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Purpose: Quality assurance (QA) for clinical trials is important. Lack of compliance can affect trial outcome. Clinical trial QA groups have different methods of dose distribution verification and analysis, all with the ultimate aim of ensuring trial compliance. The aim of this study was to gain a better understanding of different processes to inform future dosimetry audit reciprocity.
Materials: Six clinical trial QA groups participated. Intensity modulated treatment plans were generated for three different cases. A range of 17 virtual 'measurements' were generated by introducing a variety of simulated perturbations (such as MLC position deviations, dose differences, gantry rotation errors, Gaussian noise) to three different treatment plan cases. Participants were blinded to the 'measured' data details. Each group analysed the datasets using their own gamma index (γ) technique and using standardised parameters for passing criteria, lower dose threshold, γ normalisation and global γ.
Results: For the same virtual 'measured' datasets, different results were observed using local techniques. For the standardised γ, differences in the percentage of points passing with γ < 1 were also found, however these differences were less pronounced than for each clinical trial QA group's analysis. These variations may be due to different software implementations of γ.
Conclusions: This virtual dosimetry audit has been an informative step in understanding differences in the verification of measured dose distributions between different clinical trial QA groups. This work lays the foundations for audit reciprocity between groups, particularly with more clinical trials being open to international recruitment.
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http://dx.doi.org/10.1016/j.radonc.2017.10.012 | DOI Listing |
Pain Manag
September 2025
Pain Management Unit, Hospital Universitario Quirónsalud Madrid, Madrid, Spain.
Aims: The aim of this observational study is to describe the use of epiduroscopy to decrease the enlargement of the ligamentum flavum (LF) in patients with spinal stenosis, as well as the selection of the appropriate patient and the safety measures that enhance procedural success.
Materials & Methods: We introduce the patient selection protocol, define the appropriate indication and the safety measures to use the epiduroscopy as a tool to decrease the size of the LF and increase space, reducing possible complications.
Results: Among patients included in the study, there were no cases of access difficulty or coccydynia, and one case of urinary incontinence occurred in a patient with Schizas grade D (very severe) stenosis.
JMIR Res Protoc
September 2025
Department of Development & Environmental Studies, Palacký University Olomouc, Olomouc, Czech Republic.
Background: Children in low- and middle-income countries face obstacles to optimal language and cognitive development due to a variety of factors related to adverse socioeconomic conditions. One of these factors is compromised caregiver-child interactions and associated pressures on parenting. Early development interventions, such as dialogic book-sharing (DBS), address this variable, with evidence from both high-income countries and urban areas of low- and middle-income countries showing that such interventions enhance caregiver-child interaction and the associated benefits for child cognitive and socioemotional development.
View Article and Find Full Text PDFEur J Heart Fail
September 2025
Cardiology Department, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Aims: There is a lack of data from randomized clinical trials comparing treatment outcomes between conduction system pacing (CSP) modalities and biventricular pacing (BVP) in symptomatic patients with refractory atrial fibrillation (AF) scheduled for atrioventricular node ablation (AVNA). The CONDUCT-AF investigates whether CSP is non-inferior to BVP in improving left ventricular ejection fraction (LVEF) and clinical outcomes in heart failure (HF) patients with symptomatic AF undergoing AVNA.
Methods: This study is an investigator-initiated, prospective, randomized, multicentre clinical trial conducted across 10 European centres, enrolling 82 patients with symptomatic AF, HF with reduced LVEF, and narrow QRS.
JMIR Res Protoc
September 2025
Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Background: Various media are used to enhance public understanding about diseases. While mobile health apps are widely used, there is little proof for using such apps to raise awareness of skin diseases.
Objective: We intend to develop an app, called DEDIKASI-app, to raise awareness of skin diseases, including leprosy.
JAMA Intern Med
September 2025
Bayer CC AG, Basel, Switzerland.
Importance: There is an unmet need for long-term, safe, effective, and hormone-free treatments for menopausal symptoms, including vasomotor symptoms (VMS) and sleep disturbances.
Objective: To evaluate the 52-week efficacy and safety of elinzanetant, a dual neurokinin-targeted therapy, for treating moderate to severe VMS associated with menopause.
Design, Setting, And Participants: OASIS-3 was a double-blind, placebo-controlled, randomized phase 3 clinical trial that was conducted at 83 sites in North America and Europe from August 27, 2021, to February 12, 2024, and included postmenopausal women aged 40 to 65 years who were seeking treatment for moderate to severe VMS (no requirement for a minimum number of VMS events per week).