Core Outcome Measures in Effectiveness Trials

Development of a core outcome data set based on consensus standardized (COD Dementia) to assess mild to moderate dementia with MOCA and laboratory biomarkers in Nursing Home

General Information

Background: The National Institute of Health Research (NIHR) has identified the area of disease modification in dementia as important, particularly in the mild and moderate stages (MCI), and are supporting trials evaluating potential disease modifying treatments. Aim of this study is to identify a core suite of outcome domains to use in trials, the relationships among the incidence of MCI risk factors with SOSIA classification form and routine laboratory in Nursing Home.
Method: The CBA database has been developed by a dedicated working group using Delphi process. It contain records on Cognitive functioning, Functioning of Activities of daily living, Neuropsychiatric symptoms and behaviours, Quality of life and Biomarkers. This work is required to identify the core variables for measurement.
Results: Between 2015 and 2016, 670 geriatric patients were enrolled at six Italian Nursing Home. Among these patients, 41% were men and 59% were women (mean age 80 years) and SOSIA form 3 was the most frequent classification system (59%) followed by 5 (21%), 7 (11%) and 1 (9%).
The SOSIA classification is based on motor skills, the ability cognitive/behavior and comorbidity.
The average score at MOCA, adjusted for age and education, amounted to 21.0, in MMSE is 19.0. Cognitive impairment was observed in 81.3% of patients with MOCA <26.
Multivariate analysis has determined that the identification of SOSIA form is strongly associated with the MOCA score correlated with the form 5 (p=0.02), 7 (p=0.01), comorbidities (p=0.001), using the "Cumulative Illness Rating Scale=4" and the "Barthel Index=100" (p<0.001).
The MMSE score correlates with the form 3 (p=0.01) and 1 (p=0.02).
Conclusion: COD Dementia enables the creation of databases that can be used to govern the provision of long-term care with SOSIA classification form, neurological tests across different health system, to answer relevant research questions and to compare characteristics of future trials.

Mariangela Vanalli, Nursing Coordinator, Nursing Home Santa Chiara, Bergamo
and University of Milan Bicocca, Milan, Italy

Further Study Information

Current Stage:
January 2015 - November 2016
Funding source(s):
There are no funding sources

Health Area

Disease Category
Health care of older people

Disease Name

Target Population

Age Range
65 - 100


Nature / type of Intervention
Psychological & behavioural


Consensus conference
Delphi process

Development CBA database using Delphi process.

Geriatric patients with SOSIA classification

Stakeholders Involved

Clinical experts

Study Type

COS for clinical trials or clinical research
COS for practice

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