ONC: Hematopoietic Cell Transplant (2006)

- Stage II-IV breast CA
- Female
- Receiving HCT
- Well nourished upon admission for HCT (> or = 90% IBW or UBW, absence of recent wt loss or poor oral intake, serum albumin > or = 30 g/dL);
There was no statement of how many were excluded.
- Did not meet well nourished criteria at admission to study
Recruitment: No statement of how recruiting was done, or who did the recruiting
Design: Randomized clinical trial with subjects randomized to either OD or TPN; no mention as to how the randomization was done
Blinding used (if applicable): No mention of blinding
Intervention:
- Kcal need was determined using Harris-Benedict equation and protein need was set at 1.5 - 1.75 g/kg b wt; used adjusted body wt if "significantly" over IBW
- OD group: Standard iv fluids of either 5% dextrose or normal saline; given TPN if oral intake fell below 40% of need for 10 consecutive days, wt loss of 10% of admission wt, need for mechanical ventilation.
- TPN group: TPN started day before HCT (day -1); also give iv fluids; TPN was 3-in-1 admisture (final concentration17.5% dex, 5% aa, 10% lipid) 3 times/wk and other 4 days 2-in-1 formula (25% dextrose, 5% aa, final concentration); vitamins and minerals added daily
- Both groups allowed to eat ad libitum
- TPN discontinued when oral intake > or = to 50% of nutrient need for 2 consecutive days
Statistical Analysis:
- Intent-to-treat principles applied
- T-test evaluated differences between groups
- Age
- Days to engraftment
- LOS
- Days on antibiotics
- Days of fever
- Body wt changes
- Days on TPN
- Number of days until oral intake >66% of need
- Nutrient intake
- Repeated measures analysis of variance
- Changesin triceps skinfold
- Midarm muscle circumference
- Serum albumin
- Total bilirubin
- LFTs
- HGS
- Sense of well-being
- Survival analysis using Kaplan-Meier plots
- No mention of level of significance used
Timing of Measurements:
- Pt characteristics at baseline
- Clinical outcomes -- not stated when measured
- Nutrition outcomes measured at admission to +30 days post tx
- Sense of well-being was measured admission, discharge (no day mentiond so assume variable) and +30 days post tx
- Survival was > or = to 1 year post tx.
Dependent Variables
- Variable 1: LOS - days in hospital from initial hospitalization
- Variable 2: Days to engraftment (not stated how measured) (ANC > 500)
- Variable 3: Incidence of infection determined by positive blood culture
- Variable 4: Days on antibiotics - not stated how measured
- Variable 5: days of fever - > or = 100.5 F
- Variable 6: changes in total bilirubin - not stated how measured
- Variable 7: liver function tests - not stated how measured
- Variable 8: calorie intake - not stated how measured
- Variable 9: protein intake - not stated how measured
- Variable 10: number of days until oral intake met 66% of nutrient needs
- Variable 11: body wt - not stated how measured
- Variable 12: handgrip strength - not stated how measured
- Variable 13: triceps skinfold - not stated how measured
- Variable 14: midarm muscle circumference - not stated how measured
- Variable 15: serum albumin - not stated how measured
- Variable 16: days on TPN - not stated how measured
- Variable 17: sense of well-being measured using the Profile of Mood States (POMS); no info about realiability or validity
- Variable 18: survival for 1 year or more post treatment
- Variable 19: nutrition status - intact vs depleted
Overall poorly defined variables with little information how how measured or how operationalized.
Independent Variables: Assigned to oral intake only (OD) or TPN only. Also created a third group of pt who were randomized to the OD and ultimately placed on TPN and called the delayed TPN (DTPN) group
Control Variables: Age, stage of disease, source of HCT (marrow or peripheral blood), number of pt given TPN
Initial N: 55 females
Attrition (final N): 55 females; no attrition info addressed in the article
Age: 42 y for TPN and 46 y for OD; no info on DTPN group
Ethnicity: no info provided
Other relevant demographics: breast cancer stage TPN = 13 in stage II and III; 14 in stage IV. OD group 10 in stage II and III; 18 in stage IV.
Source of transplant - TPN = 3 peripheral and 24 marrow; OD = 4 peripheral and 24 marrow
no stats done from what I can tell
Anthropometrics: admission TPN wt = 68 kg OD wt = 76 kg
TPN TSF = 29 mm OD TSF = 32 mm
TPN MAMC = 21 cm OD MAMC = 24 cm
TPN HGS = 58 OD HGS = 66
TPN Alb = 31 g/L OD Alb = 32 g/L
Location:
Variables |
Treatment Group Measures and confidence intervals |
Control group Measures and confidence intervals |
Statistical Significance of Group Difference |
LOS |
28.7 +/- 8.8 | 25.4 +/- 4.3 | NS |
Days to engraftment |
12.4 days |
12.4 days |
?? |
Incidence of infection |
3 |
0 |
0.051 |
Days on antibiotics |
20.8 +/- 6.6 | 17.7 +/_ 4.5 | 0.045 |
Days of fever |
10.2 +/_ 6.4 |
8.0 +/- 6.0 |
0.19 |
Change in total bilirubin |
18.8 +/_ 29 |
11.9 +/- 6.8 |
NS |
Liver function tests |
alkaline higher; SGPT lower; GGT higher | sig | |
Calorie intake |
88% needs met |
56% needs met |
<0.001 |
Protein intake |
68% needs met |
39% needs met |
<0.0001 |
Number of days until oral intake >66% needs |
20.2 +/- 7.4 d | 19.9 +/- 6.0 days | 0.89 |
Body weight |
decrease 2% |
decrease 7% |
0.0001 |
Handgrip strength |
decrease 2% |
decrease 6% |
0.32 |
Triceps skinfold |
decrease 6% | decrease 5% | 0.82 |
MAMC |
decrease 2% |
decrease 7% |
0.05 |
Serum albumin, Day 30 |
35 +/- 6 |
38 +/- 5 |
0.55 |
Days on TPN |
17.5 +/- 7.4 | 5.3 +/- 5.9 | ?? |
Sense of well-being |
129.9 +/- 16.3 |
139.4 +/- 31.9 |
NS |
Survival at 2 years |
74% |
57% |
0.73 |
Nutrition status: intact of depleted |
Unknown | Unknown | Unknown |
While prophylactice TPN preserved nutritional status and possibly QOL better than OD, there were no differences found in clinical outcomes or survival.
Prophylactic TPN did result in a more intact nutritional status (no stats) and preservation of lean body mass in TPN but did not impact LOS or survival.
Industry: |
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University/Hospital: | Baylor University Medical Center |
Not much difference and very little information as to how exactly the measures/variables were operationalized. Cox proportional hazard model may have provided better statistical analysis than measures used
Harris-Benedict equation used to determine energy needs
Adjusted body weight was used to determine energy needs if "significantly" over IBW; however, "significantly" is not defined
Cox regression analysis not used
No info on how operationalized nutrient intake; not the best stats for this b/c of differing times by subject
Level of statistical significance not mentioned
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? | ??? | |
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? | ??? | |
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) | Yes | |
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? | 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? | No | |
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%.) | No | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
4.4. | Were reasons for withdrawals similar across groups? | ??? | |
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? | ??? | |
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? | 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? | ??? | |
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? | ??? | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | ??? | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
6.6. | Were extra or unplanned treatments described? | ??? | |
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? | No | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | ??? | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | ??? | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | No | |
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? | 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? | ??? | |
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? | No | |
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)? | No | |
8.6. | Was clinical significance as well as statistical significance reported? | No | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | No | |
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? | No | |
10. | Is bias due to study's funding or sponsorship unlikely? | No | |
10.1. | Were sources of funding and investigators' affiliations described? | No | |
10.2. | Was the study free from apparent conflict of interest? | ??? | |