Project description:Vaccinology is shifting toward synthetic RNA platforms which allow for rapid, scalable, and cell-free manufacturing of prophylactic and therapeutic vaccines. The simple development pipeline is based on in vitro transcription of antigen-encoding sequences or immunotherapies as synthetic RNA transcripts, which are then formulated for delivery. This approach may enable a quicker response to emerging disease outbreaks, as is evident from the swift pursuit of RNA vaccine candidates for the global SARS-CoV-2 pandemic. Both conventional and self-amplifying RNAs have shown protective immunization in preclinical studies against multiple infectious diseases including influenza, RSV, Rabies, Ebola, and HIV-1. Self-amplifying RNAs have shown enhanced antigen expression at lower doses compared to conventional mRNA, suggesting this technology may improve immunization. This review will explore how self-amplifying RNAs are emerging as important vaccine candidates for infectious diseases, the advantages of synthetic manufacturing approaches, and their potential for preventing and treating chronic infections.
Project description:BackgroundPatient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties.MethodsA mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ɑ.ResultsThe literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (ɑ > 0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity.ConclusionsThe ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making.Trial registrationNCT03357471.
Project description:Poultry is one of the main agricultural sub-sectors worldwide. However, public concern regarding animal welfare and antimicrobial resistance has risen in recent years. Due to the influence of management practices on microbiota, it might be considered to evaluate poultry welfare and health. Therefore, the objective of this research was to analyse the influence on microbiota balance of broilers under commercial and optimal farm conditions, using 16S rRNA sequencing analysis. The research was performed in two identical poultry houses (commercial vs. optimal). Results showed a higher level of microbiota complexity in the group reared under optimal farm conditions at the end of rearing. Regarding microbiota composition, Firmicutes was the dominant phylum during the entire growing period. However, the second most prevalent phylum was Proteobacteria at the arrival day, and Bacteroidetes from the mid-period onward in both groups. Moreover, the most predominant genera identified were Oscillospira, Ruminococcus, Bacteroides, and Coprococcus. In conclusion, it is necessary to optimize farm management as much as possible. Using gut microbiota diversity and composition as biomarkers of animal health could be an important tool for infectious disease control, with the aim of reducing the administration of antibiotics at field level.
Project description:BACKGROUND:Infectious diseases such as Human Immunodeficiency Virus and Hepatitis C are a significant problem among substance abusers. Current risk behavior measures [e.g., HIV Risk Taking Behaviour Scale (HRBS) and Risk Assessment Battery (RAB)] were developed for injection drug users and do not include newly identified risks or noninjection drug use behaviors. This study developed and provided initial, internal validation of the Behavioral Risk Assessment for Infectious Diseases (BRAID) to assess infectious disease risk behaviors among alcohol and other drug users. METHODS:A self-report measure was developed from literature regarding risk behaviors. Participants (total N=998) with alcohol/substance use disorder completed the measure in 2 phases to establish initial psychometric validity. RESULTS:Phase 1 (N=270) completed 65 self-report questions; factor analysis revealed a 12-item solution with 5 factors (Unprotected Sex with Risky Partners, Injection Use, Sex on Cocaine/Crack, Condom Availability, and Intranasal Drug Use). Infectious disease history was positively associated with Injection Use (Sample 1) and Unprotected Sex with Risky Partners (Sample 2) and negatively associated with Intranasal Drug Use (Samples 1 and 2). Phase 2 (N=728) added additional injection-related items and confirmed the factor structure of the existing BRAID. CONCLUSIONS:The BRAID is a 5-factor, 14-item self-report measure of past 6 month risk behaviors that is composed of noninjection and injection risk behaviors and was psychometrically confirmed. Though additional external (convergent/divergent) validation is needed, this report provides preliminary support for the use of the BRAID to assess infectious disease risk in substance users.
Project description:The musculoskeletal disorders (MSDs) severity and frequency questionnaire (MSFQ) has been used with agriculturists. Although it frequently appears in the literature, it does not periodically reflect the levels of MSDs. This study aimed to develop a MSDs assessment tool for agriculturists via an online database. The four hospitals that were assigned to the development and tryout group received a random selection of participants from 33 health promoting hospitals. In the development phase, 55 agriculturists (from two hospitals) completed the structured interview questionnaire. The MSFQ document for the analysis of MSDs symptoms among agriculturists was concentrated on the frequency and severity of symptoms. The online MSFQ was checked by using intraclass correlation coefficients (ICC) in a one-way random-effects model. In the tryout phase, a group of 44 agriculturists (from another two hospitals) completed a similar online MSFQ. Cronbach's alpha was used to test the reliability of the online self-reported MSDs questionnaires. A Likert rating scale, used to measure the satisfaction of users, was divided into three categories: information, program design, and benefits. The development phase showed an ICC = 0.99 with a 95% CI = 0.98-0.99. More than 65 percent of agriculturists were female, aged from 41-50 years old. A large number of them were engaged in self-cultivation. Their main crops were rice and cassava. In total, 50% reported that they had experienced mild MSDs levels. The shoulder, knee-calf, and hip-thigh areas were the top three parts of the body where agriculturists had experienced MSDs from cultivation. Excellent reliability of online MSFQ was found after the tryout. The agriculturists were very satisfied overall (information, program design, and benefits). Developments to the MSFQ and online administration did not diminish its reliability for obtaining information about the level of MSDs of agriculturists' musculoskeletal symptoms. This self-reported MSDs questionnaire was appropriate to be used among agriculturists.
Project description:The questionnaire based study gives a combined description of management, infectious diseases and reproductive performance in breeding catteries during 1 year. The mean number of cats per cattery was 6.1, and 25% of the breeders let some of their cats have free access to outdoors. Breeders reported that infection with feline panleukopenia virus, feline immunodeficiency virus or feline leukaemia virus was uncommon, but 8% of the breeders had sold or had themselves owned a cat that died of feline infectious peritonitis. Presence of conjunctivitis was reported by 33.3% of the breeders. Mean litter size was 3.7+/-1.5, with 9.7% stillbirths and 8.3% kitten mortality week 1-12. The percentage of stillborn kittens increased with the age of the queen and litter size, and also differed among breeds. Kitten mortality differed among breeds, but did not increase with age of the queen. Seven percent of the litters were delivered by caesarean section, significantly more during winter and positively associated with presence of stillborn kittens.
Project description:In 2009, in a European survey, around a quarter of Europeans reported witnessing discrimination or harassment at their workplace. The parity committee from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) designed a questionnaire survey to investigate forms of discrimination with respect to country, gender and ethnicity among medical professionals in hospitals and universities carrying out activities in the clinical microbiology (CM) and infectious diseases (ID) fields. The survey consisted of 61 questions divided into five areas (sociodemographic, professional census and environment, leadership and generic) and ran anonymously for nearly 3 months on the ESCMID website. European specialists in CM/ID. Overall, we included 1274 professionals. The majority of respondents (68%) stated that discrimination is present in medical science. A quarter of them reported personal experience with discrimination, mainly associated with gender and geographic region. Specialists from South-Western Europe experienced events at a much higher rate (37%) than other European regions. The proportion of women among full professor was on average 46% in CM and 26% in ID. Participation in high-level decision-making committees was significantly (>10 percentage points) different by gender and geographic origin. Yearly gross salary among CM/ID professionals was significantly different among European countries and by gender, within the same country. More than one-third of respondents (38%) stated that international societies in CM/ID have an imbalance as for committee member distribution and speakers at international conferences. A quarter of CM/ID specialists experienced career and research discrimination in European hospitals and universities, mainly related to gender and geographic origin. Implementing proactive policies to tackle discrimination and improve representativeness and balance in career among CM/ID professionals in Europe is urgently needed.
Project description:BackgroundSubcutaneous self-injection of medication has benefits for the patient and healthcare system, but there are barriers such as dexterity problems and injection anxiety that can prevent self-injection being used effectively. An accurate method of evaluating patients' experiences with self-injection would enable assessment of their success in giving self-injections and the likelihood of them adhering to a self-injection regimen. The aim of this study was to develop a questionnaire to measure overall patient experience with subcutaneous self-injection (the Self-Injection Assessment Questionnaire [SIAQ]), and to investigate its psychometric properties.MethodsThe construct validity and reliability of the SIAQ were tested in patients with rheumatoid arthritis who volunteered to inject certolizumab pegol using a standard syringe during an open-label multinational extension trial of the long-term safety and efficacy of this drug. The SIAQ PRE module was self-completed before the first self-injection, and the POST module was self-completed following each of three fortnightly self-injections.ResultsNinety-seven patients completed the SIAQ. All items correlated well with their respective domains in confirmatory factor analysis. As predicted, compared with other participants, patients with very low scores (less than 3 out of 10) in PRE causal domains (Feelings about injections and Self-confidence) were significantly less satisfied with their first self-injection, as were patients with a very low score in any POST causal domain (Self-confidence, Feelings about injections, Injection-site reactions and Ease of use), demonstrating known-groups validity. Causal domain scores generally correlated most strongly with the Satisfaction with self-injection domain, supporting convergent validity. The SIAQ demonstrated internal consistency and reproducibility; Cronbach's α and the test-retest coefficient were > 0.70 for all domains. Sensitivity and responsiveness were also shown, where measurable. Each language version showed structural validity.ConclusionThe SIAQ was demonstrated to be a valid, reliable tool in patients with rheumatoid arthritis.
Project description:BackgroundInfectious diseases physicians are leaders in assessing the health risks in a variety of community settings. An understudied area with substantial controversy is the safety of dental aerosols. Previous studies have used in vitro experimental designs and/or indirect measures to evaluate bacteria and viruses from dental surfaces. However, these findings may overestimate the occupational risks of dental aerosols. The purpose of this study was to directly measure dental aerosol composition to assess the health risks for dental healthcare personnel and patients.MethodsWe used a variety of aerosol instruments to capture and measure the bacterial, viral, and inorganic composition of aerosols during a variety of common dental procedures and in a variety of dental office layouts. Equipment was placed in close proximity to dentists during each procedure to best approximate the health risk hazards from the perspective of dental healthcare personnel. Devices used to capture aerosols were set at physiologic respiration rates. Oral suction devices were per the discretion of the dentist.ResultsWe detected very few bacteria and no viruses in dental aerosols-regardless of office layout. The bacteria identified were most consistent with either environmental or oral microbiota, suggesting a low risk of transmission of viable pathogens from patients to dental healthcare personnel. When analyzing restorative procedures involving amalgam removal, we detected inorganic elements consistent with amalgam fillings.ConclusionsAerosols generating from dental procedures pose a low health risk for bacterial and likely viral pathogens when common aerosol mitigation interventions, such as suction devices, are employed.