bluuebunny/crossref_metadata_2025 huggingface dataset:
Supplementary Data from Prognostic and Predictive Value of HER2 Expression in Ductal Carcinoma In Situ: Results from the UK/ANZ DCIS Randomized Trial
Authors: Thorat Mangesh A. , Levey Pauline M. , Jones J. Louise , Pinder Sarah E. , Bundred Nigel J. , Fentiman Ian S. , Cuzick Jack
Published: October 2024

Supplementary material including study design, cohort representativeness, senstivity analyses and supplementary references
Supplemental Figure 4 from The Prognostic Role of MYC Structural Variants Identified by NGS and FISH in Multiple Myeloma
Authors: Sharma Neeraj , Smadbeck James B. , Abdallah Nadine , Zepeda-Mendoza Cinthya , Binder Moritz , Pearce Kathryn E. , Asmann Yan W. , Peterson Jess F. , Ketterling Rhett P. , Greipp Patricia T. , Bergsagel P. Leif , Rajkumar S. Vincent , Kumar Shaji K. , Baughn Linda B.
Published: October 2024

Supplemental Figure 4 shows the influence of high and low MYC gene expression on OS and PFS in either the hyperdiploid or non-hyperdiploid groups of the CoMMpass cohort
Figure S1 from A Phase II Trial of the Bruton Tyrosine-Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Waldenström Macroglobulinemia
Authors: An Gang , Zhou Daobin , Cheng Shu , Zhou Keshu , Li Jianyong , Zhou Jianfeng , Xie Liping , Jin Jie , Zhong Liye , Yan Lingzhi , Guo Haiyi , Du Chenmu , Zhong Jinhua , Yu Yiling , Wu Binghao , Qiu Lugui
Published: October 2024

Study design.
Data from Standard-Dose Pembrolizumab Plus Alternate-Dose Ipilimumab in Advanced Melanoma: KEYNOTE-029 Cohort 1C, a Phase 2 Randomized Study of Two Dosing Schedules
Authors: Long Georgina V. , Robert Caroline , Butler Marcus O. , Couture Felix , Carlino Matteo S. , O'Day Steven , Atkinson Victoria , Cebon Jonathan S. , Brown Michael P. , Dalle Stéphane , Hill Andrew G. , Gibney Geoffrey T. , McCune Steven , Menzies Alexander M. , Niu Cuizhen , Ibrahim Nageatte , Moreno Blanca Homet , Diab Adi
Published: October 2024

AbstractPurpose:
Standard-dose pembrolizumab plus alternative-dose ipilimumab (1 mg/kg Q3W for 4 doses) were tolerable and had robust antitumor activity in advanced melanoma in cohort B of the phase 1 KEYNOTE-029 study. Cohort C evaluated standard-dose pembrolizumab with two other alternative ipilimumab regimens.
Patients and Methods:
Patients with treatment-naive unresectable stage III/IV melanoma were randomly assigned 1:1 to pembrolizumab 200 mg Q3W for ≤24 months plus ipilimumab 50 mg Q6W for 4 doses (PEM200+IPI50), or the same pembrolizumab regimen plus ipilimumab 100 mg Q12W for 4 doses (PEM200+IPI100). Primary end points were incidence of grade 3–5 treatment-related adverse events (TRAE) and objective response rate (ORR) per RECIST v1.1 by independent central review. Per protocol-defined thresholds, grade 3–5 TRAE incidence ≤26% indicated meaningful toxicity reduction and ORR ≥48% indicated no decrease in efficacy versus data reported for other PD-1 inhibitor/ipilimumab combinations.
Results:
Median follow-up on February 18, 2019, was 16.3 months in PEM200+IPI50 (N = 51) and 16.4 months in PEM200+IPI100 (N = 51). Grade 3–5 TRAEs occurred in 12 (24%) patients in PEM200+IPI50 and 20 (39%) in PEM200+IPI100. One patient in PEM200+IPI50 died from treatment-related autoimmune myocarditis. Immune-mediated AEs or infusion reactions occurred in 21 (42%) patients in PEM200+IPI50 and 28 (55%) in PEM200+IPI100. ORR was 55% in PEM200+IPI50; 61% in PEM200+IPI100.
Conclusions:
Pembrolizumab 200 mg Q3W plus ipilimumab 50 mg Q6W or 100 mg Q12W demonstrated antitumor activity above the predefined threshold; pembrolizumab plus ipilimumab 50 mg Q6W had lower incidence of grade 3–5 TRAEs than the predefined threshold, suggesting a reduction in toxicity.

See related commentary by Jameson-Lee and Luke, p. 5153
Table 2 from Targeting the Epidermal Growth Factor Receptor Pathway in Chemotherapy-Resistant Triple-Negative Breast Cancer: A Phase II Study
Authors: Yam Clinton , Patel Miral , Hill Holly A. , Sun Ryan , Bassett Roland L. , Kong Elisabeth , Damodaran Senthil , Koenig Kimberly B. , Abouharb Sausan , Saleem Sadia , Bisen Ajit K. , Murthy Rashmi K. , Ramirez David L. , Rauch Gaiane M. , Adrada Beatriz E. , Candelaria Rosalind P. , Wang Xiaoping , Mittendorf Elizabeth A. , Thompson Alastair M. , White Jason B. , Ravenberg Elizabeth E. , Clayborn Alyson R. , Ding Qing-Qing , Booser Daniel J. , Oke Oluchi , Brewster Abenaa M. , Hortobagyi Gabriel N. , Ibrahim Nuhad K. , Litton Jennifer K. , Valero Vicente , Arun Banu K. , Tripathy Debu , Chang Jeffrey T. , Chen Ken , Korkut Anil , Moulder Stacy L. , Huo Lei , Lim Bora , Ueno Naoto T.
Published: October 2024

TRAEs
SUPPLEMENTARY TABLE ST1 from Targeting the Epidermal Growth Factor Receptor Pathway in Chemotherapy-Resistant Triple-Negative Breast Cancer: A Phase II Study
Authors: Yam Clinton , Patel Miral , Hill Holly A. , Sun Ryan , Bassett Roland L. , Kong Elisabeth , Damodaran Senthil , Koenig Kimberly B. , Abouharb Sausan , Saleem Sadia , Bisen Ajit K. , Murthy Rashmi K. , Ramirez David L. , Rauch Gaiane M. , Adrada Beatriz E. , Candelaria Rosalind P. , Wang Xiaoping , Mittendorf Elizabeth A. , Thompson Alastair M. , White Jason B. , Ravenberg Elizabeth E. , Clayborn Alyson R. , Ding Qing-Qing , Booser Daniel J. , Oke Oluchi , Brewster Abenaa M. , Hortobagyi Gabriel N. , Ibrahim Nuhad K. , Litton Jennifer K. , Valero Vicente , Arun Banu K. , Tripathy Debu , Chang Jeffrey T. , Chen Ken , Korkut Anil , Moulder Stacy L. , Huo Lei , Lim Bora , Ueno Naoto T.
Published: October 2024

Molecular Subtypes and Pathological Response.
Effects of Different Auditory Stimuli and Cognitive Tasks on Balance in Healthy Young Adults
Authors: Gedik Toker Özge , Durgut Elif , Yılmaz Erdem Emre , Alpay Kubra , Gurses Hulya Nilgun
Published: October 2024

Introduction: This study investigated the effect of different auditory stimuli and cognitive tasks on balance in healthy young adults. Methods: Thirty-three participants, aged 23.33 ± 2.43 years, were included in the study. The hearing levels of the participants were determined. Static and dynamic postural stability and limits of stability (LOS) tests were performed in the absence of auditory stimuli, in the presence of spondee word lists at 70 dB(A) and in the presence of spondee+white noise (−6 dB signal-to-noise ratio [SNR]), while auditory stimuli were presented bilaterally with supra-aural headphones. Participants were asked to repeat the words they listened to while performing balance-related tasks. Results: No significant differences between the three conditions were observed in the postural stability and LOS results. Increase in total repetition error was observed as the listening task became more difficult. Conclusion: The presence of auditory stimuli and the cognitive tasks did not cause any changes in the participants’ balance.
Personality shapes inter- and intraspecific interactions in rodents: a behavioral experiment with Brandt’s voles (Lasiopodomys brandtii)
Authors: Shi Yunyun , Yue Yuan , Shi Caishan , Wang Jing , Zhang Yifeng
Published: October 2024

Interspecific and intraspecific interactions are integral components of antagonistic and mutualistic networks of all animal species. These interactions are affected by various factors, such as morphological, physiological, and genetic characteristics. However, the impact of personality traits on animal inter- and intraspecific interactions remains unclear. We investigated the role of different personality types (proactive and reactive) in Lasiopodomys brandtii. We examined both intraspecific interactions with Lasiopodomys brandtii and interspecific interactions with Kunming mice. We found that for intraspecific interactions, proactive individuals had higher numbers of contacts with opponents, spent more time in the vicinity of an opponent, and moved greater distances within the vicinity of an opponent. For interspecific interactions, proactive individuals had higher numbers of contacts with opponents than reactive individuals. These results suggest that proactive individuals, especially male voles, tend to occupy dominant positions in both intraspecific and interspecific relationships. Consequently, our study is meaningful in understanding how personality traits affect animal behavior, species niche differentiation, and community dynamics and local biodiversity.
Qatar’s Efforts to Change the Image of Muslims after 9/11
Authors: Latif Muhammad Asad
Published: October 2024

Islam was branded as a religion of terror and bloodshed after the 9/11 terrorist attacks. Nonetheless, there have been counter-movements to challenge this stereotyping from many Muslim nations within the past ten years. The Arab-Muslim nation of Qatar, which organized and hosted the 2022 World Cup, is one of them. The present study examines Qatar’s progress in organizing and hosting the 2022 World Cup. The study also looks into Qatar’s approach in dealing with Muslims and combating Islamophobia. A social psychology method is used in the current study to explore Qatar’s mission. Investigations by print media and interviews have made it easier to comprehend the context and causes of Islamophobia. Qatar demonstrates how an anti-Islamophobia program can be constructed by first presenting a favorable impression of Muslims and Islam and presenting the reality of Islam. Additionally, an empirical study was carried out to examine media discourse in order to examine the ways that Qatar’s positions and actions contributed to anti-Islamophobia globally.
Impact of two human milk oligosaccharides and lactose on the faecal microbiome of infants with probable cow’s milk allergy
Authors: Van den Abbeele P. , Heine R.G. , Van de Vliet M. , Favre L. , Tytgat H.L.P. , Sprenger N. , Deyaert S. , Baudot A. , Nutten S.
Published: October 2024

Cow’s milk protein allergy (CMPA) in infancy is associated with intestinal microbial dysbiosis, characterised by low Bifidobacteriaceae levels. The present study aimed to investigate the impact of two human milk oligosaccharides (HMO), lactose (L), and their combination on the faecal microbiome and metabolome of infants with CMPA. Stool samples of 12 term infants with probable CMPA (mean age 4.3 months) were analysed using a validated intestinal fermentation assay (SIFR® technology). For each substrate (i.e. HMO (2′-fucosyllactose [2′-FL] and lacto-N-neotetraose [LNnT]), L and HMO + L), taxonomic microbiome characterisation and untargeted metabolite profiling were performed at multiple timepoints. At baseline, the tested faecal microbiota overall displayed low abundances of Bifidobacteriaceae. Fermentation with either HMO or lactose significantly enriched Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium pseudocatenulatum and, for HMO + L, also Bifidobacterium bifidum. The increase in HMO-utilising bifidobacteria was associated with a significant rise in levels of short-chain fatty acids, aromatic lactic acids and N-acetylated amino acids, with additive effects being observed for HMO + L. The above data suggest that the combination of 2′-FL, LNnT and lactose helps to alleviate the previously reported CMPA-associated intestinal bacterial dysbiosis and induces the production of several beneficial metabolites. The clinical significance of these findings for infants with CMPA requires further investigation.
Discovery of new brown lacewings from the mid-Cretaceous Kachin amber highlights the Cretaceous diversity of Hemerobiidae (Insecta: Neuroptera)
Authors: CHEN ZU-LUAN , ZHUO DE , XU CHUN-PENG , LIU XING-YUE
Published: October 2024

Two new genera and two new species of the lacewing family Hemerobiidae, Mischemerobia yumini Chen, Zhuo & Liu gen. et sp. nov. and Pararchaeomegaloma suzheni Chen, Zhuo & Liu gen. et sp. nov., are described from the mid-Cretaceous Kachin amber in northern Myanmar. Mischemerobia Chen, Zhuo & Liu gen. nov. differs from the other genera by the complex configuration of forewing recurrent humeral veinlet, the presence of two forewing ORBs, and the forewing MP distally fused with CuA. Pararchaeomegaloma Chen, Zhuo & Liu gen. nov. can be distinguished from the other genera by the presence of only one forewing ORB, with posterior most branch deeply forked, and the forewing MP forked near wing margin. Our finding provides new evidence for understanding the Cretaceous diversity and early diversification of brown lacewings.
Along-Slope Bottom Current and Sediment Resuspension and Transport Induced by Internal Tides on a Continental Slope
Authors: Xie Xiaohui , Wang Jiannan , Yang Chenghao
Published: October 2024

Moored observations on a critical continental slope in the northeastern South China Sea (SCS) are presented to reveal along-slope bottom current and sediment resuspension and transport caused by internal tides. During spring tides, the bottom-intensified diurnal internal tides were observed, and their breaking generated an along-slope bottom current toward the southwest direction, with a clear ∼14-day spring–neap cycle and a maximum low-frequency velocity exceeding 0.25 m s−1. The diurnal internal tides and along-slope bottom currents showed the same seasonal variations. There were larger near-bottom along-slope velocities in winter (∼9.0 cm s−1) and summer (∼8.9 cm s−1) than in spring (6.3 cm s−1) and autumn (7.4 cm s−1). The previous theory based on radiation stress caused by wave breaking is used to reproduce the observed along-slope bottom current velocity. Strong bottom flows caused by internal tides on the critical slope inhibit deposition of fine-grained sediments and may erode bottom coarse-grained sediments, leading to the generation of near-bottom nepheloid layer with a thickness H > 130 m, as demonstrated by the fact that seafloor sediments on the critical slope are dominated by coarse-grained sediments (sands). The suspended sediments can be southwest transported by the persistent along-slope bottom current generated by internal tide breaking. It was estimated that approximately three million tons of sediments during the observation were carried along the slope to the south of the SCS. Our observations suggest that internal tide-induced sediment resuspension/deposition and along-slope transport could be important for seafloor sediment distribution of the SCS.
The Effect of Obesity on Postoperative Analgesia Practices and Complications Following Endoscopic Sinus Surgery: A Propensity Score-Matched Cohort Study
Authors: Dhar Sarit , Kothari Dhruv S. , Reeves Camille , Sheyn Anthony M. , Gillespie Marion Boyd , Rangarajan Sanjeet V.
Published: October 2024

Background:

Despite growing concern regarding over-prescription of narcotic pain medication following ambulatory surgery, little is known about the analgesic prescribing practices following endoscopic sinus surgery (ESS) in obese patients in comparison to non-obese patients.

Objective:

To compare the rates of opioid versus non-opioid prescriptions, the need for steroids, and post-operative adverse events between obese and non-obese adult patients undergoing ESS.

Methods:

Using TriNetX Live database, we identified all patients aged ≥18 years who underwent ESS (n = 1303) between 2014 and 2022 across several healthcare institutions across the state of Tennessee. We 1:1 propensity score-matched obese (BMI ≥ 30 kg/m2) and non-obese (18.5 kg/m2 ≤ BMI < 30 kg/m2) cohorts for age, gender, race, and comorbidities including asthma, nicotine dependence, and sleep apnea. Rates of prescriptions and post-operative adverse events between cohorts were analyzed using risk ratios (RR) and confidence intervals (CI).

Results:

A toal of 532 obese patients were compared to 532 propensity score-matched non-obese patients in the first 14 post-operative days following ESS. The obese cohort was significantly more likely to be prescribed analgesics generally (RR = 1.72; 95% CI = 1.20-2.47), non-opioid analgesics (RR = 1.73; 95% CI = 1.19-2.50), and opioid analgesics (RR = 1.64; 95% CI = 1.14-2.36) than non-obese patients. There was no difference in rates of antibiotic or antiemetic prescription, prednisone/methylprednisolone, dexamethasone, ED visits, critical care service, epistaxis, transfusion, anemia, revision sinus surgery, mechanical ventilation, CPAP, or inhalation airway treatments.

Conclusion:

Obese patients undergoing ESS were significantly more likely to be prescribed non-opioid and opioid analgesia in the first 14 days post-operatively compared to non-obese patients. There were no differences in post-operative adverse events or other prescriptions. Otolaryngologists should be aware that obese patients are at increased risk of opioid induced airway obstruction and steroid induced hyperglycemia, especially in patients with comorbid sleep apnea or diabetes. Emphasis on non-opioid analgesics and multimodal pain management should be advocated for this population.
Investigating the Validity Issue of Extended Time for Students with Blindness in Tests Involving Complex Tables
Authors: Miyauchi Hisae , Aomatsu Toshiaki , Seiwa Yoshiko , Matsuda Erika
Published: October 2024

Introduction: This study investigated the effectiveness of changes in the test format (braille and tactile tables) and time extensions (1.5× or 2×) for tests with complex tables for students with blindness. Additionally, it examined the challenges associated with the current test accommodations for students who are blind and explored practical strategies and considerations for educators teaching tactile table reading to these students. Methods: Forty students (20 with blindness and 20 with sight) aged 16–26 years participated. Four tasks containing print for students with sight and braille and tactile tables for students with blindness were administered. The completion time for each task was measured. The portion of students who could complete the tests within each time extension range was calculated. The traits of braille readers were quantitatively analyzed. Results: Although 70% of students finished the braille task (Task 1) within 1.5× and 100% within 2×, none could complete other complex table tasks (Tasks 2–4) within these time extensions. Significant individual variations in reading speed were observed in all table reading tasks, with no correlation between Task 1 and the other three tasks. Discussion: Findings suggest that current time extension recommendations may be inadequate for students who are blind and who need to interpret complex tables. Individual reading speed differences and a lack of correlation between braille and tactile table reading may be attributed to the complex haptic system and skills required for tactile table comprehension. Implications for Practitioners: The findings highlight the need for recognizing the shortfalls of current test accommodations for students with blindness. In addition, systematic instruction for tactile table reading, independent of braille reading, may be necessary to improve the reading skills of students with blindness.
Moral Future-Thinking: Does the Moral Circle Stand the Test of Time?
Authors: Law Kyle Fiore , Syropoulos Stylianos , Coleman Matthew , Gainsburg Izzy , O’Connor Brendan Bo
Published: October 2024

Humanity’s long-term welfare may lie in the hands of those who are presently living, raising the question of whether people today hold the generations of tomorrow in their moral circles. Five studies (NTotal = 1652; Prolific) reveal present-oriented bias in the moral standing of future generations, with greater perceived moral obligation, moral concern, and prosocial intentions for proximal relative to distal future targets. Yet, present-oriented bias appears stronger for socially close compared with socially distant targets and for human targets relative to non-human animals and entities in nature. Individual differences, including longtermism beliefs and subjective imaginative vividness, predict greater concern for and obligation to the future. Likewise, concern and obligation predict greater future-oriented generosity. Our studies are among the first to explore moral considerations for targets across deep temporal expanses, reconcile conflicting evidence in the extant literature on moral judgment and future-thinking, and offer practical implications for bettering the shared societal future.
Late-Holocene hydroclimatic change and its effect on human activity at Xiada Co on the western Tibetan Plateau
Authors: Li Xiumei , Liu Sutao , Wang Yun , Fan Baowei , Hou Juzhi , Wang Mingda , Sun Huanyu , Wang Hao , Zhang Yuxin , Zhang Chenguang , Li Zongmeng , Wang Yihan
Published: October 2024

The scarcity of paleoclimate records in the western Tibetan Plateau (TP) hinders our understanding of how environmental evolution affects past human population, agriculture, and animal husbandry. Here, we utilized a range of materials to investigate the impact of climate change on human activities in the Xiada Co basin on the western TP during the Late-Holocene. We presented a continuous compound-specific hydrogen isotope record of sedimentary leaf waxes (δ2Hwax) from a sediment core of Xiada Co, and compared it to XRF core-scanning elements, brGDGT-based mean annual air temperature (MAAT) record, and fecal stanol-based human population proxy record from the same sediment core, as well as archeological evidence from the TP. The δ2Hwax exhibited a sustained increasing trend during the period from 4700 to 900 cal yr BP, followed by a generalized decrease in δ2Hwax values during 900–0 cal yr BP. The multi-proxy analysis of Xiada Co sediments revealed that the δ2Hwax values mainly reflect changes in the ISM precipitation, and are also influenced to some extent by glacier meltwater. Furthermore, a warm and humid climate condition was conducive to human habitation. Appropriate adaptation strategies, such as the herding of cold-tolerant and dry-tolerant sheep and the cultivation of barley in the western TP, led to a surge in population density during 3400–2900 cal yr BP, despite the slightly deteriorated climate background. This study confirmed the importance of choosing the right adaptive strategies to cope with climate change for human survival and development on the Tibetan Plateau.
Development of iPSC-derived human bone marrow organoid for autonomous hematopoiesis and patient-derived HSPC engraftment
Authors: Ren Kehan , Li Ermin , Aydemir Inci , Liu Yijie , Han Xu , Bi Honghao , Wang Pan , Tao Kara , Ji Amy , Chen Yi-Hua , Yang Jing , Sukhanova Madina , Ji Peng
Published: October 2024

Current efforts in translational studies in hematology often rely on immunodeficient mouse models for engrafting patient-derived hematopoietic stem and progenitor cells (HSPCs), yet these models often face challenges in effectively engrafting cells from patients with various diseases, such as myelodysplastic syndromes (MDSs). In this study, we developed an induced pluripotent stem cell (iPSC)–derived human bone marrow organoid model that closely replicates the bone marrow microenvironment, facilitating the engraftment of HSPCs derived from patients with MDS, thereby mirroring the patients' distinct disease characteristics. Specifically, using advanced microscopy, we verified the development of a complex 3-dimensional network of endothelial, stromal, and hematopoietic cells within organoids, resembling the autonomous human marrow microenvironment. Furthermore, we showed that HSPCs derived from the donor bone marrow of normal individuals or patients with MDS can migrate to and proliferate within the organoid vascular niche while maintaining self-renewal and original genetic profiles. Within the organoids, the differentiation patterns of MDS HSPCs were significantly distinct from those of multilineage hematopoiesis in normal HSPCs, which can be correlated with the clinical manifestations of the disease. These findings underscore the significance of the organoid model in studying human hematopoiesis and the pathophysiology of hematologic diseases, thereby offering new avenues for personalized medicine and therapeutic interventions.
The Post-Stroke Checklist: longitudinal use in routine clinical practice during first year after stroke
Authors: Månsson Kristina , Söderholm Martin , Berhin Ida , Pessah-Rasmussen Hélène , Ullberg Teresa
Published: October 2024

Background

Few studies describe the use of the Post-Stroke Checklist (PSC) as a tool for longitudinal stroke follow-up in clinical practice. We mapped the prevalence of stroke-related health problems and targeted interventions at 3 and 12 months post-stroke by using the PSC.

Methods

Patients with acute stroke discharged home in 2018–2019 at Skåne University Hospital, Sweden, were invited to participate in a comprehensive nurse-led follow-up based on a 14-item PSC 3 and 12 months post-stroke. We measured time consumption, screened for stroke-related health problems, compared the findings, and recorded targeted healthcare interventions. Problems at 12 months were grouped into new, persistent, or none compared to the 3-month evaluation.

Results

Of 200 consecutively included patients, 146 (77%) completed both the 3- and 12-month follow-ups. At 12-month follow-up, 36% of patients reported no stroke-related health problems, 24% reported persistent problems, and 40% reported new problems since the 3-month evaluation. New problems at 12 months were most common within the domains: secondary prevention (23%) and life after stroke (10%). Stroke recurrence rate was 7.5%, 43% had high blood pressure, and few smokers had quit smoking. At 12 months, 53% received at least one new healthcare intervention, compared to 84% at 3 months.

Conclusions

Stroke-related health problems decreased beyond 3 months but were still present in two-thirds of patients at 1 year. This emphasizes the relevance of continuous structured follow-up using the PCS. However, the follow-up alone was insufficient to adequately achieve treatment targets for secondary prevention, which require intensified focus.

Trial registration

ClinicalTrials.gov ID NCT04295226, (04/03/2020)
Interpretation of statistical findings in randomised trials: a survey of statisticians using thematic analysis of open-ended questions
Authors: Hemming Karla , Kudrna Laura , Watson Sam , Taljaard Monica , Greenfield Sheila , Goulao Beatriz , Lilford Richard
Published: October 2024

Background

Dichotomisation of statistical significance, rather than interpretation of effect sizes supported by confidence intervals, is a long-standing problem.

Methods

We distributed an online survey to clinical trial statisticians across the UK, Australia and Canada asking about their experiences, perspectives and practices with respect to interpretation of statistical findings from randomised trials. We report a descriptive analysis of the closed-ended questions and a thematic analysis of the open-ended questions.

Results

We obtained 101 responses across a broad range of career stages (24% professors; 51% senior lecturers; 22% junior statisticians) and areas of work (28% early phase trials; 44% drug trials; 38% health service trials). The majority (93%) believed that statistical findings should be interpreted by considering (minimal) clinical importance of treatment effects, but many (61%) said quantifying clinically important effect sizes was difficult, and fewer (54%) followed this approach in practice.

Thematic analysis identified several barriers to forming a consensus on the statistical interpretation of the study findings, including: the dynamics within teams, lack of knowledge or difficulties in communicating that knowledge, as well as external pressures. External pressures included the pressure to publish definitive findings and statistical review which can sometimes be unhelpful but can at times be a saving grace. However, the concept of the minimally important difference was identified as a particularly poorly defined, even nebulous, construct which lies at the heart of much disagreement and confusion in the field.

Conclusion

The majority of participating statisticians believed that it is important to interpret statistical findings based on the clinically important effect size, but report this is difficult to operationalise. Reaching a consensus on the interpretation of a study is a social process involving disparate members of the research team along with editors and reviewers, as well as patients who likely have a role in the elicitation of minimally important differences.
Association between SMOFlipid and impaired brain development on term-equivalent age brain magnetic resonance imaging in very preterm infants
Authors: Al-Mouqdad Mountasser M. , Alshaikh Belal , Sumaily Haider H. , Alodhaidan Nabeel A. , AlMahmoud Latifah , Almotiri Ameen A. , Alkhourmi Mousa A. , Abounassif Mazen M. , Beh Ahmed F. , Alawad Mashael A. , Albraiki Amani A. , Alqarni Aziza A. , Al-Anazi Maha R. , Basodan Nadia A. , Assiri Fuddah M. , Asfour Suzan S.
Published: October 2024

Soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOFlipid) is used without evidence of benefits. We investigated the relationship between lipid emulsions and brain injury in term-equivalent age magnetic resonance imaging (MRI) in 148 very preterm infants with a birth weight of < 1500 g at ≤ 32 gestational weeks in a neonatal intensive care unit. Infants who received soybean-based lipid emulsions between January 2015 and December 2018 were compared with those who received SMOFlipids between January 2019 and December 2022. A negative binomial generalized linear model was applied for bivariate analysis. Modified log-Poisson regression with generalized linear models and a robust variance estimator (Huber–White) were applied to adjust for potential confounders. The Kidokoro score was used to determine if lipid emulsion type would affect brain morphology and growth at term-equivalent age. Eighty-six (58.9%) received SMOFlipid. SMOFlipid was associated with lower focal signal abnormality, myelination delay, increased extracerebral space, and cerebellar volume reduction (P = 0.02, P = 0.007, P = 0.01, P = 0.02, respectively). SMOFlipidis are associated with brain insult, especially in white matter, cortical gray matter, and the cerebellum. Well-designed studies are needed to investigate the effect of lipid emulsions on the central nervous system.
Intersectionality of sex and race in COVID-19 mortality and vaccination inequities in Massachusetts
Authors: Boretsky Allison , Fisher Victoria , Abuelezam Nadia N.
Published: October 2024

Background

Inequities in COVID-19 incidence, morbidity, and mortality between racial and ethnic groups in the United States (U.S.) have been documented since the start of the pandemic in early 2020. Similarly, disparities by sex for COVID-19 morbidity and mortality have emerged, with men dying at a higher rate than women. Little research has been done to understand how the intersection of sex and race impacts COVID-19 inequities in Massachusetts (MA). This cross-sectional study examined how COVID-19 mortality rates (February 2020- May 2023) and vaccination rates (December 2020-February 2023) varied by sex across racial groups in MA.

Methods

Using Massachusetts Department of Public Health data of all COVID-19 mortality cases and primary series vaccinations in MA from 2020 to 2023, we calculated both age-specific and age-adjusted COVID-19 mortality rates in order to account for differences in age distributions across sex-race groups.

Results

Overall, men across all age-race groups consistently had a higher mortality rate compared to their female counterparts. The age-standardized mortality rate difference between White men and White women is the smallest, with the rate for White men being 1.3 times higher than White women. The age-standardized mortality rate between Hispanic men and Hispanic women varies the largest, with the rate for Hispanic men being 1.7 times higher than Hispanic women. Notably, Black women and White women have similar vaccination rates, yet the age-standardized mortality rate for Black women is 1.4 times the rate of White women.

Conclusions

Our findings show that there are disparities at the intersection of sex and race for COVID-19 mortality and vaccination in MA. This highlights the importance for targeted COVID-19 interventions at the intersection of sex and race and the need for detailed COVID-19 reporting by sex within race groups.
Psychosocial factors mediate social inequalities in health-related quality of life among children and adolescents
Authors: Richard Viviane , Lorthe Elsa , Dumont Roxane , Loizeau Andrea , Baysson Hélène , Schrempft Stephanie , Zaballa María-Eugenia , Lamour Julien , Barbe Rémy P. , Posfay-Barbe Klara M. , Guessous Idris , Stringhini Silvia
Published: October 2024

Background

The present analysis aimed to assess the mediating role of psychosocial and behavioural factors in socio-economic inequalities in health-related quality of life (HRQoL) among children and adolescents.

Methods

Cross-sectional data was drawn from the randomly selected SEROCoV-KIDS cohort study in Geneva, Switzerland. Associations of socio-economic conditions (parents’ highest education, household financial situation) with HRQoL, psychosocial (parent–child relationship, school difficulties, friends, extracurricular activities) and behavioural factors (screen time, physical activity, green spaces time, sleep duration), along with associations of psychosocial and behavioural factors with HRQoL, were evaluated with generalized estimating equations. Counterfactual mediation analyses were conducted to test pathways linking socio-economic conditions to HRQoL.

Results

Of 965 children and 816 adolescents, those with disadvantaged financial circumstances were more likely to have a poor HRQoL (adjusted Odds Ratio [aOR]: 3.80; 95% confidence interval [CI]: 1.96–7.36 and aOR: 3.66; 95%CI: 2.06–6.52, respectively). Psychosocial characteristics mediated 25% (95%CI: 5–70%) and 40% (95%CI: 18–63%) of financial disparities in HRQoL among children and adolescents, respectively. Health behaviours were weakly patterned by socio-economic conditions and did not contribute to financial differences in HRQoL.

Conclusions

These findings provide empirical evidence for mechanisms explaining socio-economic disparities in child HRQoL and could inform interventions aimed to tackle health inequalities.
A UK national cross-sectional survey of stroke support groups: exploring the role of social identification and group processes in reducing loneliness
Authors: Hollands Laura , Calitri Raff , Haslam Catherine , Lamont Ruth A. , Mounce Luke , Tarrant Mark
Published: October 2024

Background

Loneliness is a common experience following stroke. Stroke support groups may protect against loneliness, but little is known about how these groups exert their influence. This research drew upon current theorising on the role of groups for health and explored i) social identification as a potential mechanism for overcoming loneliness, and ii) psychological group resources (support, control, self-esteem), and functional group processes (clear goals, group autonomy, member continuity) which might structure social identification.

Methods

Five hundred seventy-nine stroke survivors from 84 Stroke Association support groups across the UK completed a cross-sectional survey measuring: support group identification; psychological resources (given and received social support, control, self-esteem, identity centrality); functional processes (goal clarity, group autonomy, member continuity); and loneliness (3-item UCLA Loneliness Scale).

Results

Greater support group identification was associated with reduced loneliness (β = -0.45, p < 0.001). Given (β = 0.17, p = 0.001) and received (β = 0.10, p < 0.001) social support, goal clarity (β = 0.17, p = 0.002), and group member continuity (β = 0.19, p < 0.001) were all associated with greater support group identification.

Conclusions

Social identification with the group may be a mechanism by which stroke support groups alleviate loneliness, potentially through facilitating attendance, mutual social support and the development of collective goals. Further research should explore how these processes influence social identification in newly formed groups, where social identity has not yet been established.
A profile approach to physical activity levels: what’s intensity got to do with reasons and motives for exercise?
Authors: Kercher Vanessa M. Martinez , Burton Damon , Kercher Kyle A. , Heeter Kathleen N. , Brunnemer Julia , Watkins Janette M. , Pickett Andrew C. , Pickering Michael A.
Published: October 2024

Background

Despite the well-known benefits of physical activity (PA), non-communicable disease and premature mortality rates among adults continue to rise. The relationship between adults’ goals and exercise-specific motivation on the type of PA intensity one engages remains unclear. The purpose of this study was to identify physical activity (PA) profiles based on frequency and intensity (i.e., levels of PA) in an adult sample. A secondary purpose was to examine how the PA profiles differ on the reasons people have for exercising and behavioral regulation.

Methods

A Cross-sectional survey was conducted with 1,169 (46.8 ± 16.7 years) participants solicited from a hospital-affiliated wellness center, social media promotions, and a research volunteer registry. The International PA Questionnaire (IPAQ) was used to determine frequency, intensity, and time spent engaging in PA. Additionally, the Reasons to Exercise (REX-2) scale, the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3), and demographics were assessed. K-cluster analyses were performed to identify profiles based on PA levels using the IPAQ guidelines. Multivariate analysis of variance (MANOVA) was used to assess profile differences.

Results

Five distinct PA clusters were derived, and defined as: a Low, Walking, Moderate Intensity, High Intensity, and Sitting cluster (p < .001). These clusters differed significantly (p < .001) from each other with respect to motivation, the reasons adults have for exercise, and PA levels.

Conclusion

The results from this study support the important role of psychological factors such as motivation and reasons for exercise on behavioral outcomes (i.e., physical activity). For future research investigating adults PA- related behaviors, whether it be on adults starting a new exercise program or for PA maintenance, it may be beneficial to develop programs that encourage participants to reflect on the reasons they identify as important for exercising, and how such reasons contribute to their overall PA engagement behaviors.
Clinical efficacy of intracavernous injection of platelet lysate for erectile dysfunction
Authors: Chang Yi-Kai , Chiang I-Ni , Chang Hong-Chiang , Chen Yi-Hui , Chueh Shih-Chieh Jeff
Published: October 2024

Background

Among the emerging treatments for erectile dysfunction (ED), platelet-rich plasma (PRP), known for its ability to enhance tissue repair and regeneration, stands out as a promising therapeutic approach. In this innovative study, we aimed to assess the efficacy of intracavernous injections of platelet lysate (PL), a derivative of PRP, in improving erectile function among ED patients.

Methods

We enrolled twenty-six patients, aged between 35 and 70 years (mean age 51.6 ± 11.3 years), who had been experiencing ED for over six months and had an International Index of Erectile Function-5 (IIEF-5) score of 21 or less. Participants received autologous PL injections intracavernously every two weeks for a total of five administrations. We assessed Erection Hardness Score (EHS) and International Index of Erectile Function-5 (IIEF-5) bi-weekly for 16 weeks and conducted penile Doppler ultrasounds pre- and post-treatment to record peak systolic velocity (PSV) and resistance index (RI).

Results

Before treatment, the mean EHS was 2.15 ± 0.88 and IIEF-5 was 10.92 ± 5.28. Remarkable improvements were observed post-treatment, with the EHS significantly increasing to 3.15 ± 0.83 (p < 0.05) and IIEF-5 to 17.23 ± 5.26 (p < 0.05). Penile Doppler ultrasound exhibited an increase in both PSV and RI post-treatment, with the rise in RI being statistically significant.

Conclusions

Our findings indicate that intracavernous injections of PL substantially enhance erectile function, as evidenced by improvements in EHS, IIEF-5, and the RI of penile Doppler ultrasound, without hemorrhagic events or other adverse reactions apart from temporary pain at the injection site during the 16-week follow-up period. These encouraging results suggest that PL injections are a safe and effective treatment modality for patients with moderate ED, potentially providing a less invasive and more physiologically friendly alternative to current ED management strategies.

Trial registration

The study received approval from the Institutional Review Board of National Taiwan University Hospital (IRB Number 202008061RIPC, date of registration 08/28/2020).
The efficacy of infrared diode laser in enhancing the regenerative potential of human periodontal ligament stem cells (hPDLSCs)
Authors: El-Dahab Mohamed M. Abo , El Deen Ghada Nour , Shalash Mahmoud , Gheith Mostafa , Abbass Ahmed , Aly Riham M.
Published: October 2024

Background

The present study aimed to investigate the effects of infrared diode laser irradiation on the proliferation and differentiation capacity of periodontal ligament stem cells (hPDLSCs), which are optimal cell sources for periodontal regeneration.

Methods

hPDLSCs were isolated and characterized by flow cytometric analysis of mesenchymal stem cell markers, and their trilineage differentiation capacity was tested. hPDLSCs were then cultured and irradiated with infrared diode laser (970 nm) at a power of 200 mW and a fluence of 4 J/cm2 for 3 s. MTT assay was performed to assess cellular proliferation. Cell cycle analysis was performed, and the impact of infrared diode laser irradiation on the stemness and osteogenic differentiation potential of hPDLSCs was evaluated via RT‒PCR.

Results

Infrared diode laser application enhanced the stemness, viability, proliferation, and differentiation of PDLSCs. Stem cell markers (OCT4, SOX2, and NANOG) were significantly upregulated in hPDLSCs exposed to laser irradiation. There was significant overexpression of RUNX2, ALP, OPN, and OCN on day 14 after laser application.

Conclusions

These findings provide valuable insights into the specific applications of infrared diode lasers to effectively regenerate periodontal tissues. The results can aid in the development of precise clinical protocols aimed at enhancing osseointegration and promoting tissue regeneration. Ultimately, the combination of infrared diode laser with hPDLSCs is promising for stimulating periodontal regeneration.
Identifying stakeholder preferences for communicating impact from medical research: a mixed methods study
Authors: Pitrolino Katherine , Samarasinghe Buddhini , Pringle Andy , Viney Ian
Published: October 2024

Background

Documentation of research outcomes using impact case studies (ICS) is increasingly required to demonstrate the wider societal benefits of research. However, there is limited evidence of the best way to communicate research outcomes using ICS, especially when highlighting research impact that is not part of a research assessment programme. This study aims, for the first time, to analyse expectations, and methods of communicating impact from medical research across a varied set of stakeholders relevant to the Medical Research Council (MRC).

Methods

Impact narratives about outcomes and impact from MRC research were evaluated using an online survey and in depth semi-structured interviews. Participants were recruited from internal MRC databases and included early career and senior management academics as well as representatives from industry, healthcare, charities, and the government. Informed consent was gained prior to data collection and the study was approved by the university’s research ethics committee. Qualitative and quantitative analysis determined stakeholder preferences for ICS content, language and presentation as well as capturing themes and perspectives on the concept of research impact.

Results

193 participants responded to the online survey exploring definitions of impact and methods of communicating medical research outcomes. The work uncovered expectations of improved health and wellbeing as well as knowledge generation via publications and citations. In depth interviews with sixteen participants demonstrated preferences for clear, easy to read content that focused on facts and evidence and avoided both academic and hyperbolic language. Emergent themes from this work revealed that ICS need to quickly capture imagination and grab attention, while the views and expectations are quite different to press releases and are audience specific.

Conclusions

The content of ICS often focuses on non-academic impacts; however this work highlighted that evidence of academic impacts were outcomes highly valued by stakeholders relevant to the MRC. This work examined a new typology of ICS attributes, which emphasised that the language and presentation of impact narratives can influence the perception of research outcomes, providing useful information for individuals and organisations using ICS to showcase their research. It also shows that if ICS attempt to communicate challenges and issues around achieving impact from research, they may be more credible and useful to their intended audience.
Nursing care to patients who have the home as the preferred place of death: a scoping review
Authors: Sørstrøm Anne Kristine , Kymre Ingjerd Gåre , Ludvigsen Mette Spliid
Published: October 2024

Background

The existing literature on nursing care for patients who choose home as their preferred place of death is scattered and lacks a coherent overview. This scoping review aimed to explore and categorize the available evidence on how nurses provide care for patients preferring to die at home.

Methods

Studies that included nurses and were focused on nursing care for patients who choose the home as their preferred place of death were included in the review. The scoping review considered studies with quantitative, qualitative, or mixed method designs; systematic reviews; and meta-analyses. No time restrictions were added. Key information sources were Medline, CINAHL (EBSCO), Scopus (Elsevier) and Google Scholar. Systematic reviews were searched for in the Cochrane Database of Systematic Reviews. Unpublished studies and grey literature were searched for in ProQuest Dissertations and Theses. The reference list of the studies included was searched.

Results

A total of 13 studies were deemed eligible for inclusion in the review, of which (n = 11) were qualitative and (n = 2) were both qualitative and quantitative. The studies were published between 2008 and 2023 and were conducted in the United Kingdom (n = 5), Norway (n = 4), Australia, Sweden, Canada and Japan. The studies included in this review highlighted issues of competence, resource limitations, flexibility as a coping mechanism, as well as collaboration and family caregivers.

Conclusions

This review identified significant challenges in delivering nursing care for patients who prefer to die at home, including staff shortages, resource limitations, and educational deficiencies. Despite these barriers, nurses showed a strong commitment to patient care, highlighting the need for increased support and collaboration with family caregivers to improve home-based end-of-life care.

Implications for research

To improve care for patients who wish to die at home, it is crucial to address staff shortages and enhance nurse training to close knowledge gaps and ensure consistent, high-quality care. Healthcare systems must also allocate adequate resources to ensure that nurses have the necessary tools to deliver safe and effective care in home settings. Strengthening interdisciplinary collaboration will further enhance patient outcomes by supporting both nurses and family caregivers in end-of-life care.