EAL

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

Citation:

Carey S, Storey D, Biankin AV, Martin D, Young J, Allman-Farinelli M.Long-term nutritional status and quality of life following major upper gastrointestinal surgery: A cross-sectional study. Clin Nutr. 2011 Dec; 30(6): 774-779.

Study Design:

Case Study or Case Series

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To assess the long-term nutritional status of people who had major upper gastrointestinal surgery and to compare the impact of nutritional status on quality of life.

Inclusion Criteria:

Consecutive patients of three upper gastrointestinal surgeon clinics in Australia that had major upper gastrointestinal surgery with roux-en-y reconstructive surgery more than six months postoperatively (August to December 2009 and May to August 2010) were invited to the study. Two subjects were also recruited from an educational evening discussion.

Exclusion Criteria:

Recurrence of disease
Pyloric-preserving surgery
Inability to consent
Living more than two hours from the study center.

Description of Study Protocol:

Recruitment

Patients were recruited six months post-operatively by consulting surgeons in three clinics practicing in three major hospitals near Sydney, Australia then referred to research dietitian.

Design

The participants were studied at one interval with validated assessment tools. Comparison was made to medical records and patient recall.

Blinding Used

Data collected was entered without identifying characteristics; however, all participants were known as such to researchers during data collection periods.

Statistical Analysis

Statistical Package for Social Sciences version 18 (SPSS Inc., Chicago, IL).
ANOVA (Tukey's post-hoc analysis), Pearson's correlation coefficient, multiple linear regression, Chi-square, T-tests; Statistical significance P<0.05.

Data Collection Summary:

Timing of Measurements

Patients were selected at at least six months post-operatively. Comparative data was collected from pre-operative medical records and patient recall
Mean time since surgery was 32.2 (±26.0) months.

Dependent Variables

Nutritional Status was assessed using:

Weight, weight change (kg) and Body Mass Index (kg/m²)
Anthropometrics such as tricep skinfold, mid-arm circumference, mid-arm muscle mass and hand grip strength compared to standards for age ranges
Subjective Global Assessment (SGA) including:
- Weight
- Weight change
- Dietary intake and change
- Gastrointestinal symptoms and functionality
- Physical exam of fat and muscle mass categorized to Well Nourished, Mild-Moderate Malnutrition and Severe Malnutrition
Dietary Intake was assessed from three-day food diary records
Gastrointestinal symptoms were assessed using the 15-question Gastrointestinal Symptom Rating Scale (GSRS) and the Visick scale
Quality of Life was measured using the European Organization for the Research and Treatment of Cancer version 3.0 (EORTC-QLQ-C30) questionnaire.

Independent Variables

Sex
Age
Type of surgery
Time since surgery.

Control Variables

An additional group of non-participants' medical records were reviewed to ensure no selection bias.

Description of Actual Data Sample:

Initial N: 36 people (24 male, 12 female) recruited
Attrition (final N): 30 participants (20 male, 10 female); 83% participation
Age: 67.9 (±13.3) years.

Other relevant demographics

Type of surgery:

Oesophagectomy: Eight
Total gastrectomy: Five
Whipples: Nine
Partial/subtotal gastrectomy: Eight/

Anthropometrics

Body Mass Index: 24.3 (±4.9) kg/m²
Percent Weight Change: 9.8% (±10.5%).

Location

Sydney region of New South Wales, Australia.

Summary of Results:

Key Findings

No participants received pre-operative nutrition assessment or a standardized nutrition care pathway post-operatively
Functional Quality of Life was negatively correlated with time since surgery (R=-0.413, P=0.023)
Malnourished participants had poorer quality of life and more symptoms. SGA and GSRS were significant in explaining 50.3% of variance in global quality of life (F=13.646; P<0.001).
Total gastrectomy had the greatest negative impact on nutritional status and pancreaticoduodenectomy (Whipples) had the least (F=4.487; P=0.047)
Global QOL was correlated with BMI (P=0.004) and percent weight change (P=0.006) after adjustment for age.

Self-reported QOL Scores Across Nutritional Groups as Defined by Subjective Global Assessment (SGA)

Quality of Life Measures	SGA (A) Well Nourished, N=16	SGA (B) Mild to Moderate Malnutrition, N=10	SGA (C) Severe Malnutrition, N=4	Total, N=30
Global ^ab	78.6 (15.5)	69.16 (16.22)	43.75 (20.8)	70.8 (19.7)
Functional ^a	88.4 (13.8)	84.6 (15.3)	65.6 (20.7)	84.1 (16.5)
Physical ^a	90.4 (21.4)	78.0 (17.2)	63.3 (19.2)	82.7 (21.4)
Role ^ab	94.8 (11.7)	83.3 (24.9)	50.0 (23.6)	85.0 (23.3)
Symptoms ^ab	12.1 (10.5)	10.4 (6.8)	36.9 (19.9)	14.8 (13.8)
Fatigue ^ab	21.5 (18.8)	22.1 (15.7)	61.0 (45.0)	26.9 (25.6)
Nausea, Vomiting ^ab	10.9 (14.5)	8.9 (12.3)	39.6 (4.2)	14.1 (16.2)
Dyspnea ^a	4.2 (11.4)	16.7 (17.6)	41.7 (50.0)	13.3 (24.1)
Sleep ^a	12.5 (20.6)	16.7 (23.6)	50.0 (43.0)	18.9 (27.2)
Appetite ^a	18.8 (27.1)	10.0 (16.1)	75.0 (31.9)	23.3 (31.7)

^a Significant difference between SGA A and C.

^b Significant difference between SGA B and C.

Other Findings

No significant difference findings between nutritional status groups for emotional, social or cognitive function nor pain, constipation, diarrhea or finance symptoms.

Author Conclusion:

Major upper gastrointestinal surgery compromises long-term nutritional status and increases degree of symptoms
Quality of life is negatively impacted
Future intervention studies are needed to determine best practices to improve quality of life in this patient population.

Funding Source:

University/Hospital:

Royal Prince Alfred Hospital, Australia

Reviewer Comments:

Authors acknowledge this study uses a small sample size
Statistical analysis was thorough.

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)	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.)	No
	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?		Yes
	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.)	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?	Yes
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?	Yes
	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?	No
	6.6.	Were extra or unplanned treatments described?	Yes
	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?	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