Evidence Development & Decision Science

The systematic production and application of medical knowledge to clinical practice. LDI Senior Fellows analyze the process by which data affect coverage and clinical decisions, and conducts comparative effectiveness and cost effectiveness studies.

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.

Evaluating The Costs And Outcomes Of Hospital Nursing Resources: A Matched Cohort Study Of Patients With Common Medical Conditions

Aug. 31, 2020

Karen B. LasaterMatthew D. McHughPaul R. RosenbaumLinda H. Aiken, Herbert L. Smith, Joseph G. Reiter, Bijan A. Niknam, Alexander S. Hill, Lauren L. Hochman, Siddharth JainJeffrey H. Silber...

Abstract [from journal]

Background: Nursing resources, such as staffing ratios and skill mix, vary across hospitals. Better nursing resources have been linked to better patient outcomes but are assumed to increase costs. The value of investments in nursing resources, in terms of clinical benefits relative to costs, is unclear.

Objective: To determine whether there are differential clinical outcomes, costs, and value among medical patients at hospitals characterized by better or worse nursing resources.


Association Of Age, Sex, Race, And Geographic Region With Variation Of The Ratio Of Basal Cell To Cutaneous Squamous Cell Carcinomas In The United States

Jeremy Etzkorn
Aug. 26, 2020

Tess M. Lukowiak, Leora Aizman, Allison Perz, Christopher J. Miller, Joseph F. Sobanko, Thuzar M. Shin, Cerrene N. Giordano, H. William Higgins 2nd, Jeremy R. Etzkorn

Abstract [from journal]

Importance: Defining which populations are affected by basal cell carcinoma (BCC) vs cutaneous squamous cell carcinoma (cSCC) may inform targeted public health strategies. Incidence of BCC and cSCC is not reported to national cancer registries, but claims data for the treatment of BCC and cSCC provide insights into the epidemiology of keratinocyte carcinoma.

Objective: To define differences in the ratio of BCC to cSCC in adults (age, ≥18 years) in a large database of patients with commercial


Establishing An Orthopedic Excess Hospital Days In Acute Care Program

Aug. 22, 2020

Michele Fang, Frances Mao, Eric HumeS. Ryan Greysen

Abstract [from journal]

Background: Excess days in acute care (EDAC) after total joint arthroplasty (TJA) represent a large economic burden. We developed an Orthopedic EDAC program that triages TJA patients to the appropriate service line (orthopedic vs medicine) and level of care (observation vs inpatient) on re-presentation. We developed and used evidence-based protocols for the treatment of TJA patients who are rehospitalized.

Methods: We defined Orthopedic EDAC as the length of stay (LOS) during readmission and


Effect Of Operative Time On Complications Following Primary Total Hip Arthroplasty: Analysis Of The NSQIP Database

Neil Sheth, MD
Aug. 12, 2020

Mark Sikov, Matthew Sloan, Neil P. Sheth

Abstract [from journal]

Background: Long operative times in total hip arthroplasty (THA) have been shown to be associated with increased risk of revision as well as perioperative morbidity. This study assesses the effect of extended operative times on complication rates following primary THA using the most recent national data.

Methods: The National Surgical Quality Improvement Program (NSQIP) database (2008-2016) was queried for primary THA. Groups were defined by operative time 1 standard deviation (1 SD) above the


Evaluating Patient Preferences For Thermal Ablation Versus Non-Thermal, Non-Tumescent Varicose Vein Treatments

Aug. 10, 2020

Peter Pappas, Candace Gunnarsson, Guy David

Abstract [from journal]

Objective: To measure patient preferences for attributes associated with thermal ablation and non-thermal, non-tumescent varicose vein treatments.

Methods: Data were collected from an electronic patient-preference survey taken by 70 adult participants (aged 20 years or older) at 3 Center for Vein Restoration clinics in New Jersey from July 19, 2019, through August 13, 2019. Survey participation was voluntary and anonymous (participation rate of 80.5% [70/87]). Patients were shown 10


Teaching Old Drugs New Tricks: Statins For COVID-19?

Aug. 4, 2020

David C. Fajgenbaum, Daniel J. Rader

Abstract [from journal]

The COVID-19 pandemic has driven unprecedented efforts to identify existing treatments that can be quickly and effectively repurposed to reduce morbidity and mortality. In this issue of Cell Metabolism, Zhang et al. (2020) report an association between statin use and improved outcomes in a large observational study of hospitalized COVID-19 patients. Given the widespread availability, low cost, and safety of statins, this promising result should be further investigated in randomized controlled trials.

High-Performance Trauma Centers In A Single-State Trauma System : Big Saves Or Marginal Gains?

Elinore Kaufman, MD
Jul. 29, 2020

Justin S. Hatchimonji, Elinore J. Kaufman, Andrew J. Young, Brian P. Smith, Ruiying Xiong, Patrick M. Reilly, Daniel N. Holena

Abstract [from journal]

Background: Trauma centers with low observed:expected (O:E) mortality ratios are considered high performers; however, it is unknown whether improvements in this ratio are due to a small number of unexpected survivors with high mortality risk (big saves) or a larger number of unexpected survivors with moderate mortality risk (marginal gains). We hypothesized that the highest-performing centers achieve that status via larger numbers of unexpected survivors with moderate mortality risk.



Thematic Analysis Of The Medical Records Of Patients Evaluated For Kidney Transplant Who Did Not Receive A Kidney

Jul. 25, 2020

Catherine R. Butler, Janelle S. Taylor, Peter P. Reese, Ann M. O’Hare 

Abstract [from journal]

Background: A potential pitfall of policies intended to promote referral for kidney transplant is that greater numbers of patients may be evaluated for transplant without experiencing the intended benefit of receiving a kidney. Little is known about the potential implications of this experience for patients.

Methods: We performed a thematic analysis of clinician documentation in the electronic medical records of all adults at a single medical center with advanced kidney disease who were


Factors That Influenced Adoption Of A School-Based Trauma-Informed Universal Mental Health Intervention

Jul. 24, 2020

Kimberly T. Arnold, Keshia M. Pollack Porter, Shannon Frattaroli, Rachel E. Durham, Kristin Mmari, Laura K. Clary, Tamar Mendelson

Abstract [from journal]

We know little about why school administrators choose to adopt preventive mental health interventions within the context of school-based prevention trials. This study used a qualitative multiple-case study design to identify factors that influenced the adoption of a trauma-informed universal intervention by urban public school administrators during an efficacy trial. Semi-structured interviews were conducted with 15 school administrators who adopted a trauma-informed mindfulness intervention called RAP (Relax, be Aware, and do a


Resource Utilization In The First 2 Years Following Operative Correction For Tetralogy Of Fallot: Study Using Data From The Optum's De‐Identified Clinformatics Data Mart Insurance Claims Database

Jul. 21, 2020

Michael L. O'Byrne, Grace DeCost, Hannah Katcoff, Jill J. Savla, Joyce Chang, Elizabeth Goldmuntz, Peter W. Groeneveld, Joseph W. Rossano, Jennifer A. Faerber, and Laura Mercer‐Rosa

Abstract [from journal]

Background: Despite excellent operative survival, correction of tetralogy of Fallot frequently is accompanied by residual lesions that may affect health beyond the incident hospitalization. Measuring resource utilization, specifically cost and length of stay, provides an integrated measure of morbidity not appreciable in traditional outcomes.

Methods and Results: We conducted a retrospective cohort study, using de‐identified commercial insurance claims data, of 269 children who underwent