Ontario Health Technology Assessment Series最新文献

Background: Glaucoma is a condition that causes progressive damage to the optic nerve, which can lead to visual impairment and irreversible blindness. There is a spectrum of current treatments for glaucoma that aim to reduce intraocular pressure (IOP), including pharmacotherapy (eye drops), laser therapy, and the more invasive option of filtration surgery. A new class of treatments called minimally invasive glaucoma surgery (MIGS) may reduce IOP and offer a better safety profile than more invasive procedures. We conducted a budget impact analysis of MIGS for adults with glaucoma from the perspective of the Ontario Ministry of Health and Long-Term Care. We also conducted interviews with people with glaucoma and family members of people with glaucoma to determine patient preferences and values surrounding glaucoma and its treatment options, including MIGS. We completed this work to complement a health technology assessment conducted in collaboration with the Canadian Agency for Drugs and Technologies in Health (CADTH).

Methods: We analyzed the budget impact of publicly funding MIGS in adults with glaucoma in Ontario. We derived costs from the collaborative health technology assessment.¹ We assumed MIGS may be used in three subgroups: (1) MIGS in combination with cataract surgery as a replacement for cataract surgery alone in people with mild to moderate glaucoma; (2) MIGS alone as a replacement for other glaucoma treatments in people with mild to moderate glaucoma; and (3) MIGS (alone or in combination with cataract surgery) to replace filtration surgery (alone or in combination with cataract surgery) in people with advanced to severe glaucoma. We estimated the budget impact over 5 years for two possible uptake scenarios: a slow rate of uptake and a fast rate of uptake. To contextualize the lived experience of glaucoma and treatments for glaucoma, we also interviewed people with glaucoma and family members of people with glaucoma, some of whom had experience with surgical procedures such as MIGS and some of whom did not.

Results: Assuming a slow uptake scenario, the annual budget impact of publicly funding MIGS in Ontario over the next 5 years ranges from $1 million in year 1 to $18 million in year 5. Assuming a fast uptake scenario, the annual budget impact of publicly funding MIGS in Ontario over the next 5 years ranges from $6 million in year 1 to $70 million in year 5. The budget impact varies depending on the proportion of people in each of the three subgroups described above. Introducing a new MIGS billing code may reduce the overall expenditures. Interview participants felt that less invasive surgical procedures, such as MIGS, could control glaucoma progression with minimal side effects and recovery time needed.

Conclusions: We estimate that publicly funding MIGS in Ontario would result in additional costs over the next 5 years; however, this

Background: People with diabetes manage their condition by monitoring the amount of glucose (a type of sugar) in their blood, typically using a method called self-monitoring of blood glucose. Flash glucose monitoring is another method of assessing glucose levels; it uses a sensor placed under the skin and a separate touchscreen reader device. We conducted a health technology assessment of flash glucose monitoring for people with type 1 or type 2 diabetes, which included an evaluation of effectiveness and safety, the budget impact of publicly funding flash glucose monitoring, 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 for randomized controlled trials and the Cochrane ROBINS-I tool for nonrandomized 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 we analyzed the net budget impact of publicly funding flash glucose monitoring in Ontario for people with type 1 diabetes and for people with type 2 diabetes requiring intensive insulin therapy who are eligible for coverage under the Ontario Drug Benefit program. To contextualize the potential value of flash glucose monitoring, we spoke with adults with diabetes and parents of children with diabetes.

Results: Six publications met the eligibility criteria for the clinical evidence review. Compared with self-monitoring of blood glucose, people who used flash glucose monitoring spent on average 1 hour more in the target glucose range (95% confidence interval [CI] 0.41-1.59) and 0.37 hours (22 minutes) less in a high glucose range (95% CI -0.69 to -0.05) (GRADE: Moderate). Among adults with well-controlled type 1 diabetes, flash glucose monitoring was more effective than self-monitoring of blood glucose in reducing glucose variability (GRADE: Moderate). Flash glucose monitoring was more effective than self-monitoring of blood glucose in reducing the average time spent in hypoglycemia (-0.47 h [95% CI -0.73 to -0.21]) and the average number of hypoglycemia events (-0.16 [95% CI -0.29 to -0.03]) among adults with type 2 diabetes requiring intensive insulin therapy (GRADE: Moderate). Our certainty in the evidence for the effectiveness of flash glucose monitoring for other clinical outcomes, such as quality of life and severe hypoglycemia events, is low or very low. We identified no studies on flash glucose monitoring that included pregnant people, people with diabetes who did not use insulin, or children younger than 13 years of age.We identified two studies for the economic evidence review: one cost analysis and one cost-utility analysis. The cost analysis study, conducted from the perspective of United Ki

Background: Osseointegrated prosthetic implants are biocompatible metal devices that are inserted into the residual bone to integrate with the bone and attach to the external prosthesis, eliminating the need for socket prostheses and the problems that may accompany their use. We conducted a health technology assessment of osseointegrated prosthetic implants, compared with conventional socket prostheses, for people with lower-limb amputation who experience chronic problems with their prosthetic socket, leading to prosthesis intolerance and reduced mobility. Our analysis included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding osseointegrated prosthetic implants, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence on the safety and effectiveness of the latest iterations of three implant systems: the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the Endo-Exo-Femur-Prosthesis, and the Osseointegration Group of Australia-Osseointegration Prosthetic Limb (OGAP-OPL). We assessed the risk of bias of individual studies and determined 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 lifetime horizon from a public payer perspective. We also analyzed the net budget impact of publicly funding osseointegrated prosthetic implants in Ontario. To contextualize the potential value of osseointegrated prosthetic implants, we spoke with people with lower-limb amputations.

Results: We included nine studies in the clinical evidence review. All studies included patients with above-the-knee amputation who underwent two-stage surgery and mostly had short-term follow-up. With osseointegrated prosthetic implants, scores for functional outcomes improved significantly as measured by 6-Minute Walk Test (6MWT), Timed Up and Go (TUG) test, and Questionnaire for Persons with a Transfemoral Amputation (Q-TFA). The scores for quality of life measured by SF-36 showed significant improvement in the physical component summary but a nonsignificant decline for the mental component summary. The most frequently seen adverse event was superficial infection, occurring in about half of patients in some studies. Deep or bone infection was a serious adverse event, with variable rates among the studies depending on the length of follow-up. The treatment of deep or bone infection required long-term antibiotic use, surgical debridement, revision surgery, and implant extraction in some cases. Other adverse events included femoral bone fracture, implant breakage, issues with extramedullary parts that required replacement, and implant removal. Our assessment of the quality of the clinical

Background: Cervical degenerative disc disease is a multifactorial condition that begins with deterioration of the intervertebral disc and results in further degeneration within the spine involving the facet joints and ligaments. This health technology assessment examined the effectiveness, safety, durability, and cost-effectiveness of cervical artificial disc replacement (C-ADR) versus fusion for treating cervical degenerative disc disease.

Methods: We performed a systematic literature search of the clinical evidence comparing C-ADR with fusion. We assessed the risk of bias in 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 assessed the cost-effectiveness of C-ADR compared with fusion. We also estimated the budget impact of publicly funding C-ADR in Ontario over the next 5 years. To contextualize the potential value of C-ADR, we spoke with people with cervical degenerative disc disease.

Results: Eight studies of C-ADR for one-level cervical degenerative disc disease and two studies of C-ADR for two-level disease satisfied the criterion of statistical noninferiority compared with fusion on the primary outcome of 2-year overall treatment success (GRADE: Moderate). In two studies of C-ADR for two-level disease, C-ADR was statistically superior to fusion surgery for the same primary outcome (GRADE: Moderate). C-ADR was also noninferior to fusion for perioperative outcomes (e.g., operative time, blood loss), patient satisfaction, and health-related quality of life (GRADE: Moderate). C-ADR was superior to fusion for recovery and return to work, had higher technical success, and had lower rates of re-operation at the index site (GRADE: Moderate). C-ADR also maintained motion at the index-treated cervical level (GRADE: Moderate), but evidence was insufficient to determine if adjacent-level surgery rates differed between C-ADR and fusion. Current evidence is also insufficient to determine the long-term durability of C-ADR.The primary economic analysis shows that C-ADR is likely to be cost-effective compared with fusion for both one-level ($11,607/quality-adjusted life-year [QALY]) and two-level ($16,782/QALY) degeneration. Various sensitivity and scenario analyses confirm the robustness of the results. The current uptake for one-level and two-level C-ADR in Ontario is about 8% of the total eligible. For one-level involvement, the estimated net budget impact increases from $7,243 (18 procedures) in the first year to $395,623 (196 procedures) in the fifth year following public funding, for a total budget impact over 5 years of $916,326. For two-level involvement, the corresponding values are $5,460 (7 procedures) in the first year and $283,689 (76 procedures) in the fifth year, for an estimated total budget impa

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. 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 the time of writing, NIPT is publicly funded in Ontario for pregnancies at high risk of a chromosomal anomaly.

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 NIPT. We performed a systematic literature search for studies on NIPT for trisomies 21, 18, and 13, sex chromosome aneuploidies, and microdeletions in the average-risk or general population. We evaluated the cost-effectiveness of traditional prenatal screening, NIPT as a second-tier test (performed after traditional prenatal screening), and NIPT as a first-tier test (performed instead of traditional prenatal screening). We also conducted a budget impact analysis to estimate the additional costs of funding first-tier NIPT. We interviewed people who had lived experience with NIPT and people living with the conditions NIPT screens for, or their families.

Results: The pooled clinical sensitivity of NIPT in the average-risk or general population was 99.5% (95% confidence interval [CI] 81.8%-99.9%) for trisomy 21, 93.1% (95% CI 75.9%-98.3%) for trisomy 18, and 92.7% (95% CI 81.6%-99.9%) for trisomy 13. The clinical specificity for any trisomy was 99.9% (95% CI 99.8%-99.9%). Compared with traditional prenatal screening, NIPT was more accurate in detecting trisomies 21, 18, and 13, and decreased the need for diagnostic testing. We found limited evidence on NIPT for sex chromosome aneuploidies or microdeletions in the average-risk or general population. Positive NIPT results should be confirmed by diagnostic testing.Compared with traditional prenatal screening, second-tier NIPT detected more affected fetuses, substantially reduced the number of diagnostic tests performed, and slightly reduced the total cost of prenatal screening. Compared with second-tier NIPT, first-tier NIPT detected more affected cases, but also led to more diagnostic tests and additional budget of $35 million per year for average-risk pregnant people in Ontario.People who had undergone NIPT were largely supportive of the test and the benefits of earlier, more accurate results. However, many discussed the need for improved pre- and post-test counselling and raised concerns about the quality of the information they received from health care providers about the conditions NIPT can screen for.

Conclusions: NIPT is an effective and safe prenatal screening method for trisomies 21, 18, and 13 in the average-risk or general population. Compared with traditiona

Background: People with chronic urinary retention typically require intermittent catheterization. This review evaluates the effectiveness, safety, patient preference, cost-effectiveness, and budget impact of different types of intermittent catheter (IC). Specifically, we compared prelubricated catheters (hydrophilic, gel reservoir) and noncoated catheters, as well as their single use versus reuse (multiple use).

Methods: We performed a systematic literature search and included randomized controlled trials, cohort, and case-control studies that examined any type of single-use versus multiple-use IC, hydrophilic single-use versus noncoated single-use, or gel reservoir single-use versus noncoated single-use. The outcomes of interest were symptomatic urinary tract infection (UTI), hematuria, other serious adverse events, and patient satisfaction. The quality of the body of evidence was examined according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation, using the perspective of the Ontario Ministry of Health and Long-Term Care, to determine the cost-effectiveness of various intermittent catheters used in Ontario. We determined the budget impact of fully and partially funding various intermittent catheters for outpatients with chronic urinary retention. To understand patient experiences with intermittent catheterization, we interviewed 34 adults and parents of children affected by chronic urinary retention.

Results: We found 14 randomized controlled trials that met the inclusion criteria. When comparing any type of single-use or multiple-use IC, we found no difference in UTI (RR = 0.98, 95% CI 0.70-1.39), hematuria, or serious adverse events, and inconclusive evidence on patient satisfaction.Our meta-analysis of studies on people living in the community showed that hydrophilic ICs may result in fewer UTIs than single-use noncoated ICs, but given the nature of the studies, we were uncertain about this conclusion.The nature of the available evidence also did not allow us to make definitive conclusions regarding whether one type of catheter was likely to result in less hematuria, fewer serious adverse events, or greater patient satisfaction.Our economic evaluation found that owing to small differences in quality-adjusted life-years and moderate to large incremental cost differences, the lowest-cost ICs-noncoated multiple-use (using one catheter per week or one catheter per day)-have the highest probability of being cost-effective. In a subpopulation of those clinically advised not to reuse ICs, single-use noncoated ICs have the highest probability of being cost-effective. As current funding is limited in the outpatient setting, publicly funding noncoated multiple-use catheters (one per day) would result in a total additional cost of $93 million over the first 5 years. People who use ICs repor

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