SHHS

Sleep Heart Health Study

SHHS Follow-up 2 Data System Manual Volume 5 Version: 2.0

26 February 2002 i SHHS Data System Manual

Contents

1. Introduction ...... 1

2. System features and setup ...... 2

3. Getting started ...... 3 3.0.1. Turning on the system, system sign on, and system tasks ...... 3 3.1. SIGN ON screen (figure) ...... 6 3.2. TASKS screen (figure) ...... 7

4. Tutorial system ...... 8 4.1. Introduction ...... 8 4.2. Tutorial: Data entry ...... 8 4.3. PIN authorization, resetting the tutorial and exiting the tutorial system ...... 11 4.4. TASKS (help) ...... 13 4.5. DATA ENTRY screen (figure) ...... 17 4.6. Data entry screen for Form QL (figure) ...... 18 4.7. RESET TUTORIAL screen (figure) ...... 19

5. Data entry of forms ...... 20 5.1. Instructions for data entry ...... 20 5.2. DATA ENTRY screen (figure) ...... 25 5.3. Data entry screen for Form QL (figure) ...... 26

6. Data entry of medications (MD) form ...... 27 6.1. MedDB main menu ...... 27 6.2. Navigating through MedDB ...... 27 6.3. Entering a new record ...... 28 6.4. Entering medications ...... 29 6.5. Editing records ...... 31 6.6. Reports ...... 32 6.7. Transmit data ...... 32 6.8. Settings ...... 32 6.9. Exit ...... 32 6.10. MedDB - Main Menu (figure) ...... 33 6.11. Enter Record Screen (figure) ...... 34 6.12. Enter Medications Screen (figure) ...... 35 6.13. Edit Record Screen (figure) ...... 36 6.14. Transmit Data Screen (Figure) ...... 37

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7. Inventory tasks ...... 38 7.1. Inventory ...... 38 7.2. Forms inventory ...... 38 7.3. Visits inventory ...... 39 7.4. INVENTORY screen (figure) ...... 40 7.5. Sample FORMS INVENTORY screen (figure) ...... 41 7.6. Sample VISITS INVENTORY screen (figure) ...... 42

8. Database backup ...... 43 8.1. Types and schedules of backups ...... 43 8.2. Scheduled daily backup (figure) ...... 44 8.3. Cancellation of scheduled daily backup (figure) ...... 45 8.4. Scheduled 7-day backup (figure) ...... 46 8.5. Cancellation of 7-day backup (figure) ...... 47

9. Transmission of data to Coordinating Center ...... 48 9.1. Introduction ...... 48 9.2. Monthly data transmission ...... 48 9.3. Backup for transmission of data (figure) ...... 49

10. Edits ...... 50 10.1. Use of '?' as data entry code ...... 50 10.2. Other data entry codes ...... 50 10.3. Forms inventory screen with ? next form (figure) ...... 52

11. Printing blank forms ...... 53 11.1. Instructions ...... 53 11.2. PRINT menu (figure) ...... 54

12. Printing address labels ...... 56 12.1. Address labels ...... 56 12.2. PRINT LABELS menu (figure) ...... 57 12.3. Label printing screen (figure) ...... 58

13. Printing complete data forms ...... 59 13.1. View/Print DATA FORMS screen (figure) ...... 60

14. Print visit due/Time window ...... 61 14.1. Reports menu (figure) ...... 62 14.2. Visit Due Listing screen (figure) ...... 63 14.3. Visit Window Listing (figure) ...... 64

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15. Session logs and system problems ...... 65 15.1. Session logs ...... 65 15.2. System problems ...... 65 15.3. PC Anywhere ...... 65 15.4. FIX disks ...... 66 15.5. SESSION LOGS menu (figure) ...... 67 15.6. UGLY PURPLE SCREEN (figure) ...... 68 15.7. BLUE SCREEN OF DEATH (figure) ...... 69

16. Turning off the system ...... 70

17. Operating hints ...... 71

18. Certification of data system operator ...... 72 18.1. PIN Authorization (figure) ...... 73 18.2. Previous PIN authorization (figure) ...... 74 18.3. “Print authorization” screen (figure) ...... 75

19. Resources/Suppliers ...... 76

20. Appendix A. Forms for use with the tutorial ...... 77

21. Appendix B. Help screens ...... 78 21.1. Overview ...... 78 21.2. ABCD (database transaction) ...... 79 21.3. DE (data entry) ...... 87 21.4. DIRLST (forms inventory) ...... 93 21.5. FORMS (printing blank forms) ...... 96 21.6. LABMENU (printing labels) ...... 99 21.7. LOGMENU (session logs task) ...... 101 21.8. MAIN (sign on screen and backup) ...... 103 21.9. SLEEP DATA CAPTURE ...... 106 21.10. CODE DRUG MedDB ...... 108 21.11. PRINT MENU ...... 110 21.12. REPORTS MENU ...... 113 21.13. BACKUP DATABASE MENU ...... 115 21.14. Work with LOGS Menu ...... 118 21.15. TASKS menu (help) ...... 120 21.16. VISLIST (visits inventory task) ...... 124

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1. Introduction

The major functions of your SHHS data system are:

C Data entry of forms C Sleep data capture, backup, and download C Interface with MedDB (code drugs) C Inventory of forms keyed and visits completed (based on keyed forms) for each participant C Database backup C Printing sets of blank forms C Printing labels for SHHS materials C Printing lists of participants for various purposes

The data system also includes the tutorial system, an application for training staff in the first three functions listed above.

Use of the SHHS system for purposes other than those described in this manual and connection of any piece of the data system to other equipment are prohibited unless permission is received from the Coordinating Center.

The system comes with a great deal of software that is necessary for its operation and maintenance. Do not use or copy this software and do not explore the system except as directed by the Coordinating Center. Do not change any aspect of the system except as instructed by the Coordinating Center — do not change the colors, do not change the screen saver, do not add hardware or software, etc.

The data system is a complex system designed to manage the participant data recorded on SHHS data collection forms. It is not intended to be a resource to support other activities, SHHS or otherwise. We put these restrictions on its use to minimize the chance for malfunction and inconsistency in operation across field site and to preserve the confidentiality of the SHHS data.

CAUTION: The system is robust to most problems. Checks have been built in to monitor the integrity of the data (in the sense of checks to avoid duplication of data, miskeys of ID information, etc) and to minimize vulnerability of files to damage (eg, files are closed quickly and reopened as necessary). You should feel secure in your use of the system, even as you are learning. However, problems can occur, and symptoms of serious problems include messages such as "Fatal error, system halted" or "Blue screen of death". If you ever see these messages, leave the system as is and call the Coordinating Center (410-955-8175) immediately.

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2. System features and setup

Your SHHS data system is comprised of the following pieces of computer hardware equipment:

C Monitor C Keyboard C Kensington MasterPiece Plus Surge Suppressor C Dell Dimensions XPS-T600 C 250 MB ZIP drive C LaserJet 2100 printer C Mouse C Modem C Cables

The technical aspects of your system are:

C Hardware - Dell Dimensions XPS-T600

C Storage - 20 GB primary hard drive, 60 GB secondary hard drive, 250 MB ZIP drive, 1.44 MB diskette drive

C Software - Windows 98 second edition operating system - Applications used: SAS 8, Base, CORE, Stat, AF, and FSP; Norton Utilities 2001; Corel WordPerfect 9.0; Microsoft Office 2000; Veritas Backup Exec; PC Anywhere 9.0; Norton Antivirus 2001, MedDB; Compumedics Utilities

C Database model - Relational

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3. Getting started

3.1.1. Turning on the system, system sign on, and system tasks

The system has two passwords. You must call the Coordinating Center to obtain the passwords. When you have obtained the passwords, turn on the system by pressing the Master switch on the Kensington MasterPiece. All components are turned on through this master switch. The first system password screen will appear. Enter the first system password (what you type will not appear on the screen). The SIGN ON screen of the data system will appear (see 3.1). This screen illustrates several features of the SHHS system. Each screen is comprised of several windows or bars. The top bar (NHLBI: SHHS-Sleep Heart Health Study) is the Application Window. The middle bar at the upper left corner of the screen is the Tool Bar. The Tool Bar varies, depending on the type of screen. The lowest bar (SIGN ON) is the Legend Window.

The Tool Bar for the SIGN ON screen is comprised of the following:

• Backwards arrow icon which allows you to exit the current screen and return to the previous screen • icon which allows you to access the help screens • icon which allows you to minimize the SHHS system C icon which allows you to exit the SHHS system

Type your PIN as requested. Type in the second system password (what you type will not appear on the screen). If your PIN is rejected, you have not completed the tutorial and/or run the PIN authorization program. Click on submit or press ENTER to continue.

After keying your PIN and the password and pressing ENTER, the system will prompt you for whichever backups are due:

C Daily backup C 7-day backup C TR backup

Chapters 8 and 9 of this manual discuss database backup in detail. Do backup as prompted even if it is the first time accessing the system. Use the cursor to highlight OK on the backup screen and press ENTER. The system will prompt you to put the Daily backup disk in the ZIP drive. Press ENTER if the "Abort, retry, ignore, fail" message screen appears. This message is discussed in Chapter 17; if

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you get this warning message during disk copy, always respond with "fail". Never respond with "ignore"; call the Coordinating Center immediately.

Complete 7-day and TR backup if prompted to do so (the system is set up to prompt for these backups at the appropriate intervals). You should do the daily backup every day, and the 7-day backup and TR backup as prompted. Failing to do backups leaves you in a very vulnerable position -- reconstructing the database from an out-of-date file is very painful for field site and coordinating center alike.

After completing the backup, the TASK screen will appear (see 3.2). The Tool Bar for the TASKS screen is comprised of:

• Backwards arrow icon which allows you to exit the current screen and return to the previous screen C Printer icon which prints the contents of the current screen C Date/calendar icon which calculates number of days between 2 dates or the date from a given date when number of days is entered -- useful for checking visit windows (use F7 to exit from this window) C Icon which lists IDs, name codes, and names of all registered participants C Pencil and paper icon which saves and prints the log (use this icon only at request of CC) C icon which allows you to minimize the SHHS system C icon which allows you to access the help screens

The tasks/actions which can be accessed from the TASKS screen are:

C Data entry C Sleep data capture C Code drugs - MedDB C Inventory (View DB Contents) C Print forms and labels C Generate reports C Backup and transmit data C View session logs (work with logs) C Reset tutorial C Exit system

You can select a task by clicking on the button for the task or by using the tab or right arrow key to advance the cursor to the task you wish to select. As you advance the tab or right arrow key, the task box and its button will be outlined in black. Click on the button or press ENTER to start the task.

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3.2. SIGN ON screen (figure)

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3.3. TASKS screen (figure)

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4. Tutorial system

4.1. Introduction

The tutorial system is designed to let you practice data entry. Use the forms in Appendix A when working with the tutorial system. The tutorial must be completed for a PIN to be authorized for data entry.

Turn on the system and type in the first system password as instructed in Chapter 3 of this manual. When the SIGN ON screen appears, click on the arrow pointing right ( ) in the toolbar. This will close the main system and take you to the desktop. Click on the START button (lower left corner of the screen). Click on 2-SHHS-Tutorial to access the tutorial system. Use your PIN to sign onto the system. Type in the second system password (it will not appear on the screen). Press ENTER to continue. When asked to complete the different backups, Cancel out of all backups. After canceling out of backups, you will be returned to the TASKS screen.

4.2. Tutorial: Data entry

All data forms are keyed twice. The second keying is compared to the first. To enter data, click on the Data entry option, and then press ENTER. The initial DATA ENTRY menu (see 4.5) will appear. At this point, identify the form to be keyed. Enter:

C Participant ID (9999) C Alpha code (Z-ZZZ) C Date form initiated or procedure attempted C Visit — F02 C Form + rev — enter the form and revision number and press the TAB to advance to the next field C Seq no — leave blank unless a form with a sequence number is to be entered C Transaction - a - to add new form - b - to browse previously entered forms (look but do not change) - c - to change previously entered forms - d - to delete previously entered forms • DE PIN (always use your PIN; at the end of the tutorial the forms entered with your PIN will be reviewed for authorization of your PIN for DE).

The first 5 of these items are in the upper right corner of every form.

To enter new data, press ENTER if an a is already in the Transaction field. If the Transaction field is blank, type a and then press ENTER to add the form. The screen for the first keying of the

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form will appear. Figure 4.6 contains the first screen for a QL form. Key each of the forms in Appendix A to gain familiarity with the skip patterns and data entry screens.

Note that a different set of tools exists for data entry. Resting the cursor on an icon will show its function at the bottom of the screen and its name at the top of the screen. The icons and their functions (the equivalent function key is listed in parentheses) are:

Note that a different set of tools exists for data entry. The icons for the tools are:

The icons and their functions (the equivalent function key is listed in parentheses) are:

C Check mark (T) - takes the cursor to the end of the form, enabling you to exit the form and save the keyed data (by entering “y” when requested in the FINISHED field) or to cancel the transaction and exit (by entering “c” when requested) (F7) C Printer - prints current screen; this may be helpful when problems occur C Date/calendar - date calculator C Up arrow - brings back the previous screen (shift-F11) C Down arrow - brings up the next screen (shift-F12) C Rounded backwards arrow - erases all information keyed except the basic information -- field site, ID, form, etc (F2) C Red dot - cancels information and exits form (F3) C - minimizes the data system screen C - allows access to help screens

Data should be keyed exactly as they appear on the form. If a response in an "Other, specify" item exceeds the 35 characters allowed, the excess can be keyed in the General Comments. The final screen for each form ends in 5 lines (the General Comments area) where excess responses and marginal notes or other comments may be keyed. Signatures are not keyed -- type 1 if the signature is present and 2 if the signature area was left blank.

If nothing happens when data entry is attempted (ie, you press keys but numbers do not appear on the screen), press the Insert key. If the Insert key is in the wrong mode, a skinny black line will be flashing on the highlighted box. When the Insert key is in the correct mode, a flashing black box will be visible on the screen. If that does not solve the problem and you are trying to key from the numeric

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keypad at the right of your keyboard, press the Num Lock key; Num Lock light must be on (lit) for the numeric keypad to work.

After keying a field, press ENTER to advance to the next field. If you continue to key data before pressing ENTER, the computer will beep, the message “Error: Attempted data entry in gutter” will appear at the bottom of the screen, and the cursor will move to the last item entered. To correct this, press ENTER twice. The cursor will advance to the next field.

After keying a screen, press ENTER at the bottom arrow to continue to the next screen. If you need to go back to a preceding screen, press ENTER at the top arrow or click on the up arrow icon.

For “all that apply” items (such as item 4 on Form PC), key a 1 if an item is checked; if the item is not checked, leave that field blank. To bypass an item which does not have a response, such as in the above example or in a GO TO situation, you may use the cursor down arrow or press ENTER twice to move down the screen. However, the system will not allow required items to be bypassed.

Generally, you will completely fill the data entry space provided for each response; the exceptions to this are, "Other, specify" responses (which may not require the 35 characters allowed) and special response codes (?, m, n -- see page 24 for an explanation of these codes). If you do not fill the data entry space provided, you must press ENTER twice to advance to the next field (once to advance to the end of the current field and once to advance from the end of the current field to the next field). If you fill the field, you only need to press ENTER once since you have already advanced to the end of the current field.

After all data on the form have been entered, press F7 or TAB to the “Finished” field (clicking on the check (T) icon will also do this). Enter y if the form is complete. Enter c if you want to cancel the transaction (the keyed data will not be saved). Another method of canceling the transaction is to press F3 or click on the round backwards arrow icon at any time during the keying. The F7 key is especially useful when a change is being made to the form. If only one item is being changed, the F7 key can be pressed after the change to advance to the end of the form.

If you want to save the keyed data, enter y. If y was entered for “Finished”, press ENTER to do the consistency checks. Consistency checks will be done on the data that were keyed. If there are no inconsistencies, the program will continue to the second keying. If errors are found or suspected, a message indicating the items in question will appear at the bottom of the screen, and the cursor will return to the item in question. Some of these messages say "ERROR" and some say "WARNING". ERROR indicates that the keyed value has a problem that must be resolved immediately. WARNING is a flag to indicate that the keyed value is unusual and should be verified. However, the value keyed may be saved as is on the second try to exit the record (ie, a WARNING is just that and may be ignored; an ERROR demands a change somewhere in the keyed data).

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An ERROR message can be resolved in one of three ways: by correcting the keyed value, by keying a ? to indicate that the item is under review, or by keying a correction to an associated item that will render the data consistent. When an ERROR message appears, the data system operator should check the form to be sure that the data were keyed as written on the form. If the data were keyed as written, but an error is noted on the form (eg, an item was answered that should have been skipped), the data system operator may enter ? for the item(s) in question, and the ERROR message should disappear. The items marked ? will appear in edit queries from the Coordinating Center for resolution. Alternatively, if the person who completed the form is available, the item(s) in question may be edited on the form (every edit must be initialed and dated) and the corrected data entered. Edits must be verified -- the data system operator should not simply change the data on the form to what s/he thinks the response should be.

If the data were recorded correctly on the form and the recorded responses were keyed correctly but the computer will not accept the data, write down the inconsistency message, print the screen using the printer icon, and key ? for items that you cannot key as completed. Alternatively, you may cancel the transaction. Contact the Coordinating Center for further assistance.

The data for each form must be keyed twice. If the second keying of an item does not agree with the first keying, the cursor will highlight the item, the computer will beep, and the value of the first keying will be displayed at the bottom of the screen. If the first keying was correct, enter the correct value and press ENTER. If the second keying is correct, press ENTER twice to continue to the next field. The system saves the second keying, so if you are correcting an item, make sure that you key the corrected value accurately.

After a form has been keyed twice, the screen returns to the DATA ENTRY menu (see 4.5). The identification information for the last form keyed will be displayed in the lower left corner (be sure the cursor is not on the tool bar). To key another form, enter the requested information for the next form to be keyed. To exit the DATA ENTRY screen, press F7 or click on the backward arrow icon ( ) in the toolbar. This will return the screen to the TASKS screen.

All forms that are to be keyed to the data system have "keyed ( )" in the upper right corner of the first page of the form. After keying the form, the data system operator should put a check in the checkspace and initial and date the check. This does not need to be done for the tutorial forms since these will be reused by other staff. Remember to do this when keying "real" data.

4.3. PIN authorization, resetting the tutorial and exiting the tutorial system

When the tutorial has been completed, your PIN will be authorized for data entry through the Reset Tutorial option on the TASKS menu (see 4.7). Click on the authorize PIN button; the tutorial will be checked for completeness. If all the checks are passed, a page will print with the PIN

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authorization. You should reset the tutorial to allow the next person to use it. The system will reset and return you to the TASKS screen.

Exit the tutorial system by clicking on Exit system on the TASKS screen. This returns you to the desktop. Click on the Start button and then click on 1-SHHS-DE to access the data system.

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4.4. TASKS (help)

To exit help, press [F7]

OVERVIEW

Main menu of data system tasks

SCREEN ITEMS

Data entry

Click this button to key new new data forms or to make changes to forms entered previously

Sleep data capture

Click this button to start the Compumedics software for capturing sleep data stored on flash cards

Code drugs - MedDB

Click this button to start the MedDB

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software used for entering and coding patient medications (drugs)

View DB contents

Click this button to display the current of the database (DB), either by forms or by visits -- can show missing/overdue data

Print

Click this button for miscellaneous print tasks, including blank copies of data forms, mailing labels, and completed data forms (used for audits). In some cases, the list may be viewed on the screen without printing

Reports

Click this button for miscellaneous reports, including lists of upcoming visits

Backup/transmit data

Click this button to backup the data system or to transmit data to the Coordinating Center

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Work with logs

Click this button to view session logs or to clear (erase) the logs. This is used for trouble-shooting by the Coordinating Center

Reset tutorial

Click this button to reset the tutorial system. It erases any data entered into the tutorial system previously. This button is only active when using the tutorial system

Exit

Click this button to exit the system. A prompt for system backup may occur

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

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Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End TASKS.HELP ===

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4.5. DATA ENTRY screen (figure)

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4.6. Data entry screen for Form QL (figure)

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4.7. RESET TUTORIAL screen (figure)

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5. Data entry of forms

5.1. Instructions for data entry

The data forms completed for SHHS participants constitute the official database for the study. All of the SHHS findings and results will be derived from analyses of the electronic database. In SHHS, responsibility for data entry resides in each field site. It is extremely important that the computerized data files match the information recorded on the paper forms. All changes to the paper forms must be dated, initialed, and a brief explanation given as to why an item was changed. If a change is made to a paper form, the change must be made to the electronic record also. These changes (to the paper form and electronic record) should be made simultaneously. Data system operators are key to fulfilling these quality assurance requirements. If the electronic database is incorrect, the conclusions drawn from analyses of the database are likely to be incorrect.

The SHHS data system has several features designed to promote accuracy of data entry:

C Range checks at the time of data entry C Consistency checks at the time of data entry C Double keying of all data items (except General Comments), with immediate checks on agreement between keyings

These features may slow the data entry process since the data system operator will have to resolve problems in order to complete keying. Hence, it is to everyone’s advantage to complete the forms carefully, correctly and accurately so that they are as free of problems as possible when brought up for data entry.

Select Data Entry from the TASKS screen to initiate data entry of a form. The DATA ENTRY screen will appear (see 5.2). Enter data from box on top right of form:

C Participant ID C Alpha code C Visit date C Visit F02 C Form + rev — enter the form and revision number and press the TAB to advance to the next field C Seq no — leave blank unless a form with a sequence number is to be entered C Transaction - a - to add new records - b - to browse previously entered forms (look at but not change) - c - to change previously entered forms - d - to delete previously entered forms

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To enter new data, press ENTER if an a is already in the Transaction field. If the Transaction field is blank, type a and then press ENTER to add the form. The screen for the first keying of the selected form will appear. The screen for the BH form is shown in figure 5.3. Items are keyed in the order in which they appear on the form. The first 7 items of the screen are already completed from the information keyed on the DATA ENTRY screen. Each field consists of dots for the required number of characters in that item. “Other, specify” data entry areas are 35 characters in length; you do not need to fill the line. Signatures are not keyed -- type 1 if the signature is present and 2 if the signature was left blank. Type all letters, including the letter initiating the ID number, in lower case.

Note that a different set of tools exists for data entry. The icons for the tools are:

The icons and their functions (the equivalent function key is listed in parentheses) are:

C Check mark (T) - takes the cursor to the end of the form, enabling you to exit the form and save the keyed data (by entering “y” when requested in the FINISHED field) or to cancel the transaction and exit (by entering “c” when requested) (F7) C Printer - prints current screen; this may be helpful when problems occur C Date/calendar - date calculator C Up arrow - brings back the previous screen (shift-F11) C Down arrow - brings up the next screen (shift-F12) C Rounded backwards arrow - erases all information keyed except the basic information -- field site, ID, form, etc (F2) C Red dot - cancels information and exits form (F3) C - minimizes the data system screen C - allows access to help screens

Next to the “dots” (data entry area) is a blank space, called the “gutter”, where the cursor goes after a field is completed. Press ENTER to take the cursor to the next field. If a keystroke such as a character, number, or symbol is entered while the cursor is in the gutter, when ENTER is next pressed, the computer will beep and the error message “Attempted data entry in gutter” will appear. The cursor will move to the last field that was keyed. To correct this, press ENTER twice to get to the next field.

Next to the “gutter” is the item number and a brief description of the item. Note that if a “specify” has 2 lines on the form, it will also have 2 lines on the screen. Both lines will have the same item number and description. Data entry areas are right aligned; item descriptors are left aligned. Each screen has a green box at the top and bottom. After keying a screen, press ENTER at the bottom green box to continue to the next screen. If you need to go back to a preceding screen, press ENTER at the top green box or click on the arrow icon.

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Data should be keyed exactly as they appear on the form. The final screen for each form has a General Comments area where marginal notes or other comments may be keyed.

Numeric fields must be filled completely; the staff members recording data items on forms should use leading and trailing zeros as needed. For example, BILIRUBIN (item 16G on Form RZ) has the format C . Suppose the lab report gives a value of 61.0. The person recording the data on the form should write in 6 1 C 0. The data system operator keys 610. Note that punctuation marks for numeric data are not keyed.

For “all that apply” items (such as item 4 on Form PC), key a 1 if the item is checked; if the item is not checked, leave that field on the screen blank. To bypass an item, such as in the above example or in a GO TO situation, use the down arrow or press ENTER twice. The program will not allow required items to be bypassed.

After all data on the form have been entered, press F7 or TAB to the end of the screen. Enter y in the Finished field if the form is complete. Enter c to cancel the transaction (the keyed data will not be saved). Another method of canceling the transaction is to press F3 or click on the rounded backwards arrow icon at any time during the keying. The F7 key is especially useful when a change is being made to the form. If only one item is being changed, the F7 key can be pressed after the change to advance to the end of the form.

If y was entered in the Finished field, a consistency check will be done. If no inconsistencies are found, the program will continue to the second keying. If errors are found or suspected, an error message indicating the item numbers in question will appear in the lower left corner of the screen, and the cursor will return to the item in question. Some of these messages say "ERROR" and some say "WARNING". ERROR indicates that the keyed value has a problem which must be resolved immediately. WARNING is a flag to indicate that the keyed value is unusual and should be verified. However, the value keyed may be saved as is on the second try to exit the record (ie, a WARNING is just that, and may be ignored; an ERROR demands a change somewhere in the keyed data).

An ERROR message can be resolved in one of three ways: by correcting the keyed value, by keying a ? to indicate that the item is under review, or by keying a correction to an associated item that will render the data consistent. When an ERROR message appears, the data system operator should check the form to be sure that the data were keyed as written on the forms. If the data were keyed as written, but an error is noted on the form (eg, an item was answered that should have been skipped), the data system operator may enter ? for the item(s) in question, and the ERROR message should disappear. The items marked ? will appear in edit queries from the Coordinating Center for resolution until the ? is replaced with a response or other data entry code. Alternatively, if the person who completed the form is available, the item(s) in question may be edited on the form (every edit must be initialed and dated) and the corrected data entered. Edits must be verified -- the data system operator should not simply change the data on the form to what s/he thinks the response should be.

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If the data were keyed correctly and the form was completed correctly, write down the inconsistency message, print the screen, key (?) for items that you cannot key as completed, and contact the Coordinating Center for further assistance.

Please note that use of a '?' in a comment or specify item will result in an edit message; instead of keying a question mark, in these fields indicate the uncertainty in the response by keying 'possibly', 'quest', 'maybe', etc.

The data for each form must be keyed twice. If the second keying of an item does not agree with the first keying, the computer will beep and the value of the first keying will be displayed in the lower left corner of the screen. If the first keying was correct, enter the correct value and press ENTER. If the second keying is correct, press ENTER twice to continue to the next field. Since data keyed in the General Comments area are not checked for consistency and whatever is keyed during the second keying is retained, key General Comments only at the end of the second keying.

After a form has been keyed twice, the screen returns to the DATA ENTRY menu. The name of the last form that was keyed will be displayed in the lower left corner. To key another form, continue by entering the requested information for the next form to be keyed. To exit the DATA ENTRY menu, press F7 or click on the single back arrow icon. This will return the screen to the TASKS menu.

All forms that are to be keyed to the database have "keyed ( )" in the upper right corner of the first page of the form. After keying the form, the data system operator should put a check in the checkspace and initial and date the check.

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Notes: (1) If nothing happens when data entry is attempted (ie, you press keys but no numbers appear on the screen), press the Insert key. If the Insert key is in the wrong mode, the cursor will be a flashing skinny black line. When the Insert key is in the correct mode, the cursor will be a black box. Another potential solution is to turn on the Num Lock key. If you are trying to use the numeric keypad and nothing is happening, check that the Num Lock key is lit up.

(2) Guidelines for keyboard during data entry Num Lock on, Caps Lock off, Insert off Use numeric keypad and ENTER for numeric data Press ENTER after each item Use the cursor to navigate around the screen

(3) Function keys used in data entry F1 = Help F2 = Reset, start over F3 = Cancel, data not saved F7 = Go to the Finished field Shift - F11 = Go to previous page Shift - F12 = Go to next page

(4) DE codes m = missing ? = temporarily missing n = not applicable If you want to use one of these codes for a multicharacter field, type one m (or ?, n) and press ENTER. Don’t try to fill the field.

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5.2. DATA ENTRY screen (figure)

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5.3. Data entry screen for Form QL (figure)

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6. Data entry of medications (MD) form

Data entry of the medications (MD) form is done using the MedDB Software developed by the University of Seattle. Selection of Code drugs-MedDB on the TASKS menu brings you to the MedDB main menu (see 6.10).

6.1. MedDB main menu

The main menu screen (see 6.10) has six options: 1) Enter New Record, 2) Edit/View Records, 3) Reports, 4) Transmit Data, 5) Settings, and 6) Exit.

The Enter New Record option is used to enter medication data on study participants. The Edit/View Records option allows the user to alter a participant's medication data. The Reports option generates printouts for data auditing. The Transmit Data option allows the transfer of collected medication data to the Coordinating Center. (This option will NOT be used for SHHS data collection.) The Settings option is used to alter the file formats and other system settings that MedDB uses to store and transmit the data. The Exit option terminates the MedDB session.

The Refresh button located at the bottom of the screen is used to receive software updates or other notices from the developers of MedDB at the University of Seattle through the world wide web. Since the SHHS computer systems will not be linked to the world wide web, the "Refresh" option will only lead to the display of SHHS logo.

6.2. Navigating through MedDB

While the mouse is required to navigate through the different menus, the keyboard should be used for entering medication data since MedDB is designed to rely more on the keyboard than the mouse. The following are some general rules when entering data in MedDB:

• Moving within fields: Use the arrow keys to move within fields, as the mouse may not work reliably.

• Moving between fields: Use the Tab key to move through the various fields on a particular form while entering or editing data.

• Drop-down lists: MedDB has been programmed with a number of drop-down list with valid data values associated with certain data fields. These lists will be displayed automatically. If the drop-down list is not automatically displayed, the key combination of Alt-Down may be used to manually display the drop-down lists. For some data fields, the program limits the data entry to only the values in the drop-down list (i.e., participant number). In others, the program will accept user-defined values if a specific value for a variable could not be found in

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the drop-down list. For example, the name of a medication or a dose level. Note: Within drop-down lists, we recommend that you navigate using the arrow keys on the keyboard.

• Cancel buttons: Click on the Cancel button will close the current form without saving any new data or changes.

6.3. Entering a new record

In the MedDB Main Menu, click on the “Enter New Record” button. This will bring up the Enter Record screen (see 6.11). Do not leave any data field blank except for “Specify Reason for Refusal.”

The data fields must be completed in the following order (as they appear on the Enter Record screen):

• Your ID: The PIN assigned to you by the Coordinating Center for data entry. • Date Keyed: Date of data entry of the form (format MM/DD/YY). • Interviewer ID: PIN of the technician that completed the medications (MD) form. • Date Form Initiated: Date the MD form was initiated (format MM/DD/YY). • Participant ID: Participant identification number. Note that if you use the drop-down list to search for a participant, use the arrow keys to position on the participant ID and then hit the Enter key. You must hit the Enter key for the data to be entered OR you must type out the entire participant ID. • Alpha Code: Participant identification Alpha code. Entered in lower-case only. There is no drop-down list for Alpha code. • Visit: Visit number. Enter ‘2’ for visit F02. • Field Center ID: Field site identifier. • Form and Revision: Form abbreviation and revision number, located in the box in the upper right corner of the paper form. • Sequence Number: This identifies the number of PSG attempts made in Follow-up Visit 2. (If this is the first attempt, code “01", and if it is the first repeat, code “02", further repeats are coded in sequence.) • List All Meds: This information is obtained from section A of the MD form. Mark only one option. • Number of Meds:

To Enter: This information is obtained from section B of the MD form. The data to be entered is from item d: “Total number of medications for data entry.” If you entered “took none” or “refused,” then the two “number of meds” fields should be 0 (this is the default value).

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Unable: This information is obtained from section B of the MD form. The data to be entered is from item b: “Number of medications unable to transcribe.” Note that other data regarding the questions “Number of prescription and non-prescription medications able to transcribe” (item a) and “Number of night medications added” (item c) are not entered into the MedDB program.

• Specify Reason for Refusal: Complete this field if the answer to “List All Meds?” is “refused.” Otherwise, leave it blank.

If there are medications to be entered, click on the “Enter Medications” button. If there are no medications to be entered (i.e., participant took no medications or refused), click on the “Save and Close” button.

6.4. Entering medications

On the Enter Record screen, click on the “Enter Medications” button. This will bring up the Enter Medications screen (see 6.12). Again, fields should be completed in the order as they appear on the screen.

• Medication: Enter name of the medication in this field.

- Drop-down list: As letters are typed into the “Medication” field, the drop-down list will show the list of medications in the MedDB database that begin with those letters. The medication name on the form should match with a name on the drop-down list. It may require some careful and creative searching on the part of the user to find the matching medication name since some names are truncated or compacted in the list. For example, “Buffered Aspirin” is listed as “BUFFASPRIN”.

- Selecting a medication: Once the medication name has been located on the drop-down list, highlight it using the arrow keys and hit the Enter key. If the medication is not on the list, type the name in manually, using uppercase only, and hit the Enter key. Hitting the Enter key will automatically advance the cursor to the next field.

- Editing: If the Enter key is not pressed after selecting an entry on the drop-down list, the medication name will not be completed correctly and it will have to be re-entered. If you have finished the medication entry and clicked on the “Add” button before realizing the medication name is incorrect, use the mouse to select the medication from the table on the right (see 6.12). This redisplays the data so you can edit the medication name. Click on the “Update” button to save the changes. Note that once you have added a medication entry to the table, you may not edit that medication name to something that is not on the drop-down list. If you need to do this, delete the incorrect medication record and re-enter the correct data as a new entry.

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- Icons: There are two types of icons that may appear next to the “Medication” field. An icon depicting a yellow question mark on a red background indicates that the medication was not selected from the drop-down list. If the medication name was selected from the drop-down list, a blue and yellow diamond will appear next to the medication entry when it is fully completed and has been added to the table on the right.

• Dose: Enter the medication dose in the “Dose” field.

- Drop-down list: If you have selected a medication from the list, the “dose” field drop- down list will show known dosages for that medication. If the medication is not on the list, the “dose” field drop-down list will be blank.

- Entering a Dose: Select the dose using arrow keys and the Enter key if it is on the drop-down list. If it is not on the list, type the dose in manually and hit the Enter key. Do not leave this field blank! If the dosage is unknown, enter five consecutive dashes (“-----”).

- Icons: If the dosage for a specific medication is not on the list, a blue question mark on a red background will appear next to the dosage field.

• OTC check box: If the medication being entered is a prescription medication (Section C of the MD form), leave the OTC box blank. If the medication is a non-prescription medication (Section D of the MD form), click on the “OTC” box to mark it with a check.

• PRN check box: If the medication is taken PRN (Section C, column d), click on the “PRN” box. Otherwise, leave it blank. Note that the PRN box does not have to be checked for every OTC medication since, it is possible that some OTC medications are taken on a regular schedule. For example, a participant may be taking Tylenol, which is available over the counter, on a regular 6- or 8-hour schedule for symptoms of osteoarthritis.

• Taken/Day: The data for frequency of medication use by the participant is in section C, column e for prescription medications, and section D, column c for OTC medications “...Used per day, week, or month...”.

• Rx/Day: The data for prescription frequency of medication “...Prescribed per day, week, or month...” is in section C, column c.

• “Used PSG night” check box: Click on the “Used PSG night” box if the participant took the medication on the night of the sleep study (section C, column g or section D, column e).

• “Used Today” check box: Click on the “Used today” box if the participant took the medication on the day of the sleep study (section C, column f or section D, column d).

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• Add: Adding medication entries. When you are finished entering a medication, click on the “Add” button to add it to the medications table (on the right side of the screen; see 6.12).

• Reset: Resetting medication entries. If you wish to clear all fields for this particular medication, click on the “Reset” button. This does not reset the medications already entered into the table for a participant.

• Cancel: Canceling medication entries. Clicking on the “Cancel” button will exit the current session without saving any new data or changes.

• Done: When you are finished entering all medications for a participant, click on the “Done” button.

Editing medication entries: In order to edit medications already added to the table, select the medication by clicking on the medication name with the mouse. This will bring up the relevant data in the fields on the left so they can be altered. When you are finished editing the medication, click on the “Update” button to save the changes. If you wish to delete the medication entirely, click on the “deleted” box at the bottom of the screen; this will prevent that particular medication entry from being saved when you click on the “Done” button.

6.5. Editing records

In the MedDB Main Menu, click on the “Edit/View Records” button. This will bring up the Edit Record screen (see 6.13). To edit data on a study participant:

• Enter the participant ID and Alpha code. Remember to hit the Enter key after entering the participant ID, and enter the Alpha code in lower-case characters only.

• Enter the visit number and use the Tab key to move beyond the field. The other fields should fill in with the data from that record. You must tab beyond the “Visit” field or you will create a new and incorrect record for that participant ID.

• If you want to delete the entire record for that participant, including the corresponding medications list, click on the “deleted” check box on the right-hand side. Then click on the “Save and Close” button.

• If you want to change the data in sections A and B of the MD form, make the changes on the Edit Record screen and click on the “Save and Close” button.

• If you want to edit medications individually, click on the “Edit Medications” button. This will bring up the Edit Medications screen. The Edit Medications screen looks very much like the Enter Medications screen (see 6.12), and works the same way. Use the mouse to select

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individual medication entries to be changed. Click on the “Update” button to save the changes and on the “Done” button to exit the Edit Medications screen.

• If you edit the number of medications, remember to change the “Number to Enter” and “Number Unable” on the Enter New Record or Edit/View Records screen. Any changes made will be saved when you click on the “Save and Close” button.

6.6. Reports

The Reports option is used to generate printouts for data auditing.

6.7. Transmit data

Clicking on the “Transmit Data” button will bring up the Transmit Data screen (see 6.14). For the purposes of the Sleep Hearth Health Study, you will not need to use this option. This is because the main data system will automatically archive the data entered using MedDB and bundle it with the other data that will be sent to the Coordinating Center.

6.8. Settings

Contact the Coordinating Center for information on how to set the settings. Do not attempt to change any of the settings on your own.

6.9. Exit

Click on the “Exit” button to exit the MedDB program when you have completed data entry and wish to exit the system.

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6.10. MedDB - Main Menu (figure)

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6.11. Enter Record Screen (figure)

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6.12. Enter Medications Screen (figure)

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6.13. Edit Record Screen (figure)

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6.14. Transmit Data Screen (Figure)

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7. Inventory tasks

7.1. Inventory

Selection of View DB Contents on the TASKS screen (see 3.2) brings you to another menu (see 7.4), which allows you to display two types of inventories:

C Forms: Displays information on all or selected forms keyed to the database for a selected participant.

C Visits: Displays all the visits with data entered in the database for all participants, for a selected participant, or after a selected date.

7.2. Forms inventory

After clicking on the Forms Inventory button, key the Alpha code for the participant whose forms you wish to review or * for forms for all participants. You can narrow your review to forms for a particular visit by keying the visit code or you may review forms for all visits by keying *. You can review all forms by keying * or specific forms by keying the 2 letter form abbreviation of interest. Specify a sort order: 1=by date, 2=by form abbreviation, 3=by visit code, and 4=DE date (date and time of data entry). Select one or more options by tabbing the cursor to the symbol beneath the option label. The options for forms are:

Prt - print screen ? - display only forms with ? Tr - shows all transactions, including changes/deletions Fm - long format for directory display date lim - enter a date to display forms completed on or after that date (ie, with date of form on or after that date)

Press ENTER twice -- the inventory of forms that you have specified through your selections will appear on the screen. See figure 7.5 for an example of a forms inventory display. Exit from the forms inventory by clicking on the back arrow or pressing F7.

More than one option can be selected at a time -- eg, you can select Prt and ? to list and print a list of forms with unresolved ‘?’ fields.

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7.3. Visits inventory

After clicking on the Visits Inventory button, key the Alpha code of the participant whose visits you wish to review (* will list visits for all participants). Key the visit code (* will list all visits) and specify the sort order. The VISITS INVENTORY display contains the following information (see 7.6):

Past visit and date (code and date of most recent visit keyed) Alpha code Participant ID number Visit codes for all completed visits

You can specify the sort order for the display or restrict the display to a particular participant or visit. You can further tailor the display by selecting an option. The options for visits are:

Prt - print screen Miss - display missing/pending visits Datelim - limits display to visits on or after that date

Exit the VISITS INVENTORY display by clicking on the backwards arrow.

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7.4. INVENTORY screen (figure)

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7.5. Sample FORMS INVENTORY screen (figure)

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7.6. Sample VISITS INVENTORY screen (figure)

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8. Database backup

8.1. Types and schedules of backups

Three types of database backups are required in SHHS: daily backup, 7-day backup, monthly backup. The system prompts for each type of backup. Daily and 7-day backups are automatically written to the SHHS’s computer’s second hard drive (disk D) and require no disk insertion. These two types of backups are discussed below.

Database backup is required the first time the system is turned on each day and is optional thereafter throughout the day. Whenever the data system application is started or ended, you will be prompted to do a backup. Our advice is “do it”. If you always start with a backup, your backup will at least be current up to the start of any session in which problems occur. To do a daily backup, choose ‘OK’ at the “Proceed with daily backup” prompt.

Once a week the 7-day backup will be performed in addition to the daily backup. As with the daily backup, choose ‘OK’ at the “Proceed with 7-day backup” prompt and the backup will be written to the SHHS computer’s second hard drive.

The purpose of the monthly backup is for transmission of data to the Coordinating Center. The monthly backup is different from the daily and 7-day backups in that it is not written to a disk that is internal to your computer but to a JAZ disk provided to you by the Coordinating Center. Monthly backup is discussed in detail in the next chapter.

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8.2. Scheduled daily backup (figure)

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8.3. Cancellation of scheduled daily backup (figure)

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8.4. Scheduled 7-day backup (figure)

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8.5. Cancellation of 7-day backup (figure)

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9. Transmission of data to Coordinating Center

9.1. Introduction

Transmittal of data from the field sites to the Coordinating Center occurs in two ways:

C Via mailed JAZ disk to the Coordinating Center monthly C Via fax of selected forms (see below)

9.2. Monthly data transmission

On the first of each month the data system will prompt you that it is time to update the transmittal disk (abbreviated as the TR disk) and mail it to the Coordinating Center. The reminder will turn off when the TR disk has been updated. A JAZ disk labelled TR is supplied to you for this purpose. Data from the hard drive will be copied to the TR disk.

There is an option to copy data to the TR disk at times other than the beginning of the month, when the system automatically prompts for it. This is the Backup/Transmit Data option on the TASKS menu. You need only use this option when requested by the Coordinating Center.

Once the data have been copied to the TR disk, mail it to the Coordinating Center by a delivery service that allows tracking of the shipment (eg, Federal Express). Coordinating Center staff will return it to you after copying and verifying the data.

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9.3. Backup for transmission of data (figure)

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10. Edits

10.1. Use of '?' as data entry code

The data entry code '?' should be used when data are temporarily missing (eg, if handwriting cannot be deciphered and the author is not immediately available, or if you are waiting for lab results). Form items keyed as '?' need to be edited (ie, the '?' item in the form needs to be resolved). All items coded with a '?' will be listed in batch edit sheets prepared by the Coordinating Center until the '?' is replaced with a response or other data entry code. Please note that use of a '?' in a comment or specify item will result in an edit message; instead of keying a question mark in these items, indicate uncertainty in a response by keying 'possibly', 'quest', 'maybe', etc.

The FORMS INVENTORY display automatically indicates forms containing one or more ?s by placing a ? next to the form abbreviation (see 10.3). Alternatively, you may list only forms that need to be edited. To do this, select View DB contents on the TASKS menu and select By forms. Specify the Alpha code of the participant to review, * for visit, and * for form. Select the desired sort order and move the cursor to the symbol below the ? option. Press ENTER twice. All forms for the specified participant that are in need of editing will be listed.

To edit data, select Data Entry on the TASKS menu. Specify change mode (“c”) on the DATA ENTRY menu to access previously keyed forms in order to change an entry.

10.2. Other data entry codes

Use 'n' -- not applicable -- when the item is not applicable; write one 'n' in the space for the response even if the response space allows for more than one character (ie, do not write 'n/a' or 'nn', etc). Edit messages will not be sent regarding 'n' codes.

Use 'm' -- missing -- when the information requested is missing or permanently not available; code information that will become available but is currently unknown as '?'. For missing data, write one 'm' in the space for the response, even if the response space allows for more than one character (ie, do not write 'mm' or 'mmm'). Write a brief explanation on the form indicating the reason why the information is missing. Make sure that the data system operator keys the note. One edit message will be sent for each 'm' code even if there is a note in the database regarding why the item is missing. The purpose of the edit message is to verify that the information is truly missing.

All unusual values will be edited once. If the edit message is returned with a note indicating that the value is correct and is unlikely to change at the next visit (eg, height, weight, BMI), the edit message for that item will be deleted in the future. The trigger for turning off the edit message for that item is receipt at the Coordinating Center and processing of the returned edit sheet indicating that the field site verified the keyed value as correct.

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If you have questions about edits or if you think that an edit is repeated despite your having responded to it, fax the Coordinating Center a copy of the original edit sheet and the sheet with the repeat edit, together with a note describing the problem. We will investigate it and correct the problem or tell you how to correct the problem.

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10.3. Forms inventory screen with ? next form (figure)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Forms.Inv 53 SHHS Data System Manual

11. Printing blank forms

11.1. Instructions

Select the Print option on the TASKS menu to print blank forms (see 11.2). You may print all or a selected subset of forms; type x next to each form you wish to have printed (see 11.3). The forms will not be specific to a participant -- ie, there is no option to print forms with an ID number and alpha code filled in automatically. You may specify the number of copies to be printed, and if they are to be collated.

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11.2. PRINT menu (figure)

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11.3. PRINT BLANK FORMS screen (figure)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Print.For 56 SHHS Data System Manual

12. Printing address labels

12.1. Address labels

Your SHHS data system has the following option if you select the Print option on the TASKS menu (see 12.2):

Labels/CC mailing

A document will be created when you press ENTER that will allow you to print a sheet of labels with the Coordinating Center (CC) address on them. Follow the instructions on the next screen regarding printing (see 12.3). The Go button is the large round button on the right side of the printer.

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12.2. PRINT LABELS menu (figure)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Labels.men 58 SHHS Data System Manual 12. Printing address labels

12.3. Label printing screen (figure)

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13. Printing complete data forms

The SHHS data system has the option to print out data that has been entered. This is useful for auditing. From the Print menu (see 11.2), select the Data forms option. This will bring up the VIEW/PRINT DATA FORMS screen (see 13.1). Up to 25 forms may be displayed. Fill in the alpha code, visit code, and form revision for each form.

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13.1. View/Print DATA FORMS screen (figure)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts DataScreen 61 SHHS Data System Manual

14. Print visit due/Time window

A listing of visits that are due or time windows for procedures can be printed or displayed. Select the Reports option from the TASKS menu (see 14.1). To list visits that are due, click on the Visits due option. This will display the Visit Due Listing screen (see 14.2). Select the month and year and click on the View or Print option.

To list the lower and upper windows for procedures for a participant for a given visit date, click on the Time Windows option of the Reports menu (see 14.1). The Visit Window Listing screen will be displayed (see 14.3). Enter the date of the visit and the participant ID, and click on the View or Print option to display the allowable windows for height, weight, BP, ECG, and AAI.

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14.1. Reports menu (figure)

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14.2. Visit Due Listing screen (figure)

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14.3. Visit Window Listing (figure)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Windowvis 65 SHHS Data System Manual

15. Session logs and system problems

15.1. Session logs

One of the tasks on the TASKS menu is Work With Logs (see 15.5). A log of every session is created and saved to the hard disk. All of the procedures and tasks that were done during the data entry session are recorded in the log. In general, the logs are not needed. However, when there is a problem in the data session, a call should be placed to the Coordinating Center. Coordinating Center staff may direct you to view or print session logs; this is accomplished by clicking on View logs. Do not print a log unless requested by the Coordinating Center staff. Periodically you will receive a request from the Coordinating Center to clear the logs. This is done by clicking on Clear session logs.

15.2. System problems

SYSTEM ALREADY RUNNING SCREEN: See 15.6. This screen appears when you try to start the system when it is already running. When this happens, click OK and the second instance of the system will close. You do not need to call the Coordinating Center if you get this screen. You may click on the text box ("Click here when finished") as instructed and proceed as if you did not have a problem.

BLUE SCREEN OF DEATH: See 15.7. This is a cobalt blue screen, and it is symptomatic of a serious malfunction. Stop what you are doing, leave the system as is, and call the Coordinating Center immediately (410-955-8175).

15.3. PC Anywhere

PC Anywhere is installed on your SHHS data system for use only at the direction of the Coordinating Center. This software allows Coordinating Center staff to take control of your system and replace software, observe system malfunctions, and otherwise troubleshoot problems in real time. The Coordinating Center will contact you to schedule sessions as needed. You will need to turn on the modem (a red light indicates the modem is on). You will also need to exit the data system to the desktop (close all open data system applications by using F7; do not turn off the machine). Then double click (left mouse button) on the PC Anywhere icon on the desktop. When the session is completed, Coordinating Center staff will send you a message via PC Anywhere that they are done with the session, or they will call you by telephone. Most sessions are brief (no more than 30 minutes).

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Session 66 CBET Data System Manual 14. Session logs

15.4. FIX disks

When system software needs to be updated, the Coordinating Center will issue the update by sending you a FIX disk with instructions for running the FIX. Each FIX will have specific instructions; however you will always need to run the fix after exiting the system to the desktop -- close open tasks by using the F7 key (do not minimize the task screens).

FIXes are numbered. You should run each as soon as it is received, and if you have two to run at the same time, run them in ascending order. Each FIX will generate 1 or more pages of printout. Fax all pages to the Coordinating Center so that staff can check whether the FIX worked. Mail the disk back to the Coordinating Center once the Coordinating Center confirms the FIX worked properly.

When a new form version (new revision number) replaces an old form version, an end-of-use date for the old version is set in the data system. This date is usually 2 weeks from the expected date of receipt of the FIX, thus giving you a period for tranistioning to the new version. Forms with visit dates after the end-of-use date for the version will have to be transcribed to the new version.

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15.5. SESSION LOGS menu (figure)

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15.6. UGLY PURPLE SCREEN (figure)

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15.7. BLUE SCREEN OF DEATH (figure)

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16. Turning off the system

C Click on Exit System on the TASKS menu. C Either select or cancel backup (selecting backup will protect work done during the session). C Click on the Start button. C Click on Shut Down and from the SHUT DOWN WINDOWS screen, select Shut Down. C When the screen goes blank, press the Master switch on the MasterPiece to power off the system; three green lights on the MasterPiece will remain on while the system is plugged in -- these green lights are supposed to stay on. C Power off the system at night -- do not leave it on.

CAUTION: always be sure to exit the SHHS and Windows system completely before powering off the system.

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17. Operating hints

C Errors during backup: If a disk error such as:

“Data Error Reading or Writing Drive x Abort, Retry, Ignore, Fail”

should occur while doing a backup on the data system, do the following:

- Obtain a printout of the screen, if possible, or make notes of the contents of the screen, which include the error messages and the names of the files involved at the time of the interrupt. - Never select “Ignore.” Try “Retry” once, but if the error message is repeated, then choose “Abort” or “Fail.” Note the outcome of this step on the screen printout notes. - Call the Coordinating Center and fax the notes to the Coordinating Center before performing any other backup procedures on the system on which the problem occurred.

Another error message that you might encounter is:

“Disk not ready in drive x Abort, Retry, Fail”

In most cases, this message occurs when a disk has not been inserted in a drive or the disk is in the drive but not pushed in all the way. You do not need to call the Coordinating Center if this error message appears. Simply insert the disk properly and select “Retry.”

C Illegal operation in Corel WordPerfect: If you get a message that an illegal operation has occurred in Corel, restart the machine. Try to do this "gracefully" -- ie, using regular procedures. Exit the data system and use the Start button, Shut down, and Restart. Resort to Crtl-Alt-Delete only if it is the only option. Alt-F4 closes the current window.

C Using change mode: When you access keyed data records in "change" mode, you exit the selected record by keying “y” or “c” in the Finished field for the record. Key “y” if you have made a change; key “c” if you have not made any changes. When Finished = “y,” a new record is created and saved to the database. The more records that are saved, the bigger the file becomes, and the longer backup and other file processing will take.

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18. Certification of data system operator

All SHHS staff who operate the SHHS data system or key SHHS data must be certified as a data system operator. To become certified, you must complete the following tasks:

C Complete the Personnel Certification (PC) form and send it to the Coordinating Center C Read the SHHS protocol summary and consent statements C Read the SHHS Data System Manual C Read the chapter of the SHHS Manual of Operations on completion of data collection forms C Complete the tutorial: To start the Tutorial, exit the main system and access the tutorial system by clicking on SHHS-2-Tutorial on the Start button (desktop). Key the test data forms using your PIN (Appendix A). After all forms are keyed, from the TASKS menu, select the Reset Tutorial, Authorize PIN options. The PIN Authorization screen will be displayed (see 18.1). Enter the field site number and PIN. The Tutorial will be checked for completeness. If all checks are passed, a form will print authorizing your PIN for data entry. If the PIN was previously authorized, a screen displaying date of authorization will appear (see 18.2). The option to print authorization will be displayed (see 18.3). The tutorial will be reset. Send the PIN authorization form to the Coordinating Center. Remember to write your name and field site name on the materials that print from the tutorial.

Note: Each person seeking certification as data system operator must complete all 5 of these tasks. Since the Reset tutorial option erases all data in the tutorial system, each person seeking certification must complete the tutorial before the next person starts.

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18.1. PIN Authorization (figure)

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18.2. Previous PIN authorization (figure)

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18.3. “Print authorization” screen (figure)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts PrtOK 76 SHHS Data System Manual

19. Resources/Suppliers

Labels C Avery, 5363, 1 3/8" x 2 13/16", 24 labels/sheet

Toner cartridges C HP LaserJet 2100 toner cartridge (HP part HEW-C4096A)

Maintenance C Contact the CC if the system requires maintenance

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20. Appendix A. Forms for use with the tutorial

This Appendix contains completed forms for a dummy participant (ID=9999, alpha code=Z- ZZZ) and the reports and materials associated with keying of these forms and with completion of the tutorial. The forms are for use with the tutorial only. The forms included in this Appendix are:

F02: CF, EC, ET, HI, MS, PM, QL, SC, SH, SS, SV

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21. Appendix B. Help screens

21.1. Overview

This appendix contains paper copies of the HELP screens available on the SHHS data system. HELP screens are accessed by clicking on the ? icon.

The HELP screens are:

ABCD (database transaction) DE (data entry) DIRLST (forms inventory) FORMS (printing blank forms) INVENTRY (inventory task) LABMENU (printing labels) LOGMENU (session logs task) MAIN (sign on screen and backup) SLEEP DATA CAPTURE CODE DRUG MedDB VIEW DB CONTENTS PRINT MENU REPORTS MENU BACKUP DATABASE MENU WORK WITH LOGS MENU TASKS (main tasks menu) VISLST (visits inventory task)

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21.2. ABCD (database transaction)

To exit help, press [F7]

OVERVIEW

Select a database transaction of one of the following types:

add -- Key a new form

browse -- View an existing form

change -- Change data in an existing form

delete -- Delete an existing form

SCREEN ITEMS

Id

Enter patient Id

Alpha code

Enter the patient's alpha code in lower case text

Date of form

Enter the date the form was completed

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Use the format:

mmddyy , eg, 081500

for August 15, 2000

Visit

The visit code is pre-entered as f02

Form + revision

Enter the form and revision number

eg, enter cf1

for revision 1 of form "cf"

Sequence no

Some forms require sequence numbers; most do not. If a form does not require a sequence number, leave this item blank. When entering a sequence number, be sure to include leading zeroes, eg, enter 1 as 01

Your PIN

Enter your personnel identifying number (PIN) as assigned by the Coordinating Center

Form transaction

Enter the letter ( a b c or d) corresponding

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to the type of transaction requested or click the appropriate check box

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

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GUIDELINES FOR ENTERING DATA

Keyboard settings

Num lock ON

Caps OFF

Scroll lock OFF

Insert OFF

Keying basics

o Use numeric keypad for entry of numeric data items

o Press [Enter] after each data item

o Navigate using cursor controls, mouse, or up/down arrow icons.

o Avoid the use of the Tab key to move from item to item -- press [Enter] after each item

o Always key letters as lower case except in comment items

o Always key leading zeroes for numeric data -- eg, enter "25" in 3 digit field as "025" not as "25"

o Punctuation (decimal points and commas) are not keyed, eg, if the form item is "4.2",

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enter "42" rather than "4.2"

Function keys for data entry

Press: To:

[F1] Display help

[F2] Erase any changes to the form and start again

[F3] Abort transaction -- entries are not saved

[F7] Finish keying and save entries

[Shft]+[F11] Jump to "Up" icon

[Shft]+[F12] Jump to "Down" icon

Data entry toolbar

Click icon: To:

Check mark Finish keying and save entries

Printer Print screen contents

Calendar Date calculator

Up arrow Go to previous screen

Down arrow Go to next screen

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Curved back Undo/reset any entries/changes arrow to form, start again

Red circle Abort transaction, do not save

Triangle Minimize screen

? Display help

Forward/Backward buttons

Click: To:

8 (top) Go to previous screen

8 (bottom) Go to next screen

Missing value codes

Code: Means:

? Temporarily missing. Use this for items that are unclear or inconsistent and that require further investi- gation. Return later with the appropriate update and change the "?" to the correct value

d Don't know

m Data missing, cannot

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be recovered

n Not applicable

r Refused

s Too sick to respond

Double data entry

o Form is keyed and then keyed again. Disagreements between keyings are identified for resolution

Range checking

o Items are checked for invalid values as they are keyed

Required items

o Required items are checked for blank values. Use a "?" if the data item is not immediately available. This will allow the form to be keyed. You must return later to update the "?" with the missing required data

Item consistency checks

o Consistency checks among g

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items are performed after all the items on a form have been keyed. Resolve any inconsistencies found

Keying rate

o Since the system carries out many checks every time the [Enter] key is pressed, it is possible that very fast typists may type too fast for the system to keep up. So, some data entry personnel may have to slow their rate of keying to allow the checking to occur

Agreement of forms and database

o Make sure that the data items keyed into the database match the data on the forms. Any changes to the paper forms MUST also be made to the database and vice versa

Changes to "key" items

o If changes to the key items need to request a trans- actopm are needed, you must first delete the incorrect form, and then re-key the entire correct form.

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Keying marginal notes

o Marginal notes, or other pertinent additional information should be keyed on the last screen of the form in the "Notes" section. These notes are included in the permanent electronic database

To exit help, press [F7]

=== End ABCD.HELP ===

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21.3. DE (data entry)

To exit help, press [F7]

OVERVIEW

Enter or change data from data forms

GUIDELINES FOR ENTERING DATA

Keyboard settings

Num lock ON

Caps OFF

Scroll lock OFF

Insert OFF

Keying basics

o Use numeric keypad for entry of numeric data items

o Press [Enter] after each data item

o Navigate using cursor controls, mouse, or up/down arrow icons.

o Avoid the use of the Tab key to move from item to item --

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts DE 89 SHHS Data System Manual 21. Appendix B. Help screens 21.3. DE (data entry)

press [Enter] after each item

o Always key letters as lower case except in comment items

o Always key leading zeroes for numeric data -- eg, enter "25" in 3 digit field as "025" not as "25"

o Punctuation (decimal points and commas) are not keyed, eg, if the form item is "4.2", enter "42" rather than "4.2"

Function keys for data entry

Press: To:

[F1] Display help

[F2] Erase any changes to the form and start again

[F3] Abort transaction -- entries are not saved

[F7] Finish keying and save entries

[Shft]+[F11] Jump to "Up" icon

[Shft]+[F12] Jump to "Down" icon

Data entry toolbar

Click

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icon: To:

Check mark Finish keying and save entries

Printer Print screen contents

Calendar Date calculator

Up arrow Go to previous screen

Down arrow Go to next screen

Curved back Undo/reset any entries/changes arrow to form, start again

Red circle Abort transaction, do not save

Triangle Minimize screen

? Display help

Forward/Backward buttons

Click: To:

8 (top) Go to previous screen

8 (bottom) Go to next screen

Missing value codes

Code: Means:

? Temporarily missing. Use this for items

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that are unclear or inconsistent and that require further investi- gation. Return later with the appropriate update and change the "?" to the correct value

d Don't know

m Data missing, cannot be recovered

n Not applicable

r Refused

s Too sick to respond

Double data entry

o Form is keyed and then keyed again. Disagreements between keyings are identified for resolution

Range checking

o Items are checked for invalid values as they are keyed

Required items

o Required items are checked

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for blank values. Use a "?" if the data item is not immediately available. This will allow the form to be keyed. You must return later to update the "?" with the missing required data

Item consistency checks

o Consistency checks among g items are performed after all the items on a form have been keyed. Resolve any inconsistencies found

Keying rate

o Since the system carries out many checks every time the [Enter] key is pressed, it is possible that very fast typists may type too fast for the system to keep up. So, some data entry personnel may have to slow their rate of keying to allow the checking to occur

Agreement of forms and database

o Make sure that the data items keyed into the database match the data on the forms. Any changes to the paper forms MUST also

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be made to the database and vice versa

Changes to "key" items

o If changes to the key items need to request a trans- actopm are needed, you must first delete the incorrect form, and then re-key the entire correct form.

Keying marginal notes

o Marginal notes, or other pertinent additional information should be keyed on the last screen of the form in the "Notes" section. These notes are included in the permanent electronic database

To exit help, press [F7]

=== End DATA ENTRY.HELP ===

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21.4. DIRLST (forms inventory)

To exit help, press [F7]

OVERVIEW

Displays a list of forms entered into the database using a variety of sort orders and formats. Print copies of lists can be made

SCREEN ITEMS

Alpha code

Enter patient alpha code -- must use alpha code to access forms inventory

Form

Enter a form and revision number or enter a "*" to select all forms

Visit

Pre-entered as visit f02

Sort

Enter: To sort by:

1 Date and form

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2 Form and date 3 Visit and date 4 Date/time of data entry 5 Alpha code

Cancel button

Press the Cancel button to close this window

List button

Press the List button to display requested forms list

Options

Click on: To:

Prt * Print hard copy of list ? * Show forms with 1 or more "?" Tr * Show all transactions Fm * Long format for directory

Date limit

Enter lower limit to restrict display to forms with a date on or after "mmddyy" eg, "081500" for August 15, 2000

WINDOW TOOLBAR

Click icon: To:

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Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End DIRLIST.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts DIRLST 97 SHHS Data System Manual 21. Appendix B. Help screens

21.5. FORMS (printing blank forms)

To exit help, press [F7]

OVERVIEW

Print set of blank forms for use with individual patients, or, more likely, to be used as photocopy masters

Note: Only prints blank forms -- cannot print data values

SCREEN ITEMS

Visit Code

Optional. Enter a visit code to print all forms for that visit.

To Print Specific Forms

Place an "x" beside each form to be printed

To Print One Form

Optional. Enter a form and revision number, eg, "dc1" , to print the form

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Copies

Number of copies to print, default=1, maximum=9

Collate Copies

Enter "y" to collate copies or "n" to print a set for each form, "y" is the default

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

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Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End FORMS.HELP ===

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21.6. LABMENU (printing labels)

To exit help, press [F7]

OVERVIEW

Print miscellaneous administrative labels

SCREEN ITEMS

CC Labels

Click this button to print a set of mailing labels with the address of the coordinating center

Go Back

Click this button to return to the previous menu

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts LABMENU 101 SHHS Data System Manual 21. Appendix B. Help screens 21.6. LABMENU (printing labels)

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End PRINT LABELS.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts LABMENU 102 SHHS Data System Manual 21. Appendix B. Help screens

21.7. LOGMENU (session logs task)

To exit help, press [F7]

OVERVIEW

Work with sesssion logs -- use for trouble- shooting, when requested to do so by the CC

SCREEN ITEMS

View Session Logs

Click this button to view or print session logs

Clear Session Logs

Click this button to erase session logs -- only if requested to do so by the CC

Cancel

Click this button to return to the previous menu

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Logmenu 103 SHHS Data System Manual 21. Appendix B. Help screens 21.7. LOGMENU (session logs task)

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End SESSION LOGS.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Logmenu 104 SHHS Data System Manual 21. Appendix B. Help screens 21.7. LOGMENU (session logs task)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Logmenu 105 SHHS Data System Manual 21. Appendix B. Help screens

21.8. MAIN (sign on screen and backup)

To exit help, press [F7]

OVERVIEW

Sign on to the system. Perform required scheduled backups and data transmissions

Note: use of the system is restricted to certified personnel who have been issued a personnel identifying number(PIN)

SCREEN ITEMS

Enter your PIN

Enter your PIN number. You must be certified in the use of the system

Password

Enter the system password. Obtain the confidential password from the Coordinating Center at 410 955-8175

WINDOW TOOLBAR

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts MAIN 106 SHHS Data System Manual 21. Appendix B. Help screens 21.8. MAIN (sign on screen and backup)

Click icon: To:

Up arrow Close window, cancel session

Triangle Minimize screen

? Display help

Box arrow Exit system

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window, cancel session

DATABASE BACKUPS

Daily backups

o Required daily backup is requested every day at the first sign on

7-day backups

o Required 7 day backup is requested after every 7-days

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts MAIN 107 SHHS Data System Manual 21. Appendix B. Help screens 21.8. MAIN (sign on screen and backup)

DATA TRANSMISSION TO CC

Monthly transmission

o Required data transmission to the Coordinating Center is requested monthly

DISKS USED BY THE SYSTEM

Volume Contents ______

BK1 Daily backup

BK7 7-day backup

TR Monthly transmission

To exit help, press [F7]

=== End MAIN.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts MAIN 108 SHHS Data System Manual 21. Appendix B. Help screens

21.9. SLEEP DATA CAPTURE

To exit help, press [F7]

OVERVIEW

Access the Compumedics software used to capture the sleep data. Performs various additional functions including flash card formatting, copying data to zip disks for transmission to the Reading Center

SCREEN ITEMS

Capture sleep data

Click this button to start the Compumedics software for capturing sleep data stored on flash cards

Cancel

Click this button to close window and return to the Tasks menu

WINDOW TOOLBAR

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Sleep 109 SHHS Data System Manual 21. Appendix B. Help screens 21.9. SLEEP DATA CAPTURE

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End MENU_SLP.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Sleep 110 SHHS Data System Manual 21. Appendix B. Help screens

21.10. CODE DRUG MedDB

To exit help, press [F7]

OVERVIEW

Start the MedDB application used for entering and coding patient medications (drugs)

SCREEN ITEMS

Code drugs -- MedDB

Click this button to start the MedDB software

Cancel

Click this button to close window and return to the Tasks menu

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts MedDB 111 SHHS Data System Manual 21. Appendix B. Help screens 21.10. CODE DRUG MedDB

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End MENU_DRG.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts MedDB 112 SHHS Data System Manual 21. Appendix B. Help screens

21.11. PRINT MENU

To exit help, press [F7]

OVERVIEW

Select a print task. Includes printing blank forms or form sets, printing labels, and printing or viewing forms in the DB (useful for audits)

SCREEN ITEMS

Blank forms

Click this button to print blank copies of forms

Labels

Click this button to select labels for printing

Data forms

Click this button to specify up to 25 forms to be selected from the database. This forms can either be viewed on-screen or printed

Cancel

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts PrintMenu 113 SHHS Data System Manual 21. Appendix B. Help screens 21.11. PRINT MENU

Click this button to close window and return to the Tasks menu

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts PrintMenu 114 SHHS Data System Manual 21. Appendix B. Help screens 21.11. PRINT MENU

To exit help, press [F7]

=== End MENU_PRT.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts PrintMenu 115 SHHS Data System Manual 21. Appendix B. Help screens

21.12. REPORTS MENU

To exit help, press [F7]

OVERVIEW

Select from a menu of reports. Most reports can be viewed on-screen or printed -- make sure printing has completed before contiuing with the system

SCREEN ITEMS

Visits due

Click this button to print or view list of patients whose visits are upcoming (due)

Cancel

Click this button to close window and return to the Tasks menu

WINDOW TOOLBAR

Click icon: To:

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts ReportsMen 116 SHHS Data System Manual 21. Appendix B. Help screens 21.12. REPORTS MENU

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End MENU_REP.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts ReportsMen 117 SHHS Data System Manual 21. Appendix B. Help screens

21.13. BACKUP DATABASE MENU

To exit help, press [F7]

OVERVIEW

Perform database backups or database transmissions to the Coordinating Center

SCREEN ITEMS

Backup

Perform database backup

Password

Perform database transmission

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Backuphelp 118 SHHS Data System Manual 21. Appendix B. Help screens 21.13. BACKUP DATABASE MENU

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

DATABASE BACKUPS

Daily backups

o Required daily backup is requested every day at the first sign on

7-day backups

o Required 7 day backup is requested after every 7-days

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Backuphelp 119 SHHS Data System Manual 21. Appendix B. Help screens 21.13. BACKUP DATABASE MENU

DATA TRANSMISSION TO CC

Monthly transmission

o Required data transmission to the Coordinating Center is requested monthly

DISKS USED BY THE SYSTEM

Volume Contents ______

BK1 Daily backup

BK7 7-day backup

TR Monthly transmission

To exit help, press [F7]

=== End MAIN.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Backuphelp 120 SHHS Data System Manual 21. Appendix B. Help screens

21.14. Work with LOGS Menu

To exit help, press [F7]

OVERVIEW

Work with sesssion logs -- use for trouble- shooting, when requested to do so by the CC

SCREEN ITEMS

View Session Logs

Click this button to view or print session logs

Clear Session Logs

Click this button to erase session logs -- only if requested to do so by the CC

Cancel

Click this button to return to the previous menu

WINDOW TOOLBAR

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts LogMenu 121 SHHS Data System Manual 21. Appendix B. Help screens 21.14. Work with LOGS Menu

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End SESSION LOGS.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts LogMenu 122 SHHS Data System Manual 21. Appendix B. Help screens

21.15. TASKS menu (help)

To exit help, press [F7]

OVERVIEW

Main menu of data system tasks

SCREEN ITEMS

Data entry

Click this button to key new new data forms or to make changes to forms entered previously

Sleep data capture

Click this button to start the Compumedics software for capturing sleep data stored on flash cards

Code drugs - MedDB

Click this button to start the MedDB software used for entering and coding patient medications (drugs)

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Task2 123 SHHS Data System Manual 21. Appendix B. Help screens 21.15. TASKS menu (help)

View DB contents

Click this button to display the current of the database (DB), either by forms or by visits -- can show missing/overdue data

Print

Click this button for miscellaneous print tasks, including blank copies of data forms, mailing labels, and completed data forms (used for audits). In some cases, the list may be viewed on the screen without printing

Reports

Click this button for miscellaneous reports, including lists of upcoming visits

Backup/transmit data

Click this button to backup the data system or to transmit data to the Coordinating Center

Work with logs

Click this button to view session logs or to clear (erase) the logs. This is used for trouble-shooting by the Coordinating Center

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Task2 124 SHHS Data System Manual 21. Appendix B. Help screens 21.15. TASKS menu (help)

Reset tutorial

Click this button to reset the tutorial system. It erases any data entered into the tutorial system previously. This button is only active when using the tutorial system

Exit

Click this button to exit the system. A prompt for system backup may occur

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Task2 125 SHHS Data System Manual 21. Appendix B. Help screens 21.15. TASKS menu (help)

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End TASKS.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts Task2 126 SHHS Data System Manual 21. Appendix B. Help screens

21.16. VISLIST (visits inventory task)

To exit help, press [F7]

OVERVIEW

Displays a list of visits with data entered. Also displays the randomization date, visit code, and date of the most recent visit. The date of the next visit is shown

Shows patients with missed/pending visits

Shows patients currently due a visit

SCREEN ITEMS

Id

Enter patient Id.

Form

Enter a form and revision number or enter "*" to select all forms

Visit

Enter a visit code or enter "*" to select all visits

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts VISLST 127 SHHS Data System Manual 21. Appendix B. Help screens 21.16. VISLIST (visits inventory task)

Sort

Enter: To sort by:

1 Alpha code 2 Patient Id 3 Date

Options

Click on: To:

Prt * Print hard copy of list Miss * Show patients with missed/ pending visits Due * Show patients due for a visit

Date limit

Enter lower limit to restrict display to forms with a date on or after "ddmonyy" eg, "07jan99" for January 13, 1999

WINDOW TOOLBAR

Click icon: To:

Up arrow Close window and return to Tasks menu

Printer Print screen contents

Calendar Date calculator

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts VISLST 128 SHHS Data System Manual 21. Appendix B. Help screens 21.16. VISLIST (visits inventory task)

Id Find an alpha code

Pen Save snapshot to log -- for troubleshooting

Triangle Minimize screen

? Display help

WINDOW FUNCTION KEYS

Press: To:

[F1] Display help

[F7] Close window and return to Tasks menu

To exit help, press [F7]

=== End VISIT LIST.HELP ===

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts VISLST 129 SHHS Data System Manual 21. Appendix B. Help screens

SHHS Manuals/DataSys\Manall.13 SHHS Data System Manual (1:25pm Tue) 10 April 01/pts VISLST