Publications by authors named "Thomas S Marshall"
Background: Chimeric antigen receptor T-cell therapy idecabtagene vicleucel (ide-cel) showed significantly improved progression-free survival compared with standard regimens in adults with relapsed and refractory multiple myeloma who had received two to four previous regimens in the ongoing phase 3 KarMMa-3 trial (NCT03651128). This study analysed patient-reported outcomes (PROs), a KarMMa-3 secondary endpoint.
Methods: In the randomised, open-label, phase 3 KarMMa-3 trial, 386 patients in hospitals (≥18 years of age, with measurable disease and an Eastern Cooperative Oncology Group performance status score of 0 or 1, who had received two to four previous regimens-including an immunomodulatory agent, a proteasome inhibitor, and daratumumab-and had documented disease progression after receiving their last dose of the last therapy) were randomly assigned to ide-cel (n=254) or standard regimens (daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone; n=132).
Objectives: Quantify the value of functional status (FS) improvements consistent in magnitude with improvements due to levodopa-carbidopa intestinal gel (LCIG) treatment, among the advanced Parkinson's disease (APD) population.
Methods: The Health Economic Medical Innovation Simulation (THEMIS), a microsimulation that estimates future health conditions and medical spending, was used to quantify the health and cost burden of disability among the APD population, and the value of quality-adjusted life-years gained from FS improvement due to LCIG treatment compared to standard of care (SoC). A US-representative Parkinson's disease (PD)-comparable cohort was constructed in THEMIS based on observed PD patient characteristics in a nationally representative dataset.
To estimate the relationship between functional status (FS) impairment and nursing home admission (NHA) risk in Parkinson's disease (PD) patients, and quantify the effect of advanced PD (APD) treatment on NHA risk relative to standard of care (SoC). PD patients were identified in the Medicare Current Beneficiary Survey (MCBS) (1992-2010). A working definition based on the literature and clinical expert input determined APD status.
View Article and Find Full Text PDFBackground: Lack of a global consensus on the definition of advanced Parkinson's disease (APD) and considerations for timing of device-aided therapies may result in heterogeneity in care.
Objectives: To reach consensus among movement disorder specialists regarding key patient characteristics indicating transition to APD and guiding appropriate use of device-aided therapies in the management of PD symptoms.
Methods: A Delphi-panel approach was utilized to synthesize opinions of movement disorder specialists and build consensus.
Background: Parkinson's disease (PD) is an incurable, progressive neurological condition, with symptoms impacting movement, walking, and posture that eventually become severely disabling. Advanced PD (aPD) has a significant impact on quality-of-life (QoL) for patients and their caregivers/families. Levodopa/carbidopa intestinal gel (LCIG) is indicated for the treatment of advanced levodopa-responsive PD with severe motor fluctuations and hyper-/dyskinesia when available combinations of therapy have not given satisfactory results.
View Article and Find Full Text PDFPurpose: To evaluate adherence to disease-modifying therapies (DMTs) among patients with multiple sclerosis (MS) initiating oral and injectable DMTs, and to estimate the impact of adherence on relapse, health resource utilization, and medical costs.
Patients And Methods: Commercially insured MS patients (aged 18-65 years, two or more MS diagnoses, one or more DMT claims) with continuous eligibility 12 months before and after the first DMT claim date (index date) and no DMT claim during the pre-index period were identified from a large commerical claims database for the period from January 1, 2008, to September 30, 2015. Adherence to the index DMT was measured by the 12-month post-index proportion of days covered (PDC) and compared between oral and injectable DMT initiators.
Background: Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) can effectively manage motor and non-motor complications in advanced Parkinson's disease (PD). Healthcare costs, quality of life (QoL), effectiveness, and tolerability were assessed in routine care treatment with LCIG.
Methods: The seventy-seven patients enrolled in this prospective, open-label, 3-year study in routine medical care were LCIG-naïve (N = 37), or had previous LCIG treatment for <2 (N = 22), or ≥2 (N = 18) years.
Background And Objective: Chronic kidney disease (CKD) is a highly morbid disorder. The most severe form of CKD is end-stage renal disease (ESRD), in which the patient requires some form of renal replacement therapy to survive. The increasing incidence, prevalence, and costs of ESRD are major national healthcare concerns.
View Article and Find Full Text PDFBackground: The IMPACT SHPT [Improved Management of Intact Parathyroid Hormone (iPTH) with Paricalcitol-Centered Therapy Versus Cinacalcet Therapy with Low-Dose Vitamin D in Hemodialysis Patients with Secondary Hyperparathyroidism] study compared the effectiveness of paricalcitol and cinacalcet in the management of secondary hyperparathyroidism in haemodialysis patients but did not report the costs or cost effectiveness of these treatments.
Aim: The aim of this study was to compare the cost effectiveness of a paricalcitol-based regimen versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients from a US payer perspective, using a 1-year time horizon.
Methods: This was a post hoc cost-effectiveness analysis of data collected for US patients enrolled in the IMPACT SHPT study-a 28-week, randomized, open-label, phase 4, multinational study (ClinicalTrials.
Article Synopsis
- The study evaluated the use of antimuscarinic medications for urinary incontinence (UI) among residents in long-term care facilities from 2007 to 2009, focusing on their appropriateness based on cognitive and mobility assessments.
- Approximately 5,327 residents were included, with findings indicating that a majority of both treated and untreated individuals had sufficient cognitive function and mobility for appropriate antimuscarinic therapy.
- The results suggest many residents with UI could potentially benefit from antimuscarinics, but limitations in data prevented identifying which untreated residents might actually need this treatment, highlighting the importance of individualized care.
Objective: The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D, and of phosphate binders, in patients in the IMPACT SHPT study; and to extrapolate those to estimate expected annual maintenance costs.
Methods: IMPACT SHPT was a 28-week, randomized, open-label trial. Subjects from 12 countries received intravenous (IV) or oral paricalcitol, or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol.
Background: The Patient Perception of Intensity of Urgency Scale (PPIUS) is a patient-reported outcome instrument intended to measure the intensity of urgency associated with each urinary or incontinence episode. The objectives of this study were to assess the content validity, test-retest reliability, and acclimation effect of the PPIUS in overactive bladder (OAB) patients.
Methods: Patients undergoing treatment for OAB were recruited to participate in a non-interventional study by completing a three-day micturition diary including the PPIUS for three consecutive weeks.
Statement Of Problem: The best treatment for a crown that has come loose but has appropriate marginal fit and form is not clear.
Purpose: This study was designed to determine whether the retention of such crowns can be increased without remaking the crown or by extensively modifying the tooth preparation.
Material And Methods: Ninety cast metal complete crowns, divided into 9 groups of 10, were fabricated to be slightly loose in their internal adaptation to metal dies with an optimal tooth preparation.
Background: Tacrolimus 0.1% and pimecrolimus 1.0% are used for short-term and noncontinuous treatment of atopic dermatitis (AD) in patients unresponsive to conventional therapies.
View Article and Find Full Text PDFObjective: The goal of this study is to provide annual estimates for the treated prevalence and expenditures attributable to overactive bladder (OAB) in the elderly prior to Medicare Part D drug coverage.
Research Design And Methods: All Medicare claims were extracted for beneficiaries over 65 with continuous coverage for Medicare Parts A and B during 2003-2004. Two OAB definitions were created: (1) the base case included diagnosis codes that narrowly defined OAB, and (2) the sensitivity variant included additional codes indicative of OAB.
Background: Comparative effectiveness analyses using retrospective databases may be highly sensitive to common design decisions employed by researchers.
Objective: To test the sensitivity of statistical results to common research methods in retrospective database analyses. Comparisons of time to all-cause discontinuation (TTAD) across antipsychotic drug therapies are used to illustrate these effects.