COPD: Determination of Energy Needs (2007)

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

1.  To prospectively assess the nutritional status of COPD patients with acute exacerbation, during the period of hospital admission

2.  To evaluate the relationships between the nutritional indices and the pulmonary function parameters

Inclusion Criteria:
  • COPD defined according to GOLD criteria
  • Acute exacerbation
  • Free of any associated condition known to affect nutritional status negatively (cancer, liver disease, chronic renal failure, surgery performed within 6 months, severe endocrine disorders, active gastrointestinal diseases)
Exclusion Criteria:
Excluded if not included above.  None of the patients had evidence of significant reversibility (>15% of predicted baseline) of air flow obstruction after inhalation of 500 micrograms terbutaline.
Description of Study Protocol:

Recruitment

Patients consecutively admitted to hospital for standard medical treatment.

Design

Cross-Sectional Study.

Blinding used (if applicable)

Not applicable.

Intervention (if applicable)

Nutritional assessment measured through anthropometric measurements, biochemical analysis, and immunologic testing.

Statistical Analysis

Pearson correlation coefficients and Mann-Whitney U tests were used.

Data Collection Summary:

Timing of Measurements

All measurements performed within 5 days during hospitalization period.

Dependent Variables

  • Anthropometric measurements:  height, weight, BMI 
  • Biochemical analysis:  blood samples analyzed for albumin, transferrin, total lymphocyte count 
  • Immunologic testing:  delayed type hypersensitivity skin tests
  • Lung function measurements through spirometry

Independent Variables

  • Severe or mild-to-moderate COPD

Control Variables

 

Description of Actual Data Sample:

Initial N: 53 COPD patients

Attrition (final N):  53

Age:  mean age 62.75 +/- 10.98 years

Ethnicity: not mentioned

Other relevant demographics:

Anthropometrics:

Location:  Turkey

 

Summary of Results:

 

  FEV1 < 50% (n=41)

FEV1 > 50% (n=12)

IBW%

104.42 +/- 4.30 115.31 +/- 7.28

Actual body weight (kg)

64.29 +/- 2.24

69.36 +/- 4.11

Usual weight (kg) 67.78 +/- 1.79 73.90 +/- 4.14
Ideal weight (kg) 63.14 +/- 2.06 60.60 +/- 1.83
Albumin (g/dl) 4.02 +/- 0.42 4.20 +/- 0.25
Transferrin (g/dl) 257.96 +/- 81.14 242.62 +/- 28.38
Lymphocytes (/mm3) 2100.00 +/- 1193.92 2010.00 +/- 907.31

PPD (mm)

11.67 +/- 6.89

10.63 +/- 1.66

Other Findings

IBW% was found to be 104.42 +/- 4.30 in severe COPD and 115.31 +/- 7.28 in mild to moderate COPD (p = 0.07).

There was no relationship demonstrated between IBW% and FEV1.

IBW% was correlated with DLCO for the total study population (r=0.353, p = 0.035).

Weight loss greater than 5% of body weight was observed in 54% of patients.

Comparison of the patient's actual weight to their usual weight revealed statistically significant weight loss (p < 0.01).

Mean values of serum albumin and transferrin were found to be in the normal range.

Delayed type hypersensitivity skin test revealed normal immune status.

When study parameters were compared, no statistically significant differences in parameters related to nutritional status were detected between severe and mild to moderate COPD groups. 

Author Conclusion:
In conclusion, monitoring of nutritional parameters and eventual dietetic treatment should also be included in the goals of the medical treatment of patients with COPD in acute exacerbation.
Funding Source:
Reviewer Comments:
Used several markers of nutritional status.
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? 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? 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? 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? 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? 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