COPD: Bone Density (2008)
- COPD patient
- Male gender
- Ambulatory
- Moderate to severe airway obstruction
- History of tobacco smoking
- Female gender
- Disease of bone metabolism
- Malignancy
- Diabetes mellitus
- Chronic renal failure
- Hyperparathyroidism
- Hyperthyroidism
- History of bone fractures
- Long-term use of oral anticoagulants
- Alcoholism
Recruitment: Patients from study center recruited by unspecified techniques
Design: Cross sectional study
Blinding used (if applicable): Not applicable
Intervention (if applicable): Not applicable
Statistical Analysis: Student's t-tests were used to assess significant differences between groups and linear regression to assess correlations.
Timing of Measurements
Completed during the fall.
Dependent Variables:
- Osteocalcin measured with lab-specific radioimmunoassay
- Serum alkaline phosphatase, calcium, and inorganic phosphorus by Ciba-Corning Express automated blood chemistry analyzer
Independent Variables
- Age
- BMI
- Average tobacco use
- Dose and duration of corticosteroid use or control
Control Variables
- FEV1 measured by spirometry
Initial N: 65 males COPD patients (35 control, 30 treatment), 20 healthy subjects
Attrition (final N): as above
Age: Approximately 55-65 years
Ethnicity: Turkish patients assumed, not explicitly stated
Other relevant demographics:
Anthropometrics: Age and BMI of Control COPD, Treatment COPD, and Healthy Subjects were not significantly different.
Location: Center for Pulmonary Disease and Thoracic Surgery, Kecioren, Ankara, Turkey
DEPENDENT VARIABLE | CONTROL GROUP | TREATMENT GROUP | HEALTHY SUBJECTS | STATISTICAL SIGNIFICANCE |
Osteocalcin (ng/mL) | 7.03±0.19 | 3.74±0.12 | 11.26±.0.42 | p<0.01 control versus treatment, p<0.01 control and treatment versus healthy subjects |
Serum calcium (mg/dL) | 8.63±0.03 | 8.43±0.03 | 9.04±0.16 | NS |
Serum phosphatase (mg/dL) | 2.67±0.03 | 2.95±0.02 | 3.21±0.12 | NS |
Alkaline phosphatase(U/L) | 167.91±1.49 | 168.17±1.60 | 164.81±2.81 | NS |
Other Findings
No strong (significance not reported) correlations among daily dosage, total intake, or duration of intake of beclomethasone and osteocalcin levels.
- Long-term inhaled corticosteroid, beclomethosone taken regularly in clinical doses strongly reduces serum osteocalcin levels in COPD patients.
- Emphasized that COPD (versus asthmatics studied in previous research) and long-term tobacco use were associated with reduced serum osteocalcin levels in comparison with healthy subjects.
- Physicians should closely monitor patients on long-term inhaled steroid use for signs of osteoporosis.
Quality Criteria Checklist: Primary Research
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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? | No | |
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? | No | |
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? | No | |
3. | Were study groups comparable? | ??? | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | ??? | |
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.) | Yes | |
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? | ??? | |
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.) | ??? | |
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? | ??? | |
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.) | ??? | |
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? | Yes | |
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? | 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? | N/A | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | ??? | |
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? | 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? | ??? | |
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? | ??? | |
7.7. | Were the measurements conducted consistently across groups? | ??? | |
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? | ??? | |
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)? | 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? | ??? | |
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 | |