more_vertThe quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable.
Preference: Statistics, epidemiology and research design
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Senate Seeking Action on Stillbirths in Australia
Labor Senator Kristina Keneally has wasted no time since joining the Senate earlier this year, in driving the establishment of a Senate Inquiry into Stillbirth Research and Education.
Six babies a day in Australia are stillborn. One in 135 births in Australia will be a stillbirth.
Senator Keneally told the Senate that rate of stillbirths in Australia have not shifted for two decades, a tragedy that is also personal. Senator Keneally’s daughter, Caroline was stillborn in 1998.
“Stillbirth is an often overlooked, under-investigated and ignored public health issue,” she said when recommending the Inquiry to the Senate.
“It has significant economic impact. Surely we, as a country, can do better than this. There are things that we know that we’re not telling parents that could help them prevent stillbirth, and there are things we could know better with better data collection and more coordinated and better funded research.”
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) welcomed the Senate Inquiry, adding: “A large proportion of stillbirths are unexplained and the causes need to be further explored.”
RANZCOG also said in its submission, it believed the areas in which there are substantial opportunities for improvement in outcome are with the detection and management of fetal growth restriction (FGR) and avoidance of intrapartum hypoxic death – together contributing about 8 per cent of all stillbirths.
The Royal Australasian College of Physicians (RACP) told the Senate Inquiry it believed: “Stillbirth is a tragic complication of pregnancy which often remains poorly understood within the health profession and the wider community. This impacts awareness and education as well as training and research.”
RACP encouraged the Committee to explore a range of options for reducing stillbirth rates in Australia, and improving care where stillbirths occur, including undertaking an Audit of current data and collection methodologies, and mandate annual reporting to a single agency with responsibility for stillbirth oversight. It also believes it is important for States and Territories to mandate the use of the Perinatal Society of Australia and New Zealand (PSANZ) guidelines and fund Medical Practitioner Education around them at least twice per year.
RACP also said organisations providing support groups following pregnancy loss should have their programs evaluated and, where proven effective, fully funded, to make them universally available. Also in the RACP submission was a view that current stillbirth research funding should be reviewed, and funds allocated to research that addressed specific stillbirth priority areas.
Sands, an Australian miscarriage, stillbirth and neonatal death charity, used the Inquiry to advocate for improved training in bereavement care for all health professionals.
The Stillbirth Foundation’s primary recommendation was a National Action Plan for Stillbirth be developed and implemented, in a process which involves key stakeholders such as medical practitioners, midwives and nurses, health bureaucrats, families who have experienced stillbirth and representative groups.
The Stillbirth Foundation’s chief executive Victoria Bowring said a strategic and well-considered policy approach from Federal Government was “long overdue”.
She added that an action plan would be a coherent policy roadmap to set out priorities, establish measured targets and the necessary funding behind it.
“Too often we see inconsistent medical care, a lack of awareness in the community, not enough coordination and investment in research and poor data collection and management,” she said.
“We have seen a similar approach recently with the national action plan for endometriosis being developed by the Federal Government, and a similar model could work for stillbirth.”
The Committee is due to report back with its recommendations when the Parliament resumes in early 2019.
Details of the Senate Inquiry into Stillbirth Research and Education, including submissions can be found at: www.aph.gov.au/Parliamentary_Business/Committees/Senate/Stillbirth_Research_and_Education/Stillbirth
MEREDITH HORNE
Jetlag of the social kind robbing Australians of sleep
A new study has found that one third of Australians suffer from what is termed ‘social jetlag’ – a condition that surfaces when a person’s natural body clock does not align with their daily routine.
The research, published this month in international journal Sleep Medicine, shows 31 per cent of the 837 survey respondents said the time they sleep is more than an hour out of sync with their body clock on weekends compared with work nights.
Those respondents were not shift workers and had completed Sleep Health Foundation Australia’s online survey.
Lead researcher, Professor Robert Adams from the University of Adelaide and the Sleep Health Foundation, said the figure was significant.
“That’s a large chunk of our population whose body clocks are out of alignment, a problem known to negatively impact health and wellbeing,” he said.
“These findings serve to further illustrate the widespread problem of insufficient sleep in our country and indicate an urgent need for a national inquiry to relieve our sleep loss epidemic.
“We need to realise that it’s not just about how much sleep we get, it’s when we get it.”
Professor Adams said social jetlag was robbing many adult Australians of quality sleep because of a misalignment between an individual’s circadian rhythms and their environment due to social impositions like work or school.
“For instance, a person who is naturally a night owl but must start work at 7am is at a higher risk of being socially jetlagged,” Professor Adams said.
“And the same can be said of morning larks who routinely stay up late on international work calls.”
The Australian results are similar to those revealed in a large-scale Dutch study.
Full-time workers were worst affected, with some routinely suffering more than two hours social jetlag on work days compared to non-work days.
Socially jet lagged respondents were more likely to sleep too late, wake up feeling tired, be late for work, and also go to work when they felt they should have taken sick leave.
“This suggests that people with social jetlag are either less able to recognise their sickness signs or they feel a degree of pressure to work despite being unwell or just plain tired,” Professor Adams said.
“Either way, it’s time we considered the consequences of these employees driving, operating dangerous machinery and potentially spreading contagious illness in the workplace.
“We found that those with social jetlag were more likely to have a laptop, phone or other device in the bedroom and frequently use the internet in the hour before sleep, either for work or entertainment.”
The paper, Sociodemographic and behavioural correlates of social jetlag in Australian adults: Results from the 2016 National Sleep Health Study, is available at: https://doi.org/10.1016/j.sleep.2018.06.014
CHRIS JOHNSON
Vitamin D not the brain protector some believe it is
Scientists have failed to find solid clinical evidence for vitamin D as a protective neurological agent, according to new research published in Nutritional Neuroscience.
South Australian researchers believe that vitamin D is unlikely to protect individuals from multiple sclerosis, Parkinson’s disease, Alzheimer’s disease or other brain-related disorders.
“Our work counters an emerging belief held in some quarters suggesting that higher levels of vitamin D can impact positively on brain health,” said lead author Krystal Iacopetta, PhD candidate at the University of Adelaide.
“Past studies had found that patients with a neurodegenerative disease tended to have lower levels of vitamin D compared to healthy members of the population.
“This led to the hypothesis that increasing vitamin D levels, either through more UV and sun exposure or by taking vitamin D supplements, could potentially have a positive impact. A widely held community belief is that these supplements could reduce the risk of developing brain-related disorders or limit their progression.
“The results of our in-depth review and an analysis of all the scientific literature, however, indicates that this is not the case and that there is no convincing evidence supporting vitamin D as a protective agent for the brain.”
The research was based on a systematic review of more than 70 pre-clinical and clinical studies, investigating the role of vitamin D across a wide range of neurodegenerative diseases.
Ms Iacopetta believes the idea of vitamin D as a neuro-related protector has gained traction based on observational studies as opposed to evaluation of all the clinical evidence.
“Our analysis of methodologies, sample sizes, and effects on treatment and control groups shows that the link between vitamin D and brain disorders is likely to be associative – as opposed to a directly causal relationship,” she said.
“We could not establish a clear role for a neuroprotective benefit from vitamin D for any of the diseases we investigated.”
The university’s Professor Mark Hutchinson said the outcome of the research was important, as it was based on an extremely comprehensive review and analysis of current data and relevant scientific publications.
“We’ve broken a commonly held belief that vitamin D resulting from sun exposure is good for your brain,” Professor Hutchinson said.
Vitamin D is also commonly known as the sunshine vitamin, but Professor Hutchinson said there may be evidence that sun exposure – or UV light – could impact the brain beneficially, in ways other than that related to levels of vitamin D.
“There are some early studies that suggest that UV exposure could have a positive impact on some neurological disorders such as multiple sclerosis,” he said.
“We have presented critical evidence that UV light may impact molecular processes in the brain in a manner that has absolutely nothing to do with vitamin D.
“We need to complete far more research in this area to fully understand what’s happening. It may be that sensible and safe sun exposure is good for the brain and that there are new and exciting factors at play that we have yet to identify and measure.
“Unfortunately, however, it appears as if vitamin D, although essential for healthy living, is not going to be the miracle ‘sunshine tablet’ solution for brain-disorders that some were actively hoping for.”
Researchers involved in this systematic review are affiliated with the University of Adelaide, the University of South Australia and the ARC Centre of Excellence for Nanoscale BioPhotonics (CNBP).
The research paper can be found at: https://doi.org/10.1080/1028415X.2018.1493807
CHRIS JOHNSON
[Perspectives] Elias Mossialos: breaking down borders between politics and health
Doctor, academic, teacher, politician, and policy adviser. This combination of skills is at the core of Elias Mossialos’s achievements in shaping health policy in many countries. As Professor of Health Policy at the London School of Economics and Political Science (LSE) and Imperial College London for the past 15 years, he is as committed to rigorous research as he is to changing practice in health-care systems. “I want to bring ideas out of the lecture hall and into health systems”, he says. Martin McKee, Professor of European Public Health at the London School of Hygiene & Tropical Medicine, is clear about Mossialos’s contribution to global health policy developments, “Elias has spent his professional life breaking down borders.
[Comment] Retraction—Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study
Following our Expression of Concern1 we have now received further information about the conduct of the study by Philipp Jungebluth and colleagues.2 In letters to The Lancet, the President of the Karolinska Institute has sent the results and conclusions of the final investigation that has identified serious flaws in the conduct and reporting of this study. The report concludes there was scientific and ethical misconduct and requests retraction of the paper. The Lancet is therefore retracting this research article from the scientific record.
[Comment] Retraction—Engineered whole organs and complex tissues
In letters to The Lancet, the President of the Karolinska Institute has sent the results and conclusions of the final investigation that has identified serious flaws in the conduct and reporting of the study by Philipp Jungebluth and colleagues.1 The report concludes that part of the series paper by Stephen Badylak and colleagues2 referring to the Jungebluth and colleagues’ research article is therefore misleading. In accordance with a request from the Karolinska Institute, The Lancet is retracting the series paper from the scientific record.
[Comment] Women and opioids: something different is happening here
An opioid crisis is raging in the USA, spreading across Canada, and there is increased opioid prescribing and access to high potency opioids such as fentanyl in other countries.1 Action is demanded through national initiatives and strategic plans2 to address the underlying causes of this epidemic, implement effective treatments for opioid use disorders (OUD), and support research that will improve interventions. However, current planning overlooks gender differences in opioid use that have meaningful implications for preventing misuse and treating pain and OUD.
[The Lancet Commissions] Accelerate progress—sexual and reproductive health and rights for all: report of the Guttmacher–Lancet Commission
Sexual and reproductive health and rights (SRHR) are fundamental to people’s health and survival, to economic development, and to the wellbeing of humanity. Several decades of research have shown—and continue to show—the profound and measurable benefits of investment in sexual and reproductive health. Through international agreements, governments have committed to such investment. Yet progress has been stymied because of weak political commitment, inadequate resources, persistent discrimination against women and girls, and an unwillingness to address issues related to sexuality openly and comprehensively.
[Editorial] The final verdict on Paolo Macchiarini: guilty of misconduct
In this issue, we are retracting two papers by Paolo Macchiarini and co-authors after receiving requests to do so from the new President of the Karolinska Institute (KI), Ole Petter Ottersen. In its final decision, the KI finds that the research reported in the 2011 Lancet paper and elements of a Review published in 2012 “constitutes scientific misconduct”. In his request for retraction, Ottersen states that ”no ethical permit had been obtained for the underlying research. The research was carried out without sufficient support by preclinical data, and the paper presents its data in a way that is unduly positive and uncritical.