Stephen Duffield
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View article: Estimating per-protocol effects in external comparator analyses using real-world data
Estimating per-protocol effects in external comparator analyses using real-world data Open
Analysis of single arm trials complemented with external comparator arms (ECAs) may be used to support evidence of effectiveness of novel therapies in oncology research when a randomized trial is unavailable or unfeasible. However, the int…
View article: Transportability of nonlocal real-world evidence and its relevance to health technology assessment: a primer
Transportability of nonlocal real-world evidence and its relevance to health technology assessment: a primer Open
Real-world evidence (RWE) from outside Canada or the UK is sometimes included in submissions to health technology assessments by Canada’s Drug Agency/L'Agence des médicaments du Canada (CDA-AMC) and National Institute for Health and Care E…
View article: APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety
APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety Open
APPRAISE is a tool to guide bias assessment in observational studies on medication comparative effectiveness or safety. Although the tool was designed for HTA, it will be useful for many other users of RWE and will help guide optimized RWE…
View article: An Assessment of the Maturity of Cancer Survival Data Used in Economic Models for the National Institute for Health and Care Excellence’s Single Technology Appraisals
An Assessment of the Maturity of Cancer Survival Data Used in Economic Models for the National Institute for Health and Care Excellence’s Single Technology Appraisals Open
The trend toward more NICE single technology appraisals of cancer drugs relying on immature survival data are consistent with moves by regulatory agencies to encourage expedited approvals for innovative therapies. For Health Technology Ass…
View article: Global Transportability of Clinical Trial Outcomes to Real-World Lung Cancer Populations A case Study using Lung-MAP S1400I
Global Transportability of Clinical Trial Outcomes to Real-World Lung Cancer Populations A case Study using Lung-MAP S1400I Open
Importance The relevance of randomized clinical trials (RCTs) outcomes to real-world settings – especially across countries – is sometimes limited by their restrictive eligibility criteria and variations in standards of care compared to ro…
View article: Quantitative Bias Analysis for Single-Arm Trials With External Control Arms
Quantitative Bias Analysis for Single-Arm Trials With External Control Arms Open
Importance Unmeasured confounding is a key concern for decision-makers when observational datasets are used to assemble external control arms (ECAs) for single-arm trials. Objective To investigate the utility of quantitative bias analysis …
View article: Evaluating transportability of overall survival estimates from US to UK populations receiving first-line treatment for advanced non-small cell lung cancer: a retrospective cohort study
Evaluating transportability of overall survival estimates from US to UK populations receiving first-line treatment for advanced non-small cell lung cancer: a retrospective cohort study Open
Objectives The objective of this study is to explore how the UK versus the USA compare in patient characteristics, treatment patterns and overall survival (OS) of patients with advanced non-small cell lung cancer (aNSCLC) initiating first-…
View article: Transportability of patient outcomes from a US clinical trial to real-world populations - a case study using Lung-MAP S1400I (NCT02785952)
Transportability of patient outcomes from a US clinical trial to real-world populations - a case study using Lung-MAP S1400I (NCT02785952) Open
2. Abstract Background The external validity of results from clinical trials to routine clinical practice is often questioned. This is sometimes because certain real world patient groups are excluded or underrepresented in clinical trials,…
View article: Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers
Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers Open
Development of medicines in rare oncologic patient populations are growing, but well-powered randomized controlled trials are typically extremely challenging or unethical to conduct in such settings. External control arms using real-world …
View article: PP07 Improving The Use Of Real-World Evidence In The Development Of NICE Guidance
PP07 Improving The Use Of Real-World Evidence In The Development Of NICE Guidance Open
Introduction The National Institute for Health and Care Excellence (NICE) is determined to make better use of health and social care data in the development of its guidance. Real-world data (RWD) has the potential to significantly improve …
View article: PD24 Robust Real-World Evidence Generation In Comparative Effects Studies – NICE’s Methods Guidance
PD24 Robust Real-World Evidence Generation In Comparative Effects Studies – NICE’s Methods Guidance Open
Introduction Recent reviews have shown that many real-world evidence (RWE) studies suffer from avoidable methodological flaws. Meanwhile, the National Institute for Health and Care Excellence (NICE) is seeing an increase in RWE submissions…
View article: PD23 Assessing The Suitability Of Real-World Data For Answering Decision Problems – NICE’s Data Suitability Assessment Tool
PD23 Assessing The Suitability Of Real-World Data For Answering Decision Problems – NICE’s Data Suitability Assessment Tool Open
Introduction The National Institute for Health and Care Excellence (NICE) intends to increasingly use real-world evidence in developing guidance. To increase trust in such evidence, NICE has developed a framework for developing and assessi…
View article: Assessment and diagnosis of the acute hot joint: a systematic review and meta-analysis
Assessment and diagnosis of the acute hot joint: a systematic review and meta-analysis Open
Objectives Prompt diagnosis of septic arthritis (SA) in acute native hot joints is essential for avoiding unnecessary antibiotics and hospital admissions. We evaluated the utility of synovial fluid (SF) and serum tests in differentiating c…
View article: Using primary care data to assess comparative effectiveness and safety of apixaban and rivaroxaban in patients with nonvalvular atrial fibrillation in the UK: an observational cohort study
Using primary care data to assess comparative effectiveness and safety of apixaban and rivaroxaban in patients with nonvalvular atrial fibrillation in the UK: an observational cohort study Open
Objective To compare real-world effectiveness and safety of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (AFib) for prevention of stroke. Study design and setting A comparative cohort study in UK gene…
View article: Application of quantitative bias analysis for unmeasured confounding in cost–effectiveness modelling
Application of quantitative bias analysis for unmeasured confounding in cost–effectiveness modelling Open
Due to uncertainty regarding the potential impact of unmeasured confounding, health technology assessment (HTA) agencies often disregard evidence from nonrandomized studies when considering new technologies. Quantitative bias analysis (QBA…
View article: The prevalence of comorbidities in epilepsy: a systematic review
The prevalence of comorbidities in epilepsy: a systematic review Open
Comorbidities are associated with adverse patient outcomes. The authors conducted a systematic review according to a pre-determined protocol, established PRISMA guidelines and reporting standards to estimate the prevalence of common comorb…
View article: The adverse impact of COVID-19 pandemic on cardiovascular disease prevention and management in England, Scotland and Wales: A population-scale analysis of trends in medication data
The adverse impact of COVID-19 pandemic on cardiovascular disease prevention and management in England, Scotland and Wales: A population-scale analysis of trends in medication data Open
Objectives To estimate the impact of the COVID-19 pandemic on cardiovascular disease (CVD) and CVD management using routinely collected medication data as a proxy. Design Descriptive and interrupted time series analysis using anonymised in…
View article: Surface hydraulic fracturing trial at Cadia East
Surface hydraulic fracturing trial at Cadia East Open
Historically, preconditioning practice at Newcrest's Cadia Valley Operations has been to conduct the drilling and fracturing activities associated with hydraulic fracturing from underground excavations.In 2020, Newcrest undertook a trial t…
View article: P103 Assessment and diagnosis of the acute hot joint: a systematic review and meta-analysis
P103 Assessment and diagnosis of the acute hot joint: a systematic review and meta-analysis Open
Background/Aims Prompt diagnosis of septic arthritis in acute native hot joint presentations is essential to guide management. Patients are frequently admitted and treated with antibiotics whilst awaiting synovial fluid (SF) culture result…
View article: The contribution of musculoskeletal disorders and multimorbidity to health-related job loss among older working-age adults: a population-based study
The contribution of musculoskeletal disorders and multimorbidity to health-related job loss among older working-age adults: a population-based study Open
BACKGROUND: Employment is the most important source of financial income and material well-being and therefore is the main driver of the social gradient in physical health, mental health, and mortality. In addition, good employment fulfils …
View article: Systematic review of mental health comorbidities in psoriatic arthritis
Systematic review of mental health comorbidities in psoriatic arthritis Open
Anxiety and depression are highly prevalent among PsA patients. Studies of other mental health disorders were scarce. More studies are needed on the impact of these comorbidities on disease activity and long-term outcomes.Key Points• One i…