Health Care Interventions: Choosing · • The second most common cause of cancer‐related death in Australian women (lung cancer was the first) resulting in 2,914 deaths in women

Health Care Interventions: Choosing Wisely U3A Short Course (2nd of 8 sessions), April‐June 2015

Dr Ken Harvey Page 1

Health Care Interventions: Choosing Wisely

Dr Ken Harvey MB BS, FRCPA

Adjunct Associate Professor, School of Public Health and Preventive Medicine

http://www.medreach.com.au

Short Course (2nd of 8 sessions), April‐June 2014, GAA House

Issues to be explored

• Improving communication between consumers / patients and their health care providers.

• Assessing the risks, benefits and costs of interventions.

• Interventions we could discuss (questionnaire):– screening to detect cancer,

– antibiotics for upper respiratory tract infection,

– antipsychotics in dementia,

– reviewing multiple medications (polypharmacy),

– cancer treatment, (chemotherapy, radiotherapy, etc.),

– intensive care (cardiopulmonary resuscitation, etc.),

– end of life planning (Dr Rodney Syme, May 14 &21).



3

Causes of death in Australia 2010

4



Cancer deaths in Australia 2012

5

Screening to detect bowel cancer

6



Screening to detect bowel cancer

7https://www.youtube.com/watch?v=SXUJQ4NynHI

Australian bowel cancer statistics 2010‐11

• There were 14,860 new cases of bowel cancer (8,258 new cases in men and 6,602 new cases in women), accounting for 12.7 per cent of all new cancers, excluding non‐melanoma skin cancer.

• There were 3,999 deaths from bowel cancer (2,219 men and 1,780 women), accounting for 9.3 per cent of all cancer deaths in Australia (second commonest cause of cancer death).

• The average age of bowel cancer diagnosis was 69.3 years with the risk increasing with age (and family history).

• The risk of developing bowel cancer before the age of 85 was 1 in 12.

8http://canceraustralia.gov.au/affected-cancer/cancer-types/bowel-

cancer/bowel-cancer-statistics



Screening to detect bowel cancer: 2010

• Reviewed four randomised controlled trials which followed up 172,734 participants aged 45‐80 for 11 to 18 years offered biannual FOBT (and colonoscopy if positive) compared with 156,898 controls (60%‐78% compliance with at least one round of screening).

• Participants allocated to screening had a statistically significant 16% reduction in the relative risk of death from colorectal cancer (and more early‐stage tumours detected).

• The cumulative 10 year mortality from colorectal cancer in males for the decades beginning 40, 50 and 60 are respectively 5, 22 and 70 per 10,000 individuals; Thus the reduction in CRC mortality over 10 years for those aged 40, 50 and 60 is likely to be 1.25, 5.5 and 17.5 per 10,000 respectively.

• However, given the lack of an effect for all‐cause mortality, an increase in life years may not be observed.

9http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001216.pub2/full

Screening tests to detect bowel cancer I

• Pros:– Specificity (correctly identifying a person

without bowel cancer) around 92‐94%.

– Stool sample collection can be done at home.

– No need to empty the colon ahead of time.

– No need for sedation.

– Cheap.

• Cons:– Some find handling stool samples off‐putting; many fail to

complete the test.

– Sensitivity around 50‐60% (fails to detect many polyps and cancers).

– Blood can come from aspirin, NSAIDs, haemorrhoids, ulcers, etc.

– If positive (about 2‐10% of cases screened), additional investigations such as colonoscopy are needed (around 5‐10% of people with a positive FOBT are subsequently found to have cancer).

10

Immunochemical Faecal occult blood test (FOBT)



Screening tests to detect bowel cancer II

• Pros:– Detects 95% of cancers

– Removes polyps before they turn into cancer.

– Some authorities (mainly in U.S.) recommendcolonoscopy every 10 years in preference to FOBT.

– Preferred screening strategy for higher risk patients.

• Cons:– Requires prior thorough cleansing of the colon with a

laxative solution: frequent, urgent trips to the toilet!

– Requires sedation (I.V. midazolam); cannot drive home.

– Takes 30‐45 minutes, longer if polyps need to be removed (2‐3 hours in total).

– Will still miss some cancers, especially right‐sided and those developing in‐between screening (interval cancers).

– Small risk of bleeding, bowel perforation, etc. (higher in elderly).

Colonoscopy

11

Analysis of outcomes of NBCSP: 2006‐12

• The National Bowel Cancer Screening Program (NBCSP) was introduced in Australia in 2006.

• This analysis linked NBCSP, cancer incidence and mortality data to identify 22,051 people diagnosed with bowel cancer:

– 4,327 had been invited to participate in the NBCSP in 2006–2008, as part of the target population turning 50, 55 or 65 (NBCSP invitees)

– 17,724 were aged 50–69 in 2006–2008, but did not turn 50, 55 or 65 during that period and were therefore not invited to screen then (non‐invitees).

12http://www.aihw.gov.au/publication-detail/?id=60129549725




13

• Of the 2,609 people in the NBCSP invitee group with a bowel cancer diagnosis, 298 (11.4%) had died of bowel cancer before 2012.

• Of the 10,080 never‐invited people with a bowel cancer diagnosis, 1,973 (19.6%) had died of bowel cancer by the same date.

• After correcting for potential lead time bias, the result was still statistically significant (15% higher risk in the never‐invited group).

• Bowel cancers found in non‐invitees were, on average, more advanced (worse prognosis) bowel cancers compared with NBCSP invitees.

• Sensitivity: Of the NBCSP invitees who participated, 83% of those diagnosed with bowel cancer within 2 years of their screen had received a positive screening result (FOBT plus colonoscopy).

• Specificity: 93% of those who were not diagnosed with bowel cancer had received a negative screening result.

http://www.aihw.gov.au/publication-detail/?id=60129549725


• Currently, 75 out of 1000 (7.5%) people who have completed FOBT return a positive result. Of these:– 53 (70%) present for a colonoscopy. Of these:

– 1.5 (3%) are diagnosed with cancer

– 3 (6%) are diagnosed with advanced adenoma.

• FOBT is therefore a valuable tool for prioritising the use of colonoscopy for patients who are at higher than average bowel cancer risk or are symptomatic.

14https://www.mja.com.au/journal/2014/201/8/bowel-cancer-screening-plan-last



Australian Bowel Cancer Screening Program 2012‐13

15

About 33.5% of 964,000 people invited from July 2012 to June 2013 returned a completed bowel cancer screening kit for analysis

Risk of dying from colon cancer vs other diseases in the next 10 years

16http://www.shareddecisionmaking.org/Site/Female%20Age%2080.pdf



17

Screening to detect prostate cancer

18



Australian prostate cancer statistics 2010‐11

• Prostate cancer is the commonest cancer in Australian men (excluding non‐melanoma skin cancer), accounting for 30.0 per cent of all new cancers in men with 19,821 new cases diagnosed.

• It caused 3,294 deaths; 13.4% of all cancer deaths in men compared with 2,914 deaths from breast cancer in women.

• The average age of prostate cancer diagnosis was 67 years with the risk increasing with age.

• The risk of a man developing prostate cancer before the age of 85 was 1 in 5 (20%) compared with the risk of breast cancer in women of 1:8 (12.5%).

19http://canceraustralia.gov.au/affected-cancer/cancer-types/prostate-cancer/prostate-

cancer-statistics


20http://tinyurl.com/nsf287r




• Prostate cancer screening did not significantly decrease prostate cancer‐specific or overall mortality in a combined meta‐analysis of five RCTs comprised of 341,342 participants.

• Harms associated with PSA‐based screening and subsequent diagnostic evaluations are frequent, and moderate in severity.

• Over‐diagnosis and overtreatment are common and are associated with treatment‐related harms including false‐positive results for the PSA test, infection, bleeding, and pain associated with subsequent biopsy.

• Any reduction in prostate cancer‐specific mortality may take up to 10 years to accrue; therefore, men who have a life expectancy less than 10 to 15 years should be informed that screening for prostate cancer is unlikely to be beneficial.

21http://www.cochrane.org/CD004720/PROSTATE_screening-for-prostate-cancer

ncluding false-positive results for the PSA test, infection, bleeding, and pain associated with subsequent biopsy.

22



Screening to detect breast cancer

23

Australian breast cancer statistics 2010‐11

• The commonest cancer diagnosed in Australian women (excluding non‐melanoma skin cancer), accounting for 28% of all new cancers; 14,181 new cases in women and 127 new cases in men.

• The second most common cause of cancer‐related death in Australian women (lung cancer was the first) resulting in 2,914 deaths in women (23 in men).

• Of new cases of breast cancer in women:– 23% were younger than 50 years; 52% were aged 50–69 years; and

– 25% were aged 70 years and over.

• The risk of developing breast cancer before the age of 85 in Australian women was 1 in 8 (12.5%).

http://canceraustralia.gov.au/affected-cancer/cancer-types/breast-cancer/breast-cancer-statistics



Screening to detect cancer: Mammography

25https://www.youtube.com/watch?v=4GpsD5lSPps

Screening to detect cancer: Mammography

26https://www.youtube.com/watch?v=paCAc9p_GsQ



Screening for breast cancer with mammography: 2012

• A review of randomised trials comparing mammographic screening with no screening.

• Eligible trials included 600,000 women in the age range39 to 74 years.

• The trials suggested that for 2000 women invited for screening throughout 10 years, 1 will avoid dying of breast cancer and 10 healthy women will be treated unnecessarily.

• Furthermore, more than 200 women will experience important psychological distress including anxiety and uncertainty for years because of false positive findings.

27http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001877.pub5/full

Screening for breast cancer with mammography

• Because of advances in treatment and greater breast cancer awareness since the trials were carried out, it is likely that the absolute effect of screening today is smaller than in the trials.

• If screening works, it must do so by picking up breast cancers earlier so there should be a drop in the rates of advanced breast cancer, as well as a drop in deaths.

• While early stage breast cancer rates have doubled over the last 30 years there has been very little or no reduction in the incidence of advanced cancers.

• Meanwhile, over‐diagnosis rates (while contested) range from 1.5 to 15 cases for every breast cancer death prevented.

28https://theconversation.com/growing-uncertainty-about-breast-cancer-screening-15997



Better treatment, not screening reduces death?

• There has been a 28% reduction in age‐standardised breast cancer mortality in Australia since 1991 when the free BreastScreen program began.

• Women aged 40–49 years, who had the lowest BreastScreen participation (approximately 20%) had the largest mortality reduction (44%).

• Women aged 60–69 years, who had the highest BreastScreen participation (approximately 60%), had the smallest mortality reduction (19%).

• Thus most, if not all, of the reductions can be attributed to advances in adjuvant hormonal and chemotherapy, which Australian women have increasingly received since 1986.

https://theconversation.com/over-diagnosis-and-breast-cancer-screening-a-case-study-7396

Australian mammography decision data

• What happens to 1000 women aged 70 who stop having mammograms over the next 10 years:

– 26 women will develop symptoms and are diagnosed with breast cancer;

– 8 women will die of breast cancer;

– 974 women will continue with their daily life without being affected by breast cancer or attending for screening.

30http://sydney.edu.au/medicine/public-health/shdg/resources/Mammo_DA.pdf



• What happens to 1000 women aged 70 who continue having 2‐yearlymammograms over the next 10 years:

– 135 women have extra tests after an abnormal mammogram and are found not to have cancer;

– 41 women are diagnosed with breast cancer:• 32 have their cancer detected by screening and undergo treatment;

• 9 develop symptoms and are diagnosed with breast cancer between mammograms (interval cancers) and undergo treatment;

• 6 women die of breast cancer;

– 824 women are correctly reassured that they do not have breast cancer.

31


• In summary, screening 1000 women aged 70 for the next 10 years results in:

– 2 deaths from breast cancer prevented by screening;

– 15 more women diagnosed with breast cancer and receiving treatment (lumpectomy / mastectomy / radiotherapy / hormone therapy / chemotherapy / etc.);

– 135 women having extra tests after an abnormal mammogram but ultimately are found not to have breast cancer (nevertheless producing inconvenience and worry about “false alarms”);

– 824 women reassured they do not have breast cancer (at the time of screening).

32




Over to you

• Should I (or my partner) continue having screening mammograms after 70 to detect breast cancer?

33

34



Angelina Jolie’s prophylactic mastectomy

• Her mother died of ovarian cancer at age 56.

• Jolie also had a mutated BRCA1 gene.

• Among women who have inherited a mutated BRCA1 or BRCA2 gene, 60% will develop breast cancer (compared to about 12% who lack these genes).

• However, a recent University of Michigan study showed that nearly three‐quarters of U.S. women who opted to have prophylactic mastectomy actually had a very low risk of developing cancer in the healthy breast.

http://www.health.harvard.edu/blog/angelina-jolies-prophylactic-mastectomy-a-difficult-decision-201305156255

35

Screening for cancer: Conclusions

• Help you make a decision when there is no clear evidence that one choice is best;

• Provide you with easy to understand, useful, and reliable information about the options available;

• Help you weigh the pros and cons of each option (but this needs good outcome data in easy‐to‐understand, absolute numbers: currently often not available or conflicting);

• Take into consideration your own values;

• Give you the permission, knowledge and encouragement to engage your healthcare provider.

36

Shared decision making can:



Internet resources

• http://www.cancerscreening.gov.au/

• http://www.cancer.org.au/about‐cancer/early‐detection/screening‐programs/

• http://www.aihw.gov.au/cancer/screening/

• http://www.cancer.gov/cancertopics/screening

• http://www.cancer.org/healthy/findcancerearly/cancerscreeningguidelines/american‐cancer‐society‐guidelines‐for‐the‐early‐detection‐of‐cancer

37

If time: The role of the regulator (TGA)

38https://www.tga.gov.au/benefits-versus-risks-approach-regulating-therapeutic-goods

Documents

Health Care Interventions: Choosing · • The second most common cause of cancer‐related death in Australian women (lung cancer was the first) resulting in 2,914 deaths in women