What Is the Issue? Reprocessing a medical device includes cleaning, reconditioning, testing, and disinfection to ensure the device can safely be reused. In contrast to reusable medical devices, manufacturers are not required to provide instructions for properly cleaning and sterilizing single-use medical devices (SUMDs). Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers. Health Canada does not provide oversight for hospital onsite reprocessing, deferring to the oversight provided at the provincial and territorial levels. Given the potential economic and environmental benefits of using reprocessed SUMDs, there is a growing interest in determining the clinical safety of reprocessed SUMDs. Current standards for reprocessing medical devices use definitions for sterilization and disinfection based on measurement of bioburden, but not necessarily clinical outcomes such as infection. What Did We Do? To inform decisions about the appropriate use of reprocessed critical and semicritical SUMDs, CADTH sought to identify and summarize literature evaluating the clinical safety of reprocessed SUMDs, defined as infections, mortality, or other adverse events, compared with nonreprocessed (new) SUMDs. Microbiological outcomes, such as bacterial colony counts, were not included. An information specialist searched for peer-reviewed and grey literature sources. This report does not provide a comprehensive list of device reprocessors in Canada or recommend any specific methods of reprocessing medical devices. What Did We Find? We identified 8 studies, including one study based in Canada, that evaluated the use of reprocessed SUMDs compared with new SUMDs; most did not report statistically significant differences in patient outcomes between groups. Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices. Half of the included studies were published before the year 2005, which may limit applicability given potential improvements and changes over time in reprocessing standards, surgical approaches, device specifications, and patient care protocols. Most of the studies evaluated a different type of reprocessed single-use medical device for different surgical populations, so there is very limited evidence for the use of a specific device in a specific population or intervention of interest. All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings. What Does it Mean? Given various devices, clinical applications, and reprocessing methods, it is difficult to draw broad conclusions about the appropriateness of reprocessing SUMDs. While the evidence base in this review was insufficient to conclude whether
{"title":"Reprocessed Single-Use Semicritical and Critical Medical Devices","authors":"Kellee Kaulback, Jennifer Horton","doi":"10.51731/cjht.2024.854","DOIUrl":"https://doi.org/10.51731/cjht.2024.854","url":null,"abstract":"What Is the Issue? \u0000 \u0000Reprocessing a medical device includes cleaning, reconditioning, testing, and disinfection to ensure the device can safely be reused. In contrast to reusable medical devices, manufacturers are not required to provide instructions for properly cleaning and sterilizing single-use medical devices (SUMDs). \u0000Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers. Health Canada does not provide oversight for hospital onsite reprocessing, deferring to the oversight provided at the provincial and territorial levels. Given the potential economic and environmental benefits of using reprocessed SUMDs, there is a growing interest in determining the clinical safety of reprocessed SUMDs. \u0000Current standards for reprocessing medical devices use definitions for sterilization and disinfection based on measurement of bioburden, but not necessarily clinical outcomes such as infection. \u0000 \u0000What Did We Do? \u0000 \u0000To inform decisions about the appropriate use of reprocessed critical and semicritical SUMDs, CADTH sought to identify and summarize literature evaluating the clinical safety of reprocessed SUMDs, defined as infections, mortality, or other adverse events, compared with nonreprocessed (new) SUMDs. Microbiological outcomes, such as bacterial colony counts, were not included. An information specialist searched for peer-reviewed and grey literature sources. \u0000This report does not provide a comprehensive list of device reprocessors in Canada or recommend any specific methods of reprocessing medical devices. \u0000 \u0000What Did We Find? \u0000 \u0000We identified 8 studies, including one study based in Canada, that evaluated the use of reprocessed SUMDs compared with new SUMDs; most did not report statistically significant differences in patient outcomes between groups. \u0000Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices. Half of the included studies were published before the year 2005, which may limit applicability given potential improvements and changes over time in reprocessing standards, surgical approaches, device specifications, and patient care protocols. \u0000Most of the studies evaluated a different type of reprocessed single-use medical device for different surgical populations, so there is very limited evidence for the use of a specific device in a specific population or intervention of interest. All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings. \u0000 \u0000What Does it Mean? \u0000 \u0000Given various devices, clinical applications, and reprocessing methods, it is difficult to draw broad conclusions about the appropriateness of reprocessing SUMDs. \u0000While the evidence base in this review was insufficient to conclude whether ","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"43 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140252237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the Issue? Mechanical ventilation helps individuals breathe when they cannot do so on their own. During mechanical ventilation, aerosol therapy is used to deliver medication to the lungs of the person who is using the ventilator. High doses of aerosol therapy administered via metered dose inhaler for adults and older adults who are mechanically ventilated is common clinical practice. However, the reasoning behind this practice, and whether it has clinical benefits compared to no doses and standard doses, is unclear. What Did We Do? To inform decisions about high doses of aerosol therapy delivered with metered dose inhalers in adults and older adults receiving mechanical ventilation, we sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus no aerosol therapy. We also sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus standard doses. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2004, and January 25, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included study, and narratively summarized the findings. What Did We Find? We found 1 retrospective chart review that compared the clinical effectiveness of 2 different doses of inhaled high doses of aerosol therapy. The findings from this study suggest that, compared to lower doses, higher doses of salbutamol are associated with more days alive and free of acute lung injury and more days alive and free of indicators of acute respiratory distress and respiratory failure. We did not find any studies that compared the clinical effectiveness of inhaled high doses of aerosol therapy to no aerosol therapy for adults and older adults receiving mechanical ventilation that met inclusion criteria for our review. What Does It Mean? The available evidence with methodological limitations suggests that high doses of aerosol therapy with salbutamol may be associated with better clinical respiratory outcomes when compared to low doses in patients with acute lung injury who are mechanically ventilated. To inform future clinical practice, decision-makers may want to consider the potential risks and benefits and environmental implications of aerosol therapy, as well as implementation factors (e.g., resource needs, risk of contamination). Additional clinical studies would help provide a better understanding of the optimal dosage and clinical effectiveness of aerosol therapy for patients who are mechanically ventilated.
{"title":"Aerosol Therapy With Inhalers During Mechanical Ventilation","authors":"Robyn Haas, Jennie Horton","doi":"10.51731/cjht.2024.853","DOIUrl":"https://doi.org/10.51731/cjht.2024.853","url":null,"abstract":"What Is the Issue? \u0000 \u0000Mechanical ventilation helps individuals breathe when they cannot do so on their own. During mechanical ventilation, aerosol therapy is used to deliver medication to the lungs of the person who is using the ventilator. \u0000High doses of aerosol therapy administered via metered dose inhaler for adults and older adults who are mechanically ventilated is common clinical practice. However, the reasoning behind this practice, and whether it has clinical benefits compared to no doses and standard doses, is unclear. \u0000 \u0000What Did We Do? \u0000 \u0000To inform decisions about high doses of aerosol therapy delivered with metered dose inhalers in adults and older adults receiving mechanical ventilation, we sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus no aerosol therapy. We also sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus standard doses. \u0000A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2004, and January 25, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included study, and narratively summarized the findings. \u0000 \u0000What Did We Find? \u0000 \u0000We found 1 retrospective chart review that compared the clinical effectiveness of 2 different doses of inhaled high doses of aerosol therapy. The findings from this study suggest that, compared to lower doses, higher doses of salbutamol are associated with more days alive and free of acute lung injury and more days alive and free of indicators of acute respiratory distress and respiratory failure. \u0000We did not find any studies that compared the clinical effectiveness of inhaled high doses of aerosol therapy to no aerosol therapy for adults and older adults receiving mechanical ventilation that met inclusion criteria for our review. \u0000 \u0000What Does It Mean? \u0000 \u0000The available evidence with methodological limitations suggests that high doses of aerosol therapy with salbutamol may be associated with better clinical respiratory outcomes when compared to low doses in patients with acute lung injury who are mechanically ventilated. To inform future clinical practice, decision-makers may want to consider the potential risks and benefits and environmental implications of aerosol therapy, as well as implementation factors (e.g., resource needs, risk of contamination). \u0000Additional clinical studies would help provide a better understanding of the optimal dosage and clinical effectiveness of aerosol therapy for patients who are mechanically ventilated. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"8 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140253965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
CADTH recommends that Beqvez be reimbursed by public drug plans for the treatment of adults with moderately severe to severe hemophilia B (congenital factor IX deficiency) who are negative for neutralizing antibodies to variant adeno-associated virus (AAV) serotype Rh74 , if certain conditions are met. Beqvez should only be covered to treat adult patients (aged 18 years or older) with circulating coagulation factor IX (FIX:C) activity of 2% or less and bleeding that requires ongoing prophylactic treatment. Beqvez should not be covered if the patient has FIX inhibitors or has previously received gene therapy for hemophilia B. Beqvez should only be reimbursed if prescribed by specialists who have expertise in treating hemophilia B and if the cost of Beqvez is reduced. Beqvez is a 1-time therapy.
CADTH 建议,Beqvez 用于治疗中重度至重度血友病 B(先天性 IX 因子缺乏症)成人患者,且变异腺相关病毒 (AAV) 血清型 Rh74 中和抗体阴性,但需满足特定条件。Beqvez 只能用于治疗循环凝血因子 IX (FIX:C) 活性为 2% 或更低且出血需要持续预防性治疗的成年患者(18 岁或以上)。如果患者患有 FIX 抑制剂或曾接受过 B 型血友病基因治疗,则 Beqvez 不在承保范围内。Beqvez 只有在由具有治疗 B 型血友病专业知识的专科医生处方且 Beqvez 的费用降低的情况下才能获得报销。Beqvez 为一次性疗法。
{"title":"Fidanacogene Elaparvovec (Beqvez)","authors":"Cadth","doi":"10.51731/cjht.2024.851","DOIUrl":"https://doi.org/10.51731/cjht.2024.851","url":null,"abstract":"\u0000CADTH recommends that Beqvez be reimbursed by public drug plans for the treatment of adults with moderately severe to severe hemophilia B (congenital factor IX deficiency) who are negative for neutralizing antibodies to variant adeno-associated virus (AAV) serotype Rh74 , if certain conditions are met. \u0000Beqvez should only be covered to treat adult patients (aged 18 years or older) with circulating coagulation factor IX (FIX:C) activity of 2% or less and bleeding that requires ongoing prophylactic treatment. Beqvez should not be covered if the patient has FIX inhibitors or has previously received gene therapy for hemophilia B. \u0000Beqvez should only be reimbursed if prescribed by specialists who have expertise in treating hemophilia B and if the cost of Beqvez is reduced. Beqvez is a 1-time therapy. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"26 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140261975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
CADTH recommends that Rezurock be reimbursed by public drug plans for the treatment of chronic graft-versus-host disease (cGVHD) if certain conditions are met. Rezurock should only be covered to treat patients aged 12 years and older who have clinically diagnosed moderate to severe cGVHD and whose disease has not shown an adequate response to at least 2 prior lines of systemic therapy (1 of which is corticosteroids with or without calcineurin inhibitors). Rezurock should only be reimbursed if prescribed by clinicians who have experience in the diagnosis and management of patients with cGVHD, and the cost of Rezurock is reduced.
{"title":"Belumosudil (Rezurock)","authors":"Cadth","doi":"10.51731/cjht.2024.848","DOIUrl":"https://doi.org/10.51731/cjht.2024.848","url":null,"abstract":"\u0000CADTH recommends that Rezurock be reimbursed by public drug plans for the treatment of chronic graft-versus-host disease (cGVHD) if certain conditions are met. \u0000Rezurock should only be covered to treat patients aged 12 years and older who have clinically diagnosed moderate to severe cGVHD and whose disease has not shown an adequate response to at least 2 prior lines of systemic therapy (1 of which is corticosteroids with or without calcineurin inhibitors). \u0000Rezurock should only be reimbursed if prescribed by clinicians who have experience in the diagnosis and management of patients with cGVHD, and the cost of Rezurock is reduced. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"8 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140263447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the 2024 Watch List? The Watch List annual Horizon Scan report presents emerging technologies and issues that have the potential to shape the future of health care in Canada. CADTH’s 2024 Watch List focuses on care for children and youth with medical complexity. This top 10 has been divided in 2 parts — the top 5 technologies and top 5 issues related to children and youth with medical complexity that have the potential to make a significant and meaningful impact in transforming health systems in Canada over the next 5 years. These technologies and issues could shape the future of health care for not only children and youth with medical complexity, but also for others with chronic health conditions. Why Is This an Issue? Children and youth (people aged 24 years and younger) with medical complexity are a diverse group with a range of needs (e.g., single or multiple conditions, rare diseases). Although there is no single definition, common characteristics include significant functional limitations often causing the child or youth to be reliant on technology; high health care utilization, often requiring specialized care and services from different providers in multiple settings; and high health care service needs, such as care provision in the home and care coordination, which can have significant social and financial impacts on caregivers and the family. Children and youth with medical complexity account for less than 1% of all children and youth in Canada, but they account for 37% of hospital stays and 17% of emergency department visits. Due in part to the high number of health care interactions, this group experiences the effects of challenges within the health care system more acutely than their less medically complex peers. What Is the Potential Impact? The Watch List highlights areas for innovation, systems change, and investment. Advances in medical care have resulted in more children living with conditions that previously would not have been survivable in infancy and childhood. Now there are more children and youth with medical complexity, and they are living longer. Our current health systems were not designed to meet the complex needs of this group of people and their caregivers, including that many of them face challenges in accessing needed care. This year’s Watch List spotlights new and emerging technologies and key issues that could have a major impact on how patient care is provided to children and youth with medical complexity. What Else Do We Need to Know? In the 2024 Watch List, we identify and describe the top 5 new and emerging technologies that could shape the future of health care for children and youth with medical complexity in Canada, including new models of care and technologies and systems to improve communication. We also explore some considerations for health care decision-makers about the potential impact of these technologies on care pathways, health care human resources, health care inf
{"title":"2024 Watch List: Top 10 Technologies and Issues Related to Caring for Children and Youth With Medical Complexity","authors":"Cadth","doi":"10.51731/cjht.2024.850","DOIUrl":"https://doi.org/10.51731/cjht.2024.850","url":null,"abstract":"What Is the 2024 Watch List? \u0000 \u0000The Watch List annual Horizon Scan report presents emerging technologies and issues that have the potential to shape the future of health care in Canada. \u0000CADTH’s 2024 Watch List focuses on care for children and youth with medical complexity. This top 10 has been divided in 2 parts — the top 5 technologies and top 5 issues related to children and youth with medical complexity that have the potential to make a significant and meaningful impact in transforming health systems in Canada over the next 5 years. These technologies and issues could shape the future of health care for not only children and youth with medical complexity, but also for others with chronic health conditions. \u0000 \u0000Why Is This an Issue? \u0000 \u0000Children and youth (people aged 24 years and younger) with medical complexity are a diverse group with a range of needs (e.g., single or multiple conditions, rare diseases). Although there is no single definition, common characteristics include significant functional limitations often causing the child or youth to be reliant on technology; high health care utilization, often requiring specialized care and services from different providers in multiple settings; and high health care service needs, such as care provision in the home and care coordination, which can have significant social and financial impacts on caregivers and the family. \u0000Children and youth with medical complexity account for less than 1% of all children and youth in Canada, but they account for 37% of hospital stays and 17% of emergency department visits. Due in part to the high number of health care interactions, this group experiences the effects of challenges within the health care system more acutely than their less medically complex peers. \u0000 \u0000What Is the Potential Impact? \u0000 \u0000The Watch List highlights areas for innovation, systems change, and investment. \u0000Advances in medical care have resulted in more children living with conditions that previously would not have been survivable in infancy and childhood. Now there are more children and youth with medical complexity, and they are living longer. Our current health systems were not designed to meet the complex needs of this group of people and their caregivers, including that many of them face challenges in accessing needed care. This year’s Watch List spotlights new and emerging technologies and key issues that could have a major impact on how patient care is provided to children and youth with medical complexity. \u0000 \u0000What Else Do We Need to Know? \u0000 \u0000In the 2024 Watch List, we identify and describe the top 5 new and emerging technologies that could shape the future of health care for children and youth with medical complexity in Canada, including new models of care and technologies and systems to improve communication. We also explore some considerations for health care decision-makers about the potential impact of these technologies on care pathways, health care human resources, health care inf","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"127 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140078662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the Issue? Opioids are often used to help manage postoperative pain. However, their consumption can cause side effects, in addition to the risk of developing dependence with long-term use. Acetaminophen is an alternative analgesic that may provide opioid-sparing benefits for patients undergoing surgery (e.g., the need for patients to use opioids later), but there is a lack of synthesized evidence to confirm. Acetaminophen is available in different formulations, such as IV, oral, and rectal. However, there is uncertainty around the benefits of using 1 formulation over another perioperatively. What Did We Do? To inform decisions about IV acetaminophen, we sought to identify and summarize literature comparing the effectiveness of IV acetaminophen to alternative analgesics (i.e., nonsteroidal anti-inflammatory drugs [NSAIDs]), alternative formulations (i.e., oral or rectal acetaminophen), or placebo for reducing opioid consumption in patients undergoing surgery. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019, and January 9, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria. To investigate the true effect of IV acetaminophen, we excluded studies with any intraoperative opioid use. What Did We Find? For adult patients undergoing elective hip surgery, there may be no significant differences in cumulative opioid use between postoperative IV and oral acetaminophen (1 randomized controlled trial). For patients undergoing elective cesarian delivery, postoperative IV acetaminophen may result in a decrease in total morphine consumption after surgery compared to placebo (1 randomized controlled trial). For adult patients undergoing lumbar disc surgery, there may be no significant differences in total morphine consumption for patients receiving intraoperative IV acetaminophen compared to placebo (1 systematic review with 1 relevant RCT). We did not find any studies comparing the opioid-sparing effects of IV acetaminophen to NSAIDs that met our criteria for this review. What Does It Mean? Limited evidence from this review suggests that the opioid-sparing effect of IV acetaminophen may vary across types of surgery when compared to placebo. Additionally, IV acetaminophen may not offer additional opioid-sparing benefits compared to oral administration. However, we require more comprehensive research with rigorous methodological approaches to understand this topic better. Relative to opioids, IV acetaminophen has a preferable side effect profile, including a low risk of dependence; therefore, decision-makers may wish to consider using this formulation in the surgical or postsurgical setting.
{"title":"Opioid-Sparing Effects of IV Acetaminophen for Patients Undergoing Surgery","authors":"Camille Santos, C. Lachance, Sharon Bailey","doi":"10.51731/cjht.2024.849","DOIUrl":"https://doi.org/10.51731/cjht.2024.849","url":null,"abstract":"What Is the Issue? \u0000 \u0000Opioids are often used to help manage postoperative pain. However, their consumption can cause side effects, in addition to the risk of developing dependence with long-term use. \u0000Acetaminophen is an alternative analgesic that may provide opioid-sparing benefits for patients undergoing surgery (e.g., the need for patients to use opioids later), but there is a lack of synthesized evidence to confirm. Acetaminophen is available in different formulations, such as IV, oral, and rectal. However, there is uncertainty around the benefits of using 1 formulation over another perioperatively. \u0000 \u0000What Did We Do? \u0000 \u0000To inform decisions about IV acetaminophen, we sought to identify and summarize literature comparing the effectiveness of IV acetaminophen to alternative analgesics (i.e., nonsteroidal anti-inflammatory drugs [NSAIDs]), alternative formulations (i.e., oral or rectal acetaminophen), or placebo for reducing opioid consumption in patients undergoing surgery. \u0000A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019, and January 9, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria. To investigate the true effect of IV acetaminophen, we excluded studies with any intraoperative opioid use. \u0000 \u0000What Did We Find? \u0000 \u0000For adult patients undergoing elective hip surgery, there may be no significant differences in cumulative opioid use between postoperative IV and oral acetaminophen (1 randomized controlled trial). \u0000For patients undergoing elective cesarian delivery, postoperative IV acetaminophen may result in a decrease in total morphine consumption after surgery compared to placebo (1 randomized controlled trial). \u0000For adult patients undergoing lumbar disc surgery, there may be no significant differences in total morphine consumption for patients receiving intraoperative IV acetaminophen compared to placebo (1 systematic review with 1 relevant RCT). \u0000We did not find any studies comparing the opioid-sparing effects of IV acetaminophen to NSAIDs that met our criteria for this review. \u0000 \u0000What Does It Mean? \u0000 \u0000Limited evidence from this review suggests that the opioid-sparing effect of IV acetaminophen may vary across types of surgery when compared to placebo. Additionally, IV acetaminophen may not offer additional opioid-sparing benefits compared to oral administration. However, we require more comprehensive research with rigorous methodological approaches to understand this topic better. \u0000Relative to opioids, IV acetaminophen has a preferable side effect profile, including a low risk of dependence; therefore, decision-makers may wish to consider using this formulation in the surgical or postsurgical setting. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"10 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140263426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Angela M. Barbara, Lindsay Ritchie, Melissa Severn
What Is the Issue? Osteoarthritis (OA) is a chronic disease of the joints, such as the hip, shoulder, and ankle. OA causes the joints to be painful, unstable, and less functional. In adults 55 years and younger, joint trauma is a common cause of OA. Hyaluronic acid (HA) is a naturally occurring molecule found in human cells that provides lubrication when injected into the joint. HA injections are a less invasive option than surgery, with potentially fewer complications. To support decision-making about treating hip, shoulder, or ankle OA in adults 55 years and younger, it is important to understand the potential benefits and harms of using HA in this population. What Did We Do? We reviewed the clinical effectiveness of high molecular weight (MW) injection of HA in adults between the ages of 18 and 55 years with OA of the hip, shoulder, or ankle joints to guide decisions on the use of high MW HA injection. An information specialist searched for peer-reviewed and grey literature sources published on January 1, 2013 to December 12, 2023. One reviewer screened citations and selected and critically appraised the included studies. What Did We Find? The evidence for this report was based on observational before-and-after studies. We found no relevant comparative studies examining the effect of high MW HA versus placebo or no treatment. While most studies reported post-treatment outcome improvements, it is uncertain whether high MW injection of HA improves pain, function, and disability in adults 55 years and under with hip, shoulder, or ankle OA. This is due to the low-quality evidence, small sample sizes, and methodological problems. Serious side effects of high MW HA were not reported. What Does This Mean? Due to the uncertainty of the clinical effectiveness evidence, health care providers and decision-makers may consider other factors when considering high MW IA-HA for patients with hip, shoulder, or ankle OA; these factors could include acceptability, feasibility, costs, health equity, and patient values and preferences. Future research from randomized studies in large populations is needed to understand the effectiveness and safety of high MW HA injections for hip, shoulder, and ankle OA.
问题是什么? 骨关节炎(OA)是髋关节、肩关节和踝关节等关节的一种慢性疾病。OA 会导致关节疼痛、不稳定和功能减退。在 55 岁及以下的成年人中,关节创伤是导致 OA 的常见原因。透明质酸(HA)是一种存在于人体细胞中的天然分子,注入关节后可起到润滑作用。与手术相比,注射透明质酸是一种创伤较小的选择,并发症也可能较少。为了帮助 55 岁及以下的成年人做出治疗髋关节、肩关节或踝关节 OA 的决策,了解在这一人群中使用 HA 的潜在益处和弊端非常重要。 我们做了什么? 我们回顾了高分子量(MW)HA注射剂对18至55岁患有髋关节、肩关节或踝关节OA的成年人的临床疗效,以指导使用高分子量HA注射剂的决策。一位信息专家检索了2013年1月1日至2023年12月12日发表的同行评议和灰色文献资料。一位审稿人筛选了引文,并对纳入的研究进行了筛选和严格评估。 我们发现了什么? 本报告的证据基于观察性前后对比研究。我们没有发现任何相关的比较研究,对高分子量 HA 与安慰剂或不治疗的效果进行检查。虽然大多数研究报告了治疗后的效果改善情况,但目前尚不确定高分子量注射HA是否能改善55岁及以下患有髋关节、肩关节或踝关节OA的成年人的疼痛、功能和残疾状况。这主要是由于证据质量低、样本量小以及方法问题。没有关于高MW HA严重副作用的报道。 这意味着什么? 由于临床有效性证据的不确定性,医疗服务提供者和决策者在考虑为髋关节、肩关节或踝关节OA患者提供高分子量IA-HA时可能会考虑其他因素;这些因素可能包括可接受性、可行性、成本、健康公平性以及患者的价值观和偏好。未来需要对大量人群进行随机研究,以了解高分子量 HA 注射治疗髋关节、肩关节和踝关节 OA 的有效性和安全性。
{"title":"Intra-Articular Hyaluronic Acid for Osteoarthritis of the Hip, Shoulder, and Ankle","authors":"Angela M. Barbara, Lindsay Ritchie, Melissa Severn","doi":"10.51731/cjht.2024.847","DOIUrl":"https://doi.org/10.51731/cjht.2024.847","url":null,"abstract":"What Is the Issue? \u0000 \u0000Osteoarthritis (OA) is a chronic disease of the joints, such as the hip, shoulder, and ankle. OA causes the joints to be painful, unstable, and less functional. In adults 55 years and younger, joint trauma is a common cause of OA. \u0000Hyaluronic acid (HA) is a naturally occurring molecule found in human cells that provides lubrication when injected into the joint. HA injections are a less invasive option than surgery, with potentially fewer complications. \u0000To support decision-making about treating hip, shoulder, or ankle OA in adults 55 years and younger, it is important to understand the potential benefits and harms of using HA in this population. \u0000 \u0000What Did We Do? \u0000 \u0000We reviewed the clinical effectiveness of high molecular weight (MW) injection of HA in adults between the ages of 18 and 55 years with OA of the hip, shoulder, or ankle joints to guide decisions on the use of high MW HA injection. \u0000An information specialist searched for peer-reviewed and grey literature sources published on January 1, 2013 to December 12, 2023. One reviewer screened citations and selected and critically appraised the included studies. \u0000 \u0000What Did We Find? \u0000 \u0000The evidence for this report was based on observational before-and-after studies. We found no relevant comparative studies examining the effect of high MW HA versus placebo or no treatment. \u0000While most studies reported post-treatment outcome improvements, it is uncertain whether high MW injection of HA improves pain, function, and disability in adults 55 years and under with hip, shoulder, or ankle OA. This is due to the low-quality evidence, small sample sizes, and methodological problems. Serious side effects of high MW HA were not reported. \u0000 \u0000What Does This Mean? \u0000 \u0000Due to the uncertainty of the clinical effectiveness evidence, health care providers and decision-makers may consider other factors when considering high MW IA-HA for patients with hip, shoulder, or ankle OA; these factors could include acceptability, feasibility, costs, health equity, and patient values and preferences. \u0000Future research from randomized studies in large populations is needed to understand the effectiveness and safety of high MW HA injections for hip, shoulder, and ankle OA. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"24 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140265972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
CADTH recommends that Bylvay should be reimbursed by public drug plans for pruritus (itching) in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC) if certain conditions are met. Bylvay should only be covered to treat patients aged 6 months or older who have been diagnosed with PFIC type 1 (PFIC1) or PFIC type 2 (PFIC2), have severe itching, and have elevated serum bile acids. The first time Bylvay is prescribed, it should be for a trial period of 3 months to ensure that it improves the patient’s itching before it is renewed. Bylvay should only be reimbursed if it is prescribed by specialists in managing PFIC, if patients experience an improvement in their itching after using Bylvay for 3 months, and if the cost of Bylvay is reduced. Bylvay should be stopped if the patient receives a liver transplant.
{"title":"Odevixibat (Bylvay)","authors":"Cadth","doi":"10.51731/cjht.2024.846","DOIUrl":"https://doi.org/10.51731/cjht.2024.846","url":null,"abstract":"\u0000CADTH recommends that Bylvay should be reimbursed by public drug plans for pruritus (itching) in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC) if certain conditions are met. \u0000Bylvay should only be covered to treat patients aged 6 months or older who have been diagnosed with PFIC type 1 (PFIC1) or PFIC type 2 (PFIC2), have severe itching, and have elevated serum bile acids. The first time Bylvay is prescribed, it should be for a trial period of 3 months to ensure that it improves the patient’s itching before it is renewed. \u0000Bylvay should only be reimbursed if it is prescribed by specialists in managing PFIC, if patients experience an improvement in their itching after using Bylvay for 3 months, and if the cost of Bylvay is reduced. Bylvay should be stopped if the patient receives a liver transplant. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140086254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What Is the Issue Accumulating research has demonstrated that subanesthetic doses of ketamine have rapid and sustained antidepressant effects. In 2019, the US FDA approved the S-enantiomer of ketamine (esketamine) for the treatment of patients with treatment-resistant depression. Since then, there has been interest in the development of ketamine for the treatment of a broad range of mental health conditions beyond depression, including substance use disorders (SUDs). Decision-makers want to know if there is any evidence to support the use of ketamine for treating SUDs in adults. What Did We Do? To inform decisions about using ketamine for treating SUDs, we sought to identify and summarize the literature comparing the clinical and cost-effectiveness of ketamine with placebo or no treatment, with alternative interventions, or among ketamine administered via different routes for SUDs. We also searched for evidence-based recommendations for the use of ketamine for SUDs. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2018, and November 28, 2023. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? We found 2 systematic reviews (SRs) and 1 randomized controlled trial (RCT) on the use of ketamine for the treatment of patients with alcohol use disorder (AUD), cocaine use disorder (CUD), and opioid use disorder (OUD). Evidence from 2 SR suggests that a combination of ketamine infusion and psychotherapy treatment may be effective in promoting abstinence and reduced consumption of alcohol and cocaine use. There were mixed results regarding the effect of ketamine on withdrawal and craving. The effects of ketamine on OUD were inconclusive as the results were derived from a single study with a small sample size. Similarly, the effects of ketamine on health care utilization (e.g., hospital readmission, emergency department visit) in patients with severe AUD reported in a RCT were also inconclusive due to the small sample size. Adverse events associated with ketamine treatment included the dissociative and psychotomimetic effects and nondissociative effects. The authors of the included SR reported that these events were mild and transient. We did not find any studies on the cost-effectiveness or evidence-based guidelines of ketamine for treating SUDs that met our criteria for this review. What Does It Mean? The conclusions on the positive effects of ketamine for AUD and CUD should be interpreted with caution due to the high risk of bias of the studies included in the SRs. There is a need for more robust clinical trials with larger sample sizes, blinding, and low risk of bias to provide more accurate findings on clinical efficacy, dosing strategies, and safety profile of ketamine for the treatment of AUD, CUD, and OUD. Ad
{"title":"Ketamine for Adults With Substance Use Disorders","authors":"Khai Tran, Daniel W. MacDougall","doi":"10.51731/cjht.2024.845","DOIUrl":"https://doi.org/10.51731/cjht.2024.845","url":null,"abstract":"What Is the Issue \u0000 \u0000Accumulating research has demonstrated that subanesthetic doses of ketamine have rapid and sustained antidepressant effects. In 2019, the US FDA approved the S-enantiomer of ketamine (esketamine) for the treatment of patients with treatment-resistant depression. \u0000Since then, there has been interest in the development of ketamine for the treatment of a broad range of mental health conditions beyond depression, including substance use disorders (SUDs). \u0000Decision-makers want to know if there is any evidence to support the use of ketamine for treating SUDs in adults. \u0000 \u0000What Did We Do? \u0000 \u0000To inform decisions about using ketamine for treating SUDs, we sought to identify and summarize the literature comparing the clinical and cost-effectiveness of ketamine with placebo or no treatment, with alternative interventions, or among ketamine administered via different routes for SUDs. We also searched for evidence-based recommendations for the use of ketamine for SUDs. \u0000A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2018, and November 28, 2023. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. \u0000 \u0000What Did We Find? \u0000 \u0000We found 2 systematic reviews (SRs) and 1 randomized controlled trial (RCT) on the use of ketamine for the treatment of patients with alcohol use disorder (AUD), cocaine use disorder (CUD), and opioid use disorder (OUD). \u0000Evidence from 2 SR suggests that a combination of ketamine infusion and psychotherapy treatment may be effective in promoting abstinence and reduced consumption of alcohol and cocaine use. There were mixed results regarding the effect of ketamine on withdrawal and craving. \u0000The effects of ketamine on OUD were inconclusive as the results were derived from a single study with a small sample size. Similarly, the effects of ketamine on health care utilization (e.g., hospital readmission, emergency department visit) in patients with severe AUD reported in a RCT were also inconclusive due to the small sample size. \u0000Adverse events associated with ketamine treatment included the dissociative and psychotomimetic effects and nondissociative effects. The authors of the included SR reported that these events were mild and transient. \u0000We did not find any studies on the cost-effectiveness or evidence-based guidelines of ketamine for treating SUDs that met our criteria for this review. \u0000 \u0000What Does It Mean? \u0000 \u0000The conclusions on the positive effects of ketamine for AUD and CUD should be interpreted with caution due to the high risk of bias of the studies included in the SRs. \u0000There is a need for more robust clinical trials with larger sample sizes, blinding, and low risk of bias to provide more accurate findings on clinical efficacy, dosing strategies, and safety profile of ketamine for the treatment of AUD, CUD, and OUD. \u0000Ad","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"159 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140417659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
February 29 is Rare Disease Day — an occasion that inspires action and solidarity to address the challenges and opportunities of rare diseases. To address the issues faced by patients with rare diseases, in March 2023, the Government of Canada announced a national strategy for drugs for rare diseases, with an investment of up to $1.5 billion over 3 years. The strategy aims to increase the accessibility and affordability of drugs for rare diseases for patients across Canada. CADTH-led initiatives are primarily related to improving the collection, use, and quality of evidence to inform and support decision-making.
{"title":"Working Together for Better Health: A United Effort to Support the National Strategy for Drugs for Rare Diseases in Canada","authors":"Helen Mai, Trish Caetano, Carli Wallington","doi":"10.51731/cjht.2024.844","DOIUrl":"https://doi.org/10.51731/cjht.2024.844","url":null,"abstract":"\u0000February 29 is Rare Disease Day — an occasion that inspires action and solidarity to address the challenges and opportunities of rare diseases. \u0000To address the issues faced by patients with rare diseases, in March 2023, the Government of Canada announced a national strategy for drugs for rare diseases, with an investment of up to $1.5 billion over 3 years. \u0000The strategy aims to increase the accessibility and affordability of drugs for rare diseases for patients across Canada. \u0000CADTH-led initiatives are primarily related to improving the collection, use, and quality of evidence to inform and support decision-making. \u0000","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"122 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140421705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}