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Audit of Impact of NICE guidelines for Ovarian Cancer. Helen Losty Royal United Hospital Bath. Background to Audit. Ovarian cancer Ca125 in ovarian cancer Cancer strategy Scope and brief for guidelines Guideline algorithm. Methodology of Audit. Requesting of Ca 125 in primary care
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Audit of Impact of NICE guidelines for Ovarian Cancer Helen Losty Royal 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 17th November 2011
Background • 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) 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 • 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
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 Women presents to GP Ascites and/or pelvic or abdominal mass GP assesses symptoms Support and information Tests in primary care Suspicion of ovarian cancer Urgent referral: assessment in secondary care
First tests in primary care Measure serum CA125 35 IU/ml or greater Less than 35 IU/ml Assess carefully: are other clinical causes of symptoms apparent? Ultrasound of abdomen and pelvis Normal Suggestive of ovarian cancer Yes No Refer urgently Investigate 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: • 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
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
Ca 125 • 10% greater than or equal to 35IU/ml • ie 45 requests • Clinical details abstracted from information accompanying ICE request