EAL

SCI: Role of the Registered Dietitian (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of the research was to develop a multidisciplinary clinical pathway to provide a high standard of care and to control costs for the treatment of patients with severe SCI [spinal cord injury].

Inclusion Criteria:

Patient admitted to the University of Louisville Hospital with spinal cord injury since the inception of the SCI clinical pathway [CP] in 1996
Serious neurological deficit
Admitted to the intensive care unit
Historical controls were admitted to the University of Louisville Hospital within the 2 years prior to initiation of the CP; all had serious neurological deficits and were admitted to the intensive care unit during their stays

Exclusion Criteria:

Patients who did not meet the inclusion criteria were not included in the study

Description of Study Protocol:

Recruitment:

Patients admitted to the University of Louisville Hospital with spinal cord injury were included in the study

Design

Nonrandomized trial with historical controls

Blinding used (if applicable): NA

Intervention (if applicable):

All emergency care was provided according to the American College of Surgeons Advanced Trauma Life Support guidelines
- Methylprednisolone sodium succinate was administered in accordance with the National Acute Spinal Cord Injury Study
The spinal cord injury clinical pathway [SCICP] had four phases:
- Phase One: Admission to the Neurosurgical or Trauma Intensive Care Unit
  - Standardized orders were implemented
  - Early involvement of ancillary services, including dietitians, was included
  - Discharge planning was initiated
- Phase Two: Acute critical care stage
  - Appropriate stabilization occurred; if surgically stabilized, surgery occurred within 2 days of injury
  - Enteral nutrition initiated within 48 hours of injury
  - Ventilator dependent patients underwent tracheotomy within 4 days of injury
- Phase Three: Mobility and weaning stage
  - Rehabilitation intensified
  - Weaned from ventilator
- Phase Four: Pre-rehab
  - Patient transferred from intensive care to transitional care unit
  - Physical therapy and rehabilitation efforts continued
  - Patient transferred to long-term care or to a rehab facility

Statistical Analysis:

Data for the pathway group was collected prospectively, then compared to a group of historical controls whose data was collected retrospectively
The Amerian Spinal Injury Association [ASIA] motor scale was used to evaluate neurologic status
The Injury Severity Score [ISS] was used to grade the patient's overall systemic injuries
All data was analyzed using Student's t-test

Data Collection Summary:

Timing of Measurements:

Measurements for historical controls were taken retrospectively
Measurements for intervention group were taken during hospitalization period

Dependent Variables

Variable 1: Complication rates
Variable 2: Length of stay

Independent Variables:

Hospitalization in an intensive care unit for severe spinal cord injury
Use of SCICP

Control Variables:

Historic controls who did not receive SCICP protocol during care for severe spinal cord injury

Description of Actual Data Sample:

Initial N:

Historical controls: N = 22
Clinical pathway group [CP group]: N = 36

Attrition (final N):

Same

Age:

Control group: 34 + 10 yrs
CP group: 33 + 15 yrs

Ethnicity: Not mentioned

Other relevant demographics: There were no significant differences between groups on ASIA motor scores, ISS scores, mechanism of injury, or severity of injury

Anthropometrics: Not provided

Location: University of Louisville Hospital, Louisville, Kentucky

Summary of Results:

Variables

SCICP Group

Historical Control group

Statistical Significance of Group Difference

Complication rates:

Pneumonia (Avg. episodes per pt)

Decubitus ulcers (%)(total number in group)

Stage III decubitus ulcers (%) (total number in group)

1.1

25% (12)

0% (0)

1.6

54% (9)

14% (3)

p<0.05

Length of stay:

Total hospital length of stay (in days)

Total intensive care unit length of stay (in days)

Number of ventilator days

24.4 + 13.5

21.2 + 12.7

12.8 + 11.6

35.9 + 16.7

28.0 + 13.1

18.8 + 12.9

p<0.05

Other Findings: A standard set of daily charges was used to estimate costs that patients would have occurred during their hospital stays. Using this projection, the authors estimated a savings of $21,881 per SCICP patient when compared to control patients.

Author Conclusion:

The authors found that early tracheostomy and enteral feedings were important components of the clinical pathway, with enteral nutrition support helping to counteract and mitigate the effects of malnutrition, such as immune suppression. The clinical pathway included early involvement of dietitians in the care of SCI patients. The authors concluded that the most important components of the pathway were the total coordination of patient care, communication between all services, and early discharge planning, thus ensuring that all aspects of patient care are addressed.

The authors noted several limitations of their study, including:

Use of historical controls
Increased availability of rehabilitation beds in the community, possibly resulting in decreased lengths of total hospital stay

Funding Source:

University/Hospital:

University of Louisville

Reviewer Comments:

Use of historical controls weakens study
No anthropometric data or information re: pre-existing conditions included

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?	???
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.)	No
	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?	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?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	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.)	No
	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?	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?		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?	N/A
	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?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	???
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)?	No
	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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes