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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 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: • Benign gynaecology Endometriosis Fibroids Pelvic Inflammatory Disease • • • Other peritoneal inflammation Cyclical variations in pre-menopausal age group Benign conditions Urinary retention Chronic renal failure Pancreatitis • 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: – – – – 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