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Neurocritical Care Jun 2019Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has...
INTRODUCTION
Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints.
METHODS
A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel's recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers.
RESULTS
No cellular or molecular biomarker has been validated for inclusion as "core" recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms.
CONCLUSION
Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative biomarkers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.
Topics: Aneurysm, Ruptured; Biomarkers; Biomedical Research; Brain Ischemia; Common Data Elements; Humans; Intracranial Aneurysm; Microdialysis; Mortality; National Institute of Neurological Disorders and Stroke (U.S.); National Library of Medicine (U.S.); Prognosis; Specimen Handling; Subarachnoid Hemorrhage; United States; Vasospasm, Intracranial
PubMed: 31144274
DOI: 10.1007/s12028-019-00725-4 -
AIDS (London, England) Jan 2013The review explores the field of biobanking as it has evolved from a simple collection of frozen specimens to the virtual biobank. Biorepository and biospecimen science... (Review)
Review
The review explores the field of biobanking as it has evolved from a simple collection of frozen specimens to the virtual biobank. Biorepository and biospecimen science has evolved in response to the changing landscape of external regulatory pressures, the advances made in the biological sciences, and the advent of the computer chip. Biospecimen banking is a growing enterprise crucial to health science research and other biological sciences. In this review we discuss the history of biobanking, highlight current and emerging issues, discuss demands and responses, and describe an example of a biobank, the University of California, San Francisco AIDS Specimen Bank that has functioned for 30 years.
Topics: Acquired Immunodeficiency Syndrome; Biological Specimen Banks; Biomedical Research; Female; History, 20th Century; History, 21st Century; Humans; Informed Consent; Male; Practice Guidelines as Topic; Quality Control; San Francisco; Specimen Handling; User-Computer Interface
PubMed: 23135167
DOI: 10.1097/QAD.0b013e32835c1244 -
PloS One 2023The Health Brain Initiative (HBI), established by University of Miami's Comprehensive Center for Brain Health (CCBH), follows racially/ethnically diverse older adults...
BACKGROUND
The Health Brain Initiative (HBI), established by University of Miami's Comprehensive Center for Brain Health (CCBH), follows racially/ethnically diverse older adults without dementia living in South Florida. With dementia prevention and brain health promotion as an overarching goal, HBI will advance scientific knowledge by developing novel assessments and non-invasive biomarkers of Alzheimer's disease and related dementias (ADRD), examining additive effects of sociodemographic, lifestyle, neurological and biobehavioral measures, and employing innovative, methodologically advanced modeling methods to characterize ADRD risk and resilience factors and transition of brain aging.
METHODS
HBI is a longitudinal, observational cohort study that will follow 500 deeply-phenotyped participants annually to collect, analyze, and store clinical, cognitive, behavioral, functional, genetic, and neuroimaging data and biospecimens. Participants are ≥50 years old; have no, subjective, or mild cognitive impairment; have a study partner; and are eligible to undergo magnetic resonance imaging (MRI). Recruitment is community-based including advertisements, word-of-mouth, community events, and physician referrals. At baseline, following informed consent, participants complete detailed web-based surveys (e.g., demographics, health history, risk and resilience factors), followed by two half-day visits which include neurological exams, cognitive and functional assessments, an overnight sleep study, and biospecimen collection. Structural and functional MRI is completed by all participants and a subset also consent to amyloid PET imaging. Annual follow-up visits repeat the same data and biospecimen collection as baseline, except that MRIs are conducted every other year after baseline.
ETHICS AND EXPECTED IMPACT
HBI has been approved by the University of Miami Miller School of Medicine Institutional Review Board. Participants provide informed consent at baseline and are re-consented as needed with protocol changes. Data collected by HBI will lead to breakthroughs in developing new diagnostics and therapeutics, creating comprehensive diagnostic evaluations, and providing the evidence base for precision medicine approaches to dementia prevention with individualized treatment plans.
Topics: Humans; Aged; Middle Aged; Prospective Studies; Brain; Alzheimer Disease; Cognitive Dysfunction; Neuroimaging; Observational Studies as Topic
PubMed: 37889891
DOI: 10.1371/journal.pone.0293634 -
Methods in Molecular Biology (Clifton,... 2019The packaging and shipment of biospecimens is a multistep process for which a distinct set of regulations needs to be followed, depending on whether a biospecimen is... (Review)
Review
The packaging and shipment of biospecimens is a multistep process for which a distinct set of regulations needs to be followed, depending on whether a biospecimen is shipped domestically or internationally and whether the shipment contains hazardous materials. Shipments may be delayed if these regulations are not followed. Once learned, the process is straightforward. Major principles include double or triple packaging, adequate absorbent material, appropriate coolant, accurate labeling, and complete documentation. Training in packaging and shipping is often offered at major biomedical institutions and is a requirement to avoid shipping biohazards.
Topics: Biological Specimen Banks; Humans; Specimen Handling; Transportation
PubMed: 30539463
DOI: 10.1007/978-1-4939-8935-5_35 -
Neuroinformatics Jan 2022In January 2016, the Montreal Neurological Institute-Hospital (The Neuro) declared itself an Open Science organization. This vision extends beyond efforts by individual...
In January 2016, the Montreal Neurological Institute-Hospital (The Neuro) declared itself an Open Science organization. This vision extends beyond efforts by individual scientists seeking to release individual datasets, software tools, or building platforms that provide for the free dissemination of such information. It involves multiple stakeholders and an infrastructure that considers governance, ethics, computational resourcing, physical design, workflows, training, education, and intra-institutional reporting structures. The C-BIG repository was built in response as The Neuro's institutional biospecimen and clinical data repository, and collects biospecimens as well as clinical, imaging, and genetic data from patients with neurological disease and healthy controls. It is aimed at helping scientific investigators, in both academia and industry, advance our understanding of neurological diseases and accelerate the development of treatments. As many neurological diseases are quite rare, they present several challenges to researchers due to their small patient populations. Overcoming these challenges required the aggregation of datasets from various projects and locations. The C-BIG repository achieves this goal and stands as a scalable working model for institutions to collect, track, curate, archive, and disseminate multimodal data from patients. In November 2020, a Registered Access layer was made available to the wider research community at https://cbigr-open.loris.ca , and in May 2021 fully open data will be released to complement the Registered Access data. This article outlines many of the aspects of The Neuro's transition to Open Science by describing the data to be released, C-BIG's full capabilities, and the design aspects that were implemented for effective data sharing.
Topics: Humans; Information Dissemination; Software
PubMed: 34003431
DOI: 10.1007/s12021-021-09516-9 -
Frontiers in Cardiovascular Medicine 2022Over the last few years, new high-throughput biotechnologies and bioinformatic methods are revolutionizing our way of deep profiling tissue specimens at the molecular... (Review)
Review
Over the last few years, new high-throughput biotechnologies and bioinformatic methods are revolutionizing our way of deep profiling tissue specimens at the molecular levels. These recent innovations provide opportunities to advance our understanding of atherosclerosis using human lesions aborted during autopsies and cardiac surgeries. Studies on human lesions have been focusing on understanding the relationship between molecules in the lesions with tissue morphology, genetic risk of atherosclerosis, and future adverse cardiovascular events. This review will highlight ways to utilize human atherosclerotic lesions in translational research by work from large cardiovascular biobanks to tissue registries. We will also discuss the opportunities and challenges of working with human atherosclerotic lesions in the era of next-generation sequencing.
PubMed: 35872917
DOI: 10.3389/fcvm.2022.948492 -
Frontiers in Public Health 2022The West China Hospital of Sichuan University collaborated with regional medical consortia in Sichuan Province to launch a natural population cohort study (NPCS) to... (Review)
Review
OBJECTIVE
The West China Hospital of Sichuan University collaborated with regional medical consortia in Sichuan Province to launch a natural population cohort study (NPCS) to investigate the health status of residents and collect public health data in southwest China.
METHODS
Up to 80,000 participants will be enrolled by the NPCS from 11 regional medical consortia over five years. Individuals are invited to visit one of 11 participating medical consortia to fill out questionnaires, receive a free health exam, and donate biospecimens upon enrolment. All participating medical facilities adhered to standard operating procedures for collecting and processing biospecimens to ensure uniformity (serum, lithium heparinized plasma, ethylene diamine tetraacetie acid plasma, and buffy coat). The Electronic Data Capture System, Picture Archiving and Communication System, Laboratory Information Management System, Biospecimen Quality Control System, Biobank Information Management System, and will be used to sort and classify clinical indices, imaging data, laboratory parameters, pre-analytical variables, and biospecimen information, respectively. All quality assurance and quality control procedures in the NPCS biobank adhered to the "DAIDS Guidelines for Good Clinical Laboratory Practice Standards". This project will integrate high-dimensional multi-omics data, laboratory data, clinical data, questionnaire data, and environmental risk factors.
RESULTS
An estimated 2,240,000 aliquots of the sample will be stored by the end of the study. These samples are linked with comprehensively collected clinical indices, imaging data, and laboratory parameters. Big data analysis can be implemented to create predictive algorithms, explore pathogenesis mechanisms, uncover potential biomarkers, and provide information on public health.
CONCLUSIONS
NPCS will provide an integrative approach to research risk factors and pathogenesis of major chronic or endemic diseases in Sichuan Province and provide key scientific evidence to support the formulation of health management policies in China.
Topics: Humans; Biological Specimen Banks; Cohort Studies; Surveys and Questionnaires; Biomarkers; China
PubMed: 36530701
DOI: 10.3389/fpubh.2022.996169 -
Ethics & Human Research Mar 2019Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later...
Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.
Topics: Biomedical Research; Costs and Cost Analysis; Data Anonymization; Electronic Health Records; Humans; Informed Consent; Mental Competency; Risk Assessment; Selection Bias; Specimen Handling; United States; United States Dept. of Health and Human Services
PubMed: 30895751
DOI: 10.1002/eahr.500009 -
Methods in Molecular Biology (Clifton,... 2019The personnel who operate a biomedical biobank should function as a unit to efficiently manage the numerous types of biospecimens that are to be utilized for both... (Review)
Review
The personnel who operate a biomedical biobank should function as a unit to efficiently manage the numerous types of biospecimens that are to be utilized for both clinical and research purposes. Therefore, new staff must be appropriately trained before becoming fully integrated into the work environment. This chapter focuses on several key aspects to this training that should be completed by all personnel. This first step is an orientation where the new trainee is provided with the priorities and expectations of the biobank. The next and perhaps most important step is training on the various safety precautions. The trainee should learn how to protect patient privacy if human biospecimens are involved. They should gain a basic understanding of different types of biospecimens and their vulnerabilities to suboptimal storage conditions. The trainee must learn the various aspects of the day to day work which encompasses the methods and equipment needed for procuring, labeling, handling, tracking, storing, disbursing, and shipping biospecimens. They should become familiar with aspects of quality assurance.
Topics: Biological Specimen Banks; Humans; Specimen Handling
PubMed: 30539434
DOI: 10.1007/978-1-4939-8935-5_6 -
International Journal of Environmental... Sep 2022Biobanking is a critical cornerstone of the global shift towards precision medicine (PM). This transformation requires smooth and informed interaction between a range of...
BACKGROUND
Biobanking is a critical cornerstone of the global shift towards precision medicine (PM). This transformation requires smooth and informed interaction between a range of stakeholders involved in the healthcare system. In Saudi Arabia, there is still insufficient awareness of the importance of biobanking and its potential benefits for patients, the healthcare system, and society as a whole. The purpose of this study was to determine the biobanking knowledge of Saudi healthcare providers and the potential factors that might influence their self-reported attitudes toward biospecimen donation and biobanking.
METHODS
A cross-sectional study was conducted targeting 636 healthcare providers in Makkah province using a structured, self-administered questionnaire.
RESULTS
The study had a response rate of 61%. The mean knowledge level about biobanks was 3.5 (±1.8) out of 7. About one-third of the participants were aware of the Human Genome Project (HGP) (35%) or the term "biobank" (34%). The mean rating of their attitude was 37.3 (±4.3) out of 55. Most participants (74%) had a positive attitude toward medical research. Job position, general health, previous blood tests, knowledge of biobanking, and attitudes toward biomedical research were significantly related and predictors of willingness to donate biospecimens ( < 0.05). However, concerns about biospecimen misuse and confidentiality were the main reasons for not donating biospecimens.
CONCLUSIONS
This study has shown that healthcare providers mostly lack basic knowledge about HGP and biobanks and their roles and activities, and therefore are generally disinclined to actively participate in biospecimens' collection and management. It is recommended that medical trainees receive more education and awareness about biobanks and the latest personalized healthcare approaches to improve translational research outcomes and achieve precision medicine.
Topics: Attitude; Biological Specimen Banks; Biomedical Research; Cross-Sectional Studies; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Saudi Arabia
PubMed: 36231176
DOI: 10.3390/ijerph191911872