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Journal of Comparative Effectiveness Research

Laura Dormer
Welcome to the seventh volume of the Journal of Comparative Effectiveness Research. It is great to start the year with a look back at some of our successes from 2017, as well as a look forward to the content of this issue and beyond.
January 5, 2018: Journal of Comparative Effectiveness Research
Monika Parisi, Corey Pelletier, Dasha Cherepanov, Michael S Broder
AIM: With the aggregation of real-world data in healthcare, opportunities for outcomes research are growing. In this study, we summarize published literature examining comparative effectiveness research (CER), treatment patterns, quality of life (QoL) and costs in HER2-negative and triple-negative (TN) metastatic breast cancer (mBC). METHODS: PubMed (2010-January 2016) and four conferences (2013-January 2016) were searched using MeSH/keywords, including mBC, QoL, morbidity and therapeutics...
January 5, 2018: Journal of Comparative Effectiveness Research
Sonia Indacochea Caceda, Richard Rubio Ramos, Carlos Martín Saborido
Postpartum hemorrhage is one of the main causes of maternal death. Oxytocin has traditionally been used to prevent postpartum hemorrhage. AIM: To compare oxytocin with carbetocin, a long-acting analog of oxytocin, for prevention of uterine hemorrhage after cesarean delivery. MATERIALS & METHODS: Clinical data were retrieved from the 2012 Cochrane meta-analysis "Carbetocin for preventing postpartum hemorrhage". A decision tree was constructed. The direct costs were those of medications from the Peruvian official price list (DIGEMID)...
December 21, 2017: Journal of Comparative Effectiveness Research
Alexis A Krumme, Ajinkya Pawar, Sebastian Schneeweiss, Robert J Glynn, Niteesh K Choudhry, Martin Kulldorff, Adrian Santiago Ortiz, Jerome Avorn, Joshua J Gagne
Since 2010, four oral anticoagulants have been approved for marketing in addition to warfarin for treatment of thromboembolic disease. Limited head-to-head data exist comparing these treatments, leaving patients and clinicians with little guidance for selecting a strategy that balances recurrence reduction with bleeding risk. In the dabigatran, apixaban, rivaroxban, edoxaban and warfarin comparative effectiveness research study, we compare all five currently available oral anticoagulant agents for the extended treatment of deep venous thrombosis and pulmonary embolism, as well as no extended treatment, and evaluate whether results differ in specific sub-populations...
December 21, 2017: Journal of Comparative Effectiveness Research
Carla Rognoni, Oriana Ciani, Silvia Sommariva, Rosanna Tarricone
AIM: We evaluated two treatment sequences, transarterial radioembolization followed by transarterial chemoembolization and possibly sorafenib (=TTS) versus transarterial radioembolization followed by sorafenib alone (=TS), to identify the most cost-effective pathway to treat intermediate-stage hepatocellular carcinoma from the Italian healthcare system perspective. MATERIALS & METHODS: A Markov model was developed to project costs and health outcomes for TTS and TS over a lifetime horizon...
December 12, 2017: Journal of Comparative Effectiveness Research
Yingxin Xu, Kyle Fahrbach, Emily Dorman, Simona Baculea, Sarah Côté, Suzy van Sanden, Joris Diels
AIM: A systematic literature review and network meta-analysis were conducted to determine the relative efficacy and safety of interventions for treatment-naive chronic lymphocytic leukemia patients, as comparative evidence is scarce. MATERIALS & METHODS: Relative treatment effects of progression-free survival, overall survival and safety outcomes were estimated via network meta-analysis based on data identified via systematic literature review. RESULTS: Ibrutinib was superior in all pairwise comparisons for progression-free survival (probability to be better [P] range: overall population: 69-100%; fludarabine-ineligible population: 69-100%) and overall survival (P range: overall: 89-100%; fludarabine-ineligible: 91-100%) and had the highest probability of being best for all outcomes...
December 6, 2017: Journal of Comparative Effectiveness Research
Jens Olsen, Kenneth Forsstrøm Jensen, Daniel Sloth Olesen, Ann Knoop
AIM: Trastuzumab is available in an intravenous (iv.) and a subcutaneous (sc.) formulation. The objective of this study was to estimate the costs of administration of iv. and sc. trastuzumab treatment. MATERIALS & METHODS: Via interviews, we identified all the activities associated with iv. and sc. administration. The outcome was time estimates. To estimate the administration costs, the time estimates were valued by average gross wages. RESULTS:  The iv...
December 4, 2017: Journal of Comparative Effectiveness Research
Zsófia Meiszterics, Attila Kónyi, Gábor Hild, Zsolt Sárszegi, Balázs Gaszner
Aim & methods: This 6-month prospective, observational, noninterventional, open-label clinical study assessed the effectiveness/safety of trimetazidine in 737 patients with stable angina pectoris and Type 2 diabetes mellitus (OGYI/51534-1/2014). RESULTS: Trimetazidine-based therapy was effective in stable coronary artery disease, with significant improvements from baseline (p < 0.05) in: number of angina attacks/week (2.9 ± 2.4 vs 1.1 ± 1.6), angina severity (Canadian Cardiovascular Society Classification 1...
November 17, 2017: Journal of Comparative Effectiveness Research
Nyna Williams, Chris Fleming, Annie Doubleday
For comparative effectiveness research to be effective, patients and providers must collaborate in shared decision making (SDM) to make evidence-based clinical decisions that align with patient preferences. We conducted a systematic review to examine patient and provider attitudes toward and engagement in SDM in the USA. Searches in PubMed and PsycINFO identified 1585 articles published between July 2006 and December 2016, of which 290 were screened in for coding and analysis. We found that patients and providers have generally positive attitudes toward SDM, but actual engagement in SDM behavior is lagging...
November 17, 2017: Journal of Comparative Effectiveness Research
Jessica A Walsh, Oluwakayode Adejoro, Benjamin Chastek, Yujin Park
AIM: Examine treatment patterns among patients with active ankylosing spondylitis (AS) treated with a TNF inhibitor (TNFi). PATIENTS & METHODS: Patients with AS who initiated a TNFi between 1 January 2013, and 31 January 2015, were identified in the Optum Research Database. Outcomes included adherence, persistence, discontinuation and therapy modifications of the index TNFi during 12-month follow-up. RESULTS: Of the 426 patients included, 40...
November 17, 2017: Journal of Comparative Effectiveness Research
Grace Hampson, Adrian Towse, Steven D Pearson, William B Dreitlein, Chris Henshall
AIMS: To explore the challenges presented by gene therapies, discuss potential solutions, and present policy recommendations. METHODS: A review of the literature and series of expert interviews were conducted and discussed at a Policy Forum convened by The Institute for Clinical and Economic Review (ICER). The Policy Forum was attended by independent experts and senior representatives from 20 payer organizations and life sciences companies. RESULTS: Three categories of challenges are identified: evidence generation, assessing value and affordability...
November 16, 2017: Journal of Comparative Effectiveness Research
Jill Mayhew, Nicola Bonner, Rob Arbuckle, Alice Turnbull, Alexandra Bowden, Alison Skrinar
AIM: GNE myopathy, a rare, severe, progressive myopathy, presents with lower extremity distal muscle weakness. The GNE myopathy functional activity scale (GNEM-FAS) evaluates the impact of GNE myopathy on functioning in adults. This paper presents the psychometric validation of the GNEM-FAS. PATIENTS & METHODS: Validation of the GNEM-FAS was performed using data from a randomized, double-blind, placebo-controlled Phase-II study (n = 46). RESULTS: Domain score distributions were acceptable...
November 15, 2017: Journal of Comparative Effectiveness Research
Saskia Ludwig, Cathrin Theis, Ben Brown, Andreas Witthohn, Wolfram Lux, Andreas Goette
AIM: Estimate incidence and costs of cardiac device infections (CDIs) in Germany. MATERIALS & METHODS: Patients had an implantable cardioverter defibrillator implanted over 2010-2013 and were followed to December 2014 using German health insurance claims data. A case-controlled analysis was performed using propensity score matching methods. RESULTS: Risk of CDI 12 months post-implant was 3.4% overall, either 2.9% for de novo procedures versus 4...
November 14, 2017: Journal of Comparative Effectiveness Research
Heather L Gelhorn, Savita B Anand, Javad Parvizi, Tiffany Morrison, Holly Yu, Robin Pokrzywinski, Gemma Al-Jassar, Antonia F Chen
AIM: To gather qualitative data from patients on the burden, impacts and costs of surgical site infections (SSI) requiring second surgeries. PATIENTS & METHODS: Fifteen adults with SSIs from spinal (n = 4), knee replacement (n = 3) or hip replacement (n = 8) surgery participated in a focus group or individual interview. Patients completed the PROMIS Physical Functioning (PF) Short Form 10A (PROMIS-PF). RESULTS: Patients reported impacts within four primary domains: PF/activity-related; social/emotional; financial/employment; and energy/sleep...
November 9, 2017: Journal of Comparative Effectiveness Research
Peter A McCullough, Guy David, Thomas M Todoran, Emmanouil S Brilakis, Michael P Ryan, Candace Gunnarsson
AIM: To assess the relationship between type of contrast media (CM), iso-osmolar contrast media (IOCM) or low-osmolar contrast media (LOCM), and major adverse renal and cardiovascular events (MARCE). MATERIALS & METHODS: Coronary or peripheral angioplasty visits were stratified into CM cohorts: IOCM or LOCM. Multivariable regression analysis used hospital fixed effects to assess the relationship between MARCE events and type of CM. RESULTS: Among 333,533 visits (357 hospitals), the incidence of MARCE was 7...
November 9, 2017: Journal of Comparative Effectiveness Research
Paweł Kawalec, Paweł Moćko
AIM: An indirect comparison of ustekinumab versus vedolizumab in patients with active moderate-to-severe Crohn's disease who were nonresponsive or intolerant to previous TNF-antagonist therapy. METHODS: A systematic review was performed in Medline via PubMed, Embase, Cochrane Library, until 30 April 2017. Inclusion criteria were: randomized controlled trials, patients treated for Crohn's disease, ustekinumab or vedolizumab therapy. Included trials were critically appraised and afterward indirect comparison by Bucher was conducted; the manuscript was prepared in accordance to the PRISMA requirements...
November 8, 2017: Journal of Comparative Effectiveness Research
Bin Wu, Houwen Lin, Ruoyan Gai Tobe, Le Zhang, Ben He
AIM: To determine whether ticagrelor or clopidogrel provides the best outcomes for East-Asian patients with acute coronary syndrome (ACS). MATERIALS & METHODS: Identification and interrogation of electronic databases through 26 July 2016 revealed fully randomized and controlled trials wherein primary efficacy end points were major adverse cardiovascular events and all-cause death among East-Asian patients with ACS. Major bleeding and noncoronary artery bypass grafts major bleeding were primary safety end points...
November 2, 2017: Journal of Comparative Effectiveness Research
Curtis Waycaster, Marissa J Carter, Adrienne M Gilligan, Elizabeth S Mearns, Caroline E Fife, Catherine T Milne
Chronic dermal ulcers affect approximately 2.4-4.5 million people in the USA and are associated with loss of function, decreased quality of life and significant economic burden. Debridement is a critical component of wound care involving removal of nonviable tissue from chronic wounds to stimulate the granulation and epithelialization process. Clostridial collagenase ointment has been used as a method of wound debridement for more than 50 years and is currently the only enzymatic debriding ointment with US FDA approval...
October 27, 2017: Journal of Comparative Effectiveness Research
Nicolas W Shammas, Christopher W Boyes, Swetha R Palli, John A Rizzo, Brad J Martinsen, Harry Kotlarz, J A Mustapha
AIM: The incremental cost of peripheral orbital atherectomy system (OAS) plus balloon angioplasty (BA) versus BA-only for critical limb ischemia was estimated. MATERIALS & METHODS: A deterministic simulation model used clinical and healthcare utilization data from the CALCIUM 360° trial and current cost data. Incremental cost of OAS + BA versus BA-only included differential utilization during the procedure and adverse-event costs at 3, 6 and 12-months. RESULTS: For every 100 procedures, incremental annual costs to the hospital were USD$350,930 lower with OAS + BA compared with BA-only...
October 26, 2017: Journal of Comparative Effectiveness Research
Dae Hyun Yoo
The first biosimilar infliximab, CT-P13 (infliximab-dyyb) has been used for the treatment of inflammatory diseases for 4 years. CT-P13 has highly similar efficacy and safety profiles with a lower price than the originator infliximab and has been approved in 81 countries. Despite approval for clinical use, some knowledge gaps still limit the widespread and pertinent use of biosimilar CT-P13. One of the most important factors for proper utilization of CT-P13 for the treatment of immune-mediated inflammatory diseases is confidence in CT-P13, which could be enhanced by scientific evidence supporting the biosimilarity of CT-P13...
November 2017: Journal of Comparative Effectiveness Research
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