Tag: overdiagnosis

Reforming disease definitions : a new primary care led, people-centred approach

Drug Companies Shouldn’t Help Decide Who Is Sick, 2019

Abstract

Expanding disease definitions are causing more and more previously healthy people to be labelled as diseased, contributing to the problem of overdiagnosis and related overtreatment. Often the specialist guideline panels which expand definitions have close ties to industry and do not investigate the harms of defining more people as sick. Responding to growing calls to address these problems, an international group of leading researchers and clinicians is proposing a new way to set diagnostic thresholds and mark the boundaries of condition definitions, to try to tackle a key driver of overdiagnosis and overtreatment. The group proposes new evidence-informed principles, with new process and new people constituting new multi-disciplinary panels, free from financial conflicts of interest. Image wikimedia.

Conclusion

Developing a framework for this long-term reform and facilitating a global collaboration to enact it will involve proactive and reactive efforts that we hope will drive a cultural shift and a practical change in how diseases are defined. Research teams will continue to quantify estimates of overdiagnosis arising from current disease definitions, informing priorities for action. Actions include the constitution of new panels, with new processes and new people, to review and revise existing definitions. Concurrently, primary care organisations will become more reactive to expansions in definitions seen as increasing the risk of overdiagnosis, such as the controversial 2017 hypertension widening, explicitly rejected by the American Academy of Family Physicians, and other groups, and the rejection of the expanded definition of gestational diabetes by the Royal Australian College of General Practitioners. An international meeting to review progress on our proposal and develop more detailed strategies for change will take place at the December 2019 Preventing Overdiagnosis conference in Sydney

There are important limitations, uncertainties and caveats to note as we propose this ambitious reform of disease definitions, which will provoke opposition from those whose markets are directly threatened.

  1. First, we write as a group working across a multitude of influential national and international organisations, but we do not in this instance represent them.
  2. Second, our backgrounds and thinking are largely medical, and there is clearly opportunity for this initiative to be informed by evidence, experience and theories outside medicine, including, for example, from philosophy.
  3. Third, addressing the problem of expanding disease definitions is but one of many potential solutions to overdiagnosis, and much important work is underway already to try and wind back the harms of too much medicine, safely and fairly, such as calls to action within our associations, creation of new medical curricula, scientific discussion at national and international meetings and new information materials for the public.
  4. Fourth, given the novel nature of this proposal, there is not yet a mature evidence-base to support it.
  5. Fifth, there is clear synergy between this proposal and the calls for reform of clinical practice guidelines, which has not been explored in this analysis.
  6. And finally, we acknowledge moves to expand definitions, to detect and treat people earlier, are often driven by the best of intentions, and we see great merit in identifying those who will benefit from a medical label and subsequent care.

However, notwithstanding the good intentions driving a bad system, the human person can no longer be treated as an ever-expanding marketplace of diseases, benefiting professional and commercial interests while bringing great harm to those unnecessarily diagnosed.

Avoid taking drugs unless they are absolutely necessary ; very few meds are indispensable

Trust me, I’m a doctor. Perhaps not…

“Most people let their doctor make the decisions for them, but the evidence tells us that we should be cautious. Doctors make many errors of judgment, and they get much of their information from the drug industry. They therefore use far too many drugs, often because they do not know better.

We live in a world that is so overdiagnosed and overtreated that in high-income countries, our medications are the third leading cause of death after heart disease and cancer. This has been demonstrated by several independent studies in Europe and North America. It has also been shown that medical errors, including incidents apart from drug-related errors, are the third leading cause of death even when only counting hospital patients’ deaths.”

Read Trust me, I’m a doctor, by Professor Peter C. Gøtzsche, on crossfit, June 16, 2019.

Image credit theguardian.

Helping patients choose wisely

New UK recommendations emphasise shared decision making

As the tree of overdiagnosis has grown, efforts have been made to trim the branches. Initiatives such as Preventing Overdiagnosis, Too Much Medicine, Slow Medicine aim to increase our understanding of how it manifests itself. Efforts such as Choosing Wisely are underway to affect policy and change patient expectations and to change well-entrenched medical practices.

Abstract

Overdiagnosis and overtreatment are common, harmful to patients, and expensive. Doctors and patients tend to overestimate the benefit and underestimate harm of interventions. Choosing Wisely is a medically led campaign focusing on engaging doctors and patients in decisions about potentially unnecessary medical tests, treatments, and procedures. It started in the US in 2012 and has now been taken up in 22 countries worldwide, including the UK.

Read the full text on The BMJ, 2018.

“Helping patients choose wisely”

This statement grandly assumes that patients have no wisdom. Whilst it might well apply to many patients, there are equally many who are very well aware and informed of the best course of action to be taken.

bm Patient Karyse Day’s response, 2018.

Focusing on overdiagnosis as a driver of too much medicine

“Ironically, even though it causes harm, the effects of overdiagnosis look like benefits. People with disease that is overdiagnosed do well because, by definition, their disease was non-progressive. They are “cured” when cure was not necessary in the first place. This creates a cycle that reinforces efforts leading to more overdiagnosis. “

Healthcare is in a tailspin as the rush to offer technology and services turns otherwise healthy people into concerned patients by identifying disease that is not destined to cause them harm.

Abstract

Why overdiagnosis is hard to spot and to explain to individuals

Overdiagnosis, sometimes known as “pseudodisease,” turns people into patients unnecessarily. It identifies deviations, abnormalities, risk factors, and pathologies that were never destined to cause harm (such as symptoms, disability, or death). Overdiagnosis causes anxiety and other negative consequences of labelling; it leads to wasted resources and side effects as a result of unnecessary treatment. Here we consider overdiagnosis in asymptomatic people. Overdiagnosis also occurs (and causes harm) in symptomatic individuals when expanded disease definitions overmedicalise unpleasant ordinary life experiences, but we do not consider it here due to distinct conceptual differences between the two in terms of driving causes and ability to identify overdiagnosis in individuals.

Real but elusive trigger of too much medicine

Overtesting and overtreatment can be identified in a given patient. There is a consensus based on solid evidence that a patient with low back pain but without specific neurological signs or deficits who undergoes magnetic resonance imaging of the spine…

… continue reading on The BMJ, 17 August 2018.

Image credit newlifefoundation.

Does a prediabetic condition increase the risk of developing (type 2) diabetes ?

Development of type 2 diabetes mellitus in people with intermediate hyperglycaemia (‘prediabetes’)

A war on “prediabetes” has created millions of new patients and a tempting opportunity for pharma. But how real is the condition, and is it good medicine?

2018 Study Abstract

Review question
We wanted to find out whether raised blood sugar (‘prediabetes’) increases the risk of developing type 2 diabetes and how many of these people return to having normal blood sugar levels (normoglycaemia). We also investigated the difference in type 2 diabetes development in people with prediabetes compared to people with normoglycaemia.

Background
Type 2 diabetes is often diagnosed by blood sugar measurements like fasting blood glucose or glucose measurements after an oral glucose tolerance test (drinking 75 g of glucose on an empty stomach) or by measuring glycosylated haemoglobin A1c (HbA1c), a long-term marker of blood glucose levels. Type 2 diabetes can have bad effects on health in the long term (diabetic complications), like severe eye or kidney disease or diabetic feet, eventually resulting in foot ulcers.

Raised blood glucose levels (hyperglycaemia), which are above normal ranges but below the limit of diagnosing type 2 diabetes, indicate prediabetes, or intermediate hyperglycaemia. The way prediabetes is defined has important effects on public health because some physicians treat people with prediabetes with medications that can be harmful. For example, reducing the threshold for defining impaired fasting glucose (after an overnight fast) from 6.1 mmol/L or 110 mg/dL to 5.6 mmol/L or 100 mg/dL, as done by the American Diabetes Association (ADA), dramatically increased the number of people diagnosed with prediabetes worldwide.

Study characteristics
We searched for observational studies (studies where no intervention takes place but people are observed over prolonged periods of time) that investigated how many people with prediabetes at the beginning of the study developed type 2 diabetes. We also evaluated studies comparing people with prediabetes to people with normoglycaemia. Prediabetes was defined by different blood glucose measurements.

We found 103 studies, monitoring people over 1 to 24 years. More than 250,000 participants began the studies. In 41 studies the participants were of Australian, European or North American origin, in 7 studies participants were primarily of Latin American origin and in 50 studies participants were of Asian or Middle Eastern origin. Three studies had American Indians as participants, and one study each invited people from Mauritius and Nauru. Six studies included children, adolescents or both as participants.

This evidence is up to date as of 26 February 2018.

Key results
Generally, the development of new type 2 diabetes (diabetes incidence) in people with prediabetes increased over time. However, many participants also reverted from prediabetes back to normal blood glucose levels. Compared to people with normoglycaemia, those with prediabetes (any definition) showed an increased risk of developing type 2 diabetes, but results showed wide differences and depended on how prediabetes was measured. There were no clear differences with regard to several regions in the world or different populations. Because people with prediabetes may develop diabetes but may also change back to normoglycaemia almost any time, doctors should be careful about treating prediabetes because we are not sure whether this will result in more benefit than harm, especially when done on a global scale affecting many people worldwide.

Certainty of the evidence
The certainty of the evidence for overall prognosis was moderate because results varied widely. The certainty of evidence for studies comparing prediabetic with normoglycaemic people was low because the results were not precise and varied widely. In our included observational studies the researchers often did not investigate well enough whether factors like physical inactivity, age or increased body weight also influenced the development of type 2 diabetes, thus making the relationship between prediabetes and the development of type 2 diabetes less clear.

Authors’ conclusions:
Overall prognosis of people with IH worsened over time. T2DM cumulative incidence generally increased over the course of follow-up but varied with IH definition. Regression from IH to normoglycaemia decreased over time but was observed even after 11 years of follow-up. The risk of developing T2DM when comparing IH with normoglycaemia at baseline varied by IH definition. Taking into consideration the uncertainty of the available evidence, as well as the fluctuating stages of normoglycaemia, IH and T2DM, which may transition from one stage to another in both directions even after years of follow-up, practitioners should be careful about the potential implications of any active intervention for people ‘diagnosed’ with IH.

To be prediabetic : a (very) questionable condition

A third of Americans are considered prediabetic – but many may be better off without treatment

A war on “prediabetes” has created millions of new patients and a tempting opportunity for pharma. But how real is the condition, and is it good medicine?

“Practitioners should be careful about the potential implications of any active intervention for people ‘diagnosed’ with intermediate hyperglycaemia (‘prediabetes’)” cochrane.

Genome sequencing for sale on the NHS

NHS to sell DNA tests to healthy people in push to find new treatments

Service will be free for patients with serious genetic conditions as health service in England aims to recruit 5 million volunteers

“Major advances have been made in the field of genomics in recent years. We are now able to sequence the entire genome. Rapid advances in genetic technologies have led to greater availability, and at lower costs, of all forms of genetic tests, ranging from online direct to consumer DNA test kits to clinical whole genome sequencing of all 20 000 human genes.

England’s health secretary, Matt Hancock, recently announced plans to offer healthy people the option to have their whole genome sequenced by the NHS for an as yet undisclosed fee (thought to be a few hundred pounds). These “genomics volunteers” would receive a personalised health report indicating genetic risks of various diseases including cancer, dementia, and cardiovascular disease. These extensive personal genomic data will be shared with researchers to provide opportunities to improve our understanding of human diseases.

This proposal raises several important clinical, logistic, social, and ethical issues, …”

… Continue reading Think again, Mr Hancock, on The BMJ, 25 February 2019.

Drop the C-word to reduce anxiety and overtreatment, say experts

Renaming low risk conditions labelled as cancer

Removing the cancer label in low risk conditions that are unlikely to cause harm if left untreated may help reduce overdiagnosis and overtreatment, argue The BMJ

Abstract

Evidence is mounting that disease labels affect people’s psychological responses and their decisions about management options. The use of more medicalised labels can increase both concern about illness and desire for more invasive treatment. For low risk lesions where there is evidence of overdiagnosis and previous calls to replace the term cancer, we consider the potential implications of removing the cancer label and how this may be achieved.

Our changing understanding of the prognosis of cancers

Some cancers are non-growing or so slow growing that they will never cause harm if left undetected. A prime example is low risk papillary thyroid cancer. Autopsy studies show a large reservoir of undetected papillary thyroid cancer that never causes harm, and the incidence of thyroid cancer has risen substantially in many developed countries. This rise has been predominantly driven by an increase in small papillary thyroid cancers, with mortality remaining largely unchanged. These small papillary thyroid cancers are increasingly being detected because of new technologies, increased access to health services, and thyroid cancer screening. Studies show that rates of metastases, progression to clinical disease, and tumour growth in patients with small papillary thyroid cancer who receive immediate surgery are comparable with those in patients who follow active surveillance.

Likewise, for both low risk ductal carcinoma in situ (DCIS) and localised prostate cancer, detection strategies have become controversial as long term outcomes for both conditions have been shown to be excellent and there is evidence and concern about overdiagnosis and overtreament. Given the potential harms of overtreatment of DCIS, active surveillance is now being trialled internationally as an alternative approach. …

… continue reading Renaming low risk conditions labelled as cancer on The BMJ, 12 August 2018. Image  credit @bmj_company.

Too Much Medicine Helsinki Symposium 2018

Paulo Foundation International Medical Symposium, Helsinki, 15 – 17 Aug 2018

Abstracts

  • Overestimation of depression prevalence in meta-analyses via the inclusion of primary studies that assessed depression using screening tools or rating scales rather than validated diagnostic interviews
  • Clinician, patient and general public beliefs about diagnostic imaging for low back pain: A qualitative evidence synthesis
  • Overdiagnosis of low back pain
  • Defining Overdiagnosis of Mental Health Disorders: Secondary Analysis of an Overdiagnosis Scoping Review
  • Evaluating the content of Choosing Wisely recommendations and prevalence of interdisciplinary finger pointing
  • Inadequate Prescription of medicines for Parkinson’s disease in the Autonomous Community of the Basque Country. An observational study
  • Is it always necessary to treat nocturia? Natural history of nocturia among men and women during the 5-year period
  • The monocriterial source of over-testing and over-treatment: the case of bone scanning
  • Increasing prescription of opioid analgesics and neuropathic pain medicines for spinal pain in Australia
  • No benefit of additional care for ‘high-risk’ patients with acute low back pain: The PREVENT randomized, placebo-controlled trial
  • Overdiagnosis, overtreatment and low-value care in physiotherapy: a scoping review
  • Targeted information based on reimbursed drug registry
  • Journal Registration Policies and Prospective Registration in Randomized Trials of Non-Regulated Interventions: A Meta-Research Review
  • Pharmacotherapy and behavioural problems in Autism Spectrum Disorders
  • Simultaneous under and over care of eye health care in Finland
  • Decision Support and Knowledge Translation Tools to Highlight the Benefits and Downstream Harms of Screening: Resources from the Canadian Task Force for Preventive Healthcare
  • A Free Access Literature Awareness Portal That Surveilles High Quality Research and Guidelines to Inform Benefits and Downstream Harms of Screening and Prevention Strategies in Healthcare
  • From “Non‐encounters” to autonomic agency. Conceptions of patients with low back pain about their encounters in Finnish health care system
  • Does the use of CAM reflect a patients´ response to “too much medicine”?
  • Preferred Reporting Items for Overview of Systematic Reviews for abstracts (PRIO-abstracts)

Reference.

Is early detection always the best medicine ?

The Recommended Dose, with Alexandra Barratt

Hosted by acclaimed journalist and health researcher Dr Ray Moynihan, The Recommended Dose tackles the big questions in health and explores the insights, evidence and ideas of extraordinary researchers, thinkers, writers and health professionals from around the globe. The series is produced by Cochrane Australia and co-published with the BMJ.

Press Play > to listen to the recording.

Dr Ray Moynihan’s guest has led something of a double life, using both medicine and the media to explore and promote the critical role of evidence in healthcare. Now based at the University of Sydney, Alexandra Barratt‘s journey from clinician to journalist to global advocate for evidence based medicine and shared decision-making is a fascinating one.

Here Alexandra talks with Ray about her varied career and the reasons she’s ended up challenging conventional wisdom. She also talks about her research into the pros and cons of breast cancer screening and questions the widely-accepted idea that early detection is always the best medicine.

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