Ontario Health Technology Assessment Series最新文献

{"title":"Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Wounds may be caused in a variety of ways. Some wounds are difficult to heal, such as diabetic foot ulcers and venous leg ulcers. We conducted a health technology assessment of skin substitutes for adults with neuropathic diabetic foot ulcers and venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding skin substitutes, and patient preferences and values.</p><p><strong>Methods: </strong>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 studies (version 2), 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 economic literature search and conducted a cost-utility analysis with a 26-week time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding skin substitutes in adults with diabetic foot ulcers and venous leg ulcers in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with diabetic leg ulcers and venous leg ulcers, as well as their preferences for and perceptions of skin substitutes.</p><p><strong>Results: </strong>We included 40 studies in the clinical evidence review. Adults with difficult-to-heal neuropathic diabetic foot ulcers who used dermal (GRADE: High) or multi-layered (GRADE: Moderate) skin substitutes as an adjunct to standard care were more likely to experience complete wound healing than those whose who used standard care alone. Adults with difficult-to-heal venous leg ulcers who used dermal (GRADE: Moderate) or multi-layered (GRADE: High) skin substitutes as an adjunct to standard care were more likely to experience complete wound healing than those who used standard care alone. The evidence for the effectiveness of epidermal skin substitutes was inconclusive for venous leg ulcers because of the small size of the individual studies (GRADE: Very low). We found no studies on epidermal skin substitutes for diabetic foot ulcers. We could not evaluate the safety of skin substitutes versus standard care, because the number of adverse events was either very low or zero (because sample sizes were too small).In our economic analysis, the use of skin substitutes as an adjunct to standard care was more costly and more effective than standard care alone for the treatment of difficult-to-heal diabetic foot ulcers and venous leg ulcers. For diabetic foot ulcers, the incremental cost-effectiveness ratio (ICER) of skin substitutes plus standard care compared with standard care alone was $48,242 per quality-adjusted life-year (QALY), and the cost per ulcer-free week was $158. For venous leg ulcers, the ICER was $1,868,850 per QALY, and the cost per ulcer-free week was $3,235. At the commonly used willin","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 7","pages":"1-165"},"PeriodicalIF":0.0,"publicationDate":"2021-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8210978/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39073691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nonthermal Endovenous Procedures for Varicose Veins: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Varicose veins are part of the spectrum of chronic venous disease and are a sign of underlying chronic venous insufficiency. Treatments to address varicose veins include surgical vein removal under general anesthesia, or endovenous laser (EVLA) or radiofrequency ablation (RFA) under tumescent anesthesia. Two newer nonthermal endovenous procedures can close veins without any tumescent anesthesia, using either mechanochemical ablation (MOCA, a combination of mechanical and chemical techniques) or cyanoacrylate adhesive closure (CAC). We conducted a health technology assessment of these nonthermal endovenous procedures for people with symptomatic varicose veins, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MOCA and CAC, and patient preferences and values.</p><p><strong>Methods: </strong>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 or RoBANS tool, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Meta-analysis was conducted using Review Manager 5.2, where appropriate.We performed a systematic economic literature search and conducted a cost-utility analysis with a 5-year time horizon from the perspective of Ontario Ministry of Health. In our primary economic evaluation, we assessed the cost-effectiveness of nonthermal endovenous procedures (CAC and MOCA) compared with surgical vein stripping and thermal endovenous therapies (EVLA and RFA). We also analyzed the budget impact of publicly funding nonthermal and thermal endovenous therapies for adults with symptomatic varicose veins in Ontario over the next 5 years. Costs are expressed in 2020 Canadian dollars.To contextualize the potential value of nonthermal endovenous treatments, we spoke with 13 people with varicose veins who had sought various treatment options. We conducted phone interviews and qualitatively analyzed their responses regarding their care journey and the impact of different treatment options; the only nonthermal treatment that participants had experience with was CAC.</p><p><strong>Results: </strong>We included 19 primary studies reported in 25 publications comparing either MOCA or CAC with at least one other invasive treatment for symptomatic varicose veins. No studies compared MOCA with CAC. Based on evidence of low to moderate quality, MOCA resulted in slightly poorer technical outcomes (vein closure and recanalization) than thermal endovenous ablation procedures. However, clinical outcomes, quality of life improvement, and patient satisfaction were similar compared with RFA (GRADE: Very low to Moderate) and EVLA (GRADE: High). Cyanoacrylate adhesive closure resulted in little to no difference in technical outcomes, clinical outcomes, and quality of life improvement compar","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 8","pages":"1-188"},"PeriodicalIF":0.0,"publicationDate":"2021-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8208443/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39073692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prostatic Artery Embolization for Benign Prostatic Hyperplasia: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate that commonly affects older people with prostates and may lead to obstructive urinary symptoms. Symptoms may initially be mild but tend to worsen over time. Prostatic artery embolization (PAE) is an endovascular procedure to treat BPH, wherein an interventional radiologist inserts a catheter into the patient to inject tiny particles intended to reduce blood flow to the enlarged prostate, causing it to shrink in size. We conducted a health technology assessment on PAE for people with BPH, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PAE, and patient preferences and values.</p><p><strong>Methods: </strong>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 (RCTs) and the Risk of Bias in Nonrandomized Studies-of Interventions (ROBINS-I) tool for observational studies. 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 review of the economic literature. We then assessed the cost-effectiveness of PAE compared with alternative treatments (i.e., transurethral resection of the prostate [TURP] or open simple prostatectomy [OSP]) using a Markov microsimulation model. The analysis was conducted from the Ontario Ministry of Health perspective over a time horizon of 6.5 years. We also analyzed the budget impact of publicly funding PAE in people with moderate to severe BPH in Ontario.</p><p><strong>Results: </strong>We included six studies in our systematic review. Four RCTs and one observational study compared PAE with TURP, and one observational study compared PAE with OSP. All studies had considerable risk-of-bias concerns. PAE may improve BPH symptoms and urodynamic measures, but we are uncertain whether PAE achieves better results than TURP (GRADE: Very low to Low). Compared with TURP, PAE may result in higher patient satisfaction and fewer adverse events (GRADE: Not assessed). Compared with OSP, PAE may result in smaller improvements in BPH symptoms and urodynamic measures and may lead to fewer adverse events, but the evidence is very uncertain (GRADE: Very low).We did not find any published cost-effectiveness studies in the economic literature review. Our primary economic evaluation showed that, compared with TURP, PAE has an incremental cost of $328 (95% CrI: -$686 to $1,423) and a very small incremental quality-adjusted life-year (QALY) of 0.007 (95% CrI: -0.004 to 0.018). The resulting incremental cost-effectiveness ratio (ICER) of PAE versus TURP is $44,930 per QALY gained. At the commonly used willingness-to-pay values of $50,000 and $100,000 per QALY, the cost-effectiveness of PAE is uncertain (5","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 6","pages":"1-139"},"PeriodicalIF":0.0,"publicationDate":"2021-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202600/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39053159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pigmented Lesion Assay for Suspected Melanoma Lesions: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Early detection of melanoma is key, as survival rates are substantially better when the cancer is detected in its early stages. Currently, the standard of care is to biopsy any lesion suspected of melanoma for diagnostic confirmation by histopathology. As a result, most people who undergo biopsy receive negative melanoma results. If effective, a non-invasive alternative, such as pigmented lesion assay, could minimize the number of unnecessary biopsies performed. We conducted a health technology assessment of pigmented lesion assay for people with suspected melanoma lesions, which included an evaluation of diagnostic accuracy, clinical utility, the budget impact of publicly funding pigmented lesion assay, and the preferences and values of people who have undergone biopsy for suspected melanoma.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS). 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 literature search of the economic evidence. We also analyzed the budget impact of publicly funding pigmented lesion assay in adults with suspected melanoma in Ontario. To contextualize the potential value of pigmented lesion assay, we spoke with people who had undergone skin biopsy for melanoma. We also used the qualitative research synthesis from a report by the Canadian Agency for Drugs and Technologies in Health to provide context for the preferences and values of those with suspected melanoma.</p><p><strong>Results: </strong>We included seven studies in the clinical evidence review. Pigmented lesion assay has a sensitivity of 79% (95% confidence interval [CI] 58%-93%) and a specificity of 80% (95% CI 73%-85%; GRADE: Low). We found one published cost-effectiveness study with potentially serious limitations. Therefore, the cost-effectiveness of pigmented lesion assay compared with the standard care pathway is currently uncertain. Assuming a very low uptake, we estimated that the budget impact of publicly funding pigmented lesion assay in Ontario over the next 5 years is about $3.44 million if the test is used exclusively by primary care providers, or about $2.56 million if it is used exclusively by specialists. The people with whom we spoke who had experienced biopsy for suspected melanoma responded positively to the potential benefits of pigmented lesion assay, emphasizing its ease-of-use, potential increase in early detection of melanoma, and reduction in physical and emotional burden of unnecessary biopsies. Participants also felt that the accuracy of this tool was essential to ensure minimal false negatives.</p><p><strong>Conclusions: </s","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 5","pages":"1-81"},"PeriodicalIF":0.0,"publicationDate":"2021-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196402/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39053157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Internet-Delivered Cognitive Behavioural Therapy for Post-traumatic Stress Disorder or Acute Stress Disorder: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Post-traumatic stress disorder (PTSD) and acute stress disorder (ASD) are mental health conditions that may emerge following a frightening or traumatic event in a person's life. We conducted a health technology assessment of internet-delivered cognitive behavioural therapy (iCBT) for adults with PTSD or ASD, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding iCBT for PTSD or ADS, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of systematic reviews using ROBIS and of randomized controlled trials (RCTs) 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 performed a systematic economic literature search to summarize the economic evidence on the cost-effectiveness of iCBT for adults with PTSD or ASD. We did not conduct a primary economic evaluation on iCBT for adults with PTSD, as an existing cost-utility analysis is directly applicable to this research question. We did not conduct a primary economic evaluation on iCBT for adults with ASD, as there is limited clinical evidence on this topic and because evidence on iCBT for PTSD may be generalizable to iCBT for ASD at risk of progressing to PTSD. We analyzed the budget impact of publicly funding iCBT for adults with PTSD or ASD in Ontario over the next 5 years.To contextualize the potential value of iCBT for PTSD, we reviewed relevant literature on patients' preferences and values and spoke with people who have lived experience with PTSD to explore their values, needs, and priorities.</p><p><strong>Results: </strong>We identified no studies on the use of iCBT for prevention of PTSD or studies on the use of iCBT to treat ASD, nor studies that directly compared iCBT with face-to-face CBT for the treatment of PTSD. We included one systematic review of the use of iCBT to treat PTSD (10 RCTs, N = 720). Overall, iCBT is more effective than wait-list (waiting for iCBT) or usual care alone for reducing the severity of PTSD symptoms (standardized mean difference [SMD] = -0.60 [95% CI -0.97 to -0.24]; N = 560, 8 RCTs) (GRADE: Very low). Internet-delivered CBT is not more effective than non-CBT internet-delivered interventions for reducing the severity of PTSD symptoms (SMD = -0.08 [-0.52 to 0.35]; N = 82, 2 RCTs) (GRADE: Very low).We identified one economic evaluation on the cost-effectiveness of iCBT for adults with PTSD. For adults with PTSD, iCBT was found to be dominant (i.e., less costly and more effective) compared with usual care. The model used a Canadian public health care payer perspective, and there were no major limitations to the model structure, time horizon, or source of model inputs. The annual budget impact of publicly funding iCBT in Ontario","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 9","pages":"1-120"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8398719/pdf/ohtas-21-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39419868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of B-Type Natriuretic Peptide (BNP) and N-Terminal proBNP (NT-proBNP) as Diagnostic Tests in Adults With Suspected Heart Failure: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Heart failure is a complex clinical syndrome that usually presents with breathlessness, leg edema, and fatigue. Clinically measurable natriuretic neurohormones such as B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are elevated in people with heart failure. We conducted a health technology assessment of BNP and NT-proBNP tests for people with suspected heart failure, which included an evaluation of diagnostic accuracy, clinical impact, cost-effectiveness, the budget impact of publicly funding BNP and NT-proBNP tests, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a literature search of previously published systematic reviews of the clinical evidence. We conducted an overview of reviews and included only reviews with a low risk of bias as assessed using the Risk of Bias in Systematic Reviews tool (ROBIS). We excluded any reviews where we found 100% overlap of included primary studies and selected systematic reviews or health technology assessments published after 2006 for inclusion.We performed an economic literature review of BNP and NT-proBNP testing in people with suspected heart failure. Medical and health economic databases were searched from database inception until July 25, 2019. Next, we assessed the cost-effectiveness of BNP and NT-proBNP based on the published economic literature. We transferred the cost-effectiveness results of two applicable, recent economic evaluations from the National Institute for Health and Care Excellence (NICE) to the Ontario setting in lieu of conducting de novo primary economic evaluations. We also estimated the budget impact of publicly funding BNP and NT-proBNP tests in people with suspected heart failure in Ontario over the next 5 years.To contextualize the potential value of BNP and NT-proBNP testing, we spoke with people with suspected heart failure.</p><p><strong>Results: </strong>We included eight systematic reviews in the clinical evidence review. B-type natriuretic peptides and NT-proBNP had a high pooled sensitivity (80% to 94% and 86% to 96%, respectively; strength of evidence: high) and a low pooled negative likelihood ratio (0.08-0.30 and 0.09-0.23, respectively; strength of evidence: not reported) within varying thresholds or cut points and settings, as reported in seven systematic reviews. In one systematic review, when BNP or NT-proBNP was used in the diagnosis of heart failure in the emergency department (ED), there was a decrease in the mean length of hospital stay (-1.22 days; confidence interval [CI] -2.31 to -0.14; Grading of Recommendations Assessment, Development, and Evaluation [GRADE] Working Group criteria: Moderate). B-type natriuretic peptide testing did not reduce hospital admission rates (odds ratio [OR]: 0.82; CI: 0.67-1.01; GRADE: Moderate), 30-day hospital readmission rates (OR: 0.88; CI: 0.64-1,20; GRADE: Moderate), or hospital mortality rates (OR: 0.96; CI: 0.65-1.41; GRADE: Moderate). No sy","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 2","pages":"1-125"},"PeriodicalIF":0.0,"publicationDate":"2021-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129637/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39048937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proton Beam Therapy for Cancer in Children and Adults: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Proton beam therapy has potential to reduce late toxicity in cancer treatment by reducing the risk of damage to surrounding healthy tissues. We conducted a health technology assessment of proton beam therapy, compared with photon therapy, for children and adults with cancer requiring radiotherapy. Our assessment included an evaluation of safety, effectiveness, cost-effectiveness, the budget impact of publicly funding the construction and use of proton beam therapy in Ontario, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and selected and reported results from one review that was recent, high quality, and relevant to our research question. We complemented the chosen systematic review (published in 2019) with a literature search to identify randomized controlled trials published after the review. We assessed the risk of bias of each included study using the Risk of Bias in Systematic Reviews (ROBIS) tool 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 economic literature search and also analyzed the budget impact of publicly funding proton beam therapy in cancer patients in Ontario. To contextualize the potential value of proton beam therapy, we spoke with 10 people with cancer (or their caregivers) who had either received or were considering proton beam therapy.</p><p><strong>Results: </strong>We included one systematic review of the clinical evidence reporting on 215 publications on proton beam therapy in children and adults across 19 tumour categories/conditions. Compared with photon therapy, proton beam therapy may result in fewer adverse events but similar overall survival and progression-free survival in children with brain tumours (GRADE: Low), adults with esophageal cancer (GRADE: Low to Very low), head and neck cancer (GRADE: Low to Very low), and prostate cancer (GRADE: Low). Proton beam therapy may result in similar adverse events, overall survival, and progression-free survival in adults with brain tumours (GRADE: Low), breast cancer (GRADE: Low), gastrointestinal cancer (GRADE: Very low), liver cancer (GRADE: Moderate to Very low), lung cancer (GRADE: Moderate to Very low), and ocular tumours (GRADE: Low). There was insufficient evidence to evaluate the effectiveness and safety of proton beam therapy in other pediatric tumours, as well as bladder cancer, bone cancer, lymphoma, and benign tumours in adults.The economic evidence suggests that proton beam therapy may be cost-effective in pediatric populations with medulloblastoma; however, studies were based on limited clinical evidence. In other indications, the cost-effectiveness of proton beam therapy is unclear. The 5-year budget impact of funding a four-room proton beam therapy centre in Ontario would","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 1","pages":"1-142"},"PeriodicalIF":0.0,"publicationDate":"2021-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8130814/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39034196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using ROBIS, the Cochrane Risk of Bias tool, and the Newcastle-Ottawa Scale 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 economic literature search and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries.</p><p><strong>Results: </strong>We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference -2.20; 95% CI -3.47 to -0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low).When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 3","pages":"1-155"},"PeriodicalIF":0.0,"publicationDate":"2021-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129636/pdf/ohtas-21-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39048939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Repetitive Transcranial Magnetic Stimulation for People With Treatment-Resistant Depression: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Major depression is one of the most diagnosed mental illnesses in Canada. Generally, people are treated successfully with antidepressants or psychotherapy, but some people do not respond to these treatments (called treatment-resistant depression [TRD]). Repetitive transcranial magnetic stimulation (rTMS) delivers magnetic pulses to stimulate the areas of the brain associated with mood regulation. Several modalities of rTMS exist (e.g., high frequency rTMS, intermittent theta burst stimulation [iTBS], deep transcranial magnetic stimulation). We conducted a health technology assessment of rTMS for people with TRD, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding rTMS, and patient preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Systematic Reviews (ROBIS) tool and Cochrane Risk of Bias for Randomized Controlled Trials 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 economic literature search and conducted a cost-utility analysis with a 3-year horizon from a public payer perspective. We also analyzed the 5-year budget impact of publicly funding rTMS for people with TRD in Ontario. To assess the potential value of rTMS, we spoke with people who have TRD. Seven rTMS modalities were considered: low-frequency (1 Hz) stimulation, high-frequency (10-20 Hz) stimulation, unilateral stimulation, bilateral stimulation, iTBS, continuous theta burst stimulation, and deep transcranial magnetic stimulation.</p><p><strong>Results: </strong>We included 58 primary studies, 9 systematic reviews, and 1 network meta-analysis in the clinical evidence review. Most rTMS modalities were more effective than sham treatment for all outcomes (GRADE: Moderate to High). All rTMS modalities were similar to one another in response and remission rates (GRADE: not reported) and were similar to electroconvulsive therapy (ECT) in response and remission rates (GRADE: Moderate). Moreover, in both the reference case and scenario analyses, two rTMS modalities (rTMS or iTBS), followed by ECT when patients did not respond to initial treatment, were less expensive and more effective than ECT alone. They were cost-effective compared with pharmacotherapy alone at a willingness-to-pay amount of $50,000 per quality-adjusted life-year (QALY). The annual budget impact of publicly funding rTMS would range from $9.3 million in year 1 to $15.76 million in year 5, for a total of $63.2 million over the next 5 years. People with TRD we spoke with reported that their experiences were generally favourable, and their attitudes toward rTMS were positive. Similarly, psychiatrists had positive attitudes toward and acceptance of rTMS","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 4","pages":"1-232"},"PeriodicalIF":0.0,"publicationDate":"2021-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129638/pdf/ohtas-21-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39048940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis at Low Surgical Risk: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Surgical aortic valve replacement (SAVR) is the conventional treatment for patients with severe aortic valve stenosis at low surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure. We conducted a health technology assessment (HTA) of TAVI for patients with severe aortic valve stenosis at low surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding TAVI, and patient preferences and values.</p><p><strong>Methods: </strong>We used the 2016 Health Quality Ontario HTA on TAVI² as a source of eligible studies and performed a systematic literature search for studies published since the 2016 review. Eligible primary studies identified both through the 2016 HTA and through our complementary literature search were used in a de novo analysis. We assessed the risk of bias of each included 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.An applicable, previously conducted cost-effectiveness analysis was available, so we did not conduct a primary economic evaluation. We analyzed the budget impact of publicly funding TAVI in people at low surgical risk in Ontario. We also performed a literature survey of the quantitative evidence of preferences and values of patients for TAVI. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted a review to evaluate the qualitative literature on patient and provider preferences and values for TAVI. To contextualize the potential value of TAVI, we spoke with people with severe aortic valve stenosis.</p><p><strong>Results: </strong>We identified two randomized controlled trials that compared TAVI (transfemoral route) and SAVR in patients with severe aortic valve stenosis at low surgical risk. Both studies have an ongoing follow-up of 10 years, but 1-year and limited 2-year follow-up results are currently available. At 30 days, compared with SAVR, TAVI had a slightly lower risk of mortality (risk difference -0.8%, 95% confidence interval [CI] -1.5% to -0.1%, GRADE: Moderate) and disabling stroke (risk difference -0.8%, 95% CI -1.8% to -0.2%, GRADE: Moderate), and resulted in more patients with symptom improvement (risk difference 11.8%, 95% CI 8.2% to 15.5%, GRADE: High) and in a greater improvement in quality of life (GRADE: High). At 1 year, TAVI and SAVR were similar with regard to mortality (GRADE: Low), although TAVI may result in a slightly lower risk of disabling stroke (GRADE: Moderate). Both TAVI and SAVR resulted in a similar improvement in symptoms and quality of life at 1 year (GRADE: Moderate). Compared with SAVR, TAVI had a higher risk of some complications and a lower risk of others.Device-related costs for TAVI (about $25,000) are higher than for SAVR (about $6,000). A published cost-effectiveness a","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"20 14","pages":"1-148"},"PeriodicalIF":0.0,"publicationDate":"2020-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670297/pdf/ohtas-20-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38642792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}