EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To test the hypothesis that patients who receive support with feeding would experience an improved nutritional status, reduced infection rate, greater independence in activities of daily living, a shorter hospital stay and reduced mortality.

Inclusion Criteria:

Patients aged 65 years and older, admitted to three medicine-for-the-elderly wards in London, UK.

Exclusion Criteria:

Patients unable to take food orally (e.g., unconscious, severe dysphagia)
Patients not expected to survive the current admission
Patients who had plans to be discharged within four days of admission
Patients re-admitted who had already already participated in the study.

Description of Study Protocol:

Recruitment

Patients or their relatives were approached within four days of admission to participate in the study.

Design

Consenting patients were randomized into two groups: Usual care vs. feeding assistance from a trained health care assistant. Randomization was stratified by ward, and achieved using sealed envelopes prepared by an independent group. The randomization schedule was generated using a computer-generated table of random numbers.

Blinding Used

The researchers were blinded to the randomization until after subjects gave consent to participate.

Intervention

16 days of feeding assistance provided by a health care assistant (HCA) who had completed a 15-hour training program in nutrition and related topics. Each HCA completed a nutrition plan for their patients that might include: Ensuring that the patient was seated comfortably, ensuring that the meal tray was within reach, opening all packets and removing lids from food containers, checking that the correct food was served, ensuring that the patient's vision was optimized, discussing nutritional needs with relatives, ensuring that dentures were in the patient's mouth, assisting with cutting up food, providing additional milky drinks or distributing prescribed supplements and encouraging the patient.

Statistical Analysis

Power calculations were completed to determine sample size. Most data were not normally distributed so that median and range was used for most data. Between group comparisons were made with Mann-Whitney U-test, chi square, or Fisher's exact test. Normally distributed data were compared using mean, standard deviation and two-tailed T-tests. Between-group differences at baseline were controlled using a General Linear Model procedure. A sub-group analysis was performed using quartiles by length of time in the study, admission BMI and serum albumin.

Data Collection Summary:

Timing of Measurements

Admission and discharge.

Dependent Variables

BMI
Weight (kg)
Mid-arm circumference
Triceps skinfold
Mid-arm muscle circumference
Barthel score
Grip strength
Abbreviated mental test
Food intake assessment (for 6% of patients)
Days from admission to discharge
Days from admission to medically fit for discharge
Days in the study
Volume of of IV or subcutaneous fluids given
Number of oral antibiotics prescribed
Number of days on oral antibiotics
Number of IV antibiotics prescribed
Number of days on IV antibiotics
Deaths before discharge.

Independent Variables

Feeding assistance or usual care for 16 days.

Description of Actual Data Sample:

Initial N: 592
Attrition (final N): 509
Age: Mean age, 82; range, 76 to 87
Ethnicity: More than 95% white
Other relevant demographics: 63% female
Anthropometrics: Mean weight was 59kg
Location: London, UK.

Summary of Results:

Variable	Treatment Group N=292	Control Group N=300	Statistical Significance of Group Difference
	Median Interquartile Range	Median Interquartile Range	P
Volume of IV/SC fluids given (L)	3.5 (2 to 10)	7.0 (3 to 15)	0.03*
Number of IV antibiotics prescribed	1.0 (1 to 2)	2.0 (1 to 2)	0.02*
Number of days on IV antibiotics	4.0 (2 to 7)	6.0 (3 to 13)	0.02

Other Findings

There were no differences between groups in BMI, weight, mid-arm circumference, triceps skinfold, mid-arm muscle circumference, grip strength, abbreviated mental test, Barthel's score, length of stay, time on study, number of oral antibiotics prescribed, days on oral antibiotics or deaths before discharge.

Author Conclusion:

The results suggest that, in general, acute medical wards for older people employing an additional healthcare assistant to provide extra nutritional care is not a viable or cost-effective method.

Funding Source:

Reviewer Comments:

The measures of nutrition status selected (mid-arm circumference, triceps skinfold, mid-arm muscle circumference, serum albumin, grip strength, BMI and weight in kilograms are too insensitive to change within the 16-day time frame of the study.

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?	Yes
	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?	No
	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?	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?		???
	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?	No
	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?	N/A
	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?		No
	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?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	No
	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?	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)?	???
	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?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
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