How to Obtain, Enter and Score Rome III Diagnostic Questionnaire Data Using SAS

The Rome Foundation is pleased to offer a means to score the Rome III Diagnostic Questionnaire using SAS programming. Please follow the instructions below for details. We recommend that this be done by someone thoroughly familiar with SAS Programming.

Software needed:

Current and valid Microsoft Word 2000 or later installed
Valid SAS (Statistical Analysis System) Version 8 or later installed. (Vista Users, the latest SAS software release version 9.1.3. Service Pack 4 is Vista-friendly. Versions previous to this one do NOT fully support Vista.)
You will need to acquire this software program from SAS directly:
100 SAS Campus Drive
Cary, North Carolina 27513-2414 USA
Phone: (919) 677-8000
Fax: (919) 677-4444
www.sas.com/products/fsp/index.html

Hardware needed:

IBM or compatible computer with Microsoft Windows 2000 or later

If you are NOT using Windows Explorer(i.e. FireFox) as your web browser PLEASE NOTE:
the following three SAS system files may open when clicked but NOT display legible and meaningful text:

Rom3data.sas7bdat
Rom3scrn.sas7bcat
formats.sas7bcat

Incomprehensible codes mixed with alphabets may display even if you have SAS software installed. This is normal. You simply must save these files as is into the properly named and created file folder on your computers as the instructions indicate. Please be sure to save ALL these files with the same names (i.e. default as shown) in their properly named and created file folder on their computer.

Step 1: Obtain Rome III Diagnostic Questionnaire Data

The 93-item Rome III Diagnostic Questionnaire for the Adult Functional GI Disorders is fully included in the 11-page MS Word file named Rom3Test.doc. The file was created in Microsoft Word 2003 for Windows. You may revise the document to suit your needs. Follow the steps below to obtain patient data using Rome III Diagnostic Questionnaire:

Print out the 11-page MS Word file Rom3Test.doc or Rom3Test.pdf;
Assign an ID to a patient with a gastrointestinal (GI) disorder;
Write the ID in the ID field on all 11 pages of Rom3Test.doc;
Give Rom3Test.doc to patients with a GI disorder;
Collect completed Rom3Test.doc.

Allow about 20 minutes for the patient to complete the entire questionnaire.

Step 2: Enter and Store Rome III Diagnostic Questionnaire Data Using SAS

The patient data collected in Step 1 can be fully entered into a data entry screen created in SAS. You need to have a valid SAS v8.2 or a later version installed and operative on an IBM or compatible computer to run a data entry program and get a data entry screen. The data operator who will be entering patients' Rome III data needs be familiar with the contents and procedures of a data entry session started by SAS procedure FSEDIT. These contents and procedures are fully described in a SAS document called SAS/FSP User's Guide available from:

100 SAS Campus Drive
Cary, North Carolina 27513-2414 USA
Phone: (919) 677-8000
Fax: (919) 677-4444
www.sas.com/products/fsp/index.html

Information about SAS/FSP (full screen product) and FSEDIT may also be obtained at www.sas.com/products/fsp/index.html.

Follow steps below to enter your patients' Rome III data:

Create a file folder on your computer's c:\ drive. The folder will be referred to as c:\Rome3. All SAS programs needed to enter and score Rome III data refer to this path. If you prefer a different path such as d:\RomeIII, you must revise the SAS programs' path designations accordingly to make the programs work;
Copy the following SAS files into c:\Rome3 using Windows Explorer or other file transfer methods available in your computer:
- Rome3Data.sas [SAS program to open a data entry screen];
- Rom3data.sas7bdat [SAS data file to store data];
- Rom3scrn.sas7bcat [SAS file containing settings of the data entry screen];
- formats.sas7bcat [SAS file with formats of data values, egs. 1=Yes 0=No];
- Contents.lst
  This SAS file lists attributes of the SAS data set or file. All the data fields seen in the SAS data entry screen you will use to enter patients' Rome III data are described in this list file. This file may be opened in SAS or in your MS Word as a text file. Each data entry field, also known as a variable, has the following attributes described in the Contents.lst file: order of the variable in the data entry file; variable type (numeric or character); variable length or spaces it occupies; format or key to data values such as 1=Yes and 0=No; informat when appropriate (applicable to date variables only); and variable labels that describe each variable;
- Contents.doc [Microsoft Word version of Contents.lst]; and
- Rom3SAScoring3.sas [SAS program to generate Rome III diagnoses];
Run or activate your SAS by clicking the SAS icon on your desktop;
In the SAS Editor window, open or load SAS program file Rom3Data.sas;
Run Rom3Data.sas to open a SAS data entry screen - the screen is loaded by a SAS procedure called 'proc fsedit' in the SAS program file Rom3Data.sas;
Enter patients' answers seen on the Rome III Diagnostic Questionnaire into corresponding fields in the SAS data entry screen. Make sure to always enter a unique ID number and/or name for each patient. The 93 Rome III diagnostic questions are sequentially named Q1 through Q93 on the data entry screen; their sequence on the screen matches that on the questionnaire. Attributes or descriptions of each data field or variable including all the 93 Rome III questions are listed in the Contents.lst and Contents.doc files;
Should the keyboard not let you enter a number in any field, press the Insert key and try again;
Both Backspace and Delete keys should work to remove typos;
Type SAVE at the Command Line (a window at the top) to save after entering each patient's data. It's a good idea to copy or save your data file also in a secured network medium, flash drive, compact disk, or other data storage medium;
Type ADD at the Command Line to start a new screen to enter a new patient's data;
Type END at the Command Line when all patients' data have been entered. You can always come back to re-activate the screen to enter new data;

Step 3: Score and Interpret Each Patients' Rome III Diagnoses

Rome III diagnoses may be generated in SAS for each patient based on the patient's answers to the Rome III Diagnostic Questionnaire. The diagnosis is made according to the scoring algorithm using data obtained by the Rome III Diagnostic Questionnaire for the adult functional gastrointestinal disorders. A valid and current SAS program of v8.2 or later must be installed on your IBM or compatible computer to run the scoring program that was compiled in SAS v9.1.3. Follow steps below to generate a Rome III diagnostic report:

Make sure that the following SAS files are in your c:\rome3 file folder on your hard drive c:\ - all the files must be in c:\Rome3 folder for the scoring program to run:
- Rom3data.sas7bdat [SAS data file containing patients' Rome III answers];
- Formats.sas7bcat [SAS file with formats of Rome III data values and labels, egs. 1=Yes 0=No]; and
- Rom3SAScoring3.sas [SAS program to score patients' Rome III answers and generate Rome III diagnoses];
Run or activate your SAS;
In the SAS Editor window, open or load SAS program file Rom3SAScoring3.sas;
Run Rom3SAScoring3.sas to score patients' Rome III data and generate a Rome III diagnosis summary report for each patient with valid Rome III answers. A new SAS data set Rome303.sas7bcat will be generated and saved in c:\Rome3;
Diagnosis summary for each and all patients appears in the SAS output window that can be opened by pressing F7 if you are in SAS Editor window. Return to SAS Editor window by pressing F5. Should the scoring program not run properly, explanations with error messages appear in a SAS log file window that can be opened by pressing F6 when you are in either the Editor (F5) or output (F7) window.
Two files with diagnoses will be generated. The primary one appears in the SAS output window (openable by pressing F7). It can be saved by clicking the floppy disk icon on the tool bar or by the usual way of 'Save As' under 'File' on the menu bar at the top. Make sure that the output file is saved in your c:\Rome3 folder. The file will be saved by default as a SAS list file with the suffix .lst, but can be saved as a rich text file with a suffix of .rtf if so specified in the 'Save as type' option window. The .lst file can be opened in MS Word as a text file.

A second output file of the diagnoses (Rom3Diag.htm) is generated and stored automatically as an html file in c:\rome3\. This file can be viewed in SAS Results Viewer, Windows Explorer, or Microsoft Excel. When opened in Excel, the output file can be saved as an Excel file (eg. Rom3Diag.xls) for editing.

In the output file, each patient's diagnoses are identified by the patient's unique ID (you should have assigned it to each patient and entered it into SAS data file Rom3data.sas7bcat as specified in Step 2 above). Positive diagnosis of a GI condition is indicated by
- 'YES, patient has this condition'
under the name of that condition in the summary report. A

'2: Yes pending Exam/Test' indicates that a positive diagnosis must be confirmed or finalized when the right results of exam[s] and/or test[s] also are obtained. Absence of '1:Yes' or '2:Yes pending Exam/Test' suggests that the patient did not give answers to Rome III queries to lead to a diagnosis. 'Exam Needed' indicates that the diagnosis cannot be made without the right results of an exam or test.

A patient may have a positive diagnosis of multiple GI conditions. To generate and output diagnoses of GI conditions lasting at least 6 months, run the appropriate code enclosed in the ending section [colored green] of the scoring program.

For Technical Questions regarding the SAS system, please contact

SAS
100 SAS Campus Drive
Cary, North Carolina 27513-2414 USA
Phone: (919) 677-8000
Fax: (919) 677-4444
http://www.sas.com/products/fsp/index.html

For questions concerning the Rome III Questionnaire, please inquire to:

Yuming J.B. Hu, PhD
UNC GI Psychosocial Research
720 MLK Jr. Boulevard, Suite 102
Chapel Hill, North Carolina 27514 USA
Phone: (919) 966-3322
Fax: (919) 966-5099
[email protected]