Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study.

Background: RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A.

Objective: Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL).

Methods: Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]).

Injectable Poly-L-Lactic Acid for Body Aesthetic Treatments: An International Consensus on Evidence Assessment and Practical Recommendations.

Non-facial (body) rejuvenation is a treatment of increasing demand, with patients seeking to harmonize the benefits of rejuvenated facial appearance with other areas of the body. Poly-L-lactic acid (PLLA)-SCA (Sculptra®) has been approved for facial aesthetic uses since 1999 in Europe and since 2009 in the USA and more recently evaluated for the treatment of cellulite of the buttocks and thighs and other body indications. The current evidence base consists largely of prospective observational analyses and case series although systematic evaluations for a number of body areas are underway.

General practitioners' perspectives on targeted breast ultrasound as primary diagnostic test in women with focal breast complaints: An interview study.

Introduction: The high diagnostic accuracy of ultrasound opens possibilities to shift towards an initial ultrasound approach for the evaluation of focal breast complaints in women, with only additional DBT in case of unclear or suspicious ultrasound findings. As general practitioners (GPs) are important stakeholders in the diagnostic pathway, this study focuses on GPs perspective on ultrasound as primary diagnostic imaging test, as well as the GP referral process.

Methods: Sixteen Dutch GPs were interviewed on the referral process and their perceived barriers and facilitators of initial ultrasound diagnostics in women presenting with focal breast complaints.

Obstacles to using the safe surgery checklist: Perspectives of first-line personnel.

Objectives: The safe surgery checklist, presented by the World Health Organization in 2008, is an aid to performing surgical interventions safely. Research indicates that the use of checklists in clinical activities leads to a reduced number of adverse events. However, research suggests that the use of checklists differs between different institutions and even between units in the same organisation.

Patients' perceptions of targeted breast ultrasound and digital breast tomosynthesis in the diagnostic setting: A mixed methods study.

Background: Although DBT is the standard initial imaging modality for women with focal breast symptoms, the importance of ultrasound has grown rapidly in the past decades. Therefore, the Breast UltraSound Trial (BUST) focused on assessing the diagnostic value of ultrasound and digital breast tomosynthesis (DBT) for the evaluation of breast symptoms by reversing the order of breast imaging; first performing ultrasound followed by DBT. This side-study of the BUST evaluates patients' perceptions of ultrasound and DBT in a reversed setting.

Public involvement in UK health and care research 1995-2020: reflections from a witness seminar.

Background: Public involvement is important to the relevance and impact of health and care research, as well as supporting the democratisation of research. In 2020, the National Institute for Health Research (NIHR) reorganized and eliminated INVOLVE, an internationally recognised group that had played a central role in public involvement in the UK since 1996. Its remit was subsumed within a new center tasked with public involvement, participant recruitment, and evidence dissemination.

Observation of current whirlpools in graphene at room temperature.

Electron-electron interactions in high-mobility conductors can give rise to transport signatures resembling those described by classical hydrodynamics. Using a nanoscale scanning magnetometer, we imaged a distinctive hydrodynamic transport pattern-stationary current vortices-in a monolayer graphene device at room temperature. By measuring devices with increasing characteristic size, we observed the disappearance of the current vortex and thus verified a prediction of the hydrodynamic model.

A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

Background: Hyaluronic acid injections are increasingly administered for correction of infraorbital hollows (IOHs).

Objectives: The objective of this study was to examine the effectiveness (IOH correction) and safety of Restylane Eyelight hyaluronic acid (HAEYE) injections.

Methods: Patients with moderate/severe IOHs, assessed with the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (by needle/cannula) (Day 1 + optional Month 1 touch-up) or no-treatment control.

Development, implementation, and dissemination of operational innovations across the trial innovation network.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations.

The Trial Innovation Network Liaison Team: building a national clinical and translational community of practice.

In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers.

From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.

Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.

Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes.

The use of N-of-1 trials to generate real-world evidence for optimal treatment of individuals and populations.

Introduction: Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform therapeutic decisions, N-of-1 trials bring scientific methods to real-world practice.

Methods: These single-patient crossover trials generate RWD and RWE by giving individual patients various treatments in a double-blinded way in sequential periods to determine the most effective treatment for a given patient.

Quantitative assessment of the impact of standard agreement templates on multisite clinical trial start up time.

Contracting delays remain a challenge to the successful initiation of multisite clinical research in the US. The Clinical and Translational Science Awards (CTSA) Contracts Processing Study showed average contract negotiation duration of > 100 days for industry-sponsored or investigator-initiated contracts. Such delays create enormous costs to sponsors and to patients waiting to use new evidence-based treatments.

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC).

Long-Term Efficacy and Tolerability of a Daily Serum for Rejuvenation and Prejuvenation of Facial Skin.

Onjectives: To evaluate the long-term efficacy and tolerance of an anti-aging daily serum (AADS) when used twice-daily over 12 weeks by women with moderate skin fatigue and overall photodamage. The treatment targeted rejuvenation and prejuvenation of the facial skin. Method: This was an institutional review board (IRB)-approved, randomized, single-center, double-blinded, vehicle-controlled (VC) study involving healthy subjects.

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date.

Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities.

Getting groceries during the pandemic: How transit remained important despite the rise of e-delivery.

Background: We model the use of public transit to reach grocery stores and the use of online delivery services to get groceries, before and during the COVID-19 pandemic among people who used transit regularly prior to the crisis.

Methods: We draw upon a panel survey of pre-pandemic transit riders in Vancouver and Toronto. We conduct multivariable two-step tobit regression models that predict the likelihood of a respondent using transit as their primary mode for getting groceries before the pandemic (step 1) and then during the pandemic (step 2).

Cost of childhood cancer treatment in Ethiopia.

Background: Despite the recent interest in expanding pediatric oncology units in Ethiopia, reflected in the National Childhood and Adolescent Cancer Control Plan (NCACCP), little is known about the cost of running a pediatric oncology unit and treating childhood cancers.

Methods: We collected historical cost data and quantity of services provided for the pediatric oncology unit and all other departments in Tikur Anbessa Specialized Hospital (TASH) from 8 July 2018 to 7 July 2019, using a provider perspective and mixed (top-down and bottom-up) costing approaches. Direct costs (human resources, drugs, supplies, medical equipment) of the pediatric oncology unit, costs at other relevant clinical departments, and overhead cost share are summed up to estimate the total annual cost of running the unit.

Public transport access to drug treatment before and during COVID-19: Implications for the opioid epidemic.

Public transport disruptions caused by the COVID-19 pandemic had wide-ranging impacts on the ability of individuals to access health care. Individuals with opioid use disorder represent an especially vulnerable population due to the necessity of frequent, supervised doses of opioid agonists. Focused on Toronto, a major Canadian city suffering from the opioid epidemic, this analysis uses novel realistic routing methodologies to quantify how travel times to individuals\220 nearest clinics changed due to public transport disruptions from 2019 to 2020.

A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements.

Background: Skin quality may be assessed by degrees of skin smoothness, fine lines, and hydration. VYC-12L is a recently developed hyaluronic acid filler to improve skin quality.

Objective: This was a randomized, evaluator-blind study assessing safety and effectiveness of intradermal VYC-12L treatment for improving cheek skin smoothness, fine lines, and hydration.

Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues.

Cellulite: Current Treatments, New Technology, and Clinical Management.

Background: Cellulite is a well-known concern for many women; however, treatment can prove challenging because of the complexities of cellulite etiology, the various factors contributing to its appearance, and the multitude of therapies and procedures available.

Objective: To discuss current cellulite treatment options and effective clinical management.

Methods: A roundtable meeting was convened to discuss and share views on current cellulite treatment options, new technologies, and clinical management.

Cost-effectiveness of running a paediatric oncology unit in Ethiopia.

Objective: To estimate the cost-effectiveness of running a paediatric oncology unit in Ethiopia to inform the revision of the Ethiopia Essential Health Service Package (EEHSP), which ranks the treatment of childhood cancers at a low and medium priority.

Methods: We built a decision analytical model-a decision tree-to estimate the cost-effectiveness of running a paediatric oncology unit compared with a do-nothing scenario (no paediatric oncology care) from a healthcare provider perspective. We used the recently (2018-2019) conducted costing estimate for running the paediatric oncology unit at Tikur Anbessa Specialized Hospital (TASH) and employed a mixed costing approach (top-down and bottom-up).

A fast and intuitive method for calculating dynamic network reconfiguration and node flexibility.

Dynamic interactions between brain regions, either during rest or performance of cognitive tasks, have been studied extensively using a wide variance of methods. Although some of these methods allow elegant mathematical interpretations of the data, they can easily become computationally expensive or difficult to interpret and compare between subjects or groups. Here, we propose an intuitive and computationally efficient method to measure dynamic reconfiguration of brain regions, also termed flexibility.