The APTIMA V R HPV Assay (AHPV) allows detection of 14 high-risk human papillomavirus (HPV) RNA types in cervical specimens. Until present, the assay has been compared to HPV DNA tests only in triage settings. Herein, we compare AHPV with a DNA assay (Hybrid Capture V R 2; HC2) and liquid-based cytology (LBC; using PreservCyt V R ThinPrep liquid Pap) in a screening setting (French APTIMA screening evaluation [FASE] study). Women (N 5 5,006) aged 20-65 were screened by gynecologists in 17 private practices in Paris, France. One cervical specimen was collected and tested with LBC, AHPV and HC2 assays. Women were referred to colposcopy if they were ASC-US1 in LBC or HPV positive in either HPV assay. To control for verification bias, a random group (14%) with normal LBC and dually HPV negative tests underwent colposcopy. Data from 4,429 women were analyzed. Sensitivity, specificity and predictive values were calculated for the three tests. AHPV and HC2 were highly sensitive for CIN21 (92.0% and 96.7%) and CIN31 (95.7% and 95.3%) detection and much more sensitive than LBC (69.1% for CIN21 and 73.3% for CIN31). Specificity of AHPV was higher than that of HC2, but similar to that of LBC (p < 0.001). Combining LBC with either HPV test slightly increased sensitivity but compromised specificity. AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be considered as an option for routine cervical cancer screening for women over 20 years of age.Invasive cervical cancer (ICC) is the second most frequent female cancer worldwide, 1 with an estimation of 493,000 cases annually. ICC incidence and mortality rates have dramatically declined over the past five decades in developed countries, largely due to screening programs based on conventional cervical Papanicolaou (Pap) smears. 2,3 Conventional Pap smear screening, however, has limited sensitivity, positive predictive value (PPV) and reproducibility, which limits its use for primary screening. 3,4-7 Liquid-based cytology (LBC) has been shown to be more sensitive than conventional
Acceptability of medicinal products in children and older populations is pivotal in ensuring adherence and therapeutic outcomes. This review systematically identifies studies reporting on formulation aspects of oral medications that affect their acceptability in these patient groups. Particular emphasis is placed on the evaluation of the methodologies employed in the studies. Sixty-eight studies were included for analysis, with 51 (75%) in children and 17 (25%) in older populations. The studies evaluated a range of oral formulations; however, the methodologies used differ considerably in participants' characteristics, study settings, tools, acceptability definitions and criteria. It is evident that there is a lack of standardisation in study design as well as the assessment methods used in assessing acceptability of medicines in children and older populations.
Objectives The purpose of this article was to present an original standardized tool assessing the medicine's acceptability whichever their characteristics and the patient features. Methods An acceptability map was built with objective measures from medicine use assessments collected in real-life conditions. Multiple correspondence analysis (MCA) was used for the mapping process. Hierarchical classification on the principal components (HCPC) of the MCA was performed for the clustering process corresponding to distinct acceptability profiles. Key findings The results presented here focus on 234 evaluations issued from the paediatric population and gathered in four clusters: 'well-accepted' (50%), 'accepted' (19%), 'poorly accepted' (25%) and 'not accepted' medicines (6%). The first one was characterized by a dose fully taken, in a short time, with a patient's positive reaction; the second by a longer administration time, a neutral reaction and the use of methods to achieve administration (reward, divided dose). Differentiation between the two last clusters was, respectively, originated by a required dose partially taken or not taken. Conclusions The acceptability profile of each medicine can be evaluated with the map position of the related patient's assessments barycentre. This tool should satisfy expectations in terms of methods for appropriate acceptability evaluation and standardized comparison among medicines.
BackgroundLong-term multicentre studies are subject to numerous factors that may affect the integrity of their conclusions. Quality control and standardization of data collection are crucial to minimise the biases induced by these factors. Nevertheless, tools implemented to manage biases are rarely described in publications about population-based cohorts. This report aims to describe the processes implemented to control biases in the Constances cohort taking lung function results as an example.MethodsConstances is a general-purpose population-based cohort of 200,000 participants. Volunteers attend physical examinations at baseline and then every 5 years at selected study sites. Medical device specifications and measurement methods have to comply with Standard Operating Procedures developed by experts. Protocol deviations are assessed by on-site inspections and database controls. In February 2016, more than 94,000 participants yielding around 30 million readings from physical exams, had been covered by our quality program.ResultsParticipating centres accepted to revise their practices in accordance with the study research specifications. Distributors of medical devices were asked to comply with international guidelines and Constances requirements. Close monitoring enhanced the quality of measurements and recordings of the physical exams. Regarding lung function testing, spirometry acceptability rates per operator doubled in some sites within a few months and global repeatability reached 96.7 % for 29,772 acceptable maneuvers.ConclusionsDespite Constances volunteers being followed in multiple sites with heterogeneous materials, the investment of significant resources to set up and maintain a continuous quality management process has proved effective in preventing drifts and improving accuracy of collected data.
In this comprehensive sample of haematological patients receiving antifungal treatment, we observe a widespread resort to early therapy and a low mortality rate, including in patients with probable or proven IFD.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.