Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov-evaluation of a new tracking tool for the US clinical trial registry.

Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017-2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry ( ClinicalTrials.gov ). Firstly, we developed and evaluated a novel automated tracking tool ( clinical-trials-tracker.com ) for clinical trials registered on ClinicalTrials.gov . This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov . The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov : (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions' reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future

Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov-evaluation of a new tracking tool for the US clinical trial registry

Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017-2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry ( ClinicalTrials.gov ). Firstly, we developed and evaluated a novel automated tracking tool ( clinical-trials-tracker.com ) for clinical trials registered on ClinicalTrials.gov . This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov . The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov : (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions' reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future

Which factors influence treatment decision in fragility fractures of the pelvis? - results of a prospective study

Background!#!The aim of the present study was to describe specific characteristics of patients suffering from pelvic fragility fractures and evaluate factors that might influence treatment decisions which may optimize treatment pathways and patient mobility in the future.!##!Methods!#!A prospective study with patients suffering from fractures of the pelvis and aged 60 years or above was performed between 2012 and 2016. Data acquisition took place at admission, every day during hospitalization and at discharge.!##!Results!#!One hundred thirty-four patients (mean age of 79.93 (± 7.67) years), predominantly female (84%), were included. Eighty-six patients were treated non-operatively. Forty-eight patients underwent a surgical procedure. The main fracture types were B2 fractures (52.24%) and FFP IIb fractures (39.55%). At the time of discharge, pain level (NRS) could be significantly reduced (p <  0.001). Patients who underwent a surgical procedure had a significantly higher pain level on day three and four compared to the non-operative group (p = 0.032 and p = 0.023, respectively). Significant differences were found in the mobility level: patients treated operatively on day four or later were not able to stand or walk on day three as compared to non-operatively treated patients. Regarding B2 fractures, a significantly higher mobility level difference between time of admission and discharge was found in patients treated with a surgical procedure compared to patients treated non-operatively (p = 0.035).!##!Conclusions!#!Fracture type, mobility level and pain level influence the decision to proceed with surgical treatment. Especially patients suffering from B2 fractures benefitted in terms of mobility level at discharge when treated operatively.!##!Level of evidence!#!II

Experiment on effects of natural inorganic microparticles and microplastics on mussels of the family Mytilidae from five different bioregions

This dataset comprises data obtained during a 6 week-long exposure experiment of mussels of the family Mytilidae to two types of microplastics, namely polymethyl methacrylate (PMMA) and polyvinylchloride (PVC) particles and two types of natural inorganic microparticles, namely diatoms and red clay. This data was obtained from May to September 2019 in five different bioregions, which are Tasmania, Chile, Japan, Cabo Verde and Israel. We recorded body condition index, byssus thread production in 24 hours, clearance rate of the food algae and respiration rate at the end of six weeks of exposure to the four different microparticles (with an exception of the groups exposed to PVC and red clay in Tasmania, which lasted 5 weeks). Mussels were exposed to three concentrations of each particle type, which were 1.5, 15 and 150 mg/l and one group to no particles at all as control

Plastic and natural inorganic microparticles do not differ in their effects on adult mussels (Mytilidae) from different geographic regions

Highlights: • First study to compare microplastic effects over a wide biogeographical range • Comparison between natural inorganic microparticles and plastic microparticles • Significant effects on byssus production, respiration and clearance rates, but small effect sizes • No ecologically relevant difference between impact of plastic and natural inorganic microparticles on Mytilidae Abstract: Microplastics are ubiquitous in the marine environment and studies on their effects on benthic filter feeders at least partly revealed a negative influence. However, it is still unclear whether the effects of microplastics differ from those of natural suspended microparticles, which constitute a common stressor in many coastal environments. We present a series of experiments that compared the effects of six-week exposures of marine mussels to two types of natural particles (red clay and diatom shells) to two types of plastic particles (Polymethyl Methacrylate and Polyvinyl Chloride). Mussels of the family Mytilidae from temperate regions (Japan, Chile, Tasmania) through subtropical (Israel) to tropical environments (Cabo Verde) were exposed to concentrations of 1.5 mg/L, 15 mg/L and 150 mg/L of the respective microparticles. At the end of this period, we found significant effects of suspended particles on respiration rate, byssus production and condition index of the animals. There was no significant effect on clearance rate and survival. Surprisingly, we observed only small differences between the effects of the different types of particles, which suggests that the mussels were generally equally robust towards exposure to variable concentrations of suspended solids regardless of whether they were natural or plastic. We conclude, that microplastics and suspended solids elicit similar effects on the tested response variables, and that both types of microparticles mainly cause acute responses rather than more persistent carry-over effects

Lack of reproducibility of histopathological features in MYC-rearranged large B cell lymphoma using digital whole slide images: a study from the Lunenburg lymphoma biomarker consortium

Aims: Subclassification of large B cell lymphoma (LBCL) is challenging due to the overlap in histopathological, immunophenotypical and genetic data. In particular, the criteria to separate diffuse large B cell lymphoma (DLBCL) and high-grade B cell lymphoma (HGBL) are difficult to apply in practice. The Lunenburg Lymphoma Biomarker Consortium previously reported a cohort of over 5000 LBCL that included fluorescence in-situ hybridisation (FISH) data. This cohort contained 209 cases with MYC rearrangement that were available for a validation study by a panel of eight expert haematopathologists of how various histopathological features are used. Methods and results: Digital whole slide images of haematoxylin and eosin-stained sections allowed the pathologists to visually score cases independently as well as participate in virtual joint review conferences. Standardised consensus guidelines were formulated for scoring histopathological features and included overall architecture/growth pattern, presence or absence of a starry-sky pattern, cell size, nuclear pleomorphism, nucleolar prominence and a range of cytological characteristics. Despite the use of consensus guidelines, the results show a high degree of discordance among the eight expert pathologists. Approximately 50% of the cases lacked a majority score, and this discordance spanned all six histopathological features. Moreover, none of the histological variables aided in prediction of MYC single versus double/triple-hit or immunoglobulin-partner FISH-based designations or clinical outcome measures. Conclusions: Our findings indicate that there are no specific conventional morphological parameters that help to subclassify MYC-rearranged LBCL or select cases for FISH analysis, and that incorporation of FISH data is essential for accurate classification and prognostication

Correction: The 5th edition of The World Health Organization Classification of Haematolymphoid Tumours: Lymphoid Neoplasms (vol 36, pg 1720, 2022)

10.1038/s41375-023-01962-5LEUKEMIA3791944-195