EAL

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

Citation:

Laky B, Janda M, Kondalsamy-Chennakesavan S, Cleghorn G, Obermair, A. Pretreatment malnutrition and quality of life-association with prolonged length of hospital stay among patients with gynecological cancer: A cohort study. BMC Cancer. 2010; 10: 232.

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To evaluate the association between preoperative quality of live (QOL) and malnutrition with length of hospital stay (LOS) in patients with suspected or proven gynecological cancer.

Inclusion Criteria:

Patients with presumed or proven primary gynecological cancer.

Exclusion Criteria:

Recurrent cancer
Received treatment for other cancers within the past five years
Patients with psychological or cognitive impairments (eg, schizophrenia, dementia)
Patients who were non-English speaking.

Description of Study Protocol:

Recruitment

Patients at the Queensland Centre for Gynecological Cancer were screened for eligibility at their first pre-operative visit between March 2004 and December 2006. Qualified patients were asked to participate.

Design

Pre-treatment QOL and nutritional status variables were collected at the outpatient or pre-admission clinic, typically one to five weeks before primary treatment was initiated. Women were categorized according to clinical diagnosis before surgery. LOS based on treatment type (open abdominal surgery vs. vaginal or laparoscopic surgery) was compared to pre-treatment QOL and nutritional status.

Statistical Analysis

Descriptive statistics used to summarize patient characteristics, and to group patients by the main outcome variable (average vs. prolonged LOS). Univariate logistic regression analyses were conducted to calculate odds ratios adjusted for age and surgical approach for patients who had prolonged compared to average LOS
Variables significantly associated with LOS were then entered into a multi-variable model
Hosmer-Lemeshow goodness-of-fit statistic assessed fit of the models. SPSS software version 16.0 Graduate Student (SPSS Inc., Chicago, IL, USA) was used for the statistical analyses.

Data Collection Summary:

Timing of Measurements

March 2004 through December 2006.

Dependent Variable:

Length of hospital stay (average, prolonged): Prolonged LOS described as more than five days for patients who underwent open abdominal surgery; more than two days for patients who underwent vaginal or laparoscopic surgery.

Independent Variables:

Variable 1: Body mass index:
- Underweight: Lower than18.5
- Normal: 18.5 to 24.99
- Overweight: 25.0 to 29.99
- Obese: 30 or higher
Variable 2: Pre-existing co-morbidity (No or one co-morbidity; two or more co-morbidities)
Blood Variables:
- Variable 3: Albumin
  - Average: higher than 35g per L
  - Below Average: 35g per L or less
- Variable 4: Hemoglobin
  - Average: More than 120g per L
  - Below Average: 120g per L or less
- Variable 5: Lymphocytes
  - Average: 1.5 to 4.0 10⁹ per L
  - Below Average: 1.5 X 10⁹ per L or less
Variable 6: FACT-G global score [Functional Assessment of Cancer Therapy-General; measures quality of life (QOL); 27 item self-report measure that allows patients to rate current physical, social and family, emotional and functional well-being; higher scores indicate better QOL]
Nutritional Assessment Variables:
- Variable 7: PG-SGA score (Patient Generated, subjective Global Assessment), a validated nutritional assessment tool for cancer patients that records and summarizes weight changes, alterations in food intake, GI symptoms and changes in functional capacity and physical signs of malnutrition. Scores range from zero to 28; higher scores reflecting greater risk of malnutrition. Scores of nine or higher indicate critical need for nutritional intervention options and improved symptom management.
- Variable 8: PG SGA A (well nourished)
- Variable 9: PG-SGA B and C ( moderately malnourished or suspected of being malnourished and severely malnourished respectively).

Control Variables

Histology and stage:

Benign/LMP/OvCa stage I or II
OV Ca (Ovarian Cancer) stage III or IV
Endometrial cancer
Cervical cancer.

Description of Actual Data Sample:

Initial N: 194 patients gave informed written consent; 32 declined to complete FACT-G questionnaire and five had to be excluded due to incomplete data. 157 completed both PG-SGA and FACT-G questionnaire.
Attrition (final N): 157 patients (80.9%)
Age: 58 years (SD 14 years)
Other relevant demographics: Patients were presumably Australian
Anthropometrics:
- Underweight: Three (2%)
- Normal weight: 39 (25%)
- Overweight: 47 (30%)
- Obese: 67 (43%)
Location: Queensland Centre for Gynecological Cancer at the Royal Brisband and Women's Hospital, Brisbane, Australia.

Summary of Results:

Key Findings

Independent Variables	Percentage (N) with Prolonged Length of Stay	Univariate Model		Multi-variable Model
		OR P	95% CI	OR P	95% CI
BMI	No significant difference
Pre-existing co-morbidities	No significant difference
Blood albumin: Below average, 22 (14%)	86.4 (19)	8.81 P=0.007	1.83 to 42.6	0.86 P=0.88	0.12 to 6.5
Hemoglobin: Below average, 35 (23%)	86.4 (25)	3.21 P=0.01	1.31 to 7.68	2.11 0.21	0.65 to 6.86
Lymphocytes: Below average, 44 (28%)	64.4 (27)	1.46 0.35 (NS)	0.66 to 3.22
FACT-G global score, 157	(Mean + SD for group with prolonged LOS) 75.3±16.9	0.95 P≤0.0001	0.93 to 0.98	0.96 P=0.007	0.93 to 0.99
PG-SGA score, 157	9.5±6.6	1.05 P=0.001	1.05 to 1.22	0.94 0.33 (NS)	0.84 to 1.06
PG-SGA A, 118 (75%)	39.3 (44)	Reference Group
PG-SGA B and C, 39 (25%)	82.1 (32)	6.89 P≤0.001	2.48 to 19.2	5.28 P=0.05	0.98 to 28.5
Benign/LMP/OvCa stage I or II, 81 (52%)	42 (34)	Reference Group
OvCa stage III or IV, 23 (15%)	95.7 (22)	30.4 P=0.0001	3.9 to 236.7	5.28 P=0.05	0.98 to 28.5
Endometrial cancer, 36 (23%)	50.0 (18)	1.38 0.42 (NS)	0.63 to 3.04	1.71 0.07 (NS)	0.67 to 4.34
Cervical cancer, 22 (14%)	11.8 (2)	0.18 P=0.03	0.04 to 0.86	0.10 0.84 (NS)	0.01 to 0.71

Other Findings

In total, 75 (48.1%) of patients had prolonged LOS. Those with prolonged LOS were significantly older (mean age 62.8 years, SD 13.7) than patients with average LOS (mean age 54.5 years, SD 13.6) (P<0.01)
Malnutrition and low QoL were found to predict prolonged LOS independent of patients' age at diagnosis, surgical approach, albumin and hemoglobin and suspected clinical diagnosis. Patients suspected to have stage III or IV ovarian cancer were also independently at greater risk for prolonged LOS compared to other patients.
LOS was not equally distributed between tumor types. Even after adjustment for age and surgical approach 96 of all suspected advanced stage ovarian cancer patients had prolonged LOS compared with 505 of patients with endometrial cancer and 42% of patients with pelvic mass.
PG-SGA was a stronger predictor of LOS than albumin and therefore more sensitive to detect malnutrition in gynecological cancer patients.

Author Conclusion:

Prolonged LOS was found to be associated with low pre-surgical QOL and malnutrition. Strategies to reduce LOS and improve patients' well-being during hospital stay will need to address these potentially modifiable factors, particularly among women with suspected advanced ovarian cancer.

Funding Source:

University/Hospital:

National Health and Medical Research Council Career Development Award; the Endeavour International Postgraduate Research Scholoarship; the University of Queensland international Living Allowance Scholarship; and the Royal Brisbane and Women's Hospital Research Foundation.

Reviewer Comments:

This study prospectively evaluated quality of life and nutritional status and their association with length of stay in women with new cases of gynecologic cancers. The results suggest that rehabilitation of nutritional status, prior to hospitalization could be a way to improve outcomes of surgeries for these cancers and in turn reduce length of hospital stay.
Further study should assess the effect of pre-surgical nutritional interventions and interventions aimed at improving quality of life on length of hospital stay.

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)	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?	N/A
	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?	N/A
	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?	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?		Yes
	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.)	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.)	Yes
	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?		Yes
	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%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	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?		N/A
	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?	N/A
	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?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	Yes
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