bluuebunny/crossref_metadata_2025_split huggingface dataset:
Incidence and Bayesian Mapping of Myeloid Hematologic Malignancies in Sardinia, Italy
Authors: Broccia Giorgio , Carter Jonathan , Ozsin-Ozler Cansu , De Matteis Sara , Cocco Pierluigi 
Published: October 2023

Background The epidemiology of myeloid hematologic malignancies in Italy has been poorly investigated. Methods We used a validated database of 1974-2003 incident cases of hematologic malignancies among the resident population (all ages) of Sardinia, Italy, to describe the incidence of myeloid malignancies overall (N = 4389 cases) and by subtype. We investigated the time trend of acute myeloid leukemia (N = 1227 cases), chronic myeloid leukemia (N = 613 cases), and myelodysplastic syndrome (N = 1296 cases), and used Bayesian methods to explore their geographic spread, and Poisson regression analysis to estimate their association with environmental and socio-economic factors. Results The annual standardized (world population) incidence rate (IR) of myeloid malignancies over the study period was 6.5 per 100,000 (95% CI 6.2-6.7). Myelodysplastic syndromes were the most prevalent subgroup (IR = 1.7, 95% CI 1.5-1.8). Incidence of all myeloid malignancies combined increased sharply during the study period with an annual percent change (APC) of 10.06% (95% CI 9.51-10.61), 19.77% for myelodysplastic syndromes (95% CI 19.63-19.91), and 3.18% (95% CI 2.99-3.37) for acute myeloid leukemia. Chronic myeloid leukemia did not show an upward trend. Apart from sporadic excesses in small rural communities and the major urban area, there was no evidence of spatial clustering. The risk of myeloid malignancies increased with increasing prevalence of sheep breeding. Conclusions Our results might prompt further research on the local genetic and environmental determinants of myeloid hematologic malignancies.
Grade of Primary Cutaneous Leiomyosarcoma Dictates Risk for Metastatic Spread and Disease-Specific Mortality
Authors: Carr Michael J. , Sun James , Adams William A. , Dugan Michelle M. , Naqvi Syeda M. H. , Kim Youngchul , Messina Jane L. , Gonzalez Ricardo J. , Zager Jonathan S. , Mullinax John E. 
Published: October 2023

Background and Objectives Primary cutaneous leiomyosarcoma (cLMS), a rare, typically intradermal tumor, has previously been reported to exhibit an indolent course of disease with zero-to-low risk of local recurrence or distant metastasis. This study seeks to evaluate recurrence and survival of cLMS patients through study of its clinicopathologic and treatment characteristics. Methods All patients included underwent resection of primary cLMS at this institution between 2006 and 2019. A retrospective cohort study analysis of clinicopathologic characteristics, treatment, recurrence, and overall survival was performed. Data was assessed through descriptive statistics and outcome measures assessed by Cox proportional models and log-rank tests. Results Eighty-eight patients with cLMS were evaluated. The majority were men (n = 68, 77%) and Caucasian (n = 85, 97%), with median age at diagnosis of 66 years (range 20–96). 65% of tumors were located on the extremities, with a median size of 1.3 cm (range .3–15). Assessment revealed low (n = 41, 47%), intermediate (n = 29, 33%), and high (n = 18, 20%) grade tumors, demonstrating extension into subcutaneous tissue in 38/60 (60%), with 3 patients exhibiting extension into muscle (3%). All underwent resection as primary treatment with median 1 cm margins (range .5–2). With median follow-up of 27.5 months (IQR 8–51; range 1–131), no low-grade cases had recurrence or death while there was a recurrence rate of 19.1% (9/47) and death rate of 8.5% (4/47) in intermediate- to high-grade cases. Conclusions Primary tumor resection of cLMS provides excellent local control for low-grade tumors as no low-grade cases experienced recurrence. For patients with intermediate- to high-grade tumors, there is potential for local recurrence, distant metastasis, and death, and therefore surveillance following treatment is encouraged.
Patient and caregiver experiences of living with dementia in Tanzania
Authors: Walker Jessica , Dotchin Catherine , Breckons Matthew , Fisher Emily , Lyimo Godrule , Mkenda Sarah , Walker Richard , Urasa Sarah , Rogathi Jane , Spector Aimee 
Published: October 2023

Introduction: Tanzania is a low-income country with an increasing prevalence of dementia, which provides challenges for the existing healthcare system. People with dementia often don’t receive a formal diagnosis, and with a lack of formal healthcare, are often predominantly supported by family relatives. There are very few published data relating to lived experiences of people with dementia in Tanzania. This study aimed to understand people with dementia, and their caregivers’ experiences of living with dementia in Tanzania and the perceived needs of people with dementia. Methods: Qualitative, semi-structured interviews were conducted with 14 people with dementia and 12 caregivers in Moshi, Tanzania. Interviews were audio-recorded, translated, transcribed and analysed using a Framework Analysis approach. Results: Three sub-themes were identified within data describing the experience of ‘Living with Dementia in Tanzania’: ‘Deteriorations in Health’, ‘Challenges to living with Dementia in Tanzanian Culture’, and ‘Lack of Support’: people with dementia faced challenges due to social isolation, stigmatisation, and lack of caregiver knowledge on how best to provide support. Collectively, these impacted on both the physical and mental health of people with dementia. Misconceptions about dementia aetiology related to age, stresses of daily life and other co-morbidities. People with dementia were motivated to access treatment, exhibiting pluralistic health-seeking behaviours. There was an overall preference for non-pharmacological interventions over medication, with high levels of trust in medical professional opinions. Conclusions: Living with dementia in Tanzania is influenced by both cultural and religious factors. More work is needed to target supplementary healthcare (with efforts to promote accessibility), support for caregivers and public health education about dementia to overcome existent misconceptions and stigma.
The Emotional Impact and Coping Mechanisms Following Adverse Patient Events Among Canadian Vascular Surgeons and Trainees
Authors: Choi Sally HJ. , Yan Tyler D. , Misskey Jonathan , Chen Jerry C. 
Published: October 2023

Background This study’s objective is to evaluate the emotional experiences, coping mechanisms, and support resources for Canadian vascular surgeons and trainees following an adverse patient event or near miss. Methods This is a cross-sectional survey study of all Canadian Society for Vascular Surgery (CSVS) members from October to November 2021. We collected data on participant experiences with adverse events, their emotional responses, the coping mechanisms used, and their perceptions on available support resources. Results The survey was sent to 233 CSVS members yielding 66 responses. The majority (77%) of respondents had experiences with adverse event causing serious patient harm. The most common negative experience following an adverse event included feelings of negativity towards oneself, general distress, and anxiety about potential for future errors. The most common coping mechanism was seeking advice from a mentor or close colleague. Peers (82%) and senior colleagues (59%) were the most preferred sources of support. Most of the respondents would reach out to a mentor if they had 1, but 30% reported no mentor or close colleague for support. Conclusion Adverse patient events and near misses have serious negative impact on the lives of Canadian vascular surgeons and trainees. Peers and senior colleagues are the most desired source for support, but this is not universally available. Organized efforts are needed to bring awareness in our vascular surgery community on the ubiquitous nature and detrimental effects of adverse events.
Mild Stroke, Serious Problems: Limitations in Balance and Gait Capacity and the Impact on Fall Rate, and Physical Activity
Authors: Roelofs Jolanda M. B. , Zandvliet Sarah B. , Schut Ingrid M. , Huisinga Anouk C. M. , Schouten Alfred C. , Hendricks Henk T. , de Kam Digna , Aerden Leo A. M. , Bussmann Johannes B. J. , Geurts Alexander C. H. , Weerdesteyn Vivian 
Published: October 2023

Background After mild stroke persistent balance limitations may occur, creating a risk factor for fear of falling, falls, and reduced activity levels. Objective. To investigate whether individuals in the chronic phase after mild stroke show balance and gait limitations, elevated fall risk, reduced balance confidence, and physical activity levels compared to healthy controls. Methods An observational case-control study was performed. Main outcomes included the Mini-Balance Evaluation Systems Test (mini-BEST), Timed Up and Go (TUG), 10-m Walking Test (10-MWT), and 6-item version Activity-specific Balance Confidence (6-ABC) scale which were measured in 1 session. Objectively measured daily physical activity was measured for 7 consecutive days. Fall rate in daily life was recorded for 12 months. Individuals after a mild stroke were considered eligible when they: (1) sustained a transient ischemic attack or stroke longer than 6 months ago, resulting in motor and/or sensory loss in the contralesional leg at the time of stroke, (2) showed (near-) complete motor function, that is, ≥24 points on the Fugl-Meyer Assessment—Lower Extremity (range: 0-28). Results Forty-seven healthy controls and 70 participants after mild stroke were included. Participants with stroke fell more than twice as often as healthy controls, had a 2 point lower median score on the mini-BEST, were 1.7 second slower on TUG, 0.6 km/h slower on the 10-MWT, and had a 12% lower 6-ABC score. Intensity for both total activity (8%) as well as walking activity (6%) was lower in the participants with stroke, while no differences were found in terms of duration. Conclusions Individuals in the chronic phase after a mild stroke demonstrate persistent balance limitations and have an increased fall risk. Our results point at an unmet clinical need in this population.
Preoperative Anemia Is Associated With Worse Postoperative Outcomes After Open Reduction Internal Fixation of Distal Radius Fractures
Authors: Schmerler Jessica , Olson Jarod T. , Prasad Niyathi , LaPorte Dawn 
Published: October 2023

Background: Preoperative anemia has been shown to be associated with complications after numerous orthopedic procedures. No studies to our knowledge have examined its impact on outcomes after open reduction internal fixation (ORIF) of distal radius fracture (DRF). We hypothesized that patients with preoperative anemia would have increased likelihood of adverse outcomes, and likelihood would increase with severity of anemia. Methods: A total of 14 136 patients underwent ORIF for DRF over 2012-2021, identified in the National Surgical Quality Improvement Program database. Patients were classified by World Health Organization criteria as nonanemic (hematocrit >36% for women, >39% for men), mildly anemic (hematocrit 33%-36% for women, 33%-39% for men), or moderately to severely anemic (hematocrit <33% for women or men). Multivariable regressions adjusted for age, sex, race, and comorbidities statistically different between anemic and nonanemic patients were used to examine the effect of anemia on postoperative outcomes. Results: Mildly anemic patients had significantly longer length of stay and were significantly more likely to experience readmission and sepsis ( P < .05 all). Moderately to severely anemic patients had significantly longer length of stay and were significantly more likely to experience readmission, postoperative transfusion, septic shock, and any adverse event ( P < .05 all). Conclusions: Preoperative anemia is associated with increased likelihood of adverse outcomes after ORIF for DRF, and likelihood increases with severity of anemia. Surgeons should monitor patients for preoperative anemia and endeavor to identify the source of and, if safe and possible, correct the anemia preoperatively or manage and educate patients postoperatively.
Estimating counterfactual placebo HIV incidence in HIV prevention trials without placebo arms based on markers of HIV exposure
Authors: Zhu Yifan , Gao Fei , Glidden David V , Donnell Deborah , Janes Holly 
Published: October 2023

Introduction Developing alternative approaches to evaluating absolute efficacy of new HIV prevention interventions is a priority, as active-controlled designs, whereby individuals without HIV are randomized to the experimental intervention or an active control known to be effective, are increasing. With this design, however, the efficacy of the experimental intervention to prevent HIV acquisition relative to placebo cannot be evaluated directly. Methods One proposed approach to estimate absolute prevention efficacy is to use an HIV exposure marker, such as incident rectal gonorrhea, to infer counterfactual placebo HIV incidence. We formalize a statistical framework for this approach, specify working regression and likelihood-based estimation approaches, lay out three assumptions under which valid inference can be achieved, evaluate finite-sample performance, and illustrate the approach using a recent active-controlled HIV prevention trial. Results We find that in finite samples and under correctly specified assumptions accurate and precise estimates of counterfactual placebo incidence and prevention efficacy are produced. Based on data from the DISCOVER trial in men and transgender women who have sex with men, and assuming correctly specified assumptions, the estimated prevention efficacy for tenofovir alafenamide plus emtricitabine is 98.1% (95% confidence interval: 96.4%–99.4%) using the working model approach and 98.1% (95% confidence interval: 96.4%–99.7%) using the likelihood-based approach. Conclusion Careful assessment of the underlying assumptions, study of their violation, evaluation of the approach in trials with placebo arms, and advancement of improved exposure markers are needed before the HIV exposure marker approach can be relied upon in practice.
Statistical rules for safety monitoring in clinical trials
Authors: Martens Michael J , Logan Brent R 
Published: October 2023

Background/Aims Protecting patient safety is an essential component of the conduct of clinical trials. Rigorous safety monitoring schemes are implemented for these studies to guard against excess toxicity risk from study therapies. They often include protocol-specified stopping rules dictating that an excessive number of safety events will trigger a halt of the study. Statistical methods are useful for constructing rules that protect patients from exposure to excessive toxicity while also maintaining the chance of a false safety signal at a low level. Several statistical techniques have been proposed for this purpose, but the current literature lacks a rigorous comparison to determine which method may be best suitable for a given trial design. The aims of this article are (1) to describe a general framework for repeated monitoring of safety events in clinical trials; (2) to survey common statistical techniques for creating safety stopping criteria; and (3) to provide investigators with a software tool for constructing and assessing these stopping rules. Methods The properties and operating characteristics of stopping rules produced by Pocock and O’Brien-Fleming tests, Bayesian Beta-Binomial models, and sequential probability ratio tests (SPRTs) are studied and compared for common scenarios that may arise in phase II and III trials. We developed the R package “stoppingrule” for constructing and evaluating stopping rules from these methods. Its usage is demonstrated through a redesign of a stopping rule for BMT CTN 0601 (registered at Clinicaltrials.gov as NCT00745420), a phase II, single-arm clinical trial that evaluated outcomes in pediatric sickle cell disease patients treated by bone marrow transplant. Results Methods with aggressive stopping criteria early in the trial, such as the Pocock test and Bayesian Beta-Binomial models with weak priors, have permissive stopping criteria at late stages. This results in a trade-off where rules with aggressive early monitoring generally will have a smaller number of expected toxicities but also lower power than rules with more conservative early stopping, such as the O-Brien-Fleming test and Beta-Binomial models with strong priors. The modified SPRT method is sensitive to the choice of alternative toxicity rate. The maximized SPRT generally has a higher number of expected toxicities and/or worse power than other methods. Conclusions Because the goal is to minimize the number of patients exposed to and experiencing toxicities from an unsafe therapy, we recommend using the Pocock or Beta-Binomial, weak prior methods for constructing safety stopping rules. At the design stage, the operating characteristics of candidate rules should be evaluated under various possible toxicity rates in order to guide the choice of rule(s) for a given trial; our R package facilitates this evaluation.
Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review
Authors: Arundel Catherine E , Clark Laura 
Published: October 2023

Background Evidence-based methods for randomised controlled trial recruitment and retention are extremely valuable. Despite increased testing of these through studies within a trial, there remains limited high-certainty evidence for effective strategies. In addition, there has been little consideration as to whether recruitment interventions also have an impact on participant retention. Methods  A systematic review was conducted. Studies were eligible if they were randomised controlled trials using a recruitment intervention and which also assessed the impact of this on retention at any time point. Searches were conducted through MEDLINE, EMBASE, Cochrane Library, and the Northern Ireland Hub for Trials Methodology Research SWAT Repository. Two independent reviewers screened the search results and extracted data for eligible studies using a piloted extraction form. Results A total of 7815 records were identified, resulting in 10 studies being included in the review. Most studies (n = 6, 60%) focussed on the information given to participants (n = 6, 60%), with two (20%) focussing on incentives, and two focussing on trial design and recruiter interventions. Due to intervention heterogeneity, none of the interventions could be meta-analysed. Only one study found any statistically significant effect of letters including a photograph (odds ratio: 5.40, 95% CI 1.12–26.15, p = 0.04). Conclusion Assessment of the impacts of recruitment strategies, evaluated in a SWAT, on retention of participants in the host trial remains limited. Assessment of the impact of recruitment interventions on retention is recommended to minimise future research costs and waste.
Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen
Authors: Backer Mickaël De , Sengar Manju , Mathews Vikram , Salvaggio Samuel , Deltuvaite-Thomas Vaiva , Chiêm Jean-Christophe , Saad Everardo D , Buyse Marc 
Published: October 2023

Background/Aims Showing “similar efficacy” of a less intensive treatment typically requires a non-inferiority trial. Yet such trials may be challenging to design and conduct. In acute promyelocytic leukemia, great progress has been achieved with the introduction of targeted therapies, but toxicity remains a major clinical issue. There is a pressing need to show the favorable benefit/risk of less intensive treatment regimens. Methods We designed a clinical trial that uses generalized pairwise comparisons of five prioritized outcomes (alive and event-free at 2 years, grade 3/4 documented infections, differentiation syndrome, hepatotoxicity, and neuropathy) to confirm a favorable benefit/risk of a less intensive treatment regimen. We conducted simulations based on historical data and assumptions about the differences expected between the standard of care and the less intensive treatment regimen to calculate the sample size required to have high power to show a positive Net Treatment Benefit in favor of the less intensive treatment regimen. Results Across 10,000 simulations, average sample sizes of 260 to 300 patients are required for a trial using generalized pairwise comparisons to detect typical Net Treatment Benefits of 0.19 (interquartile range 0.14–0.23 for a sample size of 280). The Net Treatment Benefit is interpreted as a difference between the probability of doing better on the less intensive treatment regimen than on the standard of care, minus the probability of the opposite situation. A Net Treatment Benefit of 0.19 translates to a number needed to treat of about 5.3 patients (1/0.19 ≃ 5.3). Conclusion Generalized pairwise comparisons allow for simultaneous assessment of efficacy and safety, with priority given to the former. The sample size required would be of the order of 300 patients, as compared with more than 700 patients for a non-inferiority trial using a margin of 4% against the less intensive treatment regimen for the absolute difference in event-free survival at 2 years, as considered here.
A study of error reporting by nurses: the significant impact of nursing team dynamics
Authors: Munn Lindsay Thompson , Lynn Mary R , Knafl George J , Willis Tina Schade , Jones Cheryl B 
Published: October 2023

Background: Error reporting is crucial for organisational learning and improving patient safety in hospitals, yet errors are significantly underreported. Aims: The aim of this study was to understand how the nursing team dynamics of leader inclusiveness, safety climate and psychological safety affected the willingness of hospital nurses to report errors. Methods: The study was a cross-sectional design. Self-administered surveys were used to collect data from nurses and nurse managers. Data were analysed using linear mixed models. Bootstrap confidence intervals with bias correction were used for mediation analysis. Results: Leader inclusiveness, safety climate and psychological safety significantly affected willingness to report errors. Psychological safety mediated the relationship between safety climate and error reporting as well as the relationship between leader inclusiveness and error reporting. Conclusion: The findings of the study emphasise the importance of nursing team dynamics to error reporting and suggest that psychological safety is especially important to error reporting.
Subungual Glomus Tumor of the Hallux A Report of 4 Cases
Authors: Nishikawa Danilo Ryuko Cândido , Duarte Fernando Aires , Saito Guilherme Honda , Santos Ianara da Silva , Filho Vicente Mazzaro , Mendes Alberto Abussamra Moreira , Cabral Matheus Gomes , Prado Marcelo Pires 
Published: October 2023

This study reports the clinical outcomes and evolution of 4 patients with subungual glomus tumor (GT) of the hallux treated with tumor excision. Preoperatively, all patients had pain of intensity 9 or 10. Three were sensitive to cold and had stabbing pain, and one reported pulsatile pain. No patient presented nail alterations. There were no bone alterations on radiographic images and diagnostic suspicion of GT was supported by magnetic resonance images. Surgical treatment was indicated due to severe pain and functional limitation. The GT excision was performed by removing the nail through an L-shaped incision in the nail bed. After surgery, they all showed clinical improvement with return to previous activities and had no difficulty in wearing regular shoes. Three patients were pain-free and one had occasional stabbing pain of intensity 2. Half of them had nail changes. There has been no recurrence so far. Thus, we found that resection of subungual GT of the hallux was effective for the clinical improvement of patients. Level of Evidence: IV, case reports.