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

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

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

scholarly journals 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 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 Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcus Bateman ◽  
Jonathan P. Evans ◽  
Viana Vuvan ◽  
Val Jones ◽  
Adam C. Watts ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Health Care Professionals ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Outcome Evaluation ◽  
Core Outcome ◽  
Outcome Set ◽  
Lateral Elbow ◽  
Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

scholarly journals The development of a faecal incontinence core outcome set: an international Delphi study protocol

2021 ◽  
Vol 36 (3) ◽  
pp. 617-622
Author(s):  
Sadé Assmann ◽  
Daniel Keszthelyi ◽  
Jos Kleijnen ◽  
Merel Kimman ◽  
Foteini Anastasiou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Study Protocol ◽  
Faecal Incontinence ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Delphi Consensus ◽  
Link Type ◽  
Outcome Set

Abstract Purpose Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. Trial registration This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554. The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336.

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 Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Networks (PERN) study

2019 ◽  
Author(s):  
Simon Craig ◽  
Franz E Babl ◽  
Stuart R Dalziel ◽  
Charmaine Gray ◽  
Colin Powell ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Severe Asthma ◽  
Working Group ◽  
Core Outcome Set ◽  
Asthma Severity ◽  
Core Outcome ◽  
Acute Severe Asthma ◽  
Paediatric Asthma ◽  
Future Studies ◽  
Outcome Set

Abstract Background. Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency presentation. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. Methods / design. A five-stage approach will be used: (1) A comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) A Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) We will review current clinical practice guidelines, existing clinical trials, and literature regarding bedside assessment of asthma severity. We will then identify practice differences in clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials on acute paediatric asthma in the emergency department setting; (4) A retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications in children hospitalized with acute severe asthma, such as intubation, ICU admission, and death. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in an asthma ED population; (5) Finally, a meeting of the PERN asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients / families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials on acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. Discussion The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for RCTs in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

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