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Friday, June 1, 2018

Mobile app for autism screening ‘yields useful data’

Mobile app for autism screening yields useful data
An iPhone app that helps screen young children for signs of autism creates landmarks on the child’s face for software analysis of her facial expressions. Credit: Duke University
A Duke study of an iPhone app to screen young children for signs of autism has found that the app is easy to use, welcomed by caregivers and good at producing reliable scientific data.
The study, described June 1 in an open access journal npj Digital Medicine, points the way to broader, easier access to screening for autism and other neurodevelopmental disorders.
The app first administers caregiver consent forms and survey questions and then uses the phone’s ‘selfie’ camera to collect videos of young children’s reactions while they watch movies designed to elicit autism risk behaviors, such as patterns of emotion and attention, on the device’s screen.
The videos of the child’s reactions are sent to the study’s servers, where automatic behavioral coding software tracks the movement of video landmarks on the child’s face and quantifies the child’s emotions and attention. For example, in response to a short movie of bubbles floating across the screen, the video coding algorithm looks for movements of the face that would indicate joy.
In this study, children whose parents rated their child as having a high number of autism symptoms showed less frequent expressions of joy in response to the bubbles.
Autism screening in  is presently done in clinical settings, rather than the child’s natural environment, and highly trained people are needed to both administer the test and analyze the results. “That’s not scalable,” said New York University’s Helen Egger, M.D., one of the co-leaders of the study.
This study, from informed consent to data collection and preliminary analysis, was conducted with an app available for free from Apple Store and based on Apple’s ResearchKit open source development platform.
In one year, there were more than 10,000 downloads of the app, and 1,756 families with children aged one to six years participated in the study. Parents completed 5,618 surveys and uploaded 4,441 videos. Usable data were collected on 88 percent of the uploaded videos, demonstrating for the first time the feasibility of this type of tool for observing and coding behavior in natural environments.
“This demonstrates the feasibility of this approach,” said Geraldine Dawson, Ph.D., Director of the Duke Center for Autism and Brain Development and co-leader of the study. “Many caregivers were willing to participate, the data were high quality and the video analysis algorithms produced results consistent with the scoring we produce in our autism program here at Duke.”
An app-based approach can reach into underserved areas better and make it much easier to track an individual child’s changes over time, said Guillermo Sapiro, Edmund T. Pratt, Jr. School Professor of Electrical and Computer Engineering at Duke and a co-leader of the study.
“This technology has the potential to transform how we screen and monitor children’s development,” Sapiro said.
The reported project was a 12-month study. The entire test took about 20 minutes to complete, with only a few minutes involving the child.
The app also included a widely used questionnaire that screens for autism. Based on the questionnaire, participating families received some feedback from the app about what the child’s apparent risk for autism might be. If parents reported a high level of  symptoms on the questionnaire, they were encouraged to seek further consultation with their health care providers.
More information: Helen L. Egger et al, Automatic emotion and attention analysis of young children at home: a ResearchKit autism feasibility study, npj Digital Medicine (2018). DOI: 10.1038/s41746-018-0024-6
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AbbVie: Phase 3 lymphoma data suggest improved treatment outcomes


AbbVie announced findings from an interim analysis of the Phase 3 iNNOVATE study evaluating IMBRUVICA plus RITUXAN in previously untreated and relapsed/refractory patients with Waldenstrom’s macroglobulinemia, a rare type of non-Hodgkin’s lymphoma. At a median follow up of 26.5 months, the study successfully met its primary endpoint, demonstrating a significant improvement in progression-free survival with ibrutinib plus rituximab compared to rituximab alone. Patients taking ibrutinib plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab. Additionally, the data found that the combination with ibrutinib provided reductions in infusion reactions associated with rituximab and immunoglobin M flare. “The iNNOVATE study provides further evidence of the potential clinical benefit of IMBRUVICA-based combination therapy in patients with Waldenstrom’s macroglobulinemia,” said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company. “The data from this chemotherapy-free combination regimen suggests that patients with Waldenstrom’s macroglobulinemia, including those who are newly diagnosed, could have another beneficial therapeutic option in the future.”
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Mylan, Biocon have results from breast cancer biosimilar study at ASCO


Mylan and Biocon announced that 48-week results from the HERITAGE study will be presented at the 2018 American Society of Clinical Oncology, or ASCO, annual meeting. The HERITAGE study compared Ogivri, the first biosimilar for Herceptin approved in the U.S., to the reference product in patients with metastatic breast cancer in combination with taxanes for the first 24 weeks and then as a monotherapy until progression. Data obtained after 48 weeks of treatment will be included as part of the Clinical Science Symposium titled, “The Arrival of Biosimilars”.
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Newly US-Approved Nonopioid Med Blunts Drug Withdrawal Symptoms


Lofexidine (Lucemyra, US Worldmeds), which has been in use in the United Kingdom for more than 20 years, is now available in the United States. The drug is used in the management of symptoms of severe opioid withdrawal.
Dr Danesh Alam
In a double-blind, placebo-controlled, multicenter trial in opioid-dependent patients, lofexidine significantly improved opioid withdrawal symptoms and significantly increased completion of a 7-day opioid discontinuation treatment program compared with placebo.
“We desperately need something to address the opioid crisis, where we are losing about 100 Americans every day, with some 16 million on opioids,” Danesh Alam, MD, Northwestern Medicine Central Dupage Hospital, Winfield, Illinois, told Medscape Medical News.
“Now we have a drug that actually enables us to achieve a rapid withdrawal from opioids. When we use lofexidine, we can literally bring in someone using opioids, give them this drug, and they can immediately stop using opioids,” said Alam.
The study was presented at the American Society for Clinical Psychopharmacology (ASCP) 2018.

A Better Alternative

Currently, the standard of care for the treatment of opioid withdrawl is medication-assisted therapy with buprenorphine (multiple brands), but many patients wish to stop using opioids completely, Alam said.
“Buprenorphine is essentially another opioid, albeit a designer opioid, but a number of patients object to clinicians saying that the best evidence is to switch them over to buprenorphine and do buprenorphine for the rest of their life,” he said.
Lofexidine, a selective alpha-2-adrenergic agonist, acts on the central nervous system. Through its effect on the brain stem, it reduces the symptoms of withdrawal to a point at which they become very tolerable.
“We found in our study that you could basically give patients the lofexidine and stop the opiate. In the majority of cases, the withdrawal symptoms at that point were mild,” Alam said.
The researchers enrolled 602 men and women aged 18 years or older who sought treatment for dependence on short-acting opioids. Most were men (71%); the mean age of the patients was 35 years (±11 years).
Most patients (83%) were dependent on heroin.
Participants were randomly assigned to receive placebo, lofexidine 0.6 mg qid (2.4 mg/day), or lofexidine 0.8 mg qid (3.2 mg/day) for 7 days after abrupt opioid discontinuation.
The study assessed the benefit of lofexidine with the Short Opiate Withdrawal Scale–Gossop (SOWS-G), a 10-item inventory of common opioid withdrawal symptoms in which higher scores indicate worse symptoms; by the percentage of participants who completed the study; and by use of the Clinical Opiate Withdrawal Scale (COWS), an 11-item inventory of opioid withdrawal signs and symptoms in which higher scores indicate worse symptoms.
Scores on the SOWS-G were lower for patients treated with lofexidine at both doses compared to patients given placebo (-0.21 for lofexidine 2.4 mg, P = .02; and -0.26 for lofexidine 3.2 mg, P = .003). More patients in the lofexidine-treated group completed the 7-day trial than in the placebo group (41.5% in the 2.4-mg group (odds ratio [OR], 1.85, P = .007), and 39.6% in the 3.2-mg group (OR, 1.71; P = .02), vs 27.8% for placebo.
Mean COWS scores were significantly lower on days 1 to 5 for patients in the lofexidine groups than for patients who received placebo (P < .01).

Good Timing

The most common side effects seen with lofexidine were hypotension, orthostatic hypotension, and bradycardia, but they resulted in few study discontinuations.
The US debut of lofexidine comes at a crucial time. It was recently granted approval by the US Food and Drug Administration (FDA), as reported by Medscape Medical News.
This approval came after 17 years of hard work on the part of the National Institute on Drug Abuse (NIDA).
Dr Ivan Montoya
“Lofexidine has been used for about 25 years in the UK, and it’s widely used, especially for people who are trying to get detoxified, and the experience has been quite positive,” Ivan Montoya, MD, deputy director of NIDA, told Medscape Medical News.
“We tried to use that experience from the UK to bring the compound to the US, but the FDA needed data collected in the US, so we went through the whole submission and review process with a new drug application, and it took us about 17 years to complete the development. It was a very long process,” Montoya said.
The approval came at the right time, he added.
“It was always going to get approved, but right now there is a bigger sense of urgency, and so approval came at the right time. That’s the beauty of it, that now, in the midst of this crisis, we have this medication, which we were working on for 17 years.”
“NIDA made a very significant investment in this compound. Some $27 million were invested, taxpayers’ money,”
Some clinicians feel that clonidine could also be used in this setting, but Montoya pointed out that lofexidine differs from clonidine in two important ways.
“First, lofexidine appears to produce less hypertension than clonidine, so it’s not as bad as clonidine, and the second and most important is that lofexidine is FDA-approved, physicians can prescribe it, it can be in formularies, it can be reimbursed for, so that’s a very big advantage. That’s why NIDA decided to support the development of lofexidine, to be approved by the FDA for that indication,” he said.
Dr Alam has disclosed no relevant financial relationships. Dr Montoya is an employee of the NIDA.
American Society of Clinical Psychopharmacology (ASCP) 2018. Abstract T1, presented May 31, 2018.
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Returning to Work After Stroke


Factors such as intravenous thrombolysis and occupational therapy at 3 months independently and significantly predicted which patients would be employed 1 year after a first stroke, in a new registry study.
Overall, 34% of patients who were working at the time of their stroke were re-employed at 3 months. However, this proportion decreased to 27% at 1 year, to 25% at 5 years, and to 10% at 10 years.
“Another trend we saw is that patients who returned to work within 1 year were more likely to still be employed at 10 years,” said Arup Sen, MRCP, from the NIHR Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust of Ageing and Health at King’s College London, United Kingdom. “This suggests, in terms of planning post-stroke rehab, the time to get patients back to work would be as soon as possible — and ideally within the first year.”
In addition, a large proportion of the independent patients are not returning to work initially, Sen told Medscape Medical News. Only 39% of the functionally independent patients were back to work at 1 year, although this increased to 47% at 5 years and 69% at 10 years.
“We wanted to look at this in more detail because little is known about the long-term factors affecting return to work at different time points post-stroke,” he said during an ePoster presentation here at the 4th European Stroke Organisation Conference (ESOC) 2018. The researchers defined functional independence as a Barthel Index score greater than 90.
Sen and colleagues reviewed data for 5609 multiethnic urban patients from 2005 to 2014 from the South London Stroke Registry maintained by the Royal College of London. They further evaluated the 940 patients, or 17%, who were employed at the time the stroke occurred.

Emotional Toll of Returning to Work

The investigators also assessed anxiety and depression by using scores on the Hospital Anxiety and Depression Scale and 12-Item Short-Form survey at 1, 5, and 10 years. Potential long-term negative emotional consequences associated with a return to work emerged.
People who returned to work after stroke were statistically significantly more likely to experience anxiety and depression at 1 year (P < .01) and 5 years (P < .05) than those who did not.
“It’s paradoxical,” Sen said. “Previous studies have shown that return to work is seen as a recovery milestone.”
“Although patients are physically ready to go back to work, there may be other reasons for increased stress levels around going back to work,” he said, “such as lack of coping or adaption, social factors or workplace factors such as the work climate.”
Returning to work is a dynamic, multifaceted process that is difficult to explain by measures such as the Barthel Index alone, Sen said. “There may be other factors like fatigue, cognition, and personal factors.”
Quality-of-life concerns, including emotional issues, can persist even after successful treatment of acute ischemic stroke, suggested a study of 75 patients presented at the World Congress of Stroke in 2016.
In addition, other research in 279 people employed at the time of a stroke demonstrated that post-stroke depression predicted not returning to work almost to the same extent as physical disability.

Manual vs Nonmanual Labor

A meeting attendee asked Sen if he stratified patients by the type of employment before their stroke. Because it was a registry study, the data only indicated if a person was involved in manual labor or not, he replied.
“Interestingly, we did do a subanalysis,” he noted. “The nonmanual labor patients were less likely to return to work.” He speculated that more people in manual labor might have been physically able to go back to work, whereas people in office jobs may have been limited because of deficits in cognition.
However, session moderator Kenneth Butcher, MD, PhD, professor of neurology at the University of Alberta, Edmonton, Canada, speculated it may be more a matter of means. “In my experience, the white collar workers have the financial means to retire after they’ve had a stroke,” he said. “I think in the future you need to ask people if they want to return to work.”
“I think motivation is an important factor as well,” Sen said. “There also could be financial pressures and family pressures.”
“I think the biggest predictor of return to work is your age,” Butcher told Medscape Medical News when asked to comment. “The point estimate [for patient age] is very close to unity here, which means most stroke patients are close to the retirement age already.”
But the findings are still “quite significant,” he added. “He did show, in terms of occupation, that white collar workers were less likely to return to work. It’s plausible and requires more research, but it could also be possible that those people don’t need to return to work.”
Stroke is a life-changing event, “and if you’re in an occupation where you’re just working because you can — you might say, ‘That’s enough. I’m going to go retire now,'” he said.
The findings are interesting, but more prospective research looking at possible confounders is needed, Butcher added.
“Our database is limited, but I think we definitely will try to take the research forward,” Sen said.
Sen and Butcher have disclosed no relevant financial relationships.
4th European Stroke Organisation Conference (ESOC) 2018. Presented May 17, 2018.
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‘Cardiology culture’ a turnoff for women


It’s no wonder that fewer women opt to go into cardiology, given the work-life balance issues and gender discrimination problems that plague the field. The question is: will the community do something about it?
A survey of internal medicine resident physicians revealed that the top perceptions of cardiology were that, as a field, it is associated with adverse job conditions, interference with family life, and lack of diversity. Women and future non-cardiologists valued work-life balance more highly than did men or those committed to cardiology.
In turn, women and future non-cardiologists also had worse perceptions of cardiology as a whole, according to the survey results published online in JAMA Cardiology by Pamela Douglas, MD, of Duke University School of Medicine in Durham, North Carolina, and colleagues on the American College of Cardiology (ACC) Task Force on Diversity and Inclusion and the ACC Women in Cardiology Council.
“Little is known about factors influencing the selection of cardiology as a career. Our survey data suggest that internal medicine trainees’ most valued aspects of professional development related to work-life balance and mentorship, while their strongest perceptions of cardiology were of a negative culture and job description at odds with their perceived needs,” the authors concluded.
“Given the slight majority of female medical-school matriculants and internal medicine resident physicians, identifying and addressing cultural and societal barriers in women’s perceptions of cardiology is crucial for the field to access the full range of talent in internal medicine.”
The questionnaire had an overall response rate of 23.1%. Survey participants — totaling 1,123 individuals, or approximately 5% of all internal medicine trainees in the U.S. at the time — were contacted in 2009 and 2010 and came from 198 residency programs.
Poor Work-Life Balance
Coming in at the top of the list of professional development factors that were cited as being important to trainees were stable hours and positions that were family- and female-friendly.
And it is exactly these and other components of work-life balance — or perceived lack thereof in cardiology — that drives the underrepresentation of women in this field, suggested Anne Curtis, MD, of the University at Buffalo, State University of New York, and Fatima Rodriguez, MD, of Stanford University in California: “Why is our specialty losing so much talent?” they asked in an invited commentary, citing the fact that even though approximately half of those in medical school classes are female, women constitute only 21% of general cardiology trainees, 7.2% of interventional fellows, and 6% of electrophysiology fellows. In practice, women account for 13.2% of cardiologists and 4% of interventional cardiologists.
It seems that work-life balance is just not there in cardiology — making it a field especially undesirable among women.
“Having this factor be so important to career decisions today means that one needs to consider these issues in structuring positions in order to attract the best people,” Curtis and Rodriguez said. They explained that to reverse the “staggering problem” of the underrepresentation of women in cardiology, it will take, among other strategies, professional societies drawing attention to this problem and structured programs created to provide female role models and mentors to medical students and residents.
If cardiology has one thing going for it in the meantime, it’s the shift from a mainly private practice model to one of hospital or system employment,” the commentary states. “While there is some loss of autonomy with this model, it also creates opportunities for more structured and predictable work schedules.”
Sexual Harassment, Gender Discrimination
Last fall’s Transcatheter Cardiovascular Therapeutics (TCT) conference was dedicated to the theme of diversity and was supposed to be a call to attention and action for interventional cardiology. Instead, it was more of the same-old, said Roxana Mehran, MD, of Icahn School of Medicine at Mount Sinai in New York City, writing in a viewpoint article in the same issue of JAMA Cardiology.
“The intention was great; the reality, somewhat deflating. The sessions dedicated to diversity were bare. I watched many men in business suits waiting by the doors to get into the mitral and transcatheter aortic valve replacement sessions, while there were echoes in our empty rooms. Simply put, there was no interest.
“The attendees, men and women, had come to TCT to learn about improving their techniques, hear cutting-edge technology updates and results of late-breaking clinical trials, and enhance their practice and knowledge. Who wants to hear negative news about women and minorities? I guess I do not blame them.”
One session stood out however, and not in a good way, as Mehran shared the experience of a woman who described being asked about her “biological clock” several times during interviews for a fellowship in interventional cardiology: “I do not know of a single woman who has trained in cardiology and chosen interventional cardiology as her career who has not faced some level of sexual harassment or misconduct. This is not hyperbole,” Mehran wrote. “Nearly half of all female cardiologists report that they have been asked about their intention to have children during interviews, and more than 60% have experienced sex-based discrimination.”
It’s time for medicine to have its own #MeToo moment, she suggested, urging women to speak up about the injustices they have faced to force change — and leaders in the field to take solid action. “We all must act.”
The $2.5M Wage Gap
“We have arrived at moment when change is within arm’s reach; women and men must rally together to make the workplace fair, more productive, and better for everyone,” agreed Rashmee Shah, MD, MS, of the University of Utah School of Medicine in Salt Lake City, writing in another viewpoint in the issue.
Her focus, however, was on the wage gap between male and female cardiologists: Given that women cardiologists earn 7.3% less than male peers on average, one can estimate that they end up with $2.5 million less over a 35-year career, she estimated. And the problem actually manages to be even worse for those in academia, Shah said, where salary increases are often tied to promotion between ranks, and women are less likely than men to get those promotions, thereby being “stuck to the floor.”
“Rather than place the burden solely on women to change the status quo, the predominantly male leadership needs to assume responsibility by creating a system that measures the value provided to the organization in a uniform, transparent way,” Shah urged.
To understand why these patterns exist in the first place, it is imperative to look at the less obvious factors that prevent female advancement, she suggested: “Women, for example, receive less money for research start-up compared with men, a clear and measurable disadvantage that can propagate over time. Other factors that contribute to career success, such as a lack of sponsorship and opportunity, fewer networking options, and less effective negotiations, are more difficult to measure and not accounted for in studies of pay inequity.”
All these mechanisms not only put considerable female talent at a financial disadvantage, but also hurt employers and businesses.
“Prior research demonstrates that diverse groups, such as those that include women, have a higher collective intelligence and better performance rate,” Shah said. “The effect of collective intelligence is visible in the bottom line: organizations and companies with women in leadership positions have better financial performance rates and returns on investments. Investing in women’s salaries is not only socially and legally just, but also a financially smart investment.”
Douglas, Curtis, Rodriguez, and Shah reported having no relevant conflicts of interest.
Mehran reported various personal and institutional relationships with AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, CSL Behring, Eli Lilly/DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Abbott Laboratories, CardioKinetix, Spectranetics, Medscape, Boston Scientific, The Medicines Company, Abiomed, Claret Medical, Elixir Medical, Janssen, Osprey Medical, and Watermark Research Partners.
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Zymeworks has positive Phase 1 cancer data at ASCO


Zymeworks announced the presentation of ZW25 clinical data by Funda Meric-Bernstam, MD, Principal Investigator for the ZW25 study at the University of Texas MD Anderson Cancer Center. Data from the ongoing multi-center Phase 1 study showed single agent ZW25 induced anti-tumor activity and was well tolerated in heavily pretreated patients across a range of HER2-expressing cancers. “Since the first patient treated, ZW25’s compelling single agent activity has consistently exceeded our expectations,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “The expanded body of data presented today supports our confidence that ZW25 is an active agent with the potential to become an approved cancer treatment.”
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