scholarly journals Readiness for First-In-Human Neuromodulatory Interventions

2020 ◽  
Vol 47 (6) ◽  
pp. 785-792
Author(s):  
Iris Coates McCall ◽  
Nicole Minielly ◽  
Allison Bethune ◽  
Nir Lipsman ◽  
Patrick J. McDonald ◽  
...  
Keyword(s):  
Scoping Review ◽  
Trial Design ◽  
Focused Ultrasound ◽  
Target Function ◽  
Target Organ ◽  
Biomedical Literature ◽  
Relative Importance ◽  
Therapeutic Approaches ◽  
Structured Interviews ◽  
Treatment Refractory

ABSTRACT:Background:Novel neurointerventions present innovative therapeutic approaches to a range of treatment-refractory disorders. We sought to characterize factors that inform and define translational readiness for first-in-human (FIH) neuromodulatory trials.Methods:We used a two-part methodology involving a scoping review of the biomedical literature on the readiness of FIH trials for both neurological and non-neurological applications, and semi-structured interviews with stakeholders about decision-making for neuromodulation using magnetic resonance-guided focused ultrasound as a case example.Results:One hundred and thirty factors relevant to FIH readiness were identified in the scoping review. Trial design, adequacy of preclinical evidence, and risk were ubiquitous across biotechnologies. Target organ, target function, and inadequacy of animal models were dominant in the neurointervention literature. Interview results on the relative importance of these factors reveal divergent values, priorities, and understandings both between patients and clinicians and between patients affected by different conditions.Conclusion:Readiness of neurotechnology for FIH trials is defined by a multitude of interacting factors that pertain to clinical and nonclinical priorities, perceptions, and values.

Out of tune: Perceptions of, engagement with, and responses to mental health interventions by professional popular musicians—A scoping review

2021 ◽  
pp. 030573562110194
Author(s):  
Amy Visser ◽  
Megan Lee ◽  
Timothy Barringham ◽  
Nasim Salehi
Keyword(s):  
Mental Health ◽  
Scoping Review ◽  
Distinct Group ◽  
Well Being ◽  
Health Interventions ◽  
Therapeutic Approaches ◽  
Increased Risk ◽  
Mental Health Interventions ◽  
Industry Peers

Professional popular musicians are at increased risk of psychological distress, substance use problems, and suicide, yet little evidence is available on effective psychotherapeutic practices to address these issues. This scoping review aims to understand how professional popular musicians perceive, engage with, and respond to mental health interventions. Four databases were searched, garnering a total of 310 articles. Of these, six met inclusion criteria. Four thematic categories were explored: (1) amenability of professional popular musicians to particular therapeutic approaches; (2) attribution of treatment outcomes to tailored approaches; (3) professional popular musicians’ perceived barriers to treatment; and (4) recommendations for treatment approaches. The scoping review supports the importance of considering the characteristics of professional popular musicians as a distinct group with unique well-being needs, challenges, and strengths. There is a clear preference for tailored, affordable, and accessible approaches that consider the uniquities of musicianship and the need to explore the role of nonclinical support, such as friends, family, and industry peers.

scholarly journals Development of cancer metabolism as a therapeutic target: new pathways, patient studies, stratification and combination therapy

2019 ◽  
Vol 122 (1) ◽  
pp. 1-3 ◽  
Author(s):  
Adrian L. Harris
Keyword(s):  
Metabolic Pathways ◽  
Trial Design ◽  
Cancer Metabolism ◽  
Aerobic Glycolysis ◽  
Critical Role ◽  
Therapeutic Approaches ◽  
Preclinical Models ◽  
Wide Range ◽  
Patient Studies

AbstractCancer metabolism has undergone a resurgence in the last decade, 70 years after Warburg described aerobic glycolysis as a feature of cancer cells. A wide range of techniques have elucidated the complexity and heterogeneity in preclinical models and clinical studies. What emerges are the large differences between tissues, tumour types and intratumour heterogeneity. However, synergies with inhibition of metabolic pathways have been found for many drugs and therapeutic approaches, and a critical role of window studies and translational trial design is key to success.

The suitability of oral diacetylmorphine in treatment-refractory patients with heroin dependence: A scoping review

2021 ◽  
Vol 227 ◽  
pp. 108984
Author(s):  
Margarida L. F. Martins ◽  
Erica A. Wilthagen ◽  
Eugenia Oviedo-Joekes ◽  
Jos H. Beijnen ◽  
Nelda de Grave ◽  
...  
Keyword(s):  
Scoping Review ◽  
Heroin Dependence ◽  
Treatment Refractory

Virtual reality in presurgical patient education: A scoping review and recommended trial design guidelines

2021 ◽  
Author(s):  
Uma V. Mahajan ◽  
Kerrin S. Sunshine ◽  
Eric Z. Herring ◽  
Collin M. Labak ◽  
James M. Wright ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Patient Education ◽  
Scoping Review ◽  
Trial Design ◽  
Design Guidelines

Implementing accountability for reasonableness – the case of pharmaceutical reimbursement in Sweden

2007 ◽  
Vol 2 (2) ◽  
pp. 153-171 ◽  
Author(s):  
SANDRA JANSSON
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Social Learning ◽  
Priority Setting ◽  
Relative Importance ◽  
Priority Setting Process ◽  
Structured Interviews ◽  
Accountability For Reasonableness ◽  
Setting Process ◽  
A Priority

AbstractThis paper aims to describe the priority-setting procedure for new original pharmaceuticals practiced by the Swedish Pharmaceutical Benefits Board (LFN), to analyse the outcome of the procedure in terms of decisions and the relative importance of ethical principles, and to examine the reactions of stakeholders. All the ‘principally important’ decisions made by the LFN during its first 33 months of operation were analysed. The study is theoretically anchored in the theory of fair and legitimate priority-setting procedures by Daniels and Sabin, and is based on public documents, media articles, and semi-structured interviews. Only nine cases resulted in a rejection of a subsidy by the LFN and 15 in a limited or conditional subsidy. Total rejections rather than limitations gave rise to actions by stakeholders. Primarily, the principle of cost-effectiveness was used when limiting/conditioning or totally rejecting a subsidy. This study suggests that implementing a priority-setting process that fulfils the conditions of accountability for reasonableness can result in a priority-setting process which is generally perceived as fair and legitimate by the major stakeholders and may increase social learning in terms of accepting the necessity of priority setting in health care. The principle of cost-effectiveness increased in importance when the demand for openness and transparency increased.

scholarly journals Biomarker discovery studies for patient stratification using machine learning analysis of omics data: a scoping review

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053674
Author(s):  
Enrico Glaab ◽  
Armin Rauschenberger ◽  
Rita Banzi ◽  
Chiara Gerardi ◽  
Paula Garcia ◽  
...  
Keyword(s):  
Machine Learning ◽  
Scoping Review ◽  
Biomarker Discovery ◽  
Biomedical Literature ◽  
Molecular Signature ◽  
Biological Knowledge ◽  
Measurement Technology ◽  
Omics Data ◽  
Patient Stratification ◽  
Complex Disorders

ObjectiveTo review biomarker discovery studies using omics data for patient stratification which led to clinically validated FDA-cleared tests or laboratory developed tests, in order to identify common characteristics and derive recommendations for future biomarker projects.DesignScoping review.MethodsWe searched PubMed, EMBASE and Web of Science to obtain a comprehensive list of articles from the biomedical literature published between January 2000 and July 2021, describing clinically validated biomarker signatures for patient stratification, derived using statistical learning approaches. All documents were screened to retain only peer-reviewed research articles, review articles or opinion articles, covering supervised and unsupervised machine learning applications for omics-based patient stratification. Two reviewers independently confirmed the eligibility. Disagreements were solved by consensus. We focused the final analysis on omics-based biomarkers which achieved the highest level of validation, that is, clinical approval of the developed molecular signature as a laboratory developed test or FDA approved tests.ResultsOverall, 352 articles fulfilled the eligibility criteria. The analysis of validated biomarker signatures identified multiple common methodological and practical features that may explain the successful test development and guide future biomarker projects. These include study design choices to ensure sufficient statistical power for model building and external testing, suitable combinations of non-targeted and targeted measurement technologies, the integration of prior biological knowledge, strict filtering and inclusion/exclusion criteria, and the adequacy of statistical and machine learning methods for discovery and validation.ConclusionsWhile most clinically validated biomarker models derived from omics data have been developed for personalised oncology, first applications for non-cancer diseases show the potential of multivariate omics biomarker design for other complex disorders. Distinctive characteristics of prior success stories, such as early filtering and robust discovery approaches, continuous improvements in assay design and experimental measurement technology, and rigorous multicohort validation approaches, enable the derivation of specific recommendations for future studies.

scholarly journals Challenges and facilitators for early career researchers completing systematic or scoping reviews in the health sciences: A Scoping Review Protocol

2019 ◽  
Author(s):  
Ana Patricia Ayala ◽  
Lindsey Sikora ◽  
Shona Kirtley ◽  
Patrick R. Labelle ◽  
Erica Lenton
Keyword(s):  
Systematic Reviews ◽  
Scoping Review ◽  
Research Question ◽  
Research Integrity ◽  
Health Sciences ◽  
Early Career ◽  
Biomedical Literature ◽  
Scoping Reviews ◽  
Review Protocol ◽  
Review Cycle

An increasing number of systematic reviews (SysRev) are being published in health sciences and medicine; however, many are poorly conducted or reported.Strategies are needed to help reduce this avoidable waste in research . Systematic reviews can help decision makers interpret the deluge of published biomedical literature. However, a SysRev or scoping review may be of limited use if the methods used to conduct them are flawed, or if reporting is incomplete.At each stage during the systematic or scoping review cycle, different challenges can arise, especially for a novice researcher. All knowledge syntheses, once past the stage of question formulation, begin with the literature search. Librarians are in a strategic position to uncover issues regarding a researcher’slevel of preparedness in conducting these types of studies. From this vantage point, librarians can have a significant impact by teaching researchers about practices to properly report findings, as well as by raising awareness about which methodology might be more appropriate for their research question. Research waste is a growing concern, and librariansare part of the answer in the role they play as advocates for research integrity and transparency. This scoping review would be the first to cover this topic in a comprehensive, structured and methodologically rigorous way. Results would be of interest to librarians, researchers, educators and the wider research community in health sciences and medicine.

Development of brain stimulation

2020 ◽  
pp. 183-192
Author(s):  
Andrea Crowell ◽  
Patricio Riva-Posse ◽  
Helen S. Mayberg
Keyword(s):  
Deep Brain Stimulation ◽  
Surgical Treatment ◽  
Brain Stimulation ◽  
Trial Design ◽  
Case Series ◽  
Psychological Processes ◽  
Open Label ◽  
Technological Advances ◽  
Treatment Refractory ◽  
Potential Use

A growing circuit-based understanding of the mechanisms underlying psychological processes and psychiatric syndromes, paired with growing technological advances in neuroimaging and neuromodulation techniques, has led to the investigational use of deep brain stimulation as a surgical treatment for a variety of psychiatric disorders. Still in its early stages, there is reason for optimism about its potential use in patients with severe and treatment-refractory illness. However, as larger, randomized trials have not yet delivered on the promise of smaller, open-label case series, we must be cautious and attentive to appropriate patient selection and trial design in order to establish scientific efficacy and protect vulnerable populations.

Facilitators to Engagement in a Mother–Child Therapeutic Intervention Following Intimate Partner Violence

2020 ◽  
pp. 088626052092631
Author(s):  
Alison Fogarty ◽  
Karli Treyvaud ◽  
Priscilla Savopoulos ◽  
Amanda Jones ◽  
Allison Cox ◽  
...  
Keyword(s):  
Intimate Partner Violence ◽  
Partner Violence ◽  
Evidence Base ◽  
Intimate Partner ◽  
Therapeutic Approaches ◽  
Structured Interviews ◽  
Community Based ◽  
Women’S Perceptions ◽  
Key Barrier ◽  
Additional Support

Intimate partner violence (IPV) affects more than one in four children worldwide. Despite the growing evidence base for interventions addressing children’s IPV exposure, little is known about what assists families to engage with services. The current study sought to explore women’s perceptions of barriers and facilitators to accessing an intervention for their children following IPV. A total of 16 mothers who had engaged in a community-based, dyadic intervention for children exposed to IPV participated in the study. The Brief Relational Intervention and Screening (BRISC) is an evidenced informed program designed by Berry Street (Australia). A pilot of the intervention was implemented across one metropolitan and one regional site. In-depth semi-structured interviews were conducted with 16 mothers who had completed BRISC. Transcripts were analyzed in NVivo using thematic analysis. Key facilitators to initial engagement included strong referral pathways, clear information about the program, and initial phone contact from the service. Difficulty trusting services were identified as a key barrier to initial engagement. Facilitators of continued engagement included flexibility in service delivery, consistent and direct communication between sessions, and the therapeutic approach. Key barriers to sustained intervention engagement included children’s continued contact with their father, mothers’ experiences of guilt and blame, and the need for additional support for mothers’ own mental health. These findings highlight how service and clinician factors such as flexibility, therapeutic approaches, and communication can facilitate engagement for families affected by IPV. In addition, the study highlights the importance of including the voices of women in research to improve the acceptability of services for consumers.

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