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[Comment] Public availability of trial protocols

The Lancet has improved efforts to reduce research waste and increase the importance of scientific contributions through the Reward Campaign. One of the targets of this campaign is to make the methods of studies more accessible, which could be accomplished by increasing the public availability of research protocols. A protocol is a document that describes the aims, interventions, outcomes, statistical procedures, ethical considerations, and planned use and dissemination of data before the start of a clinical trial.

[Comment] Offline: The unspoken dangers facing UK medical science

Hope. Clarity. Certainty. Reassurance. Don’t be fooled. Brexit is not over yet. The hard part is yet to come. And many medical scientists remain anxious. A professor at one of the UK’s top universities frowned. He was born in Germany and moved to Britain (soon after receiving his PhD) where his field of research was thriving. He had recently offered a senior leadership role in his institution to another German scientist. She had declined his offer based on the worry that her team would not wish to move to a country that was exiting the European Union (EU).

[Viewpoint] The need for a complex systems model of evidence for public health

Despite major investment in both research and policy, many pressing contemporary public health challenges remain. To date, the evidence underpinning responses to these challenges has largely been generated by tools and methods that were developed to answer questions about the effectiveness of clinical interventions, and as such are grounded in linear models of cause and effect. Identification, implementation, and evaluation of effective responses to major public health challenges require a wider set of approaches1,2 and a focus on complex systems.

[Editorial] The balancing act of orphan drug pricing

In the past year, the high price tag of orphan drugs has come under severe scrutiny. Global industry players have used incentive schemes such as the USA’s Orphan Drug Act (which offers a 50% tax rebate to help cover research and development costs and 7 years of marketing exclusivity from approval), and the EU Regulation on orphan medicinal products (which offers exclusive access to market for 10 years when approved) to drive up profits in the sector. Health-care systems, under increasing pressure from under-resourcing, ageing populations, and high-price biomedical advances, can be tempted to reduce costly orphan drug programmes to balance their budgets.

[Articles] The cumulative burden of surviving childhood cancer: an initial report from the St Jude Lifetime Cohort Study (SJLIFE)

The burden of CHCs in survivors of childhood cancer is substantial and highly variable. Our assessment of total cumulative burden in survivors of paediatric cancer, with detailed characterisation of long-term CHCs, provide data to better inform future clinical guidelines, research investigations, and health services planning for this vulnerable, medically complex population.

Unacceptable kidney transplant rate for Indigenous Australians

AMA President Dr Michael Gannon has called for urgent attention in addressing the gap between Indigenous and non-Indigenous Australians accessing kidney transplants.

Figures just released show that Indigenous patients are 10 times less likely than non-Indigenous patients to be added to the waiting list for a kidney donation transplant.

About 13 per cent of patients receiving dialysis treatment in Australia are Indigenous. Only 241 of 10,551 patients with a functioning kidney transplant are Indigenous.

Some renal experts have pointed to a racially-based bias, suggesting some non-Indigenous doctors favour non-Indigenous dialysis patients.

Other specialists in the field insist the gap is not fuelled by racism.

During an interview with the ABC, Dr Gannon said these figures were unacceptable and more needed to be done to ensure Indigenous Australians received transplants when needed.

“I’m shocked by those figures. A ten-fold gap is entirely unacceptable,” Dr Gannon said.

“The topic of racism in our health system is an uncomfortable one for doctors, nurses, but it has to be one of the possible reasons for this kind of disparity.

“If there’s reasons why Aboriginal and Torres Strait Islanders are not being transplant-listed, they need to be investigated, but the problems need to be fixed.”

Dr Paul Lawton, a specialist at the Menzies School of Health Research, told the ABC that while Australian kidney specialists were well meaning, there was a “structural racism” that had led to low transplant rates for Indigenous patients.

“Currently, our system is structured so that us non-Indigenous, often male, middle-aged white kidney specialists offer kidney transplants to people like ourselves,” Dr Lawton said.

“It both makes me sad and angry that in Australia in the 21st century, we see such great disparities in access to good quality care.”

Indigenous Health Minister Ken Wyatt said he was disheartened with the figures and wanted to focus on building a heightened awareness of the issue over the next year.

According to Kidney Health Australia, about 30 of 800 kidney transplants performed each year are received by Indigenous Australians.

This under-representation can be attributed to a variety of reasons such as comorbidities, delays in listing and significant tissue matching issues. Importantly, the outcomes from transplantation are considerable poorer than among non-indigenous people.

To improve access to transplantation by Aboriginal and Torres Strait Islander renal patients, there needs to be a better understanding of how to address the barriers. There also needs to be improved support services for patients.

Kidneys for transplantation are largely from deceased donors. There are very few living kidney donors in Aboriginal and Torres Strait Islander communities, due to burden of disease and likelihood of comorbidities evident. Increasing live donations or listing more people on the waiting list is very unlikely to see improvements, given the burden of disease experienced and current barriers in the system.

The reasons for poor access to transplantation experienced by Aboriginal and Torres Strait Islander Australians are complex and can be attributed to:

• The greater burden of comorbid illness amongst Aboriginal and Torres Strait Islander dialysis patients leading to fewer patients being judge medically suitable;

• The shortage of living and deceased donors from within Aboriginal and Torres Strait Islander communities;

• The length of time on the waiting list and matching system;

• The challenges in delivering appropriate health services to people living in remote areas who might also have low health literacy and not speak English as a first language;

• The dislocation that follows from moving to transplant centres in distant capital cities; and

• The high complication rate, particularly in terms of early infectious complications leading to poor transplant outcomes, including substantially higher death and graft loss rates.

The poorer outcomes among those who receive transplants are due to higher rates of rejection, less well-matched kidneys, higher rates of infection and infection-related deaths. There are downsides to transplantation.

Prior to transplantation, these include a requirement for significant work up tests and assessments which require visits to major centres. After transplantation there is the prospect of a post-operative stay and side effects away from home and supports. The number of medications usually increases, and there is an increased risk of infections and cancers

CHRIS JOHNSON AND LUKE TOY

 

Payment incentives for community-based psychiatric care in Ontario, Canada [Research]

BACKGROUND:

In September 2011, the government of Ontario implemented payment incentives to encourage the delivery of community-based psychiatric care to patients after discharge from a psychiatric hospital admission and to those with a recent suicide attempt. We evaluated whether these incentives affected supply of psychiatric services and access to care.

METHODS:

We used administrative data to capture monthly observations for all psychiatrists who practised in Ontario between September 2009 and August 2014. We conducted interrupted time-series analyses of psychiatrist-level and patient-level data to evaluate whether the incentives affected the quantity of eligible outpatient services delivered and the likelihood of receiving follow-up care.

RESULTS:

Among 1921 psychiatrists evaluated, implementation of the incentive payments was not associated with increased provision of follow-up visits after discharge from a psychiatric hospital admission (mean change in visits per month per psychiatrist 0.0099, 95% confidence interval [CI] –0.0989 to 0.1206; change in trend 0.0032, 95% CI –0.0035 to 0.0095) or after a suicide attempt (mean change –0.0910, 95% CI –0.1885 to 0.0026; change in trend 0.0102, 95% CI 0.0045 to 0.0159). There was also no change in the probability that patients received follow-up care after discharge (change in level –0.0079, 95% CI –0.0223 to 0.0061; change in trend 0.0007, 95% CI –0.0003 to 0.0016) or after a suicide attempt (change in level 0.0074, 95% CI –0.0094 to 0.0366; change in trend 0.0006, 95% CI –0.0007 to 0.0022).

INTERPRETATION:

Our results suggest that implementation of the incentives did not increase access to follow-up care for patients after discharge from a psychiatric hospital admission or after a suicide attempt, and the incentives had no effect on supply of psychiatric services. Further research to guide design and implementation of more effective incentives is warranted.

[Comment] Childhood cancer: the long-term costs of cure

Survival after childhood cancer has substantially improved over the past several decades, and more than 80% of children diagnosed with cancer in the USA now survive at least 5 years.1 This improvement comes at a cost, however, because the curative therapies used to achieve such successful survival proportions are associated with adverse late effects, with previous research finding increased risks of morbidity,2 poor health status,3 and premature mortality4 compared with sibling and population comparison groups.

[Editorial] Family planning: accelerating the way ahead

The latest figures and progress of the Family Planning 2020 (FP2020) global partnership were released in its annual report on Dec 5. FP2020 The Way Ahead, together with a related research paper by Niamh Cahill and colleagues published online in The Lancet, paint a mixed picture. By July, 2017, more than 309 million women and girls of reproductive age in the 69 FP2020 focus (the world’s poorest) countries are using modern methods of contraception. That figure is 38ยท8 million more than at the start of the FP2020 initiative in 2012.

[Editorial] Putting research evidence at the heart of policy making

To improve patient outcomes, research must inform and shape policy. As history sadly teaches, this ideal is not always realised. But in today’s Lancet, two Articles display how research addressing knowledge gaps can inform policy for hypertension control in China.