External Supports for the Treatment of Ankle Sprain: A Review of Clinical Effectiveness

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Question(s)

  1. What is the clinical effectiveness of external supports for the treatment of individuals with ankle sprain?

Key Message

This review included one systematic review and two primary studies (one randomized controlled trial and one cohort study) regarding the clinical effectiveness of external supports for the treatment of individuals with ankle sprain. The external supports identified in this review were stockings, elastic bandages, cohesive tape, lace-up ankle supports, semi-rigid ankle supports or posterior rigid supports, and short-leg casts. Based on the findings of the systematic review, stockings were found to be significantly more effective in improving pain, swelling, functional outcomes, and range of motion compared to bandages. However, stockings showed no significant difference in pain and swelling, but had a significantly shorter period of return to sport activities compared with placebo. The systematic review found no significant differences between taping and other external supports (such as soft braces, semi-rigid braces and lace-up braces) with regards to pain, swelling, function, range of motion, patient satisfaction, and return to sports or work. There were also no significant differences between semi-rigid or posterior rigid supports compared to tape or bandages with regards to pain, range of motion, function, or return to sports or work. There was some evidence that semi-rigid or posterior rigid supports had significantly higher patient satisfaction than tape or bandages. Reported complications associated with bandages and Air-cast brace were suspected deep vein thrombosis and suspected pulmonary embolism, with Bledsoe boots were associated with cellulitis, and taping was associated with dermatitis, skin blister, bullae formation or skin abnormalities; however, the incidence rates of these complications were unclear.The included randomized controlled trial found that the addition of kinesiotape to acupuncture did not significantly improve pain, swelling, quality of life, or number of recurrent ankle sprains. The included cohort study also found no significant differences between cohesive taping and short-leg casts in terms of swelling and function. Taken together, stockings may be a better treatment option among different external supports for functional treatment for acute ankle sprains. Treatment with bandages, tape and semi-rigid or posterior rigid supports may be associated with some complications, however the risk of these complications was unclear.

Comparative Assessment of Coverage Criteria for Biologic Disease-Modifying Antirheumatic Drugs Across Canadian Public Drug Plans: An Environmental Scan

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Canada's Drug Agency conducted an Environmental Scan to better understand the similarities and differences in the current public drug programs criteria for accessing biologic drugs in the treatment of rheumatoid arthritis (RA) in Canada.

The specific objective was to identify and to compare existing criteria for reimbursing biologic drugs in RA across Canadian public formularies.

The findings of this Environmental Scan support a broader policy question regarding the harmonization of public coverage policies for biologics in Canada for patients with RA.

Adalimumab for Adult Patients with Crohn’s Disease: A Review of Clinical Effectiveness

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Question(s)

  1. What is the clinical effectiveness of adalimumab versus infliximab or vedolizumab in adult patients with Crohn’s Disease?

Key Message

Seven systematic reviews (two with meta-analyses and five with network meta-analyses) and four relevant head-to-head primary studies contained within the systematic reviews were identified regarding the clinical effectiveness of adalimumab compared to infliximab or vedolizumab in adults with Crohn’s disease. The seven systematic reviews were generally well-conducted, but there were methodological limitations in their included primary studies which provided low to moderate strength evidence. 

The identified literature revealed mixed conclusions regarding the clinical effectiveness of adalimumab compared to infliximab or vedolizumab in adults with Crohn’s disease. Specifically, in two primary studies and three network meta-analyses comparing adalimumab to infliximab, no treatment was favoured in effectiveness (e.g., disease recurrence) and safety (e.g., hospitalization due to serious infection) outcomes. However, significant findings from two primary studies and one network meta-analysis favoured the use of infliximab in terms of risk of abdominal surgery, early treatment termination, or induction of clinical response, while findings from one network meta-analysis favoured the use of adalimumab in terms of withdrawals due to adverse events. 

In three network meta-analyses comparing adalimumab to vedolizumab, no treatment was favoured in effectiveness (e.g., induction of clinical remission) and safety (e.g., withdrawals due to adverse events) outcomes. However, findings from one of the aforementioned network meta-analyses favoured adalimumab over vedolizumab in the maintenance of clinical remission.

The limitations of the included primary literature (e.g., lack of blinding of participants and health care professionals, heterogeneity of outcome measures, variation in prior abdominal surgery history, inconsistencies in study findings) should be considered when interpreting these results. Additionally, since two network meta-analyses involved studies of post-surgical patients, the findings from this report may not be generalizable to all patients living with Crohn’s disease.

Transanal Total Mesorectal Excision for Adult Patients with Rectal Cancer: A Review of Clinical Effectiveness and Cost-Effectiveness

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Question(s)

  1. What is the clinical effectiveness of Transanal Total Mesorectal Excision for adult patients with rectal cancer?
  2. What is the cost-effectiveness of Transanal Total Mesorectal Excision for adult patients with rectal cancer?

Key Message

There is strong evidence based on five high-to-moderate quality systematic reviews and six moderate-to-low quality non-randomized studies that suggests that Transanal Total Mesorectal Excision is clinically effective and safe for patients with rectal cancer based on the assessment of short-term outcomes when compared to Laparoscopic Total Mesorectal Excision. Limited evidence from two non-randomized trials was insufficient to be make statements regarding the clinical effectiveness of Transanal Total Mesorectal Excision compared with Open Total Mesorectal Excision based on the assessment of short-term outcomes.Insufficient evidence regarding long-term clinical effectiveness was identified for Transanal Total Mesorectal Excision for adult patients with rectal cancer compared to Open or Laparoscopic Total Mesorectal Excision. Conclusions based on comparative long-term clinical effectiveness cannot be made.No evidence regarding the cost-effectiveness of Transanal Total Mesorectal Excision for adult patients with rectal cancer was identified in comparison to open or Laparoscopic Total Mesorectal Excision.

Islet Cell Transplantation for Patients with Unstable or Uncontrollable Diabetes Mellitus: Clinical Effectiveness. Cost-Effectiveness and Guidelines

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Question(s)

  1. What is the clinical effectiveness of islet cell transplantation in patients with unstable type I diabetes mellitus?
  2. What is the cost-effectiveness of islet cell transplantation in patients with unstable type I diabetes mellitus?
  3. What are the evidence-based guidelines regarding the use of islet cell transplantation in patients with unstable type I diabetes mellitus?

Key Message

One systematic review, one randomized controlled trial, and five non-randomized studies were identified regarding the clinical effectiveness of islet cell transplantation compared to insulin therapy in patients with unstable type 1 diabetes. Overall, compared to insulin therapy, islet cell transplantation was associated with better glycemic control, quality of life, and some secondary complications of diabetes including macrovascular and microvascular complications. However, the results of these studies should be interpreted with caution as numerous methodological limitations were identified. One relevant economic evaluation was identified which compared the cost-effectiveness of islet cell transplantation to intensive insulin therapy in a theoretical cohort of patients with unstable type 1 diabetes. Islet cell transplantation was not cost-effective. One evidence-based guideline developed by Diabetes Canada was identified that states that patients with unstable type 1 diabetes who have preserved renal function or who have had a successful kidney transplant may be considered for islet cell transplantation (low quality evidence; weak recommendation).

Vein Illumination Devices in Long-Term and Acute Care Settings: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines

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Question(s)

  1. What is the clinical effectiveness of vein illumination devices for vascular access procedures for adult patients in an acute care and/or long-term care settings?
  2. What is the cost-effectiveness of vein illumination devices for vascular access in adult patients in acute care and/or long-term settings?
  3. What are the evidence-based guidelines for use of vascular access imaging devices for adult patients in acute care and/or long term care settings?

Key Message

This report identified limited quality evidence to evaluate the clinical efficacy of vein illumination devices for adult patients in acute or long-term care. Evidence from one randomized controlled pilot trial with significant methodological limitations found no difference in outcomes of time and attempts required for vascular access using a vein illumination device as compared to a standard vascular access protocol in a population of elderly acute care patients. This study did identify a significantly lower frequency of hematoma complications as well as less anxiety and depression in the vein illumination device treatment group at a time point following venous access. Further high-quality research is required to make definitive conclusions regarding the clinical efficacy and safety of vein illumination devices in this population. No relevant cost-effective evidence or evidence-based guidelines were identified.

e-Consult for Primary Care Clinician Access to Specialists

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eConsult (also known as e-Consultation, electronic consultation, or remote consultation) is a type of asynchronous telehealth (also known as store-and-forward) that connects primary care providers with specialists. In an eConsult service, primary care providers send a request for consultation through the system to a specialist, who then responds directly to the question(s), requests additional information, and/or schedules an appointment. eConsult services may be offered as an extension of an organization’s electronic health record system or as a standalone secure internet-based system.

Epinephrine Auto-Injectors for Anaphylaxis: A Review of the Clinical Effectiveness, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the comparative clinical effectiveness of epinephrine auto-injectors versus manually administered epinephrine for the management of individuals with anaphylaxis?
  2. What is the comparative cost-effectiveness of epinephrine auto-injectors versus manually injected epinephrine for the management of individuals with anaphylaxis?
  3. What are the evidence-based guidelines regarding management of anaphylaxis?

Key Message

​No evidence regarding the clinical effectiveness of epinephrine auto-injectors compared to manually administered epinephrine for the management of individuals with anaphylaxis was identified.

No evidence regarding the cost-effectiveness of epinephrine auto-injectors compared to manually administered epinephrine for the management of individuals with anaphylaxis was identified.

Two evidence-based guidelines were identified regarding the management of anaphylaxis. One guideline was jointly developed by the Australian and New Zealand College of Anaesthetists and the Australian and New Zealand Anaesthetic Allergy Group. The other guideline was a practice parameter update by the Joint Task Force on Practice Parameters, which represents the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology. Both guidelines recommend epinephrine administration for anaphylaxis, however neither explicitly state a preference for epinephrine auto-injectors versus manually drawn-up epinephrine for the management of individuals with anaphylaxis.

Primary Care Initiated Gender-Affirming Therapy for Gender Dysphoria: A Review of Evidence Based Guidelines

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Question(s)

  1. What are the evidence-based guidelines regarding primary care initiated gender-affirming therapy in adults with gender dysphoria?

Key Message


​One evidence-baseline clinical practice guideline was identified that provides guidance for the health of transsexual, transgender and gender-nonconforming people. The guideline suggests that with appropriate training, hormone therapy can be managed by a variety of healthcare providers, including primary care providers such as primary physician or nursing practitioner. However, the recommendations did not specify whether this treatment can be initiated by primary care providers. The quality of this guideline was limited due to insufficient reporting on searching for evidence and formulating the recommendations. This guideline did not report the strength of recommendations or the quality of the evidence.

Non-invasive Nerve Stimulation Modalities for Migraine Pain: A Review of Clinical Effectiveness and Cost-effectiveness

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Question(s)

  1. What is the clinical effectiveness of non-invasive nerve stimulation modalities for adult patients with migraine pain?
  2. What is the cost-effectiveness of non-invasive nerve stimulation modalities for adult patients with migraine pain?

Key Message

This report included two health technology assessments (HTAs) and two systematic reviews (SRs) that identified one unique primary study, in addition to two randomized controlled trials (RCTs) regarding the clinical effectiveness of various non -invasive nerve simulation (NINS) modalities for the treatment of migraine pain. However, of the included HTAs and SRs, only one of the SRs included a relevant primary study.

There is a lack of evidence on the effectiveness of NINS modalities compared to standard of care. The limited comparative clinical evidence suggests that migraine prophylaxis with NINS devices such as transcutaneous Supraorbital Neurostimulation (tSNS), transcutaneous Occipital Nerve Stimulation (tONS) and repetitive Transcranial Magnetic Stimulation (rTMS) were not different compared to standard of care (pharmacological and non-pharmacological interventions) in improving clinical symptoms. However, the findings should be interpreted with caution, in light of the limited available evidence and the quality and generalizability of included studies.  The modalities were found to be effective in improving symptoms and safe with few adverse events. No evidence was found for the clinical effectiveness of NINS devices in abortive treatments of acute migraine attacks. No evidence regarding the cost effectiveness of NINS devices compared to standard of care were identified. No evidence on the clinical and cost effectiveness of other available NINS devices were found.