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

Citation:

Kirsh KL, Dugan C, Theobald DE, Passik SD. A chart review, pilot study of two single-item screens to detect cancer patients at risk for cachexia. Palliat Support Care. 2003 Dec; 1 (4): 331-335.

PubMed ID: 16594222
 
Study Design:
Diagnostic, Validity or Reliability Study
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
  • The present study was an attempt to gather initial data to determine if two items from the Zung Self-Rating Depression Scale could be used as short screening itmes for detecting cachexia in cancer patients. Specifically, ZSDS Item Five, "I eat as much as I used to," and Item Seven, "I notice I am losing weight," were chosen for the study.
  • A random chart review was conducted of patients who had completed a variety of screening measures in our cancer network.
Inclusion Criteria:
  • Any patient undergoing treatment for malignancy
  • Able to read and write English
  • Over 18 years of age
  • No evidence of cognitive impairment severe enough to preclude giving informed consent.
Exclusion Criteria:
  • None mentioned
  • Patient must meet inclusion criteria.
Description of Study Protocol:
  • Recruitment: Charts reviewed were from one of 31 Community Cancer Care, Inc. clinics in urban and rural areas throughout Indiana
  • Design: Retrospective randomized chart review (validity study of screening tools)
  • Intervention: Cancer treatment.

Statistical Analysis

  • A series of descriptive statistics
  • Chi-squares
  • One-way ANOVAs with Bonferroni post-hoc analyses
  • Sensitivity and specificity statistics were calculated.
Data Collection Summary:

Timing of Measurements

Single chart review to obtain baseline data and six-month term data.

Dependent Variables

  • Weight
  • Appetite levels
  • Nausea
  • Albumin
  • Lymphocyte levels
  • BMI, ratios of overall body size
  • Nutrition risk per Patient-Generated Subjective Global Assessment (PG-SGA)
  • Depression symptomatology, per Zung Self-Rating Depression Scale (ZSDS).

Independent Variables

Cancer treatment.

Control Variables

Self serves as control.

Description of Actual Data Sample:

Initial N

50 Patient charts.

Demographics

  • Gender
    • Women: 33 (66%)
    • Men: 17 (34%).
  • Anthropometrics
    • Weight: 165.53±38.63 lbs
    • Height: 65.38±3.6 inches
    • BMI: 27.04±5.38 (145% to 48%).
  • BMI distribution
    • Underweight: Two (4%)
    • Normal: 18 (36%)
    • Overweight: 20 (40%)
    • Obese: Eight (16%)
    • Extremely obese: Two (4%).
  • Six months term-end
    • Weight (N=32): 164.73±38.75
    • Albumin: 3.62±0.45
    • Lymphocyte: 1.39±0.60.

Patients followed in this clinic, on average, range from 59 years to 63 years old; are married (67% to 70%); are largely Caucasian (90%); usually have breast (19% to 36%), lung (10% to 23%) or colon (10% to 13%) cancer.

Location

Clinics throughout Indiana; Community Cancer Care Inc.

Summary of Results:

Key Findings

  Statistical Significance to Nutritional Risk
(PG-SGA)
Sensitivity Specificity
ZSDS R=0.63, P<0.01    
Item #5 F=5.80, P<0.01
33%
97%

Item #7

F=6.01, P<0.01
40%
81%
2-Item Screening Tool F=13.99, P<0.001
50%
88%

Other Findings

All categories were not statistically-significant, with six-month biochemical data.

Author Conclusion:
  • A one- or two-item screening tool from Items #5 and #7 from the ZSDS, has a specific predictive ability to a PG-SGA-derived nutritional risk for the development of cachexia and may be a beneficial identifier of risk
  • Further studies are necessary to observe tool-sensitivity to clinical parameters and overall nutrition risk criteria, outside of a patient-generated subjective assessment.
Funding Source:
University/Hospital: Markey Cancer Center, University of Kentucky
Reviewer Comments:
  • Author mentions in discussion to note that the population was 60% in the BMI range of overweight to extremely obese categories. The author does not indicate why it is important to note this demographic variable, but in review, if you are inquiring about personal changes in diet and awareness of loss in weight, it does not differentiate between intentional and unintentional weight loss.
  • The two items limit a person from differentiating between positive and negative changes in diet, as well as body composition changes, rather than total weight changes. This adds to the overall poor sensitivity of the questions.
  • It would be beneficial to see how this data is relevant to other patient outcomes such as mortality, morbidity and overall oncologic prognosis. There is little information provided on the disease state of the patient population such as severity, stage and metastatic changes.
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? No
  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) 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.) 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? 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? No
  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? No
  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? No
  6.6. Were extra or unplanned treatments described? No
  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? No
  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)? No
  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