Ontario Health Technology Assessment Series最新文献

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

Background: There are currently two methods used to administer immunoglobulin: intravenous (IV) infusion, the conventional method, and subcutaneous (SC) infusion, a newer alternative. The aim of this assessment was to compare administration of SC immunoglobulin at home with IV immunoglobulin in hospital with respect to benefits, harm, and costs. We also investigated the lived experiences of patients, looking at their quality of life, satisfaction, opinions, and preferences.

Methods: We searched the literature for studies that compared home-based SC infusion with hospital- or clinic-based IV infusion of immunoglobulin in the treatment of primary and secondary immunodeficiency in adults and children. Two review authors reviewed the abstracts and full text of the relevant studies, and abstracted the data.We also performed a review of the economic literature comparing SC infusion at home versus IV infusion of immunoglobulin in a hospital or outpatient clinic in patients with primary or secondary immunodeficiency disorders. We also performed a budget impact analysis to estimate the 5-year cost burden of funding home-based SC infusion programs. All costs were reported in 2017 Canadian dollars.This health technology assessment followed a consultation plan for public engagement. We focused on interviews to examine the lived experience of patients with immunodeficiency, including those having experience of intravenous and/or subcutaneous immunoglobulin treatment.

Results: Sixteen studies met the inclusion criteria. The annual rate of serious bacterial infection per patient did not differ. The annual rate of all infections per patient was relatively lower with home-based SC infusion than with hospital-based IV infusion. Both methods provided an adequate blood (serum) level of immunoglobulin and the pooled mean difference in immunoglobulin level favoured home-based SC infusion. Severe adverse reactions were rare with either method. The risk of adverse events such as fever or headache were higher with IV, while SC infusion sometimes caused infusion site reactions such as swelling, redness, or pain. Where reported, incidence of hospitalization, antibiotic use, and missed days from work or school either did not differ or were lower for SC infusion. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) of evidence for these outcomes was determined to be low.The scores for quality of life and treatment satisfaction either did not differ between the two methods or were significantly higher for some domains with home-based SC infusion. The three important concerns of patients in Ontario regarding home-based programs are loss of supervision, cost, and frequent injections.We identified four economic studies with six analyses (five cost-minimization and one cost-utility). All six analyses suggested that home-based infusion has lower costs, with one also showing greater effectiv

Background: Diabetic neuropathic foot ulcers are a risk factor for lower leg amputation. Many experts recommend offloading with fibreglass total contact casting, removable cast walkers, and irremovable cast walkers as a way to treat these ulcers.

Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for offloading devices. We performed a systematic literature search on August 17, 2016, to identify randomized controlled trials that compared fibreglass total contact casting, removable cast walkers, and irremovable cast walkers with other treatments (offloading or non-offloading) in patients with diabetic neuropathic foot ulcers. We developed a decision-analytic model to assess the cost-effectiveness of fibreglass total contact casting, removable cast walkers, and irremovable cast walkers, and we conducted a 5-year budget impact analysis. Finally, we interviewed people with diabetes who had lived experience with foot ulcers, asking them about the different offloading devices and the factors that influenced their treatment choices.

Results: We identified 13 randomized controlled trials. The evidence suggests that total contact casting, removable cast walkers, and irremovable cast walkers are beneficial in the treatment of neuropathic, noninfected foot ulcers in patients with diabetes but without severe peripheral arterial disease. Compared to removable cast walkers, ulcer healing was improved with total contact casting (moderate quality evidence; risk difference 0.17 [95% confidence interval 0.00-0.33]) and irremovable cast walkers (low quality evidence; risk difference 0.21 [95% confidence interval 0.01-0.40]). We found no difference in ulcer healing between total contact casting and irremovable cast walkers (low quality evidence; risk difference 0.02 [95% confidence interval -0.11-0.14]). The economic analysis showed that total contact casting and irremovable cast walkers were less expensive and led to more health outcome gains (e.g., ulcers healed and quality-adjusted life-years) than removable cast walkers. Irremovable cast walkers were as effective as total contact casting and were associated with lower costs. The 5-year budget impact of funding total contact casting, removable cast walkers, and irremovable cast walkers (device costs only at 100% access) would be $17 to $20 million per year. The patients we interviewed felt that wound healing was improved with total contact casting than with removable cast walkers, but that removable cast walkers were more convenient and came with a lower cost burden. They reported no experience or familiarity with irremovable cast walkers.

Conclusions: Ulcer healing improved with total contact casting, irremovable cast walkers, and removable cast walkers, but total contact casting and irremovable cast walkers had higher rat

Background: Prostate cancer is the second most common type of cancer in Canadian men. Radical prostatectomy is one of the treatment options available, and involves removing the prostate gland and surrounding tissues. In recent years, surgeons have begun to use robot-assisted radical prostatectomy more frequently. We aimed to determine the clinical benefits and harms of the robotic surgical system for radical prostatectomy (robot-assisted radical prostatectomy) compared with the open and laparoscopic surgical methods. We also assessed the cost-effectiveness of robot-assisted versus open radical prostatectomy in patients with clinically localized prostate cancer in Ontario.

Methods: We performed a literature search and included prospective comparative studies that examined robot-assisted versus open or laparoscopic radical prostatectomy for prostate cancer. The outcomes of interest were perioperative, functional, and oncological. 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 conducted a cost-utility analysis with a 1-year time horizon. The potential long-term benefits of robot-assisted radical prostatectomy for functional and oncological outcomes were also evaluated in a 10-year Markov model in scenario analyses. In addition, we conducted a budget impact analysis to estimate the additional costs to the provincial budget if the adoption of robot-assisted radical prostatectomy were to increase in the next 5 years. A needs assessment determined that the published literature on patient perspectives was relatively well developed, and that direct patient engagement would add relatively little new information.

Results: Compared with the open approach, we found robot-assisted radical prostatectomy reduced length of stay and blood loss (moderate quality evidence) but had no difference or inconclusive results for functional and oncological outcomes (low to moderate quality evidence). Compared with laparoscopic radical prostatectomy, robot-assisted radical prostatectomy had no difference in perioperative, functional, and oncological outcomes (low to moderate quality evidence). Compared with open radical prostatectomy, our best estimates suggested that robot-assisted prostatectomy was associated with higher costs ($6,234) and a small gain in quality-adjusted life-years (QALYs) (0.0012). The best estimate of the incremental cost-effectiveness ratio (ICER) was $5.2 million per QALY gained. However, if robot-assisted radical prostatectomy were assumed to have substantially better long-term functional and oncological outcomes, the ICER might be as low as $83,921 per QALY gained. We estimated the annual budget impact to be $0.8 million to $3.4 million over the next 5 years.

Conclusions: There is no high-quality evidence that robot-assisted radical pros

Background: Cerebral palsy, a spectrum of neuromuscular conditions caused by abnormal brain development or early damage to the brain, is the most common cause of childhood physical disability. Lumbosacral dorsal rhizotomy is a neurosurgical procedure that permanently decreases spasticity and is always followed by physical therapy. The objectives of this health technology assessment were to evaluate the clinical effectiveness, safety, cost effectiveness, and family perspectives of dorsal rhizotomy.

Methods: We performed a systematic literature search until December 2015 with auto-alerts until December 2016. Search strategies were developed by medical librarians, and a single reviewer reviewed the abstracts. The health technology assessment included a clinical review based on functional outcomes, safety, and treatment satisfaction; an economic study reviewing cost-effective literature; a budget impact analysis; and interviews with families evaluating the intervention.

Results: Eighty-four studies (1 meta-analysis, 5 randomized controlled studies [RCTs], 75 observational pre-post studies, and 3 case reports) were reviewed. A meta-analysis of RCTs involving dorsal rhizotomy and physical therapy versus physical therapy confirmed reduced lower-limb spasticity and increased gross motor function (4.5%, P = .002). Observational studies reported statistically significant improvements in gross motor function over 2 years or less (12 studies, GRADE moderate) and over more than 2 years (10 studies, GRADE moderate) as well as improvements in functional independence in the short term (10 studies, GRADE moderate) and long term (4 studies, GRADE low). Major operative complications, were infrequently reported (4 studies). Bony abnormalities and instabilities monitored radiologically in the spine (15 studies) and hip (8 studies) involved minimal or clinically insignificant changes after surgery. No studies evaluated the cost effectiveness of dorsal rhizotomy. The budget impact of funding dorsal rhizotomy for treatment of Ontario children with cerebral palsy was $1.3 million per year. Families reported perceived improvements in their children and expressed satisfaction with treatment. Ontario families reported inadequate medical information on benefits or risk to make an informed decision, enormous financial burdens, and lack rehabilitation support after surgery.

Conclusions: Lumbrosacral dorsal rhizotomy and physical therapy effectively reduces lower-limb spasticity in children with spastic cerebral palsy and significantly improves their gross motor function and functional independence. Major peri-operative complications were infrequently reported. Families reported perceived improvements with dorsal rhizotomy, and surgery and post-operative rehabilitation were intensive and demanding.

Background: Atrial fibrillation is a common cardiac arrhythmia, and 15% to 20% of those who have experienced stroke have atrial fibrillation. Treatment options to prevent stroke in people with atrial fibrillation include pharmacological agents such as novel oral anticoagulants or nonpharmacological devices such as the left atrial appendage closure device with delivery system (LAAC device). The objectives of this health technology assessment were to assess the clinical effectiveness and cost-effectiveness of the LAAC device versus novel oral anticoagulants in patients without contraindications to oral anticoagulants and versus antiplatelet agents in patients with contraindications to oral anticoagulants.

Methods: We performed a systematic review and network meta-analysis. We also conducted an economic literature review, economic evaluation, and budget impact analysis to assess the cost-effectiveness and budget impact of the LAAC device compared with novel oral anticoagulants and oral antiplatelet agents (e.g., aspirin). We also spoke with patients to better understand their preferences, perspectives, and values.

Results: Seven randomized controlled studies met the inclusion criteria for indirect comparison. Five studies assessed the effectiveness of novel oral anticoagulants versus warfarin, and two studies compared the LAAC device with warfarin. No studies were identified that compared the LAAC device with aspirin in patients in whom oral anticoagulants were contraindicated. Using the random effects model, we found that the LAAC device was comparable to novel oral anticoagulants in reducing stroke (odds ratio [OR] 0.85; credible interval [Cr.I] 0.63-1.05). Similarly, the reduction in the risk of all-cause mortality was comparable between the LAAC device and novel oral anticoagulants (OR 0.71; Cr.I 0.49-1.22). The LAAC device was found to be superior to novel oral anticoagulants in preventing hemorrhagic stroke (OR 0.45; Cr.I 0.29-0.79), whereas novel oral anticoagulants were found to be superior to the LAAC device in preventing ischemic stroke (OR 0.67; Cr.I 0.24-1.64). The body of clinical evidence was found to be of moderate quality as assed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Results from the economic evaluation indicate that the LAAC device is cost-effective compared with aspirin in patients with contraindications to oral anticoagulants. In patients without contraindications to oral anticoagulants, we found that the LAAC device is not cost-effective compared with novel oral anticoagulants. Publicly funding the LAAC device in patients with nonvalvular atrial fibrillation with contraindications to oral anticoagulants could result in additional funding of $1.1 million to $7.7 million over the first five years. Patients interviewed reported on the impact of living with nonvalvular atrial fibrillation and were sup

Background: Transitions in care can increase patients' vulnerability to adverse events. In particular, patients admitted for heart failure or chronic obstructive pulmonary disorder (COPD) have high rates of readmission and return emergency department visits. Heart failure patients have the highest 30-day readmission rates in Canada, and COPD patients comprise the highest volume of readmissions. Combined, these two conditions account for the largest number of emergency department returns. Prompt follow-up of discharged patients has been linked with reduced rates of readmission, emergency department use, and death. This systematic review evaluated the clinical effectiveness of early follow-up, within either 7 days or 30 days after hospital discharge, compared with usual care or a different time to follow-up, in reducing readmissions, emergency department visits, and mortality in patients with heart failure or COPD.

Methods: We performed a literature search to identify studies published in English up to May 25, 2016, on early follow-up after discharge from hospital in patients with heart failure or COPD. A single reviewer screened the titles and abstracts and obtained full-text articles for studies meeting the eligibility criteria. The risk of bias in the studies was evaluated according to ROBINS-I and EPOC criteria, and the quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.

Results: From a total of 3,228 unique citations, we identified 10 eligible studies: one randomized controlled trial, two nonrandomized controlled trials, and seven observational studies. Four studies were specifically on 7-day follow-up and 30-day health outcomes. The other six studies were on 30-day follow-up and more variable time to health outcomes. Follow-up was conducted by general and specialist physicians, nurses, and pharmacists in clinics, by telephone, and by home visit. Risk of bias was moderate for most of the studies. Having follow-up within either 7 days or 30 days after hospitalization for heart failure or COPD was associated with lower all-cause readmissions, emergency department visits, and mortality, even after accounting for confounders such as age, sex, socioeconomic status, and disease severity (GRADE: Very low to low). However, the evidence was inconsistent. We did not find a difference in effectiveness between studies using a 7-day versus a 30-day follow-up.

Conclusions: Based on low- and very low-quality evidence, follow-up within 7 days and within 30 days of discharge from hospitalization for heart failure or COPD-compared with usual care or no follow-up-were both associated with a reduced risk of all-cause readmission, emergency department visits, and mortality. Overall, there is a lack of large, methodologically robust studies specifically