Note: Descriptions are shown in the official language in which they were submitted.
2 ~ 7 ~
~~ Backqround of t.he Invention
This invention relates to a system for eliciting confidential
information, and more specifically to a system for eliciting
confidential medical histories and information from human beings.
In certain activities, such as screening blood or plasma
donors, taking medical histories from patients, or employment
interviews, it is sometimes necessary to pose questions of a
personal or confidential nature. Because a respondent's answers may
affect his qualifications to donate blood or plasma or the selection
of appropriate medical procedures for his condition or may subject
an employer to litigation, it is important that the respondent
provide accurate and cbmplete responses. For example, units of
whole blood, red cells, platelets, and plasma, (collectively "blood
I compounds-) necessary to sustain life in surgical procedures and
I used to manufacture lifesaving pharmaceuticals can pose a
significant risk to the recipients of the blood components or
pharmaceuticals if prior donor behavior and medical conditions are
not properly addressed as a qualification for donating. Similarly,
a patient must provide truthful answers to questions about medical
history if an attending physician is to provide appropriate medical
4 treatment. Hiring or retaining an employee using illegal drugs can
result in work place accidents and other deleterious effects.
! Unfortunately, simply posing a battery of questions to a donor,
patient, or potential employee is not the best way to elicit wholly
tru~hful and accurate responses. Because the questioner must ask
1 questions of a confidentiAl nature, e.g., questions about illegal
I drug use, sexual practices, income, religion, etc., and because the
I
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~~~stioning is performed in an environmenk which may invade a
respondent~ci sense of privacy, a respondent may not always be
completely candid with his answers. Indeed, the questionnaire
environment is uncomfortable not only for the respondent but also
for the questioner, and questions may be improperly posed, or posed
in a manner perceived by the respondent as threatening.
Lack of comprehension by the respondent is also a problem,
especially if the respondent has a poor command of English, or if
the respondent perceives the ~uestions as boring. When the
respondent is using a paper form, there is not even any assurance
that the ~uestions have been completely read.
In addition, transcription errors may occur when responses are
recorded by a human interviewer or key entry errors may occur when
responses are entered into a computer database. Additionally,
interviewer bias may affect the responses. The interviewer may also
fail to ask all requisite questions. These errors and omissions can
lead to citations from the U.S. Food and Drug Administration (FDA)
and possible loss of an establishment~s license to collect and
distribute blood products. These errors may also subject the
establishment to lawsuits. Finally, after the questioning is
finished, there may be indirect information that would be useful in
making a medical decision. For example, if only a Yes/No response
is elicited, other available information, such as consistency with
answers given during a prior session, whether the respondent
answered and then changed his response, and a length of time the
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`:pondent spent considering the question may also be reasonablecriteria to consider.
Summary of the Invention
The present invention overcomes the problems and disadvantages
of the prior art by giving the respondent a number of options
customizing the manner in which questions are posed and/or answered
and assuring that all questions are addressed and responses recorded
correctly. In accordance with the respondent's pre~erence, the
questions may be asked so that the questions are audible only to the
respondent and are not visible to other persons who may be present.
Similarly, the respondent may, at his option, give his responses in
a way that does not make them visible to other persons during the
questioning session. The respondent also controls the volume of any
audible output and may choose to suppress an audible echo of his
responses. Allowing the rasponden~ to select various options to
ensure the confidentiality of his responses results in the
respondent giving more accurate, complete, and truthful information.
The invention facilitates correct responses by improved
communication because each question is displayed on a display
screen, asked via audio, and illustrated with color pictures and
graphics. The questions are presented consistently each time, thus
controlling interviewer bias. The invention also eliminates
transcription and key entry errors and the questions are stored in a
manner that makes them easy to update.
In addition, the present invention overcomes the problems and
disadvantages of the prior art by allowing the respondent to choose
the language in which the questions are asked both audibly and
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d "~played on the screen. The invention also waits a predetermined
time before accepting input from the respondent, to ensure that the
respondent has had time to read or hear the question. Lastly, the
invention keeps track of indirect information about responses, such
as consistency with prior answers, whether the respondent answered
then changed their response, and a length o time the respondent
spent considering the ~uestion.
In accordance with the purpose of the invention, as embodied
and broadly described herein, the invention is a system for
gathering confidential data from a human respondent, comprising: a
display device; means for presenting the human respondent with two
privacy alternatives that relate to a manner in which a response
should be solicited; means for receiving an input from the human
, respondent choosing one of the privacy alternatives; means for
soliciting, via the display device in accordance with the chosen
privacy alternative, the response; and means for receiving a
response from the human respondent.
In accordance with the purpose of the invention, as embodied
and broadly described herein, the invention is a system for
gathering confidential data from a human respondent, comprising: an
audio output device; means for allowing the human respondent to
control the volume of the audio output device; means for presenting
, the human respondent with two privacy alternatives that relate to a
manner in which a response should be solicited; means for receiving
an input from the human respondent choosing one of the privacy
alternatives; means for soliciting, via the output device in
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ordance with the chosen privacy alternative, the response; and
means for receiving the response from the respondent.
In accordance with the purpose of the invention, as embodied
and broadly described herein, the invention is a system for
gathering confidential data from a human respondent, comprising: a
first input device; a second input device; means for displaying two
privacy alternatives that relate to the first and second input
devices; means for receiving an input from the human respondent
choosing one of the privacy alternat:ives; means for soliciting a
response from the human respondent; and means for receiving a
response from the human respondent via one of the first and second
input devices in accordance with the chosen privacy altexnative.
In accordance with the purpose of the invention, as embodied
and broadly described herein, the invention is a system for
gathering confidential data from a human respondent, comprising: an
audio output device; means for receiving an input from the human
respondent indicating a desired degree of privacy during
questioning; means for soliciting the human respondent for a
response; means for receiving a response from the human respondent;
and means for echoing the response via the audio output device when
the human respondent indicates a predetermined degree of privacy.
In accordance with the purpose of the invention, as embodied
and broadly describPd herein, the invention is a system for
gathering confidential data from a human respondent, comprising: an
audio output device having a hands et and a loudspeaker; means for
allowing the respondent to indicate a privacy alternative relating
to whether a response is solicited via the handset or the
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ldspeaker; means for soliciting, via the audio output device in
accordance with the indicated privacy alternative, the response; and
means for receiving a response from the human respondent.
Objects and advantages of the invention will be sçt forth in
part in the description which follows and in part will be obvious
from the description or may be learned by practice of the invention.
The objects and advantages of the invention will be realized and
attained by means of the elements and combinations particularly
pointed out in the appended claims.
Brief DescriPtion of the Drawinqs
The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate several
embodiments of the invention and, together with the description,
serve to explain the principles of the invention.
Fig. 1 is a block diagram of a preferred embodiment of the
present invention;
Fig. 2 shows an example format of a question screen displayed
on a touchscreen of Fig. 1;
Fig. 3 shows an example of a question screen having the format
of Fig. 2;
Fig. 4 is a picture of a touchpad of Fig. 1 with a template
laid over it;
Fig. 5 shows an example of a display screen on a touchscreen of
Fig l;
Fig. 6 shows an example of a display screen on the touchscreen
of Fig. l;
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.
Fig. 7 shows an example of a display screen on the touchscreen
of Fig. l;
Fig. 8 shows an example of a display screen on the touchscreen
of Fig. 1;
Fig. 9 is a flowchart of a steps performed by a processor of
Fig. l;
Fig. 10 is a flowchart of a steps performed by a processor of
Fig. 1;
Fig. 11 shows a format of data stored after a set of questions
has been asked;
Fig. 12(a) shows a format of a data structure used to implement
a state machine indicating an order of questions and a screen format
for each question; and
Fig. 12(b) shows a table of the data structure of Fig. 12(a).
Detailed DescriPtion of_the Preferred Embodiments
Reference will now be made in detail to the pr~ferred
, embodiments of the invention, examples of which are illustrated in
i the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same or
I like parts.
! Overview
~! To solve the problems of conventional systems, the present -~
invention allows respondents to answer questions based on their own
sense of privacy in a language of their choice. The questions are
customized to the sex of the respondent and other factors, such as
whether the respondent has heard the questions before.
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The respondent can tune the system to achieve his sense of
privacy through volume controls, source of the audio (loudspeaker or
handsets), whether to have verbal feedback of a response, and
controlling the visibility of text and graphics on the screen that
could provide any hint as to the nature of the questions to other
persons present. The respondent also controls the input source,
using, e.g., a touchscreen or a more confidential touchpad device.
Depending on the alternatives chosen by the respondent, the
audio of each question is accompanied by a display of full text of
the question and by color graphics, which mutually reinforce each
other and serve to hold the attention of the respondent. To keep
the respondent from answering questions before they are finished,
response buttons are not activated until after a predetermined
period of time. The sequence and content of questions is controlled
by entries in an input setup file that is easily edited to change
the text, color graphics, or question order. Responses are
collected and used as input to a general respondent qualification
decision rule. The decision rule is stored in a file or table and
may be easily changed. The responses or decision result may be
output to a printer or CRT for aiding human decision making.
II. A Blood_Donor Screeninq S~stem
A blood donor is defined as any person who donates, either
freely or for compensation, whole blood or any whole blood
component, e.g., red cells, platelets or plasma.
(A) Hardware
Fig. 1 is a block diagram of a preferred embodiment of the
present invention. A system 100 of Fig. 1 is used to elicit
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c -fidential information from potential blood donors, but could also
be used to elicit con~idential information of other types, such as
information relating to medical histories, employment or welfare
eligibility. System 100 of Fig. 1 includes a monitor 101 having a
touch screen 102 and a speaker unit 103. Speaker unit 103 includes
a thumbnail switch volume control 105l a handset 104, and a
loudspeaker 107. System 100 also inc:Ludes-a touchpad 106 connected
to computer 110. Computer 110 includes a memory 112 and a processor
(CPU) 114. ~onitor 101 is connected to computer 110 in a manner
known to persons of ordinary skill in the art. Other embodiments
may use, e.g., a mouse keyboard, stylus, bar code magstripe reader,
or a Braille touchpad as an input device instead of touchscreen 102,
and may use, e.g., a headset or earphones as an audio output device
instead of handset 104.
In the described embodiment, a question is always output
verbally through speaker unit 103 using one of handset 104 and
loudspeaker 107. Speaker unit 103 is connected to computer 110. In
the described embodiment, the question is output over loudspeaker
107 when handset 104 is in its cradle. When handset 104 is picked
up, the question is output over handset 104, and not over
loudspeaker 107. Thus, if the respondent does not want the `
questions to be audible to other persons, he picks up handset 104,
and the questions cannot be heard by others. The determination of
whether handset 104 is in its cradle preferably is made by circuitry
internal to speaker unit 103. In the described embodiment, the
respondent can adjust the volume of both loudspeaker 107 and handset
104 to a level that the respondent feels is both comfortable and
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c idential using volume control 105. Computer 110 sends signals
to speaker unit 103 to control audio output and may receive status
signals from speaker unit 103.
Computer 110 preferably is a Compudyne 486 PC manufactured by
Compudyne Corp. of Addison, Texas. Touchscreen 102, which attaches
to the front of a standard computer monitor, preferably is a
TouchWindow, manufactured by Edmark, Inc. of Redmond, Nashington.
Touchpad 106 preferably is an UnMouse manufactured by MicroTouch,
Inc. of Wilming~on, Massachusetts. Speaker unit 103 preferably is a
Sound XChange unit, manufactured by InterActive, Inc. of Humboldt,
South Dakota.
In the described embodiment, computer 110 is executing under
MS-DOS 5.0 running Microsoft Windows 3.1 with multimedia extensions.
The questions are input and displayed under a computer program
written in a computer language called "Asymetrix Toolbook 1.5,"
produced by Asymetrix Corp. of Bellevue, Washington. Questions and
responses are stored in a database using Dbase IV, produced by
Borland Corp. of Scotts Valley, California. Other embodiments may
use other hardware and software components-
Fig. 2 shows an example format of a question screen 200displayed on touchscreen 102. Screen 200 includes a number of
windows, or fields, generated using ~icrosoft windows. Field 202
preferably shows a still photograph of a nurse. Field 202 is
included to ~humanize~ the display and may be omitted in other
embodiments. Field 204 preferably shows the text of a question.
Field 204 may also be blank, as described below. Field 206
preferably shows a color graphic associated with the question.
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21~5~78
`?ld 206 may also be blank, as described below. In addition,
screen 200 includes a title field 207, which contains a title of a
type of screen 200 (e.g., ~Medical History"), a label field 208,
which contains a label of the qllestion (e.g., ~Question 1~); and an
answer field 209, in which the respondent's current answer is
echoed. The respondent may change his answer at any time that the
screen is displayed, and may go back to any screen to change his
answer.
Screen 200 includes a plurality of buttons 210. Buttons 210
include a "Back~ button, a "Yes" button, a "Don't Know" button, a
"No" button, and a ~Next" button. The "Back" button indicates that
the respondent wants to display a previous question. The "Yes~
button, the ~No~ button, and the ~Don~t know~ button each represent
a possible response to a question. The "Next" button indicates that
the respondent wishes to go ~o the next question. In the described
embodiment, it is possible to skip a question by touching the "Next~
button. Other embodiments may not allow N questions to be skipped,
may have different buttons such as VCR-like but~ons to control
motion video, mutually exclusive choices of year buttons to indicate
when respGndent traveled outside the U.S., or different arrangements
of the described buttons.
Fig. 3 shows an example of a question screen 300 displayed on
touchscreen 102 and having the format of screen 200 of Fig. 2.
Field 307 pre erably shows the title of the screen ("Medical
History~). Field 302 preferably shows a still color photograph of a
nurse. Field 304 preferably shows the text of a question (e.g.,
"Have you read and do you understand the required information about
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I' '`S and associated risk factors? Do you understand the blood
donation process?") Field 306 preferably shows a color graphic
associated with the question. Field 308 shows a label associated
with the question ("Question 1"). Field 309 will contain an echo of
a button touched by the respondent. Preferably, the question is
also spoken over speaker unit 103. If handset 104 in speaker unit
103 is not picked up, the question is spoken over loudspeaker 107 in
speaker unit 103. If handset 104 is picked up, the question is
spoken over handset 104. When the respondent touches a button, the
button is echoed audibly over speaker unit 103 and visually in field
309 tunless the respondent has disabled the echo function).
Fig. 4 is a picture of touchpad 106 with a template laid over
it. The template has printed buttons 410 similar to buttons 210 of
Fig. 2. Various sections of touchpad 106 correspond to buttons 410
and touching those sec-tions of touchpad 106 (when touchpad 106 is
enabled~ has the same effect as touching buttons 210 on touchscreen
102. Other embodiments of the invention may include different or
additional buttons on touchpad 106, e.g., buttons similar to those
discussed ~elow in connection with Figs. 5 and 6.
(B) Privacy Option
Initially, during operation of the system of Fig. 1, but before
questions of a confidential nature have been asked, questions
controlling a degree of user privacy and other options, such as
language choice, are displayed on touchscreen 102. In the described
embodiment, the respondent is given a choice between two ~privacy
alternativesll for each privacy option. Fig. 5 shows an example of a
display screen 500 on touchscreen 102. Display screen 500 has four
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- ~lds: a ~language" field 502, a "yuestion text and pic~ures~' field
S04, a "repeat response verballyl' field 506, and an "answer
questions with" field 508. Screen 500 also has a ~continue" button
512, which indicates that the respondent wants to go to a next
screen. Each field 502-508 allows the respondent to select one of a
plurality of alternatives for a privacy option. The respondent
selects an alternative by touching the screen, or by using a mouse
(not shown)t touchpad 106, or some similar pointing/selection
device. _
Language field 502 allows the respondent to select the
alternative of having questions displayed and/or spoken in Bnglish
or Spanish. The question displayed in field 202 of Fig. 2 is
displayed in either English or Spanish and the question is output to
speaker unit 103. Other embodiments of the invention may allow the
respondent to choose other languages. Field 502 preferably N
defaults to "English."
Fields 504-508 allow the user to select other alternatives that
control the degree of privacy for the session. Field 504 allows the
respondent to select whether text and graphics associated with each
question are displayed on touchscreen 102. If the respondent does -
not wish potentially embarrassing text or graphics to be displayed,
he selects "not shown." Field 504 preferably defaults to "visible."
Field 506 allows the respondent to select whether his responses
are echoed ~in field 209 of Fig. 2 and through speaker unit 103) or
are not echoed. If the respondent does not wish potentially -~
embarrassing responses to be echoed, he selects "off" and his
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- ;ponses are not echoed either audibly or on touchscrePn 102.
Field 506 preferably defaulks to ~on.~
Field 508 allows the respondent to select either touchscreen
102 or touchpad 106 as the input device when responding to
confidential questions. If the respondent does not want other
persons to see him making responses (as would happen with
touchscreen 102), he sslects "Private Touchpad~ for touchpad 106.
~ield 508 preferably defaults to "touchscreen.
In the described embc~iment, at any time during the session,
the respondent can toggle the "visible"t"not shown" option. This
option is toggled by touching any part of the text or graphic
display on touchscreen 102. For example, if the tex~ and graphics
are displayed ('Ivisible" mode), touching the text or the graphic
will cause the system to enter "not shown~' mode, and the text and
graphics will be erased from touchscreen 102. The words ~Touch Here
to View the Question~ appear in the text box 204 of screen 200.
Touching these words toggle the "visible" option on.
In the embodiment of Fig. 1, at any time during the
confidential questioning, the respondent can toggle the
"touchscreen"/"private touchpad" option. This option is toggled by
touching the desired input device. For example, if the respondent
is using buttons 210 to indica~e his responses, touching touchpad
106 will cause the system to accept input from touchpad 106, and not
display the buttons 210 on the scr~en. Touching touchscreen 102
again will cause buttons 210 to be displayed again, and input to be
accepted from buttons 210 of touchscreen 102. Other embodiments may
i also allow simultaneous input from both input devices. In the
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scribed embodiment, other privacy options cannot be toggled.
Other embodiments may differ.
Fig. 6 shows an example of a display screen 600 on touchscreen
102. Display screen 600 has two fields: a "sex" field 602, and a
"donation status" field 604. Each field 602 and 604 allows the
respondent to select one of a plurality of options. Field 602 allows
the respondent to indicate his or her sex. Field 602 preferably
defaults to "male." Field 604 allows the respondent to indicate
whether he is a new donor or a repeat donor. Field 604 preferably
defaults to "new donor."
When the respondent selects ~visible'- in field 504 of Fig. 5
("visible"/"not shown"), a screen such as that of Fig. 3 is
displayed. When the respondent selects "not shown", however, a
screen such as that of Fig. 7 is displayed for each question. Fig.
7 is similar to Fig. 2, except that field 706 is blank and field 704
contains the words "Touch Her~ to View the Question."
When the respondent selects "touchscreen" in field 508 of Fig.
5 ("touchscreen"/"private touchpad"), a screen such as that of Fig.
2 is displayed. When the respondent selects "private touchpad~,
howe~er, a screen such as that of Fig. 8 is displayed for each
question. Fig. 8 is similar to Fig. 3, except that buttons 210 are
not displayed. Since the user will be indicating responses on
touchpad 106 (see Fig. 4), for privacy, the responses are not
displayed on touchscreen 102.
When the respondent selects both "priva~e touchpad" in field
508 and "not shown" in field 504 of Fig. 5, a screen (not shown)
that is similar to Fig. 7 but that does not have buttons 710 is
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c played. Since the user will be i.nd:icating responses on touchpad
106, there is no purpose in displaying buttons on touchscreen 102.
Since the respondent desires a high degree of privacy, the text and
color graphics are not displayed on touchscreen 102.
(C) Asking Questions
Fig. 9 is a flowchart of the steps performed ~y processor
114 of Fig. 1 executing a program stoxed in memory 112 during the
operation of the described embodiment for blood donor screening. In
step 902, processor 114 displays the screen of Yig. 5 on touchscreen
102 and allows the respondent to ente:r his or her pri~acy options
and language choices. The respondent may select different
alternatives or the various options until he finalizes his options
by touching "continue" button 512, which is verbally echoed. The
respondent~s choices are stored by processor 114 in memory 112 or in
some other storage medium, such as a hard disk (not shown).
Throughout this document, the term ~storage medium" is also intended
to include, e.g., an optical and/or a CD ROM storage device.
In step 904, processor 114 displays the screen of Fig. 6 on
touchscreen 102 and allows the respondent to indicate his or her sex
and whether he is a repeat donor. The respondent finalizes his
entry by touching "continue" button 612, which is verbally echoed.
Other embodiments may request that the respondent enter a social
security number, use a bar code or magstripe identification card, or
have their picture or signature recorded (not shown).
In steps 906-912, processor 114 displays screens having a
format of Fig. 2 on touchscreen 102 (or Fig. 7 or Fig. 8, depending
on the privacy options entered) and allows the respondent to enter
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- s response to questions 1 through n. The steps per~ormed to ask a
question and recei~e a response are described in connection with
Fig. 10. Fig. 9 shows a path between step 908 and 906 to indicate
that a previous question is asked when the "Back" button is touched.
In step 914, after all questions ha~e been asked, processor 114
applies a decision rule to decide if the respondent will be allowed
to donate blood. Other embodiments may output the information for
human decision making via printer or monitor instead of, or in
addition to, the decision .ule. This decision rule is discussed
below. If the result of the decision rule is ~yes,~ the respondent
is allowed to donate blood and a message to that effect is displayed
on touchscreen 102. If the result of the decision rule is ~no,~ the
respondent is deferred and is not allowed to donate blood. A
message to that effect is displayed on touchscreen 102. These
messages are displayed whether or not the ~'not shown~ option is
turned on. In step 920, processor 114 saves the donor~s status in
memory 11~ or in some other storage device, such as a hard disk,
along with a social security number or other unique ID, and/or
outputs results to a printer or another CRT.
In the described embodiment, an answer of "yes" to certain
questions (e.g., ~Have you ever had an AIDS (HIV) test that was
positive?~) will cause the respondent to be deferred as a donor.
Other embodiments may use more sophisticated decision rules. For
example, the following decision rule applies to a system where some
questions should be answered ~Yes~ and some should be answered ~No~
and the system stores previous responses from previous sessions of
each donor in a database. The current set of ~uestions and answers
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, .
:e Sessionn. The previous set of questions and answers are
Session n 1
-
If Sessionn 1 is on file then
If any answer from a current Sessionn is inconsistent
with a previous answer from Sessionn 1 then
Disqualify the donor
Else If each answer is consistent then
If all ans~-ers match a predetermined set
of answers then
Qualify the donor
Else
Disqualify the donor
Else (Sessionn 1 is not on file)
~ If all answers match a predetermined set of answers
I then Qualify the donor
j Else
Disqualify the donor
In some embodiments, the database may be stored in a memory of a
¦ computer at a central location, and processor 114 accesses the
¦ central computer~s database via modem or a network. In other
embodiments, the database may be stored in memory 112 or in a
storage device of computer 110.
The following is another example of a possible decision rule:
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If the respondent took more than one minute to answer any
question then
Disqualify the donor
Else
Qualify the donor
, ,
The following is another example of a decision rule used in a ~:
medical history taking application:
1. ~ook up respondent--(or respondent ID) in a database.
-2. If respondent is in the database then
If respondent has been identified as a litigation
risk then
Follow Doctor/Patient appointmen~ procedure A :
Else
Follow Doctor/Patient appointment procedure B
I El~e ~ :~
i If respondent is not in the database then follow
Doctor/Patient appointment procedure C
The following is another example of a decision rule where
processor 114 solicits and receives from the respondent a time
since respondent~s last donation. The system also solicits and
receives a type of donation occurring (or a type of donation is
pre defined).
.,
If time since last donation ~ minimum acceptable time
for this type of donation
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Disqualify the donor
Else
Qualify the donor
A type of donation occurring determines the minimum acceptable
period of time between donations. For example, homologous whole
blood donors may donate approximately every eight weeks.
Autologous donors may donate as often as once a week. Platelet
donors may donate more fre~uently than whole blood donors, e.g.,
on the order of every two weeks. The ~inimum acceptable periods
of time are stored in memory 112 or are stored in a database of a
central computer system and acces~ed by processor 114 via modem or
network connections. In other embodiments processor 114 may
access a database to determine a time since last donation instead
of eliciting this information from the respondent.
The result of the decision rule preferably is saved in memory
112. In other embodiments the result may also be saved an disk,
in a central database, presented to a medical professional via CRT
for additional review, or output to a printer as permanent legal
record or for other purposes. Certain embodiments, such as those
regulated by the FDA, will always print out or display a summary
of all decisions and the data used to reach the decision, so that
a human operator can verify the decision. Such a system may allow
the reviewer to store notes on why a donor was or was not allowed
to donate and to store a signature of the reviewer and/or donor.
Other embodiments may not have provisions for human oversigh~.
~ :
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- The following paragraphs describe steps`performed by
processor 114 to ask one question. All of the steps o~ Fig. 10
are performed once for each of steps 906-912 of Fig. 9. In step
1002, processor 114 initializes variables representing an initial
start time and an initial question number. The initial start time
~s also saved in a memory or other storage device. In step 1004,
if a current question should be skipped because of the donor's
sex, processor 114 sets a button (BTN) variable to "skip~' in step
1006 and control passes torstep 1022. (The respondent previously
indicated his or h~r sex in screen 600 of Fig. 6.) An example of
a skipped question would be "Have you ever had sexual contact with
another man?" when the donor is female. If, in step 1004, the
question should not be ski.pped, control passes to step 1008.
In step 1008, processor 114 determines whether the respondent
wants to display text and graphics associated with the question.
~he respondent previously indicated his preference using field 504
of Fig. 5 (or by toggling the ~display" option as discussed
above). As discussed above, the respondent can toggle the
"display~ option at any time. Therefore, processor 114 frequently
checks to see if a toggle has occurred. This check has not been
included in the flow charts for ease of explanation. If text and
graphics are to be displayed, processor 114 executes a ~show~
function in step 1012 that displays the text and color graphic for
the current question on touchscreen 102 (see Fig. 3) and outputs
the audio for the question to speaker unit 103. Processor 114
also sets an audiotimer variable to "short". The audiotimer
variable is used in steps 1014-1016 to determine when to start
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a epting input from touchscreen 102 or touchpad 106. In the
embodiment, when text and color graphics are displayed, it is
assumed that the respondent can read the text more quickly than
the text is spoken over speaker unit 103. Thus, a short amount of
time passes before processor 114 begins accepting input from
respondent. Repeat donors familiar with the questions, also may
require a "short" audiotimer until input is accepted. In some
embodiments, repeat donors are always given a "short" response
time, irrespective of whether text and graphics are to be
displayed~
If text and graphics are not to be displayed, processor 114
executes a ~hide~ function in step 1010 that does not display the
text and color graphic for the current question (see Fig. 7) and
that outputs the audio for ~he question to speaker unit 103.
Processor 114 also sets an audiotimer variable to "long". In the
embodiment, when text and graphics are not displayed, it is
assumed that the respondent must wait to hear the question spoken
over speaker unit 103. Thus, a relatively long time passes before
processor 114 begins accepting input.
In step 1014, processor 114 sets a software audio timer to
the value of the audiotimer variable. When the software audio -~
timer expires in step 1016, processor 114 displays buttons on
touchscreen 102 (if the ~touchscreen~ option has been selected)
(step 1017). No input is accepted from the selected input device
until the software audio time has expired. In the described
embodiment, when text and graphics are displayed on the screen,
then response buttons 210 are displayed and become active after
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~ic: :
2115~73
: `.ee seconds of audio. If text and graphics are not visible,
then the response buttons are not activated until the end of the
audible question.
¦ In step 1018, processor 114 waits for the respondent to touch
J~ a button and in step 1020, processor 114 sets the BTN ~ariable to
i a value representing the button touched by respondent. In step
~l 1022, processor 114 saves the end time in memory 112 or in another
storage device. Because the start and end times for the question
are both saved, it is possible to determine how long it took the
I respondent to answer the question (t = TimeEnd - TimeStart).
3, Processor 114 then saves the question number (q), the respondent's
response (BTN) (i.e., the button touched by the respondent), and
the amount of time (t) in memory 112 or a storage device. In the
described embodiment, processor 114 saves multiple responses, if
the respondent repeats questions and gives more than one response.
Other embodiments may only save the respondent's last answer.
3 Fig. 11 shows a format of a data structure used by processor
¦ 114 to store user responses for a set of questions (Sessionn).
i Information for Sessionn includes a tag, such as a donor ID and a
;~ date and the respondent's responses (ql .... qt). A donor ID can
be, e.g., a social security number or a transaction ID number.
Each response (qn) is stored as a question number, the response
(possible values include "Yes", "No~', "Don't know", or
unanswered), and the amoun~ of time it took the respondent to
answer the question.
In step 1024, processor 114 determines the flow of control in
accordance with the button touched by the respondent (or if the
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c stion was skipped because of the sex of the respondent). If
the respondent touched a ~sack~ button, processor 114 displays the
prior frame as determined from information in the ~Back~ field of
the state variable described in Figure 12(a) described below. The
result of this frame navigation may be to stay at the same
question, if there are no previous questions.
If the respondent touched a "Yes", "No", ~Don't Rnow", or
"Next~ button or if the question is skipped, processor 114
navigates to the next fram~determinecl from information in the
respective button ields of the state variable described in Figure
12(a) below. The result of frame navigation, may be to stay at
the same question, if the current question is the last question.
The following list contains some examples of questions asked
in the described blood donor screening system.
1. Have you read and do you understand the required
I information about AIDS and associated risk factors? Do ~ -
I you understand the blood donation process?
I 2. Axe you 17 years of age or older?
3. Are you feeling well today?
4. Do you have active allergy, cold or flu symptoms today7
5. Have you ever: been diagnosed as having AIDS or AIDS
related complex (ARC)?
6. Have you ever: had an AIDS (HIV) test that was positive?
7. Have you ever: used any illegal drugs (non-prescribed)
by needle, even one time?
8. Have you ever: at any time since 1977, received drugs or
money in exchange ~or sex?
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.' ~ . ' ,' ' ' '
'~
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:
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: 9. Have you ever: even one time since 1977 had sexual
contacc with another man7
10. Have you ever~ had bleeding ~endencies, clotting
disorders or hemophilia? babesiosis?
11. Have you ever: received Factor VIII (~HF), Factor IX or
other clotting factors?
12. Have you ever: engaged in sex with a person who has:
hemophilia, received Factor VIII, Factor IX, clotting
concentrates; used illegal clrugs by needle; a diagnosis
of AIDS, ARC, AIDS symptoms?
13. Have you ever: had viral hepatitis, yellow ja~ndice,
liver disease or a positive blood test for hepatitis?
Chagas' disease?
14. Have you ever: had chest pains, heart trouble, heart
surgery, or a stroke?
15. Have you ever: had any kind of cancer?
16. Have you ever: had chronic bronchitis, lung disease,
persistent cough7 shortness of breath or tuberculosis
(TB)?
17. Have you ever: had kidney disease or required dialysis?
18. Have you ever: had diabetes? insulin injections?
19. Have you ever: received human pituitary growth hormone?
taken Tegison?
20. Have you ever: had epilepsy, convulsions, seizures or
fainting spells?
21. In the Past Three Years Have you: lived or traveled
outside the U.S.?
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211~7~
` 22. In the Past Three Years Have you: had malaria, taken
antimalarial medication, lived in an area endemic for
malaria?
23. In the Past Twelve Months Have you: had surg.ery?
~¦ 24. In the Past Twelve Months Have you: had a blood
J transfusion or received blood components?
25. In the Past Twelve Months Have you: had close contact
with anyone with hepatitis (family, co-worker, friend or
~l health care profsssional)? ~:~
1 26. In the Past Twelve Months Have you: had a tattoo, ear :
1 or skin piercing, acupuncture or accidental exposure to
blood, body fluids, or needlestick?
27. In the Past Twelve Months Have you: received Hepati~is
B Immune Globulin (HBIG)?
28. In the Past Twelve Months Have you: been a sexual
partner of a prostitute? been sexually assaulted?
29. In the Past Twelve Months Have you: had or been treated .
for syphilis or gonorrhea?
30. In the Past Twelve Months Have you: been exposed or
treated for rabies? received rabies?
31. In the Past Six Months Have you: had a serious illness?
-~ 32. In the Past Six Months Have you: consulted a doctor?
33. In the Past Six Weeks Have you: been pregnant?
~ 34. In the`Past Four Weeks Have you: had any immunizations, ~:
inoculations or vaccinations? taken Accutane?
35. In the Past Four Weeks Have you: been exposed to a
communicable disease?
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i
36. In the Past Three Days Ha~e you: had dental work?
37. In the Past Three Days Have you: taken any medicine
ordered by a doctor?
38. In tha Past Three Days Have you: taken any aspirin or
products containing aspirin?
39. I believe my blood is safe for transfusion.
In general, for blood derivatives, these questions may be
derived from the American Association of Blood Banks (proposed)
, standard set, which are der.;ved from regulations of the Food and
`i Drug Administration. Examples of these questions are discussed in
, Association Bulletin of the American Association of Blood Banks,
#92-4, News Briefs, pp 5-7, November/December 1992, which is
herein incorporated by reference.
The following list contains a few examples of questions asked
in another embodiment of the system for a patient's medical
history.
~ 1. Have you ever taken medication for emotional problems?
¦ 2. Have you ever been hospitalized for emotional problems?
3. Are you sexually active?
~ 4. Has anyone in your immediate family been diagnosed or
Pl treated for breast cancer?
The specific questions asked when ~aking a medical history vary
with the purpose of taking the history. A sample medical history
is included as Appendix ~ and is herein incorporated by reference.
Fig. 12(a) shows a format of a data structure for each state
in a state machine used by processor 114 to implement the
flowcharts of Figs. 9 and 10. The state machine is stored as a
:
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211~87~
t~ .e (Fig. 12(b)) or a file in memoxy 112, where every table
entry corresponds to a state S and has the format shown in Fig.
12(a). For each state, the data s~ructure includes a name of
~! bitmap files for the graphic (field 206) and the picture of the
nurse (field 202). The data structure also includes names of
files having, respectively, the text of the question (field 204),
the label (~ield 208), and the title (field 207). The data
structure also includes a name 1202 of a file having the audio
that is to be sent to spea~er unit 103 by processor 114. The data
structure has a plurality of ~state numbers" 1204 to which control
passes depending on which button was touched by the respondent
("Yes~ No~ Don~t Xnow", ~Back~ Next~). (Skipped questions
cause control to pass to the ~'Next" screen.) In addition, the
~3l data structure has an indicator variable for whether a question
applies only to females (F), males (M) or to both sexes (B).
III. Other Embodiments
Other embodiments of the invention solicit other types of
conidential information. For example, the blood donor system
described above can be used to ask other types or confidential
questions, such as questions to screen plasma donors, questions
' relating to a medical history, employment experiencer or questions
related to eligibility for public assistance of the respondent.
All that is necessary to adapt the system for a different set of
ques~ions is to change the text files containing the questions or
change the graphics associated with the questions. In some
embodiments of ~he invention, the order of the questions changes
I depends on the responses entered. To implement this feature, the
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2 ~ 7 ~
VG 1es of state machine table of Fig. l~(b) would have ~o be
changed. The format used by the state machine would not have to
change, but could change depending on the application. For
example, if a respondent answers ~Don't Know", a next state may be
a first in a series of questions that attempt to obtain a clearer
response. In contrast, if the response to the same ~uestion is
"Yes", processor 114 may display and output to the speaker a
completely different line of questions.
Other embodiments of the invention use full motion video
instead of a static picture and graphics. For example, the static
picture of a nurse in field 302 of Fig. 3 could be replaced with a
moving picture of a nurse. In such an embodiment, full motion
video preferabiy would be achieved through use of ~icrosoft Video
for Windows, where the data required for the moving image is
stored in a file or series of files as described in the Microsoft
~ideo for Windows User's Guide available from Microsoft
Corporation, which is herein incorporated by reference.
Alternately, the picture in field 306 of Fig. 3 could be a full
motion video picture or a third window containing full motion
video could be added to a screen.
In yet another embodiment of the invention, a video camera is
added to the system of Fig. 1 (or a similar system). Processor
114 displays a screen (not shown) that asks the respondent to step
into a predetermined area and pxocessor 114 activates the video
camera to record a video record of the respondent in memory 112 or
some other storage medium. Yet another embodiment allows the
respondent to sign his or her name on monitor 101 through use of
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.x
,; ~ ~ :. ~ , .
2~L ~f~78
.~ `, .
~ . technology." Processor 114 reads respondent's signature from
touchscreen 102 and stores a graphic representation of the -
signature in a storage device. Such an embodiment could also use
a light pen as an input device.
Another embodiment solicits identification data from the
respondent. This data can be a social security number or ID
number entered by the respondent via touchscreen 102, touchpad
106, or a keyboard, or by inserting a magnetic card in a magnetic
card reader. Alternately,rthe system may assign an arbitrary ID
to the respondent and associate the ID with the respondent~s name
stored in a separate file.
In another embodiment processor 114 displays a screen showing
a medical "informed consent~ form. In this embodiment, the
respondent cannot skip the screen, but mus~ touch a button on the
screen (or some alternate input device) indicating that he has
read and understood the consent form and that he has given his
consent for the medical procedure mentioned in the form. In this
embodiment, the consent form may be too long to fit in the window,
and processor 114 scrolls the text of the consent form within the
window in response to buttons touched by the respondent. In this
embodiment, the user must scroll through the entire form before
being allowed to enter a response because it is important to be ;
able to draw an inference that the respondent has read the consent
form.
! In yet another embodiment, a processor 114 displays another
screen (similar to that of Fig. 6) that allows the respondent to
indicate whether this is the first time he has given responses to
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~ 21~ ~7~
ti questions (e.g., if he is a fir~t time blood donor). If the
respondent has never answered the questions before, processor 114
displays a series of complex questions and requires the respondent
to wait several seconds before answering. If the respondent has
seen the questions before, processor 114 displays a series of
shorter questions, and allows the respondent to answer after a
shorter period of time. This embodiment requires that the state
table of Figs. 12(a) and 12(b) indicate two transition states for
~ each button: one transition~-state for new donors and one for
`3 repeat donors.
~ In yet another embodiment, buttons 210 include a ~Pause/Play~
;i button that allows the respondent to pause and restart (play) the
two questions. Some embodiments have background music or some
type of background audio playing while waiting for a response from
the respondent. The Pause button allows the respondent to pause
the background music. Yet another embodiment of the invention
includes a keyboard as an input device. Yet another embodiment o
the invention includes a mouse or stylus that moves a cursor on a
screen as an input device. Yet another embodiment of this
invention includes a bar code or magstripe reader as an input
device.
Other embodiments of the invention store, retrieve and check
a networked central database of the names of respondents that Xave
' been deferred or that have been identified as troublesome or
- litigious patients. These embodimen~s request that the respondent
l enter their name or their ID code. If processor 114 finds the
i name or ID code in the central database, processor 114 identifies
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th~ respondent as a potentially troublesome respondent. For
example, the database could keep track of whether respondents who
have been deferred before, who have the HIV virus, who have
syphilis, malaria, or other diseases or positive results on
laboratory tests, or who have sued other doctors or hospitals. As
described above, previous responses also can be compared to
current responses as a part of the decision rule.
In another embodiment, after all the responses have been
gathered, processor 114 serds the responses to a central computer
system over a modem, where the responses are stored in a central
database.
Alternately, the central computer stores a database of
troublesome respondents. If the central computer determines that
the respondent is a potentially troublesome respondent, then a
warning signal is sent back to processor 114, and processor 114
prints or displays a warning message.
IV. Summary
The present invention solicits responses to confidential
questions and allows a respondent to select a degree of privacy
with which he feels most comfortable by allowing the respondent to
control volume of a speaker, whether audio is output through a
speaker or through a handset, whether text and graphics associated
with the question are printed on the display or not, whether a
touchscreen or a more private input device are used, and whether
responses are echoed audibly. The invention also eliminates
transcription and key entry errors and interviewer bias and makes
the system easy to update and change. The questions are presented
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i~ ~ consistent manner, and can ensure that all questions are
answered.
Other embodiment s will be apparent to those skilled in the
art from consideration of the specification and practice of the
invention disclosed herein. It is intended that the specification
and examples be considered as exemplary only, with a true scope of
the invention being indicated by the following claims.
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