SCI: Role of the Registered Dietitian (2007)

Study Design:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

The purpose of the research was to describe the outcome of deglutition disorders in the initial phases of cervical spinal cord injury, and to determine the influence of dysphagia on the incidence of pneumonia.

Inclusion Criteria:

Patients with cervical spinal cord injury admitted for initial care between January, 1997 and December, 2000.

Exclusion Criteria:

No exclusion for etiology, age or concurrent medical problems.

Description of Study Protocol:


73 consecutive patients with cervical spinal cord injury admitted for initial care between January, 1997 and December, 2000, regardless of the etiology, age or accompanying medical problems.


Prospective cohort study. 

Statistical Analysis

  • Patients were grouped according to presence or absence of tracheostomy and subgrouped for patients with and without dysphagia
  • For each subgroup, the mean duration of orotracheal intubation was calculated
  • Statistical methods were not described, but statistical results reported throughout article (chi-squared tests). 
Data Collection Summary:

Timing of Measurements

Temporal variables included the date of admission, the date of discharge, the number of days of intensive care and of mechanical ventilation, as well as dates of tracheostomy and tracheostomy closure. Assessment of deglutition at discharge.

Dependent Variables

  • Prevalence of dysphagia, screened by questionnaire and tests suggested by Loghmann et al
  • Frequency of pneumonia, diagnosed when radiological findings on plain chest X-rays correlated with elevated white blood cell count, serum C-reactive protein and clinical findings 
  • Assessment of deglutition, categorized as "resolved," "persistent, sufficient oral intake" or "persistent, insufficient oral intake." 

Independent Variables

Cervical spinal cord injury.

Control Variables

  • Date of onset of neurological symptoms
  • Associated head and chest injuries
  • Pre-existing medical conditions.
Description of Actual Data Sample:
  • Initial N: 73 consecutive patients; 51 males, 22 females
  • Attrition (final N): 68 patients; five died after five to 290 days on the ward
  • Age: Mean age was 43.5 years for those without dysphagia (range 1.4 to 86.6 years); mean age was 41.5 years for those with dysphagia (range 0.6 to 74.2 years) 
  • Other relevant demographics: Mean age at onset of spinal cord injury was 42.9 years
  • Location: Germany. 
Summary of Results:

Outcome at Discharge for 26 Patients with Dysphagia

  Dysphagia Resolved/Solved Persistent Dysphagia, Sufficient Oral Intake Persistent Dysphagia, Insufficient Oral Intake Patient Died Totals
Pharyngeal Phase
Pharyngeal and Oral Phase

Esophageal Phase






Other Findings

  • Median interval between the onset of neurologic symptoms or the accident and admission into the facility was 18 days with an interquartile range of 26 days
  • Patients spent a median of 200 days on the ward
  • Dysphagia was diagnosed in 26 of the 73 patients with cervical spinal cord injury and there was no association between dysphagia and age
  • There was a correlation between dysphagia and the level of injury such that patients with higher levels of cervical injury were more likely to have a swallowing disorder (P<0.05)
  • Tracheostomy and duration of orotracheal intubation are associated with dysphagia
  • The disorder necessitated dietary restrictions in 18 patients. Six of these patients had to be discharged with a percutaneous enterogastric feeding tube and seven had persistent problems that did not result in dietary restrictions
  • All patients with oral phase problems required dietary modifications at a significantly higher rate than those with a swallowing problem restricted to the pharyngeal phase (P=0.044)
  • The incidence of late pneumonia was significantly increased with two associated deaths. The incidence of late or multiple late pneumonia was significantly higher (58% vs. 9%) for patients with dysphagia (P<0.01).
Author Conclusion:

Dysphagia is a serious problem in the population of patients with cervical spinal cord injury. It affects about one-third of all patients with a problem in either the oral or the pharyngeal phase of swallowing or a combination of both. The notion that dysphagia is caused directly by a deficit of motor control due to spinal cord injury is not supported by our data. There is good reason to assume that it is associated with prolonged need for respiratory support and possibly with anterior spinal surgery. In particular, if only the pharyngeal phase of swallowing is impaired and the patient can cooperate, the prognosis for functional recovery is good. The situation has to be taken seriously because the risk for late pneumonia, with significant potential to cause death, is increased. It remains to be elucidated by further studies in which way the management of respirator-dependent tetraplegic patients can be modified to reduce the rate and complications of swallowing disorders. 

Funding Source:
University/Hospital: Orthopaedic University Hospital
Reviewer Comments:

Statistical analysis not well described. Subjects were not well described. No association was found regarding age and dysphagia, but some of the subjects were infants (0.6 years old). Not sure if all measurement methods would apply similarly for all ages.

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? ???
  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? ???
  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? Yes
  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? 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? N/A
  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? N/A
  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? 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? N/A
  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? ???
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? N/A
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? No
  8.2. Were correct statistical tests used and assumptions of test not violated? ???
  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)? ???
  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? No
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