SCI: Fiber and Neurogenic Bowel (2007)

Citation:

Han TR, Kim JH, Kwon BS. Chronic gastrointestinal problems and bowel dysfunction in patients with spinal cord injury. Spinal Cord 1998; 36: 485-490.

Worksheet created prior to Spring 2004 using earlier ADA research analysis template.
PubMed ID: 9670385
 
Study Design:
Cross-Sectional Study
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  • To investigate the characteristics of chronic GI problems and bowel dysfunction, where the degree of which was such that daily activities (ADL) were significantly affected.
  • To determine which factors affect bowel dysfunction.
Inclusion Criteria:
  • SCI patients, at least six months post-injury, who had completed primary care.
Exclusion Criteria:
  • SCI patients with a combined cauda equine lesion, those with a spinal cord lesion due to disease or brain damage, and those whose neurological recovery was ongoing or whose bowel habit unsettled.
Description of Study Protocol:

Recruitment:  Each participant was either an inpatient at Seoul National University Hospital, was an inpatient at the National Rehabilitation Center, or was receiving nursing care at a community society.

Design:  Cross-Sectional Study

Blinding Used (if applicable):  not applicable

Intervention (if applicable):

Detailed semi-structured individual interviews were conducted.

Statistical Analysis:

Patients were categorized according to age, duration, and neurological level of SCI, ASIA scale, degree of dependency of ADL level and ambulatory activity level.  Mantel-Haenszel chi-test was used to determine factors that may influence bowel dysfunction.

Data Collection Summary:

Timing of Measurements

Detailed semi-structured individual interviews were conducted.

Dependent Variables

  • GI problems and its adverse impact
  • Physical examination
  • Medical records review
  • Evaluation of ADL using Modified Barthel Index score.

Independent Variables

  • Evaluation of SCI level

Control Variables

Description of Actual Data Sample:

Initial N:  72 SCI patients, 48 males, 24 females

Attrition (final N):  72

Age:  mean age 38.0 +/- 11.9 years

Ethnicity:  not mentioned

Other relevant demographics:

Anthropometrics:

Location:  Korea

Summary of Results:

Other Findings

  1. Incidence of chronic GI problems was high (62.5%), most were associated with defecation difficulties such as severe constipation, difficulty with evacuation, pain associated with defecation, or urgency with incontinence.
  2. These GI problems had an extensive impact on ADL, and in particular, restricted diet (80%), restricted outdoor ambulation (64%), and caused unhappiness with bowel care (62%).
  3. Bowel dysfunction was not related to age, duration of, or the neurological level of injury, ASIA score of ADL level and bowel habits had generally settled within six months of SCI.
  4. With regard to frequency, time, and method of defecation, bowel care habits varied considerably among individuals and in relation to the extent to which practical results matched the levels of expectation generated by physician’s recommended bowel care program.
Author Conclusion:
  • The self-reported GI problems were vague and subjective, but serious enough to adversely affect various aspects of daily life.
  • In most SCI patients, bowel care habits were not related to its severity and became settled within six months of injury. Thus, during the early stage of rehabilitation, an appropriate program should be carefully designed and appropriate training be provided.
Funding Source:
University/Hospital: Seoul National University school of Medicine (Korea)
Reviewer Comments:
  • Dietary factors: Fiber and fluid not addressed.
  • Large sample size, generalizable to SCI population.
  • Volunteer bias: Patients with more severe GI problems may not be willing to participate in the study. The reported incidence rate may underestimate the truth.
  • Comprehensive results: Report both quantitative and qualitative data.
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) N/A
  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) N/A
 
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) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? Yes
  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.) Yes
  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? 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? N/A
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  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? Yes
  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)? 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? 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? ???
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