MPES-R: Multi-Parameter Evidence Synthesis in R for Survival Extrapolation-A Tutorial.

Survival extrapolation often plays an important role in health technology assessment (HTA), and there are a range of different approaches available. Approaches that can leverage external evidence (i.e.

Treatment-Switching Adjustment of Overall Survival in CheckMate 227 Part 1 Evaluating First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy for Metastatic Nonsmall Cell Lung Cancer.

Objectives: CheckMate 227 (NCT02477826) evaluated first-line nivolumab-plus-ipilimumab versus chemotherapy in patients with metastatic nonsmall cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1) expression ≥ 1% or < 1% and no EGFR/ALK alterations. However, many patients randomized to chemotherapy received subsequent immunotherapy. Here, overall survival (OS) and relative OS benefit of nivolumab-plus-ipilimumab were adjusted for potential bias introduced by treatment switching.

"Don't keep me waiting": estimating the impact of reduced vein-to-vein time on lifetime US 3L+ LBCL patient outcomes.

Chimeric antigen receptor T-cell therapy (CAR T) has revolutionized the treatment of hematological cancers. Its production requires a complex logistical process, and the time from leukapheresis to patient infusion (known as the vein-to-vein time [V2VT]) can be long during which a patients clinical condition may deteriorate. This study was designed to estimate the benefits of reduced V2VT for third-line or later (3L+) relapsed/refractory large B-cell lymphoma (R/R LBCL) patients treated with CAR T.

Impact of pneumococcal conjugate vaccines on healthcare utilization and direct costs for otitis media in children ≤2 years of age in two Swedish regions.

Unlabelled: In Sweden, the 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in 2009 and replaced by the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) or the 13- valent PCV (PCV13) from late 2009. We assessed the impact of PCVs on rates of antibiotic prescribing, tympanostomy tube placement (TTP), and healthcare resource utilization and direct costs of physician- diagnosed otitis media/acute otitis media (OM) in children ≤2 years of age living in Skåne (PCV7 then PHiD- CV) or Västra Götalandsregionen (VGR; PCV7 then PCV13). Retrospective cohort study using linked patient- level data from national and regional (Skåne and VGR) healthcare databases in Sweden from July 1, 2005, to December 31, 2013 (NCT02742753).

Risk Prediction Using Bayesian Networks: An Immunotherapy Case Study in Patients With Metastatic Renal Cell Carcinoma.

Purpose: To address the need for more accurate risk stratification models for cancer immuno-oncology, this study aimed to develop a machine-learned Bayesian network model (BNM) for predicting outcomes in patients with metastatic renal cell carcinoma (mRCC) being treated with immunotherapy.

Methods: Patient-level data from the randomized, phase III CheckMate 025 clinical trial comparing nivolumab with everolimus for second-line treatment in patients with mRCC were used to develop the BNM. Outcomes of interest were overall survival (OS), all-cause adverse events, and treatment-related adverse events (TRAE) over 36 months after treatment initiation.

Associations Between Hearing Health and Well-Being in Unilateral Hearing Impairment.

Objectives: To determine population-based risks of adverse effects on hearing and well-being outcomes associated with unilateral hearing impairment.

Design: A group of 40- to 69-year-old adults (n = 861) who reported being able to hear only in one ear and having speech reception thresholds (SRTs) in noise indicating normal hearing in that ear (SRTN/-) was selected from the UK Biobank cohort. The UK Biobank participants with SRTs indicating either normal (SRTN/N, n = 95,514) or symmetrically impaired hearing in both ears (SRTI/I, n = 17,429) were selected as comparison groups.

The Development of a New Questionnaire to Measure the Burden of Immunoglobulin Treatment in Patients with Primary Immunodeficiencies: The IgBoT-35.

Purpose: To describe the development and psychometric testing of a new questionnaire to measure the burden of immunoglobulin treatment (Ig) from the perspective of patients with primary immunodeficiencies (PID).

Patients And Methods: An online, cross-sectional survey was administered to PID patients across 10 countries (nine European and Canada) who were receiving either intravenous (IVIg) or subcutaneous (SCIg) immunoglobulin therapy. The range and distribution of the responses (ie, levels of missing data, floor and ceiling effects), exploratory factor analysis (using factor loadings of 0.

The effect of pneumococcal conjugate vaccines on otitis media from 2005 to 2013 in children aged ≤5 years: a retrospective cohort study in two Swedish regions.

Seven-valent pneumococcal conjugate vaccine (PCV7) was introduced to Sweden in 2009 and replaced by pneumococcal non-typeable protein D conjugate vaccine (PHiD-CV) or 13-valent PCV (PCV13) from late 2009. A retrospective cohort study assessed the impact of PCVs on otitis media/acute otitis media (OM) in children aged ≤5 years (NCT02742753) living in Skåne (PCV7 then PHiD-CV) or Västra Götalandsregionen (PCV7 then PCV13) between 2005 and 2013 using linked regional and national databases. Time-series analyses described differences between pre-PCV and post-PCV eras.

Hearing aids for mild to moderate hearing loss in adults.

Background: The main clinical intervention for mild to moderate hearing loss is the provision of hearing aids. These are routinely offered and fitted to those who seek help for hearing difficulties. By amplifying and improving access to sounds, and speech sounds in particular, the aim of hearing aid use is to reduce the negative consequences of hearing loss and improve participation in everyday life.

Tinnitus and Sleep Difficulties After Cochlear Implantation.

Objectives: To estimate and compare the prevalence of and associations between tinnitus and sleep difficulties in a sample of UK adult cochlear implant users and those identified as potential candidates for cochlear implantation.

Design: The study was conducted using the UK Biobank resource, a population-based cohort of 40- to 69-year olds. Self-report data on hearing, tinnitus, sleep difficulties, and demographic variables were collected from cochlear implant users (n = 194) and individuals identified as potential candidates for cochlear implantation (n = 211).

A systematic review of the reporting of tinnitus prevalence and severity.

Introduction: There is no standard diagnostic criterion for tinnitus, although some clinical assessment instruments do exist for identifying patient complaints. Within epidemiological studies the presence of tinnitus is determined primarily by self-report, typically in response to a single question. Using these methods prevalence figures vary widely.

The Effect of Prenatal and Childhood Development on Hearing, Vision and Cognition in Adulthood.

It is unclear what the contribution of prenatal versus childhood development is for adult cognitive and sensory function and age-related decline in function. We examined hearing, vision and cognitive function in adulthood according to self-reported birth weight (an index of prenatal development) and adult height (an index of early childhood development). Subsets (N = 37,505 to 433,390) of the UK Biobank resource were analysed according to visual and hearing acuity, reaction time and fluid IQ.

Investigating the association between tinnitus severity and symptoms of depression and anxiety, while controlling for neuroticism, in a large middle-aged UK population.

Objective: Clinical studies indicate increased risk for depression and anxiety among tinnitus patients. However population data are scarce, and no studies have controlled for neuroticism. We examined associations between tinnitus and symptoms of depression and anxiety in a large UK population, controlling for neuroticism, to explore whether neuroticism, as previously reported, fully explains the association between symptoms of depression and anxiety, and tinnitus.

Hearing loss and cognition: the role of hearing AIDS, social isolation and depression.

Hearing loss is associated with poor cognitive performance and incident dementia and may contribute to cognitive decline. Treating hearing loss with hearing aids may ameliorate cognitive decline. The purpose of this study was to test whether use of hearing aids was associated with better cognitive performance, and if this relationship was mediated via social isolation and/or depression.

Association of dietary factors with presence and severity of tinnitus in a middle-aged UK population.

Objective: The impact of dietary factors on tinnitus has received limited research attention, despite being a considerable concern among people with tinnitus and clinicians. The objective was to examine the link between dietary factors and presence and severity of tinnitus.

Design: This study used the UK Biobank resource, a large cross-sectional study of adults aged 40-69.

Agreement and reliability of tinnitus loudness matching and pitch likeness rating.

The ability to reproducibly match tinnitus loudness and pitch is important to research and clinical management. Here we examine agreement and reliability of tinnitus loudness matching and pitch likeness ratings when using a computer-based method to measure the tinnitus spectrum and estimate a dominant tinnitus pitch, using tonal or narrowband sounds. Group level data indicated a significant effect of time between test session 1 and 2 for loudness matching, likely procedural or perceptual learning, which needs to be accounted in study design.

Relationship between tinnitus pitch and edge of hearing loss in individuals with a narrow tinnitus bandwidth.

Objective: Psychoacoustic measures of tinnitus, in particular dominant tinnitus pitch and its relationship to the shape of the audiogram, are important in determining and verifying pathophysiological mechanisms of the condition. Our previous study postulated that this relationship might vary between different groups of people with tinnitus. For a small subset of participants with narrow tinnitus bandwidth, pitch was associated with the audiometric edge, consistent with the tonotopic reorganization theory.

Relation between speech-in-noise threshold, hearing loss and cognition from 40-69 years of age.

Background: Healthy hearing depends on sensitive ears and adequate brain processing. Essential aspects of both hearing and cognition decline with advancing age, but it is largely unknown how one influences the other. The current standard measure of hearing, the pure-tone audiogram is not very cognitively demanding and does not predict well the most important yet challenging use of hearing, listening to speech in noisy environments.

Temporal changes in breast cancer incidence in South Asian women.

Background: Breast cancer in the UK resident population of South Asian ethnicity has been lower than that in indigenous women. Leicester has a large South Asian population and a breast cancer unit with comprehensive data on diagnosed cancers. This study analysed the annual incidence of new breast cancer diagnoses in females from 1998 to 2009 to determine any changes in recent years.

Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial.

Background: Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear.

Cigarette smoking, passive smoking, alcohol consumption, and hearing loss.

The objective of this large population-based cross-sectional study was to evaluate the association between smoking, passive smoking, alcohol consumption, and hearing loss. The study sample was a subset of the UK Biobank Resource, 164,770 adults aged between 40 and 69 years who completed a speech-in-noise hearing test (the Digit Triplet Test). Hearing loss was defined as speech recognition in noise in the better ear poorer than 2 standard deviations below the mean with reference to young normally hearing listeners.

Vision impairment and dual sensory problems in middle age.

Purpose: Vision and hearing impairments are known to increase in middle age. In this study we describe the prevalence of vision impairment and dual sensory impairment in UK adults aged 40-69 years in a very large and recently ascertained data set. The associations between vision impairment, age, sex, socioeconomic status, and ethnicity are reported.