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CI: Enteral Nutrition and Fiber (2011)

Citation:

Dobb GJ, Towler SC. Diarrhoea during enteral feeding in the critically ill: a comparison of feeds with and without fibre. Intensive Care Med. 1990; 16 (4): 252-255. PMID: 2162867.

PubMed ID: 2162867
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

Determine whether EN formula with fiber can reduce frequency of diarrhea.

Inclusion Criteria:

Patient starting nasogastric tube feeding while in ICU.

Exclusion Criteria:
  • Recent history of diarrheal illness (Chron's disease, ulcerative colitis, ischemic colitis or melena)
  • Special dietary requirement
  • Recent (within previous 14 days) GI surgery
  • Patients enterally fed for less than three days were excluded from data analysis.
Description of Study Protocol:
  • Recruitment: All adult patients starting NG tube feeding in ICU
  • Design: RCT (computerized randomizaation)
  • Blinding used: Formula delivered to ICU in sterile two-liter plastic containers.

Intervention

  • Fiber Group received Enrich formula with 21g per L soy polysaccharide
  • Control Group received Ensure formula with no fiber.

Statistical Analysis

  • ANOVA to compare means of continuous variables
  • Wilcoxon rank sum test to compare scores in treatment and control groups (data were not normally distributed).
  • No Power analysis described.
Data Collection Summary:
  • Timing of measurements: Recorded and calclulated diarrhea score at each incidence
  • Dependent variables: Diarrhea (diarrhea score based on consistency (formed, semisolid, liquid) and estimated volume of +, ++ or +++)
  • Independent variables: Tube feeding formula
  • Control variables: EN formulas were isocaloric (Enrich 1.1 kcal/ml and Ensure 1.05 kcal/ml).
Description of Actual Data Sample:
  • Initial N: 91 (61 males, 30 females)
  • Attrition: None
  • Age: Fiber Group, 47±19; Control Group, 45±19 years
  • Ethnicity: Not described.

Other Relevant Demographics

  • Primarily post-operative patients who had trauma or complications from coronary surgery 
  • Mean feeding volume between groups NS different
  • Total number of feeding days similar
  • Investigators compared number of patients by diagnostic categories for treatment and control EN, but did not provide statistical evaluation (P-value) that groups were alike. There were no APACHE or illness severity scores.

Anthropometrics

Serum albumin concentration: NS difference with Fiber Group 29.3±4.3g per L (range, 18g to 37g per L) vs. Control Group, 30.3±5.1g per L (range, 17g to 41g per L).

Location

Perth, Western Australia.

Summary of Results:

Key Findings

Variables

Fiber Group (n=45)

Control group (n=46)

Statistical Significance of Group Difference

Diarrhea Incidence
16/45 (36%)
13/46 (28%)
 NS

Diarrhea per Feeding Days

 47/343 (14%)

 51/342 (15%)

NS

Severe Diarrhea per Feeding Days

 8/343 (2%)

 12/342 (3%)

NS
Constipation
17/45 (38%)
24/46 (52%)
 X2: 1.37
P=0.24
OR: 1.8
95% CI: 0.7-4.5

 

Author Conclusion:

Soy polysaccharide did not reduce diarrhea in ICU patients receiving EN.

Funding Source:
University/Hospital: Royal Perth Hospital
Reviewer Comments:
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? 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? No
  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? 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? 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? 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? Yes
  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? 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)? Yes
  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