MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy.

BACKGROUND: Mucositis is a highly significant, and sometimes dose-limiting, toxicity of cancer therapy. The goal of this systematic review was to update the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for mucositis. METHODS: A literature search was conducted to identify eligible published articles, based on predefined inclusion/exclusion criteria. Each article was independently reviewed by 2 reviewers. Studies were rated according to the presence of major and minor flaws as per previously published criteria. The body of evidence for each intervention, in each treatment setting, was assigned a level of evidence, based on previously published criteria. Guidelines were developed based on the level of evidence, with 3 possible guideline determinations: recommendation, suggestion, or no guideline possible. RESULTS: The literature search identified 8279 papers, 1032 of which were retrieved for detailed evaluation based on titles and abstracts. Of these, 570 qualified for final inclusion in the systematic reviews. Sixteen new guidelines were developed for or against the use of various interventions in specific treatment settings. In total, the MASCC/ISOO Mucositis Guidelines now include 32 guidelines: 22 for oral mucositis and 10 for gastrointestinal mucositis. This article describes these updated guidelines. CONCLUSIONS: The updated MASCC/ISOO Clinical Practice Guidelines for mucositis will help clinicians provide evidence-based management of mucositis secondary to cancer therapy.

Systematic review of basic oral care for the management of oral mucositis in cancer patients.

PURPOSE: The purpose of this project was to evaluate research in basic oral care interventions to update evidence-based practice guidelines for preventing and treating oral mucositis (OM) in cancer patients undergoing radio- or chemotherapy. METHODS: A systematic review of available literature was conducted by the Basic Oral Care Section of the Mucositis Study Group of MASCC/ISOO. Seven interventions--oral care protocols, dental care, normal saline, sodium bicarbonate, mixed medication mouthwash, chlorhexidine, and calcium phosphate--were evaluated using the Hadorn (J Clin Epidemiol 49:749-754, 1996) criteria to determine level of evidence, followed by a guideline determination of one of the following: recommendation, suggestion, or no guideline possible, using Somerfield's (Classic Pap Cur Comments 4:881-886, 2000) schema. RESULTS: Fifty-two published papers were examined by treatment population (radiotherapy, chemotherapy, and hematopoietic stem cell transplant) and by whether the intervention aimed to prevent or treat OM. The resulting practice suggestions included using oral care protocols for preventing OM across all treatment modalities and age groups and not using chlorhexidine mouthwash for preventing OM in adults with head and neck cancer undergoing radiotherapy. Considering inadequate and/or conflicting evidence, no guidelines for prevention or treatment of OM were possible for the interventions of dental care, normal saline, sodium bicarbonate, mixed medication mouthwash, chlorhexidine in patients receiving chemotherapy or hematopoietic stem cell transplant, or calcium phosphate. CONCLUSIONS: The evidence for basic oral care interventions supports the use of oral care protocols in patient populations receiving radiation and/or chemotherapy and does not support chlorhexidine for prevention of mucositis in head and neck cancer patients receiving radiotherapy. Additional well-designed research is needed for other interventions to improve the amount and quality of evidence guiding future clinical care.

Patterns of sore mouth in outpatients with cancer receiving chemotherapy.

GOALS: The aims of this secondary data analysis were to (a) categorize patterns in the development, duration, intensity, and resolution of sore mouth (which can be considered a proxy for oral mucositis) severity and distress over two cycles of chemotherapy in cancer outpatients and (b) examine the relationship of demographic (age, gender, marital status, and educational level) and disease characteristics (type of cancer and type of chemotherapy) to specific patterns of sore mouth (SM). MATERIALS AND METHODS: Visual graphical analysis (VGA) was applied to identify individual patterns of SM severity and distress in 51 outpatients receiving chemotherapy who provided daily reports of sore mouth using a computerized interactive voice response system. The majority were female (n = 41, 8%) with a mean age of 53 (SD = 8.35). Most had breast cancer (68%), and one third received chemotherapy with adriamycin and cyclophosphamide (AC). VGA is a technique in which graphs of individual patients' symptoms are coded for specific individual or group profiles. MAIN RESULTS: Seven distinct patterns were identified based on variability in onset, duration, and intensity (degree of severity or distress). Chemotherapy agents were significantly associated with patterns of SM. The AC regimen was significantly associated with late onset; however, the intensity did not last long. In contrast, patients receiving R-CHOP were significantly more likely to experience duration intensity (SM after day 15 and a score equal to or greater than a 5 on a 1-10 scale). CONCLUSIONS: VGA revealed symptom patterns often hidden in traditional analysis. Understanding individual variability is important to the design and implementation of future intervention research and clinical care.

Evidence-based guidelines for managing mucositis.

OBJECTIVES: To discuss implementation of evidence-based clinical practice guidelines for mucositis. DATA SOURCE: Published articles, book chapters, web sources, clinical experience, unpublished manuscripts. CONCLUSION: Nurses can implement evidence-based guidelines but must include an evaluation component to determine effect on clinical outcomes. IMPLICATIONS FOR NURSING PRACTICE: Nurses have an integral role implementing and evaluating evidence-based practice guidelines for managing mucositis. When evidence is lacking and guidelines have gaps, nurses can play important roles in research to overcome these gaps.

The experience of a sore mouth and associated symptoms in patients with cancer receiving outpatient chemotherapy.

This study aimed to describe sore mouth (SM) severity and distress, associated symptoms, and consequences in cancer chemotherapy outpatients. Secondary analysis was used in this study. A total of 223 patients in 4 treatment centers participated in the study. Data from an intervention study using a computer-based telephone communication system to assess patients' daily symptom experience were analyzed to obtain highest, average, and lowest ratings of severity and distress for SM, fatigue, trouble sleeping, feeling down/blue, and feeling anxious. Consequence data included oral intake, time spent lying down, ability to work, and daily activity. Approximately 51% reported SM, with a mean highest, average, and lowest severity score of 3.1 in cycle 2 and 3.09 in cycle 3. Sore mouth severity was correlated with severity of fatigue, feeling down/blue, feeling anxious, and trouble sleeping. Sore mouth distress was correlated with the same symptoms. Sore mouth severity was correlated with the number of 8-oz glasses of liquid consumed, effect on daily activity, time spent lying down, but not with ability to work. Half of patients experienced SM, which was associated with several other symptoms and led to specific consequences. Understanding the complex symptom experience of patients with SM, including consequences, will assist nurses in developing more comprehensive clinical assessments and interventions. In addition, the association of multiple symptoms with SM will provide a foundation for further research investigation in oral mucositis.

Visual graphical analysis: a technique to investigate symptom trajectories over time.

BACKGROUND: Research to address clinical symptoms and the way they change over time in an individual is of paramount importance to healthcare researchers who are interested in improving the quality of life for ill patients. However, typical statistical methods that rely on means can obscure individual trajectories of change. Visual graphical analysis (VGA) is a technique that can provide researchers with an alternative method of quantitative statistical analysis that is more sensitive to individual change and variation. OBJECTIVES: To (a) describe the use of VGA as a method to evaluate longitudinal data, (b) discuss challenges to using this method, and (c) offer recommendations for future research in which the method could be implemented. APPROACH: This methodological article uses data collected from a primary study to present the method of VGA. Daily self-reported sore mouth severity scores from patients receiving outpatient chemotherapy were used in this VGA. The steps of VGA include (a) determining inclusion criteria, (b) managing missing data, (c) creating visual graphs, (d) identifying specific patterns, and (e) performing validation and verification. DISCUSSION: Because symptoms occur differently for each patient, this method allows researchers to see symptom trajectories on an individual basis. Creation and analysis of longitudinal graphs could be used also to inspect other symptoms or clinical problems such as headaches, fatigue, constipation, nausea and vomiting, and psychological difficulties. The value of VGA is that it allows a researcher to study the patterns of an individual's experience, as opposed to averaging all individuals' responses over time. Although graphical analysis is exploratory in nature, it may lead to enhanced longitudinal recognition of symptoms that might not be identified otherwise by quantitative data analysis using summary statistics.

Promulgation of guidelines for mucositis management: educating health care professionals and patients.

BACKGROUND: The Multinational Association for Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Mucositis and Patient and Professional Education Study Groups are collaborating to improve the promulgation of the updated mucositis management guidelines. The initial step in the collaboration was to survey cancer care health professionals to determine their awareness of the original 2004 guidelines and their opinions on the usefulness of patient educational materials based on the guidelines. MATERIALS AND METHODS: The authors surveyed four samples (three US and one European) of cancer health care professionals attending three cancer-related professional conferences between May and July 2005 using a ten-item questionnaire in both paper-and-pencil and web-based formats. Data were compiled and analyzed using descriptive statistics. RESULTS: All respondents were generally aware of the importance of mucositis as a treatment-limiting toxicity with life-threatening complications and endorsed regular oral assessment and dental care practices. Only about one third of the US respondents were aware of the 2004 guidelines in contrast to 80% of the European respondents. A majority of respondents across all four surveys (66-93%) felt strongly that educational materials based on the guidelines were needed and that they would use them, while a smaller number (7-29%) indicated they might use them if a patient had a problem with mucositis. CONCLUSIONS: Awareness of the guidelines remains limited in the US, and use of the guidelines worldwide is minimal. The Mucositis and Patient and Professional Education Study Groups have developed a set of strategies to enhance dissemination, awareness, and use of the updated guidelines and to promote patient education based on the guidelines. Future work will focus on implementation and evaluation of the guidelines in clinical practice.

The role of basic oral care and good clinical practice principles in the management of oral mucositis.

BACKGROUND: The Basic Oral Care Group is one of eight subcommittees functioning within the Mucositis Study Group Guidelines Panel of the Multinational Association of Supportive Care in Cancer and International Society for Oral Oncology (MASCC/ISOO). The Basic Oral Care Group, comprised of the four authors of this paper, represented the disciplines of nursing (DBM, JJ), dentistry (MEPC), and pediatric dentistry (PW). This group reviewed research and clinical literature to update the original 2004 Mucositis Management Guidelines in the areas of basic oral care, bland rinses, protocols and education, and good clinical practices such as pain management, oral assessment, oral care, and dental care. MATERIALS AND METHODS: Over 100 articles published between 2000 and 2005 were identified, and 32 of these were useful for the analysis. Each article was rated by at least two authors using a structured rating form and systematic determination of levels of evidence, based on the American Society of Clinical Oncology criteria. Discussion at the 2005 MASCC/ISOO Geneva pre-conference meeting of the Guidelines Panel resulted in the development of consensus on the interpretation of the literature. RESULTS: Based on the literature and on Panel discussions, a revision of the original guidelines for protocols and education was produced by the group, and they developed a set of recommendations related to good clinical practices. CONCLUSIONS: Although research remains scanty for components of basic oral care, bland rinses, protocols, and education, the original 2004 guidelines with the help of newer literature from 2000 to 2005 and expert consensus among the Guidelines Panel enabled the development of useful clinical practice guidelines for managing oral mucositis in patients receiving cancer treatment with radiation and/or chemotherapy.

Barriers and strategies in implementation of oral care standards for cancer patients.

Oral complications of cancer therapy include mucositis, oral pain, poor oral intake, infection, bleeding, and difficulty communicating. Use of oral care standards can help manage these problems, but their systematic implementation is relatively rare. The purpose of this paper is to discuss barriers to implementing oral care standards, and to make suggestions for how such standards might be implemented in clinical settings. These purposes are accomplished through a review of relevant literature from various health-care disciplines, and discussion of one institution's implementation of an oral care standard for leukemia and bone marrow/stem cell transplant patients. Key principles underlying this successful institutional effort were recognition of the medical necessity of oral care, collaboration among health-care disciplines, and use of evidence-based practice wherever possible.