Results of an International Consensus Meeting to Develop a Core Outcome Set for Aphasia Treatment Research.

Purpose A core outcome set (COS; an agreed minimum set of outcomes) was developed to address the heterogeneous measurement of outcomes in poststroke aphasia treatment research. Successful implementation of a COS requires change in individual and collective research behavior. We used the Theoretical Domains Framework (TDF) to understand the factors influencing researchers' use and nonuse of the Research Outcome Measurement in Aphasia (ROMA) COS. Method Aphasia trialists and highly published treatment researchers were identified from the Cochrane review of speech and language therapy for aphasia following stroke and through database searches. Participants completed a theory-informed online survey that explored factors influencing COS use. Data were analyzed using descriptive statistics and qualitative content analysis. Results Sixty-four aphasia researchers from 13 countries participated. Most participants (81%) were aware of the ROMA COS, and participants identified more facilitators than barriers to its use. The TDF domain with the highest agreement (i.e., facilitator) was “knowledge” (84% agree/strongly agree). Participants had knowledge of the measures included in the ROMA COS, their associated benefits, and the existing recommendations. The TDF domains with the least agreement (i.e., barriers) were “reinforcement” (34% agree/strongly agree); “social influences” (41% agree/strongly agree); “memory, attention, and decision processes” (45% agree/strongly agree); and “behavioral regulation” (49% agree/strongly agree). Hence, participants identified a lack of external incentives, collegial encouragement, and monitoring systems as barriers to using the ROMA COS. The suitability and availability of individual measurement instruments, as well as burden associated with collecting the COS, were also identified as reasons for nonuse. Conclusions Overall, participants were aware of the benefits of using the ROMA COS and believed that its implementation would improve research quality; however, incentives for routine implementation were reported to be lacking. Findings will guide future revisions of the ROMA COS and the development of theoretically informed implementation strategies. Supplemental Material https://doi.org/10.23641/asha.16528524

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A core outcome set for aphasia treatment research: The ROMA consensus statement

International Journal of Stroke ◽

10.1177/1747493018806200 ◽

2018 ◽

Vol 14 (2) ◽

pp. 180-185 ◽

Cited By ~ 24

Author(s):

Sarah J Wallace ◽

Linda Worrall ◽

Tanya Rose ◽

Guylaine Le Dorze ◽

Caterina Breitenstein ◽

...

Keyword(s):

Quality Of Life ◽

Consensus Statement ◽

Outcome Measurement ◽

Core Outcome Set ◽

Core Outcome ◽

International Consensus ◽

Patient Reported ◽

Treatment Research ◽

Aphasia Treatment

Background A core outcome set (COS; an agreed, minimum set of outcomes) was needed to address the heterogeneous measurement of outcomes in aphasia treatment research and to facilitate the production of transparent, meaningful, and efficient outcome data. Objective The Research Outcome Measurement in Aphasia (ROMA) consensus statement provides evidence-based recommendations for the measurement of outcomes for adults with post-stroke aphasia within phases I–IV aphasia treatment studies. Methods This statement was informed by a four-year program of research, which comprised investigation of stakeholder-important outcomes using consensus processes, a scoping review of aphasia outcome measurement instruments, and an international consensus meeting. This paper provides an overview of this process and presents the results and recommendations arising from the international consensus meeting. Results Five essential outcome constructs were identified: Language, communication, patient-reported satisfaction with treatment and impact of treatment, emotional wellbeing, and quality of life. Consensus was reached for the following measurement instruments: Language: The Western Aphasia Battery Revised (WAB-R) (74% consensus); emotional wellbeing: General Health Questionnaire (GHQ)-12 (83% consensus); quality of life: Stroke and Aphasia Quality of Life Scale (SAQOL-39) (96% consensus). Consensus was unable to be reached for measures of communication (where multiple measures exist) or patient-reported satisfaction with treatment or impact of treatment (where no measures exist). Discussion Harmonization of the ROMA COS with other core outcome initiatives in stroke rehabilitation is discussed. Ongoing research and consensus processes are outlined. Conclusion The WAB-R, GHQ-12, and SAQOL-39 are recommended to be routinely included within phases I–IV aphasia treatment studies. This consensus statement has been endorsed by the Collaboration of Aphasia Trialists, the British Aphasiology Society, the German Society for Aphasia Research and Therapy, and the Royal College of Speech Language Therapists.

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

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-019-1364-x ◽

2019 ◽

Vol 14 (1) ◽

Cited By ~ 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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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 ◽

10.1136/bmjopen-2018-024002 ◽

2019 ◽

Vol 9 (4) ◽

pp. e024002 ◽

Cited By ~ 2

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.

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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

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000700 ◽

2019 ◽

Vol 7 (1) ◽

pp. e000700 ◽

Cited By ~ 3

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.

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Core outcomes in neonatology: development of a core outcome set for neonatal research

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2019-317501 ◽

2019 ◽

Vol 105 (4) ◽

pp. 425-431 ◽

Cited By ~ 8

Author(s):

James William Harrison Webbe ◽

James M N Duffy ◽

Elsa Afonso ◽

Iyad Al-Muzaffar ◽

Ginny Brunton ◽

...

Keyword(s):

Clinical Trials ◽

Core Outcome Set ◽

Neonatal Care ◽

Consensus Meeting ◽

High Income ◽

Core Outcome ◽

Outcome Set ◽

Outcome Selection ◽

Survey Results ◽

Meta Analyses

BackgroundNeonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

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Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

10.21203/rs.3.rs-226692/v1 ◽

2021 ◽

Author(s):

Victoria Shepherd ◽

Fiona Wood ◽

Michael Robling ◽

Elizabeth Randell ◽

Kerenza Hood

Keyword(s):

Outcome Measurement ◽

Core Outcome Set ◽

Consensus Meeting ◽

Delphi Survey ◽

Additional Patient ◽

Trial Participation ◽

Core Outcome ◽

Capacity To Consent ◽

Outcome Set ◽

Participation Decisions

Abstract BackgroundTrials involving adults who lack capacity to provide consent for themselves rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Following decades of innovations to improve informed consent in trials, the first interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measurement in the evaluation of these novel interventions will impede comparisons between their effectiveness. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation on behalf of adults who lack capacity to consent.MethodsWe used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.ResultsA total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items. Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group. We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.ConclusionsThe study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. Further work is required to identify appropriate measures and timing of outcome measurement. Enhancing the quality of proxy decisions will help improve trial participation decisions for these vulnerable groups. Trial registration: The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

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Development of a core outcome set for evaluative research into paediatric cerebral visual impairment (CVI), in the UK and Eire

BMJ Open ◽

10.1136/bmjopen-2021-051014 ◽

2021 ◽

Vol 11 (9) ◽

pp. e051014

Author(s):

Anna Pease ◽

Trudy Goodenough ◽

Cath Borwick ◽

Rose Watanabe ◽

Christopher Morris ◽

...

Keyword(s):

Literature Review ◽

Visual Impairment ◽

Qualitative Interviews ◽

Core Outcome Set ◽

Well Being ◽

Consensus Meeting ◽

Future Research ◽

Core Outcome ◽

Outcome Set ◽

Cerebral Visual Impairment

ObjectivesCerebral visual impairment (CVI) comprises a heterogeneous group of brain-related vision problems. A core outcome set (COS) represents the most important condition-specific outcomes according to patients, carers, professionals and researchers. We aimed to produce a COS for studies evaluating interventions for children with CVI, to increase the relevance of research for families and professionals and thereby to improve outcomes for affected children.DesignWe used methods recommended by the Core Outcome Measures in Effectiveness Trials Initiative. These included a proportionate literature review of outcomes used in previous studies; qualitative interviews with children and families; a two-round Delphi survey involving parents, children and professionals and a consensus meeting to ratify the most important outcomes.SettingTelephone interviews and online Delphi surveys of participants who all lived in UK or Eire.ParticipantsEighteen parents and six young people were interviewed. Delphi participants (n=80 did both rounds) included professionals working with children who have CVI (teachers, orthoptists, ophthalmologists, optometrists, qualified teachers for visually impaired, family members (parents and siblings) and affected children.ResultsThe literature review included 13 studies yielding 37 outcomes. Qualitative interviews provided 22 outcomes. After combining and refining similar items, the first round contained 23 outcomes and the second 46. At the consensus meeting, 5 attendees recommended 27 outcomes for inclusion in the CVI COS, of which 15 were ratified as most important, including 4 related to vision; 1 to family well-being; 1 to adults around the child being informed about CVI and the rest to the child’s abilities to engage with people and surroundings.ConclusionsGood engagement from participants led to the development of a COS. Future research will be useful to identify the best ways to measure COS items and potentially to update this COS as more interventions for CVI are developed.Trial registration numberISRCTN13762177.

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