Core Outcome Data Set for Dementia clinical trials
Study Code / Acronym
COD DementiaAward Number
15/62/02Programme
Health Technology AssessmentStatus / Stage
CompletedDates
12 January 2015 -6 January 2016
Duration (calculated)
00 years 11 monthsFunder(s)
NIHRFunding Amount
£47,673.97Funder/Grant study page
NIHRContracted Centre
University College LondonPrincipal Investigator
Professor Gillian LivingstonPI Contact
g.livingston@ucl.ac.ukWHO Catergories
Improving clinical trialsDisease Type
Mild DementiaModerate Dementia
CPEC Review Info
| Reference ID | 51 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Study Code / Acronym | COD Dementia |
|---|---|
| Award Number | 15/62/02 |
| Status / Stage | Completed |
| Start Date | 20150112 |
| End Date | 20160106 |
| Duration (calculated) | 00 years 11 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | University College London |
| Funding Amount | £47,673.97 |
Abstract
There are no disease modifying treatments for dementia and a lack of comparability between studies hampers interpretation and progress. We are 36 multidisciplinary researchers with expertise in the field and the Alzheimer’s Society (AS) for PPI. We will identify, evaluate, summarise and synthesise all relevant clinical trials in dementia to determine and agree a standardised ‘core set’ of relevant health outcome measures for trials of treatments to modify the course of mild and moderate dementia. This will allow direct comparison of treatments and will shape and optimise future NIHR dementia trials design. Work package (WP) 1 Use of current knowledge We have agreed sharing of and building on current outcome measures datasets including: 1. Cochrane Dementia and Cognitive Improvement Group ALOIS trials register. 2. International Consortium for Health Outcomes Measurement Working Group outcome set of what is most important to persons living with dementia. 3. Brayne and LaFortune systematic review of outcomes for non-drug studies in dementia. 4. Mountain’s European research network (Interdem) JPND funded work on outcome measures for non-pharma dementia trials. WP 2 Literature review We will use a brief systematic review to assess core outcomes used in dementia clinical studies, identify the frequency of use of each outcome and validation data. Search strategy We will search electronic databases and articles’ reference lists. We will ask experts about additional studies. Search terms We will limit to English language. We will finalise search terms with our stakeholder group to encompass dementia AND outcomes AND interventions. Inclusion/Exclusion Criteria: We will include quantitative validated outcome measures used in interventional clinical studies for mild or moderate dementia. We will exclude studies in care homes, severe dementia; outcomes if for carers, qualitative or economic; or non-validated. We will report in a PRISMA flow chart. Multiple reports of a study will be treated as one study. Data extraction: We will design a data extraction tool, pilot it on 10 included papers to ensure data is captured and understandable. This will include: ( i) Methodological characteristics, (ii) Intervention descriptors, (iii) Details of relevant outcome tool. We will search separately for validation data. Data analysis/ synthesis We will search the literature, analyse papers and tabulate the measures, to inform PPI and consensus group. Tables will include:- 1. Domains of validated outcomes, 2. Frequency of use, 3. Which groups the measure is validated in, 4. Length of measure and data on acceptability, floor and ceiling effects and how it is used. WP 3 Assessment of importance of candidate measures to patients and carers. We will summarise these latter measurements to consider the practicality of measures as well as consulting about them The Alzheimer’s Society with our researcher will lead on the PPI consultation through electronic consultation and face-to-face interviews within the network. WP 4 Consensus conference Champions will present the systematic review findings for the consensus conference to develop agreement for a ‘core’ set of outcome measures. We would expect these to consider and potentially include the following domains but these may change as evidence emerges(Howard -cognition, O’Brien -brain imaging biomarkers, Perneczky – CSF/blood biomarkers, Banerjee- quality of life, Livingston-neuropsychiatric symptoms). It is possible that there will be others that emerge or that these anticipated domains might change and if so we will change the champions as appropriate. They will oversee the initial write up of their domain. WP 5 Report on recommended outcome for NIHR clinical trials of disease modification in mild to moderate dementia.
Aims
To identify, evaluate, summarise and synthesise all relevant clinical trials in dementia to determine and agree a standardised ‘core set’ of relevant health outcome measures for trials of treatments to modify the course of mild and moderate dementia.