NEJM Perspective Podcast on the Future of Transgender Insurance Coverage

Posted by • May 19th, 2017

In this episode of the NEJM Perspective Audio Interview series, Kellan Baker, a senior fellow at the Center for American Progress, speaks with NEJM Managing Editor Stephen Morrissey on the past and future of insurance coverage for transgender people. As a small, poorly understood population, transgender people frequently encounter discrimination that includes mistreatment by health care providers, rejection by employers, and harassment in restrooms and other places of public accommodation. These experiences exacerbate health disparities such as high rates of depression, anxiety, exposure to violence, and HIV infection.

However, as Baker explains, it was not always this way. As early as the 1960s, American universities and hospitals began making strides towards providing equal care to all people, regardless of gender identity. This progress continued into the 1980s, but was halted when an exclusion on gender transition related coverage was introduced to the Medicare and Medicaid programs. These exclusions often left gender dysphoria patients without coverage, but were approved in part because they allowed employers to lower the cost of employee insurance coverage.

In recent years, pressure has been placed on health care providers, insurance companies, and government agencies to recognize gender dysphoria as a medical condition, and progress has been made toward standardized services related to gender transition. Baker acknowledges the progress, but says the highly bipartisan landscape of today has left transgender people without a solid way of getting the coverage they need.

Baker gives us a glimpse into how he believes recent events surrounding the topic — including court cases, independent research studies and examples of government intervention in insurance coverage provided by large employers — will shape the future of how transgender people are able to safely and cost-effectively go through gender transition. To listen to the full podcast, click here.

To listen and to more interviews in our archive and subscribe to our Perspective Audio Interview series, click here.

New Review Article Looks at Collaborations among Researchers, Patient Groups, and Industry

Posted by • May 10th, 2017

A growing approach to developing new treatments is a partnership among researchers, patient groups, and industry. A new article in the Clinical Trials review series gives three examples of such collaborations.

“In an era of reduced federal funding for basic and preclinical research and drug development (coupled with a higher bar for regulatory compliance),” the authors write, “the challenges that many medical professionals are routinely faced with continue to remain daunting and require new and collaborative approaches for ongoing success.” This article explains how such collaborations have helped to bridge the preclinical phase to early human research trials.

In the article, the authors describe three examples — in cystic fibrosis, multiple myeloma, and type 1 diabetes — when academic institutions, industry partners, federal agencies, and disease-focused foundations shared relevant information. “In each of the cited cases,” write the authors, “none of the major advances could have occurred in a timely manner if the partners had worked independently.”

The Changing Face of Clinical Trials series is a collection of review articles that examine the current challenges in the design, performance, and interpretation of clinical trials. Read more articles in the series here.

Three New Perspective Articles on Data Sharing

Posted by • April 28th, 2017

From “Learning What We Didn’t Know — The SPRINT Data Analysis Challenge”

This week, the New England Journal of Medicine released three new Perspective articles highlighting different discussions surrounding the sharing of clinical trial data in medicine.

The first, Bridging the Data-Sharing Divide — Seeing the Devil in the Details, Not the Other Camp, explains how the movement toward sharing data from clinical trials has divided the scientific community, and that the battle lines were evident the recent summit sponsored by NEJM. On one side stood many clinical trialists, whose lifeblood — randomized, controlled trials (RCTs) — may be threatened by data sharing. On the other side stood data scientists — many of them hailing from the genetics community, whose sharing of data markedly accelerated progress in that field.

Whose Data Are They Anyway? Can a Patient Perspective Advance the Data-Sharing Debate? explores the patient perspective on data sharing. Most patients haven’t thought much about data sharing, according to Sara Riggare, an engineer and doctoral student at the Health Informatics Center at Karolinska Institutet in Stockholm, but those who have “find the current system unreasonable. Patients expect that health care professionals and researchers use patient data in the best possible way.” Perhaps, seeing clinical trial data as the property of each patient might simplify the data-sharing discussion.

To better understand the complexities and potential benefits of data sharing, the Journal, with the assistance of the Harvard Medical School Department of Biomedical Informatics, sought to create a practical example of sharing data in the context of clinical trials, which became the SPRINT Data Analysis Challenge. The final article released this week, Learning What We Didn’t Know — The SPRINT Data Analysis Challenge, helps us decide how this contest helped to solve the question of  whether a clinical trial data set could be used by other investigators to produce new findings.

There’s Still Time to Participate in Clinical Decisions: Management of Sciatica

Posted by • April 3rd, 2017

Time hasn’t run out to participate in our last Clinical Decisions article discussion, Management of Sciatica. You have through April 5th to vote and discuss on whether you would recommend Mr. Winston, a 50-year-old bus driver who has come to your office with a 4-week history of pain in his left leg and lower back, undergo lumbar disk surgery or receive nonsurgical therapy. Read the entire case to make sure you have enough information to make an informed decision, then vote for the option that you would recommend for Mr. Winston. Participate here!

Clinical Decisions are a great way to help you evaluate treatment options and gain insight from colleagues. The articles include a case vignette, plus clinically acceptable management options, each supported in a short commentary by a respected clinician. You are invited to vote for, and comment on, the options at NEJM.org, where a diverse range of thinking is presented. Browse previous Clinical Decisions articles here!

 

New NEJM Articles on Data Sharing, and Still Time to Register for #NEJMDataSummit

Posted by • March 31st, 2017

Two new articles that explore data sharing were published by NEJM this week. The first, a Sounding Board article titled Data Authorship as an Incentive to Data Sharing, explains how designating a “data author” in clinical trials could help solve the major issue of providing academic credit to investigators who gather data in these trials. The other, a Special Article titled Use of the National Heart, Lung, and Blood Institute Data Repository, offers insight into the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) of the National Heart Lung and Blood Institute’s (NHLBI). The BioLINCC handles the preparation, presentation and use of clinical data. Depending on the complexity of the study, data preparation can take anywhere from 85 to 350 hours, showing that it is a very intense and significant step in data sharing.

Speaking of data sharing… there’s still time! If you want to be able to participate in this unique opportunity to make meaningful contributions to our free web event on Sharing Clinical Trial Data, don’t forget to sign up now. Where else will you be given the opportunity to engage with leading experts in moderated Q&A sessions, share your perspective in online working groups, and help explore possible solutions for the responsible sharing of data? Sound interesting? Sign up here.

New Clinical Decision Article: Management of Sciatica

Posted by • March 27th, 2017

In this week’s Clinical Decision, a 50-year-old bus driver comes to you with a 4-week history of pain in his left leg and lower back. He describes a combination of severe sharp and dull pain that originated in his left buttock and radiated to the dorsolateral aspect of his left thigh, as well as vague aching over the lower lumbar spine. After the first visit, you prescribe 150 mg of pregabalin per day, which is gradually increased to 600 mg daily because the symptoms had not abated.

Ten weeks after the initial onset of his symptoms, he returns for an evaluation. The medication has provided minimal alleviation of his sciatic pain. You discuss options for the next steps in managing his sciatica, but he is uncertain about invasive procedures such as lumbar disk surgery even though he feels limited by his pain.

What steps should you take next? Read the opinions, share your comments, and vote now!

Clinical Decisions are a great way to help you evaluate treatment options and gain insight from colleagues. The articles include a case vignette, plus clinically acceptable management options, each supported in a short commentary by a respected clinician. You are invited to vote for, and comment on, the options at NEJM.org, where a diverse range of thinking is presented. Browse more Clinical Decisions articles here!

Registration Now Open for Free Web Event on Sharing Clinical Trial Data

Posted by • March 20th, 2017

On March 7th, the New England Journal of Medicine named three teams hailing from universities in Israel and the United States as the winners of the SPRINT Data Analysis Challenge, which encouraged participants to explore and examine the potential of sharing clinical trial data. Open to health care professionals, researchers and data scientists, NEJM asked individuals and groups to analyze the dataset underlying the SPRINT article, “A Randomized Trial of Intensive versus Standard Blood-Pressure Control,” and challenged them to identify a novel scientific or clinical finding.

Hear what was learned from the SPRINT Challenge directly from the SPRINT PIs, data analysts, patient participants, and the NHLBI repository and view the SPRINT Challenge winners present their findings at the NEJM Aligning Incentives for Sharing Clinical Trial Data summit and free live web event on April 3-4, 2017.

NEJM invites you to participate in this open conversation. Join our expert speakers in panel discussions featuring clinical trialists, data analysts, and patient participants, as well as government and funding agencies. These moderated Q&A sessions give you a chance to share your expertise on the subject.

Together, let’s examine the potential for data sharing to teach us things we did not know, to maximize the contribution of patients who put themselves at risk, and to make a positive impact on health outcomes. Make sure to sign up here before April 3rd!

What’s New: SPRINT Data Analysis Challenge Winners Announced

Posted by • March 15th, 2017

On March 7th, the New England Journal of Medicine named three teams hailing from universities in Israel and the United States as the winners of the SPRINT Data Analysis Challenge, which encouraged participants to explore and examine the potential of sharing clinical trial data. Open to health care professionals, researchers and data scientists, NEJM asked individuals and groups to analyze the dataset underlying the SPRINT article, “A Randomized Trial of Intensive versus Standard Blood-Pressure Control,” and challenged them to identify a novel scientific or clinical finding.

Overall, 200 individuals and teams qualified to participate in the Challenge with NEJM receiving 143 submissions of novel findings based on the SPRINT data set. These entries, representing countries from around the world, were judged based on the findings’ originality and novelty, the utility of those findings to clinical medicine, and the quality and clarity of the methods used.

The multidisciplinary panel of judges were comprised of expert representatives from the clinical trial community: researchers, patient advocates and data scientists (the full list of judges can be found here). The final results were also open to evaluation by the Challenge’s more than 16,000 followers for crowd voting, which contributed to 10 percent of the total scoring.

The winners of the SPRINT Data Analysis Challenge were:

These three winning SPRINT Challenge teams will present their findings at the NEJM Aligning Incentives for Sharing Clinical Trial Data summit and free live web event on April 3-4, 2017. With the Aligning Incentives summit, NEJM aims to initiate an open and balanced discussion among clinical trials’ three key constituencies — clinical trialists, data analysts and patient participants — as well as the government and funding agencies that support research.

Join the conversation and register to attend the free web event.  Watch the SPRINT Challenge winners’ presentations and hear what was learned from the SPRINT Challenge directly from the SPRINT PIs, data analysts, patient participants, and the NHLBI depository. Visit http://events.nejm.org to view the agenda and expert speaker line up.

 

New Clinical Problem-Solving: Histology Rings True

Posted by • March 7th, 2017

In this week’s Clinical Problem-Solving Case, a 58-year-old man with nonerosive rheumatoid arthritis who was being treated with etanercept and methotrexate presented to the emergency department with a 2-week history of fevers (temperatures up to 39°C) and drenching night sweats. In the previous week, yellowing of his eyes and dark urine had developed. He reported no dyspnea, abdominal pain or distention, nausea, vomiting, dysuria, easy bruising, headache, or myalgias. What should be done? A new Clinical Problem-Solving article explains.

In this Journal feature, information about a real patient is presented in stages to an expert clinician, who responds to the information, sharing his or her reasoning with the reader. Click to read more about this case, including expert author commentary, on NEJM Resident 360.

New Quick Take: Inhibiting Plasma Kallikrein for Hereditary Angioedema Prophylaxis

Posted by • February 28th, 2017

This week’s Quick Take video describes how patients with hereditary angioedema with C1 inhibitor deficiency may have recurrent, unpredictable swelling episodes that require immediate treatment. However, current options for these patients are limited by side effects. Is there a safe and effective therapy? Take less than three minutes and find out!

Quick Take videos are a great way to quickly become familiar with the key findings of select Original Articles. This collection of brief video summaries, updated weekly, offers a succinct, innovative way to understand important article findings that have an impact on medical practice and patient care. Look for a new video each week in the featured article, or browse the collection from the Articles & Multimedia tab on NEJM.org.