17th November 2011
Audit of Impact of NICE guidelines for Ovarian Cancer
Helen LostyRoyal United Hospital Bath
17th November 2011
Background to Audit
• 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
Background
Image reproduced by kind permission of Dr Sue Barter
• Ovarian cancer is a challenge to diagnose because of the non-specific nature of symptoms and signs – “silent killer”
• Most women are diagnosed with advanced disease (stages II– IV)
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
• Known as the first and predominant ovarian tumour marker investigated
• 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:• Benign gynaecology Endometriosis Fibroids Pelvic Inflammatory Disease
• Other peritoneal inflammation• Benign conditions Urinary retention Chronic renal failure Pancreatitis
• Cyclical variations in pre-menopausal age group• Other malignant disease – gastric and lung
Ca125 – lack of sensitiviry
• 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.
Detection in primary care
Women presents to GP
GP assesses symptoms
Tests in primary care
Urgent referral: assessment in secondary care
Suspicion of ovarian cancer
Ascites and/or pelvic or abdominal mass
Support and inform
ation
Measure serum CA125
Ultrasound of abdomen and pelvis
Advise to return to GP if symptoms become more frequent and/or persistent
InvestigateRefer urgently
Assess carefully: are other clinical causes of
symptoms apparent?
Suggestive of ovarian cancer
35 IU/ml or greater
Normal
Less than 35 IU/ml
No
First tests in primary care
Yes
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:– 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
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
1 20
50
100
150
200
250
300
350
400
450
500
2010
2011
146
429
Increase in test requests from primary care 2010 vs
2011
B2=169
Q=120
Z=130
G2=176
I=108
N1=149
Q1=154
Z1=1
66G=1
06
D2=171
L=114
T=123
X=128
M=115
X1=164
K=113
F1=1
40U=1
24Y=
129S=
122
A =100
D=103
P=119
A1=131
F=105
D1=134
Y1=1
65H=1
07N=1
160
5
10
15
20
25
30
Number of Ca 125 requests per practice 2010 compared with 2011
Series1Series2
57 prac-tices
1 20%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%Percentage of normal results in 2010 and 2011
Series1
70%
90%
2010
2011