Ratings for the strength of the recommendations (Strong, Fair, Weak, Consensus, Insufficient Evidence), conclusion grades (I-V), and statement labels (Conditional versus Imperative) are defined at the end of "Major Recommendations"
Oncology (Onc) Breast Cancer: Chemotherapy Determination of Resting Energy Expenditure
Onc-Breast Cancer: Determination of Resting Energy Expenditure (REE) and Chemotherapy
Use of indirect calorimetry to measure REE is more accurate than estimation in early stage and advanced metastatic breast cancer patients. If measurement of REE is not possible or not thought to be imperative, use the Harris-Benedict Equation (HBE) to estimate calorie requirements. Limited evidence indicates that the mean estimated REE was comparable to measured REE in these populations. No research was available to compare HBE using individual error or to compare HBE with other predictive equations in these populations.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Breast Cancer: Chemotherapy and Use of Arginine Oral Supplement
Onc-Breast Cancer: Arginine and Chemotherapy
Use of an oral arginine supplement to improve long-term clinical response for patients with breast cancer prior to the start of neoadjuvant chemotherapy is not currently recommended. Evidence is not available to evaluate the safety of arginine or its effect on cancer symptoms for patients with breast cancer receiving chemotherapy. One randomized controlled trial (RCT) demonstrated a statistically significant histopathological response in tumor sizes less than 6 cm, however there was no improvement in short-term clinical response.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Breast Cancer: Auto-Hematopoietic Stem Cell Transplant (Auto-HCT) and Use of Parenteral Nutrition (PN)
Onc-Breast Cancer: Auto-HCT and PN
Parenteral nutrition should not be routinely recommended for breast cancer patients undergoing auto-HCT who are well-nourished prior to treatment. While PN may preserve nutritional status and lean body mass in these patients, it does not appear to affect length of hospital stay (LOS) or survival, and may increase risk of infectious complications.
Weak, Imperative
Recommendation Strength Rationale
Conclusion statement is a Grade III
Oncology (Onc) Breast Cancer: Radiation and the Use of Antioxidant Vitamin E Oral Supplement
Onc-Breast Cancer: Vitamin E and Radiation
If vitamin E (alpha tocopherol, 670 to 1000 mg) oral supplement is proposed to promote tolerance or reduce late-effects of radiation, advise that no research is available on the impact of vitamin E supplementation to promote tolerance of radiation. Evidence is inconclusive on the benefit of vitamin E for treatment of chronic radiation-induced fibrosis. Vitamin E supplementation may have adverse effects such as nutrient-nutrient interactions, drug-nutrient interactions (e.g., anti-coagulant and anti-hypertensive medications/herbal supplements) and disease-related complications.
Weak, Conditional
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Colorectal Cancer: Radiation and Medical Nutrition Therapy (MNT)
Onc-Colorectal Cancer: Radiation and MNT
Dietitians should provide weekly medical nutrition therapy that includes an individualized nutrition prescription and counseling for patients with colorectal cancer undergoing pelvic radiation. Individualized counseling with a focus on the consumption of regular foods may improve calorie and protein intake, nutrition status, quality of life (QOL) and reduce symptoms of anorexia, nausea, vomiting and diarrhea.
Fair, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Esophageal Cancer: Chemoradiation and Medical Nutrition Therapy (MNT)
Onc-Esophageal Cancer: Chemoradiation and MNT
The dietitian should provide MNT consisting of a pre-treatment evaluation and weekly visits for six weeks during chemoradiation treatment for esophageal cancer to improve outcomes. MNT may reduce the amount of weight loss, unplanned hospitalizations, LOS, as well as improves tolerance to treatment and the likelihood of receiving prescribed radiation dose.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Esophageal Cancer: Chemoradiation and Use of Enteral Nutrition
Onc-Esophageal Cancer: Chemoradiation and Use of Enteral Nutrition (EN)
Enteral nutrition (EN) may be used to increase calorie and protein intake in esophageal cancer patients undergoing chemoradiation therapy. EN has been shown to maintain weight, however EN has not been shown to improve tolerance to therapy or survival.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Esophageal Cancer: Chemoradiation and Use of Parenteral Nutrition
Onc-Esophageal Cancer: Use of Parenteral Nutrition and Chemoradiation
Use of parenteral nutrition (PN) to prevent weight loss or improve effectiveness of treatment for patients with esophageal cancer receiving chemoradiation therapy (CRT) is not recommended. PN has not been shown to prevent weight loss or improve effectiveness of treatment, even though patients were able to tolerate a higher dose of CRT. PN may have adverse effects such as complications related to refeeding syndrome, inadequate glycemic control and increased risk of infections.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Head and Neck Cancer: Chemoradiation and Determination of Resting Energy Expenditure (REE)
Onc-Head and Neck Cancer: Chemoradiation and Determination of REE
Use of indirect calorimetry to measure resting energy expenditure (REE) is more accurate than estimation in patients with advanced head and neck cancer undergoing chemoradiation therapy. If measurement of REE is not possible or not thought to be imperative, use the Harris Benedict Equation (HBE) to estimate calorie needs. However, limited evidence indicates that HBE underestimates REE in this population.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Head and Neck Cancer: Radiation Determination of Protein Needs
Onc-Head and Neck Cancer: Determination of Protein Needs and Radiation
The protein needs for patients with head and neck cancer undergoing radiation therapy may be higher than the recommended daily allowance (RDA). Limited evidence indicates patients consuming the RDA for protein experienced a significant decrease in weight and lean body mass (LBM) during treatment. More defined protein intervention studies are needed.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Head and Neck Cancer: Radiation and Use of Medical Food Supplement
Onc-Head and Neck Cancer: Medical Food Supplements and Radiation
Dietitians should consider use of MFS to improve protein and calorie intake for patients with head and neck cancer undergoing radiation therapy. Use of MFS may be associated with fewer treatment interruptions, a reduction of mucosal damage, and may minimize weight loss.
Fair, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade II
Oncology (Onc) Head and Neck Cancer: Radiation and Medical Nutrition Therapy (MNT)
Onc-Head and Neck Cancer: MNT and Radiation Therapy
Medical nutrition therapy that consists of nutrition assessment, intensive intervention, and ongoing monitoring and evaluation by a registered dietitian (RD) should be provided for patients with head/neck cancer being considered for radiation therapy. MNT has been shown to improve calorie and protein intake, maintain anthropometric measurements and improve quality of life (QOL).
Onc-Head and Neck Cancer: MNT and Pre-Treatment Evaluation
The dietitian should provide MNT consisting of a pre-treatment evaluation and weekly visits during radiation treatment for head and neck cancer to improve outcomes.
Strong, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade II
Oncology (Onc) Head and Neck Cancer: Radiation and Use of Enteral Nutrition (EN)
Onc-Head and Neck Cancer: Radiation and Use of EN
Use enteral nutrition to increase calorie and protein intake for outpatients with stage III or IV head and neck cancer undergoing intensive radiation treatment. Maintenance of nutritional status by EN during radiation therapy may improve tolerance of therapy to promote better outcomes.
Strong, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade II
Oncology (Onc) Head and Neck Cancer: Radiation and Use of Honey
Onc-Head and Neck Cancer: Use of Honey and Radiation
If the topical use of honey is proposed to prevent mouth sores caused by radiation treatment for patients with head and neck cancer, advise that its use may or may not be beneficial. Limited evidence shows that topical use of honey has been associated with decreased incidence of severe mucositis, weight gain and reduced treatment interruptions; however, the risks of interference with effectiveness of radiation treatment and infectious complications were not evaluated.
Weak, Conditional
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Head and Neck Cancer: Radiation
Onc-Use of Antioxidant Vitamin E Oral Supplement
Use of vitamin E oral supplements to enhance efficacy, improve tolerance and reduce late-effects of radiation therapy for patients with head/neck cancer is not recommended. While limited evidence supports the use of vitamin E oral supplements to reduce late effects (osteoradionecrosis), there is strong research reporting an increased risk for second primary cancers and decreased survival rate with use of vitamin E in doses greater than or equal to 400 International Units (IU) (268 mg).
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statements are Grades II and III
Oncology (Onc) Head and Neck Cancer: Surgery and Use of Arginine-Enhanced Medical Food Supplement or EN
Onc-Head and Neck Cancer: Post-Operative Use of Arginine
Post-operative use of arginine-enhanced MFS or EN to improve outcomes for patients with head and neck cancer is not recommended. Arginine-enhanced versus non-arginine-enhanced MFS and EN did not produce significant changes in weight and body composition in either well-nourished or malnourished subjects. Most evidence shows there is no impact of arginine-enhanced MFS or EN on immune function. Limited research reported that arginine-enhanced EN can improve post-operative complications and LOS in malnourished patients.
Fair, Imperative
Onc-Head and Neck Cancer: Pre-Operative Use of Arginine
Pre-operative use of arginine-enhanced EN to improve outcomes for patients with head and neck cancer is not recommended. No significant improvement in clinical outcomes, nutritional status, or surgery-induced immune suppression was observed among malnourished compared to patients receiving a non-enhanced EN, or those who did not receive EN.
Fair, Imperative
Recommendation Strength Rationale
- Conclusion statement are Grades II and III
Oncology (Onc) Head and Neck Cancer: Surgery and Use of Eicosapentaenoic Acid (EPA)-Enhanced Medical Food Supplement (MFS)
Onc-Head and Neck Cancer: Surgery and EPA-Enhanced MFS
If the use of an EPA-enhanced MFS is proposed to decrease post-surgical complications (e.g., infections and weight loss) for oral and laryngeal cancer patients, advise inadequate evidence exists to show a benefit. While one study comparing EPA- versus arginine-enhanced MFS found that an EPA supplement led to an increase in weight, there were no differences in fat-free mass or infectious complications.
Weak, Conditional
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Hematological Malignancies (HCT): Chemotherapy and Medical Nutrition Therapy (MNT)
Onc-HCT: Chemotherapy and MNT
Medical Nutrition Therapy that consists of nutrition assessment, intensive intervention, and ongoing monitoring and evaluation by a registered dietitian may be of benefit to patients with acute leukemias undergoing chemotherapy. Daily monitoring of intake and incorporating patient preferences have been shown to increase nutrition intake which positively affects body weight and tumor-therapy side effects (e.g., fatigue and anorexia).
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Hematological Malignancies (HCT): Determination of Calorie Needs
Onc-HCT: Determination of Calorie Needs
Use indirect calorimetry to measure REE for adult patients with hematologic malignancies undergoing allogeneic HCT. When indirect calorimetry is not available, limited evidence indicates that the estimated energy requirements are 30-35 kcal per kg per day during the first month post-transplant, and may be higher during acute graft-versus-host disease (GVHD) and/or for patients receiving >75% of their total daily energy intake via PN.
Fair, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade II
Oncology (Onc) Hematological Malignancies (HCT): Determination of Protein Needs
Onc HCT: Determination of Protein Needs
The protein needs for patients with hematologic malignancies undergoing allogeneic HCT are higher than the RDA. Limited evidence suggests that more than 2.2g protein per kg may be needed to maintain nitrogen balance. Further research is needed to define protein requirements in this population.
Fair, Conditional
Recommendation Strength Rationale
- Conclusion statement is a Grade II
Oncology (Onc) Hematological Malignancies (HCT): Use of Oral Glutamine
Onc-HCT: Use of Oral Glutamine
Use of oral glutamine to decrease incidence or severity of mucositis or to support recovery following hematopoietic cell transplantation for hematologic malignancies is not currently recommended. Glutamine supplementation did not show an effect on the incidence or severity of oral mucositis, diarrhea, oral intake or PN requirements among patients with hematologic malignancies receiving autologous or allogeneic HCT.
Fair, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Hematological Malignancies (HCT): Use of Parenteral Nutrition
Onc-HCT: Use of Parenteral Nutrition (PN)
Parenteral nutrition should only be used in selected HCT patients due to increased risk of treatment complications, increased cost, and a lack of significant improvement in treatment outcomes. Dietitians should regularly screen and monitor HCT patients for signs of malnutrition and prolonged periods of poor oral intake to identify patients who might benefit from PN. Patients most likely to benefit from PN include patients receiving allogeneic transplants from mismatched donors.
Fair, Imperative
Onc-HCT: Use of Lipid-Based PN Formulations
Patients receiving PN while undergoing HCT should receive 25 to 30% of energy as lipids. Provision of lipids is necessary to prevent fatty acid deficiency, and may improve blood glucose control.
Fair, Conditional
Onc-HCT: Use of Glutamine-Enhanced PN Formulations
Use of parenteral glutamine to decrease incidence or severity of mucositis or diarrhea following hematopoietic cell transplantation for hematologic malignancies is not currently recommended. No clear evidence indicates that use of parenteral glutamine alters incidence or duration of mucositis or diarrhea. In addition, parenteral glutamine has not been shown to decrease LOS, time to engraftment or the number of infectious complications.
Fair, Imperative
Recommendation Strength Rationale
- Conclusion statements are Grades II and III
Oncology (Onc) Non-Small Cell Lung Cancer: Chemotherapy and Determination of Resting Energy Expenditure
Onc-Lung Cancer: Chemotherapy and Determination of REE
Use of indirect calorimetry to measure REE is more accurate than estimation in patients with non-small cell lung cancer (NSLC) undergoing chemotherapy. If measurement of REE is not possible or not thought to be imperative, use HBE to estimate calorie needs. However, limited evidence indicates that the HBE may underestimate energy needs by an average of 12-13%.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Lung Cancer: Chemotherapy and Use of Antioxidant Vitamins C, E and Beta-Carotene Oral Supplements
Onc-Lung Cancer: Chemotherapy and Use of Antioxidant Supplements
The use of antioxidants (vitamin C, vitamin E, beta-carotene, selenium) above the tolerable upper intake level to improve treatment outcomes in patients with advanced non-small cell lung cancer undergoing chemotherapy is not recommended. In this population, use of high-dose multiple oral antioxidants did not significantly influence response to treatment, survival, survival time, and toxicity. More studies are needed.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Lung Cancer: Chemotherapy and Medical Nutrition Therapy
Onc-Lung Cancer: MNT and Chemotherapy
Medical Nutrition Therapy that consists of nutrition assessment, intensive intervention, and ongoing monitoring and evaluation by an RD may be of benefit to patients with small cell lung cancer undergoing chemotherapy. Providing MNT may improve protein and calorie intake, which has been shown to improve weight status and QOL.
Weak, Imperative
Recommendation Strength Rationale
- Conclusion statement is a Grade III
Oncology (Onc) Pancreatic Cancer: Use of Omega-3 Fatty Acid-Enhanced MFS or Oral Supplements
Once-Pancreatic Cancer: Use of Omega-3 Supplements for Weight Loss
Use of omega-3 fatty acids to alter the prolonged acute-phase response is not recommended for pancreatic cancer patients. Consumption of an omega-3 fatty acid-enhanced medical food supplement (mean dose 2.2 g daily) or an oral supplement (2 g EPA daily) for pancreatic cancer patients experiencing weight loss has not been shown to reduce serum C-reactive protein (CRP) concentrations after 12 weeks of EPA supplementation and there are potential drug-nutrient interactions (e.g., anti-coagulant and anti-hypertensive medications/herbal supplements).
Fair, Imperative
Onc-Pancreatic Cancer: Use of Omega-3 Supplements for Anticachectic Effects
Use of supplemental omega-3 fatty acids for anticachectic effects leading to changes in body composition (e.g., increase in LBM, weight gain or weight stabilization) is not recommended for patients with pancreatic cancer. EPA as a capsule or in a medical food supplement was not associated with an increase in LBM. Evidence that fish oil supplements stabilize weight or produce weight gain is inconclusive. There are potential drug-nutrient interactions (e.g., anti-coagulant and anti-hypertensive medications/herbal supplements).
Strong, Imperative
Recommendation Strength Rationale
- Conclusion statement are Grades I and III
Definitions:
Conditional versus Imperative Recommendations
Recommendations can be worded as conditional or imperative statements. Conditional statements clearly define a specific situation, while imperative statements are broadly applicable to the target population without restraints on their pertinence. More specifically, a conditional recommendation can be stated in if/then terminology (e.g., If an individual does not eat food sources of omega-3 fatty acids, then 1g of EPA and DHA omega-3 fatty acid supplements may be recommended for secondary prevention).
In contrast, imperative recommendations "require," or "must," or "should achieve certain goals," but do not contain conditional text that would limit their applicability to specified circumstances. (e.g., Portion control should be included as part of a comprehensive weight management program. Portion control at meals and snacks results in reduced energy intake and weight loss).
Grading the Strength of the Evidence for a Conclusion Statement or Recommendation Conclusion Grading Table
| Strength of Evidence Elements |
Grade I
Good/Strong
|
Grade II
Fair
|
Grade III
Limited/Weak
|
Grade IV
Expert Opinion Only
|
Grade V
Grade Not Assignable
|
Quality
- Scientific rigor/validity
- Considers design and execution
|
Studies of strong design for question
Free from design flaws, bias and execution problems
|
Studies of strong design for question with minor methodological concerns
OR
Only studies of weaker study design for question
|
Studies of weak design for answering the question
OR
Inconclusive findings due to design flaws, bias or execution problems
|
No studies available
Conclusion based on usual practice, expert consensus, clinical experience, opinion, or extrapolation from basic research
|
No evidence that pertains to question being addressed |
Consistency
Of findings across studies
|
Findings generally consistent in direction and size of effect or degree of association, and statistical significance with minor exceptions at most |
Inconsistency among results of studies with strong design
OR
Consistency with minor exceptions across studies of weaker designs
|
Unexplained inconsistency among results from different studies
OR
Single study unconfirmed by other studies
|
Conclusion supported solely by statements of informed nutrition or medical commentators |
NA |
Quantity
- Number of studies
- Number of subjects in studies
|
One to several good quality studies
Large number of subjects studies
Studies with negative results having sufficiently large sample size for adequate statistical power
|
Several studies by independent investigators
Doubts about adequacy of sample size to avoid Type I and Type II error
|
Limited number of studies
Low number of subjects studies and/or inadequate sample size within studies
|
Unsubstantiated by published studies |
Relevant studies have not been done |
Clinical Impact
- Importance of studies outcomes
- Magnitude of effect
|
Studied outcome relates directly to the question
Size of effect is clinically meaningful
Significant (statistical) difference is large
|
Some doubt about the statistical or clinical significance of effect |
Studies outcome is an intermediate outcome or surrogate for the true outcome of interest
OR
Size of effect is small or lacks statistical and/or clinical significance
|
Objective data unavailable |
Indicates area for future research |
Generalizability
To population of interest
|
Studied population, intervention and outcomes are free from serious doubts about generalizability |
Minor doubts about generalizability |
Serious doubts about generalizability due to narrow or different study population, intervention or outcomes studied |
Generalizability limited to scope of experience |
NA |
This grading system was based on the grading system from: Greer N, Mosser G, Logan G, Wagstrom Halaas G. A practical approach to evidence grading. Jt Comm. J Qual Improv. 2000; 26:700-712. In September 2004, The ADA Research Committee modified the grading system to this current version.
Criteria for Recommendation Rating
Criteria for Recommendation Rating
| Statement Rating |
Definition |
Implication for Practice |
| Strong |
A Strong recommendation means that the workgroup believes that the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits in the case of a strong negative recommendation), and that the quality of the supporting evidence is excellent/good (grade I or II)*. In some clearly identified circumstances, strong recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. |
Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. |
| Fair |
A Fair recommendation means that the workgroup believes that the benefits exceed the harms (or that the harms clearly exceed the benefits in the case of a negative recommendation), but the quality of evidence is not as strong (grade II or III)*. In some clearly identified circumstances, recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. |
Practitioners should generally follow a Fair recommendation but remain alert to new information and be sensitive to patient preferences. |
| Weak |
A Weak recommendation means that the quality of evidence that exists is suspect or that well-done studies (grade I, II, or III)* show little clear advantage to one approach versus another. |
Practitioners should be cautious in deciding whether to follow a recommendation classified as Weak, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. |
| Consensus |
A Consensus recommendation means that Expert opinion (grade IV)* supports the guideline recommendation even though the available scientific evidence did not present consistent results, or controlled trials were lacking. |
Practitioners should be flexible in deciding whether to follow a recommendation classified Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. |
| Insufficient Evidence |
An Insufficient Evidence recommendation means that there is both a lack of pertinent evidence (grade V)* and/or an unclear balance between benefits and harms. |
Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Insufficient Evidence and should exercise judgment and be alert to emerging publications that report evidence that clarifies the balance of benefit versus harm. Patient preference should have a substantial influencing role. |
*Conclusion statements are assigned a grade based on the strength of the evidence. Grade I is good; grade II, fair; grade III, limited; grade IV signifies expert opinion only and grade V indicates that a grade is not assignable because there is no evidence to support or refute the conclusion. The evidence and these grades are considered when assigning a rating (Strong, Fair, Weak, Consensus, Insufficient Evidence - see chart above) to a recommendation.
