AMA ensures doctors heard on Medicare review

The AMA this week hosted more than 60 leaders from across all medical specialties in Canberra to discuss the medical profession’s participation in the Governments’ Medicare Benefits Schedule (MBS) review, and the recent behaviour of Medibank Private in negotiations with hospitals. Welcoming delegates to the meeting, AMA President, Professor Brian Owler, said it was important that the medical profession was informed and united in its approach to the MBS review.

The AMA has cautiously welcomed the review, led by Sydney University Medical School Dean Professor Bruce Robinson, and supports having a schedule that allows patients access to modern medical procedures, and reflects the modern-day treatments that are provided in our health system.

But Professor Owler has voiced concern that the Government might use the review mostly to remove items from the MBS as part of a cost-cutting exercise, rather than ensuring the schedule is up-to-date and reflects advances in care and medical practice.

“We need to make sure that the Government continues to work with clinicians, that this is a clinician-led process that is based on evidence, and that the process is held in conjunction with the colleges and specialist societies where the knowledge base and expertise lies,” Professor Owler said.

He added that the AMA will continue to work with the Government in the review, and will work with the specialists and colleges in ensuring the best outcome from the review – provided it is not just about cutting costs and provided that doctors maintain access to health care for their patients.

AMA transcript – MBS Review and Medibank Private

This post was first published on GP Network News

Govt needs to relieve strain on health system’s heart

The benefits of co-ordinated care are widely recognised, and worldwide work is progressing to develop and implement systems and models of care that facilitate and support it.

In Australia, improving the continuity of patient care through better co-ordination has been on the agenda for almost two decades. As a GP, it is frustrating when the role of GPs in the co-ordination of patient care is so often undervalued by Governments in their ongoing quest for cost savings.

Despite the Government’s rhetoric acknowledging general practice as being central to the health system and its desire to rebuild it, the indexation freeze and other attempts to cut rebates stand in stark contrast to this intent.

Every time general practice is undermined with a rebate cut, the loss of an incentive, or an indexation freeze, our capacity to provide a higher level of care is compromised.

We have care planning and team care arrangements that recognise the GP’s central role in co-ordinating services to support patients to better manage their chronic and complex conditions. However, these arrangements are limited, inconsistent with established referral practices, and encased in red tape. This impacts on their effective use.

More than $1 billion has been “invested” by the Federal Government in a shared electronic health record to help ensure continuity of care. Unfortunately, most of that investment could have been saved if greater stock had been put in the advice of clinicians and the medical profession. In particular, that it must be an opt-out system and that information uploaded to the shared health recorded needed to be clinically relevant.

In the past decade there have been multiple trials around co-ordinated and collaborative care. We’ve had the Co-ordinated Care Trials in Queensland, HealthPlus in South Australia, the recent Diabetes Care Project trial, and Victoria is currently running the Care Point trial.

To varying extents, these trials recognise the role of general practice. We must build on the lessons learned from them, bearing in mind the recent findings of a report on nurse-led, hospital-based co-ordinated care interventions that found no demonstrated effect. What this shows, I believe, is that the best place for care co-ordination is at the central point of health care, which is general practice.

Private health insurers appear to be slowly coming around to the view that if they want to stem the rise in hospital-based claims (and their resultant payouts), then they need to start looking at supporting primary health care. They need to recognise that general practice holds the key for them, and that the challenge is to develop a funding model that will enable them to support GPs in keeping their patients out of hospital.

As AMA President Professor Brian Owler said in his address to the National Press Club during this year’s Family Doctor Week, there needs to be urgent recognition of the costs of providing high quality care.

If private insurers can recognise that general practice is where they need to be investing, then it is time the Federal Government did so as well.

The current review into primary health care, led by former AMA President Dr Steve Hambleton, provides a vital chance to shift the focus of our health system back to its heart.

Biosimilar drugs – should doctors be concerned?

In June, the Australian Parliament passed legislation allowing prescribed biological medicines to be substituted with biosimilar drugs when they are dispensed by pharmacists.

Under the change, the Pharmaceutical Benefits Advisory Committee (PBAC) will assess on a case-by-case basis whether a specific biological medicine can be safely switched for a biosimilar by a pharmacist. As for all prescribed medicines, doctors can still control what medicine is dispensed to their patients by marking ‘do not substitute’ on the prescription.

Is pharmacist substitution of biologicals a good thing? Or will this pose risks to patient health? And what are biological and biosimilar medicines anyway?

The AMA is satisfied with the regulatory arrangements introduced for biosimilars, but it is important that doctors are aware of the potential implications for their patients. Here’s a summary of the key facts.

What are biologicals?

A biological medicine is made from a living organism, typically extracted from a human cell or tissue-based system. Biologicals include:

hormones used to treat hormone deficiencies, e.g. insulin for diabetes;
monoclonal antibodies for the treatment of autoimmune diseases and cancers;
blood products, e.g. for the treatment of haemophilia;
immunomodulators, e.g. beta-interferon for multiple sclerosis;
enzymes, e.g. to remove blood clots; and
vaccines to prevent a number of diseases.

The manufacturing process for biologicals is complex and sensitive to variations because of the nature of the biological substances used and modified. Subtle variations of a biological substance exist between batch preparations from the same manufacturer.

What is a biosimilar?

A biosimilar is not a generic biological medicine.

A biosimilar medicine is highly similar to a biological medicine that has already been approved but for which the patent has expired. Unlike a generic medicine, which is made from the same chemical compounds and has the same chemical structure as the original brand medicine, a biosimilar is not a generic copy of the reference biological medicine.

While a biosimilar’s manufacture is based on the same active ingredient as the original biological, by their nature they cannot be identical.

Before a biosimilar can be approved for sale in Australia, any differences between the biosimilar and its reference medicine must have been shown not to affect quality, safety or efficacy through a robust clinical trial process.

Biosimilars, like generic medicines, will be significantly cheaper than the original biological medicine, although not to the same extent given the higher costs needed to invest in clinical trials, manufacturing and post-approval monitoring programs.

There are already biosimilar versions of medicines listed on the Pharmaceutical Benefits Scheme (PBS) being prescribed to patients.

What are the issues?

Biologicals are more likely to cause an immune reaction than chemical medicines.

In turn, small changes in the manufacturing process or composition of a biological may result in the emergence of immune reactions, even if the agent had previously been well tolerated. For example, in one instance a minor alteration in the manufacturing process of erythropoietin alpha triggered acquired pure red blood cell aplasia in a small cohort of patients.

It is therefore important that effective adverse event reporting mechanisms are in place to ensure that any patterns of adverse events are quickly identified and tracked to the specific biological brand.

Because of the documented variability between biologicals and biosimilars, it is conceivable that adverse reactions may increase with substitution.

Some consumer groups and pharmaceutical companies have argued that allowing biologicals to be switched at the dispensing point will make it more difficult to identify the specific brand if an adverse event occurs.

Government regulation

The Therapeutic Goods Administration (TGA) will remain the regulatory body responsible for assessing and approving a biosimilar as a safe and equally effective treatment compared to another medicine before it can be sold in Australia. The TGA is currently reviewing its assessment guidelines.

Once the biosimilar has been approved by the TGA, the PBAC will also consider if the biosimilar medicine should be listed to allow substitution by a pharmacist under the PBS.

The PBAC has stated that it will not recommend a biosimilar as suitable for substitution unless it is sure of its equal safety and effectiveness.

The PBAC’s assessment will include consideration of whether there is available data to support safe switching between the original product and the biosimilar product, and whether it can be safely substituted by a pharmacist at the point of dispensing.

Examples of biosimilar brands available in Australia include:

Aczicrit, Grandicrit and Novicrit with the active substance epoetin lambda – all have been approved by the TGA but only Novicrit is listed on the PBS; and
Nivestim, Tevagrastim and Zarzio with the active substance filgrastim – all have been approved by the TGA and all are listed on the PBS.

No biosimilar has yet been approved for substitution by a pharmacist.

What should doctors do?

When prescribing biological medicines, doctors should ensure they mark the prescription as ‘do not substitute’ if they have any concerns about the impact on their patients of switching to another brand;
doctors should discuss this decision with their patients so that patients are also aware they must not allow their pharmacist to substitute the medicine;
doctors who find out that a pharmacist has substituted a medicine ignoring the ‘do not substitute’ mark on the prescription should report the behaviour. Under PBS related legislation, this can attract a $2000 fine or 12 months in gaol. Report breaches to the Department of Human Services by phoning 132 290 or emailing pbs@humanservices.gov.au;
Any suspected adverse event should be reported to the TGA:
- by phone on 1800 044 114
- by email at adr.reports@tga.gov.au
- online at https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase

The AMA welcomes members’ views on this issue to president@ama.com.au. Member comments help inform AMA advice and activities.

AMA takes stand against racism, backs Indigenous constitutional recognition

The AMA has thrown its support behind constitutional recognition for Indigenous Australians and combating racism, condemning its insidious effects on social and emotional wellbeing.

As the on-field treatment of Indigenous AFL star Adam Goodes intensifies the focus on racism in the community, AMA President Professor Brian Owler said racist attacks were not only immoral but had all-too-real detrimental effects on the health of those who were its targets.

Professor Owler, who attended the Garma Festival at the Northern Territory town of Nhulunbuy in early this month, said the experience of Adam Goodes, who was badly shaken by the incessant booing directed at him by AFL crowds in recent weeks, showed that racism could have real consequences for individual mental health, as well as overall social and emotional wellbeing.

He said this was why the AMA viewed racism as a health issue and was committed to Indigenous constitutional recognition.

“The Aboriginal concept of ‘health’ centres on social and emotion wellbeing – a concept that applies to anyone,” the AMA President said. “Indigenous people face racism on a daily basis. The treatment of Adam Goodes raises an important questions for the nation, for non-Indigenous people, and our commitment to issues such as raising the standards of health, education, and economic outcomes of Indigenous people.”

“It comes back to social and emotional wellbeing. It is about respect for Indigenous culture and their place in the community being recognised and valued.”

In light of this, he questioned Prime Minister Tony Abbott’s decision not to support the development of a consensus Indigenous position on constitutional recognition to help inform a proposed referendum on the issue – a decision that deeply disappointed Indigenous leaders.

Professor Owler warned the Federal Government that its risks derailing its headline Indigenous Advancement Strategy and undermining recent progress in closing the gap by neglecting health issues and sidelining Indigenous leaders and communities.

The AMA President said that although Government efforts to improve school attendance, encourage young people to get a job and to make communities safer, were laudable, by themselves they would not bridge the big gap in wellbeing between Indigenous Australians and the rest of the community.

“Health is essential to learning, to going to school, for training and employment,” he said. “Health must underpin these strategies. The lack of focus on health is one of the reasons why I struggle to understand the Government’s Indigenous Advancement Strategy.”

Professor Owler said there had been real progress in addressing Indigenous disadvantage, including reducing infant mortality, but cautioned the disruption and uncertainty created by last year’s decision to slash $500 million from Indigenous services and programs put recent gains at risk.

“There is clearly a lot of good things that are being done, but we still have an enormous problem, and Indigenous health is one of those areas where you cannot take the foot off the pedal, because the moment you stop you can lose all the gains you have won,” he said.

Last year’s Budget cuts are continuing to resonate. An analysis of the 2015-16 Federal Budget by Menzies Centre for Public Policy Adjunct Associate Professor Dr Lesley Russell found that the share of total health funds being directed to Indigenous health programs will fall to 1.07 per cent this financial year before a minor improvement to 1.13 per cent in 2016-17.

Dr Russell said Commonwealth funding for Indigenous policies as a percentage of total outlays and of GDP was in decline, and that Indigenous organisations were losing out in the competition for funds to deliver Indigenous programs.

Adrian Rollins

GP pay up for grabs in primary health overhaul

Set fees and performance payments are among changes to GP remuneration being considered as part of efforts to remodel the primary health system to improve the care of patients with chronic and complex conditions.

The Federal Government’s Primary Health Care Advisory Group, led by immediate-past AMA President Dr Steve Hambleton, has canvassed a number of GP payment options in a discussion paper outlining potential reforms to address the rising chronic care challenge.

While the current fee-for-service model worked well in the majority of instances, the Better Outcomes for People with Chronic and Complex Health Conditions through Primary Health Care Discussion Paper said it did not provide incentives for the efficient management of patients who required ongoing care.

Instead, it suggested alternatives included capitated payments, where GPs, health teams, practices or a Primary Health Network receive a set amount to provide specified services over a given period of time; or pay-for-performance, where remuneration is tied to the achievement of particular care outcomes; or some combination of all three.

The discussion paper also suggests ideas about how care is organised and managed, including the creation of medical homes, GP-led team-based care, improved use of technology and upgrading techniques to monitor and evaluate care.

AMA President Professor Brian Owler welcomed the release of the discussion paper, but warned the Government that reform would not succeed without significant investment in general practice.

Professor Owler said several of the options for reform canvassed by Dr Hambleton’s Group had long been supported by the AMA, including GP-led team-based care, the improved use of technology, care coordinators, and an expanded role for private health insurers.

He said the new payment models outlined were a challenge for the medical profession, and would need ongoing discussion.

But he warned that the Government needed to support general practice if it was genuine in seeking to improve care.

“What is missing from the discussion paper is an explicit statement that we need to better fund and resource general practice if we are to meet the health challenges of the future,” Professor Owler said. “The final outcome from this Review must be more than simply re-allocating existing funding.”

Dr Hambleton emphasised that the paper had been developed to encourage discussion, but warned that things needed to change.

He said increasing life expectancy meant more patients were presenting with multiple chronic and complex health complaints, and current arrangements were increasingly struggling to meet their care needs.

More than a third of Australians have a chronic health condition and the discussion paper said that because the system was not set up to effectively manage long-term complaints, many were turning up unnecessarily in hospital and emergency departments, adding millions of dollars to the nation’s health bill.

Health Minister Sussan Ley said it was “essential” to review the provision of chronic care, because Medicare benefits for chronic care were soaring – up almost 17 per cent to $587 million in 2013-14 alone.

“We are committed to finding better ways to care for people with chronic and complex conditions and ensure they receive the right care, in the right place, at the right time,” Ms Ley said. “This discussion is a real opportunity to cater for the increase in chronic and complex conditions, and this approach ensures that health professionals and patients continue to be central to this process.”

But Professor Owler said the reality was that primary health review was being undertaken at a time when general practice was under sustained attack from the Government, and a “more positive” attitude was urgently needed.

“General practice has been the target of regular Budget cuts that undermine the viability of practices, and threaten the long term sustainability and quality of GP services,” he said. “The freeze on Medicare patient rebates is the prize example. It is causing great harm to GPs, their practices, and their patients.

“If the Government is genuine about improving how we care for patients with chronic and complex disease in primary care, greater investment and genuine commitment to positive reform is needed,” Professor Owler said.

As part of its consultation process, the Primary Health Care Advisory Group is conducting an online survey that will be open until 3 September. To access the survey and discussion paper, visit www.health.gov.au

In addition, the Group is holding a series of public meetings in major cities and regional centres around the country, and will host a nationwide webcast on 21 August.

It is due to present its final report to the Government by the end of the year.

Adrian Rollins

Higher drug price fears in trade deal fall-out

Health groups remain concerned the massive Trans-Pacific Partnership trade deal will push up the cost of medicine and hamper public health initiatives despite indications United States negotiators are prepared to give ground on controversial intellectual property protections.

While the future of the controversial trade pact is clouded following the failure of officials from 12 nations to seal an agreement in Hawaii last month, reports have emerged that the US is willing to back down on demands that data used to produce biologic medicines be subject to a 12-year exclusivity clause.

The clause would delay the competition pharmaceutical companies would face from cheaper generics, adding billions of dollars to their bottom line.

On the eve of the Hawaii talks, Trade Minister Andrew Robb told Fairfax Media he was pushing for the data exclusivity period to be slashed to five years, and it is understood the United States’ chief negotiator, US Trade Representative Michael Froman, was considering a counter-proposal for a base period of five years, followed by a three-year extension contingent on “certain circumstances”.

The secretive nature of the talks has meant that most observers have had to rely on information gained by websites like Wikileaks for information about the direction of negotiations on the deal which, if concluded, will encompass about 40 per cent of the global economy.

Mr Robb said that although the deal was not concluded at Hawaii, “we are definitely on the cusp”.

“While nothing is agreed until everything is agreed, I would say we have taken provisional decisions on more than 90 per cent of issues,” the Minister said.

But he admitted data protection for biologic medicines was among a number of “big outstanding issues” to be resolved: “You’ve got to set a balance somewhere between people getting a return on innovation on investment, and enabling competition to bring prices down for the rest of the community.”

Biologic medicines are derived from biological sources, and though they comprise only a fraction of drugs listed on the PBS, many are extraordinarily expensive, with a course of treatment often costing hundreds of thousands of dollars. In 2013-14, they accounted for a quarter ($2.3 billion) of PBS spending in 2013-14.

While the US may have given ground on access to biologic data, the AMA and other health groups remain concerned that other clauses in the proposed trade deal, including provisions allowing pharmaceutical companies to “evergreen” drug patents and giving investors scope to block governments taking public health measures, could undermine health care.

The AMA Federal Council has called on the Federal Government to reject “any provisions in trade agreements that could reduce Australia’s right to develop health policy and programs according to need”.

The Association said it was concerned that aspects of the proposed TPP could be used to attack key health policies and measures including the PBS and the cost of medicine, food labelling and tobacco control laws, restrictions on alcohol marketing, the operation of public hospitals and the regulation of environmental hazards.

Among the most controversial provisions are investor-state dispute settlement (ISDS) procedures that would enable corporations to mount legal action against government policies and laws they felt harmed the value of their investment or future profits.

Tobacco giant Philip Morris Asia used just such provisions in a 1993 investment agreement between Australia and Hong Kong to challenge Australia’s world-first tobacco plain packaging legislation in the courts and seek compensation, arguing that the policy undermined the value of its investment by ‘expropriating’ its trademarks and branding.

It is understood that Australia is arguing that health and environment policies, as well as the Pharmaceutical Benefits Scheme, be made exempt from ISDS provisions.

In addition, the TPP includes proposals demanding the removal of technical barriers to trade – provisions which companies have used to challenge regulations such as alcohol warning labels, alcohol excise, and front-of-packet food labelling.

There are also concerns market access rules in the TPP may be used to restrict government support for public hospitals and other health services by requiring that there be competitive neutrality between such entities and private health providers.

Medical charity Medecin Sans Frontieres is also apprehensive about the deal.

It said that without major changes in the Hawaii talks, the deal would have a “devastating impact” on global health.

MSF was particularly concerned about provisions it warned would “strengthen, lengthen and create new patent and regulatory monopolies for pharmaceutical products that will raise the price of medicines and reduce the availability of price-lowering generic competition”.

It said some of the most concerning provisions centred on patent evergreening, which would force governments to grant drug companies additional patents for changes they made to their medicines, even if these were of no therapeutic benefit.

Adrian Rollins

Discrimination, bullying and sexual harassment: where next for medical leadership?

Sexual harassment, the perceived career damage that can result from reporting such behaviour, and inconsistent standards of response by medical colleges and health services hit the headlines in early 2015.1 A background briefing paper published by the Royal Australasian College of Surgeons (RACS) in June 2015,2 as well as several articles in this issue of the Journal3–6 confirm these concerns are real.

Discrimination, bullying and sexual harassment (DBSH) occur in many workplace environments internationally, despite having been prohibited by law for decades. Trainees, medical students and female staff and colleagues are identified as the most likely targets. Proceduralists are particularly likely to offend. Some offenders unwittingly reproduce behaviours they have learned from role models of previous generations. Others are more deliberate or determined perpetrators, often with a reputation for misbehaviour that frequently goes unchecked. Observers who are aware of such behaviour may be covictims or coperpetrators, or both. Hospitals and professional associations sometimes foster a culture of abuse through covert sanctions against complainers, or by providing tacit approval by failing to act or by discouraging change.

There is little doubt of the perception among medical students and trainees that complaining can damage a career because “the hierarchy is too high and too strong”.7 Underreporting of abuse is prevalent across the entire health sector.8 Despite explicit professional values being taught, these seem to be overlooked, and there is a perceived disconnection between organisations’ stated values and their responses in individual cases of alleged abuse.9,10

Significant cultural change is necessary to make perpetrators aware that their behaviour will no longer be tolerated. The leadership required includes the following:

understanding what constitutes DBSH;
taking responsibility for proactively improving workplace culture and eradicating DBSH;
providing training in appropriate behaviour, including resilience, performance under pressure and speaking up when DBSH occurs;
recognising the right of victims to be able to report abuse or complain without fear of retribution;
providing appropriate timely responses to allegations, that include various levels of sanction for perpetrators; and
providing confidential counselling and support for those who have been affected.

In March this year, the RACS established an Expert Advisory Group to provide well grounded, informed and independent advice. The college published the background briefing paper, above, reviewing the evidence,2 and an issues paper11 that will cover the areas described above as well as equity between the sexes. It has also commissioned a prevalence survey of college fellows, trainees and international medical graduates, and qualitative research that captures the stories, effects and outcomes of individual cases. On the recommendations of the Expert Advisory Group, the RACS mounted an improved complaints process, and partnered with an independent external agency to provide the RACS Support Program for those affected.

Medical colleges have a vital role to play in honouring the “societal contract” that exists between the profession and the public,12 ensuring that DBSH are never tolerated and championing professionalism and standards.

Sexual harassment in the medical profession: legal and ethical responsibilities

Sexual harassment in medicine became a national concern after a senior surgeon warned that trainees who complain about these incidents are not well supported, and advised trainees that the safest action to protect their careers was to comply with unwanted requests.1 The surgeon referred to the case of Dr Caroline Tan, who was found by a tribunal to have been sexually harassed by a neurosurgeon who was involved with her surgical training. While Dr Tan successfully sued for sexual harassment,2 she reportedly faced substantial career detriment after pursuing her rights.1

While the prevalence of sexual harassment in Australian medicine is unknown, reports suggest it is an entrenched problem for both trainees3 and specialists.4,5 This is consistent with surveys in Australia, the United Kingdom, the United States, Sweden and Canada that have found between a quarter and three-quarters of women experienced sexual harassment in training or practice.6–9

Sexual harassment is an umbrella term covering a range of behaviour, from everyday exchanges communicating derogatory messages (“micro-aggressions”), through to direct acts of physical sexual assault.10

As we will show, some forms of harassment also constitute criminal sexual assault. Sexual harassment can adversely affect women’s safety and wellbeing, choice of specialty11 and career progression. The vast majority of incidents are unreported due to: lack of confidence that reporting would help; fear of adverse consequences; reluctance to be viewed as a victim; complicity of senior staff; and cultural minimisation of the problem.12 Men also experience harassment, but women are more frequently targeted.6,7

While sexual harassment occurs across professions, women in medicine are at particular risk because of male dominance of senior positions13 and the “patronage” system of training, whereby trainees depend on a small group of powerful senior colleagues for entry into training, assessment, job opportunities and career progression.

In this article, we review four dimensions of legal responsibilities owed by individuals and employers across Australia, and analyse professional standards and ethical frameworks. There are compelling legal, reputational and economic reasons for medical schools, hospitals, colleges and other organisations to create cultural change to reduce sexual harassment. These interests are further supported by an ethical and professional duty to promote gender equality and equal opportunity.

Four legal dimensions of sexual harassment

Criminal law

Criminal laws in every Australian jurisdiction make it an offence to commit sexual assault and more serious acts such as rape. Other criminal offences include indecent exposure, obscene communications and stalking.

Sexual assault is defined as an “unlawful and indecent assault” punishable by maximum prison terms of 5–21 years (Box 1). An assault is “indecent” if it has a sexual connotation and is “contrary to the ordinary standards of morality of respectable people within the community”.14 The acts found by the civil tribunal to have been committed without consent in Tan v Xenos2 (paragraphs 15–16 and 532–546) included embracing the complainant, kissing her on the lips, touching her breast, pinning her against a desk, and asking for oral sex. Such acts would constitute sexual assault if proved beyond reasonable doubt in a criminal prosecution.

Criminal laws in every state and territory set clear principles. Importantly, consent must be “freely and voluntarily given” for any sexual act to be lawful (Box 1). Consent is invalid if obtained by threat or intimidation, or by abuse of a position of authority (Box 1). Mere lack of physical resistance does not prove consent (Box 1). Therefore, sexual acts committed without any agreement will be criminal; as will sexual acts where a medical practitioner obtained “agreement” through threats, intimidation or reliance on a position of authority.

Anti-discrimination law

Legislation in all jurisdictions prohibits discrimination in the workplace. This legislation imposes two duties: individuals must not sexually harass a colleague; and employers must provide work environments free of sexual harassment.

The legislation prohibits unwelcome conduct of a sexual nature in circumstances where a reasonable person would have anticipated the other person would be offended, humiliated or intimidated (Box 2). Prohibited conduct includes inappropriate comments, sexual propositions, indecent exposure and sexual assault. Circumstances relevant in determining whether the other person would be offended, humiliated or intimidated include each person’s sex and age, and the relationship between the individuals. The concept of “unwelcome conduct”, with the element of offence, humiliation or intimidation, distinguishes unlawful harassment from lawful interactions between consenting adults. Therefore, even forms of harassment which are apparently more minor are serious and cannot be dismissed as trivial or justified as banter.

Sexual harassment under anti-discrimination legislation has consequences for individual offenders and employers. Individuals may face civil proceedings and be ordered to pay damages (Box 2). Employers are vicariously liable for an individual’s acts unless reasonable steps were taken to prevent them (Box 2). It is insufficient for an employer to merely respond after a complaint. Proactive steps include making policies, educating staff, establishing grievance procedures and monitoring workplace environments.

Where sexual harassment is proved, damages are awarded to approximate the hurt caused to the victim. In Tan v Xenos, the award was $100 000.2

Tort law

Tort law gives individuals a further range of rights enforceable in civil law, separate from their rights in anti-discrimination law and the state’s capacity to bring criminal proceedings. Some of these rights can be pursued in civil lawsuits against individuals and employers for sexual harassment. For example, an individual may be liable for battery for intentionally causing harmful or offensive physical interference with another’s body. An individual may also be liable for breach of duty, enabling a victim to sue for compensation when further losses have crystallised, such as the nature and extent of psychological injury, and the victim’s economic loss.15

Employers have a positive obligation to provide a safe workplace for employees, including an environment free of sexual harassment.16 In the branch of tort law known as negligence, employers owe employees a duty of care to prevent damage being suffered. An employer will be liable for breaching its duty of care to a harassed employee if the employer knows, or ought to know, of an employee’s propensity to harass other employees, does not take reasonable steps to prevent further offending, and the individual offender subsequently causes damage to the harassed employee.

Contract law

Employment contracts contain an implied duty requiring the employer not to engage in conduct likely to damage the relationship of trust between employer and employee.17 Connected with this is an implied term to provide a safe work environment free of sexual harassment.17 These terms may support an action for breach of contract against the employer where an employee experiences sexual harassment by another employee.

Where a person resigns because sexual harassment makes the workplace intolerable, a court or the Fair Work Commission may find the person has been subject to “constructive” dismissal. That is, workplace conditions gave the employee no reasonable alternative but to resign. Such indirect forced dismissal warrants compensation from the employer for lost remuneration. Finally, if an employee complains about harassment and resigns because of subsequent pressure or victimisation, this may constitute an additional contractual breach and a separate breach of anti-discrimination legislation (Box 2).

Professional standards

Professional codes of conduct establish clear professional and ethical responsibilities to treat colleagues with fairness and respect. These responsibilities are established for all doctors in the code of conduct of the Medical Board of Australia (Box 3).18 Other codes reinforce these profession-wide duties. The code of ethics of the Australian Medical Association urges doctors to recognise that their conduct may affect the profession’s reputation, and encourages reports of colleagues’ unprofessional conduct (clause 2.1).19

Many professional colleges address harassment in their codes of conduct. For example, the Royal Australasian College of Surgeons’ code of conduct requires surgeons to “eradicate bullying or harassment from the workplace” (clause 4.1.6).20 This code states that surgeons, by virtue of their position, should be role models for those they supervise and teach (clause 10) and are prohibited from seeking intimate relationships with trainees under their supervision (clause 10.1). Sexual harassment is prohibited by other colleges’ codes of conduct, including those of the Royal Australasian College of Physicians21 and the Australian and New Zealand College of Anaesthetists.22

Serious breaches of standards may result in notifications to the Medical Board. Under the Health Practitioner Regulation National Law, which has been enacted in every Australian state and territory, practitioners and employers must notify cases where a practitioner engages in “sexual misconduct in the practice of the profession”. Although this usually arises when practitioners breach boundaries with patients, sexual assault of colleagues has been reported to the Australian Health Practitioner Regulation Agency under these provisions or the voluntary notification provisions for unprofessional conduct.

In serious cases, tribunals can suspend or deregister practitioners for misconduct, including for repeated instances of unprofessional conduct or conduct inconsistent with being a fit and proper person to hold registration.

Conclusion

Sexual harassment is illegal and unethical. Prohibitions in Australian laws and codes of conduct are clear. Practitioners face serious consequences for committing sexual harassment, and employers can be liable for failing to take preventive action.

Nonetheless, sexual harassment of women in medicine remains a serious concern in training and clinical settings, but complaints are rare. This suggests that the problem requires cultural change rather than legal reform. A potent alloy of gender inequality, normalisation of inappropriate conduct, professional monopolies and powerful hierarchies combine to create a culture that shields offenders and silences victims.

We suggest that culture change requires a five-pronged approach. First, we need a clearer understanding of the nature and scope of the problem, its effects and potential impacts on clinical care. Many acknowledge the gravity of the problem, but others contend that concerns are infrequent and historical. The establishment of the new Royal Australasian College of Surgeons Advisory Group, which will review policies, establish a reporting framework for harassment and explore problems of gender balance, is a welcome development.

Second, we need to educate students, practitioners, employers and boards about their responsibilities. Improved knowledge can influence attitudinal and behavioural change: the goal is for doctors to cease the sexual harassment of students and colleagues. In designing educational programs, Australia may benefit from the experience of Canadian colleges, which have provided sexual harassment training for 2 decades.23 Other helpful tools may include the Victorian Equal Opportunity and Human Rights Commission’s recommendations for reform of the legal profession, directed partly at preventing sexual harassment.24

Third, health practitioners should have access to a sound complaint mechanism. However, this alone is insufficient and does not mean that victims are responsible for resolving the problem. Victims should not simply be ordered to “speak up”, as this ignores factors that impede disclosure, and leaves undisturbed the power imbalances, gender discrimination and tolerance of inappropriate conduct which foster the problem.

Fourth, we should recognise and support individuals and employers who promote respectful work environments. It takes courage for victims and bystanders to speak up about sexual harassment. Employers who set new standards of conduct demonstrate leadership and integrity. An environment that unequivocally supports women and rejects harassment can powerfully influence the behaviour of perpetrators, the careers and wellbeing of women, and the “hidden curriculum”25 communicated to students and trainees.

Finally, the medical profession can nurture wider efforts to promote women’s rights through its status in society and its broad interaction with the population. By modelling a commitment to gender equality and women’s rights to safety and dignity in the workplace, the medical profession can embody what should be core aspirations in contemporary Australia.

1
Sexual harassment as a criminal offence in Australian states and territories

The offence of sexual assault or indecent assault exists in each state and territory, with substantial penalties: Crimes Act 1900 (ACT) s 60 (7 years); Crimes Act 1900 (NSW) s 61L (5 years); Criminal Code (NT) s 188(2)(k) (5 years); Criminal Code 1899 (Qld) s 352 (10 years); Criminal Law Consolidation Act 1935 (SA) s 56 (8 years); Criminal Code Act 1924 (Tas) s 127 (21 years: s 389); Crimes Act 1958 (Vic) s 39 (10 years); Criminal Code Act Compilation Act 1913 (WA) s 323 (5 years).
Consent only exists if freely given and will not be present if obtained by threat, force or abuse of position: ACT s 67; NSW s 61HA; NT s 187(a); Qld s 348; SA s 46; Tas s 2A; Vic s 36; WA s 319.
Consent is not shown simply by lack of physical resistance: ACT s 67(2); NT s 192A(a); Vic 37AAA(e); WA s 319(2)(b).

2
Sexual harassment as discrimination in Australian states and territories

Sexual harassment can be constituted by a single act. It is generally defined as unwelcome sexual conduct in relation to the other person, committed in circumstances where a reasonable person would have anticipated the other person would be offended, humiliated or intimidated: Discrimination Act 1991 (ACT) s 58(1); Anti-Discrimination Act 1977 (NSW) s 22A ; Anti-Discrimination Act 1992 (NT) s 22; Anti-Discrimination Act 1991 (Qld) s 119; Equal Opportunity Act 1984 (SA) s 87(9); Anti-Discrimination Act 1998 (Tas) s 17(3); Equal Opportunity Act 2010 (Vic) s 92; Equal Opportunity Act 1984 (WA) s 24(3-4).
Sexual harassment is prohibited, with substantial penalties for the individual offender: ACT s 58; NSW s 22B; NT s 22(2); Qld s 119; SA s 87(1); Tas s 17(2); Vic s 93; WA s 24(1).
Substantial penalties can also be imposed on an employer, who will be vicariously liable unless appropriate preventive steps were taken: ACT s 121A; NSW s 53; NT s 105; Qld s 133(2); SA s 91; Tas s 104; Vic ss 109-110; WA s 161.

3 Sexual harassment as a breach of good medical practice

Under Good medical practice: a code of conduct for doctors in Australia,18 “good medical practice” includes:

Communicating professionally, respectfully and courteously with colleagues (clause 4.2)
Understanding the nature and consequences of harassment, and seeking to eliminate such behaviour in the workplace (clause 4.4)
Acting as a positive role model and supporting students and practitioners (clause 4.4)

Tracking funded health intervention research

Expectations that publicly funded health research should be productive, in terms of both research publication outputs and contributions to better health outcomes, are becoming increasingly explicit.1,2 This has directed attention to methods for tracking research outputs, where scholarly publication metrics — impact factors and citations — are currently the dominant indices.2,3 Publication of research is expected to disseminate new knowledge and facilitate “real-world” policy and practice impacts.

While the recent emphasis on research productivity spans all types of research,1,4–6 intervention research is particularly relevant, as its findings are likely to be more directly applicable to health policy and practice.7–9 Intervention studies tend to be less prevalent in peer-reviewed journals than descriptive and epidemiological studies, and this has been partly attributed to the practical and scientific challenges of conducting intervention research.9–11

Few studies have empirically investigated the implementation and outputs of health intervention research. As part of a project on the impact of a sample of intervention research funded by the National Health and Medical Research Council (NHMRC), here, we examine the research outputs of these grants. Specifically, we report:

the descriptive profile of NHMRC-funded intervention research in terms of topics, settings, funding terms, and stages of development of the interventions; and
whether and how statistically significant intervention effects on primary outcome variables influenced research productivity.

Methods

Data were collected between 23 July 2012 and 10 December 2013 on studies funded by the NHMRC between 1 January 2003 and 31 December 2007. Studies were eligible if they fitted our definition of health intervention research, which was: “any form of trial or evaluation of a service, program or strategy aimed at disease, injury or mental illness prevention, health promotion or psychological intervention, conducted with general or special populations, or in clinical or institutional settings”. Clinical trials of potentially prescribable drugs, vaccines and diagnostic tests were excluded.

Eligibility was assessed by two coders who reviewed titles, application abstracts, end-of-project reports to the NHMRC and publications arising from the grant. The 5-year period was selected to allow enough time for completion of the research and publication of the findings, balanced against limiting recall bias about studies completed too long ago.

Descriptive profile

Basic information on sample grants was collated, including the duration of funding and the topic of the intervention. The studies were classified according to “stage of intervention development” based on definitions from a previously published guide, distinguishing controlled interventions (efficacy), those carried out in real-life conditions (effectiveness), those that were replication or adaptation studies in different settings, or dissemination studies.12 Additional information was gathered from online surveys of chief investigators. A full description of the data collection process and response rates is provided elsewhere.13

Bibliometric analysis

To collect consistent information, we reviewed all publications submitted by chief investigators, and conducted literature searches (in Web of Science and Google Scholar databases) for the years following the commencement of each completed grant. Publications were reviewed to check if they were related to the grant in question. Key search terms included chief investigators’ names, grant numbers, project titles, intervention descriptions and relevant health issues. In the case of grants for which publications of study results could not be found, we attempted to contact chief investigators, including previous non-responders.

Assessing published results of intervention research

Two assessors reviewed publications that reported results of interventions to identify whether there were any statistically significant changes to the primary outcomes proposed in the research application summary. Where there was any uncertainty, decisions about what constituted primary outcomes were checked by other authors in a panel process. We classified interventions as: (i) those that showed statistically significant effects on primary outcomes; (ii) those with “mixed” results (eg, significant changes for some but not all primary outcomes), or if unintended or secondary outcomes were emphasised; and (iii) those that found no statistically significant effects.

Ethics approval

This project had approval from the University of Sydney Human Research Ethics Committee (15003). All chief investigators were assured that projects would not be identified because of anticipated sensitivities about publication output, ineffective interventions or lack of real-world impact.

Results

Completion

Sixty-six (80%) of the 83 intervention studies we identified were completed at the time of data collection, and 13 were ongoing. The status of four was unknown, with no responses from chief investigators. Of the 13 that were ongoing, reasons stated for incompleteness included problems recruiting study participants, being part of larger international trials or being longitudinal studies with longer follow-up. The proportion that were incomplete or ongoing was highest for the eight studies that commenced in 2007, the most recently sampled year, and included three grants scheduled for completion in 2011 or 2012.

Description of funded intervention research projects

The mean duration of funding of the 66 completed projects was 3 years (range, 2–5 years). Interventions included treatment and management (30 studies), screening and early intervention (12 studies), and primary prevention (24 studies), implemented in clinical or community settings, with many dealing with aspects of chronic disease. Topics reflected a variety of health disciplines, including medicine, psychiatry, psychology, dietetics, dentistry, physiotherapy and nursing. In terms of stage of intervention development, most focused on intervention efficacy (28 studies) or effectiveness (27 studies); 10 were replications or adaptations of an intervention in a new setting or population group; and one tested dissemination of the intervention.

Intervention effects

We could not locate published results on primary outcomes for 12 of the completed studies. There were equal numbers of studies that produced statistically significant effects (including “mixed” results; 27 studies) and those that did not show significant effects (27 studies). An example of mixed results was a school intervention that prevented (or delayed) age-related increases in students’ alcohol consumption, but did not reduce the prevalence of students’ depressive symptoms, which had been nominated as the primary objective.

Publication outputs

Publications related to each completed grant were categorised according to whether they reported on intervention effects or on “other” descriptive topics, such as measurement, intervention feasibility, epidemiological questions, or commentaries. The mean number of published articles per grant was 3.3 (range, 0–13), with 2.0 reporting results. Many investigators reported that their publication process was ongoing; eight had not yet published any articles, and twelve had not published articles on intervention effects. Among grants with published results, those with and without significant intervention effects had similar numbers of “other” publications (mean, 1.3 per grant), although the latter had smaller numbers of publications reporting intervention results and of total publications (Box).

Discussion

Our study describes the publication outputs for intervention studies funded by the NHMRC from 2003 to 2007, inclusive, and provides a benchmark to inform expectations about the publication yield of such research. We found that publications covered many aspects of intervention development8,12,14 and were not restricted to intervention effects, although studies reporting no statistically significant intervention effects produced slightly fewer results-based publications.15

While the number of publications is not an indicator of relevance to health policy,6 publication volume remains a basic metric of academic productivity.2,16 Analysis of Australian health promotion intervention research has previously identified between one and seven publications per study,17 while another Australian study of primary care research reported a mean of 2.3 publications per grant (range, 0–7 publications).18 However, the contexts and funding sources for these two studies and our study vary, and there is no endorsed benchmark for assessing numbers of publications across different areas of research.

In relation to our estimates, we acknowledge that later assessment may be required to capture complete publication outputs, and that the impact of non-responders on estimates (whether they would be lower or higher) is unknown. Further, the output estimates in our study cannot be extrapolated to non-intervention research.

Our findings on the stage of intervention development are consistent with those of other reviews of intervention research.9,10 As research type is not routinely documented by the NHMRC, the proportion of available funding that is invested in intervention research is currently unknown. However, our methods indicated that intervention research accounted for a small proportion of NHMRC grants in this period, although the interventions studied related to national health priorities and major causes of mortality and morbidity across Australia.

While intervention research typically tests effectiveness, the statistical significance of study results is not an indicator of study value.2 Some studies reporting non-significant results generated findings with important implications for policy and practice — for example, that an intervention should be discontinued or modified. It was beyond the scope of our study to critically appraise the methods of each funded study, and thus assess whether studies had sufficient statistical power to detect the changes they hypothesised.

While it is often claimed that researchers are discouraged by the difficulty of publishing statistically non-significant findings, we found no evidence for this. However, the length of time to intervention study completion and the relatively small number of intervention study publications may constitute disincentives for researchers to embark on these kinds of studies, particularly as there are no established methods to demonstrate other forms of impact, such as measures of policy change and influence on practice. Reviews of research funding have called for an increase in intervention research and for strategies to help remove the barriers faced by intervention researchers (such as dedicated funding for intervention research, longer funding periods, support for pilot studies and separate review panels).19 Meanwhile, policy agencies have suggested similar remedies to redress their concerns about a lack of definitive evidence on effective interventions in many areas.20

This is the first independent study to document the publication outputs of a set of intervention studies funded through a major national funding body. Tracking research publication outputs is important as a mechanism to ensure accountability in expenditure of public funds and, potentially, as a basis for quality improvement of research funding systems. Ongoing investigations of this kind are needed to provide information on whether current research investment patterns match the need for evidence about health care interventions.

1
Peer-reviewed publications by category of intervention results

Category	Number of studies	Total number of articles	Mean number per grant of all published articles	Total number of articles reporting results	Mean number per grant of articles reporting results	Total number of other articles

Statistically significant intervention effects	19	76	4.0	52	2.7	24
Mixed results	8	32	4.0	24	3.0	8
No statistically significant intervention effects	27	90	3.3	54	2.0	36
No published intervention effects	12	22	1.8	0	0	22
Total	66	220	3.3	130	2.0	90

Identifying and acting on potentially inappropriate care

Identifying when the wrong treatments are chosen, and putting a stop to it, is an important way to improve the quality of health care. There are many ways to do this. Strategies include using clinical guidelines or decision support systems, clinician education, clinical engagement, peer review, and adjusting the pricing, funding and availability of individual treatments. All of these methods can be useful. But there are currently few concerted efforts to evaluate and benchmark treatment choices at the hospital level, and to use this information to drive improvement.

Inappropriate care is a longstanding concern in health policy. For over 40 years, small-area analyses have shown significant geographic variation in the rates at which different subpopulations are given common surgical procedures. 1,2 The Organisation for Economic Co-operation and Development has recently published this kind of analysis, including a chapter on Australia showing the rates of nine types of hospital admission in different Medicare Local areas, adjusted for age and sex.3 A more detailed atlas of variation and supporting studies has also been published by the Australian Commission on Safety and Quality in Health Care.4

Wide variation in practice patterns has been attributed to clinicians interpreting evidence and guidelines inconsistently, with patients in different areas being under- and overtreated as a result.

A newer but burgeoning body of literature has looked at inappropriate care in a different way, focusing on the interventions themselves rather than their usage. This focus has led to the development of lists of treatments for disinvestment, either because they have not been proven effective, or because testing has shown that they are ineffective or inferior to a substitute treatment.

Both of these approaches to inappropriate care have shortcomings. Small-area variation analysis has uncovered disturbing variation in patterns of care, but has not produced meaningful policy or practice change.5 This is probably owing to the fact that variation analyses rarely take into account legitimate drivers of clinical variation such as patient morbidity and patient preferences, and so are unable to convincingly differentiate warranted from unwarranted variation.6,7

Although disinvestment work has produced much more compelling evidence of inappropriate care, it has struggled to achieve meaningful policy change. As this study shows, clinicians can continue to use a treatment long after it has been declared inappropriate.

There are few interventions that are ineffective for all patients and indications. Typically, the value of a treatment varies for different types of patients. This complicates measurement of inappropriate care and the development of policies to reduce it. Across-the-board funding cuts, or even funding cuts among specific subgroups of patients, may ignore clinical heterogeneity and deny funding for valuable, as well as ineffective, care.8 A patient may have characteristics that typically rule out a treatment, but have other characteristics that mean they are not well represented in clinical trial samples, or are not eligible for treatments that are recommended as more effective. Approaches are emerging that may help health care organisations and clinicians to distinguish, at the site of care, between patients for whom a certain treatment is warranted and those for whom it is not.8 But in many cases the coded data do not capture all of the relevant clinical variation. This presents a serious challenge to measuring and comparing clinical choices in different regions or among providers.

We sought to develop a practical way to identify which hospitals are most likely to be choosing inappropriate treatments. Our methods draw on the analytical strengths of variation and disinvestment analysis. From disinvestment analysis, we took a selection of treatments that evidence clearly shows should not be done routinely, or at all. From variation analysis, we focused on outlier hospitals — those providing a “do not do” or “do not do routinely” treatment at rates that are far in excess of the national average.

This approach overcomes several key deficiencies of variation and disinvestment research. First, focusing on procedures listed for disinvestment means that high usage rates can be convincingly linked to inappropriate practice. This is not the case in variation analysis, where the procedures analysed are generally considered effective, and where high relative usage in one area can be due to underprovision in other areas.

Second, using variation to focus on providers with high rates of potentially inappropriate care is a practical way to pursue disinvestment. Rather than advocating the removal of clinician discretion with respect to the procedures analysed, this approach advocates monitoring, with priority given to the providers where care is clearly out of step with both clinical evidence and standard practices, and therefore very likely to be inappropriate.

Third, focusing on hospitals rather than geographic areas allowed us to correct for several major deficiencies in other variation analyses. Focusing on hospitals (and specific specialties within those hospitals) allows for analysis of microcultures of care, which are likely to be obscured when practice patterns are aggregated to a regional level. Further, geographically aggregated analyses generally only make crude adjustments for patient morbidity differences, while our use of rich patient-level data allowed us to correct for variation in morbidity to a much greater extent. Finally, there are few viable policy options for dealing with variation at the geographic level. Developing strategies aimed at hospital-level accountability for practice patterns may be more productive in addressing inappropriate care.

Methods

Data

De-identified patient-level data about all public and private hospital separations (discharge, deaths and transfers) for the financial year 2010–11 were obtained from the Australian Institute of Health and Welfare after approval by each state and territory. The dataset included 8 720 771 records from 709 separate public hospital sites in all states except the Australian Capital Territory (private hospitals in each state were all grouped with a single code). Data were released as one record per admission, so it was not possible to link records to derive data on a per-person basis. Names of public hospitals were suppressed as part of the approval process.

Approval from an ethics committee was not required, but data confidentiality requirements were imposed as part of data release.

Selecting treatments for assessment

Potentially ineffective treatments were drawn from published lists of, or recommendations about, inappropriate care. These include a list of procedures identified as potential disinvestment candidates,9 a list of procedures where there had been a “reversal of evidence” — that is, where subsequent evidence had shown that early treatment recommendations were no longer appropriate10 — and examination of decisions of two national health technology assessment bodies: the Medical Services Advisory Committee in Australia and the National Institute for Health and Care Excellence in England. Only guidance published before our data period (2010–11) was used.

To select do-not-do treatments for analysis, these lists were whittled down by excluding recommendations that were vaguely expressed and treatments that were unable to be reliably coded using the International Classification of Diseases Australian Modification diagnosis and procedure codes or did not take place in hospitals. A further filter excluded treatments for which the evidence originally cited was weak or was contradicted by subsequent evidence, or was not supported by clinical experts we consulted. Finally, since we are investigating variation, we excluded cases with five or fewer occurrences and combined overlapping advice (Box 1). At each of these steps we took a conservative approach to reduce the chance that our analysis — a proof of concept — would be rejected based on the examples we used. We also looked at examples of treatments with recommendations against being performed “routinely”, but these were selected opportunistically (as with do-not-do advice, the evidence was evaluated and clinical experts were consulted).

Do-not-do and do-not-do-routinely advice was expressed as “do not (routinely) do procedure x for diagnosis y”. Clinical experts reviewed those cases which had multiple diagnoses listed to ensure that none of the additional diagnoses or procedures might provide a justification for the do-not-do (or do-not-do-routinely) procedure. Coding assignment of diagnoses and procedures was reviewed by an independent health information manager.

The filtering process excluded practically all of the original candidates of potentially inappropriate care. From the original lists, only five procedures were clearly potentially inappropriate and could be analysed in the data (Box 2). From the many do-not-do-routinely procedures, three were selected as exemplars.

Measuring use of the selected treatments

To look at variation in a fair and meaningful way, we measured the proportion of patients in a hospital who have the relevant diagnosis (such as osteoarthritis of the knee) who also received the do-not-do procedure (such as arthroscopic lavage or debridement). This partly addresses a criticism of the geographic research that it does not standardise adequately for differences in underlying rates of disease.

With this metric, we only compared hospitals that are able to provide the do-not-do treatment. These hospitals both perform the relevant procedure and treat patients (> 5) with the relevant morbidity.

Results

Incidence of each of the five do-not-do procedures is shown in Box 3.

The incidence of the five identified do-not-do treatments was quite low, with a total of 5888 procedures identified in the dataset. While this was a very small proportion of all patients, it is 4.5 per cent of all patients receiving the relevant procedures (or in one case, combination of procedures). It should be noted that this is a lower bound as we did not measure compliance with all do-not-do guidance for these procedures.

Among hospitals that perform the relevant procedure and also treat patients (> 5) with the relevant morbidity, we found that the incidence of the do-not-do procedures was highly variable (Box 4).

For all the do-not-do treatments, the outliers with the highest rates were a long way from the average. There were 25 hospital departments that provided a do-not-do treatment more than three times as often as the average hospital (within hospital comparator groups). Eight hospital departments provided do-not-do treatments at over five times the average rate, while three departments did so at over 10 times the national rate.

Again, we saw substantial variability in hospital procedure rates for the procedures that should not be done routinely (Box 5), with some hospitals clear outliers. The hospitals with the highest rates for the three do-not-do-routinely treatments offered them at more than nine times, six times and double the average rate.

Discussion

This study is the first attempt to quantify the extent of inappropriate care in Australian hospitals for a range of conditions using routine data. We have shown that it is possible to use routine hospital data to identify the incidence of potentially inappropriate care.

Importantly, the procedures used here as examples have either been shown in academic studies to be inappropriate or are recommended against in guidelines, or both. What we have shown is that, despite this advice, and even defunding in the Medicare Benefits Schedule, the procedures are still being performed. Guidelines and funding policies are clearly not sufficient to solve this problem.

Limitations

This study has a number of limitations. First, it cannot be a basis for generalising about the overall incidence of inappropriate care in Australian hospitals. We used a small, non-representative sample of hospital procedures and analysed their incidence in a single year. Because inappropriate care appears to be relatively infrequent, there may be instability in the incidence of our indicator conditions.

Second, the inappropriate care identified in this study can only be considered potentially (rather than definitively) inappropriate. Some of the identified inappropriate treatments may be coding errors or may be justified on the basis of a rare combination of patient characteristics. Routine data can only identify what is occurring, not why. We therefore suggest that the indicator be labelled “potentially inappropriate care”, although the procedures themselves would remain indicators of, prima facie, inappropriate care.

Third, we were not able to analyse rates of inappropriate care in individual private hospitals.

Fourth, we were unable to link data across settings or time. A person who had multiple treatments, one of which was a do-not-do treatment, would thus be counted once in the numerator and multiple times in the denominator. This makes our prevalence estimates conservative.

What should be done to ensure safe and effective care?

Identifying potentially inappropriate practice is irrelevant unless action occurs. The steps outlined below will allow governments to monitor more and ultimately reduce inappropriate care in Australian hospitals.

First, forms of inappropriate care should be identified and communicated in a more consistent and accessible way. This should be a role for the Australian Commission on Safety and Quality in Health Care or the health productivity and performance commission foreshadowed in the 2014 federal Budget to take over functions from the Commission together with a number of other performance-related national authorities. Such a Commission should, with clinical involvement, identify additional procedures that represent potentially inappropriate care. It might draw on parallel efforts such as NPS MedicineWise’s Choosing Wisely program and the Royal Australasian College of Physician’s EVOLVE initiative. The Commission should maintain a centralised, easily accessible and continuously updated list of questionable procedures for clinicians to use.

Second, existing data should be used to measure and benchmark a wider range of inappropriate care. In this study, data access agreements meant we could only analyse a handful of do-not-do treatments. Many more can be analysed using additional sources of clinical guidance and data that the Australian government already possesses, and that the Commission should have access to. Studies of geographic variation have linked patient data across datasets and over time.23 Linkage of this kind could allow the Commission to do more; for example, analysing inappropriate use of treatments that should not be first-line interventions. It could also link patient records across different parts of the health system to cover hospitals, the Pharmaceutical Benefits Scheme and the Medicare Benefits Scheme.

Third, the Commission should advise states and hospitals about their rates of questionable care. States should give outlier hospitals a chance to improve, but if high rates persist there should be an external clinical review. The reviews should investigate all aspects of clinical decision making in the relevant department or specialist area. This would include confirming that the data accurately recorded the treatments that were chosen and assessing whether these choices were clinically valid.

States should prioritise investigation of hospitals with high rates of potentially inappropriate care, both for practical reasons and because low rates may reflect cases where most procedures were actually legitimate. States should also consider the volume of patients with the relevant morbidity. Our cut-off (> 5) could result in investigations that affect the care of very few people. Choosing thresholds that trigger investigations is ultimately a normative decision. It involves a trade-off of unnecessary investigatory burden and waste of resources against potential clinical risks to patients associated with inappropriate care.

Ultimately, patients should have a reasonable expectation of receiving appropriate care. Our study has shown that procedures that are contrary to contemporary clinical evidence are being done in Australia, and that some hospitals seem to provide a very high rate of these procedures. These hospitals should be alerted to the fact of their aberrant practice and be subject to clinical review if that practice continues, helping to ensure that hospital care in Australia is evidence-based, effective and safe.

1
Selection process for do-not-do treatments

2
Potentially inappropriate procedures

Vertebroplasty for painful osteoporotic vertebral fractures11,12
Arthroscopic lavage or debridement for osteoarthritis of the knee13,14
Laparoscopic uterine nerve ablation for chronic pelvic pain15
Removing healthy ovaries during a hysterectomy16
Hyperbaric oxygen therapy for a range of conditions including osteomyelitis, cancer, non-diabetic wounds and ulcers, skin graft survival, Crohn’s disease, tinnitus, Bell’s palsy, soft tissue radionecrosis, cerebrovascular disease, peripheral obstructive arterial disease, sudden deafness and acoustic trauma, and carbon monoxide poisoning17–19

Fundoplication to treat gastro-oesophageal reflux disease20
Episiotomy during spontaneous vaginal births without complications21
Amniotomy during normally progressing labour22

3
Incidence of do-not-do treatments, 2010–11

4
Distribution of proportion of relevant patients receiving a do-not-do treatment in public hospitals with capacity to perform the do-not-do treatment, 2010–11

*Average rates among comparator hospitals: hyperbaric oxygen therapy (2.9%); arthroscopic lavage or debridement of the knee (3.3%); vertebroplasty (5.4%); oophorectomy (1.4%); uterine nerve ablation (2.1%).

5
Distribution of proportion of patients receiving a do-not-do-routinely treatment in public hospitals with capacity to provide the treatment, 2010–11

*The 10% of hospitals with the highest rates are identified as outliers.