Dataset Information

A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study.

ABSTRACT: Heterogeneity of descriptors and outcomes measured and reported in sedentary behaviour (SB) research hinder the meta-analysis of data and accumulation of evidence. The objective of the Core Research Outcomes for Sedentary Behaviour Interventions (CROSBI) consensus study was to identify and validate, a core outcome set (COS) to report (what, how, when to measure) in interventional sedentary behaviour studies. Outcomes, extracted from a systematic literature review, were categorized into domains and data items (COS v0.0). International experts (n = 5) provided feedback and identified additional items, which were incorporated into COS v0.1. A two round online Delphi survey was conducted to seek consensus from a wider stakeholder group and outcomes that achieved consensus in the second round COS (v0.2), were ratified by the expert panel. The final COS (v1.0) contains 53 data items across 12 domains, relating to demographics, device details, wear-time criteria, wear-time measures, posture-related measures, sedentary breaks, sedentary bouts and physical activity. Notably, results indicate that sedentary behaviour outcomes should be measured by devices that include an inclinometry or postural function. The proposed standardised COS is available openly to enhance the accumulation of pooled evidence in future sedentary behaviour intervention research and practice.

SUBMITTER: Curran F

PROVIDER: S-EPMC9367894 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study.

Curran Fiona F Dowd Kieran P KP Peiris Casey L CL van der Ploeg Hidde P HP Tremblay Mark S MS O'Donoghue Grainne G

International journal of environmental research and public health 20220805 15

Heterogeneity of descriptors and outcomes measured and reported in sedentary behaviour (SB) research hinder the meta-analysis of data and accumulation of evidence. The objective of the Core Research Outcomes for Sedentary Behaviour Interventions (CROSBI) consensus study was to identify and validate, a core outcome set (COS) to report (what, how, when to measure) in interventional sedentary behaviour studies. Outcomes, extracted from a systematic literature review, were categorized into domains a ...[more]

PMID: 35955024

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Project description:BackgroundDegenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further "how" these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research.Methods and findingsA minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery.ConclusionsThe AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS.

Project description:ObjectivesTo identify a PICU Core Outcome Measurement Set (PICU COMS), a set of measures that can be used to evaluate the PICU Core Outcome Set (PICU COS) domains in PICU patients and their families.DesignA modified Delphi consensus process.SettingFour webinars attended by PICU physicians and nurses, pediatric surgeons, rehabilitation physicians, and scientists with expertise in PICU clinical care or research ( n = 35). Attendees were from eight countries and convened from the Pediatric Acute Lung Injury and Sepsis Investigators Pediatric Outcomes STudies after PICU Investigators and the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network PICU COS Investigators.SubjectsMeasures to assess outcome domains of the PICU COS are as follows: cognitive, emotional, overall (including health-related quality of life), physical, and family health. Measures evaluating social health were also considered.InterventionsNone.Measurements and main resultsMeasures were classified as general or additional based on generalizability across PICU populations, feasibility, and relevance to specific COS domains. Measures with high consensus, defined as 80% agreement for inclusion, were selected for the PICU COMS. Among 140 candidate measures, 24 were delineated as general (broadly applicable) and, of these, 10 achieved consensus for inclusion in the COMS (7 patient-oriented and 3 family-oriented). Six of the seven patient measures were applicable to the broadest range of patients, diagnoses, and developmental abilities. All were validated in pediatric populations and have normative pediatric data. Twenty additional measures focusing on specific populations or in-depth evaluation of a COS subdomain also met consensus for inclusion as COMS additional measures.ConclusionsThe PICU COMS delineates measures to evaluate domains in the PICU COS and facilitates comparability across future research studies to characterize PICU survivorship and enable interventional studies to target long-term outcomes after critical illness.

Project description:ImportanceVasa previa, although a rare condition affecting 0.46 per 1000 pregnancies, results in high rates of fetal and neonatal mortality and morbidity. Widespread use of a core outcome set and reporting checklist may enable data harmonization, enhance evidence synthesis, and ensure prioritization of patient-important outcomes in clinical practice, future research, and clinical practice guidelines.ObjectiveTo develop a core outcome set for studies on vasa previa that includes perinatal screening, diagnosis, and management of vasa previa.Design, setting, and participantsThis survey study involved a 2-round international and cross-disciplinary Delphi survey and virtual consensus meetings conducted between March 14, 2021, and October 4, 2022. Health care professionals (HCPs) and health service users (HSUs) were invited to participate in the development of the core outcome set.ExposurePerinatal screening, diagnosis, and management of vasa previa.Main outcome and measuresCore outcomes and reporting checklist items for future studies on vasa previa were developed using Delphi surveys, small group discussions, and a consensus meeting.ResultsAn international group of 204 participants, comprising 115 HSUs and 89 HCPs representing 27 countries, rated 67 outcomes identified through a systematic review and qualitative interviews in a 2-round online Delphi survey. Through virtual small group discussions and a consensus meeting, 13 core outcomes were identified: pregnancy outcome (live birth, fetal loss [miscarriage or stillbirth], or neonatal death), severe neonatal morbidity, fetal/neonatal blood loss, neonatal intensive care unit admission for >24 hours, gestational age at birth, third trimester confirmation of vasa previa diagnosis, neurocognitive and developmental outcomes, mode of birth, maternal death or severe morbidity, maternal quality of life, duration of antepartum admission, and antepartum or peripartum hemorrhage. A 22-item reporting checklist was simultaneously developed to include important items in studies on vasa previa when possible and/or relevant.Conclusions and relevanceThe core outcome set and reporting checklist for vasa previa are hoped to encourage researchers to incorporate patient-important outcomes in future studies to enable data harmonization, improve evidence synthesis, and facilitate the development of clinical practice guidelines for this rare and highly lethal condition for which timely diagnosis and management may prevent fetal and maternal morbidity and mortality.

Project description:BACKGROUND:Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. METHODS:The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. DISCUSSION:This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.

Project description:ObjectiveEvidence for the management of acute otitis externa (AOE) is limited, with unclear diagnostic criteria and variably reported outcome measures that may not reflect key stakeholder priorities. We aimed to develop 1) a definition, 2) diagnostic criteria and 3) a core outcome set (COS) for AOE.Study designCOS development according to Core Outcome Measures in Effectiveness Trials (COMET) methodology and parallel consensus selection of diagnostic criteria/definition.SettingStakeholders from the United Kingdom.Subjects and methodsComprehensive literature review identified candidate items for the COS, definition and diagnostic criteria. Nine individuals with past AOE generated further patient-centred candidate items. Candidate items were rated for importance by patient and professional (ENT doctors, general practitioners, microbiologists, nurses, audiologists) stakeholders in a three-round online Delphi exercise. Consensus items were grouped to form the COS, diagnostic criteria, and definition.ResultsCandidate COS items from patients (n = 28) and literature (n = 25) were deduplicated and amalgamated to a final candidate list (n = 46). Patients emphasised quality-of-life and the impact on daily activities/work. Via the Delphi process, stakeholders agreed on 31 candidate items. The final COS covered six outcomes: pain; disease severity; impact on quality-of-life and daily activities; patient satisfaction; treatment-related outcome; and microbiology. 14 candidate diagnostic criteria were identified, 8 reaching inclusion consensus. The final definition for AOE was 'diffuse inflammation of the ear canal skin of less than 6 weeks duration'.ConclusionThe development and adoption of a consensus definition, diagnostic criteria and a COS will help to standardise future research in AOE, facilitating meta-analysis. Consulting former patients throughout development highlighted deficiencies in the outcomes adopted previously, in particular concerning the impact of AOE on daily life.

Dataset Information

A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study.

Publications

A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study.

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