Subscribe
×

Preference: Statistics, epidemiology and research design

1138

Under pressure – new ‘Triple Pill’ for hypertension

A new low dose three-in-one pill to treat hypertension could transform the way high blood pressure is treated around the world.

A trial led by The George Institute for Global Health revealed that most patients – 70 per cent – reached blood pressure targets with the ‘Triple Pill’, compared to just over half receiving normal care.

With high blood pressure the leading cause of disease burden worldwide, it’s expected the findings, published in JAMA, will change guidelines globally.

The George Institute’s Dr Ruth Webster said this was a major advance by showing that the Triple Pill was not only more effective than standard care, it was also safe.

“It’s estimated that more than a billion people globally suffer from high blood pressure, with the vast majority having poorly-controlled blood pressure.

“Our results could help millions of people globally reduce their blood pressure and reduce their risk of heart attack or stroke,” Dr Webster said.

The researchers tested an entirely new way of treating hypertension by giving patients three drugs, each at half dose, in a single pill for early treatment of high blood pressure.

Traditionally, patients begin treatment with one drug at a very low dose, which is increased over time with additional drugs added and increased in dosage to try to reach target.

Dr Webster said that patients are brought back at frequent intervals to see if they are meeting their targets, with multiple visits required to tailor their treatments and dosage.

“This is not only time inefficient, it’s costly,” she said.

“We also know that many doctors and patients find it too complicated, and often don’t stick to the process. This new approach is much simpler, and it works.”

The trial, which was conducted in Sri Lanka, enrolled 700 patients with an average age of 56 and blood pressure of 154/90 mm Hg.

Patients were randomly assigned to receive either the combination pill or usual care – their doctor’s choice of blood pressure lowering medication. The Triple Pill consisted of the blood pressure medications telmisartan (20 mg), amlodipine (2.5 mg), and chlorthalidone (12.5 mg).

Compared with patients receiving usual care, a significantly higher proportion of patients receiving the Triple Pill achieved their target blood pressure of 140/90 or less (with lower targets of 130/80 for patients with diabetes or chronic kidney disease).

At six months, 83 per cent of participants in the Triple Pill group were still receiving the combination pill compared to the majority of patients in the usual-care group still receiving only one, and only one third receiving two or more blood-pressure–lowering drugs.

Professor Anushka Patel, Principal Investigator of the trial and Chief Scientist at The George Institute, said this was big improvement.

“The World Heart Federation has set an ambitious goal that, by 2025, there will be a 25 per cent reduction in blood pressure levels globally, Prof Patel said.

“The Triple Pill could be a low-cost way of helping countries around the world to meet this target.

“This study has global relevance. While the most pressing need, from the perspective of the global burden of disease, is low-and middle-income countries, it’s equally relevant in a country like Australia where we’re still achieving only 40-50 per cent control rates for high blood pressure.” 

The George Institute is now looking at strategies to maximise uptake of the study results. This includes examining the acceptability of the Triple Pill approach to patients and their doctors, as well as cost-effectiveness, which will be important for governments and other payers to consider.

The study was funded by the National Health and Medical Research Council of Australia as part of the Global Alliance for Chronic Disease.

 

Racial diversity of physicians in the USA

In the United States, racial and ethnic minorities have higher rates of chronic disease, obesity, and premature death than white people.

Black patients, in particular, have among the worst health outcomes, experiencing higher rates of hypertension and stroke. And black men have the lowest life expectancy of any demographic group, living on average 4.5 fewer years than white men.

The Harvard Business Review says that a number of factors contribute to these health disparities, but one problem has been a lack of diversity among physicians.

African Americans make up 13 per cent of the US population, but only four per cent of US doctors and less than seven per cent of US medical students. Of active US doctors in 2013, 48.9 per cent were white, 11.7 per cent were Asian, 4.4 per cent were Hispanic or Latino, and 0.4 per cent were Native American or Alaska Native.

Research has found that physicians of colour are more likely to treat minority patients and practise in underserved communities. And it has been argued that sharing a racial or cultural background with one’s doctor helps promote communication and trust.

A new study from the National Bureau of Economic Research looked at how changing this ratio might improve health outcomes – and save lives.

Researchers set up an experiment that randomly assigned black male patients to black or non-black male doctors, to see whether having a doctor of their race affected patients’ decisions about preventive care.

They found that black men seen by black doctors agreed to more, and more invasive, preventive services than those seen by non-black doctors. And this effect seemed to be driven by better communication and more trust.

Increasing demand for preventive care could go a long way toward improving health. A substantial part of the difference in life expectancy between white and black men is due to chronic diseases that are amenable to prevention.

By encouraging more preventive screenings, the researchers calculate, a workforce with more black doctors could help reduce cardiovascular mortality by 16 deaths per 100,000 per year – resulting in a 19 per cent reduction in the black-white male gap in cardiovascular mortality and an 8 per cent decline in the black-white male life expectancy gap.

 

DNA to predict disease risk

Scientists have created a powerful new tool to calculate a person’s inherited risks for heart disease, breast cancer, and three other serious conditions.

Reporting on research in the journal, Nature Genetics, the New York Times revealed that, by surveying changes in DNA at 6.6 million places in the human genome, investigators at the Broad Institute and Harvard University were able to identify many more people at risk than do the usual genetic tests, which take into account very few genes.

Of 100 heart attack patients, for example, the standard methods will identify two who have a single genetic mutation that place them at increased risk. But the new tool will find 20 of them.

The researchers are now building a website that will allow anyone to upload genetic data from a company like 23andMe or Ancestry.com. Users will receive risk scores for heart disease, breast cancer, Type 2 diabetes, chronic inflammatory bowel disease, and atrial fibrillation.

People will not be charged for their scores.

A risk score, including obtaining the genetic data, should cost less than $100, said Dr Daniel Rader, a professor of molecular medicine at the University of Pennsylvania.

Dr. Rader, who was not involved with the study, said the university will soon be offering such a test to patients to assess their risk for heart disease. For now, the university will not charge for it.

Dr Sekar Kathiresan, senior author of the new paper and director of the Center for Genomic Medicine at Massachusetts General Hospital, said his team had validated the heart risk calculation in multiple populations.

But DNA is not destiny, Dr Kathiresan stressed. A healthy lifestyle and cholesterol-lowering medications can substantially reduce risk of heart attack, even in those who have inherited a genetic predisposition.

The new tool also can find people at the low end of the risk range for the five diseases. This should prove useful to certain patients: for example, a woman who is trying to decide when she should start having regular mammograms, or a 40-year-old man with a slightly high cholesterol level who wants to know if he should take a statin.

 

Exams rigged against female applicants in Japan

One of Japan’s leading medical schools has been automatically reducing the entrance exam scores of female applicants by 20 per cent for at least 12 years to graduate more male doctors, an independent inquiry has found.

The case has been examined in a report in the British Medical Journal (BMJ).

According to the BMJ, Tokyo Medical University’s acting president, Keisuke Miyazawa, admitted to the exam rigging at a press conference on 7 August after the release of a damning report by external lawyers.

“For those people whom we have caused tremendous hardship, especially female candidates whom we have hurt, we will do everything we can,” he said.

Miyazawa said that the school was considering options including financial compensation and retroactive admission of some women who would have passed without the automatic deduction. He said that he had not known of the score manipulation.

Tetsuo Yukioka, the school’s executive regent and chair of its diversity promotion panel, stood beside him.

Both men spent much of the press conference with their heads bowed in an attitude of shame.

“Society is changing rapidly and we need to respond to that, and any organisation that fails to utilise women will grow weak,” Yukioka said. “I guess that thinking had not been absorbed.”

Kenji Nakai, a lawyer who led the inquiry, said that the rigging had been ordered by the former chair of the board of regents, Masahiko Usui, 77, with the approval of the former president, Mamoru Suzuki, 69.

Both men resigned last month amid allegations that they had inflated the exam score of the son of Futoshi Sato, a health ministry official, in return for increased research funding. Usui, Suzuki, and Sato have all since been charged with bribery.

As well as discriminating against women, the school secretly penalised men who had failed the entry test more than twice before. The school had far more applicants than places – only one in 11 men and one in 33 women who tried for a place succeeded in 2018 – so multiple attempts were common.

A computer algorithm automatically deducted 20 per cent from the score of everyone taking the first multiple choice segment of the entrance exam.

Men taking the test for the first or second time were then re-awarded 20 per cent, men taking it for the third time were given back 10 per cent, and men taking it for the fourth time – plus all women – were given back 0 per cent.

The investigators also found 18 instances of applicants’ scores being inflated in return for donations to the school or bribes to its officials. In one case, a student’s mark had been raised by 49 per cent in return for a donation to the school.

Investigators examined records dating back to only 2006 so that they could report their findings earlier, said Nakai.

The principal motive for the discrimination, he said, was the perception that female doctors are more likely to quit the profession young to have children, exacerbating a doctor shortage.

Because medical graduates in Japan typically work in hospitals affiliated to their medical school, this would be a problem for the institution itself, not just for society at large.

‘Profound sexism’ among the school’s leadership also played a role, said Nakai.

The revelations have released a torrent of online criticism, much of it under the hashtag, “It’s okay to be angry about sexism”.

Female doctors in Japan have complained that staying in the profession is almost impossible after having children because childcare services are lacking and because women are expected to perform all household tasks while also working the extremely long hours demanded of male doctors.

The number of Japanese children waiting for kindergarten places this year rose to 55 000. The health ministry, which is also responsible for welfare programs, has announced plans to add 320,000 childcare places by 2021.

Suspicion is now widespread in Japan that exam rigging against women is not limited to one medical school. The education minister, Yoshimasa Hayashi, said yesterday that he plans to examine entrance procedures at schools around the country.

He will also decide what action to take against Tokyo Medical University after studying the report, he said.

 

Doctor Robot  

 

The Guardian reports that robots could soon help hospital patients eat their meals, diagnose serious illnesses, and even help people recover from operations, in an artificial intelligence revolution in the NHS in the UK.

Machines could take over a wide range of tasks currently done by doctors, nurses, health care assistants, and administrative staff, according to a report prepared by the Institute for Public Policy Research (IPPR) and eminent surgeon and former Health Minister, Lord Darzi.

Widespread adoption of artificial intelligence (AI) and ‘full automation’ by the NHS could free up as much as £12.5 billion a year worth of staff time for them to spend interacting with patients, according to the report.

“Given the scale of productivity savings required in health and care – and the shortage of frontline staff – automation presents a significant opportunity to improve both the efficiency and the quality of care in the NHS,” the report says.

“Bedside robots could help patients consume food and drink and move around their ward, and even help with exercises as part of their rehabilitation from surgery.

“In addition, someone arriving at hospital may begin by undergoing digital triage in an automated assessment suite.

“AI-based systems, include machine-learning algorithms, would be used to make more accurate diagnoses of diseases such as pneumonia, breast and skin cancers, eye diseases, and heart conditions.

“Digital technology could also take over the communication of patients’ notes, booking of appointments, and processing of prescriptions.”

The report sought to allay fears of significant job losses, signaling that machines would work alongside human beings, not replace them, so patients would benefit.

[Perspectives] David Whiteman: harnessing the power of cancer prevention

Epidemiologist David Whiteman, Deputy Director at the QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia, and his team are doing vital research to tease apart the complex interactions between environment, phenotype, and genotype that contribute to melanoma and other cancers. This research extends the previous work of his team that includes both researching causal pathways and creating models to predict a person’s risk of keratinocyte cancers and melanoma, with implications for prevention and control.

[Correspondence] A closer look at SCOOP: screening for fracture prevention – Authors’ reply

We agree with Mark Bolland and Andrew Grey that the SCOOP trial1 provides much-needed high-quality evidence for screening, but for high fracture risk rather than for osteoporosis. The observation that Fracture Risk Assessment Tool (FRAX) probabilities in women at high risk of hip fracture in the screening group tended to decrease with the addition of bone mineral density (BMD) is correct but not unexpected. The FRAX tool is calibrated to the epidemiology of hip fractures in whole populations, and because selected subgroups are likely to have health differences not captured by clinical fracture risk factors, this will lead to differences in predicted and observed outcomes within subgroups.

[Perspectives] Cerebral palsy

Thanks to my insightful and industrious academic colleagues, the challenge of writing this column usually lies in trying to do justice to a heap of monographs and articles in a few hundred words. Compared with cholera, cancer, or hysteria, though, cerebral palsy has provoked little historical scholarship—a curious omission at a time when the recovery of lost voices and experiences lies at the heart of historiographical practice. Even after a century and more of research and debate, in the words of the neurologists Anamarija Kavčič and David B Vodušek, “it is still easier to explain what cerebral palsy is not”.

[Perspectives] John Strang: global leader in tackling addiction

In an interview for BBC Newsnight in 1997, John Strang, the then newly appointed Director of the National Addiction Centre at King’s College London, UK, first spoke publicly about “take-home naloxone” for opiate users. This was a major step in reducing deaths from heroin overdose, and Strang continued to fight for the widespread uptake of naloxone for 20 years, alongside advancing the research agenda in addiction medicine. Reflecting today, Strang says “It’s taken two decades for this life-saving approach (take-home naloxone) to make a real global impact.