ONC: Hematopoietic Cell Transplant (2006)
None disclosed
Recruitment
61 patients with hematologic or non-hematologic malignancies undergoing autologous HSCT
Design
Total parenteral nutrition was given to 31 patients while partial parenteral nutrition was given to 30 patients. All patients in the TPN and 17 patients in the PPN group received growth factor in the post-transplant period.
Blinding used (if applicable)
n/a
Intervention (if applicable)
Total parenteral nutrition
•20% lipid emulsion, 5% dextrose and 29% dextrose/amino acid mixture
•30kcal/kg/day
•1g protein/kg/day
•vitamin K 20mg/week
•trace elements and vitamin supplement containing vitamins A,C, D, B1, B6 and B12 given daily
Partial parenteral nutrition
•commerically available amino acid solution with 10% dextrose with electrolytes
•340kcal/day
•0.5g protein/kg/day
Statistical Analysis
•The Kolmogorov-Smirnov and Shapiro-Wilk tests was used for the distribution of the data
•Chi-Square and Fishcer's exact tests were used for nominal data and proportional distributions
•Unpaired t test or the Mann-Whitney U test was used for numeric data from different groups
•Paired t test or Wilicoxon signed ranks test was used for before and after treatment numeric values
•All statistical comparisons were made with SPSS 10.0 for Windows
Timing of Measurements
Daily measurements:
serum concentrations of
• glucose
• urea nitrogen
• creatinine
• sodium
• potassium
•complete blood count
Twice weekly measurements:
serum levels of
• albumin
•total protein
•aspartate aminotransferase
•alanine aminotransferase
•cholesterol
•triacylglycerols
•direct and indirect bilirubin
Body weight measured on days 0, +5, +10, +15 and +20
Pre & post transplant:
•Body mass index
Dependent Variables
•nutritional status measured by body mass index and body weight
•biochemical parameters measured by glucose, urea, creatitine, sodium, potassium, aspartate aminotransferase and alanine aminotransferase
•engraftment measured by leukocyte count and platelet count
•supportive care measured by
•antibiotic use
•febrile day (over 38.1 degree C)
•culture positivity
•oral mucositis
•duration of hospital stay
•RBC transfusion
•platelet transfusion
Independent Variables
•parenteral nutrition
•growth factor
Control Variables
none identified
Initial N: 61 (32 male, 29 female)
Attrition (final N):61
Age: median TPN 34.6 +/-13.4 (14-55), PPN 36.64 +/-11.08 (21-56)
Ethnicity: not disclosed
Other relevant demographics:
•Both groups did not differ with respect to sex, age and reinfused CD34 cell numbers
•Pretransplant conditioning differed according to type and phase of disease and included high dose chemotherapy regimens
•Use of growth factor started on day 1 and continued until the leukocyte count reached 1 X 10 9/L for 3 consecutive days
•post transplant both groups allowed a standardized diet consisting of foods of low bacterial content
Anthropometrics
Pre transplantation p<0.001
| TPN | PPN | |
| Body Mass Index | 23.89 kg/m2 | 24.57 kg/m2 |
| Body Weight | 68.39 kg | 68.04 kg |
Post transplantation p<0.001
| TPN | PPN | |
| Body Mass Index | 23.11 kg/m2 | 23.12 kg/m2 |
| Body Weight | 66.33 kg | 63.98 kg |
Post transplant
| TPN | PPN | P | |
| Glucose (mg/dL) | 159.88 +/-51.66 | 136.23 +/-65.28 | 0.030 |
| Urea (mg/dL) | 34.06 +/-8.06 | 27.53 +/- 12.98 | <0.001 |
| Creatinine (mg/dL) | 1.00 +/- 0.14 | 1.02 +/- 0.3 | 0.478 |
| Na (mEq/L) | 140.41 +/- 3.04 | 139.23 +/-4.01 | 0.198 |
| K (mEq/L) | 4.30 +/- 0.58 | 4.01 +/-0.55 | 0.053 |
| AST (IU/L) | 35.45 +/- 22.59 | 34.73 +/- 23.11 | 0.773 |
| ALT (IU/L) | 49.03 +/- 48.81 | 42.16 +/-30.65 | 0.724 |
ALT = alanine aminotransferase
AST = aspartate aminotransferase
PPN = partial parenteral nutrition
TPN = total parenteral nutrition
Location:
Turkey
Variables:
•Nutrition status
After transplantation
•body mass index and body weight decreased signficantly in both groups ( P<0.001)
Biochemical parameters
At end of parenteral nutrition
• serum albumin decreased signficantly in PPN group ( P =0.019)
•serum urea and glucose levels elevated significantly in TPN group (P<0.001 and P =0.03 respectively)
Engraftment
•delay in platelet engraftment in the TPN group compared with PPN group (P = 0.014)
TPN = 15.54 days vs PPN = 12.93 days
•platelet transfusion requirements increased in TPN group compared with PPN group (P =0.004)
TPN = 1.93 U vs. PPN = 1.16 U
Supportive measures
•patients receiving TPN had a higher incidence of positive microbial cultures and clinical infection than PPN group (P = 0.05)
TPN = 64.5% vs PPN + 40%
| University/Hospital: | Gulhane Military Medical Academy (Turkey) |
Limitations
•pretransplant conditioning, which differed according to type and phase of disease could have had an effect on outcome
•patients had 10 different kinds of cancer in total, which could have an effect on outcome
•exclusion criteria was not disclosed
•unclear how the patients were chosen for study
•other medications not disclosed
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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? | No | |
| 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? | 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) | ??? | |
| 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? | No | |
| 4.1. | Were follow-up methods described and the same for all groups? | Yes | |
| 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? | No | |
| 6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | No | |
| 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? | 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? | No | |
| 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)? | ??? | |
| 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? | 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? | No | |
| 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? | No | |
| 10.2. | Was the study free from apparent conflict of interest? | Yes | |