FAQ

 

What is NEAR?
What do I do if I encounter a problem with online data entry or cannot enter online data?
Who should enter the NEAR data if multiple courses of intubation were required?
What should I do if I didn’t perform Intubation Difficulty Scale measurements prior to patient intubation?
What is the best way to ensure compliance?
What should I do if I identify an intubation that was not entered into the NEAR database?
I have a proposal for publication and would like to use data from the NEAR database. How can I obtain access to these data?
How do I get a login and password for NEAR?
How do I get access to my site’s data?
I have a username and password that grants me administrative privileges. How can I access and/or change data existing for my center?
I submitted data and then realized that I made a mistake. How can I correct the error?
How can I access data entered for other centers using administrative privileges?
We would prefer to use paper data forms to collect data in the ED. Is this permissible?
Our center is interested in participating in NEAR. How can we learn more about what this entails?

What is NEAR?

Based at Brigham and Women’s Hospital, a major Harvard teaching hospital in Boston, Massachusetts, the National Emergency Airway Registry (NEAR) is an ongoing, multicenter study of Emergency Department (ED) intubations. NEAR was initiated in 1996 to characterize emergency department airway management. Until the first phase of the NEAR study was completed, the largest prospective study of emergency department endotracheal intubation had been by Sakles, et al of 610 patients from a single emergency department. The first phase of the NEAR study prospectively enrolled 1,288 patients from 11 emergency departments in the United States and Canada. The primary objectives of NEAR I were to establish a reliable methodology for a large emergency airway management database, and to begin more comprehensive characterization of the practices, personnel, drugs, equipment, success and complication rates, and outcomes of intubation done in the ED. With this accomplished, NEAR II was begun in September 1997 and ran until early 2002, collecting data on over 8,000 emergency department intubations from over 30 centers in the USA, Canada and Singapore. This information provides unprecedented insight into current practice in emergency airway management. Data collected through the NEAR database provided the first multi-center characterization of emergency airway management and offered a compelling look at the indications, methods, personnel, and success rates. The third phase, NEAR III,was the most the most ambitious study to date, and served to collect data from almost every intubation performed in the ED of each participating center including difficult airway predictors, intubation events, and an Intubation Difficulty Scale to assess the difficulty of the intubation after it was completed. NEAR III incorporated several innovative changes such as an “intelligent” online data entry system, utilizing over 40 internal checks to ensure accurate data collection, and an intuitive query system with a variety of filters. Compliance was monitored during NEAR III to ensure a robust and representative data set. NEAR (NEAR III) focused specifically on the development of a clinical tool to predict difficult emergency endotracheal intubation. NEAR has also provided insight on drug dosing for RSI, pre-hospital intubations, pediatric intubations (NEAR4KIDS) and video-assisted laryngoscopy. The upcoming phase of NEAR will be using StudyTRAX, a new online database retrieval system which will provide standardized quality management reports to each center on demand, allowing analyses of practices and outcomes for that center with the potential for multi-center comparisons. StudyTRAX will also serve as an online secure database for entering and storing data.
Brigham and Women’s Hospital is the coordinating center through which all compliance monitoring, requests for multi-center data and data storage will occur. Requests for multi-center data can be made through the “Research and Publications” link on the NEAR website, and NEAR representatives at BWH will work with site investigators to aid participating centers in meeting compliance requirements.

What do I do if I encounter a problem with online data entry or cannot enter data online?

Make sure you are using Mozilla Firefox.  You can also use Internet Explorer, as long as you’re not using IE7 or earlier.  If you are using IE to access StudyTRAX, your use of the latest version of IE would be ideal. Check your Internet connection: are you able to access other online sites? Wait a few minutes and again attempt to enter data. If you still encounter problems, contact Andrea Fantegrossi at afantegrossi@partners.org. In the meantime, if you can, print a copy of the data form available on the NEAR website, www.nearstudy.net, under the “Downloads” toolbar. Fill out paper forms until proper access is restored. Enter the data from the paper form into the online database once the problem is resolved.

Who should enter the NEAR data if multiple courses of intubation were required?

If multiple physicians participated in a single patient encounter, the attending physician with responsibility for the overall management of the patient, or his/her designated resident, who was present for, performed, or oversaw the intubation, should enter the data for all attempts, after ensuring that accurate information (e.g., laryngoscopic view) has been obtained from all physicians who attempted to intubate.

What should I do if I didn’t perform Intubation Difficulty Scale measurements prior to patient intubation?

Check the box labeled “Not Assessed,” for each element of the Intubation Difficulty Scale measurements that was not assessed, where this question is available. Try to reinforce among all residents and attendings at your hospital the importance of performing the pre-intubation IDS measurements. Do not make up an entry or guess at what the answer should be.

What is the best way to ensure compliance?

Give periodic verbal or written reminders to residents and attendings about the necessity to enter NEAR data for EVERY intubation performed in the ED. In addition to entering every intubation in the NEAR online database, keep a paper logbook, where every intubation is logged (include the intubator, date, and patient MRN), and use this as a cross-checking mechanism. Cross-check the NEAR logbook with the online database, then cross-reference by querying CPT codes for intubation electronically or through your medical records department. If your residents maintain a procedure log, this can also provide a valuable means of cross-checking. Another essential part of compliance is identifying incomplete data submissions, contacting the responsible physician for that entry, and ensuring that he or she enters the missing data (going back to the medical record if necessary to ensure accuracy).

What should I do if I identify an intubation that was not entered into the NEAR database?

Locate the intubating physician, have him/her review the patient chart and notes, and ask that physician to enter the intubation data. Please note that we require that intubation data be entered within four weeks to the day of the intubation event. Data entered beyond this point is considered noncompliant and should be omitted.

I have a proposal for publication and would like to use data from the NEAR database. How can I obtain access to these data?

Go to the NEAR website , then select Research and Publication Form. Follow the instructions on the form to enter your research proposal and data request. Submit the form electronically to afantegrossi@partners.org. The Research and Publications Committee, which consists of several NEAR site investigators and Ron Walls, MD, principal investigator for NEAR, will consider proposals on a monthly basis. Once the committee approves your proposal, make a specific request for the needed data to afantegrossi@partners.org. A data query specialist from the NEAR team at Brigham and Women’s Hospital will query the database to obtain the data you need. If the data query specialist is one of the BWH NEAR investigators, he or she will generally perform the data extraction and participate in the writing of the manuscript with the proposing author(s). If the proposing authors wish to write the study without the assistance or participation of any additional authors, the data query can be done by a database expert and the proposing author will be advised in advance of estimated charges for the retrieval.

How do I get a login and password for NEAR?

NEAR headquarters will assign each participating site a multi-user, center-specific login and password once the center has turned in all the necessary prerequisites to joining NEAR (Letter of Agreement, Letter of Publications, compliance plan, and IRB approval). Site investigators will be provided this multi-user login information via email. The site investigator should then distribute this login to all attendings and residents who may perform intubations in the ED. This login is basically an ID tag that prevents users from one center from entering data for a different site, and from accessing another center’s data. Additionally, site investigators (and compliance personnel, if applicable) will receive an administrative center-specific login with greater permissions through which they will be able to access information that will be unavailable to other intubators. For instance, site investigators will be able to access site-specific data obtained through running reports, while other intubators will not be able to access this information through the multi-user, center specific login.

How do I get access to my site’s data?

Per the above, NEAR headquarters will assign the site investigator (and compliance person, if applicable) an administrative username and password, which will be sent by email. The administrative username and password should only be known by the site investigator and the site’s designated compliance person. By signing in to the StudyTRAX website with the administrative password and running the appropriate reports, the data for your center can be viewed. It also enables the user to retroactively fix forms that are incomplete, and to edit erroneous data (see below).

Below, please find a link to a video tutorial explaining how to access reports for your center. Please scroll down to the video titled “Reports” in order to access this information.

http://www.sciencetrax.com/support/get-started/new-users/studytrax-basics/roles/

I have a username and password that grants me administrative privileges. How can I access and/or change data existing for my center?

Go to the StudyTRAX login page, accessible through the NEAR homepage. From here, please follow the below steps:

To add a subject,

  • Login
  • Click “Home”
  • Click “New Subject” in gray toolbar
  • Click “Save and Return”
  • Click big Orange “Enroll” button
  • Click “Edit Subject” in gray toolbar
  • Save

To change data existing for your center:

  • Login
  • Click on ID of patient whose data you wish to change
  • Click “Attributes” time in lefthand pane
  • To edit data, click on “Edit Subject” icon in gray pane at top of page
  • Save changes

Please note that for intubators who are not site investigators or compliance personnel, these steps should be taken to enter missing data rather than change existing data. In order to edit data which was entered in error, please contact your compliance person or the site investigator for your center.

In order to view reports which may alert you to missing data, please access the “Reports” tab at the top of the homepage. From here, you will find a list of available reports which reflect the data from your site. Reports can also be accessed through accessing the home page, selecting the project (NEAR), and clicking on the reports displayed in the “Reports” box on the right-hand side of the page. Please note that these reports will not be available to all users, but each center’s site investigator will be able to access these reports with the administrative login information.

For more detailed instructions, please access the StudyTRAX tutorial video at http://www.sciencetrax.com/support/get-started/new-users/studytrax-basics/data-entry-basics-video/.

I submitted data and then realized that I made a mistake. How can I correct the error?

Simply inform either the compliance person or the principal investigator for your center. They have authorization to make changes to submitted data. DO NOT fill out and submit another form for the same intubation.

How can I access data for other centers using administrative privileges?

You cannot access any data not entered at your center. The user with administrative privileges can access data entered at his or her center only. If you have a data query request, submit your research idea via the Research and Publications Form. Once it has been approved, submit the specifics of your data request to afantegrossi@partners.org.

We would prefer to use paper data forms to collect data in the ED. Is this permissible?

Data can be collected in the ED on paper forms, which will be available for download on the NEAR website once they are finalized. However, the data from each paper form must be entered into the online database as soon as possible to increase the likelihood that the intubating physician will have good recall of the intubation if data are missing or questionable.  It is strongly suggested that direct data entry into the electronic NEAR database be used for the upcoming phase of NEAR.  The NEAR forms will use conditional logic which will populate additional questions based on how certain inquiries are answered, so the use of paper forms before entering data into the NEAR database may eventually result in confusion and missing data.

Our center is interested in participating in NEAR. How can we learn more about what this entails?

For information on requirements for participation, email Andrea Fantegrossi at afantegrossi@partners.org. Serious inquiries only, please.