Development of a core outcome set for general intensive care unit patients – a protocol

2021 ◽  
Author(s):  
Maj‐Brit Nørregaard Kjær ◽  
Anders Granholm ◽  
Gitte Kingo Vesterlund ◽  
Stine Estrup ◽  
Praleene Sivapalan ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Core Outcome Set ◽  
General Intensive Care Unit ◽  
Core Outcome ◽  
Outcome Set

scholarly journals A core outcome set for studies evaluating interventions to prevent and/or treat delirium for adults requiring an acute care hospital admission: an international key stakeholder informed consensus study

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Louise Rose ◽  
Lisa Burry ◽  
Meera Agar ◽  
Bronagh Blackwood ◽  
Noll L. Campbell ◽  
...  
Keyword(s):  
Systematic Review ◽  
Intensive Care Unit ◽  
Acute Care ◽  
Qualitative Interviews ◽  
Core Outcome Set ◽  
Family Members ◽  
Acute Care Hospital ◽  
Care Hospital ◽  
Core Outcome ◽  
Outcome Set

Abstract Background Trials of interventions to prevent or treat delirium in adults in an acute hospital setting report heterogeneous outcomes. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in adults with an acute care hospital admission and not admitted to an intensive care unit. Methods A rigorous COS development process was used including a systematic review, qualitative interviews, modified Delphi consensus process, and in-person consensus using nominal group technique (registration http://www.comet- initiative.org/studies/details/796). Participants in qualitative interviews were delirium survivors or family members. Participants in consensus methods comprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivors and family members. Results Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30 outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. De-duplication of outcomes and formal consensus processes involving 110 experts including researchers (N = 32), clinicians (N = 63), and delirium survivors and family members (N = 15) resulted in a COS comprising 6 outcomes: delirium occurrence and reoccurrence, delirium severity, delirium duration, cognition, emotional distress, and health-related quality of life. Study limitations included exclusion of non-English studies and stakeholders and small representation of delirium survivors/family at the in-person consensus meeting. Conclusions This COS, endorsed by the American and Australian Delirium Societies and European Delirium Association, is recommended for future clinical trials evaluating delirium prevention or treatment interventions in adults presenting to an acute care hospital and not admitted to an intensive care unit.

Sahnan K, Tozer PJ, Adegbola SO, et al (2019) Developing a Core Outcome Set for Fistulising Perianal Crohn’s Disease Gut 68:226–38

2020 ◽  
Vol 14 (2) ◽  
pp. 100-101
Author(s):  
D. Bouchard ◽  
L. Tracanelli ◽  
F. Pigot
Keyword(s):  
Crohn’S Disease ◽  
Qualité De Vie ◽  
Maladie De Crohn ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Perianal Crohn’S Disease ◽  
Revue De La Littérature ◽  
Outcome Set ◽  
Maladies Inflammatoires Intestinales ◽  
Perianal Crohn's Disease

Objectif : L’absence de standardisation des objectifs à atteindre par les traitements des fistules anopérinéales (FAP) de la maladie de Crohn limite les possibilités d’analyse et de comparaison des données issues des études disponibles. L’élaboration d’une liste standardisée d’objectifs à atteindre permettrait de résoudre ces problèmes. Cette étude valide la liste d’objectifs cruciaux (core outcome set [COS]) à atteindre pour le Crohn fistulisant. Méthode : Les objectifs susceptibles d’être retenus ont été définis par une revue de la littérature et des interviews de patients. La sélection consensuelle a été établie à l’issue d’un processus Delphi en trois étapes en évaluant sur une échelle de Likert en neuf points, l’importance que ces objectifs avaient pour définir la réussite d’un traitement. Des représentants de chacun des trois groupes impliqués dans ces traitements ont été recrutés à l’échelle nationale (chirurgiens et radiologistes, gastroentérologues et infirmières spécialisées en maladies inflammatoires intestinales, et enfin patients). Chaque intervenant a noté les différents objectifs possibles, puis a corrigé ses notes après avoir pris connaissance des autres notes données par les membres de son groupe (au deuxième tour) puis encore une fois après avoir pris connaissance des notations données par tous les participants (au troisième tour). Résultats : Au total, 295 objectifs potentiels ont été identifiés à partir d’une revue de la littérature et d’interviews, ils ont été catégorisés en 92 domaines. Cent quatre-vingt-sept participants (taux de réponse : 78,5 %) ont accordé la priorité à 49 objectifs à l’issue d’une méthode Delphi à trois cycles. Une réunion de consensus finale de 41 experts et patients s’est accordée sur un COS comprenant huit catégories d’objectifs. Ce COS comprenait trois catégories d’objectifs importants pour le patient (qualité de vie, incontinence et score combiné des priorités du patient) et cinq catégories d’objectifs retenus par les praticiens (activité de la maladie périanale, développement d’un nouvel abcès périanal, fistule nouvelle/récidivante, chirurgie non planifiée et dérivation fécale). Conclusion : Un COS sur les FAP de laMC a été élaboré par tous les acteurs clés de cette maladie. L’utilisation du COS diminuera l’hétérogénéité dans l’expression des résultats des traitements, ce qui rendra plus pertinente la comparaison des traitements entre eux, la synthèse des données et, en fin de compte, les soins rendus aux patients.

Postinflammatory hyperpigmentation: protocol for development of a core outcome set for clinical trials

2021 ◽  
Author(s):  
Bianca Y. Kang ◽  
Sarah A. Ibrahim ◽  
Divya Shokeen ◽  
Daniel I. Schlessinger ◽  
Jamie J. Kirkham ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Postinflammatory Hyperpigmentation

Development of a Core outcome set for Venous leg ulceration (CoreVen) research evaluations (protocol)

2021 ◽  
Author(s):  
Sarah Hallas ◽  
Andrea Nelson ◽  
Susan O’Meara ◽  
Una Adderley ◽  
Pauline Meskell ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set

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.

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