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

Citation:

Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krähenbühl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: An international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun; 27(3): 340-349.

PubMed ID: 18504063
 
Study Design:
Prospective Cohort Study
Class:
B - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  • To implement nutritional risk screening (NRS-2002) in hospital departments in Europe and the Middle East
  • To demonstrate the association between nutritional risk and clinical outcome.
Inclusion Criteria:

Before the study began, each department committed themselves to a fixed number of patients that could be followed simultaneously (=N0), and provided information about the average length of stay in the department (=LOS). The number of patients to be entered into the study per day (=NE) was then given by NE=N0/LOS. These patients (NE) were randomly selected daily by a random numbers generator. All patients were at least 18 years of age.

Exclusion Criteria:
  • Same-day surgery
  • Hemodialysis
  • One-day admission
  • Terminal care.
Description of Study Protocol:

Recruitment

  • There were 26 participating hospital departments. 21 were originally recruited by the sponsor, Fesenius-Kabi, because they were interested in implementing nutrition screening, but had limited experience in this and nutrition care. The remaining five departments were recruited later amongst acquaintances of the study coordinators (JK and JS) with the intention of increasing representation from Western Europe.
  • The departments (surgery, internal medicine, oncology, intensive care, gastroenterology and geriatrics) were located in Western Europe (Austria, Germany, Spain and Switzerland), Eastern Europe (Czech Republic, Hungary, Poland, Romania and Slovakia) and the Middle East (Egypt, Lebanon and Libya). All departments were from university hospitals, except for three from local hospitals and two from regional hospitals. Originally there were 28 participating departments but two withdrew due to lack of labor and non-compliance with weekly data submission as per protocol.

Design

Prospective cohort study.

Intervention

  • NRS-2002 screening was performed at admission according to ESPEN publications. The records of the randomly selected patients were examined within 24 to 36 hours after admission. Information was collected on date of admission, sex, height, weight, edema, main and secondary diagnoses, malignancy and the nutritional risk screening calculation. 
  • All patients were monitored daily to collect information on complications, surgery, date of discharge, discharge destination, mortality and LOS. A maximum monitoring duration of 28 days was decided in advance of the study. In the case of multiple complications, only the most severe complication was registered. The prospective nature of the study was ensured through weekly submission of data to the study coordinator. The local investigators were also interviewed once via telephone to assess their compliance with the study protocol.  

Statistical Analysis

  • Categorical results were analyzed by the Chi-square test and by multi-variate logistic regression analysis
  • Length of stay (LOS) was first analyzed by the Mann-Whitney test; also, LOS less than 28 days was analyzed by parametric statistics (ANOVA and General Linear Model)
  • Goodness of fit was evaluated by visual inspection of studentised residuals analyzed by:
    • Agreement with fitting to a normal distribution (chi-square)
    • Probability plot
    • Graph of studentised residuals vs. values predicted by the model (estimate), supplemented by a LOWESS smoother line with 95% CI
  • For the ANOVA, a Bonerroni post-hoc analysis was performed
  • LOS less than 28 days or 28 or more days was analyzed by multi-variate logistic regression analysis
  • LOS for all patients was analyzed by Cox proportional hazards estimation with censoring of patients with LOS 28 or more days
  • Statistical significance was set at P<0.05
  • Multi-variate analyses were performed using Systat 11
  • Inter-rater agreement for multiple raters was calculated as Cohen's Kappa by the use of PRAM (A Program for Reliability Assessment with Multiple Coders).
Data Collection Summary:

Timing of Measurements

Nutritional risk screening score was collected at admission. Other data were collected daily during hospitalization (which varied in length of stay).

Dependent Variables

  • Variable 1: Nutritional risk screening score (NRS-2002)
  • Variable 2: Complications
  • Variable 3: Mortality
  • Variable 4: Length of stay
  • Variable 5: Discharge.

Confounding Variables

  • Age
  • Speciality
  • Diagnoses
  • Co-morbidity
  • Surgery
  • Cancer
  • Region.
Description of Actual Data Sample:

Initial N

5,217 patients (166 withdrew).

Attrition (final N)

5,051 patients (2,695 males and 2,356 females); 166 patients withdrew

  • 69 due to withdrawal of the department from the study
  • 97 due to incompleteness of essential information in the patients' records.

Age

Average age: 59.8±0.3 years.

Anthropometrics 

  • Height (cm): 167.1±0.1
  • BMI (kg/m2): 26.0±0.1
  • Weight loss 5% or more: 20.4% (1,031 patients)
  • Weight Loss (kg): 10.8±0.2
  • Intake less than 75%: 32.4% (1,637 patients)
  • At-risk: 32.6% (1,647 patients).

Location:

  • Western Europe
  • Eastern Europe
  • Middle East University Hospitals.
Summary of Results:

Key Findings

Pre-study Questionnaire and Inter-rater Reliability

  • 25 of the 26 departments completed a pre-study questionnaire revealing that 28% had an interdisciplinary nutrition support team, 16% routinely performed nutrition screening or assessment for all patients at admission and 68% monitored nutrition status and intake during the admission with 24% monitoring intake daily
  • 45 cases were included in analysis of inter-rater reliability and yielded a K of 0.76, indicating a substantial agreement.

Patient Characteristics and Nutritional Risk Status (N=5,051 Patients)

  • 92.8% were screened within 36 hours after admission and 32.6% were defined to be "at-risk" by NRS-2002
  • Body weight was estimated rather than weighed in 967 (19.1%) patients; among those weighed, 611 (12.1%) patients had edema
  • 62% of the "at-risk" patients were classified as being "at-risk" mainly because of impaired nutritional status
  • Patients were within the following specialties:
    • Surgery: 37.0%
    • General internal medicine: 35.3%
    • Gastroenterology: 10.8%
    • Oncology: 6.7%
    • Intensive care: 6.1%
    • Geriatrics: 4.1%
  • Regional distribution:
    • Western Europe: 46.2%
    • Eastern Europe: 34.7%
    • Middle East: 19.1%.

Complications

  • Complications were noted in 17.6% of the patients and were significantly more frequent in "at-risk" patients
  • The crude odds ratio for complication in "at-risk" patients was 3.47
  • A significant association between the components of the nutrition screening and the odds for complications, also when adjusting for confounding variables.

Discharge and Mortality

  • Death was more frequent in "at-risk" patients than "not-at-risk" patients
  • Fewer "at-risk" patients were discharged home; more were discharged to a nursing home or within the hospital when compared to "not-at-risk" patients.

Length of Stay (LOS)

  • LOS was longer in "at-risk" patients [nine (five to 16) days] compared to "not-at-risk" patients [six (three to 11) days]
  • 93% of the patients had a LOS less than 28 days and were followed during their entire admission (LOS less than 28 days, 4,670 patients; LOS 28 or more days, 376 patients)
  • In patients with LOS less than 28 days, LOS was longer in "at-risk" (N=1,463 patients; 9.7±0.2) vs. "not-at-risk" patients (N=3,207; 7.3±0.1)
  • Analysis of LOS by ANOVA showed LOS to be longer in "at-risk" vs. "not-at-risk" patients without complications and no difference according to risk status in patients with complications
  • LOS was significantly longer in patients with complications compared to patients without complications
  • LOS was significantly related to the nutrition screening components when adjusted for a variety of confounding variables including specialty, diagnoses, co-morbidity, complications, discharge destination and geographic region
  • Logistic regression analysis of the odds for LOS less than 28 days vs. LOS 28 or more days showed that severity of disease score was not significantly related to LOS 28 or more days and that nutritional score was only marginally related to LOS 28 or more days (P=0.053)
  • LOS 28 or more days was significantly related to:
    • Age 70 or more years (P<0.0001)
    • Cancer (P<0.0001)
    • Specialties other than ICU (P<0.0001)
  • Variables associated with longer LOS included:
    • "At-risk" status
    • Age 70 or more years
    • Cancer
    • Co-morbidity
    • Complication
  • "At-risk" status had approximately the same OR as cancer and co-morbidity.

Other Findings

  • An average of 32.6% of patients entered the study were found to be at nutritional risk
  • The percent of patients "at-risk" ranged from 13% to 100%, reflecting the heterogeneity of the patient populations from the various specialties, regions and departments
  • Results showed that patients at nutritional risk had significantly higher complication rates, increased mortality and longer LOS as compared to "not-at-risk" patients
  • "At-risk" patients were also less likely to be discharged home and instead, more likely to be discharged to a nursing home, remain in the hospital or die
  • The large study allowed for adjustment of possible confounders such as age, sex, surgery, presence of cancer, specialty, region, diagnosis and co-morbidity, which could pose a bias when assessing the association between nutritional risk status and clinical outcome
  • Results from this present study do indicate that there is an association between nutritional risk and clinical outcome
  • The data also specify that the outcome is independently related both to nutritional status and severity of disease
  • Of the 3,404 "not-at-risk" patients, about 200 had an impaired general condition and a total score of two, and may have been misclassified as not being "at-risk" due to this uncertainty.
Author Conclusion:

Author concludes that this study shows that nutritional risk screening can be successfully implemented internationally and that nutritional risk is associated with a poor clinical outcome, also when most other factors known to lead to a poor clinical outcome are allowed.

Funding Source:
Other: Fresenius_Kabi
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) 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? 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? 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? Yes
  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? 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")? 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? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? Yes
  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.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? Yes
  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? N/A
  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? Yes
  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? 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)? ???
  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