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.  

Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

Nov. 20, 2020

Louise B. Russell, Laurie A. Norton, David Pagnotti, Christianne Sevinc, Sophia Anderson, Darra Finnerty Bigelow, Lauren G. Iannotte, Michael Josephs, Ryan McGilloway, Iwan Barankay, Mary E. Putt, Peter P. ReeseDavid A. Asch, Lee R. Goldberg...

Abstract [from journal]

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source

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Acute Kidney Injury In Deceased Organ Donors And Kidney Transplant Outcomes: A National Cohort Study Using A Novel Data Source

Nov. 13, 2020

Elizabeth M. SonnenbergJesse Y. Hsu, Jordana B. Cohen, Vishnu S. Potluri, Zhi Geng, Matthew H. Levine, Peter L. Abt, Peter P. Reese

Abstract [from journal]

Objective: To determine graft function and survival for kidney transplants from deceased donors with acute kidney injury (AKI) that persists at the time of organ procurement.

Background: Kidneys from donors with AKI are often discarded and may provide an opportunity to selectively expand the donor pool.

Methods: Using OPTN and DonorNet data, we studied adult kidney-only recipients between 5/1/2007-12/31/2016. DonorNet was used to characterize

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Association of Retinal Vascular Occlusion With Women Filling a Prescription for Female Hormone Therapy

Brian L. Vanderbeek, MD, MPH
Nov. 12, 2020

Delu Song, Jennifer Nadelmann, Yinxi Yu, Brian L. VanderBeek

Abstract [from journal]

Importance: Oral contraceptives have been associated with cardiovascular disease, ischemic stroke, venous thromboembolic disease, and breast cancer. Retinal vascular occlusions share the same risk factors as cardiovascular and cerebrovascular disease.

Objective: To determine whether filling a prescription of female hormone therapy (FHT) is associated with an increased risk of retinal artery occlusion (RAO) or retinal vein occlusions (RVO).

Design, setting, and participants: 

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Opioid Prescription For Pain After Osmotic Dilator Placement In Abortion Care: A Randomized Controlled Trial

Nov. 5, 2020

Divyah NagendraSarita Sonalkar, Danielle Schurr, Arden McAllister, Andrea Hsu Roe, Jade M. Shorter, Mary D. Sammel, Courtney A. Schreiber

Abstract [from journal]

Objective: To compare the overnight maximum pain scores after osmotic dilator placement prior to a dilation and evacuation (D&E) procedure in participants assigned to a prescription for ibuprofen alone or to ibuprofen plus oxycodone.

Study design: We conducted a non-blinded pragmatic, randomized controlled trial to evaluate pain management among women undergoing osmotic dilator placement prior to D&E. We randomly assigned 70 participants at 12 weeks 6 days to 23 weeks 6 days gestation

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Embedding A Linkage To Pre-exposure Prophylaxis (PrEP) Care Intervention In Social Network Strategy And Partner Notification Services: Results From A Pilot Randomized Controlled Trial

Daniel Teixeira da Silva
Oct. 22, 2020

Daniel Teixeira da Silva, Alida Bouris, Arthi Ramachandran, Olivia Blocker, Billy Davis, James Harris, Maria Pyra, Laura K. Rusie, Russell Brewer, Jade Pagkas-Bather, Anna Hotton, Jessica P. Ridgway, Moira McNulty, Ramona Bhatia, John A. Schneider

Abstract [from journal]

Background: Increased pre-exposure prophylaxis (PrEP) uptake among Black men who have sex with men and Black transgender women (BMSM/TW) is needed to end the HIV epidemic. Embedding a brief intervention in network services that engage individuals in HIV transmission networks for HIV/STI testing may be an important strategy to accelerate PrEP uptake.

Setting: Partner Services PrEP (PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for

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Effect Of Integrating Machine Learning Mortality Estimates With Behavioral Nudges To Clinicians On Serious Illness Conversations Among Patients With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial

Oct. 15, 2020

Christopher R. Manz, Ravi B. Parikh, Dylan S. Small, Chalanda N. Evans, Corey Chivers, Susan H. Regli, C. William Hanson, Justin E Bekelman, Charles A. L. Rareshide, Nina O'Connor, Lynn M. Schuchter, Lawrence N. Shulman,...

Abstract [from journal]

Importance: Serious illness conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Interventions that increase the rate of SICs between oncology clinicians and patients may improve goal-concordant care and patient outcomes.

Objective: To determine the effect of a clinician-directed intervention integrating machine learning mortality predictions with behavioral nudges on motivating clinician-patient SICs

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Examining The Potential Impact Of Race Multiplier Utilization In Estimated Glomerular Filtration Rate Calculation On African-American Care Outcomes

Oct. 15, 2020

Salman Ahmed, Cameron T. Nutt, Nwamaka D. EneanyaPeter P. Reese, Karthik Sivashanker, Michelle Morse, Thomas Sequist, Mallika L. Mendu

Abstract [from journal]

Background: Advancing health equity entails reducing disparities in care. African-American patients with chronic kidney disease (CKD) have poorer outcomes, including dialysis access placement and transplantation. Estimated glomerular filtration rate (eGFR) equations, which assign higher eGFR values to African-American patients, may be a mechanism for inequitable outcomes. Electronic health record-based registries enable population-based examination of care across racial groups.

Objective: To

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Racial/Ethnic Differences In Maternal Resilience And Associations With Low Birthweight

Diana Montoya-Williams, MD
Oct. 7, 2020

Diana Montoya-Williams, Molly Passarella, William A. Grobman, Scott A. Lorch 

Abstract [from journal]

Objective: Evaluate racial/ethnic differences in maternal resilience and its associations with low birthweight (LBW).

Study design: Retrospective cohort study of 3244 women surveyed in the Longitudinal Study of Adolescent to Adult Health. The Add Health Resilience Instrument assessed resilience. Logistic regression models explored associations between women's resilience and risk of LBW.

Result: Resilience scores were lowest in American Indian women. Women with the

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Association Between A National Insurer's Pay-For-Performance Program For Oncology And Changes In Prescribing Of Evidence-Based Cancer Drugs And Spending

Oct. 6, 2020

Justin E. BekelmanAtul Gupta, Ezra Fishman, David Debono, Michael J. Fisch, Ying Liu, Gosia Sylwestrzak, John Barron, Amol S. Navathe

Abstract [from journal]

Purpose: Cancer drug prescribing by medical oncologists accounts for the greatest variation in practice and the largest portion of spending on cancer care. We evaluated the association between a national commercial insurer's ongoing pay-for-performance (P4P) program for oncology and changes in the prescribing of evidence-based cancer drugs and spending.

Methods: We conducted an observational difference-in-differences study using administrative claims data covering 6.7% of US adults. We

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Early Noninvasive Cardiac Testing After Emergency Department Evaluation For Suspected Acute Coronary Syndrome

Benjamin Sun, MD
Oct. 5, 2020

Aniket A. Kawatkar, Adam L. Sharp, Aileen S. Baecker, Shaw Natsui, Rita F. Redberg, Ming-Sum Lee, Maros Ferencik, Yi-Lin Wu, Ernest Shen, Chengyi Zheng, Visanee V. Musigdilok, Michael K. Gould, Steve Goodacre, Praveen Thokala , Benjamin C. Sun

Abstract [from journal]

Importance: Professional guidelines recommend noninvasive cardiac testing (NIT) within 72 hours of an emergency department (ED) evaluation for suspected acute coronary syndrome. However, there is inexact evidence that this strategy reduces the risk of future death or acute myocardial infarction (MI).

Objective: To evaluate the effectiveness of early NIT in reducing the risk of death or acute MI within 30 days.

Design, setting, and participants: This retrospective,

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Early Noninvasive Cardiac Testing After Emergency Department Evaluation For Suspected Acute Coronary Syndrome

Benjamin Sun, MD
Oct. 5, 2020

Aniket A. Kawatkar, Adam L. Sharp, Aileen S. Baecker, Shaw Natsui, Rita F. Redberg, Ming-Sum Lee, Maros Ferencik, Yi-Lin Wu, Ernest Shen, Chengyi Zheng, Visanee V. Musigdilok, Michael K. Gould, Steve Goodacre, Praveen Thokala, Benjamin C. Sun

Abstract [from journal]

Importance: Professional guidelines recommend noninvasive cardiac testing (NIT) within 72 hours of an emergency department (ED) evaluation for suspected acute coronary syndrome. However, there is inexact evidence that this strategy reduces the risk of future death or acute myocardial infarction (MI).

Objective: To evaluate the effectiveness of early NIT in reducing the risk of death or acute MI within 30 days.

Design, setting, and participants: This retrospective,

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A Novel Health-Transportation Partnership Paves The Road For Young Driver Safety Through Virtual Assessment

Oct. 1, 2020

Elizabeth A. Walshe, Daniel Romer, Venkatesh Kandadai, Flaura K. Winston

Abstract [from journal]

Motor vehicle crashes remain the leading cause of adolescent mortality and injury in the United States. For young drivers, crash risk peaks immediately after licensure and declines during the next two years, making the point of licensure an important safety intervention opportunity. Legislation in Ohio established a unique health-transportation partnership among the State of Ohio, Children's Hospital of Philadelphia, and Diagnostic Driving, Inc., to identify underprepared driver license applicants through a virtual driving assessment

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In The Era Of Direct-Acting Antivirals, Liver Transplant Delisting Due To Clinical Improvement For Hepatitis C Remains Infrequent

Therese Bitterman, MD, MSCE
Sep. 21, 2020

Therese Bittermann and K. Rajender Reddy

Abstract [from journal]

Background/aims: Studies have suggested marked increases in transplant delisting due to clinical improvement for patients with hepatitis C virus (HCV) associated cirrhosis in the era of direct acting antivirals (DAAs). This study provides a 'real world' assessment of waitlist dynamics for HCV transplant candidates in the current era.

Methods: This was a retrospective cohort study of adults waitlisted for liver transplant (LT) alone between 1/1/2005-12/31/2018 using national US data. The post-

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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.

High Rates of Partial Participation in the First Year of the Merit-Based Incentive Payment System

Nate Apathy
Sep. 1, 2020

Nate C. Apathy and Jordan Everson

Abstract [from journal]

There has been widespread concern over the design of the Merit-based Incentive Payment System (MIPS) since its authorization with the Medicare Access and CHIP Reauthorization Act of 2015. Using detailed performance data from 2017, the first implementation year of MIPS, we found that although 90 percent of participating clinicians reported performance equal to or better than the low performance threshold of 3 out of 100 (a calculated composite score), almost half of clinicians did not participate in at least one of the three

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