Sleep disturbance in adults with cancer: a systematic review of evidence for best practices in assessment and management for clinical practice.

Sleep disturbance is prevalent in cancer with detrimental effects on health outcomes. Sleep problems are seldom identified or addressed in cancer practice. The purpose of this review was to identify the evidence base for the assessment and management of cancer-related sleep disturbance (insomnia and insomnia syndrome) for oncology practice. The search of the health literature included grey literature data sources and empirical databases from June 2004 to June 2012. The evidence was reviewed by a Canadian Sleep Expert Panel, comprised of nurses, psychologists, primary care physicians, oncologists, physicians specialized in sleep disturbances, researchers and guideline methodologists to develop clinical practice recommendations for pan-Canadian use reported in a separate paper. Three clinical practice guidelines and 12 randomized, controlled trials were identified as the main source of evidence. Additional guidelines and systematic reviews were also reviewed for evidence-based recommendations on the assessment and management of insomnia not necessarily in cancer. A need to routinely screen for sleep disturbances was identified and the randomized, controlled trial (RCT) evidence suggests benefits for cognitive behavioural therapy for improving sleep quality in cancer. Sleep disturbance is a prevalent problem in cancer that needs greater recognition in clinical practice and in future research.

A pan-Canadian practice guideline and algorithm: screening, assessment, and supportive care of adults with cancer-related fatigue.

PURPOSE: The purpose of the present systematic review was to develop a practice guideline to inform health care providers about screening, assessment, and effective management of cancer-related fatigue (crf) in adults. METHODS: The internationally endorsed adapte methodology was used to develop a practice guideline for pan-Canadian use. A systematic search of the literature identified a broad range of evidence: clinical practice guidelines, systematic reviews, and other guidance documents on the screening, assessment, and management of crf. The search included medline, embase, cinahl, the Cochrane Library, and other guideline and data sources to December 2009. RESULTS: Two clinical practice guidelines were identified for adaptation. Seven guidance documents and four systematic reviews also provided supplementary evidence to inform guideline recommendations. Health professionals across Canada provided expert feedback on the adapted recommendations in the practice guideline and algorithm through a participatory external review process. CONCLUSIONS: Practice guidelines can facilitate the adoption of evidence-based assessment and interventions for adult cancer patients experiencing fatigue. Development of an algorithm to guide decision-making in practice may also foster the uptake of a guideline into routine care.

Organisational standards for the delivery of intensity-modulated radiation therapy in Ontario.

By minimising the effect of irradiation on surrounding tissue, intensity-modulated radiation therapy (IMRT) can deliver higher, more effective doses to the targeted tumour site, minimising treatment-related morbidity and possibly improving cancer control and cure. A multidisciplinary IMRT Expert Panel was convened to develop the organisational standards for the delivery of IMRT. The systematic literature search used MEDLINE, EMBASE, the Cochrane Database, the National Guidelines Clearing House and the Health Technology Assessment Database. An environmental scan of unpublished literature used the Google search engine to review the websites of key organisations, cancer agencies/centres and vendor sites in Canada, the USA, Australia and Europe. In total, 22 relevant guidance documents were identified; 12 from the published literature and 10 from the environmental scan. Professional and organisational standards for the provision of IMRT were developed through the analysis of this evidence and the consensus opinion of the IMRT Expert Panel. The resulting standards address the following domains: planning of new IMRT programmes, practice setting requirements, tools, devices and equipment requirements; professional training requirements; role of personnel; and requirements for quality assurance and safety. Here the IMRT Expert Panel offers organisational and professional standards for the delivery of IMRT, with the intent of promoting innovation, improving access and enhancing patient care.

Adjuvant hormonal therapy for stage I endometrial cancer.

QUESTION: What is the role of hormonal therapy as adjuvant therapy in patients with stage i endometrial cancer? PERSPECTIVES: There is little consensus on the role of adjuvant treatment for patients with stage i endometrial cancer. Although the use of hormonal therapy has been established in advanced disease, less agreement has emerged concerning the benefits of adjuvant hormonal therapy for patients with early-stage disease. The objective of the present evidence series was to review the existing literature on the role of hormonal therapy as adjuvant therapy in patients with stage i endometrial cancer. OUTCOMES: REPORTS WERE SOUGHT THAT INCLUDED AT LEAST ONE OF THE FOLLOWING OUTCOMES: overall survival, disease-free survival, recurrence (local, or distant, or both), adverse effects, and quality of life. Because of the potential for long-term adverse effects with adjuvant hormonal treatment in this patient population, especially with regard to thromboembolic or cardiovascular events, the rates of non-cancer-related death were also of interest. METHODOLOGY: The medline, embase, and Cochrane Library databases were systematically searched for randomized controlled trials, practice guidelines, systematic reviews, and meta-analyses. The resulting evidence informed the development of the clinical practice guideline. The systematic review with meta-analyses and practice guideline were approved by the Report Approval Panel of the Program in Evidence-Based Care, and by the Gynecology Cancer Disease Site Group (DSG). RESULTS: Nine randomized trials and one published meta-analysis comparing adjuvant hormonal therapy with no adjuvant therapy in women with stage i endometrial cancer constituted the evidence base. One trial reported a statistically significant survival benefit with adjuvant progestogen as compared with no further treatment (97% vs. 69%, p < 0.001). In that trial, the treatment group had a higher number of patients with less myometrial invasion, and a lower number of patients with advanced-stage disease. These differences in baseline characteristics between the randomized groups were considered to be clinically important. In addition, the results of that trial were not consistent with those of other trials, and the trial was a source of statistical heterogeneity when data were pooled across trials. In two of the nine randomized trials, statistically significant recurrence-free benefits were detected with adjuvant hormonal therapy as compared with no further therapy. In one trial, the difference between the rates of recurrence was 16%; however, the methodologic concerns related to that that trial limited its relevance. In the other trial, the difference between the rates of recurrence was 5%. In that trial, patients were at a high risk of recurrence. None of the remaining seven randomized trials reported any significant difference in recurrence rates between treatment groups. The meta-analysis identified in the literature detected no statistically significant recurrence-free or overall survival benefit associated with adjuvant hormonal therapy as compared with no adjuvant therapy [odds ratio (or): 1.05; 95% confidence interval (ci): 0.88 to 1.24). Those results are consistent with the results of the meta-analysis in the present report, which included an additional two trials (or: 1.10; 95% ci: 0.91 to 1.34). TARGET POPULATION: This clinical recommendation applies to women with newly diagnosed stage i endometrial cancer. RECOMMENDATION: The available evidence does not demonstrate any benefit for adjuvant hormonal therapy. The use of hormonal therapy is not recommended as adjuvant treatment for patients with stage i endometrial cancer.

Human rights consultation: a 12-year experience of a pediatric bioethics committee.

For many years there has been a committee at the Children's Hospital of Pittsburgh to review research proposals to assure that the rights of children are protected. In 1974, its composition was changed and its mission broadened to include consultation and discussion of ethical issues in clinical care. The committee is called the Human Rights Committee to reflect this mission. Medical ethical consultations are performed by rotating on-call teams consisting of a physician and a nonphysician who are members of the committee. Selected cases from 48 consultations are presented to demonstrate the process and to illustrate some of the questions that were addressed. The clinical diagnoses were varied, but the commonest were congenital malformations. The most frequent reason for consultation was to question the advisability of assisted ventilation (27 cases), but other reasons concerned definitive surgery, intravenous hyperalimentation, cardiopulmonary resuscitation, and tracheostomy. Consultations are always optional and advisory. The recommendations of the consultation team are subsequently reviewed by the entire Human Rights Committee. The service has been well received by the medical staff. This method has some of the advantages of both the hospital ethics committee and the single consultant. Therefore, it should be considered when planning how to deal with these important problems.

Technical skills required in general pediatric practice.

Several years ago the American Board of Pediatrics developed a list of 101 technical procedures, which was sent to directors of accredited pediatric programs (N = 231). There was a 70% response and 72 of 101 procedures were considered necessary for residents to develop competency by at least 80% of the program directors. The list of 72 procedures was then sent to 500 randomly selected general pediatricians from a pool size of 10,304. The response rate was 35%. Forty-nine of the 72 procedures were considered necessary by 80% of those responding and one third of the skills (24 of 72) could be classified as absolutely necessary because more than 95% of practitioners considered them to be. Only 7 procedural skills were considered unnecessary by more than 50% of practitioners. It is suggested that program directors consider the 24 skills as ones that should be taught and competence in performing them be verified and recorded.

Internal medicine-pediatrics combined residency graduates: what are they doing now? Results of a survey.

BACKGROUND: While the number of internal medicine-pediatrics (med/peds) residency training programs has increased considerably in the past decade, questions continue to be raised about career paths of the graduates of these programs. It is uncertain whether med/peds graduates follow a generalist career path and whether they continue to practice both specialties. OBJECTIVE: To determine the career outcomes of graduates of med/peds residency programs. DESIGN: A survey questionnaire of graduates of med/peds residency programs. METHODS: The computer databases of the American Board of Pediatrics and the American Board of Internal Medicine were used to identify 1482 individuals who had completed training in combined med/peds residency programs between 1986 and 1995 and who had applied to either board for certification. The survey questionnaire was mailed to all graduates identified. MAIN OUTCOME MEASURES: Time spent in professional activity (patient care, teaching, administration, and research), site of principal clinical activity, ages of the patient population, types of hospital privileges, practice organization, subspecialty activity, night and weekend coverage arrangements, community size of practice, involvement in teaching, and membership in professional organizations. RESULTS: Of the total group of 1482 graduates, 87.3% are certified by the American Board of Internal Medicine, 91.3% by the American Board of Pediatrics, and 81.6% by both boards. The survey was completed by 1005 graduates (67.8%). The principal activity of almost 70% of the graduates was direct patient care. Most graduates cared for patients of all ages. More than half of all respondents noted that their principal clinical site is a community office practice. Eighty-five percent managed patients who require hospitalization. Approximately 50% of respondents had a medical school appointment. CONCLUSIONS: This study, the largest survey to date of med/peds graduates, provides strong evidence that most med/peds graduates are practicing generalists who care for adults and children. In addition, the fact that 80% of graduates achieve dual board certification suggests that these physicians are well qualified to care for the spectrum of health care needs of children and adults. Because the changing US health care system mandates a strong primary care base, these physicians will play a small but important role in providing high-quality generalist care.

Models of care for post-treatment follow-up of adult cancer survivors: a systematic review and quality appraisal of the evidence.

PURPOSE: The impact of cancer and cancer treatment on the long-term health and quality of life of survivors is substantial, leading to questions about the most appropriate configuration of services and models of care for follow-up of post-primary treatment survivors. METHODS: A systematic review and quality appraisal of the health literature for structure of services and models of follow-up care for post-treatment survivors was identified through a search of guideline sources and empirical databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Library, CINAHL, and EBSCO from 1999 through December 2009. RESULTS: Ten practice guidelines and nine randomized controlled trials comprised the evidence base for models of care for adult cancer survivors. Although the evidence base was rated as low quality, nurse-led and primary care physician models of follow-up care were equivalent for detecting recurrence. Consensus also suggests that cancer survivors may benefit from coordinated transition planning that includes the provision of survivorship care plans as part of standard care. CONCLUSIONS: Realignment of models of care is identified as a health system priority to meet the supportive care and surveillance needs of a burgeoning survivor population. Further research is needed to evaluate the efficacy of models of care in a broader population of cancer survivors with differing needs and risks. While the evidence is limited, there is research that may be used to guide the configuration of health care services and planning.

Hyperbaric oxygen therapy for late radiation tissue injury in gynecologic malignancies.

BACKGROUND: Late radiation tissue injury is a serious complication of radiotherapy for patients with gynecologic malignancies. Strategies for managing pain and other clinical features have limited efficacy; however, hyperbaric oxygen therapy (HBO(2)) may be an effective option for some patients. METHODS: In a systematic review of the literature, the Ovid medline, embase, Cochrane Library, National Guidelines Clearinghouse, and Canadian Medical Association Infobase databases were searched to June 2009 for clinical practice guidelines, systematic reviews, randomized controlled trials, or other relevant evidence. Studies that did not evaluate soft tissue necrosis, cystitis, proctitis, bone necrosis, and other complications were excluded. RESULTS: Two randomized trials, eleven nonrandomized studies, and five supporting documents comprise the evidence base. In addition, information on the harms and safety of treatment with HBO(2) were reported in three additional sources. There is modest direct evidence and emerging indirect evidence that the use of HBO(2) is broadly effective for late radiation tissue injury of the pelvis in women treated for gynecologic malignancies. CONCLUSIONS: Based on the evidence and expert consensus opinion, HBO(2) is likely effective for late radiation tissue injury of the pelvis, with demonstrated efficacy specifically for radiation damage to the anus and rectum;the main indication for HBO(2) therapy in gynecologic oncology is in the management of otherwise refractory chronic radiation injury;HBO(2) may provide symptomatic benefit in certain clinical settings (for example, cystitis, soft-tissue necrosis, and osteonecrosis); andHBO(2) may reduce the complications of gynecologic surgery in patients undergoing surgical removal of necrosis.

Survivorship services for adult cancer populations: a pan-Canadian guideline.

OBJECTIVE: Our goal was to develop evidence-based recommendations for the organization and structure of cancer survivorship services, and best-care practices to optimize the health and well-being of post-primary treatment survivors. This review sought to determine the optimal organization and care delivery structure for cancer survivorship services, and the specific clinical practices and interventions that would improve or maximize the psychosocial health and overall well-being of adult cancer survivors. DATA SOURCES: We conducted a systematic search of the Inventory of Cancer Guidelines at the Canadian Partnership Against Cancer, the U.S. National Guideline Clearinghouse, the Canadian Medical Association InfoBase, medline (ovid: 1999 through November 2009), embase (ovid: 1999 through November 2009), Psychinfo (ovid: 1999 through November 2009), the Cochrane Library (ovid; Issue 1, 2009), and cinahl (ebsco: 1999 through December 2009). Reference lists of related papers and recent review articles were scanned for additional citations. METHODS: Articles were selected for inclusion as evidence in the systematic review if they reported on organizational system components for survivors of cancer, or on psychosocial or supportive care interventions HOWELL et al. designed for survivors of cancer. Articles were excluded from the systematic review if they focused only on pediatric cancer survivor populations or on populations that transitioned from pediatric cancer to adult services; if they addressed only pharmacologic interventions or diagnostic testing and follow-up of cancer survivors; if they were systematic reviews with inadequately described methods; if they were qualitative or descriptive studies; and if they were opinion papers, letters, or editorials. DATA EXTRACTION AND SYNTHESIS: Evidence was selected and reviewed by three members of the Cancer Journey Survivorship Expert Panel (SM, TC, TKO). The resulting summary of the evidence was guided further and reviewed by the members of Cancer Journey Survivorship Expert Panel. Fourteen practice guidelines, eight systematic reviews, and sixty-thee randomized controlled trials form the evidence base for this guidance document. These publications demonstrate that survivors benefit from coordinated post-treatment care, including interventions to address specific psychosocial, supportive care, and rehabilitative concerns. CONCLUSIONS: Ongoing high-quality research is essential to optimize services for cancer survivors. Interventions that promote healthy lifestyle behaviours or that address psychosocial concerns and distress appear to improve physical functioning, psychosocial well-being, and quality of life for survivors.

Follow-up for women after treatment for cervical cancer.

QUESTION: What is the most appropriate follow-up strategy for patients with cervical cancer who are clinically disease-free after receiving primary treatment? PERSPECTIVES: For women with cervical cancer who have been treated with curative intent, follow-up includes identification of complications related to treatment and intervention in the event of recurrent disease. Most women who recur with cervical cancer are not curable; however, early identification of recurrence can alter disease management or treatment-planning options, and for those with a central pelvic recurrence and no evidence of distant disease, there is a potential for cure with additional therapy. Follow-up protocols in this population are variable, using a number of tests at a variety of intervals with questionable outcomes. OUTCOMES: Outcomes of interest included recurrence, survival, and quality of life. METHODOLOGY: The Gynecology Cancer Disease Site Group (DSG) conducted a systematic review of the literature and a narrative review of emerging clinical issues to inform the most appropriate follow-up strategy for patients with cervical cancer. The evidence was insufficient to specify a clinically useful recommended follow-up schedule, and therefore, the expert consensus opinion of the Gynecology Cancer DSG was used to develop recommendations on patient surveillance. The resulting recommendations were reviewed and approved by the Gynecology Cancer DSG and by the Program in Evidence-Based Care Report Approval Panel. An external review by Ontario practitioners completed the final phase of the review process. Feedback from all parties was incorporated to create the final practice guideline. RESULTS: The systematic review of the literature identified seventeen retrospective studies. The Gynecology Cancer DSG used a consensus process to develop recommendations based on the available evidence from the systematic review, the narrative review, and the collective clinical experience and judgment of the DSG members. PRACTICE GUIDELINE: The recommendations in this practice guideline are based on the expert consensus opinion of the Gynecology Cancer DSG, informed by evidence from retrospective studies. These are some general features of an appropriate follow-up strategy: 1. At a minimum, follow-up visits with a complete physical examination, including a pelvic-rectal exam and a patient history, should be conducted by a physician experienced in the surveillance of cancer patients. 2. There is little evidence to suggest that vaginal vault cytology adds significantly to the clinical exam in detecting early disease recurrence. 3. Routine use of various other radiologic or biologic follow-up investigations in asymptomatic patients is not advocated, because the role of those investigations has yet to be evaluated in a definitive manner. 4. A reasonable follow-up schedule involves follow-up visits every 3-4 months in the first 2 years and every 6-12 months in years 3-5. Patients should return to annual population-based general physical and pelvic examinations after 5 years of recurrence-free follow-up.