 (TBI) could vary greatly depending on where the individual is treated.

A team, led by Guoyi Gao, MD, Department of Neurosurgery, Renji Hospital, School of Medicine, described the existing standard care procedures for patients with traumatic brain injuries and the ultimate outcomes in China.

Currently, large-scale studies are required to better characterize traumatic brain injuries and identify the most effective treatment approaches.

The prospective, multicenter, longitudinal, observational study dubbed the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) was conducted in 56 neurosurgical centers in China.

The investigators gathered data of patients who were admitted to the hospital with a clinical TBI diagnosis and an indication for CT. The researchers excluded patients who were discharged directly from the emergency room.

The investigators sought primary endpoints of survival on discharge. They applied prognostic analyses to identify predictors of mortality.

Variations in mortality were compared between different centers and provinces within China and mortality was compared with expected mortality, using estimates derived by the CRASH basic model.

Between December 2014 and August 2017, the investigators enrolled 13,627 patients with a traumatic brain injury in the registry. Ultimately, they analyzed data from 13,138 patients from 52 hospitals in 22 provinces.

The majority of patients—9782 (74%)—were male, with a median age of 48 years old.

The median Glasgow Coma Scale (GCS) score was 13. In addition, the leading cause of injury was road-traffic incident (n = 6548; 50%).

A total of 637 individuals (5%) in the study died, including 552 patients (20%) suffering from a severe traumatic brain injury.

The investigators identified age, GCS score, injury severity score, pupillary light reflex, CT findings (compressed basal cistern and midline shift ≥5 mm), presence of hypoxia, systemic hypotension, altitude higher than >500 m, and GDP per capita as factors significantly tied to survival in all patients with TBI.

However, they found variation in mortality in different centers and region. Overall, the expected 14-day mortality was 1116 (13%), but there were 544 (7%) deaths observed within 14 days (observed to expected ratio, 0.49; 95% CI, 0.45-0.53).

 during a professional football player’s career is linked to an increased risk of all-cause mortality.

Among the 13,912 players included in the pfCHII analysis, the median score was 32.63 (interquartile range, 13.71-66.12). A 1-log increase in pfCHII was linked to significant increases in hazard of death for the 1969-2017 seasons (HR, 2.02; 95% CI, 1.21-3.37; 

The quadratic pfCHII was also statistically significant (HR, 0.91; 95% CI, 0.85-0.98; 

This indicates the hazard of death increased at a decreasing rate while the pfCHII increased.

Ultimately, the take home point of the study based in China was that there is a lot of variability amongst the mortality rate of TBI patients depending on where they are hospitalized.

“The results show differences in mortality between centers and regions across China, which indicates potential for identifying best practices through comparative effectiveness research,” the authors wrote. “The risk factors identified in prognostic analyses might contribute to developing benchmarks for assessing quality of care.”

Clinical characteristics and outcomes in patients with traumatic brain injury in China: a prospective, multicenter, longitudinal, observational study

Articles

Approximately 5% of the 13,000 TBI patients examined died during the course of the study.

High Variability Found in Mortality from Traumatic Brain Injuries

Time and time again, the worlds of public health, news, and medicine have merged on the topic of 

. In the last half-decade, matters on vaping effects, rising pollution concerns, and increasing COPD and lung cancer deaths have made headlines.

And in the last 6 months, a respiratory virus has altered global medicine, healthcare and society in unprecedented fashion. Its severity has strained ICU personnel and ventilator resources, and its highly infectious spread has sparked debate over public mask-wearing.

 pandemic has dramatically and irrevocably tipped over the public’s interest in respiratory health, and clinicians face heightened dual tasks: adapt to new parameters set by the virus, and serve as counselors on the developing research of SARS-CoV-2.

As providers of timely and topline clinical news and insights, 

 should provide content which reflects the new agenda of healthcare.

Introducing Lungcast, a new podcast series produced in collaboration with the American Lung Association (ALA). Hosted by chief medical officer Al Rizzo, MD, FACP, the monthly podcast series will feature interviews with world-leading researchers, clinicians, and healthcare experts on the biggest topics in respiratory care.

Every episode will be made available here on 

, as well as on the ALA’s website. Listeners can also subscribe to Lungcast on 

Our first guest is among the most qualified people in medicine to discuss the COVID-19 pandemic: world-leading virologist, AIDS research pioneer, 

1996 Man of the Year, and current coronavirus investigator David Ho, MD.

In an illustrious four-decade medical career bookended by observing the earliest cases of AIDS at Cedars-Sinai Medical Center and now leading his New York-based laboratory in COVID-19 vaccine pursuits, Ho has a world of perspective to share on epidemic response.

From US response failures to promising monoclonal antibodies, and from the caveats of herd immunity to the similarities between early AIDS discovery and COVID-19, listen in on Ho’s insights into the current pandemic.

Podcasts

World-leading virologist and AIDS researcher David Ho, MD, joins the inaugural podcast episode.

COVID-19 Complications & Searches for a Cure with Dr. David Ho

The global prevalence of irritable bowel syndrome (IBS) could be lower based on how stringent a criteria researchers use.

A team, led by Priya Oka, MBBS, Leeds Gastroenterology Institute, St James's University Hospital, determined the true global prevalence of irritable bowel syndrome.

While IBS represents one of the most common functional bowel disorders, community prevalence can vary widely between different countries. This variation might be explained by previous cross-sectional surveys that neither applied uniform diagnostic criteria or used identical methodology, rather than being due to true global variability.

In the systematic review and meta-analysis, the investigators identified data from all population-based studies using relatively uniform methodology. These studies used only the most recent iterations of the Rome criteria—Rome III and Rome IV.

The team searched several databases to identify cross-sectional surveys reporting the prevalence of irritable bowel syndrome in adults, according to the Rome III or Rome IV criteria.

The researchers also performed a manual search of a selection of conference proceedings for relevant abstracts published between 2006-2019.

They then extracted the prevalence data for all found studies, according to the criteria used to define the presence of IBS. In the meta-analysis, the investigators estimated pooled prevalence rates, according to study location and certain other characteristics such as sex and IBS subtype.

Overall, they identified 4143 citations, of which 57 studies were deemed eligible involving 92 separate adult populations totaling 423,362 participants. The pooled disease prevalence of IBS in the 53 studies from 38 countries involving 395,385 participants using the Rome III criteria was 9.2% (95% CI, 7.6-10.8; 

On the other hand, the pooled IBS prevalence from 6 studies in 34 countries involving 82,476 individuals using the Rome IV criteria was 3.8% (95% CI, 3.1-4.5; 

The investigators discovered that IBS mixed bowel habit was the most common subtype in the Rome III criteria studies. This was reported by 33.8% (95% CI, 27.8-40.0; 2=98.1%) of patients fulfilling criteria for IBS (ie, 3.7% [2·6–4·9] of all included participants had IBS-M).

However, IBS with diarrhea was the most common subtype with the Rome IV criteria (reported by 31.5% [95% CI, 23.2–40.5; 

 2= 98.1% 61.6%] of people with IBS, corresponding to 1.4% [0.9–1.9] of all included participants having IBS-D).

The investigators also found higher rates of IBS in women than males (12.0% [95% CI, 9.3–15.0] 

 8.6% [6.3–11.2]; OR, 1.46 [95% CI, 1.33–1.59]).

Prevalence also varied significantly between individual countries. This variability persisted even when the same diagnostic criteria was applied and identical methodology was using in studies.

“Even when uniform symptom-based criteria are applied, based on identical methodology, to define the presence of IBS, prevalence varies substantially between countries,” the authors wrote. “Prevalence was substantially lower with the Rome IV criteria, suggesting that these more restrictive criteria might be less suitable than Rome III for population-based epidemiological surveys.”

Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis,

There is a higher prevalence of IBS found in women than men.

Irritable Bowel Syndrome Rates Might Be Lower Than Previously Thought

 reaching the US, emergent medicines and equipment were quickly lacking. As much stress was put on social distancing parameters and protocol to expedite promising agents against the virus, there was an even greater call for often relied-upon resources.

Take, for example, blood. By March 17, the American Red Cross announced a severe blood shortage due to mass cancellation of donor drives. The situation highlighted a significant issue now unique to the COVID-19 pandemic: the virus affected non-patients as severely as it does infected persons.

Blood transfusions, a routinely critical facet of 

 care, were at risk of lacking their most precious commodity.

One way to combat the matter was emphasizing use of therapies that reduced the need for transfusions. Newest sickle cell disease therapy voxelotor (Oxbryta) fit that bill.

In the next segment of an interview with 

, Richard Drachtman, MD, clinical section chief of Pediatric Hematology/Oncology at Rutgers Medicine, discussed how the recently-approved agent came into benefit for prescribing early into the pandemic.

It’s already often the mindset of a hematologist to over-value donor blood. Once COVID-19 began to limit its availability further—especially in hard-hit areas including Drachtman’s New Brunswick, NJ—it became a responsibility to reduce the need for patient transfusions.

“Use of voxelotor has allowed me to do that,” Drachtman said. “In this time, it’s like ‘The Omega Man’ practicing medicine, driving to work in an empty town. It really has helped quite a bit.”

In Drachtman’s practice, patient volume has recently begun to increase. But transfusion need has remained low due to agents including voxelotor.

“It gives you one more option of being able to avoid transfusions in this one population of patients,” he said.

Videos

The pandemic has burdened blood drives nationally. A new sickle cell drug keeps patients from needing as many transfusions.

How Voxelotor Benefits the Blood Shortage

The ability to communicate with family members and other loved ones can be extremely difficult for patients suffering from a 

While in-person training for both the patient and communication partner has shown benefits in the past, with the advent of new technology, telehealth might be another option.

A team, led by Rachael Rietdijk, BAppSc, Faculty of Health Sciences, The University of Sydney,investigated the efficacy of telehealth-based and in-person social communication skills training for individuals with moderate-to-severe traumatic brain injuries based on outcomes reported by the survivor and a close communication partner.

The standard program often involves 35 hours of intervention consisting of a combination of group sessions and dyad sessions that are attended by both the injured patient and their communication partner. However, telehealth could allow a more expansive therapy service be reducing some of the time constraints linked to in-person training.

The partially randomized controlled trial contained a telehealth intervention group using a program called TBIconneCT, an in-person intervention group that uses the TBI Express therapy program, and a historical control arm.

The investigators examined 51 adults at least 6 months following a moderate or severe traumatic brain injury. Each patient had exhibited some communication skills deficits. The investigators also utilized communication partners, including family members, friends, and paid care of the injured individual.

The investigators sought main measures of La Trobe Communication Questionnaire total score, as well as the number of items with perceived positive change.

The researchers found trained participants had significantly more items with perceived positive change than the historical controls did. There was also a medium effect size in the sample observed for improvements in total score reported by trained communication partners following treatment.

Comparisons between telehealth and in-person groups showed medium to large effect sizes in the sample. This favored the telehealth group on certain La Trobe Communication Questionnaire variables.

“Whether delivered via telehealth or in-person, social communication skills training led to perceived positive change in communication skills,” the authors wrote. “It was unexpected that outcomes for the telehealth group were better than for the in-person group on some variables.”

Providing communication partners with skills can help enable those suffering from traumatic brain injuries to have effective conversations and create a more positive daily communication environment.

This training involves focusing on addressing negative patterns that communication partners may use in conversations with patients with TBI, including failing to follow up on the person's contributions, not giving enough information to support the person's comprehension, using questions designed to test the person's memory rather than asking for meaningful information, and querying the person's accuracy.

Training can facilitate collaborative interactions between the person with TBI and communication partners.

A Clinical Trial Investigating Telehealth and In-Person Social Communication Skills Training for People With Traumatic Brain Injury: Participant-Reported Communication Outcomes

The Journal of Head Trauma Rehabilitation

A telehealth group showed better outcomes than an in-person training group for some variables of communication skills for individuals who suffered a traumatic brain injury.

Telehealth Helps Traumatic Brain Injury Patients Recover Communication Skills

The indication is the fifth for ustekinumab (STELARA)

The approval was based on 12-week outcomes in skin clearance

Ustekinumab is dosed 4 times annually after 2 starter doses

The US Food and Drug Administration (FDA) has approved an expanded indication for ustekinumab (STELARA) as a treatment for pediatric patients aged 6-11 years old who have skin lesions or plaques associated with 

The injection interleukin-12 and -23 (IL-12; IL-23) inhibitor becomes the first biologic approved to target such pathways in this patient age population. It was approved based on the results of the CADMUS Junior study, an open-label, single-arm, multicenter phase 3 clinical in which 44 patients with moderate to severe plaque psoriasis were assessed.

Investigators observed that 77% of treated patients achieved clear or almost clear skin at week 12, following their second dose of ustekinumab. In secondary endpoints, 84% and 64% of treated patients achieved Psoriasis Area and Severity Index (PASI) scores of 75 and 90, respectively, at week 12.

The observed ustekinumab safety profile was similar to that observed in adults with plaque psoriasis.

As an injection therapy dosed 4 times annually after 2 starter doses, ustekinumab has been previously approved by the FDA for the treatment of adults and pediatric patients with moderate to severe plaque psoriasis who are phototherapy of systemic therapy candidates; adultsvwith active psoriatic arthritis; adults with Crohn’s disease; and adults with moderalty to severe active ulcerative colitis.

As plaque psoriasis presents variably in patients, clinicians face a challenge in both diagnosing and treating the chronic condition, Stacie Bell, PhD, Chief Scientific and Medical Officer of the National Psoriasis Foundation, said.

“Especially in the pediatric population, it is important for patients, parents and physicians to work together to identify an appropriate treatment,” Bell said in a 

 “The approval of new treatment options is an exciting step forward to address the unmet needs of children living with psoriasis.”

The expansion makes history for the injection biologic.

FDA Expands Ustekinumab to Pediatric Plaque Psoriasis

There are high costs related to US Food and Drug Administration (FDA)-approved anti-VEGF agents for 

neovascular age-related macular degeneration

 (nAMD). However, step-therapy requiring initial treatment with bevacizumab is currently being proposed nationally.

This proposal is not without controversy, as some do not believe in the efficacy of bevacizumab step-therapy.

A team, led by Jonathan Siktberg, BBA, examined the efficacy of bevacizumab step-therapy to treat neovascular age-related macular degeneration. The findings of the research presented were at the 

American Society of Retina Specialists (ASRS 2020) Virtual Sessions

The researchers performed a retrospective cohort study of the step-therapy protocol at the Vanderbilt University School of Medicine, which was instituted in 2012. The investigators analyzed the clinical course of 133 patients meeting the inclusion criteria of being treated within the nAMD step-therapy protocol with at least 3 consecutive monthly injections of bevacizumab from January 2012 to August 2018.

The team excluded patients if they had past intraocular surgery other than cataract surgery. The age range was 59-106.

The investigators sought primary outcomes of the success rate of the step-therapy, defined as achieving a stable injection regimen without the recurrence of neovascular age-related macular degeneration, the loss of 3 or more Snellen chart lines, or requirement of switching to an FDA-approved anti-VEGF agent.

Of the 133 patients in the study, 106 (80%) achieved treatment stability on the study drug and 70 (53%) were stable on injections every 8 weeks or longer. In addition, 36 patients (27%) required injections more frequently than every 8 weeks. For the 27 patients who failed, 14 did not switch to another drug and 13 were switched to aflibercept.

“We conclude that treatment of neovascular AMD with a regimen consisting of bevacizumab as first-line therapy is efficacious with only a minority of patients meeting failure criteria,” the authors wrote. “Given the cost-savings associated with bevacizumab compared to FDA-approved alternatives, providers should consider bevacizumab as first-line for the treatment of neovascular AMD.”

Findings of a recent study demonstrate dexamethasone implant and anti-vascular endothelial growth factor (VEGF) treatment may be useful in 

Raja Narayanan, MD, MBA, and a team of investigators evaluated the efficacy of combination dexamethasone implant and anti-VEGF therapy in eyes resistant to anti-VEGF monotherapy in age-related macular degeneration in an Asian population. A retrospective study was conducted among 16 patients (17 eyes) who were resistant to anti-VEGF injections. Cases were resistant if they had less than 10% reduction in macular thickness on optical coherence tomography.

Narayanan reported a significant reduction in macular edema as seen on optical coherence tomography. The mean thickness reduced from 612.05 microns to 306.81 microns at the last visit, which was statistically significant (

The visual acuity was not statistically significant from baseline at 1 month and last follow-up. The mean injection-free interval in patients after the dexamethasone implant was 169.8 days, which was significantly greater than the pre-injection mean of 35.2 days (

Efficacy of Bevacizumab Step-Therapy for Age-Related Macular Degeneration

There has been controversy over the efficacy and safety of step-therapy for neovascular age-related macular degeneration. 

Bevacizumab Step-Therapy Efficacious on nAMD Trial

Investigators have challenged the belief that 

 is a common cause of mortality, based on their new findings from a systematic review and meta-analysis of trials which observed the causal effect of VTE reduction on patient mortality.

In new findings from an analysis of large-scale, randomized, controlled trials, a team of US-based investigators reported an insignificant evidence of VTE effect on overall mortality.

The team, led by Nicholas D. Klemen, MD, of the Memorial Sloan Kettering Cancer Center, also challenged the utility of composite endpoints in VTE prevention assessments based on their findings.

Their systematic review and meta-analysis included research into randomized, controlled trials published in 1 of 4 databases from January 1993- March 2018. Eligible studies included patients who were at elevated VTE risk, and were assigned randomly to either anticoagulant or antiplatelet therapy versus placebo or no therapy.

Trials including an active control agent were excluded, as they may mitigate the understood lethality of VTE. Investigators also excluded trials for which mortality data were unavailable.

Meta-analysis heterogeneity was modeled via Bayesian framework. Overall mortality served as the primary endpoint; pulmonary embolism, fatal pulmonary embolism, and major patient bleeding were secondary endpoints.

“We focused our analyses on studies reporting statistically significant effects of prevention on venous thromboembolism endpoints,” Klemen and colleagues wrote.

Of the screened 4229 studies, 86 were identified as eligible randomized, controlled trials. From those, 52 were positive—and showed through data from 70,000-plus patients a significantly increased risk of VTE in control patients versus treatment arms (RR, 2.74; 95 CI%, 2.32-3.31; 

Through the meta-analysis, Klemen and colleagues observed a non-impactful causal effect of VTE prevention mortality: control group mortality included 3391 (9.8%) patients, while treatment arm mortality included 3498 (9.8%) (RR, 1.01; 95% CI, 0.97-1.06; 

 = .58). Investigators additionally observed low heterogeneity.

Regarding secondary endpoints, control patients were actually less likely to report major bleeding than treated patients (RR, 0.60; 95% CI, 0.47-0.75; 

However, investigators did observe a greater rate of overall pulmonary embolism (RR, 2.22; 95% CI 1.78-2.89; 

 <.0001) and fatal pulmonary embolism (RR, 1.58; 95% CI, 1.14-2.19; 

 = .01) in control patients versus treatment arms.

The team’s meta-analysis of the additional 34 negative trials showed similar results across all endpoints, though fatal pulmonary embolism’s effect on control versus treated patients was observed to be weaker.

The new findings come at a time when major organizations including the American Heart Association (AHA) and International Society on Thrombosis and Hemostasis (ISTH) just recently called for the advancement of preventive VTE research—noting a 2008 Surgeon General’s Call to Action for improved VTE care that went largely unanswered more than a decade ago.

 regarding the AHA and ISTH statement, Maja Zaric, MD, interventional cardiologist and assistant professor at Zucker Medical School, discussed the complicated network of morbidities associated with VTE—including pulmonary embolisms and bleeding risks.

In some instances, more than 50% of patients are at risk of such additional burdens.

“I don’t think we’ve moved an iota since 2008 in terms of dropping those numbers down to a measurable level,” Zaric said. “The research has been done…we can’t say there hasn’t been any effort to do so.”

Given the new findings from Klemen and colleagues, there may be reason to look more closely into these conflicting comorbidities than VTE itself.

“The perception that venous thromboembolism is a common cause of mortality should be revised considering the null effect of venous thromboembolism prevention on mortality,” they concluded. “Our findings call into question the use of composite endpoints in venous thromboembolism-prevention trials and provide rationale for de-escalation trials.”

Mortality risk associated with venous thromboembolism: a systematic review and Bayesian meta-analysis

A new systematic review and meta-analysis challenges the notion that preventing VTE is associated reduced mortality risk.

VTE May Not Be Significant Driver of Death

Every facet of care and every regular gathering of medical fellows has been thrown off its axis by the ongoing coronavirus 2019 (COVID-19) pandemic.

Telemedicine has entered the fold in areas where in-person healthcare can be avoided, and clinicians have become investigators to their own daily practices.

The pandemic’s effect on 

 is no less interesting than any other specialty, as clinicians are faced with an older patient clientele.

“We’ll see how that plays out in the coming months and years, but I suspect through this crisis, I think it’ll be pretty much be business as usual with taking care of patients,” W. Lloyd Clark, MD, told 

.

In the final segment of an interview with 

American Society of Retina Specialists (ASRS) 2020 Virtual Meeting

 this weekend, Clark, of the Palmetto Retinal Center, discussed how the implementation of retina-based care technology has been slow the last few months, with the hoped-for platforms just not yet being available.

Nonetheless, Clark praised the role of technology in meetings like ASRS 2020 itself, noting the “social, collegial, cohesive” nature of the retina clinicians who regularly attend the meeting and looked forward to the weekend of online connection.

“Some of the smaller meetings have been very creative, entertaining, a lot of fun to participate in,” Clark said. “There’s been some appetite to get online and see our colleagues. Because we are, as a specialty, used to meeting a lot, and used to seeing our colleagues. There’s been a desire to reconnect.”

A perspective on what's moved virtually, and what hasn't, since the pandemic began in March.

How Ophthalmology Has Evolved During COVID-19

US Food and Drug Administration (FDA) granted approval to voxelotor (Oxbryta)

, a deoxygenated sickle hemoglovin polymerization inhibitor, for the treatment of 

The therapy was touted for its ability to reduce sickle cell binding, showing a 51.1% hemoglobin response rate among patients administered 1500 mg dose in the pivotal trial included in the FDA submission.

So, nearing 1 year as an available therapy in an at-need field, where does voxelotor stand now?

, Richard Drachtman, MD, professor of Pediatrics and Clinical Section Chief of Pediatric Hematology/Oncology at Rutgers Medical, discussed his own excitement surrounding the original voxelotor approval—and his own experiences in prescribing and caring for patients with sickle cell.

“It’s been a very interesting time,” Drachtman told 

. “We’ve been prescribing it since late December-early January, and we’re seeing some very good results.”

Drachtman explained he had his own “short list” of patients he anticipated would benefit most from the new therapy once it was marketed: those with the lowest hemoglobin counts and hemolytic characteristics.

Included among those patients were the 10% to 20% of all sickle cell disease patients with primary hemolysis—who are often subjected to burdensome blood transfusions.

Drachtman also set parameters for discussing voxelotor with potentially eligible patients based on hemoglobin levels. It’s now that he’s beginning to see the impact of the new therapy which he prescribed to patients 2-3 months ago.

“We’re seeing in the patients who had very low hemoglobin levels and were very hemolytic to start significant rises in hemoglobin and significant drops in bilirubin,” he explained. “We’re seeing them not needing transfusions anymore, or to the same degree. We’re seeing significant changes in the use of healthcare, as a result.”

How has the new agent fared in its indicated patients in its first year on the market?

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