H/A: Body Composition Measurement (2009)
Citation:
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To compare REE in weight-stable and weight-losing patients with HIV infection and to discuss the relationship between abnormal body composition and REE in HIV-associated cachexia.
Inclusion Criteria:
- Weight-losing patients were defined as having lost more than 3% of their weight during the four weeks before measurement
- Weight-stable patients were defined as those without recent weight loss, independent of prior weight-loss episodes
- Controls were weight stable, in good health and on a regular diet.
Exclusion Criteria:
- Incomplete measurements
- Voluntary diet for weight reduction.
Description of Study Protocol:
Recruitment
Patients from the HIV outpatient clinics and infectious disease wards at the University of Cologne. Controls were volunteers.
Design
Case-control study.
Statistical Analysis
- Pearson's coefficient was used to determine correlations between measured and predicted REE
- Differences between subgroups were tested with Mann-Whitney Wilcoxon U-test for continuous variables and Pearson's chi-square for dichotomous variables
- Correlations between continuous variables were determined by Pearson's correlation coefficient.
Data Collection Summary:
Timing of Measurements
Measurements made on cases and controls and compared.
Dependent Variables
- REE, measured by indirect calorimetry
- Body composition, measured by bioelectrical impedance
- Body temperature, frequency and consistency of bowel movements and food intake, recorded in one-week diary
- Weight.
Independent Variables
- HIV
- Weight losing or weight stable.
Description of Actual Data Sample:
- Initial N: 69 male HIV-infected patients and 29 male healthy controls
- Attrition (final N): 65 cases, 28 with recent weight loss, 37 who were weight-stable and 29 controls. Four patients were excluded from the analysis.
- Age
- Healthy controls: 29±9 years
- Weight-stable HIV patients: 41±8 years
- Weight-losing HIV patients: 40±9 years.
- Ethnicity: Not mentioned
- Anthropometrics: Patients were significantly older than the control group
- Location: Germany.
Summary of Results:
Controls (N=29) |
Weight-Stable (N=37) |
Weight-Losing (N=28) |
|
REE (kcal/day) | 1,711±151 | 1,625±402 | 1,459±309 |
REE/kg BCM (kcal/kg/24 hr) |
48.0±3.5 |
54.8±13.1 |
56.9±16.9 |
REE/kg body weight |
23.85±2.0 |
24.0±5.2 |
23.9±6.2 |
REE vs Harris-Benedict (%) | 98.3±7.7 | 101±21 | 95±21 |
REE vs Cunningham equation (%) | 100.9±7.6 | 101±22 | 96±23 |
Other Findings
- Absolute REE was lower in weight-losing patients than in controls (1,459±309 vs. 1,711±151kcal per day, P<0.001) and in weight-stable patients (1,625±402 kcal per day, P<0.05)
- REE per kg body cell mass was higher in weight-losing and weight-stable patients than in controls (both P<0.01), due to lower body-cell mass in both patient groups (P<0.001)
- REE (percentage Harris-Benedict) was not different among the three groups
- Weight changes around the measurement were not correlated to REE (R2=0.0008, P=0.82)
- REE was independent of diarrhea, acute infection, fever or caloric intake
- REE had a stronger correlation to body weight and to Harris-Benedict's prediction than to fat-free mass or body cell mass
- REE explains less than 1% of weight changes.
Author Conclusion:
- In conclusion, our data on REE in weight-stable and in weight-losing patients cast doubt on the role of hypermetabolism in the pathogenesis of the HIV-wasting syndrome
- Usual reference values for REE are not reliable in severely malnourished patients
- Body cell mass measured by bioelectrical impedance is less reliable to predict normal REE than Harris-Benedict's equation
- More research is needed about the energy consumption of viscera vs. muscle tissue in starvation and disease-related malnutrition
- Some patients with reduced energy intake, malabsorption or diarrhea may fail to down-regulate REE, which is the normal response to starvation. But it is unlikely that hypermetabolism by itself is a major cause of weight loss in HIV-infected patients.
Funding Source:
University/Hospital: | University of Cologne (Germany) |
Reviewer Comments:
- Controls not age-matched
- Authors note that sample size may be too small to identify subgroups with relevant hypermetabolism and the fact that nutritional treatment was not standardized.
Quality Criteria Checklist: Primary Research
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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? | ??? | |
2.2. | Were criteria applied equally to all study groups? | ??? | |
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) | Yes | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | No | |
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.) | No | |
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? | 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? | 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)? | 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 | |