NIS2+™, an effective blood-based test for the diagnosis of at-risk nonalcoholic steatohepatitis in adults 65 years and older.

BACKGROUND: Older patients are at increased risk for at-risk NASH, defined as NASH with NAFLD activity scores (NAS) ≥4 and significant fibrosis (F ≥ 2). The aim of this study was to compare the performance of 2 new blood tests, NIS4® and NIS2+™, with FIB-4, NFS, ELF™, and alanine aminotransferase (ALT) for the diagnosis of at-risk NASH in a cohort of patients aged ≥65 years. METHODS: The clinical performance of multiple blood-based tests was assessed for their ability to detect at-risk NASH using the RESOLVE-IT diag cohort, a large population of patients with metabolic risk who were screened for potential inclusion in the RESOLVE-IT phase 3 trial. RESULTS: The study cohort (n = 2053) included patients with the full histological spectrum of NAFLD, with patients having liver fibrosis stages F0-4 and NAS scores 0-8. NIS4® and NIS2+™ showed similar assay performance in patients who were <65 versus ≥65 years of age (AUROC = 0.80 vs. 0.78, p = 0.47; 0.81 vs. 0.83 p = 0.45, respectively) for the identification of at-risk NASH. In patients ≥65 (n = 410), NIS2+™ exhibited the highest AUROC compared to NIS4®, FIB-4, NFS, ELF™, and ALT (AUROC = 0.83 vs. 0.78, 0.68, 0.58, 0.69, 0.74, respectively; all p ≤ 0.0009). For NIS2+™, the sensitivity and NPV for ruling-out at-risk NASH at the 0.46 cutoff were 90.2% and 86.0%, and the specificity and PPV for ruling-in at-risk NASH at the 0.68 cutoff were81.1% and 76.3%, respectively. CONCLUSIONS: The clinical performance of NIS2+™ was superior for the diagnosis of at-risk NASH in patients ≥65 years of age. These data support the clinical value of this blood-based test for the diagnosis of at-risk NASH in older adults.

Neoadjuvant pertuzumab in non-metastatic HER2-positive breast tumors: Multicentric study in Peru (NeoHer).

Several clinical trials have demonstrated the benefit of adding pertuzumab to trastuzumab plus neoadjuvant chemotherapy in the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The comparison of outcomes between nonrandomized groups of patients who received similar treatments in routine practice remains difficult. The present study aimed to evaluate the pathological complete response (pCR) rates achieved with pertuzumab among patients in routine clinical care in Peru using real-world data. The definition of pCR used was the absence of residual invasive cancer from the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. A total of 44 patients with non-metastatic HER2-positive breast cancer (stages II and III) treated with pertuzumab in the neoadjuvant setting and who underwent surgery at three private clinics in Lima (Peru) were retrospectively evaluated. The pCR was the efficacy endpoint and it was determined and compared with the results from other clinical trials. Furthermore, safety data were described. The median age was 44 years (interquartile range, 39.5-50.5 years) and 65.9% of patients were premenopausal. Regarding the clinical stage, 56.8% were IIA/IIB and 36.4% were IIIA/IIIB/IIIC. All treatment schemes included concurrent trastuzumab. The patients' treatment comprised neoadjuvant therapy of docetaxel/trastuzumab/pertuzumab (THP) with a median of 4 cycles in 30 patients (68.2%) or docetaxel/trastuzumab/pertuzumab/carboplatin (THPCarb) with a median of 6 cycles in 14 patients (31.8%). In total, 70.5% of patients experienced pCR; among hormone receptor-negative cases, 75.0% achieved pCR and in tumors expressing hormone receptors, the rate of pCR was 66.7%. Of those patients subjected to neoadjuvant treatment with THP, 66.7% (20/30) achieved pCR, whereas 78.6% (11/14) of patients who received THPCarb had a pCR. The incidence of drug-related adverse events was 59.1% and in none of the patients, administration was discontinued due to toxicity. The present results of Peruvian patients with HER2 breast cancer treated according to clinical routine demonstrated that dual blockade of HER2 with trastuzumab and pertuzumab in the neoadjuvant setting achieved high rates of pCR even in hormone receptor-positive patients. These results are consistent with those of randomized controlled trials, with a good safety profile.

Assessing 3 Outbreak Detection Algorithms in an Electronic Syndromic Surveillance System in a Resource-Limited Setting.

We evaluated the performance of X-bar chart, exponentially weighted moving average, and C3 cumulative sums aberration detection algorithms for acute diarrheal disease syndromic surveillance at naval sites in Peru during 2007-2011. The 3 algorithms' detection sensitivity was 100%, specificity was 97%-99%, and positive predictive value was 27%-46%.

Development and Implementation of the DHAPP Military eHealth Information Network System.

BACKGROUND: As the Joint United Nations Programme on HIV/AIDS, the Global Fund, and the US President's Emergency Plan for AIDS Relief focus on reaching 90-90-90 goals, military health systems are scaling up to meet the data demands of these ambitious objectives. METHODS: Since 2008, the US Department of Defense HIV/AIDS Prevention Program (DHAPP) has been working with military partners in 14 countries on implementation and adoption of a Military eHealth Information Network (MeHIN). Each country implementation plan followed a structured process using international eHealth standards. DHAPP worked with the private sector to develop a commercial-off-the-shelf (COTS) electronic medical record (EMR) for the collection of data, including patient demographic information, clinical notes for general medical care, HIV encounters, voluntary medical male circumcision, and tuberculosis screening information. RESULTS: The COTS software approach provided a zero-dollar software license and focused on sharing a single version of the EMR across countries, so that all countries could benefit from software enhancements and new features over time. DHAPP also worked with the public sector to modify open source disease surveillance tools and open access of HIV training materials. Important lessons highlight challenges to eHealth implementation, including a paucity of technology infrastructure, military leadership rotations, and the need for basic computer skills building. CONCLUSION: While not simple, eHealth systems can be built and maintained with requisite security, flexibility, and reporting capabilities that provide critical information to improve the health of individuals and organizations.

Assessing the impact of public health interventions on the transmission of pandemic H1N1 influenza a virus aboard a Peruvian navy ship.

BACKGROUND: Limited data exist on transmission dynamics and effectiveness of control measures for influenza in confined settings. OBJECTIVES: To investigate the transmission dynamics of a 2009 pandemic H1N1 influenza A outbreak aboard a Peruvian Navy ship and quantify the effectiveness of the implemented control measures. METHODS: We used surveillance data and a simple stochastic epidemic model to characterize and evaluate the effectiveness of control interventions implemented during an outbreak of 2009 pandemic H1N1 influenza A aboard a Peruvian Navy ship. RESULTS: The serological attack rate for the outbreak was 49·1%, with younger cadets and low-ranking officers at greater risk of infection than older, higher-ranking officers. Our transmission model yielded a good fit to the daily time series of new influenza cases by date of symptom onset. We estimated a reduction of 54·4% in the reproduction number during the period of intense control interventions. CONCLUSION: Our results indicate that the patient isolation strategy and other control measures put in place during the outbreak reduced the infectiousness of isolated individuals by 86·7%. Our findings support that early implementation of control interventions can limit the spread of influenza epidemics in confined settings.