Canadian Consensus Statement Research Articles

Canadian Consensus for Treatment of BRAF V600E Mutated Pediatric and AYA Gliomas.

Background: The treatment of BRAF V600E gliomas with BRAF inhibitors (BRAFis) and MEK inhibitors (MEKis) has been increasingly integrated into clinical practice for pediatric low-grade gliomas (PLGGs) and pediatric high-grade gliomas (HGGs). However, some questions remain unanswered, such as the best time to start targeted therapy, duration of treatment, and discontinuation of therapy. Given that no clinical trial has been able to address these critical questions, we developed a Canadian Consensus statement for the treatment of BRAF V600E mutated pediatric as well as adolescent and young adult (AYA) gliomas. Methods: Canadian neuro-oncologists were invited to participate in the development of this consensus. The consensus was discussed during monthly web-based national meetings, and the algorithms were revised until a consensus was achieved. Results: A total of 26 participants were involved in the development of the algorithms. Two treatment algorithms are proposed, one for the initiation of treatment and one for the discontinuation of treatment. We suggest that most patients with BRAF V600E gliomas should be treated with BRAFis ± MEKis upfront. Discontinuation of treatment can be considered in certain circumstances, and we suggest a slow wean. Conclusions: Based on expert consensus in Canada, we developed algorithms for treatment initiation of children and AYA with BRAF V600E gliomas as well as a discontinuation algorithm.

Early Botulinum Toxin Injections for Spasticity Management Post-stroke: A Delphi-based Canadian Consensus

To create a Canadian consensus statement on early intervention with botulinum toxin-A (BoNTA) injections for spasticity post-stroke. Spasticity is commonly seen in the early weeks post-stroke; if left untreated in this early period, spasticity can lead to contractures and further disability. Literature review indicates that there are very few studies examining the benefits of early BoNTA intervention on spasticity and function post-stroke. Although physicians choose to inject BoNTA in the early period post-stroke to manage spasticity, it is not clear what some of the clinical parameters are that can be used to assist in determining suitability of patients who are most likely to benefit.

Canadian consensus statement: enhanced recovery after surgery in bariatric surgery.

In Canada, bariatric surgery continues to remain the most effective treatment for severe obesity and its comorbidities. As the number of bariatric surgeries continues to grow, the need for consensus guidelines for optimal perioperative care is imperative. In colorectal surgery, enhanced recovery after surgery (ERAS) protocols were created for this purpose. The objective of this review is to develop evidence-based ERAS guidelines for bariatric surgery. A literature search of the MEDLINE database was performed using ERAS-specific search terms. Recently published articles with a focus on randomized controlled trials, systematic reviews, and meta-analyses were included. Quality of evidence and recommendations were evaluated using the GRADE assessment system. Canadian bariatric surgeons from six provinces and ten bariatric centers performed a review of the evidence surrounding ERAS in bariatric surgery and created consensus guidelines for 14 essential ERAS elements. Our main recommendations were (1) to encourage participation in a presurgical weight loss program; (2) to abstain from tobacco and excessive alcohol; (3) low-calorie liquid diet for at least 2weeks prior to surgery; (4) to avoid preanesthetic anxiolytics and long-acting opioids; (5) unfractionated or low-molecular-weight heparin prior to surgery; (6) antibiotic prophylaxis with cefazolin ± metronidazole; (7) reduced opioids during surgery; (8) surgeon preference regarding intraoperative leak testing; (9) nasogastric intubation needed only for Veress access; (10) to avoid abdominal drains and urinary catheters; (11) to prevent ileus by discontinuing intravenous fluids early; (12) postoperative analgesia with acetaminophen, short-term NSAIDS, and minimal opioids; (13) to resume full fluid diet on first postoperative day; (14) early telephone follow-up with full clinic follow-up at 3-4weeks. The purpose of addressing these ERAS elements is to develop guidelines that can be implemented and practiced clinically. ERAS is an excellent model that improves surgical efficiency and acts as a common perioperative pathway. In the interim, this multimodal bariatric perioperative guideline serves as a common consensus point for Canadian bariatric surgeons.

Management of urachal cancer: A consensus statement by the Canadian Urological Association and Genitourinary Medical Oncologists of Canada.

The urachus is a fibrous remnant of the allantois. After birth, it remains throughout life as the medial umbilical ligament running from the apex of the bladder to the umbilicus but without any further physiological role. First described by Begg in 1931, urachal cancer is a rare pathology representing less than 1% of bladder cancers.1 Usually located on the serous side of the bladder apex, these tumors are classically silent because of their extravesical and extraperitoneal location. Therefore, most patients present with local invasion or metastatic disease and, thus, are detected at a higher stage. Based on its rarity, there have been no large, prospective, randomized trials in urachal cancer and there are no evidence-based guidelines on the management of this disease. The existing evidence in the medical literature is derived from case series. In this article, led by the Genitourinary Medical Oncologists of Canada (GUMOC), we aim to review the literature of this rare disease in order to establish a Canadian consensus statement on the management of urachal cancer. To our knowledge, there is no other consensus statement available.

Physical literacy levels of Canadian children aged 8\u201312\xa0years: descriptive and normative results from the RBC Learn to Play\u2013CAPL project

BackgroundThe current physical literacy level of Canadian children is unknown. The Royal Bank of Canada (RBC) Learn to Play – Canadian Assessment of Physical Literacy (CAPL) project, which is anchored in the Canadian consensus statement definition of physical literacy, aimed to help establish the current physical literacy level of Canadian children.MethodsThe CAPL was used to assess the physical literacy (and component domains: Daily Behaviour, Physical Competence, Knowledge and Understanding, and Motivation and Confidence) of Canadian children aged 8–12 years. Data were collected from 11 sites across Canada, yielding a sample of 10,034 participants (5030 girls). Descriptive statistics by age and gender were calculated and percentile distributions of physical literacy scores, including each domain and individual measure, were derived.ResultsThe mean age of participants was 10.1 ± 1.2 years. Total physical literacy scores (out of 100) were on average 63.1 ± 13.0 for boys and 62.2 ± 11.3 for girls. For boys and girls respectively, domain scores were 19.9 ± 4.7 and 19.3 ± 4.1 (out of 32) for Physical Competence; 18.6 ± 7.9 and 18.5 ± 7.4 (out of 32) for Daily Behaviour; 12.7 ± 2.8 and 12.2 ± 2.6 (out of 18) for Motivation and Confidence; and 11.8 ± 2.8 and 12.2 ± 2.6 (out of 18) for Knowledge and Understanding. Physical Competence measures were on average 28.1 ± 8.4 cm (sit-and-reach flexibility), 33.5 ± 9.4 kg (grip strength, right + left), 23.4 ± 14.1 laps (Progressive Aerobic Cardiovascular Endurance Run [PACER] shuttle run), 61.8 ± 43.8 s (isometric plank), 19.0 ± 3.8 kg/m2 (body mass index), 67.3 ± 10.8 cm (waist circumference), and 20.6 ± 3.9 out of 28 points for the Canadian Agility and Movement Skill Assessment (CAMSA), with scores for boys higher than girls and older children higher than younger children for grip strength, PACER, plank, and CAMSA score. Girls and younger children had better scores on the sit-and-reach flexibility than boys and older children. Daily pedometer step counts were higher in boys than girls (12,355 ± 4252 vs. 10,779 ± 3624), and decreased with age.ConclusionsThese results provide the largest and most comprehensive assessment of physical literacy of Canadian children to date, providing a “state of the nation” baseline, and can be used to monitor changes and inform intervention strategies going forward.

Supplementary data: Testosterone suppression in the treatment of recurrent or metastatic prostate cancer – A Canadian consensus statement

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Testosterone suppression in the treatment of recurrent or metastatic prostate cancer - A Canadian consensus statement.

Testosterone suppression, achieved through orchiectomy or medically induced androgen-deprivation therapy (ADT), is a standard treatment for men with recurrent and metastatic prostate cancer. Current assay methods demonstrate the capacity for testosterone suppression to <0.7 nmol/l, and clinical data support improved outcomes from ADT when lower levels are achieved. Practical clinical guidelines are warranted to facilitate adoption of 0.7 nmol/l as the new standard castrate testosterone level.A pan-Canadian group of experts, representing diverse clinical specialties, identified key clinical issues, searched and reviewed relevant literature, and developed consensus statements on testosterone suppression for the treatment of prostate cancer. The expert panel found that current evidence supports the clinical benefit of achieving low testosterone levels during ADT, and encourage adoption of ≤0.7 nmol/l as a new castrate level threshold. The panel recommends regular monitoring of testosterone (e.g., every 3-6 months) and prostate-specific antigen (PSA) levels as clinically appropriate (e.g., every 3-6 months) during ADT, with reassessment of therapeutic strategy if testosterone is not suppressed or if PSA rises regardless of adequate testosterone suppression. The panel also emphasizes the need for greater awareness and education regarding testosterone assay specifications, and strongly promotes the use of mass spectrometry-based assays to ensure accurate measurement of testosterone at castrate levels.

The predictive effect of primary tumour location in the treatment of metastatic colorectal cancer: a Canadian consensus statement.

In recently published data, the predictive value of primary tumour location for the treatment of metastatic colorectal cancer with available biologic therapies has been explored. Recognizing the potential effect of those data on clinical practice, we convened a meeting of Canadian experts who treat metastatic colorectal cancer to develop a set of national, evidence-based treatment guidelines based on primary tumour location. This report summarizes the relevant evidence and presents the consensus recommendations of those experts.

Managing the Anticoagulated Patient with Spasticity? A Delphi-based Canadian Consensus Statement

Managing the Anticoagulated Patient with Spasticity? A Delphi-based Canadian Consensus Statement

Provision of dementia-related services in Canada: a comparative study.

BackgroundDementia is common, particularly among older adults, and is one of the major causes of dependency later in life. We sought to provide an overview and comparison of key services related to dementia care as the disease progresses in three large Canadian healthcare centres.MethodsWe identified family physicians, geriatric specialists, and dementia case managers from three major population centres in Canada with universal healthcare coverage. Using a standardized longitudinal dementia case vignette, participants were interviewed on services they would provide at each stage of the disease. We used principles of content analysis to generate codes and identify themes; appropriate time frames from the vignette fitting the necessary provision of services were derived from the Canadian consensus statement and determined in consultation with clinical experts. Proportions of participants that identified dementia-related care services were analyzed at each time point of the vignette using chi-square tests.ResultsThirty-four healthcare providers from Calgary (Alberta), Edmonton (Alberta), and Ottawa (Ontario) participated. Review of our data identified seven overarching themes of dementia-related care services. Services provided in the community setting include future planning and related services, educational and social support services, and home care and respite services. Although all providers consistently identified educational and social support services (e.g. the Alzheimer Society) within the appropriate time frame, the provision of other services was variable. The proportion of providers reporting potential access of future planning services was significantly different across the three sites (Calgary, 91.7 %; Edmonton; 58.3 %; and Ottawa, 30.0 %), p = 0.012. Also, the proportion of providers that identified day program services were significantly different across the three sites (Calgary, 100.0 %; Edmonton, 91.7 %; and Ottawa, 60.0 %), p = 0.023 according to a chi-square test.ConclusionsWe found important types of variability in service delivery among different regions in Canada for a typical patient with dementia and their family caregiver. Health systems can be calibrated by aligning services from different settings to appropriate time points in the vignette, which illustrates the dynamic course of service delivery and opportunities for improvement throughout the disease trajectory.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1435-1) contains supplementary material, which is available to authorized users.

Ending overly broad HIV criminalization: Canadian scientists and clinicians stand for justice.

In Canada, people living with HIV who do not disclose their HIV status prior to sexual acts risk prosecution for aggravated sexual assault even if they have sex with a condom or while having a low (or undetectable) viral load, they had no intent to transmit HIV, and no transmission occurred. In 2013, six distinguished Canadian HIV scientists and clinicians took ground-breaking action to advance justice by co-authoring the “Canadian consensus statement on HIV and its transmission in the context of the criminal law.” This effort was born out of the belief that the application of criminal law to HIV non-disclosure was being driven by a poor appreciation of the science of HIV. More than 75 HIV scientists and clinicians Canada-wide have now endorsed the statement, agreeing that “[they] have a professional and ethical responsibility to assist those in the criminal justice system to understand and interpret current medical and scientific evidence regarding HIV.” As some 61 countries have adopted laws that specifically allow for HIV criminalization, and prosecutions for HIV non-disclosure, exposure and transmission have been reported in at least 49 countries, the authors hope that others around the world will take similar action.

Canadian consensus statement on HIV and its transmission in the context of criminal law.

A poor appreciation of the science related to HIV contributes to an overly broad use of the criminal law against individuals living with HIV in cases of HIV nondisclosure. To promote an evidence-informed application of the law in Canada, a team of six Canadian medical experts on HIV and transmission led the development of a consensus statement on HIV sexual transmission, HIV transmission associated with biting and spitting, and the natural history of HIV infection. The statement is based on a literature review of the most recent and relevant scientific evidence (current as of December 2013) regarding HIV and its transmission. It has been endorsed by >70 additional Canadian HIV experts and the Association of Medical Microbiology and Infectious Disease Canada. Scientific and medical evidence clearly indicate that HIV is difficult to transmit during sex. For the purpose of informing the justice system, the per-act possibility of HIV transmission through sex, biting or spitting is described along a continuum from low possibility, to negligible possibility, to no possibility of transmission. This possibility takes into account the impact of factors such as the type of sexual acts, condom use, antiretroviral therapy and viral load. Dramatic advances in HIV therapy have transformed HIV infection into a chronic manageable condition. HIV physicians and scientists have a professional and ethical responsibility to assist those in the criminal justice system to understand and interpret the science regarding HIV. This is critical to prevent miscarriage of justice and to remove unnecessary barriers to evidence-based HIV prevention strategies.

Endocrine Therapy for Postmenopausal Women with Hormone Receptor–Positive her2–Negative Advanced Breast Cancer after Progression or Recurrence on Nonsteroidal Aromatase Inhibitor Therapy: A Canadian Consensus Statement

Approximately 22,700 Canadian women were expected to be diagnosed with breast cancer in 2012. Despite improvements in screening and adjuvant treatment options, a substantial number of postmenopausal women with hormone receptor positive (hr+) breast cancer will continue to develop metastatic disease during or after adjuvant endocrine therapy. Guidance on the selection of endocrine therapy for patients with hr+ disease that is negative for the human epidermal growth factor receptor 2 (her2-) and that has relapsed or progressed on earlier nonsteroidal aromatase inhibitor (nsai) therapy is of increasing clinical importance. Exemestane, fulvestrant, and tamoxifen are approved therapeutic options in this context. Four phase iii trials involving 2876 patients-efect, sofea, confirm, and bolero-2-have assessed the efficacy of various treatment options in this clinical setting. Data from those trials suggest that standard-dose fulvestrant (250 mg monthly) and exemestane are of comparable efficacy, that doubling the dose of fulvestrant from 250 mg to 500 mg monthly results in a 15% reduction in the risk of progression, and that adding everolimus to exemestane (compared with exemestane alone) results in a 57% reduction in the risk of progression, albeit with increased toxicity. Multiple treatment options are now available to women with hr+ her2- advanced breast cancer recurring or progressing on earlier nsai therapy, although current clinical trial data suggest more robust clinical efficacy with everolimus plus exemestane. Consideration should be given to the patient's age, functional status, and comorbidities during selection of an endocrine therapy, and use of a proactive everolimus safety management strategy is encouraged.

Canadian Consensus Conference: The FDA decision on the use of 5ARIs.

Canadian Consensus Conference: The FDA decision on the use of 5ARIs.

Use of Mismatch Repair Immunohistochemistry and Microsatellite Instability Testing

The mismatch repair (MMR) status of tumors is being increasingly recognized as a prognostic, predictive, and possible germline predisposition/Lynch syndrome (LS) biomarker in colorectal cancer and other cancer types, particularly in endometrial cancer. Current methods (clinical history and tumor morphology) to predict MMR deficiency (dMMR) are suboptimal, and implementation of reflex laboratory testing of appropriate tumors has been recommended, a strategy requiring test standardization and clinical coordination. Two web-based questionnaires were administered, a general and a specialist laboratory questionnaire, to establish the availability of such tests, requisite clinical/pathology integration, current mode of test initiation, reporting and recommendation practices, and education and attitudes among pathologists. Technical aspects were reviewed on the basis of specialist laboratory practice. Of 76 respondents, 21.5% were unaware or were uncertain whether they had access to MMR immunohistochemistry. Although 78.9% of respondents had access to such testing, an integrated approach to the identification of patients with LS is lacking, being limited to just 9 centers. The majority (70%) of testing is clinician initiated, with variable implementation of reflex testing and divergent practices in recommendation to test. Standardized reporting is lacking in many centers. Education on MMR in endometrial cancer is poor compared with that in colorectal cancer (P<0.0001). This multicenter questionnaire highlights heterogenous practices in dMMR testing and LS identification, both in clinical terms and with regard to technical aspects of testing. An integrated multidisciplinary approach is lacking, and there is a need to educate physicians and resolve ethical issues. A Canadian consensus statement and national guidelines on dMMR testing are urgently needed, requiring input from pathologists, clinicians, and genetic counselors.

Canadian Consensus Statement on the Use of Intravenous Immunoglobulin Therapy in Dermatology

As a safe, well-tolerated, and potentially beneficial therapy, intravenous immunoglobulin (IVIG) has been increasingly used by dermatologists to treat immune-mediated skin disease. However, practical and comprehensive guidelines for the use of IVIG have yet to be established. To develop the first Canadian consensus statement on the use of IVIG therapy in skin disease. A group of Canadian dermatologists convened to discuss current issues in IVIG therapy. The participants reviewed and evaluated the literature and shared clinical experience. Using a modified Delphi process, a consensus statement was developed. Herein we provide a brief overview of pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Recommendations for the management of these diseases are detailed, and therapeutic algorithms for the treatment of various autoimmune mucocutaneous blistering diseases are presented. The appropriate use of IVIG therapy is placed in context for each disease. Although preliminary data suggest that IVIG is a safe and effective therapy for many skin disorders, uncontrolled clinical trials, case series, and anecdotal case reports dominate the literature. Collaborative randomized controlled trials are required to firmly establish the role of IVIG in dermatology.

Zopiclone and zaleplon vs benzodiazepines in the treatment of insomnia: Canadian consensus statement

Zopiclone and zaleplon vs benzodiazepines in the treatment of insomnia: Canadian consensus statement