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Thus, a test that is 90% speci c gives negative results in 90% of patients without disease and positive results in 10% of patients without disease (false positives). A test with high speci city is useful to con rm a diagnosis, because a highly speci c test has fewer results that are falsely positive. For instance, to make the diagnosis of gouty arthritis, a clinician might choose a highly speci c test, such as the presence of negatively birefringent needle-shaped crystals within leukocytes on microscopic eval uation of joint uid. For instance, the sensitivity and speci city of rapid antigen detection testing in diagnosing group A -hemolytic streptococcal phar yngitis are obtained by comparing the results of rapid antigen testing with the gold standard test, throat swab culture. Application of the gold standard test to patients with positive rapid antigen tests establishes speci city. Fail ure to apply the gold standard test to patients with negative rapid antigen tests will result in an overestimation of sensitivity, since false negatives will not be identi ed. Sensitivity and speci city can also be affected by the population from which these values are derived. For instance, many diagnostic tests are evaluated rst using patients who have severe disease and control groups Diagnostic Testing and Medical Decision Making 9 who are young and well. Compared with the general population, these study groups will have more results that are truly positive (because patients have more advanced disease) and more results that are truly negative (because the control group is healthy). Thus, test sensitivity and speci city will be higher than would be expected in the general population, where more of a spectrum of health and disease is found. Clinicians should be aware of this spectrum bias when generalizing published test results to their own practice. To minimize spectrum bias, the control group should include indi viduals who have diseases related to the disease in question, but who lack this principal disease. For example, to establish the sensitivity and speci c ity of the anti-cyclic citrullinated peptide test for rheumatoid arthritis, the control group should include patients with rheumatic diseases other than rheumatoid arthritis. Other biases, including spectrum composition, popu lation recruitment, absent or inappropriate reference standard, and veri ca tion bias, are discussed in the references. It is important to remember that the reported sensitivity and speci city of a test depend on the analyte level (threshold) used to distinguish a nor mal from an abnormal test result. If the threshold is lowered, sensitivity is increased at the expense of decreased speci city.

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Important safety information, such as that conveyed in Dear Doctor Letters, should be disseminated via the Internet as well as through more traditional mechanisms. Appropriate hyperlinks to sources of detailed information on such changes can also be provided. There is, however, an increase in types of reports that do not fall neatly into either of these categories. Many of these newer reports are generated by marketing programs used by pharmaceutical companies and through the increasing use of methods to encourage contact between consumers and the pharmaceu tical company. Pharmaceutical companies continue to struggle with determining how to handle such reports. The underlying assumption of a spontaneous reporting system is that health care providers and others make an effort to report. Letter or prominent notification in the lay or professional press about a suspect serious adverse reaction); new reports are thus stimulated, although they should still be considered spontaneous reports. On the other hand, as explained in more detail within the text, solicited reports do not originate with any safety issue or safety study, but invariably arise in the course of interaction with patients for unrelated purposes. In recent years, there has been an increase in a variety of different programs, usually by manufacturers, that generate adverse experience reports to manufacturers that are neither truly spontaneous in origin nor a result of a prospective or retrospective clinical study: o patient-support and disease management programs involving, for example, telephone service for patients to obtain direct advice, or nurse-initiated calls for medicine compliance management. Generally, a patient support program is one in which patients can enroll to obtain educational information and prescription reminders. Enrollment may be through a physician, a pharmacist, or directly by a patient with a company; in each case there is likely to be at least one direct contact with the patient by the company or a contract organization, and each contact has the potential for generating adverse event information (Q. These are clearly not generated in the usual spontaneous manner that is the premise upon which our spontaneous reporting systems are based; they are usually obtained incidentally to the main purpose of the program. In none of these 58 situations is the communication of a possible adverse reaction initiated in an unsolicited way by the reporting patient or other person. Had the company, its agent, or other party not taken the initiative to contact these people, or to solicit their communication for purposes other than safety reporting, the event would most likely not have been the subject of independent voluntary reporting to a healthcare provider or directly to a company*. For this reason, such reports are regarded as solicited in nature and one cannot infer implied causality, the convention for spontaneous reports.

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Neutrophils, which are present in sputum and nasal discharge in uncomplicated rhinovirus infections, cause yellow-green discoloration through natural myeloperoxidase activity. It is uncertain whether the rhinovirus-induced increase in airway hyperreactivity is the result of local inflammation caused by rhinovirus infection of lower airway epithelial cells or if infection is limited to the upper airway with inflammatory mediators acting distantly in the lower airways. Rhinovirus-induced changes in airway reactivity may persist for up to four weeks following infection. This may explain the often persistent cough seen in many individuals following upper respiratory tract infections. It is important to note that this cough is not bacterial bronchitis and will spontaneously resolve. Treatment: There is no cure for rhinovirus infection other than the passage of time during which virus is cleared by the host immune system. Unfortunately it is this host response that is responsible for most of the symptoms of the common cold. As a result, most modern cold remedies are aimed at attenuating the effects of the immune response. Decongestants both alone and in combination with either antihistamines or anticholinergics appear to decrease rhinorrhea, nasal discharge, and subjective congestion. Nonsteriodal anti inflammatory drugs and acetaminophen may provide significant symptomatic relief, especially in combination with antihistamines or decongestants. Studies using drugs that directly impact viral replication have been disappointing to date. These agents must be used within a short period of time after infection (preferably before symptoms have appeared) in order to reduce symptoms; however, they have been more successful at decreasing spread of infection in households. Zinc lozenges have been hailed in the popular press as highly effective for treating rhinovirus colds; however, several large double blind trials involving both natura1 and experimental colds have failed to show any benefit. Echinacea, the purple coneflower, bas been a popular herbal cold remedy for decades; however, few modern studies support its effectiveness. Like echinacea, vitamin C has been touted as a popular preventive and therapeutic agent for the common cold. Analysis of the six largest vitamin C supplementation studies (> 1 g per day) fail to show any benefit in decreasing the incidence of the common cold. Some of these trials suggest a modest benefit in improvement of symptoms; however, the improvements are no greater than are seen with standard over-the-counter cold remedies. Control of nasal secretions and the use of virucidal tissues decreased rhinovirus transmission in one study.

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Which of the following best describes the pathologic features evident in this autopsy specimen. Physical examination reveals cyanosis, elevated jugular venous pressure, and peripheral edema. Chronic intra-alveolar exposure to which of the (B) Hyaline membranes and interstitial edema following proteins is most likely associated with the pathogenesis (C) Interstitial brosis of the lung parenchyma of chronic obstructive pulmonary disease in this patient. A chest 26 A 48-year-old man with a history of heavy smoking presents X-ray shows small nodular shadows in both lungs. Pulmonary with a 3-year history of persistent cough and frequent upper function studies reveal a pattern consistent with restrictive respiratory infections, associated with sputum production. The patient subsequently develops congestive Physical examination reveals prominent expiratory wheezes heart failure and expires. The patient admits to smoking one pack of reveals enlargement of hilar and mediastinal lymph nodes. On physical examination, he is Laboratory studies show elevated serum levels of angiotensin noticed to have a barrel chest and use accessory muscles for converting enzyme and an increase in 24-hour urine calcium inspiration. A chest X-ray is compatible with dif for microorganisms in the tissue are negative. Autopsy reveals extensive pulmonary brosis, and iron stains of lung tissue show numerous fer ruginous bodies. The Respiratory System 131 (A) Goodpasture syndrome (A) Alveolar proteinosis (B) Langerhans cell histiocytosis (B) Churg-Strauss syndrome (C) Lymphangioleiomyomatosis (C) Langerhans cell histiocytosis (D) Pulmonary interstitial brosis (D) Lymphangioleiomyomatosis (E) Wegener granulomatosis (E) Lymphocytic interstitial pneumonia 37 A 30-year-old woman presents with shortness of breath and 35 A 23-year-old man complains of nasal obstruction, sero bloody sputum. Physical examination reveals pulmonary sanguinous discharge, cough, and bloody sputum. A chest X-ray shows bilat X-ray shows cavitated lesions and multiple nodules over eral pleural effusions and marked hyperin ation of the lungs. A transbronchial ules, reticulonodular in ltrates, a small cavitary lesion in the lung biopsy is shown in the image. A transbron complement C3 are detected in the alveolar basement mem chial biopsy is shown in the image. Spu 41 A 55-year-old woman complains of sudden onset of fever, tum cultures are negative, and the patient does not respond dry cough, and shortness of breath. A chest X-ray discloses diffuse bilateral in ltrates, (E) Wegener granulomatosis predominantly in the lower lobes, in a reticular pattern.