Background: Vertebral compression fractures are among the most common types of fracture in patients with osteoporosis and they can arise during activities of daily living without any specific trauma event. For severely painful osteoporotic vertebral compression fractures (OVCFs) that do not respond to conservative treatment, minimally invasive percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PBK) may be used. We conducted a health technology assessment of PVP and PBK for people with painful OVCFs refractory to nonsurgical treatment that included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PVP and PBK, and patient preferences and values.
Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBIS tool for systematic reviews, the Cochrane Risk of Bias tool for RCTs, and the ROBINS-I tool for observational studies and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PVP and PBK in adults with painful OVCFs in Ontario. To contextualize the potential value of PVP and PBK, we spoke with people with OVCF.
Results: We included 10 studies in the clinical evidence review. Compared to conservative treatment (CT), there was significant (statistical and clinical) improvement in pain (up to 3 months follow-up, GRADE Low) and physical function (up to 6 months follow-up, GRADE Very low) for patients who underwent PVP. For PBK, there was significant (statistical and clinical) improvement in pain in the short term (up to 3 months follow-up, GRADE Very low) compared with CT. Overall, there were no significant differences for either PVP or PBK compared to conservative treatment for mortality, subsequent fractures or adverse events (GRADE Low to Very low). Cement leakage occurred in 4% to 39% of treated patients (PVP vs. CT, 4.0% [8/200 patients]; PVP vs. sham, 39.4% [9/99 patients]; PBK vs. CT, 4.5% [30/731 patients]) and most leakages were asymptomatic. The incremental cost-effectiveness ratio (ICER) of PVP compared with CT is $43,324 per quality-adjusted life-year (QALY) gained. The ICER of PBK compared with CT is $65,921 per QALY gained. The annual budget impact of publicly funding PVP and PBK in Ontario over the next 5 years ranges from an additional $0.5 million in Year 1 to $11.0 million in Year 5. The people we spoke to reported that their daily activities, work, social life, family relationships, and mental health were negatively impacted by OVCF. Those who underwent vertebroplasty reported a positive impact on pain relief and qu
Background: Both malignant and benign conditions may require colorectal surgery. Anastomotic leak is a serious potential complication, and assessing tissue perfusion at the planned site of anastomosis is critical to try to prevent leaks. The approaches used by surgeons to assess anastomotic integrity and tissue perfusion involve visual assessment of the planned resection area. Indocyanine green fluorescence imaging (ICGFI) is a technology that involves the use of a fluorescent dye and a near-infrared imaging system to allow surgeons to visualize tissue perfusion intraoperatively in real time. We conducted a health technology assessment of ICGFI in colorectal surgery, which included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding ICGFI for the assessment of anastomotic perfusion during colorectal surgery, and the experiences of patients undergoing colorectal cancer surgery.
Methods: We performed a systematic review of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk-of-Bias Tool for randomized controlled trials (RCTs) and the Risk-of-Bias Assessment Tool for Nonrandomized Studies (RoBANS) for nonrandomized studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing ICGFI with visual assessment alone for the visualization of anastomotic perfusion during colorectal surgery from a public payer perspective. We also analyzed the budget impact of publicly funding ICGFI for colorectal surgery in Ontario. To contextualize the potential value of publicly funding ICGFI for colorectal surgery, we summarized a qualitative literature rapid review conducted by the Canadian Agency for Drugs and Technologies in Health (now Canada's Drug Agency).
Results: We included 6 RCTs and 13 nonrandomized studies in the clinical evidence review. Compared with visual assessment alone, the addition of ICGFI to assess anastomotic perfusion during colorectal surgery reduced anastomotic leaks (GRADE: Low) and reoperations (GRADE: Low) and slightly reduced sepsis, but the evidence for the latter is very uncertain (GRADE: Very low to Low). ICGFI appeared to have little to no effect on hospital readmissions (GRADE: Low) or length of stay (GRADE: Low to Moderate), and its effect on mortality is very uncertain (GRADE: Very low). Our primary economic evaluation found that ICGFI is more effective and less costly than visual assessment alone and is highly likely to be cost-effective at the commonly used willingness-to-pay values of $50,000 and $100,000 per quality-adjusted life-year (QALY). The use of ICGFI could prevent 22 major anastomotic leaks per 1,000 patients undergoing colorectal surgery with anastomosis. Wit
Background: Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values.
Methods: We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist.
Results: We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quali
Background: Cluster headache and migraine are 2 distinct types of primary headache that can cause substantial pain, disability, and decreased quality of life. Noninvasive vagus nerve stimulation (nVNS) is a treatment option that delivers a mild electrical stimulation to a nerve in the neck. nVNS is intended to reduce the pain and duration of a headache attack, and to prevent headaches from occurring. We conducted a health technology assessment of nVNS for the acute treatment and prevention of cluster headache or migraine, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nVNS, and patient preferences and values.
Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted 2 cost-utility and cost-effectiveness analyses with a 1-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding nVNS for people with cluster headache and migraine in Ontario. To contextualize the potential value of nVNS, we spoke with people with cluster headache and migraine.
Results: We included 8 randomized trials in the clinical evidence review (3 on cluster headache, 5 on migraine). For the acute treatment of cluster headache with nVNS, we found no statistically significant improvements in terms of overall response (pain relief), pain freedom, and duration of attacks (GRADEs: Low to Very low), or acute medication use (GRADE: Moderate). We observed little to no difference in mean pain intensity or adverse events (GRADE: Low). For the preventive treatment of cluster headache (based on 1 trial), nVNS reduced the frequency of attacks per week (GRADE: Low), improved response (GRADE: Low), reduced acute medication use (GRADE: Low), and improved quality of life (GRADE: Low to Very low). More overall adverse events were observed with nVNS, but results were uncertain (GRADE: Low). For the acute treatment of migraine (based on 1 study), nVNS improved response to treatment (i.e., pain relief; GRADE: Moderate to Low) but had little to no effect on sustained response (GRADE: Low). nVNS improved pain freedom, but the results were not statistically significant (GRADE: Moderate) and there was no difference in sustained pain freedom (GRADE: Low). There was little to no difference in mean pain intensity (GRADE: Very low) or acute medication use (GRADE: Low), and the risk of adverse events was very uncertain (GRADE: Very low). For the preventive treatment of migraine (based on 4 studies), nVNS may slightly reduce the number of headache and migraine days, but we could not exclude the possibilit
Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. While some cases of NSCLC with actionable genomic alterations in the tumour cells may respond to standard therapies, they often show greater improvement with targeted therapies. The current standard of care in Ontario involves testing for actionable genomic alterations using both DNA and RNA panels via tissue testing alone. However, liquid biopsy testing may complement tissue testing by addressing some of its limitations. We conducted a health technology assessment of liquid biopsy testing using DNA panels for people with NSCLC, which included an evaluation of analytical validity, clinical validity, clinical utility, cost-effectiveness, the budget impact of publicly funding this technology, and patient preferences and values.
Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the QUADAS-2, QUADAS-C, ROBINS-I, and ROBINS-E tools and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis of 4 potential liquid biopsy testing strategies in which liquid biopsy testing was added to tissue testing in various ways; our model used a 20-year time horizon and was conducted from a public payer perspective. We also analyzed the budget impact of publicly funding liquid biopsy testing for people with NSCLC in Ontario. To contextualize the potential value of liquid biopsy testing, we spoke with people with NSCLC and family members and care partners of people with NSCLC.
Results: We included 61 studies in the clinical evidence review. Liquid biopsy testing demonstrated a modest sensitivity in detecting actionable genomic alterations in the BRAF, EGFR, ERBB2, and KRAS genes (GRADE: Moderate to High). However, for the other genes assessed, the sensitivity was either low or uncertain (GRADE: Very Low to High). Liquid biopsy testing also showed an overall high concordance with tissue testing (GRADE: High). Further, liquid biopsy testing was found to improve partial response rates, stable disease rates, and progressive disease rates for people with NSCLC with actionable genomic alterations who were receiving matched targeted therapies (GRADE: Moderate). However, we are uncertain about the clinical validity of liquid biopsy testing in predicting prognosis with standard therapies (GRADE: Very Low). Compared with tissue testing alone, we estimate that all 4 of the potential liquid biopsy testing strategies we evaluated would be more expensive and associated with an increase in quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) of the strategy in which liq
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