This section of the Living Textbook contains a series of tools for conducting pragmatic clinical research, many of them developed by the NIH Collaboratory and our partner organizations. These tools, guidances, and other resources are also available via the Collaboratory Knowledge Repository. Sets of tools are organized by their broad topic area, and include the following:
Assessing Data Quality for Healthcare Systems Data Used in Clinical Research
DescriptionThis white paper from the Collaboratory’s Phenotypes, Data Standards & Data Quality Core provides guidance, based on the best available evidence and practice, for assessing data quality in pragmatic clinical trials (PCTs) conducted through the Collaboratory. Topics covered include an overview of data quality issues in clinical research settings, data quality assessment dimensions (completeness, accuracy, and consistency), and a series of recommendations for assessing data quality.
Biostatistical Guidance Documents
DescriptionThis biostatistics research tool set includes a series of guidance documents developed by the Collaboratory Biostatistics and Study Design Core. These documents, which focus on detailed aspects of statistical design for conducting pragmatic clinical trials, provide a brief synthesis of current developments, discuss possible future directions, and, where appropriate, make recommendations for application to pragmatic clinical research.
Datasets for ClinicalTrials.gov Analyses
DescriptionAs part of a project that examined the degree to which sponsors of clinical research are complying with federal requirements for the reporting of clinical trial results, the Clinical Trials Transformation Initiative (CTTI) and the authors of the study are making the primary datasets used in the analysis available to the public.
Demonstration Project Interviews
DescriptionThe NIH Collaboratory conducted a series of interviews with principal investigators of its first round of pragmatic clinical trial Demonstration Projects. The purpose was to share challenges and lessons learned in trial implementation that may help future pragmatic trials.
Electronic Phenotype Definitions & Resources
DescriptionThe Collaboratory Phenotypes, Data Standards, and Data Quality Core is reviewing authoritative sources of electronic phenotype definitions and providing recommendations for the identification and reporting of patient characteristics and clinical conditions. These recommendations and supporting information are intended to promote data standards and help researchers make informed decisions about using electronic health record data for secondary purposes.
Ethical and Regulatory Issues in Pragmatic Clinical Trials
DescriptionA series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials was published in the October 2015 issue of Clinical Trials. The project was supported by the NIH Collaboratory, with additional support from the Patient-Centered Outcomes Research Institute. This page provides background information on the project, along with links to each of the articles.
Introduction to Pragmatic Clinical Trials
DescriptionThe Collaboratory’s Health Care Systems Interactions Core has released a brief slide set titled “Introduction to Pragmatic Clinical Trials: How Pragmatic Clinical Trials Bridge the Gap Between Research and Care.” The presentation provides an overview of the nature and distinctive features of pragmatic clinical trials, or PCTs, and examines their role in filling in gaps in clinical knowledge and informing both clinical practice and healthcare policy.
Lessons Learned from the NIH Collaboratory Demonstration Projects
DescriptionThe NIH Collaboratory Health Care Systems Interactions Core has developed a document that presents problems and solutions for PCT initiation and implementation that were developed by drawing on trial-specific experience from the NIH Collaboratory Demonstration Projects. These lessons were shared at the 2015 Collaboratory Steering Committee meeting and based on material from Collaboratory publications.
Patient Bathing Video from the ABATE Infection Project
DescriptionThis video shows how to bathe patients using 2% chlorhexidine gluconate cloths. Daily bathing will help protect patients from infection during their hospital stay. From the Active Bathing to Eliminate (ABATE) Infection project.
Patient-Reported Outcomes Tools
Description
The Collaboratory Patient-Reported Outcomes (PRO) Core and the PCORnet Patient-Reported Outcomes Task Force have developed several white papers in keeping with their mission to provide and develop strategies, tools, and resources related to the measurement, collection, and analysis of patient-generated health information, including patient-reported outcomes data.
Description
As the use of PROs in both research and routine patient care has grown, so has the use of mobile technologies (such as smartphones, tablet computers, and portable or wearable medical devices). These technologies, known collectively as “mobile health” (mHealth) devices, present a wide array of challenges and opportunities for medical research. This page contains links for a series of short video segments on mHealth technologies that were adapted from a larger web seminar sponsored by AcademyHealth and the Robert Wood Johnson Foundation and used here with kind permission from AcademyHealth.
Description
This slide presentation illustrates how to use an application programming interface (API) to create a computer adaptive testing (CAT) program that integrates PRO measures with your institution’s electronic health record (EHR) system. With a CAT approach, PRO assessment can cover a wide range of question/response items with increased precision. The authors describe a clinical use case for a mobile health solution.
PCT Reporting Template
DescriptionIn this template, users will find descriptions of reporting elements based on CONSORT guidance as well as on expertise from the NIH Collaboratory Demonstration Projects and Cores and Working Groups.
Pragmatic Trials eBook
DescriptionThe Center for Research in Implementation Science and Prevention (CRISP) at the University of Colorado has produced an eBook on pragmatic clinical trials covering topics including pragmatic trial design, study populations and settings, and real-world use. Methods for stakeholder engagement are also reviewed. The content is offered as self-study modules for researchers.
Training Front-Line Staff and Clinicians
DescriptionA guidance document, entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures, provides information to help pragmatic clinical trial teams plan training for study procedures that involve front-line clinicians and staff. The guidance was developed by the NIH Collaboratory Health Care Systems Interactions Core, drawing on trial-specific experience from the NIH Collaboratory Demonstration Projects.
Using the RxNorm System
DescriptionThe National Library of Medicine’s RxNorm is a free, publicly available resource that provides “normalized” names for brand-name and generic drugs and supplies a unique identifier for each entity that makes it possible to clearly identify a given drug. In this research tool, we offer an overview of RxNorm and explore the application of a number of its associated tools in the research setting.
Writing for the Clinical Research Setting
DescriptionThis page collects a series of recorded webinars (available as streaming video at the link above) originally offered in the fall of 2014 as part of the National Patient-Centered Clinical Research Network’s (PCORnet) “Office Hours” program. The webinar series is presented by Jonathan McCall, MS, Managing Editor for Rethinking Clinical Trials and a senior science writer and editor for the Duke Clinical Research Institute. Each presentation provides a practical introduction to a particular facet of writing for the clinical research environment.
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