Document Detail

The challenges of clinical trials in the exclusion zone: the case of the frail elderly.
MedLine Citation:
PMID:  18713194     Owner:  NLM     Status:  MEDLINE    
Frail older people have been systematically excluded from randomised controlled trials (RCT). We aim to recruit older, frail hospitalised patients in an RCT and evaluate the frailty index (FI) as a measure to describe the types of people included in the study. We recruited 315 hospitalised patients aged 65 years; age ranged from 60 to 102 years. Baseline assessment scores ranged as follow: Mini-Mental Status Examination from 7 to 30, Barthel index from 5 to 100 and FI from 2 to 24. Total deaths were 20 (6%). We demonstrated that it is feasible to recruit frail older people into RCTs. The FI does not show any 'floor' or 'ceiling' effects. We can measure frailty in an RCT cohort, and we believe that clinical trials should include more frail older people and that the use of an FI can facilitate such trials and generate reliable data to guide future medical practice in a rapidly ageing society.
Iman Ridda; Richard Lindley; Raina C MacIntyre
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Australasian journal on ageing     Volume:  27     ISSN:  1741-6612     ISO Abbreviation:  Australas J Ageing     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-08-20     Completed Date:  2008-10-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9808874     Medline TA:  Australas J Ageing     Country:  Australia    
Other Details:
Languages:  eng     Pagination:  61-6     Citation Subset:  IM    
The Children Hospital, National Center for Immunisation Research and Surveillance, Westmead, New South Wales, Australia.
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MeSH Terms
Activities of Daily Living
Age Factors
Aged, 80 and over
Delivery of Health Care*
Disability Evaluation
Feasibility Studies
Frail Elderly / statistics & numerical data*
Geriatric Assessment
Hospitalization / statistics & numerical data*
Mental Competency
Mobility Limitation
Needs Assessment
Neuropsychological Tests
New South Wales
Patient Selection*
Randomized Controlled Trials as Topic*
Risk Assessment
Sex Factors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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