Dataset Information

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

ABSTRACT:

Introduction

Primary 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 analysis

Our 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 dissemination

We 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 number

Core Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1322.

SUBMITTER: Foley KA

PROVIDER: S-EPMC6937029 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Foley Kimberley A KA Venkatraman Tishya T Ram Bina B Ells Louisa L van Sluijs Esther E Hargreaves Dougal S DS Greaves Felix F Taghavi Azar Sharabiani Mansour M Viner Russell M RM Bottle Alex A Saxena Sonia S

BMJ open 20191217 12

<h4>Introduction</h4>Primary 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 ...[more]

PMID: 31852702

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Project description:ObjectivesTo develop a core outcome set (COS) for physical activity interventions in primary schools.DesignModified-Delphi study.SettingThe UK and international.Participants104 participants from four stakeholder groups (educators, public health professionals, health researchers, parents); 16 children (aged 8-9 years) from 1 London primary school.InterventionsPhysical activity interventions.MethodsFour-stage process: (1) outcomes extracted from relevant studies identified from an umbrella review and a focus group; (2) list of outcomes produced and domains established; (3) stakeholders completed a two-round Delphi survey by rating (Round 1) and re-rating (Round 2) each outcome on a nine-point Likert Scale from 'not important' to 'critical': a>70% participant threshold identified the outcomes rated 'critical' to measure, and outcomes important to children were identified through a workshop; and (4) a stakeholder meeting to achieve consensus of the outcomes to include in the COS.ResultsIn total, 74 studies were extracted from 53 reviews. A list of 50 outcomes was produced and three domains were established: 'physical activity and health' (16 outcomes), 'social and emotional health' (22 outcomes) and 'educational performance' (12 outcomes). 104 participants completed survey Round 1; 65 participants completed both rounds. In total, 13 outcomes met the threshold; children identified 8 outcomes. Fourteen outcomes achieved consensus to produce the COS: five outcomes for physical activity and health (diet (varied and balanced), energy, fitness, intensity of physical activity, sleep (number of hours)); seven outcomes for social and emotional health (anxiety, depression, enjoyment, happiness, self-esteem, stress, well-being); and two outcomes for educational performance (concentration, focus).ConclusionsWe have developed the first COS for physical activity interventions in primary schools in consultation with those interested in the development and application of an agreed standardised set of outcomes. Future studies including these outcomes will reduce heterogeneity across studies.Trial registration numberCore Outcome Measures in Effectiveness Trials Initiative registration number 1322; Results.

Project description:BackgroundCore outcome sets are standardised sets of outcomes that should be collected and reported for all clinical trials. They have been widely developed and are increasingly influential in clinical research, but despite this, their use in public health has been limited to date. The aim of this study was to develop a core outcome set for public health trials evaluating interventions to promote physical activity in the general adult population.MethodsThe core outcome set was developed using a three-stage approach: stage one: a review of literature to identify potential domains for inclusion in the core outcome set; stage two: a Delphi survey was carried out to reach consensus about which outcome domains to include in the core outcome set; and stage three: a second Delphi survey was conducted to determine how best to measure the outcome domains included in the core outcome set.ResultsA classification of 13 outcome domains of physical activity was developed (stage one). Twenty people completed round one of the first Delphi survey (stage two), reaching a consensus to include two domains in the core outcome set, 'device-based level of physical activity' (80.0%, n = 16) and 'health-related quality of life' (70.0%, n = 14). No further consensus on the remaining outcome domains was reached in round two. Nineteen people completed the second Delphi survey (stage three). Participants rated the accelerometer (mean rating = 3.89, on a scale of 1 (do not recommend) to 5 (highly recommend)) as the best device to measure level of physical activity, and the EQ-5D (73.7%, n = 14) as the most appropriate measure of health-related quality of life.ConclusionsThis study has made progress towards the development of a core outcome set for use in physical activity trials, however, there was limited consensus about which domains to include. The development of the core outcome set was challenged by the need for trial-specific outcomes, and the complexities of collecting, processing and reporting device-based data.

Project description:BackgroundTuberculosis (TB) management can be challenging in low- and middle-income countries (LMICs) not only because of its high burden but also the prolonged treatment period involving multiple drugs. With rapid development in mobile technology, mobile health (mHealth) interventions or using a mobile device for TB management has gained popularity. Despite the potential usefulness of mHealth interventions for TB, few studies have quantitatively synthesized evidence on its effectiveness, presumably because of variability in outcome measures reported in the literature.ObjectiveThe aim of this systematic review was to evaluate the outcome measures reported in TB mHealth literature in LMICs.MethodsMEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews were searched to identify mHealth intervention studies for TB (published up to May 2018) that reported any type of outcome measures. The extracted information included the study setting, types of mHealth technology used, target population, study design, and categories of outcome measures. Outcomes were classified into 13 categories including treatment outcome, adherence, process measure, perception, technical outcome, and so on. The qualitative synthesis of evidence focused on the categories of outcome measures reported by the type of mHealth interventions.ResultsA total of 27 studies were included for the qualitative synthesis of evidence. The study designs varied widely, ranging from randomized controlled trials to economic evaluations. A total of 12 studies adopted short message service (SMS), whereas 5 studies used SMS in combination with additional technologies or mobile apps. The study populations were also diverse, including patients with TB, patients with TB/HIV, health care workers, and general patients attending a clinic. There was a wide range of variations in the definition of outcome measures across the studies. Among the diverse categories of outcome measures, treatment outcomes have been reported in 14 studies, but only 6 of them measured the outcome according to the standard TB treatment definitions by the World Health Organization.ConclusionsThis critical evaluation of outcomes reported in mHealth studies for TB management suggests that substantial variability exists in reporting outcome measures. To overcome the challenges in evidence synthesis for mHealth interventions, this study can provide insights into the development of a core set of outcome measures by intervention type and study design.

Project description:ObjectiveTo develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women.MethodsA two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect on total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as "critical" and less than 15% as "limited."ResultsA total of 228 participants from five stakeholder groups from three lower middle-income countries, seven upper middle-income countries, and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine were related to offspring: gestational age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention.ConclusionThis core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined.Database registrationCOMET Initiative, http://www.comet-initiative.org/studies/details/603, REGISTRATION NUMBER: 603.

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

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