Modelling Spillover Effects on Informal Carers: The Carer QALY Trap.

The provision of informal (unpaid) care can impose significant 'spillover effects' on carers, and accounting for these effects is consistent with the efficiency and equity objectives of health technology assessment (HTA). Inclusion of these effects in health economic models, particularly carer health-related quality of life (QOL), can have a substantial impact on net quality-adjusted life year (QALY) gains and the relative cost effectiveness of new technologies. Typically, consideration of spillover effects improves the value of a technology, but in some circumstances, consideration of spillover effects can lead to situations whereby life-extending treatments for patients may be considered cost ineffective due to their impact on carer QOL.

Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer.

As advanced non-small cell lung cancer (aNSCLC) is being increasingly divided into rare oncogene-driven subsets, conducting randomised trials becomes challenging. Using real-world data (RWD) to construct control arms for single-arm trials provides an option for comparative data. However, non-randomised treatment comparisons have the potential to be biased and cause concern for decision-makers.

Association Between Smoking History and Overall Survival in Patients Receiving Pembrolizumab for First-Line Treatment of Advanced Non-Small Cell Lung Cancer.

Importance: There is a need to tailor treatments to patients who are most likely to derive the greatest benefit from them to improve patient outcomes and enhance cost-effectiveness of cancer therapies.

Objective: To compare overall survival (OS) between patients with a current or former history of smoking with patients who never smoked and initiated pembrolizumab monotherapy as first-line (1L) treatment for advanced non-small lung cancer (NSCLC).

Design, Setting, And Participants: This retrospective cohort study compared patients diagnosed with advanced NSCLC aged 18 or higher selected from a nationwide real-world database originating from more than 280 US cancer clinics.

Keeping it real: implications of real-world treatment outcomes for first-line immunotherapy in metastatic non-small-cell lung cancer.

Tweetable abstract Recent RWD studies suggest that the performance of immunotherapy in NSCLC is not as good as that seen in RCTs. However, analyses using RWD (and their interpretation) require careful appraisal and quantification of possible sources of bias.

Assessment of Alectinib vs Ceritinib in ALK-Positive Non-Small Cell Lung Cancer in Phase 2 Trials and in Real-world Data.

Importance: Quantitative assessment of bias from unmeasured confounding and missing data can help evaluate uncertainty in findings from indirect comparisons using real-world data (RWD).

Objective: To compare the effectiveness of alectinib vs ceritinib in terms of overall survival (OS) in patients with ALK-positive, crizotinib-refractory, non-small cell lung cancer (NSCLC) and to assess the sensitivity of these findings to unmeasured confounding and missing data assumptions.

Design, Setting, And Participants: This comparative effectiveness research study compared patients from 2 phase 2 alectinib trials and real-world patients.

Impact of Including Carer Information in Time Trade-Off Tasks: Results from a Pilot Study.

Introduction: Carer quality of life (QoL) can be included in economic evaluations and captured using EQ-5D. Traditional valuation tasks require participants to imagine living in a health state for a number of years, without being told what to consider. This pilot study sought to investigate whether participants implicitly consider the impact of the health state on others, and the extent to which this may impact health state valuations.

Beyond p-values: A phase II dual-criterion design with statistical significance and clinical relevance.

Background Well-designed phase II trials must have acceptable error rates relative to a pre-specified success criterion, usually a statistically significant p-value. Such standard designs may not always suffice from a clinical perspective because clinical relevance may call for more. For example, proof-of-concept in phase II often requires not only statistical significance but also a sufficiently large effect estimate.

Incidence of primary hepatitis C infection and risk factors for transmission in an Australian prisoner cohort.

Background: Hepatitis C virus (HCV) infection is common in prisoner populations, particularly those with a history of injecting drug use (IDU). Previous studies of HCV incidence have been based on small case numbers and have not distinguished risk events in prison from those in the community.

Methods: HCV incidence was examined in a longitudinal cohort of 488 Australian prisoners with a history of IDU and documented to be seronegative within 12 months prior to enrollment.

Incidence and risk for acute hepatitis C infection during imprisonment in Australia.

To determine hepatitis C incidence and the demographic and behavioural predictors in seronegative drug injecting prisoners. Prisoners in New South Wales, Australia who: were aged 18 years and over; reported IDU; had been continuously imprisoned; had a documented negative HCV antibody test result in prison in the last 12 months; provided written informed consent. Subjects were interviewed about their demographic characteristics and detailed risk factors for transmission prior to, and since, imprisonment.

Injection of medications used in opioid substitution treatment in Australia after the introduction of a mixed partial agonist-antagonist formulation.

Objectives: To examine the levels and predictors of injection of buprenorphine-naloxone (BNX)--a combination of a partial opioid agonist and an opioid antagonist for treating opioid dependence--which was specifically developed to limit injecting. Comparison was made with injecting of two other opioid substitution treatment medications, methadone and buprenorphine (BPN); severe harms have been documented after injection of the latter.

Design And Participants: Injecting was studied in regular injecting drug users ("IDUs") and current opioid substitution treatment clients ("clients").