UWL: Association With Outcomes (2009)
- To describe the cognitive and behavioral characteristics of the test population within the frame of the PHRC REAL.FR cohort depending on their nutritional state
- To examine the modification of the patient's nutritional status in addition to the determination of the linked factors at one-year interval after inclusion.
- Patients with a diagnosis of probable Alzheimer's disease according to the DSM IV and the NINCDS-ADRDA criteria
- Participants of the French Network of Alzheimer's Disease (REAL.FR) cohort.
None specifically mentioned.
The French Network of Alzheimer's Disease (REAL.FR) began in 2000 in order to estimate the institutionalization factors among the patients with Alzheimer's disease.
Prospective cohort study.
- Comparison and descriptive analyses for each MNA group at baseline and at one year were performed
- In order to compare the three groups, ANOVA and multiple comparisons by post-hoc tests (with Bonferroni correction) were performed
- Student paired T-tests were used to compare the clinical scores between the two evaluation points for each of the MNA subgroups.
Timing of Measurements
Patients were evaluated at inclusion and at one year.
Nutritional status stratified by Mini Nutritional Assessment score: Malnutrition group (MNA less than 17.5), at risk of malnutrition (MNA, 17.5 to 23.5) and normal nutritional status (MNA more than 23.5).
- Alzheimer's disease
- Cognitive and functional characteristics assessed with Mini-Mental State Examination, Alzheimer's Disease Assessment Scale, Activities of Daily Living, Instrumental Activities of Daily Living, Neuro Psychiatric Inventory and Zarit Burden Interview for Caregiver Scale.
- Initial N: 561 patients evaluated at inclusion
- Attrition (final N): 393 patients at one year, gender not provided.
- MNA score less than 17.5, mean age was 77.1±11.5 years
- MNA score from 17.5 to 23.5, mean age was 78.8±6.6 years
- MNA score more than 23.5, mean age was 77.2±6.7 years.
Clinical Description of the Three MNA Subgroups at Baseline and After One-year Follow-up
Baseline: MNA Less than 17.5 (N=16)
Baseline: MNA 17.5 to 23.5 (N=100)
Baseline: MNA More than 23.5 (N=445)
One Year: MNA Less than 17.5 (N=10)
One Year: MNA 17.5 to 23.5 (N=65)
One Year: MNA More than 23.5 (N=318)
- At baseline, 79.3% of patients had a MNA score higher than 24 (well-nourished group), 17.8% had a MNA score between 17.5 and 23.5 (at risk of malnutrition group) and 2.9% had a MNA score lower than 17 (malnourished group)
- At baseline, the well-nourished and the malnutrition risk groups were significantly different concerning age (P=0.018), Instrumental Activities of Daily Living (P<0.0001) and Neuro Psychiatric Inventory (P<0.0001)
- The well-nourished and undernutrition groups were different concerning Mini-Mental State Examination, Neuro Psychiatric Inventory and Zarit (all P<0.0001)
- The malnutrition risk and undernutrition groups are only different concerning Neuro Psychiatric Inventory (P<0.0001): The undernutrition group had the highest NPI score (38.5 points), the malnutrition risk group had a score of 15.5 points and the well-nourished group the lowest score of 14.0 points
- At one year, the well-nourished and the malnutrition risk and undernutrition groups were different concerning the Neuro Psychiatric Inventory in a significant way
- The comparison of the three groups between baseline and one-year evaluation demonstrate for the well-nourished group an aggravation of Mini-Mental State Examination, Activities of Daily Living, Instrumental Activities of Daily Living, and Neuro Psychiatric Inventory, for the malnutrition risk group of Mini-Mental State Examination and Instrumental Activities of Daily Living, and for the undernutrition group of Mini-Mental State Examination, Instrumental Activities of Daily Living, and Neuro Psychiatric Inventory.
Among the patients with Alzheimer's disease, the most malnutritioned worsen highly on cognitive and functional capacities. Furthermore, the nutritional aggravation (evaluated by MNA) seems tightly linked to behavioral symptoms aggravation concerning the patients who live at home. If those results occur to be confirmed, behavioral symptoms treatment is a major objective in order to restore nutritional status of the patients. Intervention studies will be able to evaluate the impact of the different measures and to set guidelines.
|Government:||Clinical Research Hospital Program from the French Ministry of Health|
Only 393 out of 561 patients evaluated at one year, no reasons provided. Small numbers of subjects in MNA groups. Inclusion/exclusion criteria, recruitment methods and samples were not well described.
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||N/A|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||N/A|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||???|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||???|
|2.2.||Were criteria applied equally to all study groups?||N/A|
|2.3.||Were health, demographics, and other characteristics of subjects described?||No|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||???|
|3.||Were study groups comparable?||???|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||???|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||???|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||???|
|4.1.||Were follow-up methods described and the same for all groups?||No|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||???|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||N/A|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||Yes|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||N/A|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||Yes|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||N/A|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||Yes|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||N/A|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||N/A|
|6.6.||Were extra or unplanned treatments described?||N/A|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||N/A|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||No|
|7.7.||Were the measurements conducted consistently across groups?||N/A|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||N/A|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||Yes|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||???|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||No|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|