Dataset Information

A Core Outcome Set for Pediatric Critical Care.

ABSTRACT:

Objectives

More children are surviving critical illness but are at risk of residual or new health conditions. An evidence-informed and stakeholder-recommended core outcome set is lacking for pediatric critical care outcomes. Our objective was to create a multinational, multistakeholder-recommended pediatric critical care core outcome set for inclusion in clinical and research programs.

Design

A two-round modified Delphi electronic survey was conducted with 333 invited research, clinical, and family/advocate stakeholders. Stakeholders completing the first round were invited to participate in the second. Outcomes scoring greater than 69% "critical" and less than 15% "not important" advanced to round 2 with write-in outcomes considered. The Steering Committee held a virtual consensus conference to determine the final components.

Setting

Multinational survey.

Patients

Stakeholder participants from six continents representing clinicians, researchers, and family/advocates.

Measurements and main results

Overall response rates were 75% and 82% for each round. Participants voted on seven Global Domains and 45 Specific Outcomes in round 1, and six Global Domains and 30 Specific Outcomes in round 2. Using overall (three stakeholder groups combined) results, consensus was defined as outcomes scoring greater than 90% "critical" and less than 15% "not important" and were included in the final PICU core outcome set: four Global Domains (Cognitive, Emotional, Physical, and Overall Health) and four Specific Outcomes (Child Health-Related Quality of Life, Pain, Survival, and Communication). Families (n = 21) suggested additional critically important outcomes that did not meet consensus, which were included in the PICU core outcome set-extended.

Conclusions

The PICU core outcome set and PICU core outcome set-extended are multistakeholder-recommended resources for clinical and research programs that seek to improve outcomes for children with critical illness and their families.

SUBMITTER: Fink EL

PROVIDER: S-EPMC7785252 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Core Outcome Set for Pediatric Critical Care.

Fink Ericka L EL Maddux Aline B AB Pinto Neethi N Sorenson Samuel S Notterman Daniel D Dean J Michael JM Carcillo Joseph A JA Berg Robert A RA Zuppa Athena A Pollack Murray M MM Meert Kathleen L KL Hall Mark W MW Sapru Anil A McQuillen Patrick S PS Mourani Peter M PM Wessel David D Amey Deborah D Argent Andrew A Brunow de Carvalho Werther W Butt Warwick W Choong Karen K Curley Martha A Q MAQ Del Pilar Arias Lopez Maria M Demirkol Demet D Grosskreuz Ruth R Houtrow Amy J AJ Knoester Hennie H Lee Jan Hau JH Long Debbie D Manning Joseph C JC Morrow Brenda B Sankar Jhuma J Slomine Beth S BS Smith McKenna M Olson Lenora M LM Watson R Scott RS

Critical care medicine 20201201 12

<h4>Objectives</h4>More children are surviving critical illness but are at risk of residual or new health conditions. An evidence-informed and stakeholder-recommended core outcome set is lacking for pediatric critical care outcomes. Our objective was to create a multinational, multistakeholder-recommended pediatric critical care core outcome set for inclusion in clinical and research programs.<h4>Design</h4>A two-round modified Delphi electronic survey was conducted with 333 invited research, cl ...[more]

PMID: 33048905

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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:Study objectiveStillbirth is burdensome in low-income and middle-income countries (LMICs), especially in sub-Saharan Africa and South Asia. Currently, there are two core outcome sets (COS) for stillbirth (prevention and bereavement care), but these were developed with limited reflection of the needs of parents in an LMIC setting. To address this gap, the objective of this study was to establish consensus on the most important outcomes for stillbirth prevention and bereavement care following stillbirth in sub-Saharan Africa and South Asia.MethodsPrevious stillbirth outcomes were reviewed for inclusion into the COS by senior research leaders and community engagement and involvement members from six sub-Saharan African and two South Asian countries. An online real-time Delphi survey was then conducted with healthcare professionals, parents who have experienced a stillbirth and researchers in the field to score the agreed list. The results of the Delphi were summarised and then discussed at a virtual consensus meeting where the final COS were agreed.Results287 participants contributed towards the Delphi (143 midwives, 32 obstetricians, 50 mothers, 12 fathers and 50 researchers), with at least 2 parents attending the full consensus meetings. Consensus was reached on 13 core outcomes for stillbirth prevention covering 5 domains: obstetric, fetal, perinatal and neonatal outcomes and maternal complications. For bereavement care following a stillbirth, five core outcomes reached a consensus, which included outcomes related to labour and birth, a postpartum complication, care experience, mental health and emotional and social well-being.DiscussionThese COS will improve the consistency of outcomes for future research in an LMIC setting. Additionally, they will complement existing COS for stillbirth prevention and bereavement care developed in high-income settings. The output from this work will move us towards a global set of outcomes that can be used in stillbirth research worldwide.

Project description:IntroductionStillbirth is associated with significant physical, psychosocial and economic consequences for parents, families, wider society and the healthcare system. There is emerging momentum to design and evaluate interventions for care after stillbirth and in subsequent pregnancies. However, there is insufficient evidence to inform clinical practice compounded by inconsistent outcome reporting in research studies. To address this paucity of evidence, we plan to develop a core outcome set for stillbirth care research, through an international consensus process with key stakeholders including parents, healthcare professionals and researchers.Methods and analysisThe development of this core outcome set will be divided into five distinct phases: (1) Identifying potential outcomes from a mixed-methods systematic review and analysis of interviews with parents who have experienced stillbirth; (2) Creating a comprehensive outcome long-list and piloting of a Delphi questionnaire using think-aloud interviews; (3) Choosing the most important outcomes by conducting an international two-round Delphi survey including high-income, middle-income and low-income countries; (4) Deciding the core outcome set by consensus meetings with key stakeholders and (5) Dissemination and promotion of the core outcome set. A parent and public involvement panel and international steering committee has been convened to coproduce every stage of the development of this core outcome set.Ethics and disseminationEthical approval for the qualitative interviews has been approved by Berkshire Ethics Committee REC Reference 12/SC/0495. Ethical approval for the think-aloud interviews, Delphi survey and consensus meetings has been awarded from the University of Bristol Faculty of Health Sciences Research Ethics Committee (Reference number: 116535). The dissemination strategy is being developed with the parent and public involvement panel and steering committee. Results will be published in peer-reviewed specialty journals, shared at national and international conferences and promoted through parent organisations and charities.Prospero registration numberCRD42018087748.

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.

Dataset Information

A Core Outcome Set for Pediatric Critical Care.

Objectives

Design

Setting

Patients

Measurements and main results

Conclusions

Publications

A Core Outcome Set for Pediatric Critical Care.

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