Development of a core outcome set for general intensive care unit patients-A protocol.
Journal
Acta anaesthesiologica Scandinavica
ISSN: 1399-6576
Titre abrégé: Acta Anaesthesiol Scand
Pays: England
ID NLM: 0370270
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
received:
06
12
2021
accepted:
19
12
2021
pubmed:
29
12
2021
medline:
12
3
2022
entrez:
28
12
2021
Statut:
ppublish
Résumé
Different outcomes are reported in randomised clinical trials (RCTs) in intensive care unit (ICU) patients, and no core outcome set (COS) is available for ICU patients in general. Accordingly, we aim to develop a COS for ICU patients in general. The COS will be developed in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Handbook, using a modified Delphi consensus process and semi-structured interviews involving adults who have survived acute admission to an ICU, family members, clinicians, researchers and other stakeholders. The modified Delphi process will include two steps. Step 1: conduction of a modified Delphi survey, developed and informed by combining the outputs of a literature search of outcomes in previous COSs and semi-structured interviews with key stakeholders. We plan at least two survey rounds to obtain consensus and refine the COS. Step 2: a consensus process regarding instruments or definitions to be recommended for the measurements of the outcomes selected in Step 1. A 'patient and public involvement panel' consisting of a smaller group of patients, family members, clinicians and researchers will be included in the development, analysis and interpretation of the COS. The outlined multiple method studies will establish a COS for ICU patients in general, which may be used to increase the standardisation and comparability of results of RCTs conducted in patients in the ICU setting.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
415-424Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
Références
Blackwood B, Marshall J, Rose L. Progress on core outcome sets for critical care research. Curr Opin Crit Care. 2015;21:439-444.
Turnbull AE, Rabiee A, Davis WE, et al. Outcome measurement in ICU survivorship research from 1970 to 2013: a scoping review of 425 publications. Crit Care Med. 2016;44:1267-1277.
Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1.0. Trials. 2017;18:280.
Needham DM, Sepulveda KA, Dinglas VD, et al. Core outcome measures for clinical research in acute respiratory failure survivors: an international modified delphi consensus study. Am J Respir Crit Care Med N Y. 2017;196:1122-1130.
Dinglas VD, Cherukuri SPS, Needham DM. Core outcomes sets for studies evaluating critical illness and patient recovery. Curr Opin Crit Care. 2020;26:489-499.
Carman KL, Dardess P, Maurer M, et al. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013;32:223-231.
Karazivan P, Dumez V, Flora L, et al. The patient-as-partner approach in health care: a conceptual framework for a necessary transition. Acad Med. 2015;90:437-441.
Connolly B, Denehy L, Hart N, Pattison N, Williamson P, Blackwood B. Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set. Trials. 2018;19:294.
Bagshaw SM, Stelfox HT, Johnson JA, et al. Long-term association between frailty and health-related quality of life among survivors of critical illness: a prospective multicenter cohort study. Crit Care Med. 2015;43:973-982.
Iwashyna TJ. Trajectories of recovery and dysfunction after acute illness, with implications for clinical trial design. Am J Respir Crit Care Med. 2012;186:302-304.
Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010;304:1787-1794.
Prescott HC, Angus DC. Enhancing recovery from sepsis: a review. JAMA. 2018;319:62-75.
Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-STAndardised protocol items: the COS-STAP statement. Trials. 2019;20:116.
Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-STAndards for reporting: the COS-STAR statement. PLoS Medicine. 2016;13:e1002148.
Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64:395-400.
Brookes ST, Macefield RC, Williamson PR, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials. 2016;17:409. doi:10.1186/s13063-016-1479-x
Prinsen CAC, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a “Core Outcome Set”-a practical guideline. Trials. 2016;17:449.
Granholm A, Kaas-Hansen BS, Kjaer M-BN, et al. Patient-important outcomes other than mortality in recent ICU trials: protocol for a scoping review. Acta Anaesthesiol Scand. 2021;65:1002-1007.
Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539-549.
Dumville JC, Torgerson DJ, Hewitt CE. Reporting attrition in randomised controlled trials. BMJ. 2006;332:969-971.
Malterud K, Siersma VD, Guassora AD. Sample size in qualitative interview studies: guided by information power. Qual Health Res. 2016;26:1753-1760.
Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Medicine. 2011;8:e1000393. doi:10.1371/journal.pmed.1000393
Sverrisson KÖ, Chew MS, Olkkola KT, Rehn M, Yli-Hankala A, Møller MH. Clinical practice guideline on gastrointestinal bleeding prophylaxis for critically ill patients: endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2021;65(4):549-550. doi:10.1111/aas.13773
Rehn M, Hyldmo PK, Magnusson V, et al. Scandinavian SSAI clinical practice guideline on pre-hospital airway management. Acta Anaesthesiol Scand. 2016;60:852-864.
Møller MH, Claudius C, Junttila E, et al. Scandinavian SSAI clinical practice guideline on choice of first-line vasopressor for patients with acute circulatory failure. Acta Anaesthesiol Scand. 2016;60:1347-1366.
Møller MH, Granholm A, Junttila E, et al. Scandinavian SSAI clinical practice guideline on choice of inotropic agent for patients with acute circulatory failure. Acta Anaesthesiol Scand. 2018;62:420-450.
Myles PS, Grocott MPW, Boney O, et al. Standardizing end points in perioperative trials: towards a core and extended outcome set. Br J Anaesth. 2016;116:586-589.
Granholm A, Perner A, Krag M, et al. Development and internal validation of the Simplified Mortality Score for the Intensive Care Unit (SMS-ICU). Acta Anaesthesiol Scand. 2018;62(3):336-346. doi:10.1111/aas.13048