Data entry training for a small clinical trial

1991 ◽  
Vol 12 (5) ◽  
pp. 706
Author(s):  
Scott D. Corley ◽  
Grace Ng ◽  
Mary Jo Gillespie
1999 ◽  
Vol 33 (4) ◽  
pp. 1061-1065 ◽  
Author(s):  
Roberto Scognamillo ◽  
Carlo Strozzi ◽  
Beatrice Vincenzi ◽  
Giuseppe Recchia

2017 ◽  
Vol 77 (08) ◽  
pp. 870-878 ◽  
Author(s):  
Markus Wallwiener ◽  
Felix Heindl ◽  
Sara Brucker ◽  
Florin-Andrei Taran ◽  
Andreas Hartkopf ◽  
...  

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.


2018 ◽  
Vol 108 (6) ◽  
pp. 458-465 ◽  
Author(s):  
Justin C. Parker ◽  
Rolf W. Scharfbillig ◽  
Sara Jones

Background: Xerosis (dryness) of the foot is commonly encountered in clinical care and can lead to discomfort, pain, and predisposition to infection. Many moisturizing products are available, with little definitive research to recommend any particular formulation. Methods: We compared two commonly prescribed moisturizing products from different ends of the price spectrum (sorbolene and 25% urea cream) for their effectiveness in reducing xerosis signs using the Specified Symptom Sum Score. A randomized clinical trial of parallel design was conducted over 28 days (February–May 2015) on 41 participants with simple xerosis. Participants, therapists, assessors, and data entry personnel were blinded to treatment, and allocation was determined via a randomization table. Results: Thirty-four participants completed the study (19 urea and 15 sorbolene), with one reporting minor adverse effects. There were statistically significant improvements in both groups after 28 days. Mean differences between pre and post scores were 3.50 (95% confidence interval [CI], 2.80 to 4.20) for the urea group and 2.90 (95% CI, 2.00 to 3.80) for the sorbolene group. There was a slightly lower mean posttreatment score in the urea group (1.16; 95% CI, 0.67 to 1.64) than in the sorbolene group (1.80; 95% CI, 1.25 to 2.35), but this difference was not significant (P ≤ .09). Effect size of difference was –0.48 (95% CI, –1.16 to 0.22). Conclusions: In this study, there was no difference between using sorbolene or 25% urea cream to treat symptoms of foot xerosis. A recommendation, therefore, cannot be made based on efficacy alone; however, sorbolene treatments are invariably cheaper than urea-based ones.


1994 ◽  
Vol 3 (2) ◽  
pp. 91-99 ◽  
Author(s):  
Michael J. Bohn ◽  
Henry R. Kranzler ◽  
Despina Beazoglou ◽  
Beth A. Staehler

BMJ ◽  
1986 ◽  
Vol 292 (6524) ◽  
pp. 899-900
Author(s):  
R A Dixon

BMJ ◽  
1986 ◽  
Vol 292 (6524) ◽  
pp. 899-899
Author(s):  
J. M. Thomas

2011 ◽  
Vol 33 (7) ◽  
pp. 953-978 ◽  
Author(s):  
Carol J. Farran ◽  
Caryn D. Etkin ◽  
Judith J. McCann ◽  
Olimpia Paun ◽  
Amy R. Eisenstein ◽  
...  

This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise® Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 38-38
Author(s):  
Elizabeth Anne Johnson ◽  
Jay C. Andersen ◽  
Sandy Smith ◽  
Bharat Patel ◽  
Susan S. Night ◽  
...  

38 Background: As an innovative industry leader of Research Site Management Organizations, US Oncology Research (USOR) sought to develop a best practice to support over 65 community practice network sites to comply with Sponsor data entry expectations. Efforts led by the Clinical Trial Manager (CTM) focused on bringing research site awareness to priority data, Sponsor deadlines, and weekly performance feedback via the ‘Healthy Data Habits Pathway’. Methods: The Healthy Data Habits Pathway was created to define the role of CTM involvement in data management operations on behalf of USOR. In collaboration with Sponsor, the USOR CTM reviewed data management reports weekly for data entry trends. Results: Two separate oncology clinical trials (different Sponsors) implemented the Pathway with renal and breast oncology indications. The renal trial demonstrated an almost 90% reduction in total query count for 8 sites in 7 months while the breast trial reported 7 of 14 sites (50%) meeting Sponsor goal of 20 or fewer total queries in 13 weeks. Interventions included emailed notifications, site manager calls, and weekly CTM-Sponsor collaboration teleconferences. Conclusions: Clinical research Sponsors and sites both strive towards maintaining data integrity in an ever-evolving atmosphere of complex oncology trials and increasingly-detailed data capture requirements. Implementation of Pathway interventions increases site and Sponsor engagement in daily data management operations. [Table: see text]


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