Julia Brown
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View article: The cost of drug repurposing: parallel economic evaluation of mirtazapine for severe breathlessness in the multinational BETTER-B trial
The cost of drug repurposing: parallel economic evaluation of mirtazapine for severe breathlessness in the multinational BETTER-B trial Open
Background Breathlessness is a prevalent, distressing symptom in advanced respiratory disease. Proven treatments are lacking. Mirtazapine, an antidepressant, is increasingly prescribed. The placebo-controlled BETTER-B trial did not find si…
View article: Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study
Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study Open
Background: Adverse event monitoring is essential to monitor safety for oncology patients on early-phase clinical trials. Previous research considers that electronic patient-reported adverse events reporting is feasible and complementary t…
View article: Cross-cultural adaptation of the locally recurrent rectal cancer – Quality of life questionnaire
Cross-cultural adaptation of the locally recurrent rectal cancer – Quality of life questionnaire Open
The LRRC-QoL has now undergone cross-cultural adaptation to enable its use in 10 languages and 16 countries. Its psychometric properties will be further examined through external validation in an international cohort.
View article: RANO seizure working group-Tumor-Related Epilepsy Assessment Tool (RANO-TREAT) to assess seizure control for glioma treatment trials and clinical practice
RANO seizure working group-Tumor-Related Epilepsy Assessment Tool (RANO-TREAT) to assess seizure control for glioma treatment trials and clinical practice Open
Background No standardized method exists for seizure assessment in glioma clinical trials. We describe the development and evaluation of RANO-TREAT (Tumor Related Epilepsy Assessment Tool) for seizure assessment and its association with ch…
View article: Measurable Residual Disease–Guided Therapy for Chronic Lymphocytic Leukemia
Measurable Residual Disease–Guided Therapy for Chronic Lymphocytic Leukemia Open
With extended follow-up and increased enrollment, our trial showed that undetectable MRD and extended progression-free survival were more common with ibrutinib-venetoclax than with ibrutinib alone or FCR. The results for overall survival w…
View article: Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised controlled trial
Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised controlled trial Open
National Institute for Health and Care Research Health Technology Assessment Programme.
View article: Optimising error rates in programmes of pilot and definitive trials using Bayesian statistical decision theory
Optimising error rates in programmes of pilot and definitive trials using Bayesian statistical decision theory Open
Pilot trials are often conducted in advance of definitive trials to assess their feasibility and to inform their design. Although pilot trials typically collect primary endpoint data, preliminary tests of effectiveness have been discourage…
View article: Optimal data framework for large-scale application of low-cost sensor networks in African cities
Optimal data framework for large-scale application of low-cost sensor networks in African cities Open
Many cities in Low and Middle Income Countries (LMICs), particularly in Africa lack access to timely data from continuous networks due to the prohibitive costs of setting up conventional networks. Low-cost sensors (LCS) costing less than $…
View article: Survivorship issues in long‐term survivors of locally recurrent rectal cancer: A qualitative study
Survivorship issues in long‐term survivors of locally recurrent rectal cancer: A qualitative study Open
Aim There are increasing numbers of long‐term survivors following curative treatment for locally recurrent rectal cancer (LRRC); however, their experiences remain relatively underreported. The aim of this qualitative study was to identify …
View article: 11 Cross-Cultural Adaptation and External Validation of the Locally Recurrent Rectal Cancer – Quality of Life (LRRC-QoL) Measure
11 Cross-Cultural Adaptation and External Validation of the Locally Recurrent Rectal Cancer – Quality of Life (LRRC-QoL) Measure Open
Background Establishing an international measure of health-related quality of life (HrQoL) for patients with LRRC is central to understanding its impact from a patient perspective. The aim of this study was to cross-culturally adapt and ex…
View article: Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties
Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties Open
Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH, resulting in the reduct…
View article: Diagnostic and prognostic comparison of stress electrocardiogram, cardiovascular magnetic resonance, and single photon emission computed tomography, alone and sequentially, in stable chest pain
Diagnostic and prognostic comparison of stress electrocardiogram, cardiovascular magnetic resonance, and single photon emission computed tomography, alone and sequentially, in stable chest pain Open
In patients with suspected angina, CMR alone as the first-line test was more sensitive and prognostically accurate than exercise ECG, SPECT, or sequential combination of both tests.
View article: Patient and clinician perspectives of an eHealth intervention for supporting cancer treatment in the UK: mixed methods evaluation of the eRAPID randomised controlled trial
Patient and clinician perspectives of an eHealth intervention for supporting cancer treatment in the UK: mixed methods evaluation of the eRAPID randomised controlled trial Open
Objectives During 2015–2018, a randomised controlled trial (RCT) evaluated eRAPID, an eHealth intervention designed to capture patient-reported symptoms online during cancer treatment. eRAPID provides patients with advice on when to self-m…
View article: Registry-based study comparing health-related quality of life between patients with primary rectal cancer and locally recurrent rectal cancer
Registry-based study comparing health-related quality of life between patients with primary rectal cancer and locally recurrent rectal cancer Open
Patients with LRRC reported significantly worse overall scores in the FACT-C CCS from both a statistical and clinical perspective, demonstrating the ability of the FACT-C to distinguish between these patient groups and the benefits of the …
View article: Long-read RNA sequencing of archival tissues reveals novel genes and transcripts associated with clear cell renal cell carcinoma recurrence and immune evasion
Long-read RNA sequencing of archival tissues reveals novel genes and transcripts associated with clear cell renal cell carcinoma recurrence and immune evasion Open
The use of long-read direct RNA sequencing (DRS) and PCR cDNA sequencing (PCS) in clinical oncology remains limited, with no direct comparison between the two methods. We used DRS and PCS to study clear cell renal cell carcinoma (ccRCC), f…
View article: Mirtazapine to alleviate severe breathlessness in patients with COPD or interstitial lung diseases (BETTER-B): an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial
Mirtazapine to alleviate severe breathlessness in patients with COPD or interstitial lung diseases (BETTER-B): an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial Open
EU Horizon 2020 (grant agreement No. 825319); Cicely Saunders International Breathlessness Programme; National Institute for Health and Care Research Applied Research Collaboration South London; Australian National Health and Medical Resea…
View article: Microbiology testing capacity and antimicrobial drug resistance in surgical-site infections: a post-hoc, prospective, secondary analysis of the FALCON randomised trial in seven low-income and middle-income countries
Microbiology testing capacity and antimicrobial drug resistance in surgical-site infections: a post-hoc, prospective, secondary analysis of the FALCON randomised trial in seven low-income and middle-income countries Open
For the French and Spanish translations of the abstract see Supplementary Materials section.
View article: Temporary treatment cessation compared with continuation of tyrosine kinase inhibitors for adults with renal cancer: the STAR non-inferiority RCT
Temporary treatment cessation compared with continuation of tyrosine kinase inhibitors for adults with renal cancer: the STAR non-inferiority RCT Open
Background There is interest in using treatment breaks in oncology, to reduce toxicity without compromising efficacy. Trial design A Phase II/III multicentre, open-label, parallel-group, randomised controlled non-inferiority trial assessin…
View article: How ready is the health care system in Northeast India for surgical delivery? a mixed-methods study on surgical capacity and need
How ready is the health care system in Northeast India for surgical delivery? a mixed-methods study on surgical capacity and need Open
Background Surgical services are scarce with persisting inequalities in access across populations and regions globally. As the world’s most populous county, India’s surgical need is high and delivery rates estimated to be sub-par to meet n…
View article: No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework
No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework Open
Objective The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the …
View article: The use of master protocols for efficient trial design to evaluate radiotherapy interventions: a systematic review
The use of master protocols for efficient trial design to evaluate radiotherapy interventions: a systematic review Open
The aim of this review was to highlight why the use of master protocols trial design is particularly useful for radiotherapy intervention trials where complex setup pathways (including quality assurance, user training, and integrating mult…
View article: Protocolized care pathways in emergency general surgery: a systematic review and meta-analysis
Protocolized care pathways in emergency general surgery: a systematic review and meta-analysis Open
Background Emergency abdominal surgery is associated with significant postoperative morbidity and mortality. The delivery of standardized pathways in this setting may have the potential to transform clinical care and improve patient outcom…
View article: Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians
Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians Open
Background Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard f…
View article: Cost-Effectiveness of eRAPID eHealth Intervention for Symptom Management During Chemotherapy
Cost-Effectiveness of eRAPID eHealth Intervention for Symptom Management During Chemotherapy Open
PURPOSE A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self…
View article: Sound Levels In the Neonatal Intensive Care Unit
Sound Levels In the Neonatal Intensive Care Unit Open
Sound levels in the Neonatal Intensive Care Unit (NICU) are a source of environmental stress to already vulnerable premature infants. Many physiological changes occur when premature infants are exposed to high levels of auditory stimulatio…