EAL

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

Citation:

Kim JY, Wie GA, Cho YA, Kim SY, Kim SM, Son KH, Park SJ, Nam BH, Joung H. Development and validation of a nutrition screening tool for hospitalized cancer patients. Clin Nutr. 2011; 1-6.

Study Design:

Diagnostic, Validity or Reliability Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

The purpose of this study was to develop and validate a new malnutrition screening tool to evaluate the nutrition status of hospitalized cancer patients in Korea.

Inclusion Criteria:

Subjects were included in this study if they were hospitalized (inpatient) at the National Cancer Center in Korea between April 1 and June 2, 2008, with one of the following types of cancer:

Gastric
Colon
Lung
Liver
Pancreatic
Breast
Prostate
Uterine
Brain or spinal cord
Head and neck.

Exclusion Criteria:

Patients who were unavailable for interview due to surgery, missing appointments or discharged prior to enrollment in study were excluded from the sample
Patients who had cancer at a site not listed above were also excluded from this study (N=359).

Description of Study Protocol:

Recruitment

All patients (N=3,010) admitted to the National Cancer Center in Gyeonggi-do, Korea, between April 1, 2008 and June 2, 2008, were screened for participation in this study.

Design

The purpose of this study was to compare a new nutrition screening tool, the Malnutrition Screening Tool for Hospitalized Cancer Patients (MSTC), to a known screening tool, the Scored Patient-Generated Subjective Global Assessment (PG-SGA)
The authors stated that the PG-SGA is a popular screening tool used with cancer patients, but requires significant time and manpower to use hospital-wide
The new screening tool (MSTC) was be compared to the current gold standard, the PG-SGA.

Blinding Used

Not applicable.

Intervention

25% of subjects were assessed using both the current nutrition screening tool (the PG-SGA) as well as the new screening tool (the MSTC)
The MSTC is a model which takes into account change in intake, weight loss, body mass index and the Eastern Cooperative Oncology Group (ECOG) performance measure, which scores the amount of time the patient is in bed.

Statistical Analysis

The MSTC was compared to the PG-SGA in 257 patients. The two were compared for validity and analyzed by sensitivity, specificity and negative and positive predictive values. The correlation between the MSTC and PG-SGA was checked by the ROC curve with the area under the curve. Consistency between the two tools was evaluated with kappa (k) statistics.
Analysis of the data was completed using SAS software, version 9.1.
P-values less than 0.05 were considered significant.

Data Collection Summary:

Timing of Measurements

All data were collected between April 1 and June 2, 2008.

Dependent Variables

Characteristics measured by the PG-SGA tool include age, gender, BMI, weight loss, weight change, serum albumin and total lymphocyte count
MSTC is a model which takes into account change in intake, weight loss, body mass index and the Eastern Cooperative Oncology Group (ECOG) performance measure, which scores the amount of time the patient is in bed.

Independent Variables

Not applicable.

Control Variables

Not applicable.

Description of Actual Data Sample:

Initial N: 2,651 recruited for both development and validation study
Final N: 257 for validation study
Age: 58.6±11.1
Ethnicity: Not stated
Other relevant demographics: There were more men than women in this sample (58.8%)
Location: National Cancer Center, Gyeongggi-do, Republic of Korea.

Summary of Results:

Key Findings

Variables	Developmental Study (N=800)	Validation Study (N=257)	Statistical Significance of Group Difference
Malnourished N (%)	203 (25.4)	67 (26.1)	N/A
Well-Nourished N (%)	597 (74.6)	190 (73.9)	N/A

Other Findings

	Developmental Study		Validation Study		P-Value
	Malnourished	Well-Nourished	Malnourished	Well-Nourished	P-Value
BMI (kg/m²)	21.7±3.5	23.5±3.2	21.5±3.9	23.5±3.0	0.678
Serum Albumin (g/dL)	3.4±0.7	3.8±0.6	3.4±0.6	3.8±0.6	0.712
Total Lymphocyte Count (cell/mm³)	1,248.6±641.5	1,607.4±740.6	1,166.8±631.7	1,598.8±733.2	0.673
Weight Loss (%)	3.1±5.6	0.1±3.0	2.7±5.1	0.1±2.0	0.612
Length of Stay (days)	12.1±12.5	7.9±8.0	10.8±10.1	8.1±6.8	0.648

Validity of the Newly-Developed Malnutrition Screening Tool for Cancer Patients (MCT)

PG-SGA	MSTC		Total
PG-SGA	Low risk	High risk	Total
Well-nourished N (%)	160 (84.2)	30 (15.8)	190
Malnourished N (%)	4 (6.0)	63 (94.0)	67
Total N (%)	164 (63.8)	93 (36.2)	257
	Percentage	95% CI
Sensitivity	94.0	85.4-98.3
Specificity	84.2	78.2-89.1
Positive predictive value	67.8	57.3-77.1
Negative predictive value	97.6	93.9-99.3
Kappa value (k)	0.7

Author Conclusion:

"...the Malnutrition Screening Tool for Cancer Patients (MSTC) is a new nutrition screening tool that uses intake change, weight loss, BMI, and ECOG performance status and has a high validity compared with other currently available screening tools. The MSTC could be a useful malnutrition screening tool for cancer patients. The MSTC is the first nutrition screening tool tailored for cancer patients in Korea, and further studies on its applicability are needed."

Funding Source:

University/Hospital:

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?	N/A
	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?	???
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?	Yes
	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")?	Yes
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?	Yes
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?	???
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?	N/A
	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?	???
	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)?	???
	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?		No
	10.1.	Were sources of funding and investigators' affiliations described?	???
	10.2.	Was the study free from apparent conflict of interest?	Yes