Implementing the national invasive cervical cancer audit: a local perspective.

OBJECTIVE: To monitor the effectiveness of the cervical screening programme and identify suboptimal management in order to improve patient care. DESIGN: Retrospective study. SETTING: A university hospital serving a population of 1 million people. POPULATION: All women diagnosed with a cervical cancer between 2003 and 2006. METHODS: Analysis of data from invasive cervical cancer reviews. MAIN OUTCOME MEASURE: Categorisation of cervical cancer cases according to the Invasive Cervical Cancer Audit classification. RESULTS: Eighty-seven women were diagnosed with cervical cancer during the 3-year study period. The 'lapsed attender' group accounted for the greatest number of cases (30%), followed by screen detected (26%), interval cancers (13%), never attended (12%), lost to follow-up (10%) and never invited (9%). Women who had never attended for cytology presented with higher stage disease, stage-II or above, compared with the screen-detected cases: 60% were stage II or above, compared with 13.0%, Chi-square P = 0.018. The most frequently identified screening programme problem was patient compliance, which was determined to be the principle contributing factor in 39 cases (45%) and a secondary factor in a further ten cases. CONCLUSIONS: The categorisation of cervical cancer cases has the potential of yielding invaluable information for improving programme effectiveness. Patient compliance is the greatest challenge to the screening programme, and the need for regular screening and adherence to follow-up regimens needs to be reinforced in order to maximise the efficacy of the national screening programme.

Risk assessment for prevention of morbidity and mortality: lessons for pressure ulcer prevention.

Medicine has changed from being a reactive process that attempts to alleviate disease only when it is clinically evident to a proactive one in which it is hoped that early intervention may reduce the impact of disease or even it developing at all. In moving the focus of treatment, this inevitably means that a greater number of individuals with lesser disease burdens are treated. The logical end-point of this process is to provide preventative measures for the entire population but this can only be done if the economic costs and negative effects of treatment are out-weighed by the benefits. In the case of pressure ulcers, it is self-evident that prevention is extremely beneficial to patients. However, the cost of some of the equipment used for prevention can be high, and therefore, the balance between the optimum level of provision, the purposes of prevention and the available funding becomes critical. Consequently a screening mechanism to better match susceptible patients with resources is essential. There are, however, many problems with such screening techniques. By looking at other specialties, we can see that it is vital to know the natural history of the disease: PSA testing reveals many men who would have died never having known they had prostate cancer, thus giving them years of worry and morbidity they would probably not previously have suffered; cardiovascular risk screening is so imprecise that risk estimates are of questionable utility; antenatal Down's syndrome risk screening is prone to data-related problems that can unexpectedly reduce the effectiveness of the test. In pressure ulcer screening, there are many tools currently in use, but few (possibly none) are really effective. Finally, this paper details some suggestions for future research to combine risk tests that may offer a prospect for improving ulcer risk screening tools.

Median parameters for Down's syndrome screening should be calculated using a moving time-window method.

BACKGROUND: In Down's syndrome screening, the change in analyte concentrations in maternal serum with advancing gestational age is compensated for by converting concentration to multiples of the median (MoM) by using a mathematical equation describing the expected relationship. However, owing to assay drifts and shift, the equation may be incorrect, leading to deviation of the observed MoM distribution from the ideal MoM distribution. The NHS Fetal Anomaly Screening Programme has produced standards limiting acceptable deviation, and has provided the Down's Syndrome Screening Quality Assurance Service (DQASS) to monitor it. DQASS recommends monitoring by cumulative sum plot. METHODS: Down's screening data for 61,368 consecutive samples (12 October 2004 to 31 December 2007) was evaluated using different median assignment techniques. RESULTS: A change in the paradigm for median equation derivation is described, which significantly improves the probability that medians will be correct at any point in time. CONCLUSION: Software developers need to change the way medians are derived in their programmes.

Evaluation of Down's syndrome screening population data sets by simulation: analyser-specific parameters may be superior to meta-analysis-derived parameters.

OBJECTIVE: Choice of parameter sets used to calculate Down's syndrome risks is complicated. Published population statistics were compared with assay-specific parameters to optimise screening efficiency. DESIGN: Weight-corrected Gaussian population statistics for alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG) and unconjugated oestriol (uE(3)), expressed as log(10) multiples of median (MoM) were established for a Belgian cohort of 748 unaffected pregnancies. Using Cuckle's method and Access-specific data, Down's syndrome parameters were tailored to the Belgian cohort. Correlated marker triplets for affected and unaffected pregnancies were modelled and combined with maternal age to calculate term risks for Trisomy 21. Receiver-Operator-Curve (ROC) analysis was performed to identify the optimally-performing population set. RESULTS: Log-normal distributions for the Access markers had geometric mean MoM values close to zero and standard deviation values equal to 0.1460 (AFP), 0.2185 (HCG) and 0.1317 (uE(3)). Correlation between AFP and other markers was significant (p < 0.001). Correlation between HCG and uE(3) was not significant (p = 0.4818). The median ratio between the lowest and highest risk outcomes for the test MoM set was 4.3. Areas under ROC curves differed significantly (p < 0.001) between the models and the analyser-assay specific parameters resulted in the largest area. At a 1 in 250 threshold, sensitivity and specificity were 69% and 96%. At false-positive rates (1-specificity) = 5%, sensitivity was 72.5%. CONCLUSION: Population parameters significantly affect risk outcome and hence screening performance. Highest efficiency may be obtained with parameters tailored to an assay-specific population model. Consequently models from literature, without knowledge of the assay/analyser combination may lead to suboptimal performance.

The use and understanding of CA125 as a tumor marker for ovarian cancer: a questionnaire-based survey.

The aim of this study was to assess the level of understanding of the role of the tumor marker CA125 in ovarian cancer among doctors of different grades specializing in obstetrics and gynecology (O&G), medicine, surgery, and primary care (general practitioners [GPs]). The study involves a questionnaire-based survey. Two hundred and fifty-nine questionnaires were distributed. An overall response rate of 47.1% was achieved. All grades of doctors and all major specialties were represented. There was a significant difference in the level of self-reported CA125 ordering between the medical specialties, O&G being the most frequent users and primary care the least (P < 0.001), and between the grade of doctors, senior house officers/preregistration house officers and GPs less than consultants and middle grade doctors (P < 0.001). Electronic literature was the first source of advice for the majority of respondents (38.5%). The knowledge of false-positive causes for a raised CA125 was low in medicine, surgery, and primary care specialties, as was the awareness of the sensitivity and specificity of CA125 in epithelial and nonepithelial ovarian cancers. The role of CA125 in ovarian cancer is poorly understood, especially among doctors working outside O&G. Guidelines should be developed to aid clinicians from all specialties in the most appropriate application of CA125 in their practice. Substantial cost savings could be made by the introduction of clear protocol-driven ordering in an attempt to reduce the number of inappropriate tests performed.

Best practice in primary care pathology: review 4.

This fourth best practice review examines four series of common primary care questions in laboratory medicine are examined in this review: (1) safety monitoring for three common drugs; (2) use of prostate-specific antigen; (3) investigation of vaginal discharge; and (4) investigation of subfertility. The review is presented in question-answer format, referenced for each question series. The recommendations represent a precis of the guidance found using a standardised literature search of national and international guidance notes, consensus statements, health policy documents and evidence-based medicine reviews, supplemented by Medline Embase searches to identify relevant primary research documents. They are not standards but form a guide to be set in the clinical context. Most of them are consensus based rather than evidence based. They will be updated periodically to take account of new information.

National Institute for Health and Clinical Excellence guidelines on preoperative tests: the use of routine preoperative tests for elective surgery.

Clinical Guideline CG3 from the National Institute for Health and Clinical Excellence (NICE) makes recommendations on appropriate clinical practice in preoperative testing for elective surgery. Unfortunately, there is minimal evidence on which the guidelines could be based and therefore they were constructed on the basis of professional opinion. This resulted in the construction of a decision matrix of Byzantine complexity built on foundations of sand: surgical risk is estimated using an unvalidated ad hoc risk estimation method; anaesthetic risk is estimated using the American Society of Anesthesiologists (ASA) risk method that has been demonstrated to be incapable of generating consistent risk assessments. The resultant matrix may be suitable for use as a template for future research, but is extremely complex and inadequately rigorous for routine use.

The role of CA125 in clinical practice.

BACKGROUND: CA125 is a high molecular weight glycoprotein, which is expressed by a large proportion of epithelial ovarian cancers. The sensitivity and specificity of CA125 are poor and there are no guidelines produced by the Royal College of Pathologists or the Association of Clinical Biochemists to aid clinicians and laboratories in its most appropriate use. AIM: To identify the patient population having a CA125 measurement and to determine its contribution to individual patient management. METHODS: A retrospective case note audit looking at patients who had a CA125 measurement performed between April 2000 and April 2002. RESULTS: The study comprised 799 patients; 751 (94%) were female and 48 (6%) male; 221 (29%) females and 22 (46%) males had an abnormal result. CA125 was mainly used to investigate a wide range of signs and symptoms, and few tests were for follow up or screening of ovarian cancer. In female patients having a CA125 for suspicion of malignancy/ovarian cancer, only 39 (20%) of the abnormal results were caused by ovarian cancer. False positive results were largely caused by another malignancy (48 cases; 26%), benign ovarian disease (26 cases; 14%), and benign gynaecological conditions, particularly leiomyomas (18 cases; 9%). The specificity of CA125 for ovarian cancer increased with concentrations >1000 kU/litre. CONCLUSIONS: These results confirm the high false positive rate and poor sensitivity and specificity associated with CA125. The substantial inappropriate usage of CA125 has led to results that are useless to the clinician, have cost implications, and add to patient anxiety and clinical uncertainty.

ACP Best Practice No 181: Chemical pathology clinical investigation and management of nephrolithiasis.

Renal stones have afflicted humans for millennia but there is still no solution to this problem. This review discusses the laboratory and metabolic aspects of the clinical management of patients with renal stones, both primary and secondary in origin. First, non-pharmacological interventions such as increased fluid intake, decreased protein consumption, dietary changes in sodium, calcium, oxalate, potassium, purine, vitamins, and essential fatty acids are considered. Then specific pharmacological treatment to modify urine calcium, oxalate, urate, citrate, and acidity are considered. Finally, more unusual types of stone are examined.

A comparison of algorithms for initiation of lipid lowering therapy in primary prevention of coronary heart disease.

OBJECTIVE: To compare nine different algorithms for determining the necessity for drug treatment of hyperlipidaemia in patients without cardiovascular disease. DESIGN: Risk-factor data on 400 patients were obtained. Algorithms assessed included the Framingham model, National Cholesterol Education Program, European, British, New Zealand, British Regional Heart Study, Sheffield, Munster Heart Study and Dundee guidelines and a local general rule for treatment of atheroma (General Rule to Enable Atheroma Treatment). SETTING: Three hospital lipid clinics. RESULTS: Patients were 56% male, aged 53.8 +/- 12.3 years, 38% smoked, 55% had a family history of disease (37% familial hypercholesterolaemia, 33% hypertension and 5.2% left ventricular hypertrophy); 31% were moderately obese and 15% were diabetic. The average cholesterol level was 7.9 +/- 2.6 mmol/l. Median Framingham risk was 1.66%/year and this risk was > 2%/year for 37% and > 3%/year for 17.5%. Treatment was required for 86% by National Cholesterol Education Program, 70% by General Rule to Enable Atheroma Treatment and European, 61% by New Zealand, 58% by British, 42% by Dundee, 40% by Munster Heart Study, 25% by British Regional Heart Study and 16% by Sheffield guidelines. Algorithms varied regarding recommendations for treatment of men, women, patients with familial hypercholesterolaemia and diabetes. Confounders included risk levels, definitions and weightings for additional risk factors. CONCLUSIONS: Different algorithms vary widely in their predictions of need for drug treatment of this high-risk population with hyperlipidaemia. Authors of guidelines for cardiovascular disease need to unify risk thresholds and definitions and audit the effects of additional weighting factors so that patients can be treated consistently.

Handwashing compliance by health care workers: The impact of introducing an accessible, alcohol-based hand antiseptic.

CONTEXT: Under routine hospital conditions handwashing compliance of health care workers including nurses, physicians, and others (eg, physical therapists and radiologic technicians) is unacceptably low. OBJECTIVES: To investigate the efficacy of an education/ feedback intervention and patient awareness program (cognitive approach) on handwashing compliance of health care workers; and to compare the acceptance of a new and increasingly accessible alcohol-based waterless hand disinfectant (technical approach) with the standard sink/soap combination. DESIGN: A 6-month, prospective, observational study. SETTING: One medical intensive care unit (ICU), 1 cardiac surgery ICU, and 1 general medical ward located in a 728-bed, tertiary care, teaching facility. PARTICIPANTS: Medical caregivers in each of the above settings. INTERVENTIONS: Implementation of an education/ feedback intervention program (6 in-service sessions per each ICU) and patient awareness program, followed by a new, increasingly accessible, alcohol-based, waterless hand antiseptic agent, initially available at a ratio of 1 dispenser for every 4 patients and subsequently 1 for each patient. MAIN OUTCOME MEASURE: Direct observation of hand-washing for 1575 potential opportunities monitored over 120 hours randomized for both time of day and bed locations. RESULTS: Baseline handwashing compliance before and after defined events was 9% and 22% for health care workers in the medical ICU and 3% and 13% for health care workers in the cardiac surgery ICU, respectively. After the education/feedback intervention program, handwashing compliance changed little (medical ICU, 14% [before] and 25% [after]; cardiac surgery ICU, 6% [before] and 13% [after]). Observations after introduction of the new, increasingly accessible, alcohol-based, waterless hand antiseptic revealed significantly higher handwashing rates (P<.05), and handwashing compliance improved as accessibility was enhanced-before 19% and after 41% with 1 dispenser per 4 beds; and before 23% and after 48% with 1 dispenser for each bed. CONCLUSIONS: Education/feedback intervention and patient awareness programs failed to improve handwashing compliance. However, introduction of easily accessible dispensers with an alcohol-based waterless handwashing antiseptic led to significantly higher handwashing rates among health care workers.