EAL

ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Kathiresan AS, Brookfield KF, Schuman SI, Lucci JA 3rd. Malnutrition as a predictor of poor postoperative outcomes in gynecologic cancer patients. Arch Gynecol Obstet. 2011 Aug; 284(2): 445-451.

PubMed ID: 20803205

Study Design:

Retrospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To evaluate nutritional correlates with increased post-operative morbidity and mortality regardless of other risk factors in the gynecologic cancer patient.

Inclusion Criteria:

Women with a diagnosis of cancer on pathology with pre-operative nutritional parameters including albumin, BMI and absolute lymphocyte count (ALC).

Exclusion Criteria:

Not meeting inclusion criteria.

Description of Study Protocol:

Recruitment

Medical charts from October 2006 to June 2008 of gynecologic oncology patients who had undergone surgery at the University of Miami/Jackson Memorial Hospital, Miami.

Design

Retrospective chart review.

Statistical Analysis

Data was divided into patients with ovarian cancer vs. other gynecologic cancers and patients with bowel resection vs. no bowel resection. Continuous variables were compared between patients experiencing complicated post-operative courses and those not experiencing complication using ANOVA test and Student's T-test. Categorical variables were analyzed using the Chi-square test or Fisher's exact test, where appropriate. Multi-variable logistic regression was performed to analyze which nutritional parameters were independent predictors of increased postoperative complications.

Data Collection Summary:

Timing of Measurements

Between June 2006 and June 2008.

Dependent Variables

Age, race, cancer type and stage, number of co-morbidities, pre-operative ALC, pre-operative albumin, pre-operative BMI, estimated blood loss (EBL), intra-operative blood transfusion (BT), intra-operative complications, post-operative complications, hospital re-admissions, ICU admissions, re-operations and cancer recurrence
Pre-operative ALC and albumin were divided into three intervals:
- Below normal range
- Normal range
- Above normal range
BMI was divided into four groups:
- Underweight (BMI less than 18.49kg/m²)
- Normal (BMI 18.5 to 24.9kg/m²)
- Overweight (BMI 25.0 to 29.9kg/m²)
- Obese (BMI higher than 30kg/m²)
Albumin was included if the value was obtained within 20 days of surgery. Normal was 3.905.0g per dL for albumin and 1.0 to 3.3 (x10³ per ml) for ALC
Intra-operative complication included unintended bladder or bowel injury
Post-operative complications, hospital re-admissions, ICU admissions and re-operations were recorded if they took place within 30 days of surgery
Surgery was considered major if it was more than 200 minutes in duration.

Independent Variables

Gynecological cancer.

Description of Actual Data Sample:

Initial N: 300 females
Attrition (final N): 300
Age: 52.4 to 55.9 years
Ethnicity:
- 52% Hispanic
- 28% Caucasians
- 20% African-Americans
Other relevant demographics: cancer types:
- 71 ovarian
- 106 cervical
- 86 endometrial
- 10 vulvar
Location: Miami, FL.

Summary of Results:

Findings

Caucasians were significantly more likely to be admitted to the ICU and Hispanic patients significantly more likely to develop cancer recurrence
A lower number of co-morbidities was significantly associated with fewer post-operative complications (1.2 vs. 1.8 vs. 1.6; P=0.02)
No post-operative complications: 177 (62.3%); one complication: 57 (20.0%) and two or more complications: 50 (17.6%). Patients with two or more complications had significantly more intra-operative BT (11.4% vs. 24.6% vs. 34.0%; P=0.001) and higher EBL during surgery (377.8 vs. 593.7 vs. 680.5ml; P<0.001)
Higher EBL (412.2 vs. 1,212.4ml; P=0.001), more intra-operative BT (15% vs. 52%; P<0.001) and increased number of co-morbidities (1.3 vs. 2.2; P=0.004) correlated with significantly more ICU admissions
Decreased albumin was significantly associated more post-operative complications (4.1 vs. 3.7 vs. 3.4g per dL; P<0.001), more hospital re-admissions (3.9 vs. 3.5g per dL; P=0.01), more re-operations (3.8 vs. 3.4g per dL; P=0.03), more ICU admissions (3.9 vs. 3.0g per dL; P<0.001) and more cancer recurrence (4.0 vs. 3.3g per dL; P<0.001)
Decreased ALC (2.3 x 10³ per ml vs 1.4 x 10³ per ml; P=0.01) and BMI (31.2 vs. 27.0kg/m²; P=0.01) were also significantly correlated with higher incidence of cancer recurrence
Lower ALC (less than 1.0 x 10³ per ml) and lower albumin levels (less than 3.89g per dL) were significantly associated with more post-operative complications (11% vs. 17% vs. 31.8%; P=0.02; vs. 42.1% vs. 57.9%; P=0.002), ICU admissions (14.1% vs. 40.9%; P=0.01; 42% vs.80%; P=0.006) and cancer recurrence (8.5% vs. 45.3%; P=0.001; 33.9% vs. 73.5%; P=0.001)
Underweight patients significantly correlated with more hospital re-admissions (0.8% vs. 17.4%; P=0.001) and more cancer recurrence (1.6% vs. 12.5%; P=0.01)
Patients with ovarian cancer had significantly lower albumin levels (3.9±0.8 vs. 3.6±0.8; P=0.02) and more intra-operative BT (14.9% vs. 28.2%; P=0.004) and cancer recurrence (20.3% vs. 39.0%; P=0.004). A greater proportion of ovarian cancer patients had below normal levels (less than 3.89g per dL) which nearly reached statistical significance (39.8% vs. 60.5%; P=0.054).
Lower albumin levels and lower ALC were significantly (P=0.001).associated with more intestinal resection
Albumin was an independent predictor of increased post-operative complications. When albumin as below normal range, patients were 3.44 times more likely to develop a post-operative complication.

Author Conclusion:

Malnutrition reflected by low albumin levels is associated with significantly higher post-operative morbidity in gynecologic cancer patients.

Funding Source:

Reviewer Comments:

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)	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?	Yes
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)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	No
	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?	???
	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?	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?		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?	Yes
	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?	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)?	Yes
	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