WO2013098687A1

WO2013098687A1 - Selection of clinical guideline for cervical cancer

Info

Publication number: WO2013098687A1
Application number: PCT/IB2012/057181
Authority: WO
Inventors: Sarif Kumar Naik; Sanjay Jayavanth; Pallavi Vajinepalli; Payal Keswarpu
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2011-12-30
Filing date: 2012-12-11
Publication date: 2013-07-04
Also published as: RU2014131450A; BR112014015755A8; CN104025099A; BR112014015755A2; RU2647159C2

Abstract

The inventon provides for a medical instrument (200, 300, 600) comprisines a medical guideline database (218, 608) containing a set of clinical guidelines for cervical cancer. The medical instrument further comprises a memory (214) for storing machine executable instructions, wherein execution of the instructions causes a processor to: receive (100) demographic data (230) of a subject; receive (102) symptom data (232) descriptive of the subject; receive (104) screening test data (222) descriptive of the subject; select (106) a screening guideline subset (234) of the set of clinical guidelines in accordance with the demographic data, the symptom data, and the screening test data; generate (108) a colposcopic inspection request (236) using the screening guideline subset; receive (109) colposcopic data (235) acquired by a colposcope; and select (110) a colposcopic guideline subset (238) of the set of clinical guidelines in accordance with the demographic data, and the colposcope data.

Description

Selection of clinical guideline for cervical cancer

TECHNICAL FIELD

The invention relates to clinical decision support, in particular to the selection of clinical guidelines for cervical cancer. BACKGROUND OF THE INVENTION

Cervical cancer is the leading cancer in women in India. The high incidence of the disease is largely attributed to a lack of appropriate screening. Cytology based screening in the form of a Pap-smear has been effective in reducing the burden of disease in developed countries. However, this is difficult to implement in a resource limited setting such as India or China due to laboratory requirements and the need of skilled medical professionals.

There is therefore the need for cervical cancer screening tools that require fewer laboratory resources and/or skilled medical professionals.

SUMMARY OF THE INVENTION

The invention provides for a medical instrument, a method of operating a medical instrument, and a computer program product in the independent claims.

Embodiments are given in the dependent claims.

Embodiments of the invention may provide for an improved screening tool for cervical cancer by providing for a medical instrument which is operable for selecting a set of screening guideline subset from a set of clinical guidelines using patient demographic data, symptom data, and screening test data. The medical instrument is further operable for generating a colposcopic screening request using the screening guideline subset. The medical instrument is further operable for selecting a colposcopic guideline subset using at least the received colposcopic data and the patient demographic data.

A 'computer-readable storage medium' as used herein encompasses any tangible storage medium which may store instructions which are executable by a processor of a computing device. The computer-readable storage medium may be referred to as a computer-readable non-transitory storage medium. The computer-readable storage medium may also be referred to as a tangible computer readable medium. In some embodiments, a computer-readable storage medium may also be able to store data which is able to be accessed by the processor of the computing device. Examples of computer-readable storage media include, but are not limited to: a floppy disk, punched tape, punch cards, a magnetic hard disk drive, a solid state hard disk, flash memory, a USB thumb drive, Random Access Memory (RAM), Read Only Memory (ROM), an optical disk, a magneto-optical disk, and the register file of the processor. Examples of optical disks include Compact Disks (CD) and Digital Versatile Disks (DVD), for example CD-ROM, CD-RW, CD-R, DVD-ROM, DVD- RW, or DVD-R disks. The term computer readable-storage medium also refers to various types of recording media capable of being accessed by the computer device via a network or communication link. For example data may be retrieved over a modem, over the internet, or over a local area network. References to a computer-readable storage medium should be interpreted as possibly being multiple computer-readable storage mediums. Various executable components of a program or programs may be stored in different locations. The computer-readable storage medium may for instance be multiple computer-readable storage medium within the same computer system. The computer-readable storage medium may also be computer-readable storage medium distributed amongst multiple computer systems or computing devices.

'Computer memory' or 'memory' is an example of a computer-readable storage medium. Computer memory is any memory which is directly accessible to a processor. Examples of computer memory include, but are not limited to: RAM memory, registers, and register files. References to 'computer memory' or 'memory' should be interpreted as possibly being multiple memories. The memory may for instance be multiple memories within the same computer system. The memory may also be multiple memories distributed amongst multiple computer systems or computing devices.

'Computer storage' or 'storage' is an example of a computer-readable storage medium. Computer storage is any non- volatile computer-readable storage medium. Examples of computer storage include, but are not limited to: a hard disk drive, a USB thumb drive, a floppy drive, a smart card, a DVD, a CD-ROM, and a solid state hard drive. In some embodiments computer storage may also be computer memory or vice versa. References to 'computer storage' or 'storage' should be interpreted as possibly being multiple storage devices or units. The storage may for instance be multiple storage devices within the same computer system or computing device. The storage may also be multiple storages distributed amongst multiple computer systems or computing devices. A 'computing device' as used herein encompasses any device comprising a processor. A 'processor' as used herein encompasses an electronic component which is able to execute a program or machine executable instruction. References to the computing device comprising "a processor" should be interpreted as possibly containing more than one processor or processing core. The processor may for instance be a multi-core processor. A processor may also refer to a collection of processors within a single computer system or distributed amongst multiple computer systems. The term computing device should also be interpreted to possibly refer to a collection or network of computing devices each comprising a processor or processors. Many programs have their instructions performed by multiple processors that may be within the same computing device or which may even be distributed across multiple computing devices.

A 'user interface' as used herein is an interface which allows a user or operator to interact with a computer or computer system. A 'user interface' may also be referred to as a 'human interface device.' A user interface may provide information or data to the operator and/or receive information or data from the operator. A user interface may enable input from an operator to be received by the computer and may provide output to the user from the computer. In other words, the user interface may allow an operator to control or manipulate a computer and the interface may allow the computer indicate the effects of the operator's control or manipulation. The display of data or information on a display or a graphical user interface is an example of providing information to an operator. The receiving of data through a keyboard, mouse, trackball, touchpad, pointing stick, graphics tablet, joystick, gamepad, webcam, headset, gear sticks, steering wheel, pedals, wired glove, dance pad, remote control, one or more switches, one or more buttons, and accelerometer are all examples of user interface components which enable the receiving of information or data from an operator.

A 'hardware interface' as used herein encompasses an interface which enables the processor of a computer system to interact with and/or control an external computing device and/or apparatus. A hardware interface may allow a processor to send control signals or instructions to an external computing device and/or apparatus. A hardware interface may also enable a processor to exchange data with an external computing device and/or apparatus. Examples of a hardware interface include, but are not limited to: a universal serial bus, IEEE 1394 port, parallel port, IEEE 1284 port, serial port, RS-232 port, IEEE-488 port, Bluetooth connection, Wireless local area network connection, TCP/IP connection, Ethernet connection, control voltage interface, MIDI interface, analog input interface, and digital input interface.

A 'display' or 'display device' as used herein encompasses an output device or a user interface adapted for displaying images or data. A display may output visual, audio, and or tactile data. Examples of a display include, but are not limited to: a computer monitor, a television screen, a touch screen, tactile electronic display, Braille screen,

Cathode ray tube (CRT), Storage tube, Bistable display, Electronic paper, Vector display, Flat panel display, Vacuum fluorescent display (VF), Light-emitting diode (LED) displays, Electroluminescent display (ELD), Plasma display panels (PDP), Liquid crystal display (LCD), Organic light-emitting diode displays (OLED), a projector, and Head-mounted display.

A 'database' as used herein encompasses a data file or repository which contains data that may be accessed by a processor. Examples of databases are, but are not limited to: a data file, a relational database, a file system folder containing data files, and a spreadsheet file.

"Medical image data" as used herein encompasses two, three, or higher dimensional data that has been acquired using a medical imaging scanner. A medical imaging scanner is defined herein as a apparatus adapted for acquiring information about the physical structure of a patient and construct sets of two dimensional or three dimensional medical image data. Medical image data can be used to construct visualizations which are useful for diagnosis by a physician. This visualization can be performed using a computer.

Histopathology data, magnetic resonance imaging data, computer tomography data, and photonic probe data are examples of medical image data. A photonic probe as used herein encompasses a diagnostic instrument operable for detecting cancerous tissue using optical means. Photonic probe data is the data acquired by photonic probe.

As used herein, the term "colposcope" encompasses a low-power microscope with a powerful light source, which is used for magnified visual examination of the uterine cervix to help in the diagnosis of cervical cancer. In some cases, the colposcope may be a stereographic and binocular field microscope. In other cases the colposcope is a monocular microscope.

In one aspect the invention provides for a medical instrument comprising a processor for controlling the medical instrument. The medical instrument further comprises a medical guideline database containing a set of clinical guidelines for cervical cancer. The medical guideline database may for instance be implemented or stored within the medical instrument with direct access to the processor or the medical instrument may also comprise a server for serving the set of clinical guidelines on request to the processor. The medical instrument further comprises a memory for storing machine-executable instructions.

Execution of the instructions causes the processor to receive demographic data of a subject. The demographic data is data which is descriptive of the subject. This demographic data may for instance include personal and/or medical information about the subject. Execution of the instructions further causes the processor to receive symptom data descriptive of the subject. The symptom data as used herein encompasses data which is descriptive of a medical condition of the subject. Execution of the instructions further causes the processor to receive screening test data descriptive of the subject. Screening test data as used herein encompasses the results of a medical diagnostic test. For instance the screening test data may be, but is not limited to the results of a Pap-smear or Papanicolaou test. Execution of the instructions further causes the processor to select a screening guideline subset of the set of clinical guidelines in accordance with demographic data, the symptom data, and the screening test data. The medical instrument is able to automatically select guidelines from the set of clinical guidelines which are relevant to the subject's current medical condition. The demographic data, the symptom data, and the screening data are used to select the screening guideline subset.

Execution of the instructions further causes the processor to generate a colposcopic inspection request using the screening guideline subset. For instance the screening guideline subset may contain a recommendation for colposcopic inspection of the cervix. This may be used to generate the colposcopic inspection request. Execution of the instructions further causes the processor to receive colposcopic data acquired by the colposcope. A request is generated for the colposcopic data and then the colposcopic data is acquired by a colposcope. Execution of the instructions further causes the processor to select a colposcopic guideline subset of the set of clinical guidelines in accordance with the demographic data and the colposcope data.

The colposcopic guideline subset are the clinical guidelines relevant to the patient's particular demographic data and the results of a colposcopic examination. This embodiment of the invention may be beneficial because the demographic data and the clinical guidelines are brought together for use when screening a subject for cervical cancer.

The invention may be of benefit when screening subjects for cervical cancer and later examining them with a colposcope. In another embodiment execution of the instructions cause the processor to display the screening guideline subset on a display. This may be beneficial for physicians and also for other healthcare providers such as nurses or midwives. The display of the screening guideline subset may help to direct the choices or actions of the physician.

In another embodiment execution of the instructions further cause the processor to send the screening guideline subset directly to the colposcope.

In another embodiment execution of the instructions are divided into separate locations. For instance the computer of the colposcope and where the symptom data is received may be separate units. In some embodiments the patient demographics are retrieved or received when both selecting the screening guideline subset and when selection the colposcopic guideline subset.

In another embodiment the medical instrument comprises the colposcope. This may be particularly beneficial because the screening of the subject can be managed by the healthcare provider operating the colposcope. In another embodiment the medical instrument is at least partially implemented on the computer of the colposcope.

In another embodiment execution of the instructions cause the processor to generate colposcopic procedure instructions using the colposcopic inspection request.

Execution of the instructions further causes the processor to display the colposcopic procedure instructions on a display before receiving the colposcopic data. This embodiment may be beneficial because it may provide instructions on providing the proper colposcopic procedure. This may be particularly useful when there is a shortage of qualified medical personnel.

In another embodiment execution of the instructions further cause the processor to display the screening guideline subset on a display.

In another embodiment execution of the instructions further cause the processor to place the screening guideline subset into a patient database.

In another embodiment the symptom data is received via a user interface. For instance a physician or healthcare provider could enter the symptom data.

In another embodiment the symptom data is received from a computer system or database. In this case the symptom data could be provided by for instance a remote patient monitoring system.

In another embodiment the demographic data is received from a patient database. In another embodiment the demographic data received is from a patient database.

In another embodiment the demographic data is received from a physician. For instance a physician may type data into a computer user interface.

In another embodiment the demographic data is placed into a patient database.

In another embodiment the medical instrument comprises a patient database. The demographic data received from the patient database may be placed into a patient database for later use.

In another embodiment the instrument comprises a patient database. The demographic data may be received from a patient database. For instance the patient database may be provided by a server.

In another embodiment execution of the instructions cause the processor to schedule a follow-up procedure using the screening guideline subset.

In another embodiment execution of the instructions cause the processor to generate a set of recommendations using the screening guideline subset.

In another embodiment execution of the instructions cause the processor to generate a set of colposcopic test orders from the set of recommendations.

In another embodiment the screening test data includes results of a Pap-smear.

In another embodiment the medical instrument further comprises a medical evidence database containing a set of scientific studies of cervical cancer. Execution of the instructions further causes the processor to detect a screening subset selection stoppage. A screening subset selection stoppage as used herein is a lack of the medical instrument to select a screening guideline subset. This may for instance happen when there is insufficient data to select the screening guideline subset or when critical guidelines which are appropriate are not available.

In another embodiment execution of the instructions further cause the processor to select a screening scientific study subset from the set of scientific studies of cervical cancer if a screening subset selection stoppage is detected. The colposcopic inspection request is generated at least partially using the screening scientific study subset.

In another embodiment execution of the instructions cause the processor to display the screening scientific subset on a display and/or provide the screening scientific subset to a healthcare provider. In another embodiment execution of the instructions further cause the processor to generate a set of test orders from the screening scientific study subset using an artificial intelligence module. An artificial intelligence module may for instance be an expert system and/or a neural network. The set of test orders may comprise a request for specific diagnostic tests to be performed on the subject.

In another embodiment the medical instrument further comprises a case study database containing a set of cervical cancer case studies. A case study as used herein is data descriptive of a particular case history of a patient afflicted with cervical cancer. The case studies may be useful in guiding the actions of a physician or healthcare provider if the situations and prognosis of the patient in the case study and the subject are similar. Execution of the instructions further causes the processor to detect a screening scientific study subset selection stoppage. A screening scientific study subset selection stoppage is a lack of the scientific instrument to properly select a screening scientific study subset. This may for instance happen when there is insufficient data to select the screening scientific study subset or when guidelines which are appropriate are not available. Execution of the instructions further causes the processor to select a screening case study subset from the set of cervical cancer case studies if a screening subset selection stoppage is detected.

The colposcopic inspection request is generated at least partially using the screening case study subset. The embodiment may be useful if it is not possible to select medical guidelines or scientific studies which are relevant to the prognosis of the subject. The colposcopic inspection request is generated at least partially using the screening case study subset.

In another embodiment the screening scientific study subset selection stoppage is performed if the screening subset selection stoppage is detected. That is to say in some embodiments the selection of a screening scientific study subset may not be performed and instead the selection of a screening case study subset is performed directly.

In another embodiment the colposcopic guideline subset may also be selected at least partially using the screening test data.

In another embodiment the colposcopic data comprises an image descriptive o f the subj ect ' s cervix .

In another embodiment execution of the instructions further cause the processor to display the colposcopic guideline subset on a display.

In another embodiment execution of the instructions further cause the processor to place the colposcopic guideline subset into the patient database. In another embodiment execution of the instructions further cause the processor to schedule a follow-up procedure using the colposcopic guideline subset.

In another embodiment execution of the instructions further cause the processor to generate a set of recommendations using the colposcopic guideline subset.

In another embodiment execution of the instructions further cause the processor to generate a medical imaging test order from the set of recommendations.

In another embodiment execution of the instructions further cause the processor to generate a diagnosis using the colposcopic guideline subset.

In another embodiment execution of the instructions further cause the processor to generate a medical image request using the colposcopic guideline subset. The medical image request may comprise a request for medical imaging performed by a medical imaging apparatus. Examples of medical imaging apparatus include but are not limited to, a magnetic resonance imaging system, a computer tomography system, and diagnostic ultrasound.

In another embodiment execution of the instructions further cause the processor to receive medical image data descriptive of the subject. Execution of the instructions further causes the processor to select a medical image subset of the set of clinical guidelines in accordance with the medical image data. The medical image data may be used to select the set of clinical guidelines which are relevant. This for instance may be performed by an expert system and/or a neural network system.

In another embodiment the medical image subset may also be selected on the basis of the: demographic data, the symptom data, the screening test data, and/or the colposcopic data.

In another embodiment execution of the instructions further cause the processor to display the medical guideline subset on a display.

In another embodiment the medical image guideline subset is placed into the patient database.

In another embodiment execution of the instructions further cause the processor to generate a set of recommendations using the medical image subset.

In another embodiment execution of the instructions further cause the processor to detect a medical image subset selection stoppage. A medical image subset selection stoppage as used herein encompasses a lack of the system to select a medical image subset. This may for instance happen when there is insufficient data to select the medical image subset or when guidelines which are appropriate are not available. Execution of the instructions further cause the processor to select a medical image scientific study subset from the set of scientific studies of cervical cancer if a medical image subset selection stoppage is detected. This embodiment may include a set of scientific studies of cervical cancer. The selection of the medical image scientific study subset may be used as an alternative if clinical guidelines are not available or it is not clear which clinical guidelines apply.

In another embodiment execution of the instructions further cause the processor to display the medical image scientific subset on a display and/or provide the medical image scientific subset to a healthcare provider.

Execution of the instructions further causes the processor to generate a diagnosis using the medical image scientific study subset.

In another embodiment execution of the instructions further cause the processor to detect a medical image scientific study subset selection stoppage. A medical image scientific study subset selection stoppage is a lack of the system to select a medical image scientific study subset. This may for instance happen when there is insufficient data to select the medical image scientific study subset or when critical guidelines which are appropriate are not available.

Execution of the instructions further cause the processor to select a medical image case study subset from the set of cervical cancer case studies if a screening subset selection stoppage is detected. This embodiment may include a set of cervical cancer case studies.

In another embodiment the medical image scientific study subset selection stoppage is performed if the medical image subset selection stoppage is detected.

In another embodiment execution of the instructions cause the processor to generate a treatment plan using the medical image case study subset and/or the medical image scientific subset.

In another embodiment the medical image data comprises any one of the following: histopathology data, magnetic resonance imaging data, computer tomography data, photonic probe data, and combinations thereof.

In another embodiment the medical instrument further comprises a treatment plan database comprising a set of treatment plans. Execution of the instructions further cause the processor to select a treatment plan from the set of treatment plans in accordance with the medical image subset. In another embodiment the treatment plan is developed from or chosen using the medical image subset, the medical image scientific study subset, and/or the medical image case study subset.

In another embodiment execution of the instructions further cause the processor to detect a colposcopic subset selection stoppage. The colposcopic subset selection stoppage is a lack of the system to select the colposcopic guideline subset. This may for instance happen when there is insufficient data to select the colposcopic guideline subset or when critical guidelines which are appropriate are not available.

Execution of the instructions further cause the processor to select a colposcopic study subset from the set of scientific studies of cervical cancer if the colposcopic subset selection stoppage is detected. The medical imaging request is generated at least partially using a colposcopic scientific study subset. This may be advantageous because scientific studies can be used to generate data which is useful for guiding a physician if appropriate guidelines are not available.

In another embodiment execution of the instructions further cause the processor to display the colposcopic scientific subset on a display and/or provide the colposcopic scientific study subset to a healthcare provider.

In another embodiment execution of the instructions further cause the processor to detect a colposcopic scientific study subset selection stoppage. A colposcopic scientific study subset selection stoppage is a lack of the system to select a colposcopic scientific study subset. This may for instance happen when there is insufficient data to select the colposcopic scientific study subset or when critical guidelines which are appropriate are not available.

Execution of the instructions further cause the processor to select a colposcopic case study subset from the set of cervical cancer case studies if a screening subset selection stoppage is detected. The medical imaging request is generated at least partially using the colposcopic case study subset.

In another embodiment the colposcopic scientific study subset selection stoppage is performed if the colposcopic subset selection stoppage is detected.

In another aspect the invention provides for a method of operating a medical instrument. The medical instrument comprises a medical guideline database containing a set of clinical guidelines for cervical cancer. The method comprises the step of receiving demographic data of a subject. The method further comprises the step of receiving symptom data descriptive of the subject. The method further comprises the step of receiving screening test data descriptive of the subject. The method further comprises the step of selecting the screening guideline subset of the set of clinical guidelines in accordance with the

demographic data, the symptom data, and the screening test data. The method further comprises the step of generating a colposcopic inspection request using the screening guideline subset. The method further comprises the step of receiving colposcopic data acquired by a colposcope. The method further comprises the step of selecting a colposcopic guideline subset of the set of clinical guidelines in accordance with the demographic data and the colposcope data.

In another aspect the invention provides for a computer program product comprising machine-executable instructions for a processor controlling the medical instrument. The machine executable-instructions may be stored on a non-transitory computer readable storage medium. The medical instrument comprises a medical guideline database containing the set of clinical guidelines for cervical cancer. Execution of the instructions causes the processor to receive demographic data of a subject. Execution of the instructions further causes the processor to receive symptom data descriptive of the subject. Execution of the instructions further causes the processor to receive screening test data descriptive of the subject. Execution of the instructions further cause the processor to select a screening guideline subset of the set of clinical guidelines in accordance with the demographic data, the symptom data, and the screening test data. Execution of the instructions further causes the processor to generate a colposcopic inspection request using the screening guideline subset. Execution of the instructions further causes the processor to receive colposcopic data acquired by a colposcope. Execution of the instructions further causes the processor to select a colposcopic guideline subset of the set of clinical guidelines in accordance with the demographic data, and the colposcope data.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following preferred embodiments of the invention will be described, by way of example only, and with reference to the drawings in which:

Fig.1 shows a flow diagram which illustrates a method according to an embodiment of the invention;

Fig.2 illustrates an example of a medical instrument according to an embodiment of the invention;

Fig. 3 shows an example of a medical instrument according to a further embodiment of the invention; Fig. 4 shows a functional diagram of a clinical decision support solution implemented by an embodiment of the invention;

Fig. 5 shows a flow diagram which illustrates the building blocks of a clinical decision support system; and

Fig. 6 illustrates an example of a medical instrument according to a further embodiment of the invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Like numbered elements in these figures are either equivalent elements or perform the same function. Elements which have been discussed previously will not necessarily be discussed in later figures if the function is equivalent.

Fig. 1 shows a flow diagram which illustrates a method according to an embodiment of the invention. First in step 100 demographic data is received from a subject. Next in step 102 symptom data descriptive of the subject is received. Then in step 104 screening test data descriptive of the subject is received. In step 106 a screening guideline subset is selected from a set of clinical guidelines in accordance with the demographic data, the symptom data, and the screening test data. Next in step 108 a colposcopic inspection request is generated using the screening guidance subset. In step 109 colposcopic data acquired by a colposcope is received. And finally in step 110 a colposcopic subset of the clinical guidelines is selected using the demographic data and the colposcope data.

Fig. 2 shows an example of a medical instrument 200 according to an embodiment of the invention. The medical instrument 200 comprises a computer 202. The computer 202 comprises a processor 204 which is connected to a hardware interface 206, a user interface 210, computer storage 212, and computer memory 214. The hardware interface 206 is optionally connected to a colposcope 208. The computer 202 is shown as being connected to a server 216 which via network or other connection is able to serve the contents of a medical guideline database 218 to the processor 204. The computer 202 is further shown as being connected to an analytical instrument 220. The analytical instrument 220 is able to provide screening test data 222. The screening test data 222 may be the test results of a medical test performed on a sample of the subject.

The computer storage 212 is shown as containing a screening test data 222 that is received from the analytical instrument 220. The computer storage 212 is further shown as containing demographic data 230. In some instances the demographic data 230 may be received from another server which contains a patient or medical record database. The computer storage 212 is further shown as containing symptom data 232. The symptom data 232 may also be obtained from an external database or may also in some embodiments be received from the user interface 210. For instance a physician or other healthcare provider could enter the symptom data.

The computer storage 212 is further shown as containing a screening guideline subset. The screening guideline subset is a set of medical guidelines selected from the medical guideline database 218. The computer storage 212 is further shown as containing a colposcopic inspection request. The colposcopic inspection request 236 is generated in accordance with the screening guideline subset 234. The computer storage 212 is further shown as containing a colposcopic guideline subset 238. The colposcopic guideline subset 238 is a set of medical guidelines selected from the medical guideline database 218 in accordance with the results of the colposcopic data 235.

The computer memory 214 is shown as containing a control module. The control module comprises computer-executable code for controlling the operation and function of the medical instrument 200. The computer memory 214 is further shown as containing a screening guideline subset selection module 242. The screening guideline subset selection module 242 comprises computer-executable code for selecting the screening guideline subset from the symptom data 232, the demographic data 230, and the screening test data 222. The screening guideline subset selection module may for instance be an expert system, and/or a neural network system. The computer memory 214 is further shown as containing a colposcopic inspection request generation module. The colposcopic inspection request generation module 242 comprises computer-executable code for generating a colposcopic inspection request 236 from the screening guideline subset 234. The computer memory 214 is further shown as containing a colposcopic guideline subset selection module 246. The colposcopic guideline subset selection module 246 comprises computer-executable code for selecting the colposcopic guideline subset 238 using the demographic data 230 and the colposcopic data 235.

Fig. 3 shows an embodiment of a medical instrument 300 according to the invention. The embodiment shown in Fig. 3 is similar to that shown in Fig. 2. In addition to the features shown in Fig. 2 the embodiment shown in Fig. 3 the computer 202 is connected to a server 302 which is adapted for serving a medical evidence database 304 to the processor 204. The computer 202 is further connected to a server 306 which is configured for serving a medical case study database to the processor 204. The computer 202 is further connected to a server 307 which is configured for serving a treatment plan database 309 to the processor 204.

The computer storage 212 is further shown as containing colposcopic instructions 310. The colposcopic instructions 310 are instructions which can be displayed using a user interface such as user interface 210. For instance the computer storage 212 is further shown as containing a medical imaging request 312. The computer storage 212 is further shown as containing medical image data 314. The computer storage 212 is further shown as containing a medical image subset 316 of medical guidelines selected from the medical guideline database 218. The computer storage 212 is further shown as containing a treatment plan 318.

The computer memory is further shown as containing a colposcopic instruction module 330. The colposcopic instruction module 330 comprises computer- executable code for generating the colposcopic instructions 310 using the colposcopic inspection request 236.

The computer memory 214 is further shown as containing a medical imaging request module 332. The medical imaging request module 332 comprises computer- executable code for generating the medical imaging request 312 using the colposcopic guideline subset 238. The computer storage 214 is shown as further containing a medical imaging subset selection module 334. The medical imaging subset selection module 334 comprises computer-executable code which enables the processor 204 to generate the medical imaging subset of the guidelines using the medical image data 314 and the guideline database 218. The computer memory 214 is further shown as containing a treatment plan selection module 336. The treatment plan selection module 336 comprises computer- executable code which enables the processor to select the treatment plan 318 from the treatment plan database 309 and the medical image subset 316. The computer memory is further shown as containing a scientific study selection module 338 and a case study selection module 340. The scientific study selection module 338 is computer-executable code which enables the processor 204 to examine the medical evidence database 304 and generate replacements for medical guidelines. The computer memory 214 is shown as also containing the case study selection module 340 which comprises computer-executable code and enables the processor 204 to use the medical case study database also for replacing medical guidelines which are not available.

Fig. 4 shows a functional diagram of a clinical decision support solution implemented by an embodiment of the invention. The clinical decision support solution is used in several different levels or steps of the system. In general the clinical decision support system may go through the following steps: it may acquire data 400, analyze the data 402, interpret the data 404, and finally present data 406 for use by a healthcare professional. In the acquisition step 400 various data is collected. In step 402, content-based information retrieval is performed on demographics, symptoms and signs. Next during the interpretation clinical guidelines and/or evidence-based reasoning is used. And finally in presenting the data 406 recommendations, follow-ups, scheduling, reminders, and counseling suggestions are presented.

An embodiment of the invention, such as an implementation of Fig. 4, may provide a simple and swift on the spot screening test based on cervical cytology. This may be achieved through automatic sample preparation and machine intelligence for automatic identification of cells. However, many clinical conditions can give rise to similar

morphological features on cervical cytology. This results in varied sensitivity and specificity of the tests. In the later stage of the work-flow, colposcopic examination and/or biopsy may be required which also suffers from similar challenges.

With the increasing incidence of cervical cancer and the growing need for optimized therapy, there is a need for systems that speed up the workflow, while also providing care giver the additional checks to improve screening diagnostic and therapeutic quality. Therefore, an integrated Clinical Decision Support (CDS) system independently or incorporated into a medical instrument for providing guidance to different care givers at different stages of the care to avoid erroneous diagnosis and treatment may be a solution to the aforementioned problem.

As mentioned before, cervical cancer is the most prevalent cancer for women in India. For successful management of cervical cancer, it may be beneficial if systematic data acquisition archiving (from several modalities like, Pap-smear, HPV, colposcopes,

Genomic information VIA , Brachy MRI, etc), analysis, and presentation of data in a unified and intuitive manner to support the clinician in taking right decision to treat and follow up the patient effectively. In this disclosure an integrated clinical decision support system has been proposed to overcome the challenges faced in the current set-up. Embodiments of the invention may provide a system which; collects data, enables its query, simulates case studies, and provides assisted interpretation. The system may also provide assistance in following a patient, generate reminders, and enable therapy planning, and execution in combination with the clinical guidelines. In some embodiments, an after screening test is performed either in the form of cervical cytology or HPV test or visual examination. There are guidelines to decide on the next step of action for each individual case (e.g. ASCCP 2006 guidelines).

Even a subject with negative test result should have examinations at a certain interval for repeat testing. This may require an efficient recall mechanism. If there is a large patient population and there are scarce medical resources it is beneficial if the system is very efficient. Similarly, clinical guidelines exist for guiding decisions after colposcopy and treatment procedures. These options are dependent on the age of the women, parity status, clinical stage, co-morbidity conditions, and etc. These variables make the guidelines very specific to a particular case and also difficult to remember by the clinician.

The unavailability of skilled clinicians at various stages of care may lead to erroneous diagnosis of the disease, which is a missed opportunity to cure cervical cancer. This further leads to an increased number of cervical cancer cases therefore an increase in cervical cancer burden. Accurate interpretation is required at each stage of care which also depends on the inference drawn at previous stages in the work flow. Since at each stage of care there are different stakeholders, there are chances of erroneous diagnosis due to loss of information or inadequate information.

Embodiments of the invention may not only maintain patient information of isolated medical episodes at different stages but also streamline the workflow and provide clinical decision support. Thus it may increases the accuracy and robustness of the cervical cancer care.

Embodiments of the invention may provide an integrated cervical cancer care solution. This CDS solution may be based on one or more of the following: the patient demographics; signs and symptoms; clinical interpretation from VI/VLAVIAM and/or HPV; morphological features derived from cytology images taken from a Pap-smear test; clinical observations derived from colposcopy images; clinical interpretation from other imaging modalities like computed tomography (CT) or magnetic resonance imaging (MRI), and clinical observations from biopsy. This may be performed while providing guidance on the appropriate next steps of action using available clinical guidelines as evidence based medicine. Fig. 4 shows the building blocks of one embodiment of a CDS solution.

Fig. 5 shows a flow diagram which illustrates the building blocks of a clinical decision support system. In block 500 there is data acquisition. This may include patient demographics, signs, symptoms, clinical information from screening and/or diagnostics and/or imaging modalities. The next step is block 502 which is a clinical decision support engine. This may be based on clinical guidelines and/or clinical evidences. And finally block 504 is the data presentation. The data presentation may include recommendations, follow-up procedures, scheduling, reminders, counseling and/or planning data which can be presented to a healthcare provider.

In some embodiments the data acquisition module takes different types of information like: patient demographics, signs and symptoms (textual information), and screening and diagnosis results (image/video information).

In some embodiments the CDS engine processes the information using evidence based reasoning and multiple clinical guidelines (IFCPC, NCCN, ASCCP etc.) that are incorporated in it.

In some embodiments the data presentation module provides

recommendations, counseling, treatment planning, reminders, and etc.

In some embodiment, there is a dual step CDS engine which provides recommendations at two different levels, i.e., screening and diagnosis. In some embodiments the CDS engine has a guideline execution engine and an evidence execution engine.

In some embodiments similar cases are presented to the user when guidelines or evidences are absent.

In some embodiments the proposed CDS system is tightly coupled with the cervical cancer care work flow.

A detailed block diagram of an embodiment of a CDS system is shown in Fig. 6. This system is tightly integrated with the workflow of cervical cancer care. Fig. 6 shows an example of a medical instrument 600 or clinical decision support system according to an embodiment of the invention. The clinical decision support system shown in Fig. 6 has a first CDS engine 602, a second CDS engine 604, and a third CDS engine 606. Each of the clinical decision support engines 602, 604, 606 is connected to a clinical decision support database 608 and a patient demographic database 610. The clinical decision support database 608 may provide such things as clinical guidelines, clinical guidelines for cervical cancer, a set of scientific studies of cervical cancer, and a case study database containing a set of cervical cancer case studies.

The first clinical decision support engine 602 receives screening test data 612. The clinical decision engine 1 602 uses the screening test data 612 and information from the clinical decision support database 608 and the patient demographic database 610 to generate an interpretation and recommendations 614. These recommendations may include scheduling or re-screening the subject 616 or it may require having a colposcopic examination. If this is the case then colposcopic findings 618 are then input to a clinical decision support engine 2 604. The clinical decision support engine 2 604 uses the databases 608 and 610 to produce grating and biopsy guiding 620. Biopsy results 622 are then fed into clinical decision support engine 3 604 which then uses the patient demographics 610 and/or the clinical guideline database 608 along with magnetic resonance imaging images 624 and NCCN and/or ICMR guidelines 626 to generate a treatment plan 628. After treatment 628 the system 600 may provide recommendations 630 and/or schedule follow-up examinations of the subject.

In some embodiments the patient demographics, chief complaints, signs and symptoms are inputs for both the CDS engines.

Patient Demographics may include the age of the patient, her menstrual history, her sexual history and whether she has already reached menopause.

The signs and symptoms may include presence of any kind of discharge. If there is any discharge, then it may be described as: curdy white discharge, discharge with greenish foul smelling, bloody discharge and ulcer, and etc.

CDS engine 1 may provided inputs from screening modalities like a Pap- smear analysis (which includes normal, candidasis, trichomonas vaginalis, inflammatory, reactive, ASCUS, LSIL, HSIL, SCC and HPV), and VIA.

CDS engine 2 may takes input on the severity of cancer from diagnostic modalities like colposcopes. The inputs include aceto-white index, presence of mosaic, punctuations and atypical vessels. The inputs could be manually entered to the system or could be automatically extracted.

In some embodiments the CDS engine 1 and engine 2 are independent engines. Each engine has two components: guideline execution engine and evidence execution engines.

In this embodiment, the guideline execution engine executes guideline steps based on patient data and screening and/or diagnosis modalities inputs. The guidelines are executed using GLIF/ GLEE. It internalizes all information that is required for clinical decision support. It is specific to a given clinical guideline, which means that if multiple guidelines are adopted, these will be executed as distinct back-end modules interacting with common patient information. Each guideline execution engine has a "normal" as well as a "restricted" mode of operation, where the latter signifies the situation that the guideline pertains to an aspect that is peripheral to the current clinical episode. The choice of deciding the mode of operation of a given guideline is left to the clinician. In some embodiments an evidence execution engine initializes when the guidelines are fuzzy or not unavailable for decision making. Evidences are incorporated into the decision making using available medical databases. The evidence execution engine may also provide similar cases when neither guidelines nor evidence is present.

CDS engine 1 compiles input from patient demographics data and screening test data in accordance to clinical guidelines and evidence based reasoning to interpret. Based on the guideline's interpretation it generates a set of recommendation such as the need for follow-up (when, what, and etc.) or the need for further diagnostics test such as colposcopy. If the recommendation is for further colposcopic examination, CDS engine 2 may be activated which takes inputs from the colposcopic examinations. This engine again compiles the results from the colposcopic examination and patient demographic data in accordance to the guidelines to grade the severity of cancer and recommend further tests and/or biopsy.

After diagnosis is established by colposcopy, biopsy and staging of disease may be done through histopathology, MRI, and/or CT imaging. A treatment plan based on NCCN or ICMR guidelines are then followed. These also take into consideration the patient demographics, co-morbid conditions etc making it a complex decision making process where many specialties of medicine are involved. CDS engine 3 may utilize this information from various sources, as listed, above to suggest appropriate treatment and follow-up options based on guidelines, evidence based medicine.

While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments.

Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measured cannot be used to advantage. A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems. Any reference signs in the claims should not be construed as limiting the scope. LIST OF REFERENCE NUMERALS

200 medical instrument

202 computer

204 processor

206 hardware interface

208 colposcope

210 user interface

212 computer storage

214 computer memory

216 server

218 medical guideline database

220 analytical instrument

222 screening test data

230 demographic data

232 symptom data

234 screening guideline subset

236 colposcopic inspection request

235 colposcopic data

238 colposcopic guideline subset

240 control module

242 screening guideline subset selection module

244 colposcopic inspection request generation module

246 colposcopic guideline subset selection module

300 medical instrument

302 server

304 medical evidence database

306 server

307 server

308 medical case study database

309 treatment plan database

310 colposcopic instructions

312 medical imaging request

314 medical image data

316 medical image subset 318 treatment plan

330 colposcopic instructions module 332 medical imaging request module 334 medical imaging subset selection module 336 treatment plan selection module

338 scientific study selection module 340 case study selection module

600 medical instrument

602 clinical decision support engine 1 604 clinical decision support engine 2 606 clinical decision support engine 3 608 clinical decision support database 610 patient demographic database

612 screening test data

614 interpretations and recommendations 616 schedule rescreening

618 colposcopy findings

620 grading and biopsy guiding

622 biopsy

624 MR and CT imaging

626 NCCN and ICMR guideline

628 treatment

630 recommendations and/or follow-ups

25

Claims

CLAIMS:

1. A medical instrument (200, 300, 600) comprising:

- a processor (204) for controlling the medical instrument;

- a medical guideline database (218, 608) containing a set of clinical guidelines for cervical cancer;

- a memory (214) for storing machine executable instructions, wherein execution of the instructions causes the processor to:

- receive (100) demographic data (230) of a subject;

- receive (102) symptom data (232) descriptive of the subject;

- receive (104) screening test data (222) descriptive of the subject;

- select (106) a screening guideline subset (234) of the set of clinical guidelines in accordance with the demographic data, the symptom data, and the screening test data;

- generate (108) a colposcopic inspection request (236) using the screening guideline subset;

- receive (109) colposcopic data (235) acquired by a colposcope; and

- select (110) a colposcopic guideline subset (238) of the set of clinical guidelines in accordance with the demographic data, and the colposcope data.

2. The medical instrument of any one of the preceding claims, wherein the medical instrument comprises the colposcope (208).

3. The medical instrument of claim 2, wherein execution of the instructions further cause the processor to:

- generate colposcopic procedure instructions (310) using the colposcopic inspection request; and

- display the colposcopic procedure instructions on a display (210) before receiving the colposcopic data.

4. The medical instrument of claim 1, 2 or 3, wherein the medical instrument further comprises a medical evidence database (304) containing a set of scientific studies of cervical cancer, wherein execution of the instructions further causes the processor to:

- detect a screening subset selection stoppage;

- select a screening scientific study subset from the set of scientific studies of cervical cancer if a screening subset selection stoppage is detected, wherein the colposcopic inspection request is generated at least partially using the screening scientific study subset.

5. The medical instrument of claim 4, wherein The medical instrument of claim 1, wherein the medical instrument further comprises a case study database (308) containing a set of cervical cancer case studies, wherein execution of the instructions further causes the processor to:

- detect a screening scientific study subset selection stoppage; and

- select a screening case study subset from the set of cervical cancer case studies if a screening subset selection stoppage is detected, wherein the colposcopic inspection request is generated at least partially using the screening case study subset.

6. The medical instrument of any one of the preceding claims, wherein execution of the instructions further causes the processor to generate a medical imaging request using the colposcopic guideline subset.

7. The medical instrument of claim 6, wherein the medical instrument further comprises a medical evidence database (304) containing a set of scientific studies of cervical cancer, wherein execution of the instructions further causes the processor to:

- detect a colposcopic subset selection stoppage; and

- select a colposcopic scientific study subset from the set of scientific studies of cervical cancer if the colposcopic subset selection stoppage is detected, wherein the medical imaging request is generated at least partially using the colposcopic scientific study subset.

8. The medical instrument of claim 7, wherein the medical instrument further comprises a case study database (308) containing a set of cervical cancer case studies, wherein execution of the instructions further causes the processor to:

- detect a colposcopic scientific study subset selection stoppage; and - select a colposcopic case study subset from the set of cervical cancer case studies if a screening subset selection stoppage is detected, wherein the medical imaging request is generated at least partially using the colposcopic case study subset.

9. The medical instrument of claim 6, 7, or 8, wherein execution of the instructions further causes the processor to:

- receive medical image data (624) descriptive of the subject;

- select a medical image subset (316) of the set of clinical guidelines in accordance with the medical image data.

10. The medical instrument of claim 9, wherein the medical instrument further comprises a medical evidence database (304) containing a set of scientific studies of cervical cancer, wherein execution of the instructions further causes the processor to:

- detect a medical image subset selection stoppage; and

- select a medical image scientific study subset from the set of scientific studies of cervical cancer if a medical image subset selection stoppage is detected.

11. The medical instrument of claim 10, wherein the medical instrument further comprises a case study database (308) containing a set of cervical cancer case studies, wherein execution of the instructions further causes the processor to:

- detect a medical image scientific study subset selection stoppage; and

- select a medical image case study subset from the set of cervical cancer case studies if a screening subset selection stoppage is detected.

12. The medical instrument of claim 9, 10, or 11, wherein the medical image data comprises any one of the following: histopathology data, magnetic resonance imaging data, computed tomography data, photonic probe data, and combinations thereof.

13. The medical instrument of any one of claims 9 though 12, wherein the medical instrument further comprises a treatment plan database comprising a set of treatment plans, wherein execution of the instructions causes the processor to select a treatment plan from the set of treatment plans in accordance with the medical image subset.

14. A method of operaing a medical instrument (200, 300, 600), wherein the medical instrument comprises a medical guideline database (218, 608) containing a set of clinical guidelines for cervical cancer, the method comprising the steps of:

- receiving (100) demographic data (230) of a subject;

- receiving (102) symptom data (232) descriptive of the subject;

- receiving (104) screening test data (222) descriptive of the subject;

- selecting (106) a screening guideline subset (234) of the set of clinical guidelines in accordance with the demographic data, the symptom data, and the screening test data;

- generating (108) a colposcopic inspection request (236) using the screening guideline subset;

- receiving (109) colposcopic data (235) acquired by a colposcope; and

- selecting (110) a colposcopic guideline subset (238) of the set of clinical guidelines in accordance with the demographic data, and the colposcope data; 15. A computer program product comprising machine executable instructions (240, 242, 244, 246, 330, 332, 334, 336, 338, 340) for a processor (204) controlling a medical instrument (200, 300, 600), wherein the medical insturment comprises a medical guideline database (218, 608) containing a set of clinical guidelines for cervical cancer ,wherein execution of the instructions causes the processor to:

- receive (100) demographic data (230) of a subject;

- receive (102) symptom data (232) descriptive of the subject;

- receive (104) screening test data (222) descriptive of the subject;

- receive (109) colposcopic data (235) acquired by a colposcope; and