Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice.

BACKGROUND: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative. METHODS: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors. DISCUSSION: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.

Frequency of antiseptic resistance genes and reduced susceptibility to biocides in carbapenem-resistant Acinetobacter baumannii.

The aim of this study is to determine the frequency of quaternary ammonium compound-resistant genes, including qacA/B, qacC/D, qacE, qacΔE1, qacG, qacJ, and ß-lactamase genes, including blaCTX-M, blaTEM, blaSHV, blaOXA-23, blaVIM, blaIMP, blaNDM and blaGIM in 51 isolates of carbapenem-resistant Acinetobacter baumannii collected over a period of 2 years and to determine the MIC of chlorhexidine and quaternary ammonium compound-based disinfectant benzalkonium chloride. The qac and bla genes were detected by the PCR method. The MICs were determined using the broth microdilution method. The MIC of benzalkonium chloride was in the range of 4 to 64 µg l-1 and chlorhexidine in the range of 4 to 64 µg l-1. The qacΔE1 gene was detected in 96.07 % (49/51) isolates and qacE in 31.37 % (16/51), qacG in 23.52 % (12/51) and qacA/B in 13.72 % (7/51). The qacC/D genes and qacJ were not found in any of these strains in this study. The frequency of bla genes was as follows: 84.31 % (43/51) for blaOXA-23, 33.33 % (17/51) for blaTEM, 27.45 % (14/51) for blaVIM, 19.61 % (10/51) for blaSHV, 17.65 % (9/51) for blaNDM, 11.76 % (6/51) for blaGIM and 7.8 % (4/51) for the blaIMP. The blaCTX-M genes were negative in all the strains. From the study, we concluded that reduced susceptibility to the two disinfectants, as well as qac and bla genes, was prevalent among A. baumannii isolates from the hospital environment. This study may offer hospitals important information about the control of nosocomial infections caused by A. baumannii.

Depression, anxiety and stress among patients with dialysis and the association with quality of life.

Studies addressing the nature of relationship between psychological symptoms and quality of life among dialysis patients in Malaysia are scarce. Hence, this study is intended to investigate the association between psychological symptoms such as depression, anxiety and stress on the quality of life in dialysis patients. A cross sectional multicentre study was conducted from May to October 2012 at 15 centres that provide haemodialysis and/or peritoneal dialysis. Apart from socio-demographic profile data collection, WHOQOL-BREF and DASS21 questionnaires were administered to study subjects. All three psychological symptoms had significant impact on quality of life domains of physical health, psychological health, social impact, perceived environment and overall quality of life. These findings suggest that subjects with symptoms of depression, anxiety and stress had poorer quality of life than those without, highlighting the negative impact of psychological symptoms.

Quality of life in dialysis: A Malaysian perspective.

There is a growing interest to use quality of life as one of the dialysis outcome measurement. Based on the Malaysian National Renal Registry data on 15 participating sites, 1569 adult subjects who were alive at December 31, 2012, aged 18 years old and above were screened. Demographic and medical data of 1332 eligible subjects were collected during the administration of the short form of World Health Organization Quality of Life questionnaire (WHOQOL-BREF) in Malay, English, and Chinese language, respectively. The primary objective is to evaluate the quality of life among dialysis patients using WHOQOL-BREF. The secondary objective is to examine significant factors that affect quality of life score. Mean (SD) transformed quality of life scores were 56.2 (15.8), 59.8 (16.8), 58.2 (18.5), 59.5 (14.6), 61.0 (18.5) for (1) physical, (2) psychological, (3) social relations, (4) environment domains, and (5) combined overall quality of life and general health, respectively. Peritoneal dialysis group scored significantly higher than hemodialysis group in the mean combined overall quality of life and general health score (63.0 vs. 60.0, P < 0.001). Independent factors that were associated significantly with quality of life score in different domains include gender, body mass index, religion, education, marital status, occupation, income, mode of dialysis, hemoglobin, diabetes mellitus, coronary heart disease, cerebral vascular accident and leg amputation. Subjects on peritoneal dialysis modality achieved higher combined overall quality of life and general health score than those on hemodialysis. Religion and cerebral vascular accident were significantly associated with all domains and combined overall quality of life and general health.

Persistence of multiple genetic lineages within intrahost populations of Ross River virus.

We examined the structure and extent of genetic diversity in intrahost populations of Ross River virus (RRV) in samples from six human patients, focusing on the nonstructural (nsP3) and structural (E2) protein genes. Strikingly, although the samples were collected from contrasting ecological settings 3,000 kilometers apart in Australia, we observed multiple viral lineages in four of the six individuals, which is indicative of widespread mixed infections. In addition, a comparison with previously published RRV sequences revealed that these distinct lineages have been in circulation for at least 5 years, and we were able to document their long-term persistence over extensive geographical distances.

Single-round infectious particles enhance immunogenicity of a DNA vaccine against West Nile virus.

DNA vaccines encoding replication-defective viruses are safer than inactivated or live attenuated viruses but may fail to stimulate an immune response sufficient for effective vaccination. We augment the protective capacity of a capsid-deleted flavivirus DNA vaccine by co-expressing the capsid protein from a separate promoter. In transfected cells, the capsid-deleted RNA transcript is replicated and translated to produce secreted virus-like particles lacking the nucleocapsid. This RNA is also packaged with the help of co-expressed capsid protein to form secreted single-round infectious particles (SRIPs) that deliver the RNA into neighboring cells. In SRIP-infected cells, the RNA is replicated again and produces additional virus-like particles, but in the absence of capsid RNA no SRIPs are formed and no further spread occurs. Compared with an otherwise identical construct that does not encode capsid, our vaccine offers better protection to mice after lethal West Nile virus infection. It also elicits virus-neutralizing antibodies in horses. This approach may enable vaccination against pathogenic flaviviruses other than West Nile virus.