Amy Sitapati

Measurement characteristics of anal cytology, histopathology, and high-resolution anoscopic visual impression in an anal dysplasia screening program.

Background: The study aims were (1) to estimate agreement between consecutive anal cytologic examinations, between concurrent cytologic examination and histopathology, and between high-resolution anoscopy (HRA) visual impression and histopathology and (2) to estimate the prevalence of severe dysplasia by concurrent cytologic category. Methods: Prospective study of HIV-infected patients receiving anal dysplasia screening as part of routine care. Agreement between measures was estimated by weighted kappa-statistics. Results: Between July 2000 and September 2003, 1864 patients underwent 2947 anal cytology tests. Excluding unsatisfactory tests (6%), 642 patients had repeat cytologic evaluation and 154 had concurrent cytology tests and biopsy. Using 4-category cytology grading, kappa-agreement between the first 2 cytologic measurements was 0.36. Comparing concurrent cytology tests and biopsy, kappa-agreement was 0.36. Comparing the most severe HRA visual impression and biopsy, kappa-agreement was 0.32. The prevalence of anal intraepithelial neoplasia 3 at biopsy by concurrent cytology category was 0 (cytology normal), 21% (atypical squamous cells of uncertain significance), 27% (low-grade squamous intraepithelial lesion), and 54% (high-grade squamous intraepithelial lesion). Conclusions: These data suggest that the reproducibility of key screening measures is moderate at best but of similar magnitude to that of other studies of anal and cervical dysplasia screening. As candidate interventions to treat or prevent precursor lesions enter clinical development, standardization and improvement of measurement methods are essential.

Treatment of HIV-related inflammatory cerebral cryptococcoma with adalimumab.

Cryptococcomas have been described in AIDS patients in the setting of immune reconstitution inflammatory syndrome. We report the first case of human immunodeficiency virus-related inflammatory cerebral cryptococcoma to be treated with a recombinant human monoclonal tumor necrosis factor antagonist.

Estimating the accuracy of anal cytology in the presence of an imperfect reference standard.

Background The study aim is to estimate sensitivity and specificity of anal cytology for histologic HSIL in analyses adjusted for the imperfect biopsy reference standard. Methods and Principal Findings Retrospective cohort study of an anal dysplasia screening program for HIV infected adults. We estimated the prevalence of histologic HSIL by concurrent cytology category and the associated cytology ROC area. Cytology operating characteristics for HSIL were estimated and adjusted for the imperfect reference standard by 3 methodologies. The study cohort included 261 patients with 3 available measures: (1) referral cytology; (2) HRA cytology; and (3) HRA directed biopsy. The prevalence of biopsy HSIL varied according to the concurrent HRA cytology result: 64.5% for HSIL or ASC-H, 12.6% for LSIL, 10.9% for ASCUS, and 6.3% for no abnormality. The cytology ROC area was 0.78. The observed prevalence of HSIL was 37% (referral cytology), 24% (HRA cytology), and 24% (HRA biopsy). Unadjusted estimates of sensitivity and specificity of cytology were 0.66 and 0.90, respectively. Adjusted estimates varied from 0.47–0.89 (sensitivity) and 0.89—1.0 (specificity). Conclusions Analysis of a single dataset yields widely different estimates of anal cytology operating characteristics that depend on difficult to verify assumptions regarding the accuracy of the imperfect reference standard.

Retention: Building a Patient-Centered Medical Home in HIV Primary Care through PUFF (Patients Unable to Follow-up Found)

Here, we describe our patient-centered medical home (PCMH) quality improvement retention project conducted by a Health Resources and Services Administration (HRSA) Ryan White-funded Primary Care HIV clinic. The single urban academic clinic serving 2,776 active HIV positive patients identified 25.8% (716/2,776) patients who had not been retained in care within the prior six months during two separate six-month interval analyses. Multiple modalities including a retention specialist, a secure clinic phone message line, algorithms, flyers, brochures, database, and staff education were built to facilitate re-engagement. The project located 87.7% (628/716) patients who had not been retained. The retention specialist was directly responsible for the return of 16.2% (116/716) patients. Results from the project demonstrated that a formalized approach is a necessary component to effective retention efforts. We believe that this work will provide a strategic framework for the development of randomized control trials to formally evaluate an HIV retention intervention.

A Model for Routine Hospital-wide HIV Screening: Lessons Learned and Public Health Implications

BACKGROUND Approximately 232700 (21%) of Americans are unaware of their HIV-seropositive status; this represents a potential for virus transmission. Revised recommendations from the Centers for Disease Control for HIV screening promote routine screening in the health care setting. We describe the implementation of a hospital-wide routine HIV screening program in the District of Columbia. METHODS Rapid HIV testing was conducted at Howard University Hospital on consenting patients at least 18 years of age using the OraSure OraQuick Advance Rapid HIV-1/2 Antibody Test. The study population includes Howard University Hospital patients who were offered HIV screening over a 12-month period at no cost. Screened patients received immediate test results and, for those patients found to be preliminarily reactive, confirmatory testing and linkage to care were offered. RESULTS Of the 12836 patients who were offered testing, 7528 (58.6%) consented. Preliminary reactive test results were identified in 176 patients (2.3%). Overall, 45.5% were confirmed, of which 82.5% were confirmed positive. Screening protocol changes have led to 100% confirmation since implementation. CONCLUSIONS Hospital-wide routine HIV screening is feasible and can be implemented effectively and efficiently. The HIV screening campaign instituted at Howard University Hospital identified a substantial number of HIV-positive individuals and provided critical connection to follow-up testing, counseling, and disease management services.

Denial of Risk Behavior Does Not Exclude Asymptomatic Anorectal Sexually Transmitted Infection in HIV-Infected Men

Background The Centers for Disease Control recommend screening for asymptomatic sexually transmitted infection (STI) among HIV-infected men when there is self-report of unprotected anal-receptive exposure. The study goals were: (1) to estimate the validity and usefulness for screening policies of self-reported unprotected anal-receptive exposure as a risk indicator for asymptomatic anorectal infection with Neisseria gonorrhoeae (GC) and/or Chlamydia trachomatis (CT). (2) to estimate the number of infections that would be missed if anal diagnostic assays were not performed among patients who denied unprotected anorectal exposure in the preceding month. Methods and Findings Retrospective analysis in HIV primary care and high resolution anoscopy (HRA) clinics. HIV-infected adult men were screened for self-reported exposure during the previous month at all primary care and HRA appointments. Four sub-cohorts were defined based on microbiology methodology (GC culture and CT direct fluorescent antibody vs. GC/CT nucleic acid amplification test) and clinical setting (primary care vs. HRA). Screening question operating characteristics were estimated using contingency table methods and then pooled across subcohorts. Among 803 patients, the prevalence of anorectal GC/CT varied from 3.5–20.1% in the 4 sub-cohorts. The sensitivity of the screening question for self-reported exposure to predict anorectal STI was higher in the primary care than in the HRA clinic, 86–100% vs. 12–35%, respectively. The negative predictive value of the screening question to predict asymptomatic anorectal STI was ≥90% in all sub-cohorts. In sensitivity analyses, the probability of being an unidentified case among those denying exposure increased from 0.4–8.1% in the primary care setting, and from 0.9–18.8% in the HRA setting as the prevalence varied from 1–20%. Conclusion As STI prevalence increases, denial of unprotected anal-receptive exposure leads to an increasingly unacceptable proportion of unidentified asymptomatic anorectal STI if used as a criterion not to obtain microbiologic assays.

iCONCUR: informed consent for clinical data and bio-sample use for research

Background: Implementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings. Methods: We developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center. Results: Of patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research. Conclusion: This study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.

Utility of clinical assessment, imaging, and cryptococcal antigen titer to predict AIDS-related complicated forms of cryptococcal meningitis

BackgroundThis study aimed to evaluate the prevalence and predictors of AIDS-related complicated cryptococcal meningitis. The outcome was complicated cryptococcal meningitis: prolonged (≥ 14 days) altered mental status, persistent (≥ 14 days) focal neurologic findings, cerebrospinal fluid (CSF) shunt placement or death. Predictor variable operating characteristics were estimated using receiver operating characteristic curve (ROC) analysis. Multivariate analysis identified independent predictors of the outcome.ResultsFrom 1990-2009, 82 patients with first episode of cryptococcal meningitis were identified. Of these, 14 (17%) met criteria for complicated forms of cryptococcal meningitis (prolonged altered mental status 6, persistent focal neurologic findings 7, CSF surgical shunt placement 8, and death 5). Patients with complicated cryptococcal meningitis had higher frequency of baseline focal neurological findings, head computed tomography (CT) abnormalities, mean CSF opening pressure, and cryptococcal antigen (CRAG) titers in serum and CSF. ROC area of log2 serum and CSF CRAG titers to predict complicated forms of cryptococcal meningitis were comparable, 0.78 (95%CI: 0.66 to 0.90) vs. 0.78 (95% CI: 0.67 to 0.89), respectively (χ2, p = 0.95). The ROC areas to predict the outcomes were similar for CSF pressure and CSF CRAG titers. In a multiple logistic regression model, the following were significant predictors of the outcome: baseline focal neurologic findings, head CT abnormalities and log2 CSF CRAG titer.ConclusionsDuring initial clinical evaluation, a focal neurologic exam, abnormal head CT and large cryptococcal burden measured by CRAG titer are associated with the outcome of complicated cryptococcal meningitis following 2 weeks from antifungal therapy initiation.

Integrated precision medicine: the role of electronic health records in delivering personalized treatment

Precision Medicine involves the delivery of a targeted, personalized treatment for a given patient. By harnessing the power of electronic health records (EHRs), we are increasingly able to practice precision medicine to improve patient outcomes. In this article, we introduce the scientific community at large to important building blocks for personalized treatment, such as terminology standards that are the foundation of the EHR and allow for exchange of health information across systems. We briefly review different types of clinical decision support (CDS) and present the current state of CDS, which is already improving the care patients receive with genetic profile‐based tailored recommendations regarding diagnostic and treatment plans. We also report on limitations of current systems, which are slowly beginning to integrate new genomic data into patient records but still present many challenges. Finally, we discuss future directions and how the EHR can evolve to increase the capacity of the healthcare system in delivering Precision Medicine at the point of care. WIREs Syst Biol Med 2017, 9:e1378. doi: 10.1002/wsbm.1378

Mesothelioma in an HIV/AIDS patient without history of asbestos exposure: possible role for immunosuppression in mesothelioma: a case report

We describe a 41-year-old African-American male who initially presented in respiratory distress. He had a positive history of asthma, cigarette smoking, and only recent possible asbestos exposure six months prior to onset of symptoms. Mesothelioma was suspected after chest radiography and PET-CT, and confirmed by immunohistochemical tissue analysis. We postulate that immunosuppression enhances susceptibility to mesothelioma, since weakened immune systems are present in both HIV/AIDS patients like this 41-year-old man, and elderly patients who compose the population that classically presents with mesothelioma. Furthermore, immunosuppression may be a prerequisite to the development of mesothelioma.