Identification of Tuberculosis: A Review of the Guidelines

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Question(s)

  1. What are the evidence-based guidelines regarding the identification of latent tuberculosis infection?
  2. What are the evidence-based guidelines regarding the identification of active tuberculosis disease?

Key Message

Fourteen evidence-based guidelines for the identification of tuberculosis (TB) were identified and included in this report. Nine guidelines include recommendations regarding screening strategies for TB. Six guidelines include recommendations regarding diagnostic tests to identify latent TB infection. Nine guidelines include recommendations regarding diagnostic tests for active TB disease. Overall, there are five high-quality and nine low-quality guidelines that include between one and 64 recommendations on the identification of TB. The recommendations vary in strength and the quality of the evidence. The population and setting of interest may determine which guideline(s) and which recommendation(s) are of interest.

Local Anesthetic for Urinary Catheter Insertion: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the clinical effectiveness of local anesthetic in adults undergoing urinary catheter insertion?
  2. What is the cost-effectiveness of local anesthetic in adults undergoing urinary catheter insertion?
  3. What are the evidence-based guidelines informing the use of local anesthetic in adults undergoing urinary catheter insertion?

Key Message

This report reviewed the evidence from one systematic review with meta-analysis containing one relevant study, and six randomized controlled trials, to assess the clinical effectiveness of local anesthetic in adults undergoing urinary catheterization. Overall, there was evidence from four studies that compared to patients who received placebo, patients who received anesthetic (lidocaine) had significantly lower pain levels, or no difference in pain levels, both during and following catheter insertion. Two studies found that measures of urodynamic function were significantly different among those who received lidocaine compared to those received placebo, but results were inconsistent between the studies in terms of which metrics were different. The relevant study in the systematic review and one of the randomized controlled trials showed that pain level was significantly reduced when topical analgesics such as prilocaine or ketamine were added to lidocaine gel, compared to lidocaine gel only. One study in males found that those who received liquid paraffin lubricant had significantly less pain than those who received lidocaine gel during catheter insertion. The heterogeneity in findings may be due to differences in anesthetic doses; catheter type and size; gel application method; time intervals between instillation, catheterization, and outcome measures; reason for and duration of catheterization; population characteristics including sex and age; types of outcomes recorded; and comparison to placebo, alternative lubricant, or analgesic-augmented lidocaine gel. No economic evaluations or evidence-based guidelines were identified assessing the use of local anesthetic in urinary catheterization.

Oral Rehydration Solutions versus Drink of Choice in Children with Dehydration: A Review of Clinical Effectiveness

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Question(s)

  1. What is the comparative clinical effectiveness of oral rehydration solution versus other fluids of choice for pediatric patients with, or at risk of, dehydration?

Key Message

​One relevant randomized controlled trial was identified regarding the clinical effectiveness of half-strength apple juice followed by preferred fluids versus a commercially available electrolyte maintenance solution in pediatric patients with minimal dehydration secondary to gastroenteritis. Overall, half-strength apple juice followed by preferred fluids were found to be both non-inferior and superior to the electrolyte maintenance solution in the primary composite outcome of overall treatment failure. However, the results of this trial should be interpreted with caution as several limitations were identified. The authors of the trial concluded that dilute apple juice followed by preferred fluids may be an alternative to electrolyte maintenance solutions.

Magnetic Localization System for Sentinel Lymph Node Biopsy: A Review of the Diagnostic Accuracy, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the diagnostic accuracy of magnetic localization systems for sentinel node biopsies in patients with breast cancer?
  2. What is the safety of magnetic localization systems for sentinel node biopsies in patients with breast cancer?
  3. What is the cost-effectiveness of magnetic localization systems for sentinel node biopsies in patients with breast cancer?
  4. What are the evidence-based guidelines regarding the use of sentinel lymph node localization techniques for sentinel node biopsies in patients with breast cancer?

Key Message

One systematic review with network meta-analysis and three non-randomized studies were identified regarding the diagnostic accuracy and safety of magnetic localization systems for sentinel lymph node biopsy. Evidence from one systematic review with network meta-analysis and three non-randomized studies suggested that the detection rate for sentinel lymph node biopsy with magnetic localization systems (using a superparamagnetic iron oxide tracer) was similar, or non-inferior, to sentinel lymph node biopsy using the radioisotope method (technetium-99 with or without blue dye). The network meta-analysis found that there was no statistically significant difference in false negative rate between these two methods, but there were no data on the false positive rate. The comparative safety of magnetic localization systems was difficult to establish due to limitations in how adverse effects were reported in eligible studies. However, magnetic localization systems for sentinel lymph node biopsy appeared to be generally safe based on the available information. The main safety concern with this procedure appeared to be skin staining/discolouration. Studies with explicit and detailed comparisons of adverse effects for magnetic localization systems versus the radioisotope method (technetium-99) with or without blue dye will be helpful in clarifying the comparative safety of this technique for sentinel lymph node biopsy.

No cost-effectiveness evidence or guidelines were identified. Therefore, the cost-effectiveness of magnetic localization systems for sentinel lymph node biopsy, and recommendations regarding the use of magnetic localization systems for this procedure, are unclear.

Orthotic Bracing or Splinting of Upper Extremities in Patients with Chronic, Non-Cancer Pain: A Review of Clinical Effectiveness

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Question(s)

  1.   What is the clinical effectiveness of orthotic bracing and splinting of the upper extremities in patients with chronic, non-cancer pain?

Key Message

​Evidence of limited quality from the two included systematic reviews suggested that compared to usual care or no intervention, splint use significantly reduced pain and improved functional performance in patients with osteoarthritis involving the thumb base (rhizarthrosis), carpometacarpal joints, or the distal interphalangeal joint in the long-term (13 to 52 weeks) but not in the short term.

Evidence of limited quality from four prospective, uncontrolled, before-and-after studies suggested that compared to baseline, the use of splints for four to six weeks resulted in statistically significant reduction in pain, improvement in functional performance, as well as range in motion, pinch strength, and hand strength in in patients with osteoarthritis involving the distal interphalangeal joint, and trapeziometacarpal joints, or those diagnosed with tennis elbow or carpal tunnel syndrome.

Evidence from the two included randomized controlled trials (RCTs) indicated that a single local injection of 20 mg methylprednisolone acetate was statistically significantly more effective than night splitting for reducing pain intensity and improved figure dexterity in patients with carpal tunnel syndrome after four to six weeks of treatment. However, the findings from these RCTs on functional performance were inconclusive as one reported a statistically significantly greater improvement in favor of the steroid injection, whereas the other did not find a significant between group difference.

Sources of uncertainty in the current report included a lack of definition of ‘‘usual care,’’ and a significant overlap of primary studies, all of which had high risk of bias between the two included systematic reviews. Also, the comparator data used in meta-analysis were from usual care or no intervention without reporting separate results for either of them compared to splint. Given that lack of treatment might not result in improved outcomes, it is unclear if splints might perform equally well in comparison with usual care alone as they did in analyses that considered data from usual care or no treatment together as comparator group.

Fundamental limitations of the primary studies included in this report were the open-label design of all which disposes them to biases and the fact that four of them were prospective, uncontrolled, before-and-after studies with inherently higher likelihood of systemic biases due to lack of the risk-diminishing property of randomization. Also, the before-and-after studies investigated different kinds of splints, with variations in design and materials used in construction, custom-made devices, and splints fabricated by patients for self-use. Thus, it was unclear if the finding of these studies could be replicated using generic splints.

There were no studies identified that compared splints to pharmacological interventions for pain relief such as non-steroidal anti-inflammatory drugs, acetaminophen, topical capsaicin, and topical salicylates, as well as less conventional medications such as pregabalin and duloxetine. Furthermore, none of the studies included in this report provided outcomes on health-related quality of life, disability level, or global impression of recovery after treatment with any of the studied interventions.

Non-pharmacological and Pharmacological Intervention for Smoking Cessation Programs in Youth: A Review of Clinical Effectiveness and Guidelines

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Question(s)

  1. What is the clinical effectiveness of pharmacological and non-pharmacological smoking cessation interventions for youth?
  2. What is the clinical effectiveness of non-pharmacological smoking cessation interventions for youth?
  3. What are the evidence-based guidelines regarding smoking cessation interventions for youth?

Key Message

Three systematic reviews, nine randomized controlled trials, and two guidelines were identified that addressed the research questions, and the results were mixed.

One randomized controlled trial was identified and provided results regarding the clinical effectiveness of pharmacological and non-pharmacological smoking interventions for youth. Evidence from this randomized controlled trial suggested that there were no significant differences in smoking cessation or smoking frequency outcomes between brief advice, nicotine patch therapy and a 6-week text messaging intervention (intervention) and brief advice and nicotine patch therapy (control).

Three systematic reviews and eight randomized controlled trials were identified and examined the clinical effectiveness a variety of different non-pharmacological smoking interventions for youth. Evidence from the systematic reviews did not reveal improved smoking cessation outcomes for most comparisons; two comparisons via meta-analyses did find improved smoking cessation outcomes in favour of the intervention. Of the seven randomized controlled trials that examined smoking cessation outcomes, three studies found reductions in favour of the smoking cessation intervention, three did not find differences between groups, and one study found improvements at 3-months in favour of the intervention but not at 6-month follow-up. Mixed findings were found for other key clinical outcomes, such as smoking behaviour and quitting outcomes.

Two evidence-based guidelines regarding smoking cessation interventions for youth were identified; one guideline was commissioned by National Institute for Health and Care Excellence and the other by the Canadian Task Force on Preventive Health Care. The National Institute for Health and Care Excellence guideline recommends the consideration of nicotine replacement therapy for young people who are dependent on nicotine (strength of recommendation: weak); if nicotine replacement therapy is prescribed, the guideline recommends offering it with behavioural support (strength of recommendation: strong). The Canadian Task Force on Preventive Health Care guidelines recommend asking children and youth smokers or their parents about tobacco use by the child or youth and offering brief information and advice during primary care visits (strength of recommendation: weak). Both guidelines used rigorous methodology to inform their recommendations, but the studies included to inform the recommendations were of varying quality, ranging from low to moderate quality.

It may be premature to draw conclusions about pharmacological and non-pharmacological smoking cessation interventions for youth given the mixed findings identified in this report.

Manual Therapy for Persistent, Non-Cancer Back and Neck Pain: A Review of Clinical Effectiveness

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Question(s)

  1. What is the clinical effectiveness of manual therapy for chronic non-cancer back and neck pain?

Key Message

Four systematic reviews with meta-analyses (that included 27 unique relevant primary studies) were identified regarding the clinical effectiveness of manual therapy for adults with chronic non-cancer back and neck pain.

The systematic reviews were largely well-conducted (despite the methodological limitations of their included primary studies), and all evaluated the clinical effectiveness of various manual therapies compared with sham interventions (i.e., placebo) or no treatment. The effectiveness of manual therapy for chronic non-cancer back and neck pain was unclear due to variation in findings, significant clinical heterogeneity (e.g., differences in type of manual therapy, frequency and duration of treatments, length of follow-up), and concerns with the methodological quality of relevant primary studies. In most cases, treatment with manual therapy did not result in statistically significant differences when compared to sham therapy or no treatment in adults with persistent or chronic non-cancer back and neck pain; however, there was some evidence that suggested treatment with manual therapies improved pain, functional status, and health-related quality of life. Overall, manual therapies and their comparators (sham treatment or no treatment) were well-tolerated but were associated with mild transient adverse events such as discomfort and tiredness.

No evidence was identified regarding the comparative clinical effectiveness of manual therapies versus pharmacological interventions for adults with chronic non-cancer back and neck pain. The limitations of the included literature (e.g., high risk of performance bias due to a lack of blinding, lack of long-term follow-up data, substantial heterogeneity) should be considered when interpreting the findings of this report.

Botulinum Toxin for Temporomandibular Disorders: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the clinical effectiveness of botulinum toxin A for temporomandibular disorders?
  2. What is the cost-effectiveness of botulinum toxin A for temporomandibular disorders?
  3. What are the evidence-based guidelines regarding the treatment of temporomandibular disorders?

Key Message

None of the included systematic reviews expressed confidence in the clinical effectiveness of Botox for treating temporomandibular disorder (TMD). While there were some primary studies indicating improvements in pain scores for botulinum toxin relative to saline injections, this finding was not consistently reported across all studies and the clinical significance of the improvements was uncertain. The evidence suggests that botulinum toxin is not superior to occlusive devices, dry needling or fascial manipulation.

In the primary studies, there was heterogeneity in TMD clinical presentation, botulinum toxin administration techniques and comparator treatment approaches and this creates significant uncertainty about the clinical utility for Botox in TMD. Assessing generalizability of the results to the Canadian context is difficult given these issues.

While there have been no consistent signals of increased risk of harm for botulinum toxin relative to control groups in the data reviewed, none of the primary studies were rigorously designed to study harms. This is an important issue to be addressed in future research since botulinum toxin treatment for TMD is an invasive procedure with some risks inherent in its administration.

There was no evidence to inform the cost effectiveness of botulinum toxin in TMD and no clinical practice guidelines were identified.

Flash Glucose Monitoring System FreeStyle Libre to Monitor Glycemia in Patients With Diabetes

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Devices to monitor glycemia have recently evolved to reduce the number of steps required as compared with the traditional approach — i.e., the self-monitoring of blood glucose using test strips. One of these devices is FreeStyle Libre, which uses a technology called a flash glucose monitoring system (FGMS). An FGMS enables patients to measure their glycemia without the routine pricking of their fingers.

Remote Monitoring Programs for Cardiac Conditions in Canada

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Canada's Drug Agency is undertaking an Environmental Scan of the remote monitoring programs for people with chronic heart failure, atrial fibrillation, hypertension, and for people undergoing cardiac rehabilitation for acute and chronic conditions. This project is being conducted to help inform decision-making and to support the implementation of remote monitoring programs for these indications in rural, remote, and urban settings.

The key objectives of this Environmental Scan are to: