EAL

SCI: Lipid Abnormalities (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare lipid profile and fasting glucose by level of injury, age, and time since injury in patients with SCI

Inclusion Criteria:

Patients with SCI visiting a neurorehabilitation hospital for annual routine health checks

Exclusion Criteria:

None given

Description of Study Protocol:

Recruitment

During annual routine health checkup at the neurorehabilitation hospital

Design

Comparison by level of injury (lesions above Th5, between Th6 and Th12, below L1), age (<35, 35-55, 55-70, >70), and time lapse after injury of fasting serum lipid levels and fasting glucose measured at a single point in time. Data gathered between 1996 and 2001

Blinding used (if applicable):

Intervention (if applicable):

None

Statistical Analysis

Comparison of differences among 3 levels of injury to lipids and glucose and 4 age groups to lipids and glucose by ANOVA (analysis of variance)

Data Collection Summary:

Timing of Measurements

Fasting, during annual health check

Dependent Variables

fasting lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides) measured using an automatic analyzer (Hitachi model 717) (no information provided about specific analysis methods)
fasting glucose (same automatic analyzer)

Independent Variables

level of SCI
age
time since injury

Control Variables

No strenuous physical activity the day before the test

Description of Actual Data Sample:

Initial N: 2135 (72% men, 28% women)

Attrition (final N): NA

Age: 50±16 years

Ethnicity: not provided

Other relevant demographics: ASIA impairment scale: ASIA A: 65%; ASIA B: 17%; ASIA C:10%; ASIA D:8%

Anthropometrics: no information reported

Location: A neurorehabilitation hospital (Institut Guttmann) in Badalona, Spain

Summary of Results:

Level of Injury Age

Variables	>Th5	Th6- Th12	<L1	F,P*	<35	35-55	55-70	>70	F,P*
Total cholesterol (mmol·l^-1)	5.03±1.13	5.23±1.22	5.53±1.15	22.14 <0.001	4.50±0.94	5.21±1.07	5.63±1.18	5.69±1.2243	116.25 <0.001
HDL-c (mmol·l^-1)	1.11±0.26	1.19±0.24	1.27±0.36	1.62 NS	1.24±0.41	1.11±0.27	1.21±0.30	1.25±0.23	1.320 NS
LDL-c (mmol·l^-1)	3.56±1.10	3.61±1.24	3.82±1.06	0.252 NS	2.78±1.08	3.21±1.00	3.90±1.02	4.04±1.27	3.51 <0.05
Triglycerides (mmol·l^-1)	1.56±0.96	1.45±0.90	1.37±0.67	0.504 NS	1.28±0.59	1.42±0.91	1.55±0.85	1.63±1.05	0.955 NS
Fasting Glucose (mmol·l^-1)	5.33±1.64	5.42±1.65	5.52±1.44	1.727 NS	4.78±0.66	5.14±1.20	5.90±1.90	6.22±2.38	83.49 <0.001

* Statistical significance for differences among all groups; Values are mean±SD; all values are fasting

Other Findings

Statistically significant correlations between total cholesterol, LDL-c, and glucose with time since injury ( all p<0.05) (data not provided)

Author Conclusion:

There is a direct relationship between total cholesterol, LDL-c and glucose and age of patients with SCI, but not with severity of SCI or time since SCI.

Funding Source:

University/Hospital:

Institut Guttmann (Badalona, Spain); University of Barcelona; Hospitalet de Llorbregat; Hospital General de Catalunya (Sant Cugat del Valles-Barcelona, Spain)

Reviewer Comments:

Because the authors did not provide an n (number of subjects) for each group, it is not possible to crosscheck the results.

This study did not assess/control for any confounding variables which might affect lipid/glucose values (except for previous day's physical activity): alcohol, hypertension, cardiovascular disease, diabetes, etc. Given that, lipid and glucose results are not that much different from the upper range of normal provided.

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?	???
	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?	No
	2.2.	Were criteria applied equally to all study groups?	???
	2.3.	Were health, demographics, and other characteristics of subjects described?	???
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
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?		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?	N/A
	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.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	???
	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?	No
	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?		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?	N/A
	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?	N/A
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?	No
	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)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	???
	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?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes