Tag: statistics

JMIR Form Res. 2021 Dec 7;5(12):e33123. doi: 10.2196/33123.

ABSTRACT

BACKGROUND: Individuals with autism spectrum disorder (ASD) often exhibit difficulties in social and communication skills. For more than 30 years, specialists, parents, and caregivers have used techniques, such as applied behavioral analysis, augmentative and alternative communication, and the picture exchange communication system to support the social and communication skills of people with ASD. Even though there are many techniques devised to enhance communication, these techniques are not considered in existing social media apps for people with ASD.

OBJECTIVE: This study aimed to investigate the effect of adding accessibility features, such as text-to-speech (TTS), speech-to-text (STT), and communication symbols (CS), to a messaging app (MAAN). We hypothesized that these accessibility features can enhance the social and communication skills of adults with ASD. We also hypothesized that usage of this app can reduce social loneliness in adults with ASD.

METHODS: Semistructured interviews were conducted with 5 experts working in fields related to ASD to help design the app. Seven adults with ASD participated in the study for a period of 10 to 16 weeks. Data logs of participants’ interactions with the app were collected. Additionally, 6 participants’ parents and 1 caregiver were asked to complete a short version of the Social and Emotional Loneliness Scale for Adults (SELSA-S) questionnaire to compare pre-post study results. The Mobile Application Rating Scale: user version questionnaire was also used to evaluate the app’s usability. Following the study, interviews were conducted with participants to discuss their experiences with the app.

RESULTS: The SELSA-S questionnaire results showed no change in the family subscale; however, the social loneliness subscale showed a difference between prestudy and poststudy. The Wilcoxon signed-rank test indicated that poststudy SELSA-S results were statistically significantly higher than prestudy results (z=-2.047; P=.04). Point-biserial correlation indicated that the SELSA-S rate of change was strongly related to usage of the TTS feature (r=0.708; P=.04) and CS feature (r=-0.917; P=.002), and moderately related to usage of the STT feature (r=0.428; P=.17). Lastly, we adopted grounded theory to analyze the interview data, and the following 5 categories emerged: app support, feature relevance, user interface design, overall feedback, and recommendations.

CONCLUSIONS: This study discusses the potential for improving the communication skills of adults with ASD through special features in mobile messaging apps. The developed app aims to support the inclusion and independent life of adults with ASD. The study results showed the importance of using TTS, STT, and CS features to enhance social and communication skills, as well as reduce social loneliness in adults with ASD.

PMID:34878998 | DOI:10.2196/33123

J Med Internet Res. 2021 Dec 7;23(12):e21681. doi: 10.2196/21681.

ABSTRACT

BACKGROUND: Massive open online course (MOOC) research is an emerging field; to date, most research in this area has focused on participant engagement.

OBJECTIVE: The aim of this study is to evaluate both participant engagement and measures of satisfaction, appropriateness, and burden for a MOOC entitled Understanding Multiple Sclerosis (MS) among a cohort of 3518 international course participants.

METHODS: We assessed the association of key outcomes with participant education level, MS status, caregiver status, sex, and age using summary statistics, and 2-tailed t tests, and chi-square tests.

RESULTS: Of the 3518 study participants, 928 (26.37%) were people living with MS. Among the 2590 participants not living with MS, 862 (33.28%) identified as formal or informal caregivers. Our key findings were as follows: the course completion rate among study participants was 67.17% (2363/3518); the course was well received, with 96.97% (1502/1549) of participants satisfied, with an appropriate pitch and low burden (a mean of 2.2 hours engagement per week); people living with MS were less likely than those not living with MS to complete the course; and people with a recent diagnosis of MS, caregivers, and participants without a university education were more likely to apply the material by course completion.

CONCLUSIONS: The Understanding MS MOOC is fit for purpose; it presents information in a way that is readily understood by course participants and is applicable in their lives.

PMID:34878985 | DOI:10.2196/21681

J Med Internet Res. 2021 Dec 7;23(12):e28021. doi: 10.2196/28021.

ABSTRACT

BACKGROUND: Researchers face challenges in patient recruitment, especially for rare, fatal diseases such as amyotrophic lateral sclerosis (ALS). These challenges include obtaining sufficient statistical power as well as meeting eligibility requirements such as age, sex, and study proximity. Similarly, persons with ALS (PALS) face difficulty finding and enrolling in research studies for which they are eligible.

OBJECTIVE: The aim of this study was to describe how the federal Agency for Toxic Substances and Disease Registry’s (ATSDR) National ALS Registry is linking PALS to scientists who are conducting research, clinical trials, and epidemiological studies.

METHODS: Through the Registry’s online research notification mechanism (RNM), PALS can elect to be notified about new research opportunities. This mechanism allows researchers to upload a standardized application outlining their study design and objectives, and proof of Institutional Review Board approval. If the application is approved, ATSDR queries the Registry for PALS meeting the study’s specific eligibility criteria, and then distributes the researcher’s study material and contact information to PALS via email. PALS then need to contact the researcher directly to take part in any research. Such an approach allows ATSDR to protect the confidentiality of Registry enrollees.

RESULTS: From 2013 to 2019, a total of 46 institutions around the United States and abroad have leveraged this tool and over 600,000 emails have been sent, resulting in over 2000 patients conservatively recruited for clinical trials and epidemiological studies. Patients between the ages of 60 and 69 had the highest level of participation, whereas those between the ages of 18 and 39 and aged over 80 had the lowest. More males participated (4170/7030, 59.32%) than females (2860/7030, 40.68%).

CONCLUSIONS: The National ALS Registry’s RNM benefits PALS by connecting them to appropriate ALS research. Simultaneously, the system benefits researchers by expediting recruitment, increasing sample size, and efficiently identifying PALS meeting specific eligibility requirements. As more researchers learn about and use this mechanism, both PALS and researchers can hasten research and expand trial options for PALS.

PMID:34878988 | DOI:10.2196/28021

IEEE Trans Ultrason Ferroelectr Freq Control. 2021 Dec 8;PP. doi: 10.1109/TUFFC.2021.3134163. Online ahead of print.

ABSTRACT

We perform experiments exploring the use of White Rabbit PTP for time and frequency dissemination over long-distance optical fiber links. We use unidirectional links, to ensure compatibility with active telecommunication networks, and White Rabbit equipment with modifications for improved performance. Using fiber spools, we realize a 500 km, four-span cascaded White Rabbit link. We show short term fractional frequency stability of 2×10-12, averaging down to 2×10-15 at one day of integration time, with no frequency shift within the statistical uncertainty. We demonstrate the impact of increasing the White Rabbit SoftPLL bandwidth and the PTP message rate. We show evidence of the effect of thermal fluctuations acting on the fiber, and finally discuss the limitations of the achieved performance. We show comparisons with experimental data acquired with commercial good quality GPS receivers and show that the medium- and long- term stability and accuracy are more than one order of magnitude better with a White Rabbit PTP link.

PMID:34878974 | DOI:10.1109/TUFFC.2021.3134163

Curr Med Res Opin. 2021 Dec 8:1-22. doi: 10.1080/03007995.2021.2010437. Online ahead of print.

ABSTRACT

OBJECTIVE: The SPUR (Social, Psychological, Usage and Rational) Adherence Profiling Tool is a recently developed adaptive instrument for measuring key patient-level risk factors for adherence problems. This study describes the SPUR questionnaire’s psychometric refinement and evaluation.

METHODS: Data were collected through an online survey among individuals with type 2 diabetes in the United States. 501 participants completed multiple questionnaires, including SPUR and several validated adherence measures.A Partial Credit Model (PCM) analysis was performed to evaluate the structure of the SPUR tool and verify the assumption of a single underlying latent variable reflecting adherence. Partial least-squares discriminant analyses (PLS-DA) were conducted to identify which hierarchically-defined items within each dimension needed to be answered by a given patient. Lastly, correlations were calculated between the latent trait of SPUR adherence and other patient-reported adherence measures.

RESULTS: Of the 45 candidate SPUR items, 39 proved to fit well to the PCM confirming that SPUR responses reflected one underlying latent trait hypothesized as non-adherence. Correlations between the latent trait of the SPUR tool and other adherence measures were positive, statistically significant and ranged from 0.32 to 0.48 (p-values <0.0001). The person-item map showed that the items reflected well the range of adherence behaviors from perfect adherence to high levels of non-adherence. The PLS-DA results confirmed the relevance of using four meta-items as filters to open or close subsequent items from their corresponding SPUR dimensions.

CONCLUSIONS: The SPUR tool represents a promising new adaptive instrument for measuring adherence accurately and efficiently using digital behavioral diagnostic tool.

PMID:34878967 | DOI:10.1080/03007995.2021.2010437

Public Health Nurs. 2021 Dec 8. doi: 10.1111/phn.13026. Online ahead of print.

ABSTRACT

OBJECTIVE: Two percent of the Japanese population is comprised of foreign residents with further increase expected due to immigration policy revisions. The purpose of this paper is to examine the healthcare needs and difficulties experienced by foreign residents in Japan by level of their Japanese language fluency.

DESIGN: A quantitative, descriptive design was used.

SAMPLE: We surveyed foreign residents in the greater Tokyo area (N = 209).

MEASUREMENTS: The research team created the survey questions and the contents of the survey include foreign residents’ experiences during their visits or stays at medical and public health facilities in Japan.

RESULTS: More than 90% of the participants or their families visited medical facilities in Japan regardless of Japanese language fluency; however, those with less Japanese language fluency experienced statistically significant uneasiness or inconvenience concerning communication compared to those with native Japanese language fluency (p = .000).

CONCLUSIONS: Nurses in Japan may benefit from additional training related to use of interpreters as well as education about diversity and cultural humility. Through better understanding of the specific communication barriers of foreign residents, nurses will be able to better anticipate difficulties and address them.

PMID:34878182 | DOI:10.1111/phn.13026

Psychiatry Clin Neurosci. 2021 Dec 8. doi: 10.1111/pcn.13318. Online ahead of print.

ABSTRACT

AIM: Several studies have suggested the use of psychotropics as a possible risk factor for falling. However, there were several limitations to these previous studies, such as the use of data obtained from administrative databases and the lack of information about the time interval between psychotropics use and falling. Therefore, in this study, we aimed to assess the association between psychotropics use and falling in hospitalized patients, using reliable data collected from medical records.

METHODS: A matched (age, sex, and inpatient department) case-control study of patients hospitalized at Tokyo Medical University Hospital was performed utilizing the new-user design, based on data extracted from medical records. The outcome was the occurrence of falls. The use of 4 classes of psychotropics (antipsychotics, antidepressants, anxiolytics, and hypnotics) was compared between 254 cases (patients who experienced falls) and 254 controls (patients without falls). Multivariable logistic regression analysis was performed to clarify the associations between falling and the use of these psychotropics.

RESULTS: Univariable analyses demonstrated that the use of every class of psychotropic was statistically significantly associated with falling. Moreover, the association of the use of hypnotics with falls remained significant in the multivariable logistic regression model built including potential confounding factors, such as age, sex, inpatient department, body mass index, fall risk score measured by a fall risk assessment sheet completed on hospital admission, and the use of other classes of psychotropics.

CONCLUSIONS: Our findings suggest that the use of hypnotics may be a risk factor for falling in hospitalized patients. This article is protected by copyright. All rights reserved.

PMID:34878206 | DOI:10.1111/pcn.13318

Cochrane Database Syst Rev. 2021 Dec 8;12:MR000051. doi: 10.1002/14651858.MR000051.pub2.

ABSTRACT

BACKGROUND: Trial monitoring is an important component of good clinical practice to ensure the safety and rights of study participants, confidentiality of personal information, and quality of data. However, the effectiveness of various existing monitoring approaches is unclear. Information to guide the choice of monitoring methods in clinical intervention studies may help trialists, support units, and monitors to effectively adjust their approaches to current knowledge and evidence.

OBJECTIVES: To evaluate the advantages and disadvantages of different monitoring strategies (including risk-based strategies and others) for clinical intervention studies examined in prospective comparative studies of monitoring interventions.

SEARCH METHODS: We systematically searched CENTRAL, PubMed, and Embase via Ovid for relevant published literature up to March 2021. We searched the online ‘Studies within A Trial’ (SWAT) repository, grey literature, and trial registries for ongoing or unpublished studies.

SELECTION CRITERIA: We included randomized or non-randomized prospective, empirical evaluation studies of different monitoring strategies in one or more clinical intervention studies. We applied no restrictions for language or date of publication.

DATA COLLECTION AND ANALYSIS: We extracted data on the evaluated monitoring methods, countries involved, study population, study setting, randomization method, and numbers and proportions in each intervention group. Our primary outcome was critical and major monitoring findings in prospective intervention studies. Monitoring findings were classified according to different error domains (e.g. major eligibility violations) and the primary outcome measure was a composite of these domains. Secondary outcomes were individual error domains, participant recruitment and follow-up, and resource use. If we identified more than one study for a comparison and outcome definitions were similar across identified studies, we quantitatively summarized effects in a meta-analysis using a random-effects model. Otherwise, we qualitatively summarized the results of eligible studies stratified by different comparisons of monitoring strategies. We used the GRADE approach to assess the certainty of the evidence for different groups of comparisons.

MAIN RESULTS: We identified eight eligible studies, which we grouped into five comparisons. 1. Risk-based versus extensive on-site monitoring: based on two large studies, we found moderate certainty of evidence for the combined primary outcome of major or critical findings that risk-based monitoring is not inferior to extensive on-site monitoring. Although the risk ratio was close to ‘no difference’ (1.03 with a 95% confidence interval [CI] of 0.81 to 1.33, below 1.0 in favor of the risk-based strategy), the high imprecision in one study and the small number of eligible studies resulted in a wide CI of the summary estimate. Low certainty of evidence suggested that monitoring strategies with extensive on-site monitoring were associated with considerably higher resource use and costs (up to a factor of 3.4). Data on recruitment or retention of trial participants were not available. 2. Central monitoring with triggered on-site visits versus regular on-site visits: combining the results of two eligible studies yielded low certainty of evidence with a risk ratio of 1.83 (95% CI 0.51 to 6.55) in favor of triggered monitoring intervention. Data on recruitment, retention, and resource use were not available. 3. Central statistical monitoring and local monitoring performed by site staff with annual on-site visits versus central statistical monitoring and local monitoring only: based on one study, there was moderate certainty of evidence that a small number of major and critical findings were missed with the central monitoring approach without on-site visits: 3.8% of participants in the group without on-site visits and 6.4% in the group with on-site visits had a major or critical monitoring finding (odds ratio 1.7, 95% CI 1.1 to 2.7; P = 0.03). The absolute number of monitoring findings was very low, probably because defined major and critical findings were very study specific and central monitoring was present in both intervention groups. Very low certainty of evidence did not suggest a relevant effect on participant retention, and very low certainty evidence indicated an extra cost for on-site visits of USD 2,035,392. There were no data on recruitment. 4. Traditional 100% source data verification (SDV) versus targeted or remote SDV: the two studies assessing targeted and remote SDV reported findings only related to source documents. Compared to the final database obtained using the full SDV monitoring process, only a small proportion of remaining errors on overall data were identified using the targeted SDV process in the MONITORING study (absolute difference 1.47%, 95% CI 1.41% to 1.53%). Targeted SDV was effective in the verification of source documents, but increased the workload on data management. The other included study was a pilot study, which compared traditional on-site SDV versus remote SDV and found little difference in monitoring findings and the ability to locate data values despite marked differences in remote access in two clinical trial networks. There were no data on recruitment or retention. 5. Systematic on-site initiation visit versus on-site initiation visit upon request: very low certainty of evidence suggested no difference in retention and recruitment between the two approaches. There were no data on critical and major findings or on resource use.

AUTHORS’ CONCLUSIONS: The evidence base is limited in terms of quantity and quality. Ideally, for each of the five identified comparisons, more prospective, comparative monitoring studies nested in clinical trials and measuring effects on all outcomes specified in this review are necessary to draw more reliable conclusions. However, the results suggesting risk-based, targeted, and mainly central monitoring as an efficient strategy are promising. The development of reliable triggers for on-site visits is ongoing; different triggers might be used in different settings. More evidence on risk indicators that identify sites with problems or the prognostic value of triggers is needed to further optimize central monitoring strategies. In particular, approaches with an initial assessment of trial-specific risks that need to be closely monitored centrally during trial conduct with triggered on-site visits should be evaluated in future research.

PMID:34878168 | DOI:10.1002/14651858.MR000051.pub2

J Emerg Manag. 2021 Nov-Dec;19(6):541-559. doi: 10.5055/jem.0562.

ABSTRACT

High-reliability organizations (HROs) including commercial airlines, the NASA Space Shuttle engineering team, US Naval aircraft carrier and nuclear submarine crews, and US nuclear power plants are relatively safe. However, these organizations experience system breakdowns often with catastrophic outcomes. This study focuses on risk information management strategies employed by a nuclear energy power plant located within 10 miles of a population center. The evacuation planning zone (EPZ) includes a hospital, several schools, and a public university. The nuclear plant provides written preparedness and evacuation information for all residents within the EPZ in the event of a radiological emergency. Focusing on the campus community within the EPZ, this study investigates individual awareness regarding the potential of a radiological event, the emergency information booklet, and the information provided within the booklet. We use descriptive statistics, frequency distribution, and cross tabulations (contingency tables) to establish awareness levels. Our study determines those participants who read the emergency instructions booklet are prepared to make an informed decision in the event of a radiological incident. We find college affiliation, educational level, university role, and age significantly related to emergency instruction booklet utilization. We also find gender is significantly linked to overall risk perception regarding a radiological event. Findings support previous research regarding women’s higher levels of risk aversion and pessimism involving dangerous new risky technologies and activities like nuclear energy plants. These findings support modifying policy to ensure nuclear facilities assess the efficacy of their warning systems in alerting the public. Furthermore, our findings provide guidance regarding the evaluation of the effectiveness of emergency instruction booklet distribution.

PMID:34878164 | DOI:10.5055/jem.0562

Eur J Orthod. 2021 Dec 8:cjab077. doi: 10.1093/ejo/cjab077. Online ahead of print.

ABSTRACT

AIM: Bone remodelling can be followed through the bone turnover markers (BTMs). Aim of the present study was to record the fluctuation of an osteoclastic and an osteoblastic BTM [C-terminal telopeptide of type I collagen (CTX) and N-terminal pro-peptide of type I pro-collagen (PINP), respectively] in both the gingival crevicular fluid (GCF) and the serum of orthodontic patients before and after the initial application of orthodontic forces.

MATERIALS AND METHODS: Twenty-one Caucasian patients were prospectively evaluated. GCF and blood samples were collected in order to measure the selected biomarkers by ELISA at three time-points: exactly before, 5 days, and 14 days after bonding of the appliances. Standardized sample handling and patient preparation procedures were adopted in order to reduce pre-analytical variability.

RESULTS: GCF and serum CTX levels were found to be independent of age, although higher in the serum of female subjects. PINP levels were found higher in the serum of patients ≥25 years old, as well as in the GCF of males. A positive correlation between serum and GCF baseline PINP levels was observed.

LIMITATIONS: The effect of orthodontic treatment on bone remodelling might not be absolutely representative of the local bone microenvironment as the levels of the specific BTMs where measured within the GCF of the lower front teeth.

CONCLUSIONS: This is the first time PINP and CTX have been evaluated in the GCF and serum of orthodontic patients with fixed appliances. No statistically significant alterations of CTX and PINP levels in the GCF and the serum of patients were recorded over time during the initial stages of orthodontic treatment.

PMID:34878106 | DOI:10.1093/ejo/cjab077