Comparative Effectiveness Research / PCORI

The analysis of the relative effectiveness of different medical treatments. The Patient-Centered Outcomes Research Institute (PCORI) is a government-sponsored organization set up to fund this analysis.  

FDA Restrictions on Mifepristone: Time for a Change?

Issue Brief
Sep. 10, 2020

Mifepristone, a drug used to manage early miscarriage or end an early pregnancy, carries unique restrictions imposed by the U.S. Food and Drug Administration (FDA). Patients are required to pick up the drug in person
from a doctor or a clinic, even though they can take the drug at home. In July, a federal court ruled that the FDA must suspend these restrictions during the COVID-19 pandemic, for patients seeking an early abortion,
although the ruling did not apply to women with an early pregnancy loss. But the challenges to FDA restrictions on mifepristone predate the pandemic. This Issue Brief provides the context for this ongoing controversy, and
reviews recent evidence on the clinical and cost effectiveness of mifepristone for the medical management of first trimester miscarriage.

Effects Of Leader Tactics On The Creativity, Implementation, And Evolution Of Ideas To Improve Healthcare Delivery

Ingrid Nembhard, PhD
Aug. 31, 2020

Yuna S. H. Lee, Paul D. Cleary, Ingrid M. Nembhard

Abstract [from journal]

Background: Slow progress in quality improvement (QI) has prompted calls to identify new QI ideas. Leaders guiding these efforts are advised to use evidence-based tactics, or specific approaches to address a goal, to promote clinician and staff engagement in the generation and implementation of QI ideas, but little evidence about effective tactics exists.

Objective: Examine the association between leader tactics and the creativity, implementation outcome, and evolution of


Effects Of Dual Antiplatelet Therapy On Graft Patency After Lower Extremity Bypass

Grace Wang, MD
Aug. 7, 2020

Nathan Belkin, Jordan B. Stoecker, Benjamin M. Jackson, Scott M. Damrauer, Julia Glaser, Venkat Kalapatapu, Michael A. Golden, Grace J. Wang

Abstract [from journal]

Objective: Current guidelines recommend single agent antiplatelet therapy for patients with symptomatic peripheral arterial disease and for consideration of dual antiplatelet therapy (DAPT) after surgical revascularization. The objective of this study was both to explore prescribing patterns of single versus dual antiplatelet therapy after lower extremity bypass surgery, and to investigate the effects of antiplatelet therapy on bypass graft patency.

Methods: A retrospective analysis of


Reduction Of Postoperative Opioid Use After Elective Spine And Peripheral Nerve Surgery Using An Enhanced Recovery After Surgery Program

Aug. 6, 2020

Tracy M. Flanders, Joseph Ifrach, Saurabh Sinha, Disha S. Joshi, Ali K. Ozturk, Neil R. Malhotra, Rachel Pessoa, Michael J. Kallan, Lee A. FleisherMichael A. Ashburn, Eileen Maloney, William C. Welch, Zarina S. Ali

Abstract [from journal]

Objective: Enhanced recovery after surgery (ERAS) pathways have previously been shown to be feasible and safe in elective spinal procedures. As publications on ERAS pathways have recently emerged in elective neurosurgery, long-term outcomes are limited. We report on our 18-month experience with an ERAS pathway in elective spinal surgery.

Methods: A historical cohort of 149 consecutive patients was identified as the control group, and 1,141 patients were prospectively enrolled in an ERAS


Transplant Center Experience Influences Spontaneous Survival And Waitlist Mortality In Acute Liver Failure: An Analysis Of The UNOS Database

Aug. 2, 2020

Natalie Z. Wong, Douglas E. Schaubel, K. Rajender Reddy, Therese Bittermann

Abstract [from journal]

Transplant centers coordinate complex care in acute liver failure (ALF), for which liver transplantation (LT) can be lifesaving. We studied associations between waitlist outcomes and center (i) ALF waitlist volume (low: <20; medium: 20-39; high: 40+ listings) and (ii) total LT volume (<600; 600-1199; 1200+ LTs) in a retrospective cohort of 3,248 adults with ALF listed for LT at 92 centers nationally from 2002-2019. Predicted outcome probabilities (LT, died/too sick, spontaneous survival [SS]) were obtained with multinomial


Concordance Of Confirmatory Prostate Biopsy In Active Surveillance With National Guidelines: An Analysis From The Multi-Institutional PURC Cohort

Jul. 29, 2020

Ruchika Talwar, Brian Friel, Sameer Mittal, Leilei Xia, Claudette Fonshell, John Danella, Bruce Jacobs, Thomas Lanchoney, Jay Raman, Jeffrey Tomaszewski, Edouard Trabulsi, Adam Reese, Eric Singer, Serge Ginzburg, Marc Smaldone, Robert Uzzo, Phillip Mucksavage, Thomas J. Guzzo, ...

Abstract [from journal]

Purpose: National Comprehensive Cancer Network (NCCN) guidelines recommend confirmatory biopsy within 12 months of active surveillance (AS) enrollment. With <10 cores on initial biopsy, re-biopsy should occur within 6 months. Our objective was to determine if patients on AS within practices in the Pennsylvania Urologic Regional Collaborative (PURC) receive guideline concordant confirmatory biopsies.

Materials and methods: Within PURC, a prospective collaborative of diverse urology practices


An Analysis Of The US News & World Report Methodology For Attribution Of Specialty Care In Otolaryngology And Urology

Ankur Shah, MD
Jul. 21, 2020

Ankur A. Shah, Ryan M. Carey, Jason A. Brant, Gregory E. Tasian, Justin B. Ziemba

Abstract [from journal]

US News & World Report (USNWR) rankings can assist patients with choosing where to receive their specialty care. USNWR methodology assumes that the specialty caring for hospitalized patients is equivalent to the specialty assigned by administrative coding. We examined the frequency of discordance between USNWR methodology-assigned specialty and the actual specialty care received for 2 surgical specialties, otolaryngology (ENT) and urology (GU). Our analysis included inpatient deaths identified by USNWR coding for these


The Role Of Staffing And Classroom Characteristics On Preschool Teachers' Use Of One-To-One Intervention With Children With Autism

Jul. 6, 2020

Victor LushinSteven Marcus, Daphney Gaston, Rinad Beidas, Ashlee Lamson, Ilene Goy, Irina Godina, Joanne Rees, Rebecca Rivera, David Mandell

Abstract [from journal]

For preschool children with autism, individual (one-to-one) behavioral interventions are among the best-tested treatments. However, they are rarely used in special education preschools. We observed formally and informally delivered one-to-one behavioral interventions use by classroom staff (n = 51) in 12 classrooms across three special education preschools for children with autism, aged 3-6 years, in a major US city. We estimated the associations between one-to-one intervention use and classroom characteristics including staff-student


One-Year Changes In Sugar-Sweetened Beverage Consumers' Purchases Following Implementation Of A Beverage Tax: A Longitudinal Quasi-Experiment

Nandita Mitra, PhD
Jul. 3, 2020

Hannah G. Lawman, Sara N. Bleich, Jiali Yan, Sophia V. Hua, Caitlin M. Lowery, Ana Peterhans, Michael T. LeVasseur, Nandita MitraLaura A. GibsonChristina A. Roberto

Abstract [from journal]

Background: Few longitudinal studies examine the response to beverage taxes, especially among regular sugar-sweetened beverage (SSB) consumers.

Objective: This study aimed to examine changes in objectively measured beverage purchases associated with the Philadelphia beverage tax on sugar-sweetened and artificially sweetened beverages.

Methods: A longitudinal quasi-experiment was conducted with adult sugar-sweetened beverage (SSB) consumers in Philadelphia (n = 306) and


Effect Of Behavioral Economic Incentives For Colorectal Cancer Screening In A Randomized Trial

Shivan J. Mehta, MD, MBA
Jul. 2, 2020

Shivan J. Mehta, Catherine Reitz, Tess Niewood, Kevin G. VolppDavid A. Asch

Abstract [from journal]

Background & aims: Financial incentives might increase participation in prevention such as screening colonoscopy. We studied whether incentives informed by behavioral economics increase participation in risk assessment for colorectal cancer (CRC) and completion of colonoscopy for eligible adults.

Methods: Employees of a large academic health system (50-64 y old; n=1977) were randomly assigned to groups that underwent risk assessment for CRC screening and direct access colonoscopy scheduling


Comparison Of Medical Comorbidities In Medicare Patients Treated By Orthopaedic Surgeons And Neurosurgeons Throughout The USA

Comron Saifi, MD
Jun. 12, 2020

Alexander Beschloss, John Mueller, Jon-Michael E Caldwell, Alex Ha, Joseph M Lombardi, Ali Ozturk, Ronald Lehman, Comron Saifi

Abstract [from journal]

Medical comorbidities are a critical factor in the decision-making process for operative management and risk-stratification. The Hierarchical Condition Categories (HCC) risk adjustment model is a powerful measure of illness severity for patients treated by surgeons. The HCC is utilized by Medicare to predict medical expenditure risk and to reimburse physicians accordingly. HCC weighs comorbidities differently to calculate risk. This study determines the prevalence of medical comorbidities and the average HCC score in Medicare patients being...

Comparative Effectiveness of Proton vs Photon Therapy as Part of Concurrent Chemoradiotherapy for Locally Advanced Cancer

Dec. 26, 2019

Brian C. Baumann, Nandita Mitra, Joanna G. Harton, Ying Xiao, Andrzej P. Wojcieszynski, Peter E. Gabriel, Haoyu Zhong, Huaizhi Geng, Abigail Doucette, Jenny Wei, Peter J. O’Dwyer, Justin E. Bekelman, James M. Metz

Abstract [from journal]

Importance: Concurrent chemoradiotherapy is the standard-of-care curative treatment for many cancers but is associated with substantial morbidity. Concurrent chemoradiotherapy administered with proton therapy might reduce toxicity and achieve comparable cancer control outcomes compared with conventional photon radiotherapy by reducing the radiation dose to normal tissues.

Objective: To assess whether proton therapy in the setting of concurrent chemoradiotherapy is associated with fewer 90-day unplanned...

Interfacility Transfer of Medicare Beneficiaries With Acute Type A Aortic Dissection and Regionalization of Care in the United States

Oct. 7, 2019

Andrew B. Goldstone, Peter Chiu, Michael Baiocchi, Bharathi Lingala, Justin Lee, Joseph Rigdon, Michael P. Fischbein, Y. Joseph Woo


Background: The feasibility and effectiveness of delaying surgery to transfer patients with acute type A aortic dissection—a catastrophic disease that requires prompt intervention—to higher-volume aortic surgery hospitals is unknown. We investigated the hypothesis that regionalizing care at high-volume hospitals for acute type A aortic dissections will lower mortality. We further decomposed this hypothesis into subparts, investigating the isolated effect of transfer and the isolated effect of receiving care at a high-