MNT: Disorders of Lipid Metabolism (2015)
To evaluate whether MNT results in beneficial clinical and cost outcomes.
- Outpatient
- Primary diagnosis of hypercholesterolemia
- Met criteria for initiating drug therapy (LDL-cholesterol higher than 4.1mmol per L
- Not on lipid-lowering medication
- 21 to 75 years of age
- Two to four visits to a registered dietician (RD) over a six- to eight-week period.
Did not meet inclusion criteria.
Recruitment
Medical records review of male patients with hypercholesterolemia who had followed NCEP Step 1 diet for six to eight weeks at a VA Medical Center.
Design
Case series review for cost-benefit analysis.
Intervention
Two to four MNT sessions with a dietitian.
Statistical Analysis
- Two-tailed paired T-test to examine changes for total and LDL- and HDL-cholesterol, triglycerides and BMI
- Subjects were placed into groups based on number of RD visits (two, three or four) for analysis of covariance adjusted for age and LDL-cholesterol using least significant difference
- Subjects were evaluated for changes in risk reduction
- Cost-benefit analysis.
Timing of Measurements
- Retrospective chart review evaluating pre- and post-MNT values for lipid profile, BMI
- Need for lipid-lowering drugs evaluated post-MNT.
Study Variables
- Number of MNT visits
- Lipid profile (total, HDL- and LDL-cholesterol, triglycerides)
- Total cholesterol/HDL-cholesterol ratio
- LDL/HDL cholesterol ratio
- BMI
- Patients needing lipid lowering drugs (per NCEP guidelines)
- Cost of MNT
- Cost of lipid-lowering drugs averted as a result of MNT
- Cost:benefit ratio of MNT to lipid drug therapy (including cost of monitoring).
- Initial N: 74 subjects mean age 60.8±9.8 years
- Location: Veterans Administration Medical Center, Long Beach, CA.
As a result of MNT:
- Decrease total cholesterol 13% (P<0.0001)
- Decrease LDL-cholesterol 15% (P<0.0001)
- Decrease TG 11% (P<0.05)
- Decrease HDL-cholesterol 4% (P<0.05)
- Average RD time 144±21 minutes
- Average 2.8±0.7 sessions over 6.8±0.7 weeks
- Decrease LDL-cholesterol greater with four RD visits compared to two RD visits; decrease 21.9% vs 12.1% (P<0.027)
- Lipid drug eligibility obviated in 34 out of 67 (51%) of subjects with savings of $60,561.68 from not using the lipid-lowering medicines.
Three to four individualized RD visits of 50 minutes each over seven weeks was associated with significant cholesterol decrease and a savings of health care dollars in avoiding the use of medications.
Government: | Veterans Administration Medical Center |
University/Hospital: | VAMC Long Beach, CA |
95 subjects were in the cholesterol-lowering drug study; however, data was only available on 74 subjects because 21 subjects dropped out of the original study.
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? | Yes | |
3. | Were study groups comparable? | Yes | |
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? | Yes | |
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? | N/A | |
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? | N/A | |
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? | Yes | |
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? | 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? | 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? | 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? | N/A | |
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)? | No | |
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 | |