Transcript Audit of Impact of NICE guidelines for Ovarian Cancer

Audit of Impact of NICE
guidelines for Ovarian Cancer
Helen Losty
Royal United Hospital Bath
17th November 2011
Background to Audit
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Ovarian cancer
Ca125 in ovarian cancer
Cancer strategy
Scope and brief for guidelines
Guideline algorithm
17th November 2011
Methodology of Audit
• Requesting of Ca 125 in primary care
• Analytical method
• Methodology of audit
17th November 2011
Results of audit
17th November 2011
Background
• Ovarian cancer is a
challenge to diagnose
because of the nonspecific nature of
symptoms and signs –
“silent killer”
• Most women are
diagnosed with
advanced disease
(stages II– IV)
Image reproduced by kind permission
of Dr Sue Barter
Epidemiology
• Ovarian cancer is the 5th most common cancer in
women in the UK
• Over 6700 new cases are diagnosed each year,
accounting for approximately 1 in 20 cases of cancer
in women
• Around 4300 women die from ovarian cancer each
year in the UK, representing 6% of all cancer deaths
in women
Ca 125
• Pre eminent ovarian tumour marker
• Hybridoma defined tumour marker
• High molecular weight glycoprotein
present in serum of women with primary
epithelial ovarian cancer
• Not present on surface epithelial of normal
ovaries
Ca 125 lack of specificity
Elevated in:
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Benign gynaecology
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Endometriosis
Fibroids
Pelvic Inflammatory Disease
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Other peritoneal inflammation
Cyclical variations in pre-menopausal age group
Benign conditions
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Urinary retention
Chronic renal failure
Pancreatitis
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Other malignant disease – gastric and lung
Ca125 – lack of sensitivity
• Ca 125 not raised in 30% of women with
ovarian cancer – early stage disease
Ca125 diagnostic efficiency
• Sensitivity and specificity
Ca 125 U/mL
Sensitivity %
Specificity %
65 and greater
79
82
150
69
93
190
63
95
Cancer Strategy
• National awareness and Early Diagnosis
Initiative NAEDI 2008
• Improving outcomes – save 5,000 lives
through earlier diagnosis
• Cancer and general practice - GP’s in the
driving seat
• Increase access for GP’s to diagnostic
tests - imaging
Ovarian cancer
• Ovarian cancer – 29% present through
emergency route which is always
associated with poorer outcome
• Increase the number of women accessing
the correct treatment pathway earlier.
Ovarian cancer
Implementing NICE guidance
April 2011
NICE clinical guideline 122
Detection in primary care
Ascites and/or
pelvic or
abdominal
mass
GP assesses symptoms
Tests in primary care
Suspicion of ovarian cancer
Urgent referral: assessment in secondary care
Support and information
Women presents to GP
First tests in primary care
Measure serum
CA125
35 IU/ml or greater
Ultrasound of abdomen
and pelvis
Less than 35 IU/ml
Normal
Suggestive of
ovarian cancer
Refer urgently
Assess carefully: are other
clinical causes of
symptoms apparent?
Yes
Investigate
No
Advise to return to GP if
symptoms become more
frequent and/or persistent
Why choice of Ca125
• Least expensive option as first test compared
with ultrasound – access undeliverable or pelvic
examination which is not specific enough
• Prevalence in primary care in symptomatic
woman is only 0.23% ie if all symptomatic
patients were referred then only 1:500 would
have ovarian cancer.
• NB GP sees a patient with ovarian cancer every
5-6 years
Awareness of symptoms
and signs: 1
• Refer the woman urgently if physical
examination identifies ascites and/or a
pelvic or abdominal mass (which is not
obviously uterine fibroids)
Awareness of symptoms
and signs: 2
– Carry out tests in primary care if a woman
(especially if 50 or over) reports having any of
the following symptoms on a persistent or
frequent basis – particularly more than 12
times per month:
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persistent abdominal distension (women often refer to this as ‘bloating’)
feeling full (early satiety) and/or loss of appetite
pelvic or abdominal pain
increased urinary urgency and/or frequency
Awareness of symptoms
and signs: 3
• Consider carrying out tests in primary care if a woman
reports unexplained weight loss, fatigue or changes in
bowel habit
• Carry out appropriate tests for ovarian cancer in any
woman of 50 or over who has experienced symptoms
within the last 12 months that suggest irritable bowel
syndrome (IBS)
• Advise any woman who is not suspected of having
ovarian cancer to return to her GP if her symptoms
become more frequent and/or persistent
NICE guidelines
• Awareness of symptoms
• Facilitate improved detection in primary
care
Audit
1- On line requesting
Ca 125 methodology
• Monoclonal antibody – murine
lymphocytes immunised with ovarian
cancer cell line 433
• Sandwich IRMA
• Most important tumour marker for
monitoring therapy and progress of
patients with serous carcinoma
Audit
• Computer search of ICE for Ca125
requests from primary care
May to July 2011 vs May to July 2010
Itemised for each of 57 practices
Sole identifier was laboratory number
Results
Increase in test requests
from primary care 2010 vs
2011
Ca 125
• 10% greater than or equal to 35IU/ml
• ie 45 requests on 42 patients
• Clinical details from accompanying ICE
request and further diagnostic information
also from ICE
Distribution of Ca 125 concentrations in 45 patients with elevated valuse
25
20
Ca125
15
10
5
0
35 to 65
65-150
151-500
greater than 500
Ca 125 (35-65)
• 22 results on 21 patients – 2 patients repeat
measurements were normal
• 16/21 less than 50 years in age
• 3/21 monitoring post treatment for ovarian
cancer
• Remainder: abdominal discomfort, patient
anxiety because of FH, previous history of
cysts, suspicion of pelvic mass,
endometriosis – follow up USS
Ca125 (66-150)
• 7 patients
• 1/7 prechemo
• Nil of note on follow-up USS
Ca 125 (151-500)
• 7patients
• 1/7 – patient presenting to primary care
with abdominal pain and bloating – USS
confirmed.
• 5/7 ongoing management of known
ovarian/peritoneal tumour
• 1/7 – hepatic ascites – alcoholic liver
disease
Ca125 >500
• 7 patients
• 1/7 newly diagnosed after first presenting
to ED.
• 5/7 – monitoring/treatment of
ovarian/peritoneal tumour.
Cost of additional testing
• NICE guidelines – acknowledged extra
resource required for extra investigations
from primary care
• Ca 125 – least expensive option as first
line test
RUH reagent cost per test reduced
because of more efficient use of kits – but
using more of them!!!
Summary
• NICE guidelines – 3 fold increase in
requests from primary care.
• 10% of results above 35 U/mL cut-off – a
significant percentage of the lower values
are from younger women.
• One patient newly diagnosed after
presenting to primary care
Thank YOU