H/A: MNT (2009)
The objective of this study was to evaluate the effects of nutrition counseling with or without oral supplementation on malnourished HIV-infected patients.
To be eligible for this study subjects had to be:
- Men
- Age 18 years or older
- CD4+ cell count fewer than 500 cells per cubic millimeter
- Less than 90% usual weight-for-height or had an involuntary weight loss of more than 10% body weight in the previous six months
- Able to care for themselves as denoted of a Karnofsky score of 50 or more
- Life expectancy of at least 12 weeks
- If receiving drug therapy, the regimen must have been unchanged for eight weeks.
- Dysphagia
- Severe diarrhea (more than six watery stools per day for seven or more days)
- Cytomegalovirus or Mycobacterium avium complex infection
- Suspected or treated infection (fever, chills)
- Diagnosis of infection or hospitalization within the preceding two weeks
- Receiving anabolic agents, appetite stimulants or chemotherapy.
Recruitment
HIV-infected patients were recruited from three sources: the Houston Veterans Administration Medical Center Special Medicine clinic, an outpatient facility for HIV-infected veterans; the Thomas Street Clinic, an outpatient facility that serves Harris County (Texas) and the private practices of several physicians in the Houston, TX, area.
Design
The study consisted of a two-week baseline period followed by a six-week treatment period. During the baseline period, patients were seen at weekly intervals (visit one, visit two). At visit one, a history and physical examination were completed, the Karnofsky score was determined and a blood sample was obtained for analysis. A 24-hour dietary recall was obtained. Each patient was instructed about how to use the three-day food records that were to be completed and returned at all subsequent visits. At visit two and all subsequent visits, nutritional status, grip strength, cognitive function and quality-of-life were assessed. At visit three, patients were randomly assigned to either a normal diet (control group) or a normal diet plus oral supplement (supplement group) for six weeks. All patients in both groups received individual nutritional counseling and were told how to consume a diet intended to achieve a specific energy target (approximately 960kcal per day more than estimated total energy expenditure). Patients were seen every two weeks during the treatment period. When a patient's dietary intake did not achieve the energy target, he was counseled by the study dietitian.
Blinding used
Not possible.
Intervention
The supplemented group was provided with a specialized, medium-chain triglyceride formula suitable for HIV-infected patients with fat malabsorption.
Statistical Analysis
Fisher's exact test was used to evaluate differences in study discontinuation rates and adverse event rates in the treatment groups. All P values were based on two-tailed tests. Differences in baseline variables and in end-point change from baseline were evaluated using either analysis of variance (for baseline age, Karnofsky score, body mass index); and for end-point change in weight, cognitive function, quality-of-life or the Wilcoxon rank sum test (for baseline weight, cognitive function, quality-of-life and of baseline and end-point change in laboratory, skinfold thickness, bioelectrical impedance and grip-strength measurements). Analysis of covariance was also used to evaluate end-point change from baseline in quality-of-life scores.
Timing of Measurements
Measurements were done at baseline and then every two weeks during the six-week treatment phase.
Dependent Variables
- Nutritional parameters (weight, height, skinfold thickness, grip strength, body composition measures)
- Cognitive function (Buschke selective reminding test, which evaluates recall, short-term recall, long-term storage, long-term retrieval and consistent long-term retrieval)
- Quality-of-life (self-administered questionnaire developed for this study, evaluates physical, emotional function, burden of symptoms and sense of well-being).
Independent Variable
Nutrition counseling only vs. nutrition counseling plus oral supplement.
Control Variables
- HIV status
- Sex.
Initial N: 118 men (59 in each treatment group)
Attrition (final N): 99 (49 in supplement group, 50 in the control group)
Age: Mean age: supplementation group, 39 years; control group, 41 years
Ethnicity: Not mentioned
Anthropometrics: Only significant difference between groups is that the total quality-of-life score was higher in the control group (P=0.025) than the supplement group
Location: Houston, Texas.
Other Findings
There were no significant differences in hematologic parameters, CD4+ cell count or serum albumin level. The control group had a median increase in serum triglyceride level of 0.55mmol per liter compared with an increase of 0.02mmol per liter in the supplement group (P=0.04).
No significant differences were observed in weight, body fat, skinfold thickness, grip strength or fat-free mass. There was a significant difference between groups in total body water (change from baseline 0.6kg±0.5kg in supplement group, -0.4kg±0.3kg in control group, P=0.039). Patients in the supplement group experienced improvement in short-term recall (P=0.029) and long-term storage (P=0.047). No difference the total quality-of-life scores was detected.
The proportions of patients in the supplement (56%) and control (50%) groups who achieved 80% or more of energy target were not significantly different.
In the short term, nutrition counseling with our without oral supplementation can achieve a substantial increase in energy intake in approximately 50% of malnourished HIV-infected patients. Further study is needed to evaluate the effects of longer treatment periods on patient outcomes.
- Caloric intake not measured in groups at baseline
- Off the 19 subjects not completing the study, 17 did so for "unrelated reasons." It would have been important to know what those reasons were.
- Potential bias in measurements, especially cognitive function and quality-of-life tests
- Protocol for supplementation not well-described.
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) | 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? | ??? | |
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.) | 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? | ??? | |
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%.) | ??? | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
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? | N/A | |
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.) | N/A | |
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? | No | |
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? | Yes | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | ??? | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | No | |
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? | No | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | ??? | |
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? | ??? | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | ??? | |
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? | 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)? | Yes | |
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? | 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? | ??? | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | ??? | |