Journal of comparative effectiveness research最新文献

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Access in all areas? A roundup of developments in market access and health technology assessment: part 6. 所有地区都能通行吗?市场准入和卫生技术评估方面的发展综述:第6部分。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-10 DOI: 10.57264/cer-2024-0239
Annie Jullien Pannelay, Ramiro E Gilardino, Sreeram V Ramagopalan
{"title":"Access in all areas? A roundup of developments in market access and health technology assessment: part 6.","authors":"Annie Jullien Pannelay, Ramiro E Gilardino, Sreeram V Ramagopalan","doi":"10.57264/cer-2024-0239","DOIUrl":"10.57264/cer-2024-0239","url":null,"abstract":"<p><p>In this update, we discuss an article covering the implementation challenges of the upcoming European Union Health Technology Assessment regulation, particularly focusing on the complexity of population, intervention, comparator and outcomes requirements across member states; a user guide to applying generalized cost-effectiveness analysis for broader value assessment and finally highlight an ongoing debate surrounding National Institute for Health and Care Excellence's severity modifier implementation.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240239"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Selumetinib for children with neurofibromatosis type 1 and plexiform neurofibromas that can't be removed by surgery, and impact on how the condition affects caregivers: a plain language summary. 塞鲁美替尼用于不能通过手术切除的1型神经纤维瘤病和丛状神经纤维瘤儿童,以及对病情如何影响护理人员的影响:简单的语言总结。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-21 DOI: 10.57264/cer-2024-0184
Yulia Dinikina, Marina Dorofeeva, Fatima Nakhusheva
{"title":"Selumetinib for children with neurofibromatosis type 1 and plexiform neurofibromas that can't be removed by surgery, and impact on how the condition affects caregivers: a plain language summary.","authors":"Yulia Dinikina, Marina Dorofeeva, Fatima Nakhusheva","doi":"10.57264/cer-2024-0184","DOIUrl":"10.57264/cer-2024-0184","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;What is this summary about?: &lt;/strong&gt;Neurofibromatosis type 1 (also called NF1) is a rare genetic condition. It causes a range of symptoms that develop from childhood onwards and worsen over time. Some children with NF1 develop non-cancerous nerve tumors called plexiform neurofibromas. Plexiform neurofibromas can grow large and compress nearby tissues. This can cause severe pain, reduced movement, vision and hearing loss, and other medical problems. Some children can have plexiform neurofibromas removed surgically. Most children have tumors that cannot be removed by surgery (known as inoperable tumors). Children with inoperable plexiform neurofibromas can receive a medicine called selumetinib. This plain language summary includes important findings from two selumetinib studies in children with NF1 and inoperable plexiform neurofibromas: The SPRINT selumetinib studies are part of a clinical study program that looked at how well selumetinib works in treating children with symptomatic, inoperable plexiform neurofibromas. The SPRINT studies program included the first studies of this medicine done in children, called phase 1 and phase 2 studies. For the phase 2 study, some children had severe symptoms and some children did not. The group of children with severe symptoms is called group 1, and their results are included in this summary. The researchers monitored the participating children for up to 5 years in a long-term study to better understand how the treatment works over time. The NF1 caregivers experience study is a related study where caregivers shared their experiences of caring for children with NF1and plexiform neurofibromas.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;What were the results?: &lt;/strong&gt;A total of 74 children took part in the SPRINT phase 1 and phase 2 (group 1) study. Their ages ranged from 3 to 18.5 years, and their average age was 10.3 years. After more than 4 years of treatment, around 70% of the children (52 out of 74) had smaller tumors. For most children, the responses lasted beyond 1 year. There was a significant and lasting reduction in the intensity of the children';s tumor pain, noticeable as early as 2 months after starting the treatment. After 12 months, children reported their pain dropped from an average score of 2.2 to 0.6 and stayed low at 0.58 over 4 years. There was also an improvement in how much their pain affected the children's ability to do daily tasks. Some children had side effects related to selumetinib, although these were generally manageable. Results from the NF1 caregivers experience study showed caregivers of children with plexiform neurofibromas face significant impacts in physical, psychological, economic, and social aspects. These effects often result in a loss of productivity and difficulties with daily activity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;What do the results of the study mean?: &lt;/strong&gt;Children with NF1 who have symptomatic, inoperable plexiform neurofibromas can benefit from selumetinib treatment. Selumetinib is general","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240184"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The economic impact of stent retriever selection for acute ischemic stroke: a cost analysis of MASTRO I from the healthcare system perspective of the United States, Canada and eight European countries. 急性缺血性卒中支架回收器选择的经济影响:美国、加拿大和欧洲八个国家医疗保健系统视角下mastero I的成本分析
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-02-17 DOI: 10.57264/cer-2024-0216
Tommy Andersson, Hannes Nordmeyer, Waleed Brinjikji, Emilie Kottenmeier, Mina Kabiri, Shanti Scheffler, Patrick A Brouwer, Mahmood Mirza, Osama O Zaidat
{"title":"The economic impact of stent retriever selection for acute ischemic stroke: a cost analysis of MASTRO I from the healthcare system perspective of the United States, Canada and eight European countries.","authors":"Tommy Andersson, Hannes Nordmeyer, Waleed Brinjikji, Emilie Kottenmeier, Mina Kabiri, Shanti Scheffler, Patrick A Brouwer, Mahmood Mirza, Osama O Zaidat","doi":"10.57264/cer-2024-0216","DOIUrl":"10.57264/cer-2024-0216","url":null,"abstract":"<p><p><b>Aim:</b> According to the results of the MASTRO I living systematic review and meta-analysis, use of the EmboTrap Revascularization<sup>®</sup> Device in the treatment of acute ischemic stroke (AIS) results in higher rates of good functional outcomes (90-day modified Rankin Scale [mRS] 0-2) compared with use of the Trevo<sup>®</sup> Retriever or the Solitaire™ Revascularization Device. The aim of this analysis was to assess the potential economic impact of achieving improved functional outcomes for three commonly used stent retrievers (SRs) in the treatment of AIS. <b>Methods:</b> An economic model with short-term and long-term costs, representing a healthcare system perspective was developed using a decision tree to simulate a cohort of 1000 hypothetical patients treated for AIS with mechanical thrombectomy (MT) using EmboTrap, Trevo or Solitaire SRs. Based on the proportion of patients who achieved a 90-day mRS score of 0-2 or 3-5 for each device reported in MASTRO I (excluding patients not surviving after 90 days), this model estimated per-patient costs and the associated incremental cost savings. Results are reported from the healthcare system perspective in the US, Canada, the UK, Sweden, Germany, France, Italy, Spain, Belgium and The Netherlands. <b>Results:</b> Across all ten countries, the use of EmboTrap during MT was associated with the lowest short-term (ranging from €8412 in Italy to $66,525 in the US), long-term (ranging from €5249 in Italy to $25,757 in the US) and total (ranging from €13,661 in Italy to $92,282 in the US) per-patient costs. The total per-patient cost was higher with Trevo (ranging from €14,601 in Italy to $97,487 in the US) and Solitaire (ranging from €14,840 in Italy to $98,814 in the US). Cost savings were highest when comparing EmboTrap versus Solitaire, followed by EmboTrap versus Trevo, with Trevo versus Solitaire having the smallest cost savings. Results of sensitivity and scenario analyses supported the robustness of the base-case results. <b>Conclusion:</b> Across the ten countries, treating patients with AIS with EmboTrap resulted in lower short-term, long-term and total costs to the payer. With rising healthcare costs and limited hospital budgets, these results suggest EmboTrap proves to be an evidence-based economical choice of SR for hospitals and healthcare systems.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240216"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143433257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Budget impact analyses of hemoglobin A1c and lipid panel point-of-care testing with Afinion™ 2 in Canada and Italy. 在加拿大和意大利使用Afinion™2进行糖化血红蛋白和脂质面板即时检测的预算影响分析。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-29 DOI: 10.57264/cer-2024-0208
David Garcia, Antonio Ruffolo, Alicyia Walczyk Mooradally, Anna Zhou, Emmanuel Lazaridis, Barbara Laurelli
{"title":"Budget impact analyses of hemoglobin A1c and lipid panel point-of-care testing with Afinion™ 2 in Canada and Italy.","authors":"David Garcia, Antonio Ruffolo, Alicyia Walczyk Mooradally, Anna Zhou, Emmanuel Lazaridis, Barbara Laurelli","doi":"10.57264/cer-2024-0208","DOIUrl":"10.57264/cer-2024-0208","url":null,"abstract":"<p><p><b>Aim:</b> Screening and monitoring of diabetes or dyslipidemia frequently involves a multi-step process requiring patients to obtain test requisitions from their primary care physician (PCP), followed by a laboratory visit and re-consultation. Point-of-care testing (POCT) for hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) and lipid panel can streamline the patient care pathway. This study assessed the budget impact of introducing Afinion™ 2 POCT (Abbott Rapid Diagnostics) from the Canadian and Italian societal perspectives. <b>Methods:</b> Budget impact models were developed for Canada and Italy over a 5-year time horizon (2025 to 2029). The analyses considered the screening and monitoring of diabetes or dyslipidemia for patients utilizing the public healthcare system and attending primary care, and included direct costs (testing, consultations) and indirect costs (productivity loss, transportation) based on published sources. The budget impact (BI) was calculated by comparing scenarios with and without POCT. All costs were adjusted to Canadian dollars ($) or 2024 Euros (€). Scenario analyses were conducted to explore the impact of alternative assumptions. <b>Results:</b> The 5-year cumulative BI was -$758,006,692 (-$50,709,964 direct, -$707,296,728 indirect) for HbA<sub>1c</sub> POCT and -$726,452,755 ($2,684,011 direct, -$729,136,766 indirect) for lipid panel POCT in Canada and -€1,380,658,764 (-€6,391,954 direct, -€1,374,266,809 indirect) for HbA<sub>1c</sub> POCT and -€851,792,115 (€55,962,879 direct, -€907,754,993 indirect) for lipid panel POCT in Italy. In both countries, cost savings for both the healthcare payer and patients were observed for HbA<sub>1c</sub> POCT, while costs savings were derived from patient indirect costs for lipid panel POCT. The analyses estimated that 1,558,062 and 1,501,260 PCP consultations in Canada, 4,962,338 and 1,951,026 PCP consultations in Italy were avoided with implementation of POCT for HbA<sub>1c</sub> and lipid panel, respectively. Scenario analyses demonstrated potential further cost savings with implementation of POCT in pharmacies. <b>Conclusion:</b> This study demonstrates that the adoption of Afinion 2 POCT for HbA<sub>1c</sub> and lipid panel can provide efficiencies to different types of healthcare systems through reducing PCP consultations, saving time and money for patients and providing cost savings for payers.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240208"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864078/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum. 更正。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-07 DOI: 10.57264/cer-2024-0241
{"title":"Corrigendum.","authors":"","doi":"10.57264/cer-2024-0241","DOIUrl":"10.57264/cer-2024-0241","url":null,"abstract":"","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":"14 3","pages":"e240241"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Economic impact of reduced postoperative visits after inflatable penile prosthesis implantation. 充气阴茎假体植入术后减少术后就诊的经济影响。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-15 DOI: 10.57264/cer-2024-0204
Bradley Gill, Young Eun Shin, Kathryn Durand, Andrew Sun, Paurush Babbar, Sirikan Rojanasarot
{"title":"Economic impact of reduced postoperative visits after inflatable penile prosthesis implantation.","authors":"Bradley Gill, Young Eun Shin, Kathryn Durand, Andrew Sun, Paurush Babbar, Sirikan Rojanasarot","doi":"10.57264/cer-2024-0204","DOIUrl":"10.57264/cer-2024-0204","url":null,"abstract":"<p><p><b>Aim:</b> This study assessed the economic impact of reducing one postoperative visit following inflatable penile prosthesis (IPP) implantation. <b>Methods:</b> Scenario analyses were used to model the effects of eliminating one 30-min IPP postoperative visit from the expected 2.5 visits accounted for by the American Medical Association resource-based relative value scale data. The reduction was attributed to simplified teaching with a modified device. The recaptured time was applied to: the most frequent in-office CPT codes utilized by IPP implanters; evaluation and management of new ED patients pursuing/receiving IPPs; and in-office vasectomy. Physician work time and reimbursement were conservatively estimated using the 2024 Medicare Physician Fee Schedule and an alternative scenario where Advanced Practice Providers conducted IPP teaching was also modeled. <b>Results:</b> Annually, reducing one 30-min IPP postoperative visit for practices performing 25/50/100 IPP implants recaptured 750/1500/3000 min, respectively. This recaptured time translates into as much as $18,325 additional annual Medicare reimbursement. At 25 implants yearly, urologists could help an additional 13-25 patients with office visits and observe an additional $2049-$2270 reimbursement. At 50 implants yearly, office evaluation and counseling for 7 ED patients who progress to IPP implantation results in an additional $4125 reimbursement, excluding any diagnostic procedures and/or downstream surgical cases. At 100 implants yearly, recaptured schedule capacity can facilitate 37 in-office vasectomies, which translates to a $12,563 reimbursement. <b>Conclusion:</b> Achieving fewer IPP postoperative visits can optimize postoperative care and open schedule capacity that improves access to care for patients with urological needs.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240204"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864081/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical characteristics and treatment outcomes in multiple sclerosis patients treated with anti-CD20s who switched to fumarates: a retrospective analysis of a US healthcare claims database. 用抗cd20治疗的多发性硬化症患者改用富马酸盐治疗的临床特征和治疗结果:对美国医疗索赔数据库的回顾性分析
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-02-12 DOI: 10.57264/cer-2024-0071
Aliza B Ben-Zacharia, Jenny J Feng, Brandon P Moss, Nicholas Belviso, Yu Zhang, Filipe Branco, Jason P Mendoza, James B Lewin, Sarah M England
{"title":"Clinical characteristics and treatment outcomes in multiple sclerosis patients treated with anti-CD20s who switched to fumarates: a retrospective analysis of a US healthcare claims database.","authors":"Aliza B Ben-Zacharia, Jenny J Feng, Brandon P Moss, Nicholas Belviso, Yu Zhang, Filipe Branco, Jason P Mendoza, James B Lewin, Sarah M England","doi":"10.57264/cer-2024-0071","DOIUrl":"10.57264/cer-2024-0071","url":null,"abstract":"<p><p><b>Aim:</b> Anti-CD20 monoclonal antibodies and fumarates are common multiple sclerosis (MS) disease-modifying therapies (DMTs). Data on switching from anti-CD20s to other DMTs are limited. This retrospective, observational study of the US Komodo Health Sentinel claims database aimed to evaluate a de-escalation strategy in a real-world cohort, comparing clinical characteristics, relapses, healthcare encounters (HCEs) and healthcare costs (HCCs) between patients aged ≥18 years with stable MS who switched from anti-CD20s to fumarates ('Switchers') versus patients who stayed on anti-CD20s ('Stayers'). <b>Materials & methods:</b> Patients with MS (diagnosed 1 January 2015-31 August 2022) were propensity score matched 5:1 (Stayers:Switchers) and followed from index to end of study; end of insurance eligibility; >45-day gap in index DMT; or DMT switch. Primary outcomes were clinical characteristics and claims-based annualized relapse rate (ARR). Rates of HCEs and HCCs were estimated. <b>Results:</b> Baseline characteristics were well balanced between cohorts (Stayers, n = 540; Switchers, n = 108). Mean (SD) duration of post-index follow-up was 341.4 (250.0) days for both cohorts. Mean (SD) ARR was 0.08 (0.41; Stayers) versus 0.14 (0.5; Switchers; p = 0.3). Twenty-one Stayers (3.9%) and 1 Switcher (0.9%) were hospitalized for infections, with mean stays of 9.9 and 1 day, respectively. Mean annualized all-cause HCEs were similar between cohorts; annualized inpatient infection-related HCEs were higher for Stayers versus Switchers (mean difference: -0.05; p = 0.005). Annualized all-cause HCCs were similar between cohorts; Switchers had lower annualized infection-related HCCs overall (mean difference: -$2412; p = 0.002) and in the inpatient setting (mean difference: -$2325; p = 0.002). <b>Conclusion:</b> After 1 year, no significant differences in ARR emerged between cohorts. Switchers experienced lower inpatient infection-related HCEs, shorter inpatient infection-related hospital stays and lower overall infection-related HCCs.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240071"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The impact of a patient advisory board on a clinical comparative effectiveness trial: a comparison of patient and researcher perspectives. 患者咨询委员会对临床比较有效性试验的影响:患者和研究者观点的比较。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-30 DOI: 10.57264/cer-2024-0050
Laura M Kernan, Monica Baczko Pearl, Adina Harri, Carol A Lambourne, Robert Schlegel, C McCollister Evarts, Mary Beth Crummer, Conrad Persels, Nancy Mullen, Vincent D Pellegrini
{"title":"The impact of a patient advisory board on a clinical comparative effectiveness trial: a comparison of patient and researcher perspectives.","authors":"Laura M Kernan, Monica Baczko Pearl, Adina Harri, Carol A Lambourne, Robert Schlegel, C McCollister Evarts, Mary Beth Crummer, Conrad Persels, Nancy Mullen, Vincent D Pellegrini","doi":"10.57264/cer-2024-0050","DOIUrl":"10.57264/cer-2024-0050","url":null,"abstract":"<p><p><b>Aim:</b> To examine contributions of a patient advisory board (PAB) to the design and conduct of The Pulmonary Embolism Prevention after Hip and Knee Replacement (PEPPER) Trial (NCT02810704) and compare perceptions of PAB members and researchers on the Trial. <b>Materials & methods</b> This evaluation of the PAB was conducted by Clinical Coordinating Center (CCC) members who first discussed PAB contributions, leading to the design of a semi-structured WebEx interview individually querying PAB members on their experience. Two study team members analyzed transcriptions of the interviews for common themes, which were discussed and affirmed at an in-person meeting with PAB members. <b>Results:</b> The contribution most frequently cited as meaningful by PAB members was the creation of a recruitment video. In contrast, the research team considered the most impactful PAB recommendation to be omission of pneumatic compression boots as a study variable. PAB members spoke highly of their involvement in the trial and emphasized shared decision-making in the patient-physician relationship. <b>Conclusion:</b> Researchers and PAB members had different opinions about which PAB contributions were most impactful to the study. This likely derives from differences in perspective; PAB members focused on patient experience and the patient-surgeon relationship while researchers focused primarily on trial outcomes. PAB contributions led to two major protocol changes that had a substantial positive effect on trial design, recruitment and enrollment. This evaluation adds to the engagement literature, which contains little on what patients think of their involvement in the design and conduct of clinical research studies and will aid in encouraging treatment preference discussions between patient and surgeon, thereby supporting the goal of improved patient outcomes.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240050"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864086/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143066003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of treatment options for complicated urinary tract infections including acute pyelonephritis: a systematic literature review and network meta-analysis. 包括急性肾盂肾炎在内的复杂尿路感染治疗方案的疗效:系统文献综述和网络荟萃分析。
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-03-01 Epub Date: 2025-01-16 DOI: 10.57264/cer-2024-0214
Florian Wagenlehner, Verónica Rico Caballero, Vikalp Maheshwari, Ayantika Biswas, Priyanka Saini, Juan Quevedo, Juergen Polifka, Leonardo Ruiz, Sandrine Cure
{"title":"Efficacy of treatment options for complicated urinary tract infections including acute pyelonephritis: a systematic literature review and network meta-analysis.","authors":"Florian Wagenlehner, Verónica Rico Caballero, Vikalp Maheshwari, Ayantika Biswas, Priyanka Saini, Juan Quevedo, Juergen Polifka, Leonardo Ruiz, Sandrine Cure","doi":"10.57264/cer-2024-0214","DOIUrl":"10.57264/cer-2024-0214","url":null,"abstract":"<p><p><b>Aim:</b> Compared with uncomplicated urinary tract infections (UTIs), complicated UTIs (cUTIs) including acute pyelonephritis (AP) present with significant morbidity, a higher risk of treatment failure and typically require longer courses of treatment, or alternative antibiotics. The emergence of drug-resistant organisms represents a considerable challenge in the treatment of patients with cUTIs/AP and has limited antibiotic options. Carbapenems are considered the current last line of therapy, however, carbapenem resistance represents a growing problem. Although several established and novel treatment options are available, direct comparative evidence is lacking. <b>Methods:</b> Randomized controlled trials (RCTs) were identified by systematic literature review of Embase<sup>®</sup>, MEDLINE<sup>®</sup> and Cochrane databases (database inception to 15th June 2022). Relevant conference proceedings (2020-2022) were also reviewed. Following feasibility assessment to verify network connectivity at an overall level, outcome specific networks were prepared. Bayesian network meta-analysis (NMA) was performed (using R version 4.2.1) to determine the relative efficacy of various treatments for cUTI/AP, including cefepime + enmetazobactam. Convergence was assessed by visual inspection of trace plots. The accuracy of the posterior estimates was assessed using the Monte Carlo error for each parameter. Published study results were included in the synthesis of the relative risk (RR) of efficacy end points, using a logit link with binomial likelihood distribution. <b>Results:</b> Feasibility assessment was conducted for 40 RCTs identified, to assess the viability of constructing a network of interlinked RCTs. Of those, 28 studies were included in the master NMA network. A fixed effects model (FEM) was selected due to low statistical heterogeneity, according to I<sup>2</sup> values. For composite outcome at test of cure (TOC), ceftolozane + tazobactam, cefepime + enmetazobactam, cefiderocol, levofloxacin and plazomicin demonstrated significantly higher RRs versus carbapenems. For microbiological eradication at TOC, cefepime + enmetazobactam, plazomicin, cefiderocol, fosfomycin, meropenem + vaborbactam and ceftazidime + avibactam demonstrated significantly higher RRs versus carbapenems. RRs for cefepime + enmetazobactam were also significantly higher versus several established and novel treatment options for composite outcome, microbiological eradication and clinical cure. <b>Conclusion:</b> Against the backdrop of increasing bacterial resistance, these findings suggest that cefepime + enmetazobactam may represent an effective carbapenem-sparing treatment option in patients with cUTI including AP.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240214"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-effectiveness of cetuximab combined with radiotherapy versus radiotherapy alone in locally advanced head and neck cancer in Spain. 西妥昔单抗联合放疗与单独放疗在西班牙治疗局部晚期头颈癌的成本-效果
IF 1.9 4区 医学
Journal of comparative effectiveness research Pub Date : 2025-02-01 Epub Date: 2025-01-10 DOI: 10.57264/cer-2024-0116
Ruth Álvarez Cabellos, Jon Cacicedo, Susana Redondo Capafons, Heidi De Los Santos Real, Miriam Brines Julián, Darío Rubio-Rodríguez, Carlos Rubio-Terrés
{"title":"Cost-effectiveness of cetuximab combined with radiotherapy versus radiotherapy alone in locally advanced head and neck cancer in Spain.","authors":"Ruth Álvarez Cabellos, Jon Cacicedo, Susana Redondo Capafons, Heidi De Los Santos Real, Miriam Brines Julián, Darío Rubio-Rodríguez, Carlos Rubio-Terrés","doi":"10.57264/cer-2024-0116","DOIUrl":"10.57264/cer-2024-0116","url":null,"abstract":"<p><p><b>Aim:</b> To estimate the cost-effectiveness of cetuximab in combination with radiotherapy compared with radiotherapy alone, for the treatment of locally advanced head and neck cancer patients in Spain. <b>Methods:</b> A probabilistic Markov model (second-order Monte Carlo simulation) with a five-year time horizon and quarterly Markov cycles was performed from the perspective of the Spanish National Health System (NHS). <b>Results:</b> The additional cost and quality-adjusted life-year (QALY) gain per patient receiving radiotherapy in combination with cetuximab compared with radiotherapy alone was €4356 (95% CI: €4350-4362) and 0.2380 (95% CI: 0.2370-0.2391) QALY, respectively. The incremental cost per QALY gain was €18,303 (95% CI: €18,243-18,354) with a probability of cost-effectiveness of 65.4% for a willingness to pay of €30,000 per QALY gained. <b>Conclusion:</b> According to the results of this analysis, the addition of cetuximab to radiotherapy would be a cost-effective alternative to radiotherapy alone in the treatment of locally advanced head and neck cancer in Spain.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240116"},"PeriodicalIF":1.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","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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