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.

Evaluating the Quality of Research Ethics Review and Oversight

Oct. 7, 2020

Institutional Review Boards (IRBs)—or “Research Ethics Committees” (RECs) outside the United States—are charged with protecting human research subjects. However, the quality of IRB performance is rarely subject to the same scrutiny that the boards themselves apply to research projects. In AJOB Empirical Bioethics, we conducted the first systematic analysis of 10 IRB quality measurement tools.

Evaluating Spillover Of HIV Knowledge From Study Participants To Their Network Members In A Stepped-wedge Behavioural Intervention In Tanzania

Oct. 7, 2020

Jeffrey Rewley, Mary C. Smith Fawzi, Keith McAdam, Sylvia Kaaya, Yuanyuan Liu, Jim Todd, Irene Andrew, Jukka Pekka Onnela

Abstract [from journal]

Objectives: We aim to describe the social network members of participants of a behavioural intervention, and examine how the effects of the intervention may spillover among network members.

Design: Secondary analysis of a step-wedge randomised controlled trial.

Setting: Change agents (CAs) were recruited from waiting rooms of HIV treatment facilities in Dar es Salaam, Tanzania, and their network members (NMs) were recruited directly by CAs.



Effect Of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists On Statin Prescribing: A Cluster Randomized Clinical Trial

Oct. 7, 2020

Srinath Adusumalli, Julie E. Westover, Douglas S. Jacoby, Dylan S. Small, Christine VanZandbergen, Jessica Chen, Ann M. Cavella, Rebecca Pepe, Charles A. L. Rareshide, Christopher K. Snider, Kevin G. VolppDavid A. Asch, ...

Abstract [from journal]

Importance: Statin therapy is underused for many patients who could benefit.

Objective: To evaluate the effect of passive choice and active choice interventions in the electronic health record (EHR) to promote guideline-directed statin therapy.

Design, setting, and participants: Three-arm randomized clinical trial with a 6-month preintervention period and 6-month intervention. Randomization conducted at the cardiologist level at 16 cardiology practices in Pennsylvania


Association Of Discharge To Home Vs Institutional Postacute Care With Outcomes After Lower Extremity Joint Replacement

Amole Navathe19-head
Oct. 1, 2020

Robert E. Burke, Anne Canamucio, Elina Medvedeva, Eric L. HumeAmol S. Navathe

Abstract [from journal]

Importance: Changes in financial incentives have led to more patients being discharged home than to institutional forms of postacute care, such as skilled nursing facilities (SNFs), after elective lower extremity total joint replacement (LEJR).

Objective: To evaluate the association of this change with hospital readmissions, surgical complications, and mortality.

Design, setting, and participants: This cohort study used cross-temporal propensity-matching to identify 104


Insights From Behavioral Economics: A Case Of Delayed Diagnosis Of Autism Spectrum Disorder

Sep. 28, 2020

Kate E. Wallis, Alison M. ButtenheimDavid S. Mandell

Abstract [from journal]

We present the case of a child of color diagnosed with autism spectrum disorder (ASD) at 67 months of age. Drawing from behavioral economics, we used this case to explore errors in decision-making by clinicians and family members and structural factors that may have delayed ASD diagnosis well beyond the national average.

Implementing Nudges For Suicide Prevention In Real-World Environments: Project INSPIRE Study Protocol

Sep. 26, 2020

Molly Davis, Courtney Benjamin Wolk, Shari Jager-Hyman, Rinad S. Beidas, Jami F. Young, Jennifer A. Mautone, Alison M. Buttenheim, David S. Mandell, Kevin G. Volpp, Katherine Wislocki, Anne...

Abstract [from journal]

Background: Suicide is a global health issue. There are a number of evidence-based practices for suicide screening, assessment, and intervention that are not routinely deployed in usual care settings. The goal of this study is to develop and test implementation strategies to facilitate evidence-based suicide screening, assessment, and intervention in two settings where individuals at risk for suicide are especially likely to present: primary care and specialty mental health care. We will leverage methods from


Dementia Is Associated With Earlier Mortality For Men And Women In The United States

Sep. 19, 2020

Lindsay White, Paul Fishman, Anirban Basu, Paul K. Crane, Eric B. Larson, Norma B. Coe

Abstract [from journal]

Objectives: Sociodemographic trends in the United States may influence future dementia-associated mortality, yet there is little evidence about their potential impact. Our study objective was to estimate the effect of dementia on survival in adults stratified by sex, education, and marital status. 

Methods: Using survey data from the Health and Retirement Study (HRS) linked to Medicare claims from 1991 to 2012, we identified a retrospective cohort of adults with at least one International


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.

Hospital Readmission and Post-Acute Care Use After Intensive Care Unit Admissions: New ICU Quality Metrics?

Christopher Chesley
Sep. 10, 2020

Christopher F. ChesleyMichael O. HarhayDylan S. Small, Asaf Hanish, Hallie C. Prescott, Mark E. Mikkelsen

Abstract [from journal]

Objective: Care coordination is a national priority. Post-acute care use and hospital readmission appear to be common after critical illness. It is unknown whether specialty critical care units have different readmission rates and what these trends have been over time.

Methods: In this retrospective cohort study, a cohort of 53,539 medical/surgical patients who were treated in a critical care unit during their index admission were compared with 209,686 patients who were not treated in a


Attitudes On Prophylactic Antibiotic Use In Dermatologic Surgery: A Survey Study Of American College Of Mohs Surgery Members

Jeremy Etzkorn
Sep. 2, 2020

Leora Aizman, John S. Barbieri, Tess M. Lukowiak, Allison M. Perz, Joseph F. Sobanko, Thuzar M. Shin, Harold William Higgins, Cerrene N. Giordano, Ian A. Maher, Nicholas Golda, Christopher J. Miller, Jeremy R. Etzkorn

Abstract [from journal]

Background: Antibiotic prescriptions associated with dermatologic surgical visits are increasing and prescribing practices vary among surgeons.

Objective: To describe dermatologic surgeons' attitudes and practices regarding prophylactic antibiotic use for surgical site infection (SSI), to compare current prescribing practices to those of a 2012 survey, and to determine surgeons' interest in clinical trial data on the utility of prophylactic antibiotics.

Materials and methods: 


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


Rethinking Ethical Oversight In The Era Of The Learning Health System

David Asch
Aug. 25, 2020

David A. AschSteven Joffe, Barbara E. Bierer, Sarah M. Greene, Tracy A. Lieu, Jodyn E. Platt, Danielle Whicher, Mahnoor Ahmed, Richard Platt

Abstract [from journal]

Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent,