EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To assess effectiveness of a protocol which included screening for malnutrition, dysphagia and dehydration on admission, followed by immediate interventions, on nutritional status, hospital-acquired infections, and pressure sores, and evaluate the protocol's economical feasibility.

Inclusion Criteria:

All patients admitted to the geriatrics units (aged over 60 years) during a 10 month period in the year 2001
All non-terminally ill patients admitted for more than 2 days

Exclusion Criteria:

Patients admitted for only 1 or 2 days were not included since no significant effect of the intervention was expected in such a short period
Patients admitted for over 150 days (and waiting for institutional care) were also excluded

Description of Study Protocol:

Recruitment

Subjects were recruited from the inpatient geriatric service of a university hospital and a geriatric ward of a non-academic teaching hospital.

Design: Nonrandomized Clinical Trial, Cost-Effectiveness Study

Blinding used (if applicable): not applicable

Intervention (if applicable)

One of the geriatric wards applied the protocol while the other provided standard care
Protocol included screening for risk of malnutrition using MNA-short form, and with the full MNA if screened positively, as well as screened for dysphagia and dehydration with the adapted Enderby-Dysphagia test and by testing items sensitive for dehydration risk
Patients with 1 positive screening test were investigated by a dietitian, speech/language therapist and a geriatrician and treated immediately
Symptomatic treatment was started: high-energy diet change or protein-energy supplements in malnutrition, swallowing therapy and rehydration
Medical interventions were started for etiological factors
Patients were discussed twice a week in an interdisciplinary meeting until their nutritional status and swallowing was satisfactory

Statistical Analysis

Sex, MNA-short form, Barthel index, nosocomial infections, pressure sores and >3% weight loss were compared using chi-square tests.
Barthel index, weight on admission and MNA-short form were compared using Student's t tests.
Length of stay and weight change were tested using Mann-Whitney tests.
Weight on admission was used as a covariate in ANOVA analysis for weight changes during admission.
In the sensitivity analysis of the costs, 95% confidence intervals of mean duration of admission and antibiotic use were used to estimate confidence intervals of the costs since these appeared to contribute most significantly

Data Collection Summary:

Timing of Measurements

Body mass was measured on admit and discharge
Hospital-acquired infections and pressure sores were scored
Costs related to nutrition, infections and length of hospital stay were assessed

Dependent Variables

Weight and BMI
Barthel index
MNA-short form
Hospital-acquired infections (UTIs, respiratory tract infections and sepsis) and pressure sores were scored
Length of stay
Costs related to nutrition, infections and length of hospital stay

Independent Variables

Protocol versus standard care

Control Variables

Sex
Date of birth

Description of Actual Data Sample:

Initial N: 298 older patients, 140 with protocol, 158 with standard care

Attrition (final N): as above

Age: mean age protocol patients: 81.3 years, mean age standard care: 82.6 years

Ethnicity: not mentioned

Other relevant demographics:

Anthropometrics:

Based on retrospective study, both populations were highly similar in mean weight on admission, Barthel Activities of Daily Living Index, the short form of the Mini Nutritional Assessment, date of birth and sex. Both admitted 90% of their patients from within a 15-20 km distance of their hospitals, both have similar numbers of clinical staff, with nurses having had similar training.
There were no significant differences between groups on admission in Barthel index, MNA-short form, weight, BMI, sex and age.

Location: The Netherlands

Summary of Results:

	Intervention Group	Control Group	Significance
Length of stay	31.1 days (N = 140)	32.7 days (N=158)	0.51
Weight change	0.92 kg (N=105)	-0.76 kg (N=140)	<0.001

Other Findings

There was a 0.76 kg loss in average weight in the standard care group and a 0.92 kg gain in the intervention group (P < 0.001).

Malnutrition (defined as number of patients with >3% weight loss during admission) was also significantly lower in the intervention group (11/105) than in the control group (42/140), a reduction by 65% (P < 0.001).

After excluding patients with edema or heart failure, there was still a significant difference between the intervention group and control group in weight change (1.0 kg vs 0.0 kg, P = 0.017).

The number of hospital-acquired infections was significantly lower in the intervention group (33/140 versus 58/158, 36% difference, P = 0.01) but no significant difference in number of patients with pressure sores (23/140 versus 33/158) or in length of hospital stay was found.

Costs were not significantly different: 7516 versus 7908 Euro/patient for intervention versus controls, respectively.

Author Conclusion:

This study shows that a standardized, early interdisciplinary intervention in older inpatients at risk for protein-energy malnutrition can be effective and will not increase costs significantly. Clinically relevant differences in nutritional status by the systematic intervention were associated with a lower number of nosocomial infections. The interdisciplinary character of the intervention is also advocated by others and is the key to overall successful geriatric interventions. To safeguard implementation, external protocols cannot simply be copied, but have to be tailored very carefully to local circumstances and trained seriously to the teams that are locally available. In conclusion, we recommend the implementation of a standardized, early and symptomatically oriented, interdisciplinary approach to malnutrition and related disorders in geriatric departments.

Funding Source:

University/Hospital:

Hammersmith Hospital NHS trust

Reviewer Comments:

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)	Yes
	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)	Yes

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?		Yes
	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?	Yes
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?	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?		Yes
	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?	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?	N/A
	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?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	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?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	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?	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)?	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?		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