Biomarker-Based Point-of-Care Tests for the Evaluation of Mild Traumatic Brain Injury

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Methods

Canada's Drug Agency Horizon Scanning bulletins present an overview of the technology and available evidence on a given topic. They are not systematic reviews and do not involve the critical appraisal of all studies or include a detailed summary of study findings. They are not intended to provide recommendations for or against a particular technology.

Saliva-Based Tests to Detect Active Severe Acute Respiratory Syndrome Coronavirus 2 Infection

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New saliva-based tests for severe acute respiratory syndrome coronavirus 2 are more comfortable for individuals being tested and may pose less risk to health care workers than alternative tests

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.

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.

Pharmacogenomic Testing in Depression: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the clinical effectiveness of pharmacogenomic testing for treating all severities of diagnosed depression?
  2. What is the cost-effectiveness of pharmacogenomic testing for treating all severities of diagnosed depression?
  3. What are the evidence-based guidelines for pharmacogenomic testing in patients with all severities of diagnosed depression?

Key Message

This review was comprised of one health technology assessment report, two systematic reviews with meta-analyses, one randomized controlled trial, and three economic evaluations regarding pharmacogenomic testing versus treatment as usual for treating all severities of diagnosed depression.

One health technology assessment report suggested that the evidence for pharmacogenomic testing for depressive disorders was limited and of low to very low quality for different outcomes measured. The authors concluded that the evidence was insufficient for forming conclusions regarding clinical use. One systematic review with meta-analysis suggested that pharmacogenetic-guided prescribing had a positive effect on the likelihood of achieving symptom remission which may be confined to individuals with moderate to severe depression and a history of inadequate response or intolerability to previous psychotropic medications. One systematic review with meta-analysis suggested that the evidence was limited in quality and quantity and that primary studies suggestive of a positive effect of pharmacogenomic testing in major depressive disorders were mostly of low quality. One randomized controlled trial reported no significant difference in the improvement of depressive symptoms or safety outcomes between pharmacogenomic testing guided and unguided groups.

The health technology assessment report stated that results in one cost-effectiveness study suggested moderate cost-effectiveness of pharmacogenomics testing given the probability of having an incremental cost-effectiveness ratio below the international $1,926 cost-effectiveness threshold was 90%, while another study suggested that based on the commonly used threshold of $50,000 per quality-adjusted life year, pharmacogenomics testing would not be cost-effective. One included systematic review reported the probability of pharmacogenomics testing being cost-effective at the willingness to pay threshold of $50,000 was 94.5%. One9 of the three included economic evaluations reported the lack of conclusion on cost-effectiveness of screening for CYP2D6 in primary care patients using antidepressants. Two economic evaluations reported that pharmacogenomics testing was dominant over treatment as usual.

One guideline within the health technology assessment report recommended that a combination of therapeutic drug monitoring and genotyping may be informative in potentially nonadherent patients.

Screening and Treatment of Obstetric Anemia: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the clinical effectiveness of screening obstetric iron deficiency in the first or second trimester using ferritin testing?
  2. What is the cost effectiveness of for screening obstetric iron deficiency in the first or second trimester using ferritin testing?
  3. What are the evidence-based guidelines for assessing and treating obstetric iron deficiency?

Key Message

This review included ten guidelines. No clinical or economic studies were identified on screening for obstetric iron deficiency anemia in the first or second trimester using ferritin testing.Routine hemoglobin measurement at each trimester of pregnancy is generally recommended to assess iron deficiency anemia. Serum ferritin testing should be reserved for pregnant persons with possible hemoglobinopathies (e.g., thalassemia, sickle cell anemia), anemia of infection, vitamin B12 or folic acid deficiency, unexplained iron deficiency anemia, non-anemic persons at risk of iron deficiency, or suspected chronic blood loss. After delivery, hemoglobin should be measured within 24 to 48 hours in persons with blood loss more than 500 mL, those with uncorrected anemia detected during pregnancy or those with symptoms suggestive of anemia postnatally. Oral iron is the first line treatment with repeated measure of hemoglobin to assess compliance, correct administration and response to treatment. Intravenous iron should be used in persons who are intolerant of, or do not respond to oral iron treatment, or those with moderately severe to severe anemia. One guideline could not assess the benefits and harms of screening and iron supplementation in pregnant persons due to insufficient evidence. While the scope and purpose of the included guidelines were clearly described, only half of the identified guidelines were explicit in terms of rigour of development and authors assessed the level of evidence, which was deemed to be of very low to moderate quality. Therefore, these recommendations should be interpreted with caution.

Biopsy for Adults with Suspected Skin Cancer: A Rapid Qualitative Review

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Question(s)

  1. How do people with suspected skin cancer view skin biopsy? What are their perspectives on, expectations of, and preferences for skin biopsy and the diagnostic process for suspected skin cancer?
  2. How do health care providers who care for people with suspected skin cancer view skin biopsy? What are their perspectives on, expectations of, and preferences for with skin biopsy and the diagnostic process for suspected skin cancer?

Key Message

This review used thematic synthesis to synthesize the results of 12 included publications and described how people with suspected skin cancer and their health care providers experienced the process of diagnosis. People who were diagnosed with skin cancer were often the ones who noticed a suspicious looking lesion or mole that triggered their diagnosis. They described experiencing delays in being diagnosed because they did not immediately present to a health care provider for a variety of reasons, including being busy or not thinking it was serious. Other times people experienced a delay in being diagnosed because their physician did not order further testing or offered them reassurances that their lesions were non-cancerous. People with a concerning lesion or mole were not always reassured by their health care providers words and instead persisted in getting diagnosed by seeking a second opinion or by continuing to bring their concerns forward to their health care provider. Health care providers raised worries about the impact of referring people who turn out to not have skin cancer on the health care system. Once diagnosed, people with skin cancer described how skin cancer was an emotionally destabilizing and shocking experience. Being diagnosed with skin cancer raised fears of death and about the future. People had to at once navigate their treatment while coping with their feelings. With clear information and adequate time for consultation, communication with health care providers left people diagnosed with skin cancer felt supported and informed and able to navigate their treatment. The importance of communication with health care providers in the experiences of those diagnosed with skin cancer highlights the emotional and physical needs of skin cancer patients.After treatment, people who had been diagnosed found themselves continuing to watch their bodies and coping with feelings of uncertainty and anxiety about their future. People who had been treated described how waiting for test results was particularly fraught with anxiety during the follow-up period.

Genome-Wide Sequencing: Ethical Considerations

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This Genome-Wide Sequencing: Ethical Considerations Technology Review was conducted by Canada's Drug Agency in collaboration with Health Quality Ontario (HQO), together with a supporting rapid review of the qualitative evidence of patient preferences.

Detection and Diagnosis of Sepsis in Rural and Remote Areas: An Environmental Scan

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Canada's Drug Agency undertook an Environmental Scan to understand current practices for detecting and diagnosing sepsis in remote and rural health care settings across Canada.

The key objectives of this Environmental Scan were: