scholarly journals 816 Implications of the COVID-19 pandemic: results of a German survey on patient care and clinical trials in gynecological oncology (MONITOR-17 Survey)

2021 ◽  
Author(s):  
S Nasser ◽  
D Zocholl ◽  
S Boz ◽  
M Keller ◽  
D Dimitrova ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Gynecological Oncology

Patient care and clinical trials in gynecological oncology: Implications of the COVID-19 pandemic.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5564-5564
Author(s):  
Sara Nasser ◽  
Christina Fotopoulou ◽  
Murat Guktekin ◽  
Desislava Dimitrova ◽  
Philippe Morice ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Patient Care ◽  
Healthcare Professionals ◽  
Clinical Pathways ◽  
Trial Participation ◽  
Early Stage Disease ◽  
Gynecological Oncology ◽  
Cardiopulmonary Support ◽  
The Impact

5564 Background: This is a prospective international Survey to evaluate the impact of the COVID-19 Pandemic on the management of patients with gynecological malignancies from the multidisciplinary physicians' perspective, with particular focus on clincial infrastructures, and trial participation. Methods: The anonymous online survey consisted of 53 COVID-related questions. It was sent to all healthcare professionals in gynaecological oncology centres across Europe and the Pan-Arabian region from April 2020 to October 2020. All healthcare professionals treating women with gynecological cancers were able to participate in the survey. Results: A total of 243 answers were collected from 30 different countries. The majority (73%) of participants were gynecological oncologists from university hospitals(71%) with at least an Intensive care unit with cardiopulmonary support available at their institutions. Most institutions continued to perform elective surgeries only for oncological cases (98%). Patients had to wait on average 2 weeks longer for their surgery appointments compared to previous years(range 0-12 weeks). Cases that were prioritised for surgical intervention across all tumors (Ovarian, Endometrium, Cervical) were early stage disease (74%), primary situation (61%), and good ECOG status (63%). The radicality of surgery did not change in the majority of cases (78%) across all tumor types. During the pandemic, only 38% of clinicians stated they would start a new clinical trial. 45% stated the pandemic has negatively impacted the financial structure and support for clinical trials. 79% do not routinely screen patients included in trials for SARS CoV2. Overall, approx. 20% of clinicians did not feel well informed regarding clinical pathways for COVID-19 patients throughout the pandemic. The majority preferred regular updates and training via Webinars (75%), followed by tumorboards and interdisciplinary conferences (45%). 30% of clinicians stated that they are currently experiencing difficulties in providing adequate medical care due to staff shortage. Conclusions: Despite well-established guidelines for patient care and performing clinical trials in gynecological oncology, the COVID-19 pandemic has impacted clinical research, and financial structures. Longer waiting times for operative interventions, less support for clinical trials and concerns regarding provision of adequate medical care and triaging patients are very real. This survey underlines the necessity for building robust emergency algorithms tailored to gynecological oncology patients in the future.

Clinical Trials and P Values

PEDIATRICS ◽  
1993 ◽  
Vol 92 (1) ◽  
pp. 189-189
Author(s):  
JOHN D. LANTOS
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Randomized Trials ◽  
Therapeutic Interventions ◽  
P Values ◽  
Clinical Interventions

In Reply.— Here is the question: Are randomized trials so superior to other knowledge-generating techniques that we should not consider a fact to have been established unless it has been established by such a trial? If so, then the use of clinical interventions which have not been studied using randomized trials is wrong. if not, then we need to determine how such trials should be combined with other techniques, and how results of different techniques should be interpreted to lead to the best possible patient care, the incorporation of new therapeutic interventions into practice, and the timely discarding of techniques which are no longer sufficiently efficacious.

Commentary: Diagnostic devices in clinical trials have high stakes for patient care

BMJ ◽  
2016 ◽  
pp. i5197 ◽  
Author(s):  
Vinay K Rathi ◽  
Harlan M Krumholz ◽  
Joseph S Ross
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
High Stakes

Are excellent systematic reviews of clinical trials useful for patient care?

2008 ◽  
Vol 4 (6) ◽  
pp. 294-295 ◽  
Author(s):  
Theodore Pincus ◽  
Yusuf Yazici ◽  
Tuulikki Sokka
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Systematic Reviews

Electronic Patient-Reported Outcomes: The Time Is Ripe for Integration Into Patient Care and Clinical Research

2016 ◽  
pp. e89-e96 ◽  
Author(s):  
Lee Schwartzberg
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Patient Reported Outcomes ◽  
Care Delivery ◽  
Point Of Care ◽  
Alternative Methods ◽  
Electronic Systems ◽  
Psychological States ◽  
Longitudinal Tracking ◽  
Patient Reported

In the emerging team-based approach to delivering cancer care, collecting patient-reported outcomes (PROs) provides longitudinal monitoring of treatment adverse effects, disease complications, functional statuses, and psychological states throughout the cancer continuum for all providers to use. Electronic systems offer added capabilities, including easy quantitation of individual symptom items and aggregated scales, standardization, and longitudinal tracking of patient surveys for trend analysis over time. An ideal electronic PRO (ePRO) platform is clinically relevant, validated, and reliable and would offer patient usability. Additionally, it should allow for automated responses to and from patients, have scheduling functionality, and send real-time alerts to site personnel and patients. Clinical interfaces should be easy to read and integrated into the electronic medical record. Multiple ePRO systems, often using electronic tablets, have been created and are beginning to be widely deployed. The Patient Care Monitor is one example of a system that has evolved into a comprehensive patient engagement platform, with a complete review of systems survey and capabilities for mobile health usage. Recent clinical trials have established ePRO systems as an effective method of providing information, which aids improved patient outcomes, including reduced health resource utilization and longer time on therapy. ePROs are also increasingly incorporated into clinical trials, where they can provide more thorough reporting of adverse events than can be captured by alternative methods. Mobile devices have the potential to become the method by which all members of the provider team communicate with patients both at the point-of-care and between clinic visits to optimize care delivery.

A Focus on Evaluating Major Study Limitations in Order to Apply Clinical Trials to Patient Care: Implications for the Healthcare Team

2020 ◽  
pp. 001857872093175
Author(s):  
Mary J. Ferrill ◽  
Alireza FakhriRavari ◽  
Lisa Hong ◽  
Jody Jacobson Wedret
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Patient Care ◽  
External Validity ◽  
Healthcare Providers ◽  
Internal Validity ◽  
Healthcare Team ◽  
Evidence Based ◽  
Major Study ◽  
Clinically Significant

Background: With more than a million new biomedical articles published annually, healthcare providers must stay up to date in order to provide optimal evidence-based patient care. The concise ROOTs (relevance, observe validity, obtain clinically significant results, and translate results to clinical practice) format is a valuable tool to assist with literature evaluation. Purpose: To illustrate how major study limitations found in clinical trials might inhibit the ability to adopt the findings of such studies to patient care. Methods: Examples from published clinical trials that contain major study flaws were used to illustrate, if taken at face value, would lead to erroneous assumptions, and if adopted, could potentiallly harm patients. Conclusion: When evaluating the literature, it is crucial to identify limitations in the published literature that might reduce the internal validity, affect the results, or limit the external validity of clinical trials, hence affecting the usability of literature for patient care. This article provides examples of clinical trials that contain major study limitations with potentially erroneous assumptions. These illustrations are meant to show how important it is to delve deeper into an article before conclusions are drawn.

scholarly journals How I treat metastatic melanoma

ESMO Open ◽  
2019 ◽  
Vol 4 (Suppl 2) ◽  
pp. e000509 ◽  
Author(s):  
Reinhard Dummer ◽  
Joanna Mangana ◽  
Anna Lisa Frauchiger ◽  
Claudia Lang ◽  
Sara Micaletto ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Patient Care ◽  
Translational Research ◽  
Metastatic Melanoma ◽  
State Of The Art ◽  
Advanced Melanoma ◽  
Referral Centre ◽  
Tremendous Progress ◽  
Worldwide Network

Tremendous progress in basic and clinical research has completely revolutionised the management of advanced melanoma, and this dramatic development is still ongoing. In this environment, state-of-the-art patient care is a major challenge. We describe how patient-centred medicine is organised in a leading referral centre that is also involved in early and late clinical trials and is part of a worldwide network for translational research.

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