Michelle M Mello's research while affiliated with Stanford University and other places
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Publications (266)
Public health emergency powers laws in the US underwent a profound stress test during the COVID-19 pandemic. Designed with bioterrorism in mind, they struggled to meet the challenges of a multiyear pandemic. Public health legal powers in the US are both too limited, in that they don't clearly permit officials to implement measures necessary to comb...
This JAMA Forum discusses the $1.7 trillion omnibus bill passed in December 2022 and the areas of pandemic preparedness and the public health system it addresses and misses.
Objective
To develop a measure for fair inclusion in pivotal trials by assessing transparency and representation of enrolled women, older adults (aged 65 years and older), and racially and ethnically minoritized patients.
Design
Retrospective cross sectional study.
Population
Sponsors of novel oncology therapeutics that were approved by the US Fo...
Importance:
The association between physician fatigue and patient outcomes is important to understand but has been difficult to examine given methodological and data limitations. Surgeons frequently perform urgent procedures overnight and perform additional procedures the following day, which could adversely affect outcomes for those daytime opera...
Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer–BioNTech vaccine receiving full approval on Aug 23, 2021. Whe...
Background:
Audio recordings of oncology clinic discussions can help patients retain and understand information about their disease and treatment decisions. Access to this tool relies on acceptance of recordings by oncologists. This is the first study to evaluate experience and attitudes of oncologists toward patients recording clinic visits.
Met...
Objectives
To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.
Design
Cross-sectional descriptive analysis.
Setting and participants
Novel drugs and biologics Food and Drug Administrat...
California has focused on health equity in the state’s COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California’s 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier’s test positivity and adjusted case r...
Importance:
Clinical research supporting US Food and Drug Administration (FDA) drug approvals is largely conducted outside the US.
Objective:
To characterize where drugs were tested for FDA approval and to determine how commonly and quickly these drugs received marketing approval in the countries where they were tested, both overall and by count...
Daniel E Ho and colleagues explore the legal implications of using artificial intelligence in the response to covid-19 and call for more robust evaluation frameworks
Background
Many health care organizations want to improve their responses to patients who suffer medical injuries. Their ability to understand how well they meet patients’ needs is limited by the lack of suitable instruments for assessing injured patients’ experiences.
Methods
We aimed to generate items for a patient experience questionnaire that...
Context:
Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotio...
In December 2020, less than a year after severe acute respiratory syndrome coronavirus 2 was identified as the cause of the coronavirus pandemic, an extraordinary collaboration between scientists, the pharmaceutical industry, and government led to 2 highly efficacious, safe vaccines being approved by the US Food and Drug Administration to prevent c...
290
Background: The high prevalence of smartphone use means that most patients can easily audio record medical consultations. Oncologists’ attitudes towards recording visits are unknown yet may impact patient care. Methods: A mail survey of oncologists practicing at 5 U.S. Alliance for Clinical Trials in Oncology sites collected information on clin...
Audio Interview
Interview with Prof. Michelle Mello on health professionals’ moral duty to intervene in response to sexual harassment and gender bias. (10:02)Download
Health professionals have a moral duty to practice “upstanding” — intervening as bystanders — in response to sexual harassment and gender bias, an obligation that should be described...
In Reply We agree with Mr Kels that HIPAA has involved burdens for physicians—some real and others amplified by uncertainty and fear of liability. However, Kels misread our Viewpoint¹ insofar as he suggests that we are arguing for a private right of action to increase physicians’ liability under HIPAA. Such a move would do little to help regulate m...
Importance
The tort liability system is intended to serve 3 functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence. Deterrence, in theory, occurs because clinicians know that they may experience adverse consequences if they negligently injure patients.
Objective
To review empirical findi...
Background
Communication-and-resolution programmes (CRP) aim to increase transparency surrounding adverse events, improve patient safety and promote reconciliation by proactively meeting injured patients’ needs. Although early adopters of CRP models reported relatively smooth implementation, other organisations have struggled to achieve the same. H...
Delays stem from institutional factors and negotiating challenges, some of which appear amenable to reform
Introduction
State lawmakers have explored numerous policy alternatives to reduce overweight and obesity. Evaluating effects of these laws is important but presents substantial methodological challenges. We present a conceptual framework that allows for classification of obesity prevention laws based on ecological level of influence and the underly...
Importance
Although surprise medical bills are receiving considerable attention from lawmakers and the news media, to date there has been little systematic study of the incidence and financial consequences of out-of-network billing.
Objective
To examine out-of-network billing among privately insured patients with an inpatient admission or emergenc...
The market for patient data has never been more active. Technology companies, from startups to giants, are eager to access electronic health record (EHR) data to build the next generation of health-focused products. Medical artificial intelligence (AI) is particularly data-hungry; large, representative data sets hold promise for advancing not only...
Objectives
To develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial data sharing policies and practices.
Design
Cross sectional descriptive analysis.
Setting
Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015.
Data sources
Data sharing measures were adapted f...
Improving how health care providers respond to medical injury requires an understanding of patients’ experiences. Although many injured patients strongly desire to be heard, research rarely involves them. Institutional review boards worry about harming participants by asking them to revisit traumatic events, and hospital staff worry about provoking...
Transparency in Health and Health Care in the United States - edited by Holly Fernandez Lynch June 2019
Importance
Transparency of industry payments to physicians could engender greater public trust in physicians but might also lead to greater mistrust of physicians and the medical profession, adversely affecting the patient-physician relationship.
Objective
To examine the association between nationwide public disclosure of industry payments and Ame...
Background
Physicians with poor malpractice liability records may pose a risk to patient safety. There are long-standing concerns that such physicians tend to relocate for a fresh start, but little is known about whether, how, and where they continue to practice.
Methods
We linked an extract of the National Practitioner Data Bank to the Medicare D...
Importance
Overlapping surgery, in which more than 1 procedure performed by the same primary surgeon is scheduled so the start time of one procedure overlaps with the end time of another, is of concern because of potential adverse outcomes.
Objective
To determine the association between overlapping surgery and mortality, complications, and length...
Background:
Decades-long efforts to require parity between behavioral and physical health insurance coverage culminated in the comprehensive federal Mental Health Parity and Addiction Equity Act.
Objectives:
To determine the association between federal parity and changes in mental health care utilization and spending, particularly among high uti...
Objective
To determine the effect of the public disclosure of industry payments to physicians on patients’ awareness of industry payments and knowledge about whether their physicians had accepted industry payments.
Design
Interrupted time series with comparison group (difference-in-difference analyses of longitudinal survey).
Setting
Nationally r...
High and rising prescription drug costs have become a preoccupying policy problem in the United States. Notwithstanding broad, bipartisan interest in finding effective policy solutions, several aspects of the drug affordability problem make it an uncommonly difficult one to solve. This article reviews the moral, market, and political factors contri...
Under a new proposed rule, television advertisements for prescription drugs and biologic products would be required to disclose the product’s list price. Although there is broad support for improving price transparency, the rule raises public health and legal concerns.
Communication-and-resolution programs (CRPs) are intended to promote accountability, transparency, and learning after adverse events. In this article we address five key challenges to the programs' future success: implementation fidelity, the evidence base for CRPs and their link to patient safety, fair compensation of harmed patients, alignment of...
To promote communication with patients after medical injuries and improve patient safety, numerous hospitals have implemented communication-and-resolution programs (CRPs). Through these programs, hospitals communicate transparently with patients after adverse events; investigate what happened and offer an explanation; and, when warranted, apologize...
Importance
Approximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown.
Objective
To investigate the nature of institutional oversight of faculty cons...
Importance. Approximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown.
Objective. To investigate the nature of institutional oversight of faculty con...
Audio Interview
Interview with Dr. Rebecca Haffajee on the conflict between federal and state marijuana laws. (09:40)Download
As the marijuana-policy terrain in the United States shifts, it’s important to consider the potential public health benefits of closing the divide between federal policies and those of individual states, which are increasing...
Background
Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants’ perceptions of the risks of data sharing.
Methods
We conducted a structured surve...
State prescription drug monitoring programs (PDMPs) aim to reduce risky controlled-substance prescribing, but early programs had limited impact. Several states implemented robust features in 2012-13, such as mandates that prescribers register with the program and regularly check its registry database. Some states allow prescribers to fulfill the la...
In Reply Dr Gunn understandably objects that the clinical team evidently did not refer her sister’s case to the hospital’s communication-and-resolution program (CRP) when Dr Gunn raised concerns about her care following her death. Especially given the severe outcome, standard practice would be for health care clinicians to alert risk management so...
Context:
Although the clinical benefits of exchanging patients' health information electronically across providers have long been recognized, participation in health information exchange (HIE) has lagged behind adoption of electronic health records. Barriers erected by federal and state health information privacy law have been cited as a leading r...
In Reply Dr Hyder and colleagues contend that we incompletely represented the findings of their study of the effect of overlapping surgery on clinical outcomes by stating that their study “reported longer length of stay for some types of overlapping cases.” They note that their primary analysis showed no difference in length of stay; the difference...
Objectives
To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.
Design
Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs spon...
Importance
Dissatisfaction with medical malpractice litigation has stimulated interest by health care organizations in developing alternatives to meet patients’ needs after medical injury. In communication-and-resolution programs (CRPs), hospitals and liability insurers communicate with patients about adverse events, use investigation findings to i...
Through communication-and-resolution programs, hospitals and liability insurers communicate with patients when adverse events occur; investigate and explain what happened; and, where appropriate, apologize and proactively offer compensation. Using data recorded by program staff members and from surveys of involved clinicians, we examined case outco...
Medical malpractice reform appears to be back on the federal policy agenda, and some GOP-proposed reforms, such as safe harbors and administrative compensation, are sensible. But design and implementation details matter: patients’ needs should be front and center.
Background
Despite the investment in exploring patient-centred alternatives to medical malpractice in New Zealand (NZ), the UK and the USA, patients' experiences with these processes are not well understood. We sought to explore factors that facilitate and impede reconciliation following patient safety incidents and identify recommendations for str...
Background
The Physician Payments Sunshine Act, part of the Affordable Care Act, requires pharmaceutical and medical device firms to report payments they make to physicians and, through its Open Payments program, makes this information publicly available. Objective
To establish estimates of the exposure of the American patient population to physici...
Background
One major intent of the medical malpractice system in the United States is to deter negligent care and to create incentives for delivering high-quality health care. A study was conducted to assess whether state-level measures of malpractice risk were associated with hospital quality and patient safety.
Methods
In an observational study...
Dr Gregory House and Dr Peter Benton, of the popular television dramas House and ER, respectively, are gruff and sometimes arrogant and misanthropic characters. Part of what attracts viewers to these characters is the intriguing divide between their poor interpersonal skills and their technical brilliance and superb patient outcomes. A degree of di...
In the absence of congressional action to reinstate the federal ban on assault weapons, tort litigation offers an alternative strategy for regulating what have become the weapons of choice in mass shootings. However, opportunities to bring successful claims are limited. To prevail, plaintiffs must show that their suit fits within exceptions to the...
Objective:
To implement a communication-and-resolution program (CRP) in a setting in which liability insurers and health care facilities must collaborate to resolve incidents involving a facility and separately insured clinicians.
Study setting:
Six hospitals and clinics and a liability insurer in Washington State.
Study design:
Sites designed...
Objective:
To determine case outcomes in a communication-and-resolution program (CRP) implemented to respond to adverse events in general surgery.
Study setting:
Five acute-care hospitals in New York City.
Study design:
Following CRP implementation, hospitals recorded information about each CRP event for 22 months.
Data collection methods:
R...
Objective:
Communication and resolution programs (CRPs) involve institutions responding to adverse events using transparency with patients, event analysis, recurrence prevention, and compensation. Collaboration with regulators around CRPs could enhance health care quality.
Setting and participants:
Health care institutions, liability insurers, a...
Background: Notwithstanding near-universal agreement on the theoretical importance of truthfulness, empirical research has documented gaps between ethical norms and physician behaviors. Although prior research has explored situations in which physicians may not be truthful with patients, it has focused on contexts within specialty practice. In this...
Context:
The US medical malpractice system is designed to deter negligence and encourage quality of care through threat of liability.
Objective:
To examine whether state-level malpractice environment is associated with outcomes and costs of colorectal surgery.
Design, setting, and patients:
Observational study of 116,977 Medicare fee-for-servi...
Citations
... But in September 2022, a US federal court ruled in Braidwood Management v. Becerra [7] that requiring private insurers to cover HIV PrEP violates their rights under the Religious Freedom Restoration Act. In particular, the judge ruled that requiring the plaintiffs to purchase insurance that covers PrEP substantially burdened their religious exercise because they believe this requirement facilitated sex between unmarried and same-sex partners and that the Bible condemns such behavior [8]. As contributors to a report challenging the court's ruling [9], we sought to estimate the expected additional HIV transmissions if access to private health insurance coverage for PrEP in the US were curtailed. ...
... Further, combatting vaccine hesitancy as it relates to the COVID-19 vaccines can affect how childhood vaccination efforts are perceived in the future. Given that the COVID-19 pandemic exposed how fragile the public's trust can be of the vaccination industry, a better understanding of the reasons behind vaccine hesitancy is necessary to address and rise above the challenges produced by emerging diseases [31]. It is important to note that the survey was provided to the teachers of interest about 12 months after the vaccine was made widely available in the U.S. With this in mind, there are various strengths and limitations to this study. ...
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... Although it was not stated in the figure presented in this study, several mandates had been already adopted in Indonesia at the time, including the implementation of mandatory vaccine certificates for traveling and entering the public area, such as department stores and public transportation [50]. The mandates were thought to be a promising strategy, as a study in the United States also reported that the major reason 35% of US adults got vaccinated was to participate in recreational activities that require vaccination proof, and 19% got vaccinated because of employer's requirements [53]. This demonstrates how the government and stakeholders hold an impactful role in improving the vaccination program. ...
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... The Notice of Proposed Rulemaking proposes to permit the use and disclosure of Part 2 records based on a single prior signed consent, to expand prohibitions on the use and disclosure of Part 2 records in legal proceedings and to expand patient rights that align with the HIPAA Privacy Rule. The importance of this issue has recently become more visible because of concerns around the protections of reproductive health information following increased abortion restrictions because of the overturning of the Roe versus Wade supreme court case [40,41]. The revisions to Part 2, if enacted, would not only help BHPs engage in interoperability but would also provide greater protection for how sensitive health data can be used in legal proceedings. ...
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... Similarly, during the COVID-19 pandemic, the internet and social media have played a dominant role in public marketing and communication, yet the agency has issued limited guidance about how health information should be regulated on such platforms 10 . Although in some cases the FDA is constrained in its ability to reduce the spread of misinformation by the First Amendment's protections for speech, there is no question that there are steps available to the FDA that would better fulfill its mandate of consumer protection 11 . ...
... Though the evidence is mixed, provider and patient incentives may improve vaccination uptake. 30,34 Provider incentives may be tied to payments to a bundled group of measures that could include overall IMA compliance. Health plans could consider creating incentives specific to the HPV vaccine (either one or both doses), separate from the other adolescent vaccines and well-child visits. ...
... The strategies to influence people's confidence in COVID-19 vaccines include improving healthcare professionals' confidence in vaccines, encouraging healthcare professionals to get vaccinated, and healthcare professionals recommending vaccines to patients [2]. A coordinated, evidence-based education, communication, and behavioral intervention could improve the success of vaccination programs [9]. Pharmacists are among the most accessible and trusted healthcare providers in their communities and are able to provide health information, answer patients' health-and medicine-related questions, address vaccine concerns, correct misinformation, recommend the vaccine, and provide vaccinations to patients [10]. ...