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Guideline Summary
Guideline Title
Putting evidence into practice: evidence-based interventions for the management of oral mucositis.
Bibliographic Source(s)
Harris DJ, Eilers J, Harriman A, Cashavelly BJ, Maxwell C. Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clin J Oncol Nurs. 2008 Feb;12(1):141-52. [55 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

The Oncology Nursing Society (ONS) reaffirmed the currency of this guideline in 2011.

Scope

Disease/Condition(s)

Cancer-related oral mucositis

Note: Mucositis, an inflammation of the mucous membranes, is a commonly occurring side effect of chemotherapy and radiation.

Guideline Category
Evaluation
Management
Treatment
Clinical Specialty
Nursing
Oncology
Radiation Oncology
Intended Users
Advanced Practice Nurses
Nurses
Guideline Objective(s)

To provide recommendations for the management of oral mucositis

Target Population

Patients with cancer-related oral mucositis

Interventions and Practices Considered
  1. Oral care protocols
  2. Cryotherapy
  3. Palifermin
  4. Allopurinol
  5. Amifostine
  6. Anti-inflammatory rinses
  7. Antimicrobial agents
  8. Benzydamine HCl
  9. Caphosol
  10. Chlorhexidine
  11. Fluoride chewing gum
  12. Flurbiprofen tooth patch
  13. Gelclair® (EKR Therapeutics, Inc.)
  14. Granulocyte– or granulocyte macrophage–colony stimulating factor (subcutaneous)
  15. Honey
  16. Immunoglobulin
  17. L‐alanyl‐L‐glutamine
  18. Low‐level laser therapy
  19. Multiagent ("magic" or "miracle") rinses
  20. Oral aloe vera
  21. Pilocarpine
  22. Povidone‐iodine (oral)
  23. Tetracaine
  24. Zinc supplementation

Note: The following interventions were considered, but their effectiveness unlikely or they were not recommended: iseganan, misoprostol, vitamin E (topical), wobe‐mugos E, chlorhexidine (alcohol‐based), granulocyte macrophage–colony stimulating factor mouthwash, and sucralfate

Major Outcomes Considered
  • Functional status
  • Quality of life

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

2008 Original Guideline

The team searched MEDLINE®, the U.S. National Library of Medicine's bibliographic database, CINAHL® (Cumulative Index to Nursing and Allied Health Literature) and CCRCT (Cochrane Central Register of Controlled Trials). Searches explored the terms neoplasms for nursing, prevention and control, diet therapy, drug therapy, radiotherapy, surgery, and therapy. Other search terms included mucositis, stomatitis, mucous membrane, radiotherapy, and antineoplastic agents. A health services librarian was consulted to review the search terms and strategy. The literature search included citations from 2000 to September 2006. Sources cited before 2000 were reviewed as appropriate.

2011 Reaffirmation

PubMed, CINAHL and Cochrane Collaboration were searched from March 2008 through June 2011 using the search terms: Mucositis[ti] OR Mucositis[majr] OR "oral complication*"; limits: English, cancer.

Inclusion Criteria

  1. Full research report, systematic review, guideline or meta-analysis
  2. Study must report results of measurement of oral mucositis
  3. The study examines an intervention aimed at affecting the problem of oral mucositis
  4. Study sample must include patients with cancer

Exclusion Criteria

  1. Grey literature
  2. Descriptive study
  3. Studies reporting intervention effects on the pain of mucositis, but not the actual incidence or severity of the symptom itself

Monthly auto alerts from all databases are received. Abstracts are reviewed against inclusion and exclusion criteria, and those meeting criteria are selected to be obtained. Further full article review is done by team members assigned, and any that does not meet criteria upon full review is eliminated.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Panels of advanced practice nurses, staff nurses, and doctorally-prepared nurse researchers reviewed the literature base in the identified outcome areas. Professional health services librarians assisted in the conduct of the literature searches. Based on their analysis, the panels then formulated a judgment about the body of evidence related to the intervention under consideration. Three major components were considered by the panels in classifying the collective evidence into one of six Weight of Evidence categories (see the "Rating Scheme for the Strength of the Recommendations" field):

  • Quality of the data, with more weight assigned to levels of evidence higher in the PRISM categorization (such as randomized trials and meta-analyses)
  • Magnitude of the outcome (e.g., effect size or minimal clinically important difference)
  • Concurrence among the evidence (based on the premise that an investigator has less confidence in findings in which the lines of evidence contradict one another)
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus (Consensus Development Conference)
Description of Methods Used to Formulate the Recommendations

2008 Original Guideline

Not stated

2011 Reaffirmation

The committee met on August 8, 2013. The team consisting of nurse scientists, advanced practice nurses and staff nurses write summaries of all references retrieved for the topic and appraise the evidence based on study design, settings and sample characteristics. All evidence findings for each intervention is synthesized. The synthesized information is provided to all team members for review, and after review, the team members meet via a web meeting and conference call to apply the PEP Weight of Evidence Classification criteria External Web Site Policy. In this meeting the group decides upon the classification of the evidence for each intervention found in the search, reviews the set of references to determine if any key references are not included, and ensures consistency of intervention definitions and associated evidence summaries. Further team communication and decision making is done via email and follow up phone conferences as needed.

Rating Scheme for the Strength of the Recommendations

Recommended for Practice

Interventions for which effectiveness has been demonstrated by strong evidence from rigorously designed studies, meta-analyses, or systematic reviews, and for which expectation of harms is small compared with the benefits

  • Supportive evidence from at least two well-conducted randomized controlled trials that were performed at more than one institutional site and that included a sample size of at least 100 participants
  • Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis and included a total of 100 patients or more in its estimate of effect size and confidence intervals
  • Recommendations from a panel of experts, that derive from an explicit literature search strategy, and include thorough analysis, quality rating, and synthesis of the evidence

Likely To Be Effective

Interventions for which the evidence is less well established than for those listed under "Recommended for Practice"

  • Supportive evidence from a single well conducted randomized controlled trial that included fewer than 100 patients or was conducted at one or more institutions
  • Evidence from a meta-analysis or systematic review that incorporated quality ratings in the analysis and included fewer than 100 patients, or had no estimates of effect size and confidence intervals
  • Evidence from a synthetic review of randomized trials that incorporated quality ratings in the analysis
  • Guidelines developed largely by consensus/expert opinion rather than primarily based on the evidence and published by a panel of experts, that are not supported by synthesis and quality rating of the evidence

Benefits Balanced With Harm

Interventions for which clinicians and patients should weigh the beneficial and harmful effects according to individual circumstances and priorities

  • Supportive evidence from one or more randomized trials, meta-analyses, or systematic reviews, but where the intervention may be associated, in certain patient populations, with adverse effects that produce or potentially produce mortality, significant morbidity, functional disability, hospitalization, or excess length of stay

Effectiveness Not Established

Interventions for which there are currently insufficient data or data of inadequate quality

  • Supportive evidence from a well conducted case control study
  • Supportive evidence from a poorly controlled or uncontrolled study
    • Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
    • Evidence from non-experimental studies with high potential for bias (such as case series with comparison to historical controls)-Evidence from case series or case reports
  • Conflicting evidence, but where the preponderance of the evidence is in support of the recommendation or meta-analysis showing a trend that did not reach statistical significance

Effectiveness Unlikely

Interventions for which lack of effectiveness is less well established than for those listed under "Not Recommended for Practice"

  • Evidence from a single well conducted randomized trial with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention
  • Evidence from a well conducted case control study, a poorly controlled or uncontrolled study, a randomized trial with major methodologic flaws, or an observational study (e.g., case series with historical controls) that showed no benefit and a prominent and unacceptable pattern of adverse events and serious toxicities

Not Recommended for Practice

Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence, or the cost or burden necessary for the intervention exceeds anticipated benefit

  • Evidence from two or more well conducted randomized trials with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention and excessive costs or burden expected
  • Evidence from a single well conducted trial that showed a prominent and unacceptable pattern of adverse events and serious toxicities
  • Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis, included a total of 100 patients or more in its estimate of effect size and confidence intervals with demonstrated lack of benefit or prominent and unacceptable toxicities
  • Intervention discouraged from use by a panel of experts in the related subject, after conducting a systematic examination, quality rating and synthesis of the available evidence
Cost Analysis

The guideline developers reviewed published cost analyses.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

This guideline was accepted for publication on August 1, 2007.

Recommendations

Major Recommendations

Note from the National Guideline Clearinghouse: Recommendations have been taken from the Oncology Nursing Society Putting Evidence Into Practice (ONS PEP) quick view resource (see the "Availability of Companion Documents" field). Refer to the original guideline document for full dosages, references, and other essential information about the evidence.

Recommended for Practice

  • Oral care protocols

Likely To Be Effective

  • Cryotherapy for patients receiving bolus mucotoxic chemotherapy with short half‐life (bolus 5‐fluorouracil, melphalan)
  • Palifermin for patients undergoing hematopoietic stem cell transplantation for hematologic malignancies

Effectiveness Not Established

  • Allopurinol
  • Amifostine
  • Anti‐inflammatory rinses
  • Antimicrobial agents
  • Benzydamine hydrogen chloride (HCl)
  • Caphosol
  • Chlorhexidine
  • Fluoride chewing gum
  • Flurbiprofen tooth patch
  • Gelclair® (EKR Therapeutics, Inc.)
  • Granulocyte– or granulocyte macrophage–colony stimulating factor (subcutaneous)
  • Honey
  • Immunoglobulin
  • L‐alanyl‐L‐glutamine
  • Low‐level laser therapy
  • Multiagent ("magic" or "miracle") rinses
  • Oral aloe vera
  • Pilocarpine
  • Povidone‐iodine (oral)
  • Tetracaine
  • Zinc supplementation

Effectiveness Unlikely

  • Iseganan
  • Misoprostol
  • Vitamin E (topical)
  • Wobe‐mugos E

Not Recommended for Practice

  • Chlorhexidine (alcohol‐based)
  • Granulocyte macrophage–colony stimulating factor mouthwash
  • Sucralfate

Definitions:

Recommended for Practice

Interventions for which effectiveness has been demonstrated by strong evidence from rigorously designed studies, meta-analyses, or systematic reviews, and for which expectation of harms is small compared with the benefits

  • Supportive evidence from at least two well-conducted randomized controlled trials that were performed at more than one institutional site and that included a sample size of at least 100 participants
  • Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis and included a total of 100 patients or more in its estimate of effect size and confidence intervals
  • Recommendations from a panel of experts, that derive from an explicit literature search strategy, and include thorough analysis, quality rating, and synthesis of the evidence

Likely To Be Effective

Interventions for which the evidence is less well established than for those listed under "Recommended for Practice"

  • Supportive evidence from a single well conducted randomized controlled trial that included fewer than 100 patients or was conducted at one or more institutions
  • Evidence from a meta-analysis or systematic review that incorporated quality ratings in the analysis and included fewer than 100 patients, or had no estimates of effect size and confidence intervals
  • Evidence from a synthetic review of randomized trials that incorporated quality ratings in the analysis
  • Guidelines developed largely by consensus/expert opinion rather than primarily based on the evidence and published by a panel of experts, that are not supported by synthesis and quality rating of the evidence

Benefits Balanced With Harm

Interventions for which clinicians and patients should weigh the beneficial and harmful effects according to individual circumstances and priorities

  • Supportive evidence from one or more randomized trials, meta-analyses, or systematic reviews, but where the intervention may be associated, in certain patient populations, with adverse effects that produce or potentially produce mortality, significant morbidity, functional disability, hospitalization, or excess length of stay

Effectiveness Not Established

Interventions for which there are currently insufficient data or data of inadequate quality

  • Supportive evidence from a well conducted case control study
  • Supportive evidence from a poorly controlled or uncontrolled study
    • Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
    • Evidence from non-experimental studies with high potential for bias (such as case series with comparison to historical controls)-Evidence from case series or case reports
  • Conflicting evidence, but where the preponderance of the evidence is in support of the recommendation or meta-analysis showing a trend that did not reach statistical significance

Effectiveness Unlikely

Interventions for which lack of effectiveness is less well established than for those listed under "Not Recommended for Practice"

  • Evidence from a single well conducted randomized trial with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention
  • Evidence from a well conducted case control study, a poorly controlled or uncontrolled study, a randomized trial with major methodologic flaws, or an observational study (e.g., case series with historical controls) that showed no benefit and a prominent and unacceptable pattern of adverse events and serious toxicities

Not Recommended for Practice

Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence, or the cost or burden necessary for the intervention exceeds anticipated benefit

  • Evidence from two or more well conducted randomized trials with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention and excessive costs or burden expected
  • Evidence from a single well conducted trial that showed a prominent and unacceptable pattern of adverse events and serious toxicities
  • Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis, included a total of 100 patients or more in its estimate of effect size and confidence intervals with demonstrated lack of benefit or prominent and unacceptable toxicities
  • Intervention discouraged from use by a panel of experts in the related subject, after conducting a systematic examination, quality rating and synthesis of the available evidence
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of evidence is specifically stated for each recommendation (see "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of oral mucositis in cancer patients

Potential Harms
  • Some oral rinses may contain alcohol or other irritating ingredients.
  • Individuals who do not tolerate cold in their oral cavity do not tolerate cryotherapy well.
  • The most common side effects of palifermin include mild rash and taste changes. Other adverse effects include pruritus, erythema, cough, edema, white coating of mouth or tongue, rhinitis, arthralgia, numbness, and paresthesia.

See the "Appendix. Putting Evidence Into Practice® Card on Mucositis" in the original guideline document for more information.

Contraindications

Contraindications
  • Cryotherapy is not indicated with chemotherapy agents such as oxaliplatin, which are known to result in potential problems with exposure to cold.
  • Povidone-iodine (oral) is not to be used in patients with new granulation tissue, as it inhibits cell growth. Swallowing povidone-iodine is absolutely contraindicated.

See the "Appendix. Putting Evidence Into Practice® Card on Mucositis" in the original guideline document for more information.

Qualifying Statements

Qualifying Statements
  • Mention of specific products and opinions related to those products do not indicate or imply endorsement by the Clinical Journal of Oncology Nursing or the Oncology Nursing Society.
  • This content, published by the Oncology Nursing Society (ONS), reflects a scientific literature review. There is no representation nor guarantee that the practices described herein will, if followed, ensure safe and effective patient care. The descriptions reflect the state of general knowledge and practice in the field as described in the literature as of the date of the scientific literature review. The descriptions may not be appropriate for use in all circumstances. Those who use this content should make their own determinations regarding safe and appropriate patient-care practices, taking into account the personnel, equipment, and practices available at their healthcare facility. ONS does not endorse the practices described herein. The editors and publisher cannot be held responsible for any liability incurred as a consequence of the use or application of any of this content.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Patient Resources
Quick Reference Guides/Physician Guides
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Harris DJ, Eilers J, Harriman A, Cashavelly BJ, Maxwell C. Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clin J Oncol Nurs. 2008 Feb;12(1):141-52. [55 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2008 Feb 1 (reaffirmed 2011)
Guideline Developer(s)
Oncology Nursing Society - Professional Association
Source(s) of Funding

Oncology Nursing Society

Guideline Committee

Oncology Nursing Society Putting Evidence Into Practice® (ONS PEP) project team

Composition of Group That Authored the Guideline

Authors: Debra J. Harris, RN, MSN, OCN®; June Eilers, PhD, RN, BC, CS; Amber Harriman, RN; Barbara J. Cashavelly, MSN, RN, AOCN®; Cathy Maxwell, RN, OCN, CCRC

Financial Disclosures/Conflicts of Interest

June Eilers has served as a consultant, member of the nursing speakers bureau, and member of the advisory committee for Amgen Inc., Endo Cytogen, Merck and Company Inc., and Novartis Pharmaceuticals Corporation. Cathy Maxwell has received research grants from and worked as a nurse speaker and advisor for Amgen Inc. and MGI PHARMA Inc.

Guideline Status

This is the current release of the guideline.

The Oncology Nursing Society (ONS) reaffirmed the currency of this guideline in 2011.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Oncology Nursing Society (ONS) Web site External Web Site Policy.

Print copies: Available for purchase from the Oncology Nursing Society, 125 Enterprise Drive, Pittsburgh, PA 15275-1214; telephone, 412-859-6100; fax, 412-921-6565. The ONS Publications Catalog is available online at the Oncology Nursing Society (ONS) Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Oncology Nursing Society's Putting Evidence Into Practice (ONS PEP) managing oral mucositis evidence table. Available in Portable Document Format (PDF) from the Oncology Nursing Society (ONS) Web site External Web Site Policy.
  • ONS PEP managing oral mucositis systematic review/meta-analysis table. Available in Portable Document Format (PDF) from the ONS Web site External Web Site Policy.
  • ONS PEP quick view for managing oral mucositis. Available in Portable Document Format (PDF) from the ONS Web site External Web Site Policy.
  • Nursing-sensitive patient outcomes: the development of the putting evidence into practice resources for nursing practice. Available in Portable Document Format (PDF) from the ONS Web site External Web Site Policy.
  • Chemotherapy and biotherapy guidelines and recommendations for practice. Available in Portable Document Format (PDF) from the ONS Web site External Web Site Policy.
  • ONS PEP weight of evidence classification schema. Decision rules for summative evaluation of a body of evidence. Available in Portable Document Format (PDF) from the ONS Web site External Web Site Policy.
Patient Resources

Patient-focused instruction sheets are available from www.thecancerjourney.org External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on December 3, 2010. The information was verified by the guideline developer on February 3, 2011. The currency of the guideline was reaffirmed by the developer in 2013 and this summary was updated by ECRI Institute on November 8, 2013.

Copyright Statement

This summary is based on the original guideline, which is copyrighted by the Oncology Nursing Society (ONS).

Disclaimer

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The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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