Treatment Effect Measures Under Nonproportional Hazards.

'Treatment effect measures under nonproportional hazards' by Snapinn et al. (Pharmaceutical Statistics, 22, 181-193) recently proposed some novel estimates of treatment effect for time-to-event endpoints. In this note, we clarify three points related to the proposed estimators that help to elucidate their properties.

Sex-specific differences in alive hospital discharge following infrarenal abdominal aortic aneurysm repair.

Background And Aims: A longer time to alive hospital discharge following infrarenal abdominal aortic aneurysm (AAA) repair is associated with reduced patient-satisfaction and increased length of stay, hospital-acquired deconditioning, infection and costs. This study investigated sex-specific differences in, and drivers of, the rate of alive hospital discharge.

Methods: Examination of UK National Vascular Registry (UK NVR), 2014-2019 and Swedish National Patient Registry (SE NPR) elective AAA patients, 2010-2018, for endovascular (EVAR) or open (OAR) aneurysm repair.

Evaluating the cost-effectiveness of polygenic risk score-stratified screening for abdominal aortic aneurysm.

As the heritability of abdominal aortic aneurysm (AAA) is high and AAA partially shares genetic architecture with other cardiovascular diseases, genetic information could help inform AAA screening strategies. Exploiting pleiotropy and meta-analysing summary data from large studies, we construct a polygenic risk score (PRS) for AAA. Leveraging related traits improves PRS performance (R) by 22.

General Population Mortality Adjustment in Survival Extrapolation of Cancer Trials: Exploring Plausibility and Implications for Cost-Effectiveness Analyses in HER2-Positive Breast Cancer in Sweden.

Background: In economic evaluations of novel therapies, assessing lifetime effects based on trial data often necessitates survival extrapolation, with the choice of model affecting outcomes. The aim of this study was to assess accuracy and variability between alternative approaches to survival extrapolation.

Methods: Data on HER2-positive breast cancer patients from the Swedish National Breast Cancer Register were used to fit standard parametric distribution (SPD) models and excess hazard (EH) models adjusting the survival projections based on general population mortality (GPM).

Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial.

Introduction: There is a lack of evidence that the benefits of screening for atrial fibrillation (AF) outweigh the harms. Following the completion of the Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) pilot trial, the aim of the main SAFER trial is to establish whether population screening for AF reduces incidence of stroke risk.

Methods And Analysis: Approximately 82 000 people aged 70 years and over and not on oral anticoagulation are being recruited from general practices in England.

Perils of Randomized Controlled Trial Survival Extrapolation Assuming Treatment Effect Waning: Why the Distinction Between Marginal and Conditional Estimates Matters.

Objectives: A long-term, constant, protective treatment effect is a strong assumption when extrapolating survival beyond clinical trial follow-up; hence, sensitivity to treatment effect waning is commonly assessed for economic evaluations. Forcing a hazard ratio (HR) to 1 does not necessarily estimate loss of individual-level treatment effect accurately because of HR selection bias. A simulation study was designed to explore the behavior of marginal HRs under a waning conditional (individual-level) treatment effect and demonstrate bias in forcing a marginal HR to 1 when the estimand is "survival difference with individual-level waning".

Influence of cardiometabolic medications on abdominal aortic aneurysm growth in the UK Aneurysm Growth Study: metformin and angiotensin-converting enzyme inhibitors associated with slower aneurysm growth.

Background: There is a clinical need for treatments that can slow or prevent the growth of an abdominal aortic aneurysm, not only to reduce the need for surgery, but to provide a means to treat those who cannot undergo surgery.

Methods: Analysis of the UK Aneurysm Growth Study (UKAGS) prospective cohort was conducted to test for an association between cardiometabolic medications and the growth of an abdominal aortic aneurysm above 30 mm in diameter, using linear mixed-effect models.

Results: A total of 3670 male participants with data available on abdominal aortic aneurysm growth, smoking status, co-morbidities, and medication history were included.

Evaluation of Flexible Parametric Relative Survival Approaches for Enforcing Long-Term Constraints When Extrapolating All-Cause Survival.

Objectives: Parametric models are used to estimate the lifetime benefit of an intervention beyond the range of trial follow-up. Recent recommendations have suggested more flexible survival approaches and the use of external data when extrapolating. Both of these can be realized by using flexible parametric relative survival modeling.

Intima-media thickness at the near or far wall of the common carotid artery in cardiovascular risk assessment.

Aims: Current guidelines recommend measuring carotid intima-media thickness (IMT) at the far wall of the common carotid artery (CCA). We aimed to precisely quantify associations of near vs. far wall CCA-IMT with the risk for atherosclerotic cardiovascular disease (CVD, defined as coronary heart disease or stroke) and their added predictive values.

Geographical Variation in Underlying Social Deprivation, Cardiovascular and Other Comorbidities in Patients with Potentially Curable Cancers in England: Results from a National Registry Dataset Analysis.

Aims: To describe the prevalence of cardiovascular disease (CVD), multiple comorbidities and social deprivation in patients with a potentially curable cancer in 20 English Cancer Alliances.

Materials And Methods: This National Registry Dataset Analysis used national cancer registry data and CVD databases to describe rates of CVD, comorbidities and social deprivation in patients diagnosed with a potentially curable malignancy (stage I-III breast cancer, stage I-III colon cancer, stage I-III rectal cancer, stage I-III prostate cancer, stage I-IIIA non-small cell lung cancer, stage I-IV diffuse large B-cell lymphoma, stage I-IV Hodgkin lymphoma) between 2013 and 2018. Outcome measures included observation of CVD prevalence, other comorbidities (evaluated by the Charlson Comorbidity Index) and deprivation (using the Index of Multiple Deprivation) according to tumour site and allocation to Cancer Alliance.

Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial.

Background: Vasovagal reactions (VVRs) are the most common acute complications of blood donation. Responsible for substantial morbidity, they also reduce the likelihood of repeated donations and are disruptive and costly for blood services. Although blood establishments worldwide have adopted different strategies to prevent VVRs (including water loading and applied muscle tension [AMT]), robust evidence is limited.

Impact of a Prior Cancer Diagnosis on Quality of Care and Survival Following Acute Myocardial Infarction: Retrospective Population-Based Cohort Study in England.

Background: An increasing proportion of patients with cancer experience acute myocardial infarction (AMI). We investigated differences in quality of AMI care and survival between patients with and without previous cancer diagnoses.

Methods: A retrospective cohort study using Virtual Cardio-Oncology Research Initiative data.

Association of Intima-Media Thickness Measured at the Common Carotid Artery With Incident Carotid Plaque: Individual Participant Data Meta-Analysis of 20 Prospective Studies.

Background The association between common carotid artery intima-media thickness (CCA-IMT) and incident carotid plaque has not been characterized fully. We therefore aimed to precisely quantify the relationship between CCA-IMT and carotid plaque development. Methods and Results We undertook an individual participant data meta-analysis of 20 prospective studies from the Proof-ATHERO (Prospective Studies of Atherosclerosis) consortium that recorded baseline CCA-IMT and incident carotid plaque involving 21 494 individuals without a history of cardiovascular disease and without preexisting carotid plaque at baseline.

Prevalence of opioid dependence in New South Wales, Australia, 2014-16: Indirect estimation from multiple data sources using a Bayesian approach.

Aims: To estimate the prevalence of, and number of unobserved people with opioid dependence by sex and age group in New South Wales (NSW), Australia.

Design: We applied a Bayesian statistical modelling approach to opioid agonist treatment records linked to adverse event rate data. We estimated prevalence from three types of adverse event separately: opioid mortality, opioid-poisoning hospitalizations and opioid-related charges.

Acute heart failure presentation, management, and outcomes in cancer patients: a national longitudinal study.

Aims: Currently, little evidence exists on survival and quality of care in cancer patients presenting with acute heart failure (HF). The aim of the study is to investigate the presentation and outcomes of hospital admission with acute HF in a national cohort of patients with prior cancer.

Methods And Results: This retrospective, population-based cohort study identified 221 953 patients admitted to a hospital in England for HF during 2012-2018 (12 867 with a breast, prostate, colorectal, or lung cancer diagnosis in the previous 10 years).

Impact of a post-donation hemoglobin testing strategy on efficiency and safety of whole blood donation in England: A modeling study.

Background: Deferrals due to low hemoglobin are time-consuming and costly for blood donors and donation services. Furthermore, accepting donations from those with low hemoglobin could represent a significant safety issue. One approach to reduce them is to use hemoglobin concentration alongside donor characteristics to inform personalized inter-donation intervals.

Sex-specific differences in the standard of care for infrarenal abdominal aortic aneurysm repair, and risk of major adverse cardiovascular events and death.

Background: This study investigated whether sex-specific differences in preoperative/perioperative standard of care (SOC) account for disparity in outcomes after elective infrarenal abdominal aortic aneurysm repair.

Methods: This was a retrospective cohort study of elective infrarenal abdominal aortic aneurysm repairs (2013-2020) using depersonalized patient-level National Vascular Registry data. SOC was defined for waiting times, preoperative assessment (multidisciplinary/anaesthetic review), cardiovascular risk prevention, and perioperative medication.

Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial.

Introduction: Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF.

Cancer history as a predictor in cardiovascular risk scores: a primary care cohort study.

Background: Cardiovascular risks are raised in cancer survivors but cancer history is not included in cardiovascular risk scores that inform preventive decisions.

Aim: To assess whether cancer diagnosis should be included in cardiovascular risk scores.

Design And Setting: Cohort study using data from English general practices linked to hospital, cancer registration, and death registration data from 1990 to 2015.

The Validity of Surrogate Endpoints in Sub Groups of Metastatic Colorectal Cancer Patients Defined by Treatment Class and KRAS Status.

Findings from the literature suggest that the validity of surrogate endpoints in metastatic colorectal cancer (mCRC) may depend on a treatments' mechanism of action. We explore this and the impact of Kirsten rat sarcoma (KRAS) status on surrogacy patterns in mCRC. A systematic review was undertaken to identify randomized controlled trials (RCTs) for pharmacological therapies in mCRC.

Glycosylated haemoglobin and prognosis in 10,536 people with cancer and pre-existing diabetes: a meta-analysis with dose-response analysis.

Aims: To assess whether glycaemic control is associated with prognosis in people with cancer and pre-existing diabetes.

Methods: In this pre-registered systematic review (PROSPERO: CRD42020223956), PubMed and Web of Science were searched on 25th Nov 2021 for studies investigating associations between glycosylated haemoglobin (HbA) and prognosis in people with diabetes and cancer. Summary relative risks (RRs) and 95% Confidence Intervals (CIs) for associations between poorly controlled HbA or per 1-unit HbA increment and cancer outcomes were estimated using a random-effects meta-analysis.

Patterns of rates of mortality in the Clinical Practice Research Datalink.

The Clinical Practice Research Datalink (CPRD) is a widely used data resource, representative in demographic profile, with accurate death recordings but it is unclear if mortality rates within CPRD GOLD are similar to rates in the general population. Rates may additionally be affected by selection bias caused by the requirement that a cohort have a minimum lookback window, i.e.