Canada’s Drug Agency | Drugs, Health Technologies and Systems.

Onabotulinum Toxin A for Spasticity Associated with Multiple Sclerosis

Details

Question(s)

  1. What is the clinical effectiveness of onabotulinum toxin A (Botox) in the treatment of spasticity associated with multiple sclerosis?
  2. What is the cost-effectiveness of onabotulinum toxin A (Botox) in the treatment of spasticity associated with multiple sclerosis?
  3. What are the evidence-based guidelines for the use of onabotulinum toxin A (Botox) in a treatment regimen for spasticity associated with multiple sclerosis?

Key Message

Evidence-based clinical practice guidelines recommend the use of botulinum toxin (which includes onabotulinum toxin A [Botox]) to treat spasticity caused by multiple sclerosis. There is a lack of recent evidence regarding the clinical and cost-effectiveness of Botox as a treatment for spasticity caused by multiple sclerosis; thus, there is a need for well-designed studies on this topic.

Last Updated : March 11, 2021

Codeine for Acute Dental Pain and Acute Pain Related to Dental Procedures

Details

Question(s)

  1. What is the clinical effectiveness of codeine for patients with acute dental pain or pain related to dental procedures?
  2. What is the clinical effectiveness of codeine with acetaminophen and/or a nonsteroidal anti-inflammatory drug for patients with acute dental pain or pain related to dental procedures?

Key Message

Two overviews of systematic reviews, 4 systematic reviews, and 9 randomized controlled trials were identified comparing codeine or codeine combination drugs with placebo and/or other drugs in the management of acute dental pain. As compared to placebo, codeine was generally shown to offer a benefit to patients experiencing acute dental pain. When compared to other drugs and/or drug combinations particularly those that were acetaminophen- or ibuprofen-based codeine generally was not found to be as clinically effective for the management of acute dental pain, with the potential exception of tooth sensitivity following dental bleaching, where 1 study reported that acetaminophen plus codeine was statistically significantly superior to ibuprofen or placebo. Increased adverse events were observed with codeine-containing drugs as compared to other drugs and/or placebo. Studies included in this review demonstrated both strengths and limitations, some of which limit the extent to which the findings from these studies were relevant to this report and/or can be generalized.

Last Updated : March 3, 2021

Codeine for Pain Related to Caesarean Section: A Review of Clinical Effectiveness

Details

Question(s)

  1. What is the clinical effectiveness of codeine for patients who underwent Caesarean section?
  2. What is the clinical effectiveness of codeine with acetaminophen and/or a nonsteroidal anti-inflammatory drug for patients who underwent Caesarean section?

Key Message

Caesarean section rates have increased over the past 3 decades. Caesarean section is often associated with acute post-operative abdominal pain and medications containing codeine have been used for pain management. There are concerns related to the use of codeine for this purpose, particularly regarding the potential for neonatal toxicity and opioid-related adverse events for the postpartum patient. There is limited evidence regarding the clinical effectiveness of codeine, with or without acetaminophen or nonsteroidal anti-inflammatory drugs, in patients who have undergone Caesarean section. One randomized controlled trial found that codeine in combination with paracetamol (i.e., acetaminophen) provided better pain relief compared to paracetamol only or placebo in patients with high levels of post-Caesarean section pain. However, no difference in pain relief was observed between codeine in combination with paracetamol, paracetamol only, or placebo in patients with moderate levels of post-Caesarean section pain. No evidence was found regarding the clinical effectiveness of codeine alone for acute pain in this specific population.

Last Updated : March 3, 2021

Stellate Ganglion Block for the Treatment of Post-Traumatic Stress Disorder, Depression, and Anxiety

Details

Question(s)

  1. What is the clinical effectiveness of stellate ganglion block for the treatment of post-traumatic stress disorder?
  2. What is the clinical effectiveness of stellate ganglion block for the treatment of depression or anxiety?
  3. What are the evidence-based clinical practice guidelines regarding the use of stellate ganglion block for the treatment of post-traumatic stress disorder, depression, or anxiety?

Key Message

The evidence regarding the clinical effectiveness of stellate ganglion block for the treatment of post-traumatic stress disorder was mixed. A randomized controlled trial included in a systematic review did not detect significant differences in post-traumatic stress disorder symptoms in the stellate ganglion block versus sham groups, while another randomized controlled trial did detect significantly greater improvements in symptoms between these groups. Furthermore, the second randomized controlled trial detected significantly greater improvements in depression, anxiety, and distress, but not in pain and mental and physical functioning for participants receiving stellate ganglion block compared to sham. Authors of the randomized controlled trial included in the systematic review did not detect significant differences in rates of adverse events between groups. Of the 6 adverse events reported in the second randomized controlled trial, 3 were deemed related to stellate ganglion block treatment (injection site pain, self-resolving bradycardia, and temporary laryngeal irritation); the statistical analysis was not reported. Authors of 1 evidence-based guideline were unable to provide recommendations for or against the use of stellate ganglion block for the treatment of post-traumatic stress disorder because of insufficient evidence. No relevant literature or guidelines regarding the clinical effectiveness or use of stellate ganglion block for the treatment of depression or anxiety were identified.

Last Updated : March 3, 2021

Rituximab for the Treatment of Neuromyelitis Optica Spectrum Disorder

Details

Question(s)

  1. What is the clinical effectiveness of rituximab for the treatment of individuals with NMOSD?
  2. What is the cost-effectiveness of rituximab for the treatment of individuals with NMOSD?
  3. What are the evidence-based guidelines regarding the use of pharmacotherapy for the treatment of individuals with NMOSD?

Key Message

Four systematic reviews, 1 randomized controlled trial (RCT), 1 economic evaluation, and 2 evidence-based guidelines were identified.Four systematic reviews (2 that included moderate- to high-quality evidence and 2 that did not report the quality of the evidence) and 1 RCT (that provided high-quality evidence) reported on the clinical effectiveness of rituximab (RTX) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Overall, RTX treatment appeared to reduce the relapse rate and disability level compared with pre-treatment or placebo. In terms of reduction in relapse rate and disability, RTX was either better or not different from azathioprine (AZA). For relapse rates, disability levels, and incidence of adverse events, network meta-analyses showed that no treatment was favoured for comparisons between RTX, mycophenolate mofetil (MMF), and cyclophosphamide (CYP).One economic evaluation (of moderate quality) showed that, for patients with NMOSD, in the context of the Thai health care system, RTX biosimilar with CD27+ memory B cell monitoring regimen had the highest probability (48%) of being cost-effective, followed by AZA (30%), MMF (13%), RTX with CD27+ memory B cell monitoring regimen (9%), RTX biosimilar (0%), and RTX (0%) at a willingness-to-pay threshold of 160,000 Thai bhat (equivalent to US$5,289 in 2019 values) per quality-adjusted life-year gained.The 2 guidelines recommended immunosuppressants (RTX, AZA, and MMF) for prevention of NMOSD attacks. In addition, 1 guideline mentioned that tocilizumab, eculizumab, inebilizumab, and satralizumab can be used in NMOSD leave it up to patients who have no response to other immunosuppressants. The quality of the evidence that informed the guidelines and the strength of the recommendations were not reported.Findings need to be interpreted with caution given the limited quantity of evidence on comparative efficacy and safety between various immunosuppressants, that many of the included primary studies were retrospective studies, the heterogeneity among the studies included in the systematic reviews, and the lack of clarity with respect to the strength of the recommendations.

Last Updated : February 9, 2021

Patient Navigation Programs for People With Dementia

Details

Question(s)

  1. What is the clinical utility of patient navigation programs for people with dementia?
  2. What is the cost-effectiveness of patient navigation programs for people with dementia?
  3. What are the evidence-based guidelines regarding the use of patient navigation services for people with any medical condition?

Key Message

Patient navigation programs are generally community-based service delivery interventions (such as collaborative care, coordinated care, and case management) intended to enhance timely access to the diagnosis and treatment of individuals with chronic conditions, including dementia. Overall, for coordinated care compared with usual care, clinical findings were either mixed or there were no between-group differences in terms of hospitalization, institutionalization, or nursing home admissions; quality of life; or symptoms. For coordinated care compared with usual care, there was no statistically significant between-group difference in mortality. However, there was evidence of improvement in terms of behaviour with coordinated care compared with usual care. According to 1 economic evaluation, for patients with dementia, with the majority having no or mild cognitive impairment, collaborative dementia care management provided increased benefit (quality-adjusted life-years gained) at decreased cost. Three guidelines were identified that provided recommendations for care coordination. One guideline recommends coordinated care for people living with dementia that is organized by a single-named health or social care professional. The second guideline recommends the use of digital technology to enhance care coordination in persons with mental illness. The third guideline recommends coordinated care for people with delirium, dementia, and depression. Findings need to be interpreted in the light of limitations (such as lack of information in the study populations’ type of dementia, mixed findings in outcomes, and lack of information beyond 24 months of follow-up).

Last Updated : February 24, 2021

The Canadian Medical Imaging Inventory 2019 - 2020

Details

Abbreviations

AI artificial intelligence
CADTH Canadian Agency for Drugs and Technologies in Health
CAR Canadian Association of Radiologists
CCOHTA Canadian Coordinating Office for Health Technology Assessment
CDST clinical decision support tool
CIHI Canadian Institute for Health Information
CMII
Last Updated : January 15, 2021

Rapid Testing for the Diagnosis of Pulmonary Tuberculosis and Rifampicin Resistance: A Review of Cost-Effectiveness

Details

Question(s)

  1. What is the cost-effectiveness of rapid and simultaneous tuberculosis and antibiotic susceptibility testing for the detection of pulmonary tuberculosis or rifampicin resistance?

Key Message

The evidence regarding the cost-effectiveness of the Xpert Mycobacterium tuberculosis complex and resistance to rifampicin (Xpert MTB/RIF) test compared with smear microscopy in diagnosing tuberculosis is summarized in this report. Results from the included 6 studies showed that Xpert MTB/RIF testing is a cost-effective option compared with sputum smear microscopy. However, the generalizability of the results to the Canadian setting are unclear because of the clinical data source populations, willingness-to-pay thresholds, and assumptions used in the analyses. There is a lack of evidence regarding the cost-effectiveness of Xpert MTB/RIF testing compared with mycobacterial cultures or culture-based susceptibility testing.

Last Updated : February 19, 2021

Incentives and Support Programs to Improve Adherence to Tuberculosis Treatment

Details

Question(s)

  1. What is the clinical effectiveness of adherence incentives and support programs in those who require assistance to complete their tuberculosis treatment?
  2. What are the evidence-based guidelines regarding the use of adherence incentives and support programs in those who require assistance completing their tuberculosis treatment?

Key Message

Three overviews of reviews and 11 systematic reviews were identified regarding the clinical effectiveness of adherence incentives in those who require assistance to complete their tuberculosis treatment.Four evidence-based guidelines were identified that provided recommendations regarding the use of adherence incentives in those who require assistance completing their tuberculosis treatment.The reported clinical effectiveness of adherence incentives for patients with tuberculosis was mixed. There were no detrimental effects of providing incentives, but there was also no conclusive evidence pointing to a clinical benefit. The overall quality of the included reviews was moderate to high.The included guidelines recommended that incentives and enablers be included as a part of a patient-centred strategy for treatment and for patients with active tuberculosis or patients at high risk; however, the evidence formulating these recommendations was of low certainty or quality. Two of the included guidelines were of high methodological quality, and 2 were of lower methodological quality.

Last Updated : February 18, 2021

Peripherally Inserted Central Catheters in Pediatric Patients Performed by Radiologists Using Fluoroscopy

Details

Question(s)

  1. What is the comparative clinical effectiveness of peripherally inserted central catheter (PICC) insertions performed by radiologists in interventional radiology suites versus PICC insertions performed by nurses at the bedside/unit in pediatric patients?
  2. What are the evidence-based guidelines regarding the optimal approach for PICC insertions in pediatric patients?

Key Message

Evidence from 2 clinical studies showed that there was no difference in the rates of infection and complications between peripherally inserted central catheter (PICC) insertion at the bedside and insertion in Interventional Radiology (IR) suites. However, each of these studies focused on small subgroups of the larger pediatric population and had other methodological limitations. Evidence from 1 clinical study in a single quaternary, non-cardiac, pediatric intensive care unit suggested that the median time from PICC line order to successful insertion was longer for lines placed in the IR compared to at the bedside. Two guidelines with numerous quality limitations were identified that recommend ultrasound guidance for insertion of central venous access devices (CVAD), including PICCs: 1 was aimed at all pediatric patients and 1 was aimed at onco-hematological pediatric patients.

Last Updated : January 22, 2021