Journal of comparative effectiveness research最新文献

{"title":"Comparative efficacy of various wound dressings on scar formation following thyroidectomy: a systematic review and meta-analysis.","authors":"Yixue Jiang","doi":"10.57264/cer-2026-0101","DOIUrl":"https://doi.org/10.57264/cer-2026-0101","url":null,"abstract":"<p><p><b>Background:</b> Visible cervical scarring remains a common concern following conventional thyroidectomy and may adversely affect cosmetic satisfaction and quality of life. Although several postoperative wound interventions have been introduced to improve scar healing, their comparative effectiveness remains uncertain because of inconsistent findings across randomized controlled trials (RCTs). <b>Aim:</b> To systematically evaluate the effectiveness of postoperative wound interventions in improving scar outcomes following thyroidectomy and thyroid/parathyroid surgery. <b>Materials & methods:</b> PRISMA 2020-guided systematic review and meta-analysis searched PubMed, Scopus, Web of Science and Cochrane Central Register of Controlled Trials from inception to January 2026 for RCTs of postoperative wound interventions in adults undergoing thyroidectomy or thyroid/parathyroid surgery. Interventions included adhesive/tissue glue techniques, wound-protector devices, and oxygen therapy dressings versus postoperative wound management. Scar outcomes used instruments including the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale. Random-effects meta-analysis reported standardized mean differences (SMDs) with 95% CIs. <b>Results:</b> Fourteen RCTs met the inclusion criteria for qualitative synthesis, of which seven independent effect sizes were eligible for quantitative meta-analysis. Overall, postoperative wound interventions did not significantly improve scar outcomes compared with conventional wound management when pooled across all intervention types (SMD: -0.21; 95% CI: -0.45 to 0.04; p = 0.10), reflecting substantial heterogeneity between intervention categories (I² = 74%). Considered separately, wound-protector devices demonstrated a significant improvement in scar outcomes (SMD: -0.84; 95% CI: -1.06 to -0.62; p < 0.001), whereas tissue adhesives produced cosmetic results comparable to conventional subcuticular sutures, with no measurable scar-quality advantage (SMD: 0.14; 95% CI: -0.12 to 0.40; p = 0.29). Continuous diffusion oxygen therapy showed promising early clinical benefits but was evaluated in only one randomized trial and was therefore summarized narratively. <b>Conclusion:</b> Current randomized evidence indicates that the benefit of postoperative wound interventions on scar outcomes is intervention-specific rather than a uniform class effect: wound-protector devices show a consistent, statistically significant benefit, whereas the pooled effect across all intervention types combined does not reach significance. Tissue adhesives provide satisfactory outcomes and efficient wound closure without a measurable scar-quality advantage over standard sutures, and evidence for oxygen therapy remains preliminary. Larger, well-designed trials using standardized scar assessment and longer follow-up are required to establish optimal postoperative scar management.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260101"},"PeriodicalIF":2.8,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148891518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"US population-level model of clinical impact of lorlatinib treatment on ALK+ metastatic non-small cell lung cancer outcomes.","authors":"Adam Kasle, Devin Abrahami, David Veenstra, Robert Morlock, Priya Ramachandran, Lindsay Stansfield, Raymond Mak","doi":"10.57264/cer-2026-0096","DOIUrl":"https://doi.org/10.57264/cer-2026-0096","url":null,"abstract":"<p><p><b>Aim:</b> Lorlatinib and alectinib are next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) approved for the treatment of ALK-positive (ALK+) advanced/metastatic non-small cell lung cancer (NSCLC) after demonstrating superior efficacy over crizotinib (first-generation ALK TKI) in the CROWN and ALEX trials, respectively. This analysis estimated the US population-level clinical impact of first-line (1L) lorlatinib versus alectinib treatment for ALK+ advanced/metastatic NSCLC. <b>Materials & methods:</b> We developed a decision-analytic model comparing lorlatinib versus alectinib use in 1L. We used a three-state partitioned survival model (pre-progression, post-progression and death) and tracked incidence of brain metastases (BMs). Lorlatinib-eligible population estimates were derived from published literature and market forecasts; treatment effectiveness for lorlatinib was derived from CROWN; alectinib comparative effectiveness was informed using a match-adjusted indirect comparison (CROWN vs ALEX). We assumed lorlatinib uptake of 38% in the base case; selected scenarios included different survival extrapolations, assuming 100% lorlatinib uptake and applying risk of BM post-discontinuation. <b>Results:</b> We estimated that 3096 patients in the US would be eligible for lorlatinib. Compared with 1L alectinib use only, our model projected that 1L lorlatinib treatment results in 1620-5170 and 1590-4880 more life-years and quality-adjusted life-years, respectively, over a 20-year time horizon across scenarios. Per-patient incidence of BM ranged from 0.14-0.18 and 0.21-0.40 for lorlatinib and alectinib, respectively, resulting in 68-256 fewer BMs. Separately, for every 5-15 patients treated with 1L lorlatinib instead of 1L alectinib, one BM would be avoided. <b>Conclusion:</b> This analysis projected that 1L lorlatinib treatment in the US could result in more LYs and quality-adjusted life-years and fewer BMs versus 1L alectinib in ALK+ advanced/metastatic NSCLC.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260096"},"PeriodicalIF":2.8,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148887705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic value of liver histology in steatotic liver disease: a systematic literature review and meta-analysis.","authors":"A Sidney Barritt, Anila Qasim, Yestle Kim, Sally D Miller, John O'Donnell, Karissa Johnston","doi":"10.57264/cer-2026-0148","DOIUrl":"https://doi.org/10.57264/cer-2026-0148","url":null,"abstract":"<p><p><b>Aim:</b> Metabolic dysfunction-associated steatohepatitis (MASH) and steatotic liver disease (MASLD) are progressive liver conditions that can lead to serious long-term outcomes and adverse clinical events. Histologic liver fibrosis is an accepted short-term surrogate end point used in pivotal clinical trials supporting conditionally approved MASH therapies. This study aimed to synthesize up-to-date published associations between histologic liver fibrosis and clinical outcomes, including several novel syntheses. <b>Materials & methods:</b> A systematic literature review identified studies of MASH ± MASLD patients published January 2014 to November 2024 from Ovid MEDLINE^®, Embase and grey literature. Studies reporting hazard ratios (HRs) comparing the risk of relevant major adverse liver outcomes (MALO; e.g., cirrhosis, hepatic decompensation, hepatocellular carcinoma) and mortality by histologic liver fibrosis stage were included in meta-analysis. Pooled estimates were reported as HRs and 95% CIs. <b>Results:</b> Of 2810 returned records, there were 32 eligible studies from 39 articles. Higher fibrosis stage was associated with increased risk of clinical outcomes. Risk of progression to cirrhosis was twofold higher in F3 versus F2 (2.05 [1.45, 2.90]). Risk of hepatic decompensation was >ten-times higher in F3-4 versus F0-2 (10.93 [6.31, 18.92]). Risk of MALO and all-cause mortality were also significantly higher in F4 versus F3 and versus F2, and in F3-4 versus F0-2. Results were directionally consistent among studies of MASH-majority (≥80% MASH) populations and individually reported HRs. <b>Conclusion:</b> Increased clinical risk with more advanced fibrosis and/or cirrhosis among patients with significant liver disease supports the value of histologic liver fibrosis as a short-term surrogate for long-term clinical outcomes.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260148"},"PeriodicalIF":2.8,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148887718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical effectiveness of a digitally delivered balance program for older adults: a nonrandomized controlled trial.","authors":"Folasade Phillips, Sandhya Yadav, Cynthia Castro Sweet, Rachel Ns Foster Kirk, Mindy Hong, Samuel Mink, Jeffrey Krauss","doi":"10.57264/cer-2026-0070","DOIUrl":"10.57264/cer-2026-0070","url":null,"abstract":"<p><p><b>Aim:</b> To evaluate the clinical effectiveness of a digitally delivered balance program relative to an attention-control comparison group in older adults at risk for falls. <b>Materials & methods:</b> This nonrandomized controlled trial recruited adults aged 65 years and older with moderate-to-high fall risk. Participants were assigned to a digital balance program (exercise therapy, education and health coaching) or an attention-control group (education materials). Outcomes were assessed via self-report surveys at baseline and 3 months. Analyses including all assigned participants evaluated changes in fall rate, fall severity, physical function and medical care utilization. <b>Results:</b> A total of 687 participants were included in the analysis (intervention: n = 344; attention-control: n = 343). The mean age was 68.8 years, and 74.1% of participants were female. In the primary analysis, adjusting for baseline factors, the intervention group demonstrated a 37% lower fall rate compared with the attention-control group at 3 months (IRR: 0.63, 95% CI: 0.48-0.82, p < 0.001). The intervention group also demonstrated significant improvement in physical functioning (β = 6.86, 95% CI: 3.80-9.92, p < 0.001) and lower odds of emergency department visits (OR: 0.43, 95% CI: 0.24-0.76, p = 0.004). Intervention participants engaged in an average of 25.2 exercise therapy sessions over the 12-week period. <b>Conclusion:</b> Findings suggest that participation in the digital balance program was associated with reductions in self-reported fall rates, improvements in self-reported physical function, and lower odds of emergency department utilization. High engagement levels further indicate that digitally delivered programs offer a viable option for improving health outcomes in this population. <b>Trial Registration:</b> Clinicaltrials.gov NCT06868680 retrospectively registered 6 March 2025.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260070"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148535930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A global literature review of comorbidities and concomitant supportive medications among individuals with Rett syndrome.","authors":"Nazia Rashid, Krithika Rajagopalan, Safiuddin Shoeb Syed, Chijioke M Okeke, Regina Nwamaka Nechi, Ismaeel Yunusa","doi":"10.57264/cer-2026-0100","DOIUrl":"10.57264/cer-2026-0100","url":null,"abstract":"<p><p><b>Aim:</b> To synthesize evidence on the multisystem clinical burden of Rett syndrome, integrating comorbidity prevalence and concomitant medication use to inform proactive care. <b>Materials & methods:</b> A structured search of PubMed, Embase and Cochrane (January 2000 to July 2024), plus gray literature, identified clinical trials, observational studies, registries, and case series (n >10). Non-English articles, case reports, reviews and commentaries were excluded. Two investigators independently screened studies, extracted data and synthesized the evidence using a descriptive approach with evidence mapping. <b>Results:</b> Of 6253 records screened, 148 studies met inclusion criteria, spanning 24 countries and participants aged 7 months to 37 years. Neurological, musculoskeletal and developmental manifestations predominated (reported in 62.0%, 44.0% and 41.0% of studies, respectively). Epilepsy prevalence ranged from 15.0% to 91.0%, scoliosis 8.9-100% and gastrointestinal dysfunction was common, including constipation (16.4-82.8%) and gastroesophageal reflux (15.8-100.0%). Hand stereotypies were reported in 11.4% of studies, with prevalence of 70.0-100.0%. Among studies reporting developmental burden, inability to walk ranged from 19.0% to 100.0%. Additional comorbidities included sleep, oral, and endocrine disorders, among others. Antiepileptic medications contributed most to treatment burden (14.3-33.0% for monotherapy). Other commonly used medications targeted sleep (melatonin, 7.7-30.0%), gastrointestinal symptoms (proton-pump inhibitors, 37.0-61.0%) and behavioral symptoms (anti-anxiety agents, 10.0-21.4%). <b>Conclusion:</b> Rett syndrome imposes a substantial, lifelong multisystem burden requiring continuous surveillance. Findings highlight the importance of anticipatory, multidisciplinary care rather than symptom-driven management. Patterns of medication use, particularly for epilepsy, reflect reliance on symptom-directed therapies and highlight the need for routine medication review, careful prescribing and longitudinal monitoring to optimize outcomes.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260100"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148793934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment gaps in osteoporosis care following recurrent fractures: a nationwide cohort study.","authors":"Hyun Jin Han, Miryoung Kim, Eyoung Wang, Min Ji Kim, Hae Sun Suh","doi":"10.57264/cer-2026-0039","DOIUrl":"10.57264/cer-2026-0039","url":null,"abstract":"<p><p><b>Aim:</b> This nationwide cohort study primarily aimed to descriptively characterize real-world treatment patterns, including treatment initiation, adherence, treatment duration and discontinuation of the first treatment drug, among patients who experienced a recurrent osteoporotic fracture. <b>Materials & methods:</b> This population-based, retrospective cohort study used data from the Health Insurance Review and Assessment Database of South Korea. It included male and female patients aged 55 years and older who experienced a recurrent osteoporotic fracture within 2 years of their index fracture in 2013. <b>Results:</b> The study period was from 1 January 2012 to 31 December 2021, with an outcome assessment period from 1 January 2013 to 31 December 2017. A total of 34,558 patients with recurrent osteoporotic fractures were observed, and just over half (n = 18,462, 53.4%) received osteoporosis medication, with a significant difference in medication rates between males (23.7%) and females (58.8%) (p < 0.001). The estimated median duration of osteoporosis medication was 146 days (interquartile range: 61-365 days). The discontinuation rate of medication within 2 years of follow-up after their recurrent fracture was 80.5%, with the highest discontinuation rate (90.4%) observed among patients taking daily oral bisphosphonate medication. <b>Conclusion:</b> Although patients with recurrent fractures require intensive management, our results showed a significant unmet need in the initiation and persistence of osteoporosis medication. Therefore, it is crucial to establish a strategic treatment approach to address the treatment gap in managing osteoporosis among very high-risk patients. <b>Dataset name:</b> Health Insurance Review and Assessment Database of South Korea.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260039"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148663976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological pitfalls in indirect treatment comparisons: insights from a recent systematic review and analysis for C3 glomerulopathy.","authors":"Brian Hutton, James Fotheringham, Andrew Ervin, Raisa Sidhu, Corey Lourenco, Imtiaz A Samjoo, Chris Cameron, Bridget Dunne","doi":"10.57264/cer-2026-0054","DOIUrl":"10.57264/cer-2026-0054","url":null,"abstract":"<p><p><b>Aim:</b> Indirect treatment comparisons (ITCs), as outlined in NICE and ISPOR guidance, require careful evaluation of cross-trial heterogeneity to ensure valid comparisons, particularly in rare diseases with limited evidence. C3 glomerulopathy (C3G) is an ultra-rare, complement-mediated kidney disease with high unmet need, making appropriate application of ITC frameworks especially critical. This appraisal evaluates the feasibility of applying ITC principles to compare Phase III trials of iptacopan (APPEAR-C3G) and pegcetacoplan (VALIANT) in the absence of head-to-head evidence. <b>Materials & methods:</b> Feasibility of an ITC in C3G was assessed through critical appraisal of APPEAR-C3G and VALIANT randomized controlled trials, focusing on alignment of eligibility criteria, baseline characteristics and outcome definitions, in line with NICE DSU TSD-18, CHTE2020 and ISPOR guidance. A systematic literature review (SLR) was then conducted to identify published ITCs comparing iptacopan and pegcetacoplan in C3G, which were evaluated for methodological rigor, transparency and credibility according to NICE and ISPOR recommendations. <b>Results:</b> Substantial heterogeneity was observed between APPEAR-C3G and VALIANT. Overlap was limited to small subpopulations, with imbalances in baseline characteristics, differences in end point reporting, and noncomparable placebo responses. These issues indicate that anchored ITCs are not feasible using currently available data without extensive adjustments that conflict with NICE and ISPOR guidance. The SLR identified one ITC poster with limited methodology comparing these trials. However, when the results were subsequently published in a manuscript, crucial methodological details including justification of effect modifiers, modeling diagnostics, analytic procedures, were still unavailable. Other concerns, such as using standard matching-adjusted indirect comparison methodology in the presence of substantial cross-trial heterogeneity, and the resulting limited ESS observed frequently in rare diseases, were confirmed, thus undermining credibility of conclusions. <b>Conclusion:</b> ITCs in C3G face significant methodological challenges due to pronounced trial heterogeneity and small sample sizes inherent to this ultra-rare disease. These limitations complicate the conduct and interpretation of arising ITCs, highlighting the need for transparent and methodologically robust approaches. Consequently, payers, decision makers, and HTA bodies should interpret existing C3G ITCs with caution. These findings inform broader application of ITC methods in rare diseases, identifying areas for future evidence generation and analytical innovation.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260054"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148684709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world treatment patterns and clinical outcomes of patients with primary biliary cholangitis in the United States.","authors":"Nisreen Shamseddine, Hongbo Yang, Su Zhang, Dongni Ye, Shravanthi Seshasayee, Jingyi Chen, Sonal Kumar, Kris V Kowdley","doi":"10.57264/cer-2025-0172","DOIUrl":"10.57264/cer-2025-0172","url":null,"abstract":"<p><p><b>Background & aim:</b> Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease that can lead to increased morbidity and mortality. This study described real-world treatment patterns and clinical outcomes by line of treatment among patients with PBC in the US. <b>Materials & methods:</b> Adults (≥18 years) diagnosed with PBC on or after 1 January 17 were identified in the IQVIA PharMetrics^® Plus database and grouped into newly diagnosed, first-line (1L) and second-line or more (2L+) cohorts. Index date was initial PBC diagnosis or initiation of 1L or 2L therapy; follow-up continued until the earliest of end of continuous enrollment, death or data end. Time to treatment initiation, treatment discontinuation and negative clinical outcomes were assessed with Kaplan-Meier analysis. <b>Results:</b> The newly diagnosed, 1L and 2L+ cohorts included 1748, 1659 and 181 patients, respectively (average age at index: 52.7-54.5 years; female: 84.2-89.0%). Of the newly diagnosed cohort, 34.8% did not initiate PBC treatment within 1.5 years post-diagnosis. In the 1L cohort, median time from diagnosis to 1L initiation was 1.2 months; median time from 1L initiation to 1L discontinuation/2L initiation was nearly 5 years. In the 2L+ cohort, median time from 2L initiation to 2L discontinuation was approximately 4 years. In the untreated, 1L, and 2L+ cohorts, 18.9%, 14.4% and 19.3% of patients developed ≥1 negative clinical outcome post-index (usually cirrhosis). <b>Conclusion:</b> Results of this US population-based study demonstrate a potential unmet need for early intervention and effective treatment options for patients with PBC, as one in three patients with PBC remain untreated years after diagnosis.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250172"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148712641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Burden of fatigue or pruritus in patients with primary biliary cholangitis: a United States matched case-control study.","authors":"Sonal Kumar, Nisreen Shamseddine, Hongbo Yang, Su Zhang, Jingyi Chen, Kris V Kowdley","doi":"10.57264/cer-2025-0179","DOIUrl":"10.57264/cer-2025-0179","url":null,"abstract":"<p><p><b>Aim:</b> Primary biliary cholangitis (PBC) is a rare liver disease associated with high morbidity. This study assessed the burden of fatigue and/or pruritus among patients with PBC in the US. <b>Materials & methods:</b> This retrospective study used IQVIA PharMetrics^® Plus data (2016-2022). Patients with PBC and fatigue and/or pruritus were selected as cases. Controls were patients with PBC (no fatigue nor pruritus), matched 1:1 to cases by key characteristics. The index date for cases was a random symptom diagnosis date post-initial PBC diagnosis and for controls, a random medical visit date matching the time distribution from initial PBC diagnosis to index. Cumulative incidence of PBC comorbidities was described using Kaplan-Meier analysis and compared via Cox Proportional hazard models. Generalized estimating equations compared healthcare resource use (HRU) and costs per-patient-per-year. <b>Results:</b> A total of 1839 fatigue cases/controls (mean age [years]: 56.5; 88.7% female) and 760 pruritus cases/controls were included (mean age [years]: 55.8; 90.8% female). Comorbidities at 1, 3 and 5-years post-index were higher for cases than controls (fatigue: 1.7 vs 0.7, 2.2 vs 0.9 and 2.5 vs 1.0; pruritus: 1.9 vs 0.8, 2.3 vs 1.0 and 2.7 vs 1.0; all p < 0.001). Common comorbidities were anxiety, urinary tract infection, depression and sleep disorders (hazard ratios in cases vs controls: fatigue, 1.3-4.0; pruritus, 1.5-2.8; all p < 0.01). One-year post-index, cases had higher rates of healthcare visits (incidence rate ratios: fatigue, 1.8-5.8; pruritus 1.6-6.1) and total healthcare costs (mean cost difference: fatigue, $42,515; pruritus $40,536). <b>Conclusion:</b> Patients with PBC who experience fatigue and/or pruritus faced a greater clinical and economic burden compared with those without these symptoms, highlighting the need for effective treatments to alleviate PBC symptoms.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250179"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148712654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health resource utilization and cost analysis in Medicare beneficiaries with chronic wounds: outcomes with porcine placental extracellular matrix versus standard of care and other advanced treatments.","authors":"Jenny Levinson, Janet Mackenzie, Rebecca Decker, Serena Nally, Irene Varghese, Caitlin Sheetz, Peter Kardel, Cristin Taylor","doi":"10.57264/cer-2026-0063","DOIUrl":"10.57264/cer-2026-0063","url":null,"abstract":"<p><p><b>Aim:</b> To compare the healthcare resource utilization, spending and clinical outcomes associated with porcine placental extracellular matrix (PPECM [InnovaMatrix^® AC, Convatec Triad Life Sciences, LLC, TN, USA]) versus standard of care (SOC) and other advanced treatments (AT) among Medicare Fee-For-Service beneficiaries with diabetic foot ulcers (DFU) or venous leg ulcers (VLU). <b>Materials & methods:</b> A retrospective cohort study was conducted using 100% Medicare Parts A and B administrative claims from October 2021 through December 2024. Treatment episodes for DFU and VLU were identified and categorized as PPECM plus SOC, SOC alone or AT plus SOC. Patients were followed for 6 months after the end of each treatment episode. Outcomes included post-episode healthcare utilization by site of care, per-patient-per-month spending, wound-related complications and amputations. <b>Results:</b> The final study sample included 109,786 eligible DFU patients (117,633 episodes of care; PPECM 0.2%, SOC 95.0%, AT 4.8%) and 53,624 eligible VLU patients (56,498 episodes of care; PPECM 0.1%, SOC 95.5%, AT 4.4%). In DFU, PPECM was associated with significantly lower post-episode utilization in most sites of care compared with SOC, and fewer wound complications including amputations compared with AT. Although total post-episode costs were higher for PPECM than SOC and AT in DFU, PPECM had lower overall cost at specific types of care sites. In VLU, PPECM was associated with significantly fewer visits across most sites of care compared with AT and SOC. PPECM-treated VLU episodes had significantly lower total costs than both SOC and AT. Rates of wound complications and amputations were similar across treatment groups in VLU. <b>Conclusion:</b> Treatment with PPECM demonstrated lower overall post-episode costs compared with SOC and other AT while maintaining safety outcomes, particularly in VLU, suggesting potential value in chronic wound management.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260063"},"PeriodicalIF":2.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148794016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}