EAL

UWL: Screening and Assessment Methods (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To estimate energy requirements in diseased elderly patients with pressure ulcers.

Inclusion Criteria:

Subjects who had pressure ulcers or who were at risk of developing one

Exclusion Criteria:

Agitated or undergoing oxygen therapy, which would affect RMR
Unable to give informed consent

Description of Study Protocol:

Recruitment

Between February and July 2003, subjects who had pressure ulcers or who were at risk of developing one were invited to participate in the study. They were all inpatients of the internal medicine or geriatric departments of the University Hospital of Angers in France.

Design: Case-Control Study

Blinding used (if applicable): Not applicable

Intervention (if applicable): Not applicable

Statistical Analysis

Two-factor ANOVA was used to compared measured RMR between the pressure ulcer group and the control group and between men and women. A paired t test was used to compare measured RMR with energy intake and with predicted RMR.

Data Collection Summary:

Timing of Measurements

Body composition, REE and total food intake measured. Measured RMR compared with prediction equations of Harris-Benedict, Schofield and WHO.

Dependent Variables

Energy requirements estimated using measured RMR and multiplied by 1.26 and 1.5 to range between minimal WHO requirements and those of adults undergoing light physical activity
Energy intakes estimated using 3-day food weight records
Height, weight, BMI
Total body water calculated from bioelectrical impedance measurements
RMR measured using indirect calorimetry and standard protocol

Independent Variables

Pressure ulcer cases or hospitalized controls
Pressure ulcers evaluated according to degree of tissue damage: Stage 1, 2, 3 or 4
Volume of the pressure ulcer
Risk of developing pressure ulcer based on Norton scale

Control Variables

Description of Actual Data Sample:

Initial N: 29 patients with pressure ulcers (13 women, 16 men), 27 hospitalized controls (21 women, 6 men)

Attrition (final N): 29 cases, 27 controls

Age: mean age women controls: 86.0 +/- 7.3 years, mean age men controls: 77.0 +/- 9.3 years, mean age women with pressure ulcers: 81.4 +/- 7.9 years, mean age men with pressure ulcers: 78.1 +/- 10.9 years

Ethnicity: not mentioned

Other relevant demographics: Norton index risk of pressure ulcer cases: 14.3 +/- 3.3, Norton index risk of hospitalized controls: 13.9 +/- 3.3

Anthropometrics: Women were older (P = 0.02), lighter (P = 0.03) and shorter (P < 0.001) than men.

Location: University Hospital of Angers, France

Summary of Results:

	Controls - Women (n=21)	Controls - Men (n=6)	Pressure Ulcers - Women (n=13)	Pressure Ulcers - Men (n=16)
Height (m)	1.56 +/- 0.03	1.70 +/- 0.04	1.57 +/- 0.06	1.68 +/- 0.06
Weight (kg)	60.1 +/- 14.4	66.8 +/- 8.8	55.8 +/- 11.1	65.0 +/- 11.4
BMI	24.8 +/- 5.7	23.2 +/- 3.1	22.5 +/- 4.3	23.0 +/- 4.3
Total body water, L	28.4 +/- 4.8	35.8 +/- 4.8	27.9 +/- 4.7	35.9 +/- 7.5
Extracellular water, L	16.4 +/- 2.4	19.8 +/- 3.7	12.3 +/- 2.5	18.2 +/- 4.3
Risk score	16.1 +/- 3.3	16.2 +/- 3.1	16.8 +/- 3.2	17.3 +/- 3.5
Measured RMR, kcal/day	1094 +/- 186	1493 +/- 418	1147 +/- 228	1339 +/- 224
Energy intake, kcal/day	1241 +/- 294	1558 +/- 499	1332 +/- 372	1457 +/- 732
Protein intake, g/day	46.9 +/- 14.2	53.6 +/- 22.4	53.8 +/- 19	60.1 +/- 30.6

Other Findings

Measured RMR did not differ between the 2 groups (P = 0.48) and was not related to grade or size of the pressure ulcers.

The WHO equation (82 kcal/day, P = 0.006) and the Schofield formula (57 kcal/day, P = 0.05) slightly underestimated calculated RMR, but the Harris-Benedict equation (40 kcal/day, P = 0.13) accurately estimated it.

Energy requirements therefore ranged between 1,536 +/- 340 kcal/day and 1,828 +/- 405 kcal/day (25 - 30 kcal/kg body weight per day).

Energy intake was lower than energy requirements by 176 - 479 kcal/day.

Author Conclusion:

In conclusion, in elderly patients with pressure ulcers, energy intake was inadequate to match estimated energy requirements. Moreover, minimum calorie recommendations should range between 25 and 30 kcal/day per kg of body weight. At the very least, care should be taken to improve energy intake at these levels. In addition, the Harris-Benedict formula is a valid estimate of energy requirements in ill elderly people.

Funding Source:

Government:

INSERM (France)

Industry:

Chiesi SA

Pharmaceutical/Dietary Supplement Company:

University/Hospital:

Hospital of Angers

Reviewer Comments:

Authors note that the number of subjects per stage category was not large enough in this study and precluded definitive conclusions. Controls were not age and gender matched. Since patients and controls did not differ with regard to developing pressure ulcers, major differences might not be expected.

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?		???
	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?	???
	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.)	???
	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?	Yes
	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?		N/A
	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?	N/A
	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?		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?	N/A
	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)?	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?		???
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
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