A guide for planning triangulation studies to investigate complex causal questions in behavioural and psychiatric research.

Aims: At the basis of many important research questions is causality - does X causally impact Y? For behavioural and psychiatric traits, answering such questions can be particularly challenging, as they are highly complex and multifactorial. 'Triangulation' refers to prospectively choosing, conducting and integrating several methods to investigate a specific causal question. If different methods, with different sources of bias, all indicate a causal effect, the finding is much less likely to be spurious.

Topical or oral antibiotics in childhood acute otitis media and ear discharge: a randomized controlled non-inferiority trial.

Background: Current guidance suggests oral antibiotics can be considered for children with acute otitis media (AOM) and ear discharge, but there is an absence of evidence regarding the relative effectiveness of antibiotic-corticosteroid eardrops.

Aim: To establish whether antibiotic-corticosteroid eardrops are non-inferior to oral antibiotics in children with AOM and ear discharge.

Design And Setting: Open randomized controlled non-inferiority trial set in Dutch primary care.

Harmonising outcome measurement for child focused domestic abuse interventions. Reflections on the development and implementation of a core outcome set.

There is appetite in the UK to better measure the impact of domestic violence and abuse (DVA) interventions on children. The spread of outcomes-based commissioning means outcome measurement is no longer just the territory of academic researchers but is now firmly within the purview of practitioners and policy makers. However, outcomes measured in trials only partially represent the views of those delivering and using services with respect to how success should be defined and captured.

Protocol for the development and validation of a patient-reported experience measure (PREM) for people with hearing loss: the PREM-HeLP.

Introduction: Hearing loss is a common chronic health condition and adversely affects communication and social function resulting in loneliness, social isolation and depression. We know little about the patient experience of living with hearing loss and their views on the quality of the audiology service. In this study, we will develop and validate the first patient-reported experience measure (PREM) to understand patients' experiences of living with hearing loss and their healthcare interactions with audiology services.

Risk of bias assessments in individual participant data meta-analyses of test accuracy and prediction models: a review shows improvements are needed.

Objectives: Risk of bias assessments are important in meta-analyses of both aggregate and individual participant data (IPD). There is limited evidence on whether and how risk of bias of included studies or datasets in IPD meta-analyses (IPDMAs) is assessed. We review how risk of bias is currently assessed, reported, and incorporated in IPDMAs of test accuracy and clinical prediction model studies and provide recommendations for improvement.

Gut feeling for the diagnosis of cancer in general practice: a diagnostic accuracy review.

Objectives: Diagnostic delay in cancer is a challenge in primary care. Although screening tests are effective in diagnosing some cancers such as breast, colorectal and cervical cancers, symptom-based cancer diagnosis is often difficult due to its low incidence in primary care and the influence of patient anxiety, doctor-patient relationship and psychosocial context. A general practitioner's gut feeling for cancer may play a role in the early diagnosis of cancer in primary care where diagnostic resources are limited.

Nicotine receptor partial agonists for smoking cessation.

Background: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). This is an update of a Cochrane Review first published in 2007.

Objectives: To assess the effectiveness of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation.

General-Purpose Methods for Simulating Survival Data for Expected Value of Sample Information Calculations.

Background: Expected value of sample information (EVSI) quantifies the expected value to a decision maker of reducing uncertainty by collecting additional data. EVSI calculations require simulating plausible data sets, typically achieved by evaluating quantile functions at random uniform numbers using standard inverse transform sampling (ITS). This is straightforward when closed-form expressions for the quantile function are available, such as for standard parametric survival models, but these are often unavailable when assuming treatment effect waning and for flexible survival models.

Cross-cultural adaptation and its impact on research in emergency care.

The perspective of patients is increasingly recognised as important to care improvement and innovation. Patient questionnaires such as patient-reported outcome measures may often require cross-cultural adaptation (CCA) to gather their intended information most effectively when used in cultures and languages different to those in which they were developed. The use of CCA could be seen as a practical step in addressing the known problems of inclusion, diversity and access in medical research.

Progression of clinical markers in prodromal Parkinson's disease and dementia with Lewy bodies: a multicentre study.

The neurodegenerative synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are characterized by a typically lengthy prodromal period of progressive subclinical motor and non-motor manifestations. Among these, idiopathic REM sleep behaviour disorder is a powerful early predictor of eventual phenoconversion, and therefore represents a critical opportunity to intervene with neuroprotective therapy. To inform the design of randomized trials, it is essential to study the natural progression of clinical markers during the prodromal stages of disease in order to establish optimal clinical end points.

Universal clinical Parkinson's disease axes identify a major influence of neuroinflammation.

Background: There is large individual variation in both clinical presentation and progression between Parkinson's disease patients. Generation of deeply and longitudinally phenotyped patient cohorts has enormous potential to identify disease subtypes for prognosis and therapeutic targeting.

Methods: Replicating across three large Parkinson's cohorts (Oxford Discovery cohort (n = 842)/Tracking UK Parkinson's study (n = 1807) and Parkinson's Progression Markers Initiative (n = 472)) with clinical observational measures collected longitudinally over 5-10 years, we developed a Bayesian multiple phenotypes mixed model incorporating genetic relationships between individuals able to explain many diverse clinical measurements as a smaller number of continuous underlying factors ("phenotypic axes").

Hepatitis B Prevalence and Risk Factors in Punjab, India: A Population-Based Serosurvey.

Background: The prevalence of hepatitis B virus (HBV) infection in Punjab, India, is unknown. Understanding the statewide prevalence and epidemiology can help guide public health campaigns to reduce the burden of disease and promote elimination efforts.

Methods: A cross-sectional, population-based survey was conducted from October 2013 to April 2014 using a multistage stratified cluster sampling design.

Do general practitioners working in or alongside the emergency department improve clinical outcomes or experience? A mixed-methods study.

Objectives: To examine the effect of general practitioners (GPs) working in or alongside the emergency department (GPED) on patient outcomes and experience, and the associated impacts of implementation on the workforce.

Design: Mixed-methods study: interviews with service leaders and NHS managers; in-depth case studies (n=10) and retrospective observational analysis of routinely collected national data. We used normalisation process theory to map our findings to the theory's four main constructs of coherence, cognitive participation, collective action and reflexive monitoring.

Decline in Cognition from Mid-Life Improves Specificity of Mini-Mental State Examination: Diagnostic Test Accuracy in Caerphilly Prospective Study (CaPs).

Background: The merit of using baseline cognitive assessments in mid-life to help interpret cross-sectional cognitive tests scores in later life is uncertain.

Objective: Evaluate how accuracy for diagnosing dementia is enhanced by comparing cross-sectional results to a midlife measure.

Methods: Cohort study of 2,512 men with repeated measures of Mini-Mental State Examination (MMSE) over approximately 10 years.

Intensive behavioural interventions based on applied behaviour analysis (ABA) for young children with autism: A cost-effectiveness analysis.

Background: The economic and social costs of autism are significant. This study evaluates the cost-effectiveness of early intensive Applied Behaviour Analysis (ABA)-based interventions for autistic pre-school children in the UK.

Methods: A de novo economic analysis was developed in Microsoft Excel comparing early intensive ABA-based interventions compared with treatment as usual (TAU).

Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England.

Objective: When novel devices are used 'in human' for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.

Design: We undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device.

Pharmacological and Psychotherapeutic Interventions for Management of Obsessive-compulsive Disorder in Adults: A Systematic Review and Network Meta-analysis.

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