Clinical Reliability of point-of-care tests to support community based acute ambulatory care.

OBJECTIVE: To ensure clinicians can rely on point-of-care testing results, we assessed agreement between point-of-care tests for creatinine, urea, sodium, potassium, calcium, Hb, INR, CRP and subsequent corresponding laboratory tests. PARTICIPANTS: Community-dwelling adults referred to a community-based acute ambulatory care unit. INTERVENTIONS: The Abbott i-STATTM (Hb, clinical chemistry, INR) and the AfinionTM Analyser (CRP) and corresponding laboratory analyses. OUTCOMES: Agreement (Bland-Altman) and bias (Passing-Bablok regression). RESULTS: Among 462 adults we found an absolute mean difference between point-of-care and central laboratory analyses of 6.4g/L (95%LOA -7.9 to +20.6) for haemoglobin, -0.5mmol/L (95%LOA -4.5 to +3.5) for sodium, 0.2mmol/L (95%LOA -0.6 to +0.9) for potassium, 0.0mmol/L (95%LOA -0.3 to +0.3) for calcium, 9.0 µmol/L (95%LOA -18.5 to +36.4) for creatinine, 0.0mmol/L (95%LOA -2.7 to +2.6) for urea, -0.2 (95%LOA -2.4 to +2.0) for INR, -5.0 mg/L (95%LOA -24.4 to +14.4) for CRP. CONCLUSIONS: There was acceptable agreement and bias for these analytes, except for haemoglobin and creatinine.

Transaxillary robotic thyroidectomy: Belgian team learning from the first 50 cases.

BACKGROUND: In search for less invasive operative techniques, the da Vinci Robot System was introduced in thyroid surgery. Previous studies have reported on safety, effectiveness and improved cosmetics of transaxillary endoscopic thyroidectomy procedures in selected cases. METHODS: We report on the first 50 patients that have been treated with a gasless transaxillary robot-assisted thyroidectomy in a Belgian institution. We describe the implementation, the operative technique and results of robotic thyroid surgery. RESULTS: 48 hemithyroidectomy and 2 total thyroidectomy procedures were performed. The mean ultrasound dimensions of the nodules were 3.4 ± 1.0 cm (range 1.0-8.0 cm). The mean operative time was significantly longer than with a conventional open approach: 215 min ± 55 min (range 133 min-347 min). No major complications were observed. All patients were "satisfied" about the cosmetic outcome. CONCLUSION: Transaxillary robotic thyroid surgery is demanding, but feasible. Selected patients can benefit from this technique with an optimal cosmetic outcome. Ideal indication in the hand of our team is a hemithyroidectomy for benign nodules ranging up to 5 cm.

Diagnostic accuracy of exercise stress testing for coronary artery disease: a systematic review and meta-analysis of prospective studies.

BACKGROUND: Exercise stress testing offers a non-invasive, less expensive way of risk stratification prior to coronary angiography, and a negative stress test may actually avoid angiography. However, previous meta-analyses have not included all exercise test modalities, or patients without known Coronary artery disease (CAD). METHODS AND RESULTS: We systematically reviewed the literature to determine the diagnostic accuracy of exercise stress testing for CAD on angiography. MEDLINE (January 1966 to November 2009), MEDION (1966 to July 2009), CENTRAL (1966 to July 2009) and EMBASE (1980-2009) databases were searched for English language articles on diagnostic accuracy of exercise stress testing. We included prospective studies comparing exercise stress testing with a reference standard of coronary angiography in patients without known CAD. From 6,055 records, we included 34 studies with 3,352 participants. Overall, we found published studies regarding five different exercise testing modalities: treadmill ECG, treadmill echo, bicycle ECG, bicycle echo and myocardial perfusion imaging. The prevalence of CAD ranged from 12% to 83%. Positive and negative likelihood ratios of stress testing increased in low prevalence settings. Treadmill echo testing (LR+ = 7.94) performed better than treadmill ECG testing (LR+ = 3.57) for ruling in CAD and ruling out CAD (echo LR- = 0.19 vs. ECG LR- = 0.38). Bicycle echo testing (LR+ = 11.34) performed better than treadmill echo testing (LR+ = 7.94), which outperformed both treadmill ECG and bicycle ECG. A positive exercise test is more helpful in younger patients (LR+ = 4.74) than in older patients (LR+ = 2.8). CONCLUSIONS: The diagnostic accuracy of exercise testing varies, depending upon the age, gender and clinical characteristics of the patient, prevalence of CAD and modality of test used. Exercise testing, whether by echocardiography or ECG, is more useful at excluding CAD than confirming it. Clinicians have concentrated on individualising the treatment of CAD, but there is great scope for individualising the diagnosis of CAD using exercise testing.

[Impact of the use of point of care devices on the morbidity and the mortality of patients with oral anticoagulation]. / Impact de l'utilisation de coagulomètres portables sur la morbi-mortalité des patients sous anticoagulants oraux.

The objective of this study is to evaluate the impact of International Normalized Ratio testing by point of care devices, on morbidity and mortality of patients treated with oral anticoagulants, in comparison with usual testing in laboratory.A systematic review of literature is performed. Data from selected trials are summarized in a global meta-analysis and also in subgroups meta-analysis, according to the fact that the user of POC device is the patient himself, with or without personal treatment adaptation, the general practitioner or a health professional in an anticoagulation clinic. Results of the global meta-analysis show a reduction of major thromboembolism and all causes mortality but not of major hemorrhage. Subgroup analysis shows that most favorable results are obtained when patient himself realizes the test and adapts the treatment. Results are compared with those of other published meta-analysis and the limits of results' validity are discussed.

Is the management of thyroid nodules and differentiated thyroid cancer in accordance with recent consensus guidelines? - Results of a national survey.

OBJECTIVE: To assess approaches to patients with a potentially malignant thyroid nodule and patients with differentiated thyroid carcinoma and compare them with the European Consensus and Guidelines by the American Thyroid Association. DESIGN: A survey of the 388 active members of the Belgian Thyroid Club. METHODS: A questionnaire addressing the management of an index case and four clinical variations (including variations in the size of the tumour and histological type). The index case was a 40-year-old euthyroid woman with a 3-cm solitary thyroid nodule. Fine-needle aspiration (FNA) cytology showed cellular aspirates with numerous follicular cells and no colloid. RESULTS: The overall response rate was 41%. For the index case, respondents favoured a right lobectomy. Variations in size and histopathology of the nodule altered the management. In the case of a papillary thyroid carcinoma (PTC) of 3 cm in diameter, a total thyroidectomy and prophylactic central lymph node dissection was preferred. After a lobectomy showing a 3.5-cm follicular thyroid carcinoma (FTC), completion surgery followed by radioiodine administration was the most frequent proposal. For the follow-up of the index case with a low-risk disease, determination of serum thyroglobulin (Tg) after recombinant human TSH (rhTSH) administration was considered by the majority of respondents. For the follow-up of a clinical variation with residual disease, immediate planning of a new treatment was (mistakenly) not considered by a majority of respondents. CONCLUSIONS: In most cases, respondents were in accordance with the guidelines, although there were some unexpected variations.

The evaluation of diagnostic tests: evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed.

OBJECTIVE: Before introducing a test in clinical practice, its characteristics and added value should be assessed. Diagnostic accuracy studies only are not sufficient; the test's impact on patient outcome ought to be assessed as well. To do this, we propose a stepwise evaluation of diagnostic tests. STUDY DESIGN AND SETTING: Theoretical-conceptual approach. RESULTS: First, the test's technical accuracy refers to the ability to produce usable information under standardized conditions. In a second step, the place of the new test in the clinical pathway is determined. Thirdly, the test's diagnostic accuracy is assessed, depending on its intended goal. The fourth step assesses the test's impact on the patient outcome. Depending on the place of the test in the clinical pathway, existing evidence can be used, or new evidence will be needed. At the final step, a cost-effectiveness analysis assesses the test's financial and societal consequences. CONCLUSION: Diagnostic tests evaluation should consider the technical accuracy, the test's place in the clinical pathway, its diagnostic accuracy, and its impact on patient outcome.

Advances in the medical management of differentiated thyroid carcinoma and their impact on the surgical approach.

The introduction of recombinant human TSH and neck ultrasonography has refined the management of differentiated thyroid cancer, leading to the publication of new guidelines by the American Thyroid Association (ATA) and a consensus report by the European Thyroid Association (ETA) in 2006. In this paper, we give an overview of the current medical management of differentiated thyroid cancer (pre-surgical, post-surgical), of how the advances have been integrated into the recent 2006 ATA guidelines and ETA consensus and finally, of the impact on the surgical management (first surgery, treatment of cervical lymph nodes) of differentiated thyroid cancer.

Measuring the body temperature: how accurate is the Tempa Dot?

INTRODUCTION: We evaluated the accuracy of a disposable, sterile thermometer that is practical in use and holds no risk of cross-infections. METHODS: a cross-sectional study was set up in which we compared the Tempa Dot with the mercury thermometer in adults and children. Subjects were recruited from general practice and a paediatric ward. The mercury thermometer was used orally in subjects over 2 years of age and rectally in children up to 2 years old. The Tempa Dot was used either orally or axillary. RESULTS: The total population consisted of 212 patients, of which 131 children were younger than 16 years old. Their mean age was 17.3 years old, ranging from 1 month to 76 years. The mean difference between the mercury thermometer and the Tempa Dot, used orally or axillary, was 0.04 degrees C. For children between 0 and 16 years old, the mean difference was 0.08 degrees C. Agreement between the two methods as assessed with regression analysis and Bland and Altman plots was very good. ROC curve analysis suggests cut-off points of 37.2 and 37.6 degrees C to detect fever for the Tempa Dot at the oral and the axillary site respectively. Sensitivity and specificity were 100.0% and 79.0% for the total population, measuring orally and 100.0% and 95.9% axillary. In children, sensitivity and specificity were 100.0% and 83.1% orally, and 100.0% and 95.4% axillary. Using a single cut-off point for both measuring sites, namely 37.5 degrees C, sensitivity dropped and specificity increased for the oral site. For the axillary site, sensitivity remained unchanged and specificity was somewhat less. CONCLUSION: the Tempa Dot is a reliable alternative for the mercury thermometer. In clinical use, a cut-off point of 37.5 degrees C for both the oral and axillary site is most appropriate.

[From PICO to search terms on the Internet: how to find relevant information? New coxibs: do they have a better gastrointestinal safety?]. / Du PICO aux termes de recherche par Internet: comment accéder à l'information pertinente? Les nouveaux coxibs: ont-ils réellement une meilleure sécurité digestive?

In the first article of this series, we have shown how to translate a clinical problem into a well built question, by creating a PICO (Patient--Intervention--Comparison--Outcome). In this second article, we will explain how to transform the PICO in English search terms for use on the internet. We use these terms in the different databases to find the answer to the following clinical problem: "In patients aged 65 or over with hip osteoarthritis, and a history of peptic ulcer, is the risk of a new peptic ulcer less using a cox-2 inhibitor than with a classic nonsteroidal anti-inflammatory drug?"

[Pharmacological treatment of hypercholesterolaemia in primary prevention. The use of the different sources of information]. / Centre académique de Médecine générale a la Katholieke universitieit van Leuven (KUL).

In the first two articles of this series devoted to Evidence-Based Medicine, we have shown how to translate a clinical problem in a well formulated question and how to derive search terms from the PICO. In this article, we describe in more detail the different sources of information and how to use them. The strategy will be illustrated by answering the question whether it should be recommended to treat hypercholesterolaemia in a young woman without cardiovascular risk factors. In a following article, we will show how to adapt a search strategy to a specific question or PICO.

Cabergoline in the treatment of hyperprolactinemia: a study in 455 patients.

Cabergoline is a new long-acting dopamine agonist that is very effective and well tolerated in patients with pathological hyperprolactinemia. The aim of this study was to examine, in a very large number of hyperprolactinemic patients, the ability to normalize PRL levels with cabergoline, to determine the effective dose and tolerance, and to assess the effect on clinical symptoms, tumor shrinkage, and visual field abnormalities. We also evaluated the effects of cabergoline in a large subgroup of patients with bromocriptine intolerance or -resistance. We retrospectively reviewed the files of 455 patients (102 males and 353 females) with pathological hyperprolactinemia treated with cabergoline in 9 Belgian centers. Among these patients, 41% had a microadenoma; 42%, a macroadenoma; 16%, idiopathic hyperprolactinemia; and 1%, an empty sella. The median pretreatment serum PRL level was 124 microg/L (range, 16-26,250 microg/L). A subgroup of 292 patients had previously been treated with bromocriptine, of which 140 showed bromocriptine intolerance and 58 showed bromocriptine resistance. Treatment with cabergoline normalized serum PRL levels in 86% of all patients: in 92% of 244 patients with idiopathic hyperprolactinemia or a microprolactinoma and in 77% of 181 macroadenomas. Pretreatment visual field abnormalities normalized in 70% of patients, and tumor shrinkage was seen in 67% of cases. Side effects were noted in 13% of patients, but only 3.9% discontinued therapy because of side effects. The median dose of cabergoline at the start of therapy was 1.0 mg/week but could be reduced to 0.5 mg/week once control was achieved. Patients with a macroprolactinoma needed a higher median cabergoline dose, compared with those with idiopathic hyperprolactinemia or a microprolactinoma: 1.0 mg/week vs. 0.5 mg/week, although a large overlap existed between these groups. Twenty-seven women treated with cabergoline became pregnant, and 25 delivered a healthy child. One patient had an intended abortion and another a miscarriage. In the patients with bromocriptine intolerance, normalization of PRL was reached in 84% of cases, whereas in the bromocriptine-resistant patients, PRL could be normalized in 70%. We confirmed, in a large-scale retrospective study, the high efficacy and tolerability of cabergoline in the treatment of pathological hyperprolactinemia, leaving few patients with unacceptable side effects or inadequate clinical response. Patients with idiopathic hyperprolactinemia or a microprolactinoma, on average, needed only half the dose of cabergoline as those with macroprolactinomas and have a higher chance of obtaining PRL normalization. Cabergoline also normalized PRL in the majority of patients with known bromocriptine intolerance or -resistance. Once PRL secretion was adequately controlled, the dose of cabergoline could often be significantly decreased, which further reduced costs of therapy.

Diagnostic fine-needle aspiration cytology and immunocytochemistry analysis of a primary thyroid lymphoma presenting as an anatomic emergency.

The case of a 66-year-old woman with rapidly progressive respiratory distress caused by a massive anterior neck mass with tracheal compression is presented. Within 24 hours, fine-needle aspiration cytology (FNAC) and immunocytochemistry provided a diagnosis of high-grade B-cell lymphoma and the opportunity to institute a chemotherapeutic regimen resulting in a rapid volume reduction and airway expansion. One year after combined modality treatment the patient was in complete remission (with an estimated thyroid volume of 4 cm3). This case report illustrates the advantages of FNAC and immunocytochemistry in the diagnosis of thyroid lymphoma.

[A 35-year-old man with gynaecomastia as the first symptom of hyperthyroidism]. / Een 35-jarige man met gynaecomastie als eerste symptoom van hyperthyreoïdie.

A 35-year-old man suffered painful bilateral gynaecomastia for 2 months due to serious Graves' hyperthyroidism. During treatment with propylthiouracil and levothyroxine, the plasma concentrations of thyroid hormone, sex hormones and sex hormone-binding globulin normalised and the gynaecomastia disappeared. Gynaecomastia occurs in 30 to 40% of men diagnosed with Graves' hyperthyroidism. However, gynaecomastia as a presenting symptom of this autoimmune disease is uncommon.

[EBM: otitis media in children: how to formulate a PICO question]. / Evidence-based medicine. Otite moyenne chez l'enfant. Comment formuler une question PICO?

This series of articles begins with a problem frequently encountered in children: acute otitis media. Under the insistence of parents, antibiotics are frequently prescribed. The physician knows that the value of that therapy is debatable, but what for a child of 6 years of age? The physician whishes to compare his/her opinion with what is published in the litterature or available on the web. How to start his/her research? In this first article the physician will find out how to translate his/her practical question into a question which leads to a practical answer, and then to a PICO question. This will allow the physician to find sources of directly usable and relevant data which will offer a rational and wellfounded answer to his/her clinical question.

Systematic review and validation of prediction rules for identifying children with serious infections in emergency departments and urgent-access primary care.

BACKGROUND: Although the vast majority of children with acute infections are managed at home, this is one of the most common problems encountered in children attending emergency departments (EDs) and primary care. Distinguishing children with serious infection from those with minor or self-limiting infection is difficult. This can result in misdiagnosis of children with serious infections, which results in a poorer health outcome, or a tendency to refer or admit children as a precaution; thus, inappropriately utilising secondary-care resources. OBJECTIVES: We systematically identified clinical features and laboratory tests which identify serious infection in children attending the ED and primary care. We also identified clinical prediction rules and validated those using existing data sets. DATA SOURCES: We searched MEDLINE, Medion, EMBASE, Cumulative Index to Nursing and Allied Health Literature and Database of Abstracts of Reviews of Effects in October 2008, with an update in June 2009, using search terms that included terms related to five components: serious infections, children, clinical history and examination, laboratory tests and ambulatory care settings. We also searched references of included studies, clinical content experts, and relevant National Institute for Health and Clinical Excellence guidelines to identify relevant studies. There were no language restrictions. Studies were eligible for inclusion if they were based in ambulatory settings in economically developed countries. REVIEW METHODS: Literature searching, selection and data extraction were carried out by two reviewers. We assessed quality using the quality assessment of diagnostic accuracy studies (QUADAS) instrument, and used spectrum bias and validity of the reference standard as exclusion criteria. We calculated the positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of each feature along with the pre- and post-test probabilities of the outcome. Meta-analysis was performed using the bivariate method when appropriate. We externally validated clinical prediction rules identified from the systematic review using existing data from children attending ED or primary care. RESULTS: We identified 1939 articles, of which 35 were selected for inclusion in the review. There was only a single study from primary care; all others were performed in the ED. The quality of the included studies was modest. We also identified seven data sets (11,045 children) to use for external validation. The most useful clinical features for ruling in serious infection was parental or clinician overall concern that the illness was different from previous illnesses or that something was wrong. In low- or intermediate-prevalence settings, the presence of fever had some diagnostic value. Additional red flag features included cyanosis, poor peripheral circulation, rapid breathing, crackles on auscultation, diminished breath sounds, meningeal irritation, petechial rash, decreased consciousness and seizures. Procalcitonin (LR+ 1.75-2.96, LR- 0.08-0.35) and C-reactive protein (LR+ 2.53-3.79, LR- 0.25-0.61) were superior to white cell counts. The best performing clinical prediction rule was a five-stage decision tree rule, consisting of the physician's gut feeling, dyspnoea, temperature ≥ 40 °C, diarrhoea and age. It was able to decrease the likelihood of serious infections substantially, but on validation it provided good ruling out value only in low-to-intermediate-prevalence settings (LR- 0.11-0.28). We also identified and validated the Yale Observation Scale and prediction rules for pneumonia, meningitis and gastroenteritis. LIMITATIONS: Only a single study was identified from primary-care settings, therefore results may lack generalisability. CONCLUSIONS: Several clinical features are useful to increase or decrease the probability that a child has a serious infection. None is sufficient on its own to substantially raise or lower the risk of serious infection. Some are highly specific ('red flags'), so when present should prompt a more thorough or repeated assessment. C-reactive protein and procalcitonin demonstrate similar diagnostic characteristics and are both superior to white cell counts. However, even in children with a serious infection, red flags will occur infrequently, and their absence does not lower the risk. The diagnostic gap is currently filled by using clinical 'gut feeling' and diagnostic safety-netting, which are still not well defined. Although two prediction rules for serious infection and one for meningitis provided some diagnostic value, we do not recommend widespread implementation at this time. Future research is needed to identify predictors of serious infection in children in primary-care settings, to validate prediction rules more widely, and determine the added value of blood tests in primary-care settings. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Occult ectopic ACTH secretion due to recurrent lung carcinoid: long-term control of hypercortisolism by continuous subcutaneous infusion of octreotide.

We report on a woman with clinical Cushing's syndrome confirmed by biochemical data. The Cushing's syndrome was shown to be ACTH dependent and inferior petrosal sinus sampling pointed to an ectopic source. After resection of a lung carcinoid a well documented remission of Cushing's syndrome was obtained. At recurrence of Cushing's syndrome 18 months later the ACTH source could not be located despite extensive diagnostic procedures. Clinical and biochemical control of hypercortisolism was achieved by continuous subcutaneous infusion of octreotide. During a brief interruption of treatment recurrence of clinical and biochemical signs and symptoms of Cushing's syndrome were demonstrated. We conclude that in this case of occult ectopic ACTH secretion, presumably due to recurrent lung carcinoid, continuous subcutaneous infusion therapy with octreotide resulted in clinical and metabolic control of Cushing's syndrome for 8 years. In addition excellent tumour growth control was achieved as repeated searches for tumour recurrence or metastasis remained negative.

CUGE: a screening instrument for alcohol abuse and dependence in students.

OBJECTIVES: The prevalence of alcohol abuse on college campuses ranges from 7 to 17%. Frequent heavy drinkers place themselves and others at risk for a variety of adverse consequences and frequently remain undetected. Brief individual interventions result in a significant reduction on the number of drinks. Therefore, detection of students at risk is useful and desirable. The CUGE has been elsewhere described as a promising screening device for problem drinking in students. In order to determine the diagnostic value of this new questionnaire, we set up a validation study in a new and independent population of freshmen. METHODS: A cross-sectional diagnostic study. Participants were college freshmen of the Katholieke Universiteit Leuven. All students received a questionnaire, containing the CUGE, being the test of interest, and the CIDI as the reference test. RESULTS: The CUGE combines a very high sensitivity of 91% with a reasonable specificity of 76.3% in this validation group. CONCLUSIONS: The CUGE is an excellent screening device in this population of students. In addition, it is a short questionnaire with only yes or no questions. This makes the CUGE easily applicable as a part of broad routine questionnaires.