Ontario Health Technology Assessment Series最新文献

Background: Major depression is defined as a period of depression lasting at least 2 weeks characterized by depressed mood, most of the day, nearly every day, and/or markedly diminished interest or pleasure in all, or almost all, activities. Anxiety disorders encompass a broad range of disorders in which people experience feelings of fear and excessive worry that interfere with normal day-to-day functioning.Cognitive behavioural therapy (CBT) is a form of evidence-based psychotherapy used to treat major depression and anxiety disorders. Internet-delivered CBT (iCBT) is structured, goal-oriented CBT delivered via the internet. It may be guided, in which the patient communicates with a regulated health care professional, or unguided, in which the patient is not supported by a regulated health care professional.

Methods: We conducted a health technology assessment, which included an evaluation of clinical benefit, value for money, and patient preferences and values related to the use of iCBT for the treatment of mild to moderate major depression or anxiety disorders. We performed a systematic review of the clinical and economic literature and conducted a grey literature search. We reported Grading of Recommendations Assessment, Development, and Evaluation (GRADE) ratings if sufficient information was provided. When other quality assessment tools were used by the systematic review authors in the included studies, these were reported. We assessed the risk of bias within the included reviews. We also developed decision-analytic models to compare the costs and benefits of unguided iCBT, guided iCBT, face-to-face CBT, and usual care over 1 year using a sequential approach. We further explored the lifetime and short-term cost-effectiveness of stepped-care models, including iCBT, compared with usual care. We calculated incremental cost-effectiveness ratios (ICERs) from the perspective of the Ontario Ministry of Health and Long-Term Care and estimated the 5-year budget impact of publicly funding iCBT for mild to moderate major depression or anxiety disorders in Ontario. To contextualize the potential value of iCBT as a treatment option for major depression or anxiety disorders, we spoke with people with these conditions.

Results: People who had undergone guided iCBT for mild to moderate major depression (standardized mean difference [SMD] = 0.83, 95% CI 0.59-1.07, GRADE moderate), generalized anxiety disorder (SMD = 0.84, 95% CI 0.45-1.23, GRADE low), panic disorder (small to very large effects, GRADE low), and social phobia (SMD = 0.85, 95% CI 0.66-1.05, GRADE moderate) showed a statistically significant improvement in symptoms compared with people on a waiting list. People who had undergone iCBT for panic disorder (SMD= 1.15, 95% CI: 0.94 to 1.37) and iCBT for social anxiety disorder (SMD=0.91, 95% CI: 0.74-1.07) showed a statistically significant improvement in symptoms compared with peopl

Background: People with chronic venous insufficiency who develop leg ulcers face a difficult condition to treat. Venous leg ulcers may persist for long periods of time and have a negative impact on quality of life. Treatment requires frequent health care provider visits, creating a substantial burden across health care settings.The objective of this health technology assessment was to evaluate the effectiveness, safety, cost-effectiveness, budget impact, and patient experiences of compression stockings for prevention of venous leg ulcer recurrence.

Methods: We conducted a systematic review of the literature to identify randomized trials and observational studies examining the effectiveness of compression stockings in reducing the risk of recurrence of venous leg ulcers after healing and/or reported on the quality of life for patients and any adverse events from the wearing of compression stockings. We performed a literature search to identify studies and evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.We conducted a cost-utility analysis with a 5-year time horizon from the perspective of the Ontario Ministry of Health and Long-Term Care. We compared compression stockings to usual care (no compression stockings) and simulated a hypothetical cohort of 65-year-old patients with healed venous ulcers, using a Markov model. Model input parameters were obtained primarily from the published literature. In addition, we used Ontario costing sources and consultation with clinical experts. We estimated quality-adjusted life years gained and direct medical costs. We conducted sensitivity analyses and a budget impact analysis to estimate the additional costs required to publicly fund compression stockings in Ontario. All costs are presented in 2018 Canadian dollars.We spoke to people who recently began using compression stockings and those who have used them for many years to gain an understanding of their day-to-day experience with the management of chronic venous insufficiency and compression stockings.

Results: One randomized controlled trial reported that the recurrence rate was significantly lower at 12 months in people who were assigned to the compression stocking group compared with people assigned to the control group (risk ratio 0.43, 95% CI, 0.27-0.69; P = .001) (GRADE: Moderate). Three randomized controlled trials reported no significant difference in recurrence rates between the levels of pressure. One randomized controlled trial also reported that the risk of recurrence was six times higher in those who did not adhere to compression stockings than in those who did adhere. One single-arm cohort study showed that the recurrence rate was considerably higher in people who did not adhere or had poor adherence (79%) compared with those who adhered to compression stockings (4%).Compared with usual ca

Background: Pregnant people have a risk of carrying a fetus affected by a chromosomal anomaly. Prenatal screening is offered to pregnant people to assess their risk. In recent years, noninvasive prenatal testing (NIPT) has been introduced clinically, which uses the presence of circulating cell-free fetal DNA in the maternal blood to quantify the risk of a chromosomal anomaly. At present, NIPT is publicly funded for pregnancies at high risk of a chromosomal anomaly, and available to pregnant people at average risk if they choose to pay out of pocket.

Methods: We performed a systematic review of primary, empirical qualitative research that describes the experiences and perspectives of pregnant people, their families, clinicians, and others with lived experience relevant to NIPT. We were interested in the beliefs, experiences, preferences, and perspectives of these groups. We analyzed the evidence available in 36 qualitative and mixed-methods studies using the integrative technique of qualitative meta-synthesis.

Results: Most people (pregnant people, clinicians, and others with relevant lived experience) said that NIPT offered important information to pregnant people and their partners. Most people were very enthusiastic about widening access to NIPT because it can provide information about chromosomal anomalies quite early in pregnancy, with relatively high accuracy, and without risk of procedure-related pregnancy loss. However, many groups cautioned that widening access to NIPT may result in routinization of this test, causing potential harm to pregnant people, their families, the health care system, people living with disabilities, and society as a whole. Widened logistical, financial, emotional, and informational access may be perceived as a benefit, but it can also confer harm on various groups. Many of these challenges echo historical critiques of other forms of prenatal testing, with some issues mitigated or exacerbated by the particular features of NIPT.

Conclusions: Noninvasive prenatal testing offers significant benefit for pregnant people but may also be associated with potential harms related to informed decision-making, inequitable use, social pressure to test, and reduced support for people with disabilities.

Background: Osteoarthritis is a chronic disorder and the most common form of arthritis. The joints most commonly affected are the hip and knee. The progression of osteoarthritis results in the breakdown of tissues and cartilage and the loss of joint function, causing symptoms such as pain, stiffness, reduced physical function, and limited movement. Although there is no cure for osteoarthritis, treatment options are available to manage symptoms and optimize quality of life. Clinical guidelines recommend education, exercise, and weight loss (when necessary) as the first line of treatment.

Methods: We conducted a health technology assessment, which included an evaluation of the effectiveness, safety, and cost-effectiveness of a structured education and neuromuscular exercise program for the management of hip and/or knee osteoarthritis. We also assessed the budget impact of publicly funding such a program, and we spoke with people with osteoarthritis to gain an understanding of their preferences and values. We performed a systematic review of the clinical and economic literature published between January 1, 2008, and October 4, 2017. We also performed a grey literature search of health technology assessment websites. We assessed the risk of bias of each study, and we assessed the quality of the body of evidence according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. To evaluate the cost-effectiveness of a structured education and neuromuscular exercise program for adults with knee osteoarthritis, we conducted a cost-utility analysis from the perspective of the Ontario Ministry of Health and Long-Term Care. We also estimated the budget impact of publicly funding such a program in Ontario over the next 5 years. To contextualize the potential value of this type of program as a treatment option, we spoke with people with hip and/or knee osteoarthritis.

Results: Ten studies met our inclusion criteria for the clinical evidence review. Compared with usual care, a structured education and neuromuscular exercise program showed statistically significant short-term improvements in pain (GRADE low) and physical function (GRADE moderate), as well as statistically significant long-term improvements in performing activities of daily living (GRADE moderate) and in quality of life (GRADE moderate). The short-term improvements in pain and physical function appeared to be sustained into the medium term. Compared with patient education, a structured education and neuromuscular exercise program showed statistically significant short-term improvements in pain (GRADE low) and physical function (GRADE low) and sustained long-term improvement in physical function.Our primary economic evaluation showed that, compared with usual care, a group-based structured education and neuromuscular exercise program consisting of two educational sessions and 24 exe

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