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MNT: RDN in Medical Team (2015)

Citation:

Iwasa M, Iwata K, Hara N, Hattori A, Ishidome M, Sekoguchi-Fujikawa N, Mifuji-Moroka R, Sugimoto R, Fujita N, Kobayashi Y, Takei Y. Nutrition therapy using a multidisciplinary team improves survival rates in patients with liver cirrhosis. Nutr. 2013; 29: 1,418-1,421.

PubMed ID: 24103520
 
Study Design:
Retrospective Cohort Study
Class:
B - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
To retrospectively analyze whether nutrition therapy for liver cirrhosis (LC), performed by a multi-disciplinary team that includes registered dietitians improves survival rates.
Inclusion Criteria:
Liver cirrhosis; not otherwise described.
Exclusion Criteria:
Not described.
Description of Study Protocol:

Recruitment

Patients with liver cirrhosis who visited the Department of Gastroenterology and Hepatology at the Mie University Hospital between January 2005 and October 2012 were included in the study.

Design

  • Study One
    • Survival rates were compared between two groups of LC patients. The first group received no dietary counseling from a dietitian; the second group received dietary counseling from a dietitian.
    • The observation periods were 1,132±615 days and 926±664 days for the two groups, respectively.
  • Study Two
    • The LC patients that received nutritional counseling in Study One were split into two groups and their survival rates were compared. The first group attended liver disease courses; the second group did not attend the liver disease courses.
    • The observation periods were 802±649 days and 1,145±650 days for the two groups, respectively.

Intervention

  • Study One
    • The first group received nutritional advice from a physician and was prescribed branched-chain amino acids (BCAA) or late-evening snacks (LES) at the discretion of the attending physician
    • The second group received body-composition monitoring and advice on nutrient intake levels by a registered dietitian every one to three months. If necessary, the dietitian advised the physician to carry out BCAA or LES therapy.
    • In both groups, 30kcal to 35kcal with 1.0g to 1.5g of protein per kg of ideal bodyweight per day were recommended.
  • Study Two
    • The liver disease courses were provided every three to six months and were facilitated by a multi-disciplinary team
    • Physicians gave lectures on the importance of nutrition therapy, dietitians explained the actual condition of nutrition therapy, pharmacists provided instructions on how to take medications and nurses provided advice on various aspects of daily life
    • Sessions were held on the preparation of therapeutic foods and snacks and patients attended testing sessions.

Statistical Analysis

X2 test, Mann-Whitney U-test and Kaplan-Meier analysis were used, as appropriate. 
Data Collection Summary:

Dependent Variables

Survival rates.

Independent Variables

  • Study One: No dietary counseling from a dietitian vs. dietary counseling from a dietitian
  • Study Two (of those patients that received nutritional counseling in Study One): Attended liver-disease courses presented by the multi-disciplinary team vs. did not attend liver-disease courses. 

Control Variables

  • Age
  • Sex
  • Child-Pugh Score (A, B, C).
Description of Actual Data Sample:

Initial N

  • Study One: N=234 (139 male, 95 female)
  • Study Two: N=133 (70 male, 63 female).

Attrition (Final N)

  • Study One: N=234 
  • Study Two: N=133.

Age

  • Study One
    • No counseling from a dietitian: 66±15 years
    • Counseling with a dietitian: 67±9 years.
  • Study Two
    • Attended liver disease courses: 66±6 years
    • Did not attend courses: 67±11 years.

Ethnicity
Not described.

Other Relevant Demographics
Not described.

Anthropometrics

  • Study One
    • There was a significantly greater number of women in the second group (counseling with a dietitian; P<0.05)
    • There were no differences in the cause of LC or its severity between groups.
  • Study Two: There were more patients with hepatitis C virus (HCV) as the cause of LC in the second group (P<0.05).

Location
Tsu, Japan.

Summary of Results:

Key Findings

  • Study One: More patients died in the first group (no counseling from a dietitian) than in the second group (counseling from a dietitian; 34 vs. 20; P<0.05)
  • Study Two: More patients died in the second group (no courses) than in the first group (attended liver disease courses; 15 vs. four, P<0.05).

Other Findings

Study One
  • The difference in survival rates was even more pronounced in the subset of patients classified as Child-Pugh Class A (P<0.01).
  • The difference in survival rates was significant in male patients (P<0.05)
  • In all cirrhotic patients, Child-Pugh Classes B and C were associated with poor survival compared to Class A (P<0.001).
Author Conclusion:
  • Increased survival rates can be anticipated by early monitoring of the nutritional state of LC patients by a dietitian and by providing guidance and management for maintaining nutritional standards appropriate to the disease state of patients, compared to results achieved after administration of BCAA and LES by a physician alone
  • Combining LC nutrition therapy with a multi-disciplinary nutrition support team intervention appears to be superior to conventional methods of nutrition therapy performed by physicians and dietitians.
Funding Source:
University/Hospital: Mie University Graduate School of Medicine, Miu University Hospital
Reviewer Comments:
  • Many patients in the groups that received nutritional counseling or multi-disciplinary nutrition support team were already highly motivated to recover. This may have affected the improvement in survival rate.
  • Exclusions: Were all LC patients included in the study?
  • Causes of death: Assume LC for all?
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) 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? ???
  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? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
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? 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? 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? Yes
  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? 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? ???
  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)? ???
  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