more_vertThe International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world—foundations, government agencies, and industry—now mandate data sharing. Here we outline ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by April 18, 2016.
Preference: Government and politics
[Comment] Offline: Health—the Chinese dream
China falters. An alarming message transmitted around the world after a period of unprecedented stock market volatility last week. Where does this moment of uncertainty leave prospects for health? Rapid economic growth has delivered the fiscal space to enable China to make astonishing progress in scaling up public access to health services, especially compared with similar middle-income countries, such as India. But close observers are anxious that China’s health reforms have stalled. This week, the Government of China convened a forum of international advisers to discuss urgent challenges facing the country.
Kidnapping leaves big hole in care
Dr Ken Elliot. Picture credit: Global Business Solutions Institute
AMA President Professor Brian Owler has voiced concerns for the safety of an Australian couple kidnapped from a health clinic in Burkina Faso, and raised fears the incident will not only disadvantage the local community but could deter others from undertaking humanitarian work.
Dr Ken Elliot and his wife Jocelyn, who have worked as medical missionaries in the impoverished West African country for more than 40 years, were snatched by suspected Al Qaida-linked militants from their home in Baraboule, near Djibo, about 200 kilometres north of the capital Ouagadougou.
Reports suggest the couple, who are both in their 80s, were taken in the early hours of 16 January, and may have been taken hostage for ransom as part of a fierce struggle between rival militant factions.
They were very well known in the area, where they run a 120-bed hospital. Dr Elliot is the only surgeon, and the clinic they established in 1972 serves a population of two million.
In a video published recently for the Friends of Burkino Faso Medical Clinic by Global Business Solutions Institute, Dr Elliot talked of the “enormous need” for care in the area.
In the video, Dr Elliot said there was a great shortage of surgical care in the region, and their hospital treats everything from hernias and bladder stones to tumours.
“You name it, we do it, because there is nowhere else to do it,” he said. “When you look around and see the need, the need is enormous, [but] the rewards are enormous.”
President Owler told ABC Radio the Elliots were among hundreds of Australian doctors around the world performing humanitarian work, often in isolated areas.
“We sometimes hear their stories, but most of the time the stories are not told and they’re really unsung heroes,” the AMA President said. “We should be very proud of the sort of work that these people are doing. They do, clearly, put themselves in danger.”
Professor Owler said that, in addition to fears for the welfare of the Elliots, he was also concerned about what effect their abduction would have on the local community.
“Clearly, he and his wife have been doing humanitarian work in Africa for most of their lives, devoted their lives to heling the local people and, of course, when this sort of thing happens, it takes away a vital resource from these local people,” he said.
In the wake of the kidnapping, Djibo locals have mobilised to demand the release of the Elliots, amid concern that without them local health services will deteriorate.
A local family friend, Seydou Dicko, told the BBC that “he is not only Australian but he is someone from Burkina Faso, someone from our community, because what he did for our community even the Government itself couldn’t do more than that”.
Professor Owler said the incident could also deter others from following in the path of the Elliots and other Australian doctors providing health services for disadvantaged communities in some of the world’s poorest countries.
“I think it probably deters other people from taking up similar work in the future,” he said.
The Department of Foreign Affairs has said it is working with local authorities to try and locate the couple.
Adrian Rollins
Blocking organ donation to get harder in UK
Bereaved families who want to override the decision of a loved one to donate their organs may have to provide their reasons in writing under changes being considered in the United Kingdom to respect donor wishes.
NHS Blood and Transplant (NHSBT) has announced it is considering a range of measures to reduce the number of occasions in which families veto the decision of organ donors amid evidence the practice has cost hundreds of lives in the last five years.
The organisation has released figures showing that since 1 April 2010, 547 families in the UK have overridden the request of their loved one that their organs be donated, resulting in around 1200 people missing out on a potentially life-saving transplant.
Across the UK almost 6580 people are estimated to be currently waiting for a donated organ, and around 1000 people in need of a transplant die while waiting each year.
Families are overriding patient wishes despite evidence that the majority thinks this is wrong. A survey conducted by the NHSBT found 73 per cent thought it unacceptable that next of kin could veto a donation decision, while just 11 per cent supported it.
“While most families approached about donation support their relative’s decision to donate as recorded on the Organ Donor Register, a number of families each year override a previously made donation decision,” NHSBT Director of Organ Donation and Transplantation, Sally Johnson, said.
In response, the organisation is looking at options to curb the practise, including no longer formally asking families for consent, making it clear that their consent is not legally necessary, and asking them to provide a written explanation of their objection – something that is already required in Scotland.
“We think our proposed changes would make the existing legal situation clearer to families and, hopefully, help them to support their relative’s decision,” Ms Johnson said.
While there is no suggestion yet that Australian authorities might take similar action, there is great concern about the country’s persistently low organ donation rate.
There has been only a modest lift in the rate of deceased organ donors in the last seven years, from 12.1 per million to just 16.1 per million, despite a $250 million Government campaign.
Former Assistant Health Minister Fiona Nash sparked controversy last year when she announced a review of the Organ and Tissue Authority, with its then-head, television presenter David Koch, resigning in protest.
Mr Koch said the Authority had raised Australia’s world ranking in organ donation from 32 to 19 since it was launched in 2009, and accused Senator Nash into caving into the demands of the ShareLife advocacy group, which he claimed wanted to “take control of the money”.
The AMA has supported efforts to boost organ donor rates.
Late last month, AMA President Professor Brian Owler reiterated his call for people to consider becoming an organ donor, and to discuss the issue with their family.
“Becoming an organ donor can, quite literally, be a lifesaving decision,” Professor Owler said. “Just one donor can transform the lives of 10 other people.”
But he said that because organ and tissue donation would not proceed against the wishes of the family, it was vitally important that those who wanted to be donors “share your decision…with others, especially family members,” Professor Owler said.
View the AMA’s Position Statement on Organ and Tissue Donation and Transplantation, last updated in 2012.
Adrian Rollins
Wollongong academics disown anti-vax views
Health academics at the University of Wollongong have affirmed the lifesaving benefits of immunisation after their institution become embroiled in controversy over the decision to award a doctorate for a thesis questioning the safety and efficacy of mass vaccination programs.
Sixty-five senior medical and health researchers including Professor of Public Health Dr Heather Yeatman, Dean of Medicine Professor Ian Wilson, and Professor Alison Jones, Executive Dean of the Faculty of Science, Medicine and Health, have jointly signed a public statement backing the evidence supporting vaccination and its importance in preventing disease.
“The evidence is clear,” the statement said. “Immunisation protects children and saves lives.
“While individuals may express opinions, the international scientific evidence overwhelmingly supports immunisation to protect children from infectious diseases.”
A series of reports in The Australian newspaper revealed that Dr Judy Wilyman, described as an “anti-vaccination campaigner”, had been accepted for a PhD after submitting a thesis in which she criticised the National Immunisation Program (NIP).
In her thesis, Dr Wilyman argued that the implementation of mass vaccination programs like the NIP coincided with “the development of partnerships between academic institutions and industry” and notes the involvement of organisations including the World Bank, the International Monetary Fund, the Bill and Melinda Gates Foundation and UNICEF in urging population-wide immunisation.
“Whilst the Government claims serious adverse events to vaccines are rare this is not supported by adequate scientific evidence due to the shortcomings in clinical trials and long-term surveillance of health outcomes of recipients,” she argues. “A close examination of the ‘Swine Flu’ 2009 vaccine and the vaccine for human papillomavirus (HPV), intended to prevent cervical cancer, shows shortcomings in the evidence base and rationale for the vaccines. This investigation demonstrates that not all vaccines have been demonstrated to be safe, effective or necessary.”
The social sciences researcher called for “independent research” into the safety and efficacy of current vaccines, and added that it was important to have “comprehensive evidence that it is safe to combine multiple vaccines in the developing bodies of infants”.
Dr Yeatman said large-scale immunisation programs began in the 1930s and “immunisation provides an important safeguard against infectious disease when children go to school or play with others”.
According to Immunise Australia, mass immunisation had led to a 99 per cent plunge in deaths from vaccine-preventable disease.
“For more than 50 years, children have been immunised and it is one of our best success stories in public health,” she said.
Wollongong University has staunchly defended its decision to grant Dr Wilyman a PhD, on the grounds of academic freedom.
But, following sustained criticism, it has launched a review of the process involved in awarding PhDs – though it will not include that presented to Dr Wilyman.
Adrian Rollins
Changes to PIP eHealth initiative
Following stakeholder consultation, the Department of Health has advised the new eligibility criteria for the Practice Incentives Programme (PIP) eHealth Incentive. The changes aim to encourage GP uptake and to increase the meaningful use of the My Health Record system.
Despite advice from the AMA and other members of the PIP Advisory Group that the My Health Record is not yet fit for purpose, the Government has decided to link the incentive to use of the My Health Record. From 1 May, general practices will be required to upload a Shared Health Summary (SHS) to the My Health Record system for 0.5% of the practice’s standardised whole patient equivalent (SWPE) to be eligible for their payment. This contribution equates to about five shared health summaries per full-time equivalent GP per quarter.
Practices will be advised at the start of a quarter of the SWPE count. They will need to keep a tally of shared health summaries uploaded to be certain of meeting their target.
Related: MJA – Why e-health is so hard
To assist general practices to meet the new requirements, there will be online training available nationally from February and on demand face to face training from March/April. PIP participating general practices will be advised of the changes to the eligibility criteria for the ePIP through regular communication channels such as the PIP newsletter, websites and through Primary Health Networks.
Further consultation with the PIP Advisory Group and the broader general practice community will be undertaken in the near future regarding a tiered performance-based incentive arrangement, targeted for possible introduction in the August 2016 quarter. Under this approach, incentive payments would be linked to levels of use, such as numbers of SHSs uploaded.
Andrew Knight: e-Health revolution
Following AMA advice, the Department is considering transitioning existing PIP eHealth recipients to the new PIP eHealth arrangements as an alternative to requiring re-registration. Further advice on this matter will be provided to the PIP Advisory Group in February.
During consultations with the Department, the AMA, along with other stakeholders on the PIP Advisory Group, have repeatedly advised that the introduction of an MBS item and Service Incentive Payment for creating, uploading and updating a SHS would drive greater usage of the My Health Record. This view will be considered as part of the MBS Review.
This article was first published on GP Network News.
Latest news:
Patients face $100 x-rays
The Federal Government is coming under pressure over concerns its cuts to bulk billing incentives will leave patients needing x-rays, ultrasounds, MRIs and other diagnostic imaging services hundreds of dollars out-of-pocket.
Estimates by the Australian Diagnostic Imaging Association (ADIA) suggest general patients who are currently bulk billed will face significant up-front costs, from up to $101 for an x-ray to as much as $532 for an MRI, if the Government’s plan to wind back bulk billing incentives for diagnostic imaging and axe them for pathology services is approved.
When the changes were unveiled in the Mid-Year Economic and Fiscal Outlook in December, AMA President Professor Brian Owler condemned them as “a co-payment by stealth”.
“Cutting Medicare patient rebates for important pathology and imaging services is another example of putting the Budget bottom line ahead of good health policy,” Professor Owler said. “These services are critical to early diagnosis and management of health conditions to allow people to remain productive in their jobs for the good of the economy.”
His concerns have been borne out by the ADIA’s analysis, which shows the Medicare rebate for an x-ray will be cut by $6 under the changes, while the rebate for an ultrasound will be $12 less, that for a CT scan will be $34 lower, $43 less for a nuclear medicine service and $62 less for an MRI.
The Association said the effect of these cuts would be amplified by the fact that, under Medicare, patients have to pay the full cost of the service upfront before being able to claim the rebate.
In practice, this will mean that a general patient having an x-ray will be required to pay between $54 and $101 before being be able to claim their Medicare rebate.
Patients requiring an MRI will face the biggest upfront charge, ranging from $422 to $532.
Even after receiving their rebate, patients will still be left out-of-pocket. The ADIA calculates that for an x-ray, patients will ultimately lose between $6 and $56, while those needing an MRI will take a financial hit of between $62 and $173.
General patient diagnostic imaging expenses as a result of bulk billing incentive cuts
|
|
X-ray |
Ultrasound |
CT scan |
Nuclear Medicine |
MRI |
|
Rebate cut |
$6 |
$12 |
$34 |
$43 |
$62 |
|
Upfront costs |
$54-101 |
$117-206 |
$323-434 |
$407-463 |
$422-532 |
|
Out-of-pocket costs |
$6-56 |
$12-101 |
$34-145 |
$43-99 |
$62-173 |
Source: Australian Diagnostic Imaging Association
ADIA President Dr Christian Wriedt said the changes were introduced without consultation and, by potentially deterring people from seeking early diagnosis and treatment, represented “bad policy”.
“This will make it much more difficult for many patients to receive the life-saving level of care they need,” Dr Wriedt said. “We are talking about services that are absolutely essential to diagnosing and treating many conditions, and we’re making it harder for people to get. More people, especially those with chronic, serious conditions, will not be properly assessed.”
Shadow Health Minister Catherine King said patients with serious, ongoing conditions such as cancer and heart complaints would be hardest hit.
“Patients with serious conditions never need just one scan,” Ms King said, citing the example of someone with thyroid cancer.
She said a confirmed diagnosis involved having an ultrasound and thyroid function test, a follow-up ultrasound and pathology tests, and a final round of head or body scans.
“All up, that comes to around $1000 in upfront charges,” Ms King. “Patients will eventually get much of this back from Medicare, but they will still be left with hundreds of dollars in out-of-pocket expenses.”
Health Minister Sussan Ley has so far pushed back against such concerns, pointing out that the Government has not touched Medicare rebates and arguing that bulk billing incentives – introduced by Labor in 2009 – were an unjustified handout to providers.
But Dr Wriedt said Medicare rebates for diagnostic imaging services had not been indexed for 17 years, ratcheting up the financial pressure on providers and leaving them with little choice but to pass the bulk billing incentive cuts through to patients.
He said the Government’s strategy was to push more costs on to consumers.
“Let’s not kid ourselves. This is a cash grab and a co-payment by stealth,” he said. “They [the Government] know that this will hurt people, and particularly the most vulnerable in our communities, and yet they’re pushing ahead.”
But the Government’s plan might yet fall afoul of the Senate, where it will have to rely on the support of cross-bench senators to get the measure passed.
At least one has flagged she will join Labor in opposing the changes.
Independent Tasmanian Senator Jacqui Lambie has threatened to vote against all Government legislation in order to prevent cuts to bulk billing incentives for pathology and diagnostic imaging services.
Realisation that the cuts could result in women being charged for pap smear tests provoked widespread outrage, and almost 190,000 have signed a Change.org petition protesting the measure.
Senator Lambie said it was time the Government stopped its “sneaky attacks on Medicare”.
“Australian women should not have to pay more for vital cancer health checks,” she said. “Over my dead body will I allow the Liberals to try and sneak through more changes and cuts to our Medicare system. I will vote to block all their legislation in the Senate until they stop playing with our Medicare system.”
Adrian Rollins
[World Report] Will Nigeria’s new government fix the health system?
Nigeria’s health system has not received the attention or finances it needs to address the country’s disease burdens. Will the new government address the problems? Andrew Green reports.
Thousands of doctors join NHS strike
Around 45,000 junior doctors are estimated to have gone on strike across England as part of a stand-off with the British Government over proposed changes to contracts they believe will lead to unsafe work hours that will compromise patient safety.
Striking doctors established picket lines outside more than 100 National Health Service hospitals and clinics, according to the British Medical Association, in the first such industrial action in more than 40 years.
The NHS reported that 1279 inpatient operations and 2175 outpatient services have been cancelled as a result of the strike, while thousands of junior doctors honoured a commitment to attend work to ensure that accident and emergency departments were not affected by the protest.
NHS England said that 39 per cent of junior doctors had reported for duty – a fact seized on by Health Secretary Jeremy Hunt to imply that the industrial action did not have widespread support.
The NHS said that altogether 71 per cent of rostered staff, including junior doctors, other doctors and consultants, had showed up for work.
NHS England National Incident Director Anne Rainsberry said the strike had nonetheless “caused disruption to patient care, and we apologise to all patients affected. It’s a tough day, but the NHS is pulling out all the stops, with senior doctors and nurses often stepping in to provide cover”.
But the BMA said it was misleading of Mr Hunt to claim the strike was a flop because so many junior doctors had reported for work.
“Since we asked junior doctors who would be covering emergency care to go into work today, it is hardly surprising that they have done so, along with those who are not members of the BMA,” a BMA spokesman told the Daily Mail. “The simple fact is the Government cannot ignore the thousands who have today made it quite clear what they think of the Government’s plans.”
Several hospitals and NHS trusts placed striking doctors on a ‘black alert’, claiming they were operating under emergency conditions because an influx of cases.
Sandwell Hospital in West Bromwich declared a level 4 incident and directed striking junior doctors to return to work.
But the BMA condemned such declarations as a ploy to try to thwart the protest.
BMA Chair Dr Mark Porter said doctors had given the NHS ample warning of the impending strike to ensure hospitals could make adequate preparations and minimise the disruption to patients, such as by deferring scheduled surgery and consultations.
Striking doctors in several locations reported there were no obvious circumstances that warranted emergency declarations by their local NHS, and said that although they were equipped and prepared to abandon the strike at a moment’s notice if their services were required, they would continue to take industrial action until that time.
The doctors are striking over a plan by the Government to force them on to contracts which would increase requirements to work long shifts, including on weekends and out-of-hours. They claim there are inadequate safeguards against unsafe working hours, potentially compromising patient care and safety, while the BMA declared an in-principle objection to the Government’s aim of removing the distinction between weekend and after-hours work and the rest of the working week.
Mr Hunt said numerous studies had shown that people received lesser care on weekends than they did during the week, and “I can’t, in all conscience as Health Secretary, sit and ignore those studies”.
“We have to do something about this. People get ill every day of the week,” the Minister said, and criticised the strike as “wholly unnecessary”.
But one of the striking doctors, emergency medicine consultant Dr Rob Galloway, said the Government had left doctors with no option but to take industrial action.
Writing in the MailOnline, Dr Galloway said there was “no doubt” that junior doctor contracts needed reform, and there needed to be improvements in handling unscheduled care on weekends.
But he said that the Government, through the approach it had taken, had squandered what would have been strong support for reform.
Alongside attacks that called the commitment and integrity of doctors into question, Dr Galloway said the Government’s offer amounted to an effective pay-cut for out-of-hours work, making it even harder for hospitals to recruit and retain staff.
“If you want to improve weekend care, why on earth would you impose a pay cut for staff doing this vital weekend work, pushing them out of the NHS? The new contract as it stands will make things worse, and lead to a recruitment and retention crisis.”
The World Medical Association had thrown its support behind the junior doctors.
WMA President Sir Michael Marmot said the peak international medical organisation recognised the right of doctors to take action to improve working conditions that may also affect patient care.
“In this case, it is clear that patient care would suffer in the long term if the Government’s proposals to change the working hours of junior doctors goes ahead,” Sir Michael said, adding that the doctors had received widespread support from the public and NHS colleagues.
He urged the Government to “establish a new working relationship with junior doctors. It is essential that trust is restored on both sides, for the sake of patient care”.
The 24-hour strike is due to end this evening, Australian Eastern Standard Time.
Unless the dispute is resolved, further strikes are planned for 26 January and 10 February.
Adrian Rollins
Picture credit: William Perugini / Shutterstock.com
Latest news:
[Comment] Building evidence to improve maternal and child health
Giving children the best possible start in life is crucial to reduce health disparities.1 One of the UK Government’s efforts to support young children has been to adapt and assess the Family Nurse Partnership (FNP), a programme of prenatal and early childhood home visiting for vulnerable first-time mothers and their children. In The Lancet, Michael Robling and colleagues2 report on Building Blocks, a multisite trial of the FNP in England. My colleagues and I3,4 have developed and tested this programme previously in three randomised trials in the USA.