bluuebunny/crossref_metadata_2025_split huggingface dataset:
Baseline-adjusted proportional odds models for the quantification of treatment effects in trials with ordinal sum score outcomes
Authors: Buri Muriel , Curt Armin , Steeves John , Hothorn Torsten 
Published: May 2020

AbstractBackgroundSum scores of ordinal outcomes are common in randomized clinical trials. The approaches routinely employed for assessing treatment effects, such ast-tests or Wilcoxon tests, are not particularly powerful in detecting changes in relevant parameters or lack the ability to incorporate baseline information. Hence, tailored statistical methods are needed for the analysis of ordinal outcomes in clinical research.MethodsWe propose baseline-adjusted proportional odds logistic regression models to overcome previous limitations in the analysis of ordinal outcomes in randomized clinical trials. For the validation of our method, we focus on common ordinal sum score outcomes of neurological clinical trials such as the upper extremity motor score, the spinal cord independence measure, and the self-care subscore of the latter. We compare the statistical power of our models to other conventional approaches in a large simulation study of two-arm randomized clinical trials based on data from the European Multicenter Study about Spinal Cord Injury (EMSCI, ClinicalTrials.gov Identifier: NCT01571531). We also use the new method as an alternative analysis of the historical Sygen®clinical trial.ResultsThe simulation study of all postulated trial settings demonstrated that the statistical power of the novel method was greater than that of conventional methods. Baseline adjustments were more suited for the analysis of the upper extremity motor score compared to the spinal cord independence measure and its self-care subscore.ConclusionsThe proposed baseline-adjusted proportional odds models allow the global treatment effect to be directly interpreted. This clear interpretation, the superior statistical power compared to the conventional analysis approaches, and the availability of open-source software support the application of this novel method for the analysis of ordinal outcomes of future clinical trials.
Adjusting for comorbidity in incidence-based DALY calculations: an individual-based modeling approach
Authors: McDonald Scott A. , Haagsma Juanita A. , Cassini Alessandro , Devleesschauwer Brecht 
Published: May 2020

Abstract
Background
The co-occurrence of two or more medical conditions in the same individual is not uncommon. If disability-adjusted life year (DALY) calculations are carried out for each condition separately, multimorbidity may lead to an overestimation of the morbidity component, the Years Lived with Disability (YLD). Adjusting for comorbidity may be straightforward if all symptoms have same onset and duration; however, when the comorbid health states occur at different time points, an analytical solution to the comorbidity problem becomes more complex. The aim of this study was to develop an individual-based modelling (IBM) approach to adjust incidence-based disease burden estimation for multimorbidity that allows simulating hypothetical individuals and tracking their disease history, including possible comorbidities, over time.

Methods
We demonstrated the IBM approach using an example of external comorbidity, i.e., colon cancer comorbid with healthcare-associated pneumonia (HAP) and by assuming an independent multiplicative model. First, each cumulative progression probabilities were converted to a daily transition probabilities. Second, disability weights for simultaneously experienced health states and duration in each health state were determined. Third, YLD, adjusted for comorbidity, was calculated at every time step. We simulated a cohort of 1000 colorectal cancer patients aged 65 years. Ninety-five percent uncertainty intervals around median YLD values were estimated by Monte Carlo methods.

Results
The median estimated YLD per 1000 cases (due to both cancer and HAP) adjusted for co-morbidity was 545 YLD/1000 (95% interval: 513–585). The impact of not adjusting disability weights for co-existent health states varied from minimal to small; YLD for colorectal cancer would be overestimated only slightly – by 1.6 YLD/1000 – by not adjusting for concurrent HAP. YLD for those HAP patients who have concurrent early-stage colorectal cancer would be overestimated by 2.3 YLD/1000.

Conclusions
The computation of disease burden in the presence of multimorbidity using the incidence-based DALY approach can be handled through IBM. Our approach can be extended to other, more complicated multimorbidity scenarios which are responsible for a high current global disease burden, such as tuberculosis and HIV infection.
Feasibility and evaluation of a large-scale external validation approach for patient-level prediction in an international data network: validation of models predicting stroke in female patients newly diagnosed with atrial fibrillation
Authors: Reps Jenna M. , Williams Ross D. , You Seng Chan , Falconer Thomas , Minty Evan , Callahan Alison , Ryan Patrick B. , Park Rae Woong , Lim Hong-Seok , Rijnbeek Peter 
Published: May 2020

Abstract
Background
To demonstrate how the Observational Healthcare Data Science and Informatics (OHDSI) collaborative network and standardization can be utilized to scale-up external validation of patient-level prediction models by enabling validation across a large number of heterogeneous observational healthcare datasets.

Methods
Five previously published prognostic models (ATRIA, CHADS2, CHADS2VASC, Q-Stroke and Framingham) that predict future risk of stroke in patients with atrial fibrillation were replicated using the OHDSI frameworks. A network study was run that enabled the five models to be externally validated across nine observational healthcare datasets spanning three countries and five independent sites.

Results
The five existing models were able to be integrated into the OHDSI framework for patient-level prediction and they obtained mean c-statistics ranging between 0.57–0.63 across the 6 databases with sufficient data to predict stroke within 1 year of initial atrial fibrillation diagnosis for females with atrial fibrillation. This was comparable with existing validation studies. The validation network study was run across nine datasets within 60 days once the models were replicated. An R package for the study was published at https://github.com/OHDSI/StudyProtocolSandbox/tree/master/ExistingStrokeRiskExternalValidation.

Conclusion
This study demonstrates the ability to scale up external validation of patient-level prediction models using a collaboration of researchers and a data standardization that enable models to be readily shared across data sites. External validation is necessary to understand the transportability or reproducibility of a prediction model, but without collaborative approaches it can take three or more years for a model to be validated by one independent researcher. In this paper we show it is possible to both scale-up and speed-up external validation by showing how validation can be done across multiple databases in less than 2 months. We recommend that researchers developing new prediction models use the OHDSI network to externally validate their models.
Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection
Authors: Bullement Ash , Willis Anna , Amin Amerah , Schlichting Michael , Hatswell Anthony James , Bharmal Murtuza 
Published: May 2020

AbstractBackgroundDue to limited duration of follow up in clinical trials of cancer treatments, estimates of lifetime survival benefits are typically derived using statistical extrapolation methods. To justify the method used, a range of approaches have been proposed including statistical goodness-of-fit tests and comparing estimates against a previous data cut (i.e. interim data collected). In this study, we extend these approaches by presenting a range of extrapolations fitted to four pre-planned data cuts from the JAVELIN Merkel 200 (JM200) trial. By comparing different estimates of survival and goodness-of-fit as JM200 data mature, we undertook an iterative process of fitting and re-fitting survival models to retrospectively identify early indications of likely long-term survival.MethodsStandard and spline-based parametric models were fitted to overall survival data from each JM200 data cut. Goodness-of-fit was determined using an assessment of the estimated hazard function, information theory-based methods and objective comparisons of estimation accuracy. Best-fitting extrapolations were compared to establish which one provided the most accurate estimation, and how statistical goodness-of-fit differed.ResultsSpline-based models provided the closest fit to the final JM200 data cut, though all extrapolation methods based on the earliest data cut underestimated the ‘true’ long-term survival (difference in restricted mean survival time [RMST] at 36 months: − 1.1 to − 0.5 months). Goodness-of-fit scores illustrated that an increasingly flexible model was favored as data matured. Given an early data cut, a more flexible model better aligned with clinical expectations could be reasonably justified using a range of metrics, including RMST and goodness-of-fit scores (which were typically within a 2-point range of the statistically ‘best-fitting’ model).ConclusionsSurvival estimates from the spline-based models are more aligned with clinical expectation and provided a better fit to the JM200 data, despite not exhibiting the definitively ‘best’ statistical goodness-of-fit. Longer-term data are required to further validate extrapolations, though this study illustrates the importance of clinical plausibility when selecting the most appropriate model. In addition, hazard-based plots and goodness-of-fit tests from multiple data cuts present useful approaches to identify when a more flexible model may be advantageous.Trial registrationJAVELIN Merkel 200 was registered with ClinicalTrials.gov asNCT02155647on June 4, 2014.
Screening for atrial fibrillation and other arrhythmias in primary care
Authors: Wong Kam Cheong , Kok Cindy , Marschner Simone , Usherwood Tim , Chow Clara K. 
Published: May 2020

Abstract
Background
Atrial fibrillation (AF) and other arrhythmias are prevalent and often encountered by general practitioners (GPs). In response to the growing prevalence and to assist practitioners in the diagnosis and management of AF, the Cardiac Society of Australia & New Zealand and Heart Foundation of Australia published the first Australian AF Guidelines in 2018. We aimed to examine (a) the proportion of GPs who performed any form of AF screening and identify the methods they applied, (b) GPs’ awareness of the AF Guidelines and approaches to arrhythmia screening, (c) the roles of conventional 12-lead ECG and mobile health devices, and (d) GPs’ confidence in ECG interpretation and need for training.

Methods
A cross-sectional online survey titled “GPs Screen their patients for Atrial Fibrillation and othEr aRrhythmia (GPSAFER)” was conducted from October 2018 to March 2019. The participants were recruited via various GP networks across Australia. Ethics approval was granted by The University of Sydney.

Results
A total of 463 surveys were completed. Many GPs (394/463, 85.1%, 95% CI 81.5–88.2%) performed some forms of AF screening and applied at least one AF screening method, most frequently pulse palpation (389/463, 84.0%). Some (299/463, 64.6%) GPs considered assessing their patients for other arrhythmias (237/299, 79.3% for complete heart block and 236/299, 78.9% for long-QT). Most GPs (424/463, 91.6%) were not using mobile ECG devices in their practice but some (147/463, 31.7%) were contemplating it. One third (175/463, 37.8%) of GPs were aware of the Australian AF Guidelines; those aware were more likely to perform AF screening (98.9% vs 76.7%, p <  0.001). Factors significantly and positively associated with AF screening were “awareness of the AF Guidelines” (p <  0.001), “number of years working in general practice” (p <  0.001), and “confidence in ECG interpretation of AF” (p = 0.003). Most GPs reported that they were very or extremely confident in interpreting AF (381/463, 82.3%) and complete heart block (266/463, 57.5%). Many GPs (349/463, 75.4%) would like to receive online ECG interpretation training.

Conclusions
Assessment of arrhythmias is common in general practice and GPs are open to further training in ECG interpretation and using mobile ECG devices to aid their clinical practice. Increasing awareness of AF Guidelines and improving confidence in ECG interpretation may increase AF screening.
Analysis on professional identity and related factors among Chinese general practitioners: a National Cross-sectional Study
Authors: Li Liqing , Gan Yong , Yang Yudi , Jiang Heng , Lu Kai , Zhou Xiaogang , Nie Zhiqiang , Opoku Sampson , Zheng Yanling , Yu Fang , Lu Zuxun 
Published: May 2020

Abstract
Background
Studies on professional identity and related factors among Chinese general practitioners (GPs) are unavailable. The objective of this study was to investigate the professional identity level of GPs in China and explore factors associated with GPs’ perceptions of their professional identity.

Methods
A multistage stratified random sampling method was used to collect data with a structured self-administered questionnaire from 3236 GPs working in community health service institutions (CHIs) in China between October, 2017 and February, 2018. Professional identity was measured by the 13 items scale. Descriptive statistics were calculated and groups’ differences were estimated using nonparametric tests. Multiple linear stepwise regression analysis was used to analyze factors associated with professional identity among GPs.

Results
Based on a total score of 65 on the professional identity scale, the average score for GPs’ professional identity was 51.23 (SD = 6.56). Multiple linear stepwise regression analysis showed that GPs who practiced in Central China, with an administrative responsibility, at a moderate or higher income level, who frequently worked overtime, had more occupational development opportunities, with a higher level of job satisfaction and older GPs had higher levels of professional identity.

Conclusions
Professional identity level among GPs in China is high. Region, administrative responsibility, income level, working overtime, occupational development opportunities, age, and job satisfaction were significant predictors of professional identity.
The relationship between metabolic syndrome and increased risk of Barrett’s esophagus: an updated systematic review and meta-analysis
Authors: Karimian Mohammad , Salamati Majid , Azami Milad 
Published: May 2020

AbstractBackgroundThe relationship between metabolic syndrome (MetS) and Barrett’s esophagus (BE) is still a challenging issue, and inconsistent results have been reported in different studies. Therefore, this study was conducted to determine the relationship between MetS and BE.MethodsIn this study, we followed the MOOSE protocol and results were reported according to the PRISMA guidelines. All study steps were performed independently by two authors. If necessary, the dispute was resolved by consultation with a third author. The search strategy is designed to find published studies. Comprehensive search was done in the following databases until July 2019: Cochrane Library, PubMed/Medline, Web of Science, Science Direct, EMBASE, Scopus, CINAHL, EBSCO, and Google Scholar search engine. All analyses were performed using Comprehensive Meta-Analysis Software Ver.2, whilep-value lower than 0.05 was considered significant.ResultsIn 14 studies with a sample size of 108,416, MetS significantly increased the risk of BE (OR = 1.354; 95% CI: 1.145–1.600;P < 0.001; Heterogeneity: I2 = 81.95%;P < 0.001). Sensitivity analysis by omitting one study showed that overall estimates are still robust. Subgroup analysis was significant for continent (P < 0.001) and MetS diagnostic criteria (P = 0.043), but was not significant for variables of study type (P = 0.899), study setting (P = 0.115), control groups (P = 0.671) and quality of studies (P = 0.603). The Begg (P = 0.912) and Egger’s (P = 0.094) tests were not significant; therefore, the publication bias did not play a role in the results.ConclusionMetS increases the risk of BE compared to control groups. The results of this study can help health practitioners by identifying a treatable risk factor for the most important risk factor for esophageal carcinoma (ie, BE). Future studies should examine whether treatment for MetS reduces the risk of BE.
The effect of digital reminiscence therapy on people with dementia: a pilot randomized controlled trial
Authors: Moon SeolHwa , Park Kyongok 
Published: May 2020

Abstract
Background
Reminiscence therapy (RT) can improve various dysfunctions in people with dementia (PWD), but it may not be a cost-effective intervention. Digital RT allows multiple users to participate in a therapy simultaneously. Moreover, digital RT offers convenience, such as for uploading personal materials and presenting individual triggers of personal memories. This pilot study aimed to evaluate the effect of digital RT through a comparison with conventional RT and to develop a strategy for designing larger RCTs.

Methods
An Android application and digital content were developed for digital RT. Overall, 49 PWD enrolled in nine daycare centers in Korea met the inclusion criteria. Eight sessions of digital RT in an intervention group (n = 25) and storytelling in a control group (n = 24) with no digital materials were performed over 4 weeks from February to June 2019. Cognition, depression, behavioral and psychological symptoms of dementia (BPSD), and engagement were measured as the primary outcomes to evaluate the effect of digital RT. All outcomes except for engagement were evaluated at baseline before the intervention (T0), post-intervention (T1), and 4 weeks after the intervention (T2). Engagement was measured at the first and last intervention sessions. Differences in cognition, depression and BPSD between groups and across time points (T0, T1, and T2) were analyzed by repeated measures ANOVA. Differences in engagement between the groups and time points (the first and last sessions) were analyzed by independent t-tests. This study adhered to the CONSORT guidelines.

Results
Depression (F = 7.62, p = .001, partial η2 = .17) was significantly decreased at T1 and T2, and engagement (t = − 2.71, p = .011) was significantly increased at the last session in the digital RT group compared to the control group. However, cognition (F = 0.13, p = .821) and BPSD (F = 0.67, p = .485) were not significantly different between groups and time points.

Conclusions
Digital RT proved an innovative approach to manage PWD and will thus help PWD achieve a better mood and have more opportunities to engage in social interactions.

Trial registration
KCT0003446 in the Clinical Research Information Service. Registered 24 January 2019, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14391
The construction of a conceptual framework explaining the relation between barriers to change of management of neuropsychiatric symptoms in nursing homes: a qualitative study using focus groups
Authors: van Teunenbroek Charlotte F. , Verhagen Kim , Smalbrugge Martin , Persoon Anke , Zuidema Sytse U. , Gerritsen Debby L. 
Published: May 2020

Abstract
Background
Several efforts have been made to change management of neuropsychiatric symptoms (NPS) in nursing homes, however only few were successful. Numerous barriers to change in healthcare were identified, yet only one conceptual model is known to study their interrelationships. Unfortunately, this model does not discuss specific barriers encountered in nursing home practice. The aim of this study is to explore perceived barriers to change in the management of NPS in nursing homes and to construct a conceptual framework providing insight into the relative importance and interrelationships of these barriers when improving quality of care.

Methods
Four focus groups were conducted in different dementia special care units of one Dutch nursing home. Participants were either nursing staff, treatment staff or relatives of residents. Qualitative thematic analysis was conducted according to the five phases defined by Braun & Clarke. Finally, a conceptual framework showing the interrelations of barrier-themes was constructed using text fragments of the focus groups.

Results
We constructed a conceptual framework consisting of eight themes of barriers explaining the extent to which change in NPS-management can be achieved: ‘organizational barriers’, ‘personal barriers’, ‘deficiency of staff knowledge’, ‘suboptimal communication’, ‘inadequate (multidisciplinary) collaboration’, ‘disorganization of processes’, ‘reactive coping’ and ‘differences in perception’. Addressing ‘organizational barriers’ and ‘deficiency of staff knowledge’ is a precondition for change. ‘Suboptimal communication’ and ‘inadequate (multidisciplinary) collaboration’ play a key role in the extent of change achieved via the themes ‘differences in perception’ and ‘disorganization of processes’. Furthermore, ‘personal barriers’ influence all themes - except ‘organizational barriers’ - and may cause ‘reactive coping’, which in turn may lead to ‘difficulties to structure processes’.

Conclusions
A conceptual framework was created explaining the relationships between barriers towards achieving change focused on improving management of NPS in nursing homes. After this framework has been confirmed and refined in additional research, it can be used to study the interrelatedness of barriers to change, and to determine the importance of addressing them for achieving change in the provided care.
Usual physical activity and subsequent hospital usage over 20 years in a general population: the EPIC-Norfolk cohort
Authors: Luben Robert , Hayat Shabina , Wareham Nicholas , Pharoah Paul , Khaw Kay-Tee 
Published: May 2020

Abstract
Background
While physical activity interventions have been reported to reduce hospital stays, it is not clear if, in the general population, usual physical activity patterns may be associated with subsequent hospital use independently of other lifestyle factors.

Objective
We examined the relationship between reported usual physical activity and subsequent admissions to hospital and time spent in hospital for 11,228 men and 13,786 women aged 40–79 years in the general population.

Methods
Participants from a British prospective population-based cohort study were followed for 20 years (1999–2019) using record linkage to document hospital usage. Total physical activity was estimated by combining workplace and leisure time activity reported in a baseline lifestyle questionnaire and repeated in a subset at a second time point approximately 12 years later.

Results
Compared to those reporting no physical activity, participants who were the most active had a lower likelihood of spending more than 20 days in hospital odds ratio (OR) 0.88 (95% confidence interval (CI) 0.81–0.96) over the next 20 years after multivariable adjustment for age, sex, smoking status, education, social class and body mass index. Participants reporting any activity had a mean of 0.42 fewer hospital days per year between 1999 and 2009 compared to inactive participants, an estimated potential saving to the National Health Service (NHS) of £247 per person per year, or approximately 7% of UK health expenditure. Participants who remained physically active or became active 12 years later had lower risk of subsequent hospital usage than those who remained inactive or became inactive, p-trend < 0.001.

Conclusion
Usual physical activity in this middle-aged and older population predicts lower future hospitalisations - time spent in hospital and number of admissions independently of behavioural and sociodemographic factors. Small feasible differences in usual physical activity in the general population may potentially have a substantial impact on hospital usage and costs.