Ontario Health Technology Assessment Series最新文献

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DPYD Genotyping in Patients Who Have Planned Cancer Treatment With Fluoropyrimidines: A Health Technology Assessment. 对计划接受氟嘧啶类药物治疗的癌症患者进行 DPYD 基因分型:健康技术评估
Ontario Health Technology Assessment Series Pub Date : 2021-08-12 eCollection Date: 2021-01-01
{"title":"<i>DPYD</i> Genotyping in Patients Who Have Planned Cancer Treatment With Fluoropyrimidines: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Fluoropyrimidine drugs (such as 5-fluorouracil and capecitabine) are used to treat different types of cancer. However, these drugs may cause severe toxicity in about 10% to 40% of patients. A deficiency in the dihydropyrimidine dehydrogenase (DPD) enzyme, encoded by the <i>DPYD</i> gene, increases the risk of severe toxicity. <i>DPYD</i> genotyping aims to identify variants that lead to DPD deficiency and may help to identify people who are at higher risk of developing severe toxicity, allowing their treatment to be modified before it begins. Recommendations for fluoropyrimidine treatment modification are available for four <i>DPYD</i> variants, which are the focus of this review: <i>DPYD</i>∗2A, <i>DPYD</i>∗13, c.2846A>T, and c.1236G>A. We conducted a health technology assessment of <i>DPYD</i> genotyping for patients who have planned cancer treatment with fluoropyrimidines, which included an evaluation of clinical validity, clinical utility, the effectiveness of treatment with a reduced fluoropyrimidine dose, cost-effectiveness, the budget impact of publicly funding <i>DPYD</i> genotyping, 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 systematic review and primary study using the Risk of Bias in Systematic Reviews (ROBIS) tool and the Newcastle-Ottawa Scale, respectively, and we assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature review and conducted cost-effectiveness and cost-utility analyses with a half-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding pre-treatment <i>DPYD</i> genotyping in patients with planned fluoropyrimidine treatment in Ontario. To contextualize the potential value of <i>DPYD</i> testing, we spoke with people who had planned cancer treatment with fluoropyrimidines.</p><p><strong>Results: </strong>We included 29 observational studies in the clinical evidence review, 25 of which compared the risk of severe toxicity in carriers of a <i>DPYD</i> variant treated with a standard fluoropyrimidine dose with the risk in wild-type patients (i.e., non-carriers of the variants under assessment). Heterozygous carriers of a <i>DPYD</i> variant treated with a standard fluoropyrimidine dose may have a higher risk of severe toxicity, dose reduction, treatment discontinuation, and hospitalization compared to wild-type patients (GRADE: Low). Six studies evaluated the risk of severe toxicity in <i>DPYD</i> carriers treated with a genotype-guided reduced fluoropyrimidine dose versus the risk in wild-type patients; one study also included a second comparator group of <i>DPYD</i> carriers treated with a standard dose. The evidence was uncertain, because the results of","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 14","pages":"1-186"},"PeriodicalIF":0.0,"publicationDate":"2021-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382304/pdf/ohtas-21-14.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39386157","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}
引用次数: 0
Multi-gene Pharmacogenomic Testing That Includes Decision-Support Tools to Guide Medication Selection for Major Depression: A Health Technology Assessment. 多基因药物基因组测试,包括决策支持工具,指导药物选择严重抑郁症:健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-08-12 eCollection Date: 2021-01-01
{"title":"Multi-gene Pharmacogenomic Testing That Includes Decision-Support Tools to Guide Medication Selection for Major Depression: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Major depression is a substantial public health concern that can affect personal relationships, reduce people's ability to go to school or work, and lead to social isolation. Multi-gene pharmacogenomic testing that includes decision-support tools can help predict which depression medications and dosages are most likely to result in a strong response to treatment or to have the lowest risk of adverse events on the basis of people's genes.We conducted a health technology assessment of multi-gene pharmacogenomic testing that includes decision-support tools for people with major depression. Our assessment evaluated effectiveness, safety, cost-effectiveness, the budget impact of publicly funding multi-gene pharmacogenomic testing, 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 and the Risk of Bias Assessment Tool for Nonrandomized studies (RoBANS) 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 literature search of the economic evidence to review published cost-effectiveness studies on multi-gene pharmacogenomic testing that includes a decision-support tool in people with major depression. We developed a state-transition model and conducted a probabilistic analysis to determine the incremental cost of multi-gene pharmacogenomic testing versus treatment as usual per quality-adjusted life-year (QALY) gained for people with major depression who had inadequate response to one or more antidepressant medications. In the reference case (with GeneSight-guided care), we considered a 1-year time horizon with an Ontario Ministry of Health perspective. We also estimated the 5-year budget impact of publicly funding multi-gene pharmacogenomic testing for people with major depression in Ontario.To contextualize the potential value of multi-gene pharmacogenomic testing that includes decision-support tools, we spoke with people who have major depression and their families.</p><p><strong>Results: </strong>We included 14 studies in the clinical evidence review that evaluated six multi-gene pharmacogenomic tests. Although all tests included decision-support tools, they otherwise differed greatly, as did study design, populations included in studies, and outcomes reported. Little or no improvement was observed on change in HAM-D17 depression score compared with treatment as usual for any test evaluated (GRADE: Low-Very Low). GeneSight- and NeuroIDgenetix-guided medication selection led to statistically significant improvements in response (GRADE: Low-Very Low) and remission (GRADE: Low-Very Low), while treatment guided by CNSdose led to significant improvement in remission rates (GRADE: Low), but the study did not report on response.","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 13","pages":"1-214"},"PeriodicalIF":0.0,"publicationDate":"2021-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382305/pdf/ohtas-21-13.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39386155","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}
引用次数: 0
iStent for Adults With Glaucoma: A Health Technology Assessment. 成人青光眼治疗:健康技术评估
Ontario Health Technology Assessment Series Pub Date : 2021-07-21 eCollection Date: 2021-01-01
{"title":"iStent for Adults With Glaucoma: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Glaucoma is a condition that causes progressive damage to the optic nerve, which can lead to visual impairment and potentially to irreversible blindness. The iStent and iStent inject are devices implanted in the eye during a type of minimally invasive glaucoma surgery (MIGS) to reduce intraocular pressure by increasing trabecular outflow by bypassing the trabecular meshwork. We summarized two health technology assessments and additional recent publications that evaluated iStent for people with glaucoma, including effectiveness, safety, cost-effectiveness, the budget impact of publicly funding iStent, and patient preferences and values.</p><p><strong>Methods: </strong>We summarized two health technology assessments recently completed in Canada. In addition, we summarized new evidence we identified through expert consultation and scoping of the literature. We reported the quality of the body of clinical evidence as reported by the included health technology assessments, according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.</p><p><strong>Results: </strong>Comparing iStent with pharmacotherapy, there may be no difference in comparative clinical effectiveness (GRADE: Very low to Low). There was uncertainty around the comparative clinical effectiveness of iStent compared with filtration surgery and of iStent plus cataract surgery compared with a different MIGS procedure plus cataract surgery (GRADE: Very low). iStent with cataract surgery may improve comparative clinical effectiveness (reduced intraocular pressure and number of medications) compared with cataract surgery alone (GRADE: Low).iStent may be cost-effective compared with pharmacotherapy (incremental cost-effectiveness ratios [ICER]: $14,120-$25,596/quality-adjusted life-year [QALY]; 60%-76% and 65%-100% of iterations cost-effective at willingness-to-pay values of $50,000/QALY and $100,000/QALY, respectively). iStent with cataract surgery may not be cost-effective compared with cataract surgery alone (ICERs: $108,934-$112,380/QALY; 17%-46% and 46%-68% of iterations cost-effective at willingness-to-pay values of $50,000/QALY and $100,000/QALY, respectively). iStent may not be cost-effective compared with filtration surgery (iStent was less effective and more expensive than filtration surgery). These estimates are influenced by the long-term effectiveness of iStent.The iStent device costs approximately $1,250 (for two iStent or iStent inject devices). Based on a recent analysis by Quebec's Institut national d'excellence en santé et en services sociaux (INESSS) and our previous analysis on MIGS, publicly funding iStent may reduce some spending on glaucoma medication but, overall, iStent is likely to lead to additional costs for the public health care system. In Ontario, publicly funding MIGS over 5 years is estimated to cost a total of $40 million if uptake is slow (25,000 people) and $199 million, if u","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"21 10","pages":"1-42"},"PeriodicalIF":0.0,"publicationDate":"2021-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354382/pdf/ohtas-21-10.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39334664","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}
引用次数: 0
Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment. 成人糖尿病足溃疡和静脉性腿溃疡的皮肤替代品:一项健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-06-04 eCollection Date: 2021-01-01
{"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}
引用次数: 0
Nonthermal Endovenous Procedures for Varicose Veins: A Health Technology Assessment. 静脉曲张的非热性静脉内手术:健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-06-04 eCollection Date: 2021-01-01
{"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}
引用次数: 0
Prostatic Artery Embolization for Benign Prostatic Hyperplasia: A Health Technology Assessment. 前列腺动脉栓塞治疗良性前列腺增生症:健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-06-04 eCollection Date: 2021-01-01
{"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}
引用次数: 0
Pigmented Lesion Assay for Suspected Melanoma Lesions: A Health Technology Assessment. 疑似黑色素瘤病变的色素沉着检测:一项健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-06-04 eCollection Date: 2021-01-01
{"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}
引用次数: 0
Internet-Delivered Cognitive Behavioural Therapy for Post-traumatic Stress Disorder or Acute Stress Disorder: A Health Technology Assessment. 互联网提供的创伤后应激障碍或急性应激障碍的认知行为疗法:健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-06-01 eCollection Date: 2021-01-01
{"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}
引用次数: 0
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. 使用b型利钠肽(BNP)和n端proBNP (NT-proBNP)作为成人疑似心力衰竭的诊断试验:一项健康技术评估
Ontario Health Technology Assessment Series Pub Date : 2021-05-06 eCollection Date: 2021-01-01
{"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}
引用次数: 0
Proton Beam Therapy for Cancer in Children and Adults: A Health Technology Assessment. 质子束治疗儿童和成人癌症:健康技术评估。
Ontario Health Technology Assessment Series Pub Date : 2021-05-06 eCollection Date: 2021-01-01
{"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}
引用次数: 0
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