scholarly journals Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension: Statistical and health economic analysis plan for the 65 trial in article

2020 ◽  
Vol 21 (3) ◽  
pp. 230-231
Author(s):  
Karen Thomas ◽  
Akshay Patel ◽  
M Zia Sadique ◽  
Richard D Grieve ◽  
Alexina J Mason ◽  
...  
Keyword(s):  
Health Economic ◽  
Economic Analysis ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Health Economic Analysis ◽  
Permissive Hypotension ◽  
Critical Care Units ◽  
Parallel Group

The 65 trial is a pragmatic, multicentre, parallel-group, open-label, randomised clinical trial of permissive hypotension (targeting a mean arterial pressure target of 60–65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial will recruit 2600 patients from 65 United Kingdom adult general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. This paper describes the proposed statistical and health economic analysis for the 65 trial.

scholarly journals Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension: Statistical and Health Economic Analysis Plan for the 65 trial

2019 ◽  
pp. 175114371986038 ◽  
Author(s):  
Karen Thomas ◽  
Akshay Patel ◽  
M Zia Sadique ◽  
Richard D Grieve ◽  
Alexina J Mason ◽  
...  
Keyword(s):  
Health Economic ◽  
Economic Analysis ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Health Economic Analysis ◽  
Permissive Hypotension ◽  
Critical Care Units ◽  
Parallel Group

The 65 trial is a pragmatic, multicentre, parallel-group, open-label, randomised clinical trial of permissive hypotension (targeting a mean arterial pressure target of 60–65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial will recruit 2600 patients from 65 United Kingdom adult general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. This paper describes the proposed statistical and health economic analysis for the 65 trial.

scholarly journals Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension: Protocol for the 65 randomised clinical trial

2020 ◽  
Vol 21 (4) ◽  
pp. 281-282
Author(s):  
Alvin Richards-Belle ◽  
Paul R Mouncey ◽  
Richard D Grieve ◽  
David A Harrison ◽  
M Zia Sadique ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Randomised Clinical Trial ◽  
Vasopressor Therapy ◽  
Permissive Hypotension ◽  
Risk Of Death ◽  
South Central

Vasodilatory shock is common in critically ill patients and vasopressors are a mainstay of therapy. A meta-analysis suggested that use of a higher, as opposed to a lower, mean arterial pressure target to guide titration of vasopressor therapy, could be associated with a higher risk of death in older critically ill patients. The 65 trial is a pragmatic, multi-centre, parallel-group, open-label, randomised clinical trial of permissive hypotension (a mean arterial pressure target of 60 -65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial is conducted in 2600 patients from 65 United Kingdom adult, general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. The 65 trial received favourable ethical opinion from the South Central - Oxford C Research Ethics Committee and approval from the Health Research Authority. The results will be presented at national and international conferences and published in peer-reviewed medical journals. Trial registration: ISRCTN10580502

scholarly journals Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension: Protocol for the 65 randomised clinical trial

2019 ◽  
pp. 175114371987008 ◽  
Author(s):  
Alvin Richards-Belle ◽  
Paul R Mouncey ◽  
Richard D Grieve ◽  
David A Harrison ◽  
M Zia Sadique ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Randomised Clinical Trial ◽  
Vasopressor Therapy ◽  
Permissive Hypotension ◽  
Risk Of Death ◽  
South Central

Vasodilatory shock is common in critically ill patients and vasopressors are a mainstay of therapy. A meta-analysis suggested that use of a higher, as opposed to a lower, mean arterial pressure target to guide titration of vasopressor therapy, could be associated with a higher risk of death in older critically ill patients. The 65 trial is a pragmatic, multi-centre, parallel-group, open-label, randomised clinical trial of permissive hypotension (a mean arterial pressure target of 60–65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vasodilatory hypotension. The trial is conducted in 2600 patients from 65 United Kingdom adult, general critical care units. The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. The 65 trial received favourable ethical opinion from the South Central – Oxford C Research Ethics Committee and approval from the Health Research Authority. The results will be presented at national and international conferences and published in peer-reviewed medical journals. Trial registration: ISRCTN10580502

scholarly journals Psychological outcomes following a nurse-led preventative psychological intervention for critically ill patients trial: Statistical and health economic analysis plan

2018 ◽  
Vol 19 (4) ◽  
pp. 281-286 ◽  
Author(s):  
Jerome Wulff ◽  
Zia Sadique ◽  
Richard Grieve ◽  
David Howell ◽  
Paul Mouncey ◽  
...  
Keyword(s):  
Health Economic ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Psychological Outcomes ◽  
Post Traumatic Stress ◽  
Health Economic Analysis ◽  
Patient Reported

The Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients trial is a cluster-randomised controlled trial of the clinical and cost-effectiveness of a complex nurse-led preventative psychological intervention compared with usual care in reducing patient-reported post-traumatic stress disorder symptom severity, and other reported psychological morbidities, at six months among Level 3 (intensive care) patients in adult general critical care units in England, Wales and Northern Ireland. This paper describes the proposed statistical and health economic analyses for the Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients trial. It is important to complete and publish this plan before inspecting and locking the trial data to ensure that post hoc and data-derived decisions are avoided. Trial registration: ISRCTN53448131

PROTECT - trial: a multicentre prospective pragmatic RCT and health economic analysis of the effect of tailored repositioning to prevent pressure ulcers - study protocol

2016 ◽  
Vol 73 (2) ◽  
pp. 495-503 ◽  
Author(s):  
Dorien De Meyer ◽  
Nele Van Damme ◽  
Karen Van den Bussche ◽  
Ann Van Hecke ◽  
Sofie Verhaeghe ◽  
...  
Keyword(s):  
Health Economic ◽  
Economic Analysis ◽  
Study Protocol ◽  
Pressure Ulcers ◽  
Health Economic Analysis

scholarly journals Clinical and microbiological efficacy of continuous versus intermittent application of meropenem in critically ill patients: a randomized open-label controlled trial

Critical Care ◽  
2012 ◽  
Vol 16 (3) ◽  
pp. R113 ◽  
Author(s):  
Ivan Chytra ◽  
Martin Stepan ◽  
Jan Benes ◽  
Petr Pelnar ◽  
Alexandra Zidkova ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Open Label
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