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FNCE 2023
Session 357. Providing MNT for the Pediatric Type 1 Diabetes Population: What Does the Evidence Show?
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UWL: Association With Outcomes (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate nutritional status, including meal patterns and meal-related problems, in elderly people living at home
Moreover, the nutritional status was related to long-term mortality through re-examination of a sub-sample of the participants after three years.

Inclusion Criteria:

Subjects receiving home care in five Swedish municipalities (one rural community, one small city and three larger cities)
Over age 65 years.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment: Investigation took place in five Swedish municipalities. In each community, one to three home service areas (a total of 10) were selected with a total of 100 subjects from each participating municipality.
Design: Cross-sectional study and cohort study
Blinding used: Observers were directly involved in the care of the study subjects which may have biased the assessments.

Statistical Analysis

In the evaluation of differences between MNA categories, ANOVA or the Kruskal-Wallis test was used, in accordance with the distribution of the tested variable
For statistical analysis of the Katz ADL index, the letters A through G were given the numbers zero through six
In the three-year follow-up analyses, Student's paired T-tests or Wilcoxon's matched pairs tests were used in accordance with the distribution of the variables
Survival analyses (including Kaplan-Meier curves and log-rank tests) and logistic regression analyses were performed in order to evaluate the relationship between nutritional status and long-term outcome.

Data Collection Summary:

Timing of Measurements

Subjects were interviewed. Mortality was evaluated after a three-year period.

Dependent Variables

Mortality follow-up was performed by consulting Swedish population records (data from one municipality not available).

Independent Variables

Nutritional status assessed by means of the Mini-Nutritional Assessment
Weight, height, BMI
Mid-arm circumference and calf circumference were measured
Recent weight change
Intake of medication
Acute diseases (including psychological stress)
Mobility
Neuropsychological problems
Pressure sores or skin ulcers
Assessment of dietary intake: How many full meals were eaten, food choice, fluid intake per day, how much help was required during the meals and appetite
Self-assessment of nutritional status
Self-perceived health status
Assessment of mood
Activities of daily living assessed according to the ADL index of Katz.

Description of Actual Data Sample:

Initial N

507 eligible subjects.

Attrition (Final N)

353 subjects examined, 64% females
154 subjects were not examined: 108 refrained from participation, six were terminally ill and 40 were not suitable due to hospitalization, a recent move to institutional care or other infirmities
Mortality was evaluated in 224 study participants after a three-year period
31 of 64 elderly were reexamined after three years.

Age

Mean, 82±7 years among participants, 82±8 years among non-participants.

Ethnicity

Not mentioned.

Other Relevant Demographics

26% needed personal care once a day, 19% twice a day and 6% needed personal care around the clock.

Anthropometrics

Participants and non-participants were similar
Mean age in the study populations varied among the five municipalities (from 80.4±7 years to 83.6±6 years, P<0.05), whereas gender, civil status, MNA score and BMI were not significantly different.

Location

Sweden.

Summary of Results:

Odds Ratios and 95% Confidence Intervals for Death Within Three Years

Variables	Odds Ratio	95% Confidence Interval	P-Value
MNA	1.89	1.18-3.01	0.007
Age	1.33	1.01-1.74	0.04
Male Gender	1.60	0.86-2.99	0.14

Other Findings

8% and 41% of the elderly were assessed as malnourished or at risk of malnutrition, respectively
BMIs under 20 and under 23 were found in 12% and 31% of the subjects, respectively
6% of the study participants reported a weight loss over three kg during the last three months and 12% had lost one kg to three kg
From the self-assessed appetite, 2% reported no appetite, 18% a reduced appetite, 37% an acceptable appetite and 43% a good appetite
The subjects who scored low in MNA often reported a decreased appetite and the subjects who scored high in MNA often had a good appetite (P<0.001)
Chewing and swallowing problems and reduced appetite were more often reported by those at risk of being malnourished, compared with the well-nourished study participants (P<0.001)
Meals-on-wheels services were given to one-third, of whom 66% used one portion for several meals
The three-year mortality was 50% for those who were malnourished, 40% for those at risk of malnutrition and 28% for the well-nourished group (P<0.05)
The corresponding mortality was 50% for subjects with a BMI under 20, 35% for those with BMIs ranging from 20 to 28 and 27% for those with BMI over 28 (P=0.05)
The median MNA score had decreased from 22 (range, 20.5 to 26) to 19.5 (range, 17 to 23.5; P<0.001) in the 31 subjects re-examined after three years
After three years, a weight loss of 4.0±5.8kg was registered (P<0.001).

Author Conclusion:

About half of the home-living elderly with public support were malnourished or were at risk for malnutrition
The malnourished subjects often had problems during mealtimes and seldom ate full meals
Elderly people with BMI above 28 displayed the lowest risk of death within three years.

Funding Source:

Government:

Swedish National Board of Health and Welfare

Industry:

Semper Foods AB

Food Company:

Not-for-profit

Swedish Research Council and Karolinska Institutet

Other non-profit:

Reviewer Comments:

Data from one municipality was not available for mortality follow-up
Only 31 of 64 were re-examined after three years
Authors note the following sources of uncertainty in the study:
- Large number of observers
- Observers were directly involved in the care of the study subjects which may have biased the assessments.

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?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	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?		Yes
	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?	Yes
	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?	Yes
	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?	Yes
	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%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	???
	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?		No
	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?	No
	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?		???
	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?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
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?	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?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
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