ONC: Radiation Therapy (2007)
Patients who had head and neck cancer (stages iii and iv)
Recruitment : Not specified
Design : Prospective, time series
Blinding used (if applicable) N/A
Intervention (if applicable) N/A
Statistical Analysis
- Non-parametric tests used due to limited sample size
- Friedman's test: to evaluate difference in REE measured by Indirect Calorimetry (IC) or calculated by the Harris-Benedict (HB) formula during treatment.
- Wilcoxon's test: to evaluate differences at each point during treatment between methods.
- Bland-Altman test: to evaluate clinical concordance between methods
Timing of Measurements:
- Before treatment
- Weeks 2, 4, and 6 during chemoradiotherapy
- End of treatment
- 2 weeks after the completion of treatment
Dependent Variables
Resting Energy Expenditure (REE)
- Indirect Calorimetry (IC): metabolic monitor Deltatrac. Measurements were perfurmed for 30 min. after an overnight fast, and with patients in a supine position. REE calculated by Weir's formula.
- Harris Benedict (HB) formula
Anthropometry
- Weight: platform balance, measured to the nearest 0.2 kg
- Height: stadiometer, measured to the nearest 0.1 cm
- Skinfold thickness (triceps and subscapular): obtained in triplicate using a Holtain caliper (pressure 10 g/mm2, precise to 0.2mm)
- Midarm circumference: obtained in triplicate using a metric scale to the nearest 0.2 cm.: calculated as midarm circumference minus the product of 3.14 and triceps skinfold thickness
Independent Variables:
- treatment with chemoradiotherapy
Control Variables: None specified.
Initial N: 18 (15 male, 3 female)
Attrition (final N): 18
Age: 57 + 10.7 yrs (range: 30-71 y)
Ethnicity: Not specified.
Other relevant demographics: None specified.
Anthropometrics: Before treatment:
- Weight (kg) 66.1 + 13.7 (43.9 - 92.2)
- Body Mass Index (BMI) (kg/m2): 24.7 + 4.4 (16.9 - 31.4)
- Fat free mass (FFM) (%): 71.9 + 5.8 (62.7 - 86.3)
- Fat mass (FM) (%): 28.3 + 5.8 (13.7 - 37.3)
- Impedance (IMP): 515 + 92.5 (333 - 683)
- Triceps skinfold thickness (PTP) (mm): 13.4 + 5.9 (3 - 22.5)
- Subscapular skinfold thickness (PSB) (mm): 14.2 + 6 (4 - 28)
- Midarm muscle circumference (MAMC) (cm): 22.2 + 3.4 (15.1 - 27.1)
Location: Spain
Anthropometrics:
- Patients lost weight during treatment: BMI decreased from 24.7 + 4.4 kg/m2 to 22.3 + 4.2 kg/m2. (p<0.001). Weight decreased from 66.1 + 13.7 to 59.8 + 12.8 kg (p<0.001).
- A decrease in visceral proteins was observed: PSB decreased from 14.2 + 6 mm to 11.9 + 6mm (p<0.002); MAMC decreased from 22.2 + 3.4 cm to 21.6 + 2.9 cm. (p=.031)
- Impedance increased from 515 + 92.5 to 574.5 + 102.1 (p<0.002)
- Changes in FFM, FM and PTP = n.s.
Resting Energy Expenditure:
- REE (kcal/24 hr) changed significantly during treatment. IC: p< 0.05; HB formula: p<0.001)
Kcal/24 hr
Mean + S.D. (range)
IC HB P
Before 1563 + 343 (1110-2520) 1415 + 216 (1070-1720) 0.035
2 week 1437 + 313 (1000-2240) 1381 + 199 (1090-1820) 0.320
4 week 1380 + 296 (880-2070) 1359 + 213 (1030-1860) 0.477
End 1430 + 282 (900-2170) 1307 + 188 (1000-1740) 0.011
After 1480 + 262 (1100-2020) 1307 + 187 (1040-1770) 0.002
- REE measured by IC appeared as a U-shaped curve, with higher levels before treatment, at the end of treatment and 2 wk after treatment.
- REE as estimated by the HB formula decreased during the entire study period.
- HB formula underestimated REE measurements compared with IC. Differences were statistically significant before treatment, at the end of treatment and 2 wk after treatment (p<.05)
- Same differences were also observed when REE was expressed as kcal/kg body weight (p<0.05) and of FFM (p<.05).
- Clinical concordance between methods was unacceptable (shown by Bland-Altman graphic).
Other Findings
Thyroid hormone levels were normal during the study period.
University/Hospital: | Hospital General University Gregorio Maranon |
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) | 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? | N/A | |
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? | ??? | |
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? | 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? | 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.) | N/A | |
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? | N/A | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | Yes | |
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? | 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? | ??? | |
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 | |