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Journal of Comparative Effectiveness Research

Steven D Pearson, William B Dreitlein, Adrian Towse, Grace Hampson, Chris Henshall
AIM: To provide a framework for optimizing the development and use of real-world evidence (RWE) in drug coverage decisions. Materials & methods: The Institute for Clinical and Economic Review convened a Policy Summit with representatives from 23 payer and life science companies that compose the Institute for Clinical and Economic Review membership. RESULTS: Summit participants helped refine a new conceptual framework that emphasizes the central role of contextual considerations and the evidentiary argument that the RWE is intended to support in designing the process for the development and interpretation of RWE...
November 14, 2018: Journal of Comparative Effectiveness Research
Consuelo H Wilkins, Victoria Villalta-Gil, Mckenzie M Houston, Yvonne Joosten, Alan Richmond, Yolanda C Vaughn, Sarah C Stallings, Kenneth A Wallston
AIM: Person-centeredness shifts the focus of healthcare and research to the needs and priorities of patients and communities, and may improve health outcomes. There are no instruments available, however, with which we can assess the degree to which research is indeed person-centered. Our aim was to develop and validate a quantitative instrument to rate person-centeredness of research. MATERIALS & METHODS: Scale development and validation entailed a multistep approach that led to the seven-item Person Centeredness of Research Scale (PCoR Scale) that uses a 5-point Likert rating scale...
November 9, 2018: Journal of Comparative Effectiveness Research
Grace Hampson, Adrian Towse, William B Dreitlein, Chris Henshall, Steven D Pearson
AIM: To explore current uses of real-world evidence (RWE) in the US healthcare system, summarize key concerns and highlight various opportunities that could be realized through best use of RWE. Materials & methods: Information was gathered via a literature review and interviews to generate a background paper for the 2017 Institute for Clinical and Economic Review Policy Summit meeting. RESULTS: RWE is currently being utilized in drug development decisions, regulatory approval decisions, post-approval monitoring, payer coverage decisions (initial decisions and reassessments) and for outcomes-based contracting...
November 9, 2018: Journal of Comparative Effectiveness Research
Steven R Feldman, Corey L Pelletier, Kathleen L Wilson, Rina K Mehta, Matthew A Brouillette, David Smith, Machaon M Bonafede
AIM: Biologics and apremilast have advanced psoriasis management by adding treatment options. This study evaluated persistence, adherence and healthcare costs among biologic-naive patients receiving apremilast or biologics. METHODS: Administrative claims data for adults starting apremilast or biologics from 1 January 2013 to 30 June 2016 were matched based on demographics. RESULTS: Apremilast (n = 703) and biologics (n = 1378) had similar baseline characteristics...
November 2, 2018: Journal of Comparative Effectiveness Research
Tiffany P Quock, Eunice Chang, Jennifer S Munday, Sohum Gokhale, Tingjian Yan
AIMS: Examine mortality and healthcare costs in Medicare beneficiaries with newly diagnosed immunoglobulin light chain (AL) amyloidosis. PATIENTS & METHODS: Cases were identified in 2012-2015 Medicare 5% data with ≥1 inpatient/≥2 outpatient claims consistent with AL amyloidosis and ≥1 AL-specific treatment. Cases were matched 3:1 with disease-free controls. Descriptive statistics were reported. RESULTS:  A total of 249 (33.3%) cases were matched to 747 (66...
October 25, 2018: Journal of Comparative Effectiveness Research
Tiffany M Yu, Pravin U Dugel, Julia A Haller, Peter K Kaiser, Renée Jg Arnold
BACKGROUND: Vitreomacular traction (VMT) treatment options include watchful waiting, vitrectomy and intravitreal ocriplasmin injection (Jetrea® ). This analysis used results from the recently completed OASIS randomized clinical trial to evaluate the 2-year budget impact of ocriplasmin injection availability for treatment of stage I or II VMT without epiretinal membrane formation in a modeled US health plan. MATERIALS & METHODS:  VMT prevalence, treatment patterns and disease resolution rates were from literature, a US retinal-specialist survey and the OASIS trial...
October 23, 2018: Journal of Comparative Effectiveness Research
Lee S Schwartzberg, Trent McLaughlin, Robert B Geller, Nashat Y Gabrail, Stanley M Marks
AIM: Real-world palonosetron effectiveness was evaluated in an antiemetic regimen with highly emetogenic chemotherapy (HEC). PATIENTS & METHODS: In this Phase IV, prospective, multicenter observational study, HEC-treated cancer patients received palonosetron, a neurokinin 1 receptor antagonist, and dexamethasone. Primary objective was to assess complete response (CR) for acute (≤24 h), delayed and overall (≤120 h) chemotherapy-induced nausea and vomiting...
October 11, 2018: Journal of Comparative Effectiveness Research
Deepak B Khatry
Pivotal clinical trials of persistent disorders such as chronic obstructive pulmonary disease and severe asthma often utilize recurrent event (e.g., exacerbations) as primary study end point. Such infrequent and correlated end points usually have skewed distributions, which can result in clinical efficacy criterion being met even while clinical effectiveness may be poor. Patients, prescribers and, increasingly, payers want evidence of both a medicine's clinical efficacy and its effectiveness. This duality in evidentiary requirements is causing a shift from the traditional one-size-fits-all blockbuster drug development paradigm to newer patient-centric models...
October 3, 2018: Journal of Comparative Effectiveness Research
Chris Cameron, Brian Hutton, Cheryl Druchok, Sean McElligott, Sandhya Nair, Agata Schubert, Aaron Situ, Abhishek Varu, Reggie Villacorta
AIM: The importance of adjusting for cross-study heterogeneity when conducting network meta-analyses (NMAs) was demonstrated using a case study of biologic therapies for moderate-to-severe plaque psoriasis. METHODS: Bayesian NMAs were conducted for Psoriasis Area and Severity Index 90 response. Several covariates were considered to account for cross-trial differences: baseline risk (i.e., placebo response), prior biologic use, body weight, psoriasis duration, age, race and baseline Psoriasis Area and Severity Index score...
October 2, 2018: Journal of Comparative Effectiveness Research
Dena H Jaffe, Wing Chan, Vladimir Bezlyak, Adrian Skelly
AIM: To determine the economic and humanistic burden of neovascular age-related macular degeneration (nAMD) in a cohort of patients treated with anti-VEGF in Europe and the US. PATIENTS & METHODS:  Seventy-nine respondents from the EU and 63 from the US with a self-reported diagnosis of nAMD and in current receipt of treatment, as reported in an international, general population survey, were compared with non-nAMD controls. RESULTS: Anti-VEGF-treated nAMD patients in the EU had a greater utilization of healthcare resources, poorer quality of life and greater overall activity impairment versus non-nAMD controls...
September 21, 2018: Journal of Comparative Effectiveness Research
Iain B McInnes, Peter Nash, Christopher Ritchlin, Ernest H Choy, Steve Kanters, Howard Thom, Kunal Gandhi, Luminita Pricop, Steffen M Jugl
AIM: A network meta-analysis using randomized controlled trial data compared psoriatic arthritis (PsA) outcomes (American College of Rheumatology [ACR], Psoriasis Area Severity Index [PASI] and Psoriatic Arthritis Response Criteria [PsARC] response rates) at 12-16 weeks for secukinumab, adalimumab, apremilast, certolizumab, etanercept, golimumab, infliximab and ustekinumab. PATIENTS & METHODS: Trials were identified by systematic review. Separate networks were developed for the full-study populations, biologic-naive patients and biologic-experienced patients...
September 19, 2018: Journal of Comparative Effectiveness Research
K Jack Ishak, Michael Rael, Meagen Hicks, Sangeeta Mittal, Martin Eatock, Juan W Valle
AIM: A matching-adjusted indirect comparison (MAIC) of sunitinib and everolimus has been previously reported based on the RADIANT-3 everolimus trial. We performed an analysis using updated overall survival (OS) data based on sunitinib's trial (A6181111). METHODS: The MAIC matched on all baseline characteristics available from both studies. An anchored MAIC was performed for progression-free survival (PFS); an unanchored analysis was deemed more appropriate for OS due to crossover in both trials...
August 31, 2018: Journal of Comparative Effectiveness Research
Joshua J Gagne, Theodore Tsacogianis, Sara Bruce Wirta, James R Rogers, Frederico Calado, Chun-Lan Chang, Stuart J Turner, Raymond G Schlienger, Bogdan Balas, Abdurrahman Abdurrob, Mehdi Najafzadeh, Shirley V Wang
AIM: We examined characteristics of early sacubitril/valsartan users in a large US electronic health records database. PATIENTS & METHODS: We identified three cohorts of patients with heart failure (HF): sacubitril/valsartan patients with a prior HF diagnosis; patients with HF with reduced ejection fraction; and patients with HF treated with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a β-blocker. RESULTS: Sacubitril/valsartan patients were younger than patients in the other cohorts; the mean age of sacubitril/valsartan patients increased by 2 years in the first 15 months of marketing...
August 29, 2018: Journal of Comparative Effectiveness Research
Welton O'Neal, Elizabeth E Hur, Tesfaye Liranso, Barry Patel
AIM: Examine clinical profile of extended-release topiramate (Trokendi XR® ) and compare treatment-emergent adverse events (TEAEs) associated with Trokendi XR versus previous immediate-release topiramate (TPM-IR) treatment. PATIENTS & METHODS: Pilot retrospective study analyzing data extracted from medical charts of patients ≥6 years of age prescribed Trokendi XR. RESULTS: Trokendi XR was the most commonly used to prevent migraine...
August 23, 2018: Journal of Comparative Effectiveness Research
Michael Ruberson Ribeiro da Silva, Jéssica Barreto Ribeiro Dos Santos, Alessandra Maciel Almeida, Adriana Maria Kakehasi, Haliton Alves de Oliveira Junior, Juliana Álvares-Teodoro, Francisco de Assis Acurcio
AIM: Psoriatic arthritis is a chronic disease that can result in disability and decreased quality of life. MATERIALS & METHODS: A prospective cohort was conducted in Brazil. Disease activity was measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI), functionality by the Health Assessment Questionnaire Disability Index (HAQ-DI) and the quality of life by the EuroQol 5D (EQ-5D). RESULTS: In total, 122 patients were included...
October 2018: Journal of Comparative Effectiveness Research
Jia-Cheng Zang, Jing-Jing Du, Chen Li, Jing-Bo Wang, Xin-Long Ma
AIM: We conducted this meta-analysis for comparing the efficacy and safety in proximal humeral fractures by treatment minimally invasive plate osteosynthesis and open plating. METHODS: The potential academic literature were identified from the Cochrane Library, Springer, PubMed, Embase and ScienceDirect. Pooled data were analyzed by RevMan 5.1. RESULTS: Seven studies marched with the inclusion criteria. Meta-analysis showed the significant differences in terms of blood loss, operative time, length of hospital stays and constant score between two groups...
October 2018: Journal of Comparative Effectiveness Research
Mark V Pauly, Karen B Hirschman, Alexandra L Hanlon, Liming Huang, Kathryn H Bowles, Christine Bradway, Kathleen McCauley, Mary D Naylor
AIM: The goal of this study was to compare postacute care costs of three care management interventions. MATERIALS & METHODS: A total of 202 hospitalized older adults with cognitive impairment received either Augmented Standard Care, Resource Nurse Care or the Transitional Care Model. The Lin method was used to estimate costs at 30 and 180 days postindex hospital discharge. RESULTS: The Transitional Care Model had significantly lower costs than the Augmented Standard Care group at both 30 (p < 0...
September 2018: Journal of Comparative Effectiveness Research
Hossein Khalili, Lida Shojaei, Mostafa Mohammadi, Mohammad-Taghi Beigmohammadi, Alireza Abdollahi, Mahsa Doomanlou
AIM: Efficacy of colistin and ampicillin-sulbactam have not been compared in treatment of ventilator-associated pneumonia due to A. baumannii. Efficacy of colistin and ampicillin-sulbactam in combination with meropenem were compared in treatment of ventilator-associated pneumonia due to carbapenem-resistant A. baumannii. METHOD: 47 patients with ventilator-associated pneumonia due to carbapenem-resistant A. baumannii were randomized to receive meropenem/colistin or meropenem/ampicillin-sulbactam for 14 days...
September 2018: Journal of Comparative Effectiveness Research
Xuanqian Xie, Myra Wang, Vivian Ng, Nancy Sikich
Although published noninferiority trials (NITs) generally conclude that the experimental intervention being studied is noninferior compared with standard therapy or active control, NIT quality is often not satisfactory. We have proposed 14 questions to assist in evaluating the clinical evidence of the experimental versus standard therapy. The aim of these questions is to critically appraise NITs and support proper interpretation of study results. Readers should not only consider whether the confidence interval of the primary effect measure falls within the prespecified noninferiority margin (thus concluding noninferiority), but also assess the similarities between primary and secondary outcomes for the experimental and standard therapy...
September 2018: Journal of Comparative Effectiveness Research
Omar Abdel-Rahman
AIM: The current study aims to propose and internally validate 'M-bioscore', which is a model to help predict the outcomes of untreated metastatic breast cancer patients. METHODOLOGY: Surveillance, epidemiology and end results (SEER) database (2010-2013) was accessed. Patients were divided into two groups: a training set and a validation set. Through a Cox proportional model, multivariate analysis for potential prognostic factors was performed. M-bioscore was calculated for all patients...
September 2018: Journal of Comparative Effectiveness Research
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