bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers
Authors: Cousins S. , Huttman M. , Blencowe N. , Tsang C. , Elliott D. , Blazeby J. , Beard D. J. , Campbell M. K. , Gillies K. 
Published: May 2024

Abstract
Introduction
Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice.

Methods
PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary.

Results
Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including ‘control’, ‘mock’ and ‘sham’.

Conclusion
Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.
Complete series method (CSM): a convenient method to reduce daily heterogeneity when evaluating the regeneration time (RT) of insecticide-treated nets (ITNs)
Authors: Lugenge Aidi Galus , Odufuwa Olukayode G. , Mseti Jilly Jackson , Swai Johnson Kyeba , Skovmand Ole , Moore Sarah Jane 
Published: May 2024

Abstract
Background
“Regeneration time” (RT) denotes the time required to obtain a stable mortality rate for mosquitoes exposed to insecticide-treated nets (ITNs) after three consecutive washes of a net in a day. The RT informs the wash interval used to artificially age ITNs to simulate their lifetime performance under user conditions (20 washes). RT was estimated following World Health Organization (WHO) longitudinal method (LM) procedures. Longitudinal evaluation may introduce heterogeneity due to mosquito batch variability, complicating RT determination. To overcome this, nets at each stage of regeneration (i.e., 1, 2, 3, 5 and 7 days post wash) were prepared in advance and refrigerated; then, a complete regeneration series was tested with a single mosquito batch on 1 testing day, completing four series over 4 days. This study compared the complete series method (CSM) against the LM.

Methods
The overall heterogeneity in the methods for estimating RT of one incorporated alpha-cypermethrin and piperonyl butoxide (PBO) and one incorporated permethrin with PBO ITNs was determined using laboratory-reared resistant Anopheles arabiensis under standard laboratory conditions. LM methods and CSM were compared in two experiments with refrigerated nets acclimated for (i) 2 h (test 1) and (ii) 3 h (test 2). Four regeneration replicates per day were tested per ITN product with 50 mosquitoes exposed per replicate (equivalent sample size to LM). The heterogeneity from these methods was compared descriptively.

Results
The intra-method variability for unwashed pieces was minimal, with variance of 1.26 for CSM and 1.18 for LM. For unwashed nets, LM had substantially greater variance and ratio of LM:CSM was 2.66 in test 1 and 2.49 in test 2. The magnitude of mortality measured in bioassays depended on sample acclimation after refrigeration.

Conclusions
The CSM is a convenient method for determining the regeneration times. ITNs are prepared in advance, reducing pressure to prepare all samples to start on a single day. A complete regeneration series of samples is removed from the refrigerator, defrosted and evaluated on a single day with one mosquito batch reducing the influence of mosquito batch heterogeneity on results. Replicates can be conducted over several days but do not have to be conducted on consecutive days, allowing easy facility scheduling.

Graphical Abstract
The effect of unusual presentation on delayed diagnosis of prostate cancer: a case series
Authors: Oyortey Mawuenyo Attawa , Adanu Kekeli Kodjo , Ali Mahamudu Ayamba 
Published: May 2024

Abstract
Background
Early diagnosis of prostate cancer is key to achieving a cure and its proper management leads to a good prognosis. In Ghana a large percentage of patients present with advanced disease and unusual presentations in these patients result in greater delay in the diagnosis thus worsening the outcomes.

Case presentation
We present three African males with advanced prostate cancer who had delayed diagnosis. The first patient, a 64 year old male presented with ascites of 2 years duration with weight loss and no lower urinary tract symptoms, the second, a 69 year old man with end stage renal failure of 6 months duration and was receiving dialysis, the third case, an 87 year old man was managed for pulmonary tuberculosis after he presented with chronic cough and lower urinary tract symptoms. All patients eventually had a prostate specific antigen done which were elevated. Further investigations including prostate biopsies, abdominopelvic CT scans for case 1, abdominopelvic ultrasound, prostate biopsies and blood urea and electrolytes for case 2, prostate biopsies, chest and lumbosacral showed a diagnosis of metastatic prostate carcinoma, and all patients were managed with androgen deprivation. The second patient received additional radiotherapy.

Conclusion
A lack of knowledge of prostate cancer symptoms including unusual symptoms, can result in delayed diagnosis especially in regions of the world where a large number of patients present with advanced disease.
Towards multidimensional attentive voice tracking—estimating voice state from auditory glimpses with regression neural networks and Monte Carlo sampling
Authors: Luberadzka Joanna , Kayser Hendrik , Lücke Jörg , Hohmann Volker 
Published: May 2024

AbstractSelective attention is a crucial ability of the auditory system. Computationally, following an auditory object can be illustrated as tracking its acoustic properties, e.g., pitch, timbre, or location in space. The difficulty is related to the fact that in a complex auditory scene, the information about the tracked object is not available in a clean form. The more cluttered the sound mixture, the more time and frequency regions where the object of interest is masked by other sound sources. How does the auditory system recognize and follow acoustic objects based on this fragmentary information? Numerous studies highlight the crucial role of top-down processing in this task. Having in mind both auditory modeling and signal processing applications, we investigated how computational methods with and without top-down processing deal with increasing sparsity of the auditory features in the task of estimating instantaneous voice states, defined as a combination of three parameters: fundamental frequency F0 and formant frequencies F1 and F2. We found that the benefit from top-down processing grows with increasing sparseness of the auditory data.
A genome-wide association study identifies candidate genes for sleep disturbances in depressed individuals
Authors: Yang Xuena , Cheng Bolun , Cheng Shiqiang , Liu Li , Pan Chuyu , Meng Peilin , Li Chun’e , Chen Yujing , Zhang Jingxi , Zhang Huijie , Zhang Zhen , Wen Yan , Jia Yumeng , Liu Huan , Zhang Feng 
Published: May 2024

Abstract
Objective
This study aimed to identify candidate loci and genes related to sleep disturbances in depressed individuals and clarify the co-occurrence of sleep disturbances and depression from the genetic perspective.

Methods
The study subjects (including 58,256 self-reported depressed individuals and 6,576 participants with PHQ-9 score ≥ 10, respectively) were collected from the UK Biobank, which were determined based on the Patient Health Questionnaire (PHQ-9) and self-reported depression status, respectively. Sleep related traits included chronotype, insomnia, snoring and daytime dozing. Genome-wide association studies (GWASs) of sleep related traits in depressed individuals were conducted by PLINK 2.0 adjusting age, sex, Townsend deprivation index and 10 principal components as covariates. The CAUSALdb database was used to explore the mental traits associated with the candidate genes identified by the GWAS.

Results
GWAS detected 15 loci significantly associated with chronotype in the subjects with self-reported depression, such as rs12736689 at RNASEL (P = 1.00 × 10− 09), rs509476 at RGS16 (P = 1.58 × 10− 09) and rs1006751 at RFX4 (P = 1.54 × 10− 08). 9 candidate loci were identified in the subjects with PHQ-9 ≥ 10, of which 2 loci were associated with insomnia such as rs115379847 at EVC2 (P = 3.50 × 10− 08), and 7 loci were associated with daytime dozing, such as rs140876133 at SMYD3 (P = 3.88 × 10− 08) and rs139156969 at ROBO2 (P = 3.58 × 10− 08). Multiple identified genes, such as RNASEL, RGS16, RFX4 and ROBO2 were reported to be associated with chronotype, depression or cognition in previous studies.

Conclusion
Our study identified several candidate genes related to sleep disturbances in depressed individuals, which provided new clues for understanding the biological mechanism underlying the co-occurrence of depression and sleep disorders.
Sodium quantification in skeletal muscle: comparison between Cartesian gradient-echo and radial ultra-short echo time 23Na MRI techniques
Authors: Gerhalter Teresa , Schilling Felix , Zeitouni Nour , Linz Peter , Baudin Pierre-Yves , Kannenkeril Dennis , Kopp Christoph , Dahlmann Anke , Schmieder Roland , Uder Michael , Nagel Armin M. , Gast Lena V. 
Published: May 2024

Abstract
Background
Clinical magnetic resonance imaging (MRI) studies often use Cartesian gradient-echo (GRE) sequences with ~2-ms echo times (TEs) to monitor apparent total sodium concentration (aTSC). We compared Cartesian GRE and ultra-short echo time three-dimensional (3D) radial-readout sequences for measuring skeletal muscle aTSC.

Methods
We retrospectively evaluated 211 datasets from 112 volunteers aged 62.3 ± 12.1 years (mean ± standard deviation), acquired at 3 T from the lower leg. For 23Na MRI acquisitions, we used a two-dimensional Cartesian GRE sequence and a density-adapted 3D radial readout sequence with cuboid field-of-view (DA-3D-RAD-C). We calibrated the 23Na MR signal using reference tubes either with or without agarose and subsequently performed a relaxation correction. Additionally, we employed a six-echo 1H GRE sequence and a multi-echo spin-echo sequence to calculate proton density fat fraction (PDFF) and water T2. Paired Wilcoxon signed-rank test, Cohen dz for paired samples, and Spearman correlation were used.

Results
Relaxation correction effectively reduced the differences in muscle aTSC between the two acquisition and calibration methods (DA-3D-RAD-C using NaCl/agarose references: 20.05 versus 19.14 mM; dz = 0.395; Cartesian GRE using NaCl/agarose references: 19.50 versus 18.82 mM; dz = 0.427).
Both aTSC of the DA-3D-RAD-C and Cartesian GRE acquisitions showed a small but significant correlation with PDFF as well as with water T2.

Conclusions
Different 23Na MRI acquisition and calibration approaches affect aTSC values. Applying relaxation correction is advised to minimize the impact of sequence parameters on quantification, and considering additional fat correction is advisable for patients with increased fat fractions.

Relevance statement
This study highlights relaxation correction’s role in improving sodium MRI accuracy, paving the way for better disease assessment and comparability of measured sodium signal in patients.

Key points
• Differences in MRI acquisition methods hamper the comparability of sodium MRI measurements.
• Measured sodium values depend on used MRI sequences and calibration method.
• Relaxation correction during postprocessing mitigates these discrepancies.
• Thus, relaxation correction enhances accuracy of sodium MRI, aiding its clinical use.

Graphical Abstract
Use of Natural Language Understanding to Facilitate Surgical De-Escalation of Axillary Staging in Patients With Breast Cancer
Authors: Carleton Neil , Saadawi Gilan , McAuliffe Priscilla F. , Soran Atilla , Oesterreich Steffi , Lee Adrian V. , Diego Emilia J. 
Published: May 2024

PURPOSE Natural language understanding (NLU) may be particularly well equipped for enhanced data capture from the electronic health record given its examination of both content-driven and context-driven extraction. METHODS We developed and applied a NLU model to examine rates of pathological node positivity (pN+) and rates of lymphedema to determine whether omission of routine axillary staging could be extended to younger patients with estrogen receptor–positive (ER+)/cN0 disease. RESULTS We found that rates of pN+ and arm lymphedema were similar between patients age 55-69 years and ≥70 years, with rates of lymphedema exceeding rates of pN+ for clinical stage T1c and smaller disease. CONCLUSION Data from our NLU model suggest that omission of sentinel lymph node biopsy might be extended beyond Choosing Wisely recommendations, limited to those older than 70 years and to all postmenopausal women with early-stage ER+/cN0 disease. These data support the recently reported SOUND trial results and provide additional granularity to facilitate surgical de-escalation.
Primary Care Provider Visits Among Cancer Survivors 5-7 Years Postdiagnosis
Authors: Birken Sarah A. , Peluso Alexandra G. , Shalowitz David I. , Isom Scott , Wagi Cheyenne R. , Randazzo Aliza , Falk Derek , Strom Carla , Bell Ronny , Weaver Kathryn E. 
Published: May 2024

PURPOSE Cancer survivors experience better outcomes when primary care providers (PCPs) are engaged in their care. Nearly all survivors have a PCP engaged in their care in the initial 5 years postdiagnosis, but little is known about sustained PCP engagement. We assessed PCP engagement in survivors' care 5-7 years postdiagnosis and characterized survivors most vulnerable to loss to PCP follow-up. METHODS We linked electronic health record ambulatory care and cancer registry data from an National Cancer Institute–Designated Comprehensive Cancer Center to identify eligible survivors (≥18 years; diagnosed with breast, colorectal, or uterine cancer; had an in-network PCP). We used multiple logistic regression to assess associations between survivor demographics, clinical factors, and health care utilization and odds of sustained PCP engagement. RESULTS In 5-7 years postdiagnosis, PCPs were engaged in care for 43% of survivors. Survivors with sustained PCP-engagement were on average 4.6 years older than those without ( P < .0001); survivors had 1.36 greater odds of having regular PCP visits for each decade increase in age on cancer diagnosis ( P = .0030). Survivors were less likely to be lost to PCP follow-up if diagnosed at an earlier stage with odds at 0.57 and 0.10 for stage I and stage IV, respectively ( P = .0005), and had 2.70 greater odds of engagement in care with at least one oncology visit annually 5-7 years postdiagnosis ( P < .0001). CONCLUSION Sustained PCP engagement is endorsed as critical by survivors, PCPs, and oncologists. We found most survivors were lost to PCP follow-up 5-7 years postdiagnosis. Our study is among the first to contribute empirical evidence of survivors being lost in transition. Findings from this study demonstrate the need to bridge gaps in long-term care for cancer survivors.
Prognostic factors and outcomes in anti-neutrophil cytoplasmic antibody-associated glomerulonephritis: A retrospective single-center study from southern China
Authors: Zhong Lanxing , Zhang Ying , Jia Nan , Su Xiaotong , Zhong Menger , Zhao Chunmei 
Published: May 2024

Objective: To investigate the prognostic factors and outcomes in patients with anti-neutrophil cytoplasmic antibody-associated glomerulonephritis (ANCA-GN) in Southern China
Methods: A retrospective analysis of medical records of patients with ANCA-GN admitted to Shenzhen Hospital of Southern Medical University and Nanfang Hospital of Southern Medical University between September 2011 and September 2021 was performed. The clinical presentation, biological, and renal pathology were collected. In addition, the risk factors for end-stage renal disease (ESRD) and short-term overall survival in patients with ANCA-GN were analyzed.
Results: A total of 93 patients with ANCA-GN were included in the study. Of them, 91.4%, were perinuclear anti-neutrophil cytoplasmic antibodies (MPO-pANCA)-positive. Approximately one-quarter (24.7%) of patients had progressed to ESRD, and 7.5% died within six months. Most patients presented with hematuria (94.6%), proteinuria (78.5%), elevated serum creatinine (86.0%), anemia (90.3%), and increased erythrocyte sedimentation rate (ESR) (44.1%). The majority (94.6%) of patients presented with crescent formations at histopathological examination. Serum creatinine, hemoglobin, and Birmingham vasculitis activity score (BVAS) were all independent factors for ESRD (P<0.05). Moreover, while ANCA renal risk score (ARRS) has an impact on prognosis of nephropathy, it did not influence ESRD independently (P>0.05). The effect of Berden’s histopathologic classification on ESRD has not been confirmed. Age at onset, ESR and cardiovascular involvement were all independent factors affecting short-term overall survival of patients with ANCA-GN (P<0.05).
Conclusions: Serum creatinine, hemoglobin, and BVAS were all independent risk factors of ESRD, while ARRS and Berden’s histopathologic classification were not. Age at onset, ESR, and cardiovascular involvement were independent risk factors for the overall six-month survival rate in patients with ANCA-GN.
doi: https://doi.org/10.12669/pjms.40.6.9683
How to cite this: Zhong L, Zhang Y, Jia N, Su X, Zhong M, Zhao C. Prognostic factors and outcomes in anti-neutrophil cytoplasmic antibody-associated glomerulonephritis: A retrospective single-center study from southern China. Pak J Med Sci. 2024;40(6):1247-1255. doi: https://doi.org/10.12669/pjms.40.6.9683
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Resource Allocation in an Uncertain Environment: Application to Snowplowing Operations in Utah
Authors: Wang Yinhu , Chen Ye , Ryzhov Ilya O. , Liu Xiaoyue Cathy , Marković Nikola 
Published: May 2024

We consider a two-stage planning problem where a fleet of snowplow trucks is divided among a set of independent regions, each of which then designs routes for efficient snow removal. The central authority wishes to allocate trucks to improve service quality across the regions. Stochasticity is introduced by uncertain weather conditions and unforeseen failures of snowplow trucks. We study two versions of this problem. The first aims to minimize the maximum turnaround time (across all regions) that can be sustained with a user-specified probability. The second seeks to minimize the total expected workload that has not been completed within a user-specified time frame. We develop algorithms that solve these problems effectively and demonstrate their practical value through a case application to snowplowing operations in Utah, obtaining solutions that significantly outperform the allocation currently used in practice. Funding: Financial support from the Utah Department of Transportation [Grant 218138]; the National Science Foundation [Grant CMMI-2112758]; and the Mountain-Plains Consortium [Grant 637] is gratefully acknowledged. Supplemental Material: The e-companion is available at https://doi.org/10.1287/trsc.2023.0024 .
Realising Disability Rights in Non-Liberal Contexts
Authors: Yang Daryl WJ 
Published: May 2024

A key innovation of the United Nations (UN) Convention on the Rights of Persons with Disabilities (CRPD) is its recognition of the critical importance of the principle of meaningful participation in realising the rights enshrined in the treaty document. Hence, the CRPD is the first human rights treaty to mandate the participation of civil society in the implementation and monitoring of the treaty. What happens, however, in a non-liberal society where human rights activism is potentially risky and lacks cultural resonance?
This article turns to Singapore as a case study and analyses how one particular cross-disability representative organisation participated in the CRPD monitoring process through the ritualistic mobilisation of disability rights. This mobilisation was enabled by the CRPD’s obligations of conduct, which provide a justification for their participation in the CRPD monitoring process. Hence, the usual risks associated with human rights activism in Singapore can be mitigated because these activists are technically assisting the Singapore government in fulfilling its obligations under the treaty. Such tactics of ritualistic mobilisation are aimed ultimately at the ritualisation of disability rights, which refers to the entrenchment of the human rights model of disability policy as the dominant political paradigm through which to approach disability issues.
In addition to demonstrating the impact of obligations of conduct enshrined in the CRPD on the mobilisation of disability rights, this article adds to the growing recognition in socio-legal and human rights scholarship that civil society participation and rights mobilisation may take a variety of forms, not only the more explicit or confrontational modes that feature in Western liberal democracies. It also contributes to the growing literature on disability movements in East Asian developmental welfare states by attending to how disability rights and the CRPD are mobilised in the region to realise a more just and equal society for disabled people.