeholders are included, patients, partners, clinicians, charities and researchers will be invited to take part in the modified Delphi survey. There will be three rounds of scoring and rescoring during the Delphi survey to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions.Ethics and disseminationThe use of core outcome sets allows results from different studies to be compared and combined, thereby reducing inconsistency and aiding interpretation of study findings. It also means research is more likely to report relevant outcomes and so can reduce reporting bias. Understanding which outcomes are important to patients has the potential to act as a driver to improve both the quality and cost-effectiveness of miscarriage services.

scholarly journals Representation of published core outcome sets for research in regulatory guidance: protocol

2021 ◽  
Vol 4 ◽  
pp. 45
Author(s):  
Susanna Dodd ◽  
Rebecca Fish ◽  
Sarah Gorst ◽  
Deborah Hall ◽  
Pamela Jacobsen ◽  
...  
Keyword(s):  
Patient Involvement ◽  
European Medicines Agency ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Guidance ◽  
The Core ◽  
Key Stakeholders ◽  
Regulatory Guidelines ◽  
Core Outcomes ◽  
Guidance Documents

Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents which match in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS. Discussion: This study will identify variation between outcomes suggested in EMA and FDA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. If the findings of this study reveal a lack of concordance between COS and regulatory guidance overall or for particular disease areas, we will invite feedback from FDA and EMA and will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.

scholarly journals Representation of published core outcome sets for research in regulatory guidance: protocol

2021 ◽  
Vol 4 ◽  
pp. 45
Author(s):  
Susanna Dodd ◽  
Rebecca Fish ◽  
Sarah Gorst ◽  
Deborah Hall ◽  
Pamela Jacobsen ◽  
...  
Keyword(s):  
Patient Involvement ◽  
European Medicines Agency ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Guidance ◽  
The Core ◽  
Key Stakeholders ◽  
Regulatory Guidelines ◽  
Core Outcomes ◽  
Guidance Documents

Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents matching in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS. Discussion: This study will identify variation between outcomes suggested in FDA and EMA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. We will share the study findings (in particular, highlighting any lack of concordance between COS and regulatory guidance overall or for particular disease areas) and will invite feedback from FDA and EMA; we will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.

scholarly journals Representation of published core outcome sets for research in regulatory guidance: protocol

2021 ◽  
Vol 4 ◽  
pp. 45
Author(s):  
Susanna Dodd ◽  
Rebecca Fish ◽  
Sarah Gorst ◽  
Deborah Hall ◽  
Pamela Jacobsen ◽  
...  
Keyword(s):  
Patient Involvement ◽  
European Medicines Agency ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Guidance ◽  
The Core ◽  
Key Stakeholders ◽  
Regulatory Guidelines ◽  
Core Outcomes ◽  
Guidance Documents

Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents matching in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS. Discussion: This study will identify variation between outcomes suggested in FDA and EMA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. We will share the study findings (in particular, highlighting any lack of concordance between COS and regulatory guidance overall or for particular disease areas) and will invite feedback from FDA and EMA; we will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.

scholarly journals Protocol for the development of Core Outcome Sets for Early intervention trials to Prevent Obesity in CHildren (COS-EPOCH)

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048104
Author(s):  
Vicki Brown ◽  
Marj Moodie ◽  
Huong Ngoc Quynh Tran ◽  
Marufa Sultana ◽  
Kylie Elizabeth Hunter ◽  
...  
Keyword(s):  
Physical Activity ◽  
Early Childhood ◽  
Childhood Obesity ◽  
Obesity Prevention ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Key Stakeholders ◽  
Core Outcomes ◽  
Prevention Interventions ◽  
Early Childhood Obesity

IntroductionChildhood overweight and obesity is prevalent in the first 5 years of life, and can result in significant health and economic consequences over the lifetime. The outcomes currently measured and reported in randomised controlled trials of early childhood obesity prevention interventions to reduce this burden of obesity are heterogeneous, and measured in a variety of ways. This variability limits the comparability of findings between studies, and contributes to research waste. This protocol presents the methodology for the development of two core outcome sets (COS) for obesity prevention interventions in children aged from 1 to 5 years from a singular development process: (1) a COS for interventions targeting physical activity and sedentary behaviour and (2) a COS for interventions targeting child feeding and dietary intake. Core outcomes related to physical activity and sedentary behaviour in children aged ≤1 year will also be identified to complement an existing COS for early feeding interventions, and provide a broader set of core outcomes in this age range. This will result in a suite of COS useful for measuring and reporting outcomes in early childhood obesity prevention studies, including multicomponent interventions.Methods and analysisDevelopment of the COS will follow international best practice guidelines. A scoping review of trial registries will identify commonly reported outcomes and associated measurement instruments. Key stakeholders involved in obesity prevention, including policy-makers/funders, parents, researchers, health practitioners and community and organisational stakeholders will participate in an e-Delphi study and consensus meeting regarding inclusion of outcomes in the COS. Finally, recommended outcome measure instruments will be identified through literature review and group consensus.Ethics and disseminationDeakin University Human Research Ethics Committee (HEAG-H 231_2020). The COS will be disseminated through peer-reviewed publications and engagement with key stakeholders.

A Core Outcome Set for Trials in Glomerular Disease

2021 ◽  
pp. CJN.07840621
Author(s):  
Simon A. Carter ◽  
Liz Lightstone ◽  
Dan Cattran ◽  
Allison Tong ◽  
Arvind Bagga ◽  
...  
Keyword(s):  
United States ◽  
Core Outcome Set ◽  
Glomerular Disease ◽  
Core Outcome ◽  
Potential Core ◽  
Content Type ◽  
The Core ◽  
Care Partners ◽  
Outcome Set ◽  
Core Outcomes

Background and objectivesOutcomes reported in trials in adults with glomerular disease are often selected with minimal patient input, are heterogeneous, and may not be relevant for clinical decision making. The Standardized Outcomes in Nephrology–Glomerular Disease (SONG-GD) initiative aimed to establish a core outcome set to help ensure that outcomes of critical importance to patients, care partners, and clinicians are consistently reported.Design, setting, participants, and measurementsWe convened two 1.5-hour workshops in Melbourne, Australia, and Washington, DC, United States. Attendees were identified purposively with 50 patients/care partners and 88 health professionals from 19 countries; 51% were female. Patients and care partners were from the United States, Australia, and Canada, and had experience of a glomerular disease with systemic features (n=9), kidney-limited nephrotic disease (n=9), or other kidney-limited glomerular disease (n=8). Attendees reviewed the results of the SONG-GD Delphi survey and aims of the workshop and then discussed potential core outcomes and their implementation in trials among moderated breakout groups of eight to 12 people from diverse backgrounds. Transcripts of discussions were analyzed thematically.ResultsThree themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (i.e., applicable across diverse populations and settings). The fourth theme, preparedness for implementation, included engaging with funders and regulators, establishing reliable and validated measures, and leveraging existing endorsements for patient-reported outcomes.ConclusionsWorkshop themes demonstrated support for kidney function, disease activity, death, life participation, and cardiovascular disease, and these were established as the core outcomes for trials in adults with glomerular disease. Future work is needed to establish the core measures for each domain, with funders and regulators central to the uptake of the core outcome set in trials.

scholarly journals Development of the CORE-Kids core set of outcome domains for studies of childhood limb fractures

2021 ◽  
pp. 1-10
Author(s):  
Ben A. Marson ◽  
Joseph C. Manning ◽  
Marilyn James ◽  
Simon Craxford ◽  
Sandeep R. Deshmukh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Lower Limb ◽  
Policy Development ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set ◽  
Core Set ◽  
Limb Fractures

Aims The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development.

scholarly journals Core outcome set for three ophthalmic conditions: a healthcare professional and patient consensus on core outcome sets for amblyopia, ocular motility and strabismus (COSAMS Study)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e042403
Author(s):  
Samiya Al-Jabri ◽  
Fiona J Rowe ◽  
Jamie J Kirkham
Keyword(s):  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Routine Clinical Practice ◽  
Ocular Motility ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
The Core ◽  
Outcome Set ◽  
Core Outcomes

ObjectivesAmblyopia, strabismus and ocular motility disorders are common conditions with significant impact on visual function, appearance and quality of life. We aimed to establish a core set of outcomes for each of the three conditions for use in clinical trials and routine clinical practice.DesignA comprehensive databank of outcomes was developed from a systematic review of the literature and a series of focus groups with healthcare professionals, researchers, patients and carers. The databank of outcomes was scored in a two-round Delphi Survey completed by two stakeholder groups: healthcare professionals/researchers and patients/carers. Results of the online Delphi were discussed at a face-to-face consensus meeting where the core outcome sets were finalised.SettingUK-wide consultation.ParticipantsResearchers, clinicians, patients and carers.Outcome measuresCore outcome sets.ResultsFor amblyopia, strabismus and ocular motility, 40/42/33 participants contributed to both rounds of the Delphi; six/nine/seven members attended consensus meetings, respectively. Consensus was reached on ten core outcomes for both amblyopia and ocular motility and nine for strabismus. All three conditions shared the core outcomes: adverse events, cost, vision-related quality of life and ocular alignment. The strabismus and ocular motility disorder core sets included, in addition, measuring the deviation, binocular vision, ocular movement, patient satisfaction and symptoms. The amblyopia set, distinct from the sets for the other two conditions, included best corrected distance and near visual acuity, spherical and cylindrical refraction, compliance and treatment-related and functionality/long-term impacts.ConclusionsThe study used robust consensus methods to develop a core outcome set for three ophthalmic conditions. Implementation of these core outcome sets in clinical trials and routine clinical practice will ensure that the outcomes being measured and reported are relevant to all stakeholders. This will enhance the relevance of study findings and enable comparison of results from different studies.

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 A protocol for the Development of Core Outcome Sets for Endodontic Treatment modalities (COSET): an international consensus process

2021 ◽  
Author(s):  
Ikhlas El karim ◽  
Henry F Duncan ◽  
Siobhan Cushley ◽  
Venkatesh Nagendrababu ◽  
Lise-Lotte Kirkevang ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Endodontic Treatment ◽  
Treatment Modalities ◽  
Core Outcome ◽  
Consensus Process ◽  
International Consensus ◽  
Core Outcome Sets ◽  
Key Stakeholders ◽  
Dental Practitioners ◽  
Patient Reported

Abstract BackgroundThe outcome of endodontic treatment is generally assessed using a range of patient and clinician-centred, non-standardised clinical and radiographic outcome measures. This makes it difficult to synthesise evidence for systematic analysis of the literature and the development of clinical guidelines. Core outcome sets (COS) represent a standardised list of outcomes that should be measured and reported in all clinical studies in a particular field. Recently, clinical researchers and guideline developers have focussed on the need for integration of a patient-reported COS with clinician-centred measures. This study aims to develop a COS that includes both patient reported outcomes and clinician centred measures for various endodontic treatment modalities to be used in clinical research and practice.MethodsTo identify reported outcomes (including when and how they are measured), systematic reviews and their included clinical studies, which focus on the outcome of endodontic treatment and were published between 1990 and 2020 will be screened. The COSs will be defined by a consensus process involving key stakeholders using semi-structured interviews and an online Delphi methodology followed by an interactive virtual consensus meeting. A heterogeneous group of key ‘stakeholders’ including patients, general dental practitioners, endodontists, endodontic teachers, clinical researchers, students and policy-makers will be invited to participate. Patients will establish, via interactive interviews, which outcomes they value and feel should be included in a COS. In the Delphi process, other stakeholders will be asked to prioritise outcomes identified from the literature and patients interviews, and will have the opportunity at the end of the first round to add outcomes that are not included, but which they consider relevant. Feedback will be provided in the second round, when participants will be asked to prioritise the list again. If consensus is reached, the remaining outcomes will be discussed at an online meeting and agreement established via defined consensus rules of outcome inclusion. If consensus is not reached after the second round, a third round will be conducted with feedback, followed by the online meeting. Following identification of a COS, we will proceed to identify how and when these outcomes are measured.DiscussionUsing a rigorous methodology, the proposed consensus process aims to develop a COS for endodontic treatment that will be relevant to stakeholders. The results of the study will be shared with participants and COS users. To increase COS uptake, it will also be actively shared with clinical guideline developers, research funders and the editors of general dental and endodontology journals.Study registrationThe study is registered in COMET (https://comet-initiative.org/Studies/Details/1879)

Sign in / Sign up

Export Citation Format

Share Document