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A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

ABSTRACT: OBJECTIVE:To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. METHODS:A 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." RESULTS:A 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. CONCLUSION:This 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 REGISTRATION:COMET Initiative, http://www.comet-initiative.org/studies/details/603, REGISTRATION NUMBER: 603.

SUBMITTER: van ?t Hooft J

PROVIDER: S-EPMC7734878 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

van 't Hooft Janneke J Duffy James M N JMN Daly Mandy M Williamson Paula R PR Meher Shireen S Thom Elizabeth E Saade George R GR Alfirevic Zarko Z Mol Ben Willem J BWJ Khan Khalid S KS

Obstetrics and gynecology 20160101 1

<h4>Objective</h4>To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women.<h4>Methods</h4>A 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. Outcom ...[more]

PMID: 26646133

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Project description:BackgroundPeople living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having an agreed set of outcomes that are used in all relevant trials can ensure that study results can be compared.ObjectiveThe aim of the study was to develop a core outcome set (COS) for trials assessing the effectiveness of pharmacological and non-pharmacological interventions for preventing COVID-19 infection and transmission in care homes.MethodsThe study used established COS methodology. A list of candidate outcomes was identified by reviewing registered trials to evaluate interventions to prevent COVID-19 in care homes. Seventy key stakeholders participated in a Delphi survey, rating the candidate outcomes on a nine-point scale over two rounds, with the opportunity to propose additional outcomes. Stakeholders included care home representatives (n = 19), healthcare professionals (n = 20), people with personal experience of care homes (n = 7), researchers (n = 15) and others (n = 9). Outcomes were eligible for inclusion if they met an a priori threshold. A consensus meeting with stakeholders resulted in agreement of the final outcome set.ResultsFollowing the Delphi and consensus meeting, twenty-four outcomes were recommended for inclusion. These are grouped across four domains of infection, severity of illness, mortality, and 'other' (intervention specific or life impact). Due to the considerable heterogeneity between care homes, residents, and interventions, the relevance and importance of outcomes may differ between trial contexts. Intervention-specific outcomes would be included only where relevant to a given trial, thus reducing the measurement burden.ConclusionUsing a rapid response approach, a COS for COVID-19 prevention interventions in care homes has been developed. Future work should focus on identifying instruments for measuring these outcomes, and the interpretation and application of the COS across different trial contexts. Beyond COVID-19, the outcomes identified in this COS may have relevance to other infectious diseases in care homes, and the rapid response approach may be useful as preparation for future pandemics.

Project description:BackgroundCongenital diaphragmatic hernia (CDH) is, depending of the severity, a birth defect associated with significant mortality and morbidity. Prenatal screening by ultrasound may detect this condition and comprehensive assessment of severity is possible, allowing for in utero referral to an experienced centre for planned delivery. In an effort to improve outcomes, prenatal interventions to stimulate lung development were proposed. Along the same lines, new postnatal management strategies are being developed. In order to enable proper comparison of novel perinatal interventions as well as outcomes, a set of uniform and relevant outcome measures is required. Core outcome sets (COS) are agreed, clearly defined sets of outcomes to be measured in a standardised manner and reported consistently. Herein we aim to describe the methodology we will use to define a COS for perinatal and neonatal outcomes of foetuses and newborns with congenital diaphragmatic hernia and to draft a dissemination and implementation plan.MethodsWe will use the methodology described in the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Handbook. An international steering group will be created to guide the development of the COS. We are systematically reviewing the literature to identify all potential relevant pre- and neonatal outcomes previously used in studies on perinatal interventions for CDH. We will build a consensus on these core outcomes in a stakeholder group using the Delphi method. After completion, a stakeholder meeting will decide on a final COS, using a modified Nominal Group Technique. Thereafter, we will review potential definitions and measurements of these outcomes, and again a consensus meeting will be organised, to finalise the COS before dissemination.DiscussionWe have started a procedure to develop a COS for studies on perinatal interventions for congenital diaphragmatic hernia, with the purpose of improving the quality of research, guide clinical practice and improve patient care and eventual use in future clinical trials, systematic reviews and clinical practice guidelines.Trial registrationWe prospectively registered this study in the International Prospective Register of Systematic Reviews (PROSPERO) (registration number: CRD42019124399 ) and The Core Outcome Measures in Effectiveness Trials (COMET) Initiative (registration number: 1296 ).

Project description:To gain consensus on measurement methods for outcomes (delirium occurrence, severity, time to resolution, mortality, health-related quality of life [HrQoL], emotional distress including anxiety, depression, acute stress, and post-traumatic stress disorder, and cognition) of our Core Outcome Set (COS) for trials of interventions to prevent and/or treat delirium in critically ill adults.DesignInternational consensus process.SettingThree virtual meetings (April 2021).Patients/subjectsCritical illness survivors/family, clinicians, and researchers from six Countries.InterventionsNone.Measurements and main resultsMeasures (selected based on instrument validity, existing recommendations, and feasibility) and measurement time horizons were discussed. Participants voted on instruments and measurement timing (a priori consensus threshold ≥ 70%). Eighteen stakeholders (28% ICU survivors/family members) participated. We achieved consensus on the Confusion Assessment Method-ICU or Intensive Care Delirium Screening Checklist to measure delirium occurrence and delirium resolution (100%), Hospital Anxiety and Depression Scale for emotional distress (71%), and Montreal Cognitive Assessment-Blind for cognition (83%). We did not achieve consensus on EQ-5D five-level for HrQoL (69%) or its measurement at 6 months. We also did not achieve consensus on the Impact of Event Scale (IES)-Revised or IES-6 for post-traumatic stress (65%) or on measurement instruments for delirium severity incorporating delirium-related emotional distress. We were unable to gain consensus on when to commence and when to discontinue assessing for delirium occurrence and time to resolution, when to determine mortality. We gained consensus that emotional distress and cognition should be measured up to 12 months from hospital discharge.ConclusionsConsensus was reached on measurement instruments for four of seven outcomes in the COS for delirium prevention or treatment trials for critically ill adults. Further work is required to validate instruments for delirium severity that include delirium-related emotional distress.

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:IntroductionThe aim of this study is to explore outcomes currently reported in physiotherapy trials for bronchiectasis and investigate the level of consistency in outcome reporting. This mapping of outcomes will be used to inform the development of a core outcome set (COS) for physiotherapy research in bronchiectasis. Outcomes reported in randomised clinical trials (RCTs) and RCT protocols were reviewed and evaluated. We included trials with physiotherapy as the main intervention, including pulmonary rehabilitation, exercise prescription, airway clearance, positive expiratory pressure devices, breathing training, self-management plans, and home exercise program. Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and the physiotherapy evidence database (PEDro) were searched from inception using a prespecified search strategy. Records including adult patients with bronchiectasis were included. Outcomes were listed verbatim and categorised into domains based on a pre-specified system, frequency of reporting and sources of variation were inspected.ResultsOf 2158 abstracts screened, 37 trials (1202 participants) and 17 trial protocols were identified. Eighteen different physiotherapy techniques were investigated. A total of 331 outcomes were reported. No single outcome was reported by all trials. The most reported outcomes were lung function (27 trials, 50%), health related quality of life (26 trials, 48.1%), and dyspnoea (18 trials, 33.3%). A list of 104 unique outcomes covering 23 domains was created. Trials focus on physiological outcomes, mainly those related to respiratory system functions. Outcomes related to functioning and life impact are often neglected.ConclusionOutcome reporting in physiotherapy research for bronchiectasis was found to be inconsistent in terms of choosing and defining outcomes. Developing a core outcome set in this area of research is needed to facilitate aggregation of future trial results in systematic reviews that will in turn inform the strength of evidence for the effectiveness of physiotherapy. Outcome choice should include all stakeholders, including patients.Trial registrationThis study is registered in the PROSPERO registry under the number CRD42021266247.

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A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

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A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

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