EAL

ONC: Medical Nutrition Therapy and Nutrition Intervention in Adult Oncology Patients (2011)

Citation:

Isenring E, Capra S, Bauer J. Patient satisfaction is rated higher by radiation oncology outpatients receiving nutrition intervention compared with usual care. J Hum Nutr Diet. 2004; 17: 145-152.

PubMed ID: 15023195

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

The current study reports the levels of patient satisfaction that were associated with improved body weight, nutritional status, quality of life and bowel health outcomes in radiation oncology outpatients receiving nutrition intervention compared with usual care.

Inclusion Criteria:

Gastrointestinal or head and neck oncology patients
Recieving 20 fractions of radiotherapy
Recieving therapy at an Australian radiation oncology facility.

Exclusion Criteria:

Receiving enteral or parenteral nutrition
Requiring more than five days of hospitalization
Unable to provide informed consent.

Description of Study Protocol:

Recruitment

Patients receiving treatment from an Australian radiation oncology facility

Design

Randomized control trial

Blinding used

Not applicable

Intervention

Nutrition Intervention (NI):

Early and intensive nutrition support by the same dietitian for 12-week duration
Provision of high energy and protein oral nutrition supplements if required.

Usual Care (UC):

Education by the nurses
Provision of the resource 'Understanding Nutrition-a booklet from the QLD Cancer Fund'
Oral-nutrition supplement samples.

Statistical Analysis

Independent T-tests to compare mean patient satisfaction scores from those patients receiving NI vs. UC.
Independent T-tests were used to compare overall patient satisfaction and whether or not a patient was older than 65 years or had family or caregiver support
Significance was defined at 95% level (two-tailed)
Interpretative emphasis was on effect size as much as on statistical significance levels.

Data Collection Summary:

Timing of Measurements

Patients were assessed at baseline, four, eight and 12 weeks after commencing radiotherapy
- Body weight, nutritional status, health-related quality of life and bowel health
10 days after completing the 12-week study, patient satisfaction with clinical nutrition services questionnaire was sent out
Patients were asked to not complete the questionnaire until the research assistant telephoned the patient within four days of sending the questionnaire. At this time the research assistant would instruct the patient to complete the questionnaire as it relates to nutrition-related components of care delivered by either nurses or the dietitian and also to answer any queries.

Dependent Variables

Patient satisfaction to nutrition-related components of care
Clinical outcomes:
- Body weight, nutritional status, quality of life and bowel health.

Independent Variables

Nutrition intervention by a dietitian
Nutrition care by a nurse or physician
- Frequency of contact by nurse or dietitian were similar for only the first six weeks.

Control Variables

Radiation therapy
Length of treatment
Timing of assessments
Timing of questionnaire distribution and instruction.

Description of Actual Data Sample:

Initial N: 60

Attrition (final N): 53 (11.7%)

	Percent and mean of all patients (n=60)
Male	85% (n=51)
Female	15% (n=9)
Age	61.9±14.0 years
BMI	25.8±4.5kg/m²
Radiotherapy of the Head and Neck	88% (n=53)
Radiotherapy of the Gastrointestinal Area	12% (n=7)
Well-nourished	65% (39)
Malnourished	35% (n=21)

There were no statistically significant differences in baseline characteristics between those patients that did or did not complete the study nor between the NI and UC groups

Location: Brisbane, Australia.

Summary of Results:

Key Findings

	NI (n=25) Mean±SD	UC (n=28) Mean±SD	Mean difference ±SEM difference	P-value
Staff interpersonal skills	4.68±0.37	4.15±0.57	0.53±0.13	<0.001
Nutrition supplements	4.05±0.63	3.80±0.66	0.25±0.19	ns
Perceived health benefits	4.26±0.62	3.73±0.75	0.53±0.19	0.008
Staff presentation skills	4.81±0.35	4.58±0.46	0.23±0.11	0.044
Overall patient satisfaction	4.88±0.33	4.32±0.82	0.56±0.17	0.002

Other Findings

There were no statistically significant difference in overall patient satisfaction associated with whether or not a patient was older than 65 years or had family or caregiver support
There were no negative comments from any of the patients in the NI group regarding nutritional support
Patients rated the level of nursing care higher than other centres where they had also received treatment.

Author Conclusion:

These results have important implications for the measurement of patient satisfaction with nutrition services in the effort to ensure client focused nutrition care. These data indicate that patient satisfaction is an outcome of nutrition services and that it is measurable. As such, it is useful as it is able to determine real differences between different models of service delivery.

Funding Source:

University/Hospital:

Queensland University of Technology

Reviewer Comments:

Author comments on potential positive bias for responses to please the investigator. Bias reduction was attempted by having a non-bias research assistant administer the questionnaire but validity of bias reduction is undeterminable.
Author also indicates that patients may not be able to differentiate specific components of their care and to control for this the research assistant emphasized the questionnaire objective which in turn could have increased the potential response bias
Concern regarding clinical nutrition intervention due to the lack of change in percent of malnourished patients based on Global Assessment measures
Interpersonal skills appears to be the only statistically significant difference but author proposes a clinical significance for categories; 'staff presentation skills' and 'overall patient satisfaction'.
Questionnaire language can not be determined but referenced article utilized to develop questionnaire (Ferguson et al, 2001) uses the terms nutrition-staff and dietitian thus instrument validity is questionable since there appears to be no indication of bias reduction by changing these terms
Blinding of nurses, physicians and dietitians not mentioned
Frequency of contact by a nurse or dietitian were similar for only the first six weeks of treatment but no measure of frequency for the remaining six weeks. Possible variability in satisfaction due to differences in exposure to treatment.

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?		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?	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.)	???
	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?		???
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	???
	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?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	???
	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?	No
	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?	No
	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?	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?	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)?	Yes
	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?		No
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	No