Ontario Health Technology Assessment Series最新文献

{"title":"Interferon-Gamma Release Assay Testing for Latent Tuberculosis Infection: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Many people infected with the <i>Mycobacterium tuberculosis</i> complex (the bacteria that cause tuberculosis [TB]) have an inactive stage of infection known as latent tuberculosis infection (LTBI). A person with LTBI is at risk of developing active TB. Screening for, and treating people with, LTBI is an important part of preventing adverse health outcomes, reducing the risk of reactivation and the further spread of tuberculosis in a community. We conducted a health technology assessment of interferon-gamma release assay (IGRA) for the detection of LTBI, compared to the standard tuberculin skin test (TST) to evaluate the diagnostic accuracy, cost-effectiveness, the budget impact of publicly funding, and health care provider preferences and values.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence as an overview of systematic reviews. We reported the findings of the identified reviews, including their quality assessment of the body of evidence. We performed a systematic literature search of the economic evidence and included published Canadian cost-effectiveness 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 developed a probabilistic decision-tree model to estimate the incremental costs of IGRA strategies versus TST alone over 1 year in eligible population subgroups. IGRA was examined as a single test and in a sequential pathway with tuberculin skin test (TST; the test order depended on the type of population). We considered subpopulations at high risk of LTBI for whom IGRA would be preferred, as indicated by the Canadian TB Standards published in 2022 (hereinafter, the Standards); e.g., people who received a Bacille Calmette-Guérin (BCG) vaccine, such as BCG-vaccinated immigrants and people identified in contact investigations. We also considered people with comorbid conditions or who were undergoing treatments that may cause low immune function and, hence, may test incorrectly negative. We estimated the total 5-year budget impact (in 2024 CAD) for publicly funding IGRA testing in Ontario. To contextualize the potential value of IGRA, we spoke with health care providers about people requiring TB testing for LTBI. We attempted to reach out to people who had experience with IGRA or TST but did not receive any feedback.</p><p><strong>Results: </strong>We included 12 systematic reviews that included over 500 unique primary studies in the clinical evidence overview of reviews and found good evidence aligned with the uses of IGRA outlined in the Standards. This overview of reviews summarizes the existing evidence on diagnostic accuracy and the clinical utility of IGRA for LTBI. Interferon-gamma release assay was found to have good evidence as a rule-in test for LTBI due to consistently high specificity. The reviews reported slightly lower sensi","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 11","pages":"1-183"},"PeriodicalIF":0.0,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792883/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255963","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":"Peripheral Nerve Stimulation for Chronic Neuropathic Pain: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Chronic neuropathic pain is a major health problem that adversely affects people's physical and mental well-being, as well as their quality of life. Percutaneous peripheral nerve stimulation (PNS) may offer a minimally invasive option earlier in the treatment continuum for adults with chronic neuropathic pain that is refractory to conventional medical management. We conducted a health technology assessment of PNS for adults with chronic neuropathic pain, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PNS, 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 and the Risk of Bias in Non-randomized Studies - of Interventions for observational studies, 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 budget impact of publicly funding PNS in adults with chronic neuropathic pain in Ontario. To contextualize the potential value of PNS, we spoke to people with chronic pain, and to care partners of patients with chronic pain.</p><p><strong>Results: </strong>We included 17 publications (2 randomized controlled trials and 12 nonrandomized studies) in the clinical evidence review. These studies included chronic neuropathic pain in the trunk and the upper and lower extremities. Compared with placebo controls in adults with chronic neuropathic pain that is refractory to conventional medical management, permanent PNS likely decreases pain scores, likely improves functional outcomes, and likely improves health-related quality of life, but it has little to no effect on the use of pain medications (all GRADEs: Moderate). Compared with before implantation in adults with chronic neuropathic pain, permanent PNS may decrease pain scores, may decrease the use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). Compared with placebo controls in adults with chronic postamputation pain, temporary PNS may decrease pain scores, may decrease use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). Compared with before implantation in adults with chronic postamputation pain, temporary PNS may decrease pain scores, may decrease the use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). We did not find any studies that compared permanent PNS to temporary PNS. Implantation of a PNS system is a reasonably safe p","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 10","pages":"1-131"},"PeriodicalIF":0.0,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11778797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068556","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":"Single-Exposure, Dual-Energy Subtraction Flat Panel X-Ray Detectors: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>In medicine, x-rays are used to generate images of tissues and structures inside the body. X-rays are emitted by a source device and, after passing through the body, strike a detector, which forms an image of the tissues and structures the x-rays passed through. Dual-energy subtraction (DES) x-ray systems use radiation of different energy spectra (energy levels) and the principle of differential absorption characteristics of bone and soft tissue to produce separate bone and soft tissue x-ray images, in addition to a conventional x-ray image. The aim is to minimize potential issues with anatomical overlap with conventional x-ray that may obscure some findings. Single-exposure, DES flat panel x-ray detectors produce a conventional x-ray image in addition to DES bone and soft tissue x-ray images using a single x-ray exposure. We conducted a health technology assessment of single-exposure, DES digital flat panel x-ray detectors in adults for indications such as pneumonia, pneumothorax, and pulmonary nodules, and for visualizing lines and tubes, compared with conventional x-ray. Our assessment included an evaluation of the diagnostic accuracy, the impact on diagnostic confidence, patient management and clinical outcomes, the budget impact of publicly funding the technology, and the experiences, preferences, and values of health care providers.</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 QUADAS-C 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 literature search on the economic evidence of single-exposure, DES flat panel x-ray detectors. We did not conduct a primary economic evaluation because of limited evidence on the implications of this technology. We analyzed the budget impact of publicly funding single-exposure, DES flat panel detectors in Ontario hospitals. To contextualize the potential value of single-exposure, DES flat panel x-ray detectors, we spoke with people with expertise in diagnostic imaging, including radiologists and other health care practitioners.</p><p><strong>Results: </strong>The clinical evidence review identified 2 eligible observational studies that assessed the use of single-exposure, DES flat panel x-ray detectors to generate DES bone and soft tissue x-ray images and a conventional x-ray image. The findings of 1 study suggest an improvement in the sensitivity and specificity for the detection of pulmonary nodule calcification with the use of single-exposure, DES soft tissue and conventional x-ray images compared with using a conventional x-ray image alone (results were statistically significant for 2 out of 5 reviewers; GRADE: Low). In one study, x-ray image reviewers reported an improvement in the visibility of the tips of lines and tubes","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 9","pages":"1-76"},"PeriodicalIF":0.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11650440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855968","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":"Plasma-Based Comprehensive Genomic Profiling DNA Assays for Non-Small Cell Lung Cancer: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. While some cases of NSCLC with actionable genomic alterations in the tumour cells may respond to standard therapies, they often show greater improvement with targeted therapies. The current standard of care in Ontario involves testing for actionable genomic alterations using both DNA and RNA panels via tissue testing alone. However, liquid biopsy testing may complement tissue testing by addressing some of its limitations. We conducted a health technology assessment of liquid biopsy testing using DNA panels for people with NSCLC, which included an evaluation of analytical validity, clinical validity, clinical utility, cost-effectiveness, the budget impact of publicly funding this technology, 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 QUADAS-2, QUADAS-C, ROBINS-I, and ROBINS-E tools 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 of 4 potential liquid biopsy testing strategies in which liquid biopsy testing was added to tissue testing in various ways; our model used a 20-year time horizon and was conducted from a public payer perspective. We also analyzed the budget impact of publicly funding liquid biopsy testing for people with NSCLC in Ontario. To contextualize the potential value of liquid biopsy testing, we spoke with people with NSCLC and family members and care partners of people with NSCLC.</p><p><strong>Results: </strong>We included 61 studies in the clinical evidence review. Liquid biopsy testing demonstrated a modest sensitivity in detecting actionable genomic alterations in the <i>BRAF, EGFR, ERBB2,</i> and <i>KRAS</i> genes (GRADE: Moderate to High). However, for the other genes assessed, the sensitivity was either low or uncertain (GRADE: Very Low to High). Liquid biopsy testing also showed an overall high concordance with tissue testing (GRADE: High). Further, liquid biopsy testing was found to improve partial response rates, stable disease rates, and progressive disease rates for people with NSCLC with actionable genomic alterations who were receiving matched targeted therapies (GRADE: Moderate). However, we are uncertain about the clinical validity of liquid biopsy testing in predicting prognosis with standard therapies (GRADE: Very Low). Compared with tissue testing alone, we estimate that all 4 of the potential liquid biopsy testing strategies we evaluated would be more expensive and associated with an increase in quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) of the strategy in which liq","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 8","pages":"1-306"},"PeriodicalIF":0.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11650780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855967","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":"Level 2 Polysomnography for the Diagnosis of Sleep Disorders: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>It is estimated that half of Canadians have insufficient sleep, which over time is associated with poor physical and mental health. Currently, the only publicly funded option for the diagnosis of sleep disorders in Ontario is an in-person overnight sleep study, performed in a hospital or independent health facility (known as a level 1 polysomnography). Level 2 polysomnography has been proposed as an alternative that can be conducted at home for the diagnosis of suspected sleep disorders, if considered to have sufficient diagnostic accuracy. We conducted a health technology assessment of level 2 polysomnography for the diagnosis of suspected sleep disorders in adults and children, which included an evaluation of the test performance, cost-effectiveness, and budget impact of publicly funding level 2 polysomnography, and the experiences, preferences, and values of people with suspected sleep disorders.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to identify diagnostic accuracy, test failures and subjective measures of patient preferences. We assessed the risk of bias of each included study (using the Quality Assessment of Diagnostic Accuracy Studies [QUADAS-2] tool) and the quality of the body of evidence (according to Grading of Recommendations Assessment, Development, and Evaluation [GRADE] Working Group criteria). We performed a systematic literature search of economic evidence and conducted a primary economic evaluation and budget impact analysis to determine the cost-effectiveness and additional costs of publicly funding level 2 polysomnography for adults and children with suspected sleep disorders in Ontario. To contextualize the potential value of using level 2 polysomnography, we spoke with people with sleep disorders.</p><p><strong>Results: </strong>We included 10 studies that reported on diagnostic accuracy and found level 2 polysomnography had sensitivity ranging between 0.76-1.0 and specificity ranging between 0.40-1.0 (GRADE: Moderate to Very low) when compared with level 1 polysomnography. Studies reported test failure rates from 0% to 20%, with errors present in both level 1 and level 2 tests conducted (GRADE: Very low). As well, some of these studies reported patients were found to have mixed opinions about their experiences, with more people preferring their experience with level 2 testing at home and having better quality of sleep compared with when they underwent level 1 testing (GRADE not conducted).Our primary economic evaluation showed that for adults with suspected sleep disorders, the new diagnostic pathway with level 2 polysomnography was equally effective (outcome: confirmed diagnosis at the end of the pathway) as the current practice diagnostic pathway with level 1 polysomnography. With the assumption of a lower technical fee for level 2 polysomnography, the new diagnostic pathway with level 2 polysomnography was less costly than the c","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 7","pages":"1-157"},"PeriodicalIF":0.0,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142381933","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":"Pelvic Floor Muscle Training for Stress Urinary Incontinence, Fecal Incontinence, and Pelvic Organ Prolapse: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Stress urinary incontinence, fecal incontinence, and pelvic organ prolapse are common forms of pelvic floor dysfunction. Pelvic floor muscle training is used to improve pelvic floor function, through a program of exercises. We conducted a health technology assessment of pelvic floor muscle training for people with stress urinary incontinence, fecal incontinence, or pelvic organ prolapse, which included an evaluation of effectiveness, safety, and the budget impact of publicly funding pelvic floor muscle training, 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 included studies using the ROBIS tool, for systematic reviews, and the Cochrane Risk of Bias tool, for randomized controlled trials, and we assessed the quality of the body of evidence according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search but did not conduct a primary economic evaluation. We also analyzed the budget impact of publicly funding pelvic floor muscle training in adults with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse in Ontario. To contextualize the potential value of pelvic floor muscle training as a treatment, we spoke with people with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse.</p><p><strong>Results: </strong>We included 6 studies (4 systematic reviews and 2 randomized controlled trials) in the clinical evidence review. In comparison with no treatment, pelvic floor muscle training significantly improved symptom severity and increased patient satisfaction in women with stress urinary incontinence or pelvic organ prolapse (GRADE: Moderate). For men with stress urinary incontinence after prostatectomy, pelvic floor muscle training yielded mixed results for symptom improvement (GRADE: Very low). For adults with fecal incontinence, pelvic floor muscle training did not improve symptoms in comparison with standard care (GRADE: Very low).In the economic literature review, we included 6 cost-utility analyses that had evaluated the cost-effectiveness of pelvic floor muscle training as a treatment for people with pelvic organ prolapse or urinary incontinence. We did not identify any economic studies on pelvic floor muscle training for women or men with fecal incontinence or men with pelvic organ prolapse. The analyses included in our review found that, for women with stress urinary incontinence, pelvic floor muscle training was likely cost-effective in comparison with other nonsurgical interventions. For men with urinary incontinence after prostate surgery, pelvic floor muscle training was likely not cost-effective in comparison with standard care. For women with pelvic organ prolapse, the cost-effectiveness of pelvic floor muscle training in comparison with no acti","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 6","pages":"1-172"},"PeriodicalIF":0.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297677","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":"Fractional Exhaled Nitric Oxide Testing for the Diagnosis and Management of Asthma: a Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Asthma is a common respiratory disease characterized by airflow obstruction caused by inflammation and narrowing of the airways. Nitric oxide is a gas that is present at low levels in the lungs, but that is elevated in the presence of airway inflammation. Fractional exhaled nitric oxide (FeNO) testing may help in the diagnosis and management of asthma by measuring the amount of nitric oxide in the breath. We conducted a health technology assessment of FeNO testing for the diagnosis and management of asthma in children and adults, which included an evaluation of the accuracy, effectiveness, cost-effectiveness, the budget impact of publicly funding FeNO 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 Quality Assessment of Diagnostic Accuracy Studies tool, version 2 (QUADAS-2) and of each systematic review using the Risk of Bias Assessment Tool for Systematic Reviews (ROBIS). We evaluated 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 cost-utility analyses with a 20-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding FeNO testing in children and adults in Ontario. To contextualize the potential value of FeNO testing, we spoke with people with asthma and their care partners.</p><p><strong>Results: </strong>We included 48 primary studies assessing the diagnostic accuracy of FeNO testing and 2 reviews evaluating the effectiveness of FeNO testing for asthma management in the clinical evidence review. The use of FeNO testing for the diagnosis of asthma reported variable (~30% to 90%) sensitivities (GRADE: Very low) and consistently high (~70% to 100%) specificities (GRADE: Low) in children and adults. FeNO testing for asthma management likely reduced exacerbations in children (GRADE: Moderate) and adults (GRADE: Moderate), lowered oral corticosteroid use in children (GRADE: Moderate), and slightly improved lung function in a mixed population (GRADE: Moderate), but little to no improvement was seen in other outcomes. We found that, for asthma diagnosis, FeNO testing in addition to standard testing is cost-effective in children, with an incremental cost-effectiveness ratio (ICER) of $6,192 per quality-adjusted life-year (QALY) gained. FeNO testing is not cost-effective for asthma diagnosis in adults except when a higher FeNO cut-off is applied. For asthma management, the ICER of FeNO testing compared with standard care alone is $103,893 per QALY gained in children and $200,135 per QALY gained in adults. Publicly funding FeNO testing as an adjunct to standard testing for asthma diagnosis over the next 5 years would cost about $0.10 million to $0.","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 5","pages":"1-225"},"PeriodicalIF":0.0,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11423898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142355931","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":"Sucrose Octasulfate-Impregnated Dressings for Adults With Difficult-to-Heal Noninfected Diabetic Foot Ulcers and Difficult-to-Heal Noninfected Venous Leg Ulcers: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers and venous leg ulcers may not always heal in a timely manner despite proper wound care. Treatments that improve the healing rate of these ulcers would improve clinical outcomes for patients and may result in downstream cost savings for the health care system. We conducted a health technology assessment of sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding sucrose octasulfate-impregnated dressings, 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 trials (RoB 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 analyzed the budget impact of publicly funding sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers in Ontario. We did not conduct a primary economic evaluation because there is existing evidence to approximate the cost-effectiveness of sucrose octasulfate-impregnated dressings in Ontario. We leveraged 4 previous health technology assessments to explore the perspectives and experiences of patients with diabetic foot ulcers and venous leg ulcers, as well as the perspectives and experiences of their care partners.</p><p><strong>Results: </strong>We included 3 randomized controlled trials and 2 subsequent publications of these randomized controlled trials in the clinical evidence review. Compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings result in faster wound closure in patients with difficult-to-heal noninfected neuroischemic diabetic foot ulcers (GRADE: Moderate) and reduce ulcer size and improve health-related quality of life in the domains of pain/discomfort and anxiety/depression for patients with difficult-to-heal noninfected venous leg ulcers (GRADE: Moderate). The use of sucrose octasulfate-impregnated dressings with noninfected wounds is considered safe (GRADE: Moderate).The economic evidence showed that, compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings are highly likely to be cost-effective for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers and would lead to cost savings due to faster and increased complete wound healing. The annual budget impact of publicly funding sucrose octasulfate-impregnated dressings in Ontario over the next 5 y","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 4","pages":"1-101"},"PeriodicalIF":0.0,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11271442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789355","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":"Robotic-Assisted Surgery for Rectal Cancer: An Expedited Summary of the Clinical Evidence.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Rectal cancer is a disease in which cancer cells form in the rectum, which has the primary function of temporarily storing feces, controlling defecation, and maintaining continence. Surgery is the most common treatment for rectal cancer; surgical approaches include open, laparoscopic, and robotic assisted. We conducted an expedited summary of the clinical evidence for robotic-assisted surgery for rectal cancer, which included an evaluation of effectiveness and safety.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and randomized controlled trials (RCTs). We assessed the risk of bias in the included systematic reviews using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, version 2), and we assessed the risk of bias in the included RCT using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 1. We reported the quality of the body of evidence as evaluated in the included systematic reviews according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria if it was evaluated.</p><p><strong>Results: </strong>We included 14 studies in the clinical evidence review (12 systematic reviews and 1 RCT on robotic-assisted vs. laparoscopic rectal cancer surgery and 1 systematic review on robotic-assisted vs. open rectal cancer surgery). Compared with laparoscopic rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival; similar rates of conversion, blood transfusion, and readmission,· reduced blood loss; shorter length of stay; and improved quality of life. Compared with open rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival, reduced blood loss, and shorter length of stay.</p><p><strong>Conclusions: </strong>Robotic-assisted rectal cancer surgery may result in similar or improved clinical outcomes compared with laparoscopic and open rectal cancer surgery.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 3","pages":"1-45"},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11031254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852175","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":"Intrathecal Drug Delivery Systems for Cancer Pain: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Pain is a common and very distressing symptom for adults and children with cancer. Compared with other routes of delivery, infusing pain medication directly into the intrathecal space around the spinal cord may reduce the incidence of systemic side effects and allow for more rapid and effective pain relief. We conducted a health technology assessment of intrathecal drug delivery systems (IDDSs) for adults and children with cancer pain, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding IDDSs, patient preferences and values, and ethical considerations.</p><p><strong>Methods: </strong>We performed a systematic literature search of the clinical evidence to retrieve systematic reviews, and we selected and reported results from 2 recent reviews that were relevant to our research questions. We complemented the chosen systematic reviews with a literature search to identify primary studies published after December 2020. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review. We assessed the quality of the body of evidence according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing IDDSs with standard care (i.e., non-IDDS methods of pain management) from a public payer perspective. We also analyzed the budget impact of publicly funding IDDSs in Ontario. To contextualize the potential value of IDDSs, we spoke with patients with cancer pain and with caregivers of patients with cancer pain. We explored ethical considerations from a review of published literature on the use of IDDSs for the management of cancer pain in adults and children as well as a review of the other components of this health technology assessment to identify ethical considerations relevant to the Ontario context.</p><p><strong>Results: </strong>We included 2 systematic reviews (1 on adults and 1 on children) in the clinical evidence review. In adults with cancer pain who have a life expectancy greater than 6 months, intrathecal drug delivery was associated with a significant reduction in pain intensity compared with before implantation up to a 1-year follow-up (GRADE: Moderate to Low). Improved pain management appeared to be maintained beyond a 4-week follow-up. IDDSs likely decrease the use of systemic opioids (GRADE: Moderate to Low). They may also improve health-related quality of life (GRADE: Low), functional outcomes (GRADE: Low), and survival (GRADE: Low to Very low). In children with cancer pain, IDDSs may reduce pain intensity, improve functional outcomes, and improve survival, but the evidence is very uncertain (all GRADEs: Very low). IDDS implantation carries certain rare risks related to mechanical errors, drug-related side effects, and surgical complication","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"24 2","pages":"1-162"},"PeriodicalIF":0.0,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10855886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139724408","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}