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SCI: Fiber and Neurogenic Bowel (2007)

Citation:

Badiali D, Bracci F, Castellano V, Corrazziari E, Fuoco U, Habib FI, Scivoletto G. Sequential treatment of chronic constipation in paraplegic subjects. Spinal Cord 1997; 35: 116-120.

Worksheet created prior to Spring 2004 using earlier ADA research analysis template.
PubMed ID: 9044520
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
  • To assess if a therapeutic protocol, which combines the means to accelerate large bowel transit and to trigger the defaecatory act, can increase the frequency and optimize the timing of bowel movement, and thus decrease the necessity for the use of oral laxatives and/or enemas in SCI patients.
Inclusion Criteria:
  • SCI patients who had chronic constipation and required use of different stimuli for bowel evacuation.

 

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment:  methods not described

Design:  Nonrandomized Clinical Trial

Blinding Used (if applicable):  not applicable

Intervention (if applicable)

4 weeks of treatment:

  1. Interrupt enemas and/or laxatives.
  2. Mediterranean diet: 15g of fibers and 1500 ml/24h water, enriched with vegetables and fruit.
  3. Gradual and sequential stimuli.
  • Score 1: Abdominal massage
  • Score 2: Perianal digitations
  • Score 3: Ano-rectal digitations
  • Score 4: Glycerin suppository
  • Score 5: Rectal laxatives
  • Score 6: Oral laxatives.

Progress to the successive stimulus only if the preceding one is unsuccessful.

Statistical Analysis:  Statistical analysis carried out by means of Wilcoxon's test.

Data Collection Summary:

Timing of Measurements

  • Variables were assessed in basal condition and after 4 weeks of treatment.

Dependent Variables

  • Bowel movement frequency; bowel habit; total and segmental

Independent Variables

  • Therapeutic protocol based on high residue diet, standardized water intake, and use of sequential schedule of evacuating stimuli

Control Variables

Description of Actual Data Sample:

Initial N:  10 SCI patients, 5 male, 5 female

Attrition (final N):  10

Age:  mean age 33 years, range 20 - 60 years

Ethnicity:  not mentioned

Other relevant demographics:  SCI level ranged from C3 to L4

Anthropometrics:

Location:  Italy

Summary of Results:

Other Findings

  1. In the basal period, four and two patients used oral and rectal contact laxatives, respectively. At the end of the training period no patient took contact laxatives orally, and two used laxative suppositories. The score which expressed the degree of altered evacuation in accordance with the sequential schedule was 4.5±1.9 in the basal period, and 3.1±2.7 during the training period (P<0.05)
  2. Reported bowel frequency was 2.9±2 events per week in the basal period, and 4.1±3 events per week at the end of the training period.
  3. The total GI transit time (TGITT) was significantly reduced at the end of the study (146±15 vs. 86±17; P<0.01).
Author Conclusion:
This treatment seems to be effective in modifying patients' bowel habits, and therefore should be considered as a standardized protocol for the management of severe constipation in those who are paraplegic.
Funding Source:
University/Hospital: Univesita La Spienza (Italy), IRCCS Ospedale di Riabilitazione (Italy)
Reviewer Comments:
  • Protocol was clearly explained; intervention was conducted with high compliance rate (100%).
  • High compliance rate (100%).
  • Small sample size; however, clinical significance of the effectiveness of the treatment were evident.
  • Inclusion/exclusion criteria and recruitment methods not well described.

 

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? No
  2.2. Were criteria applied equally to all study groups? ???
  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? ???
3. Were study groups comparable? N/A
  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? 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? 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? 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? N/A
  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? 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