EAL

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

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine if increased interaction with a dietitian postoperatively and during radiotherapy results in the reduction of weight loss in patients with squamous cell carcinoma of the oral cavity

Inclusion Criteria:

All patients

squamous cell carcinoma of the oral cavity
planned surgery and radiotherapy treatments

Group I (historical control)

recruited between January 1990 and December 1991
Stages II, III and IV

Group II (intervention group)

recruited between January 1996 and December 1999
Stages III and IV

Exclusion Criteria:

None cited

Description of Study Protocol:

Recruitment

All patients were recruited consecutively after meeting inclusion criteria and at pre-surgery visit at the Canniesburn Hospital in Glasgow, Scotland.

Design

This is a two group comparison study. Group I (historical controls) were studied prospectively and later compared with Group II (intervention group). Radiotherapy occurred in an outpatient department. Medical care with a multidisciplinary team also occurred in combined clinics.

Intervention

Both groups received post-operative nutrition support in the hospital.

Group I

4 weeks post-operatively, the patients received a diet booklet during the multidisciplinary clinic and patient care transferred to radiotherapy unit
seen by radiotherapy RD once every two weeks during radiotherapy at clinic
Follow-up at 6 weeks post-radiotherapy by head and neck RD at combined clinic

Group II

4 weeks post-operatively, the patients received a diet booklet during the multidisciplinary clinic
Head and neck team dietitian continued to see patient weekly (or as frequently as needed) until radiotherapy commenced
Once radiotherapy started, patients were weighed weekly
if >2 kg weight loss in 2 weeks, dysphagia, unexplained weight loss, or if the patient had a feeding tube they were referred back to the radiotherapy RD
2 weeks post-radiotherapy, RD evaluated patients
3 weeks post-radiotherapy, referred back to head and neck RD

Statistical Analysis

Student's t test for nonpaired samples, P<0.05

Descriptive statistics

Data Collection Summary:

Timing of Measurements

1. Weight

- presurgery

- at 4wk after surgery, but before radiotherapy

- at first follow-up visit, 3-6 week after completion of radiotherapy (6-8 weeks of treatment)

- at 1 yr after treatment

2. Diet (type or consistency)

- presentation

- postsurgery

- preradiotherapy

- postradiotherapy

- 1 year after treatment

Dependent Variables

Variable 1: weight measured by scales in outpatient department
Variable 2: dietary information obtained from specifically designed dietitian's record cards, the clinical case notes, and nursing records

Independent Variables

•Dietary management

Control Variables

•Dietitians who managed both groups of patients

Description of Actual Data Sample:

Initial N:

Group I n = 26 (men 17, women 9)

Group II n = 45 (men 33, women 12)

Attrition (final N):Group I n = 22 (4 died), Group II n =26 (study was not completed at publication)

Age: Group I = 59 mean age (range 30 to >80), Group II 57 = mean age (range 37 to 84)

Ethnicity: undisclosed

Other relevant demographics:

	Avg presurgery weight, kg	Stage I %	Stage II %	Stage III %	Stage IV %
Group 1	68	0	50	31	19
Group 2	71	0	0	67	33

•3 patients in Group I had breaks in their radiotherapy schedule

Anthropometrics - n/a

Location:

Canniesburn Hospital, Glasgow, Scotland

Summary of Results:

Variables	Group I	Group II	Statistical Significance of Group Difference
% Weight Loss postsurgery postradiation combined 1 yr	3.67% ( loss of 15.4% to gain of 9.6%) 6.6% (loss of 0.8 -25.9%) 9.83% 7.82%	2.42% ( loss of 16.2% to gain of 9.1%) 4.83% (loss of 17.1% to gain of 11.2%) 6.6% 5.9%	P<0.05 P<0.05 P<0.05 no statistical significance

Near/Near-Normal Diet (%)

Group I: 61 Group II: 66.6 Presentation

11.5 15.6 Postsurgery

26.9 16.4 Preradiotherapy

30.8 28.9 Postradiotherapy

72.8 56 1 yr

Soft Diet (%)

Group I: 19.5 26.6 Presentation

38.5 15.5 Postsurgery

34.6 26.7 Preradiotherapy

42.3 24.5 Postradiotherapy

18.2 12 1 yr

Fluid Diet (%)

Group I: 19.5 6.6 Presentation

38.5 53.3 Postsurgery

38.5 31.2 Preradiotherapy

19.2 28.8 Postradiotherapy

9 16 1 yr

PEG Feeding (%)

Group I: 0 0 Presentation

11.5 15.6 Postsurgery

0 15.7 Preradiotherapy

7.7 17.8 Postradiotherapy

0 16 1 yr

Difference in weight loss between Group I and Group II (patients excluded with stage I and stage II disease to make Group I and Group II more comparable)

•weight loss between Groups increase: 4.9% compared with 2.4% in Group II postsurgery

•8.4% compared with 4.8% in Group II postradiotherapy

•12.3% compared with 6.6% in Group II overall after surgery and radiotherapy

•8.6% compared with 5.9% in Group II at 1 yr follow up

Other findings:

•A reduction in weight loss indicates improved nutrition

•This would be expected to lead to a faster postoperative recovery and improved long-term outlook for this group of patients, who are at high risk of malnutrition for a variety of reasons

Author Conclusion:

"Increasing dietary supervision of oral cancer patients in the period immediately before and after radiotherapy significantly reduces weight loss." "Continuous dietary supervision as part of a multidisciplinary dedicated head and neck oncology service reduces weight loss after combined-modality treatment for oral cancer."

Funding Source:

University/Hospital:

Canniesburn Hospital (UK)

Reviewer Comments:

- Group I had only 26 participants

- Group I was used as a historical control - author cites this as a weakness of this study

- Statistical analyses were not adequately described

All patients in group II had not completed the 1 year follow-up assessment

The groups were not comparable for disease state.

Other medications used were not discussed

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
	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
	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
	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
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
	1.	Was the research question clearly stated?	Yes
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.1.	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
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
	1.3.	Were the target population and setting specified?	Yes
	2.	Was the selection of study subjects/patients free from bias?	???
2.	Was the selection of study subjects/patients free from bias?		???
	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?	No
	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?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
	3.	Were study groups comparable?	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
	3.1.	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
	3.2.	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.)	No
	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?	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
	3.5.	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
	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.	Was method of handling withdrawals described?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	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%.)	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?	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	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
	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.	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
	5.1.	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
	5.2.	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
	5.3.	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
	5.4.	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
	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.	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
	6.1.	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
	6.2.	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
	6.3.	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
	6.4.	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
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments 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?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	No
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	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.	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
	7.1.	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
	7.2.	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
	7.3.	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
	7.4.	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
	7.5.	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
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	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?	???
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	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
	8.4.	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)?	???
	8.5.	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
	8.6.	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
	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.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	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.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes