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Harmonization of Public Coverage Policies for Biologic Drugs in the Treatment of Rheumatoid Arthritis

Details

The treatment of rheumatoid arthritis (RA) has improved considerably with the availability of specialty drugs and better disease management strategies. Although advances in therapy may have resulted in improved outcomes for some patients, the introduction of effective and often more costly drugs has resulted in increased public drug program spending. In light of budget constraints, public health care payers have implemented strategies for the use of these medications, including criteria for biologic disease-modifying antirheumatic drugs for eligible persons.

Last Updated : April 17, 2020

Serial X-Ray Radiography for the Diagnosis of Osteomyelitis: A Review of Diagnostic Accuracy, Clinical Utility, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the diagnostic accuracy of serial X-ray radiography in adults with suspected osteomyelitis?
  2. What is the clinical utility of serial X-ray radiography in adults with suspected osteomyelitis?
  3. What is the cost-effectiveness of serial X-ray radiography in adults with suspected osteomyelitis?
  4. What are the evidence-based guidelines regarding the use of diagnostic modalities in adults with suspected osteomyelitis?

Key Message

This review included three evidence-based guidelines for diagnosis of peripheral bone infection, diabetic foot infection, and native vertebral osteomyelitis in adults. No studies on the diagnostic accuracy, clinical utility and cost-effectiveness of serial X-ray radiography for diagnosis of osteomyelitis were identified.

All three guidelines were considered to be of good methodological quality. Based on moderate to low quality evidence, the guidelines had recommendations for diagnosis of osteomyelitis regarding medical examination, laboratory tests, bone biopsy and bone culture, and imaging tests. Bone biopsy and bone culture are considered as the reference standard to confirm the infection and identify the causative microorganism. Although magnetic resonance imaging, positron emission tomography and single-photon emission computed tomography were found to have higher diagnostic performance than radiography, it is recommended that conventional X-ray radiography should be the first imaging modality for detection of osteomyelitis, particularly for suspected peripheral bone infection or for osteomyelitis in diabetic foot infection. With suspected native vertebral osteomyelitis, spine magnetic resonance imaging, when feasible, is recommended as first imaging of choice. Subsequent imaging tests may be considered depending on the extent of the investigation, the availability of the imaging modalities, the level of diagnostic accuracy required, the complexity of the disease, and any contraindications.

There is a need for studies examining the diagnostic accuracy, clinical utility and cost-effectiveness of serial X-ray radiography for detection of osteomyelitis in adults.

Last Updated : March 23, 2020

Propranolol for Post-Traumatic Stress Disorder: A Review of Clinical Effectiveness

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Question(s)

  1. What is the clinical effectiveness of administering propranolol before trauma memory reactivation for patients with post-traumatic stress disorder?
  2. What is the clinical effectiveness of propranolol for the prevention of post-traumatic stress disorder or acute stress disorder?

Key Message

This report included four systematic reviews (that summarized nine unique relevant primary studies), three randomized controlled trials, and one non-randomized study regarding the clinical effectiveness of propranolol for the treatment and prevention of post-traumatic stress disorder (PTSD).

Based on the findings from the included literature, propranolol administered prior to trauma memory reactivation decreased the severity of PTSD symptoms, reduced physiological responses (e.g., heart rate, skin conductance, blood pressure), and improved cognitive performance in individuals with PTSD. Although these findings were largely consistent, one included study did not show a significant difference between treatment with propranolol and placebo with respect to severity of PTSD symptoms.

When used as a preventative measure following trauma, propranolol did not significantly reduce the risk for subsequent PTSD or acute stress disorder compared to placebo or no treatment. In addition, those who received propranolol did not consistently demonstrate improvements to PTSD symptom severity scores compared to those who received placebo or no treatment.

Regardless of the indication, individuals treated with propranolol experienced similar side effects to those who received placebo (when adverse events were reported); however, the included studies were not designed to thoroughly investigate the harms associated with the use of propranolol and these findings are indeterminate.

Last Updated : March 23, 2020

Assessment of Dehydration and Oral Rehydration Therapy for Pediatric Patients with Dehydration: A Review of Clinical Effectiveness, Clinical Utility, and Guidelines

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Question(s)

  1. What is the clinical utility of diagnostic tools for assessing dehydration in pediatric patients?
  2. What is the clinical effectiveness of methods of administration of oral rehydration therapy dehydration in pediatric patients?
  3. What are the evidence-based guidelines regarding assessment of dehydration in pediatric patients?
  4. What are the evidence-based guidelines regarding oral rehydration therapy in pediatric patients?
  5. What are the evidence-based guidelines regarding oral rehydration therapy in pediatric patients in an at-home setting by parents or caregivers?

Key Message

Two guidelines recommend oral rehydration therapy for mild to moderated dehydration in pediatric patients (strong recommendation, moderate to high level evidence). One guideline also recommends use of antiemetic agents such as ondansetron to facilitate tolerance of oral rehydration therapy in children (older than four years) and adolescents with acute gastroenteritis associated with vomiting (weak recommendation, moderate level evidence). One systematic review of 15 guidelines reported that the guidelines recommend oral rehydration therapy as first-line treatment in pediatric patients with acute gastroenteritis and moderate dehydration (strength of recommendation: not reported, level of evidence mostly moderate).This systematic review also reported that the guidelines recommend assessment of dehydration based on signs and symptoms (strength of recommendation not reported; level of evidence low or not reported), and a few of these guidelines recommend use of scoring systems.

Findings need to be interpreted in the light of limitations such as sparse reporting of methodological details and evidence supporting the recommendations. 

No relevant evidence on the comparative clinical utility of diagnostic tools for assessing dehydration was identified, therefore a summary cannot be provided.

No relevant evidence on the comparative clinical effectiveness of methods of administration of oral rehydration therapy in pediatric patients was identified.

Last Updated : March 23, 2020

The Use of Real-World Evidence for Medical Device Assessment ─ An Environmental Scan


(December 17, 2024)
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Abbreviations

  • EHR electronic health record
  • EMR electronic medical record
  • HC Health Canada
  • HF heart failure
  • HTA health technology assessment
  • PCC Pan-Canadian Health Technology Assessment Collaborative
  • RCT randomized controlled trial
  • RWD real-world data
  • RWE real-world evidence

Summary

    Experiences with and Expectations of Robotic Surgical Systems: A Rapid Qualitative Review

    Details

    Question(s)

    1. How have people undergoing surgery with the use of robotic surgical systems, and the surgical teams using them, experienced engaging with these systems?
    2. What are their (both patients and surgical teams) expectations for, and perspectives of, robotic surgical
    3. What are their (both patients and surgical teams) experiences relating to decision-making, surgery, recovery, and long-term impact of robotic surgical systems on their lives or care practices?
    4. When deciding whether to engage with robotic surgery, what is involved and what do patients and their surgical teams consider?

    Key Message

    A total of 14 publications that investigated how surgical teams and patients perceive and experience robotic surgery (RS) were included in this review. All but three studies focused on the perspectives of surgical teams. 

    There appears to be positive perspectives and excitement around RS and its potential. Surgical staff perceive RS to impact job roles and workflows by increasing job demands and technical knowledge. The set-up phase of RS is particularly time-consuming but is necessary to ensure patient safety and robot functions. 

    There is a steep learning curve to RS, and comprehensive and uniform training and education should be required for all surgical staff engaged in RS. 

    The sensory experience of RS is different from, and perhaps an improvement upon, the sensory experience of laparoscopic or open surgery. Tactile feedback is lost for surgeons in RS, creating a reliance on visual cues. The position in RS for the surgeon may be more physically comfortable than in laparoscopic or open surgery. 

    Appropriate institutional conditions and support and engagement throughout the organization are required for surgical staff to engage with RS. Surgical staff require on-demand technical support for the RS to address technical issues during surgery and to alleviate stress and concerns among staff. 

    Excellent surgical team dynamics, which include communication, trust, and positive relationships, are necessary to ensure effectiveness, safety, and efficiency during robotic procedures. A whole team training approach or a dedicated RS team were suggested as strategies to ensure team dynamics. 

    Findings were mixed around surgical teams’ perspectives related to patient outcomes and recovery. Some participants perceived there to be positive benefits to their patients from RS while some participants did not view RS to be suitable for all patients or procedures. There were no findings related to the long-term impact of RS on patient lives or care practices. 

    Patients require more information, education, and support for decision-making for RS procedures. Evidence points to a potential lack of understanding about RS and patient perspectives may differ by sex; however, due to limited published literature exploring their experiences, the patient perspective was an overall gap in this review.

    Last Updated : March 19, 2020

    Prevention of Tuberculosis: A Review of Guidelines

    Details

    Question(s)

    1. What are the evidence-based guidelines for the prevention of tuberculosis infection?

    Key Message

    Nine evidence-based guidelines for the prevention of tuberculosis (TB) infection were identified and included in this report.Five guidelines include recommendations regarding the use of the Bacillus Calmette-Guérin (BCG) vaccine for the prevention of TB. Six guidelines include recommendations regarding risk reduction measures to reduce the risk of TB transmission. Overall, there are three high-quality, one moderate-quality, and five low-quality guidelines that include between one and 71 recommendations on the prevention 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.

    Last Updated : March 18, 2020

    Tuberculosis in People with Compromised Immunity: A Review of Guidelines

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    Question(s)

    1. What are the evidence-based guidelines for the prevention, identification, or treatment of tuberculosis in people with compromised immunity?

    Key Message

    Twenty evidence-based guidelines for the prevention, identification, or treatment of TB were identified and included in this report. Four guidelines made recommendations regarding the prevention of TB in patients with compromised immunity. Twelve guidelines made recommendations regarding the identification of LTBI and nine guidelines made recommendations regarding the identification of active TB disease in patients with compromised immunity. For the treatment of TB in patients with compromised immunity, ten guidelines made recommendations regarding the treatment of LTBI and ten guidelines made recommendations regarding the treatment of active TB disease.Overall, there are seven high-quality, one moderate-quality, and twelve low-quality guidelines that include between one and 47 recommendations on TB in patients with compromised immunity. The recommendations vary in strength and the quality of the evidence, as well as the population of interest. The population and topic of interest may determine which guideline(s) and which recommendation(s) are of interest.

    Last Updated : March 18, 2020

    Treatment of Tuberculosis: A Review of Guidelines

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    Question(s)

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

    Key Message

    Eleven evidence-based guidelines for the treatment of tuberculosis (TB) were identified and included in this report. Four guidelines include recommendations regarding therapies for treating latent TB infection. Seven guidelines include recommendations regarding the treatment options for active TB disease. Nine guidelines include recommendations about different approaches for administering TB treatments. Overall, there were four high-quality and seven low-quality guidelines that include between one and 23 recommendations on the treatment 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.

    Last Updated : March 18, 2020

    Drug-Resistant Tuberculosis: A Review of the Guidelines

    Details

    Question(s)

    1. What are the evidence based-guidelines regarding the prevention, identification, or treatment of drug-resistant pulmonary tuberculosis?

    Key Message

    Ten evidence-based guidelines regarding drug-resistant tuberculosis were identified and included in this report. Seven guidelines include recommendations regarding the identification of drug-resistant tuberculosis. Nine guidelines include recommendations regarding the treatment of drug-resistant tuberculosis. Two guidelines include recommendations for infection control practices for caring for patients with drug-resistant tuberculosis.Overall, there are three high-quality guidelines and seven low-quality guidelines that include between three and 29 recommendations on drug-resistant tuberculosis. 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.

    Last Updated : March 18, 2020