bluuebunny/crossref_metadata_2025_split huggingface dataset:
Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes
Authors: Woaye-Hune Pascal , Hardouin Jean-Benoit , Lehur Paul-Antoine , Meurette Guillaume , Vanier Antoine 
Published: May 2020

Abstract
Background
Using a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation.

Methods
We used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline.

Results
Three hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates.

Conclusion
This practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues.

Trial registration
NCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.
Conventional and retrospective change in health-related quality of life of trauma patients: an explorative observational follow-up study
Authors: Haagsma Juanita A. , Spronk Inge , de Jongh Mariska A. C. , Bonsel Gouke J. , Polinder Suzanne 
Published: May 2020

Abstract
Background
Within trauma care measurement of changes in health-related quality of life (HRQL) is used in understanding patterns of recovery over time. However, conventionally-measured change in HRQL may not always reflect the change in HRQL as perceived by the patient. Recall bias and response shift may contribute to disagreement between conventional and retrospective change in HRQL. This study aimed to measure conventional and retrospective change of HRQL and assess to which extent recall bias and response shift contribute to disagreement between these two in a heterogeneous sample of adult trauma patients.

Methods
A sample of trauma patients (≥18 years) who attended the Emergency Department and were admitted to an Intensive Care unit or ward of one of ten Dutch hospitals received postal questionnaires 1 week (T1) and 3 months (T2) post-injury. At T1 and T2 participants completed the EQ-5D-3 L and EQ-VAS for their current health status. At T2 participants also filled out a recall and then-test regarding their health status at T1. The responses were used to assess conventional and retrospective change, recall bias and response shift. Wilcoxon signed rank tests were used to examine conventional and retrospective change on a group level. The intraclass correlation coefficient (ICC) was used to examine individual agreement between conventional and retrospective change. Uni- and multivariate linear regression analysis were used to investigate the association between background factors and recall bias and response shift.

Results
The EQ-5D-3 L, recall and then-test were completed by 550 patients. Mean EQ-5D-3 L summary score improved from 0.48 at T1 to 0.74 at T2. Mean EQ-VAS score improved from 56 at T1 to 73 at T2. Retrospective change was significantly higher than conventional change (EQ-5D-3 L: Z = -5.2, p < 0.05; EQ-VAS Z = -2.1, p < 0.05). Pairwise comparisons showed that agreement between conventional and retrospective change was fair (EQ-5D-3 L: ICC = 0.49; EQ-VAS: ICC = 0.48). For EQ-5-3 L response shift was significantly higher than recall bias (Z = − 4.5, p < 0.05). Patients with traumatic brain injury (TBI), severe injury and/or posttraumatic stress symptoms were more susceptible to recall bias and response shift.

Conclusions
We conclude that, compared to recall bias, response shift contributed more to the disagreement between conventional and retrospective change in EQ-5D-3 L summary score and EQ-VAS. Predictable subgroups of trauma patients were more susceptible to recall bias and response shift.
Longitudinal evaluation of the effects of illness perceptions and beliefs about cardiac rehabilitation on quality of life of patients with coronary artery disease and their caregivers
Authors: Thomson Patricia , Angus Neil J. , Andreis Federico , Rushworth Gordon F. , Mohan Andrea R. , Chung Misook L. , Leslie Stephen J. 
Published: May 2020

Abstract
Background
Patients’ negative illness perceptions and beliefs about cardiac rehabilitation (CR) can influence uptake and adherence to CR. Little is known about the interpartner influence of these antecedent variables on quality of life of patients with coronary artery disease (CAD) and their family caregivers. The aims of the study were: 1) to assess differences in illness perceptions, beliefs about CR and quality of life between patients with CAD and their family caregivers upon entry to a CR programme and at 6 months follow-up; and 2) to examine whether patients’ and caregivers’ perceptions of the patient’s illness and beliefs about CR at baseline predict their own and their partner’s quality of life at 6 months.

Methods
In this longitudinal study of 40 patient-caregiver dyads from one CR service, patients completed the Brief Illness Perception Questionnaire and Beliefs about Cardiac Rehabilitation Questionnaire at baseline and 6 months; and caregivers completed these questionnaires based on their views about the patient’s illness and CR. The Short-Form 12 Health Survey was used to assess patients’ and caregivers’ perceived health status. Dyadic data were analysed using the Actor–Partner Interdependence Model.

Results
Most patients (70%) were men, mean age 62.45 years; and most caregivers (70%) were women, mean age 59.55 years. Caregivers were more concerned about the patient’s illness than the patients themselves; although they had similar scores for beliefs about CR. Patients had poorer physical health than caregivers, but their level of mental health was similar. Caregivers’ poorer mental health at 6 months was predicted by the patient’s perceptions of timeline and illness concern (i.e. partner effects). Patient’s and caregiver’s illness perceptions and beliefs about CR were associated with their own physical and mental health at 6 months (i.e. actor effects).

Conclusions
Overall, the patients and caregivers had similar scores for illness perceptions and beliefs about CR. The actor and partner effect results indicate a need to focus on specific illness perceptions and beliefs about CR, targeting both the individual and the dyad, early in the rehabilitation process to help improve patients and caregivers physical and mental health (outcomes).
Exogenous fibroblast growth factor 1 ameliorates diabetes-induced cognitive decline via coordinately regulating PI3K/AKT signaling and PERK signaling
Authors: Wu Yanqing , Wu Chengbiao , Ye Libing , Wang Beini , Yuan Yuan , Liu Yaqian , Zheng Peipei , Xiong Jun , Li Yiyang , Jiang Ting , Li Xiaokun , Xiao Jian 
Published: May 2020

Abstract
Background
Diabetes induces central nervous system damage, leading to cognitive decline. Fibroblast growth factor 1 (FGF1) has dual function of neuroprotection and normalizing hyperglycemia. To date, the precise mechanisms and potential treating strategies of FGF1 for diabetes-induced cognitive decline (DICD) hasn’t been fully elucidated.

Methods
In this study, db/db mice were used as DICD animal model. We found that diabetes remarkably suppressed FGF1 expression in hippocampus. Thus, exogenous FGF1 had been treated for db/db mice and SH-SY5Y cells.

Results
FGF1 significantly ameliorates DICD with better spatial learning and memory function. Moreover, FGF1 blocked diabetes-induced morphological structure change, neuronal apoptosis and Aβ1–42 deposition and synaptic dysfunction in hippocampus. But normalizing glucose may not the only contributed factor for FGF1 treating DICD with evidencing that metformin-treated db/db mice has a inferior cognitive function than that in FGF1 group. Current mechanistic study had found that diabetes inhibits cAMP-response element binding protein (CREB) activity and subsequently suppresses brain derived neurotrophic factor (BDNF) level via coordinately regulating PERK signaling and PI3K/AKT signaling in hippocampus, which were reversed by FGF1.

Conclusion
We conclude that FGF1 exerts its neuroprotective role and normalizing hyperglycemia effect, consequently ameliorates DICD, implying FGF1 holds a great promise to develop a new treatment for DICD.
Clinicopathologic features of infection-related glomerulonephritis with IgA deposits: a French Nationwide study
Authors: Miquelestorena-Standley Elodie , Jaulerry Charlotte , Machet Marie-Christine , Rabot Nolwenn , Barbet Christelle , Hummel Aurélie , Karras Alexandre , Garrouste Cyril , Crepin Thomas , Ducloux Didier , Cousin Maud , Albert Catherine , Rivalan Joseph , Cornec-Le Gall Emilie , Pourreau François , Deltombe Clément , Nochy Dominique , Szlavik Nora , Felix Sophie , Croué Anne , Buob David , Rioux-Leclerc Nathalie , Doucet Laurent , Goujon Jean-Michel , Renaudin Karine , Blanchard Emmanuelle , Eymieux Sébastien , Rabant Marion , Halimi Jean-Michel 
Published: May 2020

Abstract
Background
Infection-related glomerulonephritis with IgA deposits (IRGN-IgA) is a rare disease but it is increasingly reported in the literature. Data regarding epidemiology and outcome are lacking, especially in Europe. We aimed to assess the clinical, pathologic and outcome data of IRGN-IgA.

Methods
Clinical and outcome data from patients from 11 French centers over the 2007–2017 period were collected retrospectively. We reviewed pathologic patterns and immunofluorescence of renal biopsies and evaluated C4d expression in IRGN-IgA. We analyzed the correlation between histological presentation and outcome.

Results
Twenty-seven patients (23 men, mean age: 62 ± 15 years) were included. Twenty-one (78%) had Staphylococcus aureus infection and twelve (44%) were diabetic. At the time of biopsy, 95.2% had haematuria, 48.1% had a serum creatinine level of > 4 mg/dL, and 16% had hypocomplementemia. The most common pathologic presentation included mesangial (88.9%) and endocapillary proliferative glomerulonephritis (88.9%) with interstitial fibrosis and tubular atrophy (IF/TA) (85.1%). Diffuse and global glomerular C4d expression was found in 17.8%, mostly in biopsies with acute or subacute patterns, and was associated with a short delay between infection and renal biopsy compared to segmental and focal staining. After median follow-up of 13.2 months, 23.1% died, 46.2% had persistent renal dysfunction and 15.4% reached end-stage renal disease. Renal outcome was correlated to IF/TA severity.

Conclusions
Infection-related glomerulonephritis with IgA deposits is usually associated with Staphylococcus infections and mainly affects adult men. This entity has a poor prognosis which is correlated to interstitial fibrosis and tubular atrophy severity.
Investigating the loco-regional control of simultaneous integrated boost intensity-modulated radiotherapy with different radiation fraction sizes for locally advanced non-small-cell lung cancer: clinical outcomes and the application of an extended LQ/TCP model
Authors: Qiu Bo , Li Qi Wen , Ai Xin Lei , Wang Bin , Huan Jian , Zhu Zheng Fei , Yu Gen Hua , Ji Ming , Jiang Hai Hang , Li Cheng , Zhang Jun , Chen Li , Guo Jin Yu , Zhou Yin , Liu Hui 
Published: May 2020

Abstract
Background
To investigate the loco-regional progression-free survival (LPFS) of intensity-modulated radiotherapy (IMRT) with different fraction sizes for locally advanced non-small-cell lung cancer (LANSCLC), and to apply a new radiobiological model for tumor control probability (TCP).

Methods
One hundred and three LANSCLC patients treated with concurrent radiochemotherapy were retrospectively analyzed. Factors potentially predictive of LPFS were assessed in the univariate and multivariate analysis. Patients were divided into group A (2.0 ≤ fraction size<2.2Gy), B (2.2 ≤ fraction size<2.5Gy), and C (2.5 ≤ fraction size≤3.1Gy) according to the tertiles of fraction size. A novel LQRG/TCP model, incorporating four “R”s of radiobiology and Gompertzian tumor growth, was developed to predict LPFS and compared with the classical LQ/TCP model.

Results
With a median follow-up of 22.1 months, the median LPFS was 23.8 months. Fraction size was independently prognostic of LPFS. The median LPFS of group A, B and C was 13.8, 35.7 months and not reached, respectively. Using the new LQRG/TCP model, the average absolute and relative fitting errors for LPFS were 6.9 and 19.6% for group A, 5.5 and 8.8% for group B, 6.6 and 9.5% for group C, compared with 9.5 and 29.4% for group A, 16.6 and 36.7% for group B, 24.8 and 39.1% for group C using the conventional LQ/TCP model.

Conclusions
Hypo-fractionated IMRT could be an effective approach for dose intensification in LANSCLC. Compared with conventional LQ model, the LQRG model showed a better performance in predicting follow-up time dependent LPFS.
C’est vraiment compliqué: a case study on the delivery of maternal and child health and nutrition interventions in the conflict-affected regions of Mali
Authors: Ataullahjan Anushka , Gaffey Michelle F. , Tounkara Moctar , Diarra Samba , Doumbia Seydou , Bhutta Zulfiqar A. , Bassani Diego G. 
Published: May 2020

AbstractBackgroundMali is currently in the midst of ongoing conflicts which involve jihadist groups, rebels, and the state. This conflict has primarily centered in the North of the country. Humanitarian actors delivering services in these geographies must navigate the complex environment created by conflict. This study aimed to understand how humanitarian actors make decisions around health service delivery within this context.MethodsThe current case-study utilized a mixed methods approach and focused on Mopti, Mali’s fifth administrative region and fourth largest in population. Latent content analysis was used to analyze interview transcripts guided by our research objectives and new concepts as they emerged. Indicators of coverage of health interventions in the area of maternal and child health and nutrition were compiled using Mali’s National Evaluation Platform and are presented for the conflict and non-conflict regions. Development assistance estimates for Mali by year were obtained from the Developmental Assistance for Health Database compiled by the Institute for Health Metrics and Evaluation. Administrative data was compiled from the annual reports of Mali’s Système Local d’Information Sanitaire (SLIS), Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS).ResultsOur data suggests that the reaction of the funding mechanisms to the conflict in Mali was a major barrier to timely delivery of health services to populations in need and the nature of the conflict is likely a key modifier of such reaction patterns. Concerns have been raised about the disconnect between the very high administrative capacity of large NGOs that control the work, and the consequent burden it puts on local NGOs. Population displacement and inaccurate estimates of needs made it difficult for organizations to plan program services. Moreover, actors delivering services to populations in need had to navigate an unpredictable context and numerous security threats.ConclusionsOur study highlights the need for a more flexible funding and management mechanism that can better respond to concerns and issues arising at a local level. As the conflict in Mali continues to worsen, there is an urgent need to improve service delivery to conflict-affected populations.
Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial
Authors: Forde Caroline , McMullan Ronan , Clarke Mike , Wilson Richard H. , Plummer Ruth , Grayson Margaret , McDowell Cliona , Agus Ashley , Doran Annmarie , McAuley Danny F. , Thomas Anne L. , Barnes Rosemary A. , Adams Richard , Chau Ian , Coyle Vicky 
Published: May 2020

Abstract
Background
Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications because of uncertainty about whether this would achieve comparable outcomes to using intravenous antibiotics for longer. The UK National Institute for Health Research funded the EASI-SWITCH trial to tackle this uncertainty.

Methods
The trial is a pragmatic, randomised, non-inferiority trial that aims to establish the clinical and cost-effectiveness of early switching from intravenous to oral antibiotics in cancer patients with low-risk neutropenic sepsis. Patients ≥ 16 years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of > 38 °C, neutrophil count ≤ 1.0 × 109/L, MASCC (Multinational Association of Supportive Care in Cancer) score ≥ 21 and receiving IV piperacillin/tazobactam or meropenem for less than 24 h are eligible to participate. Patients are randomised 1:1 either (i) to switch to oral ciprofloxacin and co-amoxiclav within 12–24 h of commencing intravenous antibiotics, completing at least 5 days total antibiotics (intervention), or (ii) to continue intravenous antibiotics for at least 48 h, with ongoing antibiotics being continued at the physician’s discretion (control). Patients are discharged home when their physician deems it appropriate. The primary outcome measure is a composite of treatment failures as assessed at day 14. The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death. Based on a 15% treatment failure rate in the control group and a 15% non-inferiority margin, the recruitment target is 230 patients.

Discussion
If the trial demonstrates non-inferiority of early switching to oral antibiotics, with potential benefits for patient quality of life and resource savings, this finding will have significant implications for the routine clinical management of those with low-risk neutropenic sepsis.

Trial registration
ISRCTN: 84288963. Registered on the 1 July 2015. 10.1186/ISRCTN84288963.
EudraCT: 2015-002830-35.
Revision of the Atratus Group of Culex (Melanoconion) (Diptera: Culicidae)
Authors: Sá Ivy Luizi Rodrigues de , Hutchings Rosa Sá Gomes , Hutchings Roger William , Sallum Maria Anice Mureb 
Published: May 2020

Abstract
Background
Despite the importance of some species of Culex (Melanoconion) (Diptera: Culicidae) as vectors of several arboviruses that cause diseases in humans and other animals, there are few taxonomic studies focusing on species of the subgenus, especially providing morphological keys for species identification.

Results
Thirteen species of the Atratus Group of Culex (Melanoconion) were reviewed, five new species are described, and two taxonomic changes are proposed: Cx. (Mel.) exedrus Root, 1927 and Cx. (Mel.) loturus Dyar, 1925 are resurrected from synonymy with Cx. (Mel.) dunni Dyar, 1918 and Cx. (Mel.) zeteki Dyar, 1918, respectively. The Atratus Group now includes fourteen species: Cx. (Mel.) atratus Theobald, 1901; Cx. (Mel.) caribeanus Galindo & Blanton, 1954; Cx. (Mel.) columnaris Sá & Hutchings n. sp.; Cx. (Mel.) commevynensis Bonne-Wepster & Bonne, 1919; Cx. (Mel.) comptus Sá & Sallum n. sp.; Cx. (Mel.) dunni; Cx. (Mel.) ensiformis Bonne-Wepster & Bonne, 1919; Cx. (Mel.) exedrus; Cx. (Mel.) longisetosus Sá & Sallum n. sp.; Cx. (Mel.) longistylus Sá & Sallum n. sp.; Cx. (Mel.) loturus; Cx. (Mel.) spinifer Sá & Sallum n. sp.; Cx. (Mel.) trigeminatus Clastrier, 1970; and Cx. (Mel.) zeteki. Keys, descriptions and illustrations for the identification of the male, female, pupal and fourth-instar larval stages of each species are provided. The treatment of each species includes a complete synonymy, descriptions of available life stages, a taxonomic discussion, updated bionomics and geographical distribution, and a list of material examined.

Conclusions
The taxonomy of the Atratus Group of Culex (Melanoconion) is updated, including descriptions of five new species. The number of valid species is greater than the number recognized in the previous taxonomic study of the group, increasing from seven to 14 species. Distributional and bionomical data are updated. Morphology-based identification keys for females, males, fourth-instar larvae and pupae provided in this study will facilitate species identification.
Multiplex PCR for identification of two butterfly sister species: Eurema mandarina and Eurema hecabe
Authors: Miyata Mai N. , Kageyama Daisuke , Nomura Masashi 
Published: May 2020

AbstractObjectiveIn insects, closely related species are often difficult or impossible to distinguish solely by morphological traits. Mitochondrial DNA (mtDNA) markers are often useful and reliable for distinguishing closely related species. However, useful mtDNA markers can be unavailable, particularly when such species pairs experienced hybrid introgression in the past. Although polymorphic nuclear DNA markers would be necessary to distinguish such species pairs, recombination, multiple copies, and slower mutation rates of the nuclear DNA compared with those of mtDNA often make it challenging. The objective of this study was to develop a multiplex polymerase chain reaction that can reliably amplify and distinguish theTpisequences ofEurema mandarinaandEurema hecabe.ResultsWe successfully analyzed the nucleotide sequences of the Z chromosome-linked triose phosphate isomerase (Tpi) gene to develop a multiplex polymerase chain reaction (PCR) that amplified ca. 120-bp products forE. mandarinaand ca. 375-bp products forE. hecabe. We suggest that multiplex PCR usingTpiwith appropriately designed primers can be used to accurately and reliably distinguish between other closely related Lepidoptera species.