scholarly journals Perceptions of Adolescents With Cancer Related to a Pain Management App and Its Evaluation: Qualitative Study Nested Within a Multicenter Pilot Feasibility Study (Preprint)

2017 ◽  
Author(s):  
Lindsay A Jibb ◽  
Bonnie J Stevens ◽  
Paul C Nathan ◽  
Emily Seto ◽  
Joseph A Cafazzo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Management ◽  
Pilot Study ◽  
Qualitative Study ◽  
Study Protocol ◽  
Consensus Conference ◽  
Management Support ◽  
Team Members ◽  
Study Team ◽  
Related Quality

BACKGROUND Pain in adolescents with cancer is common and negatively impacts health-related quality of life. The Pain Squad+ smartphone app, capable of providing adolescents with real-time pain management support, was developed to enhance pain management using a phased approach (ie, systematic review, consensus conference and vetting, iterative usability testing cycles). A 28-day Pain Squad+ pilot was conducted with 40 adolescents with cancer to evaluate the feasibility of implementing the app in a future clinical trial and to obtain estimates of treatment effect. OBJECTIVE The objective of our nested qualitative study was to elucidate the perceptions of adolescents with cancer to determine the acceptability and perceived helpfulness of Pain Squad+, suggestions for app improvement, and satisfaction with the pilot study protocol. METHODS Post pilot study participation, telephone-based, semistructured, and audio-recorded exit interviews were conducted with 20 adolescents with cancer (12-18 years). All interviews were transcribed and independently coded by 2 study team members. Content analysis was conducted to identify data categories and overarching themes. RESULTS Five major themes comprising multiple categories and codes emerged. These themes focused on the acceptability of the intervention, acceptability of the study, the perceived active ingredients of the intervention, the suitability of the intervention to adolescents’ lives, and recommendations for intervention improvement. CONCLUSIONS Overall, Pain Squad+ and the pilot study protocol were acceptable to adolescents with cancer. Suggestions for intervention and study improvements will be incorporated into the design of a future randomized clinical trial (RCT) aimed at assessing the effectiveness of Pain Squad+ on adolescents with cancer health outcomes.

scholarly journals 1326. Vancomycin Area Under the Concentration-Time Curve (AUC) Estimation Using a Bayesian Approach Versus First-Order Pharmacokinetic Equations: A Pilot Study

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S673-S673
Author(s):  
Jeffrey Pearson ◽  
Yazed S Alsowaida ◽  
B S Pharm ◽  
David W Kubiak ◽  
Mary P Kovacevic ◽  
...  
Keyword(s):  
Pilot Study ◽  
Median Time ◽  
Bayesian Modeling ◽  
Surgical Prophylaxis ◽  
Time Curve ◽  
Team Members ◽  
First Order ◽  
Concentration Time ◽  
Study Team ◽  
Auc Estimation

Abstract Background Current guidelines endorse area under the concentration-time curve (AUC)-based monitoring over trough-only monitoring for systemic vancomycin. Vancomycin AUC can be estimated using either Bayesian modeling software or first-order pharmacokinetic (PK) calculations. The objective of this pilot study was to evaluate and compare the efficiency and feasibility of these two approaches for calculating the estimated vancomycin AUC. Methods A single-center crossover study was conducted in four medical/surgical units at Brigham and Women’s Hospital over a 3-month time period. All adult patients who received vancomycin were included. Patients were excluded if they were receiving vancomycin for surgical prophylaxis, were on hemodialysis, if vancomycin was being dosed by level, or if vancomycin levels were never drawn. The primary endpoint was the amount of time study team members spent calculating the estimated AUC and determining regimen adjustments with Bayesian modeling compared to first-order PK calculations. Secondary endpoints included the number of vancomycin levels drawn and the percent of those drawn that were usable for AUC calculations. Results One hundred twenty-four patients received vancomycin during the study, of whom 47 met inclusion criteria. The most likely reasons for exclusion were receiving vancomycin for surgical prophylaxis (n=40) or never having vancomycin levels drawn (n=32). The median time taken to assess levels in the Bayesian arm was 9.3 minutes [interquartile range (IQR) 7.8-12.4] versus 6.8 minutes (IQR 4.8-8.0) in the 2-level PK arm (p=0.004). However, if Bayesian software is integrated into the electronic health record (EHR), the median time to assess levels was 3.8 minutes (IQR 2.3-6.8, p=0.019). In the Bayesian arm, 30 of 34 vancomycin levels (88.2%) were usable for AUC calculations, compared to 28 of 58 (48.3%) in the 2-level PK arm. Conclusion With EHR integration, the use of Bayesian software to calculate the AUC was more efficient than first-order PK calculations. Additionally, vancomycin levels were more likely to be usable in the Bayesian arm, thereby avoiding delays in estimating the vancomycin AUC. Disclosures All Authors: No reported disclosures

scholarly journals 3381 Reducing Problem Records in the Johns Hopkins University ClinicalTrials.gov Protocol Registration and Results System (PRS)

2019 ◽  
Vol 3 (s1) ◽  
pp. 126-126
Author(s):  
Oswald Tetteh ◽  
Aliya Lalji ◽  
Prince Samuel Nuamah ◽  
Anthony Keyes
Keyword(s):  
Clinical Trial ◽  
Late Results ◽  
Trial Registration ◽  
Draft Guidance ◽  
Clinical Trial Registration ◽  
Team Members ◽  
Johns Hopkins University ◽  
Study Team ◽  
Results Reporting ◽  
Clinical Trial Information

OBJECTIVES/SPECIFIC AIMS: The Johns Hopkins University Clinicaltrials.gov (CT.gov) Program has previously reported on a study showing reduction of “Late Results – per FDAAA” from 111 to 0. What we hope to do here is to focus on non-late results records. Over the years, some institutions spend their efforts solely on late results in order to avoid any penalties from the Food and Drug Administration (FDA). However, there are a number of variables that labels “problem records” within the Protocol and Registration System (PRS). These records are also subject to penalties. Our goal has been to minimize problem records and establish processes to improve and maintain our institutional compliance in regards to regulations governing clinical trials registration and results reporting. METHODS/STUDY POPULATION: The Johns Hopkins University implemented a Clinicaltrials.gov program solely mandated to assist Principal Investigators (PIs) and other study team members with clinical trial registration and results reporting. The program has developed processes in its duty towards reducing problem records in the PRS. Full-time staff have been assigned to assist research teams with registration and results reporting, while ensuring compliance with all relevant regulations. Several methods have been utilized to track metrics, such as monthly reports and internal databases. Features within the PRS have also been used to draw attention to newly-identified problem records on a daily basis in order to rectify these issues with the study team promptly. In order to ensure compliance, our office communicates with study teams regarding the problems within their CT.gov record that requires attention. In challenging cases, our program will also collaborate with the CT.gov PRS Team at the NIH to facilitate the process and avoid multiple review cycles, which can delay registration or the posting of results. Our Program has also formed internal collaborations with the Institutional Review Board (IRB) which allows us to verify study status and view active study team members. This is especially useful in cases where the study team members who are listed on the CT.gov record cannot be reached or the contact information is outdated (a common occurrence with older studies). With access in the IRB, we can contact the current study team members who may not be listed in CT.gov and assist them to resolve any outstanding issues of non-compliance within their CT.gov record. RESULTS/ANTICIPATED RESULTS: From September 2015 (before our program was established) to September 2016 (three months after the institution of our program), the total amount of problem records increased from 44% (339/774) to 45% (383/852). Since then, the processes we have developed resulted in a decline in problem records to 30% (282/955) in September 2017, and a further decline to 8% (83/1075) as of September 2018. The short rise that was observed in 2016, was a potential indicator that if our program was not instituted, it would have been more difficult to maintain compliance. DISCUSSION/SIGNIFICANCE OF IMPACT: According to the FDA Draft Guidance released in September 2018 referring to the Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank, there are a number of ways to violate the FDA regulations, resulting in potential monetary penalties, which include “failing to submit required clinical trial information or submitting clinical trial information that is false or misleading”. These regulations apply to results as well as registration and study status updates. By paying attention to all problems that are identified by the PRS, institutions can rectify errors and remain complaint with all regulations that govern clinical trial registration and results reporting.

scholarly journals Conducting an ongoing HIV clinical trial during the COVID-19 pandemic in Uganda: a qualitative study of research team and participants’ experiences and lessons learnt

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e048825
Author(s):  
Patience A Muwanguzi ◽  
Paul Kutyabami ◽  
Charles Peter Osingada ◽  
Esther M Nasuuna ◽  
Freddy Eric Kitutu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Qualitative Study ◽  
Private Security ◽  
Hiv Treatment ◽  
Private Security Companies ◽  
Research Activities ◽  
Lessons Learnt ◽  
Persons Living With Hiv ◽  
Study Team ◽  
Security Companies

ObjectiveTo explore the experiences and lessons learnt by the study team and participants of the Workplace-based HIV self-testing among Men trial during the COVID-19 pandemic in Uganda.DesignAn explorative qualitative study comprising two virtual focus group discussions (FGDs) with 12 trial team members and 32 in-depth participant interviews (N=44). Data were collected via telephone calls for in-depth interviews or Zoom for FGDs and manually analysed by inductive content analysis.SettingFourteen private security companies in two Uganda districts.ParticipantsMembers of the clinical trial study team, and men working in private security companies who undertook workplace-based HIV testing.ResultsThe key themes for participants experiences were: ‘challenges in accessing HIV treatment and care, and prevention services’, ‘misinformation’ and ‘difficulty participating in research activities’. The effects on HIV treatment and prevention resulted from; repercussions of the COVID-19 restrictions, participants fear of coinfection and negative experiences at health facilities. The difficulty in participating in research activities arose from: fear of infection with COVID-19 for the participants who tested HIV negative, transport difficulties, limited post-test psychosocial support and lack of support to initiate pre-exposure prophylaxis. The key study team reflections focused on the management of the clinical trial, effects of the local regulations and government policies and the need to adhere to ethical principles of research.ConclusionsFindings highlight the need to organise different forms of HIV support for persons living with HIV during a pandemic. Additionally, the national research regulators and ethics committees or review boards are strongly urged to develop policies and guidelines for the continuity of research and clinical trials in the event of future shocks. Furthermore, this study calls on the appropriate government agencies to ensure public and researchers’ preparedness through continuing education and support.Trial registration numberClinicaltrials.gov NCT04164433; Pre-results.

The influence of continuous local wound infusion on postoperative pain in patients undergoing transfemoral amputation

VASA ◽  
2015 ◽  
Vol 44 (5) ◽  
pp. 381-386 ◽  
Author(s):  
Christian Uhl ◽  
Thomas Betz ◽  
Andrea Rupp ◽  
Markus Steinbauer ◽  
Ingolf Töpel
Keyword(s):  
Pain Management ◽  
Pilot Study ◽  
Local Anaesthetic ◽  
Phantom Pain ◽  
Transfemoral Amputation ◽  
Postoperative Wound ◽  
Stump Pain ◽  
Management Protocol ◽  
Group 2 ◽  
Group 1

Abstract. Summary: Background: This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics. Patients and methods: We included 42 patients in this prospective observational pilot study. Patients were divided into two groups. One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment (Group 1). Group 2 was treated with analgesics in accordance with the WHO standard pain management protocol, exclusively. Results: The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group 1 for the first 5 days. Furthermore, the intake of opiates was significantly reduced in Group 1 (day 1, Group 1: 42.1 vs. Group 2: 73.5, p = 0.010; day 2, Group 1: 27.7 vs. Group 2: 52.5, p = 0.012; day 3, Group 1: 23.9 vs. Group 2: 53.5, p = 0.002; day 4, Group 1: 15.7 vs. Group 2: 48.3, p = 0.003; day 5, Group 1 13.3 vs. Group 2: 49.9, p = 0.001). There were no significant differences between the two groups, neither in phantom pain intensity at discharge nor postoperative complications and death. Conclusions: Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation. Phantom pain was not significantly affected.

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