Barriers encountered during enrollment in an internet-mediated randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Online technology is a promising resource for conducting clinical research. While the internet may improve a study's reach, as well as the efficiency of data collection, it may also introduce a number of challenges for participants and investigators. The objective of this research was to determine the challenges that potential participants faced during the enrollment phase of a randomized controlled intervention trial of Stepping Up to Health, an internet-mediated walking program that utilized a multi-step online enrollment process.</p> <p>Methods</p> <p>We conducted a quantitative content analysis of 623 help tickets logged in a participant management database during the enrollment phase of a clinical trial investigating the effect of an automated internet-mediated walking intervention. Qualitative coding was performed by two trained coders, and 10% of the sample was coded by both coders to determine inter-coder reliability. Quantitative analyses included standard descriptive statistics on ticket characteristics and theme frequency, and a Poisson regression analysis identified characteristics of potential participants who reported more frequent problems during enrollment.</p> <p>Results</p> <p>In total, 880 potential participants visited the study website and 80% completed the enrollment screening. Of the potential participants who visited the study website, 38% had help tickets logged in the participant management database. The total number of help tickets associated with individual potential participants ranged from 0 to 7 (M = .71). Overall, 46% of help tickets were initiated by email and 54% were initiated by phone. The most common help ticket theme was issues related to the study process (48%). The next most prominent theme was discussion related to obtaining medical clearance (34%), followed by issues related to pedometers and uploading (31%). Older individuals, women, and those with lower self-rated internet ability were more likely to report problems during the enrollment process.</p> <p>Conclusion</p> <p>Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00729040</p

Reliability and validity of the Japanese version of the Resilience Scale and its short version

<p>Abstract</p> <p>Background</p> <p>The clinical relevance of resilience has received considerable attention in recent years. The aim of this study is to demonstrate the reliability and validity of the Japanese version of the Resilience Scale (RS) and short version of the RS (RS-14).</p> <p>Findings</p> <p>The original English version of RS was translated to Japanese and the Japanese version was confirmed by back-translation. Participants were 430 nursing and university psychology students. The RS, Center for Epidemiologic Studies Depression Scale (CES-D), Rosenberg Self-Esteem Scale (RSES), Social Support Questionnaire (SSQ), Perceived Stress Scale (PSS), and Sheehan Disability Scale (SDS) were administered. Internal consistency, convergent validity and factor loadings were assessed at initial assessment. Test-retest reliability was assessed using data collected from 107 students at 3 months after baseline. Mean score on the RS was 111.19. Cronbach's alpha coefficients for the RS and RS-14 were 0.90 and 0.88, respectively. The test-retest correlation coefficients for the RS and RS-14 were 0.83 and 0.84, respectively. Both the RS and RS-14 were negatively correlated with the CES-D and SDS, and positively correlated with the RSES, SSQ and PSS (all p < 0.05), although the correlation between the RS and CES-D was somewhat lower than that in previous studies. Factor analyses indicated a one-factor solution for RS-14, but as for RS, the result was not consistent with previous studies.</p> <p>Conclusions</p> <p>This study demonstrates that the Japanese version of RS has psychometric properties with high degrees of internal consistency, high test-retest reliability, and relatively low concurrent validity. RS-14 was equivalent to the RS in internal consistency, test-retest reliability, and concurrent validity. Low scores on the RS, a positive correlation between the RS and perceived stress, and a relatively low correlation between the RS and depressive symptoms in this study suggest that validity of the Japanese version of the RS might be relatively low compared with the original English version.</p

How Public Health Nurses' Deal with Sexting Among Young People: a Qualitative Inquiry Using the Critical Incident Technique

Globally, the potentially harmful effects of using cell phone technology for 'sexting' among young people, is a public health concern. The background literature indicates that sexting might have adverse psychosocial consequences for some young people who share partially nude images ('selfies'). Public health nurses (PHNs) could offer guidance to children and young people on digital safety, yet little is known about their role in this regard. This study explored PHNs' knowledge and confidence in addressing the issue among young people. A qualitative study was undertaken using the Critical Incident Technique. The study took place in 2016. Eighteen semi-structured interviews were conducted with PHNs in a region of England. Data were analysed through thematic analysis, and managed through the use of NViVo 11 software. From the entire data set, thirteen critical incidents were identified of which nine were deemed relevant for reporting in this paper. PHNs regarded sexting as a contemporary 'normalised' practice that takes place in what young people consider to be trusting relationships. PHNs' knowledge was informed by media reports that supported their beliefs about young peoples' vulnerability to risk-taking sexual behaviour. They were not confident about discussing sexting with young people, even though some PHNs had done so in light of concerns about potential child sexual exploitation. PHNs have a role to play in advising young people on digital safety, but findings of the study show that their role is not fully realised. They have some knowledge of sexting as a possible signifier of abusive behaviour. However, they are not always confident in dealing with the issue. Improving PHNs ability to promote digital safety through better understanding of technology use among young people is good safeguarding practice. This may, in turn, better define this important nursing contribution to public health

Social cohesion through football: a quasi-experimental mixed methods design to evaluate a complex health promotion program

Social isolation and disengagement fragments local communities. Evidence indicates that refugee families are highly vulnerable to social isolation in their countries of resettlement. Research to identify approaches to best address this is needed. Football United is a program that aims to foster social inclusion and cohesion in areas with high refugee settlement in New South Wales, Australia, through skills and leadership development, mentoring, and the creation of links with local community and corporate leaders and organisations. The Social Cohesion through Football study’s broad goal is to examine the implementation of a complex health promotion program, and to analyse the processes involved in program implementation. The study will consider program impact on individual health and wellbeing, social inclusion and cohesion, as well as analyse how the program by necessity interacts and adapts to context during implementation, a concept we refer to as plasticity. The proposed study will be the first prospective cohort impact study to our knowledge to assess the impact of a comprehensive integrated program using football as a vehicle for fostering social inclusion and cohesion in communities with high refugee settlement

Genome-wide analyses as part of the international FTLD-TDP whole-genome sequencing consortium reveals novel disease risk factors and increases support for immune dysfunction in FTLD

Frontotemporal lobar degeneration with neuronal inclusions of the TAR DNA-binding protein 43 (FTLD-TDP) represents the most common pathological subtype of FTLD. We established the international FTLD-TDP whole-genome sequencing consortium to thoroughly characterize the known genetic causes of FTLD-TDP and identify novel genetic risk factors. Through the study of 1131 unrelated Caucasian patients, we estimated that C9orf72 repeat expansions and GRN loss-of-function mutations account for 25.5% and 13.9% of FTLD-TDP patients, respectively. Mutations in TBK1 (1.5%) and other known FTLD genes (1.4%) were rare, and the disease in 57.7% of FTLD-TDP patients was unexplained by the known FTLD genes. To unravel the contribution of common genetic factors to the FTLD-TDP etiology in these patients, we conducted a two-stage association study comprising the analysis of whole-genome sequencing data from 517 FTLD-TDP patients and 838 controls, followed by targeted genotyping of the most associated genomic loci in 119 additional FTLD-TDP patients and 1653 controls. We identified three genome-wide significant FTLD-TDP risk loci: one new locus at chromosome 7q36 within the DPP6 gene led by rs118113626 (p value = 4.82e − 08, OR = 2.12), and two known loci: UNC13A, led by rs1297319 (p value = 1.27e − 08, OR = 1.50) and HLA-DQA2 led by rs17219281 (p value = 3.22e − 08, OR = 1.98). While HLA represents a locus previously implicated in clinical FTLD and related neurodegenerative disorders, the association signal in our study is independent from previously reported associations. Through inspection of our whole-genome sequence data for genes with an excess of rare loss-of-function variants in FTLD-TDP patients (n ≥ 3) as compared to controls (n = 0), we further discovered a possible role for genes functioning within the TBK1-related immune pathway (e.g., DHX58, TRIM21, IRF7) in the genetic etiology of FTLD-TDP. Together, our study based on the largest cohort of unrelated FTLD-TDP patients assembled to date provides a comprehensive view of the genetic landscape of FTLD-TDP, nominates novel FTLD-TDP risk loci, and strongly implicates the immune pathway in FTLD-TDP pathogenesis

Acid-evoked Ca2+ signalling in rat sensory neurones: effects of anoxia and aglycaemia

Ischaemia excites sensory neurones (generating pain) and promotes calcitonin gene-related peptide release from nerve endings. Acidosis is thought to play a key role in mediating excitation via the activation of proton-sensitive cation channels. In this study, we investigated the effects of acidosis upon Ca2+ signalling in sensory neurones from rat dorsal root ganglia. Both hypercapnic (pHo 6.8) and metabolic–hypercapnic (pHo 6.2) acidosis caused a biphasic increase in cytosolic calcium concentration ([Ca2+]i). This comprised a brief Ca2+ transient (half-time approximately 30 s) caused by Ca2+ influx followed by a sustained rise in [Ca2+]i due to Ca2+ release from caffeine and cyclopiazonic acid-sensitive internal stores. Acid-evoked Ca2+ influx was unaffected by voltage-gated Ca2+-channel inhibition with nickel and acid sensing ion channel (ASIC) inhibition with amiloride but was blocked by inhibition of transient receptor potential vanilloid receptors (TRPV1) with (E)-3-(4-t-butylphenyl)-N-(2,3-dihydrobenzo[b][1,4] dioxin-6-yl)acrylamide (AMG 9810; 1 μM) and N-(4-tertiarybutylphenyl)-4-(3-cholorphyridin-2-yl) tetrahydropryazine-1(2H)-carbox-amide (BCTC; 1 μM). Combining acidosis with anoxia and aglycaemia increased the amplitude of both phases of Ca2+ elevation and prolonged the Ca2+ transient. The Ca2+ transient evoked by combined acidosis, aglycaemia and anoxia was also substantially blocked by AMG 9810 and BCTC and, to a lesser extent, by amiloride. In summary, the principle mechanisms mediating increase in [Ca2+]i in response to acidosis are a brief Ca2+ influx through TRPV1 followed by sustained Ca2+ release from internal stores. These effects are potentiated by anoxia and aglycaemia, conditions also prevalent in ischaemia. The effects of anoxia and aglycaemia are suggested to be largely due to the inhibition of Ca2+-clearance mechanisms and possible increase in the role of ASICs