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Browsing by Subject "Comparative effectiveness research"
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Item Comparative risk of severe hypoglycemia among concomitant users of thiazolidinedione antidiabetic agents and antihyperlipidemics(Elsevier, 2016-05) Leonard, Charles E.; Han, Xu; Bilker, Warren B.; Flory, James H.; Brensinger, Colleen M.; Flockhart, David A.; Gagne, Joshua J.; Cardillo, Serena; Hennessy, Sean; Department of Medicine, IU School of MedicineWe conducted high-dimensional propensity score-adjusted cohort studies to examine whether thiazolidinedione use with a statin or fibrate was associated with an increased risk of severe hypoglycemia. We found that concomitant therapy with a thiazolidinedione+fibrate was associated with a generally delayed increased risk of severe hypoglycemia.Item Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement(Wolters Kluwer, 2023) Hohenschurz-Schmidt, David J.; Cherkin, Dan; Rice, Andrew S. C.; Dworkin, Robert H.; Turk, Dennis C.; McDermott, Michael P.; Bair, Matthew J.; DeBar, Lynn L.; Edwards, Robert R.; Farrar, John T.; Kerns, Robert D.; Markman, John D.; Rowbotham, Michael C.; Sherman, Karen J.; Wasan, Ajay D.; Cowan, Penney; Desjardins, Paul; Ferguson, McKenzie; Freeman, Roy; Gewandter, Jennifer S.; Gilron, Ian; Grol-Prokopczyk, Hanna; Hertz, Sharon H.; Iyengar, Smriti; Kamp, Cornelia; Karp, Barbara I.; Kleykamp, Bethea A.; Loeser, John D.; Mackey, Sean; Malamut, Richard; McNicol, Ewan; Patel, Kushang V.; Sandbrink, Friedhelm; Schmader, Kenneth; Simon, Lee; Steiner, Deborah J.; Veasley, Christin; Vollert, Jan; Anesthesia, School of MedicineMany questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions.Item Traumatic Brain Injury-Practice Based Evidence Study: Design and Patients, Centers, Treatments, and Outcomes(Elsevier, 2015-08) Horn, Susan D.; Corrigan, John D.; Bogner, Jennifer; Hammond, Flora M.; Steel, Ronald T.; Smout, Randall J.; Barrett, Ryan S.; Dijkers, Marcel P.; Whiteneck, Gale G.; Department of Medicine, IU School of MedicineOBJECTIVES: To describe study design, patients, centers, treatments, and outcomes of a traumatic brain injury (TBI) practice-based evidence (PBE) study and to evaluate the generalizability of the findings to the U.S. TBI inpatient rehabilitation population. DESIGN: Prospective, longitudinal, observational study. SETTING: Ten inpatient rehabilitation centers. PARTICIPANTS: Patients (N=2130) enrolled between October 2008 and September 2011 and admitted for inpatient rehabilitation after an index TBI injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Return to acute care during rehabilitation, rehabilitation length of stay, FIM at discharge, residence at discharge, and 9 months postdischarge rehospitalization, FIM, participation, and subjective well-being. RESULTS: The level of admission FIM cognitive score was found to create relatively homogeneous subgroups for the subsequent analysis of best treatment combinations. There were significant differences in patient and injury characteristics, treatments, rehabilitation course, and outcomes by admission FIM cognitive subgroups. TBI-PBE study patients were overall similar to U.S. national TBI inpatient rehabilitation populations. CONCLUSIONS: This TBI-PBE study succeeded in capturing naturally occurring variation in patients and treatments, offering opportunities to study best treatments for specific patient impairments. Subsequent articles in this issue report differences between patients and treatments and associations with outcomes in greater detail.