French independent civic and scientific inquiry recommends end or radical reform to breast screening program – Alex Barratt et. al.

In October 2016 the French minister of health released the report of an independent  inquiry into mammography screening in France. The inquiry Steering Committee recommended two options for the future: End the national breast screening program, or end it in its current form and put in place a radically reformed program.  As the inquiry report has been published in French only, we provide a summary of the inquiry methods and its unexpected recommendations.

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Barratt A, Jørgensen KJ, Autier P. Reform of the National Screening Mammography Program in France. JAMA Intern Med. Published online October 30, 2017. doi:10.1001/jamainternmed.2017.5836
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How information about overdetection changes breast cancer screening decisions: a mediation analysis within a randomised controlled trial – Jolyn Hersch et. al.

We previously found in a randomised controlled trial that informing women about overdetection (also known as overdiagnosis) changed their breast screening decisions. This new paper presents a mediation analysis exploring possible psychological pathways through which exposure to overdetection information influenced women’s subsequently reported breast screening intentions.

This study involved women in NSW, aged 48-50 years, with no personal history of breast cancer. The women received one of two versions of a decision aid giving information about breast cancer deaths averted and false positives from mammography screening, either with (intervention) or without (control) information about overdetection.

We found that the intervention led to substantial improvements in women’s understanding of overdetection, and it influenced their attitudes towards having screening. Mediation analysis showed that these mechanisms involving how women THOUGHT about breast screening were particularly important, more so than those relating to how they FELT about it, in determining women’s intentions about screening participation.

These findings emphasise the need to provide good-quality information on screening outcomes, and to communicate this information effectively, so that women can make well-informed decisions.

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Hersch J, McGeechan K, Barratt A, Jansen J, Irwig L, Jacklyn G, Houssami N, Dhillon H, McCaffery K. How information about overdetection changes breast cancer screening decisions: a mediation analysis within a randomised controlled trial. BMJ Open 2017;7:e016246. doi: 10.1136/bmjopen-2017-016246
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A clinical approach to genetic testing for non-specialists – Chris Semsarian & Jodie Ingles

While genetic testing for Mendelian disease can have enormous value, care must be taken to avoid unnecessary harm. As genetic technologies continue to advance and access to all forms of genetic testing becomes more commonplace, all primary care physicians will need to understand the basic principles of management of such patients to ensure optimal care. This practice pointer article in BMJ highlights the basics of genetic testing for non-specialists and primary care physicians.

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Semsarian C, Ingles J. A clinical approach to genetic testing for non-specialists. BMJ 2017;358:j4101. doi: 10.1136/bmj.j4101
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Using a decision aid may prompt some younger women (38–50 years) to rethink breast cancer screening plans – Jolyn Hersch & Kirsten McCaffery

Screening for breast cancer may lead to both benefit (fewer breast cancer deaths) and harm (overdiagnosis of cancers that would never cause problems, and false alarms where no cancer is present). Decision aids are tools to help women understand the trade-offs and consider their informed preferences about whether to be screened. We have written a short invited commentary on a published review article whose authors systematically gathered and put together the existing studies about how decision aids affect women’s intentions regarding breast screening.

The review included 6 studies, all conducted in either Australia or the USA. The key finding highlighted by the authors was that among women aged 50 and under, decision aids increased the proportion of women intending NOT to have screening. In our commentary, we made the following main points about the interpretation of this evidence. Firstly, the number of studies addressing this topic is still quite small and the studies vary in important aspects (e.g., ages of women involved and cultural differences between countries) so we need more high-quality research in additional settings. Secondly, screening intentions changed in a relatively small number of study participants and we do not know whether actual behaviour also changed. And finally, we argued that rather than focusing on women’s screening intentions (and behaviour), the real value of decision aids lies in their capacity to help women (who are typically not well informed about breast screening) to make better informed decisions.

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Invited Commentary on: Ivlev I, Hickman EN, McDonagh MS, et al. Use of patient decision aids increased younger women’s reluctance to begin screening mammography: a systematic review and meta-analysis. J Gen Intern Med 2017;32:802–13.
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Words do matter: a systematic review on how different terminology for the same condition influences management preferences – Brooke Nickel et. al.

Changing the terminology of low risk, screen detected conditions such as ductal carcinoma in situ (DCIS), low risk prostate cancer, and low risk thyroid cancer has been recommended by several expert groups. These recommendations are to help prevent overdiagnosis and allow patients diagnosed with these conditions to consider less invasive management options such as active surveillance. However, the effect of terminology on patients’ preferences for management is not well understood.

This systematic review synthesised existing studies on terminology and its impact on management decision making. It found that when a more medicalised term was used to describe the condition there was a shift in preference towards more invasive managements and/or higher anxiety and perceived severity of the condition. These findings demonstrate that changing the terminology may be one strategy to reduce patient preference for aggressive management response to low risk conditions.

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Nickel B, Barratt A, Copp T, et al. Words do matter: a systematic review on how different terminology for the same condition influences management preferences. BMJ Open 2017;7:e014129. doi: 10.1136/bmjopen-2016-014129.
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Qualtifying low-value care: a patient-centric versus service-centric lens – Kelsey Chalmers et. al.

There is a groundswell of new research directly measuring inappropriate or low-value health care. We reviewed studies where a low-value service was measured by defining the service and the low-value patient indication, with the goal of comparing results across different populations for the same services. What we found, however, was that different studies rarely used the same denominator when investigating a low-value service, and (perhaps not surprisingly) the choice of denominator greatly impacts the interpretation of the result. For example, one study reported carotid ultrasounds were low-value 6.5% of the time (so the service is mostly appropriately used), but patients admitted for fainting will receive an unnecessary carotid ultrasound 16.2% of the time (a significant proportion of these patients received low-value care). We propose that, when possible, researchers report using all perspectives to get ‘the full picture’ on low-value health care.

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Chalmers K, Pearson S, Elshaug AG. Quantifying low-value care: a patient-centric versus service-centric lens.
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Are expanding disease definitions unnecessarily labelling women with PCOS? – Tessa Copp et. al.

Widening diagnostic criteria has resulted in a steep rise in the number of women diagnosed with Polycystic Ovary Syndrome (PCOS). The benefits of receiving this diagnosis are unclear, in particular for younger women and those with milder symptoms.  We looked at the clinical literature to examine the evidence and uncertainty surrounding PCOS diagnosis, and the psychosocial impact of a diagnosis.

Four problems with the current criteria are identified: Diagnoses have rapidly increased without clear evidence of benefit, the criteria are problematic in adolescents and young women due to overlapping symptoms of normal development, the newer types of PCOS do not have the same associated adverse long-term implications as the classic types, and PCOS may be a transitory rather than a lifelong condition for many women. Like with many conditions, there are women with severe manifestations who may benefit from the diagnosis through validation of symptoms and motivation to make diet and lifestyle changes to reduce risk of future disease. However, providing women with a diagnosis can cause serious distress, in particular fear about fertility and long-term health, as well as significant relationship strain and poor self-esteem. This may be unnecessary or for little health gain. It is problematic to diagnose women with a one size fits all label when the consequences of the disease are not the same for everyone. The benefits and harms need to be weighed up for each individual woman to make sure there are worthy grounds for diagnosis.

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Copp Tessa, Jansen Jesse, Doust Jenny, Mol Ben WJ, Dokras Anuja, McCaffery Kirsten et al. Are expanding disease definitions unnecessarily labelling women with polycystic ovary syndrome?
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Overdiagnosis, ethics, and trolley problems: why factors other than outcomes matter – Stacy Carter

Some people—like the researchers in Wiser Healthcare—worry about overdiagnosis, mostly because of the harm that it may cause. However when researchers set out to study public reactions to overdiagnosis, they’re often surprised to find that people are enthusiastic about screening and testing even when it provides little  benefit, and are willing to accept remarkably high rates of overdiagnosis harm. Why might this be?

There is a type of thought experiment in ethics that might help: trolley problems (you’ll have to read the paper to find out how they work).  Trolley problems have been used for decades to draw out people’s moral intuitions about difficult situations that require trading off harms to some against harms to others. Moral intuitions aren’t good arguments, but they can help us understand and even predict people’s reactions. Understanding these reactions, and the intuitions that might underpin them, can help us to be more ethically sensitive when taking action to reduce overdiagnosis.

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Carter Stacy M. Overdiagnosis, ethics, and trolley problems: why factors other than outcomes matter—an essay by Stacy Carter.
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Study finds “Standard Care” treatments in breast cancer clinical trials not always standard – Rachel Dear et. al.

Historically, randomized controlled trials have served as the state-of-the-art method for determining the efficacy and safety of new, innovative treatment regimens for patients with cancer and other diseases. It is imperative that such trials are carefully designed to ensure that they are scientifically and ethically sound and that experimental regimen is, indeed, superior or comparative to the current standard of care.

Now, however, researchers from The University of Sydney, led by Rachel F. Dear, MBBS, PhD, found that 29% of breast cancer clinical trials reviewed failed to establish a control arm meeting the current standard of care.

Dr. Dear and colleagues published their findings in the September issue of JNCCN – Journal of the National Comprehensive Cancer Network.

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Dear RF, McGeechan K, Barnet MB, Barratt AL and Tattersall MHN. “Standard Care” in Cancer Clinical Trials: An Analysis of Care Provided to Women in the Control Arms of Breast Cancer Clinical Trials. J Natl Compr Canc Netw 2017;15:1131-1139. doi: 10.6004/jnccn.2017.7012
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Avoiding harm and supporting autonomy are under-prioritised in cancer screening policies and practices – Lisa Parker et. al.

Cancer screening should be carried out in a way that is mindful of widely accepted ideas about right and wrong.  We argue that cancer screening policies and practices don’t pay enough attention to important matters such as avoiding harm or supporting people’s abilities to make decisions about matters that are important to them.

Screening for cancer can be a good thing, but can also cause harm.  If a screening program mainly finds false alarms and slow/non-growing cancers, and hardly ever finds cancers that are going to cause problems, then screening might not be worthwhile.  Unfortunately these kinds of screening programs are still available, and in some cases, still subsidised by governments. 

Participation in cancer screening is a personal decision, but many individuals remain poorly informed about the downsides of screening, and feel societal pressure to attend screening.

We suggest that policy committees should take more care to include a range of people with different experiences and ideas about what is important, and should avoid people with conflicts of interest. We encourage committees to spend time talking about values including views of the public.  Committees should talk about which values they used to guide their decisions, so that the public can understand and challenge them if necessary.

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Parker L, Carter S, Williams J, Barratt A. Avoiding harm and supporting autonomy are under-priortised in cancer-screening policies and practices. EJC 2017:85, 1-5.
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Guidance for modifying the definition of diseases: a checklist – Jenny Doust et. al.

Changing the definition of a disease can greatly increase the number of people diagnosed with the condition, potentially resulting in overdiagnosis and overtreatment. A 2017 study found that recent changes to the definitions of hypertension, hypercholesterolaemia and diabetes doubled the number of people said to have these conditions in China – if treated the drug costs alone would consume 56% of the current Chinese health budget (Hu, 2017). However there had been no accepted guidance for those seeking to modify a disease’s definition.

A working group of the Guidelines International Network brought together experts in taxonomy, epidemiology, pathology, genetics, and guideline development and with a range of clinical backgrounds, including members from the GRADE working group and WHO to develop a checklist that can be used by groups seeking to change a disease definition. The group developed an 8-item checklist: definition changes, number of people affected, the trigger for the change, prognostic ability of the old and new definition, disease definition precision and accuracy, potential benefits, potential harms, and the balance between potential harms and benefits. The working group will be seeking to pilot and validate the use of the checklist with guideline groups and deciding on modifications to a disease definition. (Reference: Hu XF, et al. The impact of broadened diagnostic criteria on the prevalence of hypertension, hyperlipidemia and diabetes mellitus in China. Zhonghua Yu Fang Yi Xue Za Zhi. 2017;51(5):369-377.)

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Doust J, Vandvik PO, Qaseem A, et al, Guidelines. International Network (G-I-N), Preventing Overdiagnosis Working Group. Guidance for Modifying the Definition of Diseases: A Checklist. JAMA Intern Med. 2017 Jul 1;177(7):1020-1025. doi: 10.1001/jamainternmed.2017.1302
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