bluuebunny/crossref_metadata_2025_split huggingface dataset:
Educating physicians on strong opioids by descriptive versus simulated-experience formats: a randomized controlled trial
Authors: Wegwarth Odette , Spies Claudia , Ludwig Wolf-Dieter , Donner-Banzhoff Norbert , Jonitz Günther , Hertwig Ralph 
Published: October 2022

Abstract
Background
Long-term prescriptions of strong opioids for chronic noncancer pain—which are not supported by scientific evidence—suggest miscalibrated risk perceptions among those who prescribe, dispense, and take opioids. Because risk perceptions and behaviors can differ depending on whether people learn about risks through description or experience, we investigated the effects of descriptive versus simulated-experience educative formats on physicians’ risk perceptions of strong opioids and their prescription behavior for managing chronic noncancer pain.

Methods
Three hundred general practitioners and 300 pain specialists in Germany—enrolled separately in two independent exploratory randomized controlled online trials—were randomly assigned to either a descriptive format (fact box) or a simulated-experience format (interactive simulation).

Primary endpoints
Objective risk perception (numerical estimates of opioids’ benefits and harms), actual prescriptions of seven therapy options for managing chronic pain.

Secondary endpoint
Implementation of intended prescriptions of seven therapy options for managing chronic pain.

Results
Both formats improved the proportion of correct numerical estimates of strong opioids’ benefits and harms immediately after intervention, with no notable differences between formats. Compared to description, simulated experience led to significantly lower reported actual prescription rates for strong and/or weak opioids, and was more effective at increasing prescription rates for non-drug-based therapies (e.g., means of opioid reduction) from baseline to follow-up for both general practitioners and pain specialists. Simulated experience also resulted in a higher implementation of intended behavior for some drug-based and non-drug-based therapies.

Conclusions
The two formats, which recruit different cognitive processes, may serve different risk-communication goals: If the goal is to improve exact risk perception, descriptive and simulated-experience formats are likely to be equally suitable. If, however, the goal is to boost less risky prescription habits, simulated experience may be the better choice.

Trial registration
DRKS00020358 (German Clinical Trials Register, first registration: 07/01/2020).
Responsibility driven learning in primary care: a qualitative evaluation of a medical student COVID-19 volunteering programme
Authors: Coster Samantha , Parekh Ravi , Moula Zoe , Kumar Sonia 
Published: October 2022

Abstract
Background
During the first wave of the pandemic when clinical placements were suspended, a UK medical student volunteering programme was developed to support local GP practices. This study aimed to explore the impact that volunteering in primary care had on students’ learning and professional development to inform the design of future service-learning curricula innovations.

Methods
Seventy medical students across all years volunteered across forty-five GP practices in north-west London. Ten volunteer students and six GPs who had hosted students volunteered to participate in remotely conducted, semi-structured interviews with a researcher. Transcriptions were independently coded by two researchers and analysed by thematic analysis using service learning and communities of practice as sensitising concepts.

Results
Analysis showed a strong alignment between the views of students and GPs in terms of perceived learning. Our analysis of both sets of interviews resulted in five themes describing student outcomes from the volunteering scheme: developing as a doctor, understanding the complexity of medicine, responsibility driven learning, a meaningful role in a community of practice, and seeing behind the scenes in primary care.

Discussion and conclusion
Results from this study highlighted how a meaningful service-led role and responsibility in primary care can empower and motivate students to learn beyond the traditional medical curriculum and assessments. Adopting these new ‘pro-active’ roles within general practices led volunteers, particularly those in the early years of study, to develop a better understanding of primary care and medical complexity. It also enhanced their professional skills, attitudes and behaviours, while having a beneficial impact on patient care during the pandemic.
Influencing mechanism of the use behavior of clinical practice guidelines on antimicrobials: evidence from the integration of theory of reasoned action and organizational readiness for change
Authors: Huang Junbin , Liu Wenbin , Huang Yimin 
Published: October 2022

Abstract
Background
To confront the serious challenge of antimicrobial resistance, using clinical practice guidelines (CPGs) standardizing the prescription behavior is vital. However, the overall mechanisms remains largely unknown as to how guidelines' use behavior can be improved. This study aimed to identify the determinants and investigate their relationship to bridge the knowledge gap of overall influencing mechanism of the use behavior of CPGs on antimicrobials.

Methods
By integrating theory of reasoned action (TRA) and organizational readiness for change (ORC), a structured questionnaire was developed to cover potential determinants that affect physicians’ use behaviors of CPGs on antimicrobials at the individual-level (attitude, subjective norm, and behavioral intention) and organizational-level (top management support and organizational resource allocation). A multi-stage random sampling was implemented to collect data from physicians in secondary and tertiary hospitals from eastern, central and western China. Structural equation model (SEM) was used to test the proposed hypotheses, and to analyze the relationship and mechanism among the factors.

Result
In total, 815 physicians were included. Most physicians demonstrated a positive tendency toward the use of CPGs on antimicrobials, with a mean score of 3.95 (SD = 0.70). The reliability and validity analysis showed the questionnaire constructed from the integrated theoretical model of TRA and ORC was acceptable. The SEM validation results also showed that the top management support (β = 0.688, P < 0.001), organizational resource allocation (β = 0.129, P < 0.001), individual attitudes (β = 0.164, P < 0.001), subjective norms (β = 0.322, P < 0.001), and behavioral intentions (β = 0.424, P < 0.001) were positively associated with physicians’ use behaviors of CPGs on antimicrobials. Besides, top management support, organizational resource allocation, attitudes and subjective norms showed their mediating effects on regarding use behavior, which was 0.305, 0.129, 0.164 and 0.201, respectively.

Conclusions
This study revealed the influence mechanism of the use of CPGs on antimicrobials from the individual and organizational perspectives. These findings will not only help formulate future strategies to promote the use of CPGs on antimicrobials, but also provide clues for more effective prescription interventions.
Nurses experience increased clinical and organisational competence by working with a medical quality register, RevNatus – a qualitative study
Authors: Bjørngaard Hilde , Koksvik Hege Svean , Jakobsen Bente , Grønning Kjersti 
Published: October 2022

Abstract
Background
RevNatus is a consent-based, nationwide medical quality register that collects data on patients with inflammatory rheumatic diseases during pregnancy and one year postpartum. The entering of data takes place in outpatient clinics in rheumatology wards in hospitals. The aim of this study is to explore how rheumatology nurses experience organizing and working with the medical quality register RevNatus in addition to their normal clinical patient-care tasks.

Methods
Qualitative focus group interviews and individual in-depth interviews were conducted in 2018 to gain insights into how nurses organize performing quality register work and clinical work simultaneously. Data were analysed using systematic text condensation.

Results
The informants represented seven different rheumatology outpatient clinics in Norway. The analyses showed that working with RevNatus increased the nurses’ knowledge about pregnancy and rheumatic diseases, improved the content of their nurse consultations and found the ‘register form’ as a useful template to structure the nurse consultations. The nurses took the main responsibility for RevNatus, but lack of routines and uncoordinated collaboration with the rheumatologists and secretaries made the nurses spend too much time verifying the accuracy of data or post-registering missing data.

Conclusion
The nurses experienced work with RevNatus as time-consuming, but the register work increased both their clinical and organisational competences. Routines and collaboration within the registry team are important to ensure the data quality and reduce the workload.
Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (The IMMENSE study) – a randomized controlled trial
Authors: Johansen Jeanette Schultz , Halvorsen Kjell H. , Svendsen Kristian , Havnes Kjerstin , Robinson Eirin Guldsten , Wetting Hilde Ljones , Haustreis Stine , Småbrekke Lars , Kamycheva Elena , Garcia Beate Hennie 
Published: October 2022

Abstract
Background
Suboptimal medication use contributes to a substantial proportion of hospitalizations and emergency department visits in older adults. We designed a clinical pharmacist intervention to optimize medication therapy in older hospitalized patients. Based on the integrated medicine management (IMM) model, the 5-step IMMENSE intervention comprise medication reconciliation, medication review, reconciled medication list upon discharge, patient counselling, and post discharge communication with primary care. The objective of this study was to evaluate the effects of the intervention on healthcare use and mortality.

Methods
A non-blinded parallel group randomized controlled trial was conducted in two internal medicine wards at the University Hospital of North Norway. Acutely admitted patients ≥ 70 years were randomized 1:1 to intervention or standard care (control). The primary outcome was the rate of emergency medical visits (readmissions and emergency department visits) 12 months after discharge.

Results
Of the 1510 patients assessed for eligibility, 662 patients were asked to participate, and 516 were enrolled. After withdrawal of consent and deaths in hospital, the modified intention-to-treat population comprised 480 patients with a mean age of 83.1 years (SD: 6.3); 244 intervention patients and 236 control patients. The number of emergency medical visits in the intervention and control group was 497 and 499, respectively, and no statistically significant difference was observed in rate of the primary outcome between the groups [adjusted incidence rate ratio of 1.02 (95% CI: 0.82–1.27)]. No statistically significant differences between groups were observed for any of the secondary outcomes, neither in subgroups, nor for the per-protocol population.

Conclusions
We did not observe any statistical significant effects of the IMMENSE intervention on the rate of emergency medical visits or any other secondary outcomes after 12 months in hospitalized older adults included in this study.

Trial registration
The trial was registered in clinicaltrials.gov on 28/06/2016, before enrolment started (NCT02816086).
Analysis and enhancement of risk management for ethnic differences in antineoplastic drugs in Japan
Authors: Uzu Shinobu , Sato Jun , Wakao Rika , Nonaka Takahiro 
Published: October 2022

Abstract
Background
Risk management in the post-marketing phase is crucial to minimize health problems caused by drugs. Because ethnic factors may affect drug safety, the objective of this study was to explore concrete approaches to reflecting ethnic factors in risk management under multi-regional drug development.

Methods
We assessed Pharmaceuticals and Medical Devices Agency (PMDA) review reports on antineoplastic drugs approved as new molecular entities in the last 10 years to identify any differences in the incidence of adverse drug reactions (ADRs) related to myelosuppression, hepatic impairment, renal impairment, and interstitial lung disease between Japanese and non-Japanese populations. In addition, we investigated how those ADRs were handled in the labeling of each drug.

Results
In total, 44 drugs were available for comparing the incidence of ADRs between Japanese and non-Japanese populations. Of these, 32 drugs had a higher incidence of ADRs in the Japanese population. However, the incidence of ADRs in the Japanese population was described in the labeling for 7 drugs, and only the incidence in the overall population in multi-regional phase III trials was described in the labeling for the remaining 25 drugs. Of these 25 drugs, two drugs were immediately placed under emergency safety control measures after approval because of the high incidence of ADRs in Japanese patients.

Conclusions
For drugs that might cause serious ADRs and with a higher incidence in the Japanese population, information should be provided on the incidence in the Japanese population as well as in the overall population.
Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial
Authors: Caramelli Bruno , Yu Pai Ching , Cardozo Francisco A. M. , Magalhães Iuri R. , Spera Raphael R. , Amado Daniel K. , Escalante-Rojas Maria C. , Gualandro Danielle M. , Calderaro Daniela , Tavares Caio A. M. , Borges-Junior Flavio A. , Pastana Adriana F. , Matheus Mariana G. , Brucki Sonia M. D. , Rodrigues Ana Carolina O. , Nitrini Ricardo , Caramelli Paulo 
Published: October 2022

Abstract
Background
Observational studies support a role for oral anticoagulation to reduce the risk of dementia in atrial fibrillation patients, but conclusive data are lacking. Since dabigatran offers a more stable anticoagulation, we hypothesized it would reduce cognitive decline when compared to warfarin in old patients with atrial fibrillation.

Methods
The GIRAF trial was a 24-month, randomized, parallel-group, controlled, open-label, hypothesis generating trial. The trial was done in six centers including a geriatric care unit, secondary and tertiary care cardiology hospitals in São Paulo, Brazil. We included patients aged ≥ 70 years and CHA2DS2-VASc score > 1. The primary endpoint was the absolute difference in cognitive performance at 2 years. Patients were assigned 1:1 to take dabigatran (110 or 150 mg twice daily) or warfarin, controlled by INR and followed for 24 months. Patients were evaluated at baseline and at 2 years with a comprehensive and thorough cognitive evaluation protocol of tests for different cognitive domains including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Exam (MMSE), a composite neuropsychological test battery (NTB), and computer-generated tests (CGNT).

Results
Between 2014 and 2019, 5523 participants were screened and 200 were assigned to dabigatran (N = 99) or warfarin (N = 101) treatment. After adjustment for age, log of years of education, and raw baseline score, the difference between the mean change from baseline in the dabigatran group minus warfarin group was − 0.12 for MMSE (95% confidence interval [CI] − 0.88 to 0.63; P = 0.75), 0.05 (95% CI − 0.07 to 0.18; P = 0.40) for NTB, − 0.15 (95% CI − 0.30 to 0.01; P = 0.06) for CGNT, and − 0.96 (95% CI − 1.80 to 0.13; P = 0.02) for MoCA, with higher values suggesting less cognitive decline in the warfarin group.

Conclusions
For elderly patients with atrial fibrillation, and without cognitive compromise at baseline that did not have stroke and were adequately treated with warfarin (TTR of 70%) or dabigatran for 2 years, there was no statistical difference at 5% significance level in any of the cognitive outcomes after adjusting for multiple comparisons.

Trial registration
Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF), NCT01994265.
Early corticosteroid dose tapering in patients with acute exacerbation of idiopathic pulmonary fibrosis
Authors: Anan Keisuke , Kataoka Yuki , Ichikado Kazuya , Kawamura Kodai , Johkoh Takeshi , Fujimoto Kiminori , Tobino Kazunori , Tachikawa Ryo , Ito Hiroyuki , Nakamura Takahito , Kishaba Tomoo , Inomata Minoru , Kamitani Tsukasa , Yamazaki Hajime , Ogawa Yusuke , Yamamoto Yosuke 
Published: October 2022

Abstract
Background
Although corticosteroid therapy with dose tapering is the most commonly used treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF), there is no consensus on the tapering regimen. This study aimed to investigate the association between early corticosteroid dose tapering and in-hospital mortality in patients with AE-IPF.

Methods
In this retrospective cohort study, we analyzed the data of a cohort from eight Japanese tertiary care hospitals and routinely collected administrative data from a cohort from 185 Japanese hospitals. Patients with AE-IPF were classified into the early and non-early tapering groups depending on whether the maintenance dose of corticosteroids was reduced within two weeks of admission. Propensity score analysis with inverse probability weighting (IPW) was performed to estimate the effect of early corticosteroid dose tapering.

Results
The multi-center cohort included 153 eligible patients, of whom 47 (31%) died, whereas the administrative cohort included 229 patients, of whom 51 (22%) died. Patients with early tapering tended to have a better prognosis than those without it (unadjusted hazard ratio [95% confidence interval] 0.41 [0.22–0.76] and 0.65 [0.36–1.18] in the multi-center and administrative cohorts, respectively). After IPW, the early tapering group had a better prognosis than the non-early tapering group (IPW-adjusted hazard ratio [95% confidence interval] 0.37 [0.14–0.99] and 0.27 [0.094–0.83] in the multi-center and administrative cohorts, respectively).

Conclusion
Early corticosteroid dose tapering was associated with a favorable prognosis in patients with AE-IPF. Further studies are warranted to confirm the effects of early corticosteroid dose tapering in patients with AE-IPF.
Patient variability in the blood-stage dynamics of Plasmodium falciparum captured by clustering historical data
Authors: Masserey Thiery , Penny Melissa A. , Lee Tamsin E. 
Published: October 2022

Abstract
Background
Mathematical models provide an understanding of the dynamics of a Plasmodium falciparum blood-stage infection (within-host models), and can predict the impact of control strategies that affect the blood-stage of malaria. However, the dynamics of P. falciparum blood-stage infections are highly variable between individuals. Within-host models use different techniques to capture this inter-individual variation. This struggle may be unnecessary because patients can be clustered according to similar key within-host dynamics. This study aimed to identify clusters of patients with similar parasitaemia profiles so that future mathematical models can include an improved understanding of within-host variation.

Methods
Patients’ parasitaemia data were analyzed to identify (i) clusters of patients (from 35 patients) that have a similar overall parasitaemia profile and (ii) clusters of patients (from 100 patients) that have a similar first wave of parasitaemia. For each cluster analysis, patients were clustered based on key features which previous models used to summarize parasitaemia dynamics. The clustering analyses were performed using a finite mixture model. The centroid values of the clusters were used to parameterize two established within-host models to generate parasitaemia profiles. These profiles (that used the novel centroid parameterization) were compared with profiles that used individual-specific parameterization (as in the original models), as well as profiles that ignored individual variation (using overall means for parameterization).

Results
To capture the variation of within-host dynamics, when studying the overall parasitaemia profile, two clusters efficiently grouped patients based on their infection length and the height of the first parasitaemia peak. When studying the first wave of parasitaemia, five clusters efficiently grouped patients based on the height of the peak and the speed of the clearance following the peak of parasitaemia. The clusters were based on features that summarize the strength of patient innate and adaptive immune responses. Parameterizing previous within host-models based on cluster centroid values accurately predict individual patient parasitaemia profiles.

Conclusion
This study confirms that patients have personalized immune responses, which explains the variation of parasitaemia dynamics. Clustering can guide the optimal inclusion of within-host variation in future studies, and inform the design and parameterization of population-based models.
Response to Toshihide Tsuda, Yumiko Miyano and Eiji Yamamoto [1]
Authors: Soskolne Colin L. , Bero Lisa A. , Kramer Shira , Gochfeld Michael , Ramos-Bonilla Juan Pablo , Sass Jennifer , Cranor Carl F. , Advani Shailesh , Mandrioli Daniele 
Published: October 2022

Abstract
Background
In August 2021, we published in Environmental Health a Toolkit for detecting misused epidemiological methods with the goal of providing an organizational framework for transparently evaluating epidemiological studies, a body of evidence, and resultant conclusions. Tsuda et al., the first group to utilize the Toolkit in a systematic fashion, have offered suggestions for its modification.

Main body
Among the suggested modifications made by Tsuda et al., we agree that rearrangement of Part A of the Toolkit to reflect the sequence of the epidemiological study process would facilitate its usefulness. Expansion or adaptation of the Toolkit to other disciplines would be valuable but would require the input of discipline-specific expertise. We caution against using the sections of the Toolkit to produce a tally or cumulative score, because none of the items are weighted as to importance or impact. Rather, we suggest a visual representation of how a study meets the Toolkit items, such as the heat maps used to present risk of bias criteria for studies included in Cochrane reviews. We suggest that the Toolkit be incorporated in the sub-specialty known as “forensic epidemiology,” as well as in graduate training curricula, continuing education programs, and conferences, with the recognition that it is an extension of widely accepted ethics guidelines for epidemiological research.

Conclusion
We welcome feedback from the research community about ways to strengthen the Toolkit as it is applied to a broader assemblage of research studies and disciplines, contributing to its value as a living tool/instrument. The application of the Toolkit by Tsuda et al. exemplifies the usefulness of this framework for transparently evaluating, in a systematic way, epidemiological research, conclusions relating to causation, and policy decisions.

Postscript
We note that our Toolkit has, most recently, inspired authors with discipline-specific expertise in the field of Conservation Biology to adapt it for use in the Biological Sciences.