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

17th November 2011

Results 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.

Ovarian cancerImplementing NICE guidance

April 2011

NICE clinical guideline 122

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

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

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

Ca 125

• 10% greater than or equal to 35IU/ml• ie 45 requests • Clinical details abstracted from information

accompanying ICE request