Ontario Health Technology Assessment Series最新文献

{"title":"Transcatheter Aortic Valve Implantation for Treatment of Aortic Valve Stenosis: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Surgical aortic valve replacement (SAVR) is the gold standard for treating aortic valve stenosis. It is a major operation that requires sternotomy and the use of a heart-lung bypass machine, but in appropriately selected patients with symptomatic, severe aortic valve stenosis, the benefits of SAVR usually outweigh the harms. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure that allows an artificial valve to be implanted over the poorly functioning valve.</p><p><strong>Methods: </strong>We identified and analyzed randomized controlled trials that evaluated the effectiveness and safety of TAVI compared with SAVR or balloon aortic valvuloplasty and were published before September 2015. The quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. The overall quality was determined to be high, moderate, low, or very low using a step-wise, structural methodology. We also developed a Markov decision-analytic model to assess the cost-effectiveness of TAVI compared with SAVR over a 5-year time horizon, and we conducted a 5-year budget impact analysis.</p><p><strong>Results: </strong>Rates of cardiovascular and all-cause mortality were similar for the TAVI and SAVR groups in all studies except one, which reported significantly lower all-cause mortality in the TAVI group and a higher rate of stroke in the SAVR group. Trials of high-risk patients who were not suitable candidates for SAVR showed significantly better survival with TAVI than with balloon aortic valvuloplasty. Median survival in the TAVI group was 31 months, compared with 11.7 months in the balloon aortic valvuloplasty group. Compared with SAVR, TAVI was associated with a significantly higher risk of stroke, major vascular complications, paravalvular aortic regurgitation, and the need for a permanent pacemaker. SAVR was associated with a higher risk of bleeding. Transapical TAVI was associated with higher rates of mortality and stroke than transfemoral TAVI in high-risk patients. TAVI and SAVR both improved patients' quality of life during the first year. However, because of a large amount of missing data and the lack of published data beyond 1 year, it was difficult to evaluate the impact of critical adverse outcomes on patients' longer-term health status. In the base-case analysis, when TAVI was compared with SAVR, the incremental cost-effectiveness ratio was $51,988 per quality-adjusted life-year. The 5-year budget impact of funding TAVI ranged from $7.6 to $8.3 million per year.</p><p><strong>Conclusions: </strong>Moderate quality evidence showed that TAVI and SAVR had similar mortality rates in patients who were eligible for surgery. Information about quality of life showed similar results for TAVI and SAVR in the first year, but was based on low quality evidence. Moderate quality evidence also showed that TAVI wa","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 19","pages":"1-94"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5156845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141617324","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":"Levonorgestrel-Releasing Intrauterine System (52 mg) for Idiopathic Heavy Menstrual Bleeding: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Heavy menstrual bleeding affects as many as one in three women and has negative physical, economic, and psychosocial impacts including activity limitations and reduced quality of life. The goal of treatment is to make menstruation manageable, and options include medical therapy or surgery such as endometrial ablation or hysterectomy. This review examined the evidence of effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) as a treatment alternative for idiopathic heavy menstrual bleeding.</p><p><strong>Methods: </strong>We conducted a systematic review of the clinical and economic evidence comparing LNG-IUS with usual medical therapy, endometrial ablation, or hysterectomy. Medline, EMBASE, Cochrane, and the Centres for Reviews and Dissemination were searched from inception to August 2015. The quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation to determine the cost-effectiveness and budget impact of the LNG-IUS compared with endometrial ablation and with hysterectomy. The economic evaluation was conducted from the perspective the Ontario Ministry of Health and Long-Term Care.</p><p><strong>Results: </strong>Relevant systematic reviews (n = 18) returned from the literature search were used to identify eligible randomized controlled trials, and 16 trials were included. The LNG-IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. The quality of the evidence varied from very low to moderate across outcomes. Results from the economic evaluation showed the LNG-IUS was less costly (incremental saving of $372 per person) and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation. Similarly, the LNG-IUS costs less (incremental saving of $3,138 per person) and yields higher quality-adjusted life-years (incremental value of 0.04) compared with hysterectomy. Publicly funding LNG-IUS as an alternative to endometrial ablation and hysterectomy would result in annual cost savings of $3 million to $9 million and $0.1 million to $23 million, respectively, over the first 5 years.</p><p><strong>Conclusions: </strong>The 52-mg LNG-IUS is an effective and cost-effective treatment option for idiopathic heavy menstrual bleeding. It improves quality of life and menstrual blood loss, and is well tolerated compared with endometrial ablation, hysterectomy, or usual medical therapies.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 18","pages":"1-119"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5159479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72211076","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":"Women's Experiences of Inaccurate Breast Cancer Screening Results: A Systematic Review and Qualitative Meta-synthesis.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Adjunct screening with ultrasound has the potential to detect breast cancers that may not be visible on screening mammography. The use of adjunct ultrasonography is thought to be a safe and inexpensive approach to improving the sensitivity of screening with mammography alone, but potentially at the expense of increasing the rate of false-positive findings. The objective of this review was to examine women's experiences of inaccurate breast cancer screening results and how they affect perceptions of breast cancer screening technologies.</p><p><strong>Methods: </strong>This report synthesizes 16 primary qualitative studies, which together involved 690 participating women, to examine women's experiences of inaccurate breast cancer screening results. Qualitative meta-synthesis was used to integrate findings across primary research studies.</p><p><strong>Results: </strong>The experience of a false-positive result caused short-term anxiety until the negative result was confirmed. It also led to reoccurring anxiety during future screening. The anxiety experienced in the face of a false-positive result was magnified in high-risk women, who often reflected on the previous breast cancer experiences of family members while awaiting further results. Despite this increased anxiety, women who had experienced a false-positive result were generally not deterred from future screening. Rather, the experiences heightened their awareness of breast cancer and led to a desire for more examinations and more technologies. Women who had experienced false-negative results struggled to restore trust in screening but recognized that some breast cancers were identified through mammography. They were willing to see themselves as exceptions to an otherwise beneficial service.</p><p><strong>Conclusions: </strong>Qualitative studies provide some insight into how breast cancer screening inaccuracy affects women, including their faith in the screening technology. Although women suffered marked anxiety from experiencing false-positive mammography tests and loss of confidence from false-negative results, these feelings generally did not diminish women's belief in the value of mammography screening. In many cases, the experiences reinforced the importance of risk reduction as well as screening.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 16","pages":"1-22"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947976/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34713341","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":"Fecal Microbiota Therapy for Clostridium difficile Infection: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Fecal microbiota therapy is increasingly being used to treat patients with Clostridium difficile infection. This health technology assessment primarily evaluated the effectiveness and cost-effectiveness of fecal microbiota therapy compared with the usual treatment (antibiotic therapy).</p><p><strong>Methods: </strong>We performed a literature search using Ovid MEDLINE, Embase, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment Database, Cochrane Central Register of Controlled Trials, and NHS Economic Evaluation Database. For the economic review, we applied economic filters to these search results. We also searched the websites of agencies for other health technology assessments. We conducted a meta-analysis to analyze effectiveness. The quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Using a step-wise, structural methodology, we determined the overall quality to be high, moderate, low, or very low. We used a survey to examine physicians' perception of patients' lived experience, and a modified grounded theory method to analyze information from the survey.</p><p><strong>Results: </strong>For the review of clinical effectiveness, 16 of 1,173 citations met the inclusion criteria. A meta-analysis of two randomized controlled trials found that fecal microbiota therapy significantly improved diarrhea associated with recurrent C. difficile infection versus treatment with vancomycin (relative risk 3.24, 95% confidence interval [CI] 1.85-5.68) (GRADE: moderate). While fecal microbiota therapy is not associated with a significant decrease in mortality compared with antibiotic therapy (relative risk 0.69, 95% CI 0.14-3.39) (GRADE: low), it is associated with a significant increase in adverse events (e.g., short-term diarrhea, relative risk 30.76, 95% CI 4.46-212.44; abdominal cramping, relative risk 14.81, 95% CI 2.07-105.97) (GRADE: low). For the value-for-money component, two of 151 economic evaluations met the inclusion criteria. One reported that fecal microbiota therapy was dominant (more effective and less expensive) compared with vancomycin; the other reported an incremental cost-effectiveness ratio of $17,016 USD per quality-adjusted life-year for fecal microbiota therapy compared with vancomycin. This ratio for the second study indicated that there would be additional cost associated with each recurrent C. difficile infection resolved. In Ontario, if fecal microbiota therapy were adopted to treat recurrent C. difficile infection, considering it from the perspective of the Ministry of Health and Long-Term Care as the payer, an estimated $1.5 million would be saved after the first year of adoption and $2.9 million after 3 years. The contradiction between the second economic evaluation and the savings we estimated may be a re","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 17","pages":"1-69"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4973962/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34749609","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":"Ultrasound as an Adjunct to Mammography for Breast Cancer Screening: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Screening with mammography can detect breast cancer early, before clinical symptoms appear. Some cancers, however, are not captured with mammography screening alone. Ultrasound has been suggested as a safe adjunct screening tool that can detect breast cancers missed on mammography. We investigated the benefits, harms, cost-effectiveness, and cost burden of ultrasound as an adjunct to mammography compared with mammography alone for screening women at average risk and at high risk for breast cancer.</p><p><strong>Methods: </strong>We searched Ovid MEDLINE, Ovid Embase, EBM Reviews, and the NHS Economic Evaluation Database, from January 1998 to June 2015, for evidence of effectiveness, harms, diagnostic accuracy, and cost-effectiveness. Only studies evaluating the use of ultrasound as an adjunct to mammography in the specified populations were included. We also conducted a cost analysis to estimate the costs in Ontario over the next 5 years to fund ultrasound as an adjunct to mammography in breast cancer screening for high-risk women who are contraindicated for MRI, the current standard of care to supplement mammography.</p><p><strong>Results: </strong>No studies in average-risk women met the inclusion criteria of the clinical review. We included 5 prospective, paired cohort studies in high-risk women, 4 of which were relevant to the Ontario context. Adjunct ultrasound identified between 2.3 and 5.9 additional breast cancers per 1,000 screens. The average pooled sensitivity of mammography and ultrasound was 53%, a statistically significant increase relative to mammography alone (absolute increase 13%; P < .05). The average pooled specificity of the combined test was 96%, an absolute increase in the false-positive rate of 2% relative to mammography screening alone. The GRADE for this body of evidence was low. Additional annual costs of using breast ultrasound as an adjunct to mammography for high-risk women in Ontario contraindicated for MRI would range from $15,500 to $30,250 in the next 5 years.</p><p><strong>Conclusions: </strong>We found no evidence that evaluated the comparative effectiveness or diagnostic accuracy of screening breast ultrasound as an adjunct to mammography among average-risk women aged 50 years and over. In women at high risk of developing breast cancer, there is low-quality evidence that screening with mammography and adjunct ultrasound detects additional cases of disease, with improved sensitivity compared to mammography alone. Screening with adjunct ultrasound also increases the number of false-positive findings and subsequent biopsy recommendations. It is unclear if the use of screening breast ultrasound as an adjunct to mammography will reduce breast cancer-related mortality among high-risk women. The annual cost burden of using adjunct ultrasound to screen high-risk women who cannot receive MRI in Ontario would be small.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 15","pages":"1-71"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947971/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34713340","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":"Composite Tissue Transplant of Hand or Arm: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Injuries to arms and legs following severe trauma can result in the loss of large regions of tissue, disrupting healing and function and sometimes leading to amputation of the damaged limb. People experiencing amputations of the hand or arm could potentially benefit from composite tissue transplant, which is being performed in some countries. Currently, there are no composite tissue transplant programs in Canada.</p><p><strong>Methods: </strong>We conducted a systematic review of the literature, with no restriction on study design, examining the effectiveness and cost-effectiveness of hand and arm transplant. We assessed the overall quality of the clinical evidence with GRADE. We developed a Markov decision analytic model to determine the cost-effectiveness of transplant versus standard care for a healthy adult with a hand amputation. Incremental cost-effectiveness ratios (ICERs) were calculated using a 30-year time horizon. We also estimated the impact on provincial health care costs if these transplants were publicly funded in Ontario.</p><p><strong>Results: </strong>Compared to pre-transplant function, patients' post-transplant function was significantly better. For various reasons, 17% of transplanted limbs were amputated, 6.4% of patients died within the first year after the transplant, and 10.6% of patients experienced chronic rejections. GRADE quality of evidence for all outcomes was very low. In the cost-effectiveness analysis, single-hand transplant was dominated by standard care, with increased costs ($735,647 CAD vs. $61,429) and reduced quality-adjusted life-years (QALYs) (10.96 vs. 11.82). Double-hand transplant also had higher costs compared with standard care ($633,780), but it had an increased effectiveness of 0.17 QALYs, translating to an ICER of $3.8 million per QALY gained. In most sensitivity analyses, ICERs for bilateral hand transplant were greater than $1 million per QALY gained. A hand transplant program would lead to an estimated annual budget impact of $0.9 million to $1.2 million in the next 3 years, 2016 to 2018, to treat 3 adults per year.</p><p><strong>Conclusions: </strong>Composite tissue transplant of the hand or arm may improve a patient's ability to function, but because the overall quality of evidence is of very low quality, there is considerable uncertainty as to whether benefits outweigh harms. Compared with standard care, both single- and double-hand transplants are not cost-effective.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 13","pages":"1-70"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947978/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34711849","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":"Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system.</p><p><strong>Methods: </strong>We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients' lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another.</p><p><strong>Results: </strong>One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life-year. The 5-year budget impact of funding the Argus II system ranged from $800,404 to $837,596. Retinitis pigmentosa significantly affects people's ability to navigate physical and virtual environments. Argus II was described as enabling the fundamental elements of sight. As such, it had a positive impact on quality of life for people with retinitis pigmentosa.</p><p><strong>Conclusions: </strong>Based on evidence of moderate quality, patients with advanced retinitis pigmentosa who were implanted with the Argus II retinal prosthesis system showed significant improvement in visual function, real-life functional outcomes, and quality of life, but there were complications associated with the surgery that could be managed through standard ophthalmologic treatments. The costs for the technology are high.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 14","pages":"1-63"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947979/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34713339","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":"Skin Testing for Allergic Rhinitis: A Health Technology Assessment.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Allergic rhinitis is the most common type of allergy worldwide. The accuracy of skin testing for allergic rhinitis is still debated. This health technology assessment had two objectives: to determine the diagnostic accuracy of skin-prick and intradermal testing in patients with suspected allergic rhinitis and to estimate the costs to the Ontario health system of skin testing for allergic rhinitis.</p><p><strong>Methods: </strong>We searched All Ovid MEDLINE, Embase, and Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment Database, Cochrane Central Register of Controlled Trials, and NHS Economic Evaluation Database for studies that evaluated the diagnostic accuracy of skin-prick and intradermal testing for allergic rhinitis using nasal provocation as the reference standard. For the clinical evidence review, data extraction and quality assessment were performed using the QUADAS-2 tool. We used the bivariate random-effects model for meta-analysis. For the economic evidence review, we assessed studies using a modified checklist developed by the (United Kingdom) National Institute for Health and Care Excellence. We estimated the annual cost of skin testing for allergic rhinitis in Ontario for 2015 to 2017 using provincial data on testing volumes and costs.</p><p><strong>Results: </strong>We meta-analyzed seven studies with a total of 430 patients that assessed the accuracy of skin-prick testing. The pooled pair of sensitivity and specificity for skin-prick testing was 85% and 77%, respectively. We did not perform a meta-analysis for the diagnostic accuracy of intradermal testing due to the small number of studies (n = 4). Of these, two evaluated the accuracy of intradermal testing in confirming negative skin-prick testing results, with sensitivity ranging from 27% to 50% and specificity ranging from 60% to 100%. The other two studies evaluated the accuracy of intradermal testing as a stand-alone tool for diagnosing allergic rhinitis, with sensitivity ranging from 60% to 79% and specificity ranging from 68% to 69%. We estimated the budget impact of continuing to publicly fund skin testing for allergic rhinitis in Ontario to be between $2.5 million and $3.0 million per year.</p><p><strong>Conclusions: </strong>Skin-prick testing is moderately accurate in identifying subjects with or without allergic rhinitis. The diagnostic accuracy of intradermal testing could not be well established from this review. Our best estimate is that publicly funding skin testing for allergic rhinitis costs the Ontario government approximately $2.5 million to $3.0 million per year.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 10","pages":"1-45"},"PeriodicalIF":0.0,"publicationDate":"2016-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4897001/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34560721","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":"Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: An Economic Analysis.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Untreated vertebral compression fractures can have serious clinical consequences and impose a considerable impact on patients' quality of life and on caregivers. Since non-surgical management of these fractures has limited effectiveness, vertebral augmentation procedures are gaining acceptance in clinical practice for pain control and fracture stabilization. The objective of this analysis was to determine the cost-effectiveness and budgetary impact of kyphoplasty or vertebroplasty compared with non-surgical management for the treatment of vertebral compression fractures in patients with cancer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We performed a systematic review of health economic studies to identify relevant studies that compare the cost-effectiveness of kyphoplasty or vertebroplasty with non-surgical management for the treatment of vertebral compression fractures in adults with cancer. We also performed a primary cost-effectiveness analysis to assess the clinical benefits and costs of kyphoplasty or vertebroplasty compared with non-surgical management in the same population. We developed a Markov model to forecast benefits and harms of treatments, and corresponding quality-adjusted life years and costs. Clinical data and utility data were derived from published sources, while costing data were derived using Ontario administrative sources. We performed sensitivity analyses to examine the robustness of the results. In addition, a 1-year budget impact analysis was performed using data from Ontario administrative sources. Two scenarios were explored: (a) an increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario, maintaining the current proportion of kyphoplasty versus vertebroplasty; and (b) no increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario but an increase in the proportion of kyphoplasties versus vertebroplasties.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The base case considered each of kyphoplasty and vertebroplasty versus non-surgical management. Kyphoplasty and vertebroplasty were associated with an incremental cost-effectiveness ratio of $33,471 and $17,870, respectively, per quality-adjusted life-year gained. The budgetary impact of funding vertebral augmentation procedures for the treatment of vertebral compression fractures in adults with cancer in Ontario was estimated at about $2.5 million in fiscal year 2014/15. More widespread use of vertebral augmentation procedures raised total expenditures under a number of scenarios, with costs increasing by $67,302 to $913,386.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Our findings suggest that the use of kyphoplasty or vertebroplasty in the management of vertebral compression fractures in patients with cancer may be a cost-effective strategy at commonly accepted willingness-to-pay thresholds. Nonetheless, more widespread use of kyphoplasty (and vertebroplasty t","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 12","pages":"1-34"},"PeriodicalIF":0.0,"publicationDate":"2016-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4901201/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34462148","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":"Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: A Systematic Review.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Cancers that metastasize to the spine and primary cancers such as multiple myeloma can result in vertebral compression fractures or instability. Conservative strategies, including bed rest, bracing, and analgesic use, can be ineffective, resulting in continued pain and progressive functional disability limiting mobility and self-care. Surgery is not usually an option for cancer patients in advanced disease states because of their poor medical health or functional status and limited life expectancy. The objectives of this review were to evaluate the effectiveness and safety of percutaneous image-guided vertebral augmentation techniques, vertebroplasty and kyphoplasty, for palliation of cancer-related vertebral compression fractures.</p><p><strong>Methods: </strong>We performed a systematic literature search for studies on vertebral augmentation of cancer-related vertebral compression fractures published from January 1, 2000, to October 2014; abstracts were screened by a single reviewer. For those studies meeting the eligibility criteria, full-text articles were obtained. Owing to the heterogeneity of the clinical reports, we performed a narrative synthesis based on an analytical framework constructed for the type of cancer-related vertebral fractures and the diversity of the vertebral augmentation interventions.</p><p><strong>Results: </strong>The evidence review identified 3,391 citations, of which 111 clinical reports (4,235 patients) evaluated the effectiveness of vertebroplasty (78 reports, 2,545 patients) or kyphoplasty (33 reports, 1,690 patients) for patients with mixed primary spinal metastatic cancers, multiple myeloma, or hemangiomas. Overall the mean pain intensity scores often reported within 48 hours of vertebral augmentation (kyphoplasty or vertebroplasty), were significantly reduced. Analgesic use, although variably reported, usually involved parallel decreases, particularly in opioids, and mean pain-related disability scores were also significantly improved. In a randomized controlled trial comparing kyphoplasty with usual care, improvements in pain scores, pain-related disability, and health-related quality of life were significantly better in the kyphoplasty group than in the usual care group. Bone cement leakage, mostly asymptomatic, was commonly reported after vertebroplasty and kyphoplasty. Major adverse events, however, were uncommon.</p><p><strong>Conclusions: </strong>Both vertebroplasty and kyphoplasty significantly and rapidly reduced pain intensity in cancer patients with vertebral compression fractures. The procedures also significantly decreased the need for opioid pain medication, and functional disabilities related to back and neck pain. Pain palliative improvements and low complication rates were consistent across the various cancer populations and vertebral fractures that were investigated.</p>","PeriodicalId":39160,"journal":{"name":"Ontario Health Technology Assessment Series","volume":"16 11","pages":"1-202"},"PeriodicalIF":0.0,"publicationDate":"2016-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4902848/pdf/ohtas-16-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34574313","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}