A global pilot comparative, cross-sectional study of clinical research nurses/research midwives: Definition, knowledge base, and communication skills related to the conduct of decentralized clinical trials.

Background: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research: the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries: The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes: (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.

A women-centred exploration of postpartum perineal pain when the perineum is diagnosed as intact: A French Gadamerian research study.

BACKGROUND: Postpartum perineal pain is a frequent symptom (90%) with consequences on postnatal health regardless of whether the perineum remains intact. The impact of that pain on both short and long-term health has been studied and literature suggests midwives have a role to play in addressing this issue. However, the determinants of perineal pain when no lesions are identified are under researched and there is little understanding of women's views on this topic. AIM AND OBJECTIVES: The aim of the study was to gain an understanding of postpartum perineal pain when the perineum is considered to be intact. The objectives were •To gain an understanding of postpartum pain and its consequences on health and well-being •To explore women's views and understanding of perineal pain postpartum •To gain an understanding of the determinants of postpartum perineal pain when no anatomic lesion is diagnosed. METHODS: A Gadamerian hermeneutic approach was used to achieve a shared understanding of the issue. Participants were recruited from two maternity hospitals in the French area of Vaucluse. All women aged 18 to 45 years old, having given birth vaginally to a single live child and diagnosed with an intact perineum, were invited to participate in face-to-face interviews. Eleven participants were interviewed once, six of whom agreed to a second interview which took place over the telephone due to Covid lockdown. FINDINGS: The findings identified three major themes 1. Can't honestly call it pain, 2. Reassurance in normality, 3. Managing the unexpected. The use of the word pain to describe perineal sensations in postpartum was questioned by the participants, who used inner resources to deal with these sensations. Fostering self-confidence, having the possibility to explain the sensations and qualifying them as normal were some approaches women usedto manage their postpartum perineal sensations in a positive manner.

Duality of practice in clinical research nursing.

Background: International evidence suggests that Clinical Research Nurses (CRN) can have a dual role incorporating both clinical care and research responsibilities. This duality of role often assists in meeting the clinical care and research needs of the participants and can contribute to the credibility of the CRN role. Conversely, it can also lead to feelings of confusion and role conflict as CRN's time is divided. Aim: To identify and explore experiences of clinical and research roles among CRNs. This emerged as a theme in a wider research project exploring CRNs' experiences of working with clinical nurses. Methods: Following an Interpretative Phenomenological Analysis approach, 10 CRNs participated in face-to-face semi-structured interviews. Transcribed data were analysed and a number of themes emerged. Duality of role was one of these. Findings: Findings indicated that if CRNs fulfil a dual role, this can assist in care provision, research delivery and in building positive relationships with clinical nurses. However, there were also instances when a dual role led to clinical nurses questioning the value of research and to issues with competing demands of clinical care and research. These experiences had an important impact on some of the CRNs and led to reflection on the value of their role. Conclusions: This study identifies new understandings of a dual role of the CRN. The findings will inform the preparation and practice of this group of nurses, whilst also leading to a deeper understanding of the CRN's role in care and research delivery. It will also contribute to a wider appreciation of organisational factors and social interactions that impact on health care research.

Extending the description of the clinical research nursing workforce.

Background: The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities. Aims: This study's aims were to determine differences in Clinical Research Nurses most frequently performed activities, if these activities are reflective of those previously described in the literature, and job titles Clinical Research Nurses use to self-identify. Methods: An online cross-sectional survey distributed via snowball sampling through email, social media, and research nurses' networks included questions on frequency of activities performed and information related to job titles. Pearson's chi-square test is analyzed for associations between the groups. Results: Respondents returned 252 questionnaires, 233 were eligible for analysis. Research nurse activities performed internationally showed both similarities and differences. Any between country comparisons will be limited to the United States and the United Kingdom. The three most common tasks reported were recruitment 120 (51.5%), monitoring the research participant for potential adverse events 187 (80.2%) and providing nursing leadership within the interdisciplinary team 169 (72.5%). Conclusion: Considering the context and range of activities of the original Clinical Research Nursing Domain of Practice, broadening the framework to include the leadership domain will better serve as a foundation for the specialty practice.

The lipid raft-dwelling protein US9 can be manipulated to target APP compartmentalization, APP processing, and neurodegenerative disease pathogenesis.

The trafficking behavior of the lipid raft-dwelling US9 protein from Herpes Simplex Virus strikingly overlaps with that of the amyloid precursor protein (APP). Both US9 and APP processing machinery rely on their ability to shuttle between endosomes and plasma membranes, as well as on their lateral accumulation in lipid rafts. Therefore, repurposing US9 to track/modify these molecular events represents a valid approach to investigate pathological states including Alzheimer's disease and HIV-associated neurocognitive disorders where APP misprocessing to amyloid beta formation has been observed. Accordingly, we investigated the cellular localization of US9-driven cargo in neurons and created a US9-driven functional assay based on the exogenous enzymatic activity of Tobacco Etch Virus Protease. Our results demonstrate that US9 can direct and control cleavage of recombinant proteins exposed on the luminal leaflet of transport vesicles. Furthermore, we confirmed that US9 is associated with lipid-rafts and can target functional enzymes to membrane microdomains where pathologic APP-processing is thought to occur. Overall, our results suggest strongly that US9 can serve as a molecular driver that targets functional cargos to the APP machinery and can be used as a tool to study the contribution of lipid rafts to neurodegenerative disease conditions where amyloidogenesis has been implicated.

FV-100 versus valacyclovir for the prevention of post-herpetic neuralgia and the treatment of acute herpes zoster-associated pain: A randomized-controlled trial.

This prospective, parallel-group, randomized, double-blind, multicenter study compared the efficacy and safety of FV-100 with valacyclovir for reducing pain associated with acute herpes zoster (HZ). Patients, ≥50 years of age, diagnosed with HZ within 72 h of lesion appearance who had HZ-associated pain, were randomized 1:1:1 to a 7-day course of either FV-100 200 mg QD (n = 117), FV-100 400 mg QD (n = 116), or valacyclovir 1000 mg TID (n =117). Efficacy was evaluated on the basis of the burden of illness (BOI; Zoster Brief Pain Inventory scores); incidence and duration of clinically significant pain (CSP); pain scores; incidence and severity of post-herpetic neuralgia (PHN); and times to full lesion crusting and to lesion healing. Safety was evaluated on the basis of adverse event (AE)/SAE profiles, changes in laboratory and vital signs values, and results of electrocardiograms. The burden of illness scores for pain through 30 days were 114.5, 110.3, and 118.0 for FV-100 200 mg, FV-100 400 mg, and valacyclovir 3000 mg, respectively. The incidences of PHN at 90 days for FV-100 200 mg, FV-100 400 mg, and valacyclovir 3000 mg were 17.8%, 12.4%, and 20.2%, respectively. Adverse event and SAE profiles of the two FV-100 and the valacyclovir groups were similar and no untoward signals or trends were evident. These results demonstrate a potential for FV-100 as an antiviral for the treatment of shingles that could both reduce the pain burden of the acute episode and reduce the incidence of PHN compared with available treatments.

Professional issues associated with the clinical research nurse role.

Clinical research nurses (CRNs) have a vital role in the conduct and governance of clinical trials. This article compares findings of an online survey conducted in 2012 by the Scottish Research Nurse and Coordinator's Network with two surveys undertaken ten years previously in a single Scottish Health Board, permitting analysis of the development of the CRN role. The findings show that CRNs are highly qualified and experienced. Many had access to professional development and support, while others continued to feel isolated. There is a need for a clear, flexible career structure for CRNs, with appropriate induction, training and continuous professional development.

A fine balance: Regulation of hippocampal Arc/Arg3.1 transcription, translation and degradation in a rat model of normal cognitive aging.

Memory decline is a common feature of aging. Expression of the immediate-early gene Arc is necessary for normal long-term memory, and although experience dependent Arc transcription is reportedly reduced in the aged rat hippocampus, it has not been clear whether this effect is an invariant consequence of growing older, or a finding linked specifically to age-related memory impairment. Here we show that experience dependent Arc mRNA expression in the hippocampus fails selectively among aged rats with spatial memory deficits. While these findings are consistent with the possibility that blunted Arc transcription contributes to cognitive aging, we also found increased basal ARC protein levels in the CA1 field of the hippocampus in aged rats with memory impairment, together with a loss of the experience dependent increase observed in young and unimpaired aged rats. Follow-up analysis revealed that increased basal translation and blunted ubiquitin mediated degradation may contribute to increased basal ARC protein levels noted in memory impaired aged rats. These findings indicate that Arc expression is regulated at multiple levels, and that several of these mechanisms are altered in cognitively impaired aged rats. Defining the influence of these alterations on the spatial and temporal fidelity of synapse specific, memory-related plasticity in the aged hippocampus is an important challenge.

The use of podcasts to enhance research-teaching linkages in undergraduate nursing students.

An understanding of research is important to enable nurses to provide evidence-based care. However, undergraduate nursing students often find research a challenging subject. The purpose of this paper is to present an evaluation of the introduction of podcasts in an undergraduate research module to enhance research-teaching linkages between the theoretical content and research in practice and improve the level of student support offered in a blended learning environment. Two cohorts of students (n=228 and n=233) were given access to a series of 5 "guest speaker" podcasts made up of presentations and interviews with research experts within Edinburgh Napier. These staff would not normally have contact with students on this module, but through the podcasts were able to share their research expertise and methods with our learners. The main positive results of the podcasts suggest the increased understanding achieved by students due to the multi-modal delivery approach, a more personal student/tutor relationship leading to greater engagement, and the effective use of materials for revision and consolidation purposes. Negative effects of the podcasts centred around problems with the technology, most often difficulty in downloading and accessing the material. This paper contributes to the emerging knowledge base of podcasting in nurse education by demonstrating how podcasts can be used to enhance research-teaching linkages and raises the question of why students do not exploit the opportunities for mobile learning.

Batch and continuous biodegradation of three model naphthenic acids in a circulating packed-bed bioreactor.

Generation of process waters contaminated by naphthenic acids is a serious environmental concern associated with processing of the oil sands. This together with the necessity for sustainable use of water highlights the need for development of effective technologies such as bioremediation for treatment of these contaminated waters. In this work, a circulating packed bed bioreactor and a culture developed in our laboratory were used to study batch and continuous biodegradation of trans-4-methyl-cyclohexane carboxylic acid (trans-4MCHCA), a mixture of cis- and trans-4-methyl-cyclohexane acetic acid (4-MCHAA), and mixture of these three naphthenic acids. Experimental results revealed that the biodegradability of the naphthenic acids was influenced by both carbon number and the spatial arrangement of the alkyl side branch. The maximum biodegradation rate of trans-4MCHCA observed during the continuous operation (209 mg/Lh at a residence time of 0.15 h) was significantly higher than those reported for CSTR and packed-bed bioreactors. The biodegradation rates of cis- and trans-4-MCHAA were much lower than trans-4MCHCA, with the maximum biodegradation rates determined for the two isomers being 4.2 and 7.8 mg/Lh, respectively (residence time: 3.3 h).

Managing blood glucose during and after exercise in Type 1 diabetes: reproducibility of glucose response and a trial of a structured algorithm adjusting insulin and carbohydrate intake.

AIMS AND OBJECTIVES: To enable people with Type 1 diabetes to exercise safely by investigating the reproducibility of the glucose response to an algorithm for carbohydrate and insulin adjustment during and after exercise compared to their self-management strategies. BACKGROUND: Difficulties in managing blood glucose levels in Type 1 diabetes whilst exercising is known to deter people from exercise. Currently there is a limited evidence base to aid health care professionals enable people with diabetes to exercise safely. This study seeks to address this gap. DESIGN: A quasi-experimental study was undertaken amongst people with Type 1 diabetes. METHODS: Over 14 days, 14 participants undertook four exercise sessions (40 minutes at 50%VO2max). Two sessions were undertaken in week 1 self-managing their diabetes and two sessions in week 2 using an algorithm for carbohydrate and insulin adjustment. RESULTS: The mean reduction of glucose levels detected by Continuous Glucose Monitoring during exercise was 3·1 (SD 2·03) mmol/l. Time spent within the range of 4-9 mmol/l during exercise was not significantly different between the self-managed and the algorithm weeks (-3-22·4 min). The mean reduction of blood glucose for each individual over all four exercise sessions ranged between 0·8-5·95 mmol/l. The technical error between days one and two was 2·4 mmol/l (CV=33·2%) and between days 3-4 the technical error was 2·7 mmol/l (CV=33·7%). CONCLUSIONS: The results provide useful data about the reproducibility of the blood glucose response to moderate intensity exercise, despite the variability of individual responses 40 minutes of moderate intensity exercise decreases Continuous Glucose Monitoring glucose by 3 mmol/l with or without a 30% decrease of insulin before exercise. RELEVANCE TO CLINICAL PRACTICE: This information provides valuable baseline information for people with diabetes and health care professionals who wish to encourage physical activity and undertake further research in this area.

Biodegradation kinetics of 1,4-benzoquinone in batch and continuous systems.

Combining chemical and biological treatments is a potentially economic approach to remove high concentration of recalcitrant compounds from wastewaters. In the present study, the biodegradation of 1,4-benzoquinone, an intermediate compound formed during phenol oxidation by chlorine dioxide, was investigated using Pseudomonas putida (ATCC 17484) in batch and continuous bioreactors. Batch experiments were conducted to determine the effects of 1,4-benzoquinone concentration and temperature on the microbial activity and biodegradation kinetics. Using the generated data, the maximum specific growth rate and biodegradation rate were determined as 0.94 h(-1) and 6.71 mg of 1,4-benzoquinone l(-1) h(-1). Biodegradation in a continuous bioreactor indicated a linear relationship between substrate loading and biodegradation rates prior to wash out of the cells, with a maximum biodegradation rate of 246 mg l(-1) h(-1) observed at a loading rate of 275 mg l(-1) h(-1) (residence time: 1.82 h). Biokinetic parameters were also determined using the steady state substrate and biomass concentrations at various dilution rates and compared to those obtained in batch cultures.

Scale up of diesel oil biodegradation in a baffled roller bioreactor.

Diesel oil is a suitable substance to represent petroleum contamination from accidental spills in operating and transportation facilities. Using a microbial culture enriched from a petroleum contaminated soil, biodegradation of diesel oil was carried out in 2.2, 55, and 220 L roller baffled bioreactors. The effects of bioreactor rotation speed (from 5 to 45 rpm) and liquid loading (from 18% to 73% of total volume) on the biodegradation of diesel oil were studied. In the small scale bioreactor (2.2L), the maximum rotation speed of 45 rpm resulted in the highest biodegradation rate with a first order biodegradation kinetic constant of 0.095 d(-1). In the larger scale bioreactors, rotation speed did not affect the biodegradation rate. Liquid loadings higher than 64% resulted in reduced biodegradation rates in the small scale bioreactor; however, in the larger roller bioreactors liquid loading did not affect the biodegradation rate. Biodegradation of diesel oil at 5 rpm and 73% loading is recommended for operating large scale roller baffled bioreactors. Under these conditions, high diesel oil concentrations up to 50 gL(-1) can be bioremediated at a rate of 1.61 gL(-1)d(-1).

Growth kinetics of Chlorella vulgaris and its use as a cathodic half cell.

The kinetics of growth of the algal species Chlorella vulgaris has been investigated using CO(2) as the growth substrate. The growth rate was found to increase as the dissolved CO(2) increased to 150 mg/L, but fell dramatically at higher concentrations. Increasing the radiant flux also increased growth rate. With a radiant flux of 32.3 mW falling directly on the 500 mL culture media, the growth rate reached up to 3.6 mg of cells/L-h. Both pH variation (5.5-7.0) and mass transfer rate of CO(2) (K(L)a between 6h(-1) and 17 h(-1)) had little effect on growth rate. Growing on glucose, the yeast Saccharomyces cerevisiae produced a stable 160 mV potential difference when acting as a microbial fuel cell anode with ferricyanide reduction at the cathode. The algal culture was observed to be a workable electron acceptor in a cathodic half cell. Using an optimum methylene blue mediator concentration, a net potential difference of 70 mV could be achieved between the growing C. vulgaris culture acting as a cathode and a 0.02 M potassium ferrocyanide anodic half cell. Surge current and power levels of 1.0 microA/mg of cell dry weight and 2.7 mW/m(2) of cathode surface area were measured between these two half cells.

Biodegradation kinetics of trans-4-methyl-1-cyclohexane carboxylic acid.

Naphthenic acids are a complex mixture of organic compounds which naturally occur in crude oil. Low molecular weight components of the naphthenic acids are known to be toxic in aquatic environments and there is a need to better understand the factors controlling the kinetics of their biodegradation. In this study, a relatively low molecular weight naphthenic acid compound (trans-isomer of 4-methyl-1-cyclohexane carboxylic acid) and a microbial culture developed in our laboratory were used to study the biodegradation of this naphthenic acid and to evaluate the kinetics of the process in batch cultures. The initial concentration of trans-4-methyl-1-cyclohexane carboxylic acid (50-750 mg l(-1)) did not affect the maximum specific growth rate of the bacteria at 23 degrees C (0.52 day(-1)) to the maximum biodegradable concentration (750 mg l(-1)). The maximum yield observed at this temperature and at a neutral pH was 0.21 mg of biomass per milligram of substrate. Batch experiments indicated that biodegradation can be achieved at low temperatures; however, the biodegradation rate at room temperature (23 degrees C) and neutral pH was 5 times faster than that observed at 4 degrees C. Biodegradation at various pH conditions indicated a maximum specific growth rate of 1.69 day(-1) and yield (0.41 mg mg(-1)) at a pH of 10.