Transcript of the Video Presentation

We start our demonstration of the BTRIS prototype, by clicking on the BTRIS demonstration link in the BTRIS home page and we log in using the NIH ID and password provided by the BTRIS team. Prior to logging on, please read the disclaimer to see the limits of use of the material in the BTRIS demo. Once you log in you will see a set of folders. And the reports are organized in these folders. We will start with the summary reports folder. In the summary reports folder, we see 3 reports. Let’s start with the IRB inclusion report.

Once we have selected the report, we will be prompted for the protocol that we are interested in. We will pick protocol 232, and we will run the query. It will return the report in the standard IRB format.

We can then save this document on our computer as a PDF file for printing out later or sending electronically to the IRB. Let us go back to our document list, and we will pick a different summary report, this time the demographics report. We will select a protocol number, select 232, and we can select different age limits or other subcategories, but we will look all the data from this protocol and we can see data broken down in various categories in tabular or graphical form, ethnic group, marital status, age ranges, and so on. Then we can drill down these categories if we wish, for instance, a particular age group and the marital status within that age group, by gender, and we can drill down further to see the religions of the various subjects.

Let’s go back to our document list, and now we move on to clinical data that has been collected on the subjects. We will start with laboratory reports. We have four canned laboratory reports. The first one is the Chem 20 report. Let us select that, and we select a protocol. Let’s select protocol 208, run the query and we get all the Chem 20s for everyone in the protocol. Let me scroll over so that we can see all the columns, and scroll down to get a sense of the length of this reports. Actually this is the first page of this report that has the first 100 results, and if we click up here there are about 3 pages of reports, so there are over 200 Chem 20s in this report. We can look at how the data will be graphed, and we can also save this report in various formats. Of course the PDF format as before, but we can also save it as an excel spreadsheet or as a comma separated value format that can be imported into a statistical package. We can also send the report by email or to a default or a specified file server using file transfer protocol using a password and so on. We return to our document list. We can now select the CBC and Differential which is similar to the Chem 20 report. We have the ability to create similar reports for various subsets of data.

Now, let’s go back to a report which allows us to decide which test we want. In this case, we are interested in sodium tests, for a set of patients. We don’t know if we want whole blood, serum sodium, plasma sodium, so we will pick a class of tests, in this case sodium intravascular test, and we will pick a particular subject that we are interested in. So we will go into family name and we will look into protocol number 505 and look for a particular patient named Amelia. These of course are fictitious names and select all sodium tests for Amelia. We can see we got tests from CDR, CRIS and if we scroll down we can see that these are from a variety of tests like Chem 20 panel and acute care panel. Now if we go down to the next page, we can see data that has come from CRIMSON, CRIS and CDR. Let’s move on to other clinical data types. We will look at the medications report, which has the medication administration data for patients. Let’s say we are interested in all the antibiotics that our patients may have taken. So again we select data by class. And we see here antibiotic, and we are interested in all antibiotics for a particular protocol. Let’s say we are interested in protocol 590, and select that and then we run the query. We can see we have antibiotic results from various sources like CRIMSON, and also from CRIS. Returning to my document list, we move on to the next set of data, in this case the allergies report. In this case I am interested in a particular protocol, say 505, select all the patients by selecting the first one, and holding the shift key, scrolling down and selecting the last name at the end of the list. Then move on to selecting allergies. I am interested in penicillin allergies, so I type in penicil, and I see there are actually three different allergies, penicillamine, penicillin and penicillins. And I can select all of those, run my report, and now I have a list of all the penicillin allergies for all the patients in the protocol.

And now I move on to the next report, the radiology results standard report. And once again, I will select a list of patients that I am interested in, from a protocol. I will select from protocol 505 again, and once again select all patients in the list. And I am interested in the MRI results. So I type in MRI, and I see a list of all available reports, and I select all of these. And I run my query. And the resulting report shows me the number of different items, with the result text over to the right here, and if I scroll down I can see I have got MRIs of the brain, knee, the chest, the shoulder and so on. In fact, in this report, if I go to the last page, I can see that I have got 32 pages of results, which means that I have got over 3100 reports in this data set, which I can now save to my computer as an excel spreadsheet or as a comma separated value file and so on. Returning to my document list, we will choose the last category here, the vital signs standard report. Now again, we select a protocol to get a list of patients we are interested in, and in this case, I will choose protocol 208, so I will open that up. And there is a relatively short list of patients there that I will select. And I am interested in blood pressure and heart rate, so I will look at the list of possible choices. And I see blood pressure diastolic, and if I scroll down I see a list of all possible systolic and diastolic blood pressure measurements. I will select all of those. And if I scroll further down to find the heart rate, I see heart rate/pulse, and if I scroll down, I see there are several different possibilities. I am going to select all of those, copy those over to my selection window, and run my query. And I see all the blood pressures and pulses for the set of patients.

Next we return to our list of documents, and we go to the summary reports folder, and we click on the clinical trials.gov report. This report is currently a mock up of the kind of report you will need to produce for the clinical trials.gov website when reporting the results of your clinical trials. We see there are four categories here – baseline measures, demographics, participant workflow in the study, other outcome measures, and adverse events. This is the type of data that will be collected by clinicaltrials.gov. Once you produce your report, you can then send it to clinicaltrials.gov by email or ftp. And finally, we considered a couple of reports that might be helpful for protocol development. First of all, the subject recruitment report, in which we can specify the age range of patients for instance. Here we selected 18 to 65 years, and maybe patients in that age range who had a particular test, like the hydroxyindoleacetic test, the HIAA. I will select that and run my report, and get a list of patients who might qualify for my protocol, patients who had an abnormal result on that test. Lastly we can do some hypothesis testing in hypothesis generation by looking at correlations in the database. Here we have a report that simply is looking at the occurrence of the word atrophy in any of the MRI reports or CAT scans and a low albumin result. And to see if there is a correlation between brain atrophy and albumin. So these data can be downloaded and analyzed.

And this concludes our demonstration of BTRIS, lets return to the document list. And we ask you to try out the various reports, and if you have comments, down at the bottom, you will see a little tab labeled discussion, and if you click on that, you can enter your comments about the system. We will appreciate your feedback. Don’t forget to log out when you are done.