Normalising the Implementation of Pharmacogenomic (PGx) Testing in Adult Mental Health Settings: A Theory-Based Systematic Review.

Pharmacogenomic (PGx) testing can help personalise psychiatric prescribing and improve on the currently adopted trial-and-error prescribing approach. However, widespread implementation is yet to occur. Understanding factors influencing implementation is pertinent to the psychiatric PGx field.

Proportion of Antipsychotics with CYP2D6 Pharmacogenetic (PGx) Associations Prescribed in an Early Intervention in Psychosis (EIP) Cohort: A Cross-Sectional Study.

Background: Prescribing drugs for psychosis (antipsychotics) is challenging due to high rates of poor treatment outcomes, which are in part explained by an individual's genetics. Pharmacogenomic (PGx) testing can help clinicians tailor the choice or dose of psychosis drugs to an individual's genetics, particularly psychosis drugs with known variable response due to CYP2D6 gene variants ('CYP2D6-PGx antipsychotics').

Aims: This study aims to investigate differences between demographic groups prescribed 'CYP2D6-PGx antipsychotics' and estimate the proportion of patients eligible for PGx testing based on current pharmacogenomics guidance.

Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study.

Introduction: In a small percentage of patients, pulmonary nodules found on CT scans are early lung cancers. Lung cancer detected at an early stage has a much better prognosis. The British Thoracic Society guideline on managing pulmonary nodules recommends using multivariable malignancy risk prediction models to assist in management.

Cost-effectiveness of decellularised bone allograft compared with fresh-frozen bone allograft for acetabular impaction bone grafting during a revision hip arthroplasty in the UK.

Objectives: Fresh-frozen allograft is the gold-standard bone graft material used during revision hip arthroplasty. However, new technology has been developed to manufacture decellularised bone with potentially better graft incorporation. As these grafts cost more to manufacture, the aim of this cost-effectiveness study was to estimate whether the potential health benefit of decellularised bone allograft outweighs their increased cost.

Cost-effectiveness requirements for implementing artificial intelligence technology in the Women's UK Breast Cancer Screening service.

The UK NHS Women's National Breast Screening programme aims to detect breast cancer early. The reference standard approach requires mammograms to be independently double-read by qualified radiology staff. If two readers disagree, arbitration by an independent reader is undertaken.

Evaluating high-cost technologies - no need to throw the baby out with the bathwater.

Introduction: Evidence generation for the health technology assessment (HTA) of a new technology is a long and expensive process with no guarantees that the health technology will be adopted and implemented into a health-care system. This would suggest that there is a greater risk of failure for a company developing a high-cost technology and therefore incentives (such as increasing the funding available for research or additional market exclusivity) may be needed to encourage development of such technologies as has been seen with many high-cost orphan drugs.

Areas Covered: This paper discusses some of the key issues relating to the evaluation of high-cost technologies through the use of existing HTA processes and what the challenges will be going forward.

Learning from parental experience in a neonatal surgical unit: a qualitative service evaluation.

Objectives: Patient experience is directly related to health outcomes, and parental experience can be used as a proxy for this in neonatal care. This project was designed to assess parental experience of neonatal surgical care to inform future service developments and improve the care we provide.

Methods: This was a qualitative study using rapid qualitative analysis.

Developing a method to capture parental experience in a neonatal surgical centre in the context of COVID-19: a qualitative study.

Introduction: Improved parental experience is related to improved mental and physical health outcomes for the infant. The COVID-19 pandemic abruptly impacted on healthcare delivery and services need information to shape how to manage the disruption and recovery.

Methods: Our aim was to develop a systematic process to capture parents' experience of their neonatal surgical healthcare journey during the pandemic.

The cost-effectiveness of using rapid diagnostic tests for the diagnosis of typhoid fever in patients with suspected typhoid fever: a systematic review.

Introduction: Despite the availability of several commercial rapid diagnostic tests (RDTs) developed to detect typhoid fever, the cost-effectiveness in resource-limited settings is unclear. This review aimed to explore the literature on typhoid economic evaluations in order to assess the cost-effectiveness of using typhoid RDTs in resource-limited settings.

Areas Covered: A systematic review was conducted focusing on the identification of economic evaluations of typhoid RDTs to diagnose patients with suspected typhoid fever.

What Are the Barriers and Enablers to the Implementation of Pharmacogenetic Testing in Mental Health Care Settings?

In psychiatry, the selection of antipsychotics and antidepressants is generally led by a trial-and-error approach. The prescribing of these medications is complicated by sub-optimal efficacy and high rates of adverse drug reactions (ADRs). These both contribute to poor levels of adherence.

An Analysis of Pharmacogenomic-Guided Pathways and Their Effect on Medication Changes and Hospital Admissions: A Systematic Review and Meta-Analysis.

Ninety-five percent of the population are estimated to carry at least one genetic variant that is discordant with at least one medication. Pharmacogenomic (PGx) testing has the potential to identify patients with genetic variants that puts them at risk of adverse drug reactions and sub-optimal therapy. Predicting a patient's response to medications could support the safe management of medications and reduce hospitalization.

The DANTE trial protocol: a randomised phase III trial to evaluate the Duration of ANti-PD-1 monoclonal antibody Treatment in patients with metastatic mElanoma.

Background: Immunotherapy is revolutionising the treatment of patients diagnosed with melanoma and other cancers. The first immune checkpoint inhibitor, ipilimumab (targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)), showed a survival advantage over standard chemotherapy. Subsequently the anti-programmed cell death protein 1 (PD-1) antibodies, nivolumab and pembrolizumab were shown to be more effective than ipilimumab.

Cost-effectiveness analysis of telephone-based cognitive behaviour therapy compared to treatment as usual CBT for cancer patients: Evidence from a small, randomised controlled trial.

Objective: A previous equivalence randomised trial indicated that Telephone-based Cognitive Behaviour Therapy (T-CBT) was not inferior to Treatment as Usual CBT (TAU-CBT) delivered face to face in terms of psychological benefit with both groups showing post-therapy improvements compared to pre-therapy baseline. The aim here is to clarify costs and benefits through an economic evaluation of the two therapy models.

Method: The cost-effectiveness analysis (cost per quality-adjusted life year [QALY]) was derived from a single-centre (UK-based), two-arm randomised control trial.

Early economic evaluation of an intervention to improve uptake of the NHS England Diabetes Prevention Programme.

Background: Despite reported increases in referral numbers, a large proportion of those with prediabetes still decline participation in the NHS England Diabetes Prevention Programme (NDPP). The aim of this study was to explore whether investment in interventions to improve uptake of the programme has the potential to be cost-effective.

Methods: An early cost-utility analysis was conducted using a Markov model parameterized based on secondary data sources.

Cost-effectiveness of a new autoantibody test added to Computed Tomography (CT) compared to CT surveillance alone in the diagnosis of lung cancer amongst patients with indeterminate pulmonary nodules.

Oncimmune's EarlyCDT®-Lung is a simple ELISA blood test that measures seven lung cancer specific autoantibodies and is used in the assessment of malignancy risk in patients with indeterminate pulmonary nodules (IPNs). The objective of this study was to examine the cost-effectiveness of EarlyCDT-Lung in the diagnosis of lung cancer amongst patients with IPNs in addition to CT surveillance, compared to CT surveillance alone which is the current recommendation by the British Thoracic Society guidelines. A model consisting of a combination of a decision tree and Markov model was developed using the outcome measure of the quality adjusted life year (QALY).

Cost evaluation of point-of-care testing for community-acquired influenza in adults presenting to the emergency department.

Background: Rapid molecular point-of-care tests (POCTs) for influenza have potential to produce cost savings in emergency departments (EDs) and acute care settings. To date, published projected savings have been based on estimated costs.

Objectives: This study aimed to describe the cost implications of a rapid influenza POCT using accurate real-world patient level costing data.

Early Economic Evaluation of Diagnostic Technologies: Experiences of the NIHR Diagnostic Evidence Co-operatives.

Diagnostic tests are expensive and time-consuming to develop. Early economic evaluation using decision modeling can reduce commercial risk by providing early evidence on cost-effectiveness. The National Institute for Health Research Diagnostic Evidence Co-operatives (DECs) was established to catalyze evidence generation for diagnostic tests by collaborating with commercial developers; DEC researchers have consequently made extensive use of early modeling.

An early analysis of the cost-effectiveness of a diagnostic classifier for risk stratification of haematuria patients (DCRSHP) compared to flexible cystoscopy in the diagnosis of bladder cancer.

Background: Urothelial bladder cancer (UBC) is the 5th most common cancer in Western societies. The most common symptom of UBC is haematuria. Cystoscopy the gold standard for UBC detection, allows direct observation of the bladder, but is expensive, invasive, and uncomfortable.

New paradigms for BRCA1/BRCA2 testing in women with ovarian cancer: results of the Genetic Testing in Epithelial Ovarian Cancer (GTEOC) study.

Background: Over recent years genetic testing for germline mutations in BRCA1/BRCA2 has become more readily available because of technological advances and reducing costs.

Objective: To explore the feasibility and acceptability of offering genetic testing to all women recently diagnosed with epithelial ovarian cancer (EOC).

Methods: Between 1 July 2013 and 30 June 2015 women newly diagnosed with EOC were recruited through six sites in East Anglia, UK into the Genetic Testing in Epithelial Ovarian Cancer (GTEOC) study.

Systematic review and meta-analysis to estimate the birth prevalence of five inherited metabolic diseases.

Many newborn screening programmes now use tandem mass spectrometry in order to screen for a variety of diseases. However, countries have embraced this technology with a differing pace of change and for different conditions. This has been facilitated by the ability of this diagnostic method to limit analysis to specific metabolites of interest, enabling targeted screening for particular conditions.

'Personalized medicine': what's in a name?

Over the last decade genomics and other molecular biosciences have enabled new capabilities that, according to many, have the potential to revolutionize medicine and healthcare. These developments have been associated with a range of terminologies, including 'precision', 'personalized', 'individualized' and 'stratified' medicine. In this article, based on a literature review, we examine how the terms have arisen and their various meanings and definitions.

Health needs assessment for congenital anomalies in middle-income countries: Examining the case for neural tube defects in Brazil.

Recent economic improvement in Brazil has been reflected in better maternal-child health indicators, with decreases in infant and perinatal mortality. However, under-five mortality due to congenital disorders remained unchanged, and congenital disorders have become the second leading cause of infant mortality. In the present study, we used the PHG Foundation Health Needs Assessment (HNA) Toolkit with the objective of first assessing the burden of disease caused by neural tube defects (NTDs) in Brazil and the impact of interventions already put in place to address the burden, and second to evaluate and prioritize further interventions and policies required for its prevention and treatment.