The incidence and incubation period of false-positive culture results in shoulder surgery.

BACKGROUND: Postoperative shoulder infection is a significant complication requiring timely identification and treatment. Indolent infections such as those involving Cutibacterium acnes (formerly Propionibacterium acnes) provide a diagnostic dilemma as they present differently, without the acute symptoms associated with most postoperative bone and joint infections. Furthermore, Cacnes is thought to be a common contaminant isolated from intraoperative cultures. With no consensus algorithm, long-held cultures play a major role in guiding management decisions in potential postoperative shoulder infection. Our study sought to determine the incidence of positive culture results in both open and arthroscopic procedures in noninfected patients, as well as to clarify whether an increase in the incubation time frame leads to an increased rate of culture growth. METHODS: One hundred patients were prospectively enrolled into either the open or arthroscopic procedure group. Patients with abnormal inflammatory laboratory findings, a history of shoulder surgery, or corticosteroid injection within 6 months of surgery were excluded from the study. Three cultures were obtained for each patient: superficial tissue culture, tissue culture, and "sterile" control swab. Cultures were held for 28 days and checked at regular intervals. All patients were followed up clinically for 6 months to ensure no signs of postoperative infection occurred. RESULTS: Ultimately, 95 patients were included in the final analysis. The false-positive rate was 17.0% in those who underwent open shoulder surgery and 10.4% in those who underwent arthroscopic shoulder surgery. The incidence of positive Cacnes culture results was 6.4% in the open group, whereas Cacnes was not isolated in the arthroscopic group. All positive bacterial culture results were reported within 7 days of collection. One culture result was positive for mold at 26 days. CONCLUSION: A relatively high false-positive culture rate occurred in both open and arthroscopic shoulder surgery. Cacnes was the most commonly identified bacterium in cultures in the open surgery group. Knowledge of one's institutional false-positive culture rate could be important in avoiding potentially inappropriate treatment. Additionally, we found that holding cultures longer than 14 days did not lead to an increased rate of false-positive culture results.

An unusual presentation of cutaneous histoplasmosis as a recurrent solitary and spontaneously healing lesion in an immunocompetent patient.

Infection with Histoplasma capsulatum typically manifests as a self-limiting pulmonary disease in immunocompetent patients. Systemic symptoms such as cutaneous lesions are associated with immunodeficient states. Our patient was an immunocompetent 68-year-old male who presented with a plaque on his left infraorbital area that was concerning for malignancy. Histological examination of the lesion revealed granulomatous inflammation and small yeast forms suggestive of H. capsulatum. The lesion resolved spontaneously and recurred 1 year later. On recurrence, histological examination again revealed yeast forms consistent with H. capsulatum. Serum and urine testing for H. capsulatum antigen were negative. Next-generation sequencing detected H. capsulatum, which supported the diagnosis of a cutaneous infection. The patient was prescribed and started treatment with itraconazole for 1 year after recurrence of the lesion, and he has not reported further disease recurrence to date. This case is unique because of the presentation of a primary cutaneous recurrent H. capsulatum lesion, and it demonstrated the utility of laboratory testing in its diagnosis.

Cryptococcal meningitis is a cause for cross-reactivity in cerebrospinal fluid assays for anti-Histoplasma, anti-Coccidioides and anti-Blastomyces antibodies.

BACKGROUND/OBJECTIVES: Antibody detection is commonly used for diagnosis of histoplasmosis, and cross-reactions have been recognised due to endemic mycoses but not cryptococcosis. We observed cross-reactions in an anti-Histoplasma antibody enzyme immunoassay (EIA) in the cerebrospinal fluid (CSF) from a patient with cryptococcal meningitis and sought to assess the risk of cross-reactive anti-Histoplasma antibodies in persons with cryptococcal meningitis. METHODS: An anti-cryptococcal antibody EIA was developed to measure CSF antibody response in HIV-infected subjects from Kampala, Uganda and previously healthy, HIV-negative subjects at the National Institutes of Health (NIH) with cryptococcal meningitis. Specimens were tested for cross-reactivity in assays for IgG anti-Histoplasma, anti-Blastomyces and anti-Coccidioides antibodies. RESULTS: Among 61 subjects with cryptococcal meningitis (44 Kampala cohort, 17 NIH cohort), elevated CSF anti-cryptococcal antibody levels existed in 38% (23/61). Of the 23 CSF specimens containing elevated anti-cryptococcal antibodies, falsely positive results were detected in antibody EIAs for histoplasmosis (8/23, 35%), coccidioidomycosis (6/23, 26%) and blastomycosis (1/23, 4%). Overall, 2% (2/81) of control CSF specimens had elevated anti-cryptococcal antibody detected, both from Indiana. CONCLUSIONS: Cryptococcal meningitis may cause false-positive results in the CSF for antibodies against Histoplasma, Blastomyces and Coccidioides. Fungal antigen testing should be performed to aid in differentiating true- and false-positive antibody results in the CSF.

Improvement in Diagnosis of Histoplasma Meningitis by Combined Testing for Histoplasma Antigen and Immunoglobulin G and Immunoglobulin M Anti-Histoplasma Antibody in Cerebrospinal Fluid.

Background: Central nervous system (CNS) histoplasmosis is a life-threatening condition and represents a diagnostic and therapeutic challenge. Isolation of Histoplasma capsulatum from cerebrospinal fluid (CSF) or brain tissue is diagnostic; however, culture is insensitive and slow growth may result in significant treatment delay. We performed a retrospective multicenter study to evaluate the sensitivity and specificity of a new anti-Histoplasma antibody enzyme immunoassay (EIA) for the detection of IgG and IgM antibody in the CSF for diagnosis of CNS histoplasmosis, the primary objective of the study. The secondary objective was to determine the effect of improvements in the Histoplasma galactomannan antigen detection EIA on the diagnosis of Histoplasma meningitis. Methods: Residual CSF specimens from patients with Histoplasma meningitis and controls were tested for Histoplasma antigen and anti-Histoplasma immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody using assays developed at MiraVista Diagnostics. Results: A total of 50 cases and 157 controls were evaluated. Fifty percent of patients with CNS histoplasmosis were immunocompromised, 14% had other medical conditions, and 36% were healthy. Histoplasma antigen was detected in CSF in 78% of cases and the specificity was 97%. Anti-Histoplasma IgG or IgM antibody was detected in 82% of cases and the specificity was 93%. The sensitivity of detection of antibody by currently available serologic testing including immunodiffusion and complement fixation was 51% and the specificity was 96%. Testing for both CSF antigen and antibody by EIA was the most sensitive approach, detecting 98% of cases. Conclusions: Testing CSF for anti-Histoplasma IgG and IgM antibody complements antigen detection and improves the sensitivity for diagnosis of Histoplasma meningitis.

Performance of the cobas MRSA/SA Test for Simultaneous Detection of Methicillin-Susceptible and Methicillin-Resistant Staphylococcus aureus From Nasal Swabs.

OBJECTIVES: Health care-associated methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) infections are continuing problems. Rapidly determining the MRSA colonization status of a patient facilitates practice to reduce spread of MRSA clinical disease. Sensitive detection of all SA prior to surgery, followed by decolonization, can significantly reduce postoperative infection from this pathogen. Our goal was to validate a new automated assay for this testing. METHODS: We compared performance of the cobas MRSA/SA Test on the cobas 4800 System to direct and enriched chromogenic culture using nasal swabs collected from patients at six United States sites. RESULTS: Compared to direct and enriched culture, the sensitivity for MRSA and SA was 93.1% and 93.9%, and the specificity was 97.5% and 94.2%, respectively. After discrepancy analysis, the sensitivity for MRSA and SA was 97.1% and 98.6%, and the specificity was 98.3% and 95.5%, respectively. Compared to direct culture, sensitivity for detecting any SA was 99.6%. CONCLUSIONS: The cobas MRSA/SA Test is an effective tool to simultaneously perform surveillance testing for nasal colonization of both MRSA and MSSA.

United States and European Multicenter Prospective Study for the Analytical Performance and Clinical Validation of a Novel Sensitive Fully Automated Immunoassay for Calcitonin.

BACKGROUND: The objective of this study is the validation and proof of clinical relevance of a novel electrochemiluminescence immunoassay (ECLIA) for the determination of serum calcitonin (CT) in patients with medullary thyroid carcinoma (MTC) and in different diseases of the thyroid and of calcium homeostasis. METHODS: This was a multicenter prospective study on basal serum CT concentrations performed in 9 US and European referral institutions. In addition, stimulated CT concentrations were measured in 50 healthy volunteers after intravenous calcium administration (2.5 mg/kg bodyweight). RESULTS: In total, 1929 patients and healthy controls were included. Limits of blank, detection, and quantification for the ECLIA were 0.3, 0.5, and 1 ng/L, respectively. Highest intra- and interassay coefficients of variation were 7.4% (CT concentration, 0.8 ng/L) and 7.0% (1.1 ng/L), respectively. Medians (interval) of serum CT concentrations in 783 healthy controls were 0.8 ng/L (<0.5-12.7) and 3 ng/L (<0.5-18) for females and males, respectively (97.5th percentile, 6.8 and 11.6 ng/L, respectively). Diagnostic sensitivity and specificity were 100%/97.1% and 96.2%/96.4%, for female/males, respectively. Patients (male/female) with primary hyperparathyroidism, renal failure, and neuroendocrine tumors showed CT concentrations >97.5th percentile in 33%/4.7%, 18.5%/10%, and 8.3%/12%, females/males, respectively. Peak serum CT concentrations were reached 2 min after calcium administration (161.7 and 111.8 ng/L in males and females, respectively; P < 0.001). CONCLUSIONS: Excellent analytical performance, low interindividual variability, and low impact of confounders for increased CT concentrations in non-MTC patients indicate that the investigated assay has appropriate clinical utility. Calcium-stimulated CT results suggest good test applicability owing to low interindividual variability.

Clinical Validation of a Test for the Diagnosis of Vaginitis.

OBJECTIVE: Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs. METHODS: We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent's score and Amsel's criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture. RESULTS: For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3-92.2%) and specificity was 85.8% (95% CI 83.0-88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1-93.1%) and specificity was 94.1% (95% CI 92.6-95.4%) for the Candida group. Sensitivity for Candida glabrata was 75.9% (95% CI 57.9-87.8%) and specificity was 99.7% (95% CI 99.3-99.9%). Investigational test sensitivity was 93.1% (95% CI 87.4-96.3%) and specificity was 99.3% (95% CI 98.7-99.6%) for trichomoniasis. Results from self-collected swabs were similar to clinician-collected swabs. CONCLUSION: A molecular-based test using vaginal swabs collected by clinicians or patients can accurately diagnose most common bacterial, fungal, and protozoan causes of vaginitis. Women and their clinicians seeking accurate diagnosis and appropriate selection of efficacious treatment for symptoms of vaginitis might benefit from this molecular test.

An unusual presentation of leishmaniasis in a human immunodeficiency virus-positive individual.

INTRODUCTION: Leishmaniasis is a neglected tropical disease caused by vector-borne protozoa of the genus Leishmania. Cutaneous and mucocutaneous forms result in disfiguration or mutilation, whilst visceral leishmaniasis (VL) affects multiple organs and is fatal if untreated. Notably, Leishmania are capable of establishing a chronic infection, which may reactivate years after initial infection when the host becomes immune-suppressed. CASE PRESENTATION: A 24-year-old human immunodeficiency virus (HIV)-positive male presented for excision of anal condylomas. At the time of his current condyloma excision, the patient had no additional symptoms or cutaneous findings, but was noted to have been only intermittently compliant with his antiretroviral therapy. Microscopic examination of the haematoxylin and eosin-stained anal condyloma tissue revealed koilocytic change, ulceration and brisk histiocytic inflammation containing numerous small intracellular bodies suggestive of Leishmania amastigotes. A bone marrow biopsy was performed and demonstrated similar intracellular forms. Anal condyloma tissue and bone marrow aspirate were sent to the Centers for Disease Control and Prevention's Parasitic Diseases Branch for confirmation of Leishmania and speciation. Specific immunohistochemical staining for Leishmania in the tissue section was positive and the species was confirmed as Leishmania donovani by PCR. Subsequently, the patient resumed highly active antiretroviral therapy and received anti-Leishmania therapy. CONCLUSION: Whilst the presentation of VL in HIV-positive patients is often similar to those without HIV, here we describe an unusual initial presentation of leishmaniasis in an HIV-positive patient where the parasite was found in an anal condyloma. VL is a critical diagnosis that should be considered and pursued when leishmaniasis is encountered in seemingly illogical clinical settings.

Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population.

OBJECTIVES: The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform. METHODS: In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA). RESULTS: The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2. CONCLUSIONS: The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.

Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy.

High-risk human papillomavirus (hrHPV) testing is now being introduced as a potential primary screening test for improved detection of cervical precancer and cancer. Current U.S. Food and Drug Administration-approved tests are batch tests that take several hours to complete. A rapid, non-batch test might permit point-of-care (POC) testing, which can facilitate same-day screen and management strategies. For a non-batch, random-access platform (GeneXpert; Cepheid, Sunnyvale, CA), a prototype hrHPV assay (Xpert) has been developed where testing for 14 hrHPV types can be completed in 1 h. In the first clinical evaluation, Xpert was compared to two validated hrHPV tests, the cobas HPV test (cobas, Roche Molecular Systems) and Hybrid Capture 2 (hc2, Qiagen), and to histologic outcomes using specimens from colposcopy referral populations at 7 clinical sites in the United States (n = 697). The sensitivity of Xpert for cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) (n = 141) was equal to that of cobas (90.8% versus 90.8%, P = 1) and greater than that of hc2 (90.8% versus 81.6%, P = 0.004). Xpert was more specific than cobas (42.6% versus 39.6%, P = 0.02) and less specific than hc2 (42.6% versus 47.7%, P < 0.001). Similar results were observed for cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (n = 91). HPV16 detection by Xpert identified 41.8% of the CIN2+ specimens with a positive predictive value (PPV) of 54.6%. By comparison, HPV16 detection by cobas identified 42.6% of the CIN2+ specimens with a PPV of 55.0%. hrHPV detection by the Xpert demonstrated excellent clinical performance for identifying women with CIN2+ and CIN3+ that was comparable to that of currently available clinically validated tests.

A multicenter evaluation of tests for diagnosis of histoplasmosis.

BACKGROUND: The sensitivity of the MVista Histoplasma antigen enzyme immunoassay (MiraVista Diagnostics) has been evaluated in disseminated histoplasmosis in patients with AIDS and in the "epidemic" form of acute pneumonia. Moreover, there has been no evaluation of the sensitivity of antigenemia detection in disseminated histoplasmosis after the implementation of methods to dissociate immune complexes and denature released antibodies. The goal of this study was to determine the sensitivity of the current antigen assay in different categories of histoplasmosis. METHODS: Urine and serum specimens obtained from 218 patients with histoplasmosis and 229 control subjects, including 30 with blastomycosis, were tested. RESULTS: Antigenuria was detected in 91.8% of 158 patients with disseminated histoplasmosis, 83.3% of 6 patients with acute histoplasmosis, 30.4% of 46 patients with subacute histoplasmosis, and 87.5% of 8 patients with chronic pulmonary histoplasmosis; antigenemia was present in 100% of 31 tested cases of disseminated histoplasmosis. Among patients with disseminated cases, antigenuria was detected more often and at higher concentrations in immunocompromised patients and those with severe disease. Specificity was 99.0% for patients with nonfungal infections (n = 130) and in healthy subjects (n = 69), but cross-reactivity occurred in 90% of patients with blastomycosis. CONCLUSIONS: The sensitivity of antigen detection in disseminated histoplasmosis is higher in immunocompromised patients than in immunocompetent patients and in patients with more severe illness. The sensitivity for detection of antigenemia is similar to that for antigenuria in disseminated infection.

Antigen detection in bronchoalveolar lavage fluid for diagnosis of fungal pneumonia.

PURPOSE OF REVIEW: The purpose of this review is to describe important findings published during the past 18 months using bronchoalveolar lavage (BAL) for diagnosis of pulmonary mycoses. RECENT FINDINGS: Clinical studies and meta-analysis have established a high sensitivity and specificity for Aspergillus galactomannan testing of BAL specimens for diagnosis of invasive aspergillosis, superior to that observed with other diagnostic methods. Similar findings have been reported in histoplasmosis and blastomycosis. SUMMARY: Fungal antigen testing of BAL specimens is recommended if bronchoscopy is performed for diagnosis of pulmonary infiltrates in patient groups at risk for aspergillosis or the endemic mycoses if the diagnosis cannot be established by evaluation of sputum specimens or detection of antigen in the urine or serum.

Diagnosis of histoplasmosis by antigen detection in BAL fluid.

BACKGROUND: Detection of antigen in BAL is useful for diagnosis of histoplasmosis. The MVista Histoplasma antigen enzyme immunoassay has been modified to permit quantification. The purpose of this study is to compare the sensitivity of the quantitative antigen detection assay with cytopathology and culture of BAL specimens. METHODS: BAL from patients with histoplasmosis who were evaluated at the Indiana University Medical Center and controls without histoplasmosis were studied. BAL fluid was tested in the quantitative Histoplasma antigen assay. RESULTS: Antigen was detected in the BAL in 93.5% of patients with histoplasmosis, 80% with blastomycosis, and 0% of controls with nonfungal infections. Antigen was detected in the urine of 79% and serum in 65% of patients with histoplasmosis. Cytopathology was positive in 48% and culture in 48% of patients with histoplasmosis, and 40% and 60% of patients with blastomycosis, respectively. Serology was positive in 65%. Combining BAL antigen detection and BAL cytopathology, both methods for rapid diagnosis, the sensitivity was 96.8% in histoplasmosis and 80% in blastomycosis. CONCLUSIONS: Detection of antigen in BAL complements antigen detection in serum and urine as an objective diagnostic test for histoplasmosis.

The promiscuous receptor.

OBJECTIVE: To determine the effectiveness of vitamin D therapy in patients with asymptomatic, prostate-specific antigen (PSA)-progression of prostate cancer. PATIENTS AND METHODS: Twenty-six patients with locally advanced or metastatic prostate cancer were treated with vitamin D. Vitamin D therapy was discontinued on disease progression as assessed by symptoms or serum PSA increase. The response to therapy was judged from changes in PSA level from the pretreatment baseline to 3 months after starting vitamin D therapy. RESULTS: Of the 26 patients, five (20%) responded to vitamin D; the mean (range) reduction in PSA level was 45.3 (15.9-95.1)%, and mean duration of response was 4-5 months. Patients in whom the PSA level was stabilized, but not reduced, after vitamin D treatment had a duration of response of up to 36 months. Treatment was well tolerated and was not associated with elevation of serum calcium levels. There was no significant correlation between response to therapy and stage of disease, Gleason grade, previous treatments or PSA level at diagnosis or initiation of vitamin D therapy. CONCLUSION: Vitamin D therapy is an effective and well tolerated treatment for patients with asymptomatic progressive prostate cancer, and is a useful addition to the therapeutic options.

Enhanced immune recognition of cryptic glycan markers in human tumors.

Abnormal glycosylation is one of the hallmarks of the cancer cell and is associated with tumor invasion and metastasis. The development of tumor-associated carbohydrate antigen (TACA) vaccines has been problematic due to poor immunogenicity. However, when appropriate targets can be identified, passive immunization with monoclonal antibodies (mAbs) directed against TACAs has been shown to have antitumor activity. Fas ligand (FasL) is a transmembrane protein that induces apoptosis in cells expressing its receptor, Fas. When grafted into mice, FasL-expressing tumor cells break immunologic tolerance to self-antigens and induce antibody-mediated tumor immunity. Here, five IgM mAbs were produced from mice vaccinated with FasL-expressing B16F10 mouse melanoma cells. They recognize various syngeneic and allogeneic murine tumor cell lines. One mAb, TM10, recognizes a range of human tumor cell lines, including melanoma, prostate, and ovarian cancer. It does not bind to untransformed cells. The epitopes recognized by all the mAbs were carbohydrates expressed on proteins. Using carbohydrate microarrays, the antigenic targets of TM10 were found to be high-mannose core structures of N-linked glycans. In normal cells, high-mannose clusters are hidden by extensive saccharide branching but they become exposed in cancer cells as a result of abnormal glycosylation pathways. Vaccination with FasL-expressing tumors therefore enables the immune system to break tolerance to self-antigens, allowing identification of novel TACAs that can form the basis of future humoral anticancer therapy.

Cryptococcal glucoxylomannan does not exhibit cross-reactivity in the MVista Histoplasma antigen enzyme immunoassay.

The potential for cross-reaction between Cryptococcus neoformans and Histoplasma capsulatum in antigen assays was evaluated. We tested patient samples, spleens from infected mice, and purified polysaccharides in the MVista Histoplasma antigen enzyme immunoassay and cryptococcal antigen latex agglutination system for cross-reactivity, and none was observed.

Routine collection of patient-reported outcomes in an HIV clinic setting: the first 100 patients.

BACKGROUND: Information from patient-reported outcomes (PROs) can enhance patient-provider communication and facilitate clinical research. However, there are barriers to collecting PROs within a clinic. Recent technological advances may help overcome these barriers. We examined the feasibility of using a web-based application on tablet PCs with touch screens to collect PROs in a busy, multi-provider, outpatient HIV clinical care setting. METHODS: Patients presenting for routine care were asked to complete a touch-screen-based assessment containing 62 to 111 items depending on patient responses. The assessment included instruments measuring body morphology abnormalities, depression, symptom burden, medication adherence, drug/alcohol/tobacco use, and health-related quality of life. RESULTS: Of 136 patients approached to participate in the study, 106 patients (78%) completed the assessment, 6 (4%) started but did not complete it, and 24 (18%) refused. Of those who completed the assessment, the mean age was 48 years, and 29% reported a history of injection drug use. The median time to complete the assessment was 12 minutes. The prevalence of lipoatrophy was 51%, the prevalence of lipohypertrophy was 69%, and the prevalence of moderate or severe depression was 51%. We found that 25% of those receiving highly active antiretroviral therapy noted missing a dose of their antiretroviral medications in the prior 4 days. CONCLUSIONS: Collection of PROs using touch-screen-based, internet technology was feasible in a busy HIV clinic. We found a high prevalence of body morphology abnormalities, depression, and poor adherence. Touch-screen-based collection of PROs is a promising tool to facilitate research and clinical care.

Clinical evaluation of affirm VPIII in the detection and identification of Trichomonas vaginalis, Gardnerella vaginalis, and Candida species in vaginitis/vaginosis.

OBJECTIVE: To compare the Affirm VPIII Microbial Identification Test for detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis to clinical and microscopic criteria commonly used to diagnose vaginitis. METHODS: Women that were symptomatic for vaginitis/vaginosis and asymptomatic women being seen for routine obstetric or gynecological care were included in this study. Women treated with antibiotics or antifungals within one week or women who had douched within 24 hours were excluded. Two vaginal swab specimens were simultaneously obtained from each patient, one swab was placed in sterile physiological saline for immediate microscopic wet mount examination and KOH testing. The other swab was placed in the Affirm collection tube for Affirm VPIII testing based on previously demonstrated methods. RESULTS: The Affirm assay was significantly more likely to identify Gardnerella and Candida than wet mount. 190 (45%) were positive for Gardnerella by Affirm compared to 58 (14%) by wet mount; 45 (11%) were positive for Candida by Affirm compared to 31 (7%) by wet mount; and 30 (7%) were positive for Trichomonas by Affirm compared to 23 (5%) by wet mount. Symptomatic women were significantly more likely to be positive by Affirm only (23% vs. 10%), wet mount only (3% vs. 2%) or Affirm and wet mount (15% vs. 1%). Asymptomatic women were significantly more likely to be negative for Affirm and wet mount (43% vs. 5%). CONCLUSIONS: The Affirm VPIII test is a more sensitive diagnostic test for detection and identification of symptomatic vaginitis/vaginosis than conventional clinical examination and wet mount testing.

Phase III study of combined chemohormonal therapy in metastatic prostate cancer (ECOG 3882): an Eastern Cooperative Oncology Group study.

This study, a phase III multicenter randomized trial opened by ECOG in April 1983 and closed in June 1986 was designed to evaluate whether a combination of doxorubicin and an intravenous formulation of diethylstilbestrol diphosphate (DES) was superior to doxorubicin alone in men with hormone refractory prostate cancer. All patients received doxorubicin at a dose of 50 mg/m2 iv every 3 wk either alone or with 1 g DES iv daily for 5 d followed by 1 g iv twice weekly for four cycles (12 wk). The 51 evaluable patients with visceral metastases displayed a significantly increased response rate (27% vs 63%) on the combined therapy arm (p = 0.04). However, the 111 evaluable patients with osseous disease exhibited no difference in response rate between either arm with a p-value of >0.99. Similarly, clinical response rates revealed no difference between the two arms. Cases of cardiac toxicity graded as severe, life threatening, or lethal in the combined therapy arm were 10 times more frequent in the combined-therapy arm than in the doxorubicin-alone group (6.75% compared to 0.7%). This difference was statistically significant (p = 0.0041). All of the cases of superficial and deep venous thrombosis occurred on the combined-therapy arm. There were no other significant differences in the numbers of grade 3 or 4 toxic events. The most common toxicity was hematologic. Failure-free survival duration did reach statistical significance in the combined-therapy group (p = 0.012), although the actual durations were short (2.6-3.2 mo). There was no difference in overall survival between the two groups.