Category Archives: Research tools

New NIH Collaboratory resource for the transparent reporting of PCTs

Cluster Randomized Trials, Data quality, Electronic health records, Research reporting standards, Research tools, Writing and Publishing, , , ,

The NIH Collaboratory has developed a tool to assist authors in the complete and transparent reporting of their pragmatic clinical trials (PCTs). In the PCT Reporting Template, users will find descriptions of reporting elements based on CONSORT guidance as well as on expertise from the NIH Collaboratory Demonstration Projects and Core working groups.

Particularly relevant to PCTs are recommendations on how to report the use of data from electronic health records. Other elements of importance to PCTs include reporting wider stakeholder engagement, monitoring for unanticipated changes in study arms, and specific approaches to human subjects protection. The template contains numerous links to online material in the Living Textbook, CONSORT, and the Pragmatic–Explanatory Continuum Indicator Summary tool known as PRECIS-2.

This resource is intended to assist authors in developing primary journal publications. It will be updated over time as new best practices emerge for the transparent reporting of PCTs.

Download the PCT Reporting Template.

Please note: this document opens as an Adobe PDF. If you do not have software that can open a PDF, click here to download a free version of Adobe Acrobat Reader.

This work was supported by a cooperative agreement (U54 AT007748) from the NIH Common Fund for the NIH Health Care Systems Research Collaboratory. The views presented in this document are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Originally published on September 1, 2016.

  • Questions or comments can be submitted via email. Please add “Living Textbook” to the Subject line of the email.

Collaboratory phenotypes paper published in eGEMs special issue

Clinical trials, Data standards, Electronic health records, Learning health systems, Research tools, , , ,

A recently published special issue of eGEMs explores strategic uses of evidence to transform healthcare delivery systems. In A Framework to Support the Sharing and Re-Use of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications, Rachel Richesson and Michelle Smerek of the NIH Collaboratory’s Phenotypes, Data Standards, and Data Quality Core, along with coauthor C. Blake Cameron, envision an infrastructure that facilitates re-use of computable phenotypes in a learning healthcare system.

The authors elaborate on four required components of the framework:

  • Searchable libraries of explicitly defined phenotype definitions
  • Knowledge bases with information and methods
  • Tools to identify, evaluate, and implement existing phenotype definitions
  • Motivated users and stakeholders

Read the entire eGEMs open access publication here. eGEMs (Generating Evidence & Methods to improve patient outcomes), a product of AcademyHealth’s Electronic Data Methods (EDM) Forum, is a peer-reviewed, open access journal that seeks to accelerate research and quality improvement using electronic health data.

Related resources:

You can find extensive information on computable phenotypes in the Living Textbook chapter and in Tools for Research.

ABATE Infection Study Team Releases Training Video

Cluster Randomized Trials, Comparative Effectiveness Research, Research tools, , ,

The Actiabate_fa_tag copy 2ve Bathing to Eliminate (ABATE) Infection trial was conducted in nearly 200 non-critical care hospital units across the United States. The ABATE study team developed a training video to teach nurses and nursing assistants how to approach patients to administer a bath with a topical antiseptic agent containing chlorhexidine (CHG), or help patients take a shower using the liquid CHG soap.  If the results of the trial demonstrate a reduction in unit-attributable infections or multi-drug resistant organism (MDRO) burden for the intervention units, this video could be used to train nurses and staff to implement CHG bathing in healthcare systems around the nation.

The ABATE trial (ClinicalTrials.gov #NCT02063867) is a large-scale, cluster-randomized pragmatic clinical trial (PCT) designed to assess a bathing approach for reducing multidrug-resistant organisms and hospital-associated infections (HAIs) in patients hospitalized in non-critical care units. Patients were bathed either according to the hospital unit’s usual care procedures (the control group) or bathed with a topical antiseptic agent containing chlorhexidine (CHG; the intervention group). Patients in the intervention group could shower using liquid CHG soap and a mesh sponge, or have a self-assisted or nurse-assisted bed bath using the CHG cloths. If a patient in the intervention group was colonized with, infected with, or had a recent history of methicillin-resistant Staphylococcus aureus (MRSA), the antibiotic mupirocin was additionally administered nasally for 5 days.

The investigators hypothesize that this regimen will reduce the burden of vancomycin-resistant enterococci (VRE) and Staphylococcus aureus (MRSA) in these units and translate to a reduction in overall bloodstream and urinary tract infections. They will also evaluate its ability to reduce antibiotic-resistant gram-negative bacteria and Clostridium difficile.

The ABATE Infection Trial has been conducted in hospitals in the Hospital Corporation of America (HCA) health system and is an NIH Health Care Systems Research Collaboratory UH3 Demonstration Project supported by the National Institutes of Allergy and Infectious Diseases (NIAID) and the Common Fund at the National Institutes of Health. This video was created and scripted for the trial by study investigators and filmed by Sage Products, LLC.

Watch the training video here.

NIH & FDA seek feedback on new clinical trial protocol template

Clinical trials, Institutional review boards, Randomized controlled trials, Research tools, , , ,

As part of their ongoing effort to improve the speed and efficiency of conducting clinical trials, the NIH-FDA Joint Leadership Council has created a draft clinical trial protocol template. The template contains instructional and sample text intended to assist NIH-funded investigators in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Feedback is sought from investigators, investigator-sponsors, institutional review board members, and other stakeholders involved in protocol development and review.

Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them. – Dr. Pamela McInnes, NIH

Details on the rationale and development of the protocol template are on these blog posts:

Notice Number: NOT-OD-16-043. Responses accepted through April 17, 2016.

You can access the template document as well as a template shell, comment form, and other resources at NIH’s Clinical Research Policy website.

New Lessons Learned Document Draws on Experiences of Demonstration Projects

Electronic health records, Institutional review boards, Pragmatic clinical trials, Regulatory issues, Research tools, , , , , , ,

The NIH Collaboratory’s Health Care Systems Interactions Core has published a document entitled Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects. The Principal Investigators of each of the Demonstration Projects shared their trial-specific experience with the Core to develop the document, which presents problems and solutions for initiation and implementation of pragmatic clinical trials (PCTs). Lessons learned are divided into the following categories: build partnerships, define clinically important questions, assess feasibility, involve stakeholders in study design, consider institutional review board and regulatory issues, and assess potential issues with biostatistics and the analytic plan.

Other tools available from the Health Care Systems Interactions Core include a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures and an introduction to PCTs slide set.

New Guidance Document on Training Front-Line Staff & Clinicians in PCTs

Pragmatic clinical trials, Research tools,

Tools for ResearchThe NIH Collaboratory’s Health Care Systems Interactions Core has published a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures. The purpose of this guidance is to help pragmatic clinical trial (PCT) teams plan training for study procedures that involve front-line clinicians and staff. The content was developed by drawing on trial-specific experience from the NIH Collaboratory Demonstration Projects. The document describes how training for PCTs will differ from training conducted for typical research studies, and includes a list of specific considerations, real-world examples, a checklist for PCT training design, and links to additional resources.

Other tools available from the Health Care Systems Interactions Core include an introduction to PCTs slide set.

New Biostatistical Guidance Document Available: Small-Sample Robust Variance Correction for GEE

Biostatistics, Cluster Randomized Trials, Guidance document, Pragmatic clinical trials, Research tools, , , , , , ,

Tools for ResearchThe NIH Collaboratory’s Biostatistics and Study Design Core has just published a new guidance document by Andrea Cook, PhD, of the Group Health Research Institute, on using small-sample robust variance correction for generalized estimating equations (GEE) for use in cluster-randomized trials. The document, which includes guidance on methods available in the SAS and Stata statistical analysis packages, is available directly from the NIH Collaboratory Knowledge Repository here (opens as PDF), or via the Biostatistical Guidance Documents page in the Living Textbook.

This guidance document is one in a series of research tools focused on detailed aspects of statistical design for conducting pragmatic clinical trials. Each document in this series provides a synthesis of current developments, discusses possible future directions, and, where appropriate, makes recommendations for application to pragmatic clinical research.

Mobile Health (mHealth) Research Platform to Launch

Health analytics, Mobile Health (mHealth), Patient engagement, Patient-Reported Outcomes, Research tools, , , ,

In recent health information technology news, the University of California, San Francisco (UCSF), has received a 5-year National Institutes of Health award to support its launch of a cardiovascular mHealth platform. The research platform, to be named Health ePeople, will build on the successes of UCSF’s Health eHeart Study, which began in 2013. That study, with more than 30,000 participants worldwide, uses the power of mobile technologies to collect cardiovascular data and patient-reported outcomes (PROs) from study participants.

The Health ePeople platform will advance mHealth by providing researchers with easy access to a large cohort of volunteers, along with a quick, affordable means for collecting their health data through mobile and wireless technologies. Though the platform will not be ready to enroll new participants for several months, people who want to participate in the cohort can sign up through the Health eHeart Study website.

For information and short videos on mHealth technologies, visit the Living Textbook’s chapter on mHealth and PROs.

Minimizing the Burden of Practical Research: Case Studies from the NIH Collaboratory

Pragmatic clinical trials, Research tools, , ,

In a forthcoming article in Healthcare, Dr. Eric Larson and colleagues present practical advice based on case studies from the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Physician–scientists, health services researchers, and delivery system leaders provide insight from their experience launching a pragmatic clinical trial (PCT) as part of the Collaboratory.

The authors make 5 recommendations:

  • Establish a partnership from the get-go
  • Do a pilot project
  • Take advantage of existing hospital and health system infrastructure
  • Minimize the impact on clinical workflow
  • Remember that even high-priority research questions must be balanced with the systems’ greatest priority: providing good healthcare to patients.

The authors note that researchers need to be flexible and prepared to adjust the study design to the workflow and culture of the system.

Reference: Larson E, Tachibana C, Thompson E, et al. Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. Healthcare. 2015; in press. doi:10.1016/j.hjdsi.2015.07.005

Watch Dr. Larson’s Grand Rounds Presentation from June 2013: Trials, Not Tribulations: Minimizing the Burden of Research on Health Care Systems

Patient-Reported Outcomes Workshop Report Available

Clinical outcomes, Clinical trials, Comparative Effectiveness Research, Patient-Centered Outcomes Research, Patient-Reported Outcomes, Pragmatic clinical trials, Research tools, , , , , , , , , ,

Tools for ResearchIn January of 2015, the NIH HCS Collaboratory’s Patient-Reported Outcomes (PRO) Core Group convened a 2-day workshop in Baltimore devoted to identifying barriers and possible solutions to the use of NIH-supported PRO tools in comparative-effectiveness research (CER).

Findings from the meeting, which include case study presentations and reflections from multiple stakeholders representing the research, clinical, and patient communities, were distilled into a summary document available from the NIH Collaboratory Knowledge Repository at the link below:

The workshop summary is also available on the Living Textbook’s “Tools for Research” section, under “Patient-Reported Outcomes White Paper.”