MNT: Disorders of Lipid Metabolism (2015)
Sikand G, Kashyap ML, Yang I. Medical nutrition therapy lowers serum cholesterol and saves medication costs in men with hypercholesterolemia. JADA. 1998; 98: 889-894.
To evaluate whether MNT results in beneficial clinical and cost outcomes.
- 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.
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.
Case series review for cost-benefit analysis.
Two to four MNT sessions with a dietitian.
- 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.
- Number of MNT visits
- Lipid profile (total, HDL- and LDL-cholesterol, triglycerides)
- Total cholesterol/HDL-cholesterol ratio
- LDL/HDL cholesterol ratio
- 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
|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|
|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|