Methodology for the MASCC/ISOO Mucositis Clinical Practice Guidelines Update

Members of the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) recently completed the process of updating the MASCC/ISOO Clinical Practice Guidelines for the prevention and treatment of mucositis. These guidelines, originally published in 2004, and last updated in 2007, provide clinicians with objective, evidence-based recommendations for the management of mucositis secondary to cancer therapy. This brief paper describes the methodology used to conduct the most recent systematic review in 2011, and develop new guidelines, providing the basis for the update. The overriding aims of the process were to assess evidence of effectiveness of interventions for the prevention and treatment of mucositis and to produce clinical practice guidelines for the management of mucositis using best available evidence.     

Anti-inflammatory agents in the management of alimentary mucositis

Background Alimentary mucositis is a significant complication of cancer therapy, with important clinical and economic implications.Materials and methods In June 2005, the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology conducted an evidence-based review of the literature on alimentary mucositis. The goal of this literature review was to update previously published guidelines for the management of mucositis.Results This article reports the findings of the subgroup charged with reviewing the literature related to anti-inflammatory interventions. Considerable preclinical and clinical evidence suggests that the use of anti-inflammatory agents may be a promising approach to reduce the severity of mucositis. However, there was not enough evidence to support any new guidelines advocating the use of any specific anti-inflammatory intervention.Conclusion Thus, there is a need for well-designed clinical trials evaluating the use of anti-inflammatory agents in the management of mucositis.     

The management of dyspnea in cancer patients: a systematic review

Goals of work The goal of the study is to evaluate the effectiveness of four drug classes (opioids, phenothiazines, benzodiazepines, and systemic corticosteroids) for relieving dyspnea experienced by advanced cancer patients. Materials and methods A systematic literature review was conducted to July 2006. Search sources included MEDLINE, EMBASE, HealthSTAR, CINAHL, and the Cochrane Library. Four reviewers selected evidence using predefined criteria: controlled trials not limited to cancer and involving the specified drug classes for dyspnea treatment. Main results Three systematic reviews, one with meta-analysis, two practice guidelines, and 28 controlled trials were identified. Most examined the effect of opioids, generally morphine, on dyspnea. Although the results of individual trials were mixed, the systematic review with meta-analysis detected a significant benefit for dyspnea with systemic opioids; two small placebo-controlled trials in cancer patients found systemic morphine reduced dyspnea, and dihydrocodeine also significantly reduced dyspnea in four placebo-controlled trials. Nebulized morphine was not effective in controlling dyspnea in any study or the meta-analysis. No controlled trials examined systemic corticosteroids in the treatment of cancer patients, and of the other non-opioid drugs examined, only oral promethazine, a phenothiazine, showed some benefit in the relief of dyspnea. Studies varied in methodological quality. Conclusions Systemic opioids, administered orally or parenterally, can be used to manage dyspnea in cancer patients. Oral promethazine may also be used, as a second-line agent if systemic opioids cannot be used or in addition to systemic opioids. Nebulized morphine, prochlorperazine, and benzodiazepines are not recommended for the treatment of dyspnea, and promethazine must not be used parenterally. A complete list of Supportive Care Guidelines Group members is available at: .     

Depression in palliative care: a systematic review. Part 2. Treatment

OBJECTIVE: To summarize available literature containing data on the treatment of depression in palliative care patients. METHODS: A systematic review was conducted using extensive electronic databases and hand searches. All randomized controlled trials (RCTs) of interventions for depression in patients with advanced disease were eligible. RESULTS: Three RCTs assessed pharmacological treatments. Of these, two were placebo controlled and assessed mianserin and thioridazine. The third compared two antidepressants. There were no RCTs that specifically assessed psychotherapy for patients with depression. CONCLUSION: There are too few adequate studies to draw clear conclusions about management of depression in this setting. The treatment of depression in patients with advanced disease must, for now, be informed by the larger body of evidence on effective treatments for depression in patients with either no physical illness or less severe medical conditions.     

Improving compliance in depression: a systematic review of narrative reviews

BACKGROUND AND OBJECTIVE: Narrative reviews represent a popular source of information for clinicians, especially where the evidence on a given subject is sparse and analogies from other fields of medicine may help in filling the information gap. Unfortunately, narrative reviews often follow less stringent criteria for information selection and appraisal than systematic reviews, potentially leading to incomplete or biased recommendations. The objective of the present study was to examine the quality of the recommendations provided by narrative reviews on how to improve patient adherence to pharmacological treatment of unipolar depressive disorders. METHOD: We sought to locate all narrative review papers addressing adherence to treatment in unipolar depressive disorders. In order to do so, we searched Medline and PsychInfo from 1980 to December 2003, using the following keywords: review, depressive disorders, treatment, dropout, patient compliance and adherence. We inspected the title and the abstract, whenever available to identify the relevant reviews and obtained a full copy of the publications in this subset, and read the articles to identify further relevant reviews. These were in turn copied and reviewed, until no further references were found. RESULTS AND DISCUSSION: We identified 23 reviews, providing a total of 87 recommendations. The most common recommendation was for patient education (19 times), patient-physician empathy/alliance (14 times), and education of family (nine times). Reviewers' recommendations were based on the literature on depression 54 times, and on other medical conditions 17 times. A critical appraisal of the evidence base of the recommendations showed that randomized controlled trials or meta-analyses were quoted to support the recommendations only 23% of the times, while important interventions of proven efficacy in the field of depression or in other chronic conditions (e.g. medication clinics, training of nurses, psychological treatment, and telephone follow-up) were not mentioned. Conclusions: Narrative reviews on adherence to pharmacological treatment of depressive disorders suffer not only from the limited availability of good quality evidence, but also from an incomplete critical appraisal of available evidence on interventions both for depression and for other chronic disorders.     

Current applications of health-related quality-of-life assessment in oncology

The past 5 years have seen increasing application of health-related quality-of-life (HRQOL) assessment in oncology. Most commonly, HRQOL has been studied in patients with metastatic cancer and in trials involving the use of antiemetics to control postchemotherapy nausea and vomiting. These studies have produced interesting and, in some cases, counterintuitive results. Thus far, HRQOL assessment appears to be important in clinical trials involving control of symptoms (disease-related or treatment-related), cancers with a poor prognosis, treatment arms with similar survivals, supportive care interventions, and ways of determining prognosis.Presented as an invited lecture at the 8th International Symposium: Supportive Care in Cancer, Toronto, Canada, 19–22 June 1996     

A collaborative model for the treatment of depression in homebound elders

Depression is a serious mental health problem for older adults. This study examined the effectiveness of an Advanced Practice Psychiatric Nurse (APPN)-Primary Care Physician (PCP) collaborative model to provide care to homebound elders with depressive symptoms. One hundred seventy nine individuals were screened for depression revealing an incidence of 46%. Of these, 83 (46%) were invited to participate in the study based on their depression scores; 41 (49%) agreed to participate in the study. Significant improvement in depression scores occurred for those who received treatment. Treatment included pharmacological and psychosocial interventions. As the population over the age of 65 continues to grow, many more older adults will need mental health treatment, and creative methods to provide services to homebound individuals must be explored.     

A Collaborative Model for the Treatment of Depression in Homebound Elders

Depression is a serious mental health problem for older adults. This study examined the effectiveness of an Advanced Practice Psychiatric Nurse (APPN)-Primary Care Physician (PCP) collaborative model to provide care to homebound elders with depressive symptoms. One hundred seventy nine individuals were screened for depression revealing an incidence of 46%. Of these, 83 (46%) were invited to participate in the study based on their depression scores; 41 (49%) agreed to participate in the study. Significant improvement in depression scores occurred for those who received treatment. Treatment included pharmacological and psychosocial interventions. As the population over the age of 65 continues to grow, many more older adults will need mental health treatment, and creative methods to provide services to homebound individuals must be explored.     

Cancer-Related Sleep Wake Disturbances

ObjectivesTo review the evidence on sleep wake disturbance (SWD) in adults with cancer and provide an up-to-date review of the prevalence, impact, causes, risk factors, assessment, options for treatment, and emerging science and technology.Data sourcesThese include a synthesis of review articles and sources in electronic databasesConclusionSWD is a prevalent and debilitating problem for millions of people living with cancer. If not addressed, SWD can negatively impact physical and psychological recovery from cancer. Multiple factors contribute to SWD among patients with cancer including a variety of physical symptoms related to cancer and its treatment including fatigue, anxiety, and other psychological symptoms. When SWD risk factors are predicted and clinical features evaluated, there are several treatment options and strategies available to help patients in a timely manner. There is a substantial body of evidence supporting the use of psychosocial interventions and behavioral treatments, such as cognitive behavioral therapy for insomnia (CBTI). Growing evidence supports exercise and mindfulness-based stress reduction to diminish SWD. Sleep needs to be prioritized in cancer care, but dedicated effort and resources are needed to address the patient, clinician, institutional, and societal barriers to routine sleep evaluation and effective delivery of SWD interventions.Implications for Nursing PracticeIt is important for oncology providers to be educated regarding both pharmacologic and nonpharmacological treatments. Strategies for management of SWD in the context of cancer care delivery and future research are discussed in the context of the predictive preventive and personalized medicine framework (PPPM).     

The effectiveness of non-pharmacological interventions in older adults with depressive disorders: A systematic review

BackgroundIt is widely acknowledged that mental health disorders are common in older adults and that depression is one of the most serious threats to the mental health of older adults. Although best practice guidelines point out that moderate to severe depression should be approached with pharmacotherapy together with complementary therapies, the use of antidepressant drugs in older adults has various disadvantages, such as long response time, side effects, potential risk of dependency and tolerance, poor compliance rates and high probability of drug interactions. In addition, qualitative studies of depressed people with a chronic illness have indicated that both patients and healthcare professionals prefer a psychosocial treatment for depression over a pharmacological one.ObjectiveThis review aimed to identify and synthesize the best available evidence related to the effectiveness of non-pharmacological interventions for older adults with depressive disorders.DesignSystematic review of studies with any experimental design considering non-pharmacological interventions for older adults with depressive disorders.Data sourcesAn initial search of MEDLINE and CINAHL was undertaken, followed by a second search for published and unpublished studies, from January 2000 to March 2012, of major healthcare-related electronic databases. Studies in English, Spanish and Portuguese were included in the review.Review methodsThis review considered studies that included adult patients, aged over 65 years with any type of depressive disorder, regardless of comorbidities and any previous treatments, but excluded those with manic or psychotic episodes/symptoms. All studies that met the inclusion criteria were assessed for methodological quality by two independent reviewers using a standardized critical appraisal checklist for randomized and quasi-randomized controlled studies from the Joanna Briggs Institute. Data extraction was also conducted by two independent reviewers based on the Joanna Briggs Institute data extraction form for experimental studies.ResultsTwenty-three studies met the inclusion criteria. Of those, seventeen were excluded after critical appraisal of methodological quality and six were included in this review. These studies included 520 participants and described cognitive behavior therapy, competitive memory training, reminiscence group therapy, problem-adaptation therapy, and problem-solving therapy in home care. Evidence suggests that all these interventions reduce depressive symptoms.ConclusionsAccording to evidence, non-pharmacological interventions had positive effects on improving patients’ depression and may be useful in practice. However, due to the diversity of interventions and the low number of studies per intervention included in this systematic review, evidence is not strong enough to produce a best practice guideline.     

Psychotherapy for depression

Research on the treatment of depression has shown that both pharmacological and psychosocial interventions are equally efficacious in mild depression as well as moderate and severe depression. Combined psychosocial and pharmacological interventions are also thought to be effective even for severe and chronic depression. Among psychosocial treatments, cognitive behavior therapy, behavior therapy, and interpersonal psychotherapy have been proved to effective. Cognitive behavior therapy is a structured short-term therapy designed to change the patient's negatively distorted cognition. Behavior therapy is a therapy developed based on the understanding that depression is related to a decrease of behaviors that produce positive reinforcement. Interpersonal psychotherapy is a form of short-term therapy to focus on the patient's interpersonal relations with significant others.     

Amifostine in the management of radiation-induced and chemo-induced mucositis

Introduction Mucositis is a significant complication of cancer therapy, with important clinical and economic implications. In June 2005, the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO) conducted an evidence-based update review of the literature on mucositis. The goal of this literature review is to update previously published guidelines for the management of mucositis.Results This article reports the findings of the subgroup charged with reviewing the literature related to amifostine.     

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 preconference 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.The coauthors contributed equally to the work described in this paper.     

The treatment of lymphedema related to breast cancer: a systematic review and evidence summary

Goals of work

To provide an evidence summary report on the question: What are the treatment options for women with lymphedema following treatment for breast cancer?

Methods

Cancer Care Ontario’s Supportive Care Guidelines Group (SCGG) employed systematic review methodology to produce an evidence summary on this topic. Evidence-based opinions were formulated to guide clinical decision making, and a formal external review process was conducted to validate the relevance of these opinions for Ontario practitioners.

Results

The systematic review search strategy identified ten randomized controlled trials which form the basis of this evidence summary report. Four key opinions offered by the SCGG are outlined below. Responses from the practitioner feedback process supported the validity of these opinions in Ontario. (1) There is some evidence to suggest that compression therapy and manual lymphatic drainage may improve established lymphedema, but further studies are needed. Compression garments should be worn from morning to night and be removed at bedtime. Patients should be advised that lymphedema is a lifelong condition and that compression garments must be worn on a daily basis. Patients can expect stabilization and/or modest improvement of edema with the use of the garment in the prescribed fashion. (2) There is no current evidence to support the use of medical therapies, including diuretics. (3) Additional efforts to define relevant clinical outcomes for the assessment of patients with lymphedema would be valuable. (4) These opinions are appropriate for patients with more than mild lymphedema, where the signs and symptoms are considered significant from the patients’ perspective.

     

Rehabilitation following cancer treatment

Abstract

Purpose: Cancer survivorship is increasing. However, life-saving treatments often leave people with physical, cognitive and emotional sequelae that contribute to activity and participation limitations. The purpose of this review is to summarize current evidence regarding rehabilitation interventions to address problems during survivorship. Method: Best evidence synthesis. The review took as its starting point a systematic review of patient needs and supportive care interventions following cancer treatment. The study team identified the needs which could be addressed by rehabilitation and suggested others not originally included. Then they built on the earlier review’s conclusions regarding effective intervention through extraction of results from subsequent systematic reviews and randomized controlled trials. Results: Evidence regarding the effectiveness of potential rehabilitation interventions was reviewed for physical functioning, fatigue, pain, sexual functioning, cognitive functioning, depression, employment, nutrition and participation. With the exception of physical rehabilitation interventions following breast cancer, this literature tends to focus on psychoeducational interventions, which have demonstrated limited effectiveness for rehabilitation outcomes. Conclusions: Most of the knowledge available regarding potential rehabilitation interventions comes from psychosocial oncology literature. While there are limitations, this literature provides an excellent starting point to examine the potential effectiveness of rehabilitation interventions within cancer survivorship programs.

• Implications for Rehabilitation

• Good evidence exists for the use of exercise/physical rehabilitation in reducing fatigue after treatment for most cancers, and improving upper extremity functioning following treatment for breast cancer.

• Preliminary evidence exists in a number of areas that may be improved by rehabilitation interventions, such as pain, sexual functioning, cognitive functioning and return to work, but further research is needed.

• No intervention studies addressing participation limitations were identified. Rehabilitation professionals are encouraged to take the lead in exploring participation limitations among cancer survivors and developing suitable interventions.

     

Systematic review of natural agents for the management of oral mucositis in cancer patients

Purpose

The aim of this study was to review the available literature and define clinical practice guidelines for the use of natural agents for the prevention and treatment of oral mucositis.

Methods

A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology. The body of evidence for each intervention, in each cancer treatment setting, was assigned an evidence level. Based on the evidence level, one of the following three guideline determinations was possible: recommendation, suggestion, and no guideline possible.

Results

A total of 49 papers across 15 interventions were examined. A new suggestion was developed in favor of systemic zinc supplements administered orally in the prevention of oral mucositis in oral cancer patients receiving radiation therapy or chemoradiation (Level III evidence). A recommendation was made against the use of intravenous glutamine for the prevention of oral mucositis in patients receiving high-dose chemotherapy prior to hematopoietic stem cell transplant (Level II evidence). No guideline was possible for any other agent, due to inadequate and/or conflicting evidence.

Conclusions

Of the various natural agents reviewed here, the available evidence supported a guideline only for two agents: a suggestion in favor of zinc and a recommendation against glutamine, in the treatment settings listed above. Well-designed studies of other natural agents are warranted.     

Identifying patients at risk for,and treatment of major psychiatric complications of cancer

A critically important aspect of supportive care in cancer is the prompt recognition and effective treatment of psychiatric complications. Psychiatric disorders such as depression, anxiety and delirium occur in a signifcant percentage of cancer patients, particularly as disease advances and as cancer treatments become more aggressive. This paper reviews factors that can be utilized to identify patients who are at increased risk for developing psychiatric complications, such as those with advanced disease, certain cancer treatments, uncontrolled physical symptoms, functional limitations, lack of social support, and past history of psychiatric disorder. Methods of diagnostic assessment and strategies for managing depression, anxiety, delirium and suicidal ideation are also reviewed.Presented as an invited lecture at the 6th International Symposium: Supportive Care in Cancer, New Orleans, La., USA, 2–5 March 1994     

Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup

Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.     

Estimates of quality and reliability with the physiotherapy evidence-based database scale to assess the methodology of randomized controlled trials of pharmacological and nonpharmacological interventions

BACKGROUND AND PURPOSE: Systematic reviews and meta-analyses often include an evaluation of the methodological quality of the individual studies that have been included, and are usually conducted by at least 2 individuals. The objective of this study was to assess the methodological quality and reliability of a series of randomized controlled trials (RCTs) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence-Based Database (PEDro) Scale. METHODS: Two abstractors independently reviewed 81 RCTs assessing a variety of interventions. The Cohen kappa statistic and the intraclass correlation coefficient (ICC) were used to assess agreement between abstractors. RESULTS: The average total PEDro scores were 5.94 (SD=1.43) for all studies combined, 6.88 (SD=1.2) for pharmacological studies, and 5.29 (SD=1.26) for nonpharmacological studies. The median score for pharmacological studies was significantly higher than that for nonpharmacological studies (7 versus 5). Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement (1.00) for randomization and reporting of results from between-group comparisons. The ICCs associated with the cumulative PEDro score were .91 (95% confidence interval [CI]=.83-.94) for all studies, .89 (95% CI=.78-.95) for pharmacological studies, and .91 (95% CI=.84-.952) for nonpharmacological studies. DISCUSSION AND CONCLUSION: The methodological quality for pharmacological interventions was significantly higher than that for nonpharmacological interventions. There was good agreement between raters at an individual item level and in total PEDro scores. A lack of reporting clarity, poor organization of the report, or the failure to include salient details contributed to less-than-perfect agreement between raters.