ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)
- Synchronous chemoradiation
- Most subjects were entered on the Trans Radiation Oncology Group (TROG) trials 89-04, 96-02 or 98-06 during 1990-2001
- Previously untreated patients
Recruitment
Not described
Design
Retrospective chart review
- Control group consisted of historical controls: any patient planned to receive definitive treatment for esophageal cancer from 1990-1996 prior to implementation of the nutrition pathway
- Nutrition pathway (NP) group consisted of any patient presenting to the esophagel clinic from 1997-2001 who was planned to receive definitive treatment
Nutrition Pathway group: Interviewed by RD at initial presentation to the esophageal clinic then weekly throughout chemoradiation courses
- Initial consultation nutrition assessment
- Nutrition risk (low, moderate or severe) determined by RD per NP criteria
- Low risk subjects received information and support to help maintain nutritional status
- Moderate risk subjects
- Presence of anorexia/dysphagia and/or unintentional weight loss 5-9%
- received consistency modified, high protein/high energy diet education
- Severe risk subjects received PEG or nasogastric (NG) tube placement depending on the treatment week in which risk was identified
- Severe dysphagia (puree/fluids only) and/or unintentional wt loss > 10% and/or BMI < 18 kg/m2
- PEGs were placed for severe risk subjects before starting treatment in all cases and instruction for home use was provided.
- Enteral feeding for both PEG or NG consisted of a 1.5 kcal/ml formula, nutritionally complete in 1690 calories.
- Regular follow up occurred to assess nutritional status and nutrient prescriptions were adjusted as necessary.
- Inpatients - Day 1 Chemoradiation Nutrition Assessment
- Low risk: nutrition education addressing strategies for managing nausea/vomiting and fluid intake
- Moderate risk: presence of anorexia/dysphagia and/or weight loss 5-9%
- nutrition education including textured modified, high protein/energy diet and/or managing nausea/vomiting and fluid intake
- Severe risk: severe dysphagia (puree only) and/or weight loss > 10%
- PEG placement in the first 3 weeks of chemoradiation
- Outpatients - Day 8 after chemotherapy
- Low risk: weight loss < 4 kg in past week, adequate hydration
- nutrition education reinforcing prior dietary advice
- Moderate risk: weight loss > 4 kg in past week, dehydration
- nutrition education addressing adequate fluid intake, strategies for managing nausea/anorexia, high protein/high energy diet (+/- texture modification)
- Low risk: weight loss < 4 kg in past week, adequate hydration
- Outpatients: weekly nutrition assessment
- Low and moderate risk: weight stabilized
- Severe risk: failure to stabilize weight, weight loss > 10%
- NG tube placement if > 50% of chemoradiation therapy had been provideded
- Received nutrition support in a reactive manner
- Referred to RD only as problems arose
- Nutrition risk (low, moderate or severe) classified retrospectively per nutrition pathway criteria
- Chemoradiation treatment
- Cisplatin 80 mg/m2 by IV infusion on day 1 and day 21 (or day 28) plus 5-fluorouracil 800 mg/m2 by continuous infusion on days 22-25 (or days 29-32)
- Radiation dose of 60 Gy to the tumor-bearing volume and 30 Gy to the regional lymphatics using daily incremental fractions of 2 Gy over 6 weeks.
- Categorical variables were analyzed by chi-squared or Fisher's Exact test
- Differences in continuous variables between groups were compared using Students t-test or Mann-Whitney test, depending on distribution
- All statistical analyses were two-tailed and a value of P<0.05 was considered statistically significant
- Statistics package SPSS 10.0 for Windows
Timing of Measurements
Dependent Variables
- Weight status
- Percentage of planned treatment delivered
- Number of unplanned hospital admissions
- Length of hosital stay during unplanned hospital admissions
Independent Variables
- Nutrition pathway management
Control Variables
Initial N:
Control: n=24
Nutrition pathway: n=24
Attrition (final N):
Control: n=24
Nutrition pathway: n=24
Age: See table below
Ethnicity: Not described
Other relevant demdographics: See table below
Anthropometrics See table below
Location:
Newcastle Mater Misericordiae Hospital, New South Wales, Australia
Comparison of demograpic, oncological and nutritional characteristics
Nutrition Pathway | P value | ||
(n=24) | (n=24) | ||
% male | 67 | 71 | 0.77 |
age (yrs)* | 71.9±9.8 | 66.4±10.9 | 0.07 |
Tumor type % | |||
Squamous | 71 | 71 | |
Adenocarcinoma | 29 | 29 | 1.00 |
Tumor length (cm)* | 6.1±2.2 | 6.3±3.2 | 0.34 |
Tumor position % | |||
Top | 17 | 8 | 0.79 |
Middle | 17 | 26 | |
Lower | 58 | 58 | |
Esophago-gastric junction | 8 | 8 | |
% patients w/ dysphagia | 92 | 83 | 0.38 |
Usual BMI* | 25.5±5.1 | 27.4±6.1 | 0.27 |
% usual wt loss at presentation* | 7.3±5.6 | 7.4±6.3 | 0.92 |
Nutrition risk % | |||
At low risk | 21 (n=5) | 16 (n=4) | 0.47 |
At moderate risk | 25 (n=6) | 42 (n=10) | |
At severe risk | 54 (n=13) | 42 (n=10) |
Timing and Reasons for Initial Dietetic Intervention
Control | Nutrition Pathway | P value | |
(n=24) | (n=24) | ||
% patients w/ first intervention at: | |||
First presentation to the unit | 38 (9) |
96 23) |
<0.05 |
Start of treatment | 29 (7) | 4 (1) | |
During treatment* | 33 (8) | 0 (0) | |
Reason for intervention % | |||
Dysphagia | 100 (24) | 83 (20) | 0.04 |
Wt loss | 83 (20) | 79 (19) | >0.05 |
Anorexia | 46 (11) | 46 (11) | >0.05 |
Automatic referral per NP | 0 (0) | 96 (23) | <0.05 |
Referred for other reasons§ | 21 (5) | 17 (4) | >0.05 |
§Other reasons for referral in control group: enteral nutrition required pre-treatment (n=2), low albumin/diabetes/nausea (n=1 subject each). Other reasons for referral in NP group: enteral nutriiton review as enteral nutrition had been commenced elsewhere (n=1), reflux/social situation/diabetes (n=1 patient each).
- Automatic referral as a reason for intervention occurred in 23/24 subjects, highlighting excellent compliance (96%) with the nutrition pathway protocol.
- In the control group, 33% of the subjects not seen by a RD until at least the second week of treatment.
Control | Nutrition Pathway | Pvalue | |
(n=8) | (n=13) | ||
% Receiving EN | 33 (8/24) | 54 (13/24 | >0.05 |
Week EN started | 3.6±3.0 | -0.31±2.8 | 0.001 |
Administration method % | |||
PEG | 25 (2) | 77 (10) | 0.06 |
NG | 63 (5) | 15 (2) | |
NG then PEG | 12 (1) | 8 (1) | |
BMI at start of EN* | 19.0±3.6 | 22.3±4.1 | 0.08 |
% usual wt loss at start of EN* | 17.9±5.5 | 12.3±4.7 | 0.02 |
Problems during EN (%) | |||
Nausea | 38 (3) | 46 (6) | >0.05 |
Diarrhea | 13 (1) | 0 (0) | >0.05 |
Bloating | 38 (3) | 46 (6) | >0.05 |
Tube blockage | 13 (1) | 23 (3) | >0.05 |
Vomiting | 25 (2) | 15 (2) | >0.05 |
Tube dislodgement | 13 (1) | 0 (0) | >0.05 |
Reflux | 13 (1) | 15 (2) | >0.05 |
PEG site infection | 0 (0) | 8 (1) | >0.05 |
Subjects receiving EN by nutrition risk assessment (%) | |||
Severe | 38 (5/13) | 100 (10/10) | 0.003 |
Moderate | 33 (2/6) | 30 (3/10) | >0.05 |
Low | 20 (1/5) | 0 (0/10) | >0.05 |
- In the control group, 13 subjects were assessed retrospectively as "severe nutrition risk", but only 2 received a PEG pre-treatment. In contrast, all 10 subjects in the nutrition pathway group assessed as "severe nutrition risk received a PEG pre-treatment.
- There was a significant difference in the timing of EN between the groups; however, the total number of subjects receiving EN was not different.
Control | Nutrition Pathway | P value | |
(n=16) completed | (n=22) completed | ||
% usual wt lost at end of treatment* | 16.2±6.8 | 11.0±4.9 | 0.04 |
% wt change during treatment* | -8.9±5.9 | -4.2±6.4 | 0.03 |
% wt change over treatment course/nutrition risk* | |||
Severe | -6.33±6.0 | 0.38±6.1 | 0.06 |
Moderate | -11.8±7.6 | -8.0±6.3 | 0.48 |
Low | -9.5±4.4 | -6.3±4.9 | 0.21 |
- Subjects in the nutrition pathway group lost less weight over the treatment period.
Comparison of Chemotherapy Outcomes
Control | Nutrition Pathway | P value | |
(n=24) | (n=24) | ||
Treatment received | |||
2 cycles of cisplatin & 5-FU | 92 (22) | 83 (20)* | 0.33 |
1 cycle of cisplatin & 5-FU | 8 (2) | 4 (1) | |
1 cycle of cisplatin & 2 cycles of 5-Fu | 0 (0) | 8 (2) | |
Half cycle of cisplatin & 5-FU | 0 (0) | 4 (1) | |
% subjects experiencing chemotherapy delay | 71 (17) | 67 (16) | |
Number of weeks delay§ | median 1 (0-3) | median 1 (0-3) | 0.40 |
% subjects who had a dose reduction | 42 (10) | 29 (7) | 0.34 |
% planned cisplatin dose received§ | median 100 (50-100) | median 100 (5-100) | 0.40 |
% planned 5-FU dose received§ | median 100 (50-100) | median 100 (50-100) | 0.29 |
§ Median (range) for non-normal variables
- The nutrition pathway had no effect on chemotherapy delivery compared with controls.
- There was a trend towards fewer dose reductions in subjects in the nutrition pathway group.
Comparison of Radiotherapy Outcomes
Control | Nutrition Pathway | P value | |
(n=24) | (n=24) | ||
% subjects completing radiotherapy | 50 (12) | 92 (22) | 0.001 |
% subjects who had radiotherapy break (those completing treatment) | 33 (4/12) | 27 (6/22) | 0.71 |
Number of days break (for those completing treatment)* | 0 (0-18) | 0 (0-13) | 0.48 |
% planned radiotherapy dose delivered* | median 95 (37-100) | median 100 (60-100) | 0.004 |
% radiotherapy dose delivered/nutrition risk* | |||
Severe | 83 (37-100) | 100 (60-100) | 0.06 |
Moderate | 100 (58-100) | 100 (93-100) | 0.20 |
Low | 100 (50-100) | 100 (100-100) | 0.18 |
- There was a significant difference in the percentage of subjects who completed the planned radiotherapy course: 92% of the nutrition pathway group compared with 50% of the control group, p=0.003.
- the percentage of radiotherapy dose delivered to the nutrition pathway group was also more than the percentage delivered to the control group.
- In the control group, 9/12 subjects discontinued treatment because of side effects while only 2 subjects in the nutrition pathway group did not complete treatment (both because of coincidental myocardial infarctions).
Comparison of Hospital Admissions Outcomes
Control | Nutrition Pathway |
P value |
|
(n=24) | (n=24) |
||
% patients w/ UHA |
75/(18) |
46 (11) |
0.04 |
Number of UHA/patient* |
median 1 (0-2) |
median 0 (0-4) |
0.05 |
Total number UHA/group |
24 |
16 |
|
Total LOS for all UHA (days)§ |
13.5±14.1 |
3.2±5.4 |
0.002 |
LOS admission 1 (days)* |
median 6.5 (0-52) |
median 0 (0-11) |
0.002 |
LOS admission 2 (days)* |
median 0 (0-31) |
median 0 (0-17) |
>0.05 |
Reason for admission 1: for EN (%) |
33 (6/18) |
9 (1/11) |
>0.05 |
Reason for admission 2: for EN (%) |
17 (1/6) |
0 (0/3) |
>0.05 |
Total LOS/nutrition risk (days)§ |
|||
Severe | 16 (0-52) |
2 (0-8) |
0.006 |
Moderate |
2.5 (0-11) |
0 (0-20) |
>0.05 |
Low |
16 (0-34) |
2 (0-16) |
>0.05 |
§ Mean±standard deviation for normal variables
UHA: unplanned hospital admission; LOS: length of stay; EN: enteral nutrition
- Subjects in the control group were more likely to have an unplanned hospital admission (UHA) during the treatment period with 75% of control subjects having a UHA compared with 46% of subjects in the nutrition pathway group (P=0.04).
- Although the total number of UHA was not not different betwen the groups (P=0.05), the total length of stay for all UHA was greatly reduced in the nutrition pathway group: 13.5 days (±14.1) for the control group compared with 3.2 days (±5.4) for the nutrition pathway group (P=0.002).
- Only one patient in the nutrition pathway group was admitted for enteral nutrition (1/11, a 1-day admisison for PEG placement for a patient crossing over from moderte to severe risk), whereas 6 of the 18 admissions in the control group were primarily for nutritional support.
Other Findings
- Implementation of this nutrition pathway has been associated with improved clinical outcomes, including decreased weight loss, number of unplanned hospital admissions and length of stay during the treatment course, and a higher tolerance of planned treatment.
- Recommend that all patients with esophageal cancer who will receive definitive chemoradiation receive a proactive nutritional assessment by a RD specializing in oncology on initial presentation, and appropriate nutritional support and follow-up within the multidisciplinary team.
Not-for-profit |
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- Primary weakness of the study was the use of historical controls; however, it would have been unethical to deny control subjects nutrition management via the nutrition pathway.
- No data provided re: the amount of nutrition received vs goal
- No survival data reported
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? | 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 | |
2.1. | 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 | |
2.2. | 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? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
3. | Were study groups comparable? | ??? | |
3. | Were study groups comparable? | ??? | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | 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 | |
3.2. | 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? | Yes | |
4. | Was method of handling withdrawals described? | Yes | |
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%.) | 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 | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
4.4. | Were reasons for withdrawals similar across groups? | 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 | |
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. | 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? | No | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | No | |
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 | |
5.2. | 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 | |
5.3. | 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? | Yes | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | Yes | |
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? | 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? | Yes | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
6.6. | Were extra or unplanned treatments described? | ??? | |
6.6. | Were extra or unplanned treatments described? | ??? | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | 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? | 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? | Yes | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | Yes | |
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? | 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 | |
8.2. | 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 | |
8.3. | 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)? | ??? | |
8.4. | 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)? | No | |
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 | |
8.6. | 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? | No | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | No | |
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 | |