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Interpretation of diagnostic data: 3. How to do it with a simple table (part B).

The following guidelines are useful if you want to "do it with a simple table" (Table IV): First, identify the sensitivity and specificity of the sign, symptom or diagnostic test you plan to use. Many are already in the literature, and subspecialists should either know them for their field or be able to track them down for you. Depending on whether you are considering a sign, a symptom or a diagnostic laboratory test, you will want to track down a clinical subspecialist, a radiologist, a pathologist and so on. Start your table with a total of 1000 patients, as shown in location (a + b + c + d) of panel A. Using the information you have about the patient before you apply the diagnostic test, estimate the patient's pretest likelihood (prevalence or prior probability) of the target disorder -- let's say 10%. Take this proportion of the total (100) and place it in location (a + c); the remaining 900 patients go in location (b + d) (panel B). Multiply (a + c) (100) by the sensitivity of the diagnostic test (let's say 83%) and place the result (83) in cell a and the difference (17) in cell c; similarly, multiply (b + d) (900) by the specificity of the diagnostic test (let's say 91%) and place the result (819) in cell d and the difference (81) in cell b (panel C). If (a + b) and (c + d) do not add up to 1000, you will know you have made a mistake. You can now calculate the positive predictive value, a/(a + b), and the negative predictive value, d/(c + d), as shown in panel D. You have now reached a level of understanding a fair bit beyond the rule-in/rule-out strategy discussed in part 1 of our series. Furthermore, you can already do more than most clinicians, so you may want to stop here, at least for a while. On the other hand, you may want to go further and learn how to handle slightly more complex tables with multiple cut-off points. In the next article you will find more powerful ways to take advantage of the degree of positivity and negativity of diagnostic test results.

Decision Making↗

Therapy evaluation and diagnostic accuracy in neuroendocrine tumours: assessment of radiological methods.

The diagnostic accuracy of ultrasonically guided biopsy-gun biopsies was assessed in a group of 47 patients with suspected pancreatic carcinoma. A correct diagnosis with the aid of biopsy was obtained in 44 of the 47 patients (94%). In 3 patients with a carcinoma of the pancreas the correct diagnosis was not obtained with the first biopsy. In 2 of these 3 patients, a simultaneous biopsy of a liver metastasis revealed the presence of malignant tumour growth. No major complications occurred. Biopsy-gun biopsy of the pancreas is considered a useful, reliable and non-traumatic method for the diagnosis of pancreatic malignancy. Twenty-five patients with known neuroendocrine tumour disease were biopsied with 1.2 mm and 0.9 mm biopsy-gun needles to evaluate the respective diagnostic accuracy of the 2 needle sizes. The influence of treatment-related fibrosis on the histopathological diagnosis was also evaluated. The overall diagnostic accuracy with the 0.9 mm needle was 69% as compared to 92% with the 1.2 mm needle. This difference, however, seems more related to needle guiding difficulties with the 0.9 mm needle than to insufficient tissue yield. The increased amount of fibrous tissue due to interferon treatment did not seem to negatively influence the diagnostic accuracy. In order to assess the diagnostic accuracy rate for radiologists with different experience of biopsy procedures 175 cases of renal biopsy-gun biopsies were evaluated. No statistical significant difference was found between the different operators. Provided with detailed instruction even operators with limited experience produced biopsy results equal to those of operators with extensive practice in ultrasound-guided biopsies. The automated sampling performance of the biopsy-gun, with a consistent high diagnostic sampling rate (96%), was believed to be responsible for these results. The role of duplex Doppler ultrasound in monitoring interferon treatment-related changes in carcinoid metastases was evaluated. The patients were divided into 4 groups: untreated (n = 10), progressive disease (n = 17), stable disease (n = 20) and objective response (n = 18). No significant differences in Doppler values were found between the groups, and at present duplex Doppler ultrasound does not seem to play a role in the evaluation of tumour therapy in carcinoid patients.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

[A study of diagnostic scale in borderline personality disorder that was synthesis of symptomatic and personality structural element].

The diagnostic criteria for BPD such as the DSM-III(-R) and DCR, based on polythetic format for prototypal categories, has not always been able to result in accurate clinical diagnosis of BPD. Reasons posited for this were that DSM-III(-R) criteria consist of symptom items based on descriptive phenomenology, even for Axis II personality diagnosis, and that descriptions of the criteria were vague because of the standardization of vocabulary which aimed at improved inter-rater reliability. With the polythetic "yes/no" format, diagnosis was influenced by the determination of only one item; furthermore, different combinations of items yielding a heterogeneous membership might lead to the same diagnosis. It was, therefore, considered difficult to perform an accurate diagnosis of BPD in clinical practices using the existing general diagnostic criteria, and it was realized that the development of new diagnostic criteria for BPD was necessary. For those reasons, we generated a Clinical BPD Scale (CBS) as diagnostic evaluation scale of BPD with considering advantages for clinical use. This reconstituted some features of BPD which have been reported by many researchers, synthesizing symptomatic elements and personality structural elements. CBS is composed of four clusters, Two of these four clusters are evaluated by four grade anchor points which are provided for the rating of the severity of symptoms, and that are illustrated on the radarchart for comprehensive evaluation of the severity of the disorder. CBS was confirmed to have a high degree of validity, and achieved a satisfactory degree of inter-rater reliability by ANOVA ICC, and it has been found in application of CBS to several cases in the clinical practice that the degree of severity of each symptom could be clarified and differential diagnosis was possible with this diagnostic scale. Furthermore, the outcome of treatment could be confirmed at any time during the clinical follow up. In addition, through the dimensions, it is possible to grasp the severity, and further, through spectrum and hierarchy. We considered diagnostic area of BPD and its position by CBS correlating the other closely related disorders.

Borderline Personality Disorder↗

[Thallium-dipyridamole in acute myocardial infarction treated by thrombolysis: diagnostic and prognostic value].

BACKGROUND: The management of patients who received thrombolytic therapy for acute myocardial infarction is still controversial. It is not clear if the strategies usually followed after myocardial infarction for risk stratification have the same value when applied to patients treated with thrombolysis. METHODS: To assess the diagnostic and prognostic value of dipyridamole thallium-201 scintigraphy in the "thrombolytic era", we studied 110 consecutive patients younger than 75 recovering from first uncomplicated acute myocardial infarction treated with thrombolytic agents. Patients with early angina, recurrent acute myocardial infarction, heart failure, life-threatening arrhythmias, non Q wave myocardial infarction were excluded. Ninety patients were treated with streptokinase, 14 with rtPA, 6 with APSAC: All patients underwent dipyridamole thallium scintigraphy with standard dose and coronary angiography before discharge (10-20 days). Ninety-nine patients underwent exercise test. All patients were followed-up for 22 +/- 9 months (range 8-42). Perfusion abnormalities were classified as reversible (totally or partially) defects or persistent defects and within or outside the infarct zone. RESULTS: Fifty-eight patients developed anterior and 52 inferior acute myocardial infarction. Coronary angiography showed single vessel coronary artery disease in 66 patients, multivessel disease in 34, and normal coronary arteries or sub-critical stenosis in 10. No major complications (death, myocardial infarction, threatening arrhythmias, prolonged severe hypotension) occurred after dipyridamole infusion. Sixty-two patients had reversible perfusion defects at thallium scanning (34 within the infarct zone, 21 within and outside the infarct zone, 7 outside); 38 patients had persistent defects; 10 patients had a normal scintigraphic pattern. The diagnostic value of homozonal perfusion reversible defects for identifying a patent infarct-related vessel was poor (sensitivity 69.7%, specificity 64.7%). The diagnostic values of the same scintigraphic pattern improved in detecting patent infarct-related artery with residual critical stenosis (sensibility 75.4%, specificity 77.3%); in all the false positive cases (reversible defects within the infarct zone and occluded infarct-related artery) a good collateral flow was present. The sensitivity of reversible defects outside the infarct zone in detecting multivessel disease was 64.7% vs 56.3% of exercise test; the specificity was 92% vs 64%; the positive predictive value 78.6% vs 44%; the negative predictive value 85.3% vs 74.5%; the diagnostic accuracy 83.6% vs 61.4%. During the follow-up 2 deaths, 7 recurrent myocardial infarction, 1 sustained ventricular tachycardia, 1 heart failure, 13 recurrence of unstable angina and 9 revascularization procedures occurred among patients with reversible defects (either within or outside the infarct zone) at thallium scanning. One recurrent myocardial infarction, 4 recurrence of unstable angina and 2 revascularization procedures were the events among patients with persistent defects or normal scintigraphic pattern (p < 0.001). Ischemic events occurred with similar frequency in patients with reversible perfusion defects within the outside the infarct zone (55% vs 50%, NS). CONCLUSIONS: Dipyridamole thallium-201 scintigraphy performed after uncomplicated myocardial infarction treated with thrombolytic agents is a valuable diagnostic tool in identifying viable jeopardized myocardium within the infarct zone perfused by a patent but critically narrowed vessel; it shows better diagnostic accuracy in detecting multivessel disease than does the exercise test and is able to identify a subset of patients at risk for future ischemic events after thrombolytic therapy.

Adult↗

Barium enema as a diagnostic aid in children with abdominal pain.

Diagnostic barium enema is not a substitution for well executed physical examination, and its use should be reserved only for obscure situations. An abnormal roentgenogram provides valuable information, since the fear of missing acute appendicitis in these children is minimized. When normal, this diagnostic test may bring to early operation those with minimal symptoms or unusual presentations, thus avoiding the possibility of prolonged observation and perforation. In children with known associated severe medical maladies, diagnostic barium enema can serve to reaffirm the diagnosis prior to the hazardous operative intervention. It may also eliminate the need for operation in those conditions which mimic acute appendicitis. The use of diagnostic barium enema in the past three and a half years significantly improved our diagnostic capabilities in children with abdominal pain. There was a corresponding reduction in the number of normal appendixes removed. The efficancy and, above all, the safety of this procedure make it a valuable diagnostic aid in the care of children.

Abdomen↗

Cost-effectiveness analysis of various strategies in the diagnostic management of pulmonary embolism.

BACKGROUND: Since the clinical diagnosis of pulmonary embolism is unreliable, various objective diagnostic methods (or combinations thereof) are advocated. Pulmonary angiography is the accepted reference method but is considered less suitable for initial screening due to its invasive nature. Therefore, at least nine different diagnostic management strategies employing invasive and noninvasive diagnostic tests are used in clinical practice. We assessed the cost-effectiveness of these strategies to help identify the optimal approach. METHODS: Based on assumptions derived from published data, we calculated mortality, morbidity, adequacy for the indication of anticoagulant therapy, and associated diagnostic and therapeutic costs using a decision analytic model. Additionally, a cost-effectiveness analysis was performed using incremental costs per additional life saved. RESULTS: The analysis identified three separate categories of diagnostic management strategies: (1) Treatment of all patients (or of those with an abnormal perfusion scan) results in the lowest mortality and morbidity rates but the highest costs due to inappropriate treatment of 55% to 70% of patients. (2) Pulmonary angiography strategies with or without prior perfusion-ventilation lung scintigraphy and ultrasonography of the legs have comparable low mortality and morbidity rates, costs savings of approximately 40%, and inappropriate treatment in fewer than 5% of patients. (3) Use of perfusion-ventilation scintigraphy with or without ultrasonography results in unacceptably high mortality rates. CONCLUSIONS: At present, the optimal diagnostic management strategy should include pulmonary angiography. Use of perfusion-ventilation lung scintigraphy and ultrasonography results in a 40% to 50% reduction in the number of patients requiring pulmonary angiography and is cost-effective.

Angiography↗

[Comparative study of diagnostic standards of eye-signs in blood stasis syndrome and of blood stasis syndrome].

By virtue of a diagnostic study of 781 cases on the basis of six standards, it was shown that for the effectiveness in diagnostic positive rate, sensitivity, specificity, false positive rate, false negative rate and comprehensive scoring, the International Diagnostic Standards for Blood Stasis Syndrome (BSS) and Chinese Diagnostic Standards for BSS were the best ones, BSS Eye-Signs and Japanese BSS Diagnostic Standards were the second, trial program of International Stasis Diagnostic Standards and Zhongshan's BSS tenderness points came the third. Each standard has its unique advantage and therefore, we should take the other's advantage to offset one's weakness. The causes of their weakness have been discussed and the rational recommendation for their application has been proposed.

Blood Viscosity↗

A decision support system for diagnostic consultation in laboratory tests.

1. INTRODUCTION. In primary care, the appropriate selection of test items is needed for correct diagnosis; it is also needed from the point of view of cost effectiveness. Thus, the Japan Society of Clinical Pathology recommended screening test items in clinical medicine [1]. In this study, we developed a microcomputer-based decision support system using these screening items to guide general medical practitioners to a correct interpretation of the results of laboratory tests. 2. SYSTEM Configuration The current version of the decision support system is designed to be run on PC-9821Bp (486 NEC computer) under the Window 3.0 environment. The input parameters are 26 essential items of laboratory tests, including urinalysis, fecal occult blood, hematological, and biochemical and serological tests recommended by the Japan Society of Clinical Pathology. The support system is composed of two processes. Firstly, the system can output any of the following diagnostic categories: 1) inflammatory disease, 2) muscular or myocardial disease, 3) anemia, 4) malignant tumor, 5) reno-urinary disease, 6) hepatobiliary disease, 7) diabetes mellitus, 8) gastrointestinal disease, 9) bone disease, 10) hyperlipidemia, and 11) normal. In the next step, the system can output some recommendations as to what minimum tests or what maneuver must be done to reconfirm the final diagnosis. The diagnostic part of the program uses decision-tree logic. 3. RESULTS. The subjects were 219 patients who were admitted to the Nagoya University Hospital; the diagnostic categories had been already confirmed. In each diagnostic category, 10-20 cases of infectious disease, 34 of 74 cases of malignant disease, 2 of 6 cases of muscular disease, 14 of 14 cases of anemia, 2 of 16 cases of malignant tumor, 42 of 55 cases of reno-urinary disease, 8 of 14 cases of diabetes mellitus, 9 of 20 cases of gastrointestinal disease, 3 of 26 cases of bone disease, and 14 of 18 cases of hyperlipidemia were correctly diagnosed using the first step of this system. 4. DISCUSSION. This diagnosis supporting system was very efficient for screening anemia, reno-urinary disease, diabetes mellitus, and hyperlipidemia. If this system is combined with information from disease history and physical examination, the diagnosis will be both easy and enhanced. Since the system can suggest effective tests to pinpoint the disease, unnecessary tests will be avoided. Lower diagnostic accuracy was seen in infectious disease, malignant tumor, muscular disease, and bone disease. For these diagnostic categories, additional items are necessary. In conclusion, basic tests are very useful for screening anemia, reno-urinary disease, diabetes mellitus, and hyperlipidemia; the system can provide the minimum and correct test items for diagnosis in primary care.

Clinical Laboratory Techniques↗

[An opinion regarding diagnostic radiology in new century].

I. Technology of diagnostic radiology of the chest on next century I received and discussed concerning following subjects: 1) Dose analogue images remain on next century? 2) Progress and quality of digital images. 3) Expectation of progress of CT, MR and RI on the chest. 4) Application of monochromatic X-ray for the diagnostic imaging. For the radiologists, it is very important to assess the clinical usefulness of each diagnostic modality and form consensus development annually. II. Radiologist in the next century In accordance with the progress of technology of diagnostic radiology, it is very important to know what radiologists should do in the next century. Many referring physicians may perform not only the X-ray examinations but also therapy by themselves to ensure quality and save time from the view point of patient's benefit. Besides diagnostic imaging technologies are very attractive to them. From this point of view, radiologist should see patients and grasp the clinical data of the patients and, of course, interpret diagnostic images which were ordered by themselves. And if possible, they should treat and take care the patients. To survive in the next century, radiologist must focus on an clinical relevance and subspecialization, either by organ group or by technology. In my opinion, organ group specialization seems more useful than subspecialization according to technologies. It is considered to be a survival tactics in next century that we radiologists should band together.

Forecasting↗

A review of diagnostic ultrasound of the spine and soft tissue.

BACKGROUND: Current medical applications for diagnostic ultrasound are numerous. The technology is attractive because of its ease of use, noninvasive nature and low cost. Recent technological advances have improved ultrasound images of spine-related soft tissues. OBJECTIVE: To examine and summarize the spine-related diagnostic ultrasound literature to help aid in understanding its possible applications. DATA SOURCES: This literature search was part of a larger search in which several hundred musculoskeletal diagnostic ultrasound articles were collected. MEDLINE from 1970 to present was searched electronically. Chiropractic Research Archives Collection (Vol. I-IV) were inspected manually. Bibliographies and references from studies obtained were examined thoroughly for additional references. DATA SYNTHESIS: All articles related to diagnostic ultrasound and its spinal applications were collected and reviewed, except those focusing on intraoperative spinal ultrasound in neurosurgery. RESULTS: Ultrasound has long been used to measure the spinal canal, detect cord abnormalities and examine soft tissue abnormalities. Recently, it has been used to quantify scoliotic curves, measure multifidus muscle size and image sciatic nerve lesions. CONCLUSION: Several well-documented applications of spine-related diagnostic ultrasound, along with many new possible applications, make this technology important to any clinician interested in noninvasive diagnostic applications for the spine and soft tissue.

Bone Density↗

Diagnostic laparoscopy: indication and benefit.

BACKGROUND: Patients with an obscure and unrelievable abdominal condition may be forced to receive open laparotomy for diagnosis. Diagnostic laparoscopy has been suggested as an alternative to diagnostic laparotomy in selected cases. The aim of this article is to evaluate the circumstances suitable for laparoscopic diagnosis of certain abdominal conditions and the possible advantages of that approach. METHODS: Among 256 patients undergoing elective laparoscopic operations using conventionally pneumoperitoneal techniques from January 1994 to June 1995, twenty patients received diagnostic laparoscopy. The correlation between preoperative diagnosis, laparoscopic diagnosis and pathologic diagnosis as well as the outcome of laparoscopic diagnosis and treatment have been assessed. RESULTS: Major indications for diagnostic laparoscopy included acute abdominal pain (n = 4), chronic abdominal pain (n = 6), differentiating intraabdominal tumor (n = 4), staging known malignancy (n = 3) and evaluating intraperitoneal implantation (n = 3). Two of the four patients with acute abdominal conditions, one of the six patients with chronic abdominal pain. Four of the seven patients with undifferentiated/unstaged abdominal tumors and all of the three patients with intraperitoneal-implanted drainage tubes had no reasons for a further exploratory procedure, thus preventing the morbidity or mortality which might occur after unnecessary laparotomy. The duration of operation and hospitalization was shorter than the group without laparotomy. CONCLUSIONS: Diagnostic laparoscopy benefits patients by avoiding unnecessary surgery, avoiding unnecessary delay in diagnosis and treatment and shortening the operative and hospitalized period. However, it provides only an alternative not a substitute for traditional diagnostic procedures and will never lessen the importance of conventional laparotomy.

Abdomen, Acute↗

Projecting corporate health plan utilization and charges from annual ICD-9-CM diagnostic rates: a value-added opportunity for pathologists.

OBJECTIVE: To develop an allocation method for corporate health plan resources and expenditures based on annual International Classification of Disease, 9th revision, Clinical Modification (ICD-9-CM) diagnostic rate stratification as a surrogate for disease incidence. DESIGN: A data-mining process was applied to a self-insured corporate health plan database. Annual membership rates of Current Procedural Terminology (CPT) procedure utilization and charges between 1990 and 1994 for a cohort of 7216 continuously employed plan members were stratified according to the annual rates of the 19 major ICD-9-CM diagnostic classifications. The stratified annual CPT utilization and charge rates were analyzed by correlation analysis and one-tailed t test. RESULTS: Laboratory and pathology procedure utilization and charge rates were highly correlated with specific rankings of ICD-9-CM diagnostic classifications. The health plan diagnostic rate, laboratory utilization rate, and all charge rates increased significantly during the 5 study years. CONCLUSION: Although all procedure utilization and charge rates in this health plan increased each year, their proportionality consistently was maintained among diagnostically related groups of patients. By restraining global expenditures, managed health plans conflict with historical utilization and charge patterns. Treating ICD-9-CM diagnostic groups as disease management services within a managed care plan allows procedures and expenses to be allocated according to medical necessity in the context of total membership benefits. For pathologists, who recently were mandated by the Health Care Financing Administration and the Office of Inspector General of the Department of Health and Human Services to become stewards of ICD-9-CM coding, this is a unique opportunity to lead an initiative to perfect managed care. The process will require permanent patient numbers, computerized longitudinal patient records, and standardized coded medical terminology.

Adult↗

[Optimization and diagnostic accuracy of computerized tomography with tridimensional spiral technique in the study of craniostenosis].

INTRODUCTION: Conventional Computed Tomography (CT) with three-dimensional (3D) reconstructions is considered the most complete and accurate imaging modality to diagnose craniosynostosis. However, the introduction of Spiral CT (SCT) opened new possibilities for 3D studies of the skull in pediatric patients with craniosynostosis. The purpose of our study is two fold: first, to optimize the scanning and imaging parameters to obtain diagnostic images in a single spiral scan; second, to assess the diagnostic accuracy of such images in the identification of normal and abnormal cranial vault sutures. MATERIAL AND METHODS: Seventy-eight pediatric patients (age range: 1-35 months; mean: 11.8 months) with craniosynostosis were submitted to SCT of the head. The images were acquired with the following parameters: 3- and 5-mm nominal slice thickness, 5-6 mm/s table feed (pitch 1-2), 165 mAs and 120 kV. Two different algorithms and increases were used for image reconstructions. A first set of images was reconstructed with 2-mm increases and a soft tissue algorithm: these images were used for brain studies and for 3D reconstructions. A second set of slices was reconstructed with 5-mm increases and a bone algorithm to visualize the sutures of the axial plane. The 3D images were processed with the Shaded Surface Display software with threshold values ranging 120-150 HU. All images were acquired with a single spiral scan lasting less than 30 seconds. Two blinded radiologists analyzed the 3D and the planar images independently to evaluate the course and depth of each cranial suture. The sensitivity, specificity and diagnostic accuracy of both 3D and planar SCT images were evaluated. The frequency of artifacts (the Lego effect, boiled egg, pseudoforamina, movement, and chainsaw artifacts) and their influence on the final diagnosis were studied on 3D SCT images. RESULTS: The diagnostic accuracy rates of 3D SCT images, by suture, were: sagittal 90.7%, metopic 100%, left lamboid 90.9%, right lamboid 93.9%, left coronal 85.7%, right coronal 91.1%. The diagnostic accuracy rates of the axial images, by suture, were: sagittal 90.7%, metopic 95.5%, left lamboid 86.4%, right lamboid 90.9%, left coronal 83.7%, right coronal 91.1%. The interobserver agreement on 3D images was: sagittal 91.1%, metopic 100%, left lamboid 88.9%, right lamboid 91.1%, left coronal 88.9%, right coronal 84.4%. The Lego effect artifact was the most frequent one (82%) and affected image evaluation in 6.3% of cases. CONCLUSIONS: Our results prove that 3D SCT is a very accurate technique for identifying normal and abnormal sutures and presents many advantages over conventional 3D CT in the examination of pediatric patients with craniosynostosis. The quality of 3D SCT images was adequate and the artifacts did not affect the final diagnostic yield significantly.

Child, Preschool↗

Clinical approach to the diagnostic evaluation of progressive neuromuscular diseases.

This article has reviewed the clinical approach to the diagnostic evaluation of progressive neuromuscular diseases with an emphasis on relevant neuromuscular history, family history, clinical examination findings, laboratory studies, and a brief discussion of the role of muscle biopsy. Molecular genetic and immunocytochemistry studies of muscle have been major advances in the diagnostic evaluation of the neuromuscular disease patient; however, all diagnostic information must be interpreted within the context of relevant clinical information. In some instances, a precise diagnosis is not medically possible; however, the accurate characterization of an individual patient within the most appropriate NMD clinical syndrome often allows the clinician to provide the patient and family with accurate prognostic information and anticipatory guidance for the future. After synthesizing all available clinical and diagnostic information, the physiatrist or neurologist may at times determine that an NMD patient has an inappropriate diagnosis warranting further diagnostic evaluation. This issue focuses on the rehabilitation of progressive neuromuscular diseases with an emphasis on optimization of health, prevention or minimization of complications, and enhancement of quality of life. Appropriate rehabilitation approaches require an accurate diagnosis. In addition, patient quality of life in NMD depends on access to current and accurate information. The first step in providing accurate information and appropriate treatment is constantly ensuring that NMD patients have appropriate diagnoses based on a through evaluation of clinical information and appropriate application of current medical science and available diagnostic technology.

Biopsy↗

[A project for the organization and planning of a diagnostic ultrasonography area at a radiology department].

PURPOSE: The increasing use of ultrasound (US) for both diagnostic and interventional procedures has not been supported yet by proper and adequate planning of dedicated rooms. Therefore we studied both the organization and the design of such areas. METHODS AND DISCUSSION: As for organization, we considered: a) the kind of examination performed; b) the main department activity (in-/outpatients, diagnostic or interventional procedures); c) the schedule for each room by examination type and timing (patient preparation, actual examination and read-out times). As for room design, we studied the size and location of the diagnostic unit, dressing rooms, entrances and restrooms, as well as the furniture in general. We also studied the location of waiting rooms and corridors, the location and size of the read-out areas, and the room for post-interventional monitoring, as well as all the details about microclimate and lighting. Then we designed two different modules with the relevant planimetry: one featuring two adjacent diagnostic rooms and the other featuring a single diagnostic room. Some ergonomic solutions are also proposed concerning the location of the US system relative to the stretchers entrance and the location of the post-interventional monitoring room relative to the radiologic room(s). Finally, we evaluated the size of some peculiar pieces of equipment of a radiologic room by their function. CONCLUSIONS: The functional arrangement of the diagnostic US unit and its space requirements, permits to optimize the use of the whole structure complying with the ergonomic criteria for operators and enabling the rapid throughout of patients with no waste of time.

Hospital Design and Construction↗

Diagnostic laparoscopy.

Diagnostic laparoscopy began in a surgical unit in a developing country in 1972. The developers of this technique aimed to hasten diagnosis, reduce patient distress, and improve bed utilization in an overcrowded teaching hospital wherein simple investigations such as x-rays took weeks to materialize. Over a period of 18 years reaching to 1990, 3,200 diagnostic laparoscopies were performed on adults under local anesthesia with no mortality, a complication rate of 0.09%, an 84% diagnosis rate, and 74% undergoing histologic biopsies targeting a wide spectrum of pathology. The equipment cost spread out over the 3,200 patients works out to 30 rupees (0.60 dollar) per patient. With the availability of noninvasive diagnostic aids such as ultrasound, computed tomography, and magnetic resonance imaging used US, CT, MRI under the control of target biopsy, the role of diagnostic laparoscopy has altered. Since 1990, clinicians have had the sophistication of the video camera and the pneumoperitoneum insufflator. Diagnostic laparoscopy is used for the evaluation of liver and peritoneal pathology, abdominal tuberculosis, malignancy, acute abdomen, and abdominal trauma. It often is a prelude to laparoscopic treatment of the underlying pathology, specifically in cases of acute appendicitis.

Abdomen, Acute↗

Overview of marker vaccine and differential diagnostic test technology.

Recent advances in molecular biology, immunology, microbiology, genetics and microbial pathogenesis have lead to the development of a wide variety of new approaches for developing safer and more effective vaccines based on designs such as subunit vaccines, gene deleted vaccines, live vectored vaccines, and DNA mediated vaccines. Technology tools can be as basic as identifying naturally occurring strains with deletions that support differentiating infected from vaccinated animal (DIVA) needs or be based on higher technology developments such as improved protein expression and purification methods, transgenic plant- and plant virus-based antigen production, and novel adjuvants that target specific immune responses. These new approaches, when applied to the development of marker vaccines and companion diagnostic test kits hold tremendous potential for developing improved tools for eradication and control programs. Marker vaccines and companion diagnostic test kits must meet the established licensing requirements for purity, potency, safety and efficacy. Efficacy claims are based on evaluation of the level of protection demonstrated in host animal trials and may range from "prevents infection with (a specific agent)", to "for use as an aid in the reduction of disease due to (a specific agent)." The differences in claims and recommendations are a function of the variation in protection elicited by various vaccines. For designing effective eradication programs, vaccine efficacy characteristics such as for reducing susceptibility to infections and spread of infections must be well defined; similarly, diagnostic test performance characteristics (efficacy) must be determined. In addition to data to support efficacy claims, it is imperative that safety of production and use of vaccines be evaluated. During the design of marker vaccines and diagnostic tests, it is important to consider the application of appropriate technologies to improve the safety of these products. Use of recombinant technologies for production of vaccines and/or diagnostic test antigens can reduce the biosafety concerns during production and during use, including human exposure to zoonotic pathogens during production and use, and potential spread of foreign animal disease agents due to loss of biocontainment. In addition, vaccines may induce adverse reactions. It is important to determine the frequency of adverse events and to reduce the likelihood of induction of adverse reactions through proper design.

Animals↗

Adrenal incidentaloma--experience of a standardized diagnostic programme in the Swedish prospective study.

OBJECTIVE: To report the 5-year experience of a diagnostic programme for adrenal incidentaloma with special emphasis to diagnose hormonally active and malignant lesions. DESIGN: A prospective study in which new cases of adrenal incidentalomas in Sweden have been evaluated by a standardized diagnostic protocol between January 1996 and July 2001. SETTING: Thirty-three different Swedish hospitals have contributed with cases. SUBJECTS: A total of 381 patients (217 females, 164 males) with adrenal incidentalomas were studied. INTERVENTIONS: Diagnostic procedures were undertaken according to a standardized programme. Operation was recommended if the incidentaloma had a size of more than 3-4 cm or if there was a suspicion of a hypersecreting tumour. MAIN OUTCOME MEASURES: The size of the incidentaloma, clinical characteristics of the patients and results of biochemical diagnostic tests were registered. RESULTS: The median age of the patients was 64 years (18-84 years), and the median size of the incidentalomas was 3 cm (1-20 cm). A total of 85(22%) patients were operated. Twenty of these patients were diagnosed with a benign hypersecreting tumour and 14 with a malignant tumour. Fourteen of 15 operated patients with diagnosed pheochromocytoma had elevated 24-h urinary noradrenaline and all of the patients operated because of a biochemical suspicion of aldosterone or cortisol hypersecretion (n = 6) were found to have adrenal adenomas. Of the 14 operated patients with malignant diseases, 10 were adrenal carcinomas (median size 10 cm; range 4-16 cm). In a multiple logistic regression model, incidentaloma size was significantly associated with the risk of a malignant tumour (P = 0.009), and there was a tendency of an association between age/male sex and the risk of a malignancy (both, P = 0.07). CONCLUSION: In this Swedish multicentre study of 381 cases with adrenal incidentalomas, 5% had benign hypersecreting tumours and nearly 4% had malignant tumours. The results of the biochemical diagnostic tests used had a high compatibility with the histological diagnosis found at operation in the patients with hypersecreting tumours. Tumour size, male gender and high age were predictive for the risk of a malignant tumour. A follow-up of the patients is warranted in order to establish whether there are undiscovered cases of malignant or hypersecreting tumours amongst the nonoperated patients.

Adenoma↗