Ontario Health Technology Assessment Series最新文献

Background: Post-traumatic stress disorder (PTSD) and acute stress disorder (ASD) are mental health conditions that may emerge following a frightening or traumatic event in a person's life. We conducted a health technology assessment of internet-delivered cognitive behavioural therapy (iCBT) for adults with PTSD or ASD, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding iCBT for PTSD or ADS, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of systematic reviews using ROBIS and of randomized controlled trials (RCTs) 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 to summarize the economic evidence on the cost-effectiveness of iCBT for adults with PTSD or ASD. We did not conduct a primary economic evaluation on iCBT for adults with PTSD, as an existing cost-utility analysis is directly applicable to this research question. We did not conduct a primary economic evaluation on iCBT for adults with ASD, as there is limited clinical evidence on this topic and because evidence on iCBT for PTSD may be generalizable to iCBT for ASD at risk of progressing to PTSD. We analyzed the budget impact of publicly funding iCBT for adults with PTSD or ASD in Ontario over the next 5 years.To contextualize the potential value of iCBT for PTSD, we reviewed relevant literature on patients' preferences and values and spoke with people who have lived experience with PTSD to explore their values, needs, and priorities.

Results: We identified no studies on the use of iCBT for prevention of PTSD or studies on the use of iCBT to treat ASD, nor studies that directly compared iCBT with face-to-face CBT for the treatment of PTSD. We included one systematic review of the use of iCBT to treat PTSD (10 RCTs, N = 720). Overall, iCBT is more effective than wait-list (waiting for iCBT) or usual care alone for reducing the severity of PTSD symptoms (standardized mean difference [SMD] = -0.60 [95% CI -0.97 to -0.24]; N = 560, 8 RCTs) (GRADE: Very low). Internet-delivered CBT is not more effective than non-CBT internet-delivered interventions for reducing the severity of PTSD symptoms (SMD = -0.08 [-0.52 to 0.35]; N = 82, 2 RCTs) (GRADE: Very low).We identified one economic evaluation on the cost-effectiveness of iCBT for adults with PTSD. For adults with PTSD, iCBT was found to be dominant (i.e., less costly and more effective) compared with usual care. The model used a Canadian public health care payer perspective, and there were no major limitations to the model structure, time horizon, or source of model inputs. The annual budget impact of publicly funding iCBT in Ontario

Background: Heart failure is a complex clinical syndrome that usually presents with breathlessness, leg edema, and fatigue. Clinically measurable natriuretic neurohormones such as B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are elevated in people with heart failure. We conducted a health technology assessment of BNP and NT-proBNP tests for people with suspected heart failure, which included an evaluation of diagnostic accuracy, clinical impact, cost-effectiveness, the budget impact of publicly funding BNP and NT-proBNP tests, and patient preferences and values.

Methods: We performed a literature search of previously published systematic reviews of the clinical evidence. We conducted an overview of reviews and included only reviews with a low risk of bias as assessed using the Risk of Bias in Systematic Reviews tool (ROBIS). We excluded any reviews where we found 100% overlap of included primary studies and selected systematic reviews or health technology assessments published after 2006 for inclusion.We performed an economic literature review of BNP and NT-proBNP testing in people with suspected heart failure. Medical and health economic databases were searched from database inception until July 25, 2019. Next, we assessed the cost-effectiveness of BNP and NT-proBNP based on the published economic literature. We transferred the cost-effectiveness results of two applicable, recent economic evaluations from the National Institute for Health and Care Excellence (NICE) to the Ontario setting in lieu of conducting de novo primary economic evaluations. We also estimated the budget impact of publicly funding BNP and NT-proBNP tests in people with suspected heart failure in Ontario over the next 5 years.To contextualize the potential value of BNP and NT-proBNP testing, we spoke with people with suspected heart failure.

Results: We included eight systematic reviews in the clinical evidence review. B-type natriuretic peptides and NT-proBNP had a high pooled sensitivity (80% to 94% and 86% to 96%, respectively; strength of evidence: high) and a low pooled negative likelihood ratio (0.08-0.30 and 0.09-0.23, respectively; strength of evidence: not reported) within varying thresholds or cut points and settings, as reported in seven systematic reviews. In one systematic review, when BNP or NT-proBNP was used in the diagnosis of heart failure in the emergency department (ED), there was a decrease in the mean length of hospital stay (-1.22 days; confidence interval [CI] -2.31 to -0.14; Grading of Recommendations Assessment, Development, and Evaluation [GRADE] Working Group criteria: Moderate). B-type natriuretic peptide testing did not reduce hospital admission rates (odds ratio [OR]: 0.82; CI: 0.67-1.01; GRADE: Moderate), 30-day hospital readmission rates (OR: 0.88; CI: 0.64-1,20; GRADE: Moderate), or hospital mortality rates (OR: 0.96; CI: 0.65-1.41; GRADE: Moderate). No sy

Background: Proton beam therapy has potential to reduce late toxicity in cancer treatment by reducing the risk of damage to surrounding healthy tissues. We conducted a health technology assessment of proton beam therapy, compared with photon therapy, for children and adults with cancer requiring radiotherapy. Our assessment included an evaluation of safety, effectiveness, cost-effectiveness, the budget impact of publicly funding the construction and use of proton beam therapy in Ontario, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and selected and reported results from one review that was recent, high quality, and relevant to our research question. We complemented the chosen systematic review (published in 2019) with a literature search to identify randomized controlled trials published after the review. We assessed the risk of bias of each included study using the Risk of Bias in Systematic Reviews (ROBIS) 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 also analyzed the budget impact of publicly funding proton beam therapy in cancer patients in Ontario. To contextualize the potential value of proton beam therapy, we spoke with 10 people with cancer (or their caregivers) who had either received or were considering proton beam therapy.

Results: We included one systematic review of the clinical evidence reporting on 215 publications on proton beam therapy in children and adults across 19 tumour categories/conditions. Compared with photon therapy, proton beam therapy may result in fewer adverse events but similar overall survival and progression-free survival in children with brain tumours (GRADE: Low), adults with esophageal cancer (GRADE: Low to Very low), head and neck cancer (GRADE: Low to Very low), and prostate cancer (GRADE: Low). Proton beam therapy may result in similar adverse events, overall survival, and progression-free survival in adults with brain tumours (GRADE: Low), breast cancer (GRADE: Low), gastrointestinal cancer (GRADE: Very low), liver cancer (GRADE: Moderate to Very low), lung cancer (GRADE: Moderate to Very low), and ocular tumours (GRADE: Low). There was insufficient evidence to evaluate the effectiveness and safety of proton beam therapy in other pediatric tumours, as well as bladder cancer, bone cancer, lymphoma, and benign tumours in adults.The economic evidence suggests that proton beam therapy may be cost-effective in pediatric populations with medulloblastoma; however, studies were based on limited clinical evidence. In other indications, the cost-effectiveness of proton beam therapy is unclear. The 5-year budget impact of funding a four-room proton beam therapy centre in Ontario would

Background: Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, 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 ROBIS, the Cochrane Risk of Bias tool, and the Newcastle-Ottawa Scale 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 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries.

Results: We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference -2.20; 95% CI -3.47 to -0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low).When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with

Background: Major depression is one of the most diagnosed mental illnesses in Canada. Generally, people are treated successfully with antidepressants or psychotherapy, but some people do not respond to these treatments (called treatment-resistant depression [TRD]). Repetitive transcranial magnetic stimulation (rTMS) delivers magnetic pulses to stimulate the areas of the brain associated with mood regulation. Several modalities of rTMS exist (e.g., high frequency rTMS, intermittent theta burst stimulation [iTBS], deep transcranial magnetic stimulation). We conducted a health technology assessment of rTMS for people with TRD, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding rTMS, 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 Risk of Bias in Systematic Reviews (ROBIS) tool and Cochrane Risk of Bias for Randomized Controlled Trials 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 horizon from a public payer perspective. We also analyzed the 5-year budget impact of publicly funding rTMS for people with TRD in Ontario. To assess the potential value of rTMS, we spoke with people who have TRD. Seven rTMS modalities were considered: low-frequency (1 Hz) stimulation, high-frequency (10-20 Hz) stimulation, unilateral stimulation, bilateral stimulation, iTBS, continuous theta burst stimulation, and deep transcranial magnetic stimulation.

Results: We included 58 primary studies, 9 systematic reviews, and 1 network meta-analysis in the clinical evidence review. Most rTMS modalities were more effective than sham treatment for all outcomes (GRADE: Moderate to High). All rTMS modalities were similar to one another in response and remission rates (GRADE: not reported) and were similar to electroconvulsive therapy (ECT) in response and remission rates (GRADE: Moderate). Moreover, in both the reference case and scenario analyses, two rTMS modalities (rTMS or iTBS), followed by ECT when patients did not respond to initial treatment, were less expensive and more effective than ECT alone. They were cost-effective compared with pharmacotherapy alone at a willingness-to-pay amount of $50,000 per quality-adjusted life-year (QALY). The annual budget impact of publicly funding rTMS would range from $9.3 million in year 1 to $15.76 million in year 5, for a total of $63.2 million over the next 5 years. People with TRD we spoke with reported that their experiences were generally favourable, and their attitudes toward rTMS were positive. Similarly, psychiatrists had positive attitudes toward and acceptance of rTMS

Background: Surgical aortic valve replacement (SAVR) is the conventional treatment for patients with severe aortic valve stenosis at low surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure. We conducted a health technology assessment (HTA) of TAVI for patients with severe aortic valve stenosis at low surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding TAVI, and patient preferences and values.

Methods: We used the 2016 Health Quality Ontario HTA on TAVI² as a source of eligible studies and performed a systematic literature search for studies published since the 2016 review. Eligible primary studies identified both through the 2016 HTA and through our complementary literature search were used in a de novo analysis. 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.An applicable, previously conducted cost-effectiveness analysis was available, so we did not conduct a primary economic evaluation. We analyzed the budget impact of publicly funding TAVI in people at low surgical risk in Ontario. We also performed a literature survey of the quantitative evidence of preferences and values of patients for TAVI. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted a review to evaluate the qualitative literature on patient and provider preferences and values for TAVI. To contextualize the potential value of TAVI, we spoke with people with severe aortic valve stenosis.

Results: We identified two randomized controlled trials that compared TAVI (transfemoral route) and SAVR in patients with severe aortic valve stenosis at low surgical risk. Both studies have an ongoing follow-up of 10 years, but 1-year and limited 2-year follow-up results are currently available. At 30 days, compared with SAVR, TAVI had a slightly lower risk of mortality (risk difference -0.8%, 95% confidence interval [CI] -1.5% to -0.1%, GRADE: Moderate) and disabling stroke (risk difference -0.8%, 95% CI -1.8% to -0.2%, GRADE: Moderate), and resulted in more patients with symptom improvement (risk difference 11.8%, 95% CI 8.2% to 15.5%, GRADE: High) and in a greater improvement in quality of life (GRADE: High). At 1 year, TAVI and SAVR were similar with regard to mortality (GRADE: Low), although TAVI may result in a slightly lower risk of disabling stroke (GRADE: Moderate). Both TAVI and SAVR resulted in a similar improvement in symptoms and quality of life at 1 year (GRADE: Moderate). Compared with SAVR, TAVI had a higher risk of some complications and a lower risk of others.Device-related costs for TAVI (about $25,000) are higher than for SAVR (about $6,000). A published cost-effectiveness a

Background: RhD blood group incompatibility during pregnancy can cause serious health problems for the fetus. Noninvasive fetal RhD blood group genotyping is a test for fetal RhD status that may help prevent unnecessary preventive treatment (Rh immunoglobulin [RhIG] injections) and intensive pregnancy monitoring. We conducted a health technology assessment of noninvasive fetal RhD blood group genotyping for RhD-negative (RhD-) pregnancies. Our assessment evaluated the test's diagnostic accuracy, clinical utility, and cost-effectiveness, the budget impact of publicly funding this test, and patients' and providers' preferences and values.

Methods: We performed a systematic literature search of the clinical and economic evidence to conduct an overview of reviews for test accuracy, a systematic review for clinical utility, and a review of the test's cost-effectiveness compared with usual care. We assessed the risk of bias of each included systematic review and study using the ROBIS and RoBANs tools, respectively. We assessed the quality of the body of clinical evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We developed probabilistic Markov microsimulation models to determine the cost-effectiveness and cost-utility of noninvasive fetal RhD genotyping compared with usual care from the Ontario Ministry of Health perspective. We also estimated the 5-year budget impact of publicly funding this test in Ontario. To examine patient and provider preferences related to noninvasive fetal RhD genotyping, we conducted a literature survey of quantitative studies on preference; the Canadian Agency for Drugs and Technologies in Health (CADTH) performed a review of qualitative literature about patient preferences; and we conducted interviews and an online survey with Ontario patients.

Results: We included six systematic reviews in the overview of reviews on diagnostic test accuracy and 11 studies in the clinical utility review. Across systematic reviews, test accuracy was high for noninvasive fetal RhD genotyping. The evidence suggests that implementation of noninvasive fetal RhD genotyping may lead to avoidance of unnecessary RhIG prophylaxis (GRADE: Low), good compliance with targeted RhIG prophylaxis (GRADE: Very low), and high uptake of genotyping (GRADE: Low). Alloimmunization may not increase when using noninvasive fetal RhD genotyping to target prenatal RhIG prophylaxis (GRADE: Very low), and may allow unnecessary monitoring and invasive procedures to be avoided in alloimmunized pregnancies (GRADE: Very low).We included eight published economic studies that reported inconsistent results regarding the cost-effectiveness of noninvasive fetal RhD genotyping. In nonalloimmunized RhD- pregnancies, compared with usual care, the intervention identified more maternal alloimmunization cases (probability: 0.0022 vs. 0.0020) and

Background: Skin conditions are photoresponsive if they respond to ultraviolet (UV) radiation with partial or complete clearing. Ultraviolet phototherapy is performed by exposing the skin to UV radiation on a regular basis under medical supervision. Three types of UV radiation are used to treat photoresponsive skin conditions: broadband ultraviolet B (BB-UVB), psoralen plus ultraviolet A (PUVA), and narrowband ultraviolet B (NB-UVB). Narrowband UVB phototherapy is generally more effective than BB-UVB and safer than PUVA in the management of several photoresponsive skin conditions. While typically performed in an outpatient clinic setting, home NB-UVB phototherapy may be a viable option for people with limited access to outpatient treatment. We conducted a health technology assessment of home NB-UVB phototherapy for people with photoresponsive skin conditions that included an evaluation of the effectiveness, safety, cost-effectiveness, and budget impact of publicly funding home NB-UVB phototherapy, 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 version 2 of the Cochrane risk-of-bias tool for randomized studies, and 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-utility analysis with a 10-year horizon from a public payer perspective. The cost-utility analysis was conducted for psoriasis based on the available clinical evidence. We also analyzed the budget impact of publicly funding home NB-UVB phototherapy in people with photoresponsive skin conditions in Ontario. To contextualize the potential value of NB-UVB phototherapy, we spoke with people with photoresponsive skin conditions.

Results: We included one randomized controlled trial in the clinical evidence review. We found that home NB-UVB phototherapy is at least as effective as outpatient clinic NB-UVB phototherapy for the treatment of mild to severe psoriasis (the only photoresponsive skin condition investigated in the included study). In the included study, 82% of participants were treated at home, compared with 79% treated in an outpatient clinic setting (many participants had experience with both treatment settings). They demonstrated an improvement in baseline Psoriasis Area and Severity Index 50 (mean difference 2.8%, 95% confidence interval -8.6% to 14.2%), with the mean difference exceeding the preset noninferiority margin of -15%. Similar results were observed for other psoriasis area and severity indices (GRADE: Moderate). Episodes of mild erythema, burning sensation, severe erythema, and blistering were reported in both treatment groups, but were too few to allow a comparative safety assessment (GRADE: Low).

Background: Stroke is a sudden interruption in the blood supply to a part of the brain, causing loss of neurological function. It is the third leading cause of death in Canada and affects mainly older people. In the acute setting, neuroimaging is integral to stroke evaluation and decision-making. The neuroimaging results guide patient selection for mechanical thrombectomy. Using automated image processing techniques facilitates efficient review of this information and communication between centres. We conducted a health technology assessment of automated CT perfusion imaging as a tool for selecting stroke patients with anterior circulation occlusion for mechanical thrombectomy. This assessment included an evaluation of clinical effectiveness, cost-effectiveness, and the budget impact of publicly funding automated CT perfusion imaging.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each study using QUADAS-2 or 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 approximated cost-effectiveness based on previous analyses. We also analyzed the budget impact of publicly funding automated CT perfusion imaging to evaluate people with acute ischemic stroke in Ontario.

Results: Automated CT perfusion imaging had a sensitivity of 84% for identifying the infarct core (dead tissue that does not recover despite restoring blood flow with mechanical thrombectomy), compared with diffusion-weighted MRI imaging at 24 hours. One study reported that 7% of patients were misclassified with respect to eligibility for mechanical thrombectomy (either erroneously classified as eligible or erroneously classified non-eligible). Two randomized controlled trials (DEFUSE 3 and DAWN) demonstrated the efficacy of mechanical thrombectomy up to 24 hours after stroke onset, with patient selection guided by automated CT perfusion imaging. These data showed that a significantly higher proportion of patients in the mechanical thrombectomy group achieved functional independence compared with the standard care group (DEFUSE 3: risk ratio: 2.67 [95% confidence interval 1.60-4.48]; DAWN: adjusted rate difference: 33% [95% credible interval 21%-44%]; GRADE: Moderate).A previous health technology assessment in stroke patients presenting at 0 to 6 hours after stroke symptom onset and the results from recent randomized controlled trials for patients presenting at 6 to 24 hours informed the evaluation of cost-effectiveness. Mechanical thrombectomy informed by automated CT perfusion imaging to assess eligibility is likely to be cost-effective for patients presenting at 6 to 24 hours after stroke symptom onset. The annual budget impact of publicly funding automated CT perfusion

Background: Chronic pain is costly for patients and for the health care system. It negatively affects people's physical, emotional, social, and mental health. We conducted a health technology assessment of 10-kHz high-frequency spinal cord stimulation (SCS) in adults with chronic noncancer pain that was refractory to medical management, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding 10-kHz high-frequency SCS, 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 and ROBINS-I 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. We analyzed the 5-year budget impact of publicly funding 10-kHz high-frequency SCS in Ontario for adults with chronic noncancer pain who had already tried other available SCS therapies (up to 1.2 kHz). To contextualize the potential value of 10-kHz high-frequency SCS, we spoke with people who had chronic noncancer pain.

Results: We included 5 studies (7 publications) in the clinical evidence review. Overall, 10-kHz high-frequency SCS likely provides reductions in pain intensity and functional disability, and improvements in quality of life in people with chronic noncancer pain (GRADE: Moderate). As well, patients may reduce their opioid consumption with 10-kHz high-frequency SCS (GRADE: Low). The two included economic evaluations found that 10-kHz high-frequency SCS was cost-saving compared with conventional SCS, but neither was applicable to the Ontario context. Owing to limited evidence about the effectiveness of 10-kHz high-frequency SCS in people who have first tried and failed SCS at lower frequencies (up to 1.2 kHz), we did not conduct a cost-effectiveness analysis comparing this pathway of care and 10-kHz high-frequency SCS for Ontario. Publicly funding 10-kHz high-frequency SCS (using the Freedom SCS system) in Ontario over the next 5 years would lead to a total net cost savings of $0.73 million (ranging from about $0.10 million in year 1 to about $0.21 million in year 5). However, if the province outsourced this therapy using the Senza HF10 SCS system, the total 5-year budget impact would be about $8.76 million. The people we spoke with who had chronic noncancer pain reported that their pain had a substantial negative impact on their activities and emotional well-being. Their direct knowledge of different pain therapies allowed them to provide context and comparisons when they discussed the impact of SCS on their chronic pain.

Conclusions: For adults with chronic noncancer pain that was refractory to medical management, 10-kHz high-frequency SCS was effective i