bluuebunny/crossref_metadata_2025_split huggingface dataset:
Estimating the prevalence of discrepancies between study registrations and publications: a systematic review and meta-analyses
Authors:   TARG Meta-Research Group & Collaborators
Published: October 2023

ObjectivesProspectively registering study plans in a permanent time-stamped and publicly accessible document is becoming more common across disciplines and aims to reduce risk of bias and make risk of bias transparent. Selective reporting persists, however, when researchers deviate from their registered plans without disclosure. This systematic review aimed to estimate the prevalence of undisclosed discrepancies between prospectively registered study plans and their associated publication. We further aimed to identify the research disciplines where these discrepancies have been observed, whether interventions to reduce discrepancies have been conducted, and gaps in the literature.DesignSystematic review and meta-analyses.Data sourcesScopus and Web of Knowledge, published up to 15 December 2019.Eligibility criteriaArticles that included quantitative data about discrepancies between registrations or study protocols and their associated publications.Data extraction and synthesisEach included article was independently coded by two reviewers using a coding form designed for this review (osf.io/728ys). We used random-effects meta-analyses to synthesise the results.ResultsWe reviewed k=89 articles, which included k=70 that reported on primary outcome discrepancies from n=6314 studies and, k=22 that reported on secondary outcome discrepancies from n=1436 studies. Meta-analyses indicated that between 29% and 37% (95% CI) of studies contained at least one primary outcome discrepancy and between 50% and 75% (95% CI) contained at least one secondary outcome discrepancy. Almost all articles assessed clinical literature, and there was considerable heterogeneity. We identified only one article that attempted to correct discrepancies.ConclusionsMany articles did not include information on whether discrepancies were disclosed, which version of a registration they compared publications to and whether the registration was prospective. Thus, our estimates represent discrepancies broadly, rather than our target ofundiscloseddiscrepancies betweenprospectivelyregistered study plans and their associated publications. Discrepancies are common and reduce the trustworthiness of medical research. Interventions to reduce discrepancies could prove valuable.Registrationosf.io/ktmdg. Protocol amendments are listed in online supplemental material A.
Breastfeeding experiences of patients in baby-friendly certified hospital settings: protocol for a scoping review
Authors: Durocher Keri , Jackson Kimberley T , Booth Richard , Tryphonopoulos Panagiota , Kennedy Kelly 
Published: October 2023

IntroductionThe Baby-friendly Hospital Initiative is a global programme that is meant to support breastfeeding within organisations. Most of the current literature is focused on implementation and uptake of the programme; however, little is known about the patient experience of breastfeeding within these settings. By exploring this current gap in the literature, we may discover important contextual elements of the breastfeeding experience. The objective of this protocol is to provide a framework for a scoping review where we aim to understand the extent and type of evidence in relation to the patient experience of breastfeeding in Baby-friendly Hospital Initiative (BFHI)-certified settings.Methods and analysisThe proposed scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The databases to be searched for relevant literature include MEDLINE, Embase, PsycINFO, CINAHL and Scopus in April 2023. A grey literature scan will include reviewing documents from professional organisations/associations. For all sources of evidence that meet the inclusion criteria, data will be extracted and presented in a table format. The results of the search and the study inclusion process will be reported in full in the final scoping review and presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. Participants in this review will include any individual who delivered their baby in a BFHI-certified setting. Exploring the patient experience will involve reviewing their subjective perceptions of events related to breastfeeding. These events must occur in a BFHI-certified hospital, and therefore, home births and other outpatient settings will be excluded.Ethics and disseminationEthical approval is not required for this scoping review protocol or the final review. Knowledge gained from this research will be disseminated through the primary author’s PhD dissertation work, as well as manuscript publications and conference presentations.
Patients’ and clinicians’ views on the appropriate use of safety-netting advice in consultations—an interview study from Sweden
Authors: Fernholm Rita , Wannheden Carolina , Trygg Lycke Sofia , Riggare Sara , Pukk Harenstam Karin 
Published: October 2023

BackgroundA promising approach to manage clinical uncertainty and thereby reduce the risk of preventable diagnostic harm is to use safety-netting advice (ie, communicating structured information to patients about when and where to reconsult healthcare).AimTo explore clinicians’ and patients’ views on when and how safety-netting can be successfully applied in primary-care and emergency-care settings.Design and settingAn exploratory qualitative research design; we performed focus groups and interviews in a Swedish setting.ParticipantsNine physicians working in primary or emergency care and eight patients or caregivers participated. The participants were an ethnically homogeneous group, originating from Western European or Australian backgrounds.MethodData were analysed inductively, using the framework method. The results are reported according to the Standards for Reporting Qualitative Research guidelines for reporting qualitative research.ResultsIn order to manage diagnostic uncertainty using safety-netting, clinicians and patients emphasised the need to understand thepreconditionsfor the consultation (ie, the healthcare setting, the patient’s capacity and existing power imbalance). Furthermore, participants raised the importance ofestablishing a mutual understandingregarding the patient’s perspective and the severity of the situation before engaging in safety-netting advice.ConclusionThe establishment of a shared mental model between clinician and patient of the preconditions for the clinical encounter is a vital factor affecting how safety-netting advice is communicated and received and its ability to support patients in problem detection and planning after the visit. We suggest that successful safety-netting can be viewed as a team activity, where the clinician and patient collaborate in monitoring how the patient’s condition progresses after the care visit. Furthermore, our findings suggest that to be successfully implemented, safety-netting advice needs to be tailored to the clinical context in general and to the patient–clinician encounter in particular.
Comorbidities and mortality among patients with chronic obstructive pulmonary disease
Authors: Skajaa Nils , Laugesen Kristina , Horváth-Puhó Erzsébet , Sørensen Henrik Toft 
Published: October 2023

IntroductionComorbidities are common in patients with chronic obstructive pulmonary disease (COPD). Estimates of prevalence, incidence and prognostic impact of comorbidities provide foundational knowledge of COPD epidemiology. We examined the prevalence, incidence and prognostic impact of 21 comorbidities among patients with COPD compared with the Danish general population.MethodsWe conducted a nationwide, population-based cohort study based on longitudinal Danish registry data, covering all Danish hospitals (2010–2021). The cohorts comprised 142 973 patients with a first-time hospital-based diagnosis of COPD and 428 917 age-matched and sex-matched comparators from the general population. During follow-up, we estimated the 5-year risk and risk difference, using competing risk methods when applicable.ResultsAt time of diagnosis, the comorbidities with the highest prevalence were mood, stress-related or anxiety disorders (25.2% for patients with COPD vs 13.1% for comparators), osteoporosis/hip fractures (17.4% vs 9.9%), diabetes (15.6% vs 10.5%), peripheral arterial disease (13.5% vs 4.9%) and heart failure (13.3% vs 4.0%). During follow-up, the risk of most incident comorbidities was markedly elevated among patients with COPD. The five comorbidities associated with the highest 5-year absolute risk difference with respect to the risk in the general population were mood, stress-related or anxiety disorders (5.7%), osteoporosis/hip fractures (5.6%), heart failure (4.2%), smoking-related cancers (2.8%) and peripheral arterial disease (2.7%). The 5-year mortality risk was 43% vs 17.7%. Among patients with COPD, the 5-year mortality risk markedly increased with the number of comorbidities present.ConclusionsOur population-based findings underscore the importance of considering comorbidities in the management of COPD.
Location specific rupture risk of intracranial aneurysms: case of ophthalmic aneurysms
Authors: Chiaroni Pierre-Marie , Guerra Xavier , Cortese Jonathan , Burel Julien , Courret Thomas , Constant dit Beaufils Pacome , Agripnidis Thibault , Leonard-Lorant Ian , Fauché Cédric , Bankole Nourou Dine Adeniran , Forestier Géraud , L'allinec Vincent , Sporns Peter B , Gueton Gaelle , Lorena Nico , Psychogios Marios-Nikos , Girot Jean-Baptiste , Rouchaud Aymeric , Janot Kevin , Raynaud Nicolas , Pop Raoul , Hak Jean-Francois , Kerleroux Basile , Bourcier Romain , Marnat Gaultier , Papagiannaki Chrysanthi , Sourour Nader-Antoine , Clarençon Frédéric , Shotar Eimad 
Published: October 2023

BackgroundAneurysm location is a key element in predicting the rupture risk of an intracranial aneurysm. A common impression suggests that pure ophthalmic aneurysms are under-represented in ruptured intracranial aneurysms (RIAs). The purpose of this study was to specifically evaluate the risk of rupture of ophthalmic aneurysms compared with other aneurysm locations.MethodsThis multicenter study compared the frequency of ophthalmic aneurysms in a prospective cohort of RIAs admitted to 13 neuroradiology centers between January 2021 and March 2021, with a retrospective cohort of patients with unruptured intracranial aneurysms (UIAs) who underwent cerebral angiography at the same neuroradiology centers during the same time period.Results604 intracranial aneurysms were included in this study (355 UIAs and 249 RIAs; mean age 57 years (IQR 49–65); women 309/486, 64%). Mean aneurysm size was 6.0 mm (5.3 mm for UIAs, 7.0 mm for RIAs; P<0.0001). Aneurysm shape was irregular for 37% UIAs and 73% RIAs (P<0.0001). Ophthalmic aneurysms frequency was 14.9% of UIAs (second most common aneurysm location) and 1.2% of RIAs (second least common aneurysm location; OR 0.07 (95% CI 0.02 to 0.23), P<0.0001).ConclusionsOphthalmic aneurysms seem to have a low risk of rupture compared with other intracranial aneurysm locations. This calls for a re-evaluation of the benefit–risk balance when considering preventive treatment for ophthalmic aneurysms.
Physical activity, social-communicative skills and fitness for military service
Authors: Silvala Jan , Hurtig T , Yliherva A , Taanila A , Korpelainen R 
Published: October 2023

IntroductionResearch has suggested that increased difficulties in social-communicative skills are associated with release from military service. A few studies have focused on the association between physical activity and military fitness; however, studies of the association between social-communicative skills and physical activity remain scarce. The aim of this study was to investigate the association between the amount of leisure time physical activity and fitness for military service, as well as to investigate the association between social-communicative difficulties and physical activity.MethodsThis is a population-based cross-sectional ‘Young Men in the North Project’, in which 2614 men (M age=18.1 years) participated in an obligatory military fitness call-up and filled out the study questionnaire.ResultsThe results showed that higher physical performance compared with peers and attaining the weekly amount of moderate-to-vigorous physical activity were associated with lower likelihood of being permanently or temporarily released from the service. In addition, difficulties in social-communicative skills were associated with lower physical performance and lower weekly amounts of moderate-to-vigorous physical activity. The results also showed that higher physical performance or attaining the recommended weekly amount of moderate-to-vigorous physical activity, together with higher social-communicative skills, lowered the likelihood of being permanently or temporarily released from the service.ConclusionsThese results suggest that better physical performance, or a higher level of physical activity, together with better social-communicative skills, lowers the likelihood of being permanently and temporarily released from the military service more than physical performance or physical activity alone.
NPU-Accelerated Imitation Learning for Thermal Optimization of QoS-Constrained Heterogeneous Multi-Cores
Authors: Rapp Martin , Khdr Heba , Krohmer Nikita , Henkel Jörg 
Published: October 2023

Thermal optimization of a heterogeneous clustered multi-core processor under user-defined QoS targets requires application migration and DVFS. However, selecting the core to execute each application and the VF levels of each cluster is a complex problem because (1) the diverse characteristics and QoS targets of applications require different optimizations, and (2) per-cluster DVFS requires a global optimization considering all running applications. State-of-the-art resource management for power or temperature minimization either relies on measurements that are commonly not available (such as power) or fails to consider all the dimensions of the optimization (e.g., by using simplified analytical models). To solve this, ML methods can be employed. In particular, IL leverages the optimality of an oracle policy, yet at low run-time overhead, by training a model from oracle demonstrations. We are the first to employ IL for temperature minimization under QoS targets. We tackle the complexity by training NN at design time and accelerate the run-time NN inference using NPU. While such NN accelerators are becoming increasingly widespread, they are so far only used to accelerate user applications. In contrast, we use for the first time an existing accelerator on a real platform to accelerate NN-based resource management. To show the superiority of IL compared to RL in our targeted problem, we also develop multi-agent RL-based management. Our evaluation on a
HiKey 970
board with an
Arm big.LITTLE
CPU and NPU shows that IL achieves significant temperature reductions at a negligible run-time overhead. We compare
TOP-IL
against several techniques. Compared to
ondemand
Linux governor,
TOP-IL
reduces the average temperature by up to 17 ˆC at minimal QoS violations for both techniques. Compared to the RL policy, our
TOP-IL
achieves 63 % to 89 % fewer QoS violations while resulting similar average temperatures. Moreover,
TOP-IL
outperforms the RL policy in terms of stability. We additionally show that our IL-based technique also generalizes to different software (unseen applications) and even hardware (different cooling) than used for training.
Shortest Cycles with Monotone Submodular Costs
Authors: Fomin Fedor V. , Golovach Petr A. , Korhonen Tuukka , Lokshtanov Daniel , Stamoulis Giannos 
Published: October 2023

We introduce the following submodular generalization of the
Shortest Cycle
problem. For a nonnegative monotone submodular cost function
f
defined on the edges (or the vertices) of an undirected graph
G
, we seek for a cycle
C
in
G
of minimum cost 𝖮𝖯𝖳 =
f(C)
. We give an algorithm that given an
n
-vertex graph
G
, parameter ɛ > 0, and the function
f
represented by an oracle, in time
n
𝒪
(log 1/ɛ) finds a cycle
C
in
G
with
f(C)
≤ (1+ɛ). 𝖮𝖯𝖳. This is in sharp contrast with the non-approximability of the closely related

Monotone Submodular Shortest (
s,t
-Path

problem, which requires exponentially many queries to the oracle for finding an
n
2/3-ɛ
-approximation Goel et al. [
7
], FOCS 2009. We complement our algorithm with a matching lower bound. We show that for every ɛ > 0, obtaining a (1+ɛ)-approximation requires at least
n
Ω (log 1/ ɛ)
queries to the oracle.

When the function
f
is integer-valued, our algorithm yields that a cycle of cost 𝖮𝖯𝖳 can be found in time
n
𝒪(log 𝖮𝖯𝖳)
. In particular, for 𝖮𝖯𝖳 =
n
𝒪(1)
this gives a quasipolynomial-time algorithm computing a cycle of minimum submodular cost. Interestingly, while a quasipolynomial-time algorithm often serves as a good indication that a polynomial time complexity could be achieved, we show a lower bound that
n

𝒪(log
n
)

queries are required even when 𝖮𝖯𝖳= 𝒪(
n
).

We also consider special cases of monotone submodular functions, corresponding to the number of different color classes needed to cover a cycle in an edge-colored multigraph
G
. For special cases of the corresponding minimization problem, we obtain fixed-parameter tractable algorithms and polynomial-time algorithms, when restricted to certain classes of inputs.
A Prospective Study Exploring the Safety and Efficacy of Lenvatinib for Patients with Advanced Hepatocellular Carcinoma and High Tumor Burden: The LAUNCH Study
Authors: Kobayashi Kazufumi , Ogasawara Sadahisa , Maruta Susumu , Okubo Tomomi , Itokawa Norio , Haga Yuki , Seko Yuya , Moriguchi Michihisa , Watanabe Shunji , Shiko Yuki , Takatsuka Hirokazu , Kanzaki Hiroaki , Koroki Keisuke , Inoue Masanori , Nakamura Masato , Kiyono Soichiro , Kanogawa Naoya , Kondo Takayuki , Suzuki Eiichiro , Ooka Yoshihiko , Nakamoto Shingo , Inaba Yosuke , Ikeda Masafumi , Okabe Shinichiro , Morimoto Naoki , Itoh Yoshito , Nakamura Kazuyoshi , Ito Kenji , Azemoto Ryosaku , Atsukawa Masanori , Itobayashi Ei , Kato Naoya 
Published: October 2023

Abstract

Purpose:
This study aimed to investigate the safety and efficacy of lenvatinib in real-world settings, including patients excluded from the REFLECT trial, a phase III trial that compared lenvatinib with sorafenib.

Patients and Methods:
This multicenter, nonrandomized, open-label prospective study was conducted at 10 medical facilities in Japan (jRCTs031190017). Eligible patients had advanced hepatocellular carcinoma (HCC) and were suitable for lenvatinib therapy. The study included patients with high tumor burden (with &gt;50% intrahepatic tumor volume, main portal vein invasion, or bile duct invasion), Child-Pugh B status, and receiving lenvatinib as second-line therapy following atezolizumab plus bevacizumab.

Results:
From December 2019 to September 2021, 59 patients were analyzed (47 and 12 patients with Child-Pugh A and B, respectively). In patients with Child-Pugh A, the frequency of aspartate aminotransferase elevation was high (72.7%) in the high-burden group. No other significant ad verse events (AE) were observed even in second-line treatment. However, patients with Child-Pugh B had high incidence of grade ≥3 AE (100.0%) and high discontinuation rates caused by AE (33.3%) compared with patients with Child-Pugh A (80.9% and 17.0%, respectively). Median progression-free survival was 6.4 and 2.5 months and median overall survival was 19.7 and 4.1 months in Child-Pugh A and B, respectively. Lenvatinib plasma concentration was higher in patients with Child-Pugh B on days 8 and 15 and correlated with dose modifications and lower relative dose intensity.

Conclusions:
Lenvatinib is safe and effective for advanced HCC in patients with Child-Pugh A, even with high tumor burden. However, it carries a higher risk of AE and may not provide adequate efficacy for patients with Child-Pugh B status.
A New Paradigm of the Origins of Circulating DNA in Patients with Cancer
Authors: Thierry Alain R. , Pisareva Ekaterina 
Published: October 2023

Summary:
By shedding light on the cellular origins of circulating DNA (cirDNA), this research provides important insights into the mechanisms of cirDNA production in cancer. Contrary to expectations, the increased cirDNA in patients with cancer was not derived predominantly from neoplastic cells or surrounding nonneoplastic epithelial cells; rather, the excess cirDNA originated primarily from leukocytes, implying a systemic impact of cancer on cell turnover or DNA clearance.
See related article by Mattox et al., p. 2166 (1).
Liquid Biopsies in Breast Milk for the Early Detection of Breast Cancer
Authors: Cunningham Niamh , Turner Nicholas C 
Published: October 2023

Summary:Cell-free tumor DNA has previously been detected in nonblood sources, including urine, saliva, stool, cerebrospinal fluid, and pleural fluid. In this issue, Saura and colleagues present a novel proof-of-concept study demonstrating that detection of tumor DNA in breast milk is feasible and may be a potential future strategy to screen for postpartum breast cancer.See related article by Saura et al., p. 2180 (14).
Feminist Pragmatist Design: Evolutionary Systems Change
Authors: Lake Danielle , Whipps Judy 
Published: October 2023

Abstract
What might feminist pragmatist methods of engagement have to offer to design efforts aimed at catalyzing and sustaining change in complex systems? This article examines two systemic social design initiatives emerging from classical feminist pragmatists that illustrate their core commitments and social change methods. These initiatives highlight four strategies found to be critical to feminist pragmatist social design inquiry: 1) situated and relational exploration across diverse communities, 2) iterative and experimental prototyping, 3) a willingness to accept incremental change, and 4) a commitment to deep and sustained engagement within communities.