EAL

ONC: Malnutrition Screening and Nutrition Assessment of Adult Oncology Patients (2012)

Citation:

Laky B, Janda M, Cleghorn G, Obermair A. Comparison of different nutritional assessments and body-composition measurements in detecting malnutrition among gynecologic cancer patients. Am J Clin Nutr. 2008; 87: 1,678-1,685.

PubMed ID: 18541556

Study Design:

Diagnostic, Validity or Reliability Study

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To assess the convergent validity of serum albumin, skinfold measurements, scored patient generated subjective global assessment (PG-SGA), body density measurements and total body potassium (TBK) to identify patients with gynecologic cancer at risk for malnutrition.

Inclusion Criteria:

Presumed or proven primary gynecologic cancer, both benign and malignant
- Ovarian including primary peritoneal and fallopian tube
- Endometrial
- Cervix, vulva and pseudomyxoma peritonei cancers
- Tumors of low malignant potential.
Received oncology treatment at The Royal Brisbane and Women's Hospital
Informed consent.

Exclusion Criteria:

Recurrent cancer
Treatment for other cancers within the past five years
Psychological or cognitive impairment
Non-English speaking.

Description of Study Protocol:

Recruitment: Recruited from gynecology clinic at The Royal Brisbane and Women's Hospital between March 2004 and December 2006 prior to beginning treatment
Design: Cross-sectional
Blinding used (if applicable): None.

Intervention

Prior to initiating treatment, women completed subjective global assessment (SGA) and scored patient-generated subjective global assessment (PG-SGA).
- Classified as "well nourished" vs "malnourished" based on SGA result.
Asked to complete more in-depth nutritional assessment measures and patients determined extent of participation with the following:
- Anthropometrics and skinfold thicknesses
- Serum albumin
- Total body potassium
- Body density measurement.
Control Group: Patients determined to have benign tumors post-operatively.

Statistical Analysis

Patient characteristics were described with descriptive statisticsq
Moderately and severely malnourished categories were combined into a single category, "malnourished," because of the small number of severely malnourished patients
Differences in means for age, weight, BMI, serum albumin, triceps skinfold thickness, TBK and body density measurements were compared with independent T-tests
Differences in PG-SGA scores between well-nourished and malnourished patients were examined with the Kruskal-Wallis test
To compare the concordance among nutritional assessment measures, receiver operating characteristic analysis was performed
Linear regression was performed to determine whether other nutritional assessment tools could predict TBK
- Adjusted for age in final model though weight, PG-SGA score, serum albumin, sex-corrected midupper arm muscle area were considered.
Statistical significance: P<0.05 (two sided).

Data Collection Summary:

Timing of Measurements

Data collected once on the following items, one to five weeks prior to initiating treatment for gynecologic malignancy

SGA, scored PG-SGA
Height, weight, BMI
Mid-upper arm circumference, triceps skinfold (TSF)
Total body potassium
Body density measurement.

Dependent Variables

PG-SGA score
Serum albumin
Skinfold thickness
- TSF: Measure of subcutaneous fat stores
- Mid-upper arm circumference + TSF: Measure of fat free mass and body fat
- Sex corrected arm muscle area: Measure of body muscle mass and protein status.
TBK: Measure of body cell mass and protein depletion
Body density (via BODPOD): Measure of fat-free mass and fat mass.

Independent Variables

Malnutrition risk as determined by SGA.

Description of Actual Data Sample:

Initial N

N=194 (completed both SGA and PG-SGA).

Attrition (Final N)

Skinfold thickness measurements: N=145
Serum albumin: N=179
TBK: N=51
Body density measurements: N=42.

Age

58.7±14.4 years (mean ±SD).

Ethnicity

Not described.

Anthropometrics

Weight: 78.9±23.1 kg (mean ±SD)
BMI: 30.8±8.8 (mean ±SD).

Location

Brisbane, Australia.

Summary of Results:

Key Findings

Malnutrition classification

SGA and scored PG-SGA both identified 148 (76%) of the subjects as well-nourished and 46 (24%) as moderately or severely malnourished
One subject was classified as moderately malnourished by SGA and severely malnourished by scored PG-SGA
Using SGA rating, the highest prevalence of malnutrition was found among patients with ovarian cancer. These patients tended to be significantly older, have significantly lower weights, BMI, serum albumin, TSF thickness, sex-corrected AMA, arm fat area, TBK and higher PG-SGA scores.

Relationship between SGA and other measures of nutritional status

Using ROC analysis, scored PG-SGA, pre-treatment albumin, TBK and TSF identified nutrition risk with a high probability relative to SGA (N=45)
- Area under curve (AUC) for scored PG-SGA: 0.92 (95% CI, 0.83 to 1.01; P<0.001)
- AUC pretreatment albumin: 0.92 (95% CI, 0.84 to 1.01; P<0.001)
- AUC TBK: 0.77 (95% CI, 0.61 to 0.94; P<0.005)
- AUC TSF: 0.70 (95% CI, 0.53 to 0.88; P<0.041).
Measures of age, BMI and weight were unable to differentiate between well-nourished and malnourished subjects.

Relationship between TBK and other clinical variables

Using simple linear regression, age (P<0.001), weight (P=0.015), PG-SGA scores (P=0.009), sex-corrected AMA (P<0.001) and FFM (P<0.001) were significantly correlated withTBK; albumin showed a trend towards association with TBK (P=0.053)
Using multiple linear regression, 66% of the variation in TBK was explained by age, PG-SGA scores and sex-corrected AMA.

Author Conclusion:

The scored PG-SGA is a suitable method in the clinical setting for identifying malnutrition risk in women with gynecological malignancies
Further studies are needed to determine whether the scored PG-SGA can predict which patients will develop adverse outcomes as well as how well it can assess changes in nutritional status relative to nutrition intervention.

Funding Source:

Government:	National Halth and Medical Research Committee Public Health Fellowship, Endeavour International Postgraduate Researach Scholarship
Other:	University of Queensland International Living Allowance Scholarship

Reviewer Comments:

Well-nourished patients tended to complete more of the nutrition assessment measures compared to the malnourished patients
Unclear what role the Control Group (subjects with non-malignant tumors) played in this study. There were no comparisons made between women diagnosed with gynecologic cancers and those with benign tumors.

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?		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?		N/A
	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?	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?	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?	???
	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?		???
	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?	???
	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?	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?	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?	N/A
	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)?	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?	No
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