EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To describe nursing home staff delivery of oral liquid nutritional supplements to residents with an order for supplements.

Inclusion Criteria:

Long-stay (non-Medicare) patients
Free of a feeding tube
Not receiving end-of-life care.

Exclusion Criteria:

Failure to give consent.

Description of Study Protocol:

Recruitment: A convenience sample of residents was recruited from six skilled nursing homes in northern California

Design: Direct observation of supplement delivery during and between meals

Blinding used: Unblinded

Statistical Analysis: T tests for independent samples.

Data Collection Summary:

Timing of Measurements: Observations were conducted for each meal for two consecutive days. Breakfast observation was 7:00 a.m. to 8:30 a.m., lunch was 12:00 noon to 1:30 p.m. and dinner was 5:00 p.m. to 6:30 p.m. Research personnel followed up with nursing home staff from 9:30 a.m. to 11:00 a.m., 1:30 p.m. to 3:00 p.m. and 6:30 p.m. to 8:00 p.m. to document delivery and consumption of oral nutritional supplements.

Description of Actual Data Sample:

Initial N: 352 signed consent; 179 (51%) had supplement orders

Attrition (final N): Data were available for 132 participants

Age: 85 years±9.11 years

Ethnicity: 86% white; other not specified

Other relevant demographics: Length of stay: 2.81 years±2.93 years; diagnosis of dementia 52 (42%); Minimum Data Set (MDS) cognitive performance scale 3.37±1.72; MDS eating dependency 1.43±1.50

Anthropometrics: None noted

Location: Northern California.

Summary of Results:

Nursing Home Staff Delivery of Supplements Between and During Meals (n=132)

Measure	Mean±Standard Deviation
Between meals
Frequency of delivery per resident per day	0.52±0.79
Average amount given, ounces	6.21±1.79
Average amount consumed, ounces	3.98±2.60
Average calorie intake	143.75±119.41
Average assistance time, minutes	0.08±1.47
During meals
Frequency of delivery, per resident per day	0.81±1.04
Average amount consumed, ounces	4.91±2.19
Average supplement caloric intake	230.41±111.62
Average assistance time, minutes	6.27±7.77

Other Findings

One hundred sixteen (88%) of the 132 participants had a supplement one to three times daily. The remaining 16 (12%) had an order to receive a supplement four to six times daily. Observations showed that nursing provided a supplement less than once per day. Seventy-six participants (58%) did not receive any supplements between meals.

Author Conclusion:

Oral liquid nutritional supplements are not provided consistent with orders in nursing home practice. Staff spends little time promoting supplement consumption during or between meals. The specificity of the order related to time of delivery may influence when and how often supplements are provided to residents.

Funding Source:

Reviewer Comments:

Authors note limitations of limited generalizability due to participants being predominantly female, white and residing in one geographic region. Study participants with incomplete data were significantly older than those with complete data, which may have biased results. Residents' preferences for supplements vs. other food and fluid were not directly measured in this 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)	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?	N/A
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	N/A
	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?		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?		Yes
	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?	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?		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?		???
	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?	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?	No
	6.6.	Were extra or unplanned treatments described?	No
	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?		???
	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?	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?		???
	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?	No
	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