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Comparing medication adherence in patients receiving bisphosphonates for preventing fragility fractures: a comprehensive systematic review and network meta-analysis.
No full textBACKGROUND
Bisphosphonates are effective in preventing fragility fractures; however, high rates of adherence are needed to preserve clinical benefits.
OBJECTIVE
To investigate persistence and compliance to oral and intravenous bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate).
METHODS
Searches of 12 databases, unpublished sources, and trial registries were conducted, covering the period from 2000 to April 2021. Screening, data extraction, and risk of bias assessment (Cochrane Collaboration risk-of-bias tool 1.0 & ROBINS-I) were independently undertaken by two study authors. Randomised controlled trials (RCTs) and observational studies that used prescription claim databases or hospital medical records to examine patients' adherence were included. Network meta-analyses (NMA) embedded within a Bayesian framework were conducted, investigating users' likelihood in discontinuing bisphosphonate treatment. Where meta-analysis was not possible, data were synthesised using the vote-counting synthesis method.
RESULTS
Fifty-nine RCTs and 43 observational studies were identified, resulting in a total population of 2,656,659 participants. Data from 59 RCTs and 24 observational studies were used to populate NMAs. Zoledronate users were the least likely to discontinue their treatment HR = 0.73 (95%CrI: 0.61, 0.88). Higher rates of compliance were observed in those receiving intravenous treatments. The paucity of data and the heterogeneity in the reported medication possession ratio thresholds precluded a NMA of compliance data.
CONCLUSIONS
Users of intravenously administered bisphosphonates were found to be the most adherent to treatment among bisphosphonates' users. Patterns of adherence will permit the more precise estimation of clinical and cost-effectiveness of bisphosphonates.
TRIAL REGISTRATION
PROSPERO 2020 CRD42020177166
Acceptability of donor funding for clinical trials in the UK: a qualitative empirical ethics study using focus groups to elicit the views of research patient public involvement group members, research ethics committee chairs and clinical researchers.
No full textOBJECTIVES
The Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. The aim of this study was to identify and explore concerns that may be raised by UK research ethics committees (RECs) when reviewing clinical trials funded in this way.
DESIGN
Empirical ethics combining ethical analysis and qualitative data from three focus groups held online using Frith's symbiotic approach. Data were analysed using inductive thematic approach informed by the study aims and ethical analysis.
PARTICIPANTS
22 participants were recruited: 8 research patient public involvement group members, 7 REC chairs and 7 clinical researchers. All were based in the UK.
RESULTS
With one exception, participants thought the Plutocratic Proposal may be 'all things considered' acceptable, providing their concerns were met, primary of which was upholding scientific integrity. Other concerns discussed related to the acceptability of the donor securing a place on the trial including: whether this was an unfair distribution of benefits, disclosing the identity of the donor as the funder, protecting the donor from exploitation and funding a single study with multiple donors on the same terms. Some misgivings fell outside the usual REC purview: detrimental impact of donors of bad character, establishing the trustworthiness of the matching agency and its processes and optimising research funding and resources. Despite their concerns, participants recognised that because the donor funds the whole trial, others would also potentially benefit from participating.
CONCLUSIONS
We identified concerns about the Plutocratic Proposal. UK RECs may be open to approving studies if these can be addressed. Existing governance processes will do some of this work, but additional REC guidance, particularly in relation to donors securing a place on the trial, may be necessary to help RECs navigate ethical concerns consistently
The hospitalization burden of inflammatory bowel disease in China: a nationwide study from 2013 to 2018.
No full textBackground
The past decade has witnessed a dramatic increase in the number of patients with inflammatory bowel disease (IBD) in China. The nationwide burden of hospitalization remains unclear, however. We aimed to address this gap by conducting analysis using a nationwide database.
Methods
Population-based hospitalization rates from 2013 to 2018 were calculated by extrapolating the number of patients in the database to the national level. Surgical rates, annual hospital charges, and length of stay were also used for quantification of hospitalization burden. The Poisson regression analysis and the Cochran-Armitage trend test were conducted to analyze temporal trends as expressed as annual percentage of change (APC) with 95% confidential intervals (CIs).
Results
From 2013 to 2018, the hospitalization rates for Crohn's disease (CD) and ulcerative colitis (UC) in China increased from 2.20 (95% CI = 2.17-2.22) to 3.62 (3.59-3.65) per 100,000 inhabitants ( < 0.0001) with an APC of 10.68% (6.00-15.36%) and from 6.24 (6.20-6.28) to 8.29 (8.23-8.33) per 100,000 inhabitants ( < 0.0001) with an APC of 5.73% (2.32-9.15%), respectively. Surgical rates decreased from 7.96% (7.29-8.63%) to 5.56% (5.11-6.00%) for CD patients ( < 0.0001) with APC of -6.30% (-11.33 to -1.27%) and from 3.54% (3.26-3.82%) to 2.52% (2.32-2.72%) for UC patients ( < 0.0001) with APC of -6.35% (-16.21 to 3.51). In 2018, there were estimated 166,000 IBD patients hospitalized costing a total of 149.91 + $276.46 million) across the entire China.
Conclusion
The population-based hospitalization rate of IBD increased, whereas the surgical rate decreased from 2013 to 2018 in China
Challenges of Conducting Clinical Trials during the SARS-CoV-2 Pandemic: The ASCEND Global Program Experience.
No full textThe coronavirus disease 2019 pandemic has had an unprecedented effect on health and health care and posed challenges to the conduct of clinical trials.Targeted mitigating strategies, on the basis of early and continued data collection from site surveys, limited disruption to the ASCEND trials.Flexibly allowing hemoglobin assessment at local laboratories to inform randomized treatment dosing was key to limiting the discontinuation of treatment
Laboratory coagulation tests and recombinant porcine factor VIII: A United Kingdom Haemophilia Centre Doctors' Organisation guideline.
No full textINTRODUCTION
Acquired haemophilia A (AHA) is a rare bleeding disorder caused by development of auto-antibodies to endogenous coagulation factor VIII (FVIII). Recombinant porcine factor VIII (rpFVIII) is currently licensed only for the management of bleeding in patients with AHA. Regular monitoring of rpFVIII is recommended to assess treatment effectiveness.
AIM
This guideline from the United Kingdom Haemophilia Centre Doctors' Organisation (UKHCDO) examines the current publications in the area and aims to offer advice for the laboratory monitoring of rpFVIII in patients with AHA.
METHODS
A review of the current literature was undertaken followed by critical review by the authors.
RESULTS/CONCLUSIONS
A validated one-stage clotting FVIII assay is recommended for the measurement and regular monitoring of rpFVIII. Assessment of cross-reacting rpFVIII inhibitors by one-stage porcine Bethesda assay should be performed as part of the initial diagnosis of AHA or prior to treatment with rpFVIII. Available data show that chromogenic FVIII assays underestimate rpFVIII and this should be considered if measurement of rpFVIII is required in patients receiving Emicizumab
Advanced Life Support Update.
No full textThis article is one of ten reviews selected from the Annual Update in Intensive Care and Emergency Medicine 2022. Other selected articles can be found online at https://www.biomedcentral.com/collections/annualupdate2022 . Further information about the Annual Update in Intensive Care and Emergency Medicine is available from https://link.springer.com/bookseries/8901
AlzEye: longitudinal record-level linkage of ophthalmic imaging and hospital admissions of 353 157 patients in London, UK.
No full textPURPOSE
Retinal signatures of systemic disease ('oculomics') are increasingly being revealed through a combination of high-resolution ophthalmic imaging and sophisticated modelling strategies. Progress is currently limited not mainly by technical issues, but by the lack of large labelled datasets, a sine qua non for deep learning. Such data are derived from prospective epidemiological studies, in which retinal imaging is typically unimodal, cross-sectional, of modest number and relates to cohorts, which are not enriched with subpopulations of interest, such as those with systemic disease. We thus linked longitudinal multimodal retinal imaging from routinely collected National Health Service (NHS) data with systemic disease data from hospital admissions using a privacy-by-design third-party linkage approach.
PARTICIPANTS
Between 1 January 2008 and 1 April 2018, 353 157 participants aged 40 years or older, who attended Moorfields Eye Hospital NHS Foundation Trust, a tertiary ophthalmic institution incorporating a principal central site, four district hubs and five satellite clinics in and around London, UK serving a catchment population of approximately six million people.
FINDINGS TO DATE
Among the 353 157 individuals, 186 651 had a total of 1 337 711 Hospital Episode Statistics admitted patient care episodes. Systemic diagnoses recorded at these episodes include 12 022 patients with myocardial infarction, 11 735 with all-cause stroke and 13 363 with all-cause dementia. A total of 6 261 931 retinal images of seven different modalities and across three manufacturers were acquired from 1 54 830 patients. The majority of retinal images were retinal photographs (n=1 874 175) followed by optical coherence tomography (n=1 567 358).
FUTURE PLANS
AlzEye combines the world's largest single institution retinal imaging database with nationally collected systemic data to create an exceptional large-scale, enriched cohort that reflects the diversity of the population served. First analyses will address cardiovascular diseases and dementia, with a view to identifying hidden retinal signatures that may lead to earlier detection and risk management of these life-threatening conditions
Correction: Kwok et al. Targeting the p53 Pathway in CLL: State of the Art and Future Perspectives. 2021, , 4681.
No full textThe authors wish to make the following corrections to their paper [1] [...]
Surface guided radiation therapy: An international survey on current clinical practice.
No full textIntroduction
Surface Guided Radiation Therapy (SGRT) is being increasingly implemented into clinical practice across a number of techniques and irradiation-sites. This technology, which is provided by different vendors, can be used with most simulation- and delivery-systems. However, limited guidelines and the complexity of clinical settings have led to diverse patterns of operation. With the aim to understand current clinical practice a survey was designed focusing on specifics of the clinical implementation and usage.
Materials and methods
A 32-question survey covered: type and number of systems, quality assurance (QA), clinical workflows, and identification of strengths/limitations. Respondents from different professional groups and countries were invited to participate. The survey was distributed internationally via ESTRO-membership, social media and vendors.
Results
Of the 278 institutions responding, 172 had at least one SGRT-system and 136 use SGRT clinically. Implementation and QA were primarily based on the vendors' recommendations and phantoms. SGRT was mainly implemented in breast RT (116/136), with strong but diverse representation of other sites. Many (58/135) reported at least partial elimination of skin-marks and a third (43/126) used open-masks. The most common imaging protocol reported included the combination of radiographic imaging with SGRT. Patient positioning (115/136), motion management (104/136) and DIBH (99/136) were the main applications.Main barriers to broader application were cost, system integration issues and lack of demonstrated clinical value. A lack of guidelines in terms of QA of the system was highlighted.
Conclusions
This overview of the SGRT status has the potential to support users, vendors and organisations in the development of practices, products and guidelines