bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multimethods study to develop tools for competency-based assessments of implementation research training programmes in low and middle-income countries
Authors: Alonge Olakunle , Rao Aditi , Kalbarczyk Anna , Ibisomi Latifat , Dako-Gyeke Phyllis , Mahendradhata Yodi , Rojas Carlos Alberto , Jacobs Choolwe , Torpey Kwasi , Gonzalez Marulanda Edwin Rolando , Launois Pascal , Vahedi Mahnaz 
Published: July 2024

IntroductionMethods and validated tools for evaluating the performance of competency-based implementation research (IR) training programmes in low–middle-income countries (LMICs) are lacking. In this study, we developed tools for assessing the performance of IR training programmes based on a framework of IR core competencies in LMICs.MethodsWe developed self-assessment and objective-assessment tools drawing on the IR competency framework. We used exploratory factor analyses and a one-parameter logistic model to establish construct validity and internal consistency of the tools drawing on a survey conducted in 2020 with 166 trainees before and after an index IR course across five universities and LMICs under the Special Program for Research and Training in Tropical Diseases postgraduate IR training scheme. We conducted key informant interviews (KII) with 20 trainees and five trainers to reflect on the usefulness of the tools and framework for guiding IR training in LMICs.ResultsTwo 16-item tools for self-assessment of IR knowledge and self-efficacy and a 40-item objective assessment tool were developed. The factor loadings of items in the self-assessment tools were 0.65–0.87 with Cronbach’s alpha (α) of 0.97, and 0.77–0.91 with α of 0.98 for the IR knowledge and self-efficacy tools, respectively. The distribution of item difficulty in the objective-assessment tool was consistent before and after the index IR course. Pearson correlation coefficient (r) between the self-assessed and objectively assessed IR knowledge before the index IR course was low, r=0.27 (p value: <0.01), with slight improvements after the index IR course, r=0.43 (p value: <0.01). All KII respondents reported the assessment tools and framework were valid for assessing IR competencies.ConclusionThe IR competency framework and tools developed for assessing IR competencies and performance of IR training programmes in LMICs are reliable and valid. Self-assessment methods alone may not suffice to yield a valid assessment of performance in these settings.
Study protocol for a randomised, phase II, double-blind, experimental medicine study of obinutuzumab versus rituximab in ANCA-associated vasculitis: ObiVas
Authors: McGovern Dominic Paul , McClure Mark E , Coates Matthew , Bond Simon , Martinez Del Pero Marcos , Mynard Kim , Lee Jacinta , Smith Rona M , Jayne David R , Clatworthy Menna Ruth , Jones Rachel B 
Published: July 2024

IntroductionRelapses in ANCA-associated vasculitis (AAV) increase the incidence of end-organ damage and their prevention requires prolonged immunosuppressive therapy. Rituximab, a type I anti-CD20 B cell depleting monoclonal antibody, is the current standard of care for induction of disease remission. Rituximab is not always effective and is associated with a high subsequent relapse risk. Obinutuzumab is a type II anti-CD20 humanised monoclonal antibody with the potential to obtain greater tissue B cell depletion than rituximab and reduce relapse risk in AAV.Methods and analysisObiVas is a randomised, phase II, double-blind controlled trial that will compare the mechanistic effects of rituximab and obinutuzumab in the induction treatment of patients with AAV positive for proteinase 3 ANCA (PR3-ANCA). 26 patients, either newly diagnosed or relapsing, will be recruited from a single centre and randomised in a 1:1 ratio to receive 1000 mg rituximab or obinutuzumab as induction therapy on days 1 and 15, alongside a tapering glucocorticoid regimen. The primary end point is CD19+B cell depletion in nasal-associated lymphoid tissue (NALT), assessed as change from baseline to week 26. Secondary outcomes will compare the safety and clinical efficacy of rituximab and obinutuzumab and their impact on immune biomarkers, including tissue and peripheral blood lymphocyte subsets and PR3-ANCA binding levels. Patients are followed through to week 78. The trial opened for recruitment in January 2023 and is forecasted to complete recruitment by the end of 2024.Ethics and disseminationFor all patients, informed written consent will be obtained in keeping with Good Clinical Practice. Trial results will be disseminated to the relevant scientific, clinical and patient communities on trial closure. NALT data analysis will start before trial completion. Other analyses will be reported after trial completion. This trial was given ethical approval by Edgbaston (West Midlands) Research Ethics Committee (approval reference 22/WM/0174).Trial registration numberISRCTN13069630.
Exploring subjective quality-of-life indicators in long-term care facilities: a mixed-methods research protocol
Authors: Nova Amanda A , Declercq Anja , Heckman George A , Hirdes John P , McAiney Carrie , De Lepeleire Jan 
Published: July 2024

IntroductionImproving quality of life has become a priority in the long-term care (LTC) sector internationally. With development and implementation guidance, standardised quality-of-life monitoring tools based on valid, self-report surveys could be used more effectively to benefit LTC residents, families and organisations. This research will explore the potential for subjective quality-of-life indicators in the interRAI Self-Reported Quality of Life Survey for Long-Term Care Facilities (QoL-LTCF).Methods and analysisGuided by the Medical Research Council Framework, this research will entail a (1) modified Delphi study, (2) feasibility study and (3) realist synthesis. In study 1, we will evaluate the importance of statements and scales in the QoL-LTCF by administering Delphi surveys and focus groups to purposively recruited resident and family advisors, researchers, and LTC clinicians, staff, and leadership from international quality improvement organisations. In study 2, we will critically examine the feasibility and implications of risk-adjusting subjective quality-of-life indicators. Specifically, we will collect expert stakeholder perspectives with interviews and apply a risk-adjustment methodology to QoL-LTCF data. In study 3, we will iteratively review and synthesise literature, and consult with expert stakeholders to explore the implementation of quality-of-life indicators.Ethics and disseminationThis study has received approval through a University of Waterloo Research Ethics Board and the Social and Societal Ethics Committee of KU Leuven. We will disseminate our findings in conferences, journal article publications and presentations for a variety of stakeholders.
Economic evaluation of Maternal Depression Treatment in HIV (M-DEPTH) for perinatal depression among women living with HIV in Uganda: a cost-effectiveness analysis
Authors: McBain Ryan , Okunogbe Adeyemi , Gwokyalya Violet , Wanyenze Rhoda K , Wagner Glenn 
Published: July 2024

ObjectiveWe conducted a cost-effectiveness analysis of an evidence-based collaborative care model for treatment of perinatal depression among women living with HIV in Uganda.DesignMaternal Depression Treatment in HIV (M-DEPTH) is a cluster randomised controlled trial implemented from July 2019 to August 2023, during which 391 pregnant women with mild-to-severe depressive symptoms were randomised to receive stepped care for depression (M-DEPTH: behavioural and pharmacological treatments) or care as usual (CAU: hospital referral for severe cases), at one of eight public health facilities in Uganda.MethodsWe implemented time-driven, activity-based costing to determine the economic cost of M-DEPTH from a societal perspective, compared with CAU. Change in the prevalence of depressive disorder—from enrolment to 18 months postpartum—was quantified using the Patient Health Questionnaire, with depressive disorder assigned a disability weight according to the Global Burden of Disease project. Incremental cost-effectiveness ratios (ICERs) were expressed as cost per disability-adjusted life years (DALY) averted.ResultsThe estimated economic cost of M-DEPTH was US$128.82 per participant, compared with $1.53 per participant for CAU. At baseline, prevalence of depressive disorder did not differ according to treatment assignment. Remission of depressive disorder was more prevalent among those assigned to M-DEPTH—across all time periods, including 18-month follow-up (aOR: 0.09; 95% CI 0.05 to 0.16; p<0.001). This yielded an ICER of $397 per DALY averted, when limiting benefits to those accrued over the study period. Sensitivity analyses generated estimates ranging from $162 to $418 per DALY averted.ConclusionsM-DEPTH represents a financially feasible task-shifted model of evidence-based perinatal depression screening and treatment. The intervention is cost-effective at a willingness-to-pay threshold of less than half of median gross domestic product per capita in Uganda.Trial registration numberNCT03892915.
Longitudinal cohort study of discrepancies between prescribed and administered polypharmacy rates: implications for National Aged Care Quality Indicator Programs
Authors: Wabe Nasir , Urwin Rachel , Seaman Karla , Westbrook Johanna I 
Published: July 2024

Background
Polypharmacy is frequently used as a quality indicator for older adults in Residential Aged Care Facilities (RACFs) and is measured using a range of definitions. The impact of data source choice on polypharmacy rates and the implications for monitoring and benchmarking remain unclear. We aimed to determine polypharmacy rates (≥9 concurrent medicines) by using prescribed and administered data under various scenarios, leveraging electronic data from 30 RACFs.

Method

A longitudinal cohort study of 5662 residents in New South Wales, Australia. Both prescribed and administered polypharmacy rates were calculated biweekly from January 2019 to September 2022, providing 156 assessment times. 12 different polypharmacy rates were computed separately using prescribing and administration data and incorporating different combinations of items:
medicines and non-medicinal products
,
any medicines
and
regular medicines
across four scenarios: no, 1-week, 2-week and 4-week look-back periods. Generalised estimating equation models were employed to identify predictors of discrepancies between prescribed and administered polypharmacy.

Results

Polypharmacy rates among residents ranged from 33.9% using data on administered
regular medicines
with no look-back period to 63.5% using prescribed
medicines and non-medicinal products
with a 4-week look-back period. At each assessment time, the differences between prescribed and administered polypharmacy rates were consistently more than 10.0%, 4.5%, 3.5% and 3.0%, respectively, with no, 1-week, 2-week and 4-week look-back periods. Diabetic residents faced over two times the likelihood of polypharmacy discrepancies compared with counterparts, while dementia residents consistently showed reduced likelihood across all analyses.

Conclusion
We found notable discrepancies between polypharmacy rates for prescribed and administered medicines. We recommend a review of the guidance for calculating and interpreting polypharmacy for national quality indicator programmes to ensure consistent measurement and meaningful reporting.
Evening regular activity breaks extend subsequent free-living sleep time in healthy adults: a randomised crossover trial
Authors: Gale Jennifer T , Haszard Jillian J , Wei Dorothy L , Taylor Rachael W , Peddie Meredith C 
Published: July 2024

ObjectiveTo determine if performing regular 3-min bouts of resistance exercise spread over 4 hours in an evening will impact subsequent sleep quantity and quality, sedentary time and physical activity compared with prolonged uninterrupted sitting.MethodsIn this randomised crossover trial, participants each completed two 4-hour interventions commencing at approximately 17:00 hours: (1) prolonged sitting and (2) sitting interrupted with 3 min of bodyweight resistance exercise activity breaks every 30 min. On completion, participants returned to a free-living setting. This paper reports secondary outcomes relating to sleep quality and quantity, physical activity and sedentary time which were assessed using wrist-worn ActiGraph GT3+ accelerometers paired with a sleep and wear time diary.ResultsA total of 28 participants (women, n=20), age 25.6±5.6 years, body mass index 29.5±6.7 kg/m2(mean±SD) provided data for this analysis. Compared with prolonged sitting, regular activity breaks increased mean sleep period time and time spent asleep by 29.3 min (95% CI: 1.3 to 57.2, p=0.040) and 27.7 min (95% CI: 2.3 to 52.4, p=0.033), respectively, on the night of the intervention. There was no significant effect on mean sleep efficiency (mean: 0.2%, 95% CI: −2.0 to 2.4, p=0.857), wake after sleep onset (1.0 min, 95% CI: −9.6 to 11.7, p=0.849) and number of awakenings (0.8, 95% CI: −1.8 to 3.3, p=0.550). Subsequent 24-hour and 48-hour physical activity patterns were not significantly different.ConclusionsPerforming bodyweight resistance exercise activity breaks in the evening has the potential to improve sleep period and total sleep time and does not disrupt other aspects of sleep quality or subsequent 24-hour physical activity. Future research should explore the longer-term impact of evening activity breaks on sleep.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12621000250831).
Oncological outcomes after laparotomic, laparoscopic, and robot-assisted laparoscopic staging for early-stage high–intermediate or high-risk endometrial cancer
Authors: Koek Ruben C G , Wenzel Hans , Jonges Geertruida N , Lok Christianne A R , Zweemer Ronald , Gerestein Cornelis G 
Published: July 2024

ObjectivesTo compare oncological outcomes in patients with early-stage high–intermediate or high-risk endometrial cancer undergoing surgical staging by laparotomy, conventional laparoscopy, or robot-assisted laparoscopy.MethodsPatients diagnosed between 2015 and 2021 with stage I–II (International Federation of Gynecology and Obstetrics 2009), high–intermediate or high-risk endometrial cancer who underwent staging surgery, were identified in the Netherlands Cancer Registry. Five-year disease-free survival and overall survival were calculated using the Kaplan-Meier method, and differences between groups were evaluated using log-rank testing. Additionally, survival analyses were stratified by histological subtype. The effect of surgical modality on risk of recurrence and all-cause death was assessed by performing Cox regression analysis with inverse probability treatment weighting.ResultsIn total 941 patients met the inclusion criteria, of whom 399 (42.4%) underwent staging surgery by laparotomy, 273 (29.0%) by laparoscopy, and 269 (28.6%) by robot-assisted laparoscopy. Baseline characteristics were comparable between the three groups. No difference in disease-free survival (75.0% vs 71.2% vs 79.0% p=0.35) or overall survival (72.7% vs 72.3% vs 71.2% p=0.98) was observed between patients after laparotomy, laparoscopy, or robot-assisted laparoscopy, respectively. Subanalyses based on histological subtype showed comparable disease-free survival and overall survival between surgical approaches. After correcting for possible confounders by means of inverse probability treatment weighting, there was no significantly increased risk of recurrence or risk of all-cause death after laparoscopy or robot-assisted laparoscopy.ConclusionLaparoscopic and robot-assisted laparoscopic staging surgery in women with early-stage high–intermediate or high-risk endometrial cancer are safe alternatives to laparotomic staging surgery.
ihtObtura: A novel liquid embolic agent with post-embolization radiopacity loss, in endovascular treatment of brain arteriovenous malformations, dural arteriovenous fistulas, and tumors: CLARIDAD trial
Authors: Llibre-Guerra Juan Carlos , Guimaraens Leopoldo , Kadziolka Krzysztof Bartosz , Siddiqui Adnan H , Chapot René , Gil Alberto 
Published: July 2024

BackgroundEndovascular embolization is frequently used for vascular lesions of the head and neck. Newer agents may help to enhance visualization and improve treatment outcomes.MethodsThe CLARIDAD clinical trial was a prospective, single center, first-in-man investigation of neurovascular embolization using the novel embolic agentihtObtura for a broad indication, covering the need for a liquid embolic agent in head and neck procedures. The primary outcomes assessed were therapeutic efficacy to deliverihtObtura to embolize the catheterized pedicle and associated angiographic vascularity, and subsequent loss of radiopacity. Safety endpoints included procedural adverse events, modified Rankin Scale (mRS) score, morbidity, and mortality. Radiologic and clinical follow-up evaluations were conducted at 30, 90, 180 days, and 1 year post-treatment.Results65 consecutive patients (mean age 37.8 years, 50.8% women) were treated over 129 sessions. A total of 42 brain arteriovenous malformations (AVMs; 90% grades III and IV), 8 dural arteriovenous fistulas (DAVFs), and 15 hypervascular tumors were treated withihtObtura using an average of 3.9 mL per session and 7.7 mL per patient. We achieved therapeutic effectiveness in 99% of catheterizations. Radiopacity loss was complete after 74.3% of the sessions at 30 days, 95.6% at 90 days, and 100% at the 1 year follow-up. Serious adverse events (mRS score >2) occurred in two patients (3.1%) with previously ruptured high grade AVMs leading to one death and one permanent disabling morbidity.ConclusionsThe study showed thatihtObtura was a novel, safe, and effective liquid embolic agent for the treatment of AVMs, DAVFs, and hypervascular tumors. Its key property of significant radiopacity loss contributes to improve anatomical understanding, particularly in staged procedures, as well as reduction in post-procedural imaging artifact. There may be additional benefits of eliminating tantalum from the embolic mixture in terms of lesion penetration.
Virtual Time III, Part 3: Throttling and Message Cancellation
Authors: Jefferson David , Barnes Peter D. 
Published: July 2024

This is
Part 3
of a trio of papers that unify in a natural way the two historically distinct parallel discrete event synchronization paradigms, optimistic and conservative, combining the best properties of both into a single framework called
Unified Virtual Time (UVT)
. In this part, we survey the synchronization effects that can be achieved by restricting to corner cases the relationships permitted among the control variables,
GVT
,
CVT
,
TVT
, and
LVT
, which were defined in
Part 1
. We also survey various throttling policies from the literature and describe how they can be implemented in UVT by controlling the value of
TVT
, including policies that can take advantage of rollback in addition to LP blocking. A significant result is a new category of efficient and higher precision throttling algorithms for optimistic execution that are based on
optimistic lookahead
, defined in a way that is symmetric to what we now call the
conservative lookahead
information that is traditionally used for conservative synchronization. Finally, we present a novel algorithm allowing the choice between lazy and aggressive cancellation to be made on a message-by-message basis using either external logic expressed in the model code, or policy code internal to the simulator, or a mixture of both.
Endobronchial Infection and Bacterial Lymphadenitis by Gemella morbillorum Leading to Airway Perforation and a Bronchopleural Fistula
Authors: DePrez Kaitlin N. , Ferguson John 
Published: July 2024

Introduction: Necrotizing bronchial infection with severe infectious lymphadenitis is infrequently encountered and most commonly ascribed to Aspergillus, Histoplasma, and Mycobacterium species. We present a unique cause of severe airway destruction with lymphadenitis and bronchopleural fistula formation by the bacterium Gemella morbillorum.Case: A 24‐year‐old man presented with acute symptoms of vomiting, fever, and shoulder pain. A CT of the chest demonstrated a large subcarinal mass encasing the central bronchi. The workup for malignant, fungal, and granulomatous etiologies was unrevealing, while blood cultures identified G. morbillorum. Fiberoptic bronchoscopy revealed a perforation of the right middle lobar bronchus and the formation of a bronchopleural fistula, resulting in a large hydropneumothorax with empyema. Despite antibiotic therapy, surgical intervention to repair the fistula, and ventilatory support, the progression of the bronchopleural fistula led to fatal respiratory failure.Conclusion: In cases of severe mediastinal adenopathy in a young patient, bacterial lymphadenitis should be considered in the differential diagnosis with lymphoma, germ cell tumor, granulomatosis with polyangiitis, sarcoidosis, histoplasmosis, and inflammatory myofibroblastic tumor.
Systematic Review and Meta-Analysis of Lifestyle and Reproductive Factors Associated with Risk of Breast Cancer in Asian Women
Authors: Ang Boon Hong , Teo Soo-Hwang , Ho Weang-Kee 
Published: July 2024

Abstract

Background:
Assessing breast cancer risks from lifestyle and reproductive factors is critical for developing population-specific risk prediction tools. However, limited studies have evaluated these risks in recent Asian birth cohorts.

Methods:
We systematically reviewed articles published from January 2010 to December 2023, examining breast cancer risk factors in Asian women. Data were described narratively, estimates pooled, and prevalence and attributable proportions compared across Asian populations.

Results:
Of the 128 studies reviewed, 103 reported adjusted effect sizes for meta-analysis. Lifestyle and reproductive factors were predictive of breast cancer risk in Asian women, with varying impacts on premenopausal and postmenopausal women. Relative risks were similar within Asian populations and in comparison to European populations, except for menarche, menopause, and hormone receptor therapy. However, risk factor distributions differed across populations. While alcohol intake (21%) and oral contraceptive use (20%) emerged as the most attributable modifiable risk factors in Europeans, passive smoking (24%) and higher BMI (17%, ≥24 kg/m2 among postmenopausal women) were predominant in Asians.

Conclusions:
Our study shows that while the effects of lifestyle and reproductive breast cancer risk factors are largely similar across different populations, their distributions vary.

Impact:
Our analysis underscores the importance of considering population-specific risk factor distributions when developing risk prediction tools for Asian populations.
Nonadditive Effects of Common Genetic Variants Have a Negligent Contribution to Cancer Heritability
Authors: Hammermeister Suger Austin , Harrison Tabitha A. , Henning Barbara , Turman Constance , Kraft Peter , Lindström Sara 
Published: July 2024

Abstract

Background:
Contribution of dominance effects to cancer heritability is unknown. We leveraged existing genome-wide association data for seven cancers to estimate the contribution of dominance effects to the heritability of individual cancer types.

Methods:
We estimated the proportion of phenotypic variation caused by dominance genetic effects using genome-wide association data for seven cancers (breast, colorectal, lung, melanoma, nonmelanoma skin, ovarian, and prostate) in a total of 166,772 cases and 284,824 controls.

Results:
We observed no evidence of a meaningful contribution of dominance effects to cancer heritability. By contrast, additive effects ranged between 0.11 and 0.34.

Conclusions:
In line with studies of other human traits, the dominance effects of common genetic variants play a minimal role in cancer etiology.

Impact:
These results support the assumption of an additive inheritance model when conducting cancer association studies with common genetic variants.