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.

Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses

hrHPV testing with an appropriate assay offers a promising new strategy that could increase population coverage substantially

What is already known on this topic

  • Tests performed on self samples are less sensitive and less specific than tests performed on clinician samples when using a high-risk human papillomavirus (hrHPV) assay based on signal amplification
  • Response rates for hrHPV testing are higher for self sampling kits than for conventional invitations

What this study adds

  • Tests performed on self samples are similarly sensitive and slightly less specific than tests performed on clinician samples when using a hrHPV assay based on polymerase chain reaction
  • Response rates for hrHPV testing continue to be higher for self sampling kits than for conventional invitations

2018 Study Abstract

Objective
To evaluate the diagnostic accuracy of high-risk human papillomavirus (hrHPV) assays on self samples and the efficacy of self sampling strategies to reach underscreened women.

Design
Updated meta-analysis.

Data sources
Medline (PubMed), Embase, and CENTRAL from 1 January 2013 to 15 April 2018 (accuracy review), and 1 January 2014 to 15 April 2018 (participation review).

Review methods
Accuracy review: hrHPV assay on a vaginal self sample and a clinician sample; and verification of the presence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by colposcopy and biopsy in all enrolled women or in women with positive tests. Participation review: study population included women who were irregularly or never screened; women in the self sampling arm (intervention arm) were invited to collect a self sample for hrHPV testing; women in the control arm were invited or reminded to undergo a screening test on a clinician sample; participation in both arms was documented; and a population minimum of 400 women.

Results
56 accuracy studies and 25 participation trials were included. hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ or CIN3+ (pooled ratio 0.99, 95% confidence interval 0.97 to 1.02). However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89). The specificity to exclude CIN2+ was 2% or 4% lower on self samples than on clinician samples, for hrHPV assays based on polymerase chain reaction or signal amplification, respectively. Mailing self sample kits to the woman’s home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91). Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61). Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%). Substantial interstudy heterogeneity was noted (I2>95%).

Conclusions
When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples. Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations. However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.

Whereas accuracy of new combinations of assays and self sampling devices can be evaluated in a diagnostic setting, acceptance and participation should be shown locally in a screening setting before general roll out.

Cancer of the cervix uteri

Half a million new cases of cervical cancer are added each year

Abstract

Since the publication of the last FIGO Cancer Report there have been giant strides in the global effort to reduce the burden of cervical cancer, with WHO announcing a call for elimination. In over 80 countries, including LMICs, HPV vaccination is now included in the national program. Screening has also seen major advances with implementation of HPV testing on a larger scale. However, these interventions will take a few years to show their impact. Meanwhile, over half a million new cases are added each year. Recent developments in imaging and increased use of minimally invasive surgery have changed the paradigm for management of these cases. The FIGO Gynecologic Oncology Committee has revised the staging system based on these advances. This chapter discusses the management of cervical cancer based on the stage of disease, including attention to palliation and quality of life issues.

Reference.

Overtreatment : When Medicine Does More Harm Than Good

Why do millions of people a year get tests and procedures that they don’t really need ?

Researchers estimate that 21% of medical care is unnecessary.

Kaiser Health News senior correspondent Liz Szabo moderated a discussion a panel of experts to explore overtreatment.

KHN panelists were:

  • Dr. Louise Davies, An associate professor of otolaryngology – head and neck surgery in The Dartmouth Institute for Health Policy & Clinical Practice
  • Dr. Saurabh Jha, an associate professor of radiology at the University of Pennsylvania
  • Dr. Barry Kramer, director of the division of cancer prevention at the National Cancer Institute
  • Dr. Jacqueline Kruser, a pulmonologist and critical care physician at Northwestern University Feinberg School of Medicine
  • Dr. Ranit Mishori, professor of family medicine at the Georgetown University School of Medicine.
  • Reference.
  • Video source : KHN was live.

Screening for Cervical Cancer – US Preventive Services Task Force Recommendation Statement

New Cervical Cancer Screening Guidelines: What You Need to Know

Some women have a new option for cervical cancer screening — and it doesn’t necessarily involve a Pap test — according to updated guidelines from a government-appointed panel of experts, livescience reports.

Key Points

  • Women under age 21 should not be screened for cervical cancer.
  • Women ages 21 to 29 should undergo screening every three years using a Pap test, also called “cervical cytology.” (HPV testing isn’t recommended for women ages 21 to 29 because, in this age group, HPV infection is common and is often cleared by the immune system.)
  • Women over age 65 do not need to be screened for cervical cancer if they are up to date on their screening, their tests in the previous 10 years were negative and they don’t have other risk factors for cervical cancer.

Abstract

Importance
The number of deaths from cervical cancer in the United States has decreased substantially since the implementation of widespread cervical cancer screening and has declined from 2.8 to 2.3 deaths per 100 000 women from 2000 to 2015.

Objective
To update the US Preventive Services Task Force (USPSTF) 2012 recommendation on screening for cervical cancer.

Evidence Review
The USPSTF reviewed the evidence on screening for cervical cancer, with a focus on clinical trials and cohort studies that evaluated screening with high-risk human papillomavirus (hrHPV) testing alone or hrHPV and cytology together (cotesting) compared with cervical cytology alone. The USPSTF also commissioned a decision analysis model to evaluate the age at which to begin and end screening, the optimal interval for screening, the effectiveness of different screening strategies, and related benefits and harms of different screening strategies.

Findings
Screening with cervical cytology alone, primary hrHPV testing alone, or cotesting can detect high-grade precancerous cervical lesions and cervical cancer. Screening women aged 21 to 65 years substantially reduces cervical cancer incidence and mortality. The harms of screening for cervical cancer in women aged 30 to 65 years are moderate. The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone in women aged 21 to 29 years substantially outweigh the harms. The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone, every 5 years with hrHPV testing alone, or every 5 years with both tests (cotesting) in women aged 30 to 65 years outweigh the harms. Screening women older than 65 years who have had adequate prior screening and women younger than 21 years does not provide significant benefit. Screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer provides no benefit. The USPSTF concludes with moderate to high certainty that screening women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, screening women younger than 21 years, and screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer does not result in a positive net benefit.

Conclusions and Recommendation
The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women aged 21 to 29 years. (A recommendation) The USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years with hrHPV testing alone, or every 5 years with hrHPV testing in combination with cytology (cotesting) in women aged 30 to 65 years. (A recommendation) The USPSTF recommends against screening for cervical cancer in women younger than 21 years. (D recommendation) The USPSTF recommends against screening for cervical cancer in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer. (D recommendation) The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy with removal of the cervix and do not have a history of a high-grade precancerous lesion or cervical cancer.

Recommendations of Others

… “Women at increased risk of cervical cancer (ie, women with a history of cervical cancer, a compromised immune system, or diethylstilbestrol exposure) may need to be screened more often.” …

Reference. US Preventive Services Task Force, August 21, 2018.

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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USPSTF Draft Recommendation Statement Cervical Cancer : Screening

The US Preventive Services Task Force has New Draft Guidance for Cervical Cancer Screening

These recommendations do NOT apply to women with in utero exposure to diethylstilbestrol or women who have a compromised immune system (e.g., women living with HIV).

The major change from the US Preventive Services Task Force (USPSTF) 2012 recommendation is that testing for high-risk strains of human papillomavirus (hrHPV) alone is now recommended as an alternative to cytology or Papanicolaou (Pap) screening alone beginning at age 30 years; cotesting is no longer recommended.

As in the 2012 recommendation, the USPSTF continues to recommend that women aged 21 to 29 years undergo Pap screening every 3 years.

The USPSTF recommend against screening in women younger than age 21 years because there is adequate evidence that regardless of sexual history, screening younger women does not reduce cervical cancer incidence or mortality.

The USPSTF also continues to give a thumbs down to screening in women older than age 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, as well as in women who have had a hysterectomy and their cervix removed and do not have a history of a high-grade precancerous lesions or cervical cancer.

More Information

The Little Known Truth About Mammograms

Adam Ruins The Hospital – Season 2 | Ep 203, 2017

Mammograms might be able to detect cancer but they can’t tell the difference between different types. Turns out, mammograms can harm and save much fewer lives than you think.

Diagnostic tests : how to minimise harm

We must develop new diagnostic tests to tackle real health problems, not to generate them

New diagnostic tests: more harm than good, BMJ 2017;358:j3314,
06 January 2016.

Defenders against overdiagnosis, BMJ 2017;358:j3487, 20 July 2017.

Although new diagnostics may advance the time of diagnoses in selected patients, they will increase the frequency of false alarms, overdiagnosis, and overtreatment in others.

Bjorn Hofmann, professor of medical ethics at Norwegian University of Science and Technology, explains how to minimise harm. Press Play > to listen to the recording.

Key messages

  • Innovative technologies and ample venture capital are combining to produce new disease biomarkers and mobile monitoring devices
  • These new diagnostics are technologically advanced but do not automatically provide improvements in clinical care and population health
  • They have the potential to help some but also to increase the frequency of false alarms, overdiagnosis, and overtreatment in others
  • Excessive testing and false alarms may increase healthcare workload and shift clinicians’ focus towards the healthy
  • Misleading feedback at both the population and individual levels tends to favour further market growth
  • Clinicians must provide a strong counterbalance: educating patients, respecting baseline risk, thinking downstream, and expecting misleading feedback

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The New War on Cancer

50-Year War on Cancer: Can We Win?

The signing of the National Cancer Act by President Richard M. Nixon on December 23, 1971, was considered a declaration of war on cancer.

In a multi-part series, the National Post explores why we need a new war on cancer.

Cancer nation

Where you live could affect your odds of getting cancer or dying from it.

Interactive map: Cancer is an indiscriminate disease, affecting rich and poor, old and young. Still, Canadians’ odds of getting sick depend surprisingly on where they live.

Why we need a new war on cancer

Over-treating and over-screening is doing patients more harm than good

The issue: Advances in screening and diagnosis are sending some cancer patients down aggressive treatment paths that they shouldn’t be on.
The solution: A new war on cancer and a rethinking of resources.

Drug money

Some cancer treatments cost as much as $33,000 a month, but fall well short of being wonder cures

A Post analysis of 17 cancer drugs that cost between $4,700 and $33,000 a month reveals only three had evidence that they extended lives when approved by Health Canada.

Bankrupt by cancer

Cancer is not just a life-threatening disease ― but a financial disaster.

In Canada, a country that prides itself on looking after the sick, no matter their ability to pay, Canadians are declaring bankruptcy because of cancer.

The fundraising complex

Of the $2.7 billion that cancer charities spent in 2013, only 45 per cent went towards fighting cancer.

The Post’s analysis of cancer funding reveals the depth of inefficiencies in the sector. In 2013, more than half of total funds went to salaries and overhead.

Learning to live with cancer

As science gets better at controlling cancer for longer periods of time, it might be best to kill the battle rhetoric

Nowhere else in medicine is the battle rhetoric more entrenched than in cancer. And its defeating people. Who wants to go war with their own bodies?

Prevention as the ultimate cure

Prevention saves more lives than any cancer drug

However, in the multi-billion-dollar cancer business, efforts to stop people from contracting the illness account for as little as five per cent of what’s spent.