EAL

UWL: Screening and Assessment Methods (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this study was to:

1. report the average protein and energy intake

2. to examine the adequacy of intake of stroke patients during the first 21 days of hospitalization

3. to examine the differences in energy and protein intakes of patients receiving regular diets, dysphagia diets and enteral feeding

Inclusion Criteria:

ischemic or non-surgical hemorrhagic stroke
onset of symptoms within 5 days of admission to the hospital
absence of previous stroke or subarachnoid hemorrhage
classification as normally nourished according to subjective global assessment criteria
ability to obtain informed consent from either patient or designate
functional independence at home prior to stroke

Exclusion Criteria:

Patients were not considered potential candidates if they had sustained a subarachnoid hemorrhage, traumatic brain injury or had major systemic injuries or illnesses (including infections, heart failure, gastrointestinal bleeds or active malignancies).

Description of Study Protocol:

Recruitment

This project reports results of a subset of patients recruited for a larger study examining energy expenditure in the acute post stroke period. From August 1996 to September 1999, all patients presenting to the Neurological / Neurosurgical Unit of the London Health Sciences Centre with symptoms of an acute cerebrovascular accident were screened for entrance into the study.

Design: Prospective observational study of an inception cohort

Blinding used (if applicable): not applicable

Intervention (if applicable)

As part of usual care, patients with swallowing disorders were evaluated by a speech-language pathologist and initiated on either enteral feeds or texture-modified dysphagia diets
Patients without dysphagia received therapeutically-appropriate, regularly textured hospital diets
Patients upgraded to less restrictive diets as tolerated

Statistical Analysis

Nutritional intakes of patients receiving regular diets, dysphagia diets and enteral tube feedings were compared with one-way ANOVA with post hoc multiple comparisons (Bonferroni method)

Data Collection Summary:

Timing of Measurements

Energy and protein intakes of subjects were assessed at admission to hospital and collected over 2-day periods on days 7, 11, 14 and 21.

Dependent Variables

Energy and protein intake data were collected using calorie counts and completed by assigned nursing staff, with portions of food items recorded as 0%, 25%, 33%, 50%, 75% or 100% of the serving.
Fluid balance sheets used to measure volumes of enteral formula
Energy requirements measured at the same times as the dietary intake data using indirect calorimetry, with an activity factor of 10% for bed-ridden patients or 20 - 40% for ambulatory patients
Adequacy of energy intake expressed as a percentage of actual intake/energy requirement assessed by indirect calorimetry
Adequacy of protein intake assessed as 1 g/kg of actual or adjusted body weight used to estimate requirement

Independent Variables

Enteral feeds, texture-modified dysphagia diet, or regular hospital diet

Control Variables

Description of Actual Data Sample:

Initial N: 91 patients, 63 males, 28 females

Attrition (final N): as above. Authors note that some patients were lost to follow-up when they were discharged from the hospital and were unwilling or unable to return for additional measurements.

Age: mean age 69 ± 11.3 years

Ethnicity: not mentioned

Other relevant demographics: mean BMI was 26.6 ± 4.4 (range 18 - 40) at study entry

Anthropometrics:

Location: Ontario, Canada

Summary of Results:

Mean Energy and Protein Intakes

	Regular	Enteral	Dysphagia	Average of All Diet Types
Energy - admission (kcals/kg)	20.0 ± 5.4 (n=31)	18.5 ± 6.5 (n=18)	19.2 ± 5.1 (n=11)	19.4 ± 5.7 (n=60)
Energy - day 7 (kcals/kg)	19.4 ± 5.9 (n=27)	23.1 ± 6.8 (n=16)	18.1 ± 6.2 (n=18)	20.0 ± 6.4 (n=61)
Energy - day 11 (kcals/kg)	20.5 ± 5.0 (n=25)	26.2 ± 4.5 (n=9)	20.6 ± 6.0 (n=18)	21.5 ± 5.6 (n=52)
Energy - day 14 (kcals/kg)	21.3 ± 6.2 (n=25)	26.0 ± 5.2 (n=18)	22.0 ± 5.0 (n=17)	22.3 ± 8.6 (n=50)
Energy - day 21 (kcals/kg)	22.3 ± 9.0 (n=35)	27.8 ± 9.4 (n=8)	19.4 ± 6.2 (n=17)	22.2 ± 8.6 (n=60)
Protein - admission (g/kg/day)	0.84 ± 0.28 (n=38)	0.84 ± 0.70 (n=27)	0.69 ± 0.17 (n=12)	0.814 ± 0.28 (n=77)
Protein - day 7 (g/kg/day)	0.85 ± 0.27 (n=36)	0.95 ± 0.26 (n=20)	0.67 ± 0.28 (n=18)	0.84 ± 0.29 (n=74)
Protein - day 11 (g/kg/day)	0.87 ± 0.22 (n=34)	1.08 ± 0.16 (n=16)	0.76 ± 0.26 (n=15)	0.89 ± 0.24 (n=68)
Protein - day 14 (g/kg/day)	0.80 ± 0.23 (n=33)	1.11 ± 0.17 (n=12)	0.89 ± 0.19 (n=16)	0.88 ± 0.24 (n=61)
Protein - day 21 (g/kg/day)	0.90 ± 0.31 (n=48)	1.18 ± 0.35 (n=9)	0.71 ± 0.29 (n=20)	0.90 ± 0.31 (n=77)

Other Findings

Average energy intakes of the entire study group ranged from 19.4 - 22.3 kcals/kg/day, representing 80.3 - 90.9% of measured requirements.

Protein intake ranged from 0.81 - 0.90 g/kg/day yielding adequacy of intake of 81 - 90% of requirement.

There were significant differences in energy intakes and/or adequacy of intake of patients receiving different diet types at days 11, 14 and 21 (P < 0.05) and differences in protein intake and/or adequacy of protein intake at all intervals except admission (P < 0.05).

Patients receiving enteral tube feedings consumed more calories and protein compared to those patients on regular (P = 0.023) or dysphagia diets (P = 0.039).

Author Conclusion:

On average, newly diagnosed, well-nourished, hospitalized patients consumed 80 - 91% of both their energy and protein requirements, in the early post stroke period. While this level of intake could be considered adequate, a significant number of individuals failed to consume enough protein and calories to meet their needs. Therefore, to ensure that all patients meet their nutritional requirements, they still need to be assessed individually and intake levels monitored. Patients receiving enteral feeds tended to receive more energy and protein compared to patients receiving oral diets.

Funding Source:

Reviewer Comments:

Adequacy of intake based on measurements, not estimations.
A total of 91 patients were enrolled in the study - but authors note that some patients were lost to follow-up when they were discharged from the hospital and were unwilling or unable to return for additional measurements. Not all measurements were made in all subjects.
Authors note that there may not be sufficient statistical power to detect a significant difference due to small sample sizes.
Comparisons between diets were difficult to make considering that patients may have upgraded to different diets as tolerated.
Authors note that the exclusion of underweight patients may have biased the results in favor of higher oral intakes as patients were overweight on average

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?		???
	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?		No
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	???
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	No
	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?	???
	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?		No
	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?	No
	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?		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?	Yes
	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?	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?		???
	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?	???
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?	No
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