Screening and other testing in people without symptoms detects subclinical cancers, some of which would never cause problems if left undetected and untreated.

We focused on five types of cancer – breast, thyroid, melanoma, prostate and renal – and compared lifetime risk rates between 1982, when there were no screening programs, and 2012, when screening was widespread and readily accepted.

First national level estimate of cancer overdiagnosis found 11,000 Australian women and 18,000 men (18% & 24%, respectively) diagnosed, tested, and potentially treated for cancer unnecessarily each year. The figures are significant not because of substantial financial costs, but because of the harms that occur from cancer treatment of patients who would never have had symptoms in their lifetime. Accompanying editorial, chosen by MJA editors as top article in 2020, won Bond University’s 2021 Sustainable Healthcare Research Award. Included in NCI Cancer Screening Overview (Health Professional) republished on US doctor’s webpages to inform patients about cancer screening.

Read the Associated Publication HERE

Dept of Health and Aged Care gave feedback to GPs on use of MBS services for decades, without robust evaluation. This factorial cluster randomised trial of 2,271 general practices across Australia with 18month follow-up provided 1st RCT evidence that feedback letters reduce low-value musculoskeletal diagnostic imaging on a national scale. This collaboration with Dept of Health and Aged Care resulted in ~47,000 fewer scans. Australian Clinical Trials Alliance (ACTA) Runner-Up Trial of the Year 2023. Led to follow up trial with Dept of Health and Aged Care on pathology testing and invitation from NPS MedicineWise to to partner on a new trial to reduce overuse of opioid medicines and benzodiazepines.

Read the Associated Publication HERE

Direct-to-consumer (DTC) tests are commercially marketed pathology tests, purchased by members of the public, who pay for and decide on which test to access and when. DTC testing does not require the recommendation or referral from a consulting doctor, nor the facilitation of a public health program. The potential benefits and harms of DTC tests was unknown.

We conducted a systematic online search, mapping out the range and variety of DTC tests advertised online. We identified 484 DTC tests (103 unique products), ranging from AU$12.99 to AU$1947 in cost (mean $197.83; median $148.50).

We found that only about 10% of the tests were likely to be potentially beneficial; 30% were limited in clinical utility; 40% were non-evidence-based commercial ‘health checks’; and 20% were used methods and/or target conditions that are not recognised by the general medical community. These findings had large media coverage in >150 stories reaching an estimated 27.2M audiences in the first month of publication. This work has attracted professional discussion in Australia and internationally, e.g. Pathology Update (Australia, 2022), European Federation of Clinical Chemistry and Laboratory Medicine Strategic Conference (Italy-online, 2022) and the Preventing Overdiagnosis Conference (Denmark, 2023, keynote). This has led to the founding of a Task-Force on Direct-to-consumer Tests, aiming to develop expert advice on DTCT regulation and practice in Europe.

Read the Associated Publication HERE

When is a “cancer” not cancer? Investigating the potential for new diagnostic labels for low risk cancers (prostate, breast, thyroid, melanoma)

Removing “cancer” has been identified as a strategy to curtail overdiagnosis and overtreatment of low-risk lesions.

Evidence reviews led by Wiser Healthcare researchers, and co-authored by leading pathologists, for low-risk prostate, breast, thyroid cancer and low risk melanoma summarised the case to remove the “cancer” label (or recalibrate diagnostic thresholds). Qualitative studies and randomised experimental studies demonstrated that the use of the “cancer” label for these lesions increases patient anxiety and their preference for more invasive interventions, even when this may be harmful for the patient.

Substantial knowledge impacts shown by large initial media coverage (>125 national and international news stories including front-page news story in The Sydney Morning Herald, live radio and live TV interviews on the ABC and BBC) and >500 citations (Google Scholar) from authors across 12 different countries, in fields including general medicine, primary care, oncology, and health policy. Our research was highlighted as Editor Choice in The BMJ and in Editorials in the JAMA Network. It has used by key clinician opinion leaders to: review the internationally acceptability of active surveillance (Annual Review of Medicine, 2019), highlight harms of cancer overdiagnosis (JNCI, 2022), highlight potential for overcalling of benign melanocytic lesions (Lancet, 2023), propose removal of the term ‘melanoma’ for melanoma in-situ (JAMA Dermatol, 2023). This work has reopened public and scientific debate and discussion worldwide amongst important GP organisations (e.g. RACGP) and specialist clinicians (American Thyroid Association), pathologists (World Health Organisation Classification of Skin Tumours authors), and the United States National Cancer Institute Board for Cancer Screening and Prevention.

Read the Associated Publication HERE

An innovative program of research on the potential for overdiagnosis of polycystic ovary syndrome (PCOS) produced world-first knowledge of the harms of the expanding definition on women, and also highlighted for which groups the risk of overdiagnosis is high, including adolescents, women with the milder, non-hyperandrogenic phenotype and women with minimal symptoms. The analysis article in the BMJ sparked substantial debate, leading to the recently published international guidelines for PCOS now recognising the risk of overdiagnosis in adolescents for the first time. Large media coverage, reaching an audience of close to 300,000 across 26 media impressions in 2017 and an audience of 1.8 million across 15 media impressions in 2020.

Read the Associated Paper HERE

Are opioids powerful painkillers? Landmark trial establishes that the most commonly used opioid medicine is no better than placebo in relieving acute spinal pain.

Opioids are the most common treatment for acute spinal pain; despite known harms and lack of RCT evidence on efficacy.

We conducted the world’s first trial testing an opioid for acute spinal pain. The OPAL trial (triple-blinded placebo-controlled) showed that an opioid regimen (oxycodone/naloxone up to 10mg bd up to 6 weeks) was no more effective than placebo for acute spinal pain.

When implemented the OPAL results will save countless lives globally. Published with editorial, summarised in NEJM Journal Watch, JAMA News & Nature Medicine. Sydney Research 'Research Excellence' Award 2023 and 2023 University of Sydney Vice Chancellors Award for Research Excellence. Achieved 803 media stories globally with reach of 53.6M (Meltwater Media Report) including NPR, ABC News, CNN USA, Daily Mail UK, Sydney Morning Herald, ABC TV news, 9 News, ABC Health Report.

Read the Associated Paper HERE

Improving care of back pain. Reducing the use of opioid medicines in the management of back pain.

Guidelines advise against the use of opioid medicines for low back pain given the risk of harms; but they remain the most commonly used treatment for back pain.

In the SHaPED trial we implemented the New South Wales Agency for Clinical Innovation (ACI) to improve care for low back pain in emergency departments (n=4 EDs, n=269 ED clinicians, n=4625 episodes of care for low back pain). The SHaPED intervention successfully reduced use of opioids in the ED and the opioid-sparing effect was still evident at 30 months follow-up. Importantly although less opioids were prescribed to patients, this did not compromise patients; pain relief or satisfaction with care. The trial also led other jurisdictions to adopt our intervention to improve low back pain care in the ED e.g. Brisbane, Singapore. The impact of the trial on clinical practice and policy has been recognised by prestigious awards, eg 2019 NSW Health Awards (finalist, Value Based Healthcare) and 2019 Sydney Local Health District Quality Award (highly commended, Research and Innovation), Trial of the Year ANZMUSC Clinical Trials Network.

Read the Associated Paper HERE

Paracetamol: trusted pain reliever? First trial shows paracetamol no better than placebo in relieving back pain.

Paracetamol became the preferred analgesic for back pain; without RCT evidence.

The NHMRC-funded PACE trial (n=1650) showed paracetamol is no better than placebo. The subsequent CACE (compliance-adjusted) analysis (Pain 2019) showed paracetamol even ineffective among compliant.

Reversed guidelines globally (e.g UK, German, USA, Belgian, Danish, Russian). Published with EDITORIAL, SYNOPSES in seven journals. Listed by JAMA Intern Med in 10 most influential studies of 2014. Data sharing led to eight further studies.

Read the Associated Paper HERE

Is pregabalin safe and effective for sciatica? A world-first placebo-controlled trial shows that the medicine is of no value in the management of sciatica.

Pregabalin was promoted for sciatica treatment, with no RCT evidence; however the medicine has a concerning profile of harms.

The NHMRC-funded PRECISE trial established pregabalin is no more effective than placebo but increases adverse events.

Judged one of the most important publications of 2017 by NEJM & JAMA Internal Medicine. First Finalist 2018 ACTA Trial of the Year. Changed guidelines & policy in 6 countries e.g. NICE guidance on sciatica “Do not offer gabapentinoids.” Led to upscheduling of pregabalin in UK and boxed warnings in Australia.

Read the Associated Paper HERE

We carried out a study whereby clinicians in one local health district in NSW initiated a policy to restrict knee arthroscopy for patients aged 50 years or over. Results showed a significantly greater reduction in knee arthroscopy in this district relative to other districts where there were no similar policy restrictions. The finding suggest that the implementation of a simple clinical governance process may help reduce inappropriate surgery.

Read the Associated Paper HERE

Physiotherapy for chronic whiplash: a little is as good as a lot.

Whiplash management had evolved so that lengthy/costly physiotherapy programs were common.

NHMRC-funded PROMISE trial established that one session of advice with phone support is equally as effective as a 20-session physiotherapy exercise program. An important result in terms of providing efficient and accessible care to people with whiplash.

Nine policy/guideline citations (e.g. Canada, USA, UK, Finland), editorial and podcast in Lancet. Best research presentation award from World Physiotherapy (121 member organisations, 625K physios).

Read the Associated Paper HERE

Artificial intelligence (AI) in healthcare has the potential to improve diagnostic accuracy, personalise treatment, and augment skills of healthcare workers. However, healthcare AI applications raise ethical, legal, and social issues and concerns in domains such as professional autonomy, patient care, equity and fairness, privacy, maintenance of skills, trust in healthcare, and effect on patient outcomes. This means the implementation of healthcare AI could make care better, or worse, for patients, clinicians and communities.

We conducted qualitative interviews with experts; dialogue groups with breast screening service users and with the general public about diagnostic and screening AI; a discrete choice experiment and a best worst scaling experiment.

The project culminated in a citizens’ jury. 6000 invitations were distributed randomly across Australian households, with 30 Australians selected to participate from the respondents. The jurors were diverse and closely matched to the Australian population on multiple factors. For this jury, we sought the services of the Sortition Foundation, a not-for-profit organisation. The jury was guided by the question “Under what circumstances, if any, should artificial intelligence be used in Australian health systems to detect or diagnose disease?”

Results from the project’s studies have been featured in The Conversation. Investigators have been invited keynote/featured speakers/panellists in several conferences. Jurors attended the AI.Care conference in Nov 2023 as a panel, and the session was featured in Pulse+IT. A session on regulating healthcare AI at the AHPRA Medical Board Conference in Adelaide, was voted best session of the conference, with special praise for the relevance and importance of the jury’s recommendations. Investigators have been invited to brief research science and tech communities and industry; including the Australian Data Science Network and policy staff of the Australian Medical Association.

Policy-related activities arising from the jury recommendations include contributing to the development of the Australian Alliance for Artificial Intelligence in Healthcare’s “National Policy Roadmap for Artificial Intelligence in Healthcare” and submitting a response to the Australian Government’s Discussion Paper on Safe & Responsible AI. Prof Carter has been appointed to the NSW Health AI Taskforce, which is using the jury’s recommendations to guide their approach to governing AI in the NSW Health System.

A consumer reference group on healthcare AI in collaboration with the WA Health Translation Network was established in 2024 to develop a plain-language document to empower consumers to participate in conversations about uses of AI in health systems and services.

Read the Associated Paper HERE