bluuebunny/crossref_metadata_2025_split huggingface dataset:
On model-based time trend adjustments in platform trials with non-concurrent controls
Authors: Bofill Roig Marta , Krotka Pavla , Burman Carl-Fredrik , Glimm Ekkehard , Gold Stefan M. , Hees Katharina , Jacko Peter , Koenig Franz , Magirr Dominic , Mesenbrink Peter , Viele Kert , Posch Martin 
Published: August 2022

Abstract
Background
Platform trials can evaluate the efficacy of several experimental treatments compared to a control. The number of experimental treatments is not fixed, as arms may be added or removed as the trial progresses. Platform trials are more efficient than independent parallel group trials because of using shared control groups. However, for a treatment entering the trial at a later time point, the control group is divided into concurrent controls, consisting of patients randomised to control when that treatment arm is in the platform, and non-concurrent controls, patients randomised before. Using non-concurrent controls in addition to concurrent controls can improve the trial’s efficiency by increasing power and reducing the required sample size, but can introduce bias due to time trends.

Methods
We focus on a platform trial with two treatment arms and a common control arm. Assuming that the second treatment arm is added at a later time, we assess the robustness of recently proposed model-based approaches to adjust for time trends when utilizing non-concurrent controls. In particular, we consider approaches where time trends are modeled either as linear in time or as a step function, with steps at time points where treatments enter or leave the platform trial. For trials with continuous or binary outcomes, we investigate the type 1 error rate and power of testing the efficacy of the newly added arm, as well as the bias and root mean squared error of treatment effect estimates under a range of scenarios. In addition to scenarios where time trends are equal across arms, we investigate settings with different time trends or time trends that are not additive in the scale of the model.

Results
A step function model, fitted on data from all treatment arms, gives increased power while controlling the type 1 error, as long as the time trends are equal for the different arms and additive on the model scale. This holds even if the shape of the time trend deviates from a step function when patients are allocated to arms by block randomisation. However, if time trends differ between arms or are not additive to treatment effects in the scale of the model, the type 1 error rate may be inflated.

Conclusions
The efficiency gained by using step function models to incorporate non-concurrent controls can outweigh potential risks of biases, especially in settings with small sample sizes. Such biases may arise if the model assumptions of equality and additivity of time trends are not satisfied. However, the specifics of the trial, scientific plausibility of different time trends, and robustness of results should be carefully considered.
Measuring and controlling medical record abstraction (MRA) error rates in an observational study
Authors: Garza Maryam Y. , Williams Tremaine , Myneni Sahiti , Fenton Susan H. , Ounpraseuth Songthip , Hu Zhuopei , Lee Jeannette , Snowden Jessica , Zozus Meredith N. , Walden Anita C. , Simon Alan E. , McClaskey Barbara , Sanders Sarah G. , Beauman Sandra S. , Ford Sara R. , Malloch Lacy , Wilson Amy , Devlin Lori A. , Young Leslie W. 
Published: August 2022

Abstract
Background
Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical research studies relying on secondary use data. Yet, the quality of data collected using MRA is seldom assessed. We employed a novel, theory-based framework for data quality assurance and quality control of MRA. The objective of this work is to determine the potential impact of formalized MRA training and continuous quality control (QC) processes on data quality over time.

Methods
We conducted a retrospective analysis of QC data collected during a cross-sectional medical record review of mother-infant dyads with Neonatal Opioid Withdrawal Syndrome. A confidence interval approach was used to calculate crude (Wald’s method) and adjusted (generalized estimating equation) error rates over time. We calculated error rates using the number of errors divided by total fields (“all-field” error rate) and populated fields (“populated-field” error rate) as the denominators, to provide both an optimistic and a conservative measurement, respectively.

Results
On average, the ACT NOW CE Study maintained an error rate between 1% (optimistic) and 3% (conservative). Additionally, we observed a decrease of 0.51 percentage points with each additional QC Event conducted.

Conclusions
Formalized MRA training and continuous QC resulted in lower error rates than have been found in previous literature and a decrease in error rates over time. This study newly demonstrates the importance of continuous process controls for MRA within the context of a multi-site clinical research study.
Acute disease induced cognitive dysfunction in older patients – an unrecognized syndrome
Authors: Wirth Rainer , Klimek Christiane Nicola , Lueg Gero , Pourhassan Maryam , Danielzik Louisa Maria , Krüger Caroline , Trampisch Ulrike Sonja 
Published: August 2022

Abstract
Background
It is unknown, how many older hospitalized patients experience cognitive changes independently from delirium.

Methods
In this retrospective study, cognitive function was assessed with the Montreal Cognitive Assessment on admission and discharge in 103 acute care geriatric hospital patients.

Results
Mean age was 80.8 ± 7.3 years. The total MoCA score on admission was 17.8 (±4.5) and at discharge 17.7 (±4.4). The mean difference of the total MoCA score was − 0.1 (±3.5). 12 (11.7%) patients suffered from delirium. 46 (44.7%) patients experienced significant changes of cognitive function <− 2 or > 2 MoCA points without delirium. There was no significant association between delirium during hospital stay and the prevalence and magnitude of changes in total MoCA score.

Conclusion
Cognitive changes frequently occur during acute disease of geriatric patients independently from delirium. We propose the term “acute disease induced cognitive dysfunction” (ADICD) for this entity.

Trial registration
German Clinical trial register (DRKS-ID: DRKS00025157 on 28.04.2021).
Comparison of the effectiveness of the electronic portfolio and online discussion forum methods in teaching professional belonging and ethical behaviors to nursing students: a randomized controlled trial
Authors: Baghbani Reza , Rakhshan Mahnaz , Zarifsanaiey Nahid , Nemati Reza , Daneshi Safieh 
Published: August 2022

Abstract
Background
Nursing is a profession that has had many ethical aspects and understanding professional belonging and ethics as a deep and complex process is one of the basic concepts in this field. This study aimed to compare the effectiveness of training professional belonging and ethical behaviors in two methods: electronic portfolio and online discussion forum in nursing students.

Methods
This study is a single-blinded randomized-controlled trial (RCT) with two parallel intervention groups and a third control group. The sample size was 90 selected by block randomization method. The educational contents of professional belonging and ethical behaviors were presented to the participants in two ways: electronic portfolio and online discussion forum. Demographic information form, professional belonging questionnaire, and ethical behaviors questionnaire were applied to collect data. Data were analyzed using SPSS version 24 software. Respectively mean, standard deviation and repeated measured, analysis of variance tests was used in descriptive and analytic statistic. (P value < 0.05).

Results
Comparison of the mean score of professional belonging and ethical behavior in the three stages of pretest, immediately after the test and four weeks after the test in all three groups was significant (P < 0.001). The control group had a higher mean score of professional belonging immediately after the test (108.18 ± 48.9) compared to the other two groups. Also, the online discussion forum group had a higher mean score on ethical behavior in four weeks after the test (104.2 ± 0.8) compared to the other two groups.

Conclusion
Training based on two methods of the electronic portfolio and online discussion forum increases and enhances the level of ethical behaviors in students. Therefore, the implementation of such methods of training can be useful in improving, promoting, and learning ethical behaviors in nursing students. On the other hand, training based on the two methods had a negative impact on professional belonging. Therefore, it is suggested that future studies be conducted with a greater focus on areas of professional belonging.

Trial registration
This research has been registered in Iranian Clinical Trial Registration Center (IRCT) with registration number "IRCT20180612040063N1" and registration date "16/07/2018".
How and why buy-in for health in all policies was facilitated in Ecuador: a realist case study of Plan Nacional para el Buen Vivir
Authors: Mahabir Deb Finn , Shankardass Ketan , Freiler Alix , O’Campo Patricia , Brisbois Ben , Muntaner Carles 
Published: August 2022

Abstract
Background
In 2008, Ecuador introduced Plan Nacional para el Buen Vivir (PNBV; National Plan for Good Living), which was widely recognized as a promising example of Health in All Policies (HiAP) due to the integration of policy sectors on health and health equity objectives. PBNV was implemented through three successive plans (2009–2013, 2013–2017, 2017–2021). In a time of widening global health inequities, there is growing interest in understanding how politics and governance shape HiAP implementation. The objective of this study was to test specific hypotheses about how, why, to what extent, and under what circumstances HiAP was implemented in Ecuador.

Methods
An explanatory case study approach (HiAP Analysis using Realist Methods on International Case Studies—HARMONICS) was used to understand the processes that hindered or facilitated HiAP implementation. Realist methods and systems theory were employed to test hypotheses through analysis of empirical and grey literature, and 19 key informant interviews. This case study focused on processes related to buy-in for a HiAP approach by diverse policy sectors, particularly in relation to the strong mandate and transformative governance approach that were introduced by then-President Rafael Correa’s administration to support PNBV.

Results
The mandate and governance approach of the HiAP approach achieved buy-in for implementation across diverse sectors. Support for the hypotheses was found through direct evidence about buy-in for HiAP implementation by policy sectors; and indirect evidence about allocation of governmental resources for HiAP implementation. Key mechanisms identified included: influence of political elites; challenges in dealing with political opposition and ‘siloed’ ways of thinking; and the role of strategies and resources in motivating buy-in.

Conclusion
In Ecuador, political elites were a catalyst for mechanisms that impacted buy-in and government funding for HiAP implementation. They raised awareness among policy sectors initially opposed to PNBV about the rationale for changing governance practices, and they provided financial resources to support efforts related to PNBV. Specific mechanisms help explain these phenomena further. Future studies should examine ways that PNBV may have been an impediment to health equity for some marginalized groups while strengthening HiAP implementation.
Association of maternal HDL2-c concentration in the first trimester and the risk of large for gestational age birth
Authors: Huang Dongxu , Zhu Haiyan , Zhu Yandi , Dang Qinyu , Yang Qian , Zhang Yadi , Cai Xiaxia , Zhao Xiaoyan , Liang Ning , Wang Hongliang , Yu Huanling 
Published: August 2022

Abstract
Background
Maternal lipid levels during pregnancy are critical for fetal development. Recent studies revealed that high-density lipoprotein cholesterol (HDL-c) levels during pregnancy were negatively correlated with birthweight. High-density lipoprotein 2 cholesterol (HDL2-c) is one of the major subclasses of HDL-c, and its relationship with birthweight is unclear. Association of HDL2-c concentration in the first trimester and risk of large for gestational age (LGA) was explored.

Methods
This study recruited pregnant women who registered in Fuxing Hospital from October 2018 to January 2020, had regular obstetric examinations during pregnancy, and delivered between June 2019 and September 2020. Finally, 549 participants were recruited for the study. Maternal demographic characteristics and venous blood were collected at the 6th-14th gestational week, and serum total cholesterol (TC), triglyceride (TG), HDL-c, HDL2-c, high-density lipoprotein 3 cholesterol (HDL3-c), and low-density lipoprotein cholesterol (LDL-c) concentrations were detected. Neonatal characteristics were collected at delivery. A logistic regression model was used to explore the relationship between the first trimester HDL2-c concentration and LGA incidence. A nomogram was developed, and the performance was evaluated with a concordance index.

Results
Seventy-five mothers delivered LGA infants, and the LGA incidence was 13.66%. LGA mothers had significantly lower serum HDL-c and HDL2-c concentrations than appropriate for gestational age (AGA) mothers. A logistic regression model showed that HDL2-c concentration was negatively correlated with LGA risk (odds ratio (OR) = 0.237, 95% confidence intervals (CI): 0.099–0.567, P = 0.001) when adjusted for age, prepregnancy body mass index (BMI), and parity. A nomogram was generated using all these risk factors. The area under the curve (AUC) was 0.663 (95% CI: 0.593–0.732).

Conclusions
Maternal HDL2-c concentration in the first trimester was negatively correlated with the risk of LGA.
E-cigarette use and intentions related to psychological distress among cigarette, e-cigarette, and cannabis vape users during the start of the COVID-19 pandemic
Authors: Cabral Patricia 
Published: August 2022

Abstract
Background
This study examines associations between psychological distress, intentions to use e-cigarettes, and cigarette smoking, e-cigarette use, and cannabis consumption through e-cigarette use among a diverse sample of U.S. young adults.

Procedures
Young adults (N = 314; 72.5% female) were recruited to complete an online survey during the first few months of the COVID-19 pandemic.

Results
Associations between psychological distress and cigarette smoking, e-cigarette use, cannabis vaping, and intentions to use e-cigarettes were found. Current e-cigarette use (OR = 1.23, 95% CI 1.17, 1.28, p < .001; 7.5%) and cannabis vaping (OR = 2.03, 95% CI 1.88, 2.18, p < .001; 10%) was higher among female, possibly due to the significantly higher psychological distress reported among females. Interactions between intentions to use e-cigarettes and psychological distress variables were found for all smoking and vaping behaviors.

Conclusions
Public health efforts should increase focus on providing psychological services for young adults to improve coping strategies that are alternative to smoking and vaping behaviors.
Response to written commentary in preparation for high-stakes second language writing assessment
Authors: Pearson William S. 
Published: August 2022

AbstractMany L2 learners preparing for high-stakes, on-demand English language tests (e.g., IELTS, TOEFL) undertake classroom-based test preparation involving the provision of teacher written feedback commentary (WFC) on writing that simulates test tasks. The assumption is teachers’ knowledge of both the language and testing system helps develop candidates’ language/test-taking skills and familiarity with task expectations. Prior research has indicated features of WFC’s content and delivery can impact on the extent and quality of student revisions, although preparation for writing assessment settings have yet to be explored. The present study investigated the effects of five WFC content and delivery characteristics (focus, length, explicitness, semantic function, and presence of mitigation) on three rehearsal essays written by eight candidates preparing for IELTS Writing Task 2. The qualities of content and delivery most associated with substantive, positive revisions included comments targeting Task Response, those 50 words or longer, when an explicit revision strategy was provided, the presence of mitigation through personal attribution, and question posing and criticism. The study found learners tended not to act upon descriptive end comments explicating written performance, praise, and comments below five words in length. The implications for teachers in classroom IELTS preparation contexts are discussed.
Single-center experience of induction therapy in non-systemic vasculitic neuropathy
Authors: Schneider Christian , Wassermann Meike K. , Fink Gereon R. , Lehmann Helmar C. 
Published: August 2022

Abstract
Background
No controlled studies for non-systemic vasculitic neuropathy treatment exist (NSVN). We compared the treatment response to induction therapy commonly used in clinical practice in NSVN.

Methods
In this retrospective single-center study, 43 patients with biopsy-proven NSVN were analyzed. Patients were subdivided into groups depending on their initial treatment. Relapse rates, changes of motor and sensory symptoms, adverse events, predictors of relapses, and second-line treatment were compared.

Results
Initial treatment regimens were corticosteroid monotherapy, cyclophosphamide monotherapy, pulsed corticosteroid therapy, and combination therapy. Discontinuation due to adverse events occurred in 6 of 43 patients. Clinical data did not differ between treatment groups. Within 12 months, 24.3% of patients relapsed. The median time to relapse was 4 (1.5, 6) months. No relapse occurred in the combination therapy group. However, there was no statistically significant difference in relapse-free survival between treatment groups (p = 0.58). Neither clinical data nor biopsy analysis predicted relapses sufficiently. As a second-line treatment, cyclophosphamide as mono- or combination therapy was used (7 of 9 patients) most frequently. One patient was treated with methotrexate, and one with IVIG.

Conclusions
Induction therapy used in clinical practice is effective and mainly well-tolerated in NSVN. Our data do not support an overall advantage of cyclophosphamide over corticosteroid monotherapy. Controlled trials comparing the effectiveness of induction and maintenance therapy in NSVN are warranted.
The predictive value of MAPH score for determining thrombus burden in patients with non-ST segment elevation myocardial infarction
Authors: Çakmak Karaaslan Özge , Çöteli Cem , Özilhan Murat Oğuz , Akdi Ahmet , Başyiğit Funda , Selçuk Hatice , Selçuk Mehmet Timur , Maden Orhan 
Published: August 2022

Abstract
Background
A high thrombus burden has been connected with poor clinical events in patients with non-ST segment elevation myocardial infarction (NSTEMI). In patients with STEMI, a high MAPH score has been associated with a large thrombus burden. However, the predictive value of the MAPH score in determining the thrombus burden in patients with NSTEMI is unclear. The present report aimed to evaluate the prognostic role of the MAPH score in the estimating coronary thrombus burden in NSTEMI patients. The study patients were split into two groups according to their thrombus grade. The low shear rate (LSR) and high shear rate (HSR) were estimated by haematocrit levels and serum total protein levels. The MAPH score was calculated by adding mean platelet volume (MPV) levels and age, in addition to total protein and haematocrit.

Results
The patients with a high thrombus burden (HTB) had a higher LSR, higher HSR and higher MAPH score compared to patients with low thrombus burden. MAPH score was found to be an independent predictors of HTB in Model 1 (OR: 1.124, 95% CI: 1.011–1.536; p = 0.039) and Model 2 (OR: 1.236; 95% CI: 1.002–1.525; p = 0.047). The cut-off value of the MAPH score for predicting HTB was 2 based on the Youden index.

Conclusions
The MAPH score, which calculated by adding MPV levels and age, in addition to total protein and haematocrit, is a novel, easily accessible score. The MAPH score at both LSR and HSR was an independent predictor of HTB.
Perceived sustainability of psychosocial treatment in low- and middle-income countries in South-Eastern Europe
Authors: Ribic Emina , Sikira Hana , Dzubur Kulenovic Alma , Pemovska Tamara , Russo Manuela , Jovanovic Nikolina , Radojicic Tamara , Repisti Selman , Milutinović Miloš , Blazevska Biljana , Konjufca Jon , Ramadani Fjolla , Jerotic Stefan , Savic Bojana 
Published: August 2022

Background
DIALOG+ is an evidence-based, generic, cost-saving and easily deliverable psychosocial intervention, adaptable to clinicians’ personal manner of interaction with patients. It was implemented in mental health services in five low- and middle-income countries in South-Eastern Europe during a 12-month randomised-controlled trial (IMPULSE) to improve the effectiveness of out-patient treatment for people with psychotic disorders.

Aims
To investigate barriers and facilitators to the perceived sustainability of DIALOG+ that has been successfully implemented as a part of the IMPULSE project.

Method
Three months after the IMPULSE trial's end, perceived sustainability of the DIALOG+ intervention was assessed via a short survey of clinicians and patients who took part in the trial. Quantitative data collected from the survey were analysed using descriptive statistics; content analysis assessed qualitative survey data. The views and experiences of key informants (patients, clinicians and healthcare policy influencers) regarding the sustainability and scale-up of DIALOG+ were further explored through semi-structured interviews. These data were explored using framework analysis.

Results
Clinicians mostly appreciated the comprehensiveness of DIALOG+, and patients described DIALOG+ meetings as empowering and motivating. The barrier most commonly identified by key informants was availability of financial resources; the most important facilitators were the clinically relevant structure and comprehensiveness of the DIALOG+ intervention.

Conclusions
Participants showed a willingness to sustain the implementation of DIALOG+. It is important to maintain collaboration with healthcare policy influencers to improve implementation of DIALOG+ across different levels of healthcare systems and ensure availability of resources for implementing psychosocial interventions such as DIALOG+.