Ontario Health Technology Assessment Series最新文献

Background: About 15% to 25% of people with diabetes will develop a foot ulcer. These wounds are often resistant to healing; therefore, people with diabetes experience lower limb amputation at about 20 times the rate of people without diabetes. If an ulcer does not heal with standard wound care, other therapeutic interventions are offered, one of which is hyperbaric oxygen therapy (HBOT). However, the effectiveness of this therapy is not clearly known. The objectives of this health technology assessment were to assess the safety, clinical effectiveness, and cost-effectiveness of standard wound care plus HBOT versus standard wound care alone for the treatment of diabetic foot ulcers. We also investigated the preferences and perspectives of people with diabetic foot ulcers through lived experience.

Methods: We performed a review of the clinical and economic literature for the effectiveness and cost-effectiveness of hyperbaric oxygen therapy, as well as the budget impact of HBOT from the perspective of the Ministry of Health and Long-Term Care. We assessed the quality of the body of clinical evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. To better understand the preferences, perspectives, and values of patients with diabetic foot ulcers and their experience with HBOT, we conducted interviews and administered an online survey.

Results: Seven randomized controlled trials and one nonrandomized controlled trial met the inclusion criteria. Comparing standard wound care plus HBOT with standard wound care alone, we found mixed results for major amputation rates (GRADE quality of evidence: low), a significant difference in favour of standard wound care plus HBOT on ulcers healed (GRADE quality of evidence: low), and no difference in terms of adverse events (GRADE quality of evidence: moderate). There is a large degree of uncertainty associated with the evaluation of the cost-effectiveness of standard wound care plus HBOT. However, results appear to suggest that this treatment results in lower costs and better outcomes than standard wound care alone. Funding HBOT will result in a budget impact of $4 million per year in immediate treatment costs for the Ontario Ministry of Health and Long-Term Care. This cost decreases to $0.5 million per year when downstream costs are considered. There is a substantial daily burden of care and emotional weight associated with living with diabetic foot ulcers, both of which are compounded by concern regarding possible amputation. Patients feel that HBOT is an effective treatment and reported that they were satisfied with how their ulcers healed and that this improved their quality of life.

Conclusions: The evidence makes it difficult to draw any definitive conclusions on the clinical and cost effectiveness of standard wound care plus HBOT versus standard wound care alo

Background: Men with low- to intermediate-risk prostate cancer are typically asked to choose from a variety of treatment options, including active surveillance, radical prostatectomy, or brachytherapy. The Prolaris cell cycle progression test is intended to provide additional information on personal risk status to assist men with prostate cancer in their choice of treatment. To assist with assessing that new technology, this report synthesizes qualitative research on how men with prostate cancer use information to make decisions about treatment options.

Methods: We performed a systematic review and qualitative meta-synthesis to retrieve and synthesize findings across primary qualitative studies that report on patient perspectives during prostate cancer treatment decision-making.

Results: Of 8,610 titles and abstracts reviewed, 29 studies are included in this report. Most men diagnosed with prostate cancer express that their information-seeking pathway extends beyond the medical information received from their health care provider. They access other social resources to attain additional medical information, lived-experience information, and medical administrative information to help support their final treatment decision. Men value privacy, trust, honesty, control, power, organization, and open communication during interactions with their health care providers. They also emphasize the importance of gaining comfort with their treatment choice, having a chance to confirm their health care provider's recommendations (validation of treatment plan), and exercising their preferred level of independence in the treatment decision-making process.

Conclusions: Although each prostate cancer patient is unique, studies suggest that most patients seek extensive information to help inform their treatment decisions. This may happen before, during, and after the treatment choice is made. Given the amount of information patients may access, it is important that they also establish the trustworthiness of the various types and sources of information. When information conflicts, patients may be unsure about how to proceed. Open collaboration between patients and their health care providers can help patients manage and navigate their concerns so that their values and perspectives are captured in their treatment choices.

Background: Prostate cancer is very common and many localized tumours are non-aggressive. Determining which cancers are aggressive is important for choosing the most appropriate treatment (e.g., surgery, radiation, active surveillance). Current clinical risk stratification is reliable in forecasting the prognosis of groups of men with similar clinical and pathologic characteristics, but there is residual uncertainty at the individual level. The Prolaris cell cycle progression (CCP) test, a genomic test that estimates how fast tumour cells are proliferating, could potentially be used to improve the accuracy of individual risk assessment. This health technology assessment sought to determine the clinical utility, economic impact, and patients' perceptions of the value of the CCP test in low- and intermediate-risk localized prostate cancer.

Methods: We conducted a systematic review of the clinical and economic evidence of the CCP test in low-and intermediate-risk, localized prostate cancer. Medical and health economic databases were searched from 2010 to June or July 2016. The critical appraisal of the clinical evidence included risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also analyzed the potential budget impact of adding the CCP test into current practice, from the perspective the Ontario Ministry of Health and Long-Term Care. Finally, we conducted qualitative interviews with men with prostate cancer, on the factors that influenced their treatment decision-making.

Results: For the review of clinical effectiveness, we screened 3,021 citations, and two before-after studies met our inclusion criteria. In one study, the results of the CCP test appeared to change the treatment plan (from initial to final plan) in 64.9% of cases overall (GRADE rating of the quality of evidence: Very low). In the other study, the CCP test changed the treatment received in nearly half of cases overall, compared with the initial plan (GRADE: Very low). No evidence was available on clinical outcomes of patients whose treatment was informed by CCP results. For the review of cost-effectiveness, 100 citations were identified and screened. No studies met the inclusion criteria. In our economic evaluation, we estimated that publicly funding the CCP test would result in a total net budget impact of $41.3 million in the first 5 years, mostly due to the cost of the CCP test. In our model, the relatively small cost savings ($7.3 million) due to treatment change (increased use of active surveillance and decreased use of interventional treatment) was not large enough to offset the high cost of the test. Patients viewed the test as potentially helpful but, due to the complexity of treatment decision-making, were unsure the test would ultimately change their treatment choices.

Conclusions: We found no evidence to demonstr

Background: A large proportion of the Ontario population lives with a diagnosed mental illness. Nearly 5% of Ontarians have major depressive disorder, and another 5% have another type of depressive disorder, bipolar disorder, schizophrenia, anxiety, or some other disorder not otherwise specified. Medications are commonly used to treat mental illness, but choosing the right medication for each patient is challenging, and more than 40% of patients discontinue their medication within 90 days because of adverse effects or lack of response. The Assurex GeneSight Psychotropic test is a pharmacogenomic panel that provides clinicians with a report to guide medication selection that is unique to each patient based on their individual genetic profile. However, it is uncertain whether guided treatment using GeneSight is effective compared with unguided treatment (usual care).

Methods: We performed a systematic review to identify English-language studies published before February 22, 2016, that compared GeneSight-guided care and usual care among people with mood disorders, anxiety, or schizophrenia. Primary outcomes of interest were prevention of suicide, remission of depression symptoms, response to depression therapy, depression score, and quality of life. Secondary outcomes of interest were impact on therapeutic decisions and patient and clinician satisfaction. Risk of bias was evaluated, and the quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group criteria.

Results: Four studies met the inclusion criteria. These studies used a version of GeneSight that included the CYP2D6, CYP2C19, CYP1A2, SLC6A4, and HTR2A genes; one of the studies also included CYP2C9. Patients who received the GeneSight test to guide psychotropic medication selection had improved response to depression treatment, greater improvements in measures of depression, and greater patient and clinician satisfaction compared with patients who received treatment as usual. We observed no differences in rates of complete remission from depression. The findings were based on GRADE assessment of low to very low quality evidence, and the body of evidence had several limitations: the included studies used an older version of GeneSight and were limited to a population with major depression, so results may not be generalizable to other versions of the test or different populations such as patients with anxiety or schizophrenia.

Conclusions: There is uncertainty about the use of GeneSight Psychotropic pharmacogenomic genetic panel to guide medication selection. It was associated with improvements in some patient outcomes, but not others. As well, our confidence in these findings is low because of limitations in the body of evidence.

Background: A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies.

Methods: The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology.

Results: Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes, and multiple mechanisms to provide feedback through routes to reporters and the wider community (local meetings, email alerts, bulletins, paper contributions, etc.).

Conclusions: The design of a patient safety learning system can be optimized by an awareness of the barriers to and facilitators of successful adoption and implementation identified by health care professionals. Evaluation of the effectiveness of a patient safety learning system is needed to refine its design.

Background: Percutaneous coronary intervention (PCI)-using a catheter to place a stent to keep blood vessels open-is increasingly used for high-risk patients who cannot undergo surgery. Cardiogenic shock (when the heart suddenly cannot pump enough blood) is associated with a high mortality rate. The percutaneous ventricular assist device can help control blood pressure and increase blood flow in these high-risk conditions. This health technology assessment examined the benefits, harms, and budget impact of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock. We also analyzed cost-effectiveness of the Impella device in high-risk PCI.

Methods: We performed a systematic search of the literature for studies examining the effects of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on hemodynamic stability, mortality, major adverse cardiac events, bleeding, and vascular complications. We developed a Markov decision-analytical model to assess the cost- effectiveness of Impella devices versus intra-aortic balloon pumps (IABPs), calculated incremental cost-effectiveness ratios (ICERs) using a 10-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. The economic model was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care.

Results: Eighteen studies (one randomized controlled trial and 10 observational studies for high-risk PCI, and one randomized controlled trial and six observational studies for cardiogenic shock) were included in the clinical review. Compared with IABPs, Impella 2.5, one model of the device, improved hemodynamic parameters (GRADE low-very low) but showed no significant difference in mortality (GRADE low), major adverse cardiac events (GRADE low), bleeding (GRADE low), or vascular complications (GRADE low) in high-risk PCI and cardiogenic shock. No randomized controlled trials or prospective observational studies with a control group have studied Impella CP and Impella 5.0 (other models of the device) in patients undergoing high-risk PCI or patients with cardiogenic shock. The economic model predicted that treatment with the Impella device would have fewer quality-adjusted life-years (QALYs) and higher costs than IABP in high-risk PCI patients. These observations were consistent even when uncertainty in model inputs and parameters was considered. We estimated that adopting Impella would increase costs by $2.9 to $11.5 million per year.

Conclusions: On the basis of evidence of low to very low quality, Impella 2.5 devices were associated with improved hemodynamic stability, but had mortality rates and safety profile similar to IABPs in high-risk PCI

Background: Ambulatory electrocardiography (ECG) monitors are often used to detect cardiac arrhythmia. For patients with symptoms, an external cardiac loop recorder will often be recommended. The improved recording capacity of newer Holter monitors and similar devices, collectively known as longterm continuous ambulatory ECG monitors, suggests that they will perform just as well as, or better than, external loop recorders. This health technology assessment aimed to evaluate the effectiveness, cost-effectiveness, and budget impact of longterm continuous ECG monitors compared with external loop recorders in detecting symptoms of cardiac arrhythmia.

Methods: Based on our systematic search for studies published up to January 15, 2016, we did not identify any studies directly comparing the clinical effectiveness of longterm continuous ECG monitors and external loop recorders. Therefore, we conducted an indirect comparison, using a 24-hour Holter monitor as a common comparator. We used a meta-regression model to control for bias due to variation in device-wearing time and baseline syncope rate across studies. We conducted a similar systematic search for cost-utility and cost-effectiveness studies comparing the two types of devices; none were found. Finally, we used historical claims data (2006-2014) to estimate the future 5-year budget impact in Ontario, Canada, of continued public funding for both types of longterm ambulatory ECG monitors.

Results: Our clinical literature search yielded 7,815 non-duplicate citations, of which 12 cohort studies were eligible for indirect comparison. Seven studies assessed the effectiveness of longterm continuous monitors and five assessed external loop recorders. Both types of devices were more effective than a 24-hour Holter monitor, and we found no substantial difference between them in their ability to detect symptoms (risk difference 0.01; 95% confidence interval -0.18, 0.20). Using GRADE for network meta-analysis, we evaluated the quality of the evidence as low. Our budget impact analysis showed that use of the longterm continuous monitors has grown steadily in Ontario since they became publicly funded in 2006, particularly since 2011 when monitors that can record for 14 days or longer became funded, and the use of external cardiac loop recorders has correspondingly declined. The analysis suggests that, with these trends, continued public funding of both types of longterm ambulatory ECG testing will result in additional costs ranging from $130,000 to $370,000 per year over the next 5 years.

Conclusions: Although both longterm continuous ambulatory ECG monitors and external cardiac loop recorders were more effective than a 24-hour Holter monitor in detecting symptoms of cardiac arrhythmia, we found no evidence to suggest that these two devices differ in effectiveness. Assuming that the use of longterm continuous monitors will c

Background: Surgical aortic valve replacement (SAVR) is the gold standard for treating aortic valve stenosis. It is a major operation that requires sternotomy and the use of a heart-lung bypass machine, but in appropriately selected patients with symptomatic, severe aortic valve stenosis, the benefits of SAVR usually outweigh the harms. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure that allows an artificial valve to be implanted over the poorly functioning valve.

Methods: We identified and analyzed randomized controlled trials that evaluated the effectiveness and safety of TAVI compared with SAVR or balloon aortic valvuloplasty and were published before September 2015. 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. The overall quality was determined to be high, moderate, low, or very low using a step-wise, structural methodology. We also developed a Markov decision-analytic model to assess the cost-effectiveness of TAVI compared with SAVR over a 5-year time horizon, and we conducted a 5-year budget impact analysis.

Results: Rates of cardiovascular and all-cause mortality were similar for the TAVI and SAVR groups in all studies except one, which reported significantly lower all-cause mortality in the TAVI group and a higher rate of stroke in the SAVR group. Trials of high-risk patients who were not suitable candidates for SAVR showed significantly better survival with TAVI than with balloon aortic valvuloplasty. Median survival in the TAVI group was 31 months, compared with 11.7 months in the balloon aortic valvuloplasty group. Compared with SAVR, TAVI was associated with a significantly higher risk of stroke, major vascular complications, paravalvular aortic regurgitation, and the need for a permanent pacemaker. SAVR was associated with a higher risk of bleeding. Transapical TAVI was associated with higher rates of mortality and stroke than transfemoral TAVI in high-risk patients. TAVI and SAVR both improved patients' quality of life during the first year. However, because of a large amount of missing data and the lack of published data beyond 1 year, it was difficult to evaluate the impact of critical adverse outcomes on patients' longer-term health status. In the base-case analysis, when TAVI was compared with SAVR, the incremental cost-effectiveness ratio was $51,988 per quality-adjusted life-year. The 5-year budget impact of funding TAVI ranged from $7.6 to $8.3 million per year.

Conclusions: Moderate quality evidence showed that TAVI and SAVR had similar mortality rates in patients who were eligible for surgery. Information about quality of life showed similar results for TAVI and SAVR in the first year, but was based on low quality evidence. Moderate quality evidence also showed that TAVI wa

Background: Heavy menstrual bleeding affects as many as one in three women and has negative physical, economic, and psychosocial impacts including activity limitations and reduced quality of life. The goal of treatment is to make menstruation manageable, and options include medical therapy or surgery such as endometrial ablation or hysterectomy. This review examined the evidence of effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) as a treatment alternative for idiopathic heavy menstrual bleeding.

Methods: We conducted a systematic review of the clinical and economic evidence comparing LNG-IUS with usual medical therapy, endometrial ablation, or hysterectomy. Medline, EMBASE, Cochrane, and the Centres for Reviews and Dissemination were searched from inception to August 2015. The quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation to determine the cost-effectiveness and budget impact of the LNG-IUS compared with endometrial ablation and with hysterectomy. The economic evaluation was conducted from the perspective the Ontario Ministry of Health and Long-Term Care.

Results: Relevant systematic reviews (n = 18) returned from the literature search were used to identify eligible randomized controlled trials, and 16 trials were included. The LNG-IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. The quality of the evidence varied from very low to moderate across outcomes. Results from the economic evaluation showed the LNG-IUS was less costly (incremental saving of $372 per person) and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation. Similarly, the LNG-IUS costs less (incremental saving of $3,138 per person) and yields higher quality-adjusted life-years (incremental value of 0.04) compared with hysterectomy. Publicly funding LNG-IUS as an alternative to endometrial ablation and hysterectomy would result in annual cost savings of $3 million to $9 million and $0.1 million to $23 million, respectively, over the first 5 years.

Conclusions: The 52-mg LNG-IUS is an effective and cost-effective treatment option for idiopathic heavy menstrual bleeding. It improves quality of life and menstrual blood loss, and is well tolerated compared with endometrial ablation, hysterectomy, or usual medical therapies.

Background: Adjunct screening with ultrasound has the potential to detect breast cancers that may not be visible on screening mammography. The use of adjunct ultrasonography is thought to be a safe and inexpensive approach to improving the sensitivity of screening with mammography alone, but potentially at the expense of increasing the rate of false-positive findings. The objective of this review was to examine women's experiences of inaccurate breast cancer screening results and how they affect perceptions of breast cancer screening technologies.

Methods: This report synthesizes 16 primary qualitative studies, which together involved 690 participating women, to examine women's experiences of inaccurate breast cancer screening results. Qualitative meta-synthesis was used to integrate findings across primary research studies.

Results: The experience of a false-positive result caused short-term anxiety until the negative result was confirmed. It also led to reoccurring anxiety during future screening. The anxiety experienced in the face of a false-positive result was magnified in high-risk women, who often reflected on the previous breast cancer experiences of family members while awaiting further results. Despite this increased anxiety, women who had experienced a false-positive result were generally not deterred from future screening. Rather, the experiences heightened their awareness of breast cancer and led to a desire for more examinations and more technologies. Women who had experienced false-negative results struggled to restore trust in screening but recognized that some breast cancers were identified through mammography. They were willing to see themselves as exceptions to an otherwise beneficial service.

Conclusions: Qualitative studies provide some insight into how breast cancer screening inaccuracy affects women, including their faith in the screening technology. Although women suffered marked anxiety from experiencing false-positive mammography tests and loss of confidence from false-negative results, these feelings generally did not diminish women's belief in the value of mammography screening. In many cases, the experiences reinforced the importance of risk reduction as well as screening.