scholarly journals Proposing a Core Outcome Set for Physical Activity and Exercise Interventions in People With Rare Neurological Conditions

2021 ◽  
Vol 2 ◽  
Author(s):  
Gita Ramdharry ◽  
Valentina Buscemi ◽  
Annette Boaz ◽  
Helen Dawes ◽  
Thomas Jaki ◽  
...  
Keyword(s):  
Physical Activity ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Well Being ◽  
Core Outcome ◽  
Exercise Interventions ◽  
Physical Activity Interventions ◽  
Outcome Set ◽  
Neurological Conditions ◽  
Meta Analyses

Rare neurological conditions (RNCs) encompass a variety of diseases that differ in progression and symptoms but typically include muscle weakness, sensory and balance impairment and difficulty with coordinating voluntary movement. This can limit overall physical activity, so interventions to address this are recommended. The aim of this study was to agree a core outcome measurement set for physical activity interventions in people living with RNCs. We followed established guidelines to develop core outcome sets. Broad ranging discussions in a series of stakeholder workshops led to the consensus that (1) physical well-being; (2) psychological well-being and (3) participation in day-to-day activities should be evaluated in interventions. Recommendations were further informed by a scoping review of physical activity interventions for people living with RNCs. Nearly 200 outcome measures were identified from the review with a specific focus on activities or functions (e.g, on lower limb function, ability to perform daily tasks) but limited consideration of participation based outcomes (e.g., social interaction, work and leisure). Follow on searches identified two instruments that matched the priority areas: the Oxford Participation and Activities Questionnaire and the Sources of Self-Efficacy for Physical Activity. We propose these scales as measures to assess outcomes that are particularly relevant to assess when evaluating physical activity interventions mong people with RNCs. Validation work across rare neurological conditions is now required to inform application of this core outcome set in future clinical trials to facilitate syntheses of results and meta-analyses.

scholarly journals Impact of school-based physical activity interventions in primary schools: measuring what matters

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
B Ram ◽  
T Venkatraman ◽  
K Foley ◽  
K Honeyford ◽  
L Ells ◽  
...  
Keyword(s):  
Physical Activity ◽  
Emotional Health ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Future Studies ◽  
Physical Activity Interventions ◽  
School Based ◽  
Key Stakeholders ◽  
Outcome Set

Abstract Background A growing number of small studies suggest that school-based physical activity initiatives can help children achieve the recommended 60 minutes of physical activity per day. However, the heterogeneity of outcomes and measures used in small studies prevents pooling of results to demonstrate whether short-term health benefits are sustained. Qualitative studies suggest many benefits that are not represented by outcomes in trials to date. The aim of this study was to generate a list of outcomes that have been studied to develop a core outcome set (COS) acceptable to key stakeholders for future studies evaluating school-based physical activity initiatives. Methods We searched six databases (MEDLINE, EMBASE, PsycINFO, CINAHL, CENTRAL and Cochrane Database of Systematic Reviews) systematically for reviews of school-based physical activity interventions, and extracted relevant studies to identify the outcomes and measures used in each paper. A long list was generated from the literature and a previous workshop with stakeholders. This study is registered with COMET (#1322), and with PROSPERO (CRD42019146621). Results 75/121 cited studies drawn from 53/2409 reviews met our inclusion criteria. We grouped 65 outcomes into 3 domains: (i) physical activity and health (ii) social and emotional health, and (iii) educational attainment. We will conduct two Delphi survey rounds with four stakeholder groups (health professionals, researchers, educators and parents) to rate the importance of each outcome. A core outcome set will be generated from a consensus process. Conclusions There is currently a large variation of outcomes and measures studied that precludes evidence synthesis of the impact of school-based physical activity interventions. Consensus methods are needed to focus research on the outcomes that matter the most to key stakeholders and to provide tools for future studies to assess long-term impact. Key messages Variations in outcomes studied precludes evidence synthesis of SBPA intervention impacts. A core outcome set is needed to ensure future SBPA interventions measure outcomes that matter the most.

scholarly journals Protocol for developing a core outcome set for evaluating school-based physical activity interventions in primary schools

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031868
Author(s):  
Kimberley A Foley ◽  
Tishya Venkatraman ◽  
Bina Ram ◽  
Louisa Ells ◽  
Esther van Sluijs ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Primary School ◽  
Primary Schools ◽  
Core Outcome Set ◽  
Primary School Children ◽  
Core Outcome ◽  
Physical Activity Interventions ◽  
School Based ◽  
Outcome Set

IntroductionPrimary school-based physical activity interventions, such as The Daily Mile initiative, have the potential to increase children’s physical activity levels over time, which is associated with a variety of health benefits. Comparing interventions or combining results of several studies of a single intervention is challenging because previous studies have examined different outcomes or used different measures that are not feasible or relevant for researchers in school settings. The development and implementation of a core outcome set (COS) for primary school-based physical activity interventions would ensure outcomes important to those involved in implementing and evaluating interventions are standardised.Methods and analysisOur aim is to develop a COS for studies of school-based physical activity interventions. We will achieve this by undertaking a four-stage process:(1) identify a list of outcomes assessed in studies through a systematic review of international literature; (2) establish domains from these outcomes to produce questionnaire items; (3) prioritise outcomes through a two-stage Delphi survey with four key stakeholder groups (researchers, public health professionals, educators and parents), where stakeholders rate the importance of each outcome on a 9-point Likert scale (consensus that the outcomes should be included in the COS will be determined as 70% or more of all stakeholders scoring the outcome 7%–9% and 15% or less scoring 1 to 3); (4) achieve consensus on a final COS in face-to-face meetings with a sample of stakeholders and primary school children.Ethics and disseminationWe have received ethical approval from Imperial College London (ref: 19IC5428). The results of this study will be disseminated via conference presentations/public health meetings, peer-reviewed publications and through appropriate media channels.Trial registration numberCore Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1322.

scholarly journals Core outcomes in children and adolescents with overweight/obesity exposed to physical activity interventions: protocol for the development of a core outcome set

2020 ◽  
Author(s):  
Cíntia Ehlers Botton ◽  
Angélica Trevisan De Nardi ◽  
Lucinéia Orsolin Pfeifer ◽  
Lucas Porto Santos ◽  
Larissa Xavier Neves da Silva ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Children And Adolescents ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Obese Children ◽  
Physical Activity Interventions ◽  
Outcome Set ◽  
Core Outcomes

This is the protocol for development of a COS related to clinical trials with physical activity interventions for overweight or obese children and adolescents, as well as categorize them into specific domains.

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

2019 ◽  
Vol 105 (4) ◽  
pp. 425-431 ◽  
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.

scholarly journals 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)

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)

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

BMJ Open ◽  
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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