Journal of comparative effectiveness research最新文献

{"title":"Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers.","authors":"Kristian Thorlund, Stephen Duffield, Sanjay Popat, Sreeram Ramagopalan, Alind Gupta, Grace Hsu, Paul Arora, Vivek Subbiah","doi":"10.57264/cer-2023-0147","DOIUrl":"10.57264/cer-2023-0147","url":null,"abstract":"<p><p>Development of medicines in rare oncologic patient populations are growing, but well-powered randomized controlled trials are typically extremely challenging or unethical to conduct in such settings. External control arms using real-world data are increasingly used to supplement clinical trial evidence where no or little control arm data exists. The construction of an external control arm should always aim to match the population, treatment settings and outcome measurements of the corresponding treatment arm. Yet, external real-world data is typically fraught with limitations including missing data, measurement error and the potential for unmeasured confounding given a nonrandomized comparison. Quantitative bias analysis (QBA) comprises a collection of approaches for modelling the magnitude of systematic errors in data which cannot be addressed with conventional statistical adjustment. Their applications can range from simple deterministic equations to complex hierarchical models. QBA applied to external control arm represent an opportunity for evaluating the validity of the corresponding comparative efficacy estimates. We provide a brief overview of available QBA approaches and explore their application in practice. Using a motivating example of a comparison between pralsetinib single-arm trial data versus pembrolizumab alone or combined with chemotherapy real-world data for RET fusion-positive advanced non-small cell lung cancer (aNSCLC) patients (1-2% among all NSCLC), we illustrate how QBA can be applied to external control arms. We illustrate how QBA is used to ascertain robustness of results despite a large proportion of missing data on baseline ECOG performance status and suspicion of unknown confounding. The robustness of findings is illustrated by showing that no meaningful change to the comparative effect was observed across several 'tipping-point' scenario analyses, and by showing that suspicion of unknown confounding was ruled out by use of E-values. Full R code is also provided.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230147"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139417260","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}

{"title":"Comparative effectiveness of erenumab versus rimegepant for migraine prevention using matching-adjusted indirect comparison.","authors":"Ronan Mahon, Santosh Tiwari, Mirja Koch, Matias Ferraris, Keith A Betts, Yan Wang, Sophie Gao, Pascal Proot","doi":"10.57264/cer-2023-0122","DOIUrl":"10.57264/cer-2023-0122","url":null,"abstract":"<p><p><b>Aim:</b> To compare the efficacy of erenumab versus rimegepant as preventive treatment for patients with episodic and chronic migraine using an anchor-based matching-adjusted indirect comparison. <b>Methods:</b> Patients from two phase II/III trials for erenumab (NCT02066415 and NCT02456740) were pooled and weighted to match on the baseline effect modifiers (age, sex, race, baseline monthly migraine days [MMDs], and history of chronic migraine [CM]) reported in the phase II/III trial for rimegepant (NCT03732638). Four efficacy outcomes were compared between the two erenumab regimens (70 mg and 140 mg) and rimegepant, including changes in MMDs from baseline to month 1 and month 3, changes in Migraine-Specific Quality of Life Questionnaire role function - restrictive domain score from baseline to month 3, and change in disability from baseline to Month 3. <b>Results:</b> Compared with rimegepant, erenumab 70 mg was associated with a statistically significant reduction in MMDs at month 3 (-0.90 [-1.76, -0.03]; p = 0.042) and erenumab 140 mg was associated with statistically significant reductions in MMDs at month 1 (-0.94 [-1.70, -0.19]; p = 0.014) and month 3 (-1.28 [-2.17, -0.40]; p = 0.005). The erenumab regimens also had numerical advantages over rimegepant for other efficacy outcomes. <b>Conclusion:</b> In the present study, we found that erenumab had a more favorable efficacy profile than rimegepant in reducing MMDs at month 1 and month 3 for migraine prevention. These results may help with decision-making in clinical practice and can be further validated in future clinical trials or real-world studies.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230122"},"PeriodicalIF":2.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139087093","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}

{"title":"Access in all areas? A round up of developments in market access and health technology assessment: part 3.","authors":"Alice Beattie, Catrin Treharne, Sreeram V Ramagopalan","doi":"10.57264/cer-2024-0009","DOIUrl":"10.57264/cer-2024-0009","url":null,"abstract":"<p><p>In this latest update, we explore some of the key updates in market access over recent months including the UK's voluntary scheme for branded medicines pricing, access and growth (VPAG), the first drugs funded by the Innovative Medicines Fund in the UK and the Direct Access Scheme in France, and, finally, the new Institute for Clinical and Economic Review (ICER) value assessment framework in the USA.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240009"},"PeriodicalIF":2.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139702617","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}

{"title":"Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type II diabetes in France.","authors":"Hamza Alshannaq, Richard F Pollock, Michael Joubert, Waqas Ahmed, Gregory J Norman, Peter M Lynch, Stéphane Roze","doi":"10.57264/cer-2023-0174","DOIUrl":"10.57264/cer-2023-0174","url":null,"abstract":"<p><p><b>Aim:</b> Clinical trials and real-world data for Type II diabetes both show that glycated hemoglobin (HbA1c) levels and hypoglycemia occurrence can be reduced by real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG). The present cost-utility study investigated the long-term health economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type II diabetes in France. <b>Materials & methods:</b> Effectiveness data were obtained from a real-world study, which showed rt-CGM reduced HbA1c by 0.56% (6.1 mmol/mol) versus sustained SMBG. Analyses were conducted using the IQVIA Core Diabetes Model. A French payer perspective was adopted over a lifetime horizon for a cohort aged 64.5 years with baseline HbA1c of 8.3% (67 mmol/mol). A willingness-to-pay threshold of €147,093 was used, and future costs and outcomes were discounted at 4% annually. <b>Results:</b> The analysis projected quality-adjusted life expectancy was 8.50 quality-adjusted life years (QALYs) for rt-CGM versus 8.03 QALYs for SMBG (difference: 0.47 QALYs), while total mean lifetime costs were €93,978 for rt-CGM versus €82,834 for SMBG (difference: €11,144). This yielded an incremental cost-utility ratio (ICUR) of €23,772 per QALY gained for rt-CGM versus SMBG. Results were particularly sensitive to changes in the treatment effect (i.e., change in HbA1c), annual price and quality of life benefit associated with rt-CGM, SMBG frequency, baseline patient age and complication costs. <b>Conclusion:</b> The use of rt-CGM is likely to be cost-effective versus SMBG for people with insulin-treated Type II diabetes in France.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230174"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945438/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139642262","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}

{"title":"A US national update of health condition prevalence among privately-insured autistic adults.","authors":"Anne Longo, Deondray Radford, Brittany N Hand","doi":"10.57264/cer-2023-0051","DOIUrl":"10.57264/cer-2023-0051","url":null,"abstract":"<p><p><b>Aim:</b> Previous research using state or regional samples has shown that autistic adults have a higher prevalence of health conditions in comparison to the general population. <b>Methods:</b> To build upon this important previous research, we conducted a cross-sectional retrospective study of 2019-2020 healthcare claims to determine the prevalence of conditions in a US national sample of privately insured autistic adults (n = 30,258) and an age- and sex-matched population comparison (n = 60,516) group of adults without autism diagnoses. <b>Results:</b> Like previous studies, we found that autistic adults had significantly greater odds of most mental and physical health conditions. However, our prevalence estimates differed from previous studies for several mental and physical health conditions. For example, our sample of autistic adults had higher prevalence of anxiety disorders (55%) and attention deficit hyperactivity disorders (34%), but lower prevalence of asthma (9%) and sleep disorders (3%) than previous studies. <b>Discussion & conclusion:</b> Our use of a large US national sample, more recent healthcare claims data, and different methods for identifying health conditions may have contributed to these differences. Our findings alert healthcare providers and policymakers to the health conditions most common among the growing population of autistic adults. We hope these findings lead to improved screening and management of these conditions, inform initiatives to improve access to healthcare, and guide future funding.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230051"},"PeriodicalIF":2.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139642260","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}

{"title":"Smart connected insulin dose monitoring technologies versus standard of care: a Canadian cost-effectiveness analysis.","authors":"Katalina Chan, Kåre Hansen, Sergey Muratov, Shoghag Khoudigian, Mark Lamotte","doi":"10.57264/cer-2023-0124","DOIUrl":"10.57264/cer-2023-0124","url":null,"abstract":"<p><p><b>Aim:</b> There is growing interest in novel insulin management systems that improve glycemic control. This study aimed to evaluate the cost-effectiveness of smart connected insulin re-usable pens or caps for disposable insulin pens versus pens without connected capabilities in the management of adult patients with Type 1 diabetes (T1DM) from a Canadian societal perspective. <b>Materials & methods:</b> The IQVIA Core Diabetes Model was utilized to conduct the analyses. Applying data from a non-interventional study, the connected insulin device arm was assumed to result in greater reductions (-0.67%) in glycated hemoglobin from baseline and fewer non-severe hypoglycemic events (-32.87 events/patient annually). Macro- and micro-vascular risks were predicted using the Epidemiology of Diabetes Interventions and Complications study data. Direct and indirect costs and utilities were sourced from literature. Key model outcomes included life years and quality-adjusted life-years (QALYs). Both costs and effects were annually discounted at 1.5% over a 60-year time horizon. Uncertainty was explored in scenario and probabilistic sensitivity analyses (PSA). <b>Results:</b> The connected insulin pen device was associated with lower mean discounted total costs (CAD221,943 vs 266,199; -CAD44,256), improvement in mean life expectancy (25.78 vs 24.29; +1.49 years) and gains in QALYs (18.48 vs 16.74; +1.75 QALYs) over the patient's lifetime. Most scenario analyses confirmed the base case results. The PSA showed dominance in 99.5% of cases. <b>Conclusion:</b> For adults with T1DM in Canada, a connected insulin pen device is likely to be a cost-effective treatment option associated with greater clinical benefits and lower costs relative to a standard re-usable or disposable pen.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230124"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139417262","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}

{"title":"Distinguishing cardiac catheter ablation energy modalities by applying natural language processing to electronic health records.","authors":"Jamie Margetta, Alicia Sale","doi":"10.57264/cer-2023-0053","DOIUrl":"10.57264/cer-2023-0053","url":null,"abstract":"<p><p><b>Aim:</b> Catheter ablation is used to treat symptomatic atrial fibrillation (AF) and is performed using either cryoballoon (CB) or radiofrequency (RF) ablation. There is limited real world data of CB and RF in the US as healthcare codes are agnostic of energy modality. An alternative method is to analyze patients' electronic health records (EHRs) using Optum's EHR database. <b>Objective:</b> To determine the feasibility of using patients' EHRs with natural language processing (NLP) to distinguish CB versus RF ablation procedures. <b>Data Source:</b> Optum^® de-identified EHR dataset, Optum^® Cardiac Ablation NLP Table. <b>Methods:</b> This was a retrospective analysis of existing de-identified EHR data. Medical codes were used to create an ablation validation table. Frequency analysis was used to assess ablation procedures and their associated note terms. Two cohorts were created (1) index procedures, (2) multiple procedures. Possible note term combinations included (1) cryoablation (2) radiofrequency (3) ablation, or (4) both. <b>Results:</b> Of the 40,810 validated cardiac ablations, 3777 (9%) index ablation procedures had available and matching NLP note terms. Of these, 22% (n = 844) were classified as ablation, 27% (n = 1016) as cryoablation, 49% (n = 1855) as radiofrequency ablation, and 1.6% (n = 62) as both. In the multiple procedures analysis, 5691 (14%) procedures had matching note terms. 24% (n = 1362) were classified as ablation, 27% as cryoablation, 47% as radiofrequency ablation, and 2% as both. <b>Conclusion:</b> NLP has potential to evaluate the frequency of cardiac ablation by type, however, for this to be a reliable real-world data source, mandatory data entry by providers and standardized electronic health reporting must occur.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230053"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139521015","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}

{"title":"Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial.","authors":"Ann Oluloro, Bryan Comstock, Sarah E Monsell, Maya Gross, Erika M Wolff, Liz Sage, Julianna Alson, Danielle C Lavallee, Bridgette Hempstead, Adrienne Moore, Ronit Katz, Kemi M Doll","doi":"10.57264/cer-2023-0159","DOIUrl":"10.57264/cer-2023-0159","url":null,"abstract":"<p><p><b>Aim:</b> Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion. Black women with endometrial cancer (EC) are at increased risk for social isolation when compared with White patients. We developed the Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER) study to compare and evaluate interventions to address social isolation among Black women with high-risk EC in USA. The primary objective of the SISTER study is to determine whether virtual support interventions improve treatment completion compared with Enhanced Usual Care. Secondary objectives include comparing effectiveness virtual evidence-based interventions and evaluating barriers and facilitators to social support delivery. <b>Patients & methods:</b> This is a multi-site prospective, open-label, community-engaged randomized controlled trial, consisting of three intervention arms: enhanced usual care, facilitated support group and one-to-one peer support. Primary outcome will be measured using relative dose. Qualitative semi-structured interviews will be conducted with a subset of participants to contextualize the relative degree or lack thereof of social isolation, over time. <b>Data analysis:</b> Primary analysis will be based on an intent-to-treat analysis. Multivariable analysis will be performed to determine the effect of the intervention on the primary and secondary outcomes of interest, relative dose and social isolation score. Semi-structured interviews will be qualitatively analyzed using inductive and deductive approaches of content analysis. <b>Discussion/conclusion:</b> Endometrial cancer mortality disproportionately affects Black women, and social isolation contributes to this disparity. The SISTER study aims to identify whether and to what extent differing social support vehicles improve key outcomes for Black women in the United States with high-risk EC. <b>Clinical Trial Registration:</b> NCT04930159 (ClinicalTrials.gov).</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230159"},"PeriodicalIF":2.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10945416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722841","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}

{"title":"Real-world use of inotuzumab ozogamicin is associated with lower health care costs than blinatumomab in patients with acute lymphoblastic leukemia in the first relapsed/refractory setting.","authors":"Alexander Russell-Smith, Louise Murphy, Amy Nguyen, Cori Blauer-Peterson, Marilou Terpenning, Feng Cao, Shiqiang Li, Tim Bancroft, Noah Webb, Stephanie Dorman, Richa Shah","doi":"10.57264/cer-2023-0142","DOIUrl":"10.57264/cer-2023-0142","url":null,"abstract":"<p><p><b>Aim:</b> To compare all-cause and acute lymphoblastic leukemia (ALL)-related healthcare resource utilization (HCRU) and costs among patients receiving inotuzumab ozogamicin (InO) and blinatumomab (Blina) for ALL in the first relapsed/refractory (R/R) setting. <b>Patients & methods:</b> We studied retrospective claims for adult commercial and Medicare Advantage enrollees with ALL receiving InO (n = 29) or Blina (n = 23) from 1 January 2015 to 16 February 2021. Mean per-patient-per-month (PPPM) HCRU and total costs were described and multivariable-adjusted PPPM total all-cause and ALL-related predicted costs were calculated. <b>Results:</b> Mean monthly ALL-related hospitalizations were the same for patients receiving InO and Blina (PPPM = 0.8 stays); however, the length of ALL-related hospital stay was almost twice as long among patients receiving Blina versus InO (ALL-related: InO = 7.6 days; Blina = 14.1 days; p = 0.346). In multivariable models, total ALL-related costs were 43% lower for InO compared with Blina (PPPM costs: InO = $93,767; Blina = $163,470; p = 0.021). <b>Conclusion:</b> In the first R/R setting, patients who used InO had significantly lower all-cause and ALL-related costs compared with patients who used Blina, in part driven by hospitalization patterns.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230142"},"PeriodicalIF":2.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10842295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138803841","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}

{"title":"Assessment of second primary malignancies among treated and untreated patients with chronic lymphocytic leukemia using real-world data from the USA.","authors":"Sikander Ailawadhi, Arliene Ravelo, Carmen D Ng, Bonny Shah, Neil Lamarre, Rongrong Wang, Katherine Eakle, Juliana Ml Biondo","doi":"10.57264/cer-2023-0119","DOIUrl":"10.57264/cer-2023-0119","url":null,"abstract":"<p><p><b>Aim:</b> Improved management of chronic lymphocytic leukemia (CLL) has resulted in a growing population of CLL survivors; these patients have a higher risk of developing second primary malignancies (SPMs) versus the general population. This retrospective cohort study aims to assess the timing, frequency, incidence and types of SPMs in treated and untreated patients with CLL in the USA, using the Surveillance, Epidemiology, and End Results (SEER) Medicare database, which links a nationally representative cancer registry with Medicare claims data. <b>Patients & methods:</b> Patients aged ≥66 years with newly diagnosed CLL between 1 January 2010 and 31 December 2016, who were enrolled in Parts A and B of Medicare for ≥12 months pre-diagnosis of CLL were selected from the database. Patients were assessed for ≥36 months until the end of continuous enrollment in Medicare Parts A, B and D, a switch to a health maintenance organization, death, or end of the study period (December 2019). <b>Results:</b> Of 3053 patients included in the analyses, 620 (20.3%) were treated and 2433 (79.7%) were untreated within 36 months of diagnosis. Overall, 638 (20.9%) patients developed a SPM, 26.8% of patients in the treated cohort and 19.4% of patients in the untreated cohort. The most common SPMs for both cohorts were squamous cell carcinoma and acute myeloid leukemia. Among the 166 treated patients who developed a SPM, a greater proportion developed their first SPM after treatment initiation versus those who developed their first SPM prior to treatment initiation (p < 0.001). A significantly lower percentage of patients who received targeted therapy developed a SPM (p < 0.05) versus patients treated with anti-CD20 + chemotherapy. <b>Conclusion:</b> Findings indicate that treatment type and timing can affect SPM development in patients with CLL. Combined with previous findings, this can help inform best practices in monitoring for SPM in patients with CLL.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e230119"},"PeriodicalIF":2.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10842294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139642261","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}