scholarly journals Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e043242
Author(s):  
Kirstie Haywood ◽  
Rachel Potter ◽  
Robert Froud ◽  
Gemma Pearce ◽  
Barbara Box ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Episodic Migraine ◽  
Consensus Meeting ◽  
Good Representation ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set

ObjectiveTypically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).DesignA two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.ResultsThere was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.ConclusionInternational and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.

scholarly journals Developing a core outcome set for interventions to improve discharge from mental health inpatient services: a survey, Delphi and consensus meeting with key stakeholder groups

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034215
Author(s):  
Natasha Tyler ◽  
Nicola Wright ◽  
Andrew Grundy ◽  
Justin Waring
Keyword(s):  
Mental Health ◽  
Health Services ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Service Users ◽  
Core Outcome ◽  
Stakeholder Groups ◽  
The Core ◽  
Outcome Set

ObjectiveTo develop a core set of outcomes to be used in all future studies into discharge from acute mental health services to increase homogeneity of outcome reporting.DesignWe used a cross-sectional online survey with qualitative responses to derive a comprehensive list of outcomes, followed by two online Delphi rounds and a face-to-face consensus meeting.SettingThe setting the core outcome set applies to is acute adult mental health.ParticipantsParticipants were recruited from five stakeholder groups: service users, families and carers, researchers, healthcare professionals and policymakers.InterventionsThe core outcome set is intended for all interventions that aim to improve discharge from acute mental health services to the community.ResultsNinety-three participants in total completed the questionnaire, 69 in Delphi round 1 and 68 in round 2, with relatively even representation of groups. Eleven participants attended the consensus meeting. Service users, healthcare professionals, researchers, carers/families and end-users of research agreed on a four-item core outcome set: readmission, suicide completed, service user-reported psychological distress and quality of life.ConclusionImplementation of the core outcome set in future trials research will provide a framework to achieve standardisation, facilitate selection of outcome measures, allow between-study comparisons and ultimately enhance the relevance of trial or research findings to healthcare professionals, researchers, policymakers and service users.

scholarly journals Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations

2017 ◽  
Vol 21 (26) ◽  
pp. 1-192 ◽  
Author(s):  
Lucy Webster ◽  
Derek Groskreutz ◽  
Anna Grinbergs-Saull ◽  
Rob Howard ◽  
John T O’Brien ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Disease Modification ◽  
The Core ◽  
Moderate Dementia ◽  
Outcome Set ◽  
Core Set ◽  
And Biological Markers

BackgroundThere is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials.ObjectivesTo agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI).Data sourcesWe included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches.Review methodsThe project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes.ResultsWe included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally.LimitationsMost of the trials included participants with Alzheimer’s disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer’s Society Research Network.ConclusionsCognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants.Future workWe envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog.Study registrationThe project was registered with Core Outcome Measures in Effectiveness Trials [www.comet-initiative.org/studies/details/819?result=true(accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346.FundingThe National Institute for Health Research Health Technology Assessment programme.

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 Protocol for the development of a core outcome set for cauda equina syndrome: systematic literature review, qualitative interviews, Delphi survey and consensus meeting

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024002 ◽  
Author(s):  
Nisaharan Srikandarajah ◽  
Adam J Noble ◽  
Martin Wilby ◽  
Simon Clark ◽  
Paula R Williamson ◽  
...  
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Cauda Equina Syndrome ◽  
Qualitative Interviews ◽  
Core Outcome Set ◽  
Cauda Equina ◽  
Consensus Meeting ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set

IntroductionCauda equina syndrome (CES) is a serious neurological condition most commonly due to compression of the lumbosacral nerve roots, which can result in significant disability. The evidence for acute intervention in CES is mainly from retrospective studies. There is heterogeneity in the outcomes chosen for analysis in these studies, which makes it difficult to synthesise the data across studies. This study will develop a core outcome set for use in future studies of CES, engaging with key stakeholders and using transparent methodology. This will help ensure that relevant outcomes are used in future and will facilitate attempts to summarise data across studies in systematic reviews.Methods and analysisA systematic literature review will document all the outcomes for CES after surgery mentioned in the literature. The qualitative interviews with patients with CES will be semistructured, audio recorded, transcribed and thematically analysed with the use of NVivo V.10 to identify outcomes and determine the themes described. The outcomes from the literature review and patient interviews will be combined and prioritised to determine what the most important outcomes are in CES research studies to patients and healthcare professionals. The prioritisation will be done through a two-round iterative Delphi survey and a consensus meeting. This process will decide the core outcome set for patients with CES.Ethics and disseminationREC and HRA approval was obtained on the 6/12/16 for the qualitative interviews from South Central—Hampshire A REC. REC reference 16/SC/0587. REC and HRA approval was obtained on 26/3/18 for the Delphi process and consensus meeting from North West—Greater Manchester Central REC. REC reference was 18/NW/0022. The final core outcome set will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 824.

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 Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study

10.2196/14544 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14544 ◽  
Author(s):  
Imogen Ramsey ◽  
Nadia Corsini ◽  
Amanda D Hutchinson ◽  
Julie Marker ◽  
Marion Eckert
Keyword(s):  
Cancer Survivors ◽  
Cancer Survivorship ◽  
Phase Ii ◽  
Core Outcome Set ◽  
Population Based ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set ◽  
Core Set

Background Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. Objective This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. Methods In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. Results As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. Conclusions Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. International Registered Report Identifier (IRRID) DERR1-10.2196/14544

scholarly journals Prevailing outcome themes reported by people with degenerative cervical myelopathy: findings from a semi-structured interview (Preprint)

2020 ◽  
Author(s):  
Danyal Zaman Khan ◽  
Siobhan Mairead Fitzpatrick ◽  
Bryn Hilton ◽  
Angus G.K. McNair ◽  
Ellen Sarewitz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Myelopathy ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Consensus Process ◽  
Outcome Set ◽  
Patient Reported ◽  
Degenerative Cervical Myelopathy ◽  
The Impact

BACKGROUND Degenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM (PwCM) to have amongst the lowest quality of life scores (SF-36) of chronic disease, although the drivers for this are not entirely understood. DCM research faces a number of challenges, including the heterogenous reporting of study data. The AO Spine RECODE-DCM project is an international consensus process that aims improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains which represent key aspects of the disease. OBJECTIVE To facilitate this, we sought to qualitatively explore the context and impact of patient reported outcomes in DCM on people with DCM (PwCM) and their supporters. The aim was to improve understanding of patient perspective and assist the organisation of outcomes into domains for the consensus process. METHODS A single focus group was hosted by Myelopathy.org, a charity and support group for PwCM. The 40 minute session was audio-recorded and transcribed verbatim. Data was familiarized and 2 authors performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun & Clarke’s six-phase approach. The themes were subsequently reviewed with an independent PwCM stakeholder (ES), assisting in the process of capturing the true context and importance of themes. RESULTS Five PwCM (three men and two women) and three supporters (all women) participated. The average PwCM age was 53 and the median mJOA was 11 (±IQR 2), indicating these PwCM had moderate to severe DCM. 54 codes were grouped into 10 themes that captured the impact of DCM on PwCM and their supporters. These themes included: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness/isolation and social stigma CONCLUSIONS This is the first study to undertake qualitative analysis of PwCM perspectives. It has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. These perspectives will be used to inform the development of a core outcome set for DCM which is inclusive of all relevant stakeholders, including PwCM.

scholarly journals Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study (Preprint)

2019 ◽  
Author(s):  
Imogen Ramsey ◽  
Nadia Corsini ◽  
Amanda D Hutchinson ◽  
Julie Marker ◽  
Marion Eckert
Keyword(s):  
Cancer Survivors ◽  
Cancer Survivorship ◽  
Phase Ii ◽  
Core Outcome Set ◽  
Population Based ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set ◽  
Core Set

BACKGROUND Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. OBJECTIVE This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. METHODS In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. RESULTS As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. CONCLUSIONS Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14544

scholarly journals Development of a Core Outcome Set for Clinical Trials of Traditional Chinese Medicine in Lung Cancer: a Study Protocol

2021 ◽  
Author(s):  
Mingyan Zhang ◽  
Hui Zi Chua ◽  
Bohan Niu ◽  
Kai Li ◽  
Junhua Zhang
Keyword(s):  
Lung Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Stakeholder Groups ◽  
The Core ◽  
Outcome Set

Abstract Background: Lung cancer (LC) is currently the leading cause of cancer death globally. LC accounts for a high mortality and incidence rate of cancer in both men and women. Radiotherapy and chemotherapy, though effective for some patients, have strong side effects and most of them only have palliative effect. Though many studies reported the effectiveness of traditional Chinese medicine (TCM) treatment on LC, the lack of methodological quality in clinical trials resulted in heterogeneous reporting of outcomes, making it difficult to compare and combine in different trials, limiting the validity of meta-analysis and reducing the value of clinical studies. A core outcome set (COS) could reduce outcome reporting bias and heterogeneity across studies of LC using TCM-related interventions. The aim of this study is to develop a standardized COS for LC in TCM clinical trials (COS-TCM-LC) to improve the methodological quality of TCM clinical studies to serve as a guidance in healthcare decision making for LC.Methods: The study has been developed according to the Core Outcome Set-STAandards for Development standards for the design of a COS study. The study process consisted 4 stages as follows: (1) Identifying a list of potential outcomes through systematic reviews of TCM RCTs and 2 clinical registry databases, qualitative surveys on patients and healthcare professionals to form an outcome pool and finally establishing a preliminary checklist of outcomes. (2) Selection of stakeholder groups. (3) Representatives of stakeholder groups will be invited to participate in a two-round Delphi survey. (4) A face-to-face consensus meeting will be held to determine the final COS-TCM-LC.Discussion: In this study protocol, we have followed the guidelines of COS-STAndardized Protocol (STAP) statement and checked the items in COS-STAndards for Developement (STAD). Developing a COS-TCM-LC will improve the quality of future RCTs on LC with the TCM interventions and promote better evidence-based clinical decision-making.Trial registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1483 (http://www.comet-initiative.org/studies/details/1483).

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