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Abstract: Protocol design complexity, and associated study volunteer burden, negatively impact patient recruitment and retention as well as overall research and development productivity. Complex protocols reduce the willingness of potential clinical trial participants to enroll and reduce retention rates. There have been few systematic assessments of protocol design characteristics to determine the burden placed on study volunteers, although such an assessment would offer a compelling opportunity to optimize trial designs and improve recruitment and retention performance. To be useful, an assessment would need to be patient-centric, and focused on the factors that influence participation throughout the clinical trial. Such an assessment would also need to accommodate the unique cost-value trade-off compared with current treatment patterns that each participant makes when choosing to participate and remain in a clinical trial. This article proposes a new methodology to quantify patient burden: the clinical trial patient friction coefficient (PFC). A case example is provided to illustrate the utility of the PFC. A number of applications for the PFC are envisioned: standardizing patient burden assessment to evaluate clinical trial design feasibility, shedding light on the impact of patient burden on clinical trial economics and performance, and conducting sensitivity analyses to identify factors that most reduce patient burden and improve the performance and efficiency of clinical trials. Key words

"We strive to educate and help patients, their family members, and members of the general public that are interested in clinical research understand the process and what it means to be a clinical research participant. We then help locate ongoing clinical trials through our free service called Search Clinical Trials, and honor those who have participated in clinical research."

"N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine. Keywords: clinical equipoise, early-phase trials, individualized medicine, n-of-1, remote phenotyping, single patient trial, treatment repositioning, wireless health"

"Our mission is to improve public health through prevention research, education, and clinical care." The department's clinical care and community-based initiatives aim to transform health care in San Diego through the practice of family medicine, preventive medicine, sports medicine, integrative medicine, and research that is practice-based. We have a robust portfolio of innovative clinical and public health focused research projects that address contemporary public health challenges through tools from biostatistics/bioinformatics, behavioral medicine, epidemiology, policy, and dissemination and implementation science. We have established Centers of Excellence in cardiovascular epidemiology, health behavior and equity, integrative health, tobacco control, wireless and population health, and women's health. Innovative, interdisciplinary partnerships are ongoing with Qualcomm Institute/Calit2, Moores Cancer Center, the Scripps Institute of Oceanography, Center for Microbiome Innovation, and many other departments.

Suggested by Gina Soloperta Abstract Background: Due to striking disparities in the implementation of healthcare innovations, it is imperative that researchers and practitioners can meaningfully use implementation determinant frameworks to understand why disparities exist in access, receipt, use, quality, or outcomes of healthcare. Our prior work documented and piloted the first published adaptation of an existing implementation determinant framework with health equity domains to create the Health Equity Implementation Framework. We recommended integrating these three health equity domains to existing implementation determinant frameworks: (1) culturally relevant factors of recipients, (2) clinical encounter or patient-provider interaction, and (3) societal context (including but not limited to social determinants of health). This framework was developed for healthcare and clinical practice settings. Some implementation teams have begun using the Health Equity Implementation Framework in their evaluations and asked for more guidance. Methods: We completed a consensus process with our authorship team to clarify steps to incorporate a health equity lens into an implementation determinant framework. Results: We describe steps to integrate health equity domains into implementation determinant frameworks for implementation research and practice. For each step, we compiled examples or practical tools to assist implementation researchers and practitioners in applying those steps. For each domain, we compiled definitions with supporting literature, showcased an illustrative example, and suggested sample quantitative and qualitative measures. Conclusion: Incorporating health equity domains within implementation determinant frameworks may optimize the scientific yield and equity of implementation efforts by assessing and ideally addressing implementation and equity barriers simultaneously. These practical guidance and tools provided can assist implementation rese

"About this Research Topic Healthcare narratives (such as clinical notes, discharge letters, nurse handover notes, imaging reports, patients posts on social media or feedback comments, etc.) have been used as a key communication stream that contains the majority of actionable and contextualised data, but which - despite being increasingly available in a digital form - is still not routinely analysed, and is rarely integrated with other healthcare data on a large-scale. There are many barriers and challenges in processing healthcare free text, including, for example, the variability and implicit nature of language expressions, and difficulties in sharing training and evaluation data. On the other hand, recent years have witnessed increasing needs and opportunities to process free text, with a number of success stories that have demonstrated the feasibility of using advanced Natural Language Processing to unlock evidence contained in free text to support clinical care, patient self-management, epidemiological research and audit."

"Objective: This randomized single-blind controlled trial tested the hypothesis that a prototype digital therapeutic developed to provide goal-based counseling with personalized passive and active game-based sound therapy would provide superior tinnitus outcomes, and similar usability, to a popular passive sound therapy app over a 12 week trial period. Methods: The digital therapeutic consisted of an app for iPhone or Android smartphone, Bluetooth bone conduction headphones, neck pillow speaker, and a cloud-based clinician dashboard to enable messaging and app personalization. The control app was a popular self-help passive sound therapy app called White Noise Lite (WN). The primary outcome measure was clinically meaningful change in Tinnitus Functional Index (TFI) between baseline and 12 weeks of therapy. Secondary tinnitus measures were the TFI total score and subscales across sessions, rating scales and the Client Oriented Scale of Improvement in Tinnitus (COSIT). Usability of the US and WN interventions were assessed using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ). Ninety-eight participants who were smartphone app users and had chronic moderate-severe tinnitus (>6 months, TFI score > 40) were enrolled and were randomly allocated to one of the intervention groups. Thirty-one participants in the USL group and 30 in the WN group completed 12 weeks of trial. Results: Mean changes in TFI for the USL group at 6 (16.36, SD 17.96) and 12 weeks (17.83 points, SD 19.87) were clinically meaningful (>13 points reduction), the mean change in WN scores were not clinically meaningful (6 weeks 10.77, SD 18.53; 12 weeks 10.12 points, SD 21.36). A statistically higher proportion of USL participants achieved meaningful TFI change at 6 weeks (55%) and 12 weeks (65%) than the WN group at 6 weeks (33%) and 12 weeks (43%). Mean TFI, rating and COSIT scores favored the US group but were not statistically different from WN. Usability measures

"In 2009, Ms. Leon went to the WomenHeart Science and Leadership Symposium at the Mayo Clinic, where she met Dr. Sharonne N. Hayes, a professor of cardiovascular medicine at Mayo. At that time, the largest study on SCAD included 43 patients. "I walked up to Dr. Hayes and told her we had 70 people, and we wanted research," Ms. Leon recalled. "She was like, 'Wow.'" "Everything I learned about SCAD in my medical training was wrong," Dr. Hayes said. By 2010, with the help of Dr. Hayes, and subsequently SCAD Research Inc., an organization founded by Bob Alico, who lost his wife to SCAD, Dr. Hayes devised an innovative way to do research, using online networks of far-flung patients and analyzing genetic and clinical data. "We never imagined there would be 1,000 female patients in our virtual registry," Dr. Hayes said."

Full Text PDF available: "Wearable device signals and home blood pressure data across age, sex, race, ethnicity, and clinical phenotypes in the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) study: a prospective, community-based observational study"

"While citizen science is gaining attention of late, for those of us involved in community-based public health research, community/citizen involvement in research has steadily increased over the past 50 years. Community Health Workers (CHWs), also known as Promotores de Salud in the Latino community, are critical to reaching underserved populations, where health disparities are more prevalent. CHWs/Promotores provide health education and services and may also assist with the development and implementation of community- and clinic-based research studies. Recognizing that CHWs typically have no formal academic training in research design or methods, and considering that rigor in research is critical to obtaining meaningful results, we designed instruction to fill this gap. We call this educational initiative "Building Research Integrity and Capacity" or BRIC. The BRIC training consists of eight modules that can be administered as a self-paced training or incorporated into in-person, professional development geared to a specific health intervention study. While we initially designed this culturally-grounded, applied ethics training for Latino/Hispanic community research facilitators, BRIC training modules have been adapted for and tested with non-Latino novice research facilitators. This paper describes the BRIC core content and instructional design process."

Abstract: INTRODUCTION: Spasticity in chronic spinal cord injury is a condition that can have negative repercussions on the patient's quality of life. Its treatment is complex and sometimes the outcome is insufficient. Cannabinoids have recently been used in multiple sclerosis to successfully treat spasticity that is refractory to other therapies. AIM: To quantify the clinical response of a group of patients with spastic chronic spinal cord injury to the orally administered drug delta-9-tetrahydrocannabinol-cannabidiol (Sativex®) as medication for use in special situations. PATIENTS AND METHODS: The research consists of a six-month observational study in patients with chronic spinal cord injuries with refractory spasticity. The variables collected were: modified Ashworth scale, Penn spasm frequency scale, Numeric Rating Scale, and Visual Analogue Scale for pain. Additionally, clinical variables and side effects of the treatment were also collected. RESULTS: Fifteen patients took part in this study. A significant improvement was observed on three of the scales recorded: modified Ashworth scale (z = -2.97; p = 0.003), Penn spasm frequency scale (z = -2.76; p = 0.006) and Numeric Rating Scale (z = -3.21; p = 0.001). The use of the drug was withdrawn in two patients due to side effects. CONCLUSIONS: Sativex can be considered an alternative in patients with spasticity associated with chronic spinal cord injury for whom other therapeutic measures have been insufficient. Further studies need to be conducted before the use of this drug can be recommended and so as to define a complete profile of its long-term side effects.

"Why are clinical trials a critical part of the process to develop new and promising treatments? Why do therapies take such a long time to develop? Here's why"

new project apollo patient. Co-Founder & President Company NameWholistic Research and Education Foundation Dates EmployedMay 2017 - Present Employment Duration1 yr 2 mos LocationGreater San Diego Area Wholistic Research and Education Foundation is a California-based nonprofit dedicated to exploring the health benefits of CBD-rich therapeutics. Our mission is to fund clinical and scientific research to better understand the "if, how and why" behind the potential healing power of hemp and cannabis across a multitude of ailments, as well as work to increase safe and legal access to those in need via advocacy and education. Co-Founder Company NameMana Artisan Botanics Dates EmployedMay 2017 - Present Employment Duration1 yr 2 mos LocationKona, Hawaii Mana Artisan Botanics is a purpose-driven hemp company based on the Big Island of Hawaii. We offer pure hemp extracts infused with sustainably grown Hawaiian herbs and spices - nature's mana. Each product is hand crafted artisan style, in small batches. We take great care to source our ingredients from conscientious farmers, supporting local and organic whenever available. All of our products are simple, pure and good for body and soil.

"Current research and privacy regulations, which were designed for clinical research and for small-data studies of the past, cannot support creation of the vast data resources that 21st-century science needs. These regulations enshrine data-holders (hospitals, insurers, and other entities that store people's data) as the prime movers in assembling large-scale data resources for scientific use and rely on mechanisms - such as de-identification of data and waivers of individual consent - that are unworkable going forward. They shower individuals with unwanted, paternalistic protections - such as barriers to access to their own research results - while denying them a voice in what will be done with their data."

Recommended by Meg Sweeney: "Abstract SARS-CoV-2 infection displays immense inter-individual clinical variability, ranging from silent infection to lethal disease. The role of human genetics in determining clinical response to the virus remains unclear. Studies of outliers - individuals remaining uninfected despite viral exposure and healthy young patients with life-threatening disease - presents a unique opportunity to reveal human genetic determinants of infection and disease."

"Panelists: Erica Ollmann Saphire, Ph.D., Professor and Coronavirus Task Force Member, La Jolla Institute for Immunology Evan Y. Snyder, M.D., Ph.D., F.A.A.P, Professor, Sanford Burnham Prebys (SBP) Medical Discovery Institute Joseph Payne, Founder, President and CEO, Arcturus Therapeutics Kate Broderick, Ph.D., Senior VP R&D, Inovio Pharmaceuticals 11:45 AM - 12:30 PM - PANEL DISCUSSION San Diego's Multi-faceted Attack Against the COVID-19 Pandemic From a Diagnostic Perspective Moderator: Pam Gardner, President & CEO, BVS, Inc. Panelists: Doug Bryant, President & CEO, Quidel Corporation Joshua Trotta, Sr. Director, Global Business Development - Clinical Solutions, Genetic Sciences Division, Thermo Fisher Maurice Exner, Ph.D., Vice President, R&D, Assay Development and Clinical Affairs, Hologic, Inc. Susan Tousi, Senior Vice President, Product Development, Illumina, Inc."

The COVID-19 pandemic makes it necessary for leading experts from across disciplines and geographies to come together to jointly address the challenges we are facing when coping with the disruptive nature of the coronavirus SARS-CoV-2 pandemic is having on our healthcare system and our society as a whole. The tasks upon us are enormous and include besides decoding the virus and scaling diagnostics, tackling COVID-19 within existing healthcare systems, building health data platforms that support COVID-19 focused health care, accommodating clinical trials in the era of COVID-19, and developing functional vaccines and therapeutics. The next PMWC 2021 on January 25-27 would be a virtual conference and will touch upon these critical developments and ongoing activities while also including the regulatory and investment sides that influence clinical advancements.

Camille Nebeker: I'm writing a paper on mHealth and research ethics across regulated and unregulated sectors. Came across an article that you may appreciate - it's basically saying that people need to be trained when conducting scientific research. It was aimed at clinicians - not citizen scientists:

Scientists like their insights captured via validated instruments that organize data into quantifiable outputs that can be measured and managed. Patients want to tell stories, share anecdotes, and talk about the qualitative factors that affect their quality of life. These disparate communication preferences have made it difficult for the two groups to engage, or for scientists to translate those qualitative stories into systematic assessments that quantify the burden placed on study volunteers.

Advanced Radiology MSK MRI - Christine Chung MD Christine Chung, MD, is a world renowned musculoskeletal (MSK) radiologist, professor of radiology, clinical translational researcher, and the director of the UC San Diego's MSK Imaging Research Group.