Is this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of diagnostic (IVD) regulation.

Recent changes in the regulatory assessment of medical tests reflect a growing recognition of the need for more stringent clinical evidence requirements to protect patient safety and health. Under current regulations in the United States and Europe, when needed for regulatory approval, clinical performance reports must provide clinical evidence tailored to the intended purpose of the test and allow assessment of whether the test will achieve the intended clinical benefit. The quality of evidence must be proportionate to the risk for the patient and/or public health.

Defining hypoxia in cancer: A landmark evaluation of hypoxia gene expression signatures.

Tumor hypoxia drives metabolic shifts, cancer progression, and therapeutic resistance. Challenges in quantifying hypoxia have hindered the exploitation of this potential "Achilles' heel." While gene expression signatures have shown promise as surrogate measures of hypoxia, signature usage is heterogeneous and debated.

Fall rates in bifocal, trifocal, and progressive addition lens glasses wearers.

Purpose: There is evidence that wearing multifocal glasses increases the risk of falls in older people, especially when walking on stairs and in unfamiliar settings. However, it is not clear whether all types of multifocal glasses are equally associated with falls. This study comprised a secondary analysis of data from the VISIBLE randomized controlled trial to determine whether fall rates differ among older bifocal, trifocal, and progressive addition lens glasses wearers.

Daily-life walking speed, running duration and bedtime from wrist-worn sensors predict incident dementia: A watch walk - UK biobank study.

Objective: To determine if wrist-worn sensor parameters can predict incident dementia in individuals aged 60 + years and to compare prediction with other tools.

Design: Observational cohort study.

Setting: Community PARTICIPANTS: The cohort comprised 47,371 participants without dementia, aged 60 + years, who participated in the UK Biobank study (mean age=67 ± 4 years; 52 % female).

Critical behavioral traits foster peer engagement in Online Mental Health Communities.

Online Mental Health Communities (OMHCs), such as Reddit, have witnessed a surge in popularity as go-to platforms for seeking information and support in managing mental health needs. Platforms like Reddit offer immediate interactions with peers, granting users a vital space for seeking mental health assistance. However, the largely unregulated nature of these platforms introduces intricate challenges for both users and society at large.

Treadmill belt accelerations may not accurately replicate kinematic responses to tripping on an obstacle in older people.

Background: Treadmill belt perturbations have high clinical feasibility for use in perturbation-based training in older people, but their kinematic validity is unclear. This study examined the kinematic validity of treadmill belt accelerations as a surrogate for overground walkway trips during gait in older people.

Methods: Thirty-eight community-dwelling older people were exposed to two unilateral belt accelerations (8 m s-2) whilst walking on a split-belt treadmill and two trips induced by a 14 cm trip-board whilst walking on a walkway with condition presentation randomised.

Virtual reality obstacle avoidance training can be enhanced by physical feedback via perturbations: A proof-of-concept study.

Background: Fall injuries resulting from trips are a major health concern. Virtual reality (VR) offers an effective way of training obstacle avoidance while walking due to its ability to provide safe and meaningful real-time feedback during rehabilitation. This proof-of-concept study examined the benefit of providing physical feedback during obstacle avoidance gait training using VR.

Characterizing phenotypes and clinical and health utilization associations of young people with chronic pain: latent class analysis using the electronic Persistent Pain Outcomes Collaboration database.

Using the Australiasian electronic Persistent Pain Outcomes Collaboration, a binational pain registry collecting standardized clinical data from paediatric ePPOC (PaedsePPOC) and adult pain services (AdultePPOC), we explored and characterized nationally representative chronic pain phenotypes and associations with clinical and sociodemographic factors, health care utilization, and medicine use of young people. Young people ≥15.0 and <25.

Molecular biomarkers for predicting complete response to preoperative chemoradiation in people with locally advanced rectal cancer.

This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: Primary objectives To identify and estimate the prognostic value of molecular biomarkers as predictors of pathological complete response to neoadjuvant chemoradiotherapy in people with locally advanced rectal cancer. summarises the review question in population, index prognostic factor, comparator prognostic factor(s), outcome, timing, and setting (PICOTS) format.

Sympathetic reinnervation in cardiac transplant recipients: Prevalence, time course, and association with long-term survival.

Background: Partial cardiac sympathetic reinnervation after cardiac transplant has been extensively investigated and evidenced. However, there have been no large-scale, long-term studies evaluating the prevalence, time-course, and association with long-term survival of sympathetic reinnervation of the heart.

Methods: Cardiac transplant recipients (n = 232) were recruited from outpatient clinic at a single transplant center in the United Kingdom.

Two simple modifications to the World Falls Guidelines algorithm improves its ability to stratify older people into low, intermediate and high fall risk groups.

Background: We conducted a secondary analysis of a cohort study to examine the World Falls Guidelines algorithm's ability to stratify older people into sizable fall risk groups or whether minor modifications were necessary to achieve this.

Methods: Six hundred and ninety-three community-living people aged 70-90 years (52.4% women) were stratified into low, intermediate and high fall risk groups using the original algorithm and a modified algorithm applying broader Timed Up and Go test screening with a >10-s cut point (originally >15 s).

Cognitive functioning and falls in older people: A systematic review and meta-analysis.

Objective: To identify which cognitive functions and specific neuropsychological assessments predict falls in older people living in the community.

Methods: Five electronic databases were searched until 30/08/2022 for studies assessing the association between specific cognitive functions and faller status (prospective and retrospective), in community-dwelling older people. Risk of bias was assessed with the Newcastle-Ottawa Scale.

Clinician acceptability of the ReacStep reactive balance training program for fall prevention.

Aim: To examine if a novel reactive balance training program (ReacStep) designed for clinical settings is acceptable to clinicians prescribing balance and mobility training.

Methods: ReacStep consists of tether-release reactive step training, volitional trip and slip training, and functional strength training. An open survey comprising 11-point visual analog scale items (0 = strongly disagree to 10 = strongly agree) based on the Theoretical Framework of Acceptability was sent to clinicians working in balance and mobility training.

Polymer dynamics of Alp7A reveals how two critical concentrations govern assembly of dynamically unstable actin-like proteins.

Dynamically unstable polymers capture and move cellular cargos in bacteria and eukaryotes, but regulation of their assembly remains poorly understood. Here we describe polymerization of Alp7A, a bacterial actin-like protein (ALP) that distributes copies of plasmid pLS20 among daughter cells in . Purified ATP-Alp7A forms dynamically unstable polymers with a high critical concentration for net assembly (cc = 10.

Are changes in pain intensity related to changes in balance control in individuals with chronic non-specific low back pain? A systematic review and meta-analysis.

Purpose: The aim of this study was to summarize the evidence regarding whether pain reduction in individuals with chronic non-specific low back pain (CNSLBP) following conservative interventions is related to corresponding improvements in balance control.

Methods: Randomized controlled trials were identified from 5 databases (MEDLINE, Cochrane Library, Embase, Web of Science, and PsycINFO). Two reviewers independently screened and identified relevant studies that investigated the effects of non-surgical or non-pharmacological CNSLBP treatments on both pain intensity and balance control.

Implications of obesity and insulin resistance for the treatment of oestrogen receptor-positive breast cancer.

Breast cancer is the most common cancer in women, and incidence rates are rising, it is thought in part, due to increasing levels of obesity. Endocrine therapy (ET) remains the cornerstone of systemic therapy for early and advanced oestrogen receptor-positive (ER + ) breast cancer, but despite treatment advances, it is becoming more evident that obesity and insulin resistance are associated with worse outcomes. Here, we describe the current understanding of the relationship between both obesity and diabetes and the prevalence and outcomes for ER+ breast cancer.

Impact of a tailored exercise regimen on physical capacity and plasma proteome profile in post-COVID-19 condition.

Background: Individuals affected by the post-covid condition (PCC) show an increased fatigue and the so-called post-exertion malaise (PEM) that led health professionals to advise against exercise although accumulating evidence indicates the contrary. The goal of this study is to determine the impact of a closely monitored 8-week mixed exercise program on physical capacity, symptoms, fatigue, systemic oxidative stress and plasma proteomic profiles of PCC cases.

Methods: Twenty-five women and men with PCC were assigned sequentially to exercise ( = 15) and non-exercise ( = 10) groups.

Criteria for assessing evidence for biomarker-targeted therapies in rare cancers-an extrapolation framework.

Background: Advances in targeted therapy development and tumor sequencing technology are reclassifying cancers into smaller biomarker-defined diseases. Randomized controlled trials (RCTs) are often impractical in rare diseases, leading to calls for single-arm studies to be sufficient to inform clinical practice based on a strong biological rationale. However, without RCTs, favorable outcomes are often attributed to therapy but may be due to a more indolent disease course or other biases.

Neuromuscular adaptations to perturbation-based balance training using treadmill belt accelerations do not transfer to an obstacle trip in older people: A cross-over randomised controlled trial.

Background: This study examined (i) adaptations in muscle activity following perturbation-based balance training (PBT) using treadmill belt-accelerations or PBT using walkway trips and (ii) whether adaptations during treadmill PBT transfer to a walkway trip.

Methods: Thirty-eight older people (65+ years) undertook two PBT sessions, including 11 treadmill belt-accelerations and 11 walkway trips. Surface electromyography (EMG) was measured bilaterally on the rectus femoris (RF), tibialis anterior (TA), semitendinosus (ST) and gastrocnemius medial head (GM) during the first (T1) and eleventh (T11) perturbations.