The National Health Service-Galleri multi-cancer screening trial: explanation and justification of unique and important design issues.

Despite there being a plethora of multi-cancer early-detection tests, NHS-Galleri (ISRCTN91431511) is the only randomized controlled trial (RCT) of a multi-cancer liquid biopsy in a screening setting thus far. The NHS-Galleri trial has generated much debate, and it has been criticized in the medical press. Some of these criticisms stem from differing opinions over the choice of primary endpoint, others from poor reporting in statements to journalists from those not directly involved in the trial.

Risk factors for pancreatic cancer in electronic health records: an umbrella review of systematic reviews and meta-analyses.

Background: Pancreatic cancer has poor survival because of predominantly advanced-stage diagnosis. One strategy for improving outcomes is earlier identification, possibly achievable by enhanced surveillance or improved risk prediction modelling. This umbrella review updates previous evidence with a comprehensive assessment of factors which could inform risk assessments.

Clinical referral to the NHS following multi-cancer early detection test results from the NHS-Galleri trial.

Introduction: The large, randomised, controlled NHS-Galleri trial (NCT05611632) is assessing the clinical utility of a multi-cancer early detection (MCED) test for asymptomatic cancer screening in England. We describe how we enabled the efficient referral of trial participants into existing National Health Service (NHS) urgent suspected cancer pathways for diagnostic investigations.

Methods/results: Participants were enrolled across eight of the 21 Cancer Alliance regions in England, served by 56 Hospital Trusts.

Acceptability of acceptance and commitment therapy for medication-decision-making and quality of life in women with breast cancer: A qualitative process evaluation.

Objectives: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but side effects and distress impact adherence. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to support medication decision-making and quality of life in women prescribed AET (ACTION). In a qualitative process evaluation nested in the pilot trial, we aimed to elicit participant experiences of receipt and therapists experience of delivery of ACTION to enhance our understanding of acceptability.

GPs' acceptability and feasibility for using point-of-care tests for cancer in primary care: a qualitative interview study.

Background: Primary care is the first point of contact for patients with symptoms suspicious of cancer. The availability of reliable, rapid diagnostic cancer tests, at the 'point of care', have the potential to expedite diagnosis, and support timely management of patients.

Aim: To explore the acceptability and feasibility of using point-of-care tests (POCTs) for detecting cancer among UK GPs, including barriers and facilitators to uptake.

Impact of frailty and comorbidity on initial response to lung cancer screening invitation and low-dose CT screening uptake: Findings from the Yorkshire Lung Screening Trial.

BackgroundLow-dose computed tomography screening reduces lung cancer-specific mortality in high-risk individuals. Lung cancer risk factors overlap with comorbid diseases, highlighting the significance of frailty and comorbidities for lung cancer screening (LCS). Here, we describe the prevalence of frailty and comorbidity in those invited for LCS and evaluate their associations with response to telephone risk assessment invitation and subsequent uptake of LCS.

NHS-Galleri trial: Enriched enrolment approaches and sociodemographic characteristics of enrolled participants.

Background/aims: Certain sociodemographic groups are routinely underrepresented in clinical trials, limiting generalisability. Here, we describe the extent to which enriched enrolment approaches yielded a diverse trial population enriched for older age in a randomised controlled trial of a blood-based multi-cancer early detection test (NCT05611632).

Methods: Participants aged 50-77 years were recruited from eight Cancer Alliance regions in England.

General practice chest X-ray rate is associated with earlier lung cancer diagnosis and reduced all-cause mortality: a retrospective observational study.

Background: Evidence is equivocal on whether general practice rates of investigation in symptomatic patients using chest X-ray (CXR) affect outcomes.

Aim: To determine whether there is an association between rates of CXR requested in general practice and lung cancer outcomes.

Design And Setting: Observational study using data on English general practices.

Prospective Evaluation of Lung Cancer Screening Eligibility Criteria and Lung Cancer Detection in the Yorkshire Lung Screening Trial.

Introduction: Low-dose computed tomography screening for lung cancer reduces lung cancer mortality, but there is a lack of international consensus regarding the optimal eligibility criteria for screening. The Yorkshire Lung Screening Trial was designed to evaluate lung cancer screening (LCS) implementation, and a primary objective was prospective evaluation of three predefined eligibility criteria.

Methods: Individuals who had ever smoked, aged 55 to 80 years, who responded to written invitation, underwent telephone risk assessment and if eligible by at least one criterion (PLCO ≥ 1.

Understanding ethnic inequalities in cancer diagnostic intervals: a cohort study of patients presenting suspected cancer symptoms to GPs in England.

Background: UK Asian and Black patients experience longer cancer diagnostic intervals - the period between initial symptomatic presentation in primary care and cancer diagnosis.

Aim: To determine whether the differences in diagnostic intervals are because of prolonged primary care, referral, or secondary care interval.

Design And Setting: A cohort study was undertaken of 70 971 patients with seven cancers (breast, lung, prostate, colorectal, oesophagogastric, myeloma, ovarian) diagnosed after symptom presentation in English primary care.

Biomarkers Suitable for Early Detection of Intrathoracic Cancers in Primary Care: A Systematic Review.

Intrathoracic cancers, including lung cancer, mesothelioma, and thymoma, present diagnostic challenges in primary care. Biomarkers could resolve some challenges. We synthesized evidence on biomarker performance for intrathoracic cancer detection in low-prevalence settings.

Abdominal Noncontrast Computed Tomography Scanning to Screen for Kidney Cancer and Other Abdominal Pathology Within Community-based Computed Tomography Screening for Lung Cancer: Results of the Yorkshire Kidney Screening Trial.

Background And Objective: The Yorkshire Kidney Screening Trial (YKST) assessed the feasibility of adding abdominal noncontrast computed tomography (NCCT) to lung cancer screening to screen for kidney cancer and other abdominal pathology.

Methods: A prospective diagnostic study offered abdominal NCCT to 55-80-yr-old ever-smokers attending a UK randomised lung cancer screening trial (May 2021 to October 2022). The exclusion criteria were dementia, frailty, previous kidney/lung cancer, and computed tomography (CT) of the abdomen and thorax within previous 6 and 12 mo, respectively.

Hidden systems in primary care cancer detection: an embedded qualitative intervention development study.

Background: UK cancer mortality is worse than in many other high-income countries, partly because of diagnostic delays in primary care.

Aim: To understand beliefs and behaviours of GPs, and systems of general practice teams, to inform the Think Cancer! intervention development.

Design And Setting: An embedded qualitative study guided by behaviour change models (COM-B [Capability, Opportunity, Motivation - Behaviour] and theoretical domains framework [TDF]) in primary care in Wales, UK.

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

Objective: Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability.

Understanding GPs' referral decisions for younger patients with symptoms of cancer: a qualitative interview study.

Background: Cancer incidence increases with age, so some clinical guidelines include patient age as one of the criteria used to decide whether a patient should be referred through the urgent suspected cancer (USC) pathway. Little is known about how strictly GPs adhere to these age criteria and what factors might influence their referral decisions for younger patients.

Aim: To understand GPs' clinical decision making for younger patients with concerning symptoms who do not meet the age criteria for USC referral.

Uptake and 4-week quit rates from an opt-out co-located smoking cessation service delivered alongside community-based low-dose computed tomography screening within the Yorkshire Lung Screening Trial.

Background: Up to 50% of those attending for low-dose computed tomography screening for lung cancer continue to smoke and co-delivery of smoking cessation services alongside screening may maximise clinical benefit. Here we present data from an opt-out co-located smoking cessation service delivered alongside the Yorkshire Lung Screening Trial (YLST).

Methods: Eligible YLST participants were offered an immediate consultation with a smoking cessation practitioner (SCP) at their screening visit with ongoing smoking cessation support over subsequent weeks.

The National Health Service urgent cancer referral pathway for suspected urological cancers: early economic evaluation of a risk prediction test.

Objectives: In the UK, the number of patients urgently referred for suspected cancer is increasing, and providers are struggling to cope with demand. We explore the potential cost-effectiveness of a new risk prediction test - the PinPoint test - to triage and prioritize patients urgently referred with suspected urological cancers.

Methods: Two simulation models were developed to reflect the diagnostic pathways for patients with (i) suspected prostate cancer, and (ii) bladder or kidney cancer, comparing the PinPoint test to current practice.

Digital intervention (Renewed) to support symptom management, wellbeing, and quality of life among cancer survivors in primary care: a randomised controlled trial.

Background: Many cancer survivors following primary treatment have prolonged poor quality of life.

Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors.

Design And Setting: This was a pragmatic parallel open randomised trial in UK general practices (ISRCTN:96374224).

Parkinson's disease: a scoping review of the quantitative and qualitative evidence of its diagnostic accuracy in primary care.

Background: Parkinson's disease is a multisystem condition that usually presents as a movement disorder in clinical practice. There is no objective method for its diagnosis and therefore the current diagnostic process is based on characteristic clinical signs and symptoms. As the presenting symptoms can be vague and non-specific, there is often a delay in diagnosis leading to mismanagement and delayed treatment initiation.

Priorities for implementation research on diagnosing cancer in primary care: a consensus process.

Background: The early detection and diagnosis of cancer to reduce avoidable mortality and morbidity is a challenging task in primary health care. There is a growing evidence base on how to enable earlier cancer diagnosis, but well-recognised gaps and delays exist around the translation of new research findings into routine clinical practice. Implementation research aims to accelerate the uptake of evidence by health care systems and professionals.