Ontario Health Technology Assessment Series最新文献

Background: Sensorineural hearing loss occurs as a result of damage to the hair cells in the cochlea, or to the auditory nerve. It negatively affects learning and development in children, and employment and economic attainment in adults. Current policy in Ontario is to provide unilateral cochlear implantation for patients with bilateral severe to profound sensorineural hearing loss. However, hearing with both ears as a result of bilateral cochlear implantation may offer added benefits.

Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, budget impact, and patient preferences related to bilateral cochlear implantation. We performed a systematic literature search for studies on bilateral cochlear implantation in adults and children from inception to March 2017. We conducted a cost-utility analysis with a lifetime horizon from a public payer perspective and analyzed the budget impact of publicly funding bilateral cochlear implantation in adults and children in Ontario for the next 5 years. Finally, we conducted interviews with adults who have sensorineural hearing loss and unilateral or bilateral cochlear implants, and with parents of children with bilateral cochlear implants.

Results: We included 24 publications (10 in adults, 14 in children) in the clinical evidence review. Compared with unilateral cochlear implantation, bilateral cochlear implantation improved sound localization, speech perception in noise, and subjective benefits of hearing in adults and children with severe to profound sensorineural hearing loss (GRADE: moderate to high). Bilateral cochlear implantation also allowed for better language development and more vocalization in preverbal communication in children (GRADE: moderate). The safety profile was acceptable.Bilateral cochlear implantation was more expensive and more effective than unilateral cochlear implantation. The incremental cost-effectiveness ratio was $48,978/QALY in adults and between $27,427/QALY and $30,386/QALY in children. Cost-effectiveness was highly dependent on the quality-of-life values used. We estimated that the net budget impact of publicly funding bilateral cochlear implantation for adults in Ontario would be between $510,000 and $780,000 per year for the next 5 years.Patients described the social and emotional effects of hearing loss, and the benefits and challenges of using cochlear implants.

Conclusions: Based on evidence of moderate to high quality, we found that bilateral cochlear implantation improved hearing in adults and children with severe to profound sensorineural hearing loss. Bilateral cochlear implantation was potentially cost-effective compared to unilateral cochlear implantation in adults and children. Patients with sensorineural hearing loss reported the positive effects of cochlear implants, and patients with unilateral c

Background: Under usual care, people with an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy with or without a defibrillator (CRT-D and CRT-P, respectively), or a permanent pacemaker have follow-up in-person clinic visits. Remote monitoring of these devices allows the transfer of the information stored in the device so that it can be accessed by the clinic personnel via a secured website.

Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for remote monitoring of ICDs, CRTs, and permanent pacemakers plus clinic visits compared with clinic visits alone. This is an update of a 2012 health technology assessment. In addition to the eligible randomized controlled trials (RCTs) from the 2012 publication, we included RCTs identified through a systematic literature search on June 1, 2017. We assessed the risk of bias of each 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 conducted an economic evaluation to determine the cost-effectiveness of remote monitoring blended with in-clinic follow-up compared to in-clinic follow-up alone in patients with an ICD, a CRT-D, or a pacemaker. We determined the budget impact of blended remote monitoring in patients implanted with ICD, CRT-D, CRT-P, or pacemaker devices from the perspective of the Ontario Ministry of Health and Long-Term Care. To understand patient experiences with remote monitoring, we interviewed 16 patients and family members.

Results: Based on 15 RCTs in patients with implanted ICDs or CRT-Ds, remote monitoring plus clinic visits resulted in fewer patients with inappropriate ICD shocks within 12 to 37 months of follow-up (moderate quality evidence; absolute risk difference -0.04 [95% confidence interval -0.07 to -0.01]), fewer total clinic visits (moderate quality evidence), and a shorter time to detection and treatment of events (moderate quality evidence) compared with clinic visits alone. There was a similar risk of major adverse events (moderate quality evidence).Based on 6 RCTs in patients with pacemakers, remote monitoring plus clinic visits reduced the arrhythmia burden (high quality evidence), the time to detection and treatment of arrhythmias (high quality evidence), and the number of clinic visits (moderate quality evidence]) compared with clinic visits alone. Here again, there was a similar risk of major adverse events (high quality evidence).Results from the economic evaluation showed that among ICD and CRT-D recipients, blended remote monitoring (remote monitoring plus in-clinic follow ups) was more costly (incremental value of $4,354 per person) and more effective, providing higher quality-adjusted life years (incremental value of 0.19

Background: Cognitive behavioural therapy (CBT) for psychosis is a distinct type of psychotherapy that has been recommended together with antipsychotic drugs and comprehensive usual care in the management of schizophrenia, a complex mental health disorder associated with a high economic and societal burden. The objectives of this report were to assess the effectiveness, harms, cost-effectiveness, and lived experience of CBT for psychosis in improving outcomes for adults with a primary diagnosis of schizophrenia.

Methods: We performed literature searches on March 28 and April 5, 2017, and undertook a qualitative synthesis of systematic reviews of the clinical and economic literature comparing CBT for psychosis with any comparator interventions (e.g., usual care, waitlist control, or pharmacotherapy) in adults with a diagnosis of schizophrenia as defined by any criteria (including related disorders such as schizoaffective disorder).We developed an individual-level state-transition probabilistic model for a hypothetical cohort of adults aged 18 years and older starting with first-episode psychosis. We compared three strategies: usual care, CBT for psychosis by physicians, and CBT for psychosis by regulated nonphysician therapists. The CBT was provided in person together with usual care including pharmacotherapy: 16 structured sessions (individual or group) for first-episode psychosis and 24 individual sessions for relapse or treatment-resistant disease. We calculated incremental cost-effectiveness ratios (ICERs) over 5 years using the Ontario Ministry of Health and Long-Term Care perspective and a discount rate of 1.5%. We also estimated the 5-year budget impact of publicly funding CBT for psychosis in Ontario.In addition, we interviewed 13 people with lived experience of schizophrenia and psychosis about their values and preferences surrounding CBT and other treatments.

Results: CBT for psychosis compared with usual care significantly improved overall psychotic symptoms (standard mean difference [SMD] -0.33, 95% confidence interval [CI] -0.45 to -0.21), positive symptoms (e.g., hallucinations) (SMD -0.34, 95% CI -0.58 to -0.10), auditory symptoms (SMD 0.39, 95% Cl not reported, P < .005), delusions (SMD 0.33, 95% CI not reported, P < .05) and negative symptoms (e.g., blunt affect) (SMD -0.32, 95% CI -0.59 to -0.04) at end of treatment. No significant differences were observed for social function, distress associated with psychosis, relapse, or quality of life.Compared with any control, CBT for psychosis significantly improved overall psychotic symptoms, positive symptoms, auditory hallucinations, delusions, and negative symptoms. Compared with other forms of therapy, CBT for psychosis showed inconsistent results at end of treatment for overall psychotic symptoms, positive symptoms, auditory hallucinations, and delusions. In people with first-episode psychosis, CBT for p

Background: Urinary incontinence is involuntary leakage of urine and can affect people of all ages. Incidence rises as people age, often because of reduced mobility or conditions affecting the nervous system, such as dementia and stroke. Urinary incontinence can be a distressing condition and can harm a person's physical, financial, social, and emotional well-being. People with urinary incontinence are susceptible to skin irritation, pressure sores, and urinary tract infections. Urinary incontinence is also associated with an increased risk of falls in older adults.This health technology assessment examined the effectiveness of, budget impact of, and patient values and preferences about electronic monitoring systems to assess urinary incontinence for residents of long-term care homes or geriatric hospital inpatients with complex conditions.

Methods: A clinical evidence review of the published clinical literature was conducted to June 9, 2017. Critical appraisal of the clinical evidence included assessment of risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria to reflect the certainty of the evidence.We calculated the funding required for an electronic urinary incontinence monitoring system in the first year of implementation (when facilities would buy the systems) and in subsequent years.We interviewed six people with urinary incontinence and two caregivers, who described ways urinary incontinence affected daily life.

Results: We included one observational study in the clinical review. Most of the 31 participants in the observational study were female (78%) and required high levels of care, primarily because of cognitive impairment. The quality of evidence for all outcomes was very low owing to potential risk of bias and indirectness. We are consequently uncertain about how electronic monitoring systems affect management of urinary incontinence.For patients living in long-term care homes who are eligible for the technology, we estimated that an electronic monitoring system to assess urinary incontinence would cost $6.4 million in the first year of implementation and $1.6 million in subsequent years.Patients said urinary incontinence reduced their independence and social life and adversely affected their quality of life. Incontinence made them embarrassed and reduced their self-esteem. Several respondents mentioned how expensive supplies to manage incontinence were.

Conclusions: The effectiveness of using the electronic monitoring system to assess urinary incontinence is uncertain because of the very low quality of the evidence. Introducing electronic monitoring systems would result in incremental costs, and there would be savings only if the systems substantially reduced incontinence.

Background: The standard treatment option for medication-refractory essential tremor is invasive neurosurgery. A new, noninvasive alternative is magnetic resonance-guided focused ultrasound (MRgFUS) neurosurgery. We aimed to determine the effectiveness, safety, and cost-effectiveness of MRgFUS neurosurgery for the treatment of moderate to severe, medication-refractory essential tremor in Ontario. We also spoke with people with essential tremor to gain an understanding of their experiences and thoughts regarding treatment options, including MRgFUS neurosurgery.

Methods: We performed a systematic review of the clinical literature published up to April 11, 2017, that examined MRgFUS neurosurgery alone or compared with other interventions for the treatment of moderate to severe, medication-refractory essential tremor. We assessed the risk of bias of each study 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 review of the economic literature and created Markov cohort models to assess the cost-effectiveness of MRgFUS neurosurgery compared with other treatment options, including no surgery. We also estimated the budget impact of publicly funding MRgFUS neurosurgery in Ontario for the next 5 years. To contextualize the potential value of MRgFUS neurosurgery as a treatment option for essential tremor, we spoke with people with essential tremor and their families.

Results: Nine studies met our inclusion criteria for the clinical evidence review. In noncomparative studies, MRgFUS neurosurgery was found to significantly improve tremor severity and quality of life and to significantly reduce functional disability (GRADE: very low). It was also found to be significantly more effective than a sham procedure (GRADE: high). We found no significant difference in improvements in tremor severity, functional disability, or quality of life between MRgFUS neurosurgery and deep brain stimulation (GRADE: very low). We found no significant difference in improvement in tremor severity compared with radiofrequency thalamotomy (GRADE: low). MRgFUS neurosurgery has a favourable safety profile.We estimated that MRgFUS neurosurgery has a mean cost of $23,507 and a mean quality-adjusted survival of 3.69 quality-adjusted life-years (QALYs). We also estimated that the mean costs and QALYs of radiofrequency thalamotomy and deep brain stimulation are $14,978 and 3.61 QALYs, and $57,535 and 3.94 QALYs, respectively. For people ineligible for invasive neurosurgery, we estimated the incremental cost-effectiveness ratio (ICER) of MRgFUS neurosurgery compared with no surgery as $43,075 per QALY gained. In people eligible for invasive neurosurgery, the ICER of MRgFUS neurosurgery compared with radiofrequency thalamotomy is $109,795 per QALY gained; when deep brain stimulation is compared with

Background: Type 1 diabetes is a condition in which the pancreas produces little or no insulin. People with type 1 diabetes must manage their blood glucose levels by monitoring the amount of glucose in their blood and administering appropriate amounts of insulin via injection or an insulin pump. Continuous glucose monitoring may be beneficial compared to self-monitoring of blood glucose using a blood glucose meter. It provides insight into a person's blood glucose levels on a continuous basis, and can identify whether blood glucose levels are trending up or down.

Methods: We conducted a health technology assessment, which included an evaluation of clinical benefit, value for money, and patient preferences related to continuous glucose monitoring. We compared continuous glucose monitoring with self-monitoring of blood glucose using a finger-prick and a blood glucose meter. We performed a systematic literature search for studies published since January 1, 2010. We created a Markov model projecting the lifetime horizon of adults with type 1 diabetes, and performed a budget impact analysis from the perspective of the health care payer. We also conducted interviews and focus group discussions with people who self-manage their type 1 diabetes or support the management of a child with type 1 diabetes.

Results: Twenty studies were included in the clinical evidence review. Compared with self-monitoring of blood glucose, continuous glucose monitoring improved the percentage of time patients spent in the target glycemic range by 9.6% (95% confidence interval 8.0-11.2) to 10.0% (95% confidence interval 6.75-13.25) and decreased the number of severe hypoglycemic events.Continuous glucose monitoring was associated with higher costs and small increases in health benefits (quality-adjusted life-years). Incremental cost-effectiveness ratios (ICERs) ranged from $592,206 to $1,108,812 per quality-adjusted life-year gained in analyses comparing four continuous glucose monitoring interventions to usual care. However, the uncertainty around the ICERs was large. The net budget impact of publicly funding continuous glucose monitoring assuming a 20% annual increase in adoption of continuous glucose monitoring would range from $8.5 million in year 1 to $16.2 million in year 5.Patient engagement surrounding the topic of continuous glucose monitoring was robust. Patients perceived that these devices provided important social, emotional, and medical and safety benefits in managing type 1 diabetes, especially in children.

Conclusions: Continuous glucose monitoring was more effective than self-monitoring of blood glucose in managing type 1 diabetes for some outcomes, such as time spent in the target glucose range and time spent outside the target glucose range (moderate certainty in this evidence). We were less certain that continuous glucose monitoring would reduce the number of severe hy

Background: Hospital-acquired infections (HAIs) are infections that patients contract while in the hospital that were neither present nor developing at the time of admission. In Canada an estimated 10% of adults with short-term hospitalization have HAIs. According to 2003 Canadian data, between 4% and 6% of these patients die from these infections. The most common HAIs in Ontario are caused by Clostridium difficile. The standard method of reducing and preventing these infections is decontamination of patient rooms through manual cleaning and disinfection. Several portable no-touch ultraviolet (UV) light systems have been proposed to supplement current hospital cleaning and disinfecting practices.

Methods: We searched for studies published from inception of UV disinfection technology to January 23, 2017. We compared portable UV surface-disinfecting devices used together with standard hospital room cleaning and disinfecting versus standard hospital cleaning and disinfecting alone. The primary outcome was HAI from C. difficile. Other outcomes were combined HAIs, colonization (i.e., carrying an infectious agent without exhibiting disease symptoms), and the HAI-associated mortality rate. We used Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to rate the quality of evidence of included studies. We also performed a 5-year budget impact analysis from the hospital's perspective. This assessment was limited to portable devices and did not examine wall mounted devices, which are used in some hospitals.

Results: The database search for the clinical review yielded 10 peer-reviewed publications that met eligibility criteria. Three studies focused on mercury UV-C-based technology, seven on pulsed xenon UV technology. Findings were either inconsistent or produced very low-quality evidence using the GRADE rating system. The intervention was effective in reducing the rate of the composite outcome of HAIs (combined) and colonization (but quality of evidence was low). For the review of economic studies, 152 peer-reviewed publications were identified and screened. No studies met the inclusion criteria. Under the assumption that two devices would be purchased per hospital, we estimated the 5-year budget impact of $586,023 for devices that use the pulsed xenon technology and of $634,255 for devices that use the mercury technology.

Conclusions: We are unable to make a firm conclusion about the effectiveness of this technology on HAIs given the very low to low quality of evidence. The budget impact estimates are sensitive to assumptions made about the number of UV disinfecting devices purchased per hospital, frequency of daytime use, and staff time required per use.

Background: Major depressive disorder and generalized anxiety disorder are among the most commonly diagnosed mental illnesses in Canada; both are associated with a high societal and economic burden. Treatment for major depressive disorder and generalized anxiety disorder consists of pharmacological and psychological interventions. Three commonly used psychological interventions are cognitive behavioural therapy (CBT), interpersonal therapy, and supportive therapy. The objectives of this report were to assess the effectiveness and safety of these types of therapy for the treatment of adults with major depressive disorder and/or generalized anxiety disorder, to assess the cost-effectiveness of structured psychotherapy (CBT or interpersonal therapy), to calculate the budget impact of publicly funding structured psychotherapy, and to gain a greater understanding of the experiences of people with major depressive disorder and/or generalized anxiety disorder.

Methods: We performed a literature search on October 27, 2016, for systematic reviews that compared CBT, interpersonal therapy, or supportive therapy with usual care, waitlist control, or pharmacotherapy in adult outpatients with major depressive disorder and/or generalized anxiety disorder. We developed an individual-level state-transition probabilistic model for a cohort of adult outpatients aged 18 to 75 years with a primary diagnosis of major depressive disorder to determine the cost-effectiveness of individual or group CBT (as a representative form of structured psychotherapy) versus usual care. We also estimated the 5-year budget impact of publicly funding structured psychotherapy in Ontario. Finally, we interviewed people with major depressive disorder and/or generalized anxiety disorder to better understand the impact of their condition on their daily lives and their experience with different treatment options, including psychotherapy.

Results: Interpersonal therapy compared with usual care reduced posttreatment major depressive disorder scores (standardized mean difference [SMD]: 0.24, 95% confidence interval [CI]: -0.47 to -0.02) and reduced relapse/recurrence in patients with major depressive disorder (relative risk [RR]: 0.41, 95% CI: 0.27-0.63). Supportive therapy compared with usual care improved major depressive disorder scores (SMD: 0.58, 95% CI: 0.45-0.72) and increased posttreatment recovery (odds ratio [OR]: 2.71, 95% CI: 1.19-6.16) in patients with major depressive disorder. CBT compared with usual care increased response (OR: 1.58, 95% CI: 1.11-2.26) and recovery (OR: 3.42, 95% CI: 1.98-5.93) in patients with major depressive disorder and decreased relapse/recurrence (RR: 0.68, 95% CI: 0.65-0.87]). For patients with generalized anxiety disorder, CBT improved symptoms posttreatment (SMD: 0.80, 95% CI: 0.67-0.93), improved clinical response posttreatment (RR: 0.64, 95% CI: 0.55-0.74), and improved quality-of-life

Background: Pressure injuries (bedsores) are common and reduce quality of life. They are also costly and difficult to treat. This health technology assessment evaluates the effectiveness, cost-effectiveness, budget impact, and lived experience of adding electrical stimulation to standard wound care for pressure injuries.

Methods: We conducted a systematic search for studies published to December 7, 2016, limited to randomized and non-randomized controlled trials examining the effectiveness of electrical stimulation plus standard wound care versus standard wound care alone for patients with pressure injuries. We assessed the quality of evidence through Grading of Recommendations Assessment, Development, and Evaluation (GRADE). In addition, we conducted an economic literature review and a budget impact analysis to assess the cost-effectiveness and affordability of electrical stimulation for treatment of pressure ulcers in Ontario. Given uncertainties in clinical evidence and resource use, we did not conduct a primary economic evaluation. Finally, we conducted qualitative interviews with patients and caregivers about their experiences with pressure injuries, currently available treatments, and (if applicable) electrical stimulation.

Results: Nine randomized controlled trials and two non-randomized controlled trials were found from the systematic search. There was no significant difference in complete pressure injury healing between adjunct electrical stimulation and standard wound care. There was a significant difference in wound surface area reduction favouring electrical stimulation compared with standard wound care.The only study on cost-effectiveness of electrical stimulation was partially applicable to the patient population of interest. Therefore, the cost-effectiveness of electrical stimulation cannot be determined. We estimate that the cost of publicly funding electrical stimulation for pressure injuries would be $0.77 to $3.85 million yearly for the next 5 years.Patients and caregivers reported that pressure injuries were burdensome and reduced their quality of life. Patients and caregivers also noted that electrical stimulation seemed to reduce the time it took the wounds to heal.

Conclusions: While electrical stimulation is safe to use (GRADE quality of evidence: high) there is uncertainty about whether it improves wound healing (GRADE quality of evidence: low). In Ontario, publicly funding electrical stimulation for pressure injuries could result in extra costs of $0.77 to $3.85 million yearly for the next 5 years.

Background: Retinitis pigmentosa is a group of inherited disorders characterized by the degeneration of the photoreceptors in the retina, resulting in progressive vision loss. The Argus II system is designed to restore partial functional vision in patients with profound vision loss from advanced retinitis pigmentosa. At present, it is the only treatment option approved by Health Canada for this patient population. In June 2016, Health Quality Ontario published a health technology assessment of the Argus II retinal prosthesis system for patients with advanced retinitis pigmentosa. Based on that assessment, the Ontario Health Technology Advisory Committee recommended against publicly funding the Argus II system for this population. It also recommended that Health Quality Ontario re-evaluate the evidence in 1 year. The objective of this report was to examine new evidence published since the 2016 health technology assessment.

Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences related to the Argus II system. We performed a systematic literature search for studies published since the 2016 Argus II health technology assessment. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care, and we calculated incremental cost-effectiveness ratios over a 20-year time horizon. We also conducted a five-year budget impact analysis. Finally, we interviewed people with retinitis pigmentosa about their lived experience with vision loss, and with the Argus II system.

Results: Four publications from one multicentre international study were included in the clinical review. Patients showed significant improvements in visual function and functional outcomes with the Argus II system, and these outcomes were sustained up to a 5-year follow-up (moderate quality of evidence). The safety profile was generally acceptable.In the base case economic analysis, the Argus II system was cost-effective compared with standard care if the willingness to pay was more than $97,429 per quality-adjusted life-year. We estimated that funding the Argus II system would cost the province $0.71 to $0.78 million per year over 5 years, assuming 4 implants per year.People with lived experience spoke about the challenges of retinitis pigmentosa, including the gradual but persistent progression of the disease; its impact on their quality of life and their families; and the accessibility challenges they faced. Those who used the Argus II system spoke about its positive impact on their quality of life.

Conclusions: Based on evidence of moderate quality, the Argus II retinal prosthesis system improved visual function, real-life functional outcomes, and quality of life in patients with advanced retinitis pigmentosa. The Argus II system is expen