Showing papers on "Case report form published in 2011"
TL;DR: This project transformed an existing but underused and poorly accessible CRF library into a resource capable of supporting and expediting clinical and translational investigation at the authors' institution by expanding access to the entire institution, adding more form attributes for improved information retrieval, and creating a formal information curation and maintenance process.
Abstract: Background Case report forms (CRFs) are used to collect data in clinical research. Case report form development represents a significant part of the clinical trial process and can affect study succ...
16 citations
TL;DR: In CTN trials, the relationship between assessment burden on participants and length of trial, and recruitment and retention is not as strong and direct as expected, and other factors must impinge on the conduct of the trial to influence trial participation.
Abstract: Background: Recruitment and retention in randomized clinical trials are difficult in general and particularly so in trials of substance abuse treatments. Understanding trial design characteristics that could affect recruitment and retention rates would help in the design of future trials. Objective: To test whether any of the following factors are associated with recruitment or retention: type of intervention, type of therapy, duration of treatment, total duration of trial, number of treatment sessions, number of follow-up visits, number of primary assessments, timing of primary assessments, number of case report form (CRF) pages at baseline, and number of CRF pages for the entire trial. Methods: Recruitment and retention data from 24 Clinical Trials Network (CTN) trials conducted and completed between 2001 and 2010 were analyzed using single-factor analysis of variance and single-predictor regression methods to test their association with trial design characteristics. Results: Almost all of the analyses ...
12 citations
TL;DR: The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer.
Abstract: Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. German Clinical Trial Register Number: DRKS00000040
8 citations
TL;DR: Using the PCCTC BS tool to standardize data capture and operationalize PCWG2 radiographic progression criteria, imaging data are more completely reported and workload for study research staff decreased.
Abstract: 121 Background: PCWG2 Concensus Criteria proposed time-to-event endpoints in early phase clinical trials. Chief among these was time to radiographic progression for bone scintigraphy (BS), based on a standardized definition with additional rulesets to account for early flare. The PCCTC created a tool to operationalize these definitions in clinical trials. We tested the impact of the tool on clinical trial workload and data adequacy. Methods: The BS capture tool was vetted and amended through nine versions by a multidisciplinary group from PCCTC participating institutions. Accruals at Memorial Sloan-Kettering Cancer Center on two phase III trials using the same drug, contracting research organization (CRO), and electronic data capture system were analyzed. The first trial did not use the PCCTC tool. The second incorporated the tool in its data collection plan and case report form. Workload and data capture adequacy for each trial were determine by examining the total number of imaging queries from the data...
7 citations
01 Jan 2011
TL;DR: This chapter focuses on the data-capture, reporting and query aspects of clinical data management, as these are the components that benefit from metadata.
Abstract: Clinical Study Data Management Systems (CSDMSs) support the process of managing data gathered during clinical research. Clinical research involves much more than clinical data management – for example, research-grant tracking and reporting to the sponsor and to institutional review boards (IRBs, also called Human Investigations Committees) as well as financial management. I’ll focus on the data-capture, reporting and query aspects, as these are the components that benefit from metadata.
4 citations
Patent•
17 Aug 2011
TL;DR: A clinical trial service system using electronic reports and method thereof are provided to reduce the design period of a clinical trial by creating various electronic reports using and by enabling the clinical trial researcher to use a metadata.
Abstract: PURPOSE: A clinical trial service system using electronic reports and method thereof are provided to reduce a design period of a clinical trial by creating various electronic reports using and by enabling a clinical trial researcher to use a metadata. CONSTITUTION: A clinical trial operation management server(2610) relays production of the electronic reports using a clinical test meta data. The clinical trial operation management server stores and manages a data according to a clinical test situation progress of subjects. A electronic case report generation server(2620) gives the production of the electronic reports to a user terminal. A clinical trial data collection server(2630) collects a clinical trial data.
4 citations
TL;DR: In this study of patients with non-ST-segment elevation acute coronary syndromes who were undergoing an early invasive management strategy, it was unable to demonstrate an association between adverse ischemic outcomes with the timing of antithrombin administration, however, there was an increase in bleeding outcomes as time to antithROMbin administration increased.
3 citations
Patent•
22 Mar 2011
TL;DR: In this article, an automated method is provided of generating a report of data collected from multiple sources during a clinical trial, which includes a plurality of different data fields including case report forms associated with the patients.
Abstract: An automated method is provided of generating a report of data collected from multiple sources during a clinical trial. The data includes a plurality of different data fields. A plurality of patients participate in the clinical trial. A first set of data obtained from case report forms associated with the patients is received at a processor. The case report forms are one source of data. A second set of data obtained from at least one source other than the case report forms is also received at the processor. At least some of the data in the first and second set of data include data associated with the same data fields. The processor identifies any mismatches in data associated with the same data fields in the first and second set of data. Mismatches associated with data fields obtained from the same case report forms are electronically grouped. A report is then generated of the data. The report shows the status of mismatches for each case report form or type of case report form.
3 citations