EAL

UWL: Screening and Assessment Methods (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The objective of the study was to evaluate retrospectively the influence of nutrition status on the occurence of adverse clinical events and on mortality in a sample of geriatric patients hospitalized in a rehabilitation setting.

Inclusion Criteria:

Admission to the Villa delle Querce geriatric hospital, Nemi (Rome, Italy) between September 2000 and December 2001
No patient selection criteria were used on admission.

Exclusion Criteria:

None noted.

Description of Study Protocol:

Recruitment

All patients admitted to the Villa delle Querce geriatric hospital, Nemi (Rome, Italy), between September 2000 and December 2001 were retrospectively examined.

Design

Retrospective cohort study.

Statistical Analysis

Univariate statistics were used to assess the relationship between independent and outcome variables
Survival curves were drawn for well-nourished and malnourished patients
Differences between groups in survival time were assessed by the Cox-Mantel and generalized Wilcoxon tests.

Data Collection Summary:

Timing of Measurements

Medical records were evaluated retrospectively. Nutrition status, illness severity, cognitive status, depression and functional status evaluated within 48 hours of admission for comorbidity and later for mortality and adverse clinical events.

Dependent Variables

Mortality
Adverse clinical events requiring therapeutic intervention and eight to 21 days of monitoring without residual functional impairment or carrying functional residual functional impairment.

Independent Variables

Nutritional status measured by Nutritional Global Evaluation, where malnutrition was defined as below-normal levels of fat, lean body mass and normal values for proteins and lymphocytes; protein malnutrition was defined as two out of three of the following:
- Decreased albumin
- Transferrin or lymphocytes with normal fat and lean body mass
- Protein energy malnutrition was defined as decreased measures of both energy and protein
The Nutritional Global Evaluation components and normals were: Mid-upper arm circumference (men less than 22cm; women less than 18. cm), triceps skinfold (men less than 5.2mm; women less than 9.7mm), albumin (less than 3.0g per L), transferrin (less than 1.5g per L), and lymphocytes (less than 1,200mm³)
Cumulative Illness Rating Scale
Cognitive status measured by Short Portable Mental Status Questionnaire
Depression measured using Cornell Scale
Functional status measured using Katz Index.

Control Variables

Number of medical diagnoses
Activities of daily living
Age.

Description of Actual Data Sample:

Initial N: 278 elderly subjects (154 females, 124 males)
Attrition (final N): 278
Age: 72.5±10 years for males; 74.9±8 years for females
Other relevant demographics: 4.5±2 medical conditions in each group
Anthropometrics: Height and weight were not reported
Location: A rehabilitation center in Rome, Italy.

Summary of Results:

Parameter Estimates for Logistic Models Predicting Occurrence of Adverse Clinical Events and Mortality

_______________________________________________________________________

Dependent Variables P Odds Ratio 95% CI

Variables in Equation

________________________________________________________________________

Adverse clinical Comorbidity 0.000 1.69 1.36 to 2.10

Event occurrence Cognitive status 0.000 1.22 1.11 to 1.35

NGE 0.015 2.38 1.19 to 4.80

Mortality Comorbidity 0.001 1.43 1.16 to 1.78

NGE 0.008 2.64 1.29 to 5.40

Other Findings

According to the Nutritional Global Evaluation, the prevalence of malnutrition upon admission was 56.1%
Adverse clinical events occurred in 60 subjects (21.6%) and 48 subjects (17.3%) died
In malnourished subjects, the incidence of adverse clinical events was significantly greater than that in well-nourished patents (28.2% vs. 13.1%; Χ²= 9.2; P=0.002)
Mortality was higher among malnourished patients than those with a normal Nutritional Global Evaluation (23.1% vs. 9.8% Χ²= 8.4, P =0.004)
The number of medical conditions had no effect on mortality or adverse clinical events.

Author Conclusion:

Nutritional status emerged as the main independent predictor of both mortality and occurrence of adverse clinical events. Although most patients fell into the category of mild to moderate (energy) malnutrition (148 out of 156), a mild deterioration of nutritional status (for instance, reduction in triceps skinfold thickness) seemed to be sufficient to cause an increase in the incidence of the adverse clinical events and in mortality.

Funding Source:

Other:

None reported

Reviewer Comments:

Inclusion and exclusion criteria were not described.

Quality Criteria Checklist: Primary Research
Relevance Questions
	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

Validity Questions
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?	No
	2.2.	Were criteria applied equally to all study groups?	???
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?	N/A
	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?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	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?		???
	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.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	???
	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?	N/A
	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?	???
	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)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	No
	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?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes