ONC: Medical Nutrition Therapy and Nutrition Intervention in Adult Oncology Patients (2011)
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
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
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
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
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%)
(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
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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
University/Hospital: | Canniesburn Hospital (UK) |
- 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
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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 | |