Acetylsalicylic Acid for Venous Thromboembolism Prophylaxis in Total Hip or Knee Replacement: A Review of Clinical Effectiveness and Guidelines

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Question(s)

  1. What is the clinical effectiveness of acetylsalicylic acid for venous thromboembolism prophylaxis in individuals undergoing total hip or knee replacement?
  2. What are the evidence-based guidelines regarding the use of acetylsalicylic acid for venous thromboembolism prophylaxis in individuals undergoing total hip or knee replacement?

Key Message

This review included five systematic reviews of randomized controlled trials, 15 non-randomized studies (i.e., 14 retrospective and one prospective in design) regarding the clinical effectiveness and safety of ASA for venous thromboembolism prophylaxis in patients undergoing total hip or knee arthroplasty, and three evidence-based guidelines regarding the use of aspirin in this population.In terms of effectiveness and safety profile, the use of ASA for venous thromboembolism prophylaxis after total hip or knee arthroplasty was generally not associated with significant differences compared to alternative anticoagulants including low molecular weight heparins (enoxaparin, dalteparin), Factor Xa inhibitors (rivaroxaban, apixaban), direct thrombin inhibitor (dabigatran), warfarin, or another anticoagulants. All three included guidelines recommend the use of aspirin for venous thromboembolism prophylaxis in patients undergoing total hip or knee arthroplasty based on low quality evidence. Due to significant limitations of the evidence, interpretations of the findings should be taken with cautions.

Comparative Assessment of Coverage Criteria for Biologic Disease-Modifying Antirheumatic Drugs Across Canadian Public Drug Plans: An Environmental Scan

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Pegylated Interferon Alfa 2a Therapy in Patients with Myeloproliferative Disorders: A Review of Clinical Effectiveness and Cost-Effectiveness

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Question(s)

  1. What is the clinical effectiveness of pegylated interferon alfa 2a therapy in patients with myeloproliferative disorders?
  2. What is the cost-effectiveness of pegylated interferon alfa 2a therapy in patients with myeloproliferative disorders?

Key Message

Two primary studies regarding the clinical effectiveness of pegylated interferon alfa 2a therapy in patients with myeloproliferative disorders were included in this report. No economic evaluations regarding the cost-effectiveness of pegylated interferon alfa 2a therapy in this population were identified. Overall, the body of evidence was limited in quantity and was moderate in quality.

The identified literature revealed varied conclusions regarding the clinical effectiveness of pegylated interferon alfa 2a therapy in patients with myeloproliferative disorders depending on the specific population, comparator treatment, and assessed outcome. Specifically, for patients with chronic-phase chronic myeloid leukemia included in the randomized controlled trial, there were no significant differences in complete hematologic or cytogenetic response amongst four treatment groups (i.e., imatinib plus pegylated interferon alfa 2a, imatinib plus cytarabine, imatinib 400 mg, imatinib 600 mg). Imatinib plus pegylated interferon alfa 2a resulted in significantly greater rates of major and superior molecular response, but also significantly higher rates of grade 3-4 neutropenia and thrombocytopenia, compared to imatinib 400 mg monotherapy. Information on survival outcomes was not reported in this randomized controlled trial.

In patients with polycythemia vera and myelofibrosis included in the non-randomized study, no significant differences in partial or complete response were detected amongst the three treatment groups (i.e., pegylated interferon alfa 2a, ruxolitinib, hydroxyurea ± anagrelide). However, in patients with essential thrombocythemia included in the non-randomized study, pegylated interferon alfa 2a resulted in significantly greater rates of complete response compared to ruxolitinib and hydroxyurea ± anagrelide. In the total cohort of patients with polycythemia vera, myelofibrosis, and essential thrombocythemia, pegylated interferon alfa 2a and hydroxyurea ± anagrelide resulted in significantly less improvement in quality of life compared to ruxolitinib. In the total cohort of patients, grade 1-2 adverse events were seen in 62%, 44%, and 20%, and grade 3-4 adverse events were seen in 7%, 0%, and 9% of participants receiving pegylated interferon alfa 2a, hydroxyurea ± anagrelide, and ruxolitinib, respectively (statistical analysis not reported).

Statistical tests in the randomized controlled trial and non-randomized study were mainly conducted for differences across all treatment groups, with additional post hoc tests to determine between-group differences for only select outcomes. Furthermore, the small sample size (N = 125) in the non-randomized study should also be taken into consideration when interpreting these results.5 Additionally, since the sample populations consisted of patients living in France and Hong Kong, these findings may not be generalizable to the Canadian setting.

Short-Acting Sedative Agents During Endoscopic Retrograde Cholangiopancreatography: A Review of Clinical Effectiveness and Guidelines

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Question(s)

  1. What is the clinical effectiveness of short-acting sedative agents during endoscopic retrograde cholangiopancreatography?
  2. What are the evidence-based guidelines for moderate procedural sedation during endoscopic retrograde cholangiopancreatography?

Key Message

Thirteen randomized controlled trials and one retrospective cohort study provided information regarding the clinical effectiveness of short-acting sedative agents during endoscopic retrograde cholangiopancreatography. The studies covered a wide range of short-acting sedatives, including propofol alone, etomidate alone, and remifentanil alone. Others were propofol-based combinations (i.e., propofolalfentanil, propofolesketamine, propofolfentanyl, propofolketamine, propofolmeperidine, midazolampropofol, and propofolremifentanil), midazolam-based combinations (i.e., midazolametomidate, midazolamfentanyl, midazolamketamine, midazolammeperidine, midazolampethidine, and midazolamremifentanil), and dexmedetomidine-based combinations (dexmedetomidineketamine and dexmedetomidineremifentanil).Therefore, although 14 studies were included in this report, they were spread over several unique intervention-comparator pairs. In effect, there was a limited quantity of evidence for each comparison. Also, doses of sedative agents used tended to vary from study to study, so that even where drugs appeared to be the same in two or more studies, they usually differed in doses. Other sources of limitations included inadequate determination of sample sizes to ensure that studies were adequately powered to determine differences in treatment effects between competing groups, the use of unvalidated methods to assess satisfaction with sedation and pain during the ERCP procedure, lack of adequate blinding in some randomized trials, and the use of data from different historical periods in the retrospective cohort study. Although each of the agents investigated in the included studies demonstrated some effectiveness, given the limitations discussed here and elsewhere in the report, a definitive conclusion could not be drawn about the optimal choice of short-acting sedative agents during ERCP due to the qualitative and quantitative limitations of the evidence that was available for this report. No relevant evidence-based guidelines were identified for moderate procedural sedation during endoscopic retrograde cholangiopancreatography.

Intraocular Lenses for Infants with Aphakia

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Aphakia is the absence of the lens of the eye due to surgical removal, a perforating wound or ulcer, or congenital anomaly. Interventions for optical correction of aphakia include external devices, such as glasses or contact lenses, and intraocular lens (IOL) implantation, which offers a permanent solution. However, the optimal timing of IOL implantation in pediatric patients with aphakia is unclear.

Building Inclusive Health Care Services: A Rapid Qualitative Review

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Question(s)

  1. How do people (e.g., community members, practitioners, funders) engaged with health care services (e.g., community health programs or private practice) that are situated within Indigenous communities, or largely oriented toward Indigenous peoples, conceptualize inclusive care? a. How did people describe the conditions of development, implementation and daily practice that contribute to the inclusivity (or not) of their health care services? b. How have these studies framed and engaged with the terminology of inclusivity (or related terminology of diversity, accessibility, cultural safety or awareness, etc.)?

Key Message

Building inclusive health care services with Indigenous peoples is not the exclusive domain of settler service providers, but requires ongoing participation of, direction and oversight from Indigenous peoples living in the locations where services will be or are currently located.Building inclusive health care services begins at the stage of identifying exclusion through the examination of assumptions and norms across all levels of service provision (e.g., individual, interpersonal, institutional, systemic) This process involves ongoing critical reflection on the part of leaders and practitioners of the ways in which individual behaviors and institutional or systemic attributes may reinforce and perform exclusion.Building inclusive health care services requires ongoing development and uptake of practices directed at addressing the specificity of these exclusions in health care service provision. Building inclusive health care services requires ongoing consideration of the external factors relevant to the specific service area and exploration of opportunities to reframe inclusion from how can we bring or include Indigenous peoples into our care services to how can we participate and include our practice into the lived realities of the communities we are situated within.

Ketamine for Sedation During Bronchoscopy Procedures: A Review of Clinical Effectiveness, Safety, and Guidelines

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Question(s)

  1. What is the clinical effectiveness and safety of ketamine for sedation during bronchoscopy procedures?
  2. What are the evidence-based guidelines for the use of ketamine for sedation during bronchoscopy procedures?

Key Message

Six relevant publications were identified. These comprised one systematic review, two randomized controlled trials and three non-randomized studies (one prospective single-arm study, and two retrospective studies). Various drugs, including ketamine, propofol, midazolam, fentanyl, and/or their combinations, were used for sedation for the bronchoscopy procedures.There were no significant differences in recovery time, or in the proportion of patients experiencing hypoxia, for adult or pediatric patients between sedative drug combinations that included ketamine and alternative procedural drugs.Sedative drug combinations including ketamine were associated with statistically significantly higher mean arterial pressure and a higher proportion of patients experiencing high blood pressure compared with alternate sedative combinations in adults undergoing bronchoscopy. Also, the number of pediatric patients requiring mask ventilation was statistically significantly greater in the group receiving a sedative drug combination including ketamine compared with an alternate sedative combination. The proportion of pediatric patients experiencing bronchospasm and emergence agitation was numerically higher with ketamine compared with propofol.Findings regarding hypotension and desaturation were inconsistent.Findings need to be interpreted with caution considering there is limited number of studies evaluating specific sedation procedures with ketamine for patients undergoing bronchoscopy and overall low quality of the body of evidence.No evidence-based guideline was identified hence no summary could be provided.

Sex Offender Treatment Programs Delivered In-Person or Virtually for Adults Convicted of Sexual Offences in Various Settings: A Review of Clinical Effectiveness and Guidelines

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Question(s)

  1. What is the clinical effectiveness of sex offender treatment programs for adults convicted of sexual offences in custody versus in the community?
  2. What is the clinical effectiveness of sex offender treatment programs delivered virtually versus in-person for adults convicted of sexual offences?
  3. What is the clinical effectiveness of culturally specific sex offender treatment versus standard or no treatment programs for adults convicted of sexual offences from various cultural groups?
  4. What are the evidence-based guidelines regarding best practice models for sex offender treatment programs delivered in-person or virtually?

Key Message

Evidence from three systematic reviews, one overview of meta-analyses and a non-randomized study were included in this report.Moderate- to- high quality evidence from a non-randomized study evaluating the effectiveness of the Tupiq program for Inuit individuals convicted of sexual offences showed that culturally specific values incorporated into sexual offence programs were favorably associated with reducing general and sexual reoffending compared to alternative treatment programs or no treatment.No studies that directly compared the effectiveness of community-based sexual offence programs with custody-based programs were identified. Based on informal indirect comparisons, the systematic reviews and overview suggested that sexual offence programs delivered in community settings showed more reduction in recidivism compared to control groups than custody-based programs compared to control groups. However, in the absence of appropriate indirect comparisons, the evidence remains low quality and inconclusive.No evidence comparing the effectiveness of sexual offence programs delivered in person and virtually were identified. No evidence-based guidelines regarding best practice models for sexual offence programs were identified.

Models of Care for Chronic Pain: An Environmental Scan

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Chronic pain affects approximately 19% of adults in Canada, which results in substantial physical and psychological morbidity and costs to the health care system. Canada's Drug Agency is undertaking an Environmental Scan to help inform the development of strategies and programs to respond to the care needs of Canadians affected by chronic pain.

The key objectives of this Environmental Scan are to:

Ondansetron in Patients Requiring Anti-Emetics: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

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Question(s)

  1. What is the comparative clinical effectiveness of oral ondansetron versus intravenous ondansetron?
  2. What is the comparative clinical effectiveness of ondansetron versus other anti-emetic agents for palliative patients?
  3. What is the comparative cost-effectiveness of ondansetron versus other anti-emetic agents for palliative patients?
  4. What are the evidence-based guidelines regarding the use of ondansetron for palliative patients?

Key Message

Evidence from one double-blind, randomized controlled trial suggested no difference in effectiveness between 4 mg or 8 mg orally disintegrating film tablets and 4 mg intravenous ondansetron in controlling the overall incidence of postoperative nausea and vomiting in women who underwent elective gynecological laparoscopic procedures. However, within the first six hours after surgery, the incidence of vomiting was statistically significantly lower with the 8 mg oral formulation than with the 4 mg intravenous ondansetron. There were no significant differences between any of the studied ondansetron formulations regarding incidence of postoperative nausea, analgesic consumption, time to oral intake, overall patient satisfaction, and side effects. A key source of uncertainty in the evidence was that it was based on one randomized controlled trial with an unclear level of statistical power to identify clinically meaningful differences in effects between treatment groups. Also, the study was conducted in women undergoing elective gynecological laparoscopic procedures at a single center in India, and the generalizability of the findings to patients requiring medication to control nausea and vomiting of different etiology is unknown.No relevant evidence was identified regarding the comparative clinical effectiveness or cost-effectiveness of ondansetron versus other anti-emetic agents for palliative patients. Similarly, no evidence-based guidelines for the use of ondansetron in palliative patients were identified.