scholarly journals Oncologic Patients' Misconceptions May Impede Enrollment Into Clinical Trials

2021 ◽  
Author(s):  
Nethanel Asher ◽  
Ari Raphael ◽  
Ido Wolf ◽  
Sharon Pelles ◽  
Ravit Geva
Keyword(s):  
Clinical Trials ◽  
Medical Center ◽  
Good Clinical Practice ◽  
Tertiary Hospital ◽  
Past Experience ◽  
Basic Knowledge ◽  
Future Research ◽  
Academic Education ◽  
Adequate Knowledge ◽  
Oncologic Patients

Abstract Background Clinical trials are an essential source for advances in oncologic care, yet the enrollment rate is only 2-4%. Patients' reluctance to participate is an important barrier. This study evaluates patients' level of understanding and attitudes towards clinical trials.Methods Two-hundred patients receiving active anti-neoplastic therapy at a large tertiary hospital completed an anonymous questionnaire comprised of demographic information, past experience in clinical research and basic knowledge on clinical trials. Results The majority of respondents did not meet the minimum knowledge level criteria. The concerns of those who replied that they would decline to participate in a clinical trial were related to assignment to the placebo arm, provision of informed consent and trust issues with their oncologist. Those with adequate knowledge were significantly more interested in participating in. Patients with past experience in clinical trials had a higher level of academic education, were less religious, had a better understanding of medical research and were inclined to participate in future research.Conclusions Misperceptions of clinical trials may contribute substantially to the unwillingness to participate in them.Trial registration The study was approved by the Tel Aviv Sourasky Medical Center ethics committee (0565-14-TLV January 7th, 2015) and it was conducted in full accordance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Agreement to respond to the questionnaire was taken as formal consent to participate in this study.

scholarly journals Oncologic patients’ misconceptions may impede enrollment into clinical trials: a cross-sectional study

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Nethanel Asher ◽  
Ari Raphael ◽  
Ido Wolf ◽  
Sharon Pelles ◽  
Ravit Geva
Keyword(s):  
Clinical Trials ◽  
Medical Center ◽  
Cross Sectional Study ◽  
Past Experience ◽  
Basic Knowledge ◽  
Future Research ◽  
Academic Education ◽  
Sectional Study ◽  
Cross Sectional ◽  
Oncologic Patients

Abstract Background Clinical trials are an essential source for advances in oncologic care, yet the enrollment rate is only 2-4%. Patients' reluctance to participate is an important barrier. This study evaluates patients' level of understanding and attitudes towards clinical trials. Methods This cross-sectional study was conducted in the oncology department and day care unit at the oncology division Tel Aviv Sourasky Medical Center, Israel. From January 2015 to September 2016. Two-hundred patients’ currently receiving active anti-cancer therapy at a large tertiary hospital completed an anonymous questionnaire comprised of demographic information, past experience in clinical research and basic knowledge on clinical trials. Results The majority of respondents did not meet the minimum knowledge level criteria. In those who replied they would decline to participate in a clinical trial, concern were related to potential assignment to the placebo arm, provision of informed consent and trust issues with their oncologist. Those with sufficient knowledge were significantly more interested in participating. Patients with past experience in clinical trials had a higher level of academic education, were less religious, had a better understanding of medical research and were inclined to participate in future research. Conclusions Misperceptions of clinical trials may contribute substantially to the unwillingness to participate in them.

Oncologic patients attitudes and participation in clinical trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18029-e18029
Author(s):  
Nethanel Asher ◽  
Ido Wolf ◽  
Sharon Pelles ◽  
Ravit Geva
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Center ◽  
Internal Validity ◽  
Past Experience ◽  
Basic Knowledge ◽  
Future Research ◽  
Academic Education ◽  
Oncologic Patients ◽  
Validity Tests

e18029 Background: Clinical trials are an essential part of the oncological care. However, literature indicates low accrual of only 2-4% of the oncologic population. One of the leading known barriers is the patient's hesitant attitude toward participation. This study aimed to evaluate the patients' population treated in the Tel Aviv Sourasky Medical Center (TASMC) oncology division and their understanding of clinical research in order to improve local recruitment strategies. Methods: An observatory, questionnaire based research was conducted. Patients receiving active oncology treatment in the TASMC oncologic day care unit were asked to complete an anonymous questionnaire, which was comprised of two main parts: the first evaluate demographic information and past experience in clinical research. The second investigated basic knowledge true/false test regarding clinical trials. The questionnaire was validated by both external and internal validity tests (α-Cronbach validity test) and was approved by the local ethics committee. Results: Two hundred patients completed the questionnaires. Median age was 60. 64% would consider participating in a clinical study. 23% (N = 46) had past experience in research, and compared to those with no experience they were found to have higher academic education (67.4% vs 36.9%, p < 0.0001), be more secular (76.1% vs 58.3, p = 0.037) and to have a better understanding of medical research (84.4%, vs 36.5%, p < 0.0001). They were also more inclined to participate in a future research (73% vs 44.9%, p = 0.01). Of those who would decline to participate and had failed the knowledge test (score less than 60%), the most frequent concern was related to the placebo arm (p = 0.055), ability to reject consent, and to trust issues with the treating oncologist. Conclusions: Despite a noteworthy readiness to enroll in clinical trials among the TASMC oncologic population, there were found significant knowledge and basic understanding gaps regarding clinical trials. Further efforts are needed to better understand specific accrual barriers and to develop an adapted information system.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

577 The Collaboration of Burn Outreach and Wound Care Nurses

2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S140-S140
Author(s):  
Ekta Vohra
Keyword(s):  
Wound Care ◽  
Medical Center ◽  
Academic Medical Center ◽  
Hospital Setting ◽  
Basic Knowledge ◽  
Definitive Treatment ◽  
Knowledge Gap ◽  
Burn Wound ◽  
Improvement Project ◽  
Burn Wounds

Abstract Introduction Certified wound care nurses perform a vital role in skin health and management in the hospital setting. During the certification process, minimal time is spent on burn wound education, despite the fact that wound care nurses are consulted for various wound etiologies; one of those being burns. This construct created a need for collaboration between the burn team and wound care nurses. Although all burns are essentially wounds, the reality is that all wounds are not burns. The management of the burn wound is often different from the management of pressure injuries or surgical wounds. In speaking with the wound care nurses at this large urban academic medical center, a knowledge gap was identified in burn wound care education as well as appropriate and timely consultation of the burn team. Methods This knowledge improvement project focused on educating the wound care nurses in assessment and treatment of burns, and the process for burn service consultation. Burn education was provided through in-person didactic presentations. The lecture included burn wound photos with opportunities to classify the potential depth of burn wounds as well as typical complications. Additionally, it discussed when a burn consult is needed. A basic knowledge retrospective pre-posttest method was utilized. Results An educational plan was tailored to meet the learning needs of the wound care nurses to address the knowledge gap. Post test data results were tracked. Post scores were increased, indicating a successful educational intervention. Also, while providing the education, the burn outreach coordinator identified an opportunity to expand the burn center’s presence among colleagues through collaboration with the wound care nurses. The wound nurses made excellent ambassadors for the mission of the burn service. Conclusions Provision of burn education across disciplines may improve recognition of burn wounds and facilitate definitive treatment.

scholarly journals Cohort profile of Acutelines: a large data/biobank of acute and emergency medicine

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e047349
Author(s):  
Ewoud ter Avest ◽  
Barbara C van Munster ◽  
Raymond J van Wijk ◽  
Sanne Tent ◽  
Sanne Ter Horst ◽  
...  
Keyword(s):  
Acute Care ◽  
De Novo ◽  
Medical Center ◽  
Large Data ◽  
Future Research ◽  
Imaging Data ◽  
Novel Studies ◽  
Long Term Follow Up ◽  
Registration Number

PurposeResearch in acute care faces many challenges, including enrolment challenges, legal limitations in data sharing, limited funding and lack of singular ownership of the domain of acute care. To overcome these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data, image and biobank named ‘Acutelines’.ParticipantsClinical data, imaging data and biomaterials (ie, blood, urine, faeces, hair) are collected from patients presenting to the emergency department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy) is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure used ensures automated capturing of all bed-side monitoring data (ie, vital parameters, electrophysiological waveforms) and securely importing data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration and pharmacy. Data are collected from all included participants during the first 72 hours of their hospitalisation, while follow-up data are collected at 3 months, 1 year, 2 years and 5 years after their ED visit.Findings to dateEnrolment of the first participant occurred on 1 September 2020. During the first month, 653 participants were screened for eligibility, of which 180 were approached as potential participants. In total, 151 (84%) provided consent for participation of which 89 participants fulfilled criteria for collection of biomaterials.Future plansThe main aim of Acutelines is to facilitate research in acute medicine by providing the framework for novel studies and issuing data, images and biomaterials for future research. The protocol will be extended by connecting with central registries to obtain long-term follow-up data, for which we already request permission from the participant.Trial registration numberNCT04615065.

scholarly journals “Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Larissa Niemeyer ◽  
Konstantin Mechler ◽  
Jan Buitelaar ◽  
Sarah Durston ◽  
Bram Gooskens ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Demographic Data ◽  
Autism Spectrum ◽  
Current Therapy ◽  
Future Research ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Clinical Patient ◽  
Compulsive Disorder

Abstract Background Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes). Methods Demographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed. Results In total, n = 173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria/meeting one or more of the exclusion criteria (n = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%). Conclusions The findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations. Trial registration EudraCT 2014-003080-38. Registered on 14 July 2014.

scholarly journals “Nanomaterials of curcumin-hyaluronic acid”: their various methods of formulations, clinical and therapeutic applications, present gap, and future directions

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Tanzeel Rehman Charan ◽  
Muhammad Aqeel Bhutto ◽  
Mihr Ali Bhutto ◽  
Azhar Ali Tunio ◽  
Ghulam Murtaza Khuhro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hyaluronic Acid ◽  
Future Research ◽  
Main Body ◽  
Future Directions ◽  
Research Directions ◽  
Safety And Efficacy ◽  
Therapeutic Applications ◽  
Future Research Directions ◽  
Neural Disorders

Abstract Background Nanomaterials of curcumin with hyaluronic acid have gained a lot of attention for potential therapeutic applications of curcumin and hyaluronic acid with or without other additional drugs. Overall studies of curcumin and hyaluronic acid show that nanomaterials of curcumin with hyaluronic acid accelerate the efficacy of curcumin in the treatment of various disorders like arthritis, cancer, hepatic fibrosis, neural disorders, wound healing, and skin regeneration, it is largely due to the combined effect of hyaluronic acid and curcumin. However, due to limited clinical trials and experiments on humans and animals, there is a substantial gap in research for the safety and efficacy of nanomaterials of curcumin-hyaluronic acid in the treatment of curcumin and hyaluronic acid targeted diseases and disorders. Main body of the abstract In this current review, we have first described various reported synthetic nanomaterials of curcumin-hyaluronic acid, then in the next section, we have described various fields, disorders, and diseases where these are being applied and in the final section of this review, we discussed the research gap, and future research directions needed to propose the fabricated nanocurcumin-hyaluronic acid biomaterials. Short conclusion There are substantial gaps in research for the safety and efficacy of nanomaterials of curcumin with hyaluronic acid due to limited available data of clinical trials and experiments of nanocurcumin-hyaluronic acid biomaterials on humans and animals. So, it entirely requires serious and committed efforts through the well-organized system of practical and clinical trials which provide results, data, and detections that lead to the formulation of the best drug from curcumin with hyaluronic acid for the treatment of curcumin and hyaluronic acid targeted diseases and disorders.

scholarly journals NURSING HOME TELEED INTERVENTION: ADVANCING NEW CARE MODELS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S337-S338
Author(s):  
Charlene C Quinn ◽  
Anthony Roggio ◽  
Barr Erik ◽  
Ann Gruber-Baldini
Keyword(s):  
Medical Center ◽  
Business Case ◽  
Admission Policy ◽  
Care Utilization ◽  
Future Research ◽  
Technical Equipment ◽  
Nursing Facilities ◽  
Medical Problems ◽  
Provider Satisfaction ◽  
Care Models

Abstract New reimbursement and managed care models demonstrate the need to reduce avoidable Emergency Department (ED) use and limit preventable inpatient admissions for older adults in Skilled Nursing Facilities (SNF). The objective was to develop an ED telemedicine consultation intervention for SNF residents with acute medical problems. Secondary objectives including evaluation of health care utilization, provider satisfaction. Demonstration evaluation in three urban SNFs, telemedicine linked to university medical center ED. Mobile telemedicine cart equipment assessed SNF residents for any change in condition. ED physicians used tablets with secure access to conduct the resident assessment. Provider satisfaction measures imbedded in EMRs were completed at consultation visit end. 460 patients had changes in condition, 327 resulted in 911 calls, 85 deemed eligible for telemedicine consult. Conducted 57 telehealth consults. Forty (70%) telemedicine consult residents remained in the SNF. Fourteen residents were transferred to the ED. Average satisfaction scores were 5.8/7 for SNF nurses (n=49) and 5.6 for ED physicians (n=45). Lower-rated items related to technical equipment problems. ED physicians reported residents transferred to ED after telehealth visit had better continuity of care. The intervention was effective in preventing or delaying transfer of acutely ill, medically complex SNF residents. Implementation of the intervention identified need for SNF admission policy and procedure changes; weekly telemedicine training; SNF clinical advocates; on-site tracking and linkage of EMRs across providers; HIPAA shared medical record concerns. Future research plans include analyses of detailed SNF resident characteristics and business case assessment for reduction of transfers, ED and hospital utilization.

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